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What happens when you take a reassuring whiff of your where to buy ventolin online morning coffee or recoil in horror when you sniff the cream and ventolin substitute realize itâs gone bad?. Your nose is loaded with special cells called "olfactory sensory neurons," and each of these neurons has one (and only one) odor receptor. When many molecules in the air around you stimulates one of these odor receptors, it sends a message directly to the brain, explains Justin Turner, otolaryngologist and director of the where to buy ventolin online Smell and Taste Center at Vanderbilt University.

Then your brain quickly identifies the scent and says, "Ah yes, thatâs spoiled milk. Put it down now!. "But despite the occasional spoiled milk or gas leak, modern humans donât depend too much on smell to find food where to buy ventolin online or to take care of other living necessities, explains Turner.

Thatâs likely why our sense of smell isnât as keen as many other animals.That doesnât mean we canât depend on it, however. Super SmellersThere is a great deal of variability in normal olfactory acuity, says Turner. And most of that comes down to genetics (women typically have higher smell acuity than men) or anatomy, such as a deviated where to buy ventolin online septum.

Temporary conditions (inflamed sinuses, for example) can dampen your sense of smell. In addition, smell acuity lessens as we age.Some where to buy ventolin online people, however, are super smellers. Hyperosmia is a rare condition in which the sense of smell is super-charged.

Because itâs so rare, scientists donât know much about the condition. Some illnesses, where to buy ventolin online such as migraines, are associated with hyperosmia. While some of us are better smellers than others, most of us are better at it than we might realize.

In a 2017 review of the literature, John McGann found that humans are about as average as mammals when it comes to the sense of smell. Humans can follow a scent trail where to buy ventolin online with an ability that might give bloodhounds pause, describes McGann in an interview with the journal Science about this paper. McGann is a neuroscientist who studies how the brain processes sensory input.

(Here is an entertaining video of the experiment.) Muscles at WorkStill, most of us could probably do better in the day-to-day use of our sense of smell. Lacking some pathology or abnormal structure, much of our ability to where to buy ventolin online smell comes down to habit and practice. "If youâre a sommelier and you focus your efforts into smelling wine, then your brain puts extra effort into smelling wine," says Turner.

In other words, if you try, you can train your brain to recognize smells â you can build your "smell muscles," so to speak where to buy ventolin online. Turner and the other doctors at Vanderbiltâs Smell and Taste Center use this fact to help people whoâve lost their sense of smell due to asthma treatment, or some other reason. The method is called olfactory retraining.

The patient sniffs different scents or where to buy ventolin online odors a couple of times a day for several months. "The idea here is that youâre constantly stimulating those olfactory neurons and stimulating the brain and its processing power," explains Turner.Even if you havenât lost your sense of smell, you can use a similar technique to improve it. In other words, practice.

"A good example where to buy ventolin online is a fragrance expert," says Turner. "These people get paid lots of money to identify fragrances and identify pleasurable smells that will go well together. To be able to do this, they practice, sometimes for years." If you want a better sense of smell, the next time you stop to smell the roses, pay attention..

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AbstractIntroduction http://www.soilplus.ro/member/mary-frampton/ ventolin pl. We report a very rare case of familial breast cancer and diffuse gastric cancer, with germline pathogenic variants in both BRCA1 and CDH1 genes. To the best of our knowledge, this is the first ventolin pl report of such an association.Family description. The proband is a woman diagnosed with breast cancer at the age of 52 years. She requested ventolin pl genetic counselling in 2012, at the age of 91 years, because of a history of breast cancer in her daughter, her sister, her niece and her paternal grandmother and was therefore concerned about her relatives.

Her sister and maternal aunt also had gastric cancer. She was tested for several genes associated with ventolin pl hereditary breast cancer.Results. A large deletion of BRCA1 from exons 1 to 7 and two CDH1 pathogenic cis variants were identified.Conclusion. This complex situation is challenging ventolin pl for genetic counselling and management of at-risk individuals.cancer. Breastcancer.

Gastricclinical geneticsgenetic screening/counsellingmolecular geneticsIntroductionGLI-Kruppel family member 3 (GLI3) encodes for a zinc finger transcription factor which plays a key role in the sonic hedgehog (SHH) signalling pathway essential in both limb and craniofacial development.1 2 In hand development, SHH is expressed in the zone of polarising activity (ZPA) on the posterior side of the ventolin pl handplate. The ZPA expresses SHH, creating a gradient of SHH from the posterior to the anterior side of the handplate. In the presence of SHH, full length GLI3-protein is produced (GLI3A), whereas absence of SHH causes cleavage of GLI3 into its repressor ventolin pl form (GLI3R).3 4 Abnormal expression of this SHH/GLI3R gradient can cause both preaxial and postaxial polydactyly.2Concordantly, pathogenic DNA variants in the GLI3 gene are known to cause multiple syndromes with craniofacial and limb involvement, such as. Acrocallosal syndrome5 (OMIM. 200990), Greig cephalopolysyndactyly ventolin pl syndrome6 (OMIM.

175700) and Pallister-Hall syndrome7 (OMIM. 146510). Also, in non-syndromic polydactyly, such as preaxial polydactyly-type 4 (PPD4, OMIM. 174700),8 pathogenic variants in GLI3 have been described. Out of these diseases, Pallister-Hall syndrome is the most distinct entity, defined by the presence of central polydactyly and hypothalamic hamartoma.9 The other GLI3 syndromes are defined by the presence of preaxial and/or postaxial polydactyly of the hand and feet with or without syndactyly (Greig syndrome, PPD4).

Also, various mild craniofacial features such as hypertelorism and macrocephaly can occur. Pallister-Hall syndrome is caused by truncating variants in the middle third of the GLI3 gene.10â12 The truncation of GLI3 causes an overexpression of GLI3R, which is believed to be the key difference between Pallister-Hall and the GLI3-mediated polydactyly syndromes.9 11 Although multiple attempts have been made, the clinical and genetic distinction between the GLI3-mediated polydactyly syndromes is less evident. This has for example led to the introduction of subGreig and the formulation of an Oro-facial-digital overlap syndrome.10 Other authors, suggested that we should not regard these diseases as separate entities, but as a spectrum of GLI3-mediated polydactyly syndromes.13Although phenotype/genotype correlation of the different syndromes has been cumbersome, clinical and animal studies do provide evidence that distinct regions within the gene, could be related to the individual anomalies contributing to these syndromes. First, case studies show isolated preaxial polydactyly is caused by both truncating and non-truncating variants throughout the GLI3 gene, whereas in isolated postaxial polydactyly cases truncating variants at the C-terminal side of the gene are observed.12 14 These results suggest two different groups of variants for preaxial and postaxial polydactyly. Second, recent animal studies suggest that posterior malformations in GLI3-mediated polydactyly syndromes are likely related to a dosage effect of GLI3R rather than due to the influence of an altered GLI3A expression.15Past attempts for phenotype/genotype correlation in GLI3-mediated polydactyly syndromes have directly related the diagnosed syndrome to the observed genotype.10â12 16 Focusing on individual hand phenotypes, such as preaxial and postaxial polydactyly and syndactyly might be more reliable because it prevents misclassification due to inconsistent use of syndrome definition.

Subsequently, latent class analysis (LCA) provides the possibility to relate a group of observed variables to a set of latent, or unmeasured, parameters and thereby identifying different subgroups in the obtained dataset.17 As a result, LCA allows us to group different phenotypes within the GLI3-mediated polydactyly syndromes and relate the most important predictors of the grouped phenotypes to the observed GLI3 variants.The aim of our study was to further investigate the correlation of the individual phenotypes to the genotypes observed in GLI3-mediated polydactyly syndromes, using LCA. Cases were obtained by both literature review and the inclusion of local clinical cases. Subsequently, we identified two subclasses of limb anomalies that relate to the underlying GLI3 variant. We provide evidence for two different phenotypic and genotypic groups with predominantly preaxial and postaxial hand and feet anomalies, and we specify those cases with a higher risk for corpus callosum anomalies.MethodsLiterature reviewThe Human Gene Mutation Database (HGMD Professional 2019) was reviewed to identify known pathogenic variants in GLI3 and corresponding phenotypes.18 All references were obtained and cases were included when they were diagnosed with either Greig or subGreig syndrome or PPD4.10â12 Pallister-Hall syndrome and acrocallosal syndrome were excluded because both are regarded distinct syndromes and rather defined by the presence of the non-hand anomalies, than the presence of preaxial or postaxial polydactyly.13 19 Isolated preaxial or postaxial polydactyly were excluded for two reasons. The phenotype/genotype correlations are better understood and both anomalies can occur sporadically which could introduce falsely assumed pathogenic GLI3 variants in the analysis.

Additionally, cases were excluded when case-specific phenotypic or genotypic information was not reported or if these two could not be related to each other. Families with a combined phenotypic description, not reducible to individual family members, were included as one case in the analysis.Clinical casesThe Sophia Childrenâs Hospital Database was reviewed for cases with a GLI3 variant. Within this population, the same inclusion criteria for the phenotype were valid. Relatives of the index patients were also contacted for participation in this study, when they showed comparable hand, foot, or craniofacial malformations or when a GLI3 variant was identified. Phenotypes of the hand, foot and craniofacial anomalies of the patients treated in the Sophia Children's Hospital were collected using patient documentation.

Family members were identified and if possible, clinically verified. Alternatively, family members were contacted to verify their phenotypes. If no verification was possible, cases were excluded.PhenotypesThe phenotypes of both literature cases and local cases were extracted in a similar fashion. The most frequently reported limb and craniofacial phenotypes were dichotomised. The dichotomised hand and foot phenotypes were preaxial polydactyly, postaxial polydactyly and syndactyly.

Broad halluces or thumbs were commonly reported by authors and were dichotomised as a presentation of preaxial polydactyly. The extracted dichotomised craniofacial phenotypes were hypertelorism, macrocephaly and corpus callosum agenesis. All other phenotypes were registered, but not dichotomised.Pathogenic GLI3 variantsAll GLI3 variants were extracted and checked using Alamut Visual V.2.14. If indicated, variants were renamed according to standard Human Genome Variation Society nomenclature.20 Variants were grouped in either missense, frameshift, nonsense or splice site variants. In the group of frameshift variants, a subgroup with possible splice site effect were identified for subgroup analysis when indicated.

Similarly, nonsense variants prone for nonsense mediated decay (NMD) and nonsense variants with experimentally confirmed NMD were identified.21 Deletions of multiple exons, CNVs and translocations were excluded for analysis. A full list of included mutations is available in the online supplementary materials.Supplemental materialThe location of the variant was compared with five known structural domains of the GLI3 gene. (1) repressor domain, (2) zinc finger domain, (3) cleavage site, (4) activator domain, which we defined as a concatenation of the separately identified transactivation zones, the CBP binding domain and the mediator binding domain (MBD) and (5) the MID1 interaction region domain.1 6 22â24 The boundaries of each of the domains were based on available literature (figure 1, exact locations available in the online supplementary materials). The boundaries used by different authors did vary, therefore a consensus was made.In this figure the posterior probability of an anterior phenotype is plotted against the location of the variant, stratified for the type of mutation that was observed. For better overview, only variants with a location effect were displayed.

The full figure, including all variant types, can be found in the online supplementary figure 1. Each mutation is depicted as a dot, the size of the dot represents the number of observations for that variant. If multiple observations were made, the mean posterior odds and IQR are plotted. For the nonsense variants, variants that were predicted to produce nonsense mediated decay, are depicted using a triangle. Again, the size indicates the number of observations." data-icon-position data-hide-link-title="0">Figure 1 In this figure the posterior probability of an anterior phenotype is plotted against the location of the variant, stratified for the type of mutation that was observed.

For better overview, only variants with a location effect were displayed. The full figure, including all variant types, can be found in the online supplementary figure 1. Each mutation is depicted as a dot, the size of the dot represents the number of observations for that variant. If multiple observations were made, the mean posterior odds and IQR are plotted. For the nonsense variants, variants that were predicted to produce nonsense mediated decay, are depicted using a triangle.

Again, the size indicates the number of observations.Supplemental materialLatent class analysisTo cluster phenotypes and relate those to the genotypes of the patients, an explorative analysis was done using LCA in R (R V.3.6.1 for Mac. Polytomous variable LCA, poLCA V.1.4.1.). We used our LCA to detect the number of phenotypic subgroups in the dataset and subsequently predict a class membership for each case in the dataset based on the posterior probabilities.In order to make a reliable prediction, only phenotypes that were sufficiently reported and/or ruled out were feasible for LCA, limiting the analysis to preaxial polydactyly, postaxial polydactyly and syndactyly of the hands and feet. Only full cases were included. To determine the optimal number of classes, we fitted a series of models ranging from a one-class to a six-class model.

The optimal number of classes was based on the conditional Akaike information criterion (cAIC), the non adjusted and the sample-size adjusted Bayesian information criterion (BIC and aBIC) and the obtained entropy.25 The explorative LCA produces both posterior probabilities per case for both classes and predicted class membership. Using the predicted class membership, the phenotypic features per class were determined in a univariate analysis (Ï2, SPSS V.25). Using the posterior probabilities on latent class (LC) membership, a scatter plot was created using the location of the variant on the x-axis and the probability of class membership on the y-axis for each of the types of variants (Tibco Spotfire V.7.14). Using these scatter plots, variants that give similar phenotypes were clustered.Genotype/phenotype correlationBecause an LC has no clinical value, the correlation between genotypes and phenotypes was investigated using the predictor phenotypes and the clustered phenotypes. First, those phenotypes that contribute most to LC membership were identified.

Second those phenotypes were directly related to the different types of variants (missense, nonsense, frameshift, splice site) and their clustered locations. Quantification of the relation was performed using a univariate analysis using a Ï2 test. Because of our selection criteria, meaning patients at least have two phenotypes, a multivariate using a logistic regression analysis was used to detect the most significant predictors in the overall phenotype (SPSS V.25). Finally, we explored the relation of the clustered genotypes to the presence of corpus callosum agenesis, a rare malformation in GLI3-mediated polydactyly syndromes which cannot be readily diagnosed without additional imaging.ResultsWe included 251 patients from the literature and 46 local patients,10â12 16 21 26â43 in total 297 patients from 155 different families with 127 different GLI3 variants, 32 of which were large deletions, CNVs or translocations. In six local cases, the exact variant could not be retrieved by status research.The distribution of the most frequently observed phenotypes and variants are presented in table 1.

Other recurring phenotypes included developmental delay (n=22), broad nasal root (n=23), frontal bossing or prominent forehead (n=16) and craniosynostosis (n=13), camptodactyly (n=8) and a broad first interdigital webspace of the foot (n=6).View this table:Table 1 Baseline phenotypes and genotypes of selected populationThe LCA model was fitted using the six defined hand/foot phenotypes. Model fit indices for the LCA are displayed in table 2. Based on the BIC, a two-class model has the best fit for our data. The four-class model does show a gain in entropy, however with a higher BIC and loss of df. Therefore, based on the majority of performance statistics and the interpretability of the model, a two-class model was chosen.

Table 3 displays the distribution of phenotypes and genotypes over the two classes.View this table:Table 2 Model fit indices for the one-class through six-class model evaluated in our LCAView this table:Table 3 Distribution of phenotypes and genotypes in the two latent classes (LC)Table 1 depicts the baseline phenotypes and genotypes in the obtained population. Note incomplete data especially in the cranium phenotypes. In total 259 valid genotypes were present. In total, 289 cases had complete data for all hand and foot phenotypes (preaxial polydactyly, postaxial polydactyly and syndactyly) and thus were available for LCA. Combined, for phenotype/genotype correlation 258 cases were available with complete genotypes and complete hand and foot phenotypes.Table 2 depicts the model fit indices for all models that have been fitted to our data.Table 3 depicts the distribution of phenotypes and genotypes over the two assigned LCs.

Hand and foot phenotypes were used as input for the LCA, thus are all complete cases. Malformation of the cranium and genotypes do have missing cases. Note that for the LCA, full case description was required, resulting in eight cases due to incomplete phenotypes. Out of these eight, one also had a genotype that thus needed to be excluded. Missingness of genotypic data was higher in LC2, mostly due to CNVs (table 1).In 54/60 cases, a missense variant produced a posterior phenotype.

Likewise, splice site variants show the same phenotype in 23/24 cases (table 3). For both frameshift and nonsense variants, this relation is not significant (52 anterior vs 54 posterior and 26 anterior vs 42 posterior, respectively). Therefore, only for nonsense and frameshift variants the location of the variant was plotted against the probability for LC2 membership in figure 1. A full scatterplot of all variants is available in online supplementary figure 1.Figure 1 reveals a pattern for these nonsense and frameshift variants that reveals that variants at the C-terminal of the gene predict anterior phenotypes. When relating the domains of the GLI3 protein to the observed phenotype, we observe that the majority of patients with a nonsense or frameshift variant in the repressor domain, the zinc finger domain or the cleavage site had a high probability of an LC2/anterior phenotype.

This group contains all variants that are either experimentally determined to be subject to NMD (triangle marker in figure 1) or predicted to be subject to NMD (diamond marker in figure 1). Frameshift and nonsense variants in the activator domain result in high probability for an LC1/posterior phenotype. These variants will be further referred to as truncating variants in the activator domain.The univariate relation of the individual phenotypes to these two groups of variants are estimated and presented in table 4. In our multivariate analysis, postaxial polydactyly of the foot and hand are the strongest predictors (Beta. 2.548, p<0001âand Beta.

1.47, p=0.013, respectively) for patients to have a truncating variant in the activator domain. Moreover, the effect sizes of preaxial polydactyly of the hand and feet (Beta. Â0.797, p=0123âand â1.772, p=0.001) reveals that especially postaxial polydactyly of the foot is the dominant predictor for the genetic substrate of the observed anomalies.View this table:Table 4 Univariate and multivariate analysis of the phenotype/genotype correlationTable 4 shows exploration of the individual phenotypes on the genotype, both univariate and multivariate. The multivariate analysis corrects for the presence of multiple phenotypes in the underlying population.Although the craniofacial anomalies could not be included in the LCA, the relation between the observed anomalies and the identified genetic substrates can be studied. The prevalence of hypertelorism was equally distributed over the two groups of variants (47/135 vs 21/47 respectively, p<0.229).

However for corpus callosum agenesis and macrocephaly, there was a higher prevalence in patients with a truncating variant in the activator domain (3/75 vs 11/41, p<0.001. OR. 8.8, p<0.001) and 42/123 vs 24/48, p<0.05). Noteworthy is the fact that 11/14 cases with corpus callosum agenesis in the dataset had a truncating variant in the activator domain.DiscussionIn this report, we present new insights into the correlation between the phenotype and the genotype in patients with GLI3-mediated polydactyly syndromes. We illustrate that there are two LCs of patients, best predicted by postaxial polydactyly of the hand and foot for LC1, and the preaxial polydactyly of the hand and foot and syndactyly of the foot for LC2.

Patients with postaxial phenotypes have a higher risk of having a truncating variant in the activator domain of the GLI3 gene which is also related to a higher risk of corpus callosum agenesis. These results suggest a functional difference between truncating variants on the N-terminal and the C-terminal side of the GLI3 cleavage site.Previous attempts of phenotype to genotype correlation have not yet provided the clinical confirmation of these assumed mechanisms in the pathophysiology of GLI3-mediated polydactyly syndromes. Johnston et al have successfully determined the Pallister-Hall region in which truncating variants produce a Pallister-Hall phenotype rather than Greig syndrome.11 However, in their latest population study, subtypes of both syndromes were included to explain the full spectrum of observed malformations. In 2015, Demurger et al reported the higher incidence of corpus callosum agenesis in the Greig syndrome population with truncating mutations in the activator domain.12 Al-Qattan in his review summarises the concept of a spectrum of anomalies dependent on haplo-insufficiency (through different mechanisms) and repressor overexpression.13 However, he bases this theory mainly on reviewed experimental data. Our report is the first to provide an extensive clinical review of cases that substantiate the phenotypic difference between the two groups that could fit the suggested mechanisms.

We agree with Al-Qattan et al that a variation of anomalies can be observed given any pathogenic variant in the GLI3 gene, but overall two dominant phenotypes are present. A population with predominantly preaxial anomalies and one with postaxial anomalies. The presence of preaxial or postaxial polydactyly and syndactyly is not mutually exclusive for one of these two subclasses. Meaning that preaxial polydactyly can co-occur with postaxial polydactyly. However, truncating mutations in the activator domain produce a postaxial phenotype, as can be derived from the risk in table 4.

The higher risk of corpus callosum agenesis in this population shows that differentiating between a preaxial phenotype and a postaxial phenotype, instead of between the different GLI3-mediated polydactyly syndromes, might be more relevant regarding diagnostics for corpus callosum agenesis.We chose to use LCA as an exploratory tool only in our population for two reasons. First of all, LCA can be useful to identify subgroups, but there is no âtrueâ model or number of subgroups you can detect. The best fitting model can only be estimated based on the available measures and approximates the true subgroups that might be present. Second, LC membership assignment is a statistical procedure based on the posterior probability, with concordant errors of the estimation, rather than a clinical value that can be measured or evaluated. Therefore, we decided to use our LCA only in an exploratory tool, and perform our statistics using the actual phenotypes that predict LC membership and the associated genotypes.

Overall, this method worked well to differentiate the two subgroups present in our dataset. However, outliers were observed. A qualitative analysis of these outliers is available in the online supplementary data.The genetic substrate for the two phenotypic clusters can be discussed based on multiple experiments. Overall, we hypothesise two genetic clusters. One that is due to haploinsufficiency and one that is due to abnormal truncation of the activator.

The hypothesised cluster of variants that produce haploinsufficiency is mainly based on the experimental data that confirms NMD in two variants and the NMD prediction of other nonsense variants in Alamut. For the frameshift variants, it is also likely that the cleavage of the zinc finger domain results in functional haploinsufficiency either because of a lack of signalling domains or similarly due to NMD. Missense variants could cause haploinsufficiency through the suggested mechanism by Krauss et al who have illustrated that missense variants in the MID1 domain hamper the functional interaction with the MID1-Î±4-PP2A complex, leading to a subcellular location of GLI3.24 The observed missense variants in our study exceed the region to which Krauss et al have limited the MID-1 interaction domain. An alternative theory is suggested by Zhou et al who have shown that missense variants in the MBD can cause deficiency in the signalling of GLI3A, functionally implicating a relative overexpression of GLI3R.22 However, GLI3R overexpression would likely produce a posterior phenotype, as determined by Hill et al in their fixed homo and hemizygous GLI3R models.15 Therefore, our hypothesis is that all included missense variants have a similar pathogenesis which is more likely in concordance with the mechanism introduced by Krauss et al. To our knowledge, no splice site variants have been functionally described in literature.

However, it is noted that the 15 and last exon encompasses the entire activator domain, thus any splice site mutation is by definition located on the 5â² side of the activator. Based on the phenotype, we would suggest that these variants fail to produce a functional protein. We hypothesise that the truncating variants of the activator domain lead to overexpression of GLI3R in SHH rich areas. In normal development, the presence of SHH prevents the processing of full length GLI34 into GLI3R, thus producing the full length activator. In patients with a truncating variant of the activator domain of GLI3, thus these variants likely have the largest effect in SHH rich areas, such as the ZPA located at the posterior side of the hand/footplate.

Moreover, the lack of posterior anomalies in the GLI3â699/- mouse model (hemizygous fixed repressor model) compared with the GLI3â699/â699 mouse model (homozygous fixed repressor model), suggesting a dosage effect of GLI3R to be responsible for posterior hand anomalies.15 These findings are supported by Lewandowski et al, who show that the majority of the target genes in GLI signalling are regulated by GLI3R rather than GLI3A.44 Together, these findings suggest a role for the location and type of variant in GLI3-mediated syndromes.Interestingly, the difference between Pallister-Hall syndrome and GLI3-mediated polydactyly syndromes has also been attributed to the GLI3R overexpression. However, the difference in phenotype observed in the cases with a truncating variant in the activator domain and Pallister-Hall syndrome suggest different functional consequences. When studying figure 1, it is noted that the included truncating variants on the 3â² side of the cleavage site seldomly affect the CBP binding region, which could provide an explanation for the observed differences. This binding region is included in the Pallister-Hall region as defined by Johnston et al and is necessary for the downstream signalling with GLI1.10 11 23 45 Interestingly, recent reports show that pathogenic variants in GLI1 can produce phenotypes concordant with Ellis von Krefeld syndrome, which includes overlapping features with Pallister-Hall syndrome.46 The four truncating variants observed in this study that do affect the CBP but did not result in a Pallister-Hall phenotype are conflicting with this theory. Krauss et al postulate an alternative hypothesis, they state that the MID1-Î±4-PP2A complex, which is essential for GLI3A signalling, could also be the reason for overlapping features of Opitz syndrome, caused by variants in MID1, and Pallister-Hall syndrome.

Further analysis is required to fully appreciate the functional differences between truncating mutations that cause Pallister-Hall syndrome and those that result in GLI3-mediated polydactyly syndromes.For the clinical evaluation of patients with GLI3-mediated polydactyly syndromes, intracranial anomalies are likely the most important to predict based on the variant. Unfortunately, the presence of corpus callosum agenesis was not routinely investigated or reported thus this feature could not be used as an indicator phenotype for LC membership. Interestingly when using only hand and foot phenotypes, we did notice a higher prevalence of corpus callosum agenesis in patients with posterior phenotypes. The suggested relation between truncating mutations in the activator domain causing these posterior phenotypes and corpus callosum agenesis was statistically confirmed (OR. 8.8, p<0.001).

Functionally this relation could be caused by the GLI3-MED12 interaction at the MBD. Pathogenic DNA variants in MED12 can cause Opitz-Kaveggia syndrome, a syndrome in which presentation includes corpus callosum agenesis, broad halluces and thumbs.47In conclusion, there are two distinct phenotypes within the GLI3-mediated polydactyly population. Patients with more posteriorly and more anteriorly oriented hand anomalies. Furthermore, this difference is related to the observed variant in GLI3. We hypothesise that variants that cause haploinsufficiency produce anterior anomalies of the hand, whereas variants with abnormal truncation of the activator domain have more posterior anomalies.

Furthermore, patients that have a variant that produces abnormal truncation of the activator domain, have a greater risk for corpus callosum agenesis. Thus, we advocate to differentiate preaxial or postaxial oriented GLI3 phenotypes to explain the pathophysiology as well as to get a risk assessment for corpus callosum agenesis.Data availability statementData are available upon reasonable request.Ethics statementsPatient consent for publicationNot required.Ethics approvalThe research protocol was approved by the local ethics board of the Erasmus MC University Medical Center (MEC 2015-679)..

AbstractIntroduction. We report a very rare case of familial breast cancer and diffuse gastric cancer, with germline pathogenic variants in both BRCA1 and CDH1 genes. To the best of our knowledge, this is the first report of such an association.Family description.

The proband is a woman diagnosed with breast cancer at the age of 52 years. She requested genetic counselling in 2012, at the age of 91 years, because of a history of breast cancer in her daughter, her sister, her niece and her paternal grandmother and was therefore concerned about her relatives. Her sister and maternal aunt also had gastric cancer.

She was tested for several genes associated with hereditary breast cancer.Results. A large deletion of BRCA1 from exons 1 to 7 and two CDH1 pathogenic cis variants were identified.Conclusion. This complex situation is challenging for genetic counselling and management of at-risk individuals.cancer.

Breastcancer. Gastricclinical geneticsgenetic screening/counsellingmolecular geneticsIntroductionGLI-Kruppel family member 3 (GLI3) encodes for a zinc finger transcription factor which plays a key role in the sonic hedgehog (SHH) signalling pathway essential in both limb and craniofacial development.1 2 In hand development, SHH is expressed in the zone of polarising activity (ZPA) on the posterior side of the handplate. The ZPA expresses SHH, creating a gradient of SHH from the posterior to the anterior side of the handplate.

In the presence of SHH, full length GLI3-protein is produced (GLI3A), whereas absence of SHH causes cleavage of GLI3 into its repressor form (GLI3R).3 4 Abnormal expression of this SHH/GLI3R gradient can cause both preaxial and postaxial polydactyly.2Concordantly, pathogenic DNA variants in the GLI3 gene are known to cause multiple syndromes with craniofacial and limb involvement, such as. Acrocallosal syndrome5 (OMIM. 200990), Greig cephalopolysyndactyly syndrome6 (OMIM.

175700) and Pallister-Hall syndrome7 (OMIM. 146510). Also, in non-syndromic polydactyly, such as preaxial polydactyly-type 4 (PPD4, OMIM.

174700),8 pathogenic variants in GLI3 have been described. Out of these diseases, Pallister-Hall syndrome is the most distinct entity, defined by the presence of central polydactyly and hypothalamic hamartoma.9 The other GLI3 syndromes are defined by the presence of preaxial and/or postaxial polydactyly of the hand and feet with or without syndactyly (Greig syndrome, PPD4). Also, various mild craniofacial features such as hypertelorism and macrocephaly can occur.

Pallister-Hall syndrome is caused by truncating variants in the middle third of the GLI3 gene.10â12 The truncation of GLI3 causes an overexpression of GLI3R, which is believed to be the key difference between Pallister-Hall and the GLI3-mediated polydactyly syndromes.9 11 Although multiple attempts have been made, the clinical and genetic distinction between the GLI3-mediated polydactyly syndromes is less evident. This has for example led to the introduction of subGreig and the formulation of an Oro-facial-digital overlap syndrome.10 Other authors, suggested that we should not regard these diseases as separate entities, but as a spectrum of GLI3-mediated polydactyly syndromes.13Although phenotype/genotype correlation of the different syndromes has been cumbersome, clinical and animal studies do provide evidence that distinct regions within the gene, could be related to the individual anomalies contributing to these syndromes. First, case studies show isolated preaxial polydactyly is caused by both truncating and non-truncating variants throughout the GLI3 gene, whereas in isolated postaxial polydactyly cases truncating variants at the C-terminal side of the gene are observed.12 14 These results suggest two different groups of variants for preaxial and postaxial polydactyly.

Second, recent animal studies suggest that posterior malformations in GLI3-mediated polydactyly syndromes are likely related to a dosage effect of GLI3R rather than due to the influence of an altered GLI3A expression.15Past attempts for phenotype/genotype correlation in GLI3-mediated polydactyly syndromes have directly related the diagnosed syndrome to the observed genotype.10â12 16 Focusing on individual hand phenotypes, such as preaxial and postaxial polydactyly and syndactyly might be more reliable because it prevents misclassification due to inconsistent use of syndrome definition. Subsequently, latent class analysis (LCA) provides the possibility to relate a group of observed variables to a set of latent, or unmeasured, parameters and thereby identifying different subgroups in the obtained dataset.17 As a result, LCA allows us to group different phenotypes within the GLI3-mediated polydactyly syndromes and relate the most important predictors of the grouped phenotypes to the observed GLI3 variants.The aim of our study was to further investigate the correlation of the individual phenotypes to the genotypes observed in GLI3-mediated polydactyly syndromes, using LCA. Cases were obtained by both literature review and the inclusion of local clinical cases.

Subsequently, we identified two subclasses of limb anomalies that relate to the underlying GLI3 variant. We provide evidence for two different phenotypic and genotypic groups with predominantly preaxial and postaxial hand and feet anomalies, and we specify those cases with a higher risk for corpus callosum anomalies.MethodsLiterature reviewThe Human Gene Mutation Database (HGMD Professional 2019) was reviewed to identify known pathogenic variants in GLI3 and corresponding phenotypes.18 All references were obtained and cases were included when they were diagnosed with either Greig or subGreig syndrome or PPD4.10â12 Pallister-Hall syndrome and acrocallosal syndrome were excluded because both are regarded distinct syndromes and rather defined by the presence of the non-hand anomalies, than the presence of preaxial or postaxial polydactyly.13 19 Isolated preaxial or postaxial polydactyly were excluded for two reasons. The phenotype/genotype correlations are better understood and both anomalies can occur sporadically which could introduce falsely assumed pathogenic GLI3 variants in the analysis.

Relatives of the index patients were also contacted for participation in this study, when they showed comparable hand, foot, or craniofacial malformations or when a GLI3 variant was identified. Phenotypes of the hand, foot and craniofacial anomalies of the patients treated in the Sophia Children's Hospital were collected using patient documentation. Family members were identified and if possible, clinically verified.

Alternatively, family members were contacted to verify their phenotypes. If no verification was possible, cases were excluded.PhenotypesThe phenotypes of both literature cases and local cases were extracted in a similar fashion. The most frequently reported limb and craniofacial phenotypes were dichotomised.

The dichotomised hand and foot phenotypes were preaxial polydactyly, postaxial polydactyly and syndactyly. Broad halluces or thumbs were commonly reported by authors and were dichotomised as a presentation of preaxial polydactyly. The extracted dichotomised craniofacial phenotypes were hypertelorism, macrocephaly and corpus callosum agenesis.

All other phenotypes were registered, but not dichotomised.Pathogenic GLI3 variantsAll GLI3 variants were extracted and checked using Alamut Visual V.2.14. If indicated, variants were renamed according to standard Human Genome Variation Society nomenclature.20 Variants were grouped in either missense, frameshift, nonsense or splice site variants. In the group of frameshift variants, a subgroup with possible splice site effect were identified for subgroup analysis when indicated.

The boundaries used by different authors did vary, therefore a consensus was made.In this figure the posterior probability of an anterior phenotype is plotted against the location of the variant, stratified for the type of mutation that was observed. For better overview, only variants with a location effect were displayed. The full figure, including all variant types, can be found in the online supplementary figure 1.

Each mutation is depicted as a dot, the size of the dot represents the number of observations for that variant. If multiple observations were made, the mean posterior odds and IQR are plotted. For the nonsense variants, variants that were predicted to produce nonsense mediated decay, are depicted using a triangle.

Again, the size indicates the number of observations." data-icon-position data-hide-link-title="0">Figure 1 In this figure the posterior probability of an anterior phenotype is plotted against the location of the variant, stratified for the type of mutation that was observed. For better overview, only variants with a location effect were displayed. The full figure, including all variant types, can be found in the online supplementary figure 1.

Only full cases were included. To determine the optimal number of classes, we fitted a series of models ranging from a one-class to a six-class model. The optimal number of classes was based on the conditional Akaike information criterion (cAIC), the non adjusted and the sample-size adjusted Bayesian information criterion (BIC and aBIC) and the obtained entropy.25 The explorative LCA produces both posterior probabilities per case for both classes and predicted class membership.

Using the predicted class membership, the phenotypic features per class were determined in a univariate analysis (Ï2, SPSS V.25). Using the posterior probabilities on latent class (LC) membership, a scatter plot was created using the location of the variant on the x-axis and the probability of class membership on the y-axis for each of the types of variants (Tibco Spotfire V.7.14). Using these scatter plots, variants that give similar phenotypes were clustered.Genotype/phenotype correlationBecause an LC has no clinical value, the correlation between genotypes and phenotypes was investigated using the predictor phenotypes and the clustered phenotypes.

First, those phenotypes that contribute most to LC membership were identified. Second those phenotypes were directly related to the different types of variants (missense, nonsense, frameshift, splice site) and their clustered locations. Quantification of the relation was performed using a univariate analysis using a Ï2 test.

Because of our selection criteria, meaning patients at least have two phenotypes, a multivariate using a logistic regression analysis was used to detect the most significant predictors in the overall phenotype (SPSS V.25). Finally, we explored the relation of the clustered genotypes to the presence of corpus callosum agenesis, a rare malformation in GLI3-mediated polydactyly syndromes which cannot be readily diagnosed without additional imaging.ResultsWe included 251 patients from the literature and 46 local patients,10â12 16 21 26â43 in total 297 patients from 155 different families with 127 different GLI3 variants, 32 of which were large deletions, CNVs or translocations. In six local cases, the exact variant could not be retrieved by status research.The distribution of the most frequently observed phenotypes and variants are presented in table 1.

The four-class model does show a gain in entropy, however with a higher BIC and loss of df. Therefore, based on the majority of performance statistics and the interpretability of the model, a two-class model was chosen. Table 3 displays the distribution of phenotypes and genotypes over the two classes.View this table:Table 2 Model fit indices for the one-class through six-class model evaluated in our LCAView this table:Table 3 Distribution of phenotypes and genotypes in the two latent classes (LC)Table 1 depicts the baseline phenotypes and genotypes in the obtained population.

Note incomplete data especially in the cranium phenotypes. In total 259 valid genotypes were present. In total, 289 cases had complete data for all hand and foot phenotypes (preaxial polydactyly, postaxial polydactyly and syndactyly) and thus were available for LCA.

Combined, for phenotype/genotype correlation 258 cases were available with complete genotypes and complete hand and foot phenotypes.Table 2 depicts the model fit indices for all models that have been fitted to our data.Table 3 depicts the distribution of phenotypes and genotypes over the two assigned LCs. Hand and foot phenotypes were used as input for the LCA, thus are all complete cases. Malformation of the cranium and genotypes do have missing cases.

Note that for the LCA, full case description was required, resulting in eight cases due to incomplete phenotypes. Out of these eight, one also had a genotype that thus needed to be excluded. Missingness of genotypic data was higher in LC2, mostly due to CNVs (table 1).In 54/60 cases, a missense variant produced a posterior phenotype.

A full scatterplot of all variants is available in online supplementary figure 1.Figure 1 reveals a pattern for these nonsense and frameshift variants that reveals that variants at the C-terminal of the gene predict anterior phenotypes. When relating the domains of the GLI3 protein to the observed phenotype, we observe that the majority of patients with a nonsense or frameshift variant in the repressor domain, the zinc finger domain or the cleavage site had a high probability of an LC2/anterior phenotype. This group contains all variants that are either experimentally determined to be subject to NMD (triangle marker in figure 1) or predicted to be subject to NMD (diamond marker in figure 1).

Frameshift and nonsense variants in the activator domain result in high probability for an LC1/posterior phenotype. These variants will be further referred to as truncating variants in the activator domain.The univariate relation of the individual phenotypes to these two groups of variants are estimated and presented in table 4. In our multivariate analysis, postaxial polydactyly of the foot and hand are the strongest predictors (Beta.

2.548, p<0001âand Beta. 1.47, p=0.013, respectively) for patients to have a truncating variant in the activator domain. Moreover, the effect sizes of preaxial polydactyly of the hand and feet (Beta.

Â0.797, p=0123âand â1.772, p=0.001) reveals that especially postaxial polydactyly of the foot is the dominant predictor for the genetic substrate of the observed anomalies.View this table:Table 4 Univariate and multivariate analysis of the phenotype/genotype correlationTable 4 shows exploration of the individual phenotypes on the genotype, both univariate and multivariate. The multivariate analysis corrects for the presence of multiple phenotypes in the underlying population.Although the craniofacial anomalies could not be included in the LCA, the relation between the observed anomalies and the identified genetic substrates can be studied. The prevalence of hypertelorism was equally distributed over the two groups of variants (47/135 vs 21/47 respectively, p<0.229).

Noteworthy is the fact that 11/14 cases with corpus callosum agenesis in the dataset had a truncating variant in the activator domain.DiscussionIn this report, we present new insights into the correlation between the phenotype and the genotype in patients with GLI3-mediated polydactyly syndromes. We illustrate that there are two LCs of patients, best predicted by postaxial polydactyly of the hand and foot for LC1, and the preaxial polydactyly of the hand and foot and syndactyly of the foot for LC2. Patients with postaxial phenotypes have a higher risk of having a truncating variant in the activator domain of the GLI3 gene which is also related to a higher risk of corpus callosum agenesis.

These results suggest a functional difference between truncating variants on the N-terminal and the C-terminal side of the GLI3 cleavage site.Previous attempts of phenotype to genotype correlation have not yet provided the clinical confirmation of these assumed mechanisms in the pathophysiology of GLI3-mediated polydactyly syndromes. Johnston et al have successfully determined the Pallister-Hall region in which truncating variants produce a Pallister-Hall phenotype rather than Greig syndrome.11 However, in their latest population study, subtypes of both syndromes were included to explain the full spectrum of observed malformations. In 2015, Demurger et al reported the higher incidence of corpus callosum agenesis in the Greig syndrome population with truncating mutations in the activator domain.12 Al-Qattan in his review summarises the concept of a spectrum of anomalies dependent on haplo-insufficiency (through different mechanisms) and repressor overexpression.13 However, he bases this theory mainly on reviewed experimental data.

Our report is the first to provide an extensive clinical review of cases that substantiate the phenotypic difference between the two groups that could fit the suggested mechanisms. We agree with Al-Qattan et al that a variation of anomalies can be observed given any pathogenic variant in the GLI3 gene, but overall two dominant phenotypes are present. A population with predominantly preaxial anomalies and one with postaxial anomalies.

The presence of preaxial or postaxial polydactyly and syndactyly is not mutually exclusive for one of these two subclasses. Meaning that preaxial polydactyly can co-occur with postaxial polydactyly. However, truncating mutations in the activator domain produce a postaxial phenotype, as can be derived from the risk in table 4.

Second, LC membership assignment is a statistical procedure based on the posterior probability, with concordant errors of the estimation, rather than a clinical value that can be measured or evaluated. Therefore, we decided to use our LCA only in an exploratory tool, and perform our statistics using the actual phenotypes that predict LC membership and the associated genotypes. Overall, this method worked well to differentiate the two subgroups present in our dataset.

However, outliers were observed. A qualitative analysis of these outliers is available in the online supplementary data.The genetic substrate for the two phenotypic clusters can be discussed based on multiple experiments. Overall, we hypothesise two genetic clusters.

One that is due to haploinsufficiency and one that is due to abnormal truncation of the activator. The hypothesised cluster of variants that produce haploinsufficiency is mainly based on the experimental data that confirms NMD in two variants and the NMD prediction of other nonsense variants in Alamut. For the frameshift variants, it is also likely that the cleavage of the zinc finger domain results in functional haploinsufficiency either because of a lack of signalling domains or similarly due to NMD.

Missense variants could cause haploinsufficiency through the suggested mechanism by Krauss et al who have illustrated that missense variants in the MID1 domain hamper the functional interaction with the MID1-Î±4-PP2A complex, leading to a subcellular location of GLI3.24 The observed missense variants in our study exceed the region to which Krauss et al have limited the MID-1 interaction domain. An alternative theory is suggested by Zhou et al who have shown that missense variants in the MBD can cause deficiency in the signalling of GLI3A, functionally implicating a relative overexpression of GLI3R.22 However, GLI3R overexpression would likely produce a posterior phenotype, as determined by Hill et al in their fixed homo and hemizygous GLI3R models.15 Therefore, our hypothesis is that all included missense variants have a similar pathogenesis which is more likely in concordance with the mechanism introduced by Krauss et al. To our knowledge, no splice site variants have been functionally described in literature.

In normal development, the presence of SHH prevents the processing of full length GLI34 into GLI3R, thus producing the full length activator. In patients with a truncating variant of the activator domain of GLI3, thus these variants likely have the largest effect in SHH rich areas, such as the ZPA located at the posterior side of the hand/footplate. Moreover, the lack of posterior anomalies in the GLI3â699/- mouse model (hemizygous fixed repressor model) compared with the GLI3â699/â699 mouse model (homozygous fixed repressor model), suggesting a dosage effect of GLI3R to be responsible for posterior hand anomalies.15 These findings are supported by Lewandowski et al, who show that the majority of the target genes in GLI signalling are regulated by GLI3R rather than GLI3A.44 Together, these findings suggest a role for the location and type of variant in GLI3-mediated syndromes.Interestingly, the difference between Pallister-Hall syndrome and GLI3-mediated polydactyly syndromes has also been attributed to the GLI3R overexpression.

However, the difference in phenotype observed in the cases with a truncating variant in the activator domain and Pallister-Hall syndrome suggest different functional consequences. When studying figure 1, it is noted that the included truncating variants on the 3â² side of the cleavage site seldomly affect the CBP binding region, which could provide an explanation for the observed differences. This binding region is included in the Pallister-Hall region as defined by Johnston et al and is necessary for the downstream signalling with GLI1.10 11 23 45 Interestingly, recent reports show that pathogenic variants in GLI1 can produce phenotypes concordant with Ellis von Krefeld syndrome, which includes overlapping features with Pallister-Hall syndrome.46 The four truncating variants observed in this study that do affect the CBP but did not result in a Pallister-Hall phenotype are conflicting with this theory.

Krauss et al postulate an alternative hypothesis, they state that the MID1-Î±4-PP2A complex, which is essential for GLI3A signalling, could also be the reason for overlapping features of Opitz syndrome, caused by variants in MID1, and Pallister-Hall syndrome. Further analysis is required to fully appreciate the functional differences between truncating mutations that cause Pallister-Hall syndrome and those that result in GLI3-mediated polydactyly syndromes.For the clinical evaluation of patients with GLI3-mediated polydactyly syndromes, intracranial anomalies are likely the most important to predict based on the variant. Unfortunately, the presence of corpus callosum agenesis was not routinely investigated or reported thus this feature could not be used as an indicator phenotype for LC membership.

Interestingly when using only hand and foot phenotypes, we did notice a higher prevalence of corpus callosum agenesis in patients with posterior phenotypes. The suggested relation between truncating mutations in the activator domain causing these posterior phenotypes and corpus callosum agenesis was statistically confirmed (OR. 8.8, p<0.001).

Furthermore, this difference is related to the observed variant in GLI3. We hypothesise that variants that cause haploinsufficiency produce anterior anomalies of the hand, whereas variants with abnormal truncation of the activator domain have more posterior anomalies. Furthermore, patients that have a variant that produces abnormal truncation of the activator domain, have a greater risk for corpus callosum agenesis.

Thus, we advocate to differentiate preaxial or postaxial oriented GLI3 phenotypes to explain the pathophysiology as well as to get a risk assessment for corpus callosum agenesis.Data availability statementData are available upon reasonable request.Ethics statementsPatient consent for publicationNot required.Ethics approvalThe research protocol was approved by the local ethics board of the Erasmus MC University Medical Center (MEC 2015-679)..

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Sign up for our newsletter For Sarah Blevins, finding what is generic for ventolin better ways to treat opioid use disorder is personal. ÂComing from Appalachia, I feel like those are my people,â she said. Blevins, what is generic for ventolin who grew up in Abingdon, Virginia, is one member of a small group of researchers at the University of Kentucky working on a multidisciplinary plan to treat those with opioid use disorder (OUD).

Itâs a plan, they say, that could work well treating those with OUD in rural areas. Since 2018, the researchers have been treating patients who entered what is generic for ventolin the health care system with endocarditis (a condition where germs enter the bloodstream and travel to the heart) associated with injection drug use. The group wanted to find solutions that would address the patientsâ addiction, as well as their .

The researchers hope to be able to curb opioid use disorder by providing patients at infectious disease clinics with access to mental health therapists, relapse prevention services, and medications. âOur intervention is about linking patients with IV-drug-use-associated s to outpatient addiction treatment what is generic for ventolin services,â said Blevins, a pharmacist and lead researcher on the study. She likened the approach to the way HIV is treated.

The new opioid treatment is based on approaches spelled out in what is generic for ventolin the groundbreaking HIV-treatment legislation called the Ryan White Care Act. That HIV treatment model provides not only medical care but mental health care, case management, social workers, and others. Providing help with everything from housing to jobs to mental health services and prescriptions helps the team treat the whole patient, and not just the , said Alice Thornton, M.D., one of the studyâs authors.

âAll of this goes back what is generic for ventolin to the addiction problem,â Thornton said. ÂWe have to step back and see the whole person and the root of the problem.â The team works with individuals who are eligible to enter into the program (they must be opioid drug users and they cannot be incarcerated) and treats both their endocarditis and their addiction. Whether itâs finding treatment providers closer to a patientâs homes, providing transportation assistance, or even providing mental health what is generic for ventolin services through telehealth appointments, the treatment model focuses on the whole patient and what they need.

âItâs hard to be in Appalachia and grow up there and not have at least one person that you know thatâs overdosed. And I think that speaks to the enormity of the problem.âSarah Blevins Lead researcher So far, she said, out of the 270 patients who were referred to the program, only 167 were eligible to participate. Of those, about half decided what is generic for ventolin to participate in the program.

Of those that have entered the treatment program, she said, about 17% have died from causes related to their opioid addiction. Participants are what is generic for ventolin located all across the state, Blevins said, but most come from rural eastern Kentucky. According to Bevins, in rural areas, the treatment approach could be a model for success because it helps the team offer specialized services that individuals with opioid use disorder may not have in their areas.

âIn some of the more rural areas, to continue treating that infectious disease, whether it be follow-up for their endocarditis or continued HIV care or hepatitis C care that may not be available where they are, we still provide that treatment,â she said. ÂBut also, we have this separate group that helps them stay within their (sobriety) journey or to start on their journey to sobriety.â Nationally, rural areas of what is generic for ventolin the country continue to see higher rates of opioid overdose deaths, despite lower incidents of drug use. According to the Centers for Disease Control and Prevention (CDC), the rate for drug overdose deaths involving natural and semisynthetic opioids was 4.9 per every 100,000 residents compared to 4.3 per every 100,000 residents in urban areas.

However, rural areas see lower rates of drug use, 20 per every 100,000 residents, than urban areas (22 per every what is generic for ventolin 100,000 residents). For Blevins and the University of Kentucky team, itâs not just about numbers. Itâs about the people.

âWeâre very passionate about it, because what is generic for ventolin all of us on the team except maybe one, are from Appalachia,â Blevins said. ÂWeâve seen it â the opioid crisis. Itâs hard to be in Appalachia and grow up there and not have at what is generic for ventolin least one person that you know thatâs overdosed.

And I think that speaks to the enormity of the problem.â So far, the program is young, she said, and thereâs not a lot of hard data to draw conclusions from. But Blevins believes results are promising. Some of those who have entered the program are approaching what is generic for ventolin a year in recovery and have been able to hold down jobs, get custody of their children back or clear up legal problems.

Others, however, have not. âThatâs kind of how it goes with sobriety,â what is generic for ventolin she said. ÂItâs a continual process of trying to get stable.â Before You Go The Daily Yonder is a nonprofit news platform dedicated to reporting on rural people, places, and issues.

Donations from readers like you makes it possible for us to fulfill this important mission. So far this year, weâve helped readers understand what is generic for ventolin where rural America fits in the asthma treatment ventolin, the 2020 election, and the fight for racial equity. For the rest of 2020, you have a special opportunity to double your contribution to the Daily Yonder.

Your gift will be matched dollar for dollar by NewsMatch, a nonprofit news what is generic for ventolin funding program. All you have to do to help us get this extra support is make a gift, in any amount. Itâs that simple.

Thanks what is generic for ventolin for reading the Daily Yonder, for sharing our content with friends and neighbors, and for making your contribution today. You Might Also LikeStart Preamble Start Printed Page 71142 Centers for Medicare &. Medicaid Services what is generic for ventolin (CMS), Department of Health and Human Services (HHS).

Internal Revenue Service, Department of the Treasury. Employee Benefits Security Administration, Department of Labor. Interim final rule with request for comments what is generic for ventolin.

This interim final rule with request for comments (IFC) discusses CMS's implementation of section 3713 of the asthma Aid, Relief, and Economic Security Act (CARES Act), which established Medicare Part B coverage and payment for asthma Disease 2019 (asthma treatment) treatment and its administration. This IFC implements requirements in the CARES Act that providers of asthma treatment diagnostic what is generic for ventolin tests make public their cash prices for those tests and establishes an enforcement scheme to enforce those requirements. This rule also establishes an add-on payment for cases involving the use of new asthma treatments under the Medicare Inpatient Prospective Payment System (IPPS).

This IFC provides for separate payment for new asthma treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for asthma treatment when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service. This rule also interprets and implements the requirement to maintain Medicaid beneficiary enrollment in order to receive what is generic for ventolin the temporary increase in Federal funding in the Families First asthma Response Act (FFCRA). This IFC modifies policies of the Comprehensive Care for Joint Replacement (CJR) model and adds technical changes to accommodate these policy changes.

Specifically, we are extending Performance what is generic for ventolin Year (PY) 5 by adding 6 months, creating an episode-based extreme and uncontrollable circumstances asthma treatment policy, providing two reconciliation periods for PY 5, and adding DRGs 521 and 522 for hip and knee procedures. This rule also amends regulations regarding coverage of preventive health services to implement section 3203 of the CARES Act, which shortens the timeframe within which non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage must begin to cover without cost sharing qualifying asthma preventive services, including recommended asthma treatment immunizations. This IFC also revises regulations to set forth flexibilities in the public notice requirements and post award public participation requirements for State Innovation Waivers under section 1332 of the Patient Protection and Affordable Care Act (PPACA) during the public health emergency for asthma treatment.

Effective date what is generic for ventolin. These regulations are effective on November 2, 2020, except for amendatory instructions 36 and 37, which are effective on January 1, 2021. Applicability date what is generic for ventolin.

Except as otherwise specified in this paragraph, these regulations are applicable from November 2, 2020, until the end of the public health emergency for asthma treatment as determined by the HHS Secretary. The regulations at 42 CFR 410.57, 410.152, 410.160, 411.15, 414.701, 414.707, 414.900, and 414.904 and at 42 CFR part 510 (other than 42 CFR 510.300(a)(1)(i) and (iii)) are applicable November 2, 2020. Because the requirement at section 6008(b)(3) of the Families First asthma Response Act (FFCRA) is not what is generic for ventolin limited to the duration of the public health emergency for asthma treatment, regulations at 42 CFR part 433, subpart G, apply from November 2, 2020, through the end of the last month of the public health emergency for asthma treatment in accordance with section 6008(b)(3) of the Families First asthma Response Act.

Regulations at 42 CFR 510.300(a)(1)(i) and (a)(1)(iii) are applicable October 1, 2020. Comment date what is generic for ventolin. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m.

On January 4, 2021. In commenting, what is generic for ventolin please refer to file code CMS-9912-IFC. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed).

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov.

Follow the âSubmit a commentâ instructions. 2. By regular mail.

You may mail written comments to the following address ONLY. Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention.

CMS-9912-IFC, P.O. Box 8016, Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-9912-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. Start Further Info Laura Kennedy, (410) 786-3377, for discussion related to asthma treatment and administration payment provided under Medicare Part B. Lina Rashid, (443) 902-2823, or Michelle Koltov, (301) 492-4225, Centers for Medicare &.

Medicaid Services, Department of Health and Human Services, Services, Kimberly Koch, (202) 622-0854, Department of the Treasury, for issues related to State Innovation Waivers Policy and Regulatory Revisions in Response to the asthma treatment Public Health Emergency. Dr. Terri Postma or Rhonda Sheppard, (410) 786-8465, or via email at asthma [email protected], for provisions related to Price Transparency for asthma treatment Diagnostic Testing.Start Printed Page 71143 Cristina Nigro, (410) 786-7763, for issues related to the Medicare Inpatient Prospective Payment System (IPPS) New asthma treatments Add-on Payment (NCTAP) for the remainder of the public health emergency.

David Mlawsky, (410) 786-1565, Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Elizabeth Schumacher, (202) 693-8335, Employee Benefits Security Administration, Department of Labor, Dara Alderman, (202) 317-5500, Internal Revenue Service, Department of the Treasury, for issues related to Rapid Coverage of Preventive Services for asthma. Stephanie Bell, (410) 786-0617, for issues related to the temporary increase in Federal Medicaid funding.

Bobbie Knickman, (410) 786-4161. Heather Holsey, (410) 786-0028. Sarah Mioduski, (410) 786-2014 or email [email protected] for the Comprehensive Care for Joint Replacement Model.

End Further Info End Preamble Start Supplemental Information Inspection of Public Comments. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received.

Http://regulations.gov. Follow the search instructions on that website to view public comments. Background The United States is responding to an outbreak of respiratory disease caused by a novel asthma that was first detected in China and has now been detected in more than 190 countries internationally, and all 50 States, the District of Columbia, and U.S.

Territories. The ventolin has been named âsevere acute respiratory syndrome asthma 2â (âasthmaâ) and the disease it causes has been named âasthma disease 2019â (âasthma treatmentâ). On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared the outbreak a âPublic Health Emergency of International Concern.â On January 31, 2020, pursuant to section 319 of the Public Health Service (PHS) Act (42 U.S.C.

247d), the Health and Human Services Secretary (the Secretary) determined that a public health emergency (PHE) exists for the United States to aid the nation's health care community in responding to asthma treatment (hereafter referred to as the PHE for asthma treatment). On March 11, 2020, the WHO publicly declared asthma treatment a ventolin. On March 13, 2020, President Donald J.

Trump (the President) declared the asthma treatment ventolin a national emergency. Effective October 23, 2020, the Secretary renewed the January 31, 2020 determination that was previously renewed on April 21, 2020 and July 23, 2020 that a PHE exists and has existed since January 27, 2020. The Administration is committed to ensuring that Americans have access to a asthma treatment through Operation Warp Speed, a partnership among components of the HHS, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA).

Operation Warp Speed engages with private firms and other Federal agencies, including the Department of Defense (DoD), Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. Through the work of the Federal Government and the private sector, Operation Warp Speed seeks to accelerate the development, manufacture, and distribution of a asthma treatment to the American people. The CDC has reported that some people are at higher risk of severe illness from asthma treatment.[] These higher-risk categories include.

Older adults, with risk increasing by age. People who have serious chronic medical conditions such as. ++ Obesity.

++ Cardiovascular disease. ++ Diabetes mellitus. ++ Hypertension.

++ Chronic lung disease. ++ Neurologic/Neurodevelopmental disability.[] ++ Immunocompromised individuals. Residents of Long Term Care (LTC) facilities, including nursing homes, Intermediate Care Facilities for Individuals with Intellectual and Developmental Disabilities (ICF/IIDs), inpatient psychiatric and substance abuse treatment facilities including Institutions for Mental Disease (IMDs) &.

Psychiatric Residential Treatment Facilities (PRTFs), assisted living facilities, group homes for individuals with developmental disabilities and board-and-care facilities.[] As the health care community implements and updates recommended prevention and control practices, regulatory agencies operating under appropriate waiver authority granted by the PHE for asthma treatment are also working to revise and implement regulations that support these health care community prevention and treatment practices. Based on the current and projected increases in the incidence rate of asthma treatment in the US, observed fatalities in the older adult population, and the impact on health care workers at increased risk due to treating special populations, CMSâ[] is reviewing and revising regulations, as appropriate, to offer states, providers, suppliers, and group health plans and health insurance issuers additional flexibilities in furnishing and providing services to combat the PHE for asthma treatment and to address and minimize the unique impact of the PHE for asthma treatment on other regulatory provisions. CMS addressed additional policies in three previous interim final rules with comment period (IFCs).

The âMedicare and Medicaid Programs. Policy and Regulatory Revisions in Response to the asthma treatment Public Health Emergencyâ IFC appeared in the April 6, 2020 Federal Register (85 FR 19230) with an effective date of March 31, 2020, and the âMedicare and Medicaid Programs, Basic Health Program, and Exchanges. Additional Policy and Regulatory Revisions in Response to the asthma treatment Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Programâ IFC appeared in the May 8, 2020 Federal Register (85 FR 27550) with an effective date of May 8, 2020.

The âMedicare and Medicaid Programs, Clinical Laboratory Improvement Amendments, and Patient Protection and Affordable Care Act. Additional Policy and Regulatory Revisions in Response to the asthma treatment Public Health Emergencyâ IFC appeared in the September 2, 2020 Federal Register (85 FR 54820) with an effective date of September 2, 2020. This IFC implements a number of measures intended to further the Administration's commitment to ensure every American has timely access to a asthma treatment without any out-of-pocket expenses, no matter their source of coverage, or whether they are covered at all.Start Printed Page 71144 In this IFC, CMS discusses Section 3713 of the asthma Aid, Relief, and Economic Security (CARES) Act which added the asthma treatment and its administration to section 1861(s)(10)(A) of the Social Security Act (the Act) in the same subparagraph as the flu and pneumococcal treatments and their administration.

It also specified that under Medicare Part B, beneficiaries can receive a asthma treatment vaccination (treatment and administration) with no cost sharing (deductible or copayment). In this IFC, HHS and the Departments of Labor and the Treasury (referred to collectively as âthe Departmentsâ) clarify certain aspects of coverage of preventive services without cost sharing under the current regulations implementing section 2713 of the Public Health Service (PHS) Act, as added by PPACA and incorporated into the Employee Retirement Income Security Act of 1974 (ERISA) by section 715 of ERISA and into the Internal Revenue Code (the Code) by section 9815 of the Code. The Departments also amend those regulations to implement the unique requirements related to rapid coverage of qualifying asthma preventive services under section 3203 of the CARES Act.

Specifically, this IFC clarifies that plans and issuers subject to section 2713 of the PHS Act must cover without cost sharing recommended immunizations as well as the administration of such immunizations, regardless of how the administration is billed. This IFC also defines qualifying asthma preventive services consistent with the definition provided in section 3203 of the CARES Act and clarifies that plans and issuers subject to section 2713 of the PHS Act must cover recommended immunizations for asthma treatment that are qualifying asthma preventive services, even if not listed for routine use on the Immunization Schedules of the CDC. Due to the urgent need to ensure coverage of and access to qualifying asthma preventive services, and to ensure that participants, beneficiaries, and enrollees can access qualifying asthma preventive services on the expedited basis specified by statute, this IFC also provides that during the PHE for asthma treatment, plans and issuers must cover, without cost sharing, qualifying asthma preventive services, regardless of whether such services are delivered by an in-network or out-of-network provider.

This coverage is required to be provided within 15 business days after the date the United States Preventive Services Task Force (USPSTF) or the Advisory Committee on Immunization Practices of the CDC (ACIP) makes an applicable recommendation relating to a qualifying asthma preventive service. Section 3202(b) of the CARES Act establishes a requirement to publicize cash prices for asthma treatment diagnostic testing during the PHE. For purposes of implementing section 3202(b) of the CARES Act, this IFC adds a new 45 CFR part 182, including (1) definitions of âprovider of a diagnostic test for asthma treatmentâ (or âproviderâ), âasthma treatment diagnostic test,â and âcash price,â and (2) requirements for posting cash price information on the internet, or upon request and through signage (if applicable) if the provider does not have its own website.

This IFC gives CMS discretion to take any of the following actions, which generally, but not necessarily, will occur in the following order if CMS determines the provider is noncompliant with section 3202(b)(1) of the CARES Act and the requirements of Â§â182.40. Provide a written warning notice to the provider of the specific violation(s). Request that a provider submit and comply with a corrective action plan (CAP) under Â§â182.60 if its noncompliance is not corrected after a warning notice.

Impose a civil monetary penalty (CMP) on the provider if the provider fails to respond to CMS' request to submit a CAP or to comply with the requirements of a CAP approved by CMS. This IFC creates a New asthma treatments Add-on Payment (NCTAP) under the Inpatient Prospective Payment System (IPPS) for asthma treatment cases that meet certain criteria. We believe that as drugs and biological products become available and are authorized or approved by FDA for the treatment of asthma treatment in the inpatient setting, it is appropriate to increase the current IPPS payment amounts to mitigate any potential financial disincentives for hospitals to provide new asthma treatments during the PHE.

Therefore, effective for discharges occurring on or after the effective date of this rule and until the end of the PHE for asthma treatment, this IFC establishes the NCTAP to pay hospitals the lesser of (1) 65 percent of the operating outlier threshold for the claim or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment, including the adjustment to the relative weight under section 3710 of the CARES Act, for certain cases that include the use of a drug or biological product currently authorized or approved for treating asthma treatment. The NCTAP will not be included as part of the calculation of the operating outlier payments. This IFC provides for separate payment for New asthma treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for asthma treatment when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service.

Although we do not expect that many beneficiaries would both receive a primary C-APC service and a drug or biological for treating asthma treatment on the same claim, we nonetheless believe that as drugs or biologicals become available and are authorized or approved for the treatment of asthma treatment in the outpatient setting, it would be appropriate to mitigate any potential financial disincentives for hospitals to provide these new treatments during the PHE for asthma treatment. Therefore, effective for services furnished on or after the effective date of this rule and until the end of the PHE, CMS is creating an exception to its OPPS C-APC policy to ensure separate payment for new asthma treatments that meet certain criteria. This IFC adds a new subpart G, Temporary FMAP Increase During the Public Health Emergency for asthma treatment, to 42 CFR part 433, including a new Â§â433.400.

This new provision interprets and implements section 6008(b)(3) of the FFCRA to require states, as a condition for receiving the temporary FMAP increase described at section 6008(a) of the FFCRA, to maintain beneficiary enrollment with specified protections. The terms of new Â§â433.400 are effective immediately upon display of this rule. CMS' previous interpretation, described in this preamble and in the FAQs cited therein, continues to apply up to the date this rule is effective.

This IFC modifies policies of the Comprehensive Care for Joint Replacement (CJR) model and adds technical changes to accommodate these policy changes. Specifically, we are extending Performance Year (PY) 5 an additional 6 months, creating an episode-based extreme and uncontrollable circumstances asthma treatment policy, providing two reconciliation periods for PY 5, and adding DRGs 521 and 522 for hip and knee procedures. This IFC provides for flexibilities in the public notice requirements for a State Innovation Waiver (also referred to as a section 1332 waiver) described in section 1332 of PPACA that apply during the PHE for asthma treatment.

Specifically, this IFC gives the Secretary of HHS and the Secretary of the Treasury the authority to modify, in part, the public notice procedures to Start Printed Page 71145expedite a decision on a proposed waiver request that is submitted or would otherwise become due during the PHE for asthma treatment. This IFC also gives these Secretaries the authority to modify, in part, the post-award public notice requirements for an approved waiver request that would otherwise take place or become due during the PHE for asthma treatment. II.

Provisions of the Interim Final RuleâDepartment of Health and Human Services A. Medicare Coding and Payment for asthma treatment 1. Summary This section of this IFC discusses CMS's implementation of section 3713 of the CARES Act, which established Medicare Part B coverage and payment for a asthma treatment and its administration.

While section 3713(e) of the CARES Act authorizes CMS to implement section 3713 via âprogram instruction or otherwise,â we believe it is important to clarify in this IFC our interpretation of Section 3713 and ensure the public is aware of our plans to ensure timely Medicare Part B coverage and payment for asthma treatment and its administration. 2. Background on Medicare Part B Coverage, Payment, Coding and Billing for treatments As required under section 1842(o)(1)(A)(iv) of the Act, the Medicare Part B payment allowance limits for influenza, pneumococcal, and hepatitis B ventolin (HBV) treatments are 95 percent of the Average Wholesale Price (AWP) as reflected in the published compendia except where the treatment is furnished in a hospital outpatient department, Rural Health Clinic (RHC), or Federally Qualified Health Center (FQHC), skilled nursing facility, and home health.

Where the treatment is furnished in these settings, payment for the treatment is based on reasonable cost. For preventive treatments described in section 1861(s)(10) of the Act, Medicare pays for both the treatment and its administration. Under sections 1833(a)(1)(B), annual Part B deductible and coinsurance amounts do not apply for these vaccinations.

In 2020, payment for treatments is based on the 95 percent of the AWP for a particular treatment product except where furnished in the settings for which payment is based on reasonable cost. For example, for the 2020-2021 influenza season, payment limits for adult flu treatments range from about $19 to $61 per adult dose.[] We note that in the Calendar Year 2021 Physician Fee Schedule Proposed Rule (85 FR 50162-50163), CMS proposed to increase the Medicare payment rate for administration of the flu, pneumococcal or HBV treatment furnished by a physician, non-physician practitioner, or other supplier. CMS will address public comments on the proposal and establish payment rates for administration of these treatments by a physician, non-physician practitioner, or other supplier in the Calendar Year 2021 Physician Fee Schedule Final Rule, which will be issued later this year.

Note that the payment rates for administration of these preventive treatments established in the CY 2021 Physician Fee Schedule final rule do not apply when the treatment is furnished by the providers and suppliers paid for administration under reasonable cost. Under the CY 2021 OPPS proposed rule, CMS proposed to assign the HCPCS codes for administration of the influenza, pneumococcal, and hepatitis B treatments to APC 5691, Level 1 Drug Administration. See Addendum C to the CY 2021 OPPS/ASC proposed rule.

treatment administration services are described by the types of codes used to describe professional and/or hospital outpatient services, and are typically identified by a G code for Medicare billing, or by a different AMA CPT code in the 90000 series. Many providers, professionals, and other suppliers can bill Medicare for the preventive treatments and treatment administration they furnish using claims rules similar to those that apply to the other Medicare covered items and services. Additionally, certain entities can enroll under Medicare as mass immunizers to offer and bill Medicare for flu vaccinations, pneumococcal vaccinations, or both to large groups of Medicare beneficiaries under roster billing.

A mass immunizer may be enrolled in Medicare as another type of provider or supplier such as a physician, non-physician practitioner, hospital outpatient department, home health agency or skilled nursing facility. An entity or individual that does not otherwise qualify as a Medicare provider or supplier but wishes to furnish mass immunization services may be eligible to enroll in Medicare as a âMass Immunization Roster Billerâ via the Form CMS-855 enrollment application (Medicare Enrollment Application. Clinics/Group Practices and Certain Other Suppliers.

Aside from meeting all applicable enrollment requirements in 42 CFR part 424, subpart P (and as outlined in CMS Pub. 100-08 (Program Integrity Manual), chapter 10, section 10.2.4), a party enrolled only as a mass immunization roster biller must comply with the following. (1) May not bill Medicare for any services other than pneumococcal pneumonia treatments (PPVs), influenza ventolin treatments, and their administration.

(2) must submit claims through the roster biller or centralized biller process. And (3) the enrolled entity or individual must meet all applicable state and local licensure or certification requirements. In other words, an enrolled mass immunizer roster biller may only roster bill Medicare for the services described in the previous sentence.

(For more information on the enrollment process for mass immunization roster billers, see https://www.cms.gov/âMedicare/âProvider-Enrollment-and-Certification/âBecome-a-Medicare-Provider-or-Supplier and/or contact your local Part A/B Medicare Administrative Contractor.) For entities that are already enrolled Medicare providers and suppliers, these entities would contact their MAC if they plan to submit claims as a mass immunizer. Mass immunizers may submit claims for immunizations (treatment and administration) on roster bills that include a limited set of information on each beneficiary and the treatment(s) they were given. We note that HBV vaccinations require an assessment of a patient's risk of contracting hepatitis B.

They require a physician's order and cannot be roster billed by mass immunizers. 3. Provisions of the CARES Act Section 3713 of the CARES Act provides for coverage of the asthma treatment under Part B of the Medicare program without any beneficiary cost sharing.

Section 3713(e) of the CARES Act further states that the Secretary may implement the provisions of, and the amendments made by, this section by program instruction or otherwise. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Commissioner of Food and Drugs, as delegated authority by the Secretary, may authorize, during the effective period of a declaration of emergency or threat justifying emergency authorized use, the introduction into interstate commerce of unapproved medical products or unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological and nuclear defense (CBRN) threat agents when there are no adequate, approved, and available alternatives. On March 27, 2020, on the basis of his determination of a PHE that has a significant potential to affect national security or the health and security of United States citizens living abroad involving asthma treatment, the Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the asthma treatment ventolin (85 FR 18250).

Pursuant to this declaration, the Commissioner of Food and Drugs, as delegated authority by the Secretary, may issue an emergency use authorization (EUA) for a drug or biological product if, after consultation with officials such as the Director of the CDC and the Director of the NIH, to the extent feasible and appropriate, the Commissioner reasonably concludes that, among other criteria, based on the totality of available scientific evidence, the product may be effective in diagnosing, treating or preventing such disease or condition, and the product's known and potential benefits when used to diagnose, prevent, or treat such disease or condition, outweigh its known and potential risks. FDA's June 2020 guidance to industry titled âDevelopment and Licensure of treatments to Prevent asthma treatmentâ[] and October 2020 guidance to industry titled âEmergency Use Authorization for treatments to Prevent asthma treatmentâ[] state that issuance of an EUA may be appropriate for a asthma treatment, for which there is adequate manufacturing information, once studies have demonstrated the safety and effectiveness of the treatment in a clear and compelling manner, but before the submission and/or formal review of the biologics license application for the treatment. These guidance documents state that in the case of treatments being developed for the prevention of asthma treatment, any assessment regarding an EUA would be made on a case by case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the relevant available scientific evidence.

The FDA has made clear in its October 2020 guidance to industry that for a asthma treatment for which there is adequate information to ensure its quality and consistency, issuance of an EUA would require a determination by FDA that the treatment's benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the treatment's safety and efficacy in a clear and compelling manner. Because the treatment would be intended for administration to healthy people as a prophylactic measure, there must be a higher degree of certainty about the risks and benefits of the product than needed for EUAs for medical products intended for treatment of sick patients. There are no historical examples in which Medicare has covered treatments for which an EUA was issued by FDA.

We recall that during the PHE involving the 2009 H1N1 flu outbreak,[] Influenza A (H1N1) 2009 Monovalent treatment was approved by the FDA on September 15, 2009 on the basis of a supplement to the applicant's biologics license application (BLA) for influenza ventolin treatment.[] In our review of PHEs, there are no circumstances in which a treatment product authorized for emergency use has been covered or paid for by Medicare. As discussed previously, the CDC recognizes that the categories of people at higher risk of severe illness from asthma treatment include older adults (with risk increasing by age), people with chronic conditions such as cardiovascular disease or diabetes, and residents of long-term care facilities.[] The Medicare population includes many beneficiaries who are in these higher-risk categories, primarily because most, (over 85 percent)â[] Medicare beneficiaries are over 65 years old. Given the high risk nature of the Medicare population, the circumstances of this nationwide ventolin, and FDA's guidance that an EUA may be appropriate for a asthma treatment prior to its licensure if there is a demonstration of safety and efficacy in a clear and compelling manner from at least one Phase 3 clinical trial, we believe it is appropriate for Medicare to consider any EUA under section 564 of the FD&C Act issued for a asthma treatment during the PHE to be tantamount to a license under section 351 of the PHS Act for the sole purpose of considering such a treatment to be described in section 1861(s)(10)(A) of the Act.

That is, even though section 3713 of the CARES Act refers to a asthma treatment âlicensed under section 351 of the PHS Act,â CMS could consider any treatment for which FDA issued an EUA during the PHE, when furnished consistent with terms of the EUA, to be eligible for Medicare coverage and payment. We consider our interpretation of section 3713(d) of the CARES Act to be consistent with Congress' intent to provide for Medicare coverage without deductible or coinsurance of any asthma treatment (and its administration) that FDA has authorized to be introduced into interstate commerce, which would be the case both for a treatment for which emergency use is authorized under section 564 of the FD&C Act and for a treatment that is licensed under section 351 of the PHS Act. Our interpretation also would be consistent with Congress' general intent in the CARES Act and other recent legislation to provide for rapid coverage of asthma treatments.

We note that section 3713(e) of the CARES Act permits CMS to implement the changes made by that section through âprogram instruction or otherwise,â and we intend to issue any necessary instructions for Medicare providers and suppliers expediently in order to ensure beneficiary access to asthma treatments as quickly as possible.Start Printed Page 71147 4. Implementation and Methods of Coding and Payment for asthma treatment and Administration Section 3713 of the CARES Act added the asthma treatment and its administration to section 1861(s)(10)(A) of the Act in the same subparagraph as the flu and pneumococcal treatments and their administration. As such, the Medicare allowed amount for the asthma treatment will also be 95 percent of the average wholesale price (or reasonable cost, for example under OPPS).

Because asthma treatments are being developed rapidly and systems to operationalize payment of administration will need to be implemented quickly to ensure beneficiary access, we also recognize the need to establish coding and payment for asthma treatment and administration under Medicare Part B. Because there are many product-specific factors that are still unknown, including the possibility of differential costs associated with each asthma treatment product and storage and administration requirements, we anticipate establishing a unique administration code for each asthma treatment product. We believe it is imperative that coding and payment be in place as soon as possible after asthma treatments become available.

We anticipate that payment rates for the administration of other Part B preventive treatments and related services, such as the flu and pneumococcal treatments, would serve to inform the payment rates for administration of asthma treatments. CMS ordinarily establishes Medicare payment rates for particular items and services, through notice-and-comment rulemaking. Because of the unique circumstances of the PHE for asthma treatment ventolin and the anticipated, specific conditions for the entry of asthma treatment products into the marketplace, we believe it is necessary to initially dispense with the rulemaking process in order to make Medicare payment available in a timely manner to ensure widespread access to the new treatments.

Therefore, as soon as practicable after the authorization or licensure of each asthma treatment product by FDA, we will announce the interim coding and a payment rate for its administration (or, in the case of the OPPS, an APC assignment for each treatment product's administration code), taking into consideration any product-specific costs or considerations involved in furnishing the service. Such consideration may be necessary, specifically for asthma treatments in the context of the ventolin, in order to ensure that health care providers can offer prompt access to vaccination for a large number of people as quickly as possible. We then anticipate addressing coding and payment rates for administration of the asthma treatment products through future notice-and-comment rulemaking.

In other words, the approach to payment and coding described in this IFC will ensure efficient and timely beneficiary access to asthma treatment products, that for public health purposes may need to be administered to a large number of people during a compressed period of time, until further rulemaking, such as annual rulemaking under the Medicare Physician Fee Schedule, is possible. Given that the asthma treatment and administration was added to the same subparagraph as the flu and pneumococcal treatments and administration under section 1861(s)(10)(A) of the Act, we believe it would be appropriate to use billing processes for asthma treatment vaccinations that are similar to those in place for flu and pneumococcal vaccinations. With the pressing need to ensure broad access to a asthma treatment, it would be appropriate to allow asthma treatment vaccinations to be provided through the mass immunization and roster billing process that is in place for flu and pneumococcal vaccinations.

We recognize that, at this time, there is very limited detailed information on asthma treatments and their administration and that information on these treatments is likely to evolve as they reach the market and then experience with them is gained. At this time, we believe that the asthma treatments will be administered as one or two parenteral doses, thus we believe that using the Part B influenza vaccination approach that permits certain providers and mass immunization to bill for the product strikes a balance between the need to vaccinate many millions of Medicare patients promptly and the lack of detailed information about particular asthma treatment products. Although influenza vaccination is generally only given once each flu season, CMS has contemplated how to respond to ventolins where payment for additional doses of an influenza treatment during a season may be required.

Thus, a two dose initial asthma treatment vaccination schedule can be accommodated under this general approach. Also, the CARES Act permits the Secretary to implement the provisions of, and the amendments made by, section 3713 by program instruction or otherwise. As information about treatment products becomes available, we anticipate that updated information, for example information concerning additional doses after initial vaccination, applicability of specific treatment products to subsets of our beneficiary population, or updates about billing would be disseminated primarily by program instruction.

As part of this IFC, we are updating the following regulations. At Â§â410.57, Pneumococcal treatment and flu treatment, we are amending the section heading and adding a new paragraph to reference asthma treatment. At Â§â410.152, Amounts of payment, we are amending Â§â410.152(l)(1) to include the asthma treatment in the list of treatments for which Medicare Part B pays 100 percent of the Medicare payment amount.

At Â§â410.160, Part B annual deductible, we are amending Â§â410.160(b)(2) to include the asthma treatment in the list of treatments that are not subject to the Part B annual deductible and do not count toward meeting that deductible. At Â§â411.15, Particular services excluded from coverage, we are amending Â§â411.15(e) to add an exception for asthma treatment vaccinations to the general exclusion of coverage for immunizations. At Â§â414.701, Purpose, we are amending the list of statutorily covered drugs to include the asthma treatment.

At Â§â414.707, Basis of Payment, we are amending Â§â414.707(a)(2)(iii) to include the asthma treatment in the list of treatments with a payment limit calculated using 95 percent of the average wholesale price. At Â§â414.900, Basis and scope, we are amending Â§â414.900(b)(3) to include the asthma treatment in the list of statutorily covered drugs. At Â§â414.904, Average sales price as the basis for payment, we are amending Â§â414.904(e)(1) to include the asthma treatment in the list of treatments with payment limits calculated using 95 percent of the average wholesale price.Start Printed Page 71148 5.

Medicare Advantage and Cost Plans Under sections 1852(a)(1) and 1876(c)(2) of the Act, Medicare Advantage (MA) plans and cost plan organizations must cover all benefits covered under Part A and Part B of Original Medicare, subject to limited exclusions. Therefore, all MA plans and cost plans must cover a asthma treatment and its administration described in section 1861(s)(10)(A) of the Act. As described previously, the interpretation of section 3713 of the CARES Act adopted in this rule will result in Part B coverage of a asthma treatment for which FDA issues an EUA during the PHE, and administration of that treatment when furnished consistent with terms of such EUA.

As amended by section 3713 of the CARES Act, section 1852(a)(1)(B)(iv)(VI) of the Act prohibits MA plans from using cost sharing that exceeds the cost sharing imposed under original Medicare for a asthma treatment and its administration when MA coverage is provided because they are covered under Part B under section 1861(s)(10)(A) of the Act. Section 1852(a)(5) of the Act and 42 CFR 422.109 provide that when a National Coverage Determination (NCD) or legislative change in benefits, such as the addition of Part B coverage of a asthma treatment and its administration, results in significant costs that have not been included in the capitation payments made to MA plans, coverage of the new benefit will be provided through the Medicare FFS program until the capitation payments take the new significant costs into account. The payment rates for MA organizations for contract years 2020 and 2021 have been set without including the costs for a asthma treatment and its administration.

Therefore, if coverage of a asthma treatment and its administration during that period results in significant costs, section 1852(a)(5) of the Act and Â§â422.109 will apply to require Medicare FFS coverage of the treatment and its administration. The cost projection used for the determination whether the legislative change results in significant costs is based on an analysis by the Chief Actuary of CMS of the actuarial costs associated with a NCD or the legislative change in benefits and compared to the thresholds specified in the regulation at Â§â422.109. This analysis is generally performed once a Medicare FFS payment rate is determined for the service.

If the threshold is reached, Medicare beneficiaries enrolled in MA plans will receive coverage of the asthma treatment and its administration through the Medicare FFS program and would be able to access the asthma treatment, without cost sharing, at any FFS provider or supplier that participates in Medicare and is eligible to bill under Part B for treatment administration, including those enrolled in Medicare as a mass immunizer or a physician, non-physician practitioner, hospital, clinic, or group practice. Section 3713 of the CARES Act added Medicare Part B coverage for a asthma treatment and its administration and provides that MA plans must cover the new benefit without cost sharing. While section 1876(c)(2) of the Act ensures that enrollees in Medicare cost plans will have coverage of a asthma treatment and its administration, section 3713 of the CARES Act did not amend section 1876 of the Act to provide similar cost-sharing protections for enrollees in cost plans who receive the treatment from an in-network provider.

Nor is there a provision affirmatively relieving cost plans of the obligation to cover the new Part B benefit. Because the Medicare FFS program covers Part A and Part B items and services furnished to cost plan enrollees by out-of-network health care providers that participate in the Medicare FFS program, cost plan enrollees will receive the asthma treatment and its administration without cost sharing when they go to a health care provider that is out of the cost plan's network. See 42 CFR 417.436(a)(5) and 417.448.

However, there is no requirement for cost plans to cover the asthma treatment and its administration without cost sharing (that is, with cost sharing that is the same as original Medicare) when the treatment is furnished by an in-network health care provider. Many enrollees may seek the asthma treatment from the health care provider they usually see or from whom they receive most of their health care. That provider is likely to be in-network with the cost plan.

CMS believes that it is necessary and appropriate to ensure that cost plan enrollees, like other Medicare beneficiaries, are provided access to the asthma treatment and its administration without cost sharing. Section 1876(i)(3)(D) of the Act authorizes us to impose âother terms and conditions not inconsistent with [section 1876]â that are deemed ânecessary and appropriate.â Requiring cost plans to comply with the same cost sharing protections available to Medicare beneficiaries in the FFS program and enrolled in Medicare Advantage plans is necessary and appropriate, so that cost is not a barrier for beneficiaries to get the treatment, particularly during the public health emergency when ensuring access is of paramount importance. To ensure that cost plan enrollees also do not pay cost sharing for the asthma treatment and its administration when received from an in-network provider at least until the end of the public health emergency for asthma treatment, we are adding a new paragraph (e)(4) to Â§â417.454 to require section 1876 cost plans to cover without cost sharing the asthma treatment and its administration described in section 1861(s)(10)(A) of the Act without cost sharing for the duration of the PHE for the asthma treatment ventolin, specifically the end of the emergency period defined in paragraph (1)(B) of section 1135(g) of the Act, which is the PHE declared by the Secretary on January 31, 2020 and any renewals thereof.

B. asthma treatment Coverage for Medicaid, CHIP, and BHP Beneficiaries Under section 6008 of the FFCRA, states' and territories' Medicaid programs may receive a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP). Under section 6008(b)(4) of the FFCRA, to receive that increase, a state or territory must cover asthma treatment testing services and treatments, including treatments and the administration of such treatments, for Medicaid enrollees without cost sharing.

That coverage is required during any quarter for which the state or territory claims the temporary FMAP increase under FFCRA section 6008, and the FMAP increase is available through the end of the quarter in which the PHE for asthma treatment ends. CMS is not aware of any states or territories not currently claiming this temporary FMAP increase, or of any state or territory that intends to cease claiming it. Accordingly, Medicaid coverage of a asthma treatment and its administration, without cost-sharing, is expected to be available for most Start Printed Page 71149Medicaid beneficiaries through the end of the quarter in which the PHE for asthma treatment ends.

For the remainder of this section of preamble, references to âstateâ or âstatesâ in discussions of Medicaid policy also include the territories. To meet the requirement in FFCRA section 6008(b)(4) to cover a asthma treatment and its administration without cost sharing, states must compensate Medicaid providers with a treatment administration fee or reimbursement for a provider visit during which a treatment dose is administered, even if the treatment dose is furnished to the provider at no cost. There are some very limited circumstances in which the FFCRA section 6008(b)(4) coverage requirements would not apply.

CMS has not interpreted section 6008(b)(4) of the FFCRA to require that state Medicaid programs cover the services described in that provision for individuals whose Medicaid eligibility is limited by statute to only a narrow range of benefits that would not otherwise include these services. FFCRA section 6008(b)(4) did not amend the varying benefits packages that are required for different Medicaid eligibility groups under section 1902(a)(10) of the Act. In some cases, beneficiaries' coverage is limited by statute to a very narrow range of benefits and services that typically would not include services described in FFCRA section 6008(b)(4), such as asthma treatments or their administration (see, e.g., the limitations described in the matter following section 1902(a)(10)(G) of the Act for some Medicaid eligibility groups).

Nor did FFCRA section 6008(b)(4) direct states to amend existing demonstration projects under section 1115(a) of the Act, through which states may offer eligibility to groups not otherwise eligible under title XIX of the Act, and can opt to provide these groups with limited benefits. Moreover, after FFCRA was enacted, in section 3716 of the CARES Act (Pub. L.

116-136), Congress defined eligibility for the asthma treatment testing-only optional Medicaid eligibility group described in section 1902(a)(10)(A)(ii)(XXIII) of the Act in a manner that recognized that certain limited-benefit Medicaid eligibility groups are âuninsured,â and therefore eligible to receive coverage for asthma treatment testing under that provision, without referring to or acknowledging the FFCRA section 6008(b)(4) asthma treatment testing coverage requirement. See section 1902(ss) of the Act. Accordingly, CMS does not interpret FFCRA section 6008(b)(4) to require states to provide asthma treatment testing and treatment services without cost-sharing, including treatments and their administration, to eligibility groups whose coverage is limited by statute or under an existing section 1115 demonstration to a narrow range of benefits that would not ordinarily include this coverage, such as groups that receive Medicaid coverage only for asthma treatment testing, family planning services and supplies, or tuberculosis-related services.

The asthma treatment Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured Program (asthma treatment Claims Reimbursement program) administered by the Health Resources and Services Administration (HRSA) is available for reimbursement of a asthma treatment and treatment administration costs for individuals who would not receive Medicaid coverage for a asthma treatment or its administration because their Medicaid coverage is for limited benefit packages only. After the requirements in section 6008(b)(4) of FFCRA are no longer in effect in a state, the state must cover asthma treatments recommended by the ACIP, and their administration, for several populations under existing statutory and regulatory authority. All Medicaid-enrolled children under the age of 21 eligible for the Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit must receive ACIP-recommended treatments pursuant to section 1905(r)(1)(A)(i) and (B)(iii) of the Act.[] Coverage of ACIP-recommended treatments without cost-sharing is required for any adult populations who receive coverage through Alternative Benefit Plans (ABPs), including the adult expansion population described at section 1902(a)(10)(A)(i)(VIII) of the Act, pursuant to section 1937(b)(5) of the Act, 42 CFR 440.347(a), and 45 CFR 156.115(a)(4) and 147.130.

Some states may also elect to receive a 1 percentage point FMAP increase for their expenditures on certain services, in return for covering ACIP-recommended treatments and their administration without cost-sharing for adults under section 1905(a)(13) of the Act, pursuant to section 4106 of PPACA (as codified in section 1905(b) of the Act). Children through age 18 who are eligible for Medicaid (funded through both titles XIX and XXI), as well as children who are uninsured, who are not insured with respect to the treatment and who are administered pediatric treatments by a federally qualified health center (FQHC) or rural health clinic, or who are Indians (as defined in section 4 of the Indian Health Care Improvement Act) receive ACIP-recommended vaccinations through the treatments for Children (VFC) program, described at section 1928 of the Act. The Centers for Disease Control and Prevention (CDC) will determine if asthma treatments will be included in the VFC program.

Coverage of the administration of a VFC-covered treatment for Medicaid-eligible children would be provided by the state Medicaid program. After the FFCRA section 6008(b)(4) requirements are no longer in effect in a state, the state also has the option to cover a asthma treatment and its administration for other eligibility groups. Such groups include the parent/caretaker relative eligibility group at 42 CFR 435.110, eligibility groups for individuals who are age 65 or older or who are eligible on the basis of blindness or a disability, and pregnant women enrolled under 42 CFR 435.116 who are eligible for full state plan benefits.

If a state elects to cover a asthma treatment and its administration for any one of these groups, it must do so for all of them, except that with respect to the pregnant women group described in 42 CFR 435.116, per 42 CFR 440.250(p) states can cover a treatment and its administration as a pregnancy-related service while not providing the same coverage for the other eligibility groups. Outside of the period in which FFCRA section 6008(b)(4) applies to a state, the state has the option to apply cost sharing to coverage of a asthma treatment or its administration unless the beneficiary is in an eligibility group that is exempt from cost-sharing under section 1916 or section 1916A of the Act and regulations at 42 CFR 447.56 (for example, most children under age 18, most pregnant women, most children in foster care, individuals receiving services in an institution that already had their medical assistance reduced by their income, individuals receiving hospice care, and Indians who are currently receiving or have ever received an item or service furnished by an Indian health care provider or through referral under contract health services). After the FFCRA section 6008(b)(4) requirements are no longer in effect in a state, a asthma treatment and its administration could also be a covered service for many Medicaid eligibility groups when furnished by a participating provider under certain Medicaid benefits that are mandatory for many Medicaid eligibility groups, Start Printed Page 71150depending on how the state has defined the amount, duration, and scope parameters of the benefit.

Because inpatient and outpatient hospital services, physician services, and Federally Qualified Health Center and Rural Health Clinic services are mandatory Medicaid benefits for the categorically needy populations, asthma treatment administration could be a covered service for many Medicaid beneficiaries when provided by these participating providers, at state option. States might also cover asthma treatment administration for beneficiaries under various optional state plan benefits, such as the âother licensed practitionerâ benefit described in section 1905(a)(6) of the Act and 42 CFR 440.60, or the âpreventive servicesâ benefit described in section 1905(a)(13) of the Act and 42 CFR 440.130(c). However, states would generally not have the option to cover a asthma treatment or its administration for any group whose coverage is limited by statute or under a current section 1115 demonstration to a narrow range of benefits that would not ordinarily include treatment coverage.

As described above, the asthma treatment Claims Reimbursement program administered by HRSA may be used to cover asthma treatment, including the administration of treatments, for such limited-benefit beneficiaries. In addition, a state might have the option, subject to Federal approval, to propose or amend a section 1115 demonstration to include this coverage for a group that would not otherwise be entitled to receive it under the statute or under current section 1115 authority. The FFCRA section 6008(b)(4) requirement does not apply to separate CHIPs.[] In separate CHIPs, states must cover ACIP-recommended treatments and their administration for all children under age 19 with no cost sharing.

See section 2103(c)(1)(D) and (e)(2) of the Act, and 42 CFR 457.410(b)(2) and 457.520(b)(4). Coverage of uninsured pregnant women in a separate CHIP is optional. Currently, the states that cover pregnant women in a separate CHIP include all ACIP-recommended treatments with no cost sharing in this coverage.

However, current CMS interpretation is that this treatment coverage is not required. The FFCRA section 6008(b)(4) requirement also does not apply to the Basic Health Program (BHP). Minnesota and New York are the only states that currently operate a BHP.

BHP coverage must include benefits in at least the ten essential health benefits described in section 1302(b) of the PPACA and must comply with the Exchange's cost-sharing protections,[] which includes providing all ACIP recommended treatments without cost sharing. See sections 1331(a)(1), (a)(2)(B) and (b)(2) of PPACA, and 42 CFR 600.405(a) and 600.510(b). Section 600.510(b) cross-references 45 CFR 147.130, which establishes requirements related to the coverage of preventive health services for BHP.

For ABPs, 42 CFR 440.347 cross-references 45 CFR part 156, which incorporates 45 CFR 147.130, which establishes requirements related to the coverage of preventive health services. Consistent with the changes to 45 CFR 147.130 made through this rulemaking, during the asthma treatment public health emergency BHP plans and Medicaid ABPs must provide coverage for and must not impose any cost-sharing for âqualifying asthma preventive services,â including a asthma treatment, regardless of whether the treatment is delivered by an in-network or out-of-network provider. For details on the coverage requirements for âqualifying asthma preventive servicesâ and the updates to 45 CFR 147.130 see section III of this IFC.

Lastly, we note that CMS intends this section only to be a description of current policy and existing law, with the exception noted directly above for BHP and Medicaid ABPs, and that CMS is not making any changes to its current policy or regulatory requirements in this rule. C. Price Transparency for asthma treatment Diagnostic Tests 1.

Introduction Robust asthma treatment diagnostic testing is fundamental to the Federal Government's strategy for controlling the spread of asthma treatment.[] In recognition of the importance of asthma treatment diagnostic testing, the Federal Government has taken several steps to reduce financial barriers to testing for both insured and uninsured individuals, including the following. The FFCRA was enacted on March 18, 2020. Section 6001 of the FFCRA generally requires group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for certain items and services, including in vitro diagnostic testing products for the detection of asthma, the ventolin that causes asthma treatment, or the diagnosis of asthma treatment (referred to herein collectively as asthma treatment diagnostic tests) when those items or services are furnished on or after March 18, 2020, and during the PHE for asthma treatment.

Plans and issuers must provide this coverage without imposing any cost-sharing requirements (including deductibles, copayments, and coinsurance) or prior authorization or other medical management requirements. Related items and services include those provided during urgent care center visits, in-person and telehealth office visits, and emergency room visits that result in an order for or administration of an in vitro diagnostic product, to the extent that such items and services relate to the furnishing or administration of a asthma treatment diagnostic test, or to the evaluation of an individual for purposes of determining the need of the individual for a asthma treatment diagnostic test. Section 3201 of the CARES Act, enacted on March 27, 2020, amended section 6001 of the FFCRA to include a broader range of diagnostic tests that plans and issuers must cover without any cost-sharing requirements or prior authorization or other medical management requirements.

116-139), which each appropriated funding to reimburse providers for conducting asthma treatment testing for the uninsured, and (2) the Provider Relief Fund, as appropriated in the CARES Act and the PPPHCEA.[] Start Printed Page 71151 HHS has partnered with pharmacies, retail companies, and health centers nationwide to make no-cost asthma treatment diagnostic testing available to Americans in communities across the country.[] Congress has also taken steps to facilitate the reimbursement for asthma treatment diagnostic testing and to ensure that pricing for performance of such testing is publicly available. Specifically, section 3202(a) of the CARES Act requires group health plans and issuers providing coverage for items and services described in section 6001(a) of the FFCRA to reimburse any provider of a asthma treatment diagnostic test an amount that equals the negotiated rate, or, if the plan or issuer does not have a negotiated rate with the provider, the cash price for such service that is listed by the provider on a public website. The plan or issuer may also negotiate a rate with the provider that is lower than the cash price.

More information related to health insurance issuer and group health plan coverage and reimbursement for asthma treatment diagnostic testing is available at https://www.cms.gov/âfiles/âdocument/âFFCRA-Part-42-FAQs.pdf and https://www.cms.gov/âfiles/âdocument/âFFCRA-Part-43-FAQs.pdf. Specifically, the Departments note that the reimbursement requirements under CARES Act 3202(a) will apply to asthma treatment diagnostic testing, as defined in this IFC. Section 3202(b) of the CARES Act establishes a requirement for each provider of a diagnostic test for asthma treatment to publicize cash prices for such asthma treatment diagnostic testing.

Specifically, section 3202(b)(1) of the CARES Act requires each provider of a diagnostic test for asthma treatment to make public the cash price for such test on a public internet website of such provider during the emergency period declared under section 319 of the PHS Act. Section 3202(b)(2) of the CARES Act authorizes the Secretary to impose a civil monetary penalty (CMP) on any provider of a diagnostic test for asthma treatment that does not make public its cash price for such test in compliance with section 3202(b)(1) of the CARES Act and that has not completed a corrective action plan (CAP) to comply with that section. The statute states that the amount of the CMP must not exceed $300 per day that the violation is ongoing.

(1) Definitions of âprovider of a diagnostic test for asthma treatmentâ (herein referred to as âproviderâ), âdiagnostic test for asthma treatmentâ (herein referred to as âasthma treatment diagnostic testâ), and âcash priceâ. (2) requirements for making public cash prices. And (3) penalties for non-compliance with the cash price posting requirements.

2. Requirement That Providers of asthma treatment Diagnostic Tests Make Public Cash Prices for asthma treatment Diagnostic Tests The rapid expansion of asthma treatment related diagnostic testing capacity is a top priority in HHS' strategy to combat the ventolin. asthma treatment diagnostic testing is generally performed by laboratories located in a variety of sites, including for example.

Government labs. Hospital-run labs. Clinician offices.

Stand-alone labs. Urgent care centers. And pharmacies.

There are several types of asthma treatment tests designed to detect asthma or to diagnose a possible case of asthma treatment, including molecular (RT-PCR) tests, which are used to detect the ventolin's genetic material, and antigen tests, which are used to detect specific proteins on the surface of the ventolin and serology testing, which is used to look for the presence of antibodies produced by the body in response to s. For purposes of implementing section 3202(b) of the CARES Act, we are adopting a new 45 CFR part 182, âPrice Transparency for asthma treatment Diagnostic Tests,â that will implement price transparency requirements for making public cash prices for performance of a asthma treatment diagnostic test. Section 182.10 states that part 182 implements section 3202(b) of the CARES Act.

For purposes of section 6001(a)(1) of the FFCRA, as amended by section 3201 of the CARES Act, and as explained in guidance issued by the Departments, asthma treatment diagnostic tests include all in vitro diagnostic tests, which include molecular, antigen, and serological tests. Specifically, section 6001(a) of the FFCRA, as amended by section 3201 of the CARES Act, requires plans and issuers to provide coverage for an in vitro diagnostic test, as defined in 21 CFR 809.3(a) (or its successor regulations), for the detection of asthma or diagnosis of asthma treatment, and the administration of such a test that. (1) Is approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the FD&C Act (21 U.S.C.

360(k), 360c, 360e, 360bbb-3). (2) the developer has requested, or intends to request, emergency use authorization under section 564 of the FD&C Act (21 U.S.C. 360bbb-3), unless and until the emergency use authorization request under such section 564 has been denied or the developer of such test does not submit a request under such section within a reasonable timeframe.

(3) is developed in and authorized by a state that has notified the Secretary of HHS of its intention to review tests intended to diagnose asthma treatment. Or (4) other tests that the Secretary of HHS determines appropriate in guidance.[] We are therefore at Â§â182.20 defining a âdiagnostic test for asthma treatmentâ (also referred to as a âasthma treatment diagnostic testâ) as a asthma treatment in vitro diagnostic test described in section 6001 of the FFCRA, as amended by section 3201 of the CARES Act. Such asthma treatment diagnostic tests are currently billed by providers using HCPCS and CPT codes including, but not limited to.

CPT codes 86408, 86409, 87635, 87426, 86328, and 86769 and HCPCS codes U0001 through U0004. We intend this list of billing codes to be illustrative, however, not exhaustive. Therefore, as noted previously, a âasthma treatment diagnostic testâ is defined as a asthma treatment in vitro diagnostic test described in section 6001 of the FFCRA, as amended by section 3201 of the CARES Act, even if a particular asthma treatment diagnostic test or its billing code is not included on this list.

Codes continue to be created to address new and proprietary tests as they are developed. We therefore anticipate updating this list in guidance as new tests and codes are developed. Obtaining a diagnostic test for asthma treatment generally can involve up to three separate health care services for an individual including evaluation by a practitioner of the need for such testing, and, once the provider determines the need for a asthma treatment diagnostic test, specimen collection and laboratory analysis of the specimen, that is, actual performance of a asthma treatment diagnostic Start Printed Page 71152test.

For purposes of implementing section 3202(b), we are defining âprovider of a diagnostic test for asthma treatmentâ (herein referred to as âproviderâ) as any facility that performs one or more asthma treatment diagnostic tests. CMS regulates all laboratory testing performed on humans for the purposes of diagnosis, prevention, or treatment in the U.S. Through the Clinical Laboratory Improvement Amendments CLIA program (42 U.S.C.

263a). In order to perform asthma treatment testing, a facility (whether that be a primary care provider's office, urgent care center, outpatient hospital site or stand-alone laboratory) is required to hold a CLIA certificate based on the complexity of the testing performed by the facility. Therefore, we expect that any âprovider of a diagnostic test for asthma treatmentâ would either hold or have submitted a CLIA application necessary to obtain a CLIA certificate (including a certificate of waiver, as applicable) and that such testing would occur in facilities ranging from primary care provider offices to urgent care centers to stand-alone national laboratories.

At Â§â182.20, we are defining âcash priceâ as the charge that applies to an individual who pays in cash (or cash equivalent) for a asthma treatment diagnostic test. We believe this definition will provide a clear point of reference not only for individuals who seek such tests, but also for payers who wish to negotiate reimbursement rates with providers of diagnostic tests for asthma treatment, or who wish to help direct their members to providers of diagnostic tests for asthma treatment who charge cash prices that payers believe to be reasonable. The âcash priceâ is generally analogous to the âdiscounted cash priceâ as defined at 45 CFR 180.20 for purposes of the Hospital Price Transparency final rule.

As we explained in that rule, providers often offer discounts off their gross charges or make other concessions to individuals who pay for their own care (referred to as self-pay individuals) (84 FR 65524). We also stated that the discounted cash price may be generally analogous to the âwalk-inâ rate that would apply to all self-pay individuals, regardless of insurance status, who pay in cash at the time of the service, and that such charges are often lower than the rate the hospital negotiates with third party payers because billing self-pay individuals would not require many of the administrative functions that exist for hospitals to seek payment from third party payers (for example, prior authorization and billing functions).[] It is therefore our expectation that the âcash priceâ established by the provider will be generally similar to, or lower than, rates negotiated with in-network plans and insurers. If a provider has not established a âcash priceâ for a asthma treatment diagnostic test that is lower than its gross charge or retail rate, the provider must make public the undiscounted gross or retail rate found in its master price list (which is analogous to the hospital's chargemaster).

We do not believe that posting a âcash priceâ should prevent a provider of a diagnostic test for asthma treatment from offering testing for free to individuals as charity care or in an effort to combat the public health crisis, rather, the âcash priceâ would be the maximum charge that may apply to a self-pay individual paying out-of-pocket. We solicit comment on this approach and whether any additional standards should be implemented to address any potential abuse. Under new Â§â182.30(a) and (b), these requirements apply to a âprovider of a diagnostic test for asthma treatmentâ as defined at Â§â182.20 and are applicable during the PHE for asthma treatment determined to exist nationwide as of January 27, 2020, by the HHS Secretary under section 319 of the PHS on January 31, 2020, as a result of confirmed cases of asthma treatment, including any subsequent renewals.

Finally, section 3202(b)(1) of the CARES Act states that each provider of a diagnostic test for asthma treatment shall make public the cash price for such test on a public internet website of such provider. We interpret this to mean that providers must make public the cash prices for performing asthma treatment diagnostic tests on the provider's internet website. Specifically, as discussed below, Â§â182.40(a)(1) and (2) require that each provider of a asthma treatment diagnostic test that has a website make public the cash price information described in Â§â182.40(c) electronically, and that the information itself, or a link to a web page that contains such information, must appear in a conspicuous location on a searchable homepage on the provider's website.

We recognize that some providers of a asthma treatment diagnostic test, for example, small or rural providers, may not have websites. Therefore, in the event that a provider does not have a website on which to post this cash price information, we are finalizing a policy at Â§â182.40(b) to require the provider to make public its cash price information in writing upon request within two business days and by posting signage prominently at the location where the provider offers a asthma treatment diagnostic test in a place likely to be viewed by members of the public seeking to obtain and pay for such testing. If the provider does not have its own website or a publicly accessible location then, upon request and within two business days, the provider will be required to make public its cash price information in writing to the requestor but will not be required to post signage at the location where it performs the asthma treatment diagnostic test.

For purposes of complying with the requirement that the cash price information be made public in writing, we will consider email correspondence to the requester to be an acceptable written format. We believe these policies will help ensure that the public (including individuals, issuers, health plans, and others) has access to every provider's asthma treatment diagnostic test cash prices, including those providers who do not perform asthma treatment diagnostic tests at publicly accessible locations. We seek comment on these issues, including the frequency by which providers may not have websites.

Furthermore, at Â§â182.40(a)(3), we are requiring that providers of a asthma treatment diagnostic test display their cash price information in an easily accessible manner, without barriers, including, but not limited to, ensuring the information is accessible. Free of charge. Without having to establish a user account or password.

And without having to submit personal identifiable information (PII). In addition, we are requiring at Â§â182.40(a)(4) that the provider's homepage contain certain keywords that we believe will increase the likelihood that the public will be able to locate the information using a search engine. Specifically, Â§â182.40(a)(4) requires that all of the following terms be included on the provider's homepage.

The provider's name. Âpriceâ. Âcostâ.

Âtestâ. Âasthma treatmentâ. And âasthma.â We seek Start Printed Page 71153comment on whether providers should have flexibility to select between using âasthma treatmentâ or âasthmaâ and between âcostâ and âpriceâ if the provider is linking to the information from its homepage.

Finally, we believe that it is important for the provider to include certain standardized information so that the public can understand the relationship between the posted cash price and the asthma treatment diagnostic test(s) offered by the provider. Therefore, at Â§â182.40(c)(1) through (4), we are requiring all providers to make public, along with the cash price for each asthma treatment diagnostic test(s) that they offer, information that, at minimum, includes a plain language description of each asthma treatment diagnostic test, the corresponding cash price, the billing code(s) for each such test(s), and any additional information as may be necessary for the public to be certain of the cash price for a particular asthma treatment diagnostic test. For example, if the provider offers the same test at a different cash price that is dependent on location or some other factor, then on its website listing of cash prices, the provider must indicate all the cash prices that apply to the test and relevant distinguishing information as to when each different cash price applies.

We believe that this information is necessary for the public, including group health plans and health insurance issuers offering group or individual health insurance coverage that must provide reimbursement for asthma treatment diagnostic testing pursuant to the requirements of section 3202(a) of the CARES Act. This requirement applies to cash price information posted on the provider's website, made available upon request and, where applicable, on signage. These requirements are applicable immediately.

However, we seek comment on these requirements and may, as a result of public comment, revise these requirements or finalize additional requirements. We also specifically seek comment on the definition of âdiagnostic test for asthma treatmentâ as solely a asthma treatment in vitro diagnostic test described in section 6001 of FFCRA. We seek comment on the definition of âprovider of a asthma treatment diagnostic testâ.

We seek comment on whether consumers may benefit from knowing the total cost of care for receiving a asthma treatment test, including the doctor's visit and specimen collection, in order to protect themselves against potential unexpected health care costs and make a more informed health care purchasing decision and therefore whether we should adopt a more inclusive definition of a provider of a diagnostic test for purposes of this requirement. Specifically, we seek comment on whether a âprovider of a diagnostic test for asthma treatmentâ should be expanded to include providers that perform additional services related to the performance of a asthma treatment diagnostic test, such as for specimen collection or mileage fees that may be billed as part of or in conjunction with the specimen collection, if applicable. We are particularly interested in submissions from stakeholders that include data, both anecdotal and claims-based, on the ways in which consumers request and receive asthma treatment diagnostic testing, including the site of care, frequency, and type of provider.

We seek comment on the definition of âcash priceâ. We have heard concerns from stakeholders that certain providers may use the posting of a âcash priceâ as an opportunity to âprice gougeâ.[] We therefore specifically seek comment on whether this definition or some other definition would help to mitigate concerns for price gouging by out-of-network providers. We seek comment on whether there are additional authorities and safeguards that could be used to mitigate concerns for price gouging both for group health plans and issuers and for consumers receiving a asthma treatment diagnostic test.

We seek comment regarding whether these requirements are sufficient to inform consumers of the cash price for a asthma treatment diagnostic test in advance of receiving one and what, if any, additional requirements or safeguards should be considered to avoid consumer confusion or prevent unintended consequences (for example, balance billing). Specifically, we seek comment regarding how providers should post cash prices so that they do not inadvertently deter consumers from seeking a test that would normally result in no out-of-pocket cost to the consumer. Finally, we seek comment on an approach that balances priorities to further price transparency for consumers and other stakeholders and reduce barriers to asthma treatment testing.

We recognize that these final policies become effective as of the date of display of this IFC and are applicable only until the end of the PHE. Even so, we seek comment whether and to what extent these final policies and the alternatives about which we are seeking comment (for instance, expansion of the definition of âproviderâ) may lead to. Potential cost shifting from providers or participants, beneficiaries, and enrollees to group health plans or issuers, if the group health plan and issuer reimbursement obligation for asthma treatment diagnostic testing is expanded to cover such testing without cost-sharing (including deductibles, co-pays, and co-insurance) and as payment in full for items and services that were not previously covered in such a manner by group health plans or issuers.

Potential for group health plans or issuers to negotiate rates that are lower than the cash price with out-of-network providers with whom they do not have established negotiated rates. Price gouging or other anti-competitive behavior (under both the policies and the alternatives for which we seek comment) by providers as well as any potential negative impact on premiums in the future that have not already been accounted for in 2021 rates. Please provide empirical evidence, if any, including based on claims data during the PHE for asthma treatment.

Potential savings to issuers and plans from insured consumers seeking out asthma treatment diagnostic testing from in-network providers, as opposed to the provider of their choice, as a result of these increased price transparency requirements. Price sensitivity by consumers covered by group health plans or issuers in their choice of provider, and awareness of any potential cost-shifting to group health plans or issuers, or to consumers themselves through balance billing, as a result of these increased price transparency requirements. Transparency benefits for the uninsured, who may already have an incentive to find the lowest price.

Group health plans or issuers taking on new consumer education or other potential costs, for example, costs associated with incentivizing consumers covered by group health plans or issuers to stay in network or seek care from lower cost providers.Start Printed Page 71154 3. Monitoring and Enforcement of Requirements To Publicize Cash Prices for asthma treatment Diagnostic Tests Section 3202(b)(2) of the CARES Act authorizes and provides the Secretary discretion to impose a CMP on any provider of a diagnostic test for asthma treatment that is not in compliance with section 3202(b)(1) of the CARES Act and has not completed a CAP to comply with the requirements of such paragraph, in an amount not to exceed $300 per day that the violation is ongoing. In this IFC, we are adopting mechanisms to monitor the requirement that a provider of a diagnostic test for asthma treatment publicize the cash price for diagnostic testing and enforce these requirements, as necessary.

A. Monitoring for Noncompliance and Pre-Penalty Actions Section 3202(b)(1) of the CARES Act does not prescribe monitoring procedures or the factors we should consider in imposing penalties on providers for noncompliance. We anticipate relying predominantly on complaints made to CMS by the public, including individuals, as well as issuers and plans, regarding providers' potential noncompliance.

Specifically, in response to such complaints, we may investigate and evaluate whether a provider has complied with the requirements discussed above. The monitoring methods for determining a provider's compliance with the requirements for publicizing the cash price for a asthma treatment diagnostic test may include, but are not limited to, the following, as appropriate. CMS' evaluation of complaints made to CMS.

CMS' review of an individual's or entity's analysis of noncompliance as stated in the complaint. CMS' review of providers' websites or, where a provider does not have a website, its written notice and signage. The IFC includes these monitoring methods in the regulations at Â§â182.50(a).

Impose a CMP on the provider if the provider fails to respond to CMS' request to submit a CAP or to comply with the requirements of a CAP approved by CMS. A provider that CMS identifies as noncompliant and to which it offers an opportunity to take corrective action to come into compliance may be notified via a warning notice of its deficiencies. In response to the warning letter, a provider may choose, but is not required, to submit documentation for CMS to review to determine compliance.

CMS will review any documentation a provider may submit and, where applicable, a provider's website or other form of written notice, to determine if the provider's noncompliance has been corrected. In the event that a provider does not have its own website on which to post the cash price, CMS will require documentation that the provider has the cash price in written form timely upon request and, where applicable, has posted signage at the provider's facility. At Â§â182.60, we specify the requirements for CAPs.

Specifically, Â§â182.60(a) states that a provider may be required to submit a CAP if CMS determines a provider is noncompliant or the provider's noncompliance continues after a warning notice. A violation may include, but is not limited to, a provider's failure to make public its cash price information for asthma treatment diagnostic testing required by Â§â182.40 and a provider's failure to make public its cash price information in the form and manner required under Â§â180.40. Section 182.60(b) states that CMS may request that a provider submit and comply with a CAP, specified in a notice of violation issued by CMS to a provider.

Additionally, in Â§â182.60(c), we specify the following provisions related to CAPs. A provider required to submit a CAP must do so, in the form and manner, and by the deadline, specified in the notice of violation issued by CMS to the provider, and must comply with the requirements of the CAP approved by CMS. A provider's CAP must specify elements including, but not limited to, the corrective actions or processes the provider will take to address the deficiency or deficiencies identified by CMS, and the timeframe by which the provider will complete the corrective action.

A CAP is subject to CMS review and approval. After CMS' review and approval of a provider's CAP, CMS may monitor and evaluate the provider's compliance with the corrective actions specified in the CAP. Section 182.60(d) outlines the following provisions for identifying a provider's noncompliance with CAP requests and requirements.

A provider's failure to respond to CMS' request to submit a CAP includes failure to submit a CAP in the form, manner, or by the deadline, specified in a notice of violation issued by CMS to the provider. A provider's failure to comply with the requirements of a CAP includes failure to correct violation(s) within the specified timeframes. We seek comment on this approach for monitoring providers of asthma treatment diagnostic testing for compliance with these requirements.

Specifically, we seek comments on relying predominantly on complaints to determine a provider's potential noncompliance. We further seek comments on issuing warning letters and requesting CAPs for violations related to making public cash prices for asthma treatment diagnostic testing. Additionally, we seek comments on the length of time we should specify in warning notices to allow corrections of violations before issuance of a request for CAP, and the length of time we should specify for providers to complete and return a CAP to CMS.

At Â§â182.70(a), we finalize a policy that CMS may impose a CMP on a provider that we identify as noncompliant with any of the requirements of Â§â182.40, and that fails to respond to CMS' request to submit a CAP or to comply with the requirements of a CAP approved by CMS described in Â§â182.60(d). Under the statute, the maximum daily dollar amount for a CMP to which a provider may be subject is $300, even if the provider is in violation of multiple discrete requirements of Â§â182.40. The maximum daily amount of the CMP will be adjusted annually using the multiplier determined by the Office of Management and Budget (OMB) for annually adjusting CMP amounts under 45 CFR part 102.

CMS will provide a written notice of imposition of a CMP to the provider via certified mail or another form of traceable carrier. The elements of this notice to the provider will include but are not limited to the following. The basis for the provider's noncompliance, including, but not limited to, the following.

CMS' determination as to which requirement(s) the provider has violated. And the provider's failure to respond to CMS' request to submit a Start Printed Page 71155CAP or comply with the requirements of a CAP. CMS' determination as to the effective date for the violation(s).

The amount of the penalty as of the date of the notice. A statement that a CMP may continue to be imposed for continuing violation(s). Payment instructions.

A statement of the provider's right to a hearing according to Â§â182.90 of subpart D. A statement that the provider's failure to request a hearing within 30 calendar days of the issuance of the notice permits the imposition of the penalty, and any subsequent penalties pursuant to continuing violations, without right of appeal. CMS may issue subsequent notice(s) of imposition of a CMP, according to the aforementioned requirements (in short, where investigation reveals there is continuing justification), that result from the same instance(s) of noncompliance.

A provider must pay the CMP in full within 60 calendar days after the date of the notice of imposition of a CMP from CMS. In the event a provider requests a hearing, under subpart D of 45 CFR part 182, the provider must pay the amount in full within 60 calendar days after the date of a final and binding decision to uphold, in whole or in part, the CMP. If the 60th calendar day is a weekend or a Federal holiday, then the timeframe is extended until the end of the next business day.

Should a provider elect to appeal the CMP, and where the CMP is upheld only in part by a final and binding decision, CMS will issue a modified notice of imposition of a CMP, to conform to the adjudicated finding as specified in Â§â182.70. In the event a CMP is not paid in full within 60 days, CMS will follow the collections activities set forth in 45 CFR part 30. Generally, CMS will issue a written demand for payment no later than 30 days after a debt is delinquent.

For debts not paid by the date specified in the written demand, interest, charged at a rate established by the Secretary of the Treasury, shall accrue from the date of delinquency. CMS will transfer debts 180 days or more delinquent to the Department of Treasury for collection. We seek comment on the approach we are establishing for imposing a CMP on a provider noncompliant with the regulations set forth in Â§â182.40.

Specifically, we seek comments on the length of time allowed between issuance of the request for CAP and the imposition of a CMP. In addition, we seek comments on the amount of the CMP imposed per day up to the statutory maximum daily amount that would be applicable to all noncompliant providers. C.

Appeals Process We believe it is important to establish a fair administrative process by which providers may appeal CMS' decisions to impose penalties under the requirements established by Â§â182.40. Through various programs, we have gained experience with administrative hearings and other processes to review CMS' determinations. That experience includes the processes we recently finalized in the CY 2020 Hospital Outpatient Prospective Payment System (OPPS) Price Transparency Final Rule (84 FR 65524) and corresponding regulations at 45 CFR part 180, which requires price transparency for hospitals, and we are aligning the procedures for the appeals process here with those procedures.

Therefore, a provider upon which CMS has imposed a penalty under Â§â182.70 may appeal that penalty in accordance with Â§Â§â180.100 and 180.110, subpart D, with conforming edits. Generally, under this approach, a provider upon which CMS has imposed a penalty may request a hearing of that penalty before an Administrative Law Judge (ALJ). The CMS Administrator, at his or her discretion, may review in whole or in part the ALJ's decision.

A provider against which a final order imposing a CMP is entered may obtain judicial review. We specify at Â§â182.80 the procedures for a provider to appeal the CMP imposed by CMS for its noncompliance with the requirements of Â§â182.40 to an ALJ, and for the CMS Administrator, at his or her discretion, to review in whole or in part the ALJ's decision. In so doing, we apply the following conforming modifications to the text.

References to âhospitalâ are replaced by the term âprovider.â We note that the term âprovider,â as defined at new 45 CFR 182.20 in this rule, may also include hospitals. References to âstandard chargeâ are replaced by the term âcash price.â We seek comment on the approach we are establishing for appeals. We also set forth in Â§â182.90 the consequences for failure of a provider to request a hearing.

If a provider does not request a hearing within 30 calendar days of the issuance of the notice of imposition of a CMP described in Â§â182.70(b), CMS may impose the CMP indicated in such notice and may impose additional penalties under continuing violations according to Â§â182.70(e) without right of appeal. If the 30th calendar day is a weekend or a Federal holiday, then the timeframe is extended until the end of the next business day. The provider has no right to appeal a penalty with respect to which it has not requested a hearing in accordance with 45 CFR 150.405, unless the provider can show good cause, as determined at Â§â150.405(b), for failing to timely exercise its right to a hearing.

D. Medicare Inpatient Prospective Payment System (IPPS) New asthma treatments Add-On Payment (NCTAP) for the Remainder of the Public Health Emergency (PHE) 1. Section 3710 of the CARES Act IPPS Add-On Payment for asthma treatment Patients During the PHE Section 3710 of the CARES Act amended section 1886(d)(4)(C) of the Act to provide for an increase in the weighting factor of the assigned Diagnosis-Related Group (DRG) by 20 percent for an individual diagnosed with asthma treatment discharged during the period of the PHE for asthma treatment.

Overview of IPPS New Technology Add-On Payment The new medical service or technology add-on payment policy under the IPPS provides additional payments for cases with relatively high costs involving eligible new medical services or technologies, while preserving some of the incentives inherent under an average-based prospective payment system. The payment mechanism is based on the cost to hospitals for the new medical service or technology. Sections 1886(d)(5)(K) and (L) of the Act establish a process of identifying and ensuring adequate payment for new medical services and technologies (sometimes collectively referred to in this section as ânew technologiesâ) Start Printed Page 71156under the IPPS.

The regulations at 42 CFR 412.87 and 412.88 implement these provisions. As set forth in Â§â412.88(b)(2), for a new technology other than certain antimicrobial products (for which the maximum add-on payment is 75 percent), if the costs of a discharge involving a new technology exceed the full DRG payment (including payments for Indirect Medical Education (IME) and Disproportionate Share Hospital (DSH), but excluding outlier payments)), Medicare will make a new technology add-on payment equal to the lesser of. (1) 65 percent of the costs of the new technology.

Or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment. For additional information regarding IPPS new technology add-on payments please see the FY 2021 IPPS/LTCH PPS final rule (85 FR 58602 through 58608). 3.

Overview of the Food and Drug Administration (FDA) asthma Treatment Acceleration Program The FDA has created a special emergency program for possible asthma therapies, the asthma Treatment Acceleration Program. The program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. The FDA continues to support clinical trials that are testing new treatments for asthma treatment so that valuable knowledge about their safety and effectiveness can be gained.

Additional information regarding this program is available on the FDA website at https://www.fda.gov/âdrugs/âasthma-asthma treatment-drugs/âasthma-treatment-acceleration-program-ctap. One aspect of the program is the issuance by the FDA of EUAs during the PHE for asthma treatment. On February 4, 2020, pursuant to Section 564(b)(1)(C) of the FD&C Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a PHE that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the ventolin that causes asthma treatment.[] On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the asthma treatment ventolin, pursuant to section 564 of the FD&C Act, subject to terms of any authorization issued under that section.[] There are currently five drug and biological products with EUAs issued during the PHE for asthma treatment.

In section âI. Criteria for Issuance of Authorizationâ of the current letters of authorization for these drug and biological products, the letters for two of the products state that based on the totality of scientific evidence available to FDA, it is reasonable to believe that the product may be effective in treating asthma treatment, and that, when used under the conditions described in the authorization, the known and potential benefits of the product when used to treat asthma treatment outweigh the known and potential risks of such products.[] [1] Those two drug and biological products are asthma treatment convalescent plasma and Veklury (remdesivir). The current letters of authorization for the other three products used in patients with suspected or confirmed asthma treatment do not indicate that those products are treating asthma treatment and instead treat a disease or condition caused or exacerbated by asthma treatment.[] Specifically, the letter of authorization for REGIOCIT indicates its use as a replacement solution in adult patients in a critical care setting who are being treated with Continuous Renal Replacement Therapy (CRRT) and for whom regional citrate anticoagulation (RCA) is appropriate.

The letter of authorization for Fresenius Propoven 2 percent Emulsion indicates its use to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an ICU setting. And the letter of authorization for multiFiltrate PRO System and multiBic/multiPlus Solutions indicates its use in delivering CRRT in an acute care environment. While asthma treatment convalescent plasma has received an EUA for treating asthma treatment in hospitalized patients, Veklury (remdesivir), as of October 22, 2020, is the only drug or biological product approved by FDA for treating asthma treatment.[] In order for an item or service to be considered for coverage under Medicare Part A or Part B, the item or service must fall within at least one benefit category established in the Act.

Drugs and biologicals are included within several such benefit categories. In general, section 1861(t)(1) of the Act defines drugs and biologicals to include drugs or biologicals approved for inclusion in certain compendia (except for any drugs and biologicals unfavorably evaluated therein) or that are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of a hospital furnishing that drug or biological for use in that hospital. CMS has determined that it is appropriate for CMS to consider drug and biological products which are authorized for emergency use for asthma treatment, with letters of authorization, and are used to treat asthma treatment disease, to fall within the drugs and biologicals definition in section 1861(t)(1) of the Act for Medicare purposes if they are included or approved for inclusion in the applicable compendia, or when furnished by a specific hospital if approved for use in that hospital by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of that hospital.

More information regarding EUAs for drug and biological products during the PHE for asthma treatment is available on the FDA website at https://www.fda.gov/âemergency-preparedness-and-response/âmcm-legal-regulatory-and-policy-framework/âemergency-use-authorization#asthma treatmentdrugs. 4. Overview of IPPS Outlier Payments Section 1886(d)(5)(A) of the Act provides for payments in addition to the basic prospective payments for âoutlierâ cases involving extraordinarily high costs.

To qualify for outlier payments, one criterion is that a case must have costs greater than the sum of the prospective payment rate for the MS-DRG, any IME and DSH payments, uncompensated care payments, any new technology add-on payments, and the âoutlier thresholdâ or âfixed-lossâ amount (a dollar amount by which the costs of a case must exceed payments in order to qualify for an outlier payment). We refer to the sum of the prospective payment rate for the MS-DRG (including the Section 3710 of the CARES Act add-on payment if applicable), any IME and DSH payments, uncompensated care Start Printed Page 71157payments, any new technology add-on payments, and the outlier threshold as the outlier âfixed-loss cost threshold.â Payments for eligible cases are then made based on a marginal cost factor, which is a percentage of the estimated costs above the fixed-loss cost threshold. The marginal cost factor is 80 percent for all MS-DRGs except the burn MS-DRGs, where the marginal cost factor is 90 percent.

For the complete formula for how an outlier payment is computed, we refer the reader to the FY 2021 IPPS/LTCH PPS final rule (85 FR 59043 through 59044). We note, for each claim, per the formula in the FY 2021 IPPS/LTCH PPS final rule, in determining whether the claim is eligible for an operating outlier payment and/or a capital outlier payment, an âoperating outlier thresholdâ and a âcapital outlier thresholdâ are computed, including application of a geographic adjustment to account for local cost variation. If the case is eligible, an âoperating outlier paymentâ and/or âcapital outlier paymentâ will be made for an individual claim.

Therefore, effective for discharges occurring on or after the effective date of this rule and until the end of the public health emergency, CMS is using the exceptions and adjustment authority under section 1886(d)(5)(I) of the Act to create a New asthma treatments Add-on Payment (NCTAP) under the IPPS for asthma treatment cases that meet certain criteria. First, the case must include the use of a drug or biological product authorized to treat asthma treatment as indicated in section âI. Criteria for Issuance of Authorizationâ of the current letter of authorization for the drug or biological product, or the drug or biological product must be approved by the FDA for treating asthma treatment.

Because the purpose of the NCTAP is to mitigate potential financial disincentives for hospitals to provide new asthma treatments, this criterion expeditiously provides assurance in the context of the urgency of the PHE that a treatment is new and is used to treat asthma treatment during the PHE. Currently, there are only two drug or biological products that meet this criterion. Veklury (remdesivir) and asthma treatment convalescent plasma.

However, as additional drug and biological products become available that meet this criterion, cases that use those products would become eligible for the NCTAP if the remaining criteria are met. Second, the case must also be eligible for the 20 percent increase in the weighting factor for the assigned MS-DRG for an individual diagnosed with asthma treatment discharged during the period of the PHE for asthma treatment under section 3710 of the CARES Act. The primary purposes of this criterion are to help appropriately identify asthma treatment cases to potentially receive the NCTAP, and ensure for program integrity reasons that there is a positive asthma treatment laboratory test documented in the patient's medical record.

The cost of the case is determined by multiplying the covered charges by the operating cost-to-charge ratio, the same way it is determined for new technology add-on payments and operating outlier payments. We note that all generally applicable statutory and regulatory requirements during the PHE for Medicare payment for a particular case must continue to be met, and that the NCTAP will only be available to the extent that the new asthma treatment meets all coverage requirements under Medicare, including that the use of a drug or biological product is medically reasonable and necessary for that case. No applicable Medicare requirements during the PHE are being waived by the creation of the NCTAP policy.

6. Determination of the IPPS NCTAP Amount for the Remainder of the PHE As indicated earlier, the goal of the NCTAP is to mitigate potential financial disincentives for hospitals to provide new asthma treatments. These potential financial disincentives are already mitigated in part by the IPPS outlier payment, but we recognize that the costs of a case must exceed payments by the âoutlier thresholdâ or âfixed-lossâ amount before outlier payments are made.

For FY 2021, the outlier threshold is approximately $30,000. As discussed previously, the outlier threshold is adjusted to account for local cost variation in determining whether an individual claim is eligible for outlier payments. As a simplified example for purposes of illustration, if the operating costs of a case using a new asthma treatment exceed the operating IPPS payment by $10,000, there are no Medicare outlier payments made for this case because the costs are less than the outlier threshold.

We believe that in order to further mitigate any potential financial disincentives for hospitals to provide new asthma treatments, the NCTAP, when needed, should function to partially offset costs that exceed the Medicare payment, but are less than the outlier threshold. By partially rather than fully offsetting these costs, we believe that the NCTAP, similar to the new technology add-on payment policy under the IPPS, preserves some of the incentives inherent under an average-based prospective payment system. One way in which the new technology add-on payment policy accomplishes this goal is by making the new technology add-on payment equal to the lesser of.

(1) 65 percent of the costs of the new technology. Or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment. We believe that the new technology add-on payment calculation provides an appropriate conceptual framework for the NCTAP calculation.

In the context of the urgency of the PHE for asthma treatment, however, and the practical and operational challenges of individually tailoring the payment calculation to each new treatment, we believe the NCTAP calculation should take into account 65 percent of the amount by which the costs of the case exceed the standard DRG payment, without comparison to 65 percent of the costs of the new treatment itself. As part of the approval process for the new technology add-on payment for a given new technology, the claims processing system is modified and tailored to apply the new technology add-on payment for that technology using cost and coding information according to the âlesser ofâ policy described above. In order to more expeditiously provide payment for cases meeting the previously described criteria in the context of the urgency of the PHE, we believe the NCTAP calculation should take into account 65 percent of the amount by which the costs of the case exceed the standard DRG payment for all cases that qualify Start Printed Page 71158for the NCTAP, without comparison to the costs of the new treatment as under the âlesser ofâ policy applicable for the new technology add-on payment.

We note that a hospital should not seek additional payment on the claim for drugs or biologicals procured or provided by a governmental entity to a provider at no cost to the provider to diagnose or treat patients with known or suspected asthma treatment, as described in the CMS Medicare Claims Processing Manual, Pub. 100-04, Chapter 32, Section 67. CMS will use ICD-10-PCS procedure codes XW033E5 (Introduction of Remdesivir Anti-infective into Peripheral Vein, Percutaneous Approach, New Technology Group 5) and XW043E5 (Introduction of Remdesivir Anti-infective into Central Vein, Percutaneous Approach, New Technology Group 5) to identify cases using remdesivir and ICD-10-PCS procedure codes XW13325 (Transfusion of Convalescent Plasma (Nonautologous) into Peripheral Vein, Percutaneous Approach, New Technology Group 5) and XW14325 (Transfusion of Convalescent Plasma (Nonautologous) into Central Vein, Percutaneous Approach, New Technology Group 5) to identify cases using convalescent plasma.

More information on the new procedure codes implemented into the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS) in response to the PHE for asthma treatment is available on the CMS website at https://www.cms.gov/âfiles/âdocument/âicd-10-ms-drgs-version-372-effective-august-01-2020.pdf. CMS will issue additional operational instructions on how eligible cases will be identified, including any new treatments that may become available. We also considered in the determination of the NCTAP amount that we did not want to inadvertently reduce the IPPS operating outlier payments that the hospital would have otherwise received for a costly asthma treatment case given that these outlier payments already help to mitigate potential financial disincentives for hospitals to provide new asthma treatments.

Therefore, we do not believe the calculation of the operating outlier payments should be impacted by the NCTAP. Taking these factors into account, CMS is setting the NCTAP amount for a case that meets the NCTAP eligibility criteria equal to the lesser of. (1) 65 percent of the operating outlier threshold for the claim or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment, including the adjustment to the relative weight under section 3710 of the CARES Act.

As with the new technology add-on payment and outlier payments, the costs of the case are determined by multiplying the covered charges by the operating cost-to-charge ratio. In addition, the NCTAP will not be included as part of the calculation of the operating outlier payments. Returning to our simplified example, if the cost of a case using a new asthma treatment exceeds the operating IPPS payment by $10,000 and the operating outlier threshold for the case is for purposes of illustration $30,000, the NCTAP would be $6,500 (= $10,000 excess cost Ã 0.65).

There would be no outlier payments because the excess cost of the case ($10,000) does not exceed the operating outlier threshold for the case ($30,000). As a simplified example of a case that qualifies for an operating outlier payment, if the cost of a case using a new asthma treatment exceeds the operating IPPS payment by $100,000, the NCTAP would be equal to the maximum NCTAP amount of 65 percent of the operating outlier threshold for the case. In this illustrative example, if the applicable operating outlier threshold for the claim is $30,000, that amount is $19,500 (equals first $30,000 of the excess cost before the operating outlier threshold for the claim is reached Ã 0.65).

In addition, the case would receive an outlier payment that is calculated the same way it is currently calculated in the absence of the $19,500 NCTAP, that is, $56,000 (= ($100,000 excess costâ$30,000 outlier threshold for the case) * the 0.80 outlier marginal cost factor). The combined NCTAP and outlier payment would be $75,500 (equals the $19,500 enhanced payment + the $56,000 outlier payment). E.

Medicare Outpatient Prospective Payment System (OPPS) Separate Payment for New asthma treatments Policy for the Remainder of the Public Health Emergency (PHE) 1. FDA asthma Treatment Acceleration Program The FDA has created a special emergency program to facilitate the development of asthma therapies, the asthma Treatment Acceleration Program. One aspect of the program is the issuance by the FDA of EUAs during the PHE for asthma treatment.

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the FD&C Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a PHE that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the ventolin that causes asthma treatment.[] On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biologics during the asthma treatment public health emergency, pursuant to section 564 of the FD&C Act, subject to terms of any authorization issued under that section.[] Readers should refer to Section D.3 of this interim final rule with comment period for a full discussion of the asthma Treatment Acceleration Program. There are currently five drug and biological products with EUAs issued during the PHE for asthma treatment. In section âI.

Criteria for Issuance of Authorizationâ of the current letters of authorization for these drug and biological products, the letters for two of the products state that based on the totality of scientific evidence available to FDA, it is reasonable to believe that the product may be effective in treating asthma treatment, and that, when used under the conditions described in the authorization, the known and potential benefits of the product when used to treat asthma treatment outweigh the known and potential risks of such products.[] Those drug and biological products are asthma treatment convalescent plasma and Veklury (remdesivir). While asthma treatment convalescent plasma has received an EUA for treating asthma treatment in hospitalized patients, Veklury (remdesivir), as of October 22, 2020, is the only drug or biological product approved by FDA for treating asthma treatment. As discussed in Section II.D.3 of this interim final rule with comment period, in order for an item or service to be considered for coverage under Medicare Part A or Part B, the item or service must fall within at least one benefit category established in the Act.

Drugs and biologicals are included within several such benefit categories. In general, section 1861(t)(1) of the Act defines drugs and biologicals to include drugs or biologicals approved for inclusion in certain compendia (except Start Printed Page 71159for any drugs and biologicals unfavorably evaluated therein) or that are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of a hospital furnishing that drug or biological for use in that hospital. CMS has determined that it is appropriate for CMS to consider drug and biological products which are authorized for emergency use for asthma treatment, with letters of authorization, and are used to treat asthma treatment disease, to fall within the drugs and biologicals definition in 1861(t)(1) of the Act for Medicare purposes if they are included or approved for inclusion in the applicable compendia, or when furnished by a specific hospital if approved for use in that hospital by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of that hospital.

2. OPPS Comprehensive-Ambulatory Payment Classification (C-APC) Policy To date, no drug or biological product has an EUA for the treatment of patients with asthma treatment in the outpatient setting. However, because treatment of asthma treatment is rapidly evolving, we believe it is important to ensure that separate payment is available under the OPPS for new drug and biological products (including blood products) that receive an EUA for treating asthma treatment in the outpatient setting or are approved by the FDA for treating asthma treatment in the outpatient setting, or where a drug or biological product approved under an existing EUA is authorized for use in settings other than the inpatient setting.

As part of that process, we expect to include the addition of new codes describing those treatments as soon as practicable, after their availability, to ensure efficient and timely beneficiary access to those treatments. We anticipate that most drugs and biological products authorized for use in treating asthma treatment in the outpatient setting would be separately paid under our standard OPPS payment policy because drugs and biological products are typically assigned separate Ambulatory Payment Classification payment status indicators in the OPPS unless they meet one of the criteria for packaging, which, with the exception of drug or biological products billed with a Comprehensive Ambulatory Payment Classification (C-APC) service, we do not anticipate that drugs or biological products approved or authorized to treat asthma treatment would meet. However, these products could be packaged into a C-APC when provided on the same claim as a C-APC service, in which case separate payment would not be made for these products.

Under our C-APC policy, which we adopted beginning in CY 2015, we designate a service described by a HCPCS code assigned to a C-APC as the primary service when the service is identified by OPPS status indicator âJ1â. When such a primary service is reported on a hospital outpatient claim, with certain exceptions, we make payment for all other items and services reported on the hospital outpatient claim as being integral, ancillary, supportive, dependent, and adjunctive to the primary service (hereinafter collectively referred to as âadjunctive servicesâ) and representing components of a complete comprehensive service (78 FR 74865 and 79 FR 66799). Payments for adjunctive services are packaged into the payments for the primary services.

This results in a single prospective payment for each of the primary, comprehensive services based on the costs of all reported services at the claim level. Items included in the packaged payment provided in conjunction with the primary service also include all drugs, biologicals, and radiopharmaceuticals, regardless of cost, except those drugs with pass-through payment status and self-administered drugs, unless they function as packaged supplies (78 FR 74868 through 74869 and 74909 and 79 FR 66800). Thus, under our current policy, payment for drugs or biological products with an emergency authorization or approved to treat asthma treatment in the outpatient setting would be packaged into payment for a primary C-APC service when billed on the same claim as that service.

Currently, there are 67 C-APCs in the CY 2020 OPPS, with payments ranging from approximately $1,000 to $37,000. Most C-APCs are for surgical or other intensive procedures, which we would expect most hospital outpatient departments would not perform on a patient that has an active case of asthma treatment. However, observation services can also be paid through the âComprehensive Observation Servicesâ C-APC (C-APC 8011), which packages payment for qualifying extended assessment and management encounters.

It is possible that future asthma treatments that are authorized or approved for use in the outpatient setting might be administered to patients under observation while the provider determines if the patient needs to be admitted to the hospital for asthma treatment. 3. Separate Payment Under the OPPS for New asthma treatments for the Remainder of the PHE for asthma treatment Although we do not expect that many beneficiaries would both receive a primary C-APC service and a drug or biological for treating asthma treatment, we nonetheless believe that as drugs or biologicals become available and are authorized or approved for the treatment of asthma treatment in the outpatient setting, it would be appropriate to mitigate any potential financial disincentives for hospitals to provide these new treatments during the PHE for asthma treatment.

Therefore, effective for services furnished on or after the effective date of this rule and until the end of the PHE for asthma treatment, CMS is creating an exception to its OPPS C-APC policy to ensure separate payment for new asthma treatments that meet certain criteria. Under this exception, any new asthma treatment that meets the two criteria below will, for the remainder of the PHE for asthma treatment, always be separately paid and will not be packaged into a C-APC when it is provided on the same claim as the primary C-APC service. Note that this separate payment will result in an additional copayment of 20 percent of the cost of the new asthma treatment, up to the amount of the inpatient deductible.

Because the purpose of this exception is to mitigate potential financial disincentives for hospitals to provide new asthma treatments, this criterion expeditiously provides assurance in the context of the urgency of the PHE for asthma treatment that a treatment is new and is used to treat asthma treatment disease during the PHE for asthma treatment. Second, the EUA for the drug or biological product (which could include a blood product) must authorize the use of the product in the outpatient setting or not limit its use to the inpatient setting, or the product must be approved by the FDA to treat asthma treatment disease and not limit its use to the inpatient setting. We note that during the PHE for asthma treatment this new exception to the C-Start Printed Page 71160APC packaging policy would apply to all drug and biological products that meet both of these criteria.

As of the date of issuance of this interim final rule there are two drug or biological products that meet the first criterion (Veklury (remdesivir) and asthma treatment convalescent plasma), but neither of these products is authorized or approved for use in the outpatient setting and, as a result, no product meets the second criterion. We also note that all generally applicable statutory and regulatory requirements for Medicare payment under the OPPS must continue to be met, and that OPPS payment will only be available to the extent that the new asthma treatment meets all coverage requirements under Medicare, including that the use of a drug or biological product is medically reasonable and necessary for the patient. No applicable Medicare requirements during the PHE are being waived by the creation of this C-APC exception.

4. Effects of This Exception on the OPPS Budget Neutrality Calculation As we noted in Section II.E.2, we believe it would be a fairly rare occurrence that an outpatient department would perform a C-APC procedure on a beneficiary being treated for asthma treatment because most C-APCs are for surgical or other intensive procedures and we would expect most hospital outpatients departments would not perform outpatient surgery on a patient that has an active case of asthma treatment. While it is possible that future asthma treatments that are authorized or approved for use in the outpatient setting might be administered to patients under observation while the provider determines if the patient needs to be admitted to the hospital for asthma treatment, it is our expectation that this hypothetical situation would not happen frequently.

Because we believe a new asthma treatment will rarely be provided on the same claim as a primary C-APC service, we believe new asthma treatments used in the outpatient setting will be separately paid under current policy the vast majority of the time. As a result, we do not believe it is necessary that we make an adjustment to OPPS budget neutrality calculations at this time to account for this new exception, as any budgetary effect of this new exception is likely to be de minimis. If, once new asthma treatments are being provided in the outpatient setting, the claims data indicates that these treatments are being provided on the same claim as a C-APC more frequently than we expected, we can make a prospective adjustment to the OPPS budget neutrality calculations through future rulemaking.

F. Temporary Increase in Federal Medicaid Funding 1. Background Section 6008 of the FFCRA, as amended by section 3720 of the CARES Act, provides a temporary 6.2 percentage point increase to each qualifying state and territory's Federal Medical Assistance Percentage (FMAP) under section 1905(b) of the Act (âtemporary FMAP increaseâ).

This temporary FMAP increase is effective beginning January 1, 2020 and could extend through the last day of the calendar quarter in which the PHE for asthma treatment, including any extensions, terminates, if the state claims the FMAP increase in that quarter (we refer herein to the entire period where the FMAP increase is potentially applicable as the âincreased FMAP periodâ). To qualify for the temporary FMAP increase in a given quarter, states must meet the four conditions described in subsection (b) of section 6008 of the FFCRA during that quarter. Three of these conditions (described at section 6008(b)(1), (2), and (4) of the FFCRA) could extend through the end of the increased FMAP period, if the state claims the increased FMAP through the end of the quarter in which the PHE for asthma treatment ends.

They are. (a) The state must maintain eligibility standards, methodologies, or procedures that are no more restrictive than what the state had in place as of January 1, 2020. (b) the state may not charge premiums that exceed those that were in place as of January 1, 2020;â[] and (c) the state must cover, without the imposition of cost sharing, testing services and treatments for asthma treatment, including treatments, specialized equipment, and therapies.

The fourth condition, which is described at section 6008(b)(3) of the FFCRA, extends through the last day of the month in which the PHE for asthma treatment ends. This condition provides that a state may not receive the temporary FMAP increase if âthe [s]tate fails to provide that an individual who is enrolled for benefits under [the Medicaid state] plan (or waiver) as of the date of enactment of this section [March 18, 2020] or enrolls for benefits under such plan (or waiver) during the period beginning on such date of enactment [March 18, 2020] and ending the last day of the month in which the [PHE for asthma treatment] ends shall be treated as eligible for such benefits through the end of the month in which such emergency period ends unless the individual requests a voluntary termination of eligibility or the individual ceases to be a resident of the State[.]â The language in section 6008(b)(3) of the FFCRA is somewhat ambiguous. CMS issued guidance on this condition through frequently asked questions (FAQs) posted on Medicaid.gov on April 13, 2020, May 5, 2020, and June 30, 2020.[] However, our existing interpretation (discussed in section II.F.2 of this preamble) is not the only possible interpretation that could be made.

As the PHE for asthma treatment continued, and states requested increased flexibility for managing their programs, we revisited our existing interpretation. Seeking to balance the beneficiary protections in our existing interpretation with the state flexibility that could be afforded through an alternative interpretation, this IFC establishes a blended approach as discussed below. 2.

CMS's Existing Interpretation of Section 6008(b)(3) of the FFCRA CMS first provided an interpretation of section 6008(b)(3) for implementation by states through FAQs issued in April 2020. Our most recent interpretation provided that to receive the increased FMAP under the FFCRA, a state must keep beneficiaries enrolled in Medicaid, if they were enrolled on or after March 18, 2020, with the same amount, duration, and scope of benefits. It also provided that states could not subject such beneficiaries to any increase in cost sharing or beneficiary liability for institutional services or other long-term services and supports (LTSS) during this time period.

This interpretation Start Printed Page 71161protects both beneficiary eligibility and access to medically necessary services. Under this interpretation, if a state receives information about a beneficiary's change in circumstances that would make the beneficiary ineligible for Medicaid, the state may not terminate that beneficiary's eligibility until the end of the month in which the PHE for asthma treatment ends, except in cases where the beneficiary voluntarily disenrolls or is no longer a resident of the state. Further, if the state receives information that would make a beneficiary eligible for a different eligibility group with lesser benefits, greater cost sharing, or increased beneficiary liability, the state may not transition that beneficiary to the new eligibility group but must maintain the beneficiary's enrollment in the current eligibility group until the end of the month in which the PHE for asthma treatment ends.[] In protecting access to medically necessary services pursuant to this interpretation, states must maintain current coverage in the state plan, including alternative benefit plans (ABPs), and must also maintain current coverage under any waivers and section 1115 demonstrations.

Further, if a beneficiary is enrolled in a home and community-based services (HCBS) waiver program authorized under section 1915(c) of the Act, and the individual is determined to no longer meet the level-of-care requirements or other requirements for that waiver, the state must maintain the beneficiary's enrollment in the HCBS waiver. Under this interpretation, states are not required to provide services that do not meet the state plan amount, duration, and scope criteria for a benefit (such as medical necessity). However, as a condition for receiving the temporary FMAP increase, the state must ensure that a beneficiary can continue to access the benefits package that was available to that beneficiary as of March 18, 2020 (or a later date within the PHE) through the end of the month in which the PHE for asthma treatment ends.

States have expressed concern that our existing interpretation of section 6008(b)(3) of the FFCRA makes it challenging for them to manage their programs effectively and still qualify for the increased Federal financial participation, in frustration of one purpose of section 6008 of the FFCRA to provide additional support to state Medicaid programs in their response to the asthma treatment ventolin. States made clear to CMS that this interpretation, coupled with the prohibition on adopting more restrictive eligibility standards, methodologies, or procedures under section 6008(b)(1) of the FFCRA, would impede the routine, orderly transition of beneficiaries between eligibility groups, and could lead to significant backlogs in redeterminations and appeals after the PHE for asthma treatment ends. States also noted that our existing interpretation severely limits state flexibility to control program costs in the face of growing budgetary constraints and developing fiscal challenges during the emergency period.

For example, it freezes post-eligibility treatment-of-income (PETI) calculations for institutionalized beneficiaries regardless of changes in circumstances. States have pointed out that a beneficiary receiving HCBS through a waiver approved under section 1915(c) of the Act who is subject to the PETI rules and who subsequently moves into an institution would be entitled to retain the higher personal needs allowance allowed for individuals participating in the relevant waiver, even though the beneficiary's personal needs would be far lower once in the institution. The aggregate effects of this interpretation could result in a substantial increase in the state Medicaid program's cost for the needed institutional services as beneficiaries are not contributing as much toward the cost of their care as they would be in the absence of the FFCRA 6008(b)(3) requirement.

In practice, the only cost-controlling measure available to states under our existing interpretation is reducing provider rates to the minimum level permitted under section 1902(a)(30)(A) of the Act. Such rate cuts, combined with a substantially lower volume of visits since the beginning of the ventolin,[] could put some providers out of business. This could undermine the solvency of critical provider networks and their ability to serve beneficiaries in the future, particularly in rural areas where health care workforce shortages may already exist.

3. Alternative Interpretation of Section 6008(b)(3) of the FFCRA CMS's existing interpretation of section 6008(b)(3) of the FFCRA is not the only possible, reasonable interpretation of that provision. The language in this section could also reasonably be interpreted to mean only that states must maintain the enrollment of beneficiaries who enrolled in the state's Medicaid program as of or after March 18, 2020, through the end of the month in which the PHE ends, but not the specific benefits package they were receiving at that time.

In other words, under this alternative interpretation, to fulfill the requirement in section 6008(b)(3) of the FFCRA with respect to a beneficiary who becomes ineligible for enrollment in his current Medicaid eligibility group, states would either (a) transition the beneficiary to another group for which he is eligible and enroll him for the benefits provided to that eligibility group, or (b) retain the beneficiary's enrollment in the original eligibility group, if he did not meet the eligibility criteria for any other group, and maintain the benefits provided to that group. Under this alternative interpretation, a state would be required to move a beneficiary who becomes eligible for another Medicaid eligibility group during the period in which section 6008(b)(3) of the FFCRA applies into that new group, no matter how limited the benefits package is for the new group. We refer to this alternative interpretation as the âenrollment interpretation.â Under the enrollment interpretation, states claiming the 6.2 percentage point temporary FMAP increase would be permitted to make programmatic changes, such as changes to the medical necessity criteria or utilization control procedures in determining coverage for benefits.

Elimination of optional benefits Start Printed Page 71162coverage. Increases in cost-sharing responsibilities (except with respect to testing services and treatments for asthma treatment per section 6008(b)(4) of the FFCRA). Or changes to the PETI methodology.

For example, states would be permitted to establish a limit on the number of visits permitted for a given service and to require a copayment for a service in accordance with Medicaid statute and regulations. These programmatic changes would not jeopardize the state's receipt of the temporary FMAP increase. In considering this interpretation, we note that Congress expressly conditioned receipt of the temporary FMAP increase on a state's temporarily not implementing âmore restrictiveâ âeligibility standards, methodologies, or proceduresâ in section 6008(b)(1), on temporarily not imposing higher premiums in section 6008(b)(2), and on covering asthma treatment testing and treatment services without cost-sharing in section 6008(b)(4).

However, Congress did not legislate with the same express clarity in section 6008(b)(3) with respect to states' ability or inability to reduce the amount, duration, and scope of benefits other than asthma treatment testing and treatment services or to eliminate optional benefits. Further, while Congress expressly prohibited states from imposing cost sharing on testing services and treatments for asthma treatment in section 6008(b)(4) of the FFCRA, Congress did not expressly provide in section 6008(b)(3) for any limitation on cost sharing, or on states' ability to modify cost sharing or beneficiaries' liability for the cost of other services (e.g., in accordance with the PETI rules set forth in 42 CFR part 435, subpart H, and 42 CFR 435.832 for beneficiaries receiving institutional services or other long-term services and supports who are subject to the PETI rules). Under the enrollment interpretation, states would be required to make individual beneficiary eligibility changes short of disenrollment from Medicaid entirely.

For example, states would be required to make changes to a beneficiary's eligibility to reflect a change in income, or a change related to age, pregnancy status, need for LTSS or other eligibility factors. A change of service, such as moving from participation in an HCBS waiver authorized under section 1915(c) of the Act into an institution or vice versa, would also require a change in eligibility for a beneficiary enrolled in an eligibility group specific to HCBS recipients, such as the group described at 42 CFR 435.217, or an eligibility group for individuals living in an institution like the special income level group described at 42 CFR 435.236. The enrollment interpretation would require states to move a beneficiary who loses eligibility under one Medicaid eligibility group and becomes eligible in a second Medicaid eligibility group into the second eligibility group, even if the second eligibility group confers lesser benefits or results in increased financial liability for the beneficiary.

However, as with our existing interpretation, under the enrollment interpretation states would not be permitted to terminate a beneficiary's eligibility unless the individual requested such termination or was no longer a state resident. If a beneficiary loses eligibility under one Medicaid eligibility group and is not eligible for another group, in order to claim the temporary FMAP increase, the state must maintain the beneficiary's enrollment in the current group until the end of the month in which the PHE for asthma treatment ends. Like the programmatic changes discussed previously, individual beneficiary eligibility changes would not jeopardize receipt of the temporary FMAP increase.

This optional coverage of tuberculosis and tuberculosis-related services is excepted from the definition of MEC at 26 CFR 1.5000A-2(b)(2)(ii) and transferring a beneficiary from an eligibility group that provides MEC to the eligibility group for individuals infected with tuberculosis would result in a significant reduction in available benefits. Another example of non-MEC coverage available through Medicaid is the optional eligibility group limited to family planning and related services at 42 CFR 435.214, which also provides only a limited benefits package pursuant to the matter following section 1902(a)(10)(G) of the Act, and which is excluded from MEC at 26 CFR 1.5000A-2(b)(2)(i). If the enrollment interpretation was adopted, following the postpartum period for coverage of pregnant women at 42 CFR 435.116, states that cover the optional family planning group (or that provide family planning-only coverage through a section 1115 demonstration) would be required to transfer women who do not qualify for a full-benefit Medicaid eligibility group into family planning-only coverage if they meet the eligibility requirements for the family planning-only group or demonstration.

The enrollment interpretation of section 6008(b)(3) of the FFCRA would make it more challenging for some beneficiaries to access medically necessary services, including services related to the asthma treatment ventolin. A beneficiary transferred to the family planning group following the end of her postpartum period would continue to have access to provider visits for family planning and outpatient drugs and supplies related to those visits, but she would no longer have access to testing services and treatment for asthma treatment, pursuant to CMS's interpretation of section 6008(b)(4) of the FFCRA, which is discussed above in section II.B. In addition, she would lose access to inpatient and outpatient hospital services, prescription drugs, and other Medicaid-covered services that are unrelated to family planning.

Beneficiaries with certain chronic conditions like diabetes and sickle cell disease are at higher risk for severe illness from the ventolin that causes asthma treatment.[] Under the enrollment interpretation, individuals who lose eligibility for a group that offers MEC may be transitioned to a limited benefit eligibility group, in a state that offers such coverage, in which they would no longer have access to the benefits needed to manage their chronic conditions. Not only would this negatively impact the beneficiary who loses comprehensive Medicaid coverage as a result of this interpretation, but it could also undermine states' asthma treatment response efforts during the public health emergency. 4.

Adopting a Blended Approach As we considered changing our interpretation of section 6008(b)(3) of the FFCRA, CMS examined the implications of both the existing and alternative interpretations on each of the major Medicaid stakeholder groups. Based on that analysis, this IFC adopts a blended approach. It is intended to balance the interests of states, providers, and beneficiaries, without materially undermining their ability to address the challenges presented by asthma treatment.Start Printed Page 71163 Looking first at states, the circumstances facing each state during the PHE for asthma treatment are different.

States have sent a strong message to CMS that they need more flexibility to make choices that meet their unique needs. They have made clear that our existing interpretation of section 6008(b)(3) of the FFCRA has interfered with their ability to implement cost-saving decisions in the face of increasing beneficiary enrollment and declining state revenues. The enrollment interpretation would allow states to impose coverage limitations that reduce spending and allow for better management of state programs during the PHE for asthma treatment.

More flexibility in managing their programs could help states to stretch scarce financial resources over the long term, including after the PHE for asthma treatment ends, and that could ultimately benefit both providers and beneficiaries. Supporting states and providers fighting the ventolin is consistent with the protections and the various provider relief funds established by Congress in the FFCRA, the CARES Act, and the PPPHCEA. While the enrollment interpretation of section 6008(b)(3) of the FFCRA may be the preferred option for states, we recognize that it could negatively impact certain provider types.

Under the enrollment interpretation, states could eliminate optional benefits. For example, a state could cut its optional dental benefit, and dentists in that state would lose Medicaid reimbursement. CMS's existing interpretation, however, leaves states with little ability to manage program costs other than by cutting provider rates to the fullest extent permitted under section 1902(a)(30)(A) of the Act.

We believe such rate cuts represent a far more significant threat to providers and their continued availability to beneficiaries. Under the enrollment interpretation, states may be less likely to reduce provider rates, which could benefit both providers and beneficiaries. Considering the impact on beneficiaries, our existing interpretation provided the strongest protections for beneficiary access to medically necessary care during the PHE.

It ensured that beneficiaries remained enrolled in Medicaid and that no new coverage restrictions were imposed. Every Medicaid beneficiary who had access to MEC and to testing services and treatment for asthma treatment as of or after March 18, 2020 would continue to have access to these services under the existing interpretation. The enrollment interpretation would also protect beneficiary enrollment in Medicaid.

At the same time, it would expand state flexibility to make cost-saving decisions that could reduce beneficiaries' coverage below what they had access to as of or after March 18, 2020. Under the enrollment interpretation, some beneficiaries would be transitioned from MEC to non-MEC coverage, which may not include testing services and treatment for asthma treatment pursuant to CMS's interpretation of FFCRA section 6008(b)(4). Ensuring access to testing and treatment, along with care for the chronic health conditions that place beneficiaries at higher risk for asthma treatment, is important for fighting the ventolin.

Seeking to balance the needs of each stakeholder group, both in fighting the ventolin and ensuring long-term program sustainability, this IFC adopts a blended approach to interpreting section 6008(b)(3) of the FFCRA. This blended approach adopts the state flexibility available through the enrollment interpretationâallowing states to make programmatic changes to benefits and cost sharing and to transition individual beneficiaries between eligibility groups with differing benefit packagesâwhile also establishing parameters to prevent beneficiaries from losing access to comprehensive coverage, consistent with our existing interpretation, through the end of the month in which the PHE for asthma treatment ends. This blended approach is expected to give states more flexibility, beyond what is available under our existing interpretation, to manage their Medicaid programs.

Under this blended approach, CMS is giving states a wider degree of flexibility to effectuate enrollment transitions during the PHE for asthma treatment, which could decrease backlogs in redeterminations and appeals following the PHE for asthma treatment, thereby simplifying state implementation of the conditions in FFCRA section 6008(b)(3) and administration of the state plan. These parameters are also expected to help ensure that states are determining eligibility, and providing care and services, in a manner that is consistent with the best interests of beneficiaries, as described in section 1902(a)(19) of the Act. That is because CMS is giving states less flexibility to reduce beneficiaries' coverage under this blended approach than might be available to states under the enrollment interpretation, in an effort to help protect beneficiaries' access to potentially necessary medical care during the period in which the FFCRA 6008(b)(3) requirement applies.

We therefore believe this blended approach balances the interests of all stakeholders consistent with the statute. This IFC adds a new subpart G, Temporary FMAP Increase During the Public Health Emergency for asthma treatment, to 42 CFR part 433, including a new Â§â433.400. Section 433.400(a) describes the statutory basis for this provision, while Â§â433.400(b) provides definitions specific to this subpart.

As described in detail below, Â§â433.400(c) requires states, as a condition for receiving the temporary FMAP increase, to maintain beneficiary enrollment in an eligibility group that provides one of three tiers of coverage through the end of the month in which the PHE for asthma treatment ends, except under the circumstances specified in paragraph (d). This provision generally does not require states to provide the exact same (or greater) amount, duration, and scope of medical assistance, or maintain the cost-sharing or PETI liability for a particular beneficiary at the same (or lower) level that was applicable to the beneficiary as of March 18, 2020 or subsequent date of initial enrollment during the PHE. Section 433.400 is effective immediately upon display of this rule.

CMS' previous interpretation, as described in section II.F.2. Of this preamble, continues to apply from the beginning of the quarter up to the date that this IFC is displayed. 5.

Maintaining Enrollment in the Same Tier of Coverage As discussed, we believe that interpreting FFCRA section 6008(b)(3) only to require continued enrollment in a state's Medicaid program (even if benefits are strictly limited), could have significant negative consequences for both beneficiaries and efforts to combat the asthma treatment ventolin. Some beneficiaries may transition from medical assistance that qualifies as MEC to non-MEC coverage, and some may even lose access to asthma treatment testing Start Printed Page 71164services and treatment. CMS has not interpreted section 6008(b)(4) of the FFCRA to require state Medicaid programs to cover asthma treatment testing services and treatment for beneficiaries whose Medicaid eligibility is limited by statute or under existing section 1115 demonstration authority to coverage for care and services that are for a specific (non-asthma treatment-related) condition, disease or purpose and that would not otherwise include asthma treatment testing and treatment services.

Consistent with the blended approach to interpreting section 6008(b)(3) of the FFCRA that is described above, and consistent with section 1902(a)(4) and (a)(19) of the Act, we are requiring states to ensure that beneficiaries who were validly enrolled for benefits as of or after March 18, 2020 with access to minimum essential coverage retain access to minimum essential coverage, and to ensure that beneficiaries with access to testing services and treatment for asthma treatment maintain access to those services. We believe it is reasonable to interpret the term âenrolled for benefitsâ in section 6008(b)(3) to mean validly enrolled, such that those who were erroneously enrolled are not to be considered âenrolled for benefitsâ for purposes of FFCRA section 6008. Therefore, we define âvalidly enrolledâ at Â§â433.400(b) to mean that the beneficiary was enrolled in Medicaid based on a determination of eligibility, including during the retroactive eligibility period, and that the beneficiary was not erroneously granted eligibility at the point of application or last redetermination (if such last redetermination was completed prior to March 18, 2020) because of.

(1) Agency error. Or (2) fraud (as evidenced by a fraud conviction) or abuse (as determined following the completion of an investigation pursuant to 42 CFR 455.15 and 455.16) attributed to the beneficiary or the beneficiary's representative which was material to the determination of eligibility. Terminating the eligibility of beneficiaries who are not validly enrolled as defined at Â§â433.400(b) will not impact a state's ability to claim the temporary FMAP increase.

We note that prior to termination, however, the state must complete a redetermination consistent with 42 CFR 435.916 and provide the beneficiary with advance notice and the opportunity for a fair hearing consistent with 42 CFR part 431, subpart E. Additionally, individuals receiving medical assistance during a presumptive eligibility period in accordance with section 1902(a)(47) of the Act and 42 CFR part 435, subpart L, have not received a determination of eligibility by the state under the state plan and therefore are not considered to be validly enrolled for continuous coverage under section 6008(b)(3) of the FFCRA. In order to receive the temporary FMAP increase (defined at Â§â433.400(b)) for any quarter in which it is available, a state must meet the requirements described in paragraph (c).

As described in Â§â433.400(c)(1)(i), for the quarter in which this rule becomes effective, states would be expected to meet the requirements described in Â§â433.400(c)(2) and (3) only from the date of display through the end of the quarter. CMS' previous interpretation, as described in section II.F.2. Of this preamble and in the FAQs cited therein, continues to apply from the beginning of the quarter up to the date this rule is effective.

For all quarters following the effective date of this rule, states would be expected to meet the requirements of Â§â433.400(c) for the entirety of the quarter in order to claim the temporary FMAP increase. Section 433.400(c)(2) requires states to maintain the enrollment of all beneficiaries who were validly enrolled on or after March 18, 2020. Paragraphs (c)(2)(i), (ii), and (iii) of 433.400 establish safeguards for the maintenance of enrollment.

For beneficiaries who were not validly enrolled during this period, and whom the state is therefore permitted to disenroll, the state must provide advance notice of termination and fair hearing rights in accordance with 42 CFR 435.917 and 42 CFR part 431, subpart E, when terminating coverage. Consistent with the Secretary's rulemaking authority under section 1102 of the Act and section 1902(a)(19) of the Act, which provides for such safeguards as are needed to ensure that care and services are provided in a manner consistent with the best interests of beneficiaries, Â§â433.400(c)(2) establishes three tiers of Medicaid coverage. These coverage tiers will help to ensure that beneficiaries protected under section 6008(b)(3) of the FFCRA in states claiming the temporary FMAP increase, who no longer meet eligibility requirements for the initial eligibility group in which they are enrolled but who become eligible under a different eligibility group or who lose Medicaid eligibility entirely, do not experience a reduction in covered benefits that would be inconsistent with section 1902(a)(19) of the Act, or with our interpretation of sections 6008(b)(3) and (4) of the FFCRA.

In contrast, if the beneficiary lost eligibility for a group that provides MEC, but gained eligibility for coverage that does not meet the definition of MEC, the state may not move the beneficiary to the new group or demonstration but must instead maintain the beneficiary's access to coverage meeting the definition of MEC during the period in which the rule applies, except as discussed below. For example, the state must transition a beneficiary enrolled in the eligibility group for children under age 19 at 42 CFR 435.118 to the adult group described at 42 CFR 435.119 when the beneficiary reaches age 19, provided that the state covers this group and the beneficiary meets the eligibility requirements of the group. That is because the medical assistance provided under the eligibility group for children under age 19 includes full state plan benefits with no cost sharing, which meets the definition of MEC, and the medical assistance offered under the adult group may include a somewhat different set of benefits through the state's ABP, and may include cost sharing for certain services, but it also meets the definition of MEC.

This transition would therefore be permissible under Â§â433.400(c)(2)(i). In contrast, a state may not transition a beneficiary from the eligibility group for children under age 19 or the adult group, both of which provide MEC, to a limited benefit group that does not provide MEC, such as the family planning group at 42 CFR 435.214, which covers only family planning and family planning-related services. As described further in Â§â433.400(c)(2)(iv), if a beneficiary receiving tier 1 coverage no longer meets the eligibility requirements for the original group in which he or she was enrolled, and the beneficiary does not meet the requirements for any other eligibility groups with tier 1 coverage, the state Start Printed Page 71165must continue to provide the medical assistance offered under the eligibility group in which the beneficiary was eligible on or after March 18, 2020.

At Â§â433.400(c)(2)(i)(B), we establish a variation on this requirement for beneficiaries who have coverage meeting the definition of MEC as of or after March 18, 2020, and whom the state subsequently determines are eligible for coverage under a Medicare Savings Program eligibility group. The Medicare Savings Program is defined at Â§â433.400(b) to include the eligibility groups described at section 1902(a)(10)(E)(i), (iii), and (iv) of the Act. For such beneficiaries, the state satisfies the requirement described in paragraph (c)(2) of this section if it furnishes the medical assistance available through the Medicare Savings Program, because the coverage that beneficiary receives under the Medicare program qualifies as MEC.

Thus, for example, a beneficiary enrolled in the adult group as of or after March 18, 2020, may be transitioned to a Medicare Savings Program eligibility group, such as the qualified Medicare beneficiaries (QMB) group described at section 1902(a)(10)(E)(i) of the Act, when the beneficiary reaches age 65, if the beneficiary meets the eligibility requirements of the QMB group. Such a beneficiary would receive Medicaid coverage of Medicare premiums and Medicare-related cost sharing through the QMB group. However, unless that beneficiary was also eligible for another full-benefit Medicaid eligibility group, all of the beneficiary's health care services would be provided through Medicare and the beneficiary would not receive any other Medicaid covered services.

While the medical assistance provided under the adult group differs from the medical assistance provided under the QMB group, the beneficiary maintains access to MEC. Therefore, the state may transition the beneficiary from the adult group to a Medicare Savings Program group. The second tier of coverage, which is described at Â§â433.400(c)(2)(ii), consists of coverage that is not defined as MEC but that is robust enough to include access to coverage of both testing services and treatment for asthma treatment under CMS's interpretation of FFCRA section 6008(b)(4).

Not all Medicaid coverage qualifies as MEC, and the non-MEC coverage provided to beneficiaries can vary greatly. As noted previously, some beneficiaries' coverage is limited by statute or existing section 1115 demonstration authority to a very narrow range of services that would not include asthma treatment testing or treatment services, and CMS has not interpreted section 6008(b)(4) of the FFCRA to require states to cover asthma treatment testing and treatment services for those beneficiaries. However, other Medicaid beneficiaries receive a relatively robust set of benefits, such as pregnancy-related services described in the matter following section 1902(a)(10)(G) of the Act, which would include testing services and treatment for asthma treatment, including treatments, specialized equipment, and therapies, during the period when FFCRA section 6008(b)(4) applies in a state, but which does not qualify as MEC in all states.

Section 433.400(c)(2)(ii) of this IFC provides that states must continue to provide Medicaid coverage that includes coverage of asthma treatment testing services and treatments, including treatments, specialized equipment, and therapies, to beneficiaries who had access to coverage in tier 2 as of or after March 18, 2020. Thus, states must transition beneficiaries who lose eligibility for tier 2 coverage but gain access to MEC coverage in tier 1 or to other coverage in tier 2 to the new eligibility group or demonstration, but they may not transition such beneficiaries to coverage that does not include access to testing services and treatment for asthma treatment. This interpretation is consistent with the requirement for states claiming the temporary FMAP increase to provide coverage for testing services and treatments for asthma treatment, as described at section 6008(b)(4), and with CMS's interpretation of that requirement.

Consistent with Â§â433.400(c)(2)(ii), a state must transition a beneficiary from tier 2 coverage to tier 1 coverage if that beneficiary becomes eligible for coverage that qualifies as MEC. For example, a state must transition a woman receiving tier 2 postpartum coverage under the pregnant women group described at 42 CFR 435.116 (in a state in which such coverage is not considered MEC) to the adult group described at 42 CFR 435.119 at the end of the postpartum period, because coverage under the adult group qualifies as MEC and is therefore included in tier 1. If this postpartum beneficiary was not eligible for any eligibility groups with tier 1 coverage, such as in a state that does not cover the adult group, but was eligible for tier 2 coverage, such as through a limited benefit section 1115 demonstration providing non-MEC coverage that includes access to testing services and treatment for asthma treatment, the state must move her to that coverage.

If such a beneficiary is not eligible for any other tier 1 or tier 2 coverage, the state must continue to provide the medical assistance available through the pregnant women group until the end of the month in which the PHE for asthma treatment ends, in order to qualify for the temporary FMAP increase, as described at Â§â433.400(c)(2)(iv). For example, a woman receiving non-MEC pregnancy related coverage that includes coverage of testing services and treatments for asthma treatment could not be transitioned to coverage of only family planning services at the end of the postpartum period. The third tier, described at Â§â433.400(c)(2)(iii), includes coverage that is not MEC and that also does not cover testing services and treatment for asthma treatment, including treatments, specialized equipment, and therapies, under CMS's interpretation of FFCRA section 6008(b)(4).

Coverage under tier 3 may include coverage for the eligibility group limited to family planning described at 42 CFR 435.214 or the eligibility group for individuals with tuberculosis described at 42 CFR 435.215. Coverage through an existing family planning demonstration or other limited benefit section 1115 demonstration may also be included in tier 3 if it does not cover asthma treatment testing and treatment. If a beneficiary loses eligibility for coverage meeting the tier 3 description during the period in which the FFCRA section 6008(b)(3) requirement applies, and the beneficiary gains eligibility for a group that provides coverage in tier 1 or tier 2, then, under Â§â433.400(c)(2)(iii), the state must transfer the beneficiary into that new eligibility group as coverage in those tiers is more robust than coverage in tier 3.

The coverage in tier 3 differs from the coverage in tier 1, which is always considered MEC and the coverage in tier 2, which always includes testing services and treatment for asthma treatment. The coverage available to a beneficiary in tier 3 is more limited and may vary widely from one group or demonstration to the next. Coverage limited to family planning and family planning-related services is significantly different from coverage in a limited-benefit section 1115 demonstration that focuses, for example, on preventing the progression of a specific disease.

Therefore, the requirement in Â§â433.400(c)(2)(iii) for tier 3 coverage differs somewhat from the requirements in Â§â433.400(c)(2)(i) and (ii) for tiers 1 and 2. If a beneficiary becomes ineligible for the tier 3 eligibility group or demonstration in which he or she is enrolled and becomes eligible for another eligibility group or demonstration with coverage that is also within tier 3, the state must continue to provide the coverage Start Printed Page 71166available through the eligibility group or demonstration for which the beneficiary was eligible as of or after March 18, 2020, unless the beneficiary requests a voluntary termination to transition to the new eligibility group or demonstration, as discussed below. Transitioning a beneficiary from one eligibility group offering tier 3 coverage to another eligibility group offering tier 3 coverage would not satisfy the requirement in Â§â433.400(c)(2)(iii).

We note that beneficiaries enrolled in certain limited-benefit state plan eligibility groups may be eligible for coverage in the optional asthma treatment testing group authorized under section 1902(a)(10)(A)(ii)(XXIII), and such individuals can be enrolled in both limited benefit groups. Section 3716 of the CARES Act amended section 1902(ss) of the Act to establish that individuals eligible for certain optional eligibility groups, such as the eligibility group limited to family planning and related services described at 1902(a)(10)(A)(ii)(XXI) of the Act, are considered âuninsuredâ for purposes of eligibility under the optional asthma treatment testing group and therefore may obtain asthma treatment testing coverage under that group in addition to coverage under the other optional eligibility group. In addition, beneficiaries in each benefit tier retain the right to request a voluntary transition to a different eligibility group (provided that they meet the applicable eligibility requirements), even if such transition results in a change in the individual's benefit package that would not otherwise satisfy the conditions of this rule, such as a transition from an eligibility group with coverage in tier 1 to an eligibility group with coverage in tier 3 or a transition from one tier 3 group to another tier 3 group.

Such a transition is permissible under the exception at Â§â433.400(d)(1)(i), as described at Â§â433.400(d)(3)(i), in which a beneficiary may request a voluntary termination of eligibility, and would not impact the state's ability to claim the temporary FMAP increase. Section 42 CFR 430.400(c)(2)(iv) specifies that for any beneficiary who is validly enrolled and receiving medical assistance on or after March 18, 2020, and who is determined ineligible for Medicaid prior to the last day of the month in which the PHE for asthma treatment ends, except as provided in paragraph (d), a state meets the requirements of Â§â430.400(c)(2)(i), (ii), or (iii) by continuing the provide the same coverage that the individual would have received absent the determination of ineligibility. For example, if a beneficiary is enrolled in the age and disability-related poverty level group described at section 1902(a)(10)(A)(ii)(X) of the Act, and the beneficiary reports a change in resources that would result in ineligibility for this group, if the beneficiary is not eligible for coverage in any other Medicaid eligibility group, the state would continue to provide that individual with the coverage available to beneficiaries enrolled in the age and disability-related poverty level group.

The requirement at Â§â430.400(c)(2)(iv) also applies in cases where a state finds a beneficiary ineligible on a procedural basis, such as a failure to respond to a request for additional information, with an exception related to residency described at Â§â430.400(d)(3). For example, if a state receives information from quarterly wage data, which indicates that a child's household income exceeds the income standard for the eligibility group for children under age 19 (described at 42 CFR 435.118), the child is not eligible on another basis, and the beneficiary's family does not respond to a request from the state for additional information, the child may be determined ineligible on a procedural basis. In this case, through the end of the month in which the PHE for asthma treatment ends, the state would continue to provide the child with the same coverage provided to beneficiaries enrolled in the eligibility group for children under age 19.

Changes to Benefits, Cost Sharing, and PETI Section 433.400 of this IFC allows states, during the period when section 6008(b)(3) of the FFCRA applies, to move a beneficiary from one eligibility group to another when the beneficiary becomes ineligible for one group and eligible for another group, as long as the coverage provided under the new group is within the same tier of coverage (applicable to tier 1 and tier 2 coverage only) or a beneficiary may also be moved to a more generous tier of coverage than the coverage available to the beneficiary on or after March 18, 2020. Section 433.400(c)(3) specifies that states may make programmatic changes to coverage, cost sharing, and beneficiary liability without violating the requirements for receiving the temporary FMAP increase, provided that such changes do not violate the individual beneficiary protections at Â§â433.400(c)(2) or the requirements under section 6008(b)(4) of the FFCRA to cover asthma treatment testing and treatment services without cost-sharing. As described at Â§â433.400(c)(3), states may generally make changes to benefits offered under the state plan (as allowed under relevant provisions of the Act) or a section 1115 demonstration.

For example, section 6008(b)(3) of the FFCRA does not prohibit a state from eliminating an optional benefit from its state plan. Therefore, a state could eliminate dental services for individuals age 21 and above, and still comply with section 6008(b)(3) of the FFCRA. Note that under section 1905(r)(5) of the Act, as part of the mandatory EPSDT benefit, states must provide beneficiaries under age 21 with all necessary health care, diagnostic services, treatment, and other measures described in section 1905(a) of the Act, to correct or ameliorate defects and physical and mental illnesses and conditions discovered by EPSDT screening services, whether or not such services are covered under the state plan.

However, states need not maintain EPSDT benefits for beneficiaries who turn 21 in order to comply with the terms of section 6008(b)(3) of the FFCRA. Additionally, states are permitted to change the scope of benefits provided to beneficiaries without violating the requirements of section 6008(b)(3) for claiming the temporary FMAP increase, as long as they comply with otherwise applicable Medicaid law, including section 6008(b)(4) of the FFCRA. For example, section 6008(b)(3) of the FFCRA does not prohibit states from applying service authorization criteria, including for services authorized under section 1915(c) of the Act, in determining the amount, duration, or scope of coverage a beneficiary is entitled to receive under the state's program.

We also note that Start Printed Page 71167regardless of the flexibility provided at Â§â433.400(c)(3), states retain their obligations to provide services and supports in the âmost integrated settingâ under the integration mandate of Title II of the Americans with Disabilities Act (ADA), as interpreted by the Supreme Court in Olmstead v. L.C., 527 U.S. 581 (1999) (hereafter âOlmsteadâ),[] to avoid unjustified institutionalization or segregation.

If the elimination of an optional benefit results in or places an individual with a disability at risk of unjustified institutionalization or segregation, it may be a violation of the state's obligations under the ADA and Olmstead.[] States' Olmstead obligations do not confer Medicaid authority or create Medicaid obligations where they do not otherwise exist. States may choose to (and in some cases would be required to) use funds outside of or in addition to Medicaid to comply with Olmstead responsibilities. Finally, states may generally establish or increase cost sharing (consistent with sections 1916 and 1916A of the Act, implementing regulations at 42 CFR 447.50 through 447.90, and the state plan), and increase beneficiary obligations under the PETI rules, and still comply with FFCRA section 6008(b)(3).

However, states should also comply with FFCRA 6008(b)(4) if they are claiming the temporary FMAP increase. For example, a state may increase the liability of individuals receiving Medicaid coverage for institutional services under the state plan through otherwise permissible reductions in their standard personal needs allowances or family allowances. In addition, they may transfer a beneficiary from one program furnishing HCBS (for example, a waiver program authorized under section 1915(c) of the Act) to another as a beneficiary's health status and level of care changes.

Prior to reducing benefits or increasing cost sharing or beneficiary liability a state must provide proper advance notice and comply with other applicable statutory and regulatory requirements. In particular, the advance notice requirements that apply under 42 CFR 431.211 preclude states from reducing benefits or increasing cost sharing or beneficiary liability retroactively. Additionally, 42 CFR 440.230(b) limits states' flexibility to reduce the amount, duration, or scope of benefits.

That regulation requires that each Medicaid service must be sufficient in amount, duration, and scope to reasonably achieve its purpose. 7. Exceptions to Maintaining Enrollment Section 433.400(d) of this IFC describes the exceptions to the continuous enrollment requirement in Â§â433.400(c)(2).

Section 6008(b)(3) of the FFCRA specifies that a beneficiary's Medicaid enrollment may be terminated if the beneficiary requests a voluntary termination of eligibility or the beneficiary is no longer a resident of the state. These exceptions are described in Â§â433.400(d)(1)(i) and (ii). Because a beneficiary who dies is no longer a state resident, Â§â433.400(d)(1)(iii) also provides an exception for deceased beneficiaries.

Section 433.400(d)(2) provides that states that have elected the option under section 1903(v)(4) of the Act to provide coverage to certain lawfully residing children and/or pregnant women, must limit the provision of services for these beneficiaries to services necessary for treatment of an emergency medical condition, as defined in section 1903(v)(3) of the Act, when they no longer meet the criteria at section 1903(v)(4) of the Act. This is because section 1903(v) of the Act prohibits the provision of FFP for otherwise eligible non-citizens who are not in a satisfactory immigration status, except as provided under paragraphs (2) (authorizing FFP for services necessary to treat an emergency medical condition) and (4) (relating to coverage of certain lawfully residing children and/or pregnant women) of section 1903(v) of the Act. Finally, Â§â433.400(d)(3) clarifies the exceptions at Â§â433.400(d)(1).

As noted above, Â§â433.400(d)(1)(i) provides an exception for beneficiaries who request a voluntary termination. Section 433.400(d)(3)(i) provides that this exception applies not only to beneficiaries who request that their Medicaid coverage be terminated in its entirety, but also to beneficiaries who request a voluntary transition to a different eligibility group (provided that they meet the applicable eligibility requirements), even if such transition results in a change in the individual's benefit package that would not otherwise satisfy the conditions of Â§â433.400(c)(2). For example, a state may transition a beneficiary from an eligibility group with coverage in tier 1 to an eligibility group with coverage in tier 3, at the beneficiary's request.

Such a transition would not impact the state's ability to claim the temporary FMAP increase because the change resulted from a beneficiary request for voluntary termination from the original eligibility group. Additionally, as described at Â§â433.400(d)(3)(ii), individuals who are identified as receiving benefits in more than one state via a data match with the Public Assistance Reporting Information System (PARIS) interstate matching service in accordance with Â§â435.945(d) and who fail to respond to a request for information to verify their residency in the reasonable period permitted by the state, consistent with Â§â435.952(c)(2)(iii), are generally considered to no longer be residents of the state for purposes of section 6008(b)(3) of the FFCRA, provided that the state takes all available reasonable measures to determine state residency prior to termination. These measures include, but are not limited to, reviewing existing information in the beneficiary's record to validate state residency, checking available state electronic data sources such as the Department of Motor Vehicles records or other state benefit programs, and coordinating with agencies in the other state(s) in which the PARIS interstate match identified the beneficiary as receiving benefits to determine the state in which the individual is a resident for purposes of Medicaid eligibility.

If the state is unable to verify the beneficiary's continued residency in the state because the beneficiary fails to respond to requests for additional information and the state's alternative efforts cannot verify the beneficiary's continued residency in the state through other sources, that beneficiary's Medicaid enrollment may be terminated in accordance with Â§â435.400(d)(1)(ii). Such an individual will be considered a non-resident for purposes of section 6008(b)(3) of the FFCRA until such time as the state has information verifying residency. If, after termination, the state obtains information that verifies residency, the state must reinstate the individual's eligibility back to the date of termination.

G. Updates to the Comprehensive Care for Joint Replacement (CJR) Model, Performance Year (PY) 5 During the asthma treatment Public Health Emergency (PHE) 1. Background Under the authority of section 1115A of the Act, through notice-and-comment Start Printed Page 71168rulemaking, the Innovation Center established the CJR model in a final rule titled âMedicare Program.

This model tests bundled payment and quality measurement for an episode of care associated with hip and knee replacements to encourage hospitals, physicians, and post-acute care providers to work together to improve the quality and coordination of care from the initial hospitalization through recovery. All related care covered by Medicare Parts A and B within 90 days of hospital discharge from the LEJR procedure is included in the episode of care. During the first CJR model performance period, the CJR model required hospitals located in the 67 MSAs selected participation to participate in the model through December 31, 2020 unless the hospital was an episode initiator for an LEJR episode in the risk-bearing phase of Models 2 or 4 of the Bundled Payments for Care Improvement (BPCI) initiative.

Hospitals located in one of the 67 MSAs that participated in Model 1 of the BPCI initiative, which ended on December 31, 2016, were required to begin participating in the CJR model when their participation in the BPCI model ended. In the December 1, 2017 Federal Register, we published another final rule (82 FR 57066), titled âMedicare Program. Cancellation of Advancing Care Coordination Through Episode Payment and Cardiac Rehabilitation Incentive Payment Models.

Changes to Comprehensive Care for Joint Replacement Payment Model. Extreme and Uncontrollable Circumstances Policy for the Comprehensive Care for Joint Replacement Payment Modelâ (referred to as the âDecember 2017 final ruleâ), that implemented revisions to the CJR model, including giving rural and low volume hospitals selected for participation in the CJR model as well as those hospitals located in 33 of the 67 metropolitan statistical areas (MSAs)â[] a one-time option to choose whether to continue their participation in the model through December 31, 2020 (that is, continue their participation through PY5). An interim final rule with comment period was also issued in conjunction with the December 2017 final rule (82 FR 57092) in order to address the need for a policy to provide some flexibility in the determination of episode costs for providers located in areas impacted by extreme and uncontrollable circumstances.

This extreme and uncontrollable circumstances policy was adopted as final in the final rule (83 FR 26604) we published in the June 8, 2018 Federal Register, titled âMedicare Program. Changes to the Comprehensive Care for Joint Replacement Payment Model (CJR). Extreme and Uncontrollable Circumstances Policy for the CJR Model.â In the February 24, 2020 Federal Register (85 FR 10516), we published the proposed rule titled âMedicare Program.

Comprehensive Care for Joint Replacement Model Three-Year Extension and Changes to Episode Definition and Pricingâ (hereinafter referred to as the âFebruary 2020 proposed ruleâ). Among other changes, this proposed rule proposed to add three additional performance years to the CJR model (i.e., performance years 6 through 8). In the April 6, 2020 Federal Register (85 FR 19230), we published an interim final rule with comment period (IFC) titled âMedicare and Medicaid Programs.

Policy and Regulatory Revisions in Response to the asthma treatment Public Health Emergencyâ (hereinafter referred to as the âApril 2020 IFCâ). In the April 2020 IFC, to account for the impact of the PHE for asthma treatment on CJR participant hospitals, we extended PY5 through March 31, 2021, and adjusted the extreme and uncontrollable circumstances policy to account for asthma treatment by specifying that all episodes with a date of admission to the anchor hospitalization that is on or within 30 days before the date that the emergency period (as defined in section 1135(g) of the Act) begins or that occurs through the termination of the emergency period (as described in section 1135(e) of the Act), actual episode payments are capped at the target price determined for that episode under Â§ââ510.300. Additionally, in the May 29, 2020 Federal Register (85 FR 32460), CMS published a proposed rule titled âMedicare Program.

Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2021 Rates. Quality Reporting and Medicare and Medicaid Promotion Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals. (hereinafter referred to as the FY 2021 IPPS/LTCH proposed rule).

(1) Extending performance year 5 an additional 6 months to provide for continuity of model operations with the same scope while we continue to consider comments received on our proposal to extend the model to performance years 6 through 8 and adopt other changes to the model. (2) making changes to the reconciliation process for PY5 to allow for two periods and to enable more frequent receipt of reconciliation reports by participants. (3) making a technical change, retroactive to October 1, 2020, to ensure that the model continues to include the same inpatient Lower Extremity Joint Replacement (LEJR) procedures, despite the adoption of new MS-DRGs to describe those procedures.

In the February 2020 proposed rule, we proposed to extend the CJR model by adding three performance years (PY6 through 8), from January 1, 2021 to December 31, 2023, to revise target prices, to change the definition of an episode of care to Start Printed Page 71169include outpatient procedures for Total Knee Arthroplasty and Total Hip Arthroplasty, as well as to revise other sections of 42 CFR part 510.[] In response to the PHE for asthma treatment, in the April 2020 IFC we extended PY 5 an additional 3 months to end on March 31, 2021 rather than on December 31, 2020 as finalized in November 2015 final rule. While we continue to consider the addition of performance years to the model and other changes proposed in the February 2020 proposed rule, we also do not want to create a disruption to the model by allowing the model to end on March 31, 2021, which could be disruptive to hospitals and patient care during the PHE if it is still ongoing at that time. Implementing an additional six months of PY5, so that PY5 now ends on September 30, 2021, provides participant hospitals additional relief and stability in model operations.

In the event the three-year extension is finalized, participant hospitals would be in a worse position if PY 5 was not extended to September 30, 2021 because participant hospitals would have made operational choices in reliance on the model ending on March 31, 2021 and then have to adjust to model changes on top of the significant burden of managing asthma treatment and under asthma treatment safety protocols and utilization changes. Overall, this means a nine-month extension from the original conclusion of the model as finalized in the November 2015 final rule (80 FR 73274), which had established that the model would end on December 31, 2020 with no new episodes initiating after October 4, 2020. We received several comments on the April 2020 IFC supporting the policy to extend PY5 an additional three months and asking that we extend PY5 by 12 months instead, not just the 3 months in the April 2020 IFC.

In addition, commenters noted that though state and local guidelines have laid out a process for regions and facilities to determine when to re-open elective procedures, the progression of asthma treatment could impact elective procedures well into 2021. We appreciate commenters' request to extend PY 5 by 12 additional months because of the impact asthma treatment has had on LEJR procedures. We observe that asthma treatment has had an impact on CJR procedures from February 2020 to August 2020.

Table 1 depicts recent Medicare claims data comparing February to August of 2019 and February to August of 2020. These numbers reflect episode volume for each month, accounting for any CJR episode that began within that month. Table 1âCJR Episode Volume ComparisonâFebruaryMarchAprilMayJuneJulyAugust201962146174651560195836606058382020524533748762242403638383090 In light of these data, we believe providing an additional 6 months beyond what we adopted in the April 2020 IFC provides participant hospitals relief from asthma treatment challenges.

Therefore, we are implementing an additional 6-month extension of CJR PY 5 and amending the provisions at 42 CFR 510.2 and 510.200(a) to reflect this extension. We note that in our February 2020 proposed rule to extend and modify the CJR model through PYs 6 to 8 (CMS-5529-P), we proposed PY 6 would comprise all CJR episodes ending on or after January 1, 2021 and on or before December 31, 2021. However, since we are amending PY 5 such that it comprises all CJR episodes ending on or after January 1, 2020 and on or before September 30, 2021, we seek comment on the duration of PY 6, if finalized.

In particular, we seek comment on the potential for PYs 6 through 8 to remain 12-month performance years and each begin with episodes ending on or after October 1 each year. We also seek comment on increasing the duration of proposed PY 6 to 15 months. Under this alternative, PY 6 would comprise all CJR episodes ending on or after October 1, 2021 and on or before December 31, 2022.

PY 7 and PY 8 would remain 12 months and each begin with episodes ending on or after January 1, 2023 or January 1, 2024, respectively. 3. Additional Reconciliations for Performance Year 5 Currently, following the end of each performance year, CMS determines actual episode payments and calculates the amount of a reconciliation payment or repayment amount, as described in 42 CFR 510.305.

Each performance year is reconciled twice. The first reconciliation calculation process begins after a 2-month period of claims runout, while the final reconciliation calculation process begins after a 14-month period of claims runout. The initial reconciliation of a given performance year is conducted concurrently with the final reconciliation of the previous performance year, and the resulting amounts are netted against one another for one annual reconciliation payment or repayment amount, as set forth in 42 CFR 510.305.

The initial reconciliation process typically begins in late February of the calendar year following the performance year, with reports and reconciliation amounts issued in June. Final reconciliation for the performance year is issued the following June. Absent modification to the reconciliation process, the extension of PY 5 to a total of 21 months, from January 1, 2020 through September 30, 2021 would mean that participant hospitals would experience a 21-month gap between the PY4 final reconciliation in June of 2020 and initial PY 5 reconciliation in early 2022.

We believe this significant gap is problematic because participant hospitals gain important feedback from their annual reconciliation reports that they can use to gauge their quality performance and efforts at cost-savings. These annual reports also facilitate the relationships that participant hospitals have established with clinicians and other entities with whom they coordinate care and/or have gainsharing arrangements. Further, not having an initial reconciliation for PY5 until early 2022 is not consistent with the model design goal of reconciling one time a year and netting against final reconciliation amounts from the prior year.

Therefore, we believe there is good cause to conduct two initial, and two final, reconciliations of PY5. The first initial reconciliation will apply to the first 12 months of PY5 in order to maintain consistency with the 12 month reconciliation cycles for previous PYs 2-4 (we note that PY 1 was 9 months rather than 12 months), and the second initial reconciliation will apply to the Start Printed Page 71170remaining 9 months of PY5. To minimize confusion, we will refer to these two subsets of PY5 as performance year subset 5.1and 5.2, respectively.

The initial reconciliation of performance year subset 5.1 will occur fourteen months after the start of PY5, which is the same timeline as would have occurred PY5 under the December 2017 final rule. After the usual 2-month period of claims runout, the initial reconciliation for performance year subset 5.1 episodes will begin in late February of 2021 using 12 months of claims from CY 2020 to calculate reconciliation payments, with the resulting amounts netted against the results of the concurrent PY4 final reconciliation calculation when we issue reports and reconciliation amounts to participants in June 2021. Participants can expect to receive their 2021 reconciliation reports on approximately the same schedule as in previous model years.

The nine additional months of PY 5 (performance year subset 5.2) will be reconciled one full calendar year after the reconciliation of PY 4 final/performance year subset 5.1 initial. We will use claims data for the initial reconciliation of performance year subset 5.2 that reflect a 2-month period of claims runout (as set forth in 42 CFR 510.305(e)(1)(i)), as we have for PY 1-4 and performance year subset 5.1. In short, performance year subset 5.2 will run from January 1, 2021 through September 30, 2021.

While alignment with the performance year subset 5.1 subsequent reconciliation calculation is the primary reason for this delay in the performance year subset 5.2 initial reconciliation, it is also necessary to allow time to receive certain input files to perform the initial reconciliation calculation, including standardized claims files and quality data. These data are generally not available more than a few weeks prior to the usual reconciliation process start date in late February. Therefore, the reconciliation process will occur on the same schedule as PY 1 through 4 and performance year subset 5.1, with the reconciliation report available one year after the reports from the previous year's reconciliation.

We note that, as part of the separate reconciliation calculation processes for performance year subsets 5.1 and 5.2, we will calculate a separate Composite Quality Score (CQS) for each of performance year subsets 5.1 and 5.2, including a separate set of quality improvement points and quality performance points for each performance year subset. In order to conduct separate CQS calculations for each time period, we are amending 42 CFR 510.400 to indicate that the required data submissions that previously applied to PY 5 will now apply to performance year subset 5.1, and we are adding a required data submission for performance year subset 5.2. These additional requirements will reflect the timeframe of performance year subset 5.2, but will otherwise parallel the requirements for performance year subset 5.1, and will not require an increased amount of data for performance year subset 5.2 as compared to performance year subset 5.1.

We recognize that some of the timeframe for both performance year subsets 5.1 and 5.2 quality data collection overlap with the effective dates of the asthma treatment waiverâ[] that provided reporting exemptions for hospitals participating in quality reporting programs, so we will use quality data reported before and after the effective dates of the asthma treatment waiver, for those quality measures to which the waiver applied. The final reconciliation calculation for performance year subset 5.2 will occur one year after the initial reconciliation of performance year subset 5.2. Although we will use claims data that were available 14 months after the end of performance year subset 5.2 for the subsequent reconciliation (as set forth in 42 CFR 510.305(i)(1)), as with the initial reconciliation, we will not begin the subsequent reconciliation calculation process until 17 months after the end of performance year subset 5.2.

We would begin the final reconciliation calculation for performance year subset 5.2 in late February 2023 with reconciliation payment amounts and reports issued in June, because input files that are required for the final reconciliation will not be available until 17 months after the end of performance year subset 5.2. In particular, we need to receive the reconciliation results from Accountable Care Organizations (ACOs) that overlap with CJR in order to conduct the ACO overlap calculation. Since we cannot state with confidence that we will have access to those data prior to the normal reconciliation process start date in late February 2023, we will perform the reconciliation calculation at the same time of year that we have performed previous reconciliations.

As noted above, we will conduct the final reconciliation of performance year subset 5.2 independently. Table 2 illustrates the timelines for performance year subsets 5.1 and 5.2. Table 2âTimelines for Performance Years 4 and 5Performance year (PY)Performance periodInitial reconciliation calculation startSubsequent reconciliation calculation startReconciliation amount (+/â)401/01/2019 to 12/31/20192 months after 12/31/2019.

Late February 202014 months after 12/31/2019. Late February 2021Net PY3 and PY4 reconciliation amounts.5 (two periods)01/01/2020 to 09/30/2021Subset 5.101/01/2020 to 12/31/20212 months after 12/31/2020. Late February 202114 months after 12/31/2020.

Late February 2022Net PY4 and PY5.1 reconciliation amounts.Start Printed Page 71171Subset 5.201/01/2021 to 09/30/20215 months after 09/30/2021. Late February 202217 months after 09/30/2021. Late February 2023Net PY5.1 and PY5.2 reconciliation.

DRG 521 and DRG 522 In this IFC we are amending our regulations at Â§â510.300(a) to specify that, as of October 1, 2020, the CJR model includes episodes when the MS-DRG assigned at discharge for an anchor hospitalization is one of two new MS-DRGs we adopted in the FY 2021 IPPS/LTCH final rule (85 FR 58432). MS-DRG 521 (Hip Replacement with Principal Diagnosis of Hip Fracture with Major Complications and Comorbidities (MCC)) and MS-DRG 522 (Hip Replacement with Principal Diagnosis of Hip Fracture, without MCC). As indicated in 42 CFR 510.300(a)(1), the CJR model episode definition historically included MS-DRG 469 (Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity with MCC) and MS-DRG 470 (Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity without MCC).

For purposes of calculating quality adjusted target prices, we further subdivided episodes within each MS-DRG based on the presence or absence of a primary hip fracture. In the FY 2021 IPPS/LTCH final rule, we stated that because the CJR model would continue until at least March 31, 2021, we intended to adopt a policy in the CJR final rule that incorporates these new MS-DRGs into the CJR model as of October 1, 2020 to avoid disruption to the model for the remainder of PY5 (as extended) and thereafter, if our proposal to extend the CJR model through PY8 were finalized (85 FR 58502). To this end, we are adopting the change in this IFC, with retroactive effect to October 1, 2020.

This change ensures that hip replacements with a principal diagnosis of hip fracture, with and without MCC, will continue to trigger CJR model episodes even though they are now assigned to these new DRGs rather than MS-DRGs 469 and 470. As background, in the FY 2021 IPPS/LTCH proposed rule (85 FR 32510), CMS proposed the creation of two new MS-DRGs, 521 and 522 (Hip Replacement with primary hip fracture, with and without major complications and comorbidities, respectively). Because the FY2021 IPPS/LTCH proposed rule was published after the CJR February 2020 proposed rule, the new MS-DRGs 521 and 522 were not addressed in the February 2020 proposed rule.

Most commenters agreed that MS-DRGs 521 and 522 should be included in the definition of a CJR model episode, noting their assumption that this would have a neutral economic impact on the model and participants, as the CJR model already provides for separate quality adjusted target prices for hip fracture cases for MS-DRGs 469 and 470. Multiple commenters stated their belief that there is value in maintaining hip fracture cases in the CJR model, including that it is administratively simpler and that maintaining hip fractures in the CJR model would mean those procedures remain subject to the value-based care incentives of the CJR model. Some commenters suggested that quality adjusted target prices for episodes previously triggered by MS-DRG 469 and MS-DRG 470 with hip fracture could apply to episodes triggered by the new MS-DRGs.

Others noted that if the DRGs were added retroactively, they would not want the new DRGs to retroactively impact quality adjusted target prices. As of October 1, 2020, MS-DRGs 521 and 522 separately identify a subset of LEJR procedures that were previously grouped to MS-DRGs 469 and 470, and if the definition of a CJR model episode is not revised to accommodate this technical change the LEJR procedures associated with these new codes will no longer be part of the CJR model. This result would be highly disruptive to the CJR model, because it would remove a significant number of episodes midway through a performance year.

Therefore, we believe there is good cause for this rulemaking to change the definition of a CJR model episode to include MS-DRGs 521 and 522. Indeed, it would be contrary to the public interest to undertake traditional notice and comment rulemaking to adopt these regulatory changes because they are intended to preserve the model's scope in light of underlying technical changes in the IPPS. Based on the public comments previously described, we believe that including DRGs 521 and 522 in the CJR episode definition is less disruptive to participant hospitals than the alternative, which would be to allow hip replacements with a primary hip fracture to drop abruptly out of the model (or to drop out of the model until we were able to undertake full notice and comment rulemaking to add them back at a later point).

We believe that failure to retroactively incorporate MS-DRGs 521 and 522 into the CJR model as of October 1, 2020 would be contrary to the public interest because it would result in approximately 20-25% of all LEJR episodes to be dropped from the CJR model. The categories of episodes that would be dropped tend to be associated with emergent surgeries, high-costs, and complex post-acute care needs. Dropping these episodes from the model would create confusion, increase administrative burden for participant hospitals, and remove the opportunity for participant hospitals to earn reconciliation payments by coordinating care for these complex, high-cost episodes.

Operationally, this is a seamless transition for participant hospitals, which have continued to bill Medicare Start Printed Page 71172FFS as usual for hip replacements with hip fractures. Beginning on October 1, 2020, the Medicare IPPS grouper began to assign those hospitalizations to one of the new MS-DRGs, with no billing changes required of participant hospitals. The new MS-DRGs will be incorporated into the CJR episode reconciliation data system, and will be included in participant hospitals' monthly data feeds going forward.

Participant hospitals were notified of their quality adjusted target prices for episodes beginning on October 1, 2020 for MS-DRGs 469 and 470, with and without hip fracture. As of October 1, 2020, the quality adjusted target prices for MS-DRGs 469 and 470 with hip fracture will apply to episodes initiated by the new MS-DRGs 521 and 522, respectively, for the remainder of PY5 (including both performance year subsets 5.1 and 5.2). Given that the CJR model currently provides separate quality adjusted target prices for episodes with and without a hip fracture, incorporating the new DRGs would have minimal financial impact on the model.

The PY5 quality adjusted target price calculation methodology includes the application of update factors (80 FR 73342-73346), which incorporate annual changes to each CMS payment system (for example, IPPS, OPPS, and SNF). The update factor is calculated and applied twice per year, in order to incorporate both fiscal year and calendar year payment system updates. The MS-DRG weights assigned to the new MS-DRGs 521 and 522 in the FY 2021 IPPS/LTCH final rule (84 FR 42044) will be incorporated into the IPPS update factor as part of the calculation of the quality adjusted target prices for episodes beginning between October 1, 2020 and December 31, 2020.

These FY 2021 MS-DRG weights will continue in the quality adjusted target prices for episodes that begin between January 1, 2021 and September 30, 2021, which will incorporate CY 2021 payment system updates. As a result, baseline prices for hip replacements with primary hip fracture, which would have been assigned the MS-DRGs 469 and 470 and stratified by hip fracture status, are comparable to those same episodes in the performance period that are assigned to MS-DRGs 521 and 522, respectively. For the remainder of PY5, we will calculate quality adjusted target prices for episodes initiated by MS-DRGs 521 and 522 using baseline episodes initiated by MS-DRG 469 with fracture and MS-DRG 470 with fracture, respectively, but updated to include the MS-DRG weights assigned to MS-DRGs 521 and 522 for FY 2021.

In this IFC we are incorporating the new MS-DRGs 521 and 522 into the CJR model episode definition as of October 1, 2020, updating quality adjusted target prices to reflect the applicable MS-DRG weights, and amending the provisions at 42 CFR 510.300(a)(1)(i) and (iii) to reflect these changes. 5. Changes to Extreme and Uncontrollable Circumstances Policy for the PHE for asthma treatment We are also modifying the extreme and uncontrollable circumstances adjustment for asthma treatment in Â§â510.300(k)(4) to expire on March 31, 2021 or the last day of the emergency period, whichever is earlier.

In addition, we are adopting a more targeted adjustment, which will apply after March 31, 2021 or the last day of emergency period (whichever is earlier), so that financial safeguards continue to apply for CJR episodes during which a CJR beneficiary receives a positive asthma treatment diagnosis. Currently, the extreme and uncontrollable circumstances adjustment for asthma treatment provides financial safeguards for participant hospitals that have a CCN primary address that is located in an emergency area during an emergency period, as those terms are defined in section 1135(g) of the Act, for which the Secretary issued a waiver or modification of requirements under section 1135 of the Act on March 13, 2020, effectively applying the financial safeguards to all participant hospitals. These financial safeguards, wherein actual episode payments are capped at the target price determined for that episode, apply to fracture or non-fracture episode with a date of admission to the anchor hospitalization that is on or within 30 days before the date that the emergency period (as defined in section 1135(g) of the Act) begins or that occurs through the termination of the emergency period (as described in section 1135(e) of the Act).

In the April 2020 IFC we explained this extreme and uncontrollable circumstances adjustment, noting that the previous CJR model policy for extreme and uncontrollable circumstances was not applicable to the PHE for the asthma treatment ventolin. We also indicated that we did not expect many new CJR episodes to initiate in light of the asthma treatment ventolin and the related guidance to avoid elective surgeries. We further stated that we wanted to avoid inadvertently creating incentives to place cost considerations above patient safety within the CJR model, given the challenges to the health care delivery system in responding to asthma treatment cases and the expenses associated with treating the ventolin.

A commenter recommended CMS hold participant hospitals harmless from performance-related penalties for the 2020 performance year and urged CMS to make appropriate adjustments for the 2020 and 2021 performance years and to address the impact of asthma treatment on financial expenditures, performance scores and risk adjustment. We appreciate commenters' positive feedback on the April 2020 IFC and our decision to provide relief to participant hospitals. At the onset on the PHE, we quickly developed financial safeguards in the April 2020 IFC due to the mandatory nature of the model and the location of all 471-participant hospitals in MSAs where asthma treatment was most prevalent.

For example, there are 98 participant hospitals in the New York/New Jersey Metropolitan Area, which was the epicenter for asthma treatment.[] Further, at that time, we did not possess data that allowed CMS to determine the asthma treatment ventolin's effect on the CJR model, and believed it was most prudent to waive downside risk for all episodes thorough the duration of the PHE. Since publishing the April 2020 IFC, we reviewed Medicare claims data and observe a steep decline in the initiation of episodes in April 2020 (See Table 1). Post April 2020, CJR episodes are increasing, and though not at normal utilization as compared to 2019 Medicare claims data, the data reflects a continual initiation of CJR episodes despite the ongoing PHE.

In addition, related Federal guidance to avoid elective surgeries has expired, which allows certain participant hospitals to initiate elective LEJR procedures.[] The continual initiation of CJR episodes during the PHE is contrary to our assumption in the April 2020 IFC, that Start Printed Page 71173is, we did not expect many new CJR episodes to initiate during the PHE. Absent a change to specify an end date, the current extreme and uncontrollable adjustment in 42 CFR 510.300(k)(4) would continue as long as the PHE. Unfortunately, the combination of CJR episode volume increasing to levels we did not anticipate during the PHE and the continued renewal of the PHE threatens the ability of the CJR model to generate any savings over the course of the model.

With greater surgical volume, we do not believe such a broad extreme and uncontrollable circumstances policy for asthma treatment remains necessary. For these reasons, we are implementing an end date to the extreme and uncontrollable circumstances adjustment for asthma treatment. Specifically, for a fracture or non-fracture episode with a date of admission to the anchor hospitalization that is on or within 30 days before the date that the emergency period (as defined in section 1135(g) of the Act) begins or that occurs on or before March 31, 2021 or the last day of such emergency period, whichever is earlier, actual episode payments are capped at the quality adjusted target price determined for that episode under Â§ââ510.300.

We are amending the provisions at 42 CFR 510.305(k)(4) to reflect this change. In addition, in order to account for CJR beneficiaries with a positive asthma treatment diagnosis during a CJR episode that initiates after the adjustments for extreme and uncontrollable circumstances specified in Â§â510.305(k)(4) end, we are amending our regulations at Â§â510.305(e)(1)(i) to cap actual episode payments at the quality adjusted target price for the episode, effectively waiving downside risk for all episodes with actual episode payments that include a claim with a asthma treatment diagnosis code. This policy will apply after March 31, 2021 or the last day of the PHE, whichever occurs earlier.

In response to commenters' questions about how the CJR model will alleviate financial risk associated with asthma treatment once the PHE expires, we explored the flexibilities provided by other CMMI models and found them to be consistent with a targeted, episode-based approach to providing financial relief from asthma treatment. In order to be responsible stewards of the Medicare Trust Fund, we are adopting a policy to provide participant hospitals continuing financial protection from the effect of asthma treatment on the CJR model that may continue beyond the end of the PHE for asthma treatment or March 31, 2021 (whichever is earlier). Specifically, at the initial and subsequent reconciliations of performance year subset 5.2, which will include episodes subject to this new adjustment policy, we will identify episodes with actual episode payments with any claim containing a asthma treatment diagnosis and costs for those episodes will be capped at the quality adjusted target price, effectively waiving downside risk for that episode.

A asthma treatment diagnosis is identified by the following ICD-10-CM diagnosis codes. B97.29. U07.1.

Or any other ICD-10-CM diagnosis code that is recommended by the Centers for Disease Control and Prevention for the coding of a confirmed case of asthma treatment.[] We understand that ICD-10 diagnosis codes B97.29 (which was used for dates of service on or after January 27, 2020 through March 31, 2020) and U07.1 (which was used for dates of service on or after April 1, 2020 through September 30, 2020) might not be used for dates of service to which our new adjustment policy will apply. Nevertheless, given the potential for uncertainty as to whether either of these codes will be used for dates of service after September 30, 2020, we are including them in the definition of âasthma treatment diagnosis codeâ that we are adding to Â§â510.2 for completeness. In order to provide participant hospitals continuing financial protection from the effect of asthma treatment on the CJR model that may continue beyond the end of the PHE for asthma treatment or March 31, 2021, whichever occurs earlier, we are implementing that actual episode payments are capped at the quality adjusted target price determined for that episode under Â§â510.300 for episodes with actual episode payments that include a claim with a asthma treatment diagnosis code and initiate after the earlier of March 31, 2021 or the last day of the emergency period.

III. Provisions of the Interim Final RuleâDepartments of the Treasury, Labor and Health and Human Services A. Rapid Coverage of Preventive Services for asthma 1.

Background In addition to the steps Congress took to ensure coverage of asthma treatment diagnostic testing, in section 3203 of the CARES Act, Congress required group health plans and health insurance issuers offering group or individual health insurance coverage to cover, without cost sharing, qualifying asthma preventive services. This coverage is required to be provided âpursuant to section 2713(a) of the [PHS] Act,â including its implementing regulations or any successor regulations. Section 2713 of the PHS Act was added by section 1001 of PPACA and incorporated by reference into ERISA by section 715 of ERISA and into the Code by section 9815 of the Code.

Section 2713 of the PHS Act and the regulations implementing section 2713 of the PHS Act require non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage to provide coverage of certain specified preventive items and services without cost sharing. These services include. Evidence-based items or services that have in effect a rating of âAâ or âBâ in the current recommendations of the USPSTF with respect to the individual involved.

With respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA). With respect to women, preventive care and screenings provided for in comprehensive guidelines supported by HRSA (not otherwise addressed by the recommendations of the USPSTF), subject to certain exemptions and accommodations (see 45 CFR 147.131 through 147.133). The Departments' current regulations (herein referred to as the 2015 Final Regulations) under section 2713 of the PHS Act at 26 CFR 54.9815-2713.

29 CFR 2590.715-2713. And 45 CFR 147.130 require that plans and issuers provide coverage of recommended preventive services for plan years that begin on or after September 23, 2010, or, if later, for plan years that begin on or after the date that is one year after the date the recommendation or guideline is issued. Under the 2015 Final Regulations, if a recommended preventive service is billed separately (or is tracked as individual encounter data separately) from an office visit, then a plan or issuer Start Printed Page 71174may impose cost-sharing requirements with respect to the office visit.

However, if a preventive service is not billed separately (or is not tracked as individual encounter data separately) from an office visit and the primary purpose of the office visit is the delivery of such an item or service, then a plan or issuer may not impose cost-sharing requirements with respect to the office visit. The 2015 Final Regulations generally do not require a plan and issuer that has a network of providers to provide benefits for applicable preventive items or services that are delivered by an out-of-network provider. Moreover, the 2015 Final Regulations generally do not preclude a plan or issuer that has a network of providers from imposing cost-sharing requirements for preventive services that are delivered by an out-of-network provider.

Therefore, the 2015 Final Regulations require coverage without cost sharing for applicable immunizations that are recommended by ACIP for routine use, and state that a recommendation is considered to be for âroutine useâ if it appears on the Immunization Schedules of the CDC. Section 3203 of the CARES Act establishes a more accelerated timeline for required coverage of qualifying asthma preventive services than other recommended preventive services under PHS Act section 2713. As stated above, coverage of qualifying asthma preventive services must be provided no later than 15 business days following an applicable recommendation.

In addition, it is possible that items, services, and immunizations used to prevent or mitigate asthma treatment will not, in the immediate future, be recommended as part of a usual course of preventive care, but rather for more urgent use. As reflected by the expedited timeline for coverage Congress established in section 3203 of the CARES Act, the need to provide coverage of qualifying asthma preventive services is urgent. Therefore, as discussed below, this IFC requires coverage of asthma treatment immunizations within 15 business days after the immunization has been recommended by ACIP and adopted by the CDC, regardless of whether it appears on the Immunization Schedules of the CDC for routine use.

Additionally, in light of the current PHE for asthma treatment, it is imperative that group health plans and health insurance issuers provide full coverage for these items and services, including costs for the administration of treatments, and ensure timely access to coverage as Congress intended. Accordingly, in this IFC, the Departments provide certain clarifications previously made with respect to the 2015 Final Regulations and amend those regulations to implement unique requirements related to covering qualifying asthma preventive services.[] 2. Scope of Requirement To Cover Certain Recommended Preventive Services Under Section 2713 of the Public Health Service Act a.

Related Items and Services In implementing section 2713 of the PHS Act, the 2015 Final Regulations addressed whether office visit charges associated with certain recommended preventive services must be covered without cost sharing. Specifically, Example 1 in the 2015 Final Regulations illustrates how the requirements apply in situations where a provider bills a plan for an office visit where a preventive screening for cholesterol abnormalities (which has in effect a rating of A or B from the USPSTF) is conducted and for the laboratory work of the cholesterol screening test. In that example, the plan may not impose any cost-sharing requirements with respect to the separately billed laboratory work of the cholesterol screening test.

Because the office visit is billed separately from the cholesterol screening test, the 2015 Final Regulations provide that the plan may impose cost-sharing requirements for the office visit. Prior to the publication of the 2015 Final Regulations, the Departments received questions from stakeholders regarding discrete coverage issues related to certain recommended preventive services. In particular, with respect to colonoscopies, stakeholders asked whether certain related services (such as the cost of polyp removal or anesthesia) must also be covered without cost sharing.

The Departments clarified in subregulatory guidance that a plan or issuer may not impose cost sharing for polyp removal during a preventive screening colonoscopy, as such service is an integral part of a colonoscopy, and also stated that anesthesia provided in connection with a preventive colonoscopy must be covered without cost sharing.[] Consistent with the examples provided in the 2015 Final Regulations and subregulatory guidance cited in the preamble to the rulemaking promulgating the 2015 Final Regulations, the Departments further clarify that under the 2015 Final Regulations and this IFC, plans and issuers subject to section 2713 of the PHS Act must cover, without cost sharing, items and services that are integral to the furnishing of the recommended preventive service, regardless of whether the item or service is billed separately. For example, several of the recommended preventive services involve screenings for the presence of certain health conditions, such as diabetes, or a variety of sexually transmitted s. These recommended screenings, typically performed by laboratories, cannot be conducted without first collecting a specimen.

Accordingly, plans and issuers subject to section 2713 of the PHS Act must cover without cost sharing both the specimen collection and the recommended preventive service, regardless of how the specimen collection is billed. Similarly, a recommended immunization generally cannot be furnished without being administered by a medical professional. As qualifying asthma preventive services are expected to include immunizations, plans and issuers subject to section 2713 of the PHS Act Start Printed Page 71175must cover without cost sharing such an immunization and its administration, regardless of how the administration is billed, and regardless of whether a asthma treatment or any other immunization requires the administration of multiple doses in order to be considered a complete vaccination.

This includes coverage without cost sharing of the administration of a required preventive immunization in instances where a third party, such as the Federal Government, pays for the preventive immunization. Further, if a asthma treatment immunization is not billed separately (or is not tracked as individual encounter data separately) from an office visit and the primary purpose of the visit is the delivery of the recommended asthma treatment immunization, then consistent with the 2015 Final Regulations, the plan or issuer may not impose cost-sharing requirements with respect to the office visit. The Departments seek comment on this clarification.

B. Out-of-Network Coverage During the PHE for asthma treatment The 2015 Final Regulations permit a group health plan or issuer that has a network of providers to omit coverage or to impose cost-sharing requirements for recommended preventive services when such services are provided by an out-of-network provider, unless the plan or issuer does not have in its network a provider who can provide the service.[] This approach reflects that, as noted earlier in this section of the preamble, recommended preventive services generally are obtained as part of a regular course of preventive care, so participants, beneficiaries, and enrollees typically have the opportunity to seek such care from an in-network provider. By contrast, in the immediate term, newly developed qualifying asthma preventive services might be available from a narrower range of providers than other, more established recommended preventive services.

To help ensure full access to and the widespread use of qualifying asthma preventive services to mitigate the effect of the PHE for asthma treatment and slow transmission of the ventolin, it is critical that individuals be able to receive such services from any provider authorized to provide the service. Therefore, this IFC amends the 2015 Final Regulations to require that plans and issuers subject to section 2713 of the PHS Act must cover without cost sharing a qualifying asthma preventive service, regardless of whether such service is delivered by an in-network or out-of-network provider. This is based on the Departments' view that participants, beneficiaries, and enrollees may not be able to locate in-network providers consistently during the emergency period.

To satisfy this requirement, the Departments are of the view that plans and issuers must administer this out-of-network coverage requirement in such a way that makes receiving out-of-network services for qualifying asthma preventive services a meaningful benefit for participants, beneficiaries, and enrollees. To be a meaningful benefit, the Departments are of the view that plans and issuers must administer this out-of-network coverage requirement in a way that ensures that participants, beneficiaries, and enrollees have access to a variety of out-of-network providers for such services. To the extent plans and issuers reimburse out-of-network providers an unreasonably low amount for qualifying asthma preventive services, including for administration of a asthma treatment, this approach could severely limit the number of such providers that are willing to provide the service, which would contravene the purpose of the requirement to provide out-of-network coverage without cost sharing of qualifying asthma preventive services.

Therefore, this IFC provides that with respect to a qualifying asthma preventive service and a provider with whom the plan or issuer does not have a negotiated rate for such service (such as an out-of-network provider), the plan or issuer must reimburse the provider for such service in an amount that is reasonable, as determined in comparison to prevailing market rates for such service. The Departments will consider the amount of payment to be reasonable, for example, if the plan or issuer pays the provider the amount that would be paid under Medicare for the item or service. In the Departments' view, these minimum payment standards are necessary and appropriate because providers that participate in the asthma treatment Vaccination Program contractually agree to administer a asthma treatment regardless of an individual's ability to pay and regardless of their coverage status, and also may not seek any reimbursement, including through balance billing, from a treatment recipient.

The Departments request comment on all aspects of this approach. The Departments request comment on the issue of network adequacy and whether and, if so, how long provider networks are expected to be inadequate. The Departments also request comment on the safeguards in this IFC to ensure that out-of-network reimbursement rates are reasonable and that providers administering a publicly funded asthma treatment are reimbursed by group health plans and issuers prevailing market rates in the absence of a negotiated rate, and whether other examples of reasonable reimbursement rates, in addition to Medicare rates, would be useful.

3. Definition of Qualifying asthma Preventive Services Section 3203(b)(1) of the CARES Act defines âqualifying asthma preventive serviceâ as an item, service, or immunization that is intended to prevent or mitigate asthma treatment and that isâ(A) an evidence-based item or service that has in effect a rating of `A' or `B' in the current recommendations of the USPSTF. Or (B) an immunization that has in effect a recommendation from ACIP with respect to the individual involved.

The statutory provisions describing USPSTF and ACIP recommendations in this definition are substantively identical to the ones at section 2713(a)(1) and (2) of the PHS Act. However, as stated above, under the 2015 Final Regulations, only âimmunizations for routine use in children, adolescents, and adultsâ that are recommended by ACIP must be covered without cost sharing.[] A recommendation is considered to be for routine use if it is listed on the CDC's Immunization Schedules.[] This IFC provides a definition of qualifying asthma preventive services that is consistent with the statutory definition in section 3203 of the CARES Act. However, the Departments note that unlike the other preventive service immunizations required to be covered without cost sharing under section 2713 of the PHS Act and the 2015 Final Regulations, this definition and related coverage requirement are not limited to asthma treatment immunizations recommended by ACIP for âroutine use.â While other preventive items and services may be recommended for routine use, for reasons described elsewhere in this section of the preamble, the PHE for asthma treatment presents unique circumstances and qualifying asthma preventive services might not, in the immediate term, be recommended for routine use, according to specified schedules.

Rather, the Start Printed Page 71176Departments generally expect consumers should receive an immunization for asthma treatment as soon as it becomes available to the general public, or as soon as it becomes available to them based on their status as part of a high-risk or high-priority population, as recommended by ACIP. Plans and issuers subject to section 2713 of the PHS Act must cover, without cost sharing, asthma treatment immunizations that are recommended by ACIP and adopted by the Director of CDC, even if not listed for routine use on the CDC Immunization Schedules, pursuant to 26 CFR 54.9815-2713T(a). 29 CFR 2590.715-2713(a).

And 45 CFR 147.130(a), and subject to the additional changes described later in this section of the preamble.[] 4. Qualifying asthma Preventive ServicesâTiming Requirement Section 2713 of the PHS Act and the 2015 Final Regulations require plans and issuers to cover recommended preventive items and services beginning with the first plan year (or in the individual market, policy year) that is one year after the date the recommendation or guideline is issued. Section 3203 of the CARES Act accelerates the timeline for coverage of qualifying asthma preventive services without cost sharing, requiring coverage to be provided within 15 business days after the date on which a recommendation is made relating to such service.

This IFC codifies these timing requirements at 26 CFR 54.9815-2713T(b)(3). 29 CFR 2590.715-2713(b)(3). And 45 CFR 147.130(b)(3).

In addition, the IFC adds a sunset provision at 26 CFR 54.9815-2713T(e). 29 CFR 2590.715-2713(e). And 45 CFR 147.130(e), under which the amendments made to the regulations will not apply with respect to qualifying asthma preventive services furnished on or after the expiration of the PHE for asthma treatment.

The Departments note, however, that coverage under section 3203 of the CARES Act is not limited to the duration of the PHE for asthma treatment and therefore the statutory provisions will continue to apply. B. Diagnostic Testing for asthma treatment Section 6001 of the FFCRA generally requires group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits for asthma treatment diagnostic tests and certain items and services related to diagnostic testing for asthma treatment when those items or services are furnished on or after March 18, 2020, and during the duration of the PHE for asthma treatment.

Under the FFCRA, plans and issuers must provide this coverage without imposing any cost-sharing requirements (including deductibles, copayments, and coinsurance) or prior authorization or other medical management requirements. Section 3201 of the CARES Act, enacted on March 27, 2020, amended section 6001 of the FFCRA to include a broader range of diagnostic tests that plans and issuers must cover without any cost-sharing requirements or prior authorization or other medical management requirements. Section 3202(a) of the CARES Act provides that a plan or issuer providing coverage of items or services described in section 6001(a) of the FFCRA shall reimburse the provider of the diagnostic testing at a rate negotiated with the provider, or if there is no negotiated rate, at an amount that equals the cash price for such service as listed by the provider on a public internet website.

As previously articulated in guidance, the Departments interpret the requirement to provide coverage without cost sharing in section 6001 of the FFCRA, together with section 3202(a) of the CARES Act, as establishing a process for setting reimbursement rates and protecting participants, beneficiaries, and enrollees from being balance billed for an applicable asthma treatment test.[] These provisions help ensure consumers can be tested for asthma treatment without barriers related to cost, and are critical to the ability to detect the ventolin and stop its spread. However, testing efforts have continued to be hampered by challenges, such as delays in obtaining results, issues with test accuracy, and supply shortages.[] The Departments encourage group health plans and issuers of group or individual health insurance coverage to consider market-driven approaches to addressing these continued challenges surrounding asthma treatment diagnostic testing. The Departments encourage plans and issuers to explore using payment arrangements that create incentives for providers to reduce the time it takes to provide results for diagnostic testing for asthma treatment, while maintaining the accuracy rates of their test results in instances where it is within the ability of providers to address a delay.

At certain points in this PHE, there have been wide variations in the time it takes providers to make test results available to consumers. These delays in obtaining test results increase the risk that infected individuals may unknowingly infect others. These delays could be caused by large volumes of tests to process and/or inadequate resources.

Pay-for-performance arrangements, where reimbursement rates are based on the time it takes to make test results available, could encourage innovative approaches by providers to reduce the turnaround time. The Departments encourage group health plans and issuers of group or individual health insurance coverage to consider developing such arrangements with providers, and strongly encourage plans and issuers that do so to incorporate safeguards to ensure that the payment arrangements are not structured in a way that prioritizes speed over accuracy or that result in unintended consequences, such as reduction in access to asthma treatment diagnostic testing or non-compliance with balance billing restrictions. IV.

Provisions of the Interim Final Rule Regarding State Innovation WaiversâDepartment of the Treasury and Health and Human Services A. State Innovation Waivers Policy and Regulatory Revisions in Response to the PHE for asthma treatment Public Health Emergency 1. Background Section 1332 of the PPACA permits states to apply for a State Innovation Waiver (also referred to as âsection 1332 waiversâ or âState Relief and Empowerment Waiversâ) to pursue innovative strategies for providing their residents with access to higher value, more affordable health coverage.

The overarching goal of section 1332 waivers is to give all Americans the opportunity to obtain high value and affordable health coverage regardless of income, geography, age, sex, or health status, Start Printed Page 71177while simultaneously empowering states to develop health coverage strategies that best meet the needs of their residents. Section 1332 waivers provide states an opportunity to promote a stable health insurance market that offers more choice and affordability to their residents. Under section 1332 of the PPACA, a State Innovation Waiver can be approved by HHS and the Department of the Treasury if it provides access to quality health coverage that is at least as comprehensive and affordable as would be provided absent the waiver, provides coverage to a comparable number of residents of the state as would be provided coverage absent a waiver, and does not increase the Federal deficit.

To date, HHS and the Department of the Treasury have approved 15 state waiver requests, 14 of which implement state-based reinsurance programs.[] As noted in a recent data brief issued by CMS, section 1332 state-based reinsurance waivers have resulted in a statewide average premium reduction ranging from four to 37 percent in calendar year 2020 for residents in states with approved waivers.[] Reinsurance provides a direct benefit to consumers by paying a portion of provider claims that would otherwise be paid by consumers through higher premiums and lowering premiums for people in the individual health insurance market. HHS and the Department of the Treasury continue to encourage states to take advantage of the flexibilities available through section 1332 waivers in order to pursue solutions to help lower costs and increase coverage choices for Americans faced with unaffordable premiums and reduced competition in the insurance market both during and after the PHE for asthma treatment. Section 1332(a)(4)(B) of the PPACA requires the Secretary of HHS and the Secretary of the Treasury (the Secretaries) to issue regulations regarding procedures for State Innovation Waivers.

On March 14, 2011, HHS and the Department of the Treasury published the âApplication, Review, and Reporting Process for Waivers for State Innovationâ proposed rule (76 FR 13553) to implement section 1332(a)(4)(B) of the PPACA.[] On February 27, 2012, HHS and the Department of the Treasury published the âApplication, Review, and Reporting Process for Waivers for State Innovationâ final rule (77 FR 11700) (hereinafter referred to as the â2012 Final Ruleâ).[] On October 24, 2018, HHS and the Department of the Treasury issued the âState Relief and Empowerment Waiversâ guidance (83 FR 53575) (hereinafter referred to as the â2018 Guidanceâ), which superseded the previous guidance published on December 16, 2015 (80 FR 78131), and provided additional information about the requirements that states must meet regarding section 1332 waiver proposals, the Secretaries' application review procedures, pass-through funding determinations, certain analytical requirements, and operational considerations.[] Section 1332(a)(4)(B) of the PPACA also directs HHS and the Department of the Treasury to issue regulations that provide for state and Federal public notice and comment sufficient to ensure a meaningful level of public input regarding a state's section 1332 waiver plan, both during the application process and after a waiver is implemented. Current regulations and guidance address how states may apply for a waiver, information states must include in an application, public notice and comment requirements, and HHS' and the Department of the Treasury's monitoring and compliance activities, including state reporting requirements (collectively referred to as public notice procedures). The Secretaries are setting forth a process for states to request modifications to the public notice procedures during the PHE for asthma treatment prior to and after approval of a section 1332 waiver that continue to meet the statutory and regulatory requirements that the public has an opportunity to provide meaningful input.

Further the Secretaries are promulgating this rule so that HHS and the Department of the Treasury do not impose requirements that are unreasonable or unnecessarily burdensome regarding state compliance consistent with section 1332(a)(4)(B)(iii) of the PPACA during the PHE for asthma treatment 19. This IFC promulgates rules to establish a framework for the Secretaries to modify some of the existing regulatory public notice procedures to expedite a decision on a proposed waiver request during the PHE for asthma treatment when a delay would undermine or compromise the purpose of the proposed waiver request and be contrary to the interests of consumers. The Secretaries will also make available such flexibility regarding public notice procedures should any state with an approved section 1332 waiver request an extension or amendment of an approved section 1332 waiver during the PHE for asthma treatment.

Similarly, this IFC also establishes a framework for the Secretaries to modify, in part, post award public notice procedures for an approved waiver request that would otherwise take place or become due during the PHE for asthma treatment. The Secretaries will also make available such flexibility for post award public notice procedures for approved waiver extensions, amendments, or phase-out for a waiver should those otherwise take place or become due during the PHE for asthma treatment. HHS and the Department of the Treasury are of the view that section 1332 waivers are a critical tool for states to ensure patients have stable access to health care coverage, including during the PHE for asthma treatment.

These interim final provisions are effective immediately for the duration of the PHE for asthma treatment. HHS and the Department of the Treasury note that existing threats to consumers' access to health coverage or careâsuch as in geographic areas in which issuer participation has been low for some timeâwould not be considered emergency situations for purposes of applying the flexibilities adopted in this rulemaking. 2.

Public Notice Procedures and Approval Processes During the PHE (31 CFR 33.118 and 45 CFR 155.1318) Section 1332(a)(4)(B) of the PPACA provides that the Secretary of HHS and the Secretary of the Treasury shall issue regulations providing a process for public notice and comment at the state level, including public hearings, and a process for providing public notice and comment after the application is received by the Secretaries, that are both sufficient to ensure a meaningful level of public input. Current regulations at Â§Â§â33.112 and 155.1312 specify state public notice and participation requirements for proposed waiver requests, and Â§Â§â33.116(b) and 155.1316(b) specify the accompanying public notice and comment period requirements under the Federal public notice and approval process.Start Printed Page 71178 Under the current regulations at Â§Â§â33.112 and 155.1312, states are required to provide a public notice and comment period prior to submitting an application for a new section 1332 waiver. The notice must include a comprehensive description of the section 1332 waiver application.

Information about where the application is available for public review. Where the written comments may be submitted. And the location, date, and time of public hearings that will be convened by the state to seek public input on the application for a section 1332 waiver.[] After issuing the public notice and prior to submitting an application for a section 1332 waiver, the state must hold public hearings to allow the public to learn about and comment on the state's application, and must publish the date, time, and location of the hearings in a prominent location on the state's public website.[] As set forth in Â§Â§â33.112(a)(2) and 155.1312(a)(2), as part of the public notice and comment period, a state with one or more federally recognized tribes must conduct a separate process for meaningful consultation with such tribes, if applicable.

As HHS and the Department of the Treasury explained in the 2012 Final Rule preamble, this tribal consultation must be conducted in accordance with Executive Order (E.O.) 13175, and, as E.O. 13175 also applies to Medicaid, a state may use a Medicaid consultation process to satisfy the consultation needed for a section 1332 waiver (77 FR 11700, 11706). Furthermore, the state should include in its section 1332 waiver application a description of issues raised and comments received.

In addition, under section 1332(a)(4)(B)(iii) of the PPACA and the existing implementing regulations at Â§Â§â33.116(b) and 155.1316(b), the Secretary of HHS and the Secretary of the Treasury are required to provide a Federal public notice and comment period following their preliminary determination that a state's section 1332 waiver application is complete. Section 1332 waivers may vary significantly in their complexity and breadth. The existing regulations generally provide states and the Federal Government flexibility in determining and/or extending the length of the comment periods.

Both the state and the Federal public notice and comment periods must be sufficient to ensure a meaningful level of public input. The 2018 Guidanceâ[] further specifies that the state comment period should be no less than 30 days, and explains that consistent with HHS regulations, waiver applications must be posted online in a manner that meets technical standards for website accessibility similar to applicable national standardsâ[] to ensure access for individuals with disabilities. HHS and the Department of the Treasury recognize that the current section 1332 regulations regarding state and Federal public notice procedures and comment period requirements may impose barriers for states pursuing a proposed waiver request during the PHE for asthma treatment.[] It is the mission of HHS to enhance and protect the health and well-being of all Americans.

As such, HHS and the Department of the Treasury are issuing this guidance to protect public health and to prevent the spread of asthma treatment by limiting the need for in-person gatherings related to section 1332 waivers during the PHE. Additionally, states may face uncertainty as to whether their waiver request will be approved in time, given the state and Federal public notice procedures or other public participation requirement associated with state procedures that would otherwise require an in-person gathering, to expeditiously reform their health insurance markets and to protect consumers from the effects of the PHE for asthma treatment. Some states may not consider more robust changes because they are concerned that the current section 1332 waiver application requirements are too time-consuming or burdensome to pursue during the PHE for asthma treatment.

Therefore, HHS and the Department of the Treasury are of the view that having the flexibility to modify certain public notice procedures and participation requirements during the PHE for asthma treatment will protect public health and health insurance markets, and will increase flexibility and reduce burdens for states seeking to use section 1332 waivers as a means of innovation for providing coverage, lowering premiums, and improving their health care markets. Section 1332 waivers are a critical tool for states to ensure patients across the country have access to health care coverage. About 10.7 million individuals on average rely on the Exchanges to purchase individual health insurance coverage throughout the year.[] Although recently there have been positive premium stabilization and insurer participation trends, the asthma treatment ventolin has introduced new uncertainties in the individual and small group markets such that past trends resulting in limited access and affordability may return in some areas.

For example, in response to the uncertainty created by the PHE for asthma treatment regarding health care utilization rates and claims costs, such as those associated with testing and treatment for asthma treatment, premiums may increase and issuers may reduce their presence or coverage options in the individual and small group markets. Additionally, due to the PHE for asthma treatment, some issuers may have difficulty predicting the composition of their risk pools given uncertainty about Start Printed Page 71179the risk profiles of many new enrollees coming from employer-sponsored coverage and the potential transition of other enrollees to Medicaid due to income loss. Therefore, HHS and the Department of the Treasury are concerned that past trends that threaten the stability of the individual market risk pool may return, leading some issuers to cease offering coverage on the Exchanges in some states and counties and leading other issuers to increase their rates, leaving some geographic areas with limited or no affordable Exchange coverage options.

Permitting the Secretary of HHS and the Secretary of the Treasury to modify the public notice procedures, in part, will help states seeking section 1332 waivers to address such circumstances more quickly and develop innovative ways to ensure consumers have access to affordable health care coverage. As such, HHS and the Department of the Treasury are of the view that, if certain safeguards are met, it is in the best interest of the public to provide states applying for section 1332 waivers with the option to request to modify public notice procedures during the PHE for asthma treatment. This IFC adds the new Â§Â§â33.118 and 155.1318 and provides that the Secretary of HHS and the Secretary of the Treasury may modify, in part, the state public notice requirements specified in Â§Â§â33.112 and 155.1312 and the Federal public notice requirements specified at Â§Â§â33.116(b) and 155.1316(b) to expedite a decision on a proposed waiver request during the PHE for asthma treatment when a delay would undermine or compromise the purpose of the proposed waiver request and be contrary to the interests of consumers.

Examples of the public notice procedures that currently apply under the aforementioned regulations that a state may seek to have waived or modified include the requirement that states notify the public and hold hearings prior to submitting an application, that the state hold more than one public hearing in more than one location and that HHS and the Department of the Treasury provide for public notice and comment after an application is determined to be complete. States may also seek to modify the state and/or Federal comment periods to be less than 30 days and to host public hearings virtually rather than in-person. For a state to qualify for modification of the state or Federal public notice requirements to expedite a decision on a proposed waiver request during the PHE for asthma treatment, a delay must undermine or compromise the purpose of the proposed waiver request and be contrary to the interests of consumers.

During the PHE for asthma treatment, the Secretary of HHS and the Secretary of the Treasury (the Secretaries) may modify the Federal and/or state public notice procedures, in part, if the state meets all of the following. The state requests a modification in the form and manner specified by the Secretaries. The state acted in good faith, and in a diligent, timely, and prudent manner in the preparation of the request for the modification for the waiver, and the waiver application request.

The state details in its request for a modification, as applicable, the reason(s) the state seeks a modification from the state public notice procedures, describes how the state meets the modification criteria, and describes the alternative public notice procedures it proposes to implement at the state level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the state's request for a modification. The state details in its request for a modification, as applicable, the justification for the request and the alternative public notice procedures it requests to be implemented at the Federal level. The state must, as applicable, implement the alternative public notice procedures at the state level if the state's modification request is approved and, if required, amend the waiver application to specify that it is the state's intent to comply with those alternative public notice procedures in the state's modification request.

Any state submitting a proposed waiver request during the PHE for asthma treatment can submit a request to the Secretary of HHS and the Secretary of the Treasury for this modification from the state and/or Federal public notice procedures or include such a request in its section 1332 waiver application request. The Secretary of HHS and the Secretary of the Treasury's review and consideration of a modification request will vary based on the state's circumstances, its modification request, and the complexity and breadth of the state's proposed section 1332 waiver request. For example, during the PHE for asthma treatment, many states are prohibiting in-person public gatherings or establishing stay-at-home orders due to the public health threat.[] States seeking new section 1332 waiver(s) that have such prohibitions in effect at the time they would have otherwise have to conduct public notice would most likely be unable to comply with the public notice requirements to hold two in-person public hearings prior to submission of their section 1332 waiver applications in accordance with the 2018 Guidance addressing requirements under Â§Â§â33.112(b) and 155.1312(b).

In such cases, this IFC will allow the Secretaries to grant the state's request to hold the two public hearings virtually, rather than in-person, or to hold one public hearing at the state level, rather than two public hearings at the state level. As another example, the Secretaries may agree with a state that, due to emergency circumstances that have arisen related to the PHE for asthma treatment, there is insufficient time for the state to provide public notice and hold any public hearings at the state level prior to submitting its section 1332 waiver application as required by Â§Â§â33.112(a) and 155.1312(a), and grant the state's request to provide public notice and hold public hearings at the state level after the state submits its section 1332 waiver application. In situations where HHS and the Department of the Treasury determine that public notice and hearings are warranted on a different timeframe and may occur after the submission of a state's waiver application request, the state will be required to amend the application request as necessary to reflect public comments or other relevant feedback received during the alternative public notice procedures.

HHS and the Department of the Treasury will evaluate a state's request for a modification and issue their modification determination within approximately 15 calendar days after the request is received. In assessing whether a state acted in good faith, and in a diligent, timely, and prudent manner in the preparation of the modification request for the waiver, and for the waiver application, HHS and the Department of the Treasury will evaluate whether the relevant circumstances constitute an emergency. HHS and the Department of the Treasury remind states that any public participation processes must continue to comply with applicable Federal civil rights laws, including taking reasonable steps to provide meaningful access for individuals with limited English Start Printed Page 71180proficiency and taking appropriate steps to ensure effective communication with individuals with disabilities, including accessibility of information and communication technology.

Please note that virtual meetings may present additional accessibility challenges for people with communications and mobility disabilities, as well as to those who lack broadband access. Ensuring effective communication may include providing American Sign Language interpretation and real-time captioning, and ensuring that the platform is interoperable with assistive technology for those with mobility difficulties. HHS and the Department of the Treasury especially encourage states to strive to obtain meaningful input from potentially affected populations, including low-income residents, residents with high expected health care costs, persons less likely to have access to care, and members of federally-recognized tribes, if applicable, as part of any alternative public participation process.[] The Secretary of HHS will publish on the CMS website any modification determinations within 15 calendar days of the Secretary of HHS and the Secretary of the Treasury making such a determination, as well as the approved revised timeline for public comment at the state and Federal level, as applicable.

Under Â§Â§â33.120(c) and 155.1320(c), to ensure continued public input within at least 6 months after the implementation date, and annually thereafter, states are required to hold a public forum at which members of the public have an opportunity to provide comments on the progress of the program authorized by the section 1332 waiver and to provide a summary of this forum to the Secretary of HHS as part of the quarterly and annual reports required under Â§Â§â33.124 and 155.1324. Under Â§Â§â33.120(c)(1) and 155.1320(c)(1), states are required to publish the date, time, and location of the public forum in a prominent location on the state's public website at least 30 days prior to the date of the planned public forum. This IFC adds new Â§Â§â33.120(c)(2) and 155.1320(c)(2), which provide that the Secretary of HHS and the Secretary of the Treasury (the Secretaries) may waive, in part, post award public notice requirements for an approved waiver outlined in Â§Â§â33.120(c) and 155.1320(c) during the PHE for asthma treatment when the application of the post award public notice procedures would be contrary to the interests of consumers during the PHE for asthma treatment.

The Secretaries may modify the post award public notice procedures, in part, when the state meets all of the following. The state requests a modification in the form and manner specified by the Secretaries. The state acts in good faith, and in a diligent, timely, and prudent manner to comply with the monitoring and compliance requirements under the regulations and specific terms and conditions of the waiver and to submit and prepare the request for a modification.

The state details in its request for a modification the reason(s) the state seeks a modification from the state post award public notice procedures, describes how the state meets the modification criteria, and describes the alternative post award public notice procedures it proposes to implement at the state level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the state's request for a modification. As part of HHS and the Department of the Treasury's monitoring and oversight of approved section 1332 waivers, the Secretary of HHS and the Secretary of the Treasury, at their discretion, monitor the state's compliance with the specific terms and conditions of the waiver including, but not limited to, compliance with the guardrails, reporting requirements, and the post award forum requirements. Under the flexibilities provided in this IFC, the Secretaries may, for example, allow the public forum for an approved waiver that would take place or become due during the PHE for asthma treatment to be held virtually rather than as an in person gathering.

The state is required to publish on its website any modification requests and determinations by HHS and the Department of the Treasury within 15 calendar days of receipt of the determination, as well as information on the approved revised timeline for the state's post award public notice procedures, as applicable. Since the state is already required to post materials as part of post award annual reporting requirements, such as the notice for the public forum and annual report, states will be responsible for ensuring that the public is aware of the determination to modify the public notice procedures and must include this information along with the information required under Â§Â§â33.120(c)(1) and 155.1320(c)(1) in a prominent location on the state's public website. HHS and the Department of the Treasury are of the view that post award forums are critical to ensure that the public has a regular opportunity to learn about and comment on the progress of section 1332 waivers.

States that receive approval, to modify, in part, these post award public notice procedures would still need to meet all other requirements specified in Â§Â§â33.112(b) and 155.1312(b). For example, should the state receive a modification approval that permits it to hold the post award public forum virtually instead of in person, the state must still publish the notice of its post award public notice on Start Printed Page 71181the state's public website and use other effective means to communicate the required information to the public. The public notice must include the website, date, and time of the public forum that will be convened by the state, information related to the timeframe for comments, and how comments from the public on the section 1332 waiver must be submitted.

HHS and the Department of the Treasury remind states that they still must also comply with Federal civil rights requirements, including laws pertaining to accessibility, if the Secretary of HHS and the Secretary of the Treasury approve a modification from all or a portion of the post award public notice procedures. In such a circumstance, the state would need to ensure these virtual public hearings are as accessible as possible during the PHE for asthma treatment so members of the public can participate and submit comments. The state should also track how many people are attending these forums, if possible.

Section 553(b)(B) authorizes the agency to waive these procedures, however, if the agency finds good cause that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. Section 553(d) ordinarily requires a 30-day delay in the effective date of a final rule from the date of its publication in the Federal Register. This 30-day delay in effective date can be waived, however, if an agency finds good cause to support an earlier effective date.

Finally, the Congressional Review Act (CRA) requires a delay in the effective date for major rules unless an agency finds good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, in which case the rule shall take effect at such time as the agency determines. 5 U.S.C. 801(a)(3), 808(2).

As noted earlier in this preamble, on January 30, 2020, the International Health Regulations Emergency Committee of the WHO declared the outbreak a âPublic Health Emergency of international concern.â On January 31, 2020, pursuant to section 319 of the PHS, the HHS Secretary determined that a PHE exists for the United States to aid the nation's health care community in responding to asthma treatment. On March 11, 2020, the WHO publicly declared asthma treatment a ventolin. On March 13, 2020, the President declared the asthma treatment ventolin a national emergency.

Effective October 23, 2020, the HHS Secretary renewed the January 31, 2020 determination, which was previously renewed on April 21, 2020 and July 25, 2020, that a PHE exists and has existed since January 27, 2020. This declaration, along with the HHS Secretary's January 30, 2020 declaration of a PHE, conferred on the HHS Secretary certain waiver authorities under section 1135 of the Act. On March 13, 2020, the HHS Secretary authorized waivers under section 1135 of the Act, effective March 1, 2020.[] It is critically important that the Departments implement the policies in this IFC as quickly as possible.

As the United States is in the midst of the PHE for asthma treatment, the Departments find good cause to waive notice of proposed rulemaking under the APA, 5 U.S.C. 553(b)(B). For those same reasons, as authorized by section 808(2) of the CRA, the Departments find it is impracticable and contrary to the public interest not to waive the delay in effective date of this IFC under section 801 of the CRA.

Therefore, the Departments find there is good cause to waive the CRA's delay in effective date pursuant to section 808(2) of the CRA. Thus, the Departments find good cause to waive the applicable delays in the effective date and, moreover, to establish these policies in this IFC applicable as of the date of display at the Office of the Federal Register. In this IFC, consistent with section 1902(a)(4) and (a)(19) of the Act, the Department adds a new subpart G to 42 CFR part 433 to provide states with more flexibility, subject to certain safeguards, in implementing the requirement in section 6008(b)(3) of the FFCRA that states maintain Medicaid beneficiary enrollment in order to receive the temporary increase in Federal funding in the FFCRA.

This temporary funding increase is effective beginning January 1, 2020 and could extend through the last day of the calendar quarter in which the PHE for asthma treatment, including any extensions, terminates, if the state claims the temporary funding increase in that quarter. This provision of the IFC is immediately necessary to ensure that states can determine eligibility and provide care and services during the PHE in a manner that is consistent with simplicity of administration and the best interests of beneficiaries and also claim the temporary funding increase. In this IFC, HHS and the Department of the Treasury are setting forth flexibilities in the public notice and post award public participation requirements for a State Innovation Waiver described in section 1332 of PPACA during the PHE for asthma treatment.

HHS and the Department of the Treasury recognize that following the normal state and Federal public notice procedures and the state post award requirements for section 1332 waivers may impose barriers for states pursuing a proposed waiver request during the PHE for asthma treatment. This guidance is intended to protect public health and prevent the spread of asthma treatment by limiting the need for in-person gatherings related to a section 1332 waiver. Additionally, states may face uncertainty as to whether their waiver requests will be approved in time to expeditiously reform their health insurance markets and to protect consumers from the effects of the PHE for asthma treatment.

Some states may not consider more robust changes because they were concerned that the current section 1332 waiver application requirements are too time-consuming or burdensome to be helpful during the PHE for asthma treatment. HHS and the Department of the Treasury are of the view that the flexibility to modify certain public notice procedures and participation requirements will increase flexibility and reduce burden for states seeking to use section 1332 waivers as a means of innovation for providing coverage, lowering premiums, and improving their health care markets during the PHE for asthma treatment. As such, these flexibilities are immediately necessary to provide states applying for a section 1332 waiver or during the post award period with the option to request a modification from the state and/or Federal public notice requirements when a delay would undermine or compromise the purpose of the waiver and be contrary to the interests of consumers.

HHS and the Department of the Treasury are of the view that it could be contrary to the public interest to require full notice and comment during the current PHE for asthma treatment because following the normal timeframes and requirements could result in waiver approvals for Start Printed Page 71182innovative waivers taking effect after issuers have already made their decisions regarding issuer participation in the individual market and after rates for the upcoming plan year have been submitted. A modification from the public participation requirements would be beneficial to the public interest by providing states and the Federal Government the flexibilities necessary to review and approve, as appropriate, section 1332 waivers that expand access to coverage on a faster timeframe. In this IFC, the Departments amend the regulations under section 2713 of the PHS Act to implement the requirement in section 3203 of the CARES Act that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage provide coverage without cost sharing for qualifying asthma preventive services.

This coverage must be provided within 15 business days after the date on which a recommendation is made by the USPSTF or ACIP. The Departments also establish in this IFC that this coverage must be provided regardless of whether the service is delivered by an in-network or out-of-network provider. The Departments are issuing these amendments under the authority of section 9833 of the Code, section 734 of ERISA, and section 2792 of the PHS Act.

These sections authorize the Secretaries of the Treasury, Labor, and HHS to promulgate any interim final rules that the Secretaries determine are appropriate to carry out the provisions of chapter 100 of the Code, part 7 of subtitle B of title I of ERISA, and part A of title XXVII of the PHS Act, which include PHS Act sections 2701 through 2728 and the incorporation of those sections into ERISA section 715 and Code section 9815. In addition, section 7805(e) of the Code restricts any temporary regulation issued by Treasury and the IRS under the Code, such as interim final regulations, to a duration of 3 years. Several asthma treatment candidates are currently in late-stage development.

Once a treatment is authorized or approved by FDA, the Departments expect that ACIP may move expeditiously to recommend the immunization. In addition, unlike other preventive items and services typically provided according to regularly scheduled intervals, items and services intended to prevent or mitigate asthma treatment will not, in the immediate future, be provided as part of a usual course of preventive care. Instead, the Departments expect consumers to receive these services once they are recommended for the general public or specific high-risk or high-priority populations.

To help ensure full access to and the widespread use of qualifying asthma preventive services to mitigate the PHE for asthma treatment 19, it is critical that individuals be able to receive such services from any provider authorized to provide the service. This is consistent with the objectives of Operation Warp Speed, which, as mentioned above, is a partnership among components of the Federal Government that engages with private firms to accelerate the development, manufacture, and distribution of a asthma treatment to the American people. The provisions of this IFC therefore are immediately necessary to ensure group health plan and group and individual health insurance coverage of these items and services is prompt and broad, to ensure timely access to combat the ventolin.

In this IFC, the Department adds a requirement at Â§â417.454 to require section 1876 cost plans to cover without cost sharing the asthma treatment 19 treatment and its administration described in section 1861(s)(10)(A) of the Act without cost sharing for the duration of the PHE for the asthma treatment ventolin, specifically the end of the emergency period defined in paragraph (1)(B) of section 1135(g) of the Act, which is the PHE declared by the Secretary on January 31, 2020 and any renewals thereof. While section 1876(c)(2) of the Act ensures that enrollees in Medicare cost plans will have coverage of a asthma treatment and its administration, section 3713 of the CARES Act did not amend section 1876 of the Act to provide similar cost-sharing protections for enrollees in cost plans who receive the treatment from an in-network provider. Currently, there is no requirement for cost plans to cover the asthma treatment and its administration without cost sharing (that is, with cost sharing that is the same as original Medicare) when the treatment is furnished by an in-network health care provider.

This provision of the IFC is immediately necessary to ensure that cost plan enrollees, like other Medicare beneficiaries, are provided access to the asthma treatment and its administration without cost sharing. This immediate action will ensure that cost is not a barrier for beneficiaries to get the treatment, particularly during the public health emergency when ensuring access is paramount importance. The delay necessary for notice and comment rulemaking is both contrary to the public interest and impractical here as it would delay access to a asthma treatment without cost sharing and be contrary to the need to ensure access to a asthma treatment for enrollees in cost plans on the same basis as is ensured for other Medicare beneficiaries.

Further, as underscored by the timeline for coverage Congress established in section 3203 of the CARES Act, the need to provide coverage of qualifying asthma preventive services is urgent. Following a recommendation of the USPTF or ACIP, the requirement to provide coverage without cost sharing of qualifying asthma preventive services, which are expected to include immunizations, takes effect within 15 business days. Plans and issuers need immediate guidance to understand their obligations under section 3203 of the CARES Act and to take steps that will enable them to comply with those requirements as soon as the coverage requirement goes into effect.

Delaying these provisions would likewise delay plans' and issuers' ability to prepare for the availability of a asthma treatment, resulting in barriers in access to coverage of these critical services during the PHE for asthma treatment. As of the date of display of this regulation, there are not any asthma preventive services including treatments for asthma that are required to be covered. However, because emergency use authorization or approval of a asthma treatment may be imminent, the Departments are of the view it is critical that these regulations under section 2713 of the PHS Act be issued and effective prior to such authorization or approval.

The Departments are of the view that it would be impracticable and contrary to the public interest to undertake normal notice and comment rulemaking procedures in light of the urgent need to ensure coverage of and access to qualifying asthma preventive services to protect the public health as well as the health and safety of individuals and communities to prevent the spread of asthma treatment. For these same reasons, the Departments are of the view a delayed effective date would also be contrary to the public interest. Ensuring individuals have access to a asthma treatment as soon as it becomes available is critical to ending the PHE for asthma treatment, and therefore it is imperative that these regulations are in effect on the date such a treatment becomes available and recommended by ACIP.

Undertaking the standard rulemaking process of publishing a proposed rule, seeking public comment, carefully Start Printed Page 71183analyzing those public comments, and subsequently publishing a final rule would possibly and perhaps likely jeopardize such an effective date. The Departments are of the view that it would be impracticable and contrary to the public interest to undertake normal notice and comment procedures and to thereby delay the effective date of this IFC. The Departments find good cause to waive notice of proposed rulemaking under the APA, 5 U.S.C.

The provisions in this IFC will go into effect on the date of display. This IFC implements the requirement that providers of diagnostic tests for asthma treatment make public their cash prices for asthma treatment diagnostic tests and specifies the asthma treatment diagnostic tests to which this requirement applies. This IFC further defines âprovider of a diagnostic test for asthma treatmentâ (referred to as âproviderâ) as any facility that performs one or more asthma treatment diagnostic tests.

In addition, this IFC defines âcash priceâ as the charge that applies to an individual who pays cash (or cash equivalent) for a asthma treatment diagnostic test. This IFC gives CMS discretion to take any of the following actions if CMS determines a provider is noncompliant with the requirements of new 45 CFR 182.50. Provide a written warning notice to the provider of the specific violation(s).

Therefore, it is critically important that we implement the policies in this IFC as quickly as possible in order for stakeholders to know with certainty during the PHE for asthma treatment how to comply with the law and what penalties they will face for noncompliance during the PHE for asthma treatment. Moreover, these rules are necessary for CMS to enforce section 3202(b) of the CARES Act and to ensure plans, issuers, and consumers know in advance the price for a diagnostic test for asthma treatment during the PHE for asthma treatment. For these reasons, we believe it would be impracticable and contrary to the public interest to undertake normal notice and comment rulemaking procedures and to delay the effective date of the new requirements being adopted at 45 CFR part 182.

In this IFC, the Department creates a New asthma treatments Add-on Payment (NCTAP) under the Inpatient Prospective Payment System (IPPS) for asthma treatment cases that meet certain criteria. The Department is of the view that it would be impracticable and contrary to the public interest to undertake normal notice and comment procedures and to thereby delay the effective date of this IFC. As drug and biological products become available and are authorized or approved by FDA for the treatment of asthma treatment in the inpatient setting, there may be potential financial disincentives for hospitals to provide these new asthma treatments to Medicare inpatients during the PHE because the costs of these new treatments are not yet reflected in Medicare payment rates and there are no new technology add-on payments for these treatments.

The delay necessary for notice and comment rulemaking is both contrary to the public interest and impracticable because of the urgency in ensuring there are not financial disincentives for hospitals to provide asthma treatments to beneficiaries during the PHE. We expect that increasing the current IPPS payment amounts for sufficiently costly cases to mitigate potential financial disincentives for hospitals to provide new asthma treatments during the PHE will potentially improve and speed access to these treatments for Medicare patients. We also believe that the establishment of the NCTAP provides greater transparency and predictability to the public, including innovators that are developing new asthma treatments, as to how Medicare payments for cases involving these treatments will be determined when those treatments become available.

In this IFC, the Department assures separate payment for new asthma treatments provided in the outpatient setting for the remainder of the Public Health Emergency for asthma treatment. The Department is of the view that it would be impracticable and contrary to the public interest to undertake normal notice and comment procedures and to thereby delay the effective date of this IFC. We anticipate that most drugs and biological products authorized or approved for use in treating asthma treatment in the outpatient setting would be separately paid under our standard OPPS payment policy.

However, these products could be packaged into a Comprehensive Ambulatory Payment Classification (C-APC) payment when provided on the same claim as a C-APC service, in which case separate payment would not be made for these products. Although we do not expect that many beneficiaries would both receive a primary C-APC service and a drug or biological for treating asthma treatment, we nonetheless believe that as drugs or biologicals become available and are authorized or approved for the treatment of asthma treatment in the outpatient setting, it would be appropriate to mitigate any potential financial disincentives for hospitals to provide these new treatments during the PHE for asthma treatment. The delay necessary for notice and comment rulemaking to address this issue is both contrary to the public interest and impracticable because of the urgency in ensuring there are not financial disincentives for hospitals to provide asthma treatments to beneficiaries.

Therefore, effective for services furnished on or after the effective date of this rule and until the end of the PHE for asthma treatment, CMS is creating an exception to its OPPS C-APC policy to ensure separate payment for new asthma treatments that meet certain criteria. In this IFC, the Department adds changes to the CJR model that are immediately necessary to continue the CJR model consistent with model goals to, cover inpatient major lower joint replacements without interruption, and to reduce operational and financial uncertainty for CJR hospital participants during and beyond the PHE. Ending on March 31, 2021 would be disruptive to hospitals and patient care during the PHE.

The end date of March 31, 2021, means hospitals stop initiating episodes under the model after January 2, 2021, before the end of the public health emergency as renewed on October 23, 2020.[] Extending the model through an additional six months of performance year (PY) 5, so that PY 5 now ends on September 30, 2021, provides participant hospitals with greater certainty in model operations during the remainder of the PHE. Through this IFC we are implementing four changes to the CJR model needed to extend PY 5. These are.

(1) Extending PY 5 an additional 6 months to provide for continuity of model operations with the same scope while we continue to consider comments received on our proposal to extend the model to PYs 6 through 8 and adopt other changes to the model Start Printed Page 71184(42 CFR 510.2 and 510.200(a)). (2) making changes to the reconciliation process for PY 5 to allow for two periods and to enable more frequent receipt of reconciliation reports by participants (42 CFR 510.2, 42 CFR 510.200, 42 CFR 510.305(b), (d)(1), (e), (i)(1) and (2), and (j)(1) and (2), and 42 CFR 510.400(b)(3)(v), and adding 42 CFR 510.400(b)(3)(vi)). (3) making a technical change, retroactive to October 1, 2020, to ensure that the model continues to include the same inpatient Lower Extremity Joint Replacement (LEJR) procedures, despite the adoption of new MS-DRGs to describe those procedures (42 CFR 510.300(a)(1)(i) and (iii)).

And (4) making changes to the extreme and uncontrollable circumstances policy for asthma treatment to adapt to an increase in CJR episode volume and renewal of the PHE, while providing protection against financial consequences of asthma treatment after the extreme and uncontrollable circumstances policy no longer applies (42 CFR 510.300). Implementing an additional six months of PY 5, so that PY 5 now ends on September 30, 2021 (hospitals stop initiating new episodes under the model after July 2, 2021) provides participant hospitals additional relief and stability in model operations while the end of the PHE remains unknown. We have modified the reconciliation process to provide payments consistent with the current annual reconciliation schedule for hospitals for greater stability.

Absent modification to the reconciliation process, the extension of PY 5 to a total of 21 months, from January 1, 2020 through September 30, 2021 would mean that participant hospitals would experience a 21-month gap between the PY4 final reconciliation in June of 2020 and initial PY 5 reconciliation in early 2022. In the FY 2021 IPPS/LTCH final rule, we stated that because the CJR model would continue until at least March 31, 2021, we intended to adopt a policy in the CJR final rule that incorporates new MS-DRGs for the same procedures currently included in the CJR model, under prior MS-DRGs, as of their effective date to avoid disruption to the model for the remainder of PY5 (as extended) and thereafter, if our proposal to extend the CJR model through PY8 were finalized (85 FR 58502). We are adopting the change in this IFC, retroactive to October 1, 2020 because without a change the model ceases to continue as a comprehensive joint replacement model.

Not making this change would have a significant impact on operational stability. Finally, this interim final rule with comment specifies an end for the current extreme and uncontrollable adjustment in 42 CFR 510.300(k)(4). In order to provide participant hospitals continuing financial protection from the effect of asthma treatment on the CJR model that may continue beyond the end of the PHE for asthma treatment or March 31, 2021, whichever occurs earlier, we are implementing that actual episode payments are capped at the quality adjusted target price determined for that episode under Â§â510.300 for episodes with actual episode payments that include a claim with a asthma treatment diagnosis code and initiate after the earlier of March 31, 2021 or the last day of the emergency period.

Collection of Information Requirements Under the Paperwork Reduction Act of 1995, the Departments are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to OMB for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (PRA) requires that the Departments solicit comment on the following issues. The need for the information collection and its usefulness in carrying out the proper functions of the agency.

The accuracy of the estimate of the information collection burden. The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

The Departments are soliciting public comment on each of the section 3506(c)(2)(A)-required issues for the following information collection requirements (ICRs). The requirements and burden will be submitted to under OMB Control Number 0938-NEW. A.

ICRs for Price Transparency for asthma treatment Diagnostic Tests As discussed in section II.C of this IFC, section 3202(b) of the CARES Act establishes a requirement to publicize cash prices for asthma treatment diagnostic tests during the PHE. For purposes of implementing section 3202(b) of the CARES Act, we are adding new 45 CFR part 182, âPrice Transparency for asthma treatment Diagnostic Tests,â that will codify price transparency requirements for the performance of a asthma treatment diagnostic test. There are several types of asthma treatment tests designed to detect asthma or to diagnose a possible case of asthma treatment, including.

Molecular (RT-PCR) tests, which are used to detect the ventolin's genetic material. Antigen tests, which are used to detect specific proteins on the surface of the ventolin. And serology testing, which is used to look for the presence of antibodies produced by the body in response to s.

For purposes of 45 CFR part 182, we are defining âprovider of a diagnostic test for asthma treatmentâ as any facility that performs one or more asthma treatment diagnostic tests. In order to perform a diagnostic test for asthma treatment and report patient-specific results, a facility (whether that be a primary care provider's office, urgent care center, outpatient hospital site or stand-alone laboratory) is required to hold a CLIA certificate based on the complexity of the testing performed by the facility. Therefore, we expect that any âprovider of a asthma treatment diagnostic testâ would hold a CLIA certificate (including a certificate of waiver or certificate of registration) and that such testing would occur in facilities ranging from primary care provider offices to urgent care centers to stand-alone national laboratories.

As explained in section VIII.B of this IFC, we estimate that approximately 83,309 CLIA providers could potentially be performing asthma treatment diagnostic tests and need to publicize their cash prices. For purposes of this IFC, we are estimating it will take a business operations specialist (13-1000), on average 1 hour for a total of 83,309 burden hours to compile and make public the cash prices for asthma treatment diagnostic tests, at an hourly wage of $36.31 as published by the BLS in 2019.[] We estimate the overhead and fringe benefit cost to be 100 percent of wages. Therefore, we estimate a one-time cost per provider to be $72.62 Start Printed Page 71185($36.31 Ã 2) and the total cost estimated to be $6,049,900 (83,309 hours Ã $72.62) to collect, compile and post the required information.

The request must describe the reason the state seeks a modification from the state public notice procedures, describe how the state meets the modification criteria, describe the alternative public notice procedures it proposes to implement at the state level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the state's request for a modification. The request must describe the reason the state seeks a modification from the Federal public notice procedures and the alternative public notice procedures it requests to be implemented at the Federal level, as applicable. A state with an approved section 1332 waiver can submit a request to HHS and the Department of Treasury for a modification from post award public notice procedures.

The request must specify the reason the state seeks a modification from the post award public notice procedures, describe how the state meets the modification criteria, and describe the alternative procedures it proposes to implement at the state level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the state's request for a modification. While HHS and the Department of Treasury do not have data available to predict the number of states that will likely request a modification of either the waiver application or the post award public notice procedures, HHS and the Department of Treasury estimate it will take a senior manager 1 hour to prepare a state's request, with an equivalent cost of approximately $118.[] In addition, if HHS and the Department of Treasury approve a state's modification request, the state will have to post the determination on their website within 15 days of the approval. HHS and the Department of Treasury estimate that for each state, it will take a network and computer systems administrator 15 minutes to post the approval with an equivalent cost of approximately $21.[] Assuming that approximately 15 states will submit a modification request, the total burden hours for all states will be 15 hours, with an equivalent cost of approximately $1,775.

HHS and the Department of Treasury have assumed that 15 states will submit a request because, as of display of this IFC, 15 states have an approved 1332 waiver. This is an upper bound, since some states may not need to request the available modification for their waivers, and therefore, will incur no burden. Furthermore, assuming that approximately 15 states receive approval of the modification request and then must post the approval, the total burden hours for all states will be approximately 3.75 hours, with an equivalent cost of approximately $319.

This is an upper bound, since some states may not receive approval, and therefore, will incur a lower (or no) burden. The total estimated burden hours assuming approximately 15 states apply for and receive approval of the modification request is 18.75 hours, with an equivalent cost of approximately $2,094. Table 3âEstimated Cost and Burden Hours per RespondentBLS occupationAverage burden hour per respondent (in hours)Hourly wage ratesTotal cost per respondentSenior Manager1$118.30$118.30Network and Computer Systems Administrator0.2585.0221.26Total1.25139.56 Table 4âEstimated Total Cost and Burden for all RespondentsâNumber of respondentsNumber of responsesBurden hours per respondentTotal burden hoursTotal costModification Request1515115$1,775Posting modification approval15150.253.75319Total151.2518.752,094 Start Printed Page 71186 C.

ICRs Regarding the Comprehensive Joint Replacement (CJR) Model Section 1115A(d)(3) of the Social Security Act exempts the Center for Medicare and Medicaid Innovation (CMMI) model tests and expansions, from the PRA. The section provides that Chapter 35 of title 44, United States Code, which includes such provisions as the PRA, shall not apply to the testing and evaluation of CMMI models or expansion of such models. D.

ICRs Regarding Enrollment as Mass Immunization Roster Biller As discussed in section II.A.1. Of this IFC, a mass immunizer may be enrolled in Medicare as another type of provider or supplier such as a physician, non-physician practitioner, hospital outpatient department, home health agency, or skilled nursing facility. However, an entity that does not otherwise qualify as a Medicare provider or supplier but wishes to furnish mass immunization services may be eligible to enroll in Medicare as a âMass Immunization Roster Billerâ via the Form CMS-855B enrollment application (Medicare Enrollment Application.

Clinics/Group Practices and Certain Other Suppliers. OMB Control No.. 0938-0685.

Cost of Completing Form CMS-855B Using our internal data, we generally estimate that approximately 60,000 entities (the preponderance of which will be pharmacies) will seek to enroll as mass immunization roster billers pursuant to the IFC, all of whom will attempt enrollment in the 12-month period following the IFC's display. According to the most recent wage data provided by the Bureau of Labor Statistics (BLS) for May 2019 (see http://www.bls.gov/âoes/âcurrent/âoes_ânat.htm), the mean hourly wages for the following categories are. Table 5âNational Occupational Employment and Wage EstimatesOccupation titleOccupation codeMean hourly wage ($/hr)Fringe benefits and overhead ($/hr)Adjusted hourly wage ($/hr)Healthcare Diagnosing or Treating Practitioners29-100049.2649.2698.52Medical Secretaries and Administrative Assistants43-601318.3118.3136.62 Consistent with Form CMS-855B projections made in recent rulemaking efforts, it will take each entity an average of 2.5 hours to obtain and furnish the information on the Form CMS-855B.

Per our experience, the entity's medical secretary will secure and report this data, a task that would take approximately 2 hours. Additionally, a health diagnosing and treating practitioner of the entity will review and sign the form, a process we estimate takes 30 minutes. We therefore project a total burden of 150,000 hours (60,000 suppliers Ã 2.5 hrs) at a cost of $7,350,000 (60,000 suppliers Ã ((2 hrs Ã $36.62/hr) + (0.5 hrs Ã $98.52/hr)).

When averaged over the typical 3-year OMB approval period, we estimate an annual burden of 50,000 hours (150,000 hrs/3) at a cost of $2,450,000 ($7,350,000/3). 2. Appeals Pursuant to 42 CFR part 498, a mass immunization roster biller may appeal the denial or revocation of its enrollment.

While there are information collection requirements associated with the appeals process, we believe they are exempt from the PRA. In accordance with the implementing regulations of the PRA at 5 CFR 1320.4(a)(2), the information collection requirements associated with the appeals process are subsequent to an administrative action (specifically, the denial or revocation of a mass immunization roster biller's enrollment). Therefore, we have not developed burden estimates.

We also believe that any costs associated with mass immunization roster biller enrollment will, in any event, be de minimis. This is because we anticipate, based on past experience, there would be comparatively few denials and revocations of such enrollments. Response to Comments Because of the large number of public comments normally received on Federal Register documents, the Departments are not able to acknowledge or respond to them individually.

All comments received by the date and time specified in the DATES section of this preamble will be considered, and, when the Departments proceed with a subsequent document, the Departments will respond to the comments in the preamble to that document. Regulatory Impact Analysis A. Statement of Need The flexibilities and changes contained within this IFC are responsive to the PHE for asthma treatment.

The policies implemented in this IFC will provide flexibilities, during the PHE for asthma treatment, to states pursuing waivers under section 1332 of the PPACA and to states with approved section 1332 waivers. Additionally, the policies and regulatory updates implemented in this IFC will increase the affordability with regards to section 1332 waiver applications and support continuity of health insurance coverage for consumers in the individual and small group (or merged) market during the PHE for asthma treatment. This IFC also implements section 3202(b) of the CARES Act, which requires that providers of asthma treatment diagnostic tests make public their cash prices for those tests and establishes an enforcement scheme to enforce those requirements during the PHE for asthma treatment.

In section 3203 of the CARES Act, Congress required group health plans and issuers of group or individual health insurance coverage to cover without cost sharing qualifying asthma preventive services, and required such coverage to be provided within 15 business days after the date on which an applicable recommendation is made relating to such service. The Departments codify these requirements in this IFC, and finalize amendments to the regulations implementing section 2713 of the PHS Act at 26 CFR 54.9815-2713. 29 CFR 2590.715-2713.

And 45 CFR 147.130 that are intended to help ensure full access to and the widespread use of qualifying asthma preventive services to mitigate the public health emergency. B. Overall Impact The Departments have examined the potential impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Start Printed Page 71187Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub.

L. 96 354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub.

L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a âsignificant regulatory actionâ as an action that is likely to result in a rule. (1) Having an annual effect on the economy of $100 million or more in any one year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as âeconomically significantâ).

(2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency. (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof. Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any one year), and a âsignificantâ regulatory action is subject to review by the OMB. The Departments have determined that these rules are likely to have economic impacts of $100 million or more in at least one year, and thus, meet the definition of âeconomically significantâ under Executive Order 12866 and a major rule under the Congressional Review Act. Therefore, the Departments have provided an assessment of the potential costs, benefits, and transfers associated with this rule.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by OMB. C. Detailed Economic Analysis 1.

Effect of Price Transparency for asthma treatment Diagnostic Tests During the PHE As discussed in section II.C of this IFC, Section 3202(b) of the CARES Act establishes a requirement to publicize cash prices for asthma treatment diagnostic tests during the PHE. For purposes of implementing section 3202(b) of the CARES Act, we are adding new 45 CFR part 182, âPrice Transparency for asthma treatment Diagnostic Tests,â that will codify price transparency requirements for the actual performance of a asthma treatment diagnostic test. At Â§â182.20, we are defining a âasthma treatment diagnostic testâ as a asthma treatment in vitro diagnostic test described in section 6001 of the FFCRA, as amended by section 3201 of the CARES Act.

This IFC defines a âprovider of a diagnostic test for asthma treatmentâ (referred to as âproviderâ) as any facility that performs one or more asthma treatment diagnostic tests. In order to perform a asthma treatment diagnostic tests and report patient-specific results, a facility is required to hold a CLIA certificate based on the complexity of the testing performed by the facility. This IFC requires providers of asthma treatment diagnostic tests to make public the cash price for such tests on a public internet website of such provider during the emergency period declared under section 319 of the PHS Act.

In the event that a provider does not have its own website on which to post this cash price information, Â§â182.40(b) states that the provider would be required to make public its cash price information in writing, within two business days upon request, and by posting signage prominently at the provider's asthma treatment diagnostic testing location, if such location is accessible to the public. We anticipate that price transparency has potential beneficial marketplace benefits generally, as discussed in detail in the CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates, Price Transparency Requirements for Hospitals To Make Standard Charges Public Final Rule (84 FR 65524) and the Transparency in Coverage Proposed Rule (84 FR 65464). As noted in section II.C of this IFC, section 3202 of the CARES Act addresses reimbursement of asthma treatment diagnostic tests.

Section 3202(a) of the CARES Act requires group health plans and issuers that provide coverage for items and services described in section 6001(a) of the FFCRA to reimburse any provider of a asthma treatment diagnostic test an amount that equals the negotiated rate, or, if the plan or issuer does not have a negotiated rate with the provider, the cash price for such service that is listed by the provider on a public website. We anticipate that price transparency in asthma treatment diagnostic testing, in particular, will help improve clarity for consumers and the plans and issuers that are required to cover the cost of performing a asthma treatment diagnostic test when there is no negotiated rate between the plan or issuer and the provider. For individuals without insurance and for health plans and health insurance issuers attempting to negotiate a rate for performance of a asthma treatment diagnostic test with a provider that has posted its cash price, that cash price could provide some context and a baseline against which those negotiations can occur.

Moreover, price transparency in asthma treatment diagnostic tests will assist the uninsured in determining the cash price at various providers when price shopping for asthma treatment diagnostic tests. Assessments of broader transparency policies yield per-capita estimates of annual expenditure reductions ranging from between $3 and $5 (= $2.8 million + $1.3 million + $7.0 million + $2.3 million two-year savings, across 1.3 million California public employees and their family members, per Boynton and Robinson (2015)), to $6.50 (= $7.9 million + $36 million five-year savings found by Brown (2018), divided across the 1.36 million residents of New Hampshire), to $17 (= $13.2 million three-year savings across 0.26 million beneficiaries, per Rhoads (2019)).[] If the $6.50 median result is extrapolated from the context of general health spendingâwhich is approximately $10,000 per capita in the United Statesâto a range of between $60 and $1,200 in asthma treatment diagnostic testing (= $60 per test, across between one and 20 tests), the estimate of rule-induced reductions in annual consumer expenditures could range from $13 million to $254 million. (This expenditure change combines transfers (to patients or insurers from providers) Start Printed Page 71188with potential societal resource cost savings.

Only the latter portion should be compared against estimates of the provision's administrative and paperwork costs.) We note, however, that this estimate is based on annual expenditure reductions. Because this requirement is only applicable for the remainder of the PHE, which may be less than a year, the saving impact is likely to be lower. To comply with the regulatory updates in this IFC, providers would need to review their billing practices and determine their âcash priceâ for asthma treatment diagnostic tests.

They would further need to publicly post the cash prices for all asthma treatment diagnostic tests along with associated plain language descriptions and HCPCS or CPT billing codes. The provider would be required to make all of this information public on the provider's internet website. As discussed in section VI.C, we estimate it would take a Business Operations Specialist, on average 1 hour to compile and make public the cash prices for the asthma treatment diagnostic tests that the facility offers at an hourly wage of $36.31 as published by the 2019 Bureau of Labor Statistics.[] We estimate the overhead and fringe benefit cost to be 100 percent of wages.

Therefore, we estimate a one-time cost per provider to be $72.62 (36.31 Ã 2). We expect that approximately 30 percentâ[] (n = 83,309) of the total CLIA-certified laboratories (n = 277,699â[] ) could potentially be performing asthma treatment diagnostic tests and need to publicize their cash prices in such form and manner as prescribed in new 45 CFR part 182 during the PHE for asthma treatment, including any subsequent renewals. The total cost is estimated to be $ $6,049,900 (83,309 hours Ã $72.62) to collect, compile and post the required information.

We seek comment on the burden estimate for providers of a diagnostic test for asthma treatment, specifically the number of burden hours estimated to post their cash price for asthma treatment diagnostic test. 2. Effects of Medicare Inpatient Prospective Payment System (IPPS) New asthma treatments Add-on Payment (NCTAP) for the Remainder of the Public Health Emergency (PHE) As drug and biological products become available and are authorized or approved by FDA for the treatment of asthma treatment in the inpatient setting, there may be potential financial disincentives for hospitals to provide these new asthma treatments to Medicare inpatients during the PHE because the costs of these new treatments are not yet reflected in Medicare payment rates and there are no new technology add-on payments for these treatments.

We expect that increasing the current IPPS payment amounts for sufficiently costly cases to mitigate potential financial disincentives for hospitals to provide new asthma treatments during the PHE will potentially improve and speed access to these treatments for Medicare patients. We also believe that the establishment of the NCTAP provides greater transparency and predictability to the public, including innovators that are developing new asthma treatments, as to how Medicare payments for cases involving these treatments will be determined when those treatments become available. Given it is unknown what the cost and utilization of inpatient stays using these new treatments will be, the net overall cost of the NCTAP policy is not estimable.

On one extreme, if all of the new asthma treatments decrease the net cost of hospitalizations (for example, due to shortened lengths of stay), including the cost of the new treatment, below the Medicare payment as increased by section 3710 of the CARES Act then there would be no NCTAP payments made and no additional cost to the Medicare program as a result of this policy. On the other extreme, if all of the new asthma treatments result in the net cost of hospitalizations that exceed the outlier threshold (for example, due to the cost of the new treatment), the cost to the Medicare program would be the sum over all NCTAP cases of 0.65 times the outlier threshold for each case. 3.

Effects of the Medicare Outpatient Prospective Payment System (OPPS) Separate Payment for New asthma treatments Policy for the Remainder of the Public Health Emergency (PHE) for asthma treatment This IFC provides for separate payment for New asthma treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for asthma treatment when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service. As we noted in Section II.E.2, we believe it would be a fairly rare occurrence that an outpatient department would perform a C-APC procedure on a beneficiary being treated for asthma treatment because most C-APCs are for surgical or other intensive procedures and we would expect most hospital outpatients departments would not perform outpatient surgery on a patient that has an active case of asthma treatment. While it is possible that future asthma treatments that are authorized or approved for use in the outpatient setting might be administered to patients under observation while the provider determines if the patient needs to be admitted to the hospital for asthma treatment, it is our expectation that this hypothetical situation would not happen frequently.

Effects of Temporary Increase in Federal Medicaid Funding This IFC interprets the requirement in section 6008(b)(3) of the FFCRA that states maintain Medicaid beneficiary enrollment as a condition of receiving the temporary FMAP increase described at section 6008(a) of the FFCRA. This IFC provides states with greater flexibility than current CMS guidance to transition beneficiaries between eligibility groups, to modify the amount, duration, and scope of coverage available to beneficiaries, and to make changes to applicable cost sharing and beneficiary liability. At the same time, this IFC protects beneficiary access to medical assistance by requiring states to maintain each beneficiary's coverage in one of three tiers, thereby protecting access to the basic coverage a beneficiary was receiving as of or after March 18, 2020.

We anticipate that this IFC will result in lessened financial burden on state Medicaid agencies and the Federal Government as compared to CMS's existing interpretation of the FFCRA 6008(b)(3) requirement. It would be highly challenging to estimate specific cost savings resulting from this IFC because such an estimate would be almost entirely dependent on state behavior under the unique circumstances of the PHE for asthma treatment-Start Printed Page 7118919. First, we believe that some savings may result from transitioning beneficiaries to different eligibility groups with greater cost sharing or beneficiary liability.

However, we know that states have faced both system and operational constraints that may prevent them from processing routine actions, such as transitioning a beneficiary from one group to another following a change in circumstances. A state that has been processing eligibility renewals and redeterminations during the PHE may be able to make such transitions relatively quickly, while a state that has been unable to process changes without violating the requirements for receiving the temporary FMAP increase may need more time to begin transferring beneficiaries between groups. Second, we anticipate that states will implement the new flexibilities offered by this rule in a variety of ways and to different degrees.

States may, for example, look for cost savings through the elimination of an optional benefit, establishing new copayments for services that are unrelated to the PHE, or increasing beneficiary liability for institutional care through a reduction to the personal needs allowance. Because each state's financial situation is unique and the characteristics of each Medicaid program are different, it is difficult to predict how states will respond to this IFC. While one state may elect to implement just one cost saving flexibility, another state may utilize all available options, and yet another state may elect not to make any program changes.

Based on the recent feedback we have received from states, we do anticipate that some states will implement some of these cost saving measures, which will result in decreased financial burden for states and cost savings for the Federal Government. While our current interpretation of section 6008(b)(3) of the FFCRA provides the strongest protections for beneficiary access to coverage, the safeguards established by this IFC will ensure that all beneficiaries maintain the same basic level of access to coverage that they were receiving as of or after March 18, 2020. All beneficiaries who had access to minimum essential coverage will maintain access to such coverage, and every beneficiary who had access to testing services and treatment for asthma treatment, including treatments, will retain such access.

Individual beneficiaries may be required to pay cost sharing that they were not previously charged (except with respect to testing and treatment services related to asthma treatment, which states cannot charge under section 6008(b)(4) of the FFCRA if they are claiming the temporary FMAP increase), or they may need to meet additional prior authorization or medical necessity requirements. 5. Effects of Updates to the Comprehensive Care for Joint Replacement (CJR) Model, Performance Year (PY) 5 During the PHE The evolving impact of the PHE for the asthma treatment has created difficulties in forecasting the state of the LEJR market for 2021.

For example, Table 1 indicates CJR episode volume increasing and moving back toward traditional levels from April to June, but then decreasing again in July and August. It is difficult to predict the impact of extending PY 5 an additional 6 months with the amended policies described above because there exists a potential for variation between PY 5 target prices and PY 5 actual episode costs (as a result of asthma treatment) which creates uncertainty in calculating anticipated net reconciliation amounts for PY 5. As a result, the Office of the Actuary was unable create projections regarding Medicare program spending in 2021 for MS-DRGs 469, 470, 521, or 522 or discrete impact estimates regarding the effect of extending CJR PY 5 an additional 6 months with the amended policies described above.

In assessing the potential cost or savings for this extension, CMMI internal analysis considered the following data points. First, the Second Annual CJR Evaluation Report,[] indicates participant hospitals reduced spending by 3.7 percent (difference in claims) during the first 2 years of the CJR model. Additionally, if the episode definition policy were not amended to include the new MS-DRGs and fracture episodes were no longer included in the CJR episode definition October 1, 2020âMarch 31, 2021, episode volume would decrease significantly and the cost saving effect of the CJR model would be limited to only non-fracture episodes, which are generally the less costly episodes.

We also know that while the CJR model achieves program savings, this observation is not net of reconciliation payments and administrative costs. Further, our February 2020 proposed rule (85 FR 10516) proposes payment methodology revisions to the target price methodology to improve payment accuracy as the current methodology tends to excessive payment. Given the confluence of factors affecting payments, including episode volume, actual episode costs, and even target prices, we cannot confidently estimate cost or savings associated with the CJR model changes in this final rule, specifically, the provisions.

To add reconciliation periods to PY 5, to add MS-DRGs 521 and 522 to the episode definition, to change the extreme and uncontrollable circumstances policy, and to extend PY5 6 months. We will continue to refine this analysis. If the February 2020 proposed rule is finalized after review and response to comment, we will strive to provide a more detailed estimate for future model performance years.

6. Effects of Rapid Coverage of Preventative Services for asthma This IFC requires that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage provide coverage for qualifying asthma preventive services, including recommended asthma treatment immunizations and their administration, without any cost sharing. It also requires plans and issuers to provide coverage within 15 business days after the date on which an applicable recommendation is made by USPSTF or ACIP relating to such a service.

In addition, it requires that during the PHE for asthma treatment a group health plan or issuer that has a network of providers to provide coverage without cost sharing regardless of whether the service is delivered by an in-network or out-of-network provider. Making these qualifying asthma preventive services, including asthma treatment immunizations, available without any delay is in the interest of public health, as making these services available as quickly as possible may encourage individuals to take advantage of these services and therefore may slow the transmission of asthma treatment. Access to qualifying asthma preventive services without cost sharing will encourage more individuals to obtain them.

Increased use of qualifying asthma preventive services may reduce the transmission and spread of the disease and thus potentially result in better overall health outcomes. In the immediate term, newly developed qualifying asthma preventive services might be available from a narrower range of providers than other, more established recommended preventive items and services. If asthma treatment immunizations require specialized storage and administration services, only a limited number of Start Printed Page 71190providers may be able to offer them at first.

If consumers have to incur additional burdens, long wait times, and increased travel times to find an in-network provider that can provide such services, it will limit access and discourage them from obtaining such services. Therefore, the Departments are of the view that requiring out-of-network coverage without cost sharing for qualifying asthma preventive services will help ensure that consumers are able to obtain the preventive services without cost sharing as soon as possible. Plans and issuers will incur the cost of the qualifying asthma preventive services and administration of such services.

Providing coverage within 15 business days after a recommendation is made relating to such services is likely to impose significant administrative costs on issuers, group health plans, and other service providers to update systems to include billing codes for the preventive services, negotiate prices with network providers, determine reimbursements for out-of-network providers, and conduct outreach to providers, participants, beneficiaries, and enrollees in a very short time period. Depending on the magnitude of the costs of qualifying asthma preventive services and administration of such services relative to the potential cost of treatment for the disease, this may have an impact on premiums. There are uncertainties regarding the price of potential qualifying asthma preventive services, including asthma treatment immunizations.

If the prices are high and there is widespread use of such services, premiums may increase. If the timing of availability of the preventive services is such that plans and issuers are unable to take them into account when setting premiums, it may result in lower profits or losses for plans and issuers. The costs to plans and issuers will be lower if a third party, such as the Federal Government, covers the cost of the immunizations.

In addition, the costs associated with providing coverage for qualifying asthma preventive services may be offset by savings from avoidance of treatment for asthma treatment. During the PHE for asthma treatment, costs to group health plans or issuers that have networks of providers will be higher if a significant number of participants, beneficiaries, or enrollees go to out-of-network providers, and the issuers and plans reimburse those out-of-network providers at higher levels than their negotiated rate with in-network providers. However, if consumers can obtain the qualifying asthma preventive services where they usually obtain health care services, consumers are likely to receive the services from an in-network provider.

Plans and issuers may also wish to educate participants, beneficiaries, or enrollees about the availability of the services from in-network providers and encourage them to obtain these services from their usual providers. This approach could limit the number of participants, beneficiaries, or enrollees going to out-of-network providers instead of staying in network, but there will be associated administrative burdens and costs. The total cost to plans and issuers related to qualifying asthma preventive services that are immunizations will depend on the cost and number of required immunization doses to be administered, the number of people who will choose to get immunized against asthma treatment and which providers will be able to provide the preventive services.

For the 2018-19 influenza season, 62.6 percent of children 6 months through 17 years and 45.3 percent of adults 18 years and older obtained the influenza treatment.[] Given the severity of asthma treatment, the Departments anticipate the immunization rates for asthma treatment are likely to ultimately be higher than for influenza, although initial rates may be lower until an adequate supply is available. Total costs to plans and issuers will depend on the cost of covering qualifying asthma preventive services, the number of people choosing to obtain such services, and whether a third party such as the Federal Government covers the costs of any immunizations. The Departments seek comment on any potential costs and burdens that may be incurred by plans and issuers due to the requirements to cover the costs and administration of such qualifying asthma preventive services without any cost sharing regardless of whether the service is delivered by an in-network or out-of-network provider.

The Departments also seek comment on the potential effects and costs consumers may face as a result of this provision. 7. Effects of Changes to State Innovation Waivers Policy and Regulatory Revisions in Response to the asthma treatment Public Health Emergency This IFC establishes a framework for states to request the Secretary of HHS and the Secretary of the Treasury to modify, in part, the public notice procedures outlined in 31 CFR 33.112 and 33.116 and 45 CFR 155.1312 and 155.1316 to expedite a decision on a proposed section 1332 waiver request during the PHE for asthma treatment.

Regulations at Â§Â§â33.112 and 155.1312 require a state to provide a public notice and comment period at the state level prior to submitting an application for a section 1332 waiver. The regulations at Â§Â§â33.116 and 155.1316 establish Federal public notice requirements for state section 1332 waiver applications. This IFC also establishes a framework at the new 31 CFR 33.120(c)(2) and 45 CFR 155.1320(c)(2) for states to request the Secretaries to modify, in part, the post award public notice procedures outlined in Â§Â§â33.120(c) and 155.1320(c) for an approved waiver that would otherwise take place or become due during the PHE for asthma treatment.

As stated above, HHS and the Department of the Treasury are of the view that requiring states that meet the criteria outlined in this IFC to comply with the full public notice procedures during the PHE for asthma treatment could cause undue harm to the public. Allowing the Secretaries to modify, in part, these requirements will enable states to request and receive approval for waiver requests more quickly and also implement changes that will provide consumers with access to affordable health insurance coverage during the current PHE for asthma treatment. States that request modifications from the public notice procedures will incur some burden, as discussed in the Collection of Information Requirements section.

For a state that requests and receives a modification of the public notice procedures, we acknowledge that consumers may receive less prior notice than would occur without the modification. Through this IFC, the HHS and the Department of Treasury intend to provide an appropriate balance and permit flexibility where a state can ensure a sufficient opportunity for meaningful public input given the circumstances in the PHE for asthma treatment while also ensuring the safety of the public. If a state's modification request is approved there may be a shorter comment period at the state or Federal level, or the comment periods may be the same number of days (for example 30 days) but perhaps on a different timeframe.

For example, a state may conduct the state public comment period concurrently with the Federal public comment period instead of before. States with approved modification requests may experience a reduction in costs related to post award public notice procedures. However, if Start Printed Page 71191the state's modification request is approved, the state must also implement alternative public notice procedures and, if required, amend the waiver application to specify that it is the state's intent to comply with those alternative public notice requirements in the state's modification request.

States may also need to employ additional technologies to host virtual hearings instead of in person gatherings. In this case, there may be no reduction in costs related to public notice procedures. HHS and the Department of the Treasury seek comment on any potential costs and burdens that may be incurred by states due to the flexibilities afforded in this IFC.

HHS and the Department of the Treasury also seek comment on the potential effects and costs consumers may face as a result of a state's action taken as a result of the flexibilities in this IFC. 8. Effects of Medicare Coding and Payment for asthma treatment This IFC discusses CMS's implementation of section 3713 of the CARES Act (Pub.

L. 116-136), which established Medicare Part B coverage and payment for a asthma treatment and its administration. This IFC requires that Medicare provide coverage for qualifying asthma treatments administration, without any cost sharing.

Making asthma treatments, available without any delay is in the interest of public health, as making these services available as quickly as possible may encourage individuals to take advantage of these services and therefore may slow the transmission of asthma treatment. Access to asthma treatments without cost sharing will encourage more individuals to obtain them. In the immediate term, any newly developed asthma treatments might be available from a narrower range of providers than other, more established recommended preventive items and services.

If asthma treatments require specialized storage and administration services, only a limited number of providers may be able to offer them at first. If beneficiaries have to incur additional burdens, long wait times, and increased travel times to find Medicare providers and suppliers that can provide such services, it will limit access and discourage them from obtaining such services. Medicare providers and suppliers will incur costs for providing asthma treatments and administration of such services.

There are uncertainties regarding the cost to the Medicare program for asthma treatments and administration at this time. The total cost to Medicare related to asthma treatments and administration cost are dependent on and the number of required immunization doses to be administered, the number of people who will choose to get immunized against asthma treatment and which providers and suppliers will be able to provide the preventive services. 9.

Effects of Application Fee as Part of Form CMS-855B Enrollment as Mass Immunization Roster Biller Consistent with Â§â424.514, an entity enrolling in Medicare as a mass immunization roster biller via the Form CMS-855B must pay an application fee at the time of enrollment. The application fees for each of the past 3 calendar years were or are $569 (CY 2018), $586, (CY 2019), and $595 (CY 2020). The differing fee amounts are predicated on changes/increases in the Consumer Price Index (CPI) for all urban consumers (all items.

Applying this prospective fee amount to the previously mentioned 60,000 projected mass immunization roster biller applicants in the first year of this rule, we estimate a total application fee cost to enrollees of $36,400,000 (or 60,000 Ã $608). This represents a transfer from mass immunizer suppliers to the Federal Government. D.

Regulatory Alternatives Considered The Department considered not implementing the changes to the CJR model but determined the effect of the changes, particularly relief from financial risk for asthma treatment cases and stability in model operations, to be very important for participant hospitals during the PHE. Further, if the three-year extension of the CJR model is finalized, it would be much more difficult for participant hospitals to stop model value-based operations, and then restart value operations when hospitals already have significant burden managing asthma treatment and under asthma treatment safety protocols and utilization changes. The Departments considered not requiring plans and issuers to provide coverage for qualifying asthma preventive services without cost sharing from out-of-network providers.

However, in the near term, newly developed qualifying asthma preventive services might be available from a narrower range of providers than other, more established recommended preventive services because of specialized storage and administration requirements. If there are only a limited number of in-network providers that can administer these services, consumers may incur additional burden related to travel and long wait times to obtain these services, which can result in lower utilization. The Departments are concerned that allowing plans and issuers to impose cost sharing for asthma treatment immunizations provided by out-of-network providers would discourage individuals from seeking immunization, potentially leading to reduced administration of any asthma treatment and prolonging the PHE for asthma treatment, contrary to the intent of the CARES Act.

In order to ensure that the immunization services will be available to all consumers enrolled in non-grandfathered group health plans and non-grandfathered group and individual health insurance coverage, the Departments are therefore requiring such plans and issuers to cover without cost sharing a qualifying asthma preventive service, regardless of whether such service is delivered by an in-network or out-of-network provider. The Departments anticipate that as such services become more widely available over time, consumers will be able to obtain them more easily from in-network providers. HHS and the Department of the Treasury considered providing states with the flexibility to waive all of the public notice procedures outlined in 31 CFR 33.112 and 33.116 and 45 CFR 155.1312 and 155.1316 to expedite a decision on a proposed section 1332 waiver request during the PHE for asthma treatment.

This approach would have allowed a state to request to completely eliminate a public notice or reporting requirement pre- or post-award. However, HHS and the Department of the Treasury were concerned that that this would violate the statutory requirements regarding a meaningful level of input from the public. In addition, HHS and the Department of Treasury are committed to transparency and value public input on waiver proposals and value public feedback to ensure consumers are aware of waiver proposals that may affect them.

HHS and the Department of the Treasury anticipate working with states on their modification request to ensure the public is provided the opportunity to provide feedback on waiver proposals and the progress of the program authorized by the section 1332 waiver.Start Printed Page 71192 E. Regulatory Flexibility Act The Regulatory Flexibility Act, (5 U.S.C. 601, et seq.), requires agencies to analyze options for regulatory relief of small entities to prepare an initial regulatory flexibility analysis to describe the impact of the proposed rule on small entities, unless the head of the agency can certify that the rule will not have a significant economic impact on a substantial number of small entities.

The RFA generally defines a âsmall entityâ as (1) a proprietary firm meeting the size standards of the Small Business Administration (SBA), (2) a not-for-profit organization that is not dominant in its field, or (3) a small government jurisdiction with a population of less than 50,000. States and individuals are not included in the definition of âsmall entity.â HHS uses a change in revenues of more than 3 to 5 percent as its measure of significant economic impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions.

Individuals and states are not included in the definition of a small entity. This IFC is not preceded by a general notice of proposed rulemaking, and thus the requirements of RFA do not apply. In addition, section 1102(b)(2) of the Act provides that whenever the Secretaries promulgate a final version of a rule or regulation with respect to which an initial regulatory impact analysis is required, the Secretaries shall prepare a final regulatory impact analysis with respect to the final version of such rule or regulation.

Such analysis is required to set forth, with respect to small rural hospitals, the matters required under section 604 of title 5, United States Code, to be set forth with respect to small entities. The Departments are not required to prepare a final regulatory impact analysis, because this regulatory action is being issued as an interim final rule without being preceded by a general notice of proposed rulemaking. F.

Unfunded Mandates Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing any proposed rule or any final rule for which a general notice of proposed rulemaking was published that includes any Federal mandate that may result in expenditures in any 1 year by a state, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2020, that threshold is approximately $156 million. This IFC was not preceded by a general notice of proposed rulemaking, and thus the requirements of UMRA do not apply.

G. Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this rule aims to alleviate burden on State and local governments, the requirements of Executive Order 13132 are not applicable.

In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have federalism implications or limit the policy making discretion of the states, the Departments have engaged in efforts to consult with and work cooperatively with affected states, including participating in conference calls with and attending conferences of the NAIC, and consulting with state insurance officials on an individual basis. While developing this rule, the Departments attempted to balance the states' interests in regulating health insurance issuers with the need to ensure market stability. By doing so, the Departments complied with the requirements of Executive Order 13132.

H. Reducing Regulation and Controlling Regulatory Costs Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017 and requires that the costs associated with significant new regulations âshall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.â This IFC's designation under Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs (82 FR 9339), which was issued on January 30, 2017, will be informed by public comments received. Start List of Subjects 26 CFR Part 54 Excise taxesHealth careHealth insurancePensionsReporting and recordkeeping requirements 29 CFR Part 2590 Employee benefit plansHealth careHealth insurancePenaltiesPensionsPrivacyReporting and recordkeeping requirements 31 CFR Part 33 Health careHealth insuranceReporting and recordkeeping requirements 42 CFR Part 410 DiseasesHealth facilitiesHealth professionsLaboratoriesMedicareReporting and recordkeeping requirementsRural areasX-rays 42 CFR Part 411 DiseasesMedicareReporting and recordkeeping requirements 42 CFR Part 414 Administrative practice and procedureBiologicsDiseasesDrugsHealth facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 417 Administrative practice and procedureGrant programs-healthHealth careHealth insuranceHealth maintenance organizations (HMO)Loan programs-healthMedicareReporting and recordkeeping requirements 42 CFR Part 433 Administrative practice and procedureChild supportClaimsGrant programs-healthMedicaidReporting and recordkeeping requirements 42 CFR Part 510 Administrative practice and procedureHealth facilitiesMedicareReporting and recordkeeping requirement 45 CFR Part 147 Age discriminationCitizenship and naturalizationCivil rightsHealth careHealth insuranceIndividuals with disabilitiesIntergovernmental relationsReporting and recordkeeping requirementsSex discrimination 45 CFR Part 155 Administrative practice and procedureAdvertisingBrokersConflict of interestsConsumer protectionGrant programs-healthGrants administrationHealth careHealth insuranceHealth maintenance organizations (HMO)Health recordsHospitalsIndiansIndividuals with disabilitiesIntergovernmental relationsLoan programs-healthMedicaidOrganization and functions (Government agencies)Public assistance programsReporting and recordkeeping requirementsState flexibilityTechnical assistanceWomen and youth 45 CFR Part 182 asthma treatment diagnostic testingReporting and recordkeeping requirements End List of Subjects Start Signature Dated.

October 21, 2020. Seema Verma, Administrator, Centers for Medicare &. Medicaid Services.

Azar II, Secretary, Department of Health and Human Services. Sunita Lough, Deputy Commissioner for Services and Enforcement, Internal Revenue Service. Approved.

October 28, 2020. David J. Kautter, Assistant Secretary of the Treasury (Tax Policy).

Signed at Washington DC, this 29th day of October, 2020. Jeanne Klinefelter Wilson, Acting Assistant Secretary, Employee Benefits Security Administration, Department of Labor. End Signature DEPARTMENT OF THE TREASURY Internal Revenue Service Amendments to the Regulations For the reasons set forth in the preamble, the Department of the Treasury amends 26 CFR part 54 as set forth below.

Start Part End Part Start Amendment Part Par. 1. The authority citation for part 54 continues to read in part as follows:End Amendment Part Start Authority 26 U.S.C.

7805, unless otherwise noted. End Authority * * * * * Section 54.9815-2713T also issued under 26 U.S.C. 9833.

* * * * * Start Amendment Part2. Section 54.9815-2713T is added to read as follows. End Amendment Part Coverage of preventive health services (temporary).

(a) Servicesâ(1) In general. Beginning at the time described in paragraph (b) of this section and subject to Â§â54.9815-2713A, a group health plan, or a health insurance issuer offering group health insurance coverage, must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) forâ (i) Evidence-based items or services that have in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force with respect to the individual involved (except as otherwise provided in paragraph (c) of this section). (ii) Immunizations for routine use in children, adolescents, and adults that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the individual involved (for purposes of this paragraph (a)(1)(ii), a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is considered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention, and a recommendation is considered to be for routine use if it is listed on the Immunization Schedules of the Centers for Disease Control and Prevention).

(iii) With respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Administration. (iv) With respect to women, such additional preventive care and screenings not described in paragraph (a)(1)(i) of this section as provided for in comprehensive guidelines supported by the Health Resources and Services Administration for purposes of section 2713(a)(4) of the Public Health Service Act, subject to 45 CFR 147.131, 147.132, and 147.133. And (v) Any qualifying asthma preventive service, which means an item, service, or immunization that is intended to prevent or mitigate asthma disease 2019 (asthma treatment) and that is, with respect to the individual involvedâ (A) An evidence-based item or service that has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force.

(i) If an item or service described in paragraph (a)(1) of this section is billed separately (or is tracked as individual encounter data separately) from an office visit, then a plan or issuer may impose cost-sharing requirements with respect to the office visit. (ii) If an item or service described in paragraph (a)(1) of this section is not billed separately (or is not tracked as individual encounter data separately) from an office visit and the primary purpose of the office visit is the delivery of such an item or service, then a plan or issuer may not impose cost-sharing requirements with respect to the office visit. (iii) If an item or service described in paragraph (a)(1) of this section is not billed separately (or is not tracked as individual encounter data separately) from an office visit and the primary purpose of the office visit is not the delivery of such an item or service, then a plan or issuer may impose cost-sharing requirements with respect to the office visit.

(iv) The rules of this paragraph (a)(2) are illustrated by the following examples. (A) Example 1â(1) Facts. An individual covered by a group health plan visits an in-network health care provider.

While visiting the provider, the individual is screened for cholesterol abnormalities, which has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force with respect to the individual. The provider bills the plan for an office visit and for the laboratory work of the cholesterol screening test. (2) Conclusion.

In paragraph (a)(2)(iv)(A)(1) of this section, the plan may not impose any cost-sharing requirements with respect to the separately-billed laboratory work of the cholesterol screening test. Because the office visit is billed separately from the cholesterol screening test, the plan may impose cost-sharing requirements for the office visit. (B) Example 2â(1) Facts.

Same facts as in paragraph (a)(2)(iv)(A)(1) of this section (Example 1). As the result of the screening, the individual is diagnosed with hyperlipidemia and is prescribed a course of treatment that is not included in the recommendations under paragraph (a)(1) of this section. (2) Conclusion.

In paragraph (a)(2)(iv)(B)(1) of this section, because the treatment is not included in the recommendations under paragraph (a)(1) of this section, the plan is not prohibited from imposing cost-sharing requirements with respect to the treatment. (C) Example 3â(1) Facts. An individual covered by a group health plan visits an in-network health care provider to discuss recurring abdominal pain.

During the visit, the individual Start Printed Page 71194has a blood pressure screening, which has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force with respect to the individual. The provider bills the plan for an office visit. (2) Conclusion.

A child covered by a group health plan visits an in-network pediatrician to receive an annual physical exam described as part of the comprehensive guidelines supported by the Health Resources and Services Administration. During the office visit, the child receives additional items and services that are not described in the comprehensive guidelines supported by the Health Resources and Services Administration, nor otherwise described in paragraph (a)(1) of this section. The provider bills the plan for an office visit.

(2) Conclusion. In paragraph (a)(2)(iv)(D)(1) of this section, the service was not billed as a separate charge and was billed as part of an office visit. Moreover, the primary purpose for the visit was to deliver items and services described as part of the comprehensive guidelines supported by the Health Resources and Services Administration.

Therefore, the plan may not impose a cost-sharing requirement with respect to the office visit. (3) Out-of-network providers. (i) Subject to paragraphs (a)(3)(ii) and (iii) of this section, nothing in this section requires a plan or issuer that has a network of providers to provide benefits for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing cost-sharing requirements for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider.

(ii) If a plan or issuer does not have in its network a provider who can provide an item or service described in paragraph (a)(1) of this section, the plan or issuer must cover the item or service when performed by an out-of-network provider, and may not impose cost-sharing with respect to the item or service. (iii) A plan or issuer must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for any qualifying asthma preventive service described in paragraph (a)(1)(v) of this section, regardless of whether such service is delivered by an in-network or out-of-network provider. For purposes of this paragraph (a)(3)(iii), with respect to a qualifying asthma preventive service and a provider with whom the plan or issuer does not have a negotiated rate for such service (such as an out-of-network provider), the plan or issuer must reimburse the provider for such service in an amount that is reasonable, as determined in comparison to prevailing market rates for such service.

(4) Reasonable medical management. Nothing prevents a plan or issuer from using reasonable medical management techniques to determine the frequency, method, treatment, or setting for an item or service described in paragraph (a)(1) of this section to the extent not specified in the relevant recommendation or guideline. To the extent not specified in a recommendation or guideline, a plan or issuer may rely on the relevant clinical evidence base and established reasonable medical management techniques to determine the frequency, method, treatment, or setting for coverage of a recommended preventive health service.

(5) Services not described. Nothing in this section prohibits a plan or issuer from providing coverage for items and services in addition to those recommended by the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, or provided for by guidelines supported by the Health Resources and Services Administration, or from denying coverage for items and services that are not recommended by that task force or that advisory committee, or under those guidelines. A plan or issuer may impose cost-sharing requirements for a treatment not described in paragraph (a)(1) of this section, even if the treatment results from an item or service described in paragraph (a)(1) of this section.

(b) Timingâ(1) In general. A plan or issuer must provide coverage pursuant to paragraph (a)(1) of this section for plan years that begin on or after September 23, 2010, or, if later, for plan years that begin on or after the date that is one year after the date the recommendation or guideline is issued, except as provided in paragraph (b)(3) of this section. (2) Changes in recommendations or guidelines.

(i) A plan or issuer that is required to provide coverage for any items and services specified in any recommendation or guideline described in paragraph (a)(1) of this section on the first day of a plan year, or as otherwise provided in paragraph (b)(3) of this section, must provide coverage through the last day of the plan or policy year, even if the recommendation or guideline changes or is no longer described in paragraph (a)(1) of this section, during the applicable plan or policy year. (ii) Notwithstanding paragraph (b)(2)(i) of this section, to the extent a recommendation or guideline described in paragraph (a)(1)(i) of this section that was in effect on the first day of a plan year, or as otherwise provided in paragraph (b)(3) of this section, is downgraded to a âDâ rating, or any item or service associated with any recommendation or guideline specified in paragraph (a)(1) of this section is subject to a safety recall or is otherwise determined to pose a significant safety concern by a Federal agency authorized to regulate the item or service during a plan or policy year, there is no requirement under this section to cover these items and services through the last day of the applicable plan or policy year. (3) Rapid coverage of preventive services for asthma.

In the case of a qualifying asthma preventive service described in paragraph (a)(1)(v) of this section, a plan or issuer must provide coverage for such item, service, or immunization in accordance with this section by the date that is 15 business days after the date on which a recommendation specified in paragraph (a)(1)(v)(A) or (B) of this section is made relating to such item, service, or immunization. (c) Recommendations not current. For purposes of paragraph (a)(1)(i) of this section, and for purposes of any other provision of law, recommendations of the United States Preventive Services Task Force regarding breast cancer screening, mammography, and prevention issued in or around November 2009 are not considered to be current.

(d) Applicability date. The provisions of paragraphs (a)(1)(i) through (iv), (a)(2), (a)(3)(i) and (ii), (a)(4) through (5), (b)(1) and (2), and (c) of this section are applicable as of April 16, 2012. (e) Sunset date.

The provisions of paragraphs (a)(1)(v), (a)(3)(iii), and (b)(3) of this section will not apply with respect to a qualifying asthma preventive service furnished on or after the expiration of the public health emergency determined on January 31, 2020, to exist nationwide as of January 27, 2020, by the Secretary of Health and Start Printed Page 71195Human Services pursuant to section 319 of the Public Health Service Act, as a result of asthma treatment, including any subsequent renewals of that determination. DEPARTMENT OF LABOR Employee Benefits Security Administration For the reasons set forth in the preamble, the Department of Labor amends 29 CFR part 2590 as set forth below. Start Part End Part Start Amendment Part3.

The authority citation for part 2590 continues to read as follows. End Amendment Part Start Authority 29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a, 1185b, 1191, 1191a, 1191b, and 1191c.

L. 111-148, 124 Stat. 119, as amended by Pub.

2130. Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012).

End Authority Start Amendment Part4. Section 2590.715-2713 is amendedâ End Amendment Part Start Amendment Parta. In paragraph (a)(1)(iii) by removing âandâ after the semicolon.

End Amendment Part Start Amendment Partb. In paragraph (a)(1)(iv) by removing the period at the end of the paragraph and adding â. Andâ in its place.

End Amendment Part Start Amendment Partc. By adding paragraph (a)(1)(v). End Amendment Part Start Amendment Partd.

By revising paragraph (a)(3)(i). End Amendment Part Start Amendment Parte. By adding paragraph (a)(3)(iii).

End Amendment Part Start Amendment Partf. By revising paragraphs (b)(1) and (b)(2)(i) and (ii). And End Amendment Part Start Amendment Partg.

By adding paragraphs (b)(3) and (e). End Amendment Part The revisions and additions read as follows. Coverage of preventive health services.

(a) * * * (1) * * * (v) Any qualifying asthma preventive service, which means an item, service, or immunization that is intended to prevent or mitigate asthma disease 2019 (asthma treatment) and that is, with respect to the individual involvedâ (A) An evidence-based item or service that has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force. Or (B) An immunization that has in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (regardless of whether the immunization is recommended for routine use). For purposes of this paragraph (a)(1)(v)(B), a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is considered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention.

* * * * * (3) * * * (i) Subject to paragraphs (a)(3)(ii) and (iii) of this section, nothing in this section requires a plan or issuer that has a network of providers to provide benefits for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing cost-sharing requirements for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider. * * * * * (iii) A plan or issuer must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for any qualifying asthma preventive service described in paragraph (a)(1)(v) of this section, regardless of whether such service is delivered by an in-network or out-of-network provider. For purposes of this paragraph (a)(3)(iii), with respect to a qualifying asthma preventive service and a provider with whom the plan or issuer does not have a negotiated rate for such service (such as an out-of-network provider), the plan or issuer must reimburse the provider for such service in an amount that is reasonable, as determined in comparison to prevailing market rates for such service.

* * * * * (b) * * * (1) In general. A plan or issuer must provide coverage pursuant to paragraph (a)(1) of this section for plan years that begin on or after September 23, 2010, or, if later, for plan years that begin on or after the date that is one year after the date the recommendation or guideline is issued, except as provided in paragraph (b)(3) of this section. (2) * * * (i) A plan or issuer that is required to provide coverage for any items and services specified in any recommendation or guideline described in paragraph (a)(1) of this section on the first day of a plan year, or as otherwise provided in paragraph (b)(3) of this section, must provide coverage through the last day of the plan or policy year, even if the recommendation or guideline changes or is no longer described in paragraph (a)(1) of this section, during the applicable plan or policy year.

(ii) Notwithstanding paragraph (b)(2)(i) of this section, to the extent a recommendation or guideline described in paragraph (a)(1)(i) of this section that was in effect on the first day of a plan year, or as otherwise provided in paragraph (b)(3) of this section, is downgraded to a âDâ rating, or any item or service associated with any recommendation or guideline specified in paragraph (a)(1) of this section is subject to a safety recall or is otherwise determined to pose a significant safety concern by a Federal agency authorized to regulate the item or service during a plan or policy year, there is no requirement under this section to cover these items and services through the last day of the applicable plan or policy year. (3) Rapid coverage of preventive services for asthma. In the case of a qualifying asthma preventive service described in paragraph (a)(1)(v) of this section, a plan or issuer must provide coverage for such item, service, or immunization in accordance with this section by the date that is 15 business days after the date on which a recommendation specified in paragraph (a)(1)(v)(A) or (B) of this section is made relating to such item, service, or immunization.

* * * * * (e) Sunset date. The provisions of paragraphs (a)(1)(v), (a)(3)(iii), and (b)(3) of this section will not apply with respect to a qualifying asthma preventive service furnished on or after the expiration of the public health emergency determined on January 31, 2020, to exist nationwide as of January 27, 2020, by the Secretary of Health and Human Services pursuant to section 319 of the Public Health Service Act, as a result of asthma treatment, including any subsequent renewals of that determination. DEPARTMENT OF THE TREASURY Office of the Secretary Amendments to the Regulations For the reasons set forth in the preamble, the Department of Treasury amends 31 CFR part 33 as set forth below.

Start Part End Part Start Amendment Part5. The authority citation for part 33 continues to read as follows. End Amendment Part Start Authority Start Printed Page 71196 Sec.

119. End Authority Start Amendment Part6. Section 33.118 is added to read as follows.

End Amendment Part Modification from the normal public notice requirements during the public health emergency. (a) The Secretary and the Secretary of Health and Human Services may modify, in part, the State public notice requirements under Â§â33.112 and the Federal public notice procedures under Â§â33.116 to expedite a decision on a proposed waiver request during the public health emergency for asthma treatment, as defined in 42 CFR 400.200, when a delay would undermine or compromise the purpose of the proposed waiver request and be contrary to the interests of consumers. These flexibilities are limited to event-triggered, emergent situations, and the flexibilities outlined in this section will not be available for States seeking to address a threat to consumers' access to health coverage or care that existed prior to the public health emergency for asthma treatment.

(b) A State must meet all of the following criteria to request a modification under paragraph (a) of this section. (1) The State must request a modification under paragraph (a) of this section, in the form and manner specified by the Secretaries. (2) The State must have acted in good faith, and in a diligent, timely, and prudent manner in the preparation of the request for a modification under paragraph (a) of this section, and the waiver application request, as applicable.

(3) The State must, as applicable, detail in its request for a modification from State-level notice procedures under paragraph (a) of this section the justification for the request and the alternative public notice procedures it proposes to implement at the State level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the State's request for a modification. As a condition of receiving a modification approval, a State must implement public notice procedures, including public hearings, at the State level and, if required, amend the waiver application request. (4) The State must, as applicable, detail in its request for a modification from Federal-level notice procedures under paragraph (a) of this section the justification for the request as it relates to the public health emergency and the alternative public notice procedures it requests to be implemented at the Federal level.

(c) The Secretary and the Secretary of Health and Human Services will evaluate a State's request for a modification under paragraph (a) of this section and issue their exemption determination within approximately 15 calendar days after the request is received. (d) The Secretary of Health and Human Services will publish on the Centers for Medicare and Medicaid Services (CMS) website any modification determinations within 15 calendar days of the Secretary and the Secretary of Health and Human Services making such a determination, as well as the approved revised timeline for public comment under the approved alternative State or Federal public notice procedures, as applicable. (e) The State must publish on its website any modification requests and determinations within 15 calendar days of receipt of the determination, as well as the approved revised timeline for public comment under the alternative State or Federal public notice procedures, as applicable.

(f) The State must, as applicable, implement the alternative public notice procedures at the State level if the State's exemption request is approved and, if required, amend the waiver application request. Start Amendment Part7. Section 33.120 is amendedâ End Amendment Part Start Amendment Parta.

In paragraph (c)(1) by adding a paragraph heading. And End Amendment Part Start Amendment Partb. By adding paragraph (c)(2).

End Amendment Part The additions read as follows. Monitoring and compliance. * * * * * (c) * * * (1) Notification requirements for public forum.

* * * (2) Modification from the normal post-award requirements during the public health emergency. (i) The Secretary and the Secretary of Health and Human Services may modify, in part, State post-award requirements under this paragraph (c)(2) for an approved waiver request during the public health emergency for asthma treatment, as defined in 42 CFR 400.200, when the application of the post award public notice requirements would be contrary to the interests of consumers during the public health emergency. These flexibilities are limited to event-triggered, emergent situations, and the flexibilities outlined in this section will not be available for States seeking to address a threat to consumers' access to health coverage or care that existed prior to the public health emergency for asthma treatment.

(ii) A State must meet all of the following criteria to request a modification under paragraph (c) of this section. (A) The State must request a modification under this paragraph (c)(2), in the form and manner specified by the Secretaries. (B) The State must have acted in good faith, and in a diligent, timely, and prudent manner to comply with the monitoring and compliance requirement under the waiver and the terms and conditions of the agreement between the Secretary and the Secretary of Health and Human Services, as applicable, and the State to implement a section 1332 waiver and to submit and prepare the request for a modification under this paragraph (c)(2).

(C) The State must detail in its request for a modification under this paragraph (c)(2) the alternative post award public notice procedures it proposes to implement at the State level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the State's request for a modification. (D) The Secretary and the Secretary of Health and Human Services will evaluate a State's request for a modification under this paragraph (c)(2) and issue their modification determination within approximately 15 calendar days after the request is received. (E) The State must publish on its website any modification requests and determinations within 15 calendar days of the receipt of the determination as well as information on the approved revised timeline for the state's post award public notice procedures, as applicable.

* * * * * DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare &. Medicaid Services For the reasons stated in the preamble, the Centers for Medicare &. Medicaid Services amends 42 CFR chapter IV as set forth below.

Start Part End Part Start Amendment Part8. The authority citation part 414 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

1302, 1395m, 1395hh, 1395rr, and 1395ddd. End Authority Start Printed Page 71197 Start Amendment Part9. Section 410.57 is amended by adding paragraph (c) to read as follows.

End Amendment Part Pneumococcal treatment, flu treatment, and asthma treatment. * * * * * (c) Medicare Part B pays for the asthma treatment and its administration. Start Amendment Part10.

Section 410.152 is amended by revising paragraph (l)(1) to read as follows. End Amendment Part Amounts of payment. * * * * * (l) * * * (1) Pneumococcal (as specified in paragraph (h) of this section), influenza, hepatitis B, and asthma treatment and administration.

* * * * * Start Amendment Part11. Section 410.160 is amended by revising paragraph (b)(2) to read as follows. End Amendment Part Part B annual deductible.

* * * * * (b) * * * (2) Pneumococcal, influenza, and hepatitis b, and asthma treatments and their administration. * * * * * Start Part End Part Start Amendment Part12. The authority citation part 411 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, and 1395nn. End Authority Start Amendment Part13.

Section 411.15 is amended by. End Amendment Part Start Amendment Parta. Removing âandâ at the end of paragraph (e)(3).

End Amendment Part Start Amendment Partb. Removing the period at the end of paragraph (e)(4) and adding â. Andâ in its place.

And End Amendment Part Start Amendment Partc. Adding paragraph (e)(5). End Amendment Part The addition reads as follows.

Particular services excluded from coverage. * * * * * (e) * * * (5) asthma treatment vaccinations that are reasonable and necessary for the prevention of illness. * * * * * Start Part End Part Start Amendment Part14.

The authority citation part 414 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

End Authority Start Amendment Part15. Section 414.701 is revised to read as follows. End Amendment Part Purpose.

This subpart implements section 1842(o) of the Act by specifying the methodology for determining the payment allowance limit for drugs and biologicals covered under Part B of Title XVIII of the Act (hereafter in this subpart referred to as the âprogramâ) that are not paid on a cost or prospective payment system basis. Examples of drugs that are subject to the rules contained in this subpart are. Drugs furnished incident to a physician's service.

Durable medical equipment (DME) drugs. Separately billable drugs at independent dialysis facilities not under the ESRD composite rate. Statutorily covered drugs, for example, influenza, pneumococcal, hepatitis, and asthma treatments, antigens, hemophilia blood clotting factor, immunosuppressive drugs and certain oral anti-cancer drugs.

Start Amendment Part16. Section 414.707 is amended by revising paragraph (a)(2)(iii) to read as follows. End Amendment Part Basis of payment.

(a) * * * (2) * * * (iii) Pneumococcal, influenza, and asthma treatments as well as hepatitis B treatment that is furnished to individuals at high or intermediate risk of contracting hepatitis B (as determined by the Secretary). * * * * * Start Amendment Part17. Section 414.900 is amended by revising paragraph (b)(3)(ii) to read as follows.

End Amendment Part Basis and scope. * * * * * (b) * * * (3) * * * (ii) Pneumococcal, Hepatitis B, and asthma treatments. * * * * * Start Amendment Part18.

Section 414.904 is amended by revising paragraph (e)(1) to read as follows. End Amendment Part Average sales price as the basis for payment. * * * * * (e) * * * (1) treatments.

The payment limits for hepatitis B treatment furnished to individuals at high or intermediate risk of contracting hepatitis B (as determined by the Secretary), pneumococcal treatment, influenza treatment, and asthma treatment are calculated using 95 percent of the average wholesale price. * * * * * Start Part End Part Start Amendment Part19. The authority citation for part 417 is revised to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh, and 300e, 300e-5, and 300e-9, and 31 U.S.C. 9701.

End Authority Start Amendment Part20. Section 417.454 is amended by adding paragraph (e)(4) to read as follows. End Amendment Part Medicare enrollees.

* * * * * (e) * * * (4) A asthma treatment and its administration described in section 1861(s)(10)(A) for the duration of the emergency period defined in paragraph (1)(B) of section 1135(g) of the Act. Start Part End Part Start Amendment Part21. The authority citation for part 433 continues to read as follows.

End Amendment Part Start Authority Sec. 1102 of the Social Security Act, (42 U.S.C. 1302).

End Authority Start Amendment Part22. Subpart G, consisting of Â§â433.400, is added to read as follows. End Amendment Part Continued Enrollment for Temporary FMAP Increase.

(a) Statutory basis. This subpart interprets and implements section 6008(b)(3) of the Families First asthma Response Act (FFCRA) and section 1902(a)(4) and (a)(19) of the Social Security Act. (b) Definitions.

For purposes of this subpartâ asthma treatment means asthma Disease 2019. Medicare Savings Program means the coverage of Medicare premiums and cost sharing furnished to individuals described in, and determined by the state to be eligible under, section 1902(a)(10)(E)(i), 1902(a)(10)(E)(iii), or 1902(a)(10)(E)(iv) of the Act. Minimum essential coverage (MEC) has the meaning provided under section 5000A(f)(1) of the Internal Revenue Code and implementing regulations at 26 CFR 1.5000A-2 and includes minimum essential coverage determined by the Secretary under 26 CFR 1.5000A-2(f).

Public Health Emergency for asthma treatment has the same definition provided in Â§â400.200 of this chapter. Temporary FMAP increase means the 6.2 percentage point increase in the Start Printed Page 71198State's Federal medical assistance percentage (FMAP) that is authorized under section 6008(a) of the FFCRA through the end of the fiscal quarter in which the Public Health Emergency for asthma treatment ends. Validly enrolled means that the beneficiary was enrolled in Medicaid based on a determination of eligibility.

A beneficiary is not validly enrolled if the agency determines the eligibility was erroneously granted at the most recent determination, redetermination, or renewal of eligibility (if such last redetermination or renewal was completed prior to March 18, 2020) because of agency error or fraud (as evidenced by a fraud conviction) or abuse (as determined following the completion of an investigation pursuant to Â§Â§â455.15 and 455.16 of this chapter) attributed to the beneficiary or the beneficiary's representative, which was material to the determination of eligibility. Individuals receiving medical assistance during a presumptive eligibility period in accordance with part 435, subpart L, of this chapter have not received a determination of eligibility by the state under the state plan and are not considered validly enrolled beneficiaries for purposes of this section. (c) General requirements.

(1) In order to claim the temporary FMAP increase for. (i) The quarter in which November 2, 2020, falls, a state must meet the requirements described in paragraph (c)(2) of this section from November 2, 2020, through the end of the quarter. (ii) Any quarter beginning after November 2, 2020, through the quarter in which the public health emergency for asthma treatment, including any extensions, ends, a state must meet the requirements described in paragraphs (c)(2) of this section.

(2) Except as provided in paragraph (d) of this section, for all beneficiaries validly enrolled for benefits under the state plan, a waiver of such plan, or a demonstration project under section 1115(a) of the Act as of or after March 18, 2020, the state must maintain the beneficiary's enrollment as follows, through the end of the month in which the public health emergency for asthma treatment ends. (i)(A) For beneficiaries whose Medicaid coverage meets the definition of MEC in paragraph (b) of this section as of or after March 18, 2020, the state must continue to provide Medicaid coverage that meets the definition of MEC, except as provided in paragraph (c)(2)(i)(B) of this section. (B) For beneficiaries described in paragraph (c)(2)(i)(A) whom the state subsequently determines are eligible for coverage under a Medicare Savings Program eligibility group, the state satisfies the requirement described in paragraph (c)(2) of this section if it furnishes the medical assistance available through the Medicare Savings Program.

(ii) For beneficiaries whose Medicaid coverage as of or after March 18, 2020 does not meet the definition of MEC in paragraph (b) of this section but does include coverage for testing services and treatments for asthma treatment, including treatments, specialized equipment, and therapies, the state must continue to provide Medicaid coverage that includes such testing services and treatments. (iii) For beneficiaries not described in paragraph (c)(2)(i) or (ii) of this section, the state must continue to provide at least the same level of medical assistance as was provided as of or after March 18, 2020. (iv) If a state determines that a validly enrolled beneficiary is no longer eligible for Medicaid, including on a procedural basis, the state meets the requirements described in paragraph (c)(2)(i), (ii), or (iii) of this section by continuing to provide the same Medicaid coverage that the beneficiary would have received absent the determination of ineligibility.

(3) Otherwise permissible changes to beneficiary coverage, cost sharing, and post-eligibility treatment of income, including both changes affecting an individual beneficiary and approved changes to the state plan, a section 1115 demonstration and/or a waiver authorized under section 1915 of the Act impacting multiple beneficiaries, will not impact a state's ability to claim the temporary FMAP increase provided that any such changes do not violate the requirement to maintain beneficiary enrollment described at paragraph (c)(2) of this section or the requirement in section 6008(b)(4) of the FFCRA. (d) Exceptions. (1) Consistent with the condition to claim the temporary FMAP increase described in paragraph (c)(2) of this section, a state may terminate a beneficiary's Medicaid enrollment prior to the first day of the month after the public health emergency for asthma treatment ends in the following circumstances.

(i) The beneficiary or the beneficiary's representative requests a voluntary termination of eligibility. (ii) The beneficiary ceases to be a resident of the state. Or (iii) The beneficiary dies.

(2) States which have elected the option under section 1903(v)(4) of the Act to provide full benefits to lawfully residing children or pregnant women must limit coverage for such beneficiaries if they no longer meet the definition of a lawfully residing child or pregnant woman under such section to services necessary for treatment of an emergency medical condition, as defined in section 1903(v)(3) of the Act. (3)(i) For purposes of paragraph (d)(1)(i) of this section, a beneficiary may request a voluntary termination of eligibility from the Medicaid coverage in which the beneficiary is enrolled to transition to other Medicaid coverage for which the beneficiary is eligible, even if the transition to the new Medicaid coverage would not be consistent with paragraph (c)(2) of this section. (ii) For purposes of paragraph (d)(1)(ii) of this section, beneficiaries who were identified through a data match with the Public Assistance Reporting Information System in accordance with Â§â435.945(d) of this chapter indicating simultaneous enrollment in two or more states, and who fail to respond to a request for information to verify their residency, may be treated as not being a state resident for purposes of paragraph (d)(1)(ii) of this section, provided that the state takes all reasonably available measures to attempt to verify the beneficiary's state residency.

If a beneficiary's enrollment is terminated under the exception at paragraph (d)(1)(ii) of this section based on a PARIS data match and the state subsequently obtains information verifying residency, the state must reinstate the beneficiary's Medicaid enrollment retroactive to the date of termination. Start Part End Part Start Amendment Part23. The authority citation for part 510 is revised to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302, 1315(a), and 1395hh. End Authority Start Amendment Part24.

Section 510.2 is amended byâ End Amendment Part Start Amendment Parta. Adding a definition for âasthma treatment Diagnosis Codeâ in alphabetical order. And End Amendment Part Start Amendment Partb.

Revising the definitions for âLower-extremity joint replacement (LEJR)â, âPerformance yearâ, and âQuality improvement pointsâ. End Amendment Part The addition and revisions read as follows. Definitions.

* * * * * asthma treatment Diagnosis Code means any of the following ICD-10-CM diagnosis codes:Start Printed Page 71199 (1) B97.29. (2) U07.1. Or (3) Any other ICD-10-CM diagnosis code that is recommended by the Centers for Disease Control and Prevention for the coding of a confirmed case of asthma treatment.

* * * * * Lower-extremity joint replacement (LEJR) means any procedure that is within MS-DRG 469 or 470, or, on or after October 1, 2020, MS-DRG 521 or 522, including lower-extremity joint replacement procedures or reattachment of a lower extremity. * * * * * Performance year means one of the years in which the CJR model is being tested. Performance years for the model correlate to calendar years with the exceptions of performance year 1, which is April 1, 2016 through December 31, 2016 and performance year 5, which is January 1, 2020 through September 30, 2021.

For reconciliation purposes, performance year 5 is divided into two subsets, performance year subset 5.1 (January 1, 2020 through December 31, 2020) and performance year subset 5.2 (January 1, 2021 through September 30, 2021). * * * * * Quality improvement points are points that CMS adds to a participant hospital's composite quality score for a measure if the hospital's performance percentile on an individual quality measure for performance years 2 through 4 and for performance year subsets 5.1 and 5.2, increases from the previous performance year or performance year subset by at least 2 deciles on the performance percentile scale, as described in Â§â510.315(d). For performance year 1, CMS adds quality improvement points to a participant hospital's composite quality score for a measure if the hospital's performance percentile on an individual quality measure increases from the corresponding time period in the previous year by at least 2 deciles on the performance percentile scale, as described in Â§â510.315(d).

* * * * * Start Amendment Part25. Section 510.200 is amended by revising paragraphs (a) and (d)(6) to read as follows. End Amendment Part Time periods, included and excluded services, and attribution.

(a) Time periods. All episodes must begin on or after April 1, 2016 and end on or before September 30, 2021. * * * * * (d) * * * (6) For performance years 1 through 4 and for performance year subsets 5.1 and 5.2, payments for otherwise included items and services in excess of 2 standard deviations above the mean regional episode payment in accordance with Â§â510.300(b)(5).

* * * * * Start Amendment Part26. Section 510.300 is amended by revising paragraphs (a) introductory text, (a)(1)(i), (a)(1)(iii), (a)(2) and (3), (b)(1)(iii), (b)(2)(iii), (b)(8), (c)(1) and (2), and (c)(3)(iii) to read as follows. End Amendment Part Determination of episode quality-adjusted target prices.

(a) General. CMS establishes episode quality-adjusted target prices for participant hospitals for each performance year or performance year subset of the model as specified in this section. Episode quality-adjusted target prices are established according to the following.

(1) * * * (i)(A) MS-DRG 469 with hip fracture. Or (B) For episodes beginning on or after October 1, 2020, MS-DRG 521. * * * * * (iii)(A) MS-DRG 470 with hip fracture.

Or (B) For episodes beginning on or after October 1, 2020, MS-DRG 522. Or * * * * * (2) Applicable time period for performance year or performance year subset episode quality-adjusted target prices. Episode quality-adjusted target prices are updated to account for Medicare payment updates no less than 2 times per year, for updated quality-adjusted target prices effective October 1 and January 1, and at other intervals if necessary.

(3) Episodes that straddle performance years or performance year subsets or payment updates. The quality-adjusted target price that applies to the type of episode as of the date of admission for the anchor hospitalization is the quality-adjusted target price that applies to the episode. * * * * * (b) * * * (1) * * * (iii) Episodes beginning in 2016 through 2018 for each of performance year subsets 5.1 and 5.2.

(2) * * * (iii) Regional historical episode payments for performance year 4 and each of performance year subsets 5.1 and 5.2. * * * * * (8) Inclusion of reconciliation payments and repayments. For performance years 3, 4, and each of performance year subsets 5.1 and 5.2 only, reconciliation payments and repayment amounts under Â§â510.305(f)(2) and (3) and from LEJR episodes included in the BPCI initiative are included in historical episode payments.

(c) * * * (1) Discount factors affected by the quality incentive payments and the composite quality score. In all performance years and performance year subsets, the discount factor may be affected by the quality incentive payment and composite quality score as provided in Â§â510.315 to create the effective discount factor or applicable discount factor used for calculating reconciliation payments and repayment amounts. The quality-adjusted target prices incorporate the effective or applicable discount factor at reconciliation.

(2) Discount factor for reconciliation payments. The discount factor for reconciliation payments in all performance years and performance year subsets is 3.0 percent. (3) * * * (iii) In performance year 4 and each of performance year subsets 5.1 and 5.2, 3.0 percent.

CMS uses a series of reconciliation processes, which CMS performs as described in paragraphs (d) and (f) of this section, after the end of each performance year 1 through 4 to establish final payment amounts to participant hospitals for CJR episodes for a given performance year. Following the end of each performance year 1 through 4, CMS determines actual episode payments for each episode for the performance year (other than episodes that have been canceled in accordance with Â§â510.210(b)), and determines the amount of a reconciliation payment or repayment amount. Within performance year 5, CMS separately performs the reconciliation processes described in paragraphs (d) and (f) of this section for performance year subsets 5.1 and 5.2 and following the end of each performance year subset 5.1 and 5.2, CMS separately determines the actual Start Printed Page 71200episode payment for each episode for the subset of the performance year (other than episodes that have been canceled in accordance with Â§â510.210(b)) and determines the amount of a reconciliation payment or repayment for each of performance year subsets 5.1 and 5.2.

* * * * * (d) * * * (1) Beginning 2 months after the end of each of performance years 1 through 4 and performance year subset 5.1 and 5 months after the end of performance year subset 5.2, CMS does all of the following. * * * * * (e) Calculation of the NPRA. By comparing the quality-adjusted target prices described in Â§â510.300 and the participant hospital's actual episode spending for each of performance years 1 through 4 and each of performance year subsets 5.1 and 5.2 and applying the adjustments in paragraph (e)(1)(v) of this section, CMS establishes an NPRA for each participant hospital for each such performance year or performance year subset.

(1) Initial calculation. In calculating the NPRA for each participant hospital for each of performance years 1 through 4 and each of performance year subsets 5.1 and 5.2, CMS does the following. (i) Determines actual episode payments for each episode included in the performance year or performance year subset (other than episodes that have been canceled in accordance with Â§â510.210(b)) using claims data that is available 2 months after the end of the performance year or performance year subset.

Actual episode payments are capped, as applicable, at the amount determined in accordance with Â§â510.300(b)(5) for the performance year or performance year subset at the amount determined in paragraph (k) of this section for episodes affected by extreme and uncontrollable circumstances, or at the quality adjusted target price determined for that episode under Â§â510.300 for an episode with actual episode payments that include a claim with a asthma treatment diagnosis code and initiate after the earlier of March 31, 2021 or the last day of the emergency period described in paragraph (k)(4) of this section. (ii) Multiplies each episode quality-adjusted target price by the number of episodes included in the performance year or performance year subset (other than episodes that have been canceled in accordance with Â§â510.210(b)) to which that episode quality-adjusted target price applies. (iii) Aggregates the amounts computed in paragraph (e)(1)(ii) of this section for all episodes included in the performance year or performance year subset (other than episodes that have been canceled in accordance with Â§â510.210(b)).

* * * * * (v) * * * (A) Limitation on loss. Except as provided in paragraph (e)(1)(v)(C) of this section, the total amount of the NPRA and subsequent reconciliation calculation for a performance year or performance year subset cannot exceed the following. * * * * * (3) For performance year 4 and each of performance year subsets 5.1 and 5.2, 20 percent of the amount calculated in paragraph (e)(1)(iii) of this section for the performance year or performance year subset.

* * * * * (B) Limitation on gain. The total amount of the NPRA and subsequent reconciliation calculation for a performance year or performance year subset cannot exceed the following. * * * * * (3) For performance year 4 and each of performance year subsets 5.1 and 5.2, 20 percent of the amount calculated in paragraph (e)(1)(iii) of this section for the performance year or performance year subset.

* * * * * (C) Financial loss limits for rural hospitals, SCHs, MDHs, and RRCs. If a participant hospital is a rural hospital, SCH, MDH, or RRC, then for performance year 2, the total repayment amount for which the participant hospital is responsible due to the NPRA and subsequent reconciliation calculation cannot exceed 3 percent of the amount calculated in paragraph (e)(1)(iii) of this section. For performance years 3 and 4 and for performance year subsets 5.1 and 5.2, the amount cannot exceed 5 percent of the amount calculated in paragraph (e)(1)(iii) of this section.

(f) * * * (1) * * * (ii) Subject to paragraph (f)(1)(iii) of this section, for performance years 2 through 4 and for each of performance year subsets 5.1 and 5.2, results from the subsequent reconciliation calculation for a prior year's reconciliation as described in paragraph (i) of this section and the post-episode spending and ACO overlap calculations as described in paragraph (j) of this section are added to the current year's NPRA in order to determine the reconciliation payment or repayment amount. * * * * * (g) * * * (1) CMS assesses each participant hospital's performance on quality metrics, as described in Â§â510.315, to determine whether the participant hospital is eligible to receive a reconciliation payment for a performance year or performance year subset. * * * * * (3) If the hospital's composite quality score described in Â§â510.315 is below acceptable, defined as less than 4.00 for a performance year or performance year subset, the hospital is not eligible for a reconciliation payment.

* * * * * (h) Reconciliation report. CMS issues each participant hospital a CJR reconciliation report for the performance year or performance year subset. Each CJR reconciliation report contains the following.

* * * * * (5) As applicable, the NPRA and subsequent reconciliation calculation amount for the previous performance year or performance year subset. (6) As applicable, the post-episode spending amount and ACO overlap calculation for the previous performance year or performance year subset. * * * * * (i) Subsequent reconciliation calculation.

(1) Fourteen months after the end of each of performance years 1 through 4 and performance year subset 5.1 and seventeen months after the end of performance year subset 5.2, CMS performs an additional calculation, using claims data available at that time, to account for final claims run-out and any additional episode cancelations due to overlap between the CJR model and other CMS models and programs, or for other reasons as specified in Â§â510.210(b). (2) The subsequent calculation for each of performance years 1 through 4 and performance year subset 5.1 occurs concurrently with the first reconciliation process for the following performance year (or in the case of performance year subset 5.1, with the first reconciliation of performance year subset 5.2). If the result of the subsequent calculation is different than zero, CMS applies the stop-loss and stop-gain limits in paragraph (e) of this section to the aggregate calculation of the amounts described in paragraphs (e)(1)(iv) and (i)(1) of this section for that performance year or performance year subset (the initial reconciliation Start Printed Page 71201and the subsequent reconciliation calculation) to ensure such amount does not exceed the applicable stop-loss or stop-gain limits.

(This amount will be assessed independently for performance year subset 5.2 in 2023.) This adjustment is made only when the participant hospital is a participant or provider/supplier in the ACO and the beneficiary in the CJR episode is assigned to one of the following ACO models or programs. (i) The Pioneer ACO model. (ii) The Medicare Shared Savings Program (excluding Track 3 for CJR episodes that initiate on or after July 1, 2017).

(iii) The Comprehensive ESRD Care Initiative (excluding a track with downside risk for CJR episodes that initiate after July 1, 2017). (iv) The Next Generation ACO model (excluding CJR episodes that initiate on or after July 1, 2017). (2) If the average post-episode Medicare Parts A and B payments for a participant hospital in the prior performance year or performance year subset is greater than 3 standard deviations above the regional average post-episode payments for the same performance year or performance year subset, then the spending amount exceeding 3 standard deviations above the regional average post-episode payments for the same performance year or performance year subset is subtracted from the net reconciliation or added to the repayment amount for the subsequent performance year for years 1 through 4 and performance year subset 5.1, and assessed independently for performance year subset 5.2.

(k) * * * (4) For a fracture or non-fracture episode with a date of admission to the anchor hospitalization that is on or within 30 days before the date that the emergency period (as defined in section 1135(g) of the Act) begins or that occurs on or before March 31, 2021 or the last day of such emergency period, whichever is earlier, actual episode payments are capped at the quality adjusted target price determined for that episode under Â§â510.300. Start Amendment Part28. Section 510.315 is amended by revising paragraphs (a), (b) introductory text, and (d) to read as follows.

End Amendment Part Composite quality scores for determining reconciliation payment eligibility and quality incentive payments. (a) General. A participant hospital's eligibility for a reconciliation payment under Â§â510.305(g), and the determination of quality incentive payments under paragraph (f) of this section, for a performance year or performance year subset depend on the hospital's composite quality score (including any quality performance points and quality improvement points earned) for that performance year or performance year subset.

(b) Composite quality score. CMS calculates a composite quality score for each participant hospital for each performance year or performance year subset which equals the sum of the following. * * * * * (d) Quality improvement points.

For performance year 1, if a participant hospital's quality performance percentile on an individual measure described in Â§â510.400(a) increases from the corresponding time period in the previous year by at least 2 deciles on the performance percentile scale, then the hospital is eligible to receive quality improvement points equal to 10 percent of the total available point for that individual measure up to a maximum composite quality score of 20 points. For each of performance years 2 through 4 and for each of performance year subsets 5.1 and 5.2, if a participant hospital's quality performance percentile on an individual measure described in Â§â510.400(a) increases from the previous performance year or performance year subset by at least 2 deciles on the performance percentile scale, then the hospitals is eligible to receive quality improvement points equal to 10 percent of the total available point for that individual measure up to a maximum composite quality score of 20 points. * * * * * Start Amendment Part29.

Section 510.400 is amended byâ End Amendment Part Start Amendment Parta. Revising paragraphs (a) introductory text, (b)(2) introductory text, (b)(2)(i), (b)(2)(ii) introductory text, and (b)(3)(v) introductory text. And End Amendment Part Start Amendment Partb.

By adding paragraph (b)(3)(vi). End Amendment Part The revisions and addition read as follows. Quality measures and reporting.

(a) Reporting of quality measures. The following quality measures are used for public reporting, for determining whether a participant hospital is eligible for reconciliation payments under Â§â510.305(g), and whether a participant hospital is eligible for quality incentive payments under Â§â510.315(f) in the performance year or performance year subset. * * * * * (b) * * * (2) Hospitals must also submit the amount of requested THA/TKA patient-reported outcomes data required for each performance year or performance year subset of the model in order to be considered successful in submitting voluntary data.

(i) The amount of requested THA/TKA patient-reported outcomes data to submit, in order to be considered successful will increase each subsequent year of the model over the 5 years of the model (with the exception of performance year subset 5.2, for which CMS will request the same amount of THA/TKA patient-reported outcomes data as performance year subset 5.1, updated to reflect the timeframe applicable to performance year subset 5.2). (ii) A phase-in approach that determines the amount of requested THA/TKA patient-reported outcomes data to submit over performance years 1 through 4 and performance year subset 5.1 (with the exception of performance year subset 5.2, for which CMS will request the same amount of THA/TKA patient-reported outcomes as performance year subset 5.1, updated to reflect the timeframe applicable to performance year subset 5.2) of the program will be applied so that in year 1 successful submission of data would mean CMS received all requested THA/TKA patient-reported outcomes and limited risk variable data on both of the following. * * * * * (3) * * * (v) Year 5 (subset 5.1, January 1, 2020-December 31, 2020).

Submitâ * * * * * (vi) Year 5 (subset 5.2, January 1, 2021-September 30, 2021). Submitâ (A) Post-operative data on primary elective THA/TKA procedures for â¥80% or â¥200 procedures performed between July 1, 2019 and June 30, 2020. And (B) Pre-operative data on primary elective THA/TKA procedures for â¥80% or â¥200 procedures performed between July 1, 2020 and June 30, 2021, unless CMS requests a more limited data set, in Start Printed Page 71202which case, submit all requested data elements.

* * * * * DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary For the reasons set forth in the preamble, the Department of Health and Human Services amends 45 CFR parts 147, 155, and 182 as set forth below. Start Part End Part Start Amendment Part30. The authority citation for part 147 is revised to read as follows.

End Amendment Part Start Authority 42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92, as amended, and section 3203, Pub. L.

116-136, 134 Stat. 281. End Authority Start Amendment Part31.

Section 147.130 is amendedâ End Amendment Part Start Amendment Parta. In paragraph (a)(1)(iii) by removing âandâ after the semicolon. End Amendment Part Start Amendment Partb.

In paragraph (a)(1)(iv) by removing the period at the end of the paragraph and adding â. Andâ in its place. End Amendment Part Start Amendment Partc.

By adding paragraph (a)(1)(v). End Amendment Part Start Amendment Partd. By revising paragraph (a)(3)(i).

End Amendment Part Start Amendment Parte. By adding paragraph (a)(3)(iii). End Amendment Part Start Amendment Partf.

By revising paragraphs (b)(1) and (b)(2)(i) and (ii). And End Amendment Part Start Amendment Partg. By adding paragraphs (b)(3) and (e).

Or (B) An immunization that has in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (regardless of whether the immunization is recommended for routine use). For purposes of this paragraph (a)(1)(v)(B), a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is considered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention. * * * * * (3) * * * (i) Subject to paragraphs (a)(3)(ii) and (iii) of this section, nothing in this section requires a plan or issuer that has a network of providers to provide benefits for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing cost-sharing requirements for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider.

* * * * * (iii) A plan or issuer must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for any qualifying asthma preventive service described in paragraph (a)(1)(v) of this section, regardless of whether such service is delivered by an in-network or out-of-network provider. For purposes of this paragraph (a)(3)(iii), with respect to a qualifying asthma preventive service and a provider with whom the plan or issuer does not have a negotiated rate for such service (such as an out-of-network provider), the plan or issuer must reimburse the provider for such service in an amount that is reasonable, as determined in comparison to prevailing market rates for such service. * * * * * (b) * * * (1) In general.

A plan or issuer must provide coverage pursuant to paragraph (a)(1) of this section for plan years (in the individual market, policy years) that begin on or after September 23, 2010, or, if later, for plan years (in the individual market, policy years) that begin on or after the date that is one year after the date the recommendation or guideline is issued, except as provided in paragraph (b)(3) of this section. (2) * * * (i) A plan or issuer that is required to provide coverage for any items and services specified in any recommendation or guideline described in paragraph (a)(1) of this section on the first day of a plan year (in the individual market, policy year), or as otherwise provided in paragraph (b)(3) of this section, must provide coverage through the last day of the plan or policy year, even if the recommendation or guideline changes or is no longer described in paragraph (a)(1) of this section, during the applicable plan or policy year. (ii) Notwithstanding paragraph (b)(2)(i) of this section, to the extent a recommendation or guideline described in paragraph (a)(1)(i) of this section that was in effect on the first day of a plan year (in the individual market, policy year), or as otherwise provided in paragraph (b)(3) of this section, is downgraded to a âDâ rating, or any item or service associated with any recommendation or guideline specified in paragraph (a)(1) of this section is subject to a safety recall or is otherwise determined to pose a significant safety concern by a Federal agency authorized to regulate the item or service during a plan or policy year, there is no requirement under this section to cover these items and services through the last day of the applicable plan or policy year.

The provisions of paragraphs (a)(1)(v), (a)(3)(iii), and (b)(3) of this section will not apply with respect to a qualifying asthma preventive service furnished on or after the expiration of the public health emergency determined on January 31, 2020, to exist nationwide as of January 27, 2020, by the Secretary of Health and Human Services pursuant to section 319 of the Public Health Service Act, as a result of asthma treatment, including any subsequent renewals of that determination. Start Part End Part Start Amendment Part32. The authority citation for part 155 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 18021-18024, 18031-18033, 18041-18042, 18051, 18054, 18071, and 18081-18083. End Authority Start Amendment Part33.

Section 155.1318 is added to read as follows. End Amendment Part Modification from the normal public notice requirements during the public health emergency. (a) The Secretary and the Secretary of the Treasury may modify, in part, the State public notice requirements under Start Printed Page 71203Â§â155.1312 and the Federal public notice procedures under Â§â155.1316 to expedite a decision on a proposed waiver request during the public health emergency, as defined in 42 CFR 400.200, when a delay would undermine or compromise the purpose of the proposed waiver request and be contrary to the interests of consumers.

(2) The State must have acted in good faith, and in a diligent, timely, and prudent manner in the preparation of the request for a modification under paragraph (a) of this section, and the waiver application request, as applicable. (3) The State must, as applicable, detail in its request for a modification from State-level notice procedures under paragraph (a) of this section the justification for the request as it relates to the public health emergency and the alternative public notice procedures it proposes to implement at the State level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the State's request for a modification. (4) The State must, as applicable, detail in its request for a modification from Federal-level notice procedures under paragraph (a) of this section the justification for the request and the alternative public notice procedures it requests to be implemented at the Federal level.

(c) The Secretary and the Secretary of the Treasury will evaluate a State's request for a modification under paragraph (a) of this section and issue their modification determination within approximately 15 calendar days after the request is received. (d) The Secretary will publish on the CMS website any modification determinations within 15 calendar days of the Secretary and the Secretary of the Treasury making such a determination, as well as the approved revised timeline for public comment under the approved alternative State or Federal public notice procedures, as applicable. (e) The State must publish on its website any modification requests and determinations within 15 calendar days of receipt of the determination, as well as the approved revised timeline for public comment under the alternative State or Federal public notice procedures, as applicable.

(f) The State must, as applicable, implement the alternative public notice procedures at the State level if the State's modification request is approved and, if required, amend the waiver application request. Start Amendment Part34. Section 155.1320 is amendedâ End Amendment Part Start Amendment Parta.

In paragraph (c)(1) by adding a paragraph heading. And End Amendment Part Start Amendment Partb. By adding paragraph (c)(2).

End Amendment Part The additions read as follows. Monitoring and compliance. * * * * * (c) * * * (1) Notification requirements for public forum.

* * * (2) Modification from the normal post award requirements during the public health emergency. (i) The Secretary and the Secretary of the Treasury may modify, in part, State post award requirements under this paragraph (c)(2) for an approved waiver request during the public health emergency, as defined in 42 CFR 400.200, when the application of the post award public notice requirements would be contrary to the interests of consumers during the public health emergency. These flexibilities are limited to event-triggered, emergent situations, and the flexibilities outlined in this section will not be available for States seeking to address a threat to consumers' access to health coverage or care that existed prior to the public health emergency for asthma treatment.

(ii) A State must meet all of the following criteria to request a modification under paragraph (c) of this section. (A) The State must request a modification under paragraph (c)(2) of this section, in the form and manner specified by the Secretaries. (B) The State must have acted in good faith, and in a diligent, timely, and prudent manner to comply with the monitoring and compliance requirement under the waiver and the terms and conditions of the agreement between the Secretary and the Secretary of the Treasury, as applicable, and the State to implement a section 1332 waiver and to submit and prepare the request for a modification under paragraph (c)(2) of this section.

(C) The State must detail in its request for a modification under paragraph (c)(2) of this section the alternative post award public notice procedures it proposes to implement at the State level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the State's request for a modification. (D) The Secretary and the Secretary of the Treasury will evaluate a State's request for a modification under paragraph (c)(2) of this section and issue their modification determination within approximately 15 calendar days after the request is received. (E) The State must publish on its website any modification requests and determinations within 15 calendar days of receipt of the determination, as well as information on the approved revised timeline for the State's post award public notice procedures, as applicable.

* * * * * Start Amendment Part35. Subchapter E-T, consisting of part 182, is added to subtitle A to read as follows. End Amendment Part Start Part 182.10 Basis and scope.

182.20 Definitions. 182.30 Applicability. 182.40 Requirements for making public cash prices for a diagnostic test for asthma treatment.

182.50 Monitoring and enforcement. 182.60 Corrective action plans. 182.70 Civil monetary penalties.

182.80 Appeal of penalty. 182.90 Failure to request a hearing. Start Authority Section 3202(b), Pub.

End Authority Basis and scope. This part implements section 3202(b)(1) of the asthma Aid, Relief, and Economic Security Act (Pub. L.

116-136, March 27, 2020) (CARES Act), which requires that during the emergency period declared under section 319 of the PHS Act (42 U.S.C. Start Printed Page 71204247d), providers of diagnostic tests for asthma treatment make public the cash price for such tests on a public internet website of such provider. This part also implements section 3202(b)(2) of the CARES Act, which authorizes the Secretary to impose a civil monetary penalty (CMP) on any provider of a diagnostic test for asthma treatment that does not comply with section 3202(b)(1) of the CARES Act and that has not completed a corrective action plan to comply with that section, in an amount that does not exceed $300 per day that the violation is ongoing.

asthma treatment for purposes of this part is the abbreviated term for the ventolin called asthma and the disease it causes, called asthma disease 2019. Diagnostic test for asthma treatment (âasthma treatment diagnostic testâ) means a asthma treatment in vitro diagnostic test described in section 6001 of the Families First asthma Response Act (Pub. L.

116-127, March 18, 2020), as amended by section 3201 of the CARES Act (Pub. L. 116-136, March 27, 2020).

Provider of a diagnostic test for asthma treatment (âproviderâ) means any facility that performs one or more asthma treatment diagnostic tests. Applicability. (a) General applicability.

The requirements of this part apply to each provider of a diagnostic test for asthma treatment as defined at Â§â182.20. (b) Duration of requirements. The requirements of this part are applicable during the public health emergency (PHE) determined to exist nationwide as of January 27, 2020, by the Secretary of Health and Human Services pursuant to section 319 of the PHS Act on January 31, 2020, as a result of confirmed cases of asthma treatment, including any subsequent renewals.

Requirements for making public cash prices for a diagnostic test for asthma treatment. (a) General rules. (1) Except as provided under paragraph (b) of this section, a provider of a asthma treatment diagnostic test must make public the information described in paragraph (c) of this section electronically via the internet.

(2) The information described in paragraph (c) of this section, or a link to such information, must appear in a conspicuous location on a searchable homepage of the provider's website. (3) The information described in paragraph (c) of this section must be displayed in a manner that is easily accessible, without barriers, and ensures that the information is accessible. (i) Free of charge.

(ii) Without having to establish a user account or password. And (iii) Without having to submit personal identifiable information (PII). (4) The provider must include all of the following terms on its homepage.

(i) The provider's name. (ii) The term âpriceâ. (iii) The term âcostâ.

(iv) The term âtestâ. (v) The term âasthma treatmentâ. And (vi) The term âasthmaâ.

(b) Exception. A provider of a asthma treatment diagnostic test that does not have its own website must make public the information described in paragraph (c) of this section. (1) In writing, within two business days upon request.

And (2) On a sign posted prominently at the location where the provider offers a asthma treatment diagnostic test, if such location is accessible to the public. (c) Required information. For purposes of paragraphs (a) and (b) of this section, the provider must make public the following information.

And (4) Any additional information as may be necessary for the public to have certainty of the cash price that applies to each asthma treatment diagnostic test. Monitoring and enforcement. (a) Monitoring.

(1) CMS may evaluate whether a provider has complied with the requirements under Â§â182.40. (2) CMS may use methods to monitor and assess provider compliance with the requirements under this part, including, but not limited to, the following, as appropriate. (i) CMS' evaluation of complaints made to CMS.

(ii) CMS review of an individual's or entity's analysis of noncompliance as stated in the complaint. (iii) CMS review of providers' websites. (b) Actions to address provider noncompliance.

(3) Impose a civil monetary penalty on the provider if the provider fails to respond to CMS' request to submit a corrective action plan or to comply with the requirements of a corrective action plan approved by CMS. Corrective action plans. (a) Violations requiring a corrective action plan.

If CMS determines a provider's noncompliance with the requirements of this part continues after a warning notice, a corrective action plan may be required. A violation may include, but is not limited to, the following. (1) A provider's failure to make public its cash price information required by Â§â182.40.

(2) A provider's failure to make public its cash price information in the form and manner required under Â§â182.40. (b) Notice of violation. CMS may request that a provider submit and comply with a corrective action plan, specified in a notice of violation issued by CMS to a provider.

(c) Compliance with corrective action plan requests and corrective actions. (1) A provider required to submit a corrective action plan must do so, in the form and manner, and by the deadline, specified in the notice of violation issued by CMS to the provider, and must comply with the requirements of the corrective action plan approved by CMS. (2) A provider's corrective action plan must specify elements including, but not limited to.

(i) The corrective actions or processes the provider will take to address the deficiency or deficiencies identified by CMS. (ii) The timeframe by which the provider will complete the corrective action. (3) A corrective action plan is subject to CMS review and approval.

(4) After CMS' review and approval of a provider's corrective action plan, CMS may monitor and evaluate the provider's compliance with the corrective actions specified in the corrective action plan. (d) Noncompliance with corrective action plan requests and requirements. (1) A provider's failure to respond to Start Printed Page 71205CMS' request to submit a corrective action plan includes failure to submit a corrective action plan in the form, manner, or by the deadline, specified in a notice of violation issued by CMS to the provider.

(2) A provider's failure to comply with the requirements of a corrective action plan includes failure to correct violation(s) within the specified timeframes. Civil monetary penalties. (a) Basis for imposing civil monetary penalties.

CMS may impose a civil monetary penalty on a provider identified by CMS as noncompliant according to Â§â182.50, and that fails to respond to CMS' request to submit a corrective action plan or to comply with the requirements of a corrective action plan approved by CMS as described in Â§â182.60(d). (b) Notice of imposition of a civil monetary penalty. (1) If CMS imposes a penalty in accordance with this part, CMS will provide a written notice of imposition of a civil monetary penalty to the provider via certified mail or another form of traceable carrier.

(2) This notice to the provider may include, but is not limited to, the following. (i) The basis for the provider's noncompliance, including, but not limited to, the following. (A) CMS' determination as to which requirement(s) the provider has violated.

(B) The provider's failure to respond to CMS' request to submit a corrective action plan or comply with the requirements of a corrective action plan, as described in Â§â182.60(d). (ii) CMS' determination as to the effective date for the violation(s). This date is the latest date of the following.

(A) The first day the provider is required to meet the requirements of this part. (B) A date determined by CMS, such as one resulting from monitoring activities specified in Â§â182.50, or development of a corrective action plan as specified in Â§â182.60. (iii) The amount of the penalty as of the date of the notice.

(vii) A statement that the provider's failure to request a hearing within 30 calendar days of the issuance of the notice permits the imposition of the penalty, and any subsequent penalties pursuant to continuing violations, without right of appeal in accordance with Â§â182.90. (3) If the civil monetary penalty is upheld, in part, by a final and binding decision according to subpart D of this part, CMS will issue a modified notice of imposition of a civil monetary penalty, to conform to the adjudicated finding. (c) Amount of the civil monetary penalty.

(1) CMS may impose a civil monetary penalty upon a provider for a violation of each requirement of this part. (2) The maximum daily dollar amount for a civil monetary penalty to which a provider may be subject is $300. Even if the provider is in violation of multiple discrete requirements of this part, the maximum total sum that a single provider may be assessed per day is $300.

(3) The maximum daily amount of the civil monetary penalty will be adjusted annually using the multiplier determined by the Office of Management and Budget for annually adjusting civil monetary penalty amounts under part 102 of this title. (d) Timing of payment of civil monetary penalty. (1) A provider must pay the civil monetary penalty in full within 60 calendar days after the date of the notice of imposition of a civil monetary penalty from CMS under paragraph (b) of this section.

(2) In the event a provider requests a hearing, pursuant to subpart D of this part, the provider must pay the amount in full within 60 calendar days after the date of a final and binding decision, according to subpart D of this part, to uphold, in whole or in part, the civil monetary penalty. (3) If the 60th calendar day described in paragraphs (d)(1) and (2) of this section is a weekend or a Federal holiday, then the timeframe is extended until the end of the next business day. (4) In the event a civil money penalty is not paid in full within 60 days, CMS will follow the collections activities set forth in 45 CFR part 30.

(e) Continuing violations. CMS may issue subsequent notice(s) of imposition of a civil monetary penalty, according to paragraph (b) of this section, that result from the same instance(s) of noncompliance. Appeal of penalty.

(a) A provider upon which CMS has imposed a penalty under this part may appeal that penalty in accordance with subpart D of part 150 of this title, except as specified in paragraph (b) of this section. (b) For purposes of applying subpart D of part 150 of this title to appeals of civil monetary penalties under this part. (1) âRespondentâ means a provider, as defined in Â§â182.20 that received a notice of imposition of a civil monetary penalty according to Â§â182.70(b).

(2) In deciding whether the amount of a civil money penalty is reasonable, the administrative law judge (ALJ) may only consider evidence of record relating to the following. (i) The provider's posting(s) of its cash price information, if available. (ii) Material the provider timely previously submitted to CMS (including with respect to corrective actions and corrective action plans).

(a) If a provider does not request a hearing within 30 calendar days of the issuance of the notice of imposition of a civil monetary penalty described in Â§â182.70(b), CMS may impose the civil monetary penalty indicated in such notice without right of appeal in accordance with this part. (1) If the 30th calendar day described paragraph (a) of this section is a weekend or a Federal holiday, then the timeframe is extended until the end of the next business day. (2) [Reserved] (b) The provider has no right to appeal a penalty with respect to which it has not requested a hearing in accordance with Â§â150.405 of this title, unless the provider can show good cause, as determined at Â§â150.405(b) of this title, for failing to timely exercise its right to a hearing.

End Part Start Part End Part Start Amendment Part36. Effective January 1, 2021, transfer part 182 from subchapter E-T to subchapter E. End Amendment Part Start Amendment Part37.

Effective January 1, 2021, remove subchapter E-T. End Amendment Part End Supplemental Information [FR Doc. 2020-24332 Filed 11-2-20.

Sign up for our newsletter For Sarah Blevins, finding better ways to where to buy ventolin online treat opioid use disorder is personal. ÂComing from Appalachia, I feel like those are my people,â she said. Blevins, who grew up in Abingdon, Virginia, is one member of a small group of researchers where to buy ventolin online at the University of Kentucky working on a multidisciplinary plan to treat those with opioid use disorder (OUD). Itâs a plan, they say, that could work well treating those with OUD in rural areas.

Since 2018, the researchers have been treating patients who entered the health care where to buy ventolin online system with endocarditis (a condition where germs enter the bloodstream and travel to the heart) associated with injection drug use. The group wanted to find solutions that would address the patientsâ addiction, as well as their . The researchers hope to be able to curb opioid use disorder by providing patients at infectious disease clinics with access to mental health therapists, relapse prevention services, and medications. âOur intervention is about linking patients with IV-drug-use-associated s to outpatient addiction treatment services,â said Blevins, a pharmacist and lead researcher where to buy ventolin online on the study.

She likened the approach to the way HIV is treated. The new opioid treatment is based where to buy ventolin online on approaches spelled out in the groundbreaking HIV-treatment legislation called the Ryan White Care Act. That HIV treatment model provides not only medical care but mental health care, case management, social workers, and others. Providing help with everything from housing to jobs to mental health services and prescriptions helps the team treat the whole patient, and not just the , said Alice Thornton, M.D., one of the studyâs authors.

âAll of where to buy ventolin online this goes back to the addiction problem,â Thornton said. ÂWe have to step back and see the whole person and the root of the problem.â The team works with individuals who are eligible to enter into the program (they must be opioid drug users and they cannot be incarcerated) and treats both their endocarditis and their addiction. Whether itâs finding treatment providers closer to a patientâs homes, providing transportation assistance, or even providing mental health where to buy ventolin online services through telehealth appointments, the treatment model focuses on the whole patient and what they need. âItâs hard to be in Appalachia and grow up there and not have at least one person that you know thatâs overdosed.

And I think that speaks to the enormity of the problem.âSarah Blevins Lead researcher So far, she said, out of the 270 patients who were referred to the program, only 167 were eligible to participate. Of those, about half decided to participate in where to buy ventolin online the program. Of those that have entered the treatment program, she said, about 17% have died from causes related to their opioid addiction. Participants are located all across the state, Blevins said, but where to buy ventolin online most come from rural eastern Kentucky.

According to Bevins, in rural areas, the treatment approach could be a model for success because it helps the team offer specialized services that individuals with opioid use disorder may not have in their areas. âIn some of the more rural areas, to continue treating that infectious disease, whether it be follow-up for their endocarditis or continued HIV care or hepatitis C care that may not be available where they are, we still provide that treatment,â she said. ÂBut also, we have this separate group that helps them stay within their (sobriety) journey or to start on their journey to sobriety.â Nationally, rural areas of the country continue to see higher rates of opioid where to buy ventolin online overdose deaths, despite lower incidents of drug use. According to the Centers for Disease Control and Prevention (CDC), the rate for drug overdose deaths involving natural and semisynthetic opioids was 4.9 per every 100,000 residents compared to 4.3 per every 100,000 residents in urban areas.

However, rural areas see lower rates of drug use, 20 per every 100,000 residents, where to buy ventolin online than urban areas (22 per every 100,000 residents). For Blevins and the University of Kentucky team, itâs not just about numbers. Itâs about the people. âWeâre very passionate about it, because all of us on the team except maybe one, where to buy ventolin online are from Appalachia,â Blevins said.

ÂWeâve seen it â the opioid crisis. Itâs hard to be in Appalachia and grow up there and not where to buy ventolin online have at least one person that you know thatâs overdosed. And I think that speaks to the enormity of the problem.â So far, the program is young, she said, and thereâs not a lot of hard data to draw conclusions from. But Blevins believes results are promising.

Some of those who have entered the program are approaching a where to buy ventolin online year in recovery and have been able to hold down jobs, get custody of their children back or clear up legal problems. Others, however, have not. âThatâs kind of how where to buy ventolin online it goes with sobriety,â she said. ÂItâs a continual process of trying to get stable.â Before You Go The Daily Yonder is a nonprofit news platform dedicated to reporting on rural people, places, and issues.

Donations from readers like you makes it possible for us to fulfill this important mission. So far this year, weâve helped readers understand where rural America fits in the asthma treatment ventolin, the where to buy ventolin online 2020 election, and the fight for racial equity. For the rest of 2020, you have a special opportunity to double your contribution to the Daily Yonder. Your gift will be matched dollar for dollar where to buy ventolin online by NewsMatch, a nonprofit news funding program.

All you have to do to help us get this extra support is make a gift, in any amount. Itâs that simple. Thanks for reading the Daily Yonder, for sharing our content with friends where to buy ventolin online and neighbors, and for making your contribution today. You Might Also LikeStart Preamble Start Printed Page 71142 Centers for Medicare &.

Medicaid Services (CMS), Department of where to buy ventolin online Health and Human Services (HHS). Internal Revenue Service, Department of the Treasury. Employee Benefits Security Administration, Department of Labor. Interim final rule with where to buy ventolin online request for comments.

This interim final rule with request for comments (IFC) discusses CMS's implementation of section 3713 of the asthma Aid, Relief, and Economic Security Act (CARES Act), which established Medicare Part B coverage and payment for asthma Disease 2019 (asthma treatment) treatment and its administration. This IFC implements requirements in the CARES Act that providers of asthma treatment diagnostic tests make public their cash prices for those tests and establishes an enforcement scheme to enforce those where to buy ventolin online requirements. This rule also establishes an add-on payment for cases involving the use of new asthma treatments under the Medicare Inpatient Prospective Payment System (IPPS). This IFC provides for separate payment for new asthma treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for asthma treatment when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service.

This rule also interprets and implements the requirement to maintain Medicaid beneficiary enrollment in order to receive the temporary increase in Federal funding in the Families First asthma where to buy ventolin online Response Act (FFCRA). This IFC modifies policies of the Comprehensive Care for Joint Replacement (CJR) model and adds technical changes to accommodate these policy changes. Specifically, we are extending Performance Year (PY) 5 by adding 6 months, where to buy ventolin online creating an episode-based extreme and uncontrollable circumstances asthma treatment policy, providing two reconciliation periods for PY 5, and adding DRGs 521 and 522 for hip and knee procedures. This rule also amends regulations regarding coverage of preventive health services to implement section 3203 of the CARES Act, which shortens the timeframe within which non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage must begin to cover without cost sharing qualifying asthma preventive services, including recommended asthma treatment immunizations.

This IFC also revises regulations to set forth flexibilities in the public notice requirements and post award public participation requirements for State Innovation Waivers under section 1332 of the Patient Protection and Affordable Care Act (PPACA) during the public health emergency for asthma treatment. Effective date where to buy ventolin online. These regulations are effective on November 2, 2020, except for amendatory instructions 36 and 37, which are effective on January 1, 2021. Applicability where to buy ventolin online date.

Except as otherwise specified in this paragraph, these regulations are applicable from November 2, 2020, until the end of the public health emergency for asthma treatment as determined by the HHS Secretary. The regulations at 42 CFR 410.57, 410.152, 410.160, 411.15, 414.701, 414.707, 414.900, and 414.904 and at 42 CFR part 510 (other than 42 CFR 510.300(a)(1)(i) and (iii)) are applicable November 2, 2020. Because the requirement at section 6008(b)(3) of the Families First asthma Response Act (FFCRA) is not limited to where to buy ventolin online the duration of the public health emergency for asthma treatment, regulations at 42 CFR part 433, subpart G, apply from November 2, 2020, through the end of the last month of the public health emergency for asthma treatment in accordance with section 6008(b)(3) of the Families First asthma Response Act. Regulations at 42 CFR 510.300(a)(1)(i) and (a)(1)(iii) are applicable October 1, 2020.

Comment where to buy ventolin online date. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. On January 4, 2021. In commenting, please refer to where to buy ventolin online file code CMS-9912-IFC.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed). 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov.

Follow the âSubmit a commentâ instructions. 2. By regular mail. You may mail written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-9912-IFC, P.O. Box 8016, Baltimore, MD 21244-8016.

Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-9912-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

Start Further Info Laura Kennedy, (410) 786-3377, for discussion related to asthma treatment and administration payment provided under Medicare Part B. Lina Rashid, (443) 902-2823, or Michelle Koltov, (301) 492-4225, Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Services, Kimberly Koch, (202) 622-0854, Department of the Treasury, for issues related to State Innovation Waivers Policy and Regulatory Revisions in Response to the asthma treatment Public Health Emergency. Dr.

Terri Postma or Rhonda Sheppard, (410) 786-8465, or via email at asthma [email protected], for provisions related to Price Transparency for asthma treatment Diagnostic Testing.Start Printed Page 71143 Cristina Nigro, (410) 786-7763, for issues related to the Medicare Inpatient Prospective Payment System (IPPS) New asthma treatments Add-on Payment (NCTAP) for the remainder of the public health emergency. David Mlawsky, (410) 786-1565, Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Elizabeth Schumacher, (202) 693-8335, Employee Benefits Security Administration, Department of Labor, Dara Alderman, (202) 317-5500, Internal Revenue Service, Department of the Treasury, for issues related to Rapid Coverage of Preventive Services for asthma. Stephanie Bell, (410) 786-0617, for issues related to the temporary increase in Federal Medicaid funding.

Bobbie Knickman, (410) 786-4161. Heather Holsey, (410) 786-0028. Sarah Mioduski, (410) 786-2014 or email [email protected] for the Comprehensive Care for Joint Replacement Model. End Further Info End Preamble Start Supplemental Information Inspection of Public Comments.

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received. Http://regulations.gov. Follow the search instructions on that website to view public comments.

Background The United States is responding to an outbreak of respiratory disease caused by a novel asthma that was first detected in China and has now been detected in more than 190 countries internationally, and all 50 States, the District of Columbia, and U.S. Territories. The ventolin has been named âsevere acute respiratory syndrome asthma 2â (âasthmaâ) and the disease it causes has been named âasthma disease 2019â (âasthma treatmentâ). On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared the outbreak a âPublic Health Emergency of International Concern.â On January 31, 2020, pursuant to section 319 of the Public Health Service (PHS) Act (42 U.S.C.

Effective October 23, 2020, the Secretary renewed the January 31, 2020 determination that was previously renewed on April 21, 2020 and July 23, 2020 that a PHE exists and has existed since January 27, 2020. The Administration is committed to ensuring that Americans have access to a asthma treatment through Operation Warp Speed, a partnership among components of the HHS, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA). Operation Warp Speed engages with private firms and other Federal agencies, including the Department of Defense (DoD), Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. Through the work of the Federal Government and the private sector, Operation Warp Speed seeks to accelerate the development, manufacture, and distribution of a asthma treatment to the American people.

The CDC has reported that some people are at higher risk of severe illness from asthma treatment.[] These higher-risk categories include. Older adults, with risk increasing by age. People who have serious chronic medical conditions such as. ++ Obesity.

++ Cardiovascular disease. ++ Diabetes mellitus. ++ Hypertension. ++ Chronic lung disease.

++ Neurologic/Neurodevelopmental disability.[] ++ Immunocompromised individuals. Residents of Long Term Care (LTC) facilities, including nursing homes, Intermediate Care Facilities for Individuals with Intellectual and Developmental Disabilities (ICF/IIDs), inpatient psychiatric and substance abuse treatment facilities including Institutions for Mental Disease (IMDs) &. Psychiatric Residential Treatment Facilities (PRTFs), assisted living facilities, group homes for individuals with developmental disabilities and board-and-care facilities.[] As the health care community implements and updates recommended prevention and control practices, regulatory agencies operating under appropriate waiver authority granted by the PHE for asthma treatment are also working to revise and implement regulations that support these health care community prevention and treatment practices. Based on the current and projected increases in the incidence rate of asthma treatment in the US, observed fatalities in the older adult population, and the impact on health care workers at increased risk due to treating special populations, CMSâ[] is reviewing and revising regulations, as appropriate, to offer states, providers, suppliers, and group health plans and health insurance issuers additional flexibilities in furnishing and providing services to combat the PHE for asthma treatment and to address and minimize the unique impact of the PHE for asthma treatment on other regulatory provisions.

CMS addressed additional policies in three previous interim final rules with comment period (IFCs). The âMedicare and Medicaid Programs. Policy and Regulatory Revisions in Response to the asthma treatment Public Health Emergencyâ IFC appeared in the April 6, 2020 Federal Register (85 FR 19230) with an effective date of March 31, 2020, and the âMedicare and Medicaid Programs, Basic Health Program, and Exchanges. Additional Policy and Regulatory Revisions in Response to the asthma treatment Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Programâ IFC appeared in the May 8, 2020 Federal Register (85 FR 27550) with an effective date of May 8, 2020.

In this IFC, HHS and the Departments of Labor and the Treasury (referred to collectively as âthe Departmentsâ) clarify certain aspects of coverage of preventive services without cost sharing under the current regulations implementing section 2713 of the Public Health Service (PHS) Act, as added by PPACA and incorporated into the Employee Retirement Income Security Act of 1974 (ERISA) by section 715 of ERISA and into the Internal Revenue Code (the Code) by section 9815 of the Code. The Departments also amend those regulations to implement the unique requirements related to rapid coverage of qualifying asthma preventive services under section 3203 of the CARES Act. Specifically, this IFC clarifies that plans and issuers subject to section 2713 of the PHS Act must cover without cost sharing recommended immunizations as well as the administration of such immunizations, regardless of how the administration is billed. This IFC also defines qualifying asthma preventive services consistent with the definition provided in section 3203 of the CARES Act and clarifies that plans and issuers subject to section 2713 of the PHS Act must cover recommended immunizations for asthma treatment that are qualifying asthma preventive services, even if not listed for routine use on the Immunization Schedules of the CDC.

Due to the urgent need to ensure coverage of and access to qualifying asthma preventive services, and to ensure that participants, beneficiaries, and enrollees can access qualifying asthma preventive services on the expedited basis specified by statute, this IFC also provides that during the PHE for asthma treatment, plans and issuers must cover, without cost sharing, qualifying asthma preventive services, regardless of whether such services are delivered by an in-network or out-of-network provider. This coverage is required to be provided within 15 business days after the date the United States Preventive Services Task Force (USPSTF) or the Advisory Committee on Immunization Practices of the CDC (ACIP) makes an applicable recommendation relating to a qualifying asthma preventive service. Section 3202(b) of the CARES Act establishes a requirement to publicize cash prices for asthma treatment diagnostic testing during the PHE. For purposes of implementing section 3202(b) of the CARES Act, this IFC adds a new 45 CFR part 182, including (1) definitions of âprovider of a diagnostic test for asthma treatmentâ (or âproviderâ), âasthma treatment diagnostic test,â and âcash price,â and (2) requirements for posting cash price information on the internet, or upon request and through signage (if applicable) if the provider does not have its own website.

This IFC creates a New asthma treatments Add-on Payment (NCTAP) under the Inpatient Prospective Payment System (IPPS) for asthma treatment cases that meet certain criteria. We believe that as drugs and biological products become available and are authorized or approved by FDA for the treatment of asthma treatment in the inpatient setting, it is appropriate to increase the current IPPS payment amounts to mitigate any potential financial disincentives for hospitals to provide new asthma treatments during the PHE. Therefore, effective for discharges occurring on or after the effective date of this rule and until the end of the PHE for asthma treatment, this IFC establishes the NCTAP to pay hospitals the lesser of (1) 65 percent of the operating outlier threshold for the claim or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment, including the adjustment to the relative weight under section 3710 of the CARES Act, for certain cases that include the use of a drug or biological product currently authorized or approved for treating asthma treatment. The NCTAP will not be included as part of the calculation of the operating outlier payments.

This IFC provides for separate payment for New asthma treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for asthma treatment when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service. Although we do not expect that many beneficiaries would both receive a primary C-APC service and a drug or biological for treating asthma treatment on the same claim, we nonetheless believe that as drugs or biologicals become available and are authorized or approved for the treatment of asthma treatment in the outpatient setting, it would be appropriate to mitigate any potential financial disincentives for hospitals to provide these new treatments during the PHE for asthma treatment. Therefore, effective for services furnished on or after the effective date of this rule and until the end of the PHE, CMS is creating an exception to its OPPS C-APC policy to ensure separate payment for new asthma treatments that meet certain criteria. This IFC adds a new subpart G, Temporary FMAP Increase During the Public Health Emergency for asthma treatment, to 42 CFR part 433, including a new Â§â433.400.

Specifically, we are extending Performance Year (PY) 5 an additional 6 months, creating an episode-based extreme and uncontrollable circumstances asthma treatment policy, providing two reconciliation periods for PY 5, and adding DRGs 521 and 522 for hip and knee procedures. This IFC provides for flexibilities in the public notice requirements for a State Innovation Waiver (also referred to as a section 1332 waiver) described in section 1332 of PPACA that apply during the PHE for asthma treatment. Specifically, this IFC gives the Secretary of HHS and the Secretary of the Treasury the authority to modify, in part, the public notice procedures to Start Printed Page 71145expedite a decision on a proposed waiver request that is submitted or would otherwise become due during the PHE for asthma treatment. This IFC also gives these Secretaries the authority to modify, in part, the post-award public notice requirements for an approved waiver request that would otherwise take place or become due during the PHE for asthma treatment.

II. Provisions of the Interim Final RuleâDepartment of Health and Human Services A. Medicare Coding and Payment for asthma treatment 1. Summary This section of this IFC discusses CMS's implementation of section 3713 of the CARES Act, which established Medicare Part B coverage and payment for a asthma treatment and its administration.

For preventive treatments described in section 1861(s)(10) of the Act, Medicare pays for both the treatment and its administration. Under sections 1833(a)(1)(B), annual Part B deductible and coinsurance amounts do not apply for these vaccinations. In 2020, payment for treatments is based on the 95 percent of the AWP for a particular treatment product except where furnished in the settings for which payment is based on reasonable cost. For example, for the 2020-2021 influenza season, payment limits for adult flu treatments range from about $19 to $61 per adult dose.[] We note that in the Calendar Year 2021 Physician Fee Schedule Proposed Rule (85 FR 50162-50163), CMS proposed to increase the Medicare payment rate for administration of the flu, pneumococcal or HBV treatment furnished by a physician, non-physician practitioner, or other supplier.

CMS will address public comments on the proposal and establish payment rates for administration of these treatments by a physician, non-physician practitioner, or other supplier in the Calendar Year 2021 Physician Fee Schedule Final Rule, which will be issued later this year. Note that the payment rates for administration of these preventive treatments established in the CY 2021 Physician Fee Schedule final rule do not apply when the treatment is furnished by the providers and suppliers paid for administration under reasonable cost. Under the CY 2021 OPPS proposed rule, CMS proposed to assign the HCPCS codes for administration of the influenza, pneumococcal, and hepatitis B treatments to APC 5691, Level 1 Drug Administration. See Addendum C to the CY 2021 OPPS/ASC proposed rule.

Payment amounts for these preventive treatments and their administration are not adjusted based on product-specific factors. Generally, providers and suppliers bill for the treatment and the treatment administration separately using different codes. For example, many treatment products are identified by AMA CPT codes in the 90000 series, while others are identified by Level II HCPCS codes, usually beginning with the letter Q. treatment administration services are described by the types of codes used to describe professional and/or hospital outpatient services, and are typically identified by a G code for Medicare billing, or by a different AMA CPT code in the 90000 series.

Many providers, professionals, and other suppliers can bill Medicare for the preventive treatments and treatment administration they furnish using claims rules similar to those that apply to the other Medicare covered items and services. Additionally, certain entities can enroll under Medicare as mass immunizers to offer and bill Medicare for flu vaccinations, pneumococcal vaccinations, or both to large groups of Medicare beneficiaries under roster billing. A mass immunizer may be enrolled in Medicare as another type of provider or supplier such as a physician, non-physician practitioner, hospital outpatient department, home health agency or skilled nursing facility. An entity or individual that does not otherwise qualify as a Medicare provider or supplier but wishes to furnish mass immunization services may be eligible to enroll in Medicare as a âMass Immunization Roster Billerâ via the Form CMS-855 enrollment application (Medicare Enrollment Application.

Clinics/Group Practices and Certain Other Suppliers. OMB Control No.. 0938-0685. Expires 12/21).

And (3) the enrolled entity or individual must meet all applicable state and local licensure or certification requirements. In other words, an enrolled mass immunizer roster biller may only roster bill Medicare for the services described in the previous sentence. (For more information on the enrollment process for mass immunization roster billers, see https://www.cms.gov/âMedicare/âProvider-Enrollment-and-Certification/âBecome-a-Medicare-Provider-or-Supplier and/or contact your local Part A/B Medicare Administrative Contractor.) For entities that are already enrolled Medicare providers and suppliers, these entities would contact their MAC if they plan to submit claims as a mass immunizer. Mass immunizers may submit claims for immunizations (treatment and administration) on roster bills that include a limited set of information on each beneficiary and the treatment(s) they were given.

We note that HBV vaccinations require an assessment of a patient's risk of contracting hepatitis B. They require a physician's order and cannot be roster billed by mass immunizers. 3. Provisions of the CARES Act Section 3713 of the CARES Act provides for coverage of the asthma treatment under Part B of the Medicare program without any beneficiary cost sharing.

Specifically, section 3713 amended section 1861(s)(10)(A) of the Act to include asthma treatment and its administration. The amendments made are effective on the date of Start Printed Page 71146enactment and apply to a asthma treatment beginning on the date that such treatment is licensed under section 351 of the PHS Act (42 U.S.C. 262). Section 3713(e) of the CARES Act further states that the Secretary may implement the provisions of, and the amendments made by, this section by program instruction or otherwise.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Commissioner of Food and Drugs, as delegated authority by the Secretary, may authorize, during the effective period of a declaration of emergency or threat justifying emergency authorized use, the introduction into interstate commerce of unapproved medical products or unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological and nuclear defense (CBRN) threat agents when there are no adequate, approved, and available alternatives. On March 27, 2020, on the basis of his determination of a PHE that has a significant potential to affect national security or the health and security of United States citizens living abroad involving asthma treatment, the Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the asthma treatment ventolin (85 FR 18250). Pursuant to this declaration, the Commissioner of Food and Drugs, as delegated authority by the Secretary, may issue an emergency use authorization (EUA) for a drug or biological product if, after consultation with officials such as the Director of the CDC and the Director of the NIH, to the extent feasible and appropriate, the Commissioner reasonably concludes that, among other criteria, based on the totality of available scientific evidence, the product may be effective in diagnosing, treating or preventing such disease or condition, and the product's known and potential benefits when used to diagnose, prevent, or treat such disease or condition, outweigh its known and potential risks. FDA's June 2020 guidance to industry titled âDevelopment and Licensure of treatments to Prevent asthma treatmentâ[] and October 2020 guidance to industry titled âEmergency Use Authorization for treatments to Prevent asthma treatmentâ[] state that issuance of an EUA may be appropriate for a asthma treatment, for which there is adequate manufacturing information, once studies have demonstrated the safety and effectiveness of the treatment in a clear and compelling manner, but before the submission and/or formal review of the biologics license application for the treatment.

These guidance documents state that in the case of treatments being developed for the prevention of asthma treatment, any assessment regarding an EUA would be made on a case by case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the relevant available scientific evidence. The FDA has made clear in its October 2020 guidance to industry that for a asthma treatment for which there is adequate information to ensure its quality and consistency, issuance of an EUA would require a determination by FDA that the treatment's benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the treatment's safety and efficacy in a clear and compelling manner. Because the treatment would be intended for administration to healthy people as a prophylactic measure, there must be a higher degree of certainty about the risks and benefits of the product than needed for EUAs for medical products intended for treatment of sick patients. There are no historical examples in which Medicare has covered treatments for which an EUA was issued by FDA.

We consider our interpretation of section 3713(d) of the CARES Act to be consistent with Congress' intent to provide for Medicare coverage without deductible or coinsurance of any asthma treatment (and its administration) that FDA has authorized to be introduced into interstate commerce, which would be the case both for a treatment for which emergency use is authorized under section 564 of the FD&C Act and for a treatment that is licensed under section 351 of the PHS Act. Our interpretation also would be consistent with Congress' general intent in the CARES Act and other recent legislation to provide for rapid coverage of asthma treatments. We note that section 3713(e) of the CARES Act permits CMS to implement the changes made by that section through âprogram instruction or otherwise,â and we intend to issue any necessary instructions for Medicare providers and suppliers expediently in order to ensure beneficiary access to asthma treatments as quickly as possible.Start Printed Page 71147 4. Implementation and Methods of Coding and Payment for asthma treatment and Administration Section 3713 of the CARES Act added the asthma treatment and its administration to section 1861(s)(10)(A) of the Act in the same subparagraph as the flu and pneumococcal treatments and their administration.

As such, the Medicare allowed amount for the asthma treatment will also be 95 percent of the average wholesale price (or reasonable cost, for example under OPPS). Because asthma treatments are being developed rapidly and systems to operationalize payment of administration will need to be implemented quickly to ensure beneficiary access, we also recognize the need to establish coding and payment for asthma treatment and administration under Medicare Part B. Because there are many product-specific factors that are still unknown, including the possibility of differential costs associated with each asthma treatment product and storage and administration requirements, we anticipate establishing a unique administration code for each asthma treatment product. We believe it is imperative that coding and payment be in place as soon as possible after asthma treatments become available.

We anticipate establishing specific coding and payment rates through technical direction to the MACs, including instructions to make this information available to the public. We also anticipate posting information on coding, payment, and billing for asthma treatments and treatment administration on the CMS website. This approach will maintain public transparency while allowing CMS to pay appropriately for particular treatments and treatment administration as quickly as practicable once they are authorized or licensed for use by FDA. We anticipate that payment rates for the administration of other Part B preventive treatments and related services, such as the flu and pneumococcal treatments, would serve to inform the payment rates for administration of asthma treatments.

CMS ordinarily establishes Medicare payment rates for particular items and services, through notice-and-comment rulemaking. Because of the unique circumstances of the PHE for asthma treatment ventolin and the anticipated, specific conditions for the entry of asthma treatment products into the marketplace, we believe it is necessary to initially dispense with the rulemaking process in order to make Medicare payment available in a timely manner to ensure widespread access to the new treatments. Therefore, as soon as practicable after the authorization or licensure of each asthma treatment product by FDA, we will announce the interim coding and a payment rate for its administration (or, in the case of the OPPS, an APC assignment for each treatment product's administration code), taking into consideration any product-specific costs or considerations involved in furnishing the service. Such consideration may be necessary, specifically for asthma treatments in the context of the ventolin, in order to ensure that health care providers can offer prompt access to vaccination for a large number of people as quickly as possible.

We then anticipate addressing coding and payment rates for administration of the asthma treatment products through future notice-and-comment rulemaking. In other words, the approach to payment and coding described in this IFC will ensure efficient and timely beneficiary access to asthma treatment products, that for public health purposes may need to be administered to a large number of people during a compressed period of time, until further rulemaking, such as annual rulemaking under the Medicare Physician Fee Schedule, is possible. Given that the asthma treatment and administration was added to the same subparagraph as the flu and pneumococcal treatments and administration under section 1861(s)(10)(A) of the Act, we believe it would be appropriate to use billing processes for asthma treatment vaccinations that are similar to those in place for flu and pneumococcal vaccinations. With the pressing need to ensure broad access to a asthma treatment, it would be appropriate to allow asthma treatment vaccinations to be provided through the mass immunization and roster billing process that is in place for flu and pneumococcal vaccinations.

Also, the CARES Act permits the Secretary to implement the provisions of, and the amendments made by, section 3713 by program instruction or otherwise. As information about treatment products becomes available, we anticipate that updated information, for example information concerning additional doses after initial vaccination, applicability of specific treatment products to subsets of our beneficiary population, or updates about billing would be disseminated primarily by program instruction. As part of this IFC, we are updating the following regulations. At Â§â410.57, Pneumococcal treatment and flu treatment, we are amending the section heading and adding a new paragraph to reference asthma treatment.

At Â§â410.152, Amounts of payment, we are amending Â§â410.152(l)(1) to include the asthma treatment in the list of treatments for which Medicare Part B pays 100 percent of the Medicare payment amount. At Â§â410.160, Part B annual deductible, we are amending Â§â410.160(b)(2) to include the asthma treatment in the list of treatments that are not subject to the Part B annual deductible and do not count toward meeting that deductible. At Â§â411.15, Particular services excluded from coverage, we are amending Â§â411.15(e) to add an exception for asthma treatment vaccinations to the general exclusion of coverage for immunizations. At Â§â414.701, Purpose, we are amending the list of statutorily covered drugs to include the asthma treatment.

Therefore, all MA plans and cost plans must cover a asthma treatment and its administration described in section 1861(s)(10)(A) of the Act. As described previously, the interpretation of section 3713 of the CARES Act adopted in this rule will result in Part B coverage of a asthma treatment for which FDA issues an EUA during the PHE, and administration of that treatment when furnished consistent with terms of such EUA. As amended by section 3713 of the CARES Act, section 1852(a)(1)(B)(iv)(VI) of the Act prohibits MA plans from using cost sharing that exceeds the cost sharing imposed under original Medicare for a asthma treatment and its administration when MA coverage is provided because they are covered under Part B under section 1861(s)(10)(A) of the Act. Section 1852(a)(5) of the Act and 42 CFR 422.109 provide that when a National Coverage Determination (NCD) or legislative change in benefits, such as the addition of Part B coverage of a asthma treatment and its administration, results in significant costs that have not been included in the capitation payments made to MA plans, coverage of the new benefit will be provided through the Medicare FFS program until the capitation payments take the new significant costs into account.

The payment rates for MA organizations for contract years 2020 and 2021 have been set without including the costs for a asthma treatment and its administration. Therefore, if coverage of a asthma treatment and its administration during that period results in significant costs, section 1852(a)(5) of the Act and Â§â422.109 will apply to require Medicare FFS coverage of the treatment and its administration. The cost projection used for the determination whether the legislative change results in significant costs is based on an analysis by the Chief Actuary of CMS of the actuarial costs associated with a NCD or the legislative change in benefits and compared to the thresholds specified in the regulation at Â§â422.109. This analysis is generally performed once a Medicare FFS payment rate is determined for the service.

If the estimated cost of an NCD or legislative change represents at least 0.1 percent of the national average per capita costs or the average cost of furnishing a single service exceeds the cost threshold established in using the formula in Â§â422.109(a), it is considered a significant cost and the FFS Medicare program provides coverage for the service until the costs are factored into Medicare Advantage payments. Therefore, this legislative change would be subject to an analysis whether the new benefit results in significant costs. The significant cost threshold will be met assuming that the projected cost per-beneficiary-per-year is greater than approximately $13, which is 0.1 percent of the national average per capita costs. If the threshold is reached, Medicare beneficiaries enrolled in MA plans will receive coverage of the asthma treatment and its administration through the Medicare FFS program and would be able to access the asthma treatment, without cost sharing, at any FFS provider or supplier that participates in Medicare and is eligible to bill under Part B for treatment administration, including those enrolled in Medicare as a mass immunizer or a physician, non-physician practitioner, hospital, clinic, or group practice.

Section 3713 of the CARES Act added Medicare Part B coverage for a asthma treatment and its administration and provides that MA plans must cover the new benefit without cost sharing. While section 1876(c)(2) of the Act ensures that enrollees in Medicare cost plans will have coverage of a asthma treatment and its administration, section 3713 of the CARES Act did not amend section 1876 of the Act to provide similar cost-sharing protections for enrollees in cost plans who receive the treatment from an in-network provider. Nor is there a provision affirmatively relieving cost plans of the obligation to cover the new Part B benefit. Because the Medicare FFS program covers Part A and Part B items and services furnished to cost plan enrollees by out-of-network health care providers that participate in the Medicare FFS program, cost plan enrollees will receive the asthma treatment and its administration without cost sharing when they go to a health care provider that is out of the cost plan's network.

See 42 CFR 417.436(a)(5) and 417.448. However, there is no requirement for cost plans to cover the asthma treatment and its administration without cost sharing (that is, with cost sharing that is the same as original Medicare) when the treatment is furnished by an in-network health care provider. Many enrollees may seek the asthma treatment from the health care provider they usually see or from whom they receive most of their health care. That provider is likely to be in-network with the cost plan.

asthma treatment Coverage for Medicaid, CHIP, and BHP Beneficiaries Under section 6008 of the FFCRA, states' and territories' Medicaid programs may receive a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP). Under section 6008(b)(4) of the FFCRA, to receive that increase, a state or territory must cover asthma treatment testing services and treatments, including treatments and the administration of such treatments, for Medicaid enrollees without cost sharing. That coverage is required during any quarter for which the state or territory claims the temporary FMAP increase under FFCRA section 6008, and the FMAP increase is available through the end of the quarter in which the PHE for asthma treatment ends. CMS is not aware of any states or territories not currently claiming this temporary FMAP increase, or of any state or territory that intends to cease claiming it.

Accordingly, Medicaid coverage of a asthma treatment and its administration, without cost-sharing, is expected to be available for most Start Printed Page 71149Medicaid beneficiaries through the end of the quarter in which the PHE for asthma treatment ends. For the remainder of this section of preamble, references to âstateâ or âstatesâ in discussions of Medicaid policy also include the territories. To meet the requirement in FFCRA section 6008(b)(4) to cover a asthma treatment and its administration without cost sharing, states must compensate Medicaid providers with a treatment administration fee or reimbursement for a provider visit during which a treatment dose is administered, even if the treatment dose is furnished to the provider at no cost. There are some very limited circumstances in which the FFCRA section 6008(b)(4) coverage requirements would not apply.

Moreover, after FFCRA was enacted, in section 3716 of the CARES Act (Pub. L. 116-136), Congress defined eligibility for the asthma treatment testing-only optional Medicaid eligibility group described in section 1902(a)(10)(A)(ii)(XXIII) of the Act in a manner that recognized that certain limited-benefit Medicaid eligibility groups are âuninsured,â and therefore eligible to receive coverage for asthma treatment testing under that provision, without referring to or acknowledging the FFCRA section 6008(b)(4) asthma treatment testing coverage requirement. See section 1902(ss) of the Act.

Accordingly, CMS does not interpret FFCRA section 6008(b)(4) to require states to provide asthma treatment testing and treatment services without cost-sharing, including treatments and their administration, to eligibility groups whose coverage is limited by statute or under an existing section 1115 demonstration to a narrow range of benefits that would not ordinarily include this coverage, such as groups that receive Medicaid coverage only for asthma treatment testing, family planning services and supplies, or tuberculosis-related services. The asthma treatment Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured Program (asthma treatment Claims Reimbursement program) administered by the Health Resources and Services Administration (HRSA) is available for reimbursement of a asthma treatment and treatment administration costs for individuals who would not receive Medicaid coverage for a asthma treatment or its administration because their Medicaid coverage is for limited benefit packages only. After the requirements in section 6008(b)(4) of FFCRA are no longer in effect in a state, the state must cover asthma treatments recommended by the ACIP, and their administration, for several populations under existing statutory and regulatory authority. All Medicaid-enrolled children under the age of 21 eligible for the Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit must receive ACIP-recommended treatments pursuant to section 1905(r)(1)(A)(i) and (B)(iii) of the Act.[] Coverage of ACIP-recommended treatments without cost-sharing is required for any adult populations who receive coverage through Alternative Benefit Plans (ABPs), including the adult expansion population described at section 1902(a)(10)(A)(i)(VIII) of the Act, pursuant to section 1937(b)(5) of the Act, 42 CFR 440.347(a), and 45 CFR 156.115(a)(4) and 147.130.

After the FFCRA section 6008(b)(4) requirements are no longer in effect in a state, the state also has the option to cover a asthma treatment and its administration for other eligibility groups. Such groups include the parent/caretaker relative eligibility group at 42 CFR 435.110, eligibility groups for individuals who are age 65 or older or who are eligible on the basis of blindness or a disability, and pregnant women enrolled under 42 CFR 435.116 who are eligible for full state plan benefits. If a state elects to cover a asthma treatment and its administration for any one of these groups, it must do so for all of them, except that with respect to the pregnant women group described in 42 CFR 435.116, per 42 CFR 440.250(p) states can cover a treatment and its administration as a pregnancy-related service while not providing the same coverage for the other eligibility groups. Outside of the period in which FFCRA section 6008(b)(4) applies to a state, the state has the option to apply cost sharing to coverage of a asthma treatment or its administration unless the beneficiary is in an eligibility group that is exempt from cost-sharing under section 1916 or section 1916A of the Act and regulations at 42 CFR 447.56 (for example, most children under age 18, most pregnant women, most children in foster care, individuals receiving services in an institution that already had their medical assistance reduced by their income, individuals receiving hospice care, and Indians who are currently receiving or have ever received an item or service furnished by an Indian health care provider or through referral under contract health services).

After the FFCRA section 6008(b)(4) requirements are no longer in effect in a state, a asthma treatment and its administration could also be a covered service for many Medicaid eligibility groups when furnished by a participating provider under certain Medicaid benefits that are mandatory for many Medicaid eligibility groups, Start Printed Page 71150depending on how the state has defined the amount, duration, and scope parameters of the benefit. Because inpatient and outpatient hospital services, physician services, and Federally Qualified Health Center and Rural Health Clinic services are mandatory Medicaid benefits for the categorically needy populations, asthma treatment administration could be a covered service for many Medicaid beneficiaries when provided by these participating providers, at state option. States might also cover asthma treatment administration for beneficiaries under various optional state plan benefits, such as the âother licensed practitionerâ benefit described in section 1905(a)(6) of the Act and 42 CFR 440.60, or the âpreventive servicesâ benefit described in section 1905(a)(13) of the Act and 42 CFR 440.130(c). However, states would generally not have the option to cover a asthma treatment or its administration for any group whose coverage is limited by statute or under a current section 1115 demonstration to a narrow range of benefits that would not ordinarily include treatment coverage.

Coverage of uninsured pregnant women in a separate CHIP is optional. Currently, the states that cover pregnant women in a separate CHIP include all ACIP-recommended treatments with no cost sharing in this coverage. However, current CMS interpretation is that this treatment coverage is not required. The FFCRA section 6008(b)(4) requirement also does not apply to the Basic Health Program (BHP).

Minnesota and New York are the only states that currently operate a BHP. BHP coverage must include benefits in at least the ten essential health benefits described in section 1302(b) of the PPACA and must comply with the Exchange's cost-sharing protections,[] which includes providing all ACIP recommended treatments without cost sharing. See sections 1331(a)(1), (a)(2)(B) and (b)(2) of PPACA, and 42 CFR 600.405(a) and 600.510(b). Section 600.510(b) cross-references 45 CFR 147.130, which establishes requirements related to the coverage of preventive health services for BHP.

C. Price Transparency for asthma treatment Diagnostic Tests 1. Introduction Robust asthma treatment diagnostic testing is fundamental to the Federal Government's strategy for controlling the spread of asthma treatment.[] In recognition of the importance of asthma treatment diagnostic testing, the Federal Government has taken several steps to reduce financial barriers to testing for both insured and uninsured individuals, including the following. The FFCRA was enacted on March 18, 2020.

Section 6001 of the FFCRA generally requires group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for certain items and services, including in vitro diagnostic testing products for the detection of asthma, the ventolin that causes asthma treatment, or the diagnosis of asthma treatment (referred to herein collectively as asthma treatment diagnostic tests) when those items or services are furnished on or after March 18, 2020, and during the PHE for asthma treatment. Plans and issuers must provide this coverage without imposing any cost-sharing requirements (including deductibles, copayments, and coinsurance) or prior authorization or other medical management requirements. Related items and services include those provided during urgent care center visits, in-person and telehealth office visits, and emergency room visits that result in an order for or administration of an in vitro diagnostic product, to the extent that such items and services relate to the furnishing or administration of a asthma treatment diagnostic test, or to the evaluation of an individual for purposes of determining the need of the individual for a asthma treatment diagnostic test. Section 3201 of the CARES Act, enacted on March 27, 2020, amended section 6001 of the FFCRA to include a broader range of diagnostic tests that plans and issuers must cover without any cost-sharing requirements or prior authorization or other medical management requirements.

The asthma treatment Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured Program provides reimbursements on a rolling basis directly to eligible providers for claims that are attributed to the testing and treatment of asthma treatment for certain uninsured individuals. The program is funded via (1) the FFCRA Relief Fund, which includes funds received from the Public Health and Social Services Emergency Fund, as appropriated in the FFCRA and the Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA) (Pub. L. 116-139), which each appropriated funding to reimburse providers for conducting asthma treatment testing for the uninsured, and (2) the Provider Relief Fund, as appropriated in the CARES Act and the PPPHCEA.[] Start Printed Page 71151 HHS has partnered with pharmacies, retail companies, and health centers nationwide to make no-cost asthma treatment diagnostic testing available to Americans in communities across the country.[] Congress has also taken steps to facilitate the reimbursement for asthma treatment diagnostic testing and to ensure that pricing for performance of such testing is publicly available.

Specifically, section 3202(a) of the CARES Act requires group health plans and issuers providing coverage for items and services described in section 6001(a) of the FFCRA to reimburse any provider of a asthma treatment diagnostic test an amount that equals the negotiated rate, or, if the plan or issuer does not have a negotiated rate with the provider, the cash price for such service that is listed by the provider on a public website. The plan or issuer may also negotiate a rate with the provider that is lower than the cash price. More information related to health insurance issuer and group health plan coverage and reimbursement for asthma treatment diagnostic testing is available at https://www.cms.gov/âfiles/âdocument/âFFCRA-Part-42-FAQs.pdf and https://www.cms.gov/âfiles/âdocument/âFFCRA-Part-43-FAQs.pdf. Specifically, the Departments note that the reimbursement requirements under CARES Act 3202(a) will apply to asthma treatment diagnostic testing, as defined in this IFC.

Section 3202(b) of the CARES Act establishes a requirement for each provider of a diagnostic test for asthma treatment to publicize cash prices for such asthma treatment diagnostic testing. Specifically, section 3202(b)(1) of the CARES Act requires each provider of a diagnostic test for asthma treatment to make public the cash price for such test on a public internet website of such provider during the emergency period declared under section 319 of the PHS Act. Section 3202(b)(2) of the CARES Act authorizes the Secretary to impose a civil monetary penalty (CMP) on any provider of a diagnostic test for asthma treatment that does not make public its cash price for such test in compliance with section 3202(b)(1) of the CARES Act and that has not completed a corrective action plan (CAP) to comply with that section. The statute states that the amount of the CMP must not exceed $300 per day that the violation is ongoing.

We believe that cash price posting by providers of diagnostic tests for asthma treatment is important for not only for plans and issuers that must comply under section 3202(a) of the CARES Act but also for individuals who seek asthma treatment diagnostic testing. Therefore, we are adopting in this IFC policies that implement the requirement in section 3202(b) of the CARES Act that providers of diagnostic tests for asthma treatment make public their cash price for such tests on the internet. Specifically, we are finalizing the following. (1) Definitions of âprovider of a diagnostic test for asthma treatmentâ (herein referred to as âproviderâ), âdiagnostic test for asthma treatmentâ (herein referred to as âasthma treatment diagnostic testâ), and âcash priceâ.

(2) requirements for making public cash prices. And (3) penalties for non-compliance with the cash price posting requirements. 2. Requirement That Providers of asthma treatment Diagnostic Tests Make Public Cash Prices for asthma treatment Diagnostic Tests The rapid expansion of asthma treatment related diagnostic testing capacity is a top priority in HHS' strategy to combat the ventolin.

asthma treatment diagnostic testing is generally performed by laboratories located in a variety of sites, including for example. Government labs. Hospital-run labs. Clinician offices.

Stand-alone labs. Urgent care centers. And pharmacies. There are several types of asthma treatment tests designed to detect asthma or to diagnose a possible case of asthma treatment, including molecular (RT-PCR) tests, which are used to detect the ventolin's genetic material, and antigen tests, which are used to detect specific proteins on the surface of the ventolin and serology testing, which is used to look for the presence of antibodies produced by the body in response to s.

For purposes of implementing section 3202(b) of the CARES Act, we are adopting a new 45 CFR part 182, âPrice Transparency for asthma treatment Diagnostic Tests,â that will implement price transparency requirements for making public cash prices for performance of a asthma treatment diagnostic test. Section 182.10 states that part 182 implements section 3202(b) of the CARES Act. For purposes of section 6001(a)(1) of the FFCRA, as amended by section 3201 of the CARES Act, and as explained in guidance issued by the Departments, asthma treatment diagnostic tests include all in vitro diagnostic tests, which include molecular, antigen, and serological tests. Specifically, section 6001(a) of the FFCRA, as amended by section 3201 of the CARES Act, requires plans and issuers to provide coverage for an in vitro diagnostic test, as defined in 21 CFR 809.3(a) (or its successor regulations), for the detection of asthma or diagnosis of asthma treatment, and the administration of such a test that.

(1) Is approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the FD&C Act (21 U.S.C. 360(k), 360c, 360e, 360bbb-3). (2) the developer has requested, or intends to request, emergency use authorization under section 564 of the FD&C Act (21 U.S.C. 360bbb-3), unless and until the emergency use authorization request under such section 564 has been denied or the developer of such test does not submit a request under such section within a reasonable timeframe.

We intend this list of billing codes to be illustrative, however, not exhaustive. Therefore, as noted previously, a âasthma treatment diagnostic testâ is defined as a asthma treatment in vitro diagnostic test described in section 6001 of the FFCRA, as amended by section 3201 of the CARES Act, even if a particular asthma treatment diagnostic test or its billing code is not included on this list. Codes continue to be created to address new and proprietary tests as they are developed. We therefore anticipate updating this list in guidance as new tests and codes are developed.

Obtaining a diagnostic test for asthma treatment generally can involve up to three separate health care services for an individual including evaluation by a practitioner of the need for such testing, and, once the provider determines the need for a asthma treatment diagnostic test, specimen collection and laboratory analysis of the specimen, that is, actual performance of a asthma treatment diagnostic Start Printed Page 71152test. For purposes of implementing section 3202(b), we are defining âprovider of a diagnostic test for asthma treatmentâ (herein referred to as âproviderâ) as any facility that performs one or more asthma treatment diagnostic tests. CMS regulates all laboratory testing performed on humans for the purposes of diagnosis, prevention, or treatment in the U.S. Through the Clinical Laboratory Improvement Amendments CLIA program (42 U.S.C.

We believe this definition will provide a clear point of reference not only for individuals who seek such tests, but also for payers who wish to negotiate reimbursement rates with providers of diagnostic tests for asthma treatment, or who wish to help direct their members to providers of diagnostic tests for asthma treatment who charge cash prices that payers believe to be reasonable. The âcash priceâ is generally analogous to the âdiscounted cash priceâ as defined at 45 CFR 180.20 for purposes of the Hospital Price Transparency final rule. As we explained in that rule, providers often offer discounts off their gross charges or make other concessions to individuals who pay for their own care (referred to as self-pay individuals) (84 FR 65524). We also stated that the discounted cash price may be generally analogous to the âwalk-inâ rate that would apply to all self-pay individuals, regardless of insurance status, who pay in cash at the time of the service, and that such charges are often lower than the rate the hospital negotiates with third party payers because billing self-pay individuals would not require many of the administrative functions that exist for hospitals to seek payment from third party payers (for example, prior authorization and billing functions).[] It is therefore our expectation that the âcash priceâ established by the provider will be generally similar to, or lower than, rates negotiated with in-network plans and insurers.

If a provider has not established a âcash priceâ for a asthma treatment diagnostic test that is lower than its gross charge or retail rate, the provider must make public the undiscounted gross or retail rate found in its master price list (which is analogous to the hospital's chargemaster). We do not believe that posting a âcash priceâ should prevent a provider of a diagnostic test for asthma treatment from offering testing for free to individuals as charity care or in an effort to combat the public health crisis, rather, the âcash priceâ would be the maximum charge that may apply to a self-pay individual paying out-of-pocket. We solicit comment on this approach and whether any additional standards should be implemented to address any potential abuse. Under new Â§â182.30(a) and (b), these requirements apply to a âprovider of a diagnostic test for asthma treatmentâ as defined at Â§â182.20 and are applicable during the PHE for asthma treatment determined to exist nationwide as of January 27, 2020, by the HHS Secretary under section 319 of the PHS on January 31, 2020, as a result of confirmed cases of asthma treatment, including any subsequent renewals.

Therefore, in the event that a provider does not have a website on which to post this cash price information, we are finalizing a policy at Â§â182.40(b) to require the provider to make public its cash price information in writing upon request within two business days and by posting signage prominently at the location where the provider offers a asthma treatment diagnostic test in a place likely to be viewed by members of the public seeking to obtain and pay for such testing. If the provider does not have its own website or a publicly accessible location then, upon request and within two business days, the provider will be required to make public its cash price information in writing to the requestor but will not be required to post signage at the location where it performs the asthma treatment diagnostic test. For purposes of complying with the requirement that the cash price information be made public in writing, we will consider email correspondence to the requester to be an acceptable written format. We believe these policies will help ensure that the public (including individuals, issuers, health plans, and others) has access to every provider's asthma treatment diagnostic test cash prices, including those providers who do not perform asthma treatment diagnostic tests at publicly accessible locations.

We seek comment on these issues, including the frequency by which providers may not have websites. Furthermore, at Â§â182.40(a)(3), we are requiring that providers of a asthma treatment diagnostic test display their cash price information in an easily accessible manner, without barriers, including, but not limited to, ensuring the information is accessible. Free of charge. Without having to establish a user account or password.

Âpriceâ. Âcostâ. Âtestâ. Âasthma treatmentâ.

And âasthma.â We seek Start Printed Page 71153comment on whether providers should have flexibility to select between using âasthma treatmentâ or âasthmaâ and between âcostâ and âpriceâ if the provider is linking to the information from its homepage. Finally, we believe that it is important for the provider to include certain standardized information so that the public can understand the relationship between the posted cash price and the asthma treatment diagnostic test(s) offered by the provider. Therefore, at Â§â182.40(c)(1) through (4), we are requiring all providers to make public, along with the cash price for each asthma treatment diagnostic test(s) that they offer, information that, at minimum, includes a plain language description of each asthma treatment diagnostic test, the corresponding cash price, the billing code(s) for each such test(s), and any additional information as may be necessary for the public to be certain of the cash price for a particular asthma treatment diagnostic test. For example, if the provider offers the same test at a different cash price that is dependent on location or some other factor, then on its website listing of cash prices, the provider must indicate all the cash prices that apply to the test and relevant distinguishing information as to when each different cash price applies.

We also specifically seek comment on the definition of âdiagnostic test for asthma treatmentâ as solely a asthma treatment in vitro diagnostic test described in section 6001 of FFCRA. We seek comment on the definition of âprovider of a asthma treatment diagnostic testâ. We seek comment on whether consumers may benefit from knowing the total cost of care for receiving a asthma treatment test, including the doctor's visit and specimen collection, in order to protect themselves against potential unexpected health care costs and make a more informed health care purchasing decision and therefore whether we should adopt a more inclusive definition of a provider of a diagnostic test for purposes of this requirement. Specifically, we seek comment on whether a âprovider of a diagnostic test for asthma treatmentâ should be expanded to include providers that perform additional services related to the performance of a asthma treatment diagnostic test, such as for specimen collection or mileage fees that may be billed as part of or in conjunction with the specimen collection, if applicable.

We are particularly interested in submissions from stakeholders that include data, both anecdotal and claims-based, on the ways in which consumers request and receive asthma treatment diagnostic testing, including the site of care, frequency, and type of provider. We seek comment on the definition of âcash priceâ. We have heard concerns from stakeholders that certain providers may use the posting of a âcash priceâ as an opportunity to âprice gougeâ.[] We therefore specifically seek comment on whether this definition or some other definition would help to mitigate concerns for price gouging by out-of-network providers. We seek comment on whether there are additional authorities and safeguards that could be used to mitigate concerns for price gouging both for group health plans and issuers and for consumers receiving a asthma treatment diagnostic test.

Even so, we seek comment whether and to what extent these final policies and the alternatives about which we are seeking comment (for instance, expansion of the definition of âproviderâ) may lead to. Potential cost shifting from providers or participants, beneficiaries, and enrollees to group health plans or issuers, if the group health plan and issuer reimbursement obligation for asthma treatment diagnostic testing is expanded to cover such testing without cost-sharing (including deductibles, co-pays, and co-insurance) and as payment in full for items and services that were not previously covered in such a manner by group health plans or issuers. Potential for group health plans or issuers to negotiate rates that are lower than the cash price with out-of-network providers with whom they do not have established negotiated rates. Price gouging or other anti-competitive behavior (under both the policies and the alternatives for which we seek comment) by providers as well as any potential negative impact on premiums in the future that have not already been accounted for in 2021 rates.

Please provide empirical evidence, if any, including based on claims data during the PHE for asthma treatment. Potential savings to issuers and plans from insured consumers seeking out asthma treatment diagnostic testing from in-network providers, as opposed to the provider of their choice, as a result of these increased price transparency requirements. Price sensitivity by consumers covered by group health plans or issuers in their choice of provider, and awareness of any potential cost-shifting to group health plans or issuers, or to consumers themselves through balance billing, as a result of these increased price transparency requirements. Transparency benefits for the uninsured, who may already have an incentive to find the lowest price.

Monitoring for Noncompliance and Pre-Penalty Actions Section 3202(b)(1) of the CARES Act does not prescribe monitoring procedures or the factors we should consider in imposing penalties on providers for noncompliance. We anticipate relying predominantly on complaints made to CMS by the public, including individuals, as well as issuers and plans, regarding providers' potential noncompliance. Specifically, in response to such complaints, we may investigate and evaluate whether a provider has complied with the requirements discussed above. The monitoring methods for determining a provider's compliance with the requirements for publicizing the cash price for a asthma treatment diagnostic test may include, but are not limited to, the following, as appropriate.

CMS' evaluation of complaints made to CMS. CMS' review of an individual's or entity's analysis of noncompliance as stated in the complaint. CMS' review of providers' websites or, where a provider does not have a website, its written notice and signage. The IFC includes these monitoring methods in the regulations at Â§â182.50(a).

Additionally, at Â§â182.50(b), we are finalizing discretion for CMS to take any of the following actions if CMS determines the provider is noncompliant with the requirements of Â§â182.40. Provide a written warning notice to the provider of the specific violation(s). Request that a provider submit and comply with a CAP under Â§â182.60. Impose a CMP on the provider if the provider fails to respond to CMS' request to submit a CAP or to comply with the requirements of a CAP approved by CMS.

A provider that CMS identifies as noncompliant and to which it offers an opportunity to take corrective action to come into compliance may be notified via a warning notice of its deficiencies. In response to the warning letter, a provider may choose, but is not required, to submit documentation for CMS to review to determine compliance. CMS will review any documentation a provider may submit and, where applicable, a provider's website or other form of written notice, to determine if the provider's noncompliance has been corrected. In the event that a provider does not have its own website on which to post the cash price, CMS will require documentation that the provider has the cash price in written form timely upon request and, where applicable, has posted signage at the provider's facility.

At Â§â182.60, we specify the requirements for CAPs. Specifically, Â§â182.60(a) states that a provider may be required to submit a CAP if CMS determines a provider is noncompliant or the provider's noncompliance continues after a warning notice. A violation may include, but is not limited to, a provider's failure to make public its cash price information for asthma treatment diagnostic testing required by Â§â182.40 and a provider's failure to make public its cash price information in the form and manner required under Â§â180.40. Section 182.60(b) states that CMS may request that a provider submit and comply with a CAP, specified in a notice of violation issued by CMS to a provider.

After CMS' review and approval of a provider's CAP, CMS may monitor and evaluate the provider's compliance with the corrective actions specified in the CAP. Section 182.60(d) outlines the following provisions for identifying a provider's noncompliance with CAP requests and requirements. A provider's failure to respond to CMS' request to submit a CAP includes failure to submit a CAP in the form, manner, or by the deadline, specified in a notice of violation issued by CMS to the provider. A provider's failure to comply with the requirements of a CAP includes failure to correct violation(s) within the specified timeframes.

We seek comment on this approach for monitoring providers of asthma treatment diagnostic testing for compliance with these requirements. Specifically, we seek comments on relying predominantly on complaints to determine a provider's potential noncompliance. We further seek comments on issuing warning letters and requesting CAPs for violations related to making public cash prices for asthma treatment diagnostic testing. Additionally, we seek comments on the length of time we should specify in warning notices to allow corrections of violations before issuance of a request for CAP, and the length of time we should specify for providers to complete and return a CAP to CMS.

B. Civil Monetary Penalties Under section 3202(b)(2) of the CARES Act, CMS may impose a CMP on a provider that we identify as noncompliant. At Â§â182.70, we are finalizing requirements related to imposition of CMPs. At Â§â182.70(a), we finalize a policy that CMS may impose a CMP on a provider that we identify as noncompliant with any of the requirements of Â§â182.40, and that fails to respond to CMS' request to submit a CAP or to comply with the requirements of a CAP approved by CMS described in Â§â182.60(d).

Under the statute, the maximum daily dollar amount for a CMP to which a provider may be subject is $300, even if the provider is in violation of multiple discrete requirements of Â§â182.40. The maximum daily amount of the CMP will be adjusted annually using the multiplier determined by the Office of Management and Budget (OMB) for annually adjusting CMP amounts under 45 CFR part 102. CMS will provide a written notice of imposition of a CMP to the provider via certified mail or another form of traceable carrier. The elements of this notice to the provider will include but are not limited to the following.

The basis for the provider's noncompliance, including, but not limited to, the following. CMS' determination as to which requirement(s) the provider has violated. And the provider's failure to respond to CMS' request to submit a Start Printed Page 71155CAP or comply with the requirements of a CAP. CMS' determination as to the effective date for the violation(s).

The amount of the penalty as of the date of the notice. A statement that a CMP may continue to be imposed for continuing violation(s). Payment instructions. A statement of the provider's right to a hearing according to Â§â182.90 of subpart D.

A statement that the provider's failure to request a hearing within 30 calendar days of the issuance of the notice permits the imposition of the penalty, and any subsequent penalties pursuant to continuing violations, without right of appeal. CMS may issue subsequent notice(s) of imposition of a CMP, according to the aforementioned requirements (in short, where investigation reveals there is continuing justification), that result from the same instance(s) of noncompliance. A provider must pay the CMP in full within 60 calendar days after the date of the notice of imposition of a CMP from CMS. In the event a provider requests a hearing, under subpart D of 45 CFR part 182, the provider must pay the amount in full within 60 calendar days after the date of a final and binding decision to uphold, in whole or in part, the CMP.

If the 60th calendar day is a weekend or a Federal holiday, then the timeframe is extended until the end of the next business day. Should a provider elect to appeal the CMP, and where the CMP is upheld only in part by a final and binding decision, CMS will issue a modified notice of imposition of a CMP, to conform to the adjudicated finding as specified in Â§â182.70. In the event a CMP is not paid in full within 60 days, CMS will follow the collections activities set forth in 45 CFR part 30. Generally, CMS will issue a written demand for payment no later than 30 days after a debt is delinquent.

In addition, we seek comments on the amount of the CMP imposed per day up to the statutory maximum daily amount that would be applicable to all noncompliant providers. C. Appeals Process We believe it is important to establish a fair administrative process by which providers may appeal CMS' decisions to impose penalties under the requirements established by Â§â182.40. Through various programs, we have gained experience with administrative hearings and other processes to review CMS' determinations.

That experience includes the processes we recently finalized in the CY 2020 Hospital Outpatient Prospective Payment System (OPPS) Price Transparency Final Rule (84 FR 65524) and corresponding regulations at 45 CFR part 180, which requires price transparency for hospitals, and we are aligning the procedures for the appeals process here with those procedures. Therefore, a provider upon which CMS has imposed a penalty under Â§â182.70 may appeal that penalty in accordance with Â§Â§â180.100 and 180.110, subpart D, with conforming edits. Generally, under this approach, a provider upon which CMS has imposed a penalty may request a hearing of that penalty before an Administrative Law Judge (ALJ). The CMS Administrator, at his or her discretion, may review in whole or in part the ALJ's decision.

References to âstandard chargeâ are replaced by the term âcash price.â We seek comment on the approach we are establishing for appeals. We also set forth in Â§â182.90 the consequences for failure of a provider to request a hearing. If a provider does not request a hearing within 30 calendar days of the issuance of the notice of imposition of a CMP described in Â§â182.70(b), CMS may impose the CMP indicated in such notice and may impose additional penalties under continuing violations according to Â§â182.70(e) without right of appeal. If the 30th calendar day is a weekend or a Federal holiday, then the timeframe is extended until the end of the next business day.

The provider has no right to appeal a penalty with respect to which it has not requested a hearing in accordance with 45 CFR 150.405, unless the provider can show good cause, as determined at Â§â150.405(b), for failing to timely exercise its right to a hearing. D. Medicare Inpatient Prospective Payment System (IPPS) New asthma treatments Add-On Payment (NCTAP) for the Remainder of the Public Health Emergency (PHE) 1. Section 3710 of the CARES Act IPPS Add-On Payment for asthma treatment Patients During the PHE Section 3710 of the CARES Act amended section 1886(d)(4)(C) of the Act to provide for an increase in the weighting factor of the assigned Diagnosis-Related Group (DRG) by 20 percent for an individual diagnosed with asthma treatment discharged during the period of the PHE for asthma treatment.

To implement this temporary adjustment, Medicare's claims processing systems apply an adjustment factor to increase the Medicare Severity-DRG (MS-DRG) relative weight that would otherwise be applied by 20 percent when determining IPPS operating payments. For additional information regarding this add-on payment, including which claims are eligible for the 20 percent increase in the MS-DRG weighting factor, please see the Medicare Learning Network (MLN) Matters article âNew asthma treatment Policies for Inpatient Prospective Payment System (IPPS) Hospitals, Long-Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs) due to Provisions of the CARES Actâ available on the CMS website at https://www.cms.gov/âfiles/âdocument/âse20015.pdf. 2. Overview of IPPS New Technology Add-On Payment The new medical service or technology add-on payment policy under the IPPS provides additional payments for cases with relatively high costs involving eligible new medical services or technologies, while preserving some of the incentives inherent under an average-based prospective payment system.

The payment mechanism is based on the cost to hospitals for the new medical service or technology. Sections 1886(d)(5)(K) and (L) of the Act establish a process of identifying and ensuring adequate payment for new medical services and technologies (sometimes collectively referred to in this section as ânew technologiesâ) Start Printed Page 71156under the IPPS. The regulations at 42 CFR 412.87 and 412.88 implement these provisions. As set forth in Â§â412.88(b)(2), for a new technology other than certain antimicrobial products (for which the maximum add-on payment is 75 percent), if the costs of a discharge involving a new technology exceed the full DRG payment (including payments for Indirect Medical Education (IME) and Disproportionate Share Hospital (DSH), but excluding outlier payments)), Medicare will make a new technology add-on payment equal to the lesser of.

(1) 65 percent of the costs of the new technology. Or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment. For additional information regarding IPPS new technology add-on payments please see the FY 2021 IPPS/LTCH PPS final rule (85 FR 58602 through 58608). 3.

One aspect of the program is the issuance by the FDA of EUAs during the PHE for asthma treatment. On February 4, 2020, pursuant to Section 564(b)(1)(C) of the FD&C Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a PHE that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the ventolin that causes asthma treatment.[] On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the asthma treatment ventolin, pursuant to section 564 of the FD&C Act, subject to terms of any authorization issued under that section.[] There are currently five drug and biological products with EUAs issued during the PHE for asthma treatment. In section âI. Criteria for Issuance of Authorizationâ of the current letters of authorization for these drug and biological products, the letters for two of the products state that based on the totality of scientific evidence available to FDA, it is reasonable to believe that the product may be effective in treating asthma treatment, and that, when used under the conditions described in the authorization, the known and potential benefits of the product when used to treat asthma treatment outweigh the known and potential risks of such products.[] [1] Those two drug and biological products are asthma treatment convalescent plasma and Veklury (remdesivir).

The current letters of authorization for the other three products used in patients with suspected or confirmed asthma treatment do not indicate that those products are treating asthma treatment and instead treat a disease or condition caused or exacerbated by asthma treatment.[] Specifically, the letter of authorization for REGIOCIT indicates its use as a replacement solution in adult patients in a critical care setting who are being treated with Continuous Renal Replacement Therapy (CRRT) and for whom regional citrate anticoagulation (RCA) is appropriate. The letter of authorization for Fresenius Propoven 2 percent Emulsion indicates its use to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an ICU setting. And the letter of authorization for multiFiltrate PRO System and multiBic/multiPlus Solutions indicates its use in delivering CRRT in an acute care environment. While asthma treatment convalescent plasma has received an EUA for treating asthma treatment in hospitalized patients, Veklury (remdesivir), as of October 22, 2020, is the only drug or biological product approved by FDA for treating asthma treatment.[] In order for an item or service to be considered for coverage under Medicare Part A or Part B, the item or service must fall within at least one benefit category established in the Act.

4. Overview of IPPS Outlier Payments Section 1886(d)(5)(A) of the Act provides for payments in addition to the basic prospective payments for âoutlierâ cases involving extraordinarily high costs. To qualify for outlier payments, one criterion is that a case must have costs greater than the sum of the prospective payment rate for the MS-DRG, any IME and DSH payments, uncompensated care payments, any new technology add-on payments, and the âoutlier thresholdâ or âfixed-lossâ amount (a dollar amount by which the costs of a case must exceed payments in order to qualify for an outlier payment). We refer to the sum of the prospective payment rate for the MS-DRG (including the Section 3710 of the CARES Act add-on payment if applicable), any IME and DSH payments, uncompensated care Start Printed Page 71157payments, any new technology add-on payments, and the outlier threshold as the outlier âfixed-loss cost threshold.â Payments for eligible cases are then made based on a marginal cost factor, which is a percentage of the estimated costs above the fixed-loss cost threshold.

The marginal cost factor is 80 percent for all MS-DRGs except the burn MS-DRGs, where the marginal cost factor is 90 percent. For the complete formula for how an outlier payment is computed, we refer the reader to the FY 2021 IPPS/LTCH PPS final rule (85 FR 59043 through 59044). We note, for each claim, per the formula in the FY 2021 IPPS/LTCH PPS final rule, in determining whether the claim is eligible for an operating outlier payment and/or a capital outlier payment, an âoperating outlier thresholdâ and a âcapital outlier thresholdâ are computed, including application of a geographic adjustment to account for local cost variation. If the case is eligible, an âoperating outlier paymentâ and/or âcapital outlier paymentâ will be made for an individual claim.

For additional information regarding IPPS outlier payments please see the FY 2021 IPPS/LTCH PPS final rule (85 FR 59034 through 59041). 5. Eligibility Criteria for an IPPS New asthma treatments Add-on Payment (NCTAP) for the Remainder of the PHE We believe that as drugs or biological products become available and are authorized or approved by FDA for the treatment of asthma treatment in the inpatient setting, it would be appropriate to increase the current IPPS payment amounts to mitigate any potential financial disincentives for hospitals to provide these new treatments during the PHE. Therefore, effective for discharges occurring on or after the effective date of this rule and until the end of the public health emergency, CMS is using the exceptions and adjustment authority under section 1886(d)(5)(I) of the Act to create a New asthma treatments Add-on Payment (NCTAP) under the IPPS for asthma treatment cases that meet certain criteria.

First, the case must include the use of a drug or biological product authorized to treat asthma treatment as indicated in section âI. Criteria for Issuance of Authorizationâ of the current letter of authorization for the drug or biological product, or the drug or biological product must be approved by the FDA for treating asthma treatment. Because the purpose of the NCTAP is to mitigate potential financial disincentives for hospitals to provide new asthma treatments, this criterion expeditiously provides assurance in the context of the urgency of the PHE that a treatment is new and is used to treat asthma treatment during the PHE. Currently, there are only two drug or biological products that meet this criterion.

Veklury (remdesivir) and asthma treatment convalescent plasma. However, as additional drug and biological products become available that meet this criterion, cases that use those products would become eligible for the NCTAP if the remaining criteria are met. Second, the case must also be eligible for the 20 percent increase in the weighting factor for the assigned MS-DRG for an individual diagnosed with asthma treatment discharged during the period of the PHE for asthma treatment under section 3710 of the CARES Act. The primary purposes of this criterion are to help appropriately identify asthma treatment cases to potentially receive the NCTAP, and ensure for program integrity reasons that there is a positive asthma treatment laboratory test documented in the patient's medical record.

CMS may conduct post-payment medical review to confirm the presence of a positive asthma treatment laboratory test and, if no such test is contained in the medical record, the NCTAP will be recouped. Third, the operating cost of the case must exceed the operating Federal payment under the IPPS, including the add-on payment under section 3710 of the CARES Act. The primary purpose of this criterion is to ensure that the NCTAP is made only when needed. The cost of the case is determined by multiplying the covered charges by the operating cost-to-charge ratio, the same way it is determined for new technology add-on payments and operating outlier payments.

We note that all generally applicable statutory and regulatory requirements during the PHE for Medicare payment for a particular case must continue to be met, and that the NCTAP will only be available to the extent that the new asthma treatment meets all coverage requirements under Medicare, including that the use of a drug or biological product is medically reasonable and necessary for that case. No applicable Medicare requirements during the PHE are being waived by the creation of the NCTAP policy. 6. Determination of the IPPS NCTAP Amount for the Remainder of the PHE As indicated earlier, the goal of the NCTAP is to mitigate potential financial disincentives for hospitals to provide new asthma treatments.

These potential financial disincentives are already mitigated in part by the IPPS outlier payment, but we recognize that the costs of a case must exceed payments by the âoutlier thresholdâ or âfixed-lossâ amount before outlier payments are made. For FY 2021, the outlier threshold is approximately $30,000. As discussed previously, the outlier threshold is adjusted to account for local cost variation in determining whether an individual claim is eligible for outlier payments. As a simplified example for purposes of illustration, if the operating costs of a case using a new asthma treatment exceed the operating IPPS payment by $10,000, there are no Medicare outlier payments made for this case because the costs are less than the outlier threshold.

Or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment. We believe that the new technology add-on payment calculation provides an appropriate conceptual framework for the NCTAP calculation. In the context of the urgency of the PHE for asthma treatment, however, and the practical and operational challenges of individually tailoring the payment calculation to each new treatment, we believe the NCTAP calculation should take into account 65 percent of the amount by which the costs of the case exceed the standard DRG payment, without comparison to 65 percent of the costs of the new treatment itself. As part of the approval process for the new technology add-on payment for a given new technology, the claims processing system is modified and tailored to apply the new technology add-on payment for that technology using cost and coding information according to the âlesser ofâ policy described above.

In order to more expeditiously provide payment for cases meeting the previously described criteria in the context of the urgency of the PHE, we believe the NCTAP calculation should take into account 65 percent of the amount by which the costs of the case exceed the standard DRG payment for all cases that qualify Start Printed Page 71158for the NCTAP, without comparison to the costs of the new treatment as under the âlesser ofâ policy applicable for the new technology add-on payment. We note that a hospital should not seek additional payment on the claim for drugs or biologicals procured or provided by a governmental entity to a provider at no cost to the provider to diagnose or treat patients with known or suspected asthma treatment, as described in the CMS Medicare Claims Processing Manual, Pub. 100-04, Chapter 32, Section 67. CMS will use ICD-10-PCS procedure codes XW033E5 (Introduction of Remdesivir Anti-infective into Peripheral Vein, Percutaneous Approach, New Technology Group 5) and XW043E5 (Introduction of Remdesivir Anti-infective into Central Vein, Percutaneous Approach, New Technology Group 5) to identify cases using remdesivir and ICD-10-PCS procedure codes XW13325 (Transfusion of Convalescent Plasma (Nonautologous) into Peripheral Vein, Percutaneous Approach, New Technology Group 5) and XW14325 (Transfusion of Convalescent Plasma (Nonautologous) into Central Vein, Percutaneous Approach, New Technology Group 5) to identify cases using convalescent plasma.

Taking these factors into account, CMS is setting the NCTAP amount for a case that meets the NCTAP eligibility criteria equal to the lesser of. (1) 65 percent of the operating outlier threshold for the claim or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment, including the adjustment to the relative weight under section 3710 of the CARES Act. As with the new technology add-on payment and outlier payments, the costs of the case are determined by multiplying the covered charges by the operating cost-to-charge ratio. In addition, the NCTAP will not be included as part of the calculation of the operating outlier payments.

Returning to our simplified example, if the cost of a case using a new asthma treatment exceeds the operating IPPS payment by $10,000 and the operating outlier threshold for the case is for purposes of illustration $30,000, the NCTAP would be $6,500 (= $10,000 excess cost Ã 0.65). There would be no outlier payments because the excess cost of the case ($10,000) does not exceed the operating outlier threshold for the case ($30,000). As a simplified example of a case that qualifies for an operating outlier payment, if the cost of a case using a new asthma treatment exceeds the operating IPPS payment by $100,000, the NCTAP would be equal to the maximum NCTAP amount of 65 percent of the operating outlier threshold for the case. In this illustrative example, if the applicable operating outlier threshold for the claim is $30,000, that amount is $19,500 (equals first $30,000 of the excess cost before the operating outlier threshold for the claim is reached Ã 0.65).

FDA asthma Treatment Acceleration Program The FDA has created a special emergency program to facilitate the development of asthma therapies, the asthma Treatment Acceleration Program. One aspect of the program is the issuance by the FDA of EUAs during the PHE for asthma treatment. On February 4, 2020, pursuant to Section 564(b)(1)(C) of the FD&C Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a PHE that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the ventolin that causes asthma treatment.[] On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biologics during the asthma treatment public health emergency, pursuant to section 564 of the FD&C Act, subject to terms of any authorization issued under that section.[] Readers should refer to Section D.3 of this interim final rule with comment period for a full discussion of the asthma Treatment Acceleration Program. There are currently five drug and biological products with EUAs issued during the PHE for asthma treatment.

In section âI. Criteria for Issuance of Authorizationâ of the current letters of authorization for these drug and biological products, the letters for two of the products state that based on the totality of scientific evidence available to FDA, it is reasonable to believe that the product may be effective in treating asthma treatment, and that, when used under the conditions described in the authorization, the known and potential benefits of the product when used to treat asthma treatment outweigh the known and potential risks of such products.[] Those drug and biological products are asthma treatment convalescent plasma and Veklury (remdesivir). While asthma treatment convalescent plasma has received an EUA for treating asthma treatment in hospitalized patients, Veklury (remdesivir), as of October 22, 2020, is the only drug or biological product approved by FDA for treating asthma treatment. As discussed in Section II.D.3 of this interim final rule with comment period, in order for an item or service to be considered for coverage under Medicare Part A or Part B, the item or service must fall within at least one benefit category established in the Act.

Drugs and biologicals are included within several such benefit categories. In general, section 1861(t)(1) of the Act defines drugs and biologicals to include drugs or biologicals approved for inclusion in certain compendia (except Start Printed Page 71159for any drugs and biologicals unfavorably evaluated therein) or that are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of a hospital furnishing that drug or biological for use in that hospital. CMS has determined that it is appropriate for CMS to consider drug and biological products which are authorized for emergency use for asthma treatment, with letters of authorization, and are used to treat asthma treatment disease, to fall within the drugs and biologicals definition in 1861(t)(1) of the Act for Medicare purposes if they are included or approved for inclusion in the applicable compendia, or when furnished by a specific hospital if approved for use in that hospital by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of that hospital. 2.

OPPS Comprehensive-Ambulatory Payment Classification (C-APC) Policy To date, no drug or biological product has an EUA for the treatment of patients with asthma treatment in the outpatient setting. However, because treatment of asthma treatment is rapidly evolving, we believe it is important to ensure that separate payment is available under the OPPS for new drug and biological products (including blood products) that receive an EUA for treating asthma treatment in the outpatient setting or are approved by the FDA for treating asthma treatment in the outpatient setting, or where a drug or biological product approved under an existing EUA is authorized for use in settings other than the inpatient setting. As part of that process, we expect to include the addition of new codes describing those treatments as soon as practicable, after their availability, to ensure efficient and timely beneficiary access to those treatments. We anticipate that most drugs and biological products authorized for use in treating asthma treatment in the outpatient setting would be separately paid under our standard OPPS payment policy because drugs and biological products are typically assigned separate Ambulatory Payment Classification payment status indicators in the OPPS unless they meet one of the criteria for packaging, which, with the exception of drug or biological products billed with a Comprehensive Ambulatory Payment Classification (C-APC) service, we do not anticipate that drugs or biological products approved or authorized to treat asthma treatment would meet.

However, these products could be packaged into a C-APC when provided on the same claim as a C-APC service, in which case separate payment would not be made for these products. Under our C-APC policy, which we adopted beginning in CY 2015, we designate a service described by a HCPCS code assigned to a C-APC as the primary service when the service is identified by OPPS status indicator âJ1â. When such a primary service is reported on a hospital outpatient claim, with certain exceptions, we make payment for all other items and services reported on the hospital outpatient claim as being integral, ancillary, supportive, dependent, and adjunctive to the primary service (hereinafter collectively referred to as âadjunctive servicesâ) and representing components of a complete comprehensive service (78 FR 74865 and 79 FR 66799). Payments for adjunctive services are packaged into the payments for the primary services.

Most C-APCs are for surgical or other intensive procedures, which we would expect most hospital outpatient departments would not perform on a patient that has an active case of asthma treatment. However, observation services can also be paid through the âComprehensive Observation Servicesâ C-APC (C-APC 8011), which packages payment for qualifying extended assessment and management encounters. It is possible that future asthma treatments that are authorized or approved for use in the outpatient setting might be administered to patients under observation while the provider determines if the patient needs to be admitted to the hospital for asthma treatment. 3.

Separate Payment Under the OPPS for New asthma treatments for the Remainder of the PHE for asthma treatment Although we do not expect that many beneficiaries would both receive a primary C-APC service and a drug or biological for treating asthma treatment, we nonetheless believe that as drugs or biologicals become available and are authorized or approved for the treatment of asthma treatment in the outpatient setting, it would be appropriate to mitigate any potential financial disincentives for hospitals to provide these new treatments during the PHE for asthma treatment. Therefore, effective for services furnished on or after the effective date of this rule and until the end of the PHE for asthma treatment, CMS is creating an exception to its OPPS C-APC policy to ensure separate payment for new asthma treatments that meet certain criteria. Under this exception, any new asthma treatment that meets the two criteria below will, for the remainder of the PHE for asthma treatment, always be separately paid and will not be packaged into a C-APC when it is provided on the same claim as the primary C-APC service. Note that this separate payment will result in an additional copayment of 20 percent of the cost of the new asthma treatment, up to the amount of the inpatient deductible.

CMS has identified two criteria for asthma treatments to receive this exception. First, the treatment must be a drug or biological product (which could include a blood product) authorized to treat asthma treatment, as indicated in section âI. Criteria for Issuance of Authorizationâ of the letter of authorization for the drug or biological product, or the drug or biological product must be approved by the FDA for treating asthma treatment. Because the purpose of this exception is to mitigate potential financial disincentives for hospitals to provide new asthma treatments, this criterion expeditiously provides assurance in the context of the urgency of the PHE for asthma treatment that a treatment is new and is used to treat asthma treatment disease during the PHE for asthma treatment.

Second, the EUA for the drug or biological product (which could include a blood product) must authorize the use of the product in the outpatient setting or not limit its use to the inpatient setting, or the product must be approved by the FDA to treat asthma treatment disease and not limit its use to the inpatient setting. We note that during the PHE for asthma treatment this new exception to the C-Start Printed Page 71160APC packaging policy would apply to all drug and biological products that meet both of these criteria. As of the date of issuance of this interim final rule there are two drug or biological products that meet the first criterion (Veklury (remdesivir) and asthma treatment convalescent plasma), but neither of these products is authorized or approved for use in the outpatient setting and, as a result, no product meets the second criterion. We also note that all generally applicable statutory and regulatory requirements for Medicare payment under the OPPS must continue to be met, and that OPPS payment will only be available to the extent that the new asthma treatment meets all coverage requirements under Medicare, including that the use of a drug or biological product is medically reasonable and necessary for the patient.

No applicable Medicare requirements during the PHE are being waived by the creation of this C-APC exception. 4. Effects of This Exception on the OPPS Budget Neutrality Calculation As we noted in Section II.E.2, we believe it would be a fairly rare occurrence that an outpatient department would perform a C-APC procedure on a beneficiary being treated for asthma treatment because most C-APCs are for surgical or other intensive procedures and we would expect most hospital outpatients departments would not perform outpatient surgery on a patient that has an active case of asthma treatment. While it is possible that future asthma treatments that are authorized or approved for use in the outpatient setting might be administered to patients under observation while the provider determines if the patient needs to be admitted to the hospital for asthma treatment, it is our expectation that this hypothetical situation would not happen frequently.

Temporary Increase in Federal Medicaid Funding 1. Background Section 6008 of the FFCRA, as amended by section 3720 of the CARES Act, provides a temporary 6.2 percentage point increase to each qualifying state and territory's Federal Medical Assistance Percentage (FMAP) under section 1905(b) of the Act (âtemporary FMAP increaseâ). This temporary FMAP increase is effective beginning January 1, 2020 and could extend through the last day of the calendar quarter in which the PHE for asthma treatment, including any extensions, terminates, if the state claims the FMAP increase in that quarter (we refer herein to the entire period where the FMAP increase is potentially applicable as the âincreased FMAP periodâ). To qualify for the temporary FMAP increase in a given quarter, states must meet the four conditions described in subsection (b) of section 6008 of the FFCRA during that quarter.

Three of these conditions (described at section 6008(b)(1), (2), and (4) of the FFCRA) could extend through the end of the increased FMAP period, if the state claims the increased FMAP through the end of the quarter in which the PHE for asthma treatment ends. They are. (a) The state must maintain eligibility standards, methodologies, or procedures that are no more restrictive than what the state had in place as of January 1, 2020. (b) the state may not charge premiums that exceed those that were in place as of January 1, 2020;â[] and (c) the state must cover, without the imposition of cost sharing, testing services and treatments for asthma treatment, including treatments, specialized equipment, and therapies.

Seeking to balance the beneficiary protections in our existing interpretation with the state flexibility that could be afforded through an alternative interpretation, this IFC establishes a blended approach as discussed below. 2. CMS's Existing Interpretation of Section 6008(b)(3) of the FFCRA CMS first provided an interpretation of section 6008(b)(3) for implementation by states through FAQs issued in April 2020. Our most recent interpretation provided that to receive the increased FMAP under the FFCRA, a state must keep beneficiaries enrolled in Medicaid, if they were enrolled on or after March 18, 2020, with the same amount, duration, and scope of benefits.

It also provided that states could not subject such beneficiaries to any increase in cost sharing or beneficiary liability for institutional services or other long-term services and supports (LTSS) during this time period. This interpretation Start Printed Page 71161protects both beneficiary eligibility and access to medically necessary services. Under this interpretation, if a state receives information about a beneficiary's change in circumstances that would make the beneficiary ineligible for Medicaid, the state may not terminate that beneficiary's eligibility until the end of the month in which the PHE for asthma treatment ends, except in cases where the beneficiary voluntarily disenrolls or is no longer a resident of the state. Further, if the state receives information that would make a beneficiary eligible for a different eligibility group with lesser benefits, greater cost sharing, or increased beneficiary liability, the state may not transition that beneficiary to the new eligibility group but must maintain the beneficiary's enrollment in the current eligibility group until the end of the month in which the PHE for asthma treatment ends.[] In protecting access to medically necessary services pursuant to this interpretation, states must maintain current coverage in the state plan, including alternative benefit plans (ABPs), and must also maintain current coverage under any waivers and section 1115 demonstrations.

For example, states may not implement any new restrictions such as a reduction in the number of covered visits or a prior authorization requirement. Beneficiary coverage may not be reduced on an individual basis either. For example, if a beneficiary has reached age 21 and would no longer be eligible for the Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit, the state must continue to provide EPSDT services to the beneficiary when medically necessary, through the end of the month in which the PHE for asthma treatment ends. Further, if a beneficiary is enrolled in a home and community-based services (HCBS) waiver program authorized under section 1915(c) of the Act, and the individual is determined to no longer meet the level-of-care requirements or other requirements for that waiver, the state must maintain the beneficiary's enrollment in the HCBS waiver.

Under this interpretation, states are not required to provide services that do not meet the state plan amount, duration, and scope criteria for a benefit (such as medical necessity). However, as a condition for receiving the temporary FMAP increase, the state must ensure that a beneficiary can continue to access the benefits package that was available to that beneficiary as of March 18, 2020 (or a later date within the PHE) through the end of the month in which the PHE for asthma treatment ends. States have expressed concern that our existing interpretation of section 6008(b)(3) of the FFCRA makes it challenging for them to manage their programs effectively and still qualify for the increased Federal financial participation, in frustration of one purpose of section 6008 of the FFCRA to provide additional support to state Medicaid programs in their response to the asthma treatment ventolin. States made clear to CMS that this interpretation, coupled with the prohibition on adopting more restrictive eligibility standards, methodologies, or procedures under section 6008(b)(1) of the FFCRA, would impede the routine, orderly transition of beneficiaries between eligibility groups, and could lead to significant backlogs in redeterminations and appeals after the PHE for asthma treatment ends.

States also noted that our existing interpretation severely limits state flexibility to control program costs in the face of growing budgetary constraints and developing fiscal challenges during the emergency period. For example, it freezes post-eligibility treatment-of-income (PETI) calculations for institutionalized beneficiaries regardless of changes in circumstances. States have pointed out that a beneficiary receiving HCBS through a waiver approved under section 1915(c) of the Act who is subject to the PETI rules and who subsequently moves into an institution would be entitled to retain the higher personal needs allowance allowed for individuals participating in the relevant waiver, even though the beneficiary's personal needs would be far lower once in the institution. The aggregate effects of this interpretation could result in a substantial increase in the state Medicaid program's cost for the needed institutional services as beneficiaries are not contributing as much toward the cost of their care as they would be in the absence of the FFCRA 6008(b)(3) requirement.

Alternative Interpretation of Section 6008(b)(3) of the FFCRA CMS's existing interpretation of section 6008(b)(3) of the FFCRA is not the only possible, reasonable interpretation of that provision. The language in this section could also reasonably be interpreted to mean only that states must maintain the enrollment of beneficiaries who enrolled in the state's Medicaid program as of or after March 18, 2020, through the end of the month in which the PHE ends, but not the specific benefits package they were receiving at that time. In other words, under this alternative interpretation, to fulfill the requirement in section 6008(b)(3) of the FFCRA with respect to a beneficiary who becomes ineligible for enrollment in his current Medicaid eligibility group, states would either (a) transition the beneficiary to another group for which he is eligible and enroll him for the benefits provided to that eligibility group, or (b) retain the beneficiary's enrollment in the original eligibility group, if he did not meet the eligibility criteria for any other group, and maintain the benefits provided to that group. Under this alternative interpretation, a state would be required to move a beneficiary who becomes eligible for another Medicaid eligibility group during the period in which section 6008(b)(3) of the FFCRA applies into that new group, no matter how limited the benefits package is for the new group.

We refer to this alternative interpretation as the âenrollment interpretation.â Under the enrollment interpretation, states claiming the 6.2 percentage point temporary FMAP increase would be permitted to make programmatic changes, such as changes to the medical necessity criteria or utilization control procedures in determining coverage for benefits. Elimination of optional benefits Start Printed Page 71162coverage. Increases in cost-sharing responsibilities (except with respect to testing services and treatments for asthma treatment per section 6008(b)(4) of the FFCRA). Or changes to the PETI methodology.

Further, while Congress expressly prohibited states from imposing cost sharing on testing services and treatments for asthma treatment in section 6008(b)(4) of the FFCRA, Congress did not expressly provide in section 6008(b)(3) for any limitation on cost sharing, or on states' ability to modify cost sharing or beneficiaries' liability for the cost of other services (e.g., in accordance with the PETI rules set forth in 42 CFR part 435, subpart H, and 42 CFR 435.832 for beneficiaries receiving institutional services or other long-term services and supports who are subject to the PETI rules). Under the enrollment interpretation, states would be required to make individual beneficiary eligibility changes short of disenrollment from Medicaid entirely. For example, states would be required to make changes to a beneficiary's eligibility to reflect a change in income, or a change related to age, pregnancy status, need for LTSS or other eligibility factors. A change of service, such as moving from participation in an HCBS waiver authorized under section 1915(c) of the Act into an institution or vice versa, would also require a change in eligibility for a beneficiary enrolled in an eligibility group specific to HCBS recipients, such as the group described at 42 CFR 435.217, or an eligibility group for individuals living in an institution like the special income level group described at 42 CFR 435.236.

The enrollment interpretation would require states to move a beneficiary who loses eligibility under one Medicaid eligibility group and becomes eligible in a second Medicaid eligibility group into the second eligibility group, even if the second eligibility group confers lesser benefits or results in increased financial liability for the beneficiary. However, as with our existing interpretation, under the enrollment interpretation states would not be permitted to terminate a beneficiary's eligibility unless the individual requested such termination or was no longer a state resident. If a beneficiary loses eligibility under one Medicaid eligibility group and is not eligible for another group, in order to claim the temporary FMAP increase, the state must maintain the beneficiary's enrollment in the current group until the end of the month in which the PHE for asthma treatment ends. Like the programmatic changes discussed previously, individual beneficiary eligibility changes would not jeopardize receipt of the temporary FMAP increase.

In most cases, transferring a beneficiary from one eligibility group to another would not result in a significant change in available benefits. With a few exceptions, Medicaid is considered to be minimum essential coverage (MEC) as defined in section 5000A(f) of the Internal Revenue Code of 1986 (âCodeâ) and implementing regulations at 26 CFR 1.5000A-2. Certain Medicaid eligibility groups, however, such as the optional eligibility group for individuals infected with tuberculosis (described at 42 CFR 435.215), provide only limited benefits pursuant to the matter following section 1902(a)(10)(G) of the Act. This optional coverage of tuberculosis and tuberculosis-related services is excepted from the definition of MEC at 26 CFR 1.5000A-2(b)(2)(ii) and transferring a beneficiary from an eligibility group that provides MEC to the eligibility group for individuals infected with tuberculosis would result in a significant reduction in available benefits.

Another example of non-MEC coverage available through Medicaid is the optional eligibility group limited to family planning and related services at 42 CFR 435.214, which also provides only a limited benefits package pursuant to the matter following section 1902(a)(10)(G) of the Act, and which is excluded from MEC at 26 CFR 1.5000A-2(b)(2)(i). If the enrollment interpretation was adopted, following the postpartum period for coverage of pregnant women at 42 CFR 435.116, states that cover the optional family planning group (or that provide family planning-only coverage through a section 1115 demonstration) would be required to transfer women who do not qualify for a full-benefit Medicaid eligibility group into family planning-only coverage if they meet the eligibility requirements for the family planning-only group or demonstration. The enrollment interpretation of section 6008(b)(3) of the FFCRA would make it more challenging for some beneficiaries to access medically necessary services, including services related to the asthma treatment ventolin. A beneficiary transferred to the family planning group following the end of her postpartum period would continue to have access to provider visits for family planning and outpatient drugs and supplies related to those visits, but she would no longer have access to testing services and treatment for asthma treatment, pursuant to CMS's interpretation of section 6008(b)(4) of the FFCRA, which is discussed above in section II.B.

In addition, she would lose access to inpatient and outpatient hospital services, prescription drugs, and other Medicaid-covered services that are unrelated to family planning. Beneficiaries with certain chronic conditions like diabetes and sickle cell disease are at higher risk for severe illness from the ventolin that causes asthma treatment.[] Under the enrollment interpretation, individuals who lose eligibility for a group that offers MEC may be transitioned to a limited benefit eligibility group, in a state that offers such coverage, in which they would no longer have access to the benefits needed to manage their chronic conditions. Not only would this negatively impact the beneficiary who loses comprehensive Medicaid coverage as a result of this interpretation, but it could also undermine states' asthma treatment response efforts during the public health emergency. 4.

They have made clear that our existing interpretation of section 6008(b)(3) of the FFCRA has interfered with their ability to implement cost-saving decisions in the face of increasing beneficiary enrollment and declining state revenues. The enrollment interpretation would allow states to impose coverage limitations that reduce spending and allow for better management of state programs during the PHE for asthma treatment. More flexibility in managing their programs could help states to stretch scarce financial resources over the long term, including after the PHE for asthma treatment ends, and that could ultimately benefit both providers and beneficiaries. Supporting states and providers fighting the ventolin is consistent with the protections and the various provider relief funds established by Congress in the FFCRA, the CARES Act, and the PPPHCEA.

While the enrollment interpretation of section 6008(b)(3) of the FFCRA may be the preferred option for states, we recognize that it could negatively impact certain provider types. Under the enrollment interpretation, states could eliminate optional benefits. For example, a state could cut its optional dental benefit, and dentists in that state would lose Medicaid reimbursement. CMS's existing interpretation, however, leaves states with little ability to manage program costs other than by cutting provider rates to the fullest extent permitted under section 1902(a)(30)(A) of the Act.

Every Medicaid beneficiary who had access to MEC and to testing services and treatment for asthma treatment as of or after March 18, 2020 would continue to have access to these services under the existing interpretation. The enrollment interpretation would also protect beneficiary enrollment in Medicaid. At the same time, it would expand state flexibility to make cost-saving decisions that could reduce beneficiaries' coverage below what they had access to as of or after March 18, 2020. Under the enrollment interpretation, some beneficiaries would be transitioned from MEC to non-MEC coverage, which may not include testing services and treatment for asthma treatment pursuant to CMS's interpretation of FFCRA section 6008(b)(4).

Ensuring access to testing and treatment, along with care for the chronic health conditions that place beneficiaries at higher risk for asthma treatment, is important for fighting the ventolin. Seeking to balance the needs of each stakeholder group, both in fighting the ventolin and ensuring long-term program sustainability, this IFC adopts a blended approach to interpreting section 6008(b)(3) of the FFCRA. This blended approach adopts the state flexibility available through the enrollment interpretationâallowing states to make programmatic changes to benefits and cost sharing and to transition individual beneficiaries between eligibility groups with differing benefit packagesâwhile also establishing parameters to prevent beneficiaries from losing access to comprehensive coverage, consistent with our existing interpretation, through the end of the month in which the PHE for asthma treatment ends. This blended approach is expected to give states more flexibility, beyond what is available under our existing interpretation, to manage their Medicaid programs.

This is consistent with section 1902(a)(4) of the Act, which requires the state plan to provide for such methods of administration as are necessary for the proper and efficient operation of the plan. CMS is also exercising its general rulemaking authority under sections 1102 and 1902(a)(19) of the Act to establish parameters under which states must operate when they exercise the flexibility that CMS is providing with respect to compliance with section 6008(b)(3) of the FFCRA. The parameters established by this IFC will help to ensure that states are determining eligibility, and providing care and services, in a manner that is consistent with the simplicity of administration, as described in section 1902(a)(19) of the Act. Under this blended approach, CMS is giving states a wider degree of flexibility to effectuate enrollment transitions during the PHE for asthma treatment, which could decrease backlogs in redeterminations and appeals following the PHE for asthma treatment, thereby simplifying state implementation of the conditions in FFCRA section 6008(b)(3) and administration of the state plan.

These parameters are also expected to help ensure that states are determining eligibility, and providing care and services, in a manner that is consistent with the best interests of beneficiaries, as described in section 1902(a)(19) of the Act. That is because CMS is giving states less flexibility to reduce beneficiaries' coverage under this blended approach than might be available to states under the enrollment interpretation, in an effort to help protect beneficiaries' access to potentially necessary medical care during the period in which the FFCRA 6008(b)(3) requirement applies. We therefore believe this blended approach balances the interests of all stakeholders consistent with the statute. This IFC adds a new subpart G, Temporary FMAP Increase During the Public Health Emergency for asthma treatment, to 42 CFR part 433, including a new Â§â433.400.

Section 433.400(a) describes the statutory basis for this provision, while Â§â433.400(b) provides definitions specific to this subpart. As described in detail below, Â§â433.400(c) requires states, as a condition for receiving the temporary FMAP increase, to maintain beneficiary enrollment in an eligibility group that provides one of three tiers of coverage through the end of the month in which the PHE for asthma treatment ends, except under the circumstances specified in paragraph (d). This provision generally does not require states to provide the exact same (or greater) amount, duration, and scope of medical assistance, or maintain the cost-sharing or PETI liability for a particular beneficiary at the same (or lower) level that was applicable to the beneficiary as of March 18, 2020 or subsequent date of initial enrollment during the PHE. Section 433.400 is effective immediately upon display of this rule.

CMS' previous interpretation, as described in section II.F.2. Of this preamble, continues to apply from the beginning of the quarter up to the date that this IFC is displayed. 5. Maintaining Enrollment in the Same Tier of Coverage As discussed, we believe that interpreting FFCRA section 6008(b)(3) only to require continued enrollment in a state's Medicaid program (even if benefits are strictly limited), could have significant negative consequences for both beneficiaries and efforts to combat the asthma treatment ventolin.

Some beneficiaries may transition from medical assistance that qualifies as MEC to non-MEC coverage, and some may even lose access to asthma treatment testing Start Printed Page 71164services and treatment. CMS has not interpreted section 6008(b)(4) of the FFCRA to require state Medicaid programs to cover asthma treatment testing services and treatment for beneficiaries whose Medicaid eligibility is limited by statute or under existing section 1115 demonstration authority to coverage for care and services that are for a specific (non-asthma treatment-related) condition, disease or purpose and that would not otherwise include asthma treatment testing and treatment services. Consistent with the blended approach to interpreting section 6008(b)(3) of the FFCRA that is described above, and consistent with section 1902(a)(4) and (a)(19) of the Act, we are requiring states to ensure that beneficiaries who were validly enrolled for benefits as of or after March 18, 2020 with access to minimum essential coverage retain access to minimum essential coverage, and to ensure that beneficiaries with access to testing services and treatment for asthma treatment maintain access to those services. We believe it is reasonable to interpret the term âenrolled for benefitsâ in section 6008(b)(3) to mean validly enrolled, such that those who were erroneously enrolled are not to be considered âenrolled for benefitsâ for purposes of FFCRA section 6008.

Therefore, we define âvalidly enrolledâ at Â§â433.400(b) to mean that the beneficiary was enrolled in Medicaid based on a determination of eligibility, including during the retroactive eligibility period, and that the beneficiary was not erroneously granted eligibility at the point of application or last redetermination (if such last redetermination was completed prior to March 18, 2020) because of. (1) Agency error. Or (2) fraud (as evidenced by a fraud conviction) or abuse (as determined following the completion of an investigation pursuant to 42 CFR 455.15 and 455.16) attributed to the beneficiary or the beneficiary's representative which was material to the determination of eligibility. Terminating the eligibility of beneficiaries who are not validly enrolled as defined at Â§â433.400(b) will not impact a state's ability to claim the temporary FMAP increase.

CMS' previous interpretation, as described in section II.F.2. Of this preamble and in the FAQs cited therein, continues to apply from the beginning of the quarter up to the date this rule is effective. For all quarters following the effective date of this rule, states would be expected to meet the requirements of Â§â433.400(c) for the entirety of the quarter in order to claim the temporary FMAP increase. Section 433.400(c)(2) requires states to maintain the enrollment of all beneficiaries who were validly enrolled on or after March 18, 2020.

Paragraphs (c)(2)(i), (ii), and (iii) of 433.400 establish safeguards for the maintenance of enrollment. For beneficiaries who were not validly enrolled during this period, and whom the state is therefore permitted to disenroll, the state must provide advance notice of termination and fair hearing rights in accordance with 42 CFR 435.917 and 42 CFR part 431, subpart E, when terminating coverage. Consistent with the Secretary's rulemaking authority under section 1102 of the Act and section 1902(a)(19) of the Act, which provides for such safeguards as are needed to ensure that care and services are provided in a manner consistent with the best interests of beneficiaries, Â§â433.400(c)(2) establishes three tiers of Medicaid coverage. These coverage tiers will help to ensure that beneficiaries protected under section 6008(b)(3) of the FFCRA in states claiming the temporary FMAP increase, who no longer meet eligibility requirements for the initial eligibility group in which they are enrolled but who become eligible under a different eligibility group or who lose Medicaid eligibility entirely, do not experience a reduction in covered benefits that would be inconsistent with section 1902(a)(19) of the Act, or with our interpretation of sections 6008(b)(3) and (4) of the FFCRA.

The first tier of coverage, under paragraph (c)(2)(i) of Â§â433.400, consists of Medicaid coverage that meets the definition of MEC, as defined in section 5000A(f) of the Code and implementing regulations at regulation at 26 CFR 1.5000A-2. Under Â§â433.400(c)(2)(i)(A), for beneficiaries whose Medicaid coverage as of or after March 18, 2020 meets the definition of MEC, the state must generally continue to provide Medicaid coverage that meets the definition of MEC throughout the period in which this rule applies. This means that if a state determines a beneficiary ineligible for the group in which he or she is currently enrolled, which provides MEC, and finds the beneficiary eligible for another group that also provides MEC, the state would transition the beneficiary to the new eligibility group. In contrast, if the beneficiary lost eligibility for a group that provides MEC, but gained eligibility for coverage that does not meet the definition of MEC, the state may not move the beneficiary to the new group or demonstration but must instead maintain the beneficiary's access to coverage meeting the definition of MEC during the period in which the rule applies, except as discussed below.

For example, the state must transition a beneficiary enrolled in the eligibility group for children under age 19 at 42 CFR 435.118 to the adult group described at 42 CFR 435.119 when the beneficiary reaches age 19, provided that the state covers this group and the beneficiary meets the eligibility requirements of the group. That is because the medical assistance provided under the eligibility group for children under age 19 includes full state plan benefits with no cost sharing, which meets the definition of MEC, and the medical assistance offered under the adult group may include a somewhat different set of benefits through the state's ABP, and may include cost sharing for certain services, but it also meets the definition of MEC. This transition would therefore be permissible under Â§â433.400(c)(2)(i). In contrast, a state may not transition a beneficiary from the eligibility group for children under age 19 or the adult group, both of which provide MEC, to a limited benefit group that does not provide MEC, such as the family planning group at 42 CFR 435.214, which covers only family planning and family planning-related services.

As described further in Â§â433.400(c)(2)(iv), if a beneficiary receiving tier 1 coverage no longer meets the eligibility requirements for the original group in which he or she was enrolled, and the beneficiary does not meet the requirements for any other eligibility groups with tier 1 coverage, the state Start Printed Page 71165must continue to provide the medical assistance offered under the eligibility group in which the beneficiary was eligible on or after March 18, 2020. At Â§â433.400(c)(2)(i)(B), we establish a variation on this requirement for beneficiaries who have coverage meeting the definition of MEC as of or after March 18, 2020, and whom the state subsequently determines are eligible for coverage under a Medicare Savings Program eligibility group. The Medicare Savings Program is defined at Â§â433.400(b) to include the eligibility groups described at section 1902(a)(10)(E)(i), (iii), and (iv) of the Act. For such beneficiaries, the state satisfies the requirement described in paragraph (c)(2) of this section if it furnishes the medical assistance available through the Medicare Savings Program, because the coverage that beneficiary receives under the Medicare program qualifies as MEC.

Therefore, the state may transition the beneficiary from the adult group to a Medicare Savings Program group. The second tier of coverage, which is described at Â§â433.400(c)(2)(ii), consists of coverage that is not defined as MEC but that is robust enough to include access to coverage of both testing services and treatment for asthma treatment under CMS's interpretation of FFCRA section 6008(b)(4). Not all Medicaid coverage qualifies as MEC, and the non-MEC coverage provided to beneficiaries can vary greatly. As noted previously, some beneficiaries' coverage is limited by statute or existing section 1115 demonstration authority to a very narrow range of services that would not include asthma treatment testing or treatment services, and CMS has not interpreted section 6008(b)(4) of the FFCRA to require states to cover asthma treatment testing and treatment services for those beneficiaries.

However, other Medicaid beneficiaries receive a relatively robust set of benefits, such as pregnancy-related services described in the matter following section 1902(a)(10)(G) of the Act, which would include testing services and treatment for asthma treatment, including treatments, specialized equipment, and therapies, during the period when FFCRA section 6008(b)(4) applies in a state, but which does not qualify as MEC in all states. Section 433.400(c)(2)(ii) of this IFC provides that states must continue to provide Medicaid coverage that includes coverage of asthma treatment testing services and treatments, including treatments, specialized equipment, and therapies, to beneficiaries who had access to coverage in tier 2 as of or after March 18, 2020. Thus, states must transition beneficiaries who lose eligibility for tier 2 coverage but gain access to MEC coverage in tier 1 or to other coverage in tier 2 to the new eligibility group or demonstration, but they may not transition such beneficiaries to coverage that does not include access to testing services and treatment for asthma treatment. This interpretation is consistent with the requirement for states claiming the temporary FMAP increase to provide coverage for testing services and treatments for asthma treatment, as described at section 6008(b)(4), and with CMS's interpretation of that requirement.

For example, a woman receiving non-MEC pregnancy related coverage that includes coverage of testing services and treatments for asthma treatment could not be transitioned to coverage of only family planning services at the end of the postpartum period. The third tier, described at Â§â433.400(c)(2)(iii), includes coverage that is not MEC and that also does not cover testing services and treatment for asthma treatment, including treatments, specialized equipment, and therapies, under CMS's interpretation of FFCRA section 6008(b)(4). Coverage under tier 3 may include coverage for the eligibility group limited to family planning described at 42 CFR 435.214 or the eligibility group for individuals with tuberculosis described at 42 CFR 435.215. Coverage through an existing family planning demonstration or other limited benefit section 1115 demonstration may also be included in tier 3 if it does not cover asthma treatment testing and treatment.

If a beneficiary loses eligibility for coverage meeting the tier 3 description during the period in which the FFCRA section 6008(b)(3) requirement applies, and the beneficiary gains eligibility for a group that provides coverage in tier 1 or tier 2, then, under Â§â433.400(c)(2)(iii), the state must transfer the beneficiary into that new eligibility group as coverage in those tiers is more robust than coverage in tier 3. The coverage in tier 3 differs from the coverage in tier 1, which is always considered MEC and the coverage in tier 2, which always includes testing services and treatment for asthma treatment. The coverage available to a beneficiary in tier 3 is more limited and may vary widely from one group or demonstration to the next. Coverage limited to family planning and family planning-related services is significantly different from coverage in a limited-benefit section 1115 demonstration that focuses, for example, on preventing the progression of a specific disease.

Section 3716 of the CARES Act amended section 1902(ss) of the Act to establish that individuals eligible for certain optional eligibility groups, such as the eligibility group limited to family planning and related services described at 1902(a)(10)(A)(ii)(XXI) of the Act, are considered âuninsuredâ for purposes of eligibility under the optional asthma treatment testing group and therefore may obtain asthma treatment testing coverage under that group in addition to coverage under the other optional eligibility group. In addition, beneficiaries in each benefit tier retain the right to request a voluntary transition to a different eligibility group (provided that they meet the applicable eligibility requirements), even if such transition results in a change in the individual's benefit package that would not otherwise satisfy the conditions of this rule, such as a transition from an eligibility group with coverage in tier 1 to an eligibility group with coverage in tier 3 or a transition from one tier 3 group to another tier 3 group. Such a transition is permissible under the exception at Â§â433.400(d)(1)(i), as described at Â§â433.400(d)(3)(i), in which a beneficiary may request a voluntary termination of eligibility, and would not impact the state's ability to claim the temporary FMAP increase. Section 42 CFR 430.400(c)(2)(iv) specifies that for any beneficiary who is validly enrolled and receiving medical assistance on or after March 18, 2020, and who is determined ineligible for Medicaid prior to the last day of the month in which the PHE for asthma treatment ends, except as provided in paragraph (d), a state meets the requirements of Â§â430.400(c)(2)(i), (ii), or (iii) by continuing the provide the same coverage that the individual would have received absent the determination of ineligibility.

For example, if a beneficiary is enrolled in the age and disability-related poverty level group described at section 1902(a)(10)(A)(ii)(X) of the Act, and the beneficiary reports a change in resources that would result in ineligibility for this group, if the beneficiary is not eligible for coverage in any other Medicaid eligibility group, the state would continue to provide that individual with the coverage available to beneficiaries enrolled in the age and disability-related poverty level group. The requirement at Â§â430.400(c)(2)(iv) also applies in cases where a state finds a beneficiary ineligible on a procedural basis, such as a failure to respond to a request for additional information, with an exception related to residency described at Â§â430.400(d)(3). For example, if a state receives information from quarterly wage data, which indicates that a child's household income exceeds the income standard for the eligibility group for children under age 19 (described at 42 CFR 435.118), the child is not eligible on another basis, and the beneficiary's family does not respond to a request from the state for additional information, the child may be determined ineligible on a procedural basis. In this case, through the end of the month in which the PHE for asthma treatment ends, the state would continue to provide the child with the same coverage provided to beneficiaries enrolled in the eligibility group for children under age 19.

If the beneficiary is subsequently determined eligible for a different eligibility group that provides the same tier of coverage, in this case tier 1, the state would transfer the beneficiary to the new eligibility group. CMS is available for technical assistance to help states ensure that all beneficiaries retain coverage in either the same tier or in a more robust tier of coverage when their eligibility changes in a manner that would ordinarily result in a transition between eligibility groups. 6. Changes to Benefits, Cost Sharing, and PETI Section 433.400 of this IFC allows states, during the period when section 6008(b)(3) of the FFCRA applies, to move a beneficiary from one eligibility group to another when the beneficiary becomes ineligible for one group and eligible for another group, as long as the coverage provided under the new group is within the same tier of coverage (applicable to tier 1 and tier 2 coverage only) or a beneficiary may also be moved to a more generous tier of coverage than the coverage available to the beneficiary on or after March 18, 2020.

Section 433.400(c)(3) specifies that states may make programmatic changes to coverage, cost sharing, and beneficiary liability without violating the requirements for receiving the temporary FMAP increase, provided that such changes do not violate the individual beneficiary protections at Â§â433.400(c)(2) or the requirements under section 6008(b)(4) of the FFCRA to cover asthma treatment testing and treatment services without cost-sharing. As described at Â§â433.400(c)(3), states may generally make changes to benefits offered under the state plan (as allowed under relevant provisions of the Act) or a section 1115 demonstration. For example, section 6008(b)(3) of the FFCRA does not prohibit a state from eliminating an optional benefit from its state plan. Therefore, a state could eliminate dental services for individuals age 21 and above, and still comply with section 6008(b)(3) of the FFCRA.

Note that under section 1905(r)(5) of the Act, as part of the mandatory EPSDT benefit, states must provide beneficiaries under age 21 with all necessary health care, diagnostic services, treatment, and other measures described in section 1905(a) of the Act, to correct or ameliorate defects and physical and mental illnesses and conditions discovered by EPSDT screening services, whether or not such services are covered under the state plan. However, states need not maintain EPSDT benefits for beneficiaries who turn 21 in order to comply with the terms of section 6008(b)(3) of the FFCRA. Additionally, states are permitted to change the scope of benefits provided to beneficiaries without violating the requirements of section 6008(b)(3) for claiming the temporary FMAP increase, as long as they comply with otherwise applicable Medicaid law, including section 6008(b)(4) of the FFCRA. For example, section 6008(b)(3) of the FFCRA does not prohibit states from applying service authorization criteria, including for services authorized under section 1915(c) of the Act, in determining the amount, duration, or scope of coverage a beneficiary is entitled to receive under the state's program.

Section 440.230(b) still applies as a limit on state flexibility. That regulation requires that each Medicaid service must be sufficient in amount, duration, and scope to reasonably achieve its purpose. In considering optional changes to coverage, states may wish to avoid service authorization changes that lead to more individuals being placed in institutional or congregate settings, as these settings have had a disproportionate share of asthma treatment cases and deaths. We also note that Start Printed Page 71167regardless of the flexibility provided at Â§â433.400(c)(3), states retain their obligations to provide services and supports in the âmost integrated settingâ under the integration mandate of Title II of the Americans with Disabilities Act (ADA), as interpreted by the Supreme Court in Olmstead v.

L.C., 527 U.S. 581 (1999) (hereafter âOlmsteadâ),[] to avoid unjustified institutionalization or segregation. If the elimination of an optional benefit results in or places an individual with a disability at risk of unjustified institutionalization or segregation, it may be a violation of the state's obligations under the ADA and Olmstead.[] States' Olmstead obligations do not confer Medicaid authority or create Medicaid obligations where they do not otherwise exist. States may choose to (and in some cases would be required to) use funds outside of or in addition to Medicaid to comply with Olmstead responsibilities.

Finally, states may generally establish or increase cost sharing (consistent with sections 1916 and 1916A of the Act, implementing regulations at 42 CFR 447.50 through 447.90, and the state plan), and increase beneficiary obligations under the PETI rules, and still comply with FFCRA section 6008(b)(3). However, states should also comply with FFCRA 6008(b)(4) if they are claiming the temporary FMAP increase. For example, a state may increase the liability of individuals receiving Medicaid coverage for institutional services under the state plan through otherwise permissible reductions in their standard personal needs allowances or family allowances. In addition, they may transfer a beneficiary from one program furnishing HCBS (for example, a waiver program authorized under section 1915(c) of the Act) to another as a beneficiary's health status and level of care changes.

7. Exceptions to Maintaining Enrollment Section 433.400(d) of this IFC describes the exceptions to the continuous enrollment requirement in Â§â433.400(c)(2). Section 6008(b)(3) of the FFCRA specifies that a beneficiary's Medicaid enrollment may be terminated if the beneficiary requests a voluntary termination of eligibility or the beneficiary is no longer a resident of the state. These exceptions are described in Â§â433.400(d)(1)(i) and (ii).

Because a beneficiary who dies is no longer a state resident, Â§â433.400(d)(1)(iii) also provides an exception for deceased beneficiaries. Section 433.400(d)(2) provides that states that have elected the option under section 1903(v)(4) of the Act to provide coverage to certain lawfully residing children and/or pregnant women, must limit the provision of services for these beneficiaries to services necessary for treatment of an emergency medical condition, as defined in section 1903(v)(3) of the Act, when they no longer meet the criteria at section 1903(v)(4) of the Act. This is because section 1903(v) of the Act prohibits the provision of FFP for otherwise eligible non-citizens who are not in a satisfactory immigration status, except as provided under paragraphs (2) (authorizing FFP for services necessary to treat an emergency medical condition) and (4) (relating to coverage of certain lawfully residing children and/or pregnant women) of section 1903(v) of the Act. Finally, Â§â433.400(d)(3) clarifies the exceptions at Â§â433.400(d)(1).

Additionally, as described at Â§â433.400(d)(3)(ii), individuals who are identified as receiving benefits in more than one state via a data match with the Public Assistance Reporting Information System (PARIS) interstate matching service in accordance with Â§â435.945(d) and who fail to respond to a request for information to verify their residency in the reasonable period permitted by the state, consistent with Â§â435.952(c)(2)(iii), are generally considered to no longer be residents of the state for purposes of section 6008(b)(3) of the FFCRA, provided that the state takes all available reasonable measures to determine state residency prior to termination. These measures include, but are not limited to, reviewing existing information in the beneficiary's record to validate state residency, checking available state electronic data sources such as the Department of Motor Vehicles records or other state benefit programs, and coordinating with agencies in the other state(s) in which the PARIS interstate match identified the beneficiary as receiving benefits to determine the state in which the individual is a resident for purposes of Medicaid eligibility. If the state is unable to verify the beneficiary's continued residency in the state because the beneficiary fails to respond to requests for additional information and the state's alternative efforts cannot verify the beneficiary's continued residency in the state through other sources, that beneficiary's Medicaid enrollment may be terminated in accordance with Â§â435.400(d)(1)(ii). Such an individual will be considered a non-resident for purposes of section 6008(b)(3) of the FFCRA until such time as the state has information verifying residency.

If, after termination, the state obtains information that verifies residency, the state must reinstate the individual's eligibility back to the date of termination. G. Updates to the Comprehensive Care for Joint Replacement (CJR) Model, Performance Year (PY) 5 During the asthma treatment Public Health Emergency (PHE) 1. Background Under the authority of section 1115A of the Act, through notice-and-comment Start Printed Page 71168rulemaking, the Innovation Center established the CJR model in a final rule titled âMedicare Program.

Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Servicesâ published in the November 24, 2015 Federal Register (80 FR 73274) (referred to as the âNovember 2015 final ruleâ). The CJR model, which was implemented on April 1, 2016, aims to support better and more efficient care for beneficiaries undergoing the most common inpatient surgeries for Medicare beneficiaries. Hip and knee replacements (also called lower extremity joint replacements or LEJR). This model tests bundled payment and quality measurement for an episode of care associated with hip and knee replacements to encourage hospitals, physicians, and post-acute care providers to work together to improve the quality and coordination of care from the initial hospitalization through recovery.

All related care covered by Medicare Parts A and B within 90 days of hospital discharge from the LEJR procedure is included in the episode of care. During the first CJR model performance period, the CJR model required hospitals located in the 67 MSAs selected participation to participate in the model through December 31, 2020 unless the hospital was an episode initiator for an LEJR episode in the risk-bearing phase of Models 2 or 4 of the Bundled Payments for Care Improvement (BPCI) initiative. Hospitals located in one of the 67 MSAs that participated in Model 1 of the BPCI initiative, which ended on December 31, 2016, were required to begin participating in the CJR model when their participation in the BPCI model ended. In the December 1, 2017 Federal Register, we published another final rule (82 FR 57066), titled âMedicare Program.

Cancellation of Advancing Care Coordination Through Episode Payment and Cardiac Rehabilitation Incentive Payment Models. Changes to Comprehensive Care for Joint Replacement Payment Model. Extreme and Uncontrollable Circumstances Policy for the Comprehensive Care for Joint Replacement Payment Modelâ (referred to as the âDecember 2017 final ruleâ), that implemented revisions to the CJR model, including giving rural and low volume hospitals selected for participation in the CJR model as well as those hospitals located in 33 of the 67 metropolitan statistical areas (MSAs)â[] a one-time option to choose whether to continue their participation in the model through December 31, 2020 (that is, continue their participation through PY5). An interim final rule with comment period was also issued in conjunction with the December 2017 final rule (82 FR 57092) in order to address the need for a policy to provide some flexibility in the determination of episode costs for providers located in areas impacted by extreme and uncontrollable circumstances.

Among other changes, this proposed rule proposed to add three additional performance years to the CJR model (i.e., performance years 6 through 8). In the April 6, 2020 Federal Register (85 FR 19230), we published an interim final rule with comment period (IFC) titled âMedicare and Medicaid Programs. Policy and Regulatory Revisions in Response to the asthma treatment Public Health Emergencyâ (hereinafter referred to as the âApril 2020 IFCâ). In the April 2020 IFC, to account for the impact of the PHE for asthma treatment on CJR participant hospitals, we extended PY5 through March 31, 2021, and adjusted the extreme and uncontrollable circumstances policy to account for asthma treatment by specifying that all episodes with a date of admission to the anchor hospitalization that is on or within 30 days before the date that the emergency period (as defined in section 1135(g) of the Act) begins or that occurs through the termination of the emergency period (as described in section 1135(e) of the Act), actual episode payments are capped at the target price determined for that episode under Â§ââ510.300.

Additionally, in the May 29, 2020 Federal Register (85 FR 32460), CMS published a proposed rule titled âMedicare Program. Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2021 Rates. Quality Reporting and Medicare and Medicaid Promotion Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals. (hereinafter referred to as the FY 2021 IPPS/LTCH proposed rule).

In the FY 2021 IPPS/LTCH proposed rule (85 FR 32510), we solicited comment on the effect of the proposal to create new MS-DRG 521 and MS-DRG 522, the effect this proposal would have on the CJR model and whether to incorporate MS-DRG 521 and MS-DRG 522, if finalized, into the CJR model's proposed extension to December 31, 2023. Through this IFC we are implementing four changes to the CJR model. These are. (1) Extending performance year 5 an additional 6 months to provide for continuity of model operations with the same scope while we continue to consider comments received on our proposal to extend the model to performance years 6 through 8 and adopt other changes to the model.

(2) making changes to the reconciliation process for PY5 to allow for two periods and to enable more frequent receipt of reconciliation reports by participants. (3) making a technical change, retroactive to October 1, 2020, to ensure that the model continues to include the same inpatient Lower Extremity Joint Replacement (LEJR) procedures, despite the adoption of new MS-DRGs to describe those procedures. And (4) making changes to the extreme and uncontrollable circumstances policy for asthma treatment to adapt to an increase in CJR episode volume and renewal of the PHE, while providing protection against financial consequences of asthma treatment after the extreme and uncontrollable circumstances policy no longer applies. 2.

Extension of Performance Year 5 to September 30, 2021 We are implementing a 6-month extension to CJR performance year (PY) 5 such that the model will now end on September 30, 2021. In the February 2020 proposed rule, we proposed to extend the CJR model by adding three performance years (PY6 through 8), from January 1, 2021 to December 31, 2023, to revise target prices, to change the definition of an episode of care to Start Printed Page 71169include outpatient procedures for Total Knee Arthroplasty and Total Hip Arthroplasty, as well as to revise other sections of 42 CFR part 510.[] In response to the PHE for asthma treatment, in the April 2020 IFC we extended PY 5 an additional 3 months to end on March 31, 2021 rather than on December 31, 2020 as finalized in November 2015 final rule. While we continue to consider the addition of performance years to the model and other changes proposed in the February 2020 proposed rule, we also do not want to create a disruption to the model by allowing the model to end on March 31, 2021, which could be disruptive to hospitals and patient care during the PHE if it is still ongoing at that time. Implementing an additional six months of PY5, so that PY5 now ends on September 30, 2021, provides participant hospitals additional relief and stability in model operations.

We appreciate commenters' request to extend PY 5 by 12 additional months because of the impact asthma treatment has had on LEJR procedures. We observe that asthma treatment has had an impact on CJR procedures from February 2020 to August 2020. Table 1 depicts recent Medicare claims data comparing February to August of 2019 and February to August of 2020. These numbers reflect episode volume for each month, accounting for any CJR episode that began within that month.

Table 1âCJR Episode Volume ComparisonâFebruaryMarchAprilMayJuneJulyAugust201962146174651560195836606058382020524533748762242403638383090 In light of these data, we believe providing an additional 6 months beyond what we adopted in the April 2020 IFC provides participant hospitals relief from asthma treatment challenges. Therefore, we are implementing an additional 6-month extension of CJR PY 5 and amending the provisions at 42 CFR 510.2 and 510.200(a) to reflect this extension. We note that in our February 2020 proposed rule to extend and modify the CJR model through PYs 6 to 8 (CMS-5529-P), we proposed PY 6 would comprise all CJR episodes ending on or after January 1, 2021 and on or before December 31, 2021. However, since we are amending PY 5 such that it comprises all CJR episodes ending on or after January 1, 2020 and on or before September 30, 2021, we seek comment on the duration of PY 6, if finalized.

3. Additional Reconciliations for Performance Year 5 Currently, following the end of each performance year, CMS determines actual episode payments and calculates the amount of a reconciliation payment or repayment amount, as described in 42 CFR 510.305. Each performance year is reconciled twice. The first reconciliation calculation process begins after a 2-month period of claims runout, while the final reconciliation calculation process begins after a 14-month period of claims runout.

The initial reconciliation of a given performance year is conducted concurrently with the final reconciliation of the previous performance year, and the resulting amounts are netted against one another for one annual reconciliation payment or repayment amount, as set forth in 42 CFR 510.305. The initial reconciliation process typically begins in late February of the calendar year following the performance year, with reports and reconciliation amounts issued in June. Final reconciliation for the performance year is issued the following June. Absent modification to the reconciliation process, the extension of PY 5 to a total of 21 months, from January 1, 2020 through September 30, 2021 would mean that participant hospitals would experience a 21-month gap between the PY4 final reconciliation in June of 2020 and initial PY 5 reconciliation in early 2022.

The first initial reconciliation will apply to the first 12 months of PY5 in order to maintain consistency with the 12 month reconciliation cycles for previous PYs 2-4 (we note that PY 1 was 9 months rather than 12 months), and the second initial reconciliation will apply to the Start Printed Page 71170remaining 9 months of PY5. To minimize confusion, we will refer to these two subsets of PY5 as performance year subset 5.1and 5.2, respectively. The initial reconciliation of performance year subset 5.1 will occur fourteen months after the start of PY5, which is the same timeline as would have occurred PY5 under the December 2017 final rule. After the usual 2-month period of claims runout, the initial reconciliation for performance year subset 5.1 episodes will begin in late February of 2021 using 12 months of claims from CY 2020 to calculate reconciliation payments, with the resulting amounts netted against the results of the concurrent PY4 final reconciliation calculation when we issue reports and reconciliation amounts to participants in June 2021.

Participants can expect to receive their 2021 reconciliation reports on approximately the same schedule as in previous model years. The nine additional months of PY 5 (performance year subset 5.2) will be reconciled one full calendar year after the reconciliation of PY 4 final/performance year subset 5.1 initial. We will use claims data for the initial reconciliation of performance year subset 5.2 that reflect a 2-month period of claims runout (as set forth in 42 CFR 510.305(e)(1)(i)), as we have for PY 1-4 and performance year subset 5.1. In short, performance year subset 5.2 will run from January 1, 2021 through September 30, 2021.

Consistent with using two months of claims run out, we will pull claims for the initial reconciliation in December 2021. However, we will not reconcile performance year subset 5.2 until late February 2022 along with the final reconciliation for performance year subset 5.1. This means that we will not begin reconciliation calculation for performance year subset 5.2 until five months after the end of performance year subset 5.2 in order to align the initial reconciliation calculation for performance year subset 5.2 with the timing of the subsequent reconciliation calculation for performance year subset 5.1. While alignment with the performance year subset 5.1 subsequent reconciliation calculation is the primary reason for this delay in the performance year subset 5.2 initial reconciliation, it is also necessary to allow time to receive certain input files to perform the initial reconciliation calculation, including standardized claims files and quality data.

These data are generally not available more than a few weeks prior to the usual reconciliation process start date in late February. Therefore, the reconciliation process will occur on the same schedule as PY 1 through 4 and performance year subset 5.1, with the reconciliation report available one year after the reports from the previous year's reconciliation. We note that, as part of the separate reconciliation calculation processes for performance year subsets 5.1 and 5.2, we will calculate a separate Composite Quality Score (CQS) for each of performance year subsets 5.1 and 5.2, including a separate set of quality improvement points and quality performance points for each performance year subset. In order to conduct separate CQS calculations for each time period, we are amending 42 CFR 510.400 to indicate that the required data submissions that previously applied to PY 5 will now apply to performance year subset 5.1, and we are adding a required data submission for performance year subset 5.2.

These additional requirements will reflect the timeframe of performance year subset 5.2, but will otherwise parallel the requirements for performance year subset 5.1, and will not require an increased amount of data for performance year subset 5.2 as compared to performance year subset 5.1. We recognize that some of the timeframe for both performance year subsets 5.1 and 5.2 quality data collection overlap with the effective dates of the asthma treatment waiverâ[] that provided reporting exemptions for hospitals participating in quality reporting programs, so we will use quality data reported before and after the effective dates of the asthma treatment waiver, for those quality measures to which the waiver applied. The final reconciliation calculation for performance year subset 5.2 will occur one year after the initial reconciliation of performance year subset 5.2. Although we will use claims data that were available 14 months after the end of performance year subset 5.2 for the subsequent reconciliation (as set forth in 42 CFR 510.305(i)(1)), as with the initial reconciliation, we will not begin the subsequent reconciliation calculation process until 17 months after the end of performance year subset 5.2.

Table 2 illustrates the timelines for performance year subsets 5.1 and 5.2. Table 2âTimelines for Performance Years 4 and 5Performance year (PY)Performance periodInitial reconciliation calculation startSubsequent reconciliation calculation startReconciliation amount (+/â)401/01/2019 to 12/31/20192 months after 12/31/2019. Late February 202014 months after 12/31/2019. Late February 2021Net PY3 and PY4 reconciliation amounts.5 (two periods)01/01/2020 to 09/30/2021Subset 5.101/01/2020 to 12/31/20212 months after 12/31/2020.

Late February 202114 months after 12/31/2020. Late February 2022Net PY4 and PY5.1 reconciliation amounts.Start Printed Page 71171Subset 5.201/01/2021 to 09/30/20215 months after 09/30/2021. Late February 202217 months after 09/30/2021. Late February 2023Net PY5.1 and PY5.2 reconciliation.

In order to reflect the changes in reconciliation timing and other changes associated with additional reconciliations in PY5, we are amending the following provisions. 42 CFR 510.2, 42 CFR 510.200, 42 CFR 510.305(b), (d)(1), (e), (i)(1) and (2), and (j)(1) and (2), and 42 CFR 510.400(b)(3)(v), and adding 42 CFR 510.400(b)(3)(vi). 4. DRG 521 and DRG 522 In this IFC we are amending our regulations at Â§â510.300(a) to specify that, as of October 1, 2020, the CJR model includes episodes when the MS-DRG assigned at discharge for an anchor hospitalization is one of two new MS-DRGs we adopted in the FY 2021 IPPS/LTCH final rule (85 FR 58432).

MS-DRG 521 (Hip Replacement with Principal Diagnosis of Hip Fracture with Major Complications and Comorbidities (MCC)) and MS-DRG 522 (Hip Replacement with Principal Diagnosis of Hip Fracture, without MCC). As indicated in 42 CFR 510.300(a)(1), the CJR model episode definition historically included MS-DRG 469 (Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity with MCC) and MS-DRG 470 (Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity without MCC). For purposes of calculating quality adjusted target prices, we further subdivided episodes within each MS-DRG based on the presence or absence of a primary hip fracture. In the FY 2021 IPPS/LTCH final rule, we stated that because the CJR model would continue until at least March 31, 2021, we intended to adopt a policy in the CJR final rule that incorporates these new MS-DRGs into the CJR model as of October 1, 2020 to avoid disruption to the model for the remainder of PY5 (as extended) and thereafter, if our proposal to extend the CJR model through PY8 were finalized (85 FR 58502).

To this end, we are adopting the change in this IFC, with retroactive effect to October 1, 2020. This change ensures that hip replacements with a principal diagnosis of hip fracture, with and without MCC, will continue to trigger CJR model episodes even though they are now assigned to these new DRGs rather than MS-DRGs 469 and 470. As background, in the FY 2021 IPPS/LTCH proposed rule (85 FR 32510), CMS proposed the creation of two new MS-DRGs, 521 and 522 (Hip Replacement with primary hip fracture, with and without major complications and comorbidities, respectively). Because the FY2021 IPPS/LTCH proposed rule was published after the CJR February 2020 proposed rule, the new MS-DRGs 521 and 522 were not addressed in the February 2020 proposed rule.

We solicited comment in the FY2021 IPPS/LTCH proposed rule on the effect this proposal would have on the CJR model and whether to incorporate MS-DRG 521 and MS-DRG 522, if finalized, into the CJR model's proposed extension to December 31, 2023. The public also had the opportunity to address this issue in comments responding to the CJR February 2020 proposed rule, as the comment period for that rule had been extended. We received three comments in response to the February 2020 proposed rule and 20 comments in response to the FY2021 IPPS/LTCH proposed rule addressing the effects of the proposed new MS-DRGs on the CJR model. Most commenters agreed that MS-DRGs 521 and 522 should be included in the definition of a CJR model episode, noting their assumption that this would have a neutral economic impact on the model and participants, as the CJR model already provides for separate quality adjusted target prices for hip fracture cases for MS-DRGs 469 and 470.

Multiple commenters stated their belief that there is value in maintaining hip fracture cases in the CJR model, including that it is administratively simpler and that maintaining hip fractures in the CJR model would mean those procedures remain subject to the value-based care incentives of the CJR model. Some commenters suggested that quality adjusted target prices for episodes previously triggered by MS-DRG 469 and MS-DRG 470 with hip fracture could apply to episodes triggered by the new MS-DRGs. Others noted that if the DRGs were added retroactively, they would not want the new DRGs to retroactively impact quality adjusted target prices. As of October 1, 2020, MS-DRGs 521 and 522 separately identify a subset of LEJR procedures that were previously grouped to MS-DRGs 469 and 470, and if the definition of a CJR model episode is not revised to accommodate this technical change the LEJR procedures associated with these new codes will no longer be part of the CJR model.

This result would be highly disruptive to the CJR model, because it would remove a significant number of episodes midway through a performance year. Therefore, we believe there is good cause for this rulemaking to change the definition of a CJR model episode to include MS-DRGs 521 and 522. Indeed, it would be contrary to the public interest to undertake traditional notice and comment rulemaking to adopt these regulatory changes because they are intended to preserve the model's scope in light of underlying technical changes in the IPPS. Based on the public comments previously described, we believe that including DRGs 521 and 522 in the CJR episode definition is less disruptive to participant hospitals than the alternative, which would be to allow hip replacements with a primary hip fracture to drop abruptly out of the model (or to drop out of the model until we were able to undertake full notice and comment rulemaking to add them back at a later point).

Beginning on October 1, 2020, the Medicare IPPS grouper began to assign those hospitalizations to one of the new MS-DRGs, with no billing changes required of participant hospitals. The new MS-DRGs will be incorporated into the CJR episode reconciliation data system, and will be included in participant hospitals' monthly data feeds going forward. Participant hospitals were notified of their quality adjusted target prices for episodes beginning on October 1, 2020 for MS-DRGs 469 and 470, with and without hip fracture. As of October 1, 2020, the quality adjusted target prices for MS-DRGs 469 and 470 with hip fracture will apply to episodes initiated by the new MS-DRGs 521 and 522, respectively, for the remainder of PY5 (including both performance year subsets 5.1 and 5.2).

Given that the CJR model currently provides separate quality adjusted target prices for episodes with and without a hip fracture, incorporating the new DRGs would have minimal financial impact on the model. The PY5 quality adjusted target price calculation methodology includes the application of update factors (80 FR 73342-73346), which incorporate annual changes to each CMS payment system (for example, IPPS, OPPS, and SNF). The update factor is calculated and applied twice per year, in order to incorporate both fiscal year and calendar year payment system updates. The MS-DRG weights assigned to the new MS-DRGs 521 and 522 in the FY 2021 IPPS/LTCH final rule (84 FR 42044) will be incorporated into the IPPS update factor as part of the calculation of the quality adjusted target prices for episodes beginning between October 1, 2020 and December 31, 2020.

5. Changes to Extreme and Uncontrollable Circumstances Policy for the PHE for asthma treatment We are also modifying the extreme and uncontrollable circumstances adjustment for asthma treatment in Â§â510.300(k)(4) to expire on March 31, 2021 or the last day of the emergency period, whichever is earlier. In addition, we are adopting a more targeted adjustment, which will apply after March 31, 2021 or the last day of emergency period (whichever is earlier), so that financial safeguards continue to apply for CJR episodes during which a CJR beneficiary receives a positive asthma treatment diagnosis. Currently, the extreme and uncontrollable circumstances adjustment for asthma treatment provides financial safeguards for participant hospitals that have a CCN primary address that is located in an emergency area during an emergency period, as those terms are defined in section 1135(g) of the Act, for which the Secretary issued a waiver or modification of requirements under section 1135 of the Act on March 13, 2020, effectively applying the financial safeguards to all participant hospitals.

These financial safeguards, wherein actual episode payments are capped at the target price determined for that episode, apply to fracture or non-fracture episode with a date of admission to the anchor hospitalization that is on or within 30 days before the date that the emergency period (as defined in section 1135(g) of the Act) begins or that occurs through the termination of the emergency period (as described in section 1135(e) of the Act). In the April 2020 IFC we explained this extreme and uncontrollable circumstances adjustment, noting that the previous CJR model policy for extreme and uncontrollable circumstances was not applicable to the PHE for the asthma treatment ventolin. We also indicated that we did not expect many new CJR episodes to initiate in light of the asthma treatment ventolin and the related guidance to avoid elective surgeries. We further stated that we wanted to avoid inadvertently creating incentives to place cost considerations above patient safety within the CJR model, given the challenges to the health care delivery system in responding to asthma treatment cases and the expenses associated with treating the ventolin.

We received comments on both the April 2020 IFC and the CJR February 2020 proposed rule about the extreme and uncontrollable circumstances adjustment. Commenters favored the extreme and uncontrollable circumstances policy for asthma treatment and commended CMS for providing relief to participant hospitals. Some commenters questioned what steps CMS would take once the PHE ends and noted the uncertainty in the current policy since there is not a concrete end date for the PHE. A commenter recommended CMS hold participant hospitals harmless from performance-related penalties for the 2020 performance year and urged CMS to make appropriate adjustments for the 2020 and 2021 performance years and to address the impact of asthma treatment on financial expenditures, performance scores and risk adjustment.

We appreciate commenters' positive feedback on the April 2020 IFC and our decision to provide relief to participant hospitals. At the onset on the PHE, we quickly developed financial safeguards in the April 2020 IFC due to the mandatory nature of the model and the location of all 471-participant hospitals in MSAs where asthma treatment was most prevalent. For example, there are 98 participant hospitals in the New York/New Jersey Metropolitan Area, which was the epicenter for asthma treatment.[] Further, at that time, we did not possess data that allowed CMS to determine the asthma treatment ventolin's effect on the CJR model, and believed it was most prudent to waive downside risk for all episodes thorough the duration of the PHE. Since publishing the April 2020 IFC, we reviewed Medicare claims data and observe a steep decline in the initiation of episodes in April 2020 (See Table 1).

Post April 2020, CJR episodes are increasing, and though not at normal utilization as compared to 2019 Medicare claims data, the data reflects a continual initiation of CJR episodes despite the ongoing PHE. In addition, related Federal guidance to avoid elective surgeries has expired, which allows certain participant hospitals to initiate elective LEJR procedures.[] The continual initiation of CJR episodes during the PHE is contrary to our assumption in the April 2020 IFC, that Start Printed Page 71173is, we did not expect many new CJR episodes to initiate during the PHE. Absent a change to specify an end date, the current extreme and uncontrollable adjustment in 42 CFR 510.300(k)(4) would continue as long as the PHE. Unfortunately, the combination of CJR episode volume increasing to levels we did not anticipate during the PHE and the continued renewal of the PHE threatens the ability of the CJR model to generate any savings over the course of the model.

In addition, in order to account for CJR beneficiaries with a positive asthma treatment diagnosis during a CJR episode that initiates after the adjustments for extreme and uncontrollable circumstances specified in Â§â510.305(k)(4) end, we are amending our regulations at Â§â510.305(e)(1)(i) to cap actual episode payments at the quality adjusted target price for the episode, effectively waiving downside risk for all episodes with actual episode payments that include a claim with a asthma treatment diagnosis code. This policy will apply after March 31, 2021 or the last day of the PHE, whichever occurs earlier. In response to commenters' questions about how the CJR model will alleviate financial risk associated with asthma treatment once the PHE expires, we explored the flexibilities provided by other CMMI models and found them to be consistent with a targeted, episode-based approach to providing financial relief from asthma treatment. In order to be responsible stewards of the Medicare Trust Fund, we are adopting a policy to provide participant hospitals continuing financial protection from the effect of asthma treatment on the CJR model that may continue beyond the end of the PHE for asthma treatment or March 31, 2021 (whichever is earlier).

Specifically, at the initial and subsequent reconciliations of performance year subset 5.2, which will include episodes subject to this new adjustment policy, we will identify episodes with actual episode payments with any claim containing a asthma treatment diagnosis and costs for those episodes will be capped at the quality adjusted target price, effectively waiving downside risk for that episode. A asthma treatment diagnosis is identified by the following ICD-10-CM diagnosis codes. B97.29. U07.1.

Provisions of the Interim Final RuleâDepartments of the Treasury, Labor and Health and Human Services A. Rapid Coverage of Preventive Services for asthma 1. Background In addition to the steps Congress took to ensure coverage of asthma treatment diagnostic testing, in section 3203 of the CARES Act, Congress required group health plans and health insurance issuers offering group or individual health insurance coverage to cover, without cost sharing, qualifying asthma preventive services. This coverage is required to be provided âpursuant to section 2713(a) of the [PHS] Act,â including its implementing regulations or any successor regulations.

Section 2713 of the PHS Act was added by section 1001 of PPACA and incorporated by reference into ERISA by section 715 of ERISA and into the Code by section 9815 of the Code. Section 2713 of the PHS Act and the regulations implementing section 2713 of the PHS Act require non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage to provide coverage of certain specified preventive items and services without cost sharing. These services include. Evidence-based items or services that have in effect a rating of âAâ or âBâ in the current recommendations of the USPSTF with respect to the individual involved.

Immunizations for routine use in children, adolescents, and adults that have in effect a recommendation from ACIP with respect to the individual involved. A recommendation of ACIP is considered to be âin effectâ after it has been adopted by the Director of the CDC. A recommendation is considered to be for âroutine useâ if it appears on the Immunization Schedules of the CDC. With respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA).

With respect to women, preventive care and screenings provided for in comprehensive guidelines supported by HRSA (not otherwise addressed by the recommendations of the USPSTF), subject to certain exemptions and accommodations (see 45 CFR 147.131 through 147.133). The Departments' current regulations (herein referred to as the 2015 Final Regulations) under section 2713 of the PHS Act at 26 CFR 54.9815-2713. 29 CFR 2590.715-2713. And 45 CFR 147.130 require that plans and issuers provide coverage of recommended preventive services for plan years that begin on or after September 23, 2010, or, if later, for plan years that begin on or after the date that is one year after the date the recommendation or guideline is issued.

Under the 2015 Final Regulations, if a recommended preventive service is billed separately (or is tracked as individual encounter data separately) from an office visit, then a plan or issuer Start Printed Page 71174may impose cost-sharing requirements with respect to the office visit. However, if a preventive service is not billed separately (or is not tracked as individual encounter data separately) from an office visit and the primary purpose of the office visit is the delivery of such an item or service, then a plan or issuer may not impose cost-sharing requirements with respect to the office visit. The 2015 Final Regulations generally do not require a plan and issuer that has a network of providers to provide benefits for applicable preventive items or services that are delivered by an out-of-network provider. Moreover, the 2015 Final Regulations generally do not preclude a plan or issuer that has a network of providers from imposing cost-sharing requirements for preventive services that are delivered by an out-of-network provider.

However, if a plan or issuer does not have in its network a provider who can provide a preventive service, then the plan or issuer must cover the recommended preventive service when performed by an out-of-network provider and may not impose cost sharing with respect to the recommended preventive service. Many items and services required to be covered under section 2713 of the PHS Act typically are provided as part of the usual course of preventive care, often according to regularly scheduled intervals. Examples include immunizations provided according to schedules established by the CDC and other annual screenings or counseling. Therefore, the 2015 Final Regulations require coverage without cost sharing for applicable immunizations that are recommended by ACIP for routine use, and state that a recommendation is considered to be for âroutine useâ if it appears on the Immunization Schedules of the CDC.

Section 3203 of the CARES Act establishes a more accelerated timeline for required coverage of qualifying asthma preventive services than other recommended preventive services under PHS Act section 2713. As stated above, coverage of qualifying asthma preventive services must be provided no later than 15 business days following an applicable recommendation. In addition, it is possible that items, services, and immunizations used to prevent or mitigate asthma treatment will not, in the immediate future, be recommended as part of a usual course of preventive care, but rather for more urgent use. As reflected by the expedited timeline for coverage Congress established in section 3203 of the CARES Act, the need to provide coverage of qualifying asthma preventive services is urgent.

Therefore, as discussed below, this IFC requires coverage of asthma treatment immunizations within 15 business days after the immunization has been recommended by ACIP and adopted by the CDC, regardless of whether it appears on the Immunization Schedules of the CDC for routine use. Additionally, in light of the current PHE for asthma treatment, it is imperative that group health plans and health insurance issuers provide full coverage for these items and services, including costs for the administration of treatments, and ensure timely access to coverage as Congress intended. Accordingly, in this IFC, the Departments provide certain clarifications previously made with respect to the 2015 Final Regulations and amend those regulations to implement unique requirements related to covering qualifying asthma preventive services.[] 2. Scope of Requirement To Cover Certain Recommended Preventive Services Under Section 2713 of the Public Health Service Act a.

Prior to the publication of the 2015 Final Regulations, the Departments received questions from stakeholders regarding discrete coverage issues related to certain recommended preventive services. In particular, with respect to colonoscopies, stakeholders asked whether certain related services (such as the cost of polyp removal or anesthesia) must also be covered without cost sharing. The Departments clarified in subregulatory guidance that a plan or issuer may not impose cost sharing for polyp removal during a preventive screening colonoscopy, as such service is an integral part of a colonoscopy, and also stated that anesthesia provided in connection with a preventive colonoscopy must be covered without cost sharing.[] Consistent with the examples provided in the 2015 Final Regulations and subregulatory guidance cited in the preamble to the rulemaking promulgating the 2015 Final Regulations, the Departments further clarify that under the 2015 Final Regulations and this IFC, plans and issuers subject to section 2713 of the PHS Act must cover, without cost sharing, items and services that are integral to the furnishing of the recommended preventive service, regardless of whether the item or service is billed separately. For example, several of the recommended preventive services involve screenings for the presence of certain health conditions, such as diabetes, or a variety of sexually transmitted s.

These recommended screenings, typically performed by laboratories, cannot be conducted without first collecting a specimen. Accordingly, plans and issuers subject to section 2713 of the PHS Act must cover without cost sharing both the specimen collection and the recommended preventive service, regardless of how the specimen collection is billed. Similarly, a recommended immunization generally cannot be furnished without being administered by a medical professional. As qualifying asthma preventive services are expected to include immunizations, plans and issuers subject to section 2713 of the PHS Act Start Printed Page 71175must cover without cost sharing such an immunization and its administration, regardless of how the administration is billed, and regardless of whether a asthma treatment or any other immunization requires the administration of multiple doses in order to be considered a complete vaccination.

Out-of-Network Coverage During the PHE for asthma treatment The 2015 Final Regulations permit a group health plan or issuer that has a network of providers to omit coverage or to impose cost-sharing requirements for recommended preventive services when such services are provided by an out-of-network provider, unless the plan or issuer does not have in its network a provider who can provide the service.[] This approach reflects that, as noted earlier in this section of the preamble, recommended preventive services generally are obtained as part of a regular course of preventive care, so participants, beneficiaries, and enrollees typically have the opportunity to seek such care from an in-network provider. By contrast, in the immediate term, newly developed qualifying asthma preventive services might be available from a narrower range of providers than other, more established recommended preventive services. To help ensure full access to and the widespread use of qualifying asthma preventive services to mitigate the effect of the PHE for asthma treatment and slow transmission of the ventolin, it is critical that individuals be able to receive such services from any provider authorized to provide the service. Therefore, this IFC amends the 2015 Final Regulations to require that plans and issuers subject to section 2713 of the PHS Act must cover without cost sharing a qualifying asthma preventive service, regardless of whether such service is delivered by an in-network or out-of-network provider.

This is based on the Departments' view that participants, beneficiaries, and enrollees may not be able to locate in-network providers consistently during the emergency period. To satisfy this requirement, the Departments are of the view that plans and issuers must administer this out-of-network coverage requirement in such a way that makes receiving out-of-network services for qualifying asthma preventive services a meaningful benefit for participants, beneficiaries, and enrollees. To be a meaningful benefit, the Departments are of the view that plans and issuers must administer this out-of-network coverage requirement in a way that ensures that participants, beneficiaries, and enrollees have access to a variety of out-of-network providers for such services. To the extent plans and issuers reimburse out-of-network providers an unreasonably low amount for qualifying asthma preventive services, including for administration of a asthma treatment, this approach could severely limit the number of such providers that are willing to provide the service, which would contravene the purpose of the requirement to provide out-of-network coverage without cost sharing of qualifying asthma preventive services.

The Departments request comment on the issue of network adequacy and whether and, if so, how long provider networks are expected to be inadequate. The Departments also request comment on the safeguards in this IFC to ensure that out-of-network reimbursement rates are reasonable and that providers administering a publicly funded asthma treatment are reimbursed by group health plans and issuers prevailing market rates in the absence of a negotiated rate, and whether other examples of reasonable reimbursement rates, in addition to Medicare rates, would be useful. 3. Definition of Qualifying asthma Preventive Services Section 3203(b)(1) of the CARES Act defines âqualifying asthma preventive serviceâ as an item, service, or immunization that is intended to prevent or mitigate asthma treatment and that isâ(A) an evidence-based item or service that has in effect a rating of `A' or `B' in the current recommendations of the USPSTF.

Or (B) an immunization that has in effect a recommendation from ACIP with respect to the individual involved. The statutory provisions describing USPSTF and ACIP recommendations in this definition are substantively identical to the ones at section 2713(a)(1) and (2) of the PHS Act. However, as stated above, under the 2015 Final Regulations, only âimmunizations for routine use in children, adolescents, and adultsâ that are recommended by ACIP must be covered without cost sharing.[] A recommendation is considered to be for routine use if it is listed on the CDC's Immunization Schedules.[] This IFC provides a definition of qualifying asthma preventive services that is consistent with the statutory definition in section 3203 of the CARES Act. However, the Departments note that unlike the other preventive service immunizations required to be covered without cost sharing under section 2713 of the PHS Act and the 2015 Final Regulations, this definition and related coverage requirement are not limited to asthma treatment immunizations recommended by ACIP for âroutine use.â While other preventive items and services may be recommended for routine use, for reasons described elsewhere in this section of the preamble, the PHE for asthma treatment presents unique circumstances and qualifying asthma preventive services might not, in the immediate term, be recommended for routine use, according to specified schedules.

Qualifying asthma Preventive ServicesâTiming Requirement Section 2713 of the PHS Act and the 2015 Final Regulations require plans and issuers to cover recommended preventive items and services beginning with the first plan year (or in the individual market, policy year) that is one year after the date the recommendation or guideline is issued. Section 3203 of the CARES Act accelerates the timeline for coverage of qualifying asthma preventive services without cost sharing, requiring coverage to be provided within 15 business days after the date on which a recommendation is made relating to such service. This IFC codifies these timing requirements at 26 CFR 54.9815-2713T(b)(3). 29 CFR 2590.715-2713(b)(3).

And 45 CFR 147.130(b)(3). In addition, the IFC adds a sunset provision at 26 CFR 54.9815-2713T(e). 29 CFR 2590.715-2713(e). And 45 CFR 147.130(e), under which the amendments made to the regulations will not apply with respect to qualifying asthma preventive services furnished on or after the expiration of the PHE for asthma treatment.

Section 3201 of the CARES Act, enacted on March 27, 2020, amended section 6001 of the FFCRA to include a broader range of diagnostic tests that plans and issuers must cover without any cost-sharing requirements or prior authorization or other medical management requirements. Section 3202(a) of the CARES Act provides that a plan or issuer providing coverage of items or services described in section 6001(a) of the FFCRA shall reimburse the provider of the diagnostic testing at a rate negotiated with the provider, or if there is no negotiated rate, at an amount that equals the cash price for such service as listed by the provider on a public internet website. As previously articulated in guidance, the Departments interpret the requirement to provide coverage without cost sharing in section 6001 of the FFCRA, together with section 3202(a) of the CARES Act, as establishing a process for setting reimbursement rates and protecting participants, beneficiaries, and enrollees from being balance billed for an applicable asthma treatment test.[] These provisions help ensure consumers can be tested for asthma treatment without barriers related to cost, and are critical to the ability to detect the ventolin and stop its spread. However, testing efforts have continued to be hampered by challenges, such as delays in obtaining results, issues with test accuracy, and supply shortages.[] The Departments encourage group health plans and issuers of group or individual health insurance coverage to consider market-driven approaches to addressing these continued challenges surrounding asthma treatment diagnostic testing.

The Departments encourage plans and issuers to explore using payment arrangements that create incentives for providers to reduce the time it takes to provide results for diagnostic testing for asthma treatment, while maintaining the accuracy rates of their test results in instances where it is within the ability of providers to address a delay. At certain points in this PHE, there have been wide variations in the time it takes providers to make test results available to consumers. These delays in obtaining test results increase the risk that infected individuals may unknowingly infect others. These delays could be caused by large volumes of tests to process and/or inadequate resources.

State Innovation Waivers Policy and Regulatory Revisions in Response to the PHE for asthma treatment Public Health Emergency 1. Background Section 1332 of the PPACA permits states to apply for a State Innovation Waiver (also referred to as âsection 1332 waiversâ or âState Relief and Empowerment Waiversâ) to pursue innovative strategies for providing their residents with access to higher value, more affordable health coverage. The overarching goal of section 1332 waivers is to give all Americans the opportunity to obtain high value and affordable health coverage regardless of income, geography, age, sex, or health status, Start Printed Page 71177while simultaneously empowering states to develop health coverage strategies that best meet the needs of their residents. Section 1332 waivers provide states an opportunity to promote a stable health insurance market that offers more choice and affordability to their residents.

Under section 1332 of the PPACA, a State Innovation Waiver can be approved by HHS and the Department of the Treasury if it provides access to quality health coverage that is at least as comprehensive and affordable as would be provided absent the waiver, provides coverage to a comparable number of residents of the state as would be provided coverage absent a waiver, and does not increase the Federal deficit. To date, HHS and the Department of the Treasury have approved 15 state waiver requests, 14 of which implement state-based reinsurance programs.[] As noted in a recent data brief issued by CMS, section 1332 state-based reinsurance waivers have resulted in a statewide average premium reduction ranging from four to 37 percent in calendar year 2020 for residents in states with approved waivers.[] Reinsurance provides a direct benefit to consumers by paying a portion of provider claims that would otherwise be paid by consumers through higher premiums and lowering premiums for people in the individual health insurance market. HHS and the Department of the Treasury continue to encourage states to take advantage of the flexibilities available through section 1332 waivers in order to pursue solutions to help lower costs and increase coverage choices for Americans faced with unaffordable premiums and reduced competition in the insurance market both during and after the PHE for asthma treatment. Section 1332(a)(4)(B) of the PPACA requires the Secretary of HHS and the Secretary of the Treasury (the Secretaries) to issue regulations regarding procedures for State Innovation Waivers.

This IFC promulgates rules to establish a framework for the Secretaries to modify some of the existing regulatory public notice procedures to expedite a decision on a proposed waiver request during the PHE for asthma treatment when a delay would undermine or compromise the purpose of the proposed waiver request and be contrary to the interests of consumers. The Secretaries will also make available such flexibility regarding public notice procedures should any state with an approved section 1332 waiver request an extension or amendment of an approved section 1332 waiver during the PHE for asthma treatment. Similarly, this IFC also establishes a framework for the Secretaries to modify, in part, post award public notice procedures for an approved waiver request that would otherwise take place or become due during the PHE for asthma treatment. The Secretaries will also make available such flexibility for post award public notice procedures for approved waiver extensions, amendments, or phase-out for a waiver should those otherwise take place or become due during the PHE for asthma treatment.

HHS and the Department of the Treasury are of the view that section 1332 waivers are a critical tool for states to ensure patients have stable access to health care coverage, including during the PHE for asthma treatment. These interim final provisions are effective immediately for the duration of the PHE for asthma treatment. HHS and the Department of the Treasury note that existing threats to consumers' access to health coverage or careâsuch as in geographic areas in which issuer participation has been low for some timeâwould not be considered emergency situations for purposes of applying the flexibilities adopted in this rulemaking. 2.

Where the written comments may be submitted. And the location, date, and time of public hearings that will be convened by the state to seek public input on the application for a section 1332 waiver.[] After issuing the public notice and prior to submitting an application for a section 1332 waiver, the state must hold public hearings to allow the public to learn about and comment on the state's application, and must publish the date, time, and location of the hearings in a prominent location on the state's public website.[] As set forth in Â§Â§â33.112(a)(2) and 155.1312(a)(2), as part of the public notice and comment period, a state with one or more federally recognized tribes must conduct a separate process for meaningful consultation with such tribes, if applicable. As HHS and the Department of the Treasury explained in the 2012 Final Rule preamble, this tribal consultation must be conducted in accordance with Executive Order (E.O.) 13175, and, as E.O. 13175 also applies to Medicaid, a state may use a Medicaid consultation process to satisfy the consultation needed for a section 1332 waiver (77 FR 11700, 11706).

Furthermore, the state should include in its section 1332 waiver application a description of issues raised and comments received. In addition, under section 1332(a)(4)(B)(iii) of the PPACA and the existing implementing regulations at Â§Â§â33.116(b) and 155.1316(b), the Secretary of HHS and the Secretary of the Treasury are required to provide a Federal public notice and comment period following their preliminary determination that a state's section 1332 waiver application is complete. Section 1332 waivers may vary significantly in their complexity and breadth. The existing regulations generally provide states and the Federal Government flexibility in determining and/or extending the length of the comment periods.

Additionally, states may face uncertainty as to whether their waiver request will be approved in time, given the state and Federal public notice procedures or other public participation requirement associated with state procedures that would otherwise require an in-person gathering, to expeditiously reform their health insurance markets and to protect consumers from the effects of the PHE for asthma treatment. Some states may not consider more robust changes because they are concerned that the current section 1332 waiver application requirements are too time-consuming or burdensome to pursue during the PHE for asthma treatment. Therefore, HHS and the Department of the Treasury are of the view that having the flexibility to modify certain public notice procedures and participation requirements during the PHE for asthma treatment will protect public health and health insurance markets, and will increase flexibility and reduce burdens for states seeking to use section 1332 waivers as a means of innovation for providing coverage, lowering premiums, and improving their health care markets. Section 1332 waivers are a critical tool for states to ensure patients across the country have access to health care coverage.

About 10.7 million individuals on average rely on the Exchanges to purchase individual health insurance coverage throughout the year.[] Although recently there have been positive premium stabilization and insurer participation trends, the asthma treatment ventolin has introduced new uncertainties in the individual and small group markets such that past trends resulting in limited access and affordability may return in some areas. For example, in response to the uncertainty created by the PHE for asthma treatment regarding health care utilization rates and claims costs, such as those associated with testing and treatment for asthma treatment, premiums may increase and issuers may reduce their presence or coverage options in the individual and small group markets. Additionally, due to the PHE for asthma treatment, some issuers may have difficulty predicting the composition of their risk pools given uncertainty about Start Printed Page 71179the risk profiles of many new enrollees coming from employer-sponsored coverage and the potential transition of other enrollees to Medicaid due to income loss. Therefore, HHS and the Department of the Treasury are concerned that past trends that threaten the stability of the individual market risk pool may return, leading some issuers to cease offering coverage on the Exchanges in some states and counties and leading other issuers to increase their rates, leaving some geographic areas with limited or no affordable Exchange coverage options.

States may also seek to modify the state and/or Federal comment periods to be less than 30 days and to host public hearings virtually rather than in-person. For a state to qualify for modification of the state or Federal public notice requirements to expedite a decision on a proposed waiver request during the PHE for asthma treatment, a delay must undermine or compromise the purpose of the proposed waiver request and be contrary to the interests of consumers. During the PHE for asthma treatment, the Secretary of HHS and the Secretary of the Treasury (the Secretaries) may modify the Federal and/or state public notice procedures, in part, if the state meets all of the following. The state requests a modification in the form and manner specified by the Secretaries.

The state acted in good faith, and in a diligent, timely, and prudent manner in the preparation of the request for the modification for the waiver, and the waiver application request. The state details in its request for a modification, as applicable, the reason(s) the state seeks a modification from the state public notice procedures, describes how the state meets the modification criteria, and describes the alternative public notice procedures it proposes to implement at the state level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the state's request for a modification. The state details in its request for a modification, as applicable, the justification for the request and the alternative public notice procedures it requests to be implemented at the Federal level. The state must, as applicable, implement the alternative public notice procedures at the state level if the state's modification request is approved and, if required, amend the waiver application to specify that it is the state's intent to comply with those alternative public notice procedures in the state's modification request.

As another example, the Secretaries may agree with a state that, due to emergency circumstances that have arisen related to the PHE for asthma treatment, there is insufficient time for the state to provide public notice and hold any public hearings at the state level prior to submitting its section 1332 waiver application as required by Â§Â§â33.112(a) and 155.1312(a), and grant the state's request to provide public notice and hold public hearings at the state level after the state submits its section 1332 waiver application. In situations where HHS and the Department of the Treasury determine that public notice and hearings are warranted on a different timeframe and may occur after the submission of a state's waiver application request, the state will be required to amend the application request as necessary to reflect public comments or other relevant feedback received during the alternative public notice procedures. HHS and the Department of the Treasury will evaluate a state's request for a modification and issue their modification determination within approximately 15 calendar days after the request is received. In assessing whether a state acted in good faith, and in a diligent, timely, and prudent manner in the preparation of the modification request for the waiver, and for the waiver application, HHS and the Department of the Treasury will evaluate whether the relevant circumstances constitute an emergency.

HHS and the Department of the Treasury remind states that any public participation processes must continue to comply with applicable Federal civil rights laws, including taking reasonable steps to provide meaningful access for individuals with limited English Start Printed Page 71180proficiency and taking appropriate steps to ensure effective communication with individuals with disabilities, including accessibility of information and communication technology. Please note that virtual meetings may present additional accessibility challenges for people with communications and mobility disabilities, as well as to those who lack broadband access. Ensuring effective communication may include providing American Sign Language interpretation and real-time captioning, and ensuring that the platform is interoperable with assistive technology for those with mobility difficulties. HHS and the Department of the Treasury especially encourage states to strive to obtain meaningful input from potentially affected populations, including low-income residents, residents with high expected health care costs, persons less likely to have access to care, and members of federally-recognized tribes, if applicable, as part of any alternative public participation process.[] The Secretary of HHS will publish on the CMS website any modification determinations within 15 calendar days of the Secretary of HHS and the Secretary of the Treasury making such a determination, as well as the approved revised timeline for public comment at the state and Federal level, as applicable.

In addition, under the new Â§Â§â33.118 and 155.1318, the state will be required to publish on its website any modification requests and determinations within 15 calendar days of receipt of the determination, as well as the approved revised timeline for public comment at the state and Federal level, as applicable. 3. Monitoring and Compliance (31 CFR 33.120 and 45 CFR 155.1320) As section 1332 waivers are likely to a have a significant impact on individuals, states, and the Federal Government, the 2012 Final Rule established processes and methodologies to ensure that the Secretary of HHS and the Secretary of the Treasury receive adequate and appropriate information regarding section 1332 waivers (consistent with section 1332(a)(4)(B)(iv) of the PPACA). Under Â§Â§â33.120(c) and 155.1320(c), to ensure continued public input within at least 6 months after the implementation date, and annually thereafter, states are required to hold a public forum at which members of the public have an opportunity to provide comments on the progress of the program authorized by the section 1332 waiver and to provide a summary of this forum to the Secretary of HHS as part of the quarterly and annual reports required under Â§Â§â33.124 and 155.1324.

Under Â§Â§â33.120(c)(1) and 155.1320(c)(1), states are required to publish the date, time, and location of the public forum in a prominent location on the state's public website at least 30 days prior to the date of the planned public forum. This IFC adds new Â§Â§â33.120(c)(2) and 155.1320(c)(2), which provide that the Secretary of HHS and the Secretary of the Treasury (the Secretaries) may waive, in part, post award public notice requirements for an approved waiver outlined in Â§Â§â33.120(c) and 155.1320(c) during the PHE for asthma treatment when the application of the post award public notice procedures would be contrary to the interests of consumers during the PHE for asthma treatment. The Secretaries may modify the post award public notice procedures, in part, when the state meets all of the following. The state requests a modification in the form and manner specified by the Secretaries.

The state acts in good faith, and in a diligent, timely, and prudent manner to comply with the monitoring and compliance requirements under the regulations and specific terms and conditions of the waiver and to submit and prepare the request for a modification. The state details in its request for a modification the reason(s) the state seeks a modification from the state post award public notice procedures, describes how the state meets the modification criteria, and describes the alternative post award public notice procedures it proposes to implement at the state level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the state's request for a modification. As part of HHS and the Department of the Treasury's monitoring and oversight of approved section 1332 waivers, the Secretary of HHS and the Secretary of the Treasury, at their discretion, monitor the state's compliance with the specific terms and conditions of the waiver including, but not limited to, compliance with the guardrails, reporting requirements, and the post award forum requirements. Under the flexibilities provided in this IFC, the Secretaries may, for example, allow the public forum for an approved waiver that would take place or become due during the PHE for asthma treatment to be held virtually rather than as an in person gathering.

HHS and the Department of the Treasury will work closely with states that have these approved flexibilities through oversight and monitoring activities to ensure open communication with states during the PHE for asthma treatment. HHS and the Department of the Treasury also will remain focused on ensuring the public is informed about the implementation of programs authorized by section 1332 waivers and have a meaningful opportunity to comment on the implementation. The Secretary of HHS and the Secretary of the Treasury will evaluate a state's request for a modification and issue their modification determination within approximately 15 calendar days after the request is received. The state is required to publish on its website any modification requests and determinations by HHS and the Department of the Treasury within 15 calendar days of receipt of the determination, as well as information on the approved revised timeline for the state's post award public notice procedures, as applicable.

Since the state is already required to post materials as part of post award annual reporting requirements, such as the notice for the public forum and annual report, states will be responsible for ensuring that the public is aware of the determination to modify the public notice procedures and must include this information along with the information required under Â§Â§â33.120(c)(1) and 155.1320(c)(1) in a prominent location on the state's public website. HHS and the Department of the Treasury are of the view that post award forums are critical to ensure that the public has a regular opportunity to learn about and comment on the progress of section 1332 waivers. States that receive approval, to modify, in part, these post award public notice procedures would still need to meet all other requirements specified in Â§Â§â33.112(b) and 155.1312(b). For example, should the state receive a modification approval that permits it to hold the post award public forum virtually instead of in person, the state must still publish the notice of its post award public notice on Start Printed Page 71181the state's public website and use other effective means to communicate the required information to the public.

The public notice must include the website, date, and time of the public forum that will be convened by the state, information related to the timeframe for comments, and how comments from the public on the section 1332 waiver must be submitted. HHS and the Department of the Treasury remind states that they still must also comply with Federal civil rights requirements, including laws pertaining to accessibility, if the Secretary of HHS and the Secretary of the Treasury approve a modification from all or a portion of the post award public notice procedures. In such a circumstance, the state would need to ensure these virtual public hearings are as accessible as possible during the PHE for asthma treatment so members of the public can participate and submit comments. The state should also track how many people are attending these forums, if possible.

V. Waiver of Proposed Rulemaking Section 553(b) of the APA requires the agency to publish a notice of the proposed rule in the Federal Register that includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subjects and issues involved. Section 553(c) further requires the agency to give interested parties the opportunity to participate in the rulemaking through public comment before the provisions of the rule take effect. Section 553(b)(B) authorizes the agency to waive these procedures, however, if the agency finds good cause that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued.

Section 553(d) ordinarily requires a 30-day delay in the effective date of a final rule from the date of its publication in the Federal Register. This 30-day delay in effective date can be waived, however, if an agency finds good cause to support an earlier effective date. Finally, the Congressional Review Act (CRA) requires a delay in the effective date for major rules unless an agency finds good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, in which case the rule shall take effect at such time as the agency determines. 5 U.S.C.

801(a)(3), 808(2). As noted earlier in this preamble, on January 30, 2020, the International Health Regulations Emergency Committee of the WHO declared the outbreak a âPublic Health Emergency of international concern.â On January 31, 2020, pursuant to section 319 of the PHS, the HHS Secretary determined that a PHE exists for the United States to aid the nation's health care community in responding to asthma treatment. On March 11, 2020, the WHO publicly declared asthma treatment a ventolin. On March 13, 2020, the President declared the asthma treatment ventolin a national emergency.

553(b)(B). For those same reasons, as authorized by section 808(2) of the CRA, the Departments find it is impracticable and contrary to the public interest not to waive the delay in effective date of this IFC under section 801 of the CRA. Therefore, the Departments find there is good cause to waive the CRA's delay in effective date pursuant to section 808(2) of the CRA. Thus, the Departments find good cause to waive the applicable delays in the effective date and, moreover, to establish these policies in this IFC applicable as of the date of display at the Office of the Federal Register.

In this IFC, consistent with section 1902(a)(4) and (a)(19) of the Act, the Department adds a new subpart G to 42 CFR part 433 to provide states with more flexibility, subject to certain safeguards, in implementing the requirement in section 6008(b)(3) of the FFCRA that states maintain Medicaid beneficiary enrollment in order to receive the temporary increase in Federal funding in the FFCRA. This temporary funding increase is effective beginning January 1, 2020 and could extend through the last day of the calendar quarter in which the PHE for asthma treatment, including any extensions, terminates, if the state claims the temporary funding increase in that quarter. This provision of the IFC is immediately necessary to ensure that states can determine eligibility and provide care and services during the PHE in a manner that is consistent with simplicity of administration and the best interests of beneficiaries and also claim the temporary funding increase. In this IFC, HHS and the Department of the Treasury are setting forth flexibilities in the public notice and post award public participation requirements for a State Innovation Waiver described in section 1332 of PPACA during the PHE for asthma treatment.

HHS and the Department of the Treasury are of the view that the flexibility to modify certain public notice procedures and participation requirements will increase flexibility and reduce burden for states seeking to use section 1332 waivers as a means of innovation for providing coverage, lowering premiums, and improving their health care markets during the PHE for asthma treatment. As such, these flexibilities are immediately necessary to provide states applying for a section 1332 waiver or during the post award period with the option to request a modification from the state and/or Federal public notice requirements when a delay would undermine or compromise the purpose of the waiver and be contrary to the interests of consumers. HHS and the Department of the Treasury are of the view that it could be contrary to the public interest to require full notice and comment during the current PHE for asthma treatment because following the normal timeframes and requirements could result in waiver approvals for Start Printed Page 71182innovative waivers taking effect after issuers have already made their decisions regarding issuer participation in the individual market and after rates for the upcoming plan year have been submitted. A modification from the public participation requirements would be beneficial to the public interest by providing states and the Federal Government the flexibilities necessary to review and approve, as appropriate, section 1332 waivers that expand access to coverage on a faster timeframe.

In this IFC, the Departments amend the regulations under section 2713 of the PHS Act to implement the requirement in section 3203 of the CARES Act that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage provide coverage without cost sharing for qualifying asthma preventive services. This coverage must be provided within 15 business days after the date on which a recommendation is made by the USPSTF or ACIP. The Departments also establish in this IFC that this coverage must be provided regardless of whether the service is delivered by an in-network or out-of-network provider. The Departments are issuing these amendments under the authority of section 9833 of the Code, section 734 of ERISA, and section 2792 of the PHS Act.

In addition, unlike other preventive items and services typically provided according to regularly scheduled intervals, items and services intended to prevent or mitigate asthma treatment will not, in the immediate future, be provided as part of a usual course of preventive care. Instead, the Departments expect consumers to receive these services once they are recommended for the general public or specific high-risk or high-priority populations. To help ensure full access to and the widespread use of qualifying asthma preventive services to mitigate the PHE for asthma treatment 19, it is critical that individuals be able to receive such services from any provider authorized to provide the service. This is consistent with the objectives of Operation Warp Speed, which, as mentioned above, is a partnership among components of the Federal Government that engages with private firms to accelerate the development, manufacture, and distribution of a asthma treatment to the American people.

The provisions of this IFC therefore are immediately necessary to ensure group health plan and group and individual health insurance coverage of these items and services is prompt and broad, to ensure timely access to combat the ventolin. In this IFC, the Department adds a requirement at Â§â417.454 to require section 1876 cost plans to cover without cost sharing the asthma treatment 19 treatment and its administration described in section 1861(s)(10)(A) of the Act without cost sharing for the duration of the PHE for the asthma treatment ventolin, specifically the end of the emergency period defined in paragraph (1)(B) of section 1135(g) of the Act, which is the PHE declared by the Secretary on January 31, 2020 and any renewals thereof. While section 1876(c)(2) of the Act ensures that enrollees in Medicare cost plans will have coverage of a asthma treatment and its administration, section 3713 of the CARES Act did not amend section 1876 of the Act to provide similar cost-sharing protections for enrollees in cost plans who receive the treatment from an in-network provider. Currently, there is no requirement for cost plans to cover the asthma treatment and its administration without cost sharing (that is, with cost sharing that is the same as original Medicare) when the treatment is furnished by an in-network health care provider.

Following a recommendation of the USPTF or ACIP, the requirement to provide coverage without cost sharing of qualifying asthma preventive services, which are expected to include immunizations, takes effect within 15 business days. Plans and issuers need immediate guidance to understand their obligations under section 3203 of the CARES Act and to take steps that will enable them to comply with those requirements as soon as the coverage requirement goes into effect. Delaying these provisions would likewise delay plans' and issuers' ability to prepare for the availability of a asthma treatment, resulting in barriers in access to coverage of these critical services during the PHE for asthma treatment. As of the date of display of this regulation, there are not any asthma preventive services including treatments for asthma that are required to be covered.

However, because emergency use authorization or approval of a asthma treatment may be imminent, the Departments are of the view it is critical that these regulations under section 2713 of the PHS Act be issued and effective prior to such authorization or approval. The Departments are of the view that it would be impracticable and contrary to the public interest to undertake normal notice and comment rulemaking procedures in light of the urgent need to ensure coverage of and access to qualifying asthma preventive services to protect the public health as well as the health and safety of individuals and communities to prevent the spread of asthma treatment. For these same reasons, the Departments are of the view a delayed effective date would also be contrary to the public interest. Ensuring individuals have access to a asthma treatment as soon as it becomes available is critical to ending the PHE for asthma treatment, and therefore it is imperative that these regulations are in effect on the date such a treatment becomes available and recommended by ACIP.

For those same reasons, as authorized by section 808(2) of the CRA, the Departments find it is impracticable and contrary to the public interest not to waive the delay in effective date of this IFC under section 801 of the CRA. Therefore, the Departments find there is good cause to waive the CRA's delay in effective date pursuant to section 808(2) of the CRA. The provisions in this IFC will go into effect on the date of display. This IFC implements the requirement that providers of diagnostic tests for asthma treatment make public their cash prices for asthma treatment diagnostic tests and specifies the asthma treatment diagnostic tests to which this requirement applies.

This IFC further defines âprovider of a diagnostic test for asthma treatmentâ (referred to as âproviderâ) as any facility that performs one or more asthma treatment diagnostic tests. In addition, this IFC defines âcash priceâ as the charge that applies to an individual who pays cash (or cash equivalent) for a asthma treatment diagnostic test. This IFC gives CMS discretion to take any of the following actions if CMS determines a provider is noncompliant with the requirements of new 45 CFR 182.50. Provide a written warning notice to the provider of the specific violation(s).

Request that a provider submit and comply with a CAP. Impose a CMP on the provider if the provider fails to respond to CMS' request to submit a CAP or to comply with the requirements of a CAP approved by CMS. As indicated above, these requirements are applicable during the PHE for asthma treatment (and any extensions to the PHE for asthma treatment). Therefore, it is critically important that we implement the policies in this IFC as quickly as possible in order for stakeholders to know with certainty during the PHE for asthma treatment how to comply with the law and what penalties they will face for noncompliance during the PHE for asthma treatment.

Moreover, these rules are necessary for CMS to enforce section 3202(b) of the CARES Act and to ensure plans, issuers, and consumers know in advance the price for a diagnostic test for asthma treatment during the PHE for asthma treatment. For these reasons, we believe it would be impracticable and contrary to the public interest to undertake normal notice and comment rulemaking procedures and to delay the effective date of the new requirements being adopted at 45 CFR part 182. In this IFC, the Department creates a New asthma treatments Add-on Payment (NCTAP) under the Inpatient Prospective Payment System (IPPS) for asthma treatment cases that meet certain criteria. The Department is of the view that it would be impracticable and contrary to the public interest to undertake normal notice and comment procedures and to thereby delay the effective date of this IFC.

As drug and biological products become available and are authorized or approved by FDA for the treatment of asthma treatment in the inpatient setting, there may be potential financial disincentives for hospitals to provide these new asthma treatments to Medicare inpatients during the PHE because the costs of these new treatments are not yet reflected in Medicare payment rates and there are no new technology add-on payments for these treatments. The delay necessary for notice and comment rulemaking is both contrary to the public interest and impracticable because of the urgency in ensuring there are not financial disincentives for hospitals to provide asthma treatments to beneficiaries during the PHE. We expect that increasing the current IPPS payment amounts for sufficiently costly cases to mitigate potential financial disincentives for hospitals to provide new asthma treatments during the PHE will potentially improve and speed access to these treatments for Medicare patients. We also believe that the establishment of the NCTAP provides greater transparency and predictability to the public, including innovators that are developing new asthma treatments, as to how Medicare payments for cases involving these treatments will be determined when those treatments become available.

Although we do not expect that many beneficiaries would both receive a primary C-APC service and a drug or biological for treating asthma treatment, we nonetheless believe that as drugs or biologicals become available and are authorized or approved for the treatment of asthma treatment in the outpatient setting, it would be appropriate to mitigate any potential financial disincentives for hospitals to provide these new treatments during the PHE for asthma treatment. The delay necessary for notice and comment rulemaking to address this issue is both contrary to the public interest and impracticable because of the urgency in ensuring there are not financial disincentives for hospitals to provide asthma treatments to beneficiaries. Therefore, effective for services furnished on or after the effective date of this rule and until the end of the PHE for asthma treatment, CMS is creating an exception to its OPPS C-APC policy to ensure separate payment for new asthma treatments that meet certain criteria. In this IFC, the Department adds changes to the CJR model that are immediately necessary to continue the CJR model consistent with model goals to, cover inpatient major lower joint replacements without interruption, and to reduce operational and financial uncertainty for CJR hospital participants during and beyond the PHE.

Ending on March 31, 2021 would be disruptive to hospitals and patient care during the PHE. The end date of March 31, 2021, means hospitals stop initiating episodes under the model after January 2, 2021, before the end of the public health emergency as renewed on October 23, 2020.[] Extending the model through an additional six months of performance year (PY) 5, so that PY 5 now ends on September 30, 2021, provides participant hospitals with greater certainty in model operations during the remainder of the PHE. Through this IFC we are implementing four changes to the CJR model needed to extend PY 5. These are.

Implementing an additional six months of PY 5, so that PY 5 now ends on September 30, 2021 (hospitals stop initiating new episodes under the model after July 2, 2021) provides participant hospitals additional relief and stability in model operations while the end of the PHE remains unknown. We have modified the reconciliation process to provide payments consistent with the current annual reconciliation schedule for hospitals for greater stability. Absent modification to the reconciliation process, the extension of PY 5 to a total of 21 months, from January 1, 2020 through September 30, 2021 would mean that participant hospitals would experience a 21-month gap between the PY4 final reconciliation in June of 2020 and initial PY 5 reconciliation in early 2022. In the FY 2021 IPPS/LTCH final rule, we stated that because the CJR model would continue until at least March 31, 2021, we intended to adopt a policy in the CJR final rule that incorporates new MS-DRGs for the same procedures currently included in the CJR model, under prior MS-DRGs, as of their effective date to avoid disruption to the model for the remainder of PY5 (as extended) and thereafter, if our proposal to extend the CJR model through PY8 were finalized (85 FR 58502).

We are adopting the change in this IFC, retroactive to October 1, 2020 because without a change the model ceases to continue as a comprehensive joint replacement model. Not making this change would have a significant impact on operational stability. Finally, this interim final rule with comment specifies an end for the current extreme and uncontrollable adjustment in 42 CFR 510.300(k)(4). In order to provide participant hospitals continuing financial protection from the effect of asthma treatment on the CJR model that may continue beyond the end of the PHE for asthma treatment or March 31, 2021, whichever occurs earlier, we are implementing that actual episode payments are capped at the quality adjusted target price determined for that episode under Â§â510.300 for episodes with actual episode payments that include a claim with a asthma treatment diagnosis code and initiate after the earlier of March 31, 2021 or the last day of the emergency period.

This policy is consistent with flexibilities and protections for impact of asthma treatment in other Innovation Center models. For all of these revisions, we believe it is contrary to the public interest to undertake traditional notice and comment rulemaking to adopt these regulatory changes because they preserve the model's scope and operations at current levels, fostering model stability now and in the future for hospital operations during and beyond the PHE. VI. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, the Departments are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to OMB for review and approval.

In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (PRA) requires that the Departments solicit comment on the following issues. The need for the information collection and its usefulness in carrying out the proper functions of the agency. The accuracy of the estimate of the information collection burden. The quality, utility, and clarity of the information to be collected.

Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. The Departments are soliciting public comment on each of the section 3506(c)(2)(A)-required issues for the following information collection requirements (ICRs). The requirements and burden will be submitted to under OMB Control Number 0938-NEW. A.

Antigen tests, which are used to detect specific proteins on the surface of the ventolin. And serology testing, which is used to look for the presence of antibodies produced by the body in response to s. For purposes of 45 CFR part 182, we are defining âprovider of a diagnostic test for asthma treatmentâ as any facility that performs one or more asthma treatment diagnostic tests. In order to perform a diagnostic test for asthma treatment and report patient-specific results, a facility (whether that be a primary care provider's office, urgent care center, outpatient hospital site or stand-alone laboratory) is required to hold a CLIA certificate based on the complexity of the testing performed by the facility.

Therefore, we expect that any âprovider of a asthma treatment diagnostic testâ would hold a CLIA certificate (including a certificate of waiver or certificate of registration) and that such testing would occur in facilities ranging from primary care provider offices to urgent care centers to stand-alone national laboratories. As explained in section VIII.B of this IFC, we estimate that approximately 83,309 CLIA providers could potentially be performing asthma treatment diagnostic tests and need to publicize their cash prices. For purposes of this IFC, we are estimating it will take a business operations specialist (13-1000), on average 1 hour for a total of 83,309 burden hours to compile and make public the cash prices for asthma treatment diagnostic tests, at an hourly wage of $36.31 as published by the BLS in 2019.[] We estimate the overhead and fringe benefit cost to be 100 percent of wages. Therefore, we estimate a one-time cost per provider to be $72.62 Start Printed Page 71185($36.31 Ã 2) and the total cost estimated to be $6,049,900 (83,309 hours Ã $72.62) to collect, compile and post the required information.

B. ICRs for State Innovation Waivers Policy and Regulatory Revision in Response to asthma treatment Public Health Emergency This IFC provides that states are required to submit modification requests to the Secretary of HHS and the Secretary of the Treasury in order to obtain approval for the modifications made available by this IFC. Any state can submit a request to the Secretaries for a modification from the state and/or Federal public notice procedures or include such a request in their section 1332 waiver application if the waiver application is submitted during the PHE for asthma treatment. The request must describe the reason the state seeks a modification from the state public notice procedures, describe how the state meets the modification criteria, describe the alternative public notice procedures it proposes to implement at the state level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the state's request for a modification.

The request must describe the reason the state seeks a modification from the Federal public notice procedures and the alternative public notice procedures it requests to be implemented at the Federal level, as applicable. A state with an approved section 1332 waiver can submit a request to HHS and the Department of Treasury for a modification from post award public notice procedures. The request must specify the reason the state seeks a modification from the post award public notice procedures, describe how the state meets the modification criteria, and describe the alternative procedures it proposes to implement at the state level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the state's request for a modification. While HHS and the Department of Treasury do not have data available to predict the number of states that will likely request a modification of either the waiver application or the post award public notice procedures, HHS and the Department of Treasury estimate it will take a senior manager 1 hour to prepare a state's request, with an equivalent cost of approximately $118.[] In addition, if HHS and the Department of Treasury approve a state's modification request, the state will have to post the determination on their website within 15 days of the approval.

HHS and the Department of Treasury estimate that for each state, it will take a network and computer systems administrator 15 minutes to post the approval with an equivalent cost of approximately $21.[] Assuming that approximately 15 states will submit a modification request, the total burden hours for all states will be 15 hours, with an equivalent cost of approximately $1,775. HHS and the Department of Treasury have assumed that 15 states will submit a request because, as of display of this IFC, 15 states have an approved 1332 waiver. This is an upper bound, since some states may not need to request the available modification for their waivers, and therefore, will incur no burden. Furthermore, assuming that approximately 15 states receive approval of the modification request and then must post the approval, the total burden hours for all states will be approximately 3.75 hours, with an equivalent cost of approximately $319.

The section provides that Chapter 35 of title 44, United States Code, which includes such provisions as the PRA, shall not apply to the testing and evaluation of CMMI models or expansion of such models. D. ICRs Regarding Enrollment as Mass Immunization Roster Biller As discussed in section II.A.1. Of this IFC, a mass immunizer may be enrolled in Medicare as another type of provider or supplier such as a physician, non-physician practitioner, hospital outpatient department, home health agency, or skilled nursing facility.

However, an entity that does not otherwise qualify as a Medicare provider or supplier but wishes to furnish mass immunization services may be eligible to enroll in Medicare as a âMass Immunization Roster Billerâ via the Form CMS-855B enrollment application (Medicare Enrollment Application. Clinics/Group Practices and Certain Other Suppliers. OMB Control No.. 0938-0685.

Expires 12/21). This section discusses our burden estimates for the enrollment of mass immunization roster billers via the Form CMS-855B application as well as the PRA exemption we are claiming for the appeals process. 1. Cost of Completing Form CMS-855B Using our internal data, we generally estimate that approximately 60,000 entities (the preponderance of which will be pharmacies) will seek to enroll as mass immunization roster billers pursuant to the IFC, all of whom will attempt enrollment in the 12-month period following the IFC's display.

According to the most recent wage data provided by the Bureau of Labor Statistics (BLS) for May 2019 (see http://www.bls.gov/âoes/âcurrent/âoes_ânat.htm), the mean hourly wages for the following categories are. Table 5âNational Occupational Employment and Wage EstimatesOccupation titleOccupation codeMean hourly wage ($/hr)Fringe benefits and overhead ($/hr)Adjusted hourly wage ($/hr)Healthcare Diagnosing or Treating Practitioners29-100049.2649.2698.52Medical Secretaries and Administrative Assistants43-601318.3118.3136.62 Consistent with Form CMS-855B projections made in recent rulemaking efforts, it will take each entity an average of 2.5 hours to obtain and furnish the information on the Form CMS-855B. Per our experience, the entity's medical secretary will secure and report this data, a task that would take approximately 2 hours. Additionally, a health diagnosing and treating practitioner of the entity will review and sign the form, a process we estimate takes 30 minutes.

We therefore project a total burden of 150,000 hours (60,000 suppliers Ã 2.5 hrs) at a cost of $7,350,000 (60,000 suppliers Ã ((2 hrs Ã $36.62/hr) + (0.5 hrs Ã $98.52/hr)). When averaged over the typical 3-year OMB approval period, we estimate an annual burden of 50,000 hours (150,000 hrs/3) at a cost of $2,450,000 ($7,350,000/3). 2. Appeals Pursuant to 42 CFR part 498, a mass immunization roster biller may appeal the denial or revocation of its enrollment.

This is because we anticipate, based on past experience, there would be comparatively few denials and revocations of such enrollments. Response to Comments Because of the large number of public comments normally received on Federal Register documents, the Departments are not able to acknowledge or respond to them individually. All comments received by the date and time specified in the DATES section of this preamble will be considered, and, when the Departments proceed with a subsequent document, the Departments will respond to the comments in the preamble to that document. Regulatory Impact Analysis A.

Statement of Need The flexibilities and changes contained within this IFC are responsive to the PHE for asthma treatment. The policies implemented in this IFC will provide flexibilities, during the PHE for asthma treatment, to states pursuing waivers under section 1332 of the PPACA and to states with approved section 1332 waivers. Additionally, the policies and regulatory updates implemented in this IFC will increase the affordability with regards to section 1332 waiver applications and support continuity of health insurance coverage for consumers in the individual and small group (or merged) market during the PHE for asthma treatment. This IFC also implements section 3202(b) of the CARES Act, which requires that providers of asthma treatment diagnostic tests make public their cash prices for those tests and establishes an enforcement scheme to enforce those requirements during the PHE for asthma treatment.

B. Overall Impact The Departments have examined the potential impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Start Printed Page 71187Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96 354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995.

Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

(3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof. Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any one year), and a âsignificantâ regulatory action is subject to review by the OMB. The Departments have determined that these rules are likely to have economic impacts of $100 million or more in at least one year, and thus, meet the definition of âeconomically significantâ under Executive Order 12866 and a major rule under the Congressional Review Act.

Therefore, the Departments have provided an assessment of the potential costs, benefits, and transfers associated with this rule. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by OMB. C. Detailed Economic Analysis 1.

In order to perform a asthma treatment diagnostic tests and report patient-specific results, a facility is required to hold a CLIA certificate based on the complexity of the testing performed by the facility. This IFC requires providers of asthma treatment diagnostic tests to make public the cash price for such tests on a public internet website of such provider during the emergency period declared under section 319 of the PHS Act. In the event that a provider does not have its own website on which to post this cash price information, Â§â182.40(b) states that the provider would be required to make public its cash price information in writing, within two business days upon request, and by posting signage prominently at the provider's asthma treatment diagnostic testing location, if such location is accessible to the public. We anticipate that price transparency has potential beneficial marketplace benefits generally, as discussed in detail in the CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates, Price Transparency Requirements for Hospitals To Make Standard Charges Public Final Rule (84 FR 65524) and the Transparency in Coverage Proposed Rule (84 FR 65464).

As noted in section II.C of this IFC, section 3202 of the CARES Act addresses reimbursement of asthma treatment diagnostic tests. Section 3202(a) of the CARES Act requires group health plans and issuers that provide coverage for items and services described in section 6001(a) of the FFCRA to reimburse any provider of a asthma treatment diagnostic test an amount that equals the negotiated rate, or, if the plan or issuer does not have a negotiated rate with the provider, the cash price for such service that is listed by the provider on a public website. We anticipate that price transparency in asthma treatment diagnostic testing, in particular, will help improve clarity for consumers and the plans and issuers that are required to cover the cost of performing a asthma treatment diagnostic test when there is no negotiated rate between the plan or issuer and the provider. For individuals without insurance and for health plans and health insurance issuers attempting to negotiate a rate for performance of a asthma treatment diagnostic test with a provider that has posted its cash price, that cash price could provide some context and a baseline against which those negotiations can occur.

Because this requirement is only applicable for the remainder of the PHE, which may be less than a year, the saving impact is likely to be lower. To comply with the regulatory updates in this IFC, providers would need to review their billing practices and determine their âcash priceâ for asthma treatment diagnostic tests. They would further need to publicly post the cash prices for all asthma treatment diagnostic tests along with associated plain language descriptions and HCPCS or CPT billing codes. The provider would be required to make all of this information public on the provider's internet website.

As discussed in section VI.C, we estimate it would take a Business Operations Specialist, on average 1 hour to compile and make public the cash prices for the asthma treatment diagnostic tests that the facility offers at an hourly wage of $36.31 as published by the 2019 Bureau of Labor Statistics.[] We estimate the overhead and fringe benefit cost to be 100 percent of wages. Therefore, we estimate a one-time cost per provider to be $72.62 (36.31 Ã 2). We expect that approximately 30 percentâ[] (n = 83,309) of the total CLIA-certified laboratories (n = 277,699â[] ) could potentially be performing asthma treatment diagnostic tests and need to publicize their cash prices in such form and manner as prescribed in new 45 CFR part 182 during the PHE for asthma treatment, including any subsequent renewals. The total cost is estimated to be $ $6,049,900 (83,309 hours Ã $72.62) to collect, compile and post the required information.

We also believe that the establishment of the NCTAP provides greater transparency and predictability to the public, including innovators that are developing new asthma treatments, as to how Medicare payments for cases involving these treatments will be determined when those treatments become available. Given it is unknown what the cost and utilization of inpatient stays using these new treatments will be, the net overall cost of the NCTAP policy is not estimable. On one extreme, if all of the new asthma treatments decrease the net cost of hospitalizations (for example, due to shortened lengths of stay), including the cost of the new treatment, below the Medicare payment as increased by section 3710 of the CARES Act then there would be no NCTAP payments made and no additional cost to the Medicare program as a result of this policy. On the other extreme, if all of the new asthma treatments result in the net cost of hospitalizations that exceed the outlier threshold (for example, due to the cost of the new treatment), the cost to the Medicare program would be the sum over all NCTAP cases of 0.65 times the outlier threshold for each case.

3. Effects of the Medicare Outpatient Prospective Payment System (OPPS) Separate Payment for New asthma treatments Policy for the Remainder of the Public Health Emergency (PHE) for asthma treatment This IFC provides for separate payment for New asthma treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for asthma treatment when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service. As we noted in Section II.E.2, we believe it would be a fairly rare occurrence that an outpatient department would perform a C-APC procedure on a beneficiary being treated for asthma treatment because most C-APCs are for surgical or other intensive procedures and we would expect most hospital outpatients departments would not perform outpatient surgery on a patient that has an active case of asthma treatment. While it is possible that future asthma treatments that are authorized or approved for use in the outpatient setting might be administered to patients under observation while the provider determines if the patient needs to be admitted to the hospital for asthma treatment, it is our expectation that this hypothetical situation would not happen frequently.

Because we believe a new asthma treatment will rarely be provided on the same claim as a primary C-APC service, we believe new asthma treatments used in the outpatient setting will be separately paid under current policy the vast majority of the time. As a result, we believe any budgetary effect of this new exception is likely to be de minimis. 4. Effects of Temporary Increase in Federal Medicaid Funding This IFC interprets the requirement in section 6008(b)(3) of the FFCRA that states maintain Medicaid beneficiary enrollment as a condition of receiving the temporary FMAP increase described at section 6008(a) of the FFCRA.

This IFC provides states with greater flexibility than current CMS guidance to transition beneficiaries between eligibility groups, to modify the amount, duration, and scope of coverage available to beneficiaries, and to make changes to applicable cost sharing and beneficiary liability. At the same time, this IFC protects beneficiary access to medical assistance by requiring states to maintain each beneficiary's coverage in one of three tiers, thereby protecting access to the basic coverage a beneficiary was receiving as of or after March 18, 2020. We anticipate that this IFC will result in lessened financial burden on state Medicaid agencies and the Federal Government as compared to CMS's existing interpretation of the FFCRA 6008(b)(3) requirement. It would be highly challenging to estimate specific cost savings resulting from this IFC because such an estimate would be almost entirely dependent on state behavior under the unique circumstances of the PHE for asthma treatment-Start Printed Page 7118919.

First, we believe that some savings may result from transitioning beneficiaries to different eligibility groups with greater cost sharing or beneficiary liability. However, we know that states have faced both system and operational constraints that may prevent them from processing routine actions, such as transitioning a beneficiary from one group to another following a change in circumstances. A state that has been processing eligibility renewals and redeterminations during the PHE may be able to make such transitions relatively quickly, while a state that has been unable to process changes without violating the requirements for receiving the temporary FMAP increase may need more time to begin transferring beneficiaries between groups. Second, we anticipate that states will implement the new flexibilities offered by this rule in a variety of ways and to different degrees.

While our current interpretation of section 6008(b)(3) of the FFCRA provides the strongest protections for beneficiary access to coverage, the safeguards established by this IFC will ensure that all beneficiaries maintain the same basic level of access to coverage that they were receiving as of or after March 18, 2020. All beneficiaries who had access to minimum essential coverage will maintain access to such coverage, and every beneficiary who had access to testing services and treatment for asthma treatment, including treatments, will retain such access. Individual beneficiaries may be required to pay cost sharing that they were not previously charged (except with respect to testing and treatment services related to asthma treatment, which states cannot charge under section 6008(b)(4) of the FFCRA if they are claiming the temporary FMAP increase), or they may need to meet additional prior authorization or medical necessity requirements. 5.

Effects of Updates to the Comprehensive Care for Joint Replacement (CJR) Model, Performance Year (PY) 5 During the PHE The evolving impact of the PHE for the asthma treatment has created difficulties in forecasting the state of the LEJR market for 2021. For example, Table 1 indicates CJR episode volume increasing and moving back toward traditional levels from April to June, but then decreasing again in July and August. It is difficult to predict the impact of extending PY 5 an additional 6 months with the amended policies described above because there exists a potential for variation between PY 5 target prices and PY 5 actual episode costs (as a result of asthma treatment) which creates uncertainty in calculating anticipated net reconciliation amounts for PY 5. As a result, the Office of the Actuary was unable create projections regarding Medicare program spending in 2021 for MS-DRGs 469, 470, 521, or 522 or discrete impact estimates regarding the effect of extending CJR PY 5 an additional 6 months with the amended policies described above.

Further, our February 2020 proposed rule (85 FR 10516) proposes payment methodology revisions to the target price methodology to improve payment accuracy as the current methodology tends to excessive payment. Given the confluence of factors affecting payments, including episode volume, actual episode costs, and even target prices, we cannot confidently estimate cost or savings associated with the CJR model changes in this final rule, specifically, the provisions. To add reconciliation periods to PY 5, to add MS-DRGs 521 and 522 to the episode definition, to change the extreme and uncontrollable circumstances policy, and to extend PY5 6 months. We will continue to refine this analysis.

If the February 2020 proposed rule is finalized after review and response to comment, we will strive to provide a more detailed estimate for future model performance years. 6. Effects of Rapid Coverage of Preventative Services for asthma This IFC requires that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage provide coverage for qualifying asthma preventive services, including recommended asthma treatment immunizations and their administration, without any cost sharing. It also requires plans and issuers to provide coverage within 15 business days after the date on which an applicable recommendation is made by USPSTF or ACIP relating to such a service.

In the immediate term, newly developed qualifying asthma preventive services might be available from a narrower range of providers than other, more established recommended preventive items and services. If asthma treatment immunizations require specialized storage and administration services, only a limited number of Start Printed Page 71190providers may be able to offer them at first. If consumers have to incur additional burdens, long wait times, and increased travel times to find an in-network provider that can provide such services, it will limit access and discourage them from obtaining such services. Therefore, the Departments are of the view that requiring out-of-network coverage without cost sharing for qualifying asthma preventive services will help ensure that consumers are able to obtain the preventive services without cost sharing as soon as possible.

Plans and issuers will incur the cost of the qualifying asthma preventive services and administration of such services. Providing coverage within 15 business days after a recommendation is made relating to such services is likely to impose significant administrative costs on issuers, group health plans, and other service providers to update systems to include billing codes for the preventive services, negotiate prices with network providers, determine reimbursements for out-of-network providers, and conduct outreach to providers, participants, beneficiaries, and enrollees in a very short time period. Depending on the magnitude of the costs of qualifying asthma preventive services and administration of such services relative to the potential cost of treatment for the disease, this may have an impact on premiums. There are uncertainties regarding the price of potential qualifying asthma preventive services, including asthma treatment immunizations.

During the PHE for asthma treatment, costs to group health plans or issuers that have networks of providers will be higher if a significant number of participants, beneficiaries, or enrollees go to out-of-network providers, and the issuers and plans reimburse those out-of-network providers at higher levels than their negotiated rate with in-network providers. However, if consumers can obtain the qualifying asthma preventive services where they usually obtain health care services, consumers are likely to receive the services from an in-network provider. Plans and issuers may also wish to educate participants, beneficiaries, or enrollees about the availability of the services from in-network providers and encourage them to obtain these services from their usual providers. This approach could limit the number of participants, beneficiaries, or enrollees going to out-of-network providers instead of staying in network, but there will be associated administrative burdens and costs.

The total cost to plans and issuers related to qualifying asthma preventive services that are immunizations will depend on the cost and number of required immunization doses to be administered, the number of people who will choose to get immunized against asthma treatment and which providers will be able to provide the preventive services. For the 2018-19 influenza season, 62.6 percent of children 6 months through 17 years and 45.3 percent of adults 18 years and older obtained the influenza treatment.[] Given the severity of asthma treatment, the Departments anticipate the immunization rates for asthma treatment are likely to ultimately be higher than for influenza, although initial rates may be lower until an adequate supply is available. Total costs to plans and issuers will depend on the cost of covering qualifying asthma preventive services, the number of people choosing to obtain such services, and whether a third party such as the Federal Government covers the costs of any immunizations. The Departments seek comment on any potential costs and burdens that may be incurred by plans and issuers due to the requirements to cover the costs and administration of such qualifying asthma preventive services without any cost sharing regardless of whether the service is delivered by an in-network or out-of-network provider.

The regulations at Â§Â§â33.116 and 155.1316 establish Federal public notice requirements for state section 1332 waiver applications. This IFC also establishes a framework at the new 31 CFR 33.120(c)(2) and 45 CFR 155.1320(c)(2) for states to request the Secretaries to modify, in part, the post award public notice procedures outlined in Â§Â§â33.120(c) and 155.1320(c) for an approved waiver that would otherwise take place or become due during the PHE for asthma treatment. As stated above, HHS and the Department of the Treasury are of the view that requiring states that meet the criteria outlined in this IFC to comply with the full public notice procedures during the PHE for asthma treatment could cause undue harm to the public. Allowing the Secretaries to modify, in part, these requirements will enable states to request and receive approval for waiver requests more quickly and also implement changes that will provide consumers with access to affordable health insurance coverage during the current PHE for asthma treatment.

States that request modifications from the public notice procedures will incur some burden, as discussed in the Collection of Information Requirements section. For a state that requests and receives a modification of the public notice procedures, we acknowledge that consumers may receive less prior notice than would occur without the modification. Through this IFC, the HHS and the Department of Treasury intend to provide an appropriate balance and permit flexibility where a state can ensure a sufficient opportunity for meaningful public input given the circumstances in the PHE for asthma treatment while also ensuring the safety of the public. If a state's modification request is approved there may be a shorter comment period at the state or Federal level, or the comment periods may be the same number of days (for example 30 days) but perhaps on a different timeframe.

In this case, there may be no reduction in costs related to public notice procedures. HHS and the Department of the Treasury seek comment on any potential costs and burdens that may be incurred by states due to the flexibilities afforded in this IFC. HHS and the Department of the Treasury also seek comment on the potential effects and costs consumers may face as a result of a state's action taken as a result of the flexibilities in this IFC. 8.

Effects of Medicare Coding and Payment for asthma treatment This IFC discusses CMS's implementation of section 3713 of the CARES Act (Pub. L. 116-136), which established Medicare Part B coverage and payment for a asthma treatment and its administration. This IFC requires that Medicare provide coverage for qualifying asthma treatments administration, without any cost sharing.

If beneficiaries have to incur additional burdens, long wait times, and increased travel times to find Medicare providers and suppliers that can provide such services, it will limit access and discourage them from obtaining such services. Medicare providers and suppliers will incur costs for providing asthma treatments and administration of such services. There are uncertainties regarding the cost to the Medicare program for asthma treatments and administration at this time. The total cost to Medicare related to asthma treatments and administration cost are dependent on and the number of required immunization doses to be administered, the number of people who will choose to get immunized against asthma treatment and which providers and suppliers will be able to provide the preventive services.

9. Effects of Application Fee as Part of Form CMS-855B Enrollment as Mass Immunization Roster Biller Consistent with Â§â424.514, an entity enrolling in Medicare as a mass immunization roster biller via the Form CMS-855B must pay an application fee at the time of enrollment. The application fees for each of the past 3 calendar years were or are $569 (CY 2018), $586, (CY 2019), and $595 (CY 2020). The differing fee amounts are predicated on changes/increases in the Consumer Price Index (CPI) for all urban consumers (all items.

United State city average, CPI-U) for the 12-month period ending on June 30 of the previous year. Although we cannot predict future changes to the CPI, the fee amounts between 2018 and 2020 increased by an average of $13 per year. We believe this is a reasonable barometer with which to establish a CY 2021 fee estimate (strictly for purposes of this IFC) of $608. Applying this prospective fee amount to the previously mentioned 60,000 projected mass immunization roster biller applicants in the first year of this rule, we estimate a total application fee cost to enrollees of $36,400,000 (or 60,000 Ã $608).

This represents a transfer from mass immunizer suppliers to the Federal Government. D. Regulatory Alternatives Considered The Department considered not implementing the changes to the CJR model but determined the effect of the changes, particularly relief from financial risk for asthma treatment cases and stability in model operations, to be very important for participant hospitals during the PHE. Further, if the three-year extension of the CJR model is finalized, it would be much more difficult for participant hospitals to stop model value-based operations, and then restart value operations when hospitals already have significant burden managing asthma treatment and under asthma treatment safety protocols and utilization changes.

The Departments considered not requiring plans and issuers to provide coverage for qualifying asthma preventive services without cost sharing from out-of-network providers. However, in the near term, newly developed qualifying asthma preventive services might be available from a narrower range of providers than other, more established recommended preventive services because of specialized storage and administration requirements. If there are only a limited number of in-network providers that can administer these services, consumers may incur additional burden related to travel and long wait times to obtain these services, which can result in lower utilization. The Departments are concerned that allowing plans and issuers to impose cost sharing for asthma treatment immunizations provided by out-of-network providers would discourage individuals from seeking immunization, potentially leading to reduced administration of any asthma treatment and prolonging the PHE for asthma treatment, contrary to the intent of the CARES Act.

However, HHS and the Department of the Treasury were concerned that that this would violate the statutory requirements regarding a meaningful level of input from the public. In addition, HHS and the Department of Treasury are committed to transparency and value public input on waiver proposals and value public feedback to ensure consumers are aware of waiver proposals that may affect them. HHS and the Department of the Treasury anticipate working with states on their modification request to ensure the public is provided the opportunity to provide feedback on waiver proposals and the progress of the program authorized by the section 1332 waiver.Start Printed Page 71192 E. Regulatory Flexibility Act The Regulatory Flexibility Act, (5 U.S.C.

601, et seq.), requires agencies to analyze options for regulatory relief of small entities to prepare an initial regulatory flexibility analysis to describe the impact of the proposed rule on small entities, unless the head of the agency can certify that the rule will not have a significant economic impact on a substantial number of small entities. The RFA generally defines a âsmall entityâ as (1) a proprietary firm meeting the size standards of the Small Business Administration (SBA), (2) a not-for-profit organization that is not dominant in its field, or (3) a small government jurisdiction with a population of less than 50,000. States and individuals are not included in the definition of âsmall entity.â HHS uses a change in revenues of more than 3 to 5 percent as its measure of significant economic impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions.

The Departments are not required to prepare a final regulatory impact analysis, because this regulatory action is being issued as an interim final rule without being preceded by a general notice of proposed rulemaking. F. Unfunded Mandates Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing any proposed rule or any final rule for which a general notice of proposed rulemaking was published that includes any Federal mandate that may result in expenditures in any 1 year by a state, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2020, that threshold is approximately $156 million.

This IFC was not preceded by a general notice of proposed rulemaking, and thus the requirements of UMRA do not apply. G. Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this rule aims to alleviate burden on State and local governments, the requirements of Executive Order 13132 are not applicable.

Reducing Regulation and Controlling Regulatory Costs Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017 and requires that the costs associated with significant new regulations âshall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.â This IFC's designation under Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs (82 FR 9339), which was issued on January 30, 2017, will be informed by public comments received. Start List of Subjects 26 CFR Part 54 Excise taxesHealth careHealth insurancePensionsReporting and recordkeeping requirements 29 CFR Part 2590 Employee benefit plansHealth careHealth insurancePenaltiesPensionsPrivacyReporting and recordkeeping requirements 31 CFR Part 33 Health careHealth insuranceReporting and recordkeeping requirements 42 CFR Part 410 DiseasesHealth facilitiesHealth professionsLaboratoriesMedicareReporting and recordkeeping requirementsRural areasX-rays 42 CFR Part 411 DiseasesMedicareReporting and recordkeeping requirements 42 CFR Part 414 Administrative practice and procedureBiologicsDiseasesDrugsHealth facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 417 Administrative practice and procedureGrant programs-healthHealth careHealth insuranceHealth maintenance organizations (HMO)Loan programs-healthMedicareReporting and recordkeeping requirements 42 CFR Part 433 Administrative practice and procedureChild supportClaimsGrant programs-healthMedicaidReporting and recordkeeping requirements 42 CFR Part 510 Administrative practice and procedureHealth facilitiesMedicareReporting and recordkeeping requirement 45 CFR Part 147 Age discriminationCitizenship and naturalizationCivil rightsHealth careHealth insuranceIndividuals with disabilitiesIntergovernmental relationsReporting and recordkeeping requirementsSex discrimination 45 CFR Part 155 Administrative practice and procedureAdvertisingBrokersConflict of interestsConsumer protectionGrant programs-healthGrants administrationHealth careHealth insuranceHealth maintenance organizations (HMO)Health recordsHospitalsIndiansIndividuals with disabilitiesIntergovernmental relationsLoan programs-healthMedicaidOrganization and functions (Government agencies)Public assistance programsReporting and recordkeeping requirementsState flexibilityTechnical assistanceWomen and youth 45 CFR Part 182 asthma treatment diagnostic testingReporting and recordkeeping requirements End List of Subjects Start Signature Dated. October 21, 2020. Seema Verma, Administrator, Centers for Medicare &.

Medicaid Services. Dated. October 26, 2020. Alex M.

Azar II, Secretary, Department of Health and Human Services. Sunita Lough, Deputy Commissioner for Services and Enforcement, Internal Revenue Service. Approved. October 28, 2020.

David J. Kautter, Assistant Secretary of the Treasury (Tax Policy). Signed at Washington DC, this 29th day of October, 2020. Jeanne Klinefelter Wilson, Acting Assistant Secretary, Employee Benefits Security Administration, Department of Labor.

End Signature DEPARTMENT OF THE TREASURY Internal Revenue Service Amendments to the Regulations For the reasons set forth in the preamble, the Department of the Treasury amends 26 CFR part 54 as set forth below. Start Part End Part Start Amendment Part Par. 1. The authority citation for part 54 continues to read in part as follows:End Amendment Part Start Authority 26 U.S.C.

7805, unless otherwise noted. End Authority * * * * * Section 54.9815-2713T also issued under 26 U.S.C. 9833. * * * * * Start Amendment Part2.

Section 54.9815-2713T is added to read as follows. End Amendment Part Coverage of preventive health services (temporary). (a) Servicesâ(1) In general. Beginning at the time described in paragraph (b) of this section and subject to Â§â54.9815-2713A, a group health plan, or a health insurance issuer offering group health insurance coverage, must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) forâ (i) Evidence-based items or services that have in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force with respect to the individual involved (except as otherwise provided in paragraph (c) of this section).

(ii) Immunizations for routine use in children, adolescents, and adults that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the individual involved (for purposes of this paragraph (a)(1)(ii), a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is considered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention, and a recommendation is considered to be for routine use if it is listed on the Immunization Schedules of the Centers for Disease Control and Prevention). (iii) With respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Administration. (iv) With respect to women, such additional preventive care and screenings not described in paragraph (a)(1)(i) of this section as provided for in comprehensive guidelines supported by the Health Resources and Services Administration for purposes of section 2713(a)(4) of the Public Health Service Act, subject to 45 CFR 147.131, 147.132, and 147.133. And (v) Any qualifying asthma preventive service, which means an item, service, or immunization that is intended to prevent or mitigate asthma disease 2019 (asthma treatment) and that is, with respect to the individual involvedâ (A) An evidence-based item or service that has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force.

(ii) If an item or service described in paragraph (a)(1) of this section is not billed separately (or is not tracked as individual encounter data separately) from an office visit and the primary purpose of the office visit is the delivery of such an item or service, then a plan or issuer may not impose cost-sharing requirements with respect to the office visit. (iii) If an item or service described in paragraph (a)(1) of this section is not billed separately (or is not tracked as individual encounter data separately) from an office visit and the primary purpose of the office visit is not the delivery of such an item or service, then a plan or issuer may impose cost-sharing requirements with respect to the office visit. (iv) The rules of this paragraph (a)(2) are illustrated by the following examples. (A) Example 1â(1) Facts.

An individual covered by a group health plan visits an in-network health care provider. While visiting the provider, the individual is screened for cholesterol abnormalities, which has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force with respect to the individual. The provider bills the plan for an office visit and for the laboratory work of the cholesterol screening test. (2) Conclusion.

As the result of the screening, the individual is diagnosed with hyperlipidemia and is prescribed a course of treatment that is not included in the recommendations under paragraph (a)(1) of this section. (2) Conclusion. In paragraph (a)(2)(iv)(B)(1) of this section, because the treatment is not included in the recommendations under paragraph (a)(1) of this section, the plan is not prohibited from imposing cost-sharing requirements with respect to the treatment. (C) Example 3â(1) Facts.

An individual covered by a group health plan visits an in-network health care provider to discuss recurring abdominal pain. During the visit, the individual Start Printed Page 71194has a blood pressure screening, which has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force with respect to the individual. The provider bills the plan for an office visit. (2) Conclusion.

In paragraph (a)(2)(iv)(C)(1) of this section, the blood pressure screening is provided as part of an office visit for which the primary purpose was not to deliver items or services described in paragraph (a)(1) of this section. Therefore, the plan may impose a cost-sharing requirement for the office visit charge. (D) Example 4â(1) Facts. A child covered by a group health plan visits an in-network pediatrician to receive an annual physical exam described as part of the comprehensive guidelines supported by the Health Resources and Services Administration.

During the office visit, the child receives additional items and services that are not described in the comprehensive guidelines supported by the Health Resources and Services Administration, nor otherwise described in paragraph (a)(1) of this section. The provider bills the plan for an office visit. (2) Conclusion. In paragraph (a)(2)(iv)(D)(1) of this section, the service was not billed as a separate charge and was billed as part of an office visit.

Moreover, the primary purpose for the visit was to deliver items and services described as part of the comprehensive guidelines supported by the Health Resources and Services Administration. Therefore, the plan may not impose a cost-sharing requirement with respect to the office visit. (3) Out-of-network providers. (i) Subject to paragraphs (a)(3)(ii) and (iii) of this section, nothing in this section requires a plan or issuer that has a network of providers to provide benefits for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing cost-sharing requirements for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider.

Nothing prevents a plan or issuer from using reasonable medical management techniques to determine the frequency, method, treatment, or setting for an item or service described in paragraph (a)(1) of this section to the extent not specified in the relevant recommendation or guideline. To the extent not specified in a recommendation or guideline, a plan or issuer may rely on the relevant clinical evidence base and established reasonable medical management techniques to determine the frequency, method, treatment, or setting for coverage of a recommended preventive health service. (5) Services not described. Nothing in this section prohibits a plan or issuer from providing coverage for items and services in addition to those recommended by the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, or provided for by guidelines supported by the Health Resources and Services Administration, or from denying coverage for items and services that are not recommended by that task force or that advisory committee, or under those guidelines.

A plan or issuer may impose cost-sharing requirements for a treatment not described in paragraph (a)(1) of this section, even if the treatment results from an item or service described in paragraph (a)(1) of this section. (b) Timingâ(1) In general. A plan or issuer must provide coverage pursuant to paragraph (a)(1) of this section for plan years that begin on or after September 23, 2010, or, if later, for plan years that begin on or after the date that is one year after the date the recommendation or guideline is issued, except as provided in paragraph (b)(3) of this section. (2) Changes in recommendations or guidelines.

(c) Recommendations not current. For purposes of paragraph (a)(1)(i) of this section, and for purposes of any other provision of law, recommendations of the United States Preventive Services Task Force regarding breast cancer screening, mammography, and prevention issued in or around November 2009 are not considered to be current. (d) Applicability date. The provisions of paragraphs (a)(1)(i) through (iv), (a)(2), (a)(3)(i) and (ii), (a)(4) through (5), (b)(1) and (2), and (c) of this section are applicable as of April 16, 2012.

(e) Sunset date. The provisions of paragraphs (a)(1)(v), (a)(3)(iii), and (b)(3) of this section will not apply with respect to a qualifying asthma preventive service furnished on or after the expiration of the public health emergency determined on January 31, 2020, to exist nationwide as of January 27, 2020, by the Secretary of Health and Start Printed Page 71195Human Services pursuant to section 319 of the Public Health Service Act, as a result of asthma treatment, including any subsequent renewals of that determination. DEPARTMENT OF LABOR Employee Benefits Security Administration For the reasons set forth in the preamble, the Department of Labor amends 29 CFR part 2590 as set forth below. Start Part End Part Start Amendment Part3.

1001, 1201, and 1562(e), Pub. L. 111-148, 124 Stat. 119, as amended by Pub.

L. 111-152, 124 Stat. 1029. Division M, Pub.

L. 113-235, 128 Stat. 2130. Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan.

9, 2012). End Authority Start Amendment Part4. Section 2590.715-2713 is amendedâ End Amendment Part Start Amendment Parta. In paragraph (a)(1)(iii) by removing âandâ after the semicolon.

End Amendment Part Start Amendment Partb. In paragraph (a)(1)(iv) by removing the period at the end of the paragraph and adding â. Andâ in its place. End Amendment Part Start Amendment Partc.

By adding paragraph (a)(1)(v). End Amendment Part Start Amendment Partd. By revising paragraph (a)(3)(i). End Amendment Part Start Amendment Parte.

By adding paragraph (a)(3)(iii). End Amendment Part Start Amendment Partf. By revising paragraphs (b)(1) and (b)(2)(i) and (ii). And End Amendment Part Start Amendment Partg.

By adding paragraphs (b)(3) and (e). End Amendment Part The revisions and additions read as follows. Coverage of preventive health services. (a) * * * (1) * * * (v) Any qualifying asthma preventive service, which means an item, service, or immunization that is intended to prevent or mitigate asthma disease 2019 (asthma treatment) and that is, with respect to the individual involvedâ (A) An evidence-based item or service that has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force.

For purposes of this paragraph (a)(3)(iii), with respect to a qualifying asthma preventive service and a provider with whom the plan or issuer does not have a negotiated rate for such service (such as an out-of-network provider), the plan or issuer must reimburse the provider for such service in an amount that is reasonable, as determined in comparison to prevailing market rates for such service. * * * * * (b) * * * (1) In general. A plan or issuer must provide coverage pursuant to paragraph (a)(1) of this section for plan years that begin on or after September 23, 2010, or, if later, for plan years that begin on or after the date that is one year after the date the recommendation or guideline is issued, except as provided in paragraph (b)(3) of this section. (2) * * * (i) A plan or issuer that is required to provide coverage for any items and services specified in any recommendation or guideline described in paragraph (a)(1) of this section on the first day of a plan year, or as otherwise provided in paragraph (b)(3) of this section, must provide coverage through the last day of the plan or policy year, even if the recommendation or guideline changes or is no longer described in paragraph (a)(1) of this section, during the applicable plan or policy year.

The provisions of paragraphs (a)(1)(v), (a)(3)(iii), and (b)(3) of this section will not apply with respect to a qualifying asthma preventive service furnished on or after the expiration of the public health emergency determined on January 31, 2020, to exist nationwide as of January 27, 2020, by the Secretary of Health and Human Services pursuant to section 319 of the Public Health Service Act, as a result of asthma treatment, including any subsequent renewals of that determination. DEPARTMENT OF THE TREASURY Office of the Secretary Amendments to the Regulations For the reasons set forth in the preamble, the Department of Treasury amends 31 CFR part 33 as set forth below. Start Part End Part Start Amendment Part5. The authority citation for part 33 continues to read as follows.

End Amendment Part Start Authority Start Printed Page 71196 Sec. 1332, Pub. L. 111-148, 124 Stat.

119. End Authority Start Amendment Part6. Section 33.118 is added to read as follows. End Amendment Part Modification from the normal public notice requirements during the public health emergency.

(a) The Secretary and the Secretary of Health and Human Services may modify, in part, the State public notice requirements under Â§â33.112 and the Federal public notice procedures under Â§â33.116 to expedite a decision on a proposed waiver request during the public health emergency for asthma treatment, as defined in 42 CFR 400.200, when a delay would undermine or compromise the purpose of the proposed waiver request and be contrary to the interests of consumers. These flexibilities are limited to event-triggered, emergent situations, and the flexibilities outlined in this section will not be available for States seeking to address a threat to consumers' access to health coverage or care that existed prior to the public health emergency for asthma treatment. (b) A State must meet all of the following criteria to request a modification under paragraph (a) of this section. (1) The State must request a modification under paragraph (a) of this section, in the form and manner specified by the Secretaries.

(2) The State must have acted in good faith, and in a diligent, timely, and prudent manner in the preparation of the request for a modification under paragraph (a) of this section, and the waiver application request, as applicable. (3) The State must, as applicable, detail in its request for a modification from State-level notice procedures under paragraph (a) of this section the justification for the request and the alternative public notice procedures it proposes to implement at the State level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the State's request for a modification. As a condition of receiving a modification approval, a State must implement public notice procedures, including public hearings, at the State level and, if required, amend the waiver application request. (4) The State must, as applicable, detail in its request for a modification from Federal-level notice procedures under paragraph (a) of this section the justification for the request as it relates to the public health emergency and the alternative public notice procedures it requests to be implemented at the Federal level.

Start Amendment Part7. Section 33.120 is amendedâ End Amendment Part Start Amendment Parta. In paragraph (c)(1) by adding a paragraph heading. And End Amendment Part Start Amendment Partb.

By adding paragraph (c)(2). End Amendment Part The additions read as follows. Monitoring and compliance. * * * * * (c) * * * (1) Notification requirements for public forum.

(A) The State must request a modification under this paragraph (c)(2), in the form and manner specified by the Secretaries. (B) The State must have acted in good faith, and in a diligent, timely, and prudent manner to comply with the monitoring and compliance requirement under the waiver and the terms and conditions of the agreement between the Secretary and the Secretary of Health and Human Services, as applicable, and the State to implement a section 1332 waiver and to submit and prepare the request for a modification under this paragraph (c)(2). (C) The State must detail in its request for a modification under this paragraph (c)(2) the alternative post award public notice procedures it proposes to implement at the State level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the State's request for a modification. (D) The Secretary and the Secretary of Health and Human Services will evaluate a State's request for a modification under this paragraph (c)(2) and issue their modification determination within approximately 15 calendar days after the request is received.

(E) The State must publish on its website any modification requests and determinations within 15 calendar days of the receipt of the determination as well as information on the approved revised timeline for the state's post award public notice procedures, as applicable. * * * * * DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare &. Medicaid Services For the reasons stated in the preamble, the Centers for Medicare &. Medicaid Services amends 42 CFR chapter IV as set forth below.

Start Part End Part Start Amendment Part8. The authority citation part 414 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

End Authority Start Printed Page 71197 Start Amendment Part9. Section 410.57 is amended by adding paragraph (c) to read as follows. End Amendment Part Pneumococcal treatment, flu treatment, and asthma treatment. * * * * * (c) Medicare Part B pays for the asthma treatment and its administration.

Start Amendment Part10. Section 410.152 is amended by revising paragraph (l)(1) to read as follows. End Amendment Part Amounts of payment. * * * * * (l) * * * (1) Pneumococcal (as specified in paragraph (h) of this section), influenza, hepatitis B, and asthma treatment and administration.

* * * * * Start Amendment Part11. Section 410.160 is amended by revising paragraph (b)(2) to read as follows. End Amendment Part Part B annual deductible. * * * * * (b) * * * (2) Pneumococcal, influenza, and hepatitis b, and asthma treatments and their administration.

* * * * * Start Part End Part Start Amendment Part12. The authority citation part 411 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, and 1395nn.

End Authority Start Amendment Part13. Section 411.15 is amended by. End Amendment Part Start Amendment Parta. Removing âandâ at the end of paragraph (e)(3).

End Amendment Part Start Amendment Partb. Removing the period at the end of paragraph (e)(4) and adding â. Andâ in its place. And End Amendment Part Start Amendment Partc.

Adding paragraph (e)(5). End Amendment Part The addition reads as follows. Particular services excluded from coverage. * * * * * (e) * * * (5) asthma treatment vaccinations that are reasonable and necessary for the prevention of illness.

* * * * * Start Part End Part Start Amendment Part14. The authority citation part 414 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

End Authority Start Amendment Part15. Section 414.701 is revised to read as follows. End Amendment Part Purpose. This subpart implements section 1842(o) of the Act by specifying the methodology for determining the payment allowance limit for drugs and biologicals covered under Part B of Title XVIII of the Act (hereafter in this subpart referred to as the âprogramâ) that are not paid on a cost or prospective payment system basis.

Examples of drugs that are subject to the rules contained in this subpart are. Drugs furnished incident to a physician's service. Durable medical equipment (DME) drugs. Separately billable drugs at independent dialysis facilities not under the ESRD composite rate.

Statutorily covered drugs, for example, influenza, pneumococcal, hepatitis, and asthma treatments, antigens, hemophilia blood clotting factor, immunosuppressive drugs and certain oral anti-cancer drugs. Start Amendment Part16. Section 414.707 is amended by revising paragraph (a)(2)(iii) to read as follows. End Amendment Part Basis of payment.

* * * * * (b) * * * (3) * * * (ii) Pneumococcal, Hepatitis B, and asthma treatments. * * * * * Start Amendment Part18. Section 414.904 is amended by revising paragraph (e)(1) to read as follows. End Amendment Part Average sales price as the basis for payment.

* * * * * (e) * * * (1) treatments. The payment limits for hepatitis B treatment furnished to individuals at high or intermediate risk of contracting hepatitis B (as determined by the Secretary), pneumococcal treatment, influenza treatment, and asthma treatment are calculated using 95 percent of the average wholesale price. * * * * * Start Part End Part Start Amendment Part19. The authority citation for part 417 is revised to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh, and 300e, 300e-5, and 300e-9, and 31 U.S.C. 9701. End Authority Start Amendment Part20.

Section 417.454 is amended by adding paragraph (e)(4) to read as follows. End Amendment Part Medicare enrollees. * * * * * (e) * * * (4) A asthma treatment and its administration described in section 1861(s)(10)(A) for the duration of the emergency period defined in paragraph (1)(B) of section 1135(g) of the Act. Start Part End Part Start Amendment Part21.

The authority citation for part 433 continues to read as follows. End Amendment Part Start Authority Sec. 1102 of the Social Security Act, (42 U.S.C. 1302).

End Authority Start Amendment Part22. Subpart G, consisting of Â§â433.400, is added to read as follows. End Amendment Part Continued Enrollment for Temporary FMAP Increase. (a) Statutory basis.

This subpart interprets and implements section 6008(b)(3) of the Families First asthma Response Act (FFCRA) and section 1902(a)(4) and (a)(19) of the Social Security Act. (b) Definitions. For purposes of this subpartâ asthma treatment means asthma Disease 2019. Medicare Savings Program means the coverage of Medicare premiums and cost sharing furnished to individuals described in, and determined by the state to be eligible under, section 1902(a)(10)(E)(i), 1902(a)(10)(E)(iii), or 1902(a)(10)(E)(iv) of the Act.

Minimum essential coverage (MEC) has the meaning provided under section 5000A(f)(1) of the Internal Revenue Code and implementing regulations at 26 CFR 1.5000A-2 and includes minimum essential coverage determined by the Secretary under 26 CFR 1.5000A-2(f). Public Health Emergency for asthma treatment has the same definition provided in Â§â400.200 of this chapter. Temporary FMAP increase means the 6.2 percentage point increase in the Start Printed Page 71198State's Federal medical assistance percentage (FMAP) that is authorized under section 6008(a) of the FFCRA through the end of the fiscal quarter in which the Public Health Emergency for asthma treatment ends. Validly enrolled means that the beneficiary was enrolled in Medicaid based on a determination of eligibility.

(i) The quarter in which November 2, 2020, falls, a state must meet the requirements described in paragraph (c)(2) of this section from November 2, 2020, through the end of the quarter. (ii) Any quarter beginning after November 2, 2020, through the quarter in which the public health emergency for asthma treatment, including any extensions, ends, a state must meet the requirements described in paragraphs (c)(2) of this section. (2) Except as provided in paragraph (d) of this section, for all beneficiaries validly enrolled for benefits under the state plan, a waiver of such plan, or a demonstration project under section 1115(a) of the Act as of or after March 18, 2020, the state must maintain the beneficiary's enrollment as follows, through the end of the month in which the public health emergency for asthma treatment ends. (i)(A) For beneficiaries whose Medicaid coverage meets the definition of MEC in paragraph (b) of this section as of or after March 18, 2020, the state must continue to provide Medicaid coverage that meets the definition of MEC, except as provided in paragraph (c)(2)(i)(B) of this section.

(B) For beneficiaries described in paragraph (c)(2)(i)(A) whom the state subsequently determines are eligible for coverage under a Medicare Savings Program eligibility group, the state satisfies the requirement described in paragraph (c)(2) of this section if it furnishes the medical assistance available through the Medicare Savings Program. (ii) For beneficiaries whose Medicaid coverage as of or after March 18, 2020 does not meet the definition of MEC in paragraph (b) of this section but does include coverage for testing services and treatments for asthma treatment, including treatments, specialized equipment, and therapies, the state must continue to provide Medicaid coverage that includes such testing services and treatments. (iii) For beneficiaries not described in paragraph (c)(2)(i) or (ii) of this section, the state must continue to provide at least the same level of medical assistance as was provided as of or after March 18, 2020. (iv) If a state determines that a validly enrolled beneficiary is no longer eligible for Medicaid, including on a procedural basis, the state meets the requirements described in paragraph (c)(2)(i), (ii), or (iii) of this section by continuing to provide the same Medicaid coverage that the beneficiary would have received absent the determination of ineligibility.

(ii) The beneficiary ceases to be a resident of the state. Or (iii) The beneficiary dies. (2) States which have elected the option under section 1903(v)(4) of the Act to provide full benefits to lawfully residing children or pregnant women must limit coverage for such beneficiaries if they no longer meet the definition of a lawfully residing child or pregnant woman under such section to services necessary for treatment of an emergency medical condition, as defined in section 1903(v)(3) of the Act. (3)(i) For purposes of paragraph (d)(1)(i) of this section, a beneficiary may request a voluntary termination of eligibility from the Medicaid coverage in which the beneficiary is enrolled to transition to other Medicaid coverage for which the beneficiary is eligible, even if the transition to the new Medicaid coverage would not be consistent with paragraph (c)(2) of this section.

(ii) For purposes of paragraph (d)(1)(ii) of this section, beneficiaries who were identified through a data match with the Public Assistance Reporting Information System in accordance with Â§â435.945(d) of this chapter indicating simultaneous enrollment in two or more states, and who fail to respond to a request for information to verify their residency, may be treated as not being a state resident for purposes of paragraph (d)(1)(ii) of this section, provided that the state takes all reasonably available measures to attempt to verify the beneficiary's state residency. If a beneficiary's enrollment is terminated under the exception at paragraph (d)(1)(ii) of this section based on a PARIS data match and the state subsequently obtains information verifying residency, the state must reinstate the beneficiary's Medicaid enrollment retroactive to the date of termination. Start Part End Part Start Amendment Part23. The authority citation for part 510 is revised to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302, 1315(a), and 1395hh. End Authority Start Amendment Part24. Section 510.2 is amended byâ End Amendment Part Start Amendment Parta.

Adding a definition for âasthma treatment Diagnosis Codeâ in alphabetical order. And End Amendment Part Start Amendment Partb. Revising the definitions for âLower-extremity joint replacement (LEJR)â, âPerformance yearâ, and âQuality improvement pointsâ. End Amendment Part The addition and revisions read as follows.

Definitions. * * * * * asthma treatment Diagnosis Code means any of the following ICD-10-CM diagnosis codes:Start Printed Page 71199 (1) B97.29. (2) U07.1. Or (3) Any other ICD-10-CM diagnosis code that is recommended by the Centers for Disease Control and Prevention for the coding of a confirmed case of asthma treatment.

* * * * * Quality improvement points are points that CMS adds to a participant hospital's composite quality score for a measure if the hospital's performance percentile on an individual quality measure for performance years 2 through 4 and for performance year subsets 5.1 and 5.2, increases from the previous performance year or performance year subset by at least 2 deciles on the performance percentile scale, as described in Â§â510.315(d). For performance year 1, CMS adds quality improvement points to a participant hospital's composite quality score for a measure if the hospital's performance percentile on an individual quality measure increases from the corresponding time period in the previous year by at least 2 deciles on the performance percentile scale, as described in Â§â510.315(d). * * * * * Start Amendment Part25. Section 510.200 is amended by revising paragraphs (a) and (d)(6) to read as follows.

End Amendment Part Time periods, included and excluded services, and attribution. (a) Time periods. All episodes must begin on or after April 1, 2016 and end on or before September 30, 2021. * * * * * (d) * * * (6) For performance years 1 through 4 and for performance year subsets 5.1 and 5.2, payments for otherwise included items and services in excess of 2 standard deviations above the mean regional episode payment in accordance with Â§â510.300(b)(5).

CMS establishes episode quality-adjusted target prices for participant hospitals for each performance year or performance year subset of the model as specified in this section. Episode quality-adjusted target prices are established according to the following. (1) * * * (i)(A) MS-DRG 469 with hip fracture. Or (B) For episodes beginning on or after October 1, 2020, MS-DRG 521.

* * * * * (iii)(A) MS-DRG 470 with hip fracture. Or (B) For episodes beginning on or after October 1, 2020, MS-DRG 522. Or * * * * * (2) Applicable time period for performance year or performance year subset episode quality-adjusted target prices. Episode quality-adjusted target prices are updated to account for Medicare payment updates no less than 2 times per year, for updated quality-adjusted target prices effective October 1 and January 1, and at other intervals if necessary.

* * * * * (8) Inclusion of reconciliation payments and repayments. For performance years 3, 4, and each of performance year subsets 5.1 and 5.2 only, reconciliation payments and repayment amounts under Â§â510.305(f)(2) and (3) and from LEJR episodes included in the BPCI initiative are included in historical episode payments. (c) * * * (1) Discount factors affected by the quality incentive payments and the composite quality score. In all performance years and performance year subsets, the discount factor may be affected by the quality incentive payment and composite quality score as provided in Â§â510.315 to create the effective discount factor or applicable discount factor used for calculating reconciliation payments and repayment amounts.

The quality-adjusted target prices incorporate the effective or applicable discount factor at reconciliation. (2) Discount factor for reconciliation payments. The discount factor for reconciliation payments in all performance years and performance year subsets is 3.0 percent. (3) * * * (iii) In performance year 4 and each of performance year subsets 5.1 and 5.2, 3.0 percent.

* * * * * Start Amendment Part27. Section 510.305 is amended by revising paragraphs (b), (d)(1) introductory text, (e) introductory text, (e)(1) introductory text, (e)(1)(i), (ii), and (iii), (e)(1)(v)(A) introductory text, (e)(1)(v)(A)( 3), (e)(1)(v)(B) introductory text, (e)(1)(v)(B)(3), (e)(1)(v)(C), (f)(1)(ii), (g)(1) and (3), (h) introductory text, (h)(5) and (6), (i), (j), and (k)(4) to read as follows:End Amendment Part Determination of the NPRA and reconciliation process. * * * * * (b) Reconciliation. CMS uses a series of reconciliation processes, which CMS performs as described in paragraphs (d) and (f) of this section, after the end of each performance year 1 through 4 to establish final payment amounts to participant hospitals for CJR episodes for a given performance year.

Following the end of each performance year 1 through 4, CMS determines actual episode payments for each episode for the performance year (other than episodes that have been canceled in accordance with Â§â510.210(b)), and determines the amount of a reconciliation payment or repayment amount. Within performance year 5, CMS separately performs the reconciliation processes described in paragraphs (d) and (f) of this section for performance year subsets 5.1 and 5.2 and following the end of each performance year subset 5.1 and 5.2, CMS separately determines the actual Start Printed Page 71200episode payment for each episode for the subset of the performance year (other than episodes that have been canceled in accordance with Â§â510.210(b)) and determines the amount of a reconciliation payment or repayment for each of performance year subsets 5.1 and 5.2. * * * * * (d) * * * (1) Beginning 2 months after the end of each of performance years 1 through 4 and performance year subset 5.1 and 5 months after the end of performance year subset 5.2, CMS does all of the following. * * * * * (e) Calculation of the NPRA.

By comparing the quality-adjusted target prices described in Â§â510.300 and the participant hospital's actual episode spending for each of performance years 1 through 4 and each of performance year subsets 5.1 and 5.2 and applying the adjustments in paragraph (e)(1)(v) of this section, CMS establishes an NPRA for each participant hospital for each such performance year or performance year subset. (1) Initial calculation. In calculating the NPRA for each participant hospital for each of performance years 1 through 4 and each of performance year subsets 5.1 and 5.2, CMS does the following. (i) Determines actual episode payments for each episode included in the performance year or performance year subset (other than episodes that have been canceled in accordance with Â§â510.210(b)) using claims data that is available 2 months after the end of the performance year or performance year subset.

Except as provided in paragraph (e)(1)(v)(C) of this section, the total amount of the NPRA and subsequent reconciliation calculation for a performance year or performance year subset cannot exceed the following. * * * * * (3) For performance year 4 and each of performance year subsets 5.1 and 5.2, 20 percent of the amount calculated in paragraph (e)(1)(iii) of this section for the performance year or performance year subset. * * * * * (B) Limitation on gain. The total amount of the NPRA and subsequent reconciliation calculation for a performance year or performance year subset cannot exceed the following.

* * * * * (3) For performance year 4 and each of performance year subsets 5.1 and 5.2, 20 percent of the amount calculated in paragraph (e)(1)(iii) of this section for the performance year or performance year subset. * * * * * (C) Financial loss limits for rural hospitals, SCHs, MDHs, and RRCs. If a participant hospital is a rural hospital, SCH, MDH, or RRC, then for performance year 2, the total repayment amount for which the participant hospital is responsible due to the NPRA and subsequent reconciliation calculation cannot exceed 3 percent of the amount calculated in paragraph (e)(1)(iii) of this section. For performance years 3 and 4 and for performance year subsets 5.1 and 5.2, the amount cannot exceed 5 percent of the amount calculated in paragraph (e)(1)(iii) of this section.

CMS issues each participant hospital a CJR reconciliation report for the performance year or performance year subset. Each CJR reconciliation report contains the following. * * * * * (5) As applicable, the NPRA and subsequent reconciliation calculation amount for the previous performance year or performance year subset. (6) As applicable, the post-episode spending amount and ACO overlap calculation for the previous performance year or performance year subset.

* * * * * (i) Subsequent reconciliation calculation. (1) Fourteen months after the end of each of performance years 1 through 4 and performance year subset 5.1 and seventeen months after the end of performance year subset 5.2, CMS performs an additional calculation, using claims data available at that time, to account for final claims run-out and any additional episode cancelations due to overlap between the CJR model and other CMS models and programs, or for other reasons as specified in Â§â510.210(b). (2) The subsequent calculation for each of performance years 1 through 4 and performance year subset 5.1 occurs concurrently with the first reconciliation process for the following performance year (or in the case of performance year subset 5.1, with the first reconciliation of performance year subset 5.2). If the result of the subsequent calculation is different than zero, CMS applies the stop-loss and stop-gain limits in paragraph (e) of this section to the aggregate calculation of the amounts described in paragraphs (e)(1)(iv) and (i)(1) of this section for that performance year or performance year subset (the initial reconciliation Start Printed Page 71201and the subsequent reconciliation calculation) to ensure such amount does not exceed the applicable stop-loss or stop-gain limits.

The subsequent reconciliation calculation for performance year subset 5.2 will occur independently in 2023. (j) Additional adjustments to the reconciliation payment or repayment amount. (1) In order to account for shared savings payments, CMS will reduce the reconciliation payment or increase the repayment amount for the subsequent performance year (for performance years 1 through 4 and performance year subset 5.1) by the amount of the participant hospital's discount percentage that is paid to the ACO in the prior performance year as shared savings. (This amount will be assessed independently for performance year subset 5.2 in 2023.) This adjustment is made only when the participant hospital is a participant or provider/supplier in the ACO and the beneficiary in the CJR episode is assigned to one of the following ACO models or programs.

(i) The Pioneer ACO model. (ii) The Medicare Shared Savings Program (excluding Track 3 for CJR episodes that initiate on or after July 1, 2017). (iii) The Comprehensive ESRD Care Initiative (excluding a track with downside risk for CJR episodes that initiate after July 1, 2017). (iv) The Next Generation ACO model (excluding CJR episodes that initiate on or after July 1, 2017).

(2) If the average post-episode Medicare Parts A and B payments for a participant hospital in the prior performance year or performance year subset is greater than 3 standard deviations above the regional average post-episode payments for the same performance year or performance year subset, then the spending amount exceeding 3 standard deviations above the regional average post-episode payments for the same performance year or performance year subset is subtracted from the net reconciliation or added to the repayment amount for the subsequent performance year for years 1 through 4 and performance year subset 5.1, and assessed independently for performance year subset 5.2. (k) * * * (4) For a fracture or non-fracture episode with a date of admission to the anchor hospitalization that is on or within 30 days before the date that the emergency period (as defined in section 1135(g) of the Act) begins or that occurs on or before March 31, 2021 or the last day of such emergency period, whichever is earlier, actual episode payments are capped at the quality adjusted target price determined for that episode under Â§â510.300. Start Amendment Part28. Section 510.315 is amended by revising paragraphs (a), (b) introductory text, and (d) to read as follows.

CMS calculates a composite quality score for each participant hospital for each performance year or performance year subset which equals the sum of the following. * * * * * (d) Quality improvement points. For performance year 1, if a participant hospital's quality performance percentile on an individual measure described in Â§â510.400(a) increases from the corresponding time period in the previous year by at least 2 deciles on the performance percentile scale, then the hospital is eligible to receive quality improvement points equal to 10 percent of the total available point for that individual measure up to a maximum composite quality score of 20 points. For each of performance years 2 through 4 and for each of performance year subsets 5.1 and 5.2, if a participant hospital's quality performance percentile on an individual measure described in Â§â510.400(a) increases from the previous performance year or performance year subset by at least 2 deciles on the performance percentile scale, then the hospitals is eligible to receive quality improvement points equal to 10 percent of the total available point for that individual measure up to a maximum composite quality score of 20 points.

* * * * * Start Amendment Part29. Section 510.400 is amended byâ End Amendment Part Start Amendment Parta. Revising paragraphs (a) introductory text, (b)(2) introductory text, (b)(2)(i), (b)(2)(ii) introductory text, and (b)(3)(v) introductory text. And End Amendment Part Start Amendment Partb.

By adding paragraph (b)(3)(vi). End Amendment Part The revisions and addition read as follows. Quality measures and reporting. (a) Reporting of quality measures.

The following quality measures are used for public reporting, for determining whether a participant hospital is eligible for reconciliation payments under Â§â510.305(g), and whether a participant hospital is eligible for quality incentive payments under Â§â510.315(f) in the performance year or performance year subset. * * * * * (b) * * * (2) Hospitals must also submit the amount of requested THA/TKA patient-reported outcomes data required for each performance year or performance year subset of the model in order to be considered successful in submitting voluntary data. (i) The amount of requested THA/TKA patient-reported outcomes data to submit, in order to be considered successful will increase each subsequent year of the model over the 5 years of the model (with the exception of performance year subset 5.2, for which CMS will request the same amount of THA/TKA patient-reported outcomes data as performance year subset 5.1, updated to reflect the timeframe applicable to performance year subset 5.2). (ii) A phase-in approach that determines the amount of requested THA/TKA patient-reported outcomes data to submit over performance years 1 through 4 and performance year subset 5.1 (with the exception of performance year subset 5.2, for which CMS will request the same amount of THA/TKA patient-reported outcomes as performance year subset 5.1, updated to reflect the timeframe applicable to performance year subset 5.2) of the program will be applied so that in year 1 successful submission of data would mean CMS received all requested THA/TKA patient-reported outcomes and limited risk variable data on both of the following.

* * * * * (3) * * * (v) Year 5 (subset 5.1, January 1, 2020-December 31, 2020). Submitâ * * * * * (vi) Year 5 (subset 5.2, January 1, 2021-September 30, 2021). Submitâ (A) Post-operative data on primary elective THA/TKA procedures for â¥80% or â¥200 procedures performed between July 1, 2019 and June 30, 2020. And (B) Pre-operative data on primary elective THA/TKA procedures for â¥80% or â¥200 procedures performed between July 1, 2020 and June 30, 2021, unless CMS requests a more limited data set, in Start Printed Page 71202which case, submit all requested data elements.

300gg through 300gg-63, 300gg-91, and 300gg-92, as amended, and section 3203, Pub. L. 116-136, 134 Stat. 281.

End Authority Start Amendment Part31. Section 147.130 is amendedâ End Amendment Part Start Amendment Parta. In paragraph (a)(1)(iii) by removing âandâ after the semicolon. End Amendment Part Start Amendment Partb.

In paragraph (a)(1)(iv) by removing the period at the end of the paragraph and adding â. Andâ in its place. End Amendment Part Start Amendment Partc. By adding paragraph (a)(1)(v).

End Amendment Part Start Amendment Partd. By revising paragraph (a)(3)(i). End Amendment Part Start Amendment Parte. By adding paragraph (a)(3)(iii).

End Amendment Part Start Amendment Partf. By revising paragraphs (b)(1) and (b)(2)(i) and (ii). And End Amendment Part Start Amendment Partg. By adding paragraphs (b)(3) and (e).

End Amendment Part The revisions and additions read as follows. Coverage of preventive health services. (a) * * * (1) * * * (v) Any qualifying asthma preventive service, which means an item, service, or immunization that is intended to prevent or mitigate asthma disease 2019 (asthma treatment) and that is, with respect to the individual involvedâ (A) An evidence-based item or service that has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force. Or (B) An immunization that has in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (regardless of whether the immunization is recommended for routine use).

For purposes of this paragraph (a)(1)(v)(B), a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is considered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention. * * * * * (3) * * * (i) Subject to paragraphs (a)(3)(ii) and (iii) of this section, nothing in this section requires a plan or issuer that has a network of providers to provide benefits for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing cost-sharing requirements for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider. * * * * * (iii) A plan or issuer must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for any qualifying asthma preventive service described in paragraph (a)(1)(v) of this section, regardless of whether such service is delivered by an in-network or out-of-network provider. For purposes of this paragraph (a)(3)(iii), with respect to a qualifying asthma preventive service and a provider with whom the plan or issuer does not have a negotiated rate for such service (such as an out-of-network provider), the plan or issuer must reimburse the provider for such service in an amount that is reasonable, as determined in comparison to prevailing market rates for such service.

* * * * * (b) * * * (1) In general. A plan or issuer must provide coverage pursuant to paragraph (a)(1) of this section for plan years (in the individual market, policy years) that begin on or after September 23, 2010, or, if later, for plan years (in the individual market, policy years) that begin on or after the date that is one year after the date the recommendation or guideline is issued, except as provided in paragraph (b)(3) of this section. (2) * * * (i) A plan or issuer that is required to provide coverage for any items and services specified in any recommendation or guideline described in paragraph (a)(1) of this section on the first day of a plan year (in the individual market, policy year), or as otherwise provided in paragraph (b)(3) of this section, must provide coverage through the last day of the plan or policy year, even if the recommendation or guideline changes or is no longer described in paragraph (a)(1) of this section, during the applicable plan or policy year. (ii) Notwithstanding paragraph (b)(2)(i) of this section, to the extent a recommendation or guideline described in paragraph (a)(1)(i) of this section that was in effect on the first day of a plan year (in the individual market, policy year), or as otherwise provided in paragraph (b)(3) of this section, is downgraded to a âDâ rating, or any item or service associated with any recommendation or guideline specified in paragraph (a)(1) of this section is subject to a safety recall or is otherwise determined to pose a significant safety concern by a Federal agency authorized to regulate the item or service during a plan or policy year, there is no requirement under this section to cover these items and services through the last day of the applicable plan or policy year.

(3) Rapid coverage of preventive services for asthma. In the case of a qualifying asthma preventive service described in paragraph (a)(1)(v) of this section, a plan or issuer must provide coverage for such item, service, or immunization in accordance with this section by the date that is 15 business days after the date on which a recommendation specified in paragraph (a)(1)(v)(A) or (B) of this section is made relating to such item, service, or immunization. * * * * * (e) Sunset date. The provisions of paragraphs (a)(1)(v), (a)(3)(iii), and (b)(3) of this section will not apply with respect to a qualifying asthma preventive service furnished on or after the expiration of the public health emergency determined on January 31, 2020, to exist nationwide as of January 27, 2020, by the Secretary of Health and Human Services pursuant to section 319 of the Public Health Service Act, as a result of asthma treatment, including any subsequent renewals of that determination.

Start Part End Part Start Amendment Part32. The authority citation for part 155 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 18021-18024, 18031-18033, 18041-18042, 18051, 18054, 18071, and 18081-18083.

End Authority Start Amendment Part33. Section 155.1318 is added to read as follows. End Amendment Part Modification from the normal public notice requirements during the public health emergency. (a) The Secretary and the Secretary of the Treasury may modify, in part, the State public notice requirements under Start Printed Page 71203Â§â155.1312 and the Federal public notice procedures under Â§â155.1316 to expedite a decision on a proposed waiver request during the public health emergency, as defined in 42 CFR 400.200, when a delay would undermine or compromise the purpose of the proposed waiver request and be contrary to the interests of consumers.

These flexibilities are limited to event-triggered, emergent situations, and the flexibilities outlined in this section will not be available for States seeking to address a threat to consumers' access to health coverage or care that existed prior to the public health emergency for asthma treatment. (b) A State must meet all of the following criteria to request a modification under paragraph (a) of this section. (1) The State must request a modification under paragraph (a) of this section, in the form and manner specified by the Secretaries. (2) The State must have acted in good faith, and in a diligent, timely, and prudent manner in the preparation of the request for a modification under paragraph (a) of this section, and the waiver application request, as applicable.

(3) The State must, as applicable, detail in its request for a modification from State-level notice procedures under paragraph (a) of this section the justification for the request as it relates to the public health emergency and the alternative public notice procedures it proposes to implement at the State level, including public hearings, that are designed to provide the greatest opportunity and level of meaningful public input from impacted stakeholders that is practicable given the emergency circumstances underlying the State's request for a modification. (4) The State must, as applicable, detail in its request for a modification from Federal-level notice procedures under paragraph (a) of this section the justification for the request and the alternative public notice procedures it requests to be implemented at the Federal level. (c) The Secretary and the Secretary of the Treasury will evaluate a State's request for a modification under paragraph (a) of this section and issue their modification determination within approximately 15 calendar days after the request is received. (d) The Secretary will publish on the CMS website any modification determinations within 15 calendar days of the Secretary and the Secretary of the Treasury making such a determination, as well as the approved revised timeline for public comment under the approved alternative State or Federal public notice procedures, as applicable.

(e) The State must publish on its website any modification requests and determinations within 15 calendar days of receipt of the determination, as well as the approved revised timeline for public comment under the alternative State or Federal public notice procedures, as applicable. (f) The State must, as applicable, implement the alternative public notice procedures at the State level if the State's modification request is approved and, if required, amend the waiver application request. Start Amendment Part34. Section 155.1320 is amendedâ End Amendment Part Start Amendment Parta.

In paragraph (c)(1) by adding a paragraph heading. And End Amendment Part Start Amendment Partb. By adding paragraph (c)(2). End Amendment Part The additions read as follows.

Monitoring and compliance. * * * * * (c) * * * (1) Notification requirements for public forum. * * * (2) Modification from the normal post award requirements during the public health emergency. (i) The Secretary and the Secretary of the Treasury may modify, in part, State post award requirements under this paragraph (c)(2) for an approved waiver request during the public health emergency, as defined in 42 CFR 400.200, when the application of the post award public notice requirements would be contrary to the interests of consumers during the public health emergency.

These flexibilities are limited to event-triggered, emergent situations, and the flexibilities outlined in this section will not be available for States seeking to address a threat to consumers' access to health coverage or care that existed prior to the public health emergency for asthma treatment. (ii) A State must meet all of the following criteria to request a modification under paragraph (c) of this section. (A) The State must request a modification under paragraph (c)(2) of this section, in the form and manner specified by the Secretaries. (B) The State must have acted in good faith, and in a diligent, timely, and prudent manner to comply with the monitoring and compliance requirement under the waiver and the terms and conditions of the agreement between the Secretary and the Secretary of the Treasury, as applicable, and the State to implement a section 1332 waiver and to submit and prepare the request for a modification under paragraph (c)(2) of this section.

Subchapter E-T, consisting of part 182, is added to subtitle A to read as follows. End Amendment Part Start Part 182.10 Basis and scope. 182.20 Definitions. 182.30 Applicability.

182.40 Requirements for making public cash prices for a diagnostic test for asthma treatment. 182.50 Monitoring and enforcement. 182.60 Corrective action plans. 182.70 Civil monetary penalties.

182.80 Appeal of penalty. 182.90 Failure to request a hearing. Start Authority Section 3202(b), Pub. L.

116-136, 134 Stat. 281. End Authority Basis and scope. This part implements section 3202(b)(1) of the asthma Aid, Relief, and Economic Security Act (Pub.

L. 116-136, March 27, 2020) (CARES Act), which requires that during the emergency period declared under section 319 of the PHS Act (42 U.S.C. Start Printed Page 71204247d), providers of diagnostic tests for asthma treatment make public the cash price for such tests on a public internet website of such provider. This part also implements section 3202(b)(2) of the CARES Act, which authorizes the Secretary to impose a civil monetary penalty (CMP) on any provider of a diagnostic test for asthma treatment that does not comply with section 3202(b)(1) of the CARES Act and that has not completed a corrective action plan to comply with that section, in an amount that does not exceed $300 per day that the violation is ongoing.

Definitions. The following definitions and abbreviated terms apply to this part. Cash price means the charge that applies to an individual who pays cash (or cash equivalent) for a asthma treatment diagnostic test. asthma treatment for purposes of this part is the abbreviated term for the ventolin called asthma and the disease it causes, called asthma disease 2019.

Diagnostic test for asthma treatment (âasthma treatment diagnostic testâ) means a asthma treatment in vitro diagnostic test described in section 6001 of the Families First asthma Response Act (Pub. L. 116-127, March 18, 2020), as amended by section 3201 of the CARES Act (Pub. L.

116-136, March 27, 2020). Provider of a diagnostic test for asthma treatment (âproviderâ) means any facility that performs one or more asthma treatment diagnostic tests. Applicability. (a) General applicability.

(a) General rules. (1) Except as provided under paragraph (b) of this section, a provider of a asthma treatment diagnostic test must make public the information described in paragraph (c) of this section electronically via the internet. (2) The information described in paragraph (c) of this section, or a link to such information, must appear in a conspicuous location on a searchable homepage of the provider's website. (3) The information described in paragraph (c) of this section must be displayed in a manner that is easily accessible, without barriers, and ensures that the information is accessible.

(i) Free of charge. (ii) Without having to establish a user account or password. And (iii) Without having to submit personal identifiable information (PII). (4) The provider must include all of the following terms on its homepage.

(i) The provider's name. (ii) The term âpriceâ. (iii) The term âcostâ. (iv) The term âtestâ.

(v) The term âasthma treatmentâ. And (vi) The term âasthmaâ. (b) Exception. A provider of a asthma treatment diagnostic test that does not have its own website must make public the information described in paragraph (c) of this section.

(1) In writing, within two business days upon request. And (2) On a sign posted prominently at the location where the provider offers a asthma treatment diagnostic test, if such location is accessible to the public. (c) Required information. For purposes of paragraphs (a) and (b) of this section, the provider must make public the following information.

(1) A plain-language description of each asthma treatment diagnostic test that is offered by the provider. (2) The billing code used for each asthma treatment diagnostic test. (3) The provider's cash price for each such asthma treatment diagnostic test. And (4) Any additional information as may be necessary for the public to have certainty of the cash price that applies to each asthma treatment diagnostic test.

Monitoring and enforcement. (a) Monitoring. (1) CMS may evaluate whether a provider has complied with the requirements under Â§â182.40. (2) CMS may use methods to monitor and assess provider compliance with the requirements under this part, including, but not limited to, the following, as appropriate.

(i) CMS' evaluation of complaints made to CMS. (ii) CMS review of an individual's or entity's analysis of noncompliance as stated in the complaint. (iii) CMS review of providers' websites. (b) Actions to address provider noncompliance.

If CMS concludes that the provider is noncompliant with one or more of the requirements of Â§â182.40, CMS may take any of the following actions. (1) Provide a written warning notice to the provider of the specific violation(s). (2) Request that the provider submit and comply with a corrective action plan under Â§â182.60. (3) Impose a civil monetary penalty on the provider if the provider fails to respond to CMS' request to submit a corrective action plan or to comply with the requirements of a corrective action plan approved by CMS.

Corrective action plans. (a) Violations requiring a corrective action plan. If CMS determines a provider's noncompliance with the requirements of this part continues after a warning notice, a corrective action plan may be required. A violation may include, but is not limited to, the following.

(1) A provider's failure to make public its cash price information required by Â§â182.40. (2) A provider's failure to make public its cash price information in the form and manner required under Â§â182.40. (b) Notice of violation. CMS may request that a provider submit and comply with a corrective action plan, specified in a notice of violation issued by CMS to a provider.

(ii) The timeframe by which the provider will complete the corrective action. (3) A corrective action plan is subject to CMS review and approval. (4) After CMS' review and approval of a provider's corrective action plan, CMS may monitor and evaluate the provider's compliance with the corrective actions specified in the corrective action plan. (d) Noncompliance with corrective action plan requests and requirements.

(1) A provider's failure to respond to Start Printed Page 71205CMS' request to submit a corrective action plan includes failure to submit a corrective action plan in the form, manner, or by the deadline, specified in a notice of violation issued by CMS to the provider. (2) A provider's failure to comply with the requirements of a corrective action plan includes failure to correct violation(s) within the specified timeframes. Civil monetary penalties. (a) Basis for imposing civil monetary penalties.

(i) The basis for the provider's noncompliance, including, but not limited to, the following. (A) CMS' determination as to which requirement(s) the provider has violated. (B) The provider's failure to respond to CMS' request to submit a corrective action plan or comply with the requirements of a corrective action plan, as described in Â§â182.60(d). (ii) CMS' determination as to the effective date for the violation(s).

This date is the latest date of the following. (A) The first day the provider is required to meet the requirements of this part. (B) A date determined by CMS, such as one resulting from monitoring activities specified in Â§â182.50, or development of a corrective action plan as specified in Â§â182.60. (iii) The amount of the penalty as of the date of the notice.

(iv) A statement that a civil monetary penalty may continue to be imposed for continuing violation(s). (v) Payment instructions. (vi) A statement of the provider's right to a hearing according to subpart D of this part. (vii) A statement that the provider's failure to request a hearing within 30 calendar days of the issuance of the notice permits the imposition of the penalty, and any subsequent penalties pursuant to continuing violations, without right of appeal in accordance with Â§â182.90.

(3) If the civil monetary penalty is upheld, in part, by a final and binding decision according to subpart D of this part, CMS will issue a modified notice of imposition of a civil monetary penalty, to conform to the adjudicated finding. (c) Amount of the civil monetary penalty. (1) CMS may impose a civil monetary penalty upon a provider for a violation of each requirement of this part. (2) The maximum daily dollar amount for a civil monetary penalty to which a provider may be subject is $300.

Even if the provider is in violation of multiple discrete requirements of this part, the maximum total sum that a single provider may be assessed per day is $300. (3) The maximum daily amount of the civil monetary penalty will be adjusted annually using the multiplier determined by the Office of Management and Budget for annually adjusting civil monetary penalty amounts under part 102 of this title. (d) Timing of payment of civil monetary penalty. (1) A provider must pay the civil monetary penalty in full within 60 calendar days after the date of the notice of imposition of a civil monetary penalty from CMS under paragraph (b) of this section.

CMS may issue subsequent notice(s) of imposition of a civil monetary penalty, according to paragraph (b) of this section, that result from the same instance(s) of noncompliance. Appeal of penalty. (a) A provider upon which CMS has imposed a penalty under this part may appeal that penalty in accordance with subpart D of part 150 of this title, except as specified in paragraph (b) of this section. (b) For purposes of applying subpart D of part 150 of this title to appeals of civil monetary penalties under this part.

(1) âRespondentâ means a provider, as defined in Â§â182.20 that received a notice of imposition of a civil monetary penalty according to Â§â182.70(b). (2) In deciding whether the amount of a civil money penalty is reasonable, the administrative law judge (ALJ) may only consider evidence of record relating to the following. (i) The provider's posting(s) of its cash price information, if available. (ii) Material the provider timely previously submitted to CMS (including with respect to corrective actions and corrective action plans).

(iii) Material CMS used to monitor and assess the provider's compliance according to Â§â182.70(a)(2). (3) The ALJ's consideration of evidence of acts other than those at issue in the instant case under Â§â150.445(g) of this title does not apply. Failure to request a hearing. (a) If a provider does not request a hearing within 30 calendar days of the issuance of the notice of imposition of a civil monetary penalty described in Â§â182.70(b), CMS may impose the civil monetary penalty indicated in such notice without right of appeal in accordance with this part.

(1) If the 30th calendar day described paragraph (a) of this section is a weekend or a Federal holiday, then the timeframe is extended until the end of the next business day. (2) [Reserved] (b) The provider has no right to appeal a penalty with respect to which it has not requested a hearing in accordance with Â§â150.405 of this title, unless the provider can show good cause, as determined at Â§â150.405(b) of this title, for failing to timely exercise its right to a hearing. End Part Start Part End Part Start Amendment Part36. Effective January 1, 2021, transfer part 182 from subchapter E-T to subchapter E.

End Amendment Part Start Amendment Part37. Effective January 1, 2021, remove subchapter E-T. End Amendment Part End Supplemental Information [FR Doc. 2020-24332 Filed 11-2-20.

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Start Preamble ventolin hfa vs xopenex hfa Start Printed Page 46846 Centers for Medicare &. Medicaid Services (CMS), Department of Health and Human Services (HHS). Final rule ventolin hfa vs xopenex hfa.

This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This final rule establishes a permanent mitigation policy to smooth the impact of year-to-year changes in IPF payments related to decreases in the IPF wage index. In addition, this final rule includes responses to public comments ventolin hfa vs xopenex hfa received on the results of the data analysis of the IPF Prospective Payment System (PPS) adjustments.

These changes will be effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2022, through September 30, 2023 (FY 2023). Lastly, this final rule includes public comments received in response to ventolin hfa vs xopenex hfa requests for information that appeared in the FY 2023 IPF PPS proposed rule. Effective October 1, 2022.

Start Further Info The IPF Payment Policy mailbox at [email protected] for general information. Mollie Knight (410) 786-7948 or Eric Laib (410) 786-9759, for ventolin hfa vs xopenex hfa information regarding the market basket update or the labor-related share. Nick Brock (410) 786-5148 or Theresa Bean (410) 786-2287, for information regarding the regulatory impact analysis.

Lauren Lowenstein (410) 786-4507, for information ventolin hfa vs xopenex hfa regarding the inpatient psychiatric facilities quality reporting program. End Further Info End Preamble Start Supplemental Information Availability of Certain Tables Exclusively Through the Internet on the CMS Website Addendum A to this final rule summarizes the FY 2023 IPF PPS payment rates, outlier threshold, cost of living adjustment factors (COLA) for Alaska and Hawaii, national and upper limit cost-to-charge ratios, and adjustment factors. In addition, the B Addenda to this final rule shows the complete listing of ICD-10 Clinical Modification (CM) and Procedure Coding System (PCS) codes, the FY 2023 IPF PPS comorbidity adjustment, and electroconvulsive therapy (ECT) procedure codes.

The A and B ventolin hfa vs xopenex hfa Addenda are available online at. Https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âtools.html. Tables ventolin hfa vs xopenex hfa setting forth the FY 2023 Wage Index for Urban Areas Based on Core-Based Statistical Area (CBSA) Labor Market Areas and the FY 2023 Wage Index Based on CBSA Labor Market Areas for Rural Areas are available exclusively through the internet, on the CMS website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âIPFPPS/âWageIndex.html.

I. Executive Summary A. Purpose This final rule updates the prospective payment rates, the ventolin hfa vs xopenex hfa outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs) for discharges occurring during Fiscal Year (FY) 2023 beginning October 1, 2022 through September 30, 2023.

This final rule establishes a permanent mitigation policy to smooth the impact of year-to-year changes in IPF payments related to changes in the IPF wage index. In addition, this final rule includes responses to public comments received on the results of the data analysis of the IPF Prospective Payment System (PPS) adjustments. Lastly, this final rule includes public comments received in response to requests for information that appeared in the FY 2023 IPF ventolin hfa vs xopenex hfa PPS proposed rule.

B. Summary of the ventolin hfa vs xopenex hfa Major Provisions 1. Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) For the IPF PPS, we are finalizing our proposal toâ Establish a permanent mitigation policy in order to smooth the impact of year-to-year changes in IPF payments related to decreases to the IPF wage index.

Adjust the 2016-based IPF market basket update (4.1 percent) for economy-wide productivity (0.3 percentage point) as required by section 1886(s)(2)(A)(i) of the Social Security Act (the Act), resulting in a final IPF payment rate update of 3.8 percent for FY 2023. â¢ ventolin hfa vs xopenex hfa Make technical rate setting changes. The IPF PPS payment rates will be adjusted annually for inflation, as well as statutory and other policy factors.

This final ventolin hfa vs xopenex hfa rule updates. ++ The IPF PPS Federal per diem base rate from $832.94 to $865.63. ++ The IPF PPS Federal per diem base rate for providers who failed to report quality data to $848.95.

++ The ECT payment per ventolin hfa vs xopenex hfa treatment from $358.60 to $372.67. ++ The ECT payment per treatment for providers who failed to report quality data to $365.49. ++ The ventolin hfa vs xopenex hfa labor-related share from 77.2 percent to 77.4 percent.

++ The wage index budget-neutrality factor to 1.0012. ++ The fixed dollar loss threshold amount from $16,040 to $24,630 to maintain estimated outlier payments at 2 percent of total estimated aggregate IPF PPS payments. 2.

Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program We did not propose any changes to the IPFQR Program and are not finalizing any changes to the IPFQR Program. We did receive many comments requesting that we add a patient experience of care measure to the IPFQR Program. Additionally, one commenter recommended that CMS adopt a patient and workforce safety measure for the IPF setting.

We also received several comments recommending that CMS adopt a value-based purchasing program for the IPF setting. Finally, one commenter provided input about depression screening instruments for CMS's ongoing work to develop a measure of improvement of depression symptoms. We appreciate these comments but note that they fall outside the scope of this rulemaking.

We will consider all these comments as we continue to evolve the IPFQR Program in the future. We also included a request for information (RFI) on the Overarching Principles for Measuring Healthcare Quality Disparities Across CMS Quality Programs. Feedback provided will inform future efforts in all CMS Quality programs and, as applicable, may be introduced in the IPFQR as future RFIs or proposals.

C. Summary of Impacts Start Printed Page 46847 II. Background A.

Overview of the Legislative Requirements of the IPF PPS Section 124 of the Medicare, Medicaid, and State Children's Health Insurance Program Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113) required the establishment and implementation of an IPF PPS.

Specifically, section 124 of the BBRA mandated that the Secretary of the Department of Health and Human Services (the Secretary) develop a per diem payment perspective system (PPS) for inpatient hospital services furnished in psychiatric hospitals and excluded psychiatric units including an adequate patient classification system that reflects the differences in patient resource use and costs among psychiatric hospitals and excluded psychiatric units. ÂExcluded psychiatric unitâ means a psychiatric unit of an acute care hospital or of a Critical Access Hospital (CAH), which is excluded from payment under the Inpatient Prospective Payment System (IPPS) or CAH payment system, respectively. These excluded psychiatric units will be paid under the IPF PPS.

Section 405(g)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) extended the IPF PPS to psychiatric distinct part units of CAHs.

Sections 3401(f) and 10322 of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by section 10319(e) of that Act and by section 1105(d) of the Health Care and Education Reconciliation Act of 2010 (Pub.

L. 111-152) (hereafter referred to jointly as âthe Affordable Care Actâ) added subsection (s) to section 1886 of the Act. Section 1886(s)(1) of the Act titled âReference to Establishment and Implementation of System,â refers to section 124 of the BBRA, which relates to the establishment of the IPF PPS.

Section 1886(s)(2)(A)(i) of the Act requires the application of the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act to the IPF PPS for the rate year (RY) beginning in 2012 (that is, a RY that coincides with a FY) and each subsequent RY. Section 1886(s)(2)(A)(ii) of the Act required the application of an âother adjustmentâ that reduced any update to an IPF PPS base rate by a percentage point amount specified in section 1886(s)(3) of the Act for the RY beginning in 2010 through the RY beginning in 2019. As noted in the FY 2020 IPF PPS final rule, for the RY beginning in 2019, section 1886(s)(3)(E) of the Act required that the other adjustment reduction be equal to 0.75 percentage point.

That was the final year the statute required the application of this adjustment. Because FY 2021 was a RY beginning in 2020, FY 2021 was the first year section 1886(s)(2)(A)(ii) did not apply since its enactment. Sections 1886(s)(4)(A) through (D) of the Act require that for RY 2014 and each subsequent RY, IPFs that fail to report required quality data with respect to such a RY will have their annual update to a standard Federal rate for discharges reduced by 2.0 percentage points.

This may result in an annual update being less than 0.0 for a RY, and may result in payment rates for the upcoming RY being less than such payment rates for the preceding RY. Any reduction for failure to report required quality data will apply only to the RY involved, and the Secretary will not consider such reduction in computing the payment amount for a subsequent RY. Additional information about the specifics of the current IPFQR Program is available in the FY 2020 IPF PPS and Quality Reporting Updates for FY Beginning October 1, 2019 final rule (84 FR 38459 through 38468).

To implement and periodically update these provisions, we have published various proposed and final rules and notices in the Federal Register. For more information regarding these documents, see the CMS website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âindex.html?. Âredirect=â/âInpatientPsychFacilPPS/â.

B. Overview of the IPF PPS On November 15, 2004, we published the IPF PPS final rule in the Federal Register (69 FR 66922). The November 2004 IPF PPS final rule established the IPF PPS, as required by section 124 of the BBRA and codified at 42 CFR part 412, subpart N.

The November 2004 IPF PPS final rule set forth the Federal per diem base rate for the implementation year (the 18-month period from January 1, 2005 through June 30, 2006), and provided payment for the inpatient operating and capital costs to IPFs for covered psychiatric services they furnish (that is, routine, ancillary, and capital costs, but not costs of approved educational activities, bad debts, and other services or items that are outside the scope of the IPF PPS). Covered psychiatric services include services for which benefits are provided under the fee-for-service Part A (Hospital Insurance Program) of the Medicare program. The IPF PPS established the Federal per diem base rate for each patient day in an IPF derived from the national average daily routine operating, ancillary, and capital costs in IPFs in FY 2002.

The average per diem cost was updated to the midpoint of the first year under the IPF PPS, standardized to account for the overall positive effects of the IPF PPS payment adjustments, and adjusted for budget-neutrality. The Federal per diem payment under the IPF PPS is comprised of the Federal per diem base rate described previously and certain patient- and facility-level payment adjustments for characteristics that were found in the regression analysis to be associated with statistically significant per diem cost differences. With statistical significance defined as p less than 0.05.

A complete discussion of the regression analysis that established the IPF PPS adjustment factors can be found in the November 2004 IPF PPS final rule (69 FR 66933 through 66936). The patient-level adjustments include age, Diagnosis-Related Group (DRG) assignment, and comorbidities, as well as adjustments to reflect higher per diem costs at the beginning of a Start Printed Page 46848 patient's IPF stay and lower costs for later days of the stay. Facility-level adjustments include adjustments for the IPF's wage index, rural location, teaching status, a cost-of-living adjustment for IPFs located in Alaska and Hawaii, and an adjustment for the presence of a qualifying emergency department (ED).

The IPF PPS has additional payment policies for outlier cases, interrupted stays, and a per treatment payment for patients who undergo electroconvulsive therapy (ECT). During the IPF PPS mandatory 3-year transition period, stop-loss payments were also provided. However, since the transition ended as of January 1, 2008, these payments are no longer available.

C. Annual Requirements for Updating the IPF PPS Section 124 of the BBRA did not specify an annual rate update strategy for the IPF PPS and was broadly written to give the Secretary discretion in establishing an update methodology. In the November 2004 IPF PPS final rule (69 FR 66922), we implemented the IPF PPS using the following update strategy.

Calculate the final Federal per diem base rate to be budget-neutral for the 18-month period of January 1, 2005 through June 30, 2006. Use a July 1 through June 30 annual update cycle. Allow the IPF PPS first update to be effective for discharges on or after July 1, 2006 through June 30, 2007.

In developing the IPF PPS, and to ensure that the IPF PPS can account adequately for each IPF's case-mix, we performed an extensive regression analysis of the relationship between the per diem costs and certain patient and facility characteristics to determine those characteristics associated with statistically significant cost differences on a per diem basis. That regression analysis is described in detail in our November 28, 2003 IPF proposed rule (68 FR 66923. 66928 through 66933) and our November 15, 2004 IPF final rule (69 FR 66933 through 66960).

For characteristics with statistically significant cost differences, we used the regression coefficients of those variables to determine the size of the corresponding payment adjustments. In the November 2004 IPF final rule, we explained the reasons for delaying an update to the adjustment factors, derived from the regression analysis, including waiting until we have IPF PPS data that yields as much information as possible regarding the patient-level characteristics of the population that each IPF serves. We indicated that we did not intend to update the regression analysis and the patient-level and facility-level adjustments until we complete that analysis.

Until that analysis is complete, we stated our intention to publish a notice in the Federal Register each spring to update the IPF PPS (69 FR 66966). On May 6, 2011, we published a final rule in the Federal Register titled, âInpatient Psychiatric Facilities Prospective Payment SystemâUpdate for Rate Year Beginning July 1, 2011 (RY 2012)â (76 FR 26432), which changed the payment rate update period to a RY that coincides with a FY update. Therefore, final rules are now published in the Federal Register in the summer to be effective on October 1st.

When proposing changes in IPF payment policy, a proposed rule is issued in the spring, and the final rule in the summer to be effective on October 1st. For a detailed list of updates to the IPF PPS, we refer readers to our regulations at 42 CFR 412.428. The most recent IPF PPS annual update was published in a final rule on August 4, 2021 in the Federal Register titled, âMedicare Program.

FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)â (86 FR 42608), which updated the IPF PPS payment rates for FY 2022. That final rule updated the IPF PPS Federal per diem base rates that were published in the FY 2021 IPF PPS Rate Update final rule (85 FR 47042) in accordance with our established policies. III.

Analysis of and Responses to Public Comments We received 396 public comments, 27 of which pertained to proposed IPF PPS payment policies, 20 of which pertained to the request for comments on addressing healthcare disparities and advancing healthcare equity in the IPFQR Program, and the remainder were seeking to encourage the addition of a patient experience of care measure into the IPFQR Program. Comments were from health systems, national and state-level provider and patient advocacy organizations, MedPAC, and individuals. We reviewed each comment and grouped related comments, after which we placed them in categories based on subject matter or section(s) of the regulation affected.

Summaries of the public comments received and our responses to those comments are provided in the appropriate sections in the preamble of this final rule. IV. Provisions of the FY 2023 IPF PPS Final Rule and Responses to Comments A.

FY 2023 Market Basket Update and Productivity Adjustment for the IPF PPS 1. Background Originally, the input price index that was used to develop the IPF PPS was the âExcluded Hospital with Capitalâ market basket. This market basket was based on 1997 Medicare cost reports for Medicare participating inpatient rehabilitation facilities (IRFs), IPFs, long-term care hospitals (LTCHs), cancer hospitals, and children's hospitals.

Although âmarket basketâ technically describes the mix of goods and services used in providing health care at a given point in time, this term is also commonly used to denote the input price index (that is, cost category weights and price proxies) derived from that market basket. The term market basket as used in this document, refers to an input price index. Since the IPF PPS inception, the market basket used to update IPF PPS payments has been rebased and revised to reflect more recent data on IPF cost structures.

We last rebased and revised the IPF market basket in the FY 2020 IPF PPS rule, where we adopted a 2016-based IPF market basket, using Medicare cost report data for both Medicare participating freestanding psychiatric hospitals and psychiatric units. We refer readers to the FY 2020 IPF PPS final rule for a detailed discussion of the 2016-based IPF PPS market basket and its development (84 FR 38426 through 38447). References to the historical market baskets used to update IPF PPS payments are listed in the FY 2016 IPF PPS final rule (80 FR 46656).

2. FY 2023 IPF Market Basket Update For FY 2023 (beginning October 1, 2022 and ending September 30, 2023), we proposed to update the IPF PPS payments by a market basket increase factor with a productivity adjustment as required by section 1886(s)(2)(A)(i) of the Act. Consistent with historical practice, we proposed to estimate the market basket update for the IPF PPS based on the most recent forecast available at the time of rulemaking from IHS Global Inc.

(IGI). IGI is a nationally recognized economic and financial forecasting firm with which CMS contracts to forecast the components of the market baskets and productivity adjustment. For the proposed rule, based on IGI's fourth quarter 2021 forecast with historical data through the third quarter of 2021, the proposed 2016-based IPF market basket increase factor for FY 2023 was 3.1 percent.

Start Printed Page 46849 Section 1886(s)(2)(A)(i) of the Act requires that, after establishing the increase factor for a FY, the Secretary of the Department of Health and Human Services (the Secretary) shall reduce such increase factor for FY 2012 and each subsequent FY, by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide, private nonfarm business multifactor productivity (MFP) (as projected by the Secretary for the 10-year period ending with the applicable FY, year, cost reporting period, or other annual period) (the âproductivity adjustmentâ). The United States Department of Labor's Bureau of Labor Statistics (BLS) publishes the official measures of productivity for the United States economy.

We note that previously the productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the Act was published by BLS as private nonfarm business MFP. Beginning with the November 18, 2021 release of productivity data, BLS replaced the term âmultifactor productivityâ with âtotal factor productivityâ (TFP). BLS noted that this is a change in terminology only and will not affect the data or methodology.

As a result of the BLS name change, the productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the Act is now published by BLS as private nonfarm business total factor productivity. However, as mentioned previously, the data and methods are unchanged. We refer readers to www.bls.gov for the BLS historical published TFP data.

A complete description of IGI's TFP projection methodology is available on the CMS website at https://www.cms.gov/âResearch-Statistics-Data-and-Systems/âStatistics-Trends-and-Reports/âMedicareProgramRatesStats/âMarketBasketResearch. In addition, in the FY 2022 IPF final rule (86 FR 42611), we noted that effective with FY 2022 and forward, CMS changed the name of this adjustment to refer to it as the productivity adjustment rather than the MFP adjustment. For the FY 2023 IPF PPS proposed rule, based on IGI's fourth quarter 2021 forecast, the proposed productivity adjustment for FY 2023 (the 10-year moving average growth in TFP for the period ending FY 2023) was projected to be 0.4 percent.

Accordingly, we proposed to reduce the proposed 3.1 percent IPF market basket update by this proposed 0.4 percentage point productivity adjustment, as mandated by the Act. This resulted in a proposed FY 2023 IPF PPS payment rate update of 2.7 percent (3.1â0.4 = 2.7). We also proposed that if more recent data became available, we would use such data, if appropriate, to determine the FY 2023 IPF market basket update and productivity adjustment for the final rule.

Comment. Commenters appreciated the positive proposed update to the IPF market basket for FY 2023. However, many commenters expressed concern that the proposed 2.7 percent market basket update (reflecting a 3.1 percent market basket update less 0.4 percentage point productivity adjustment) was inadequate, particularly noting the historically high inflation rates.

The commenters acknowledged that CMS will refresh the market basket update in the final rule but were deeply concerned the revised update would continue to be insufficient relative to input cost inflation. They stated that hospitals on the front lines of the âasthma disease 2019â (abbreviated âasthma treatmentâ) Public Health Emergency (PHE) during the past 2 years continue to weather a number of market pressures such as labor shortages (which have led to use of more contract labor) and supply chain issues. One commenter stated that the rate update does not account for the many issues that their system encounters, including higher acuity patients, additional staffing to meet acuity needs and care for underserved patients.

Another commenter stated that unlike many of the other hospitals and providers, IPFs did not receive any targeted funding allocation from the Provider Relief Fund to address their increased costs as well as the increased need for mental healthcare and addiction treatment during this ventolin. Many commenters believe CMS's current methodology for updating the market basket is ill-suited to adequately adjust Medicare payments in a highly inflationary environment. Therefore, they recommended that CMS consider other methods and data sources to calculate the final rule market basket update and an alternative approach to better align the market basket increases with increases in cost to treat patients, including using the authority under section 1886(s) of the Act to further increase IPF rates to better adjust FY 2023 payments to IPFs to account for inflation.

Response. We believe the 2016-based IPF market basket increase adequately reflects the average change in the price of goods and services hospitals purchase in order to provide IPF medical services, and is appropriate to use as the IPF payment update factor. As described in the FY 2020 IPF final rule (84 FR 38426 through 38447), the IPF market basket is a fixed-weight, Laspeyres-type index that measures price changes over time and would not reflect increases in costs associated with changes in the volume or intensity of input goods and services.

As such, the IPF market basket update would reflect the prospective price pressures described by the commenters as increasing during a high inflation period (such as faster wage growth or higher energy prices), but would inherently not reflect other factors that might increase the level of costs, such as the quantity of labor used or any shifts between contract and staff nurses. We note that cost changes (that is, the product of price and quantities) would only be reflected when a market basket is rebased and the base year weights are updated to a more recent time period. We agree with the commenters that recent higher inflationary trends have impacted the outlook for price growth over the next several quarters.

Based on IGI's fourth quarter 2021 forecast with historical data through the third quarter of 2021, the proposed 2016-based IPF market basket update for FY 2023 was 3.1 percent, reflecting forecasted compensation price growth of 3.5 percent (by comparison, compensation price growth in the IPF market basket averaged 2.2 percent from 2012-2021). In the FY 2023 IPF PPS proposed rule, we proposed that if more recent data became available, we would use such data, if appropriate, to derive the final FY 2023 IPF market basket update for the final rule. For this final rule, we now have an updated forecast of the price proxies underlying the market basket that incorporates more recent historical data and reflects a revised outlook regarding the United States economy and expected price inflation for FY 2023 for IPFs.

Based on IGI's second quarter 2022 forecast with historical data through the first quarter of 2022, the final FY 2023 IPF market basket update is 4.1 percent (reflecting forecasted compensation price growth of 4.5 percent) and the final FY 2023 productivity adjustment is 0.3 percentage point. Therefore, for FY 2023, the final IPF productivity-adjusted market basket update is 3.8 percent (4.1 percent less 0.3 percentage point), compared to the proposed 2.7 percent productivity-adjusted market basket update. We note that the final FY 2023 IPF market basket growth rate of 4.1 percent would be the highest market basket update we have implemented in a final rule since the beginning of the IPF PPS.

Start Printed Page 46850 With respect to the comment about the lack of a targeted funding allocation for IPFs from the Provider Relief Fund, we do not agree with the commenter and note that IPFs were included in the types of eligible specialty hospitals for rural targeted distribution payments.[] Lastly, regarding commenters' request that CMS consider other methods and data sources to calculate the final rule market basket update, including the authority under section 1886(s) of the Act, while we generally agree that the Secretary has broad authority under the statute to establish the methodology for updating the IPF PPS base rate, our longstanding policy since the inception of the IPF PPS has been to update IPF PPS payments based on an appropriate market basket. As discussed earlier in this section of this final rule, the market basket used to update IPF PPS payments has been rebased and revised over the history of the IPF PPS to reflect more recent data on IPF cost structures, and we believe it continues to appropriately reflect IPF cost structures. We did not propose to use other methods or data sources to calculate the final market basket update for FY 2023, and we are not finalizing such an approach for this final rule.

Consistent with our proposal, we have used more recent data to calculate a final IPF productivity-adjusted market basket update of 3.8 percent for FY 2023. Comment. One commenter stated that the market basket updates in FY 2021 and FY 2022 are currently estimated to underinflate the base IPF rate by 1.9 percent, which means the base rate for FY 2023 is 1.9 percent too low.

Response. The IPF market basket updates are set prospectively, which means that the update relies on a mix of both historical data for part of the period for which the update is calculated and forecasted data for the remainder. For instance, the FY 2023 market basket update in this final rule reflects historical data through the first quarter of CY 2022 and forecasted data through the third quarter of CY 2023.

While there is no precedent to adjust for market basket forecast error in the IPF payment update, a forecast error can be calculated by comparing the actual market basket increase for a given year less the forecasted market basket increase. Due to the uncertainty regarding future price trends, forecast errors can be both positive and negative. This was the case for the FY 2020 IPF forecast error, which was -0.7 percentage point, and the FY 2021 IPF forecast error, which was +0.7 percentage point.

FY 2022 historical data is not yet available to calculate a forecast error for FY 2022. Regarding the comment that the FY 2023 IPF base rate is 1.9 percent too low, we disagree with this assertion as it does not consider years in which the base rates may have been overinflated. For this final rule, we have incorporated more recent historical data and forecasts to capture the price and wage pressures facing IPFs.

We believe it is the best available projection of inflation to determine the applicable percentage increase for the IPF payments in FY 2023. Comment. One commenter stated that with the significant increase in inflation that has already taken place in 2022, they did not support using 2021 historical data to set the FY 2023 rates.

The commenter stated that an additional increase should be added to the 2021 historical data to help offset the significant increased costs that providers are currently experiencing. Response. In determining the FY 2023 IPF market basket update of 4.1 percent, a combination of observed and forecasted trends were used.

Actual experience is incorporated through first quarter 2022, and forecasted trends through the remaining quarters of FY 2022 and all of FY 2023. Likewise, the FY 2024 market basket update would reflect not only historical data through 2022 but also forecasted trends through FY 2024. Comment.

Several commenters disagreed with the assumptions underpinning the productivity adjustment. They stated that the productivity adjustment to the market basket update assumes IPFs can increase overall productivity at the same rate as increases in the broader economy, and referenced CMS Office of the Actuary analysis that compares private non-farm total factor productivity growth measure and a hospital-specific measure ( https://www.cms.gov/âfiles/âdocument/âproductivity-memo.pdf). The commenters stated that IPF services are highly labor-intensive, and therefore, IPFs cannot improve productivity using strategies like offshoring or automation that are commonly deployed in other sectors of the economy.

The commenters claimed that during the PHE productivity fell as result of having to use temporary staffing due to labor shortages. In addition, the commenters stated that although CMS is required by statute to implement a productivity adjustment to the market basket update, they requested that CMS work with the Congress to permanently eliminate the productivity adjustment. Furthermore, the commenters recommended that CMS use its Section 1135 waiver authority to remove the productivity adjustment for any FY that was covered under the PHE determination (that is, 2020, 2021, and 2022) from the calculation of market basket for FY 2023 and any year thereafter that the PHE continues.

Response. Section 1886(s)(2)(A)(i) of the Act requires the application of a productivity adjustment to the IPF PPS market basket increase factor. As required by statute, the FY 2023 productivity adjustment is derived based on the 10-year moving average growth in economy-wide productivity for the period ending FY 2023.

Regarding the suggestion that CMS consider section 1135 waiver authority to suspend application of the productivity adjustment, such authority is unavailable in this circumstance. Section 1135 of the Act authorizes the Secretary to waive or modify only those statutory provisions and regulations described at section 1135(b) of the Act, such as conditions of participation or providers' regulatory deadlines. Payment requirements, such as the application of the productivity adjustment under the IPF PPS, are not one of the types of requirements set out under this subsection.

Final Decision. After consideration of the comments we received, we are finalizing a FY 2023 IPF productivity-adjusted market basket update equal to 3.8 percent based on the more recent data available. This 3.8 percent update is based on a more recent forecast of the FY 2023 IPF market basket update of 4.1 percent reduced by a statutorily required productivity adjustment of 0.3 percentage point.

3. FY 2023 IPF Labor-Related Share Due to variations in geographic wage levels and other labor-related costs, we believe that payment rates under the IPF PPS should continue to be adjusted by a geographic wage index, which would apply to the labor-related portion of the Federal per diem base rate (hereafter referred to as the labor-related share). The labor-related share is determined by identifying the national average proportion of total costs that are related to, influenced by, or vary with the local labor market.

We proposed to continue to classify a cost category as labor-related if the costs are labor-intensive and vary with the local labor market. Based on our definition of the labor-related share and the cost categories in the 2016-based IPF market basket, we proposed to include in the labor-related share the sum of the relative importance of Wages and Salaries. Employee Start Printed Page 46851 Benefits.

Professional Fees. Labor-related. Administrative and Facilities Support Services.

Installation, Maintenance, and Repair Services. All Other. Labor-related Services.

And a portion of the Capital-Related relative importance from the 2016-based IPF market basket. For more details regarding the methodology for determining specific cost categories for inclusion in the 2016-based IPF labor-related share, see the FY 2020 IPF PPS final rule (84 FR 38445 through 38447). The relative importance reflects the different rates of price change for these cost categories between the base year (FY 2016) and FY 2023.

Based on IGI's fourth quarter 2021 forecast of the 2016-based IPF market basket, the sum of the FY 2023 relative importance moving average of Wages and Salaries. Employee Benefits. Professional Fees.

Labor-related. Administrative and Facilities Support Services. Installation, Maintenance, and Repair Services.

All Other. Labor-related Services was 74.4 percent. We proposed, consistent with prior rulemaking, that the portion of Capital-Related costs that are influenced by the local labor market is 46 percent.

Since the relative importance for Capital-Related costs was 6.6 percent of the 2016-based IPF market basket for FY 2023, we proposed to take 46 percent of 6.6 percent to determine a labor-related share of Capital-Related costs for FY 2023 of 3.0 percent. Therefore, we proposed a total labor-related share for FY 2023 of 77.4 percent (the sum of 74.4 percent for the labor-related share of operating costs and 3.0 percent for the labor-related share of Capital-Related costs). We also proposed that if more recent data became available, we would use such data, if appropriate to determine the FY 2023 labor-related share for the final rule.

For more information on the labor-related share and its calculation, we refer readers to the FY 2020 IPF PPS final rule (84 FR 38445 through 38447). We invited public comments on the proposed labor-related share for FY 2023. Comment.

One commenter did not support CMS's proposal to increase the labor-related share from 77.2 percent in FY 2022 to 77.4 percent in FY 2023, stating that any increase to the labor-related share penalizes facilities that have a wage index less than 1.0. The commenter also stated that there is a growing disparity between high-wage and low-wage states that harms hospitals in many rural and underserved communities. In addition, the commenter stated that they believe CMS should consider excluding the labor portion of capital related costs for FY 2023 and going forward.

Response. We proposed to use the FY 2023 relative importance values for the labor-related cost categories from the 2016-based IPF market basket because it accounts for more recent data regarding price pressures and cost structure of IPFs. This methodology is consistent with the determination of the labor-related share since the implementation of the IPF PPS in 2007.

The labor-related cost categories reflect IPF costs that are related to, influenced by, or vary with the local labor market, which would include a portion of the capital-related costs. Therefore, we disagree with the commenter that we should exclude the labor portion of capital-related costs for FY 2023 and going forward. As stated in the FY 2023 IPF proposed rule, we also proposed that if more recent data became available, we would use such data, if appropriate, to determine the FY 2023 labor-related share for the final rule.

Based on IHS Global Inc.'s second quarter 2022 forecast with historical data through the first quarter of 2022, the FY 2023 labor-related share for the final rule is 77.4 percent, unchanged from the proposed rule. Final Decision. After consideration of the comments we received, we are finalizing a FY 2023 labor-related share equal to 77.4 percent based on the latest available IGI forecast.

Table 1 shows the FY 2023 labor-related share and the final FY 2022 labor-related share using the 2016-based IPF market basket relative importance. B. Updates to the IPF PPS Rates for FY Beginning October 1, 2022 The IPF PPS is based on a standardized Federal per diem base rate calculated from the IPF average per diem costs and adjusted for budget-neutrality in the implementation year.

The Federal per diem base rate is used as the standard payment per day under the IPF PPS and is adjusted by the patient-level and facility-level adjustments that are applicable to the IPF stay. A detailed explanation of how we calculated the average per diem cost Start Printed Page 46852 appears in the November 2004 IPF PPS final rule (69 FR 66926). 1.

Determining the Standardized Budget-Neutral Federal Per Diem Base Rate Section 124(a)(1) of the BBRA required that we implement the IPF PPS in a budget-neutral manner. In other words, the amount of total payments under the IPF PPS, including any payment adjustments, had to be projected to be equal to the amount of total payments that would have been made if the IPF PPS were not implemented. Therefore, we calculated the budget-neutrality factor by setting the total estimated IPF PPS payments to be equal to the total estimated payments that would have been made under the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA) (Pub.

L. 97-248) methodology had the IPF PPS not been implemented. A step-by-step description of the methodology used to estimate payments under the TEFRA payment system appears in the November 2004 IPF PPS final rule (69 FR 66926).

Under the IPF PPS methodology, we calculated the final Federal per diem base rate to be budget-neutral during the IPF PPS implementation period (that is, the 18-month period from January 1, 2005 through June 30, 2006) using a July 1 update cycle. We updated the average cost per day to the midpoint of the IPF PPS implementation period (October 1, 2005), and this amount was used in the payment model to establish the budget-neutrality adjustment. Next, we standardized the IPF PPS Federal per diem base rate to account for the overall positive effects of the IPF PPS payment adjustment factors by dividing total estimated payments under the TEFRA payment system by estimated payments under the IPF PPS.

The information concerning this standardization can be found in the November 2004 IPF PPS final rule (69 FR 66932) and the RY 2006 IPF PPS final rule (71 FR 27045). We then reduced the standardized Federal per diem base rate to account for the outlier policy, the stop loss provision, and anticipated behavioral changes. A complete discussion of how we calculated each component of the budget-neutrality adjustment appears in the November 2004 IPF PPS final rule (69 FR 66932 through 66933) and in the RY 2007 IPF PPS final rule (71 FR 27044 through 27046).

The final standardized budget-neutral Federal per diem base rate established for cost reporting periods beginning on or after January 1, 2005 was calculated to be $575.95. The Federal per diem base rate has been updated in accordance with applicable statutory requirements and Â§â412.428 through publication of annual notices or proposed and final rules. A detailed discussion on the standardized budget-neutral Federal per diem base rate and the electroconvulsive therapy (ECT) payment per treatment appears in the FY 2014 IPF PPS update notice (78 FR 46738 through 46740).

These documents are available on the CMS website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âindex.html. IPFs must include a valid procedure code for ECT services provided to IPF beneficiaries in order to bill for ECT services, as described in our Medicare Claims Processing Manual, Chapter 3, Section 190.7.3 (available at https://www.cms.gov/âRegulations-and-Guidance/âGuidance/âManuals/âDownloads/âclm104c03.pdf.) There were no changes to the ECT procedure codes used on IPF claims as a result of the final update to the ICD-10-PCS code set for FY 2023. Addendum B to this final rule shows the ECT procedure codes for FY 2023 and is available on our website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âtools.html.

2. Update of the Federal Per Diem Base Rate and Electroconvulsive Therapy Payment per Treatment The current (FY 2022) Federal per diem base rate is $832.94 and the ECT payment per treatment is $358.60. For the final FY 2023 Federal per diem base rate, we applied the payment rate update of 3.8 percentâthat is, the 2016-based IPF market basket increase for FY 2023 of 4.1 percent less the productivity adjustment of 0.3 percentage pointâand the wage index budget-neutrality factor of 1.0012 (as discussed in section IV.D.1 of this final rule) to the FY 2022 Federal per diem base rate of $832.94, yielding a final Federal per diem base rate of $865.63 for FY 2023.

Similarly, we applied the 3.8 percent payment rate update and the 1.0012 wage index budget-neutrality factor to the FY 2022 ECT payment per treatment of $358.60, yielding a final ECT payment per treatment of $372.67 for FY 2023. Section 1886(s)(4)(A)(i) of the Act requires that for RY 2014 and each subsequent RY, in the case of an IPF that fails to report required quality data with respect to such RY, the Secretary will reduce any annual update to a standard Federal rate for discharges during the RY by 2.0 percentage points. Therefore, we are applying a 2.0 percentage points reduction to the Federal per diem base rate and the ECT payment per treatment as follows.

For IPFs that fail to report required data under the IPFQR Program, we applied a 1.8 percent payment rate updateâthat is, the IPF market basket increase for FY 2023 of 4.1 percent less the productivity adjustment of 0.3 percentage point for an update of 3.8 percent, and further reduced by 2.0 percentage points in accordance with section 1886(s)(4)(A)(i) of the Actâand the wage index budget-neutrality factor of 1.0012 to the FY 2022 Federal per diem base rate of $832.94, yielding a Federal per diem base rate of $848.95 for FY 2023. For IPFs that fail to report required data under the IPFQR Program, we applied the 1.8 percent annual payment rate update and the final 1.0012 wage index budget-neutrality factor to the FY 2022 ECT payment per treatment of $358.60, yielding an ECT payment per treatment of $365.49 for FY 2023. C.

Updates to the IPF PPS Patient-Level Adjustment Factors 1. Overview of the IPF PPS Adjustment Factors The IPF PPS payment adjustments were derived from a regression analysis of 100 percent of the FY 2002 Medicare Provider and Analysis Review (MedPAR) data file, which contained 483,038 cases. For a more detailed description of the data file used for the regression analysis, see the November 2004 IPF PPS final rule (69 FR 66935 through 66936).

We proposed to continue to use the existing regression-derived adjustment factors established in 2005 for FY 2023. However, we have used more recent claims data to simulate payments to finalize the outlier fixed dollar loss threshold amount and to assess the impact of the IPF PPS updates. 2.

IPF PPS Patient-Level Adjustments The IPF PPS includes payment adjustments for the following patient-level characteristics. Medicare Severity Diagnosis Related Groups (MS-DRGs) assignment of the patient's principal diagnosis, selected comorbidities, patient age, and the variable per diem adjustments. A.

Update to MS-DRG Assignment We believe it is important to maintain for IPFs the same diagnostic coding and Diagnosis Related Group (DRG) classification used under the IPPS for providing psychiatric care. For this reason, when the IPF PPS was implemented for cost reporting periods beginning on or after January 1, 2005, Start Printed Page 46853 we adopted the same diagnostic code set (ICD-9-CM) and DRG patient classification system (MS-DRGs) that were utilized at the time under the IPPS. In the RY 2009 IPF PPS notice (73 FR 25709), we discussed CMS' effort to better recognize resource use and the severity of illness among patients.

CMS adopted the new MS-DRGs for the IPPS in the FY 2008 IPPS final rule with comment period (72 FR 47130). In the RY 2009 IPF PPS notice (73 FR 25716), we provided a crosswalk to reflect changes that were made under the IPF PPS to adopt the new MS-DRGs. For a detailed description of the mapping changes from the original DRG adjustment categories to the current MS-DRG adjustment categories, we refer readers to the RY 2009 IPF PPS notice (73 FR 25714).

The IPF PPS includes payment adjustments for designated psychiatric DRGs assigned to the claim based on the patient's principal diagnosis. The DRG adjustment factors were expressed relative to the most frequently reported psychiatric DRG in FY 2002, that is, DRG 430 (psychoses). The coefficient values and adjustment factors were derived from the regression analysis discussed in detail in the November 28, 2003 IPF proposed rule (68 FR 66923.

66928 through 66933) and the November 15, 2004 IPF final rule (69 FR 66933 through 66960). Mapping the DRGs to the MS-DRGs resulted in the current 17 IPF MS-DRGs, instead of the original 15 DRGs, for which the IPF PPS provides an adjustment. For FY 2023, we did not propose any changes to the IPF MS-DRG adjustment factors.

Therefore, we are retaining the existing IPF MS-DRG adjustment factors. In the FY 2015 IPF PPS final rule published August 6, 2014 in the Federal Register titled, âInpatient Psychiatric Facilities Prospective Payment SystemâUpdate for FY Beginning October 1, 2014 (FY 2015)â (79 FR 45945 through 45947), we finalized conversions of the ICD-9-CM-based MS-DRGs to ICD-10-CM/PCS-based MS-DRGs, which were implemented on October 1, 2015. Further information on the ICD-10-CM/PCS MS-DRG conversion project can be found on the CMS ICD-10-CM website at https://www.cms.gov/âMedicare/âCoding/âICD10/âICD-10-MS-DRG-Conversion-Project.html.

For FY 2023, we proposed to continue making the existing payment adjustment for psychiatric diagnoses that group to one of the existing 17 IPF MS-DRGs listed in Addendum A. Addendum A is available on our website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âtools.html. Psychiatric principal diagnoses that do not group to one of the 17 designated MS-DRGs will still receive the Federal per diem base rate and all other applicable adjustments.

However, the payment will not include an MS-DRG adjustment. The diagnoses for each IPF MS-DRG will be updated as of October 1, 2022, using the final IPPS FY 2023 ICD-10-CM/PCS code sets. The FY 2023 IPPS/LTCH PPS final rule includes tables of the changes to the ICD-10-CM/PCS code sets, which underlie the FY 2023 IPF MS-DRGs.

Both the FY 2023 IPPS final rule and the tables of final changes to the ICD-10-CM/PCS code sets, which underlie the FY 2023 MS-DRGs, are available on the CMS IPPS website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âAcuteInpatientPPS/âindex.html. Code First As discussed in the ICD-10-CM Official Guidelines for Coding and Reporting, certain conditions have both an underlying etiology and multiple body system manifestations due to the underlying etiology. For such conditions, ICD-10-CM has a coding convention that requires the underlying condition be sequenced first followed by the manifestation.

Wherever such a combination exists, there is a âuse additional codeâ note at the etiology code, and a âcode firstâ note at the manifestation code. These instructional notes indicate the proper sequencing order of the codes (etiology followed by manifestation). In accordance with the ICD-10-CM Official Guidelines for Coding and Reporting, when a primary (psychiatric) diagnosis code has a âcode firstâ note, the provider will follow the instructions in the ICD-10-CM Tabular List.

The submitted claim goes through the CMS processing system, which will identify the principal diagnosis code as non-psychiatric and search the secondary codes for a psychiatric code to assign a DRG code for adjustment. The system will continue to search the secondary codes for those that are appropriate for comorbidity adjustment. For more information on the code first policy, we refer readers to the November 2004 IPF PPS final rule (69 FR 66945) and see sections I.A.13 and I.B.7 of the FY 2020 ICD-10-CM Coding Guidelines, available at https://www.cdc.gov/ânchs/âdata/âicd/â10cmguidelines-FY2020_âfinal.pdf.

In the FY 2015 IPF PPS final rule, we provided a code first table for reference that highlights the same or similar manifestation codes where the code first instructions apply in ICD-10-CM that were present in ICD-9-CM (79 FR 46009). In FY 2022 there were 18 codes finalized for deletion from the ICD-10-CM codes in the IPF Code First table. For FY 2023, we proposed to delete 2 ICD-10-PCS codes and add 48 ICD-10-PCS codes to the IPF Code First table.

For this FY 2023 IPF PPS final rule, we are finalizing our proposal to delete 2 ICD-10-PCS codes to add 48 ICD-10-PCS codes to the IPF Code First table. The FY 2023 Code First table is shown in Addendum B on the CMS website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âtools.html. B.

Payment for Comorbid Conditions The intent of the comorbidity adjustments is to recognize the increased costs associated with comorbid conditions by providing additional payments for certain existing medical or psychiatric conditions that are expensive to treat. In our RY 2012 IPF PPS final rule (76 FR 26451 through 26452), we explained that the IPF PPS includes 17 comorbidity categories and identified the new, revised, and deleted ICD-9-CM diagnosis codes that generate a comorbid condition payment adjustment under the IPF PPS for RY 2012 (76 FR 26451). Comorbidities are specific patient conditions that are secondary to the patient's principal diagnosis and that require treatment during the stay.

Diagnoses that relate to an earlier episode of care and have no bearing on the current hospital stay are excluded and must not be reported on IPF claims. Comorbid conditions must exist at the time of admission or develop subsequently, and affect the treatment received, length of stay (LOS), or both treatment and LOS. For each claim, an IPF may receive only one comorbidity adjustment within a comorbidity category, but it may receive an adjustment for more than one comorbidity category.

Current billing instructions for discharge claims, on or after October 1, 2015, require IPFs to enter the complete ICD-10-CM codes for up to 24 additional diagnoses if they co-exist at the time of admission, or develop subsequently and impact the treatment provided. The comorbidity adjustments were determined based on the regression analysis using the diagnoses reported by IPFs in FY 2002. The principal diagnoses were used to establish the DRG adjustments and were not accounted for in establishing the comorbidity category adjustments, except where ICD-9-CM code first instructions applied.

In a code first situation, the submitted claim goes through the CMS processing system, Start Printed Page 46854 which will identify the principal diagnosis code as non-psychiatric and search the secondary codes for a psychiatric code to assign an MS-DRG code for adjustment. The system will continue to search the secondary codes for those that are appropriate for comorbidity adjustment. As noted previously, it is our policy to maintain the same diagnostic coding set for IPFs that is used under the IPPS for providing the same psychiatric care.

The 17 comorbidity categories formerly defined using ICD-9-CM codes were converted to ICD-10-CM/PCS in our FY 2015 IPF PPS final rule (79 FR 45947 through 45955). The goal for converting the comorbidity categories is referred to as replication, meaning that the payment adjustment for a given patient encounter is the same after ICD-10-CM implementation as it will be if the same record had been coded in ICD-9-CM and submitted prior to ICD-10-CM/PCS implementation on October 1, 2015. All conversion efforts were made with the intent of achieving this goal.

For FY 2023, we proposed to continue to use the same comorbidity adjustment factors in effect in FY 2022. The FY 2023 comorbidity adjustment factors are found in Addendum A, available on the CMS website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âtools.html. For FY 2023, we proposed to add 10 ICD-10-CM/PCS codes and remove 1 ICD-10-CM/PCS code from the Coagulation Factor category.

Proposed to add 3 ICD-10-CM/PCS codes and remove 11 ICD-10-CM/PCS codes from the Oncology Treatment comorbidity category. And proposed to add 4 ICD-10-CM/PCS codes to the Poisoning comorbidity category. Comment.

One commenter expressed concerns that the proposed FY 2023 comorbidity codes detailed in Addenda B were not displayed on the CMS website at the time the proposed rule was posted. Response. We appreciate the concern that this commenter raised.

Due to unanticipated technical issues, we were unable to post the B addenda until a few days after the display of the proposed rule. We apologize for any inconvenience that this delay caused, and will continue to work to ensure that addenda are posted as soon as possible after the display of the proposed rule for each FY. We encourage readers to contact the IPF Payment Policy mailbox at [email protected] in order to bring issues like this to our attention as soon as possible.

The proposed FY 2023 comorbidity codes are shown in Addenda B, available on the CMS website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âtools.html. In accordance with the policy established in the FY 2015 IPF PPS final rule (79 FR 45949 through 45952), we reviewed all new FY 2023 ICD-10-CM codes to remove codes that were site âunspecifiedâ in terms of laterality from the FY 2023 ICD-10-CM/PCS codes in instances where more specific codes are available. As we stated in the FY 2015 IPF PPS final rule, we believe that specific diagnosis codes that narrowly identify anatomical sites where disease, injury, or a condition exists should be used when coding patients' diagnoses whenever these codes are available.

We finalized in the FY 2015 IPF PPS rule, that we would remove site âunspecifiedâ codes from the IPF PPS ICD-10-CM/PCS codes in instances when laterality codes (site specified codes) are available, as the clinician should be able to identify a more specific diagnosis based on clinical assessment at the medical encounter. There were no proposed changes to the FY 2023 ICD-10-CM/PCS codes, therefore, we did not propose to remove any of the new codes. C.

Patient Age Adjustments As explained in the November 2004 IPF PPS final rule (69 FR 66922), we analyzed the impact of age on per diem cost by examining the age variable (range of ages) for payment adjustments. In general, we found that the cost per day increases with age. The older age groups are costlier than the under 45 age group, the differences in per diem cost increase for each successive age group, and the differences are statistically significant.

For FY 2023, we proposed continuing to use the patient age adjustments currently in effect in FY 2022, as shown in Addendum A of this rule (see https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âtools.html). We did not receive any comments on this proposal and are finalizing it as proposed. d.

Variable Per Diem Adjustments We explained in the November 2004 IPF PPS final rule (69 FR 66946) that the regression analysis indicated that per diem cost declines as the length of stay (LOS) increases. The variable per diem adjustments to the Federal per diem base rate account for ancillary and administrative costs that occur disproportionately in the first days after admission to an IPF. As discussed in the November 2004 IPF PPS final rule, we used a regression analysis to estimate the average differences in per diem cost among stays of different lengths (69 FR 66947 through 66950).

As a result of this analysis, we established variable per diem adjustments that begin on day 1 and decline gradually until day 21 of a patient's stay. For day 22 and thereafter, the variable per diem adjustment remains the same each day for the remainder of the stay. However, the adjustment applied to day 1 depends upon whether the IPF has a qualifying ED.

If an IPF has a qualifying ED, it receives a 1.31 adjustment factor for day 1 of each stay. If an IPF does not have a qualifying ED, it receives a 1.19 adjustment factor for day 1 of the stay. The ED adjustment is explained in more detail in section IV.D.4 of this final rule.

For FY 2023, we proposed to continue to use the variable per diem adjustment factors currently in effect, as shown in Addendum A to this rule, which is available on the CMS website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âtools.html. A complete discussion of the variable per diem adjustments appears in the November 2004 IPF PPS final rule (69 FR 66946). D.

Updates to the IPF PPS Facility-Level Adjustments The IPF PPS includes facility-level adjustments for the wage index, IPFs located in rural areas, teaching IPFs, cost of living adjustments for IPFs located in Alaska and Hawaii, and IPFs with a qualifying ED. 1. Wage Index Adjustment a.

Background As discussed in the RY 2007 IPF PPS final rule (71 FR 27061), RY 2009 IPF PPS (73 FR 25719) and the RY 2010 IPF PPS notices (74 FR 20373), in order to provide an adjustment for geographic wage levels, the labor-related portion of an IPF's payment is adjusted using an appropriate wage index. Currently, an IPF's geographic wage index value is determined based on the actual location of the IPF in an urban or rural area, as defined in Â§â412.64(b)(1)(ii)(A) and (C). Due to the variation in costs and because of the differences in geographic wage levels, in the November 2004 IPF PPS final rule, we required that payment rates under the IPF PPS be adjusted by a geographic wage index.

We proposed and finalized a policy to use the unadjusted, pre-floor, pre-reclassified IPPS hospital wage index to account for geographic differences in IPF labor costs. We implemented use of the pre-floor, pre-reclassified IPPS hospital wage data to compute the IPF wage index since there was not an IPF- Start Printed Page 46855 specific wage index available. We believe that IPFs generally compete in the same labor market as IPPS hospitals so the pre-floor, pre-reclassified IPPS hospital wage data should be reflective of labor costs of IPFs.

We believe this pre-floor, pre-reclassified IPPS hospital wage index to be the best available data to use as proxy for an IPF specific wage index. As discussed in the RY 2007 IPF PPS final rule (71 FR 27061 through 27067), under the IPF PPS, the wage index is calculated using the IPPS wage index for the labor market area in which the IPF is located, without considering geographic reclassifications, floors, and other adjustments made to the wage index under the IPPS. For a complete description of these IPPS wage index adjustments, we refer readers to the FY 2019 IPPS/LTCH PPS final rule (83 FR 41362 through 41390).

Our wage index policy at Â§â412.424(a)(2) provides that we use the best Medicare data available to estimate costs per day, including an appropriate wage index to adjust for wage differences. When the IPF PPS was implemented in the November 2004 IPF PPS final rule, with an effective date of January 1, 2005, the pre-floor, pre-reclassified IPPS hospital wage index that was available at the time was the FY 2005 pre-floor, pre-reclassified IPPS hospital wage index. Historically, the IPF wage index for a given RY has used the pre-floor, pre-reclassified IPPS hospital wage index from the prior FY as its basis.

This has been due in part to the pre-floor, pre-reclassified IPPS hospital wage index data that were available during the IPF rulemaking cycle, where an annual IPF notice or IPF final rule was usually published in early May. This publication timeframe was relatively early compared to other Medicare payment rules because the IPF PPS follows a RY, which was defined in the implementation of the IPF PPS as the 12-month period from July 1 to June 30 (69 FR 66927). Therefore, the best available data at the time the IPF PPS was implemented was the pre-floor, pre-reclassified IPPS hospital wage index from the prior FY (for example, the RY 2006 IPF wage index was based on the FY 2005 pre-floor, pre-reclassified IPPS hospital wage index).

In the RY 2012 IPF PPS final rule, we changed the reporting year timeframe for IPFs from a RY to the FY, which begins October 1 and ends September 30 (76 FR 26434 through 26435). In that FY 2012 IPF PPS final rule, we continued our established policy of using the pre-floor, pre-reclassified IPPS hospital wage index from the prior year (that is, from FY 2011) as the basis for the FY 2012 IPF wage index. This policy of basing a wage index on the prior year's pre-floor, pre-reclassified IPPS hospital wage index has been followed by other Medicare payment systems, such as hospice and inpatient rehabilitation facilities.

By continuing with our established policy, we remained consistent with other Medicare payment systems. In FY 2020, we finalized the IPF wage index methodology to align the IPF PPS wage index with the same wage data timeframe used by the IPPS for FY 2020 and subsequent years. Specifically, we finalized the use of the pre-floor, pre-reclassified IPPS hospital wage index from the FY concurrent with the IPF FY as the basis for the IPF wage index.

For example, the FY 2020 IPF wage index was based on the FY 2020 pre-floor, pre-reclassified IPPS hospital wage index rather than on the FY 2019 pre-floor, pre-reclassified IPPS hospital wage index. We explained in the FY 2020 proposed rule (84 FR 16973), that using the concurrent pre-floor, pre-reclassified IPPS hospital wage index will result in the most up-to-date wage data being the basis for the IPF wage index. We noted that it would also result in more consistency and parity in the wage index methodology used by other Medicare payment systems.

We indicated that the Medicare skilled nursing facility (SNF) PPS already used the concurrent IPPS hospital wage index data as the basis for the SNF PPS wage index. CMS proposed and finalized similar policies to use the concurrent pre-floor, pre-reclassified IPPS hospital wage index data in other Medicare payment systems, such as hospice and inpatient rehabilitation facilities. Thus, the wage adjusted Medicare payments of various provider types are based upon wage index data from the same timeframe.

For FY 2023, we proposed to continue to use the concurrent pre-floor, pre-reclassified IPPS hospital wage index as the basis for the IPF wage index. Comment. One commenter recommended we revise our policy so that the post-reclassification and post-floor hospital inpatient PPS wage index is used to calculate the wage index for IPFs.

The commenter believe that the continued use of the pre-reclassification and pre-floor hospital inpatient wage index is unreasonable because it places IPFs at a disadvantage in the labor markets in which they operate relative to hospitals in the same markets. Another commenter recommended the application of a non-budget neutral wage index floor along with an annual cap on CBSAs with high wage indices and asserted that that the impact of certain wage index changes could be eliminated by allowing IPFs to reclassify to another CBSA as they are permitted to do under the IPPS. Response.

We appreciate the commenters' recommendations. We did not propose the specific policies suggested by commenters, but we will take them into consideration to potentially inform future rulemaking. We do not believe that the continued use of the pre-reclassification and pre-floor hospital inpatient wage index for FY 2023 is unreasonable or that this policy puts IPFs at a disadvantage relative to hospitals in the labor markets in which they operate.

As we have previously discussed in the RY 2007 final rule (71 FR 27066), we believe that the actual location of an IPF (as opposed to the location of affiliated providers) is most appropriate for determining the wage adjustment because the prevailing wages in the area in which the IPF is located influence the cost of a case. In that same RY 2007 final rule (71 FR 27066), we also stated that we believe the ârural floorâ is required only for the acute care hospital payment system, because section 4410 of the Balanced Budget Act of 1997 (Pub. L.

105-33) applies specifically to acute care hospitals and not excluded hospitals and excluded units. Therefore, we believe using the pre-floor, pre-reclassified IPPS hospital wage index is the best available data to use as a proxy for an IPF wage index because it best reflects the variation in local labor costs of IPFs in the various geographic areas in which they are located and uses the most recent IPPS hospital wage data without any geographic reclassifications, floors, or other adjustments. Final Decision.

After consideration of the comments received, we are finalizing our proposal for FY 2023 to continue to use the concurrent pre-floor, pre-reclassified IPPS hospital wage index as the basis for the IPF wage index. We will apply the IPF wage index adjustment to the labor-related share of the national base rate and ECT payment per treatment. The labor-related share of the national rate and ECT payment per treatment will change from 77.2 percent in FY 2022 to 77.4 percent in FY 2023.

This percentage reflects the labor-related share of the 2016-based IPF market basket for FY 2023 (see section IV.A of this rule). Start Printed Page 46856 b. Office of Management and Budget (OMB) Bulletins 1.

Background The wage index used for the IPF PPS is calculated using the unadjusted, pre-reclassified and pre-floor IPPS wage index data and is assigned to the IPF on the basis of the labor market area in which the IPF is geographically located. IPF labor market areas are delineated based on the Core-Based Statistical Area (CBSAs) established by the OMB. Generally, OMB issues major revisions to statistical areas every 10 years, based on the results of the decennial census.

However, OMB occasionally issues minor updates and revisions to statistical areas in the years between the decennial censuses through OMB Bulletins. These bulletins contain information regarding CBSA changes, including changes to CBSA numbers and titles. OMB bulletins may be accessed online at https://www.whitehouse.gov/âomb/âinformation-for-agencies/âbulletins/â.

In accordance with our established methodology, the IPF PPS has historically adopted any CBSA changes that are published in the OMB bulletin that corresponds with the IPPS hospital wage index used to determine the IPF wage index and, when necessary and appropriate, has proposed and finalized transition policies for these changes. In the RY 2007 IPF PPS final rule (71 FR 27061 through 27067), we adopted the changes discussed in the OMB Bulletin No. 03-04 (June 6, 2003), which announced revised definitions for MSAs, and the creation of Micropolitan Statistical Areas and Combined Statistical Areas.

In adopting the OMB CBSA geographic designations in RY 2007, we did not provide a separate transition for the CBSA-based wage index since the IPF PPS was already in a transition period from TEFRA payments to PPS payments. In the RY 2009 IPF PPS notice, we incorporated the CBSA nomenclature changes published in the most recent OMB bulletin that applied to the IPPS hospital wage index used to determine the current IPF wage index and stated that we expected to continue to do the same for all the OMB CBSA nomenclature changes in future IPF PPS rules and notices, as necessary (73 FR 25721). Subsequently, CMS adopted the changes that were published in past OMB bulletins in the FY 2016 IPF PPS final rule (80 FR 46682 through 46689), the FY 2018 IPF PPS rate update (82 FR 36778 through 36779), the FY 2020 IPF PPS final rule (84 FR 38453 through 38454), and the FY 2021 IPF PPS final rule (85 FR 47051 through 47059).

We direct readers to each of these rules for more information about the changes that were adopted and any associated transition policies. In part due to the scope of changes involved in adopting the CBSA delineations for FY 2021, we finalized a 2-year transition policy in the FY 2021 IPF PPS final rule consistent with our past practice of using transition policies to help mitigate negative impacts on hospitals of certain wage index policy changes. We applied a 5-percent cap on wage index decreases to all IPF providers that had any decrease in their wage indexes, regardless of the circumstance causing the decline, so that an IPF's final wage index for FY 2021 would not be less than 95 percent of its final wage index for FY 2020, regardless of whether the IPF was part of an updated CBSA.

We refer readers to the FY 2021 IPF PPS final rule (85 FR 47058 through 47059) for a more detailed discussion about the wage index transition policy for FY 2021. On March 6, 2020, OMB issued OMB Bulletin 20-01 (available on the web at https://www.whitehouse.gov/âwp-content/âuploads/â2020/â03/âBulletin-20-01.pdf). In considering whether to adopt this bulletin, we analyzed whether the changes in this bulletin would have a material impact on the IPF PPS wage index.

This bulletin creates only one Micropolitan statistical area. As discussed in further detail in section IV.D.1.b.ii of this final rule since Micropolitan areas are considered rural for the IPF PPS wage index, this bulletin has no material impact on the IPF PPS wage index. That is, the constituent county of the new Micropolitan area was considered rural effective as of FY 2021 and would continue to be considered rural if we adopted OMB Bulletin 20-01.

Therefore, we did not propose to adopt OMB Bulletin 20-01 in the FY 2022 IPF PPS proposed rule. 2. Micropolitan Statistical Areas OMB defines a âMicropolitan Statistical Areaâ as a CBSA associated with at least one urban cluster that has a population of at least 10,000, but less than 50,000 (75 FR 37252).

We refer to these as Micropolitan Areas. After extensive impact analysis, consistent with the treatment of these areas under the IPPS as discussed in the FY 2005 IPPS final rule (69 FR 49029 through 49032), we determined the best course of action would be to treat Micropolitan Areas as âruralâ and include them in the calculation of each state's IPF PPS rural wage index. We refer readers to the FY 2007 IPF PPS final rule (71 FR 27064 through 27065) for a complete discussion regarding treating Micropolitan Areas as rural.

C. Permanent Cap on Wage Index Decreases As discussed in section IV.D.1.b.(1) of this final rule, we have proposed and finalized temporary transition policies in the past to mitigate significant changes to payments due to changes to the IPF PPS wage index. Specifically, for FY 2016 (80 FR 46652), we implemented a 50/50 blend for all geographic areas consisting of the wage index values computed using the then-current OMB area delineations and the wage index values computed using new area delineations based on OMB Bulletin No.

13-01. In FY 2021 (85 FR 47059), we implemented a 2-year transition to mitigate any negative effects of wage index changes by applying a 5-percent cap on any decrease in an IPF's wage index from the IPF's final wage index from FY 2020. We explained that we believe the 5-percent cap would provide greater transparency and would be administratively less complex than the prior methodology of applying a 50/50 blended wage index.

We indicated that no cap would be applied to the reduction in the wage index for the second year, that is, FY 2022, and that this transition approach struck an appropriate balance by providing a transition period to mitigate the resulting short-term instability and negative impacts on providers and time for them to adjust to their new labor market area delineations and wage index values. In FY 2022 (86 FR 42616 through 42617), a couple of commenters recommended CMS extend the transition period adopted in the FY 2021 IPF PPS final rule. We did not propose to modify the transition policy that was finalized in the FY 2021 IPF PPS final rule, and we did not extend the transition period for FY 2022.

In the FY 2022 IPF PPS final rule, we stated that we continued to believe that applying the 5-percent cap transition policy in year one provided an adequate safeguard against any significant payment reductions associated with the adoption of the revised CBSA delineations in FY 2021, allowed for sufficient time to make operational changes for future FYs, and provided a reasonable balance between mitigating some short-term instability in IPF payments and improving the accuracy of the payment adjustment for differences in area wage levels. However, we acknowledged that certain changes to wage index policy may significantly affect Medicare payments. Start Printed Page 46857 In addition, we reiterated that our policy principles with regard to the wage index include generally using the most current data and information available and providing that data and information, as well as any approaches to addressing any significant effects on Medicare payments resulting from these potential scenarios, in notice and comment rulemaking.

With these policy principles in mind, we considered for the FY 2023 proposed rule how best to address the potential scenarios about which commenters raised concerns. That is, scenarios in which changes to wage index policy may significantly affect Medicare payments. In the past, we have established transition policies of limited duration to phase in significant changes to labor market areas.

In taking this approach in the past, we sought to mitigate short-term instability and fluctuations that can negatively impact providers due to wage index changes. In accordance with the requirements of the IPF PPS wage index regulations at Â§â412.424(a)(2), we use an appropriate wage index based on the best available data, including the best available labor market area delineations, to adjust IPF PPS payments for wage differences. We have previously stated that, because the wage index is a relative measure of the value of labor in prescribed labor market areas, we believe it is important to implement new labor market area delineations with as minimal a transition as is reasonably possible.

However, we recognize that changes to the wage index have the potential to create instability and significant negative impacts on certain providers even when labor market areas do not change. In addition, year-to-year fluctuations in an area's wage index can occur due to external factors beyond a provider's control, such as the asthma treatment PHE, and for an individual provider, these fluctuations can be difficult to predict. We also recognize that predictability in Medicare payments is important to enable providers to budget and plan their operations.

In light of these considerations, we proposed a permanent approach to smooth year-to-year changes in providers' wage indexes. We proposed a policy that we believe increases the predictability of IPF PPS payments for providers and mitigates instability and significant negative impacts to providers resulting from changes to the wage index. As previously discussed, we believe applying a 5-percent cap on wage index decreases for FY 2021 provided greater transparency and was administratively less complex than prior transition methodologies.

In addition, we believe this methodology mitigated short-term instability and fluctuations that can negatively impact providers due to wage index changes. Lastly, we believe the 5-percent cap applied to all wage index decreases for FY 2021 provided an adequate safeguard against significant payment reductions related to the adoption of the revised CBSAs. However, as discussed earlier in this section of the proposed rule, we recognize there are circumstances that a 2-year mitigation policy, like the one adopted for FY 2021, would not effectively address future years in which providers continue to be negatively affected by significant wage index decreases.

We explained in the FY 2023 IPF PPS proposed rule (87 FR 19424) that typical year-to-year variation in the IPF PPS wage index has historically been within 5 percent, and we expected this will continue to be the case in future years. Because providers are usually experienced with this level of wage index fluctuation, we stated that we believe applying a 5-percent cap on all wage index decreases each year, regardless of the reason for the decrease, would effectively mitigate instability in IPF PPS payments due to any significant wage index decreases that may affect providers in a year. Therefore, we believe this approach would address concerns about instability that commenters raised in the FY 2022 IPF PPS rule.

In addition, we noted that we believe applying a 5-percent cap on all wage index decreases would support increased predictability about IPF PPS payments for providers, enabling them to more effectively budget and plan their operations. Lastly, because applying a 5-percent cap on all wage index decreases would represent a small overall impact on the labor market area wage index system, we believe it would ensure the wage index is a relative measure of the value of labor in prescribed labor market areas. As discussed in further detail in section IV.D.1.e of this final rule, we estimated that applying a 5-percent cap on all wage index decreases would have a very small effect on the wage index budget neutrality factor for FY 2023.

Because the wage index is a measure of the value of labor (wage and wage-related costs) in a prescribed labor market area relative to the national average, we explained that we anticipated that in the absence of proposed policy changes most providers would not experience year-to-year wage index declines greater than 5 percent in any given year. Therefore, we anticipated that the impact to the wage index budget neutrality factor in future years would continue to be minimal. We also stated that we believe that the 5-percent cap would likely be applied similarly to all IPFs in the same labor market area, as the hospital average hourly wage data in the CBSA (and any relative decreases compared to the national average hourly wage) will be similar.

We explained that, while this policy may result in IPFs in a CBSA receiving a higher wage index than others in the same area (such as situations when delineations change), we believe the impact would be temporary. The Secretary has broad authority under section 1886(s)(1) of the Act and Section 124 of the BBRA to establish appropriate payment adjustments under the IPF PPS, including the wage index adjustment. As discussed earlier in this section, the IPF PPS regulations specify that we use an appropriate wage index based on the best available data.

For the reasons discussed in this section, we stated in the proposed rule that we believe a 5-percent cap on wage index decreases would be appropriate for the IPF PPS (87 FR 19424). Therefore, for FY 2023 and subsequent years, we proposed to apply a 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, regardless of the circumstances causing the decline. That is, we proposed that an IPF's wage index for FY 2023 would not be less than 95 percent of its final wage index for FY 2022, regardless of whether the IPF is part of an updated CBSA, and that for subsequent years, a provider's wage index would not be less than 95 percent of its wage index calculated in the prior FY.

This also means that if an IPF's prior FY wage index is calculated with the application of the 5-percent cap, the following year's wage index would not be less than 95 percent of the IPF's capped wage index in the prior FY. For example, if an IPF's wage index for FY 2023 is calculated with the application of the 5-percent cap, then its wage index for FY 2024 would not be less than 95 percent of its capped wage index in FY 2023. Lastly, we proposed that a new IPF would be paid the wage index for the area in which it is geographically located for its first full or partial FY with no cap applied because a new IPF would not have a wage index in the prior FY.

We proposed to reflect the permanent cap on wage index decreases at Â§â412.424(d)(1)(i). Comment. We received 11 comments supporting the proposal of a permanent cap on wage index decreases.

One commenter recommended that CMS consider a more gradual reduction of the Start Printed Page 46858 wage index cap, such as between 1 and 2 percent. Response. We appreciate commenters' support for the proposed permanent cap on wage index decreases.

We also appreciate the suggestion to consider a lower threshold for the permanent cap. However, we are not finalizing a lower threshold for the cap. Furthermore, as we discussed in the FY 2023 IPF PPS proposed rule (87 FR 19424), we believe applying a 5-percent cap on wage index decreases would be appropriate for the IPF PPS, because it would effectively mitigate instability in IPF PPS payments due to any significant wage index decreases, and would also represent a small overall impact on the labor market area wage index system and would therefore ensure the wage index is a relative measure of the value of labor in prescribed labor market areas.

Based on the data used for this FY 2023 IPF PPS final rule, we estimate that only 1.3 percent of providers will experience wage index changes of more than 5 percent. In contrast, we estimate that approximately 12.2 percent of providers will experience wage index decreases of more than 2 percent, and 32.1 percent will experience wage index decreases of more than 1 percent. Therefore, if we were to cap wage index decreases at a lower threshold, for example 1 or 2 percent as the commenter suggested, the wage index cap would affect more providers and, accordingly, would result in a larger budget neutrality effect.

Furthermore, the wage index cap policy would represent a relatively larger overall impact on the labor market area wage index system, since more IPFs in a greater number of labor market areas would be affected by the cap. We therefore do not believe it would be appropriate to apply a 1 or 2 percent cap on wage index decreases as the commenter suggested. Comment.

MedPAC supported the proposal to cap wage index decreases at 5 percent, but suggested also applying a cap to increases of more than 5 percent. Response. We appreciate MedPAC's suggestion that the cap on wage index changes of more than 5 percent should also be applied to increases in the wage index.

However, as we discussed in the proposed rule, one purpose of the proposed policy is to help mitigate the significant negative impacts of certain wage index changes. As we noted in the FY 2023 IPF PPS proposed rule (87 FR 19424), we believe applying a 5-percent cap on all wage index decreases would support increased predictability about IPF PPS payments for providers, enabling them to more effectively budget and plan their operations. That is, we proposed to cap decreases because we believe that a provider would be able to more effectively budget and plan when there is predictability about its expected minimum level of IPF PPS payments in the upcoming fiscal year.

We did not propose to limit wage index increases because we do not believe such a policy is needed to enable IPFs to more effectively budget and plan their operations. Therefore, we believe it is appropriate for providers that experience an increase in their wage index value to receive that wage index value. Comment.

Several commenters recommended that CMS apply the wage index cap in a non-budget neutral manner. Response. In accordance with our longstanding policy under the IPF PPS, we updated the wage index in such a way that total estimated payments to IPFs for FY 2023 are the same with or without the changes (that is, in a budget-neutral manner) by applying a budget neutrality factor to the IPF PPS rates.

We proposed to apply the wage index cap in a budget-neutral manner in accordance with this overall budget neutrality policy for the IPF PPS wage index so that wage index changes do not increase aggregate Medicare spending. In the FY 2023 IPF PPS proposed rule, we noted that applying a 5-percent cap on all wage index decreases would have a very small effect on the wage index budget neutrality factor for FY 2023. We explained that we anticipate that in the absence of proposed policy changes most providers will not experience year-to-year wage index declines greater than 5 percent in any given year and that we expect the impact to the wage index budget neutrality factor in future years will continue to be minimal.

Comment. Two commenters opposed the proposal to pay any new provider the wage index for the area in which it is geographically located for its first full or partial FY with no cap applied. One commenter expressed concern that this policy will create an unnecessary inequity in Medicare payments for IPFs in the same market.

Another commenter asserted that new facilities will struggle to fill hospital beds and recruit staff if their wage index is lower than other IPFs in the same CBSA. This commenter further noted that ultimately, the addition of a new facility will most likely increase the region's wage index in the future. Response.

We appreciate the concerns that commenters raised, but we do not agree that this proposal would create an unnecessary inequity in IPF PPS payments or make it more difficult for new facilities to fill hospital beds and recruit staff. As we discussed in the FY 2023 IPF PPS proposed rule (87 FR 19424), while this policy may result in IPFs in a CBSA receiving a higher wage index than others in the same area (such as situations when delineations change), we believe the impact would be temporary because, over time, wage levels in a CBSA will converge to the same level. In addition, as we have previously stated, we believe the IPF PPS wage index accurately reflects the cost of labor in a prescribed labor market area.

Therefore, we believe the IPF PPS wage index would accurately reflect the labor costs that a new provider would face. As we noted earlier in this section, we proposed to apply the permanent 5-percent cap on wage index decreases in order to mitigate instability, support increased predictability about IPF PPS payments, and enable providers to more effectively budget and plan their operations. We do not believe that changes to the wage index in a labor market area would represent a change for a new provider in that labor market area.

In contrast to other providers in the same area, a new provider would not have a prior year wage index against which to compare the current year wage index. Therefore, we do not believe that applying the cap to new providers would be appropriate. Comment.

A commenter recommended that CMS retroactively apply the 5-percent cap policy to the FY 2022 wage index for providers that experienced wage index decreases due to their transition to a new CBSA based on the new OMB delineations that were finalized for FY 2021. Response. As noted previously, in FY 2021, we implemented a 2-year transition to mitigate any negative effects of wage index changes by applying a 5-percent cap on any decrease in an IPF's wage index from the IPF's final wage index from FY 2020.

We indicated that no cap would be applied to the reduction in the second year, FY 2022. In the FY 2023 IPF PPS proposed rule, we did not propose to modify that transition policy to extend the transition period for FY 2022. We have historically implemented transitions of limited duration, as discussed in the FY 2016 (80 FR 46652) final rule, to address CBSA changes due to substantial updates to OMB delineations.

In accordance with our policy principles that we use the most updated data and information available with regard to the wage index, as noted in the FY 2022 IPF PPS final rule (86 FR 42617), we proposed that the FY 2023 IPF PPS 5-percent cap wage index policy would be prospective to mitigate any significant decreases beginning in FY 2023. Start Printed Page 46859 Final Decision. After consideration of the comments received, we are finalizing as proposed a permanent 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, which we will apply in a budget-neutral manner.

We are also finalizing as proposed that a new IPF will be paid the wage index for the area in which it is geographically located for its first full or partial FY with no cap applied because a new IPF would not have a wage index in the prior FY. We are reflecting the permanent cap on wage index decreases at Â§â412.424(d)(1)(i). As previously discussed, we believe this methodology will maintain the IPF PPS wage index as a relative measure of the value of labor in prescribed labor market areas, increase predictability of IPF PPS payments for providers, and mitigate instability and significant negative impacts to providers resulting from significant changes to the wage index.

In section VIII.C.2 of this final rule, we estimate the impact to payments for providers in FY 2023 based on this policy. We also note that we will examine the effects of this policy on an ongoing basis in the future in order to assess its appropriateness. D.

Adjustment for Rural Location In the November 2004 IPF PPS final rule, (69 FR 66954) we provided a 17-percent payment adjustment for IPFs located in a rural area. This adjustment was based on the regression analysis, which indicated that the per diem cost of rural facilities was 17-percent higher than that of urban facilities after accounting for the influence of the other variables included in the regression. This 17-percent adjustment has been part of the IPF PPS each year since the inception of the IPF PPS.

For FY 2023, we proposed to continue to apply a 17-percent payment adjustment for IPFs located in a rural area as defined at Â§â412.64(b)(1)(ii)(C) (see 69 FR 66954 for a complete discussion of the adjustment for rural locations). We did not receive any comments on this proposal, and we are finalizing it as proposed. E.

Budget Neutrality Adjustment Changes to the wage index are made in a budget-neutral manner so that updates do not increase expenditures. For FY 2023, we proposed to continue to apply a budget-neutrality adjustment in accordance with our existing budget-neutrality policy. This policy requires us to update the wage index in such a way that total estimated payments to IPFs for FY 2023 are the same with or without the changes (that is, in a budget-neutral manner) by applying a budget neutrality factor to the IPF PPS rates.

As discussed in section IV.E.2 of this final rule, we used the March 2022 update of the FY 2021 IPF claims to calculate the final FY 2023 IPF PPS wage index budget neutrality factor. We used the following steps, which include the 5-percent cap on decreases to a provider's wage index, to ensure that the rates reflect the FY 2023 update to the wage indexes (based on the FY 2019 hospital cost report data) and the labor-related share in a budget-neutral manner. Step 1.

Simulate estimated IPF PPS payments, using the FY 2022 IPF wage index values (available on the CMS website) and labor-related share (as published in the FY 2022 IPF PPS final rule (86 FR 42608). Step 2. Simulate estimated IPF PPS payments using the final FY 2023 IPF wage index values (available on the CMS website), including application of the 5-percent cap on wage index decreases, and the final FY 2023 labor-related share (based on the latest available data as discussed previously).

Step 3. Divide the amount calculated in step 1 by the amount calculated in step 2. The resulting quotient is the FY 2023 budget-neutral wage adjustment factor of 1.0012.

Step4. Apply the FY 2023 budget-neutral wage adjustment factor from step 3 to the FY 2022 IPF PPS Federal per diem base rate after the application of the market basket update described in section IV.A of this final rule, to determine the FY 2023 IPF PPS Federal per diem base rate. As discussed in section IV.D.1.c of this final rule, we also followed these steps to separately calculate the budget neutrality factor associated with the 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year.

First, we calculated the budget neutrality factor associated with the FY 2023 IPF wage index and FY 2023 labor-related share. We divided the amount of simulated payments using the FY 2022 IPF wage index and labor-related share by the amount of simulated payments using the FY 2023 wage index and FY 2023 labor-related share. The resulting quotient is 1.0013.

Next, we calculated the budget neutrality factor associated with the 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year. We divided the amount of simulated payments using the FY 2023 wage index and FY 2023 labor-related share by the amount of simulated payments using the FY 2023 wage index, the 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, and the FY 2023 labor-related share. The resulting quotient is 0.9999.

The combined budget neutrality factor, which is the FY 2023 budget-neutral wage adjustment factor as discussed earlier in this section, is 1.0012. 2. Teaching Adjustment In the November 2004 IPF PPS final rule (69 FR 66922), we implemented regulations at Â§â412.424(d)(1)(iii) to establish a facility-level adjustment for IPFs that are, or are part of, teaching hospitals.

The teaching adjustment accounts for the higher indirect operating costs experienced by hospitals that participate in graduate medical education (GME) programs. The payment adjustments are made based on the ratio of the number of full-time equivalent (FTE) interns and residents training in the IPF and the IPF's average daily census (ADC). Under the IPPS, Medicare makes direct GME payments (for direct costs such as resident and teaching physician salaries, and other direct teaching costs) to all teaching hospitals including those paid under a PPS, and those paid under the TEFRA rate-of-increase limits.

These direct GME payments are made separately from payments for hospital operating costs and are not part of the IPF PPS. In addition, direct GME payments do not address the estimated higher indirect operating costs teaching hospitals may face. The results of the regression analysis of FY 2002 IPF data established the basis for the payment adjustments included in the November 2004 IPF PPS final rule.

The results showed that the indirect teaching cost variable is significant in explaining the higher costs of IPFs that have teaching programs. We calculated the teaching adjustment based on the IPF's âteaching variable,â which is (1 + (the number of FTE residents training in the IPF/the IPF's ADC)). The teaching variable is then raised to the 0.5150 power to result in the teaching adjustment.

This formula is subject to the limitations on the number of FTE residents, which are described in this section of the final rule. We established the teaching adjustment in a manner that limited the incentives for IPFs to add FTE residents for the purpose of increasing their teaching adjustment. We imposed a cap on the number of FTE residents that may be counted for purposes of calculating the teaching adjustment.

The cap limits the number of FTE residents that teaching IPFs may count for the purpose of calculating the IPF PPS teaching adjustment, not the number of Start Printed Page 46860 residents teaching institutions can hire or train. We calculated the number of FTE residents that trained in the IPF during a âbase yearâ and used that FTE resident number as the cap. An IPF's FTE resident cap is ultimately determined based on the final settlement of the IPF's most recent cost report filed before November 15, 2004 (publication date of the IPF PPS final rule).

A complete discussion of the temporary adjustment to the FTE cap to reflect residents due to hospital closure or residency program closure appears in the RY 2012 IPF PPS proposed rule (76 FR 5018 through 5020) and the RY 2012 IPF PPS final rule (76 FR 26453 through 26456). In the regression analysis, the logarithm of the teaching variable had a coefficient value of 0.5150. We converted this cost effect to a teaching payment adjustment by treating the regression coefficient as an exponent and raising the teaching variable to a power equal to the coefficient value.

We note that the coefficient value of 0.5150 was based on the regression analysis holding all other components of the payment system constant. A complete discussion of how the teaching adjustment was calculated appears in the November 2004 IPF PPS final rule (69 FR 66954 through 66957) and the RY 2009 IPF PPS notice (73 FR 25721). As with other adjustment factors derived through the regression analysis, we do not plan to rerun the teaching adjustment factors in the regression analysis until we more fully analyze IPF PPS data.

Therefore, in this FY 2023 final rule, we will continue to retain the coefficient value of 0.5150 for the teaching adjustment to the Federal per diem base rate. 3. Cost of Living Adjustment for IPFs Located in Alaska and Hawaii The IPF PPS includes a payment adjustment for IPFs located in Alaska and Hawaii based upon the area in which the IPF is located.

As we explained in the November 2004 IPF PPS final rule, the FY 2002 data demonstrated that IPFs in Alaska and Hawaii had per diem costs that were disproportionately higher than other IPFs. Other Medicare prospective payment systems (for example, the IPPS and LTCH PPS) adopted a COLA to account for the cost differential of care furnished in Alaska and Hawaii. We analyzed the effect of applying a COLA to payments for IPFs located in Alaska and Hawaii.

The results of our analysis demonstrated that a COLA for IPFs located in Alaska and Hawaii will improve payment equity for these facilities. As a result of this analysis, we provided a COLA in the November 2004 IPF PPS final rule. A COLA for IPFs located in Alaska and Hawaii is made by multiplying the non-labor-related portion of the Federal per diem base rate by the applicable COLA factor based on the COLA area in which the IPF is located.

The COLA factors through 2009 were published by the Office of Personnel Management (OPM), and the OPM memo showing the 2009 COLA factors is available at https://www.chcoc.gov/âcontent/ânonforeign-area-retirement-equity-assurance-act. We note that the COLA areas for Alaska are not defined by county as are the COLA areas for Hawaii. In 5 CFR 591.207, the OPM established the following COLA areas.

City of Anchorage, and 80-kilometer (50-mile) radius by road, as measured from the Federal courthouse. City of Fairbanks, and 80-kilometer (50-mile) radius by road, as measured from the Federal courthouse. City of Juneau, and 80-kilometer (50-mile) radius by road, as measured from the Federal courthouse.

Rest of the state of Alaska. As stated in the November 2004 IPF PPS final rule, we update the COLA factors according to updates established by the OPM. However, sections 1911 through 1919 of the Non-foreign Area Retirement Equity Assurance Act, as contained in subtitle B of title XIX of the National Defense Authorization Act (NDAA) for FY 2010 (Pub.

L. 111-84, October 28, 2009), transitions the Alaska and Hawaii COLAs to locality pay. Under section 1914 of NDAA, locality pay was phased in over a 3-year period beginning in January 2010, with COLA rates frozen as of the date of enactment, October 28, 2009, and then proportionately reduced to reflect the phase-in of locality pay.

When we published the proposed COLA factors in the RY 2012 IPF PPS proposed rule (76 FR 4998), we inadvertently selected the FY 2010 COLA rates, which had been reduced to account for the phase-in of locality pay. We did not intend to propose the reduced COLA rates because that would have understated the adjustment. Since the 2009 COLA rates did not reflect the phase-in of locality pay, we finalized the FY 2009 COLA rates for RY 2010 through RY 2014.

In the FY 2013 IPPS/LTCH final rule (77 FR 53700 through 53701), we established a new methodology to update the COLA factors for Alaska and Hawaii, and adopted this methodology for the IPF PPS in the FY 2015 IPF final rule (79 FR 45958 through 45960). We adopted this new COLA methodology for the IPF PPS because IPFs are hospitals with a similar mix of commodities and services. We believe it is appropriate to have a consistent policy approach with that of other hospitals in Alaska and Hawaii.

Therefore, the IPF COLAs for FY 2015 through FY 2017 were the same as those applied under the IPPS in those years. As finalized in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53700 and 53701), the COLA updates are determined every 4 years, when the IPPS market basket labor-related share is updated. Because the labor-related share of the IPPS market basket was most recently updated for FY 2022, the COLA factors were updated in FY 2022 IPPS/LTCH rulemaking (86 FR 45547).

As such, we also updated the IPF PPS COLA factors for FY 2022 (86 FR 42621 through 42622) to reflect the updated COLA factors finalized in the FY 2022 IPPS/LTCH rulemaking. Table 2 shows the IPF PPS COLA factors effective for FY 2022 through FY 2025. Start Printed Page 46861 We did not receive any comments about the proposed COLA factors for FY 2023, and are finalizing them as proposed.

The IPF PPS COLA factors for FY 2023 are also shown in Addendum A to this final rule, and is available on the CMS website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âtools.html. 4. Adjustment for IPFs With a Qualifying Emergency Department (ED) The IPF PPS includes a facility-level adjustment for IPFs with qualifying EDs.

We provide an adjustment to the Federal per diem base rate to account for the costs associated with maintaining a full-service ED. The adjustment is intended to account for ED costs incurred by a psychiatric hospital with a qualifying ED or an excluded psychiatric unit of an IPPS hospital or a CAH, for preadmission services otherwise payable under the Medicare Hospital Outpatient Prospective Payment System (OPPS), furnished to a beneficiary on the date of the beneficiary's admission to the hospital and during the day immediately preceding the date of admission to the IPF (see Â§â413.40(c)(2)), and the overhead cost of maintaining the ED. This payment is a facility-level adjustment that applies to all IPF admissions (with one exception which we described), regardless of whether a particular patient receives preadmission services in the hospital's ED.

The ED adjustment is incorporated into the variable per diem adjustment for the first day of each stay for IPFs with a qualifying ED. Those IPFs with a qualifying ED receive an adjustment factor of 1.31 as the variable per diem adjustment for day 1 of each patient stay. If an IPF does not have a qualifying ED, it receives an adjustment factor of 1.19 as the variable per diem adjustment for day 1 of each patient stay.

The ED adjustment is made on every qualifying claim except as described in this section of the final rule. As specified in Â§â412.424(d)(1)(v)(B), the ED adjustment is not made when a patient is discharged from an IPPS hospital or CAH and admitted to the same IPPS hospital's or CAH's excluded psychiatric unit. We clarified in the November 2004 IPF PPS final rule (69 FR 66960) that an ED adjustment is not made in this case because the costs associated with ED services are reflected in the DRG payment to the IPPS hospital or through the reasonable cost payment made to the CAH.

Therefore, when patients are discharged from an IPPS hospital or CAH and admitted to the same hospital's or CAH's excluded psychiatric unit, the IPF receives the 1.19 adjustment factor as the variable per diem adjustment for the first day of the patient's stay in the IPF. For FY 2023, we proposed to continue to retain the 1.31 adjustment factor for IPFs with qualifying EDs. We did not receive any comments on this proposal, and we are finalizing it as proposed.

A complete discussion of the steps involved in the calculation of the ED adjustment factors are in the November 2004 IPF PPS final rule (69 FR 66959 through 66960) and the RY 2007 IPF PPS final rule (71 FR 27070 through 27072). E. Other Final Payment Adjustments and Policies 1.

Outlier Payment Overview The IPF PPS includes an outlier adjustment to promote access to IPF care for those patients who require expensive care and to limit the financial risk of IPFs treating unusually costly patients. In the November 2004 IPF PPS final rule, we implemented regulations at Â§â412.424(d)(3)(i) to provide a per-case payment for IPF stays that are extraordinarily costly. Providing additional payments to IPFs for extremely costly cases strongly improves the accuracy of the IPF PPS in determining resource costs at the patient and facility level.

These additional payments reduce the financial losses that would otherwise be incurred in treating patients who require costlier care, and therefore, reduce the incentives for IPFs to under-serve these patients. We make outlier payments for discharges in which an IPF's estimated total cost for a case exceeds a fixed dollar loss threshold amount (multiplied by the IPF's facility-level adjustments) plus the Federal per diem payment amount for the case. In instances when the case qualifies for an outlier payment, we pay 80 percent of the difference between the estimated cost for the case and the adjusted threshold amount for days 1 through 9 of the stay (consistent with the median LOS for IPFs in FY 2002), and 60 percent of the difference for day 10 and thereafter.

The adjusted threshold amount is equal to the outlier threshold amount adjusted for wage area, teaching status, rural area, and the COLA adjustment (if applicable), plus the amount of the Medicare IPF Start Printed Page 46862 payment for the case. We established the 80 percent and 60 percent loss sharing ratios because we were concerned that a single ratio established at 80 percent (like other Medicare PPSs) might provide an incentive under the IPF per diem payment system to increase LOS in order to receive additional payments. After establishing the loss sharing ratios, we determined the current fixed dollar loss threshold amount through payment simulations designed to compute a dollar loss beyond which payments are estimated to meet the 2-percent outlier spending target.

Each year when we update the IPF PPS, we simulate payments using the latest available data to compute the fixed dollar loss threshold so that outlier payments represent 2 percent of total estimated IPF PPS payments. 2. Update to the Outlier Fixed Dollar Loss Threshold Amount In accordance with the update methodology described in Â§â412.428(d), we proposed to update the fixed dollar loss threshold amount used under the IPF PPS outlier policy.

Based on the regression analysis and payment simulations used to develop the IPF PPS, we established a 2-percent outlier policy, which strikes an appropriate balance between protecting IPFs from extraordinarily costly cases while ensuring the adequacy of the Federal per diem base rate for all other cases that are not outlier cases. Our longstanding methodology for updating the outlier fixed dollar loss threshold involves using the best available data, which is typically the most recent available data. Last year for the FY 2022 IPF PPS final rule, we finalized the use of FY 2019 claims rather than the more recent FY 2020 claims for updating the outlier fixed dollar loss threshold (86 FR 42623).

We noted that our use of the FY 2019 claims to set the final outlier fixed dollar loss threshold for FY 2022 deviated from our longstanding practice of using the most recent available year of claims, but remained otherwise consistent with the established outlier update methodology. We explained that we finalized our proposal to deviate from our longstanding practice of using the most recent available year of claims only because, and to the extent that, the asthma treatment PHE appeared to have significantly impacted the FY 2020 IPF claims. We further stated that we intended to continue to analyze further data in order to better understand both the short-term and long-term effects of the asthma treatment PHE on IPFs (86 FR 42624).

For the FY 2023 IPF PPS proposed rule, consistent with our longstanding practice, we analyzed the most recent available data for simulating IPF PPS payments in FY 2023. We observed a continuation of two main trends that we noted in our analysis of FY 2020 claims for FY 2022âthat is, an overall increase in average cost per day and an overall decrease in the number of covered days. However, we also identified that some providers had significant increases in their charges, resulting in higher than normal estimated cost per day that would skew our estimate of outlier payments for FY 2022 and FY 2023.

In the proposed rule (87 FR 19428), we noted that historically, we have applied statistical trims under the IPF PPS in order to improve the statistical validity of the data used for ratesetting. In the November 2004 final rule, we explained that we applied a 3 standard deviation trim on cost per day prior to calculating the average per diem cost used to calculate the IPF PPS Federal per diem base rate (69 FR 66927). Furthermore, as discussed in section IV.E.3 of this final rule, our longstanding policy applies a ceiling on a provider's cost-to-charge ratio when it exceeds 3 standard deviations from the mean cost-to-charge ratio for urban or rural providers.

We proposed a similar approach in order to address the skew in estimated cost per day that we observed in the FY 2021 claims. Specifically, we proposed for FY 2023 to exclude providers from our simulation of IPF PPS payments for FY 2022 and FY 2023 if their change in estimated average cost per day is outside 3 standard deviations from the mean. In the proposed rule (87 FR 19428), we stated that based on an analysis of the December 2021 update of FY 2021 IPF claims and the FY 2022 rate increases, we believe it is necessary to update the fixed dollar loss threshold amount to maintain an outlier percentage that equals 2 percent of total estimated IPF PPS payments.

We proposed to update the IPF outlier threshold amount for FY 2023 using FY 2021 claims data and the same methodology that we used to set the initial outlier threshold amount in the RY 2007 IPF PPS final rule (71 FR 27072 and 27073), which is also the same methodology that we used to update the outlier threshold amounts for years 2008 through 2022. However, as discussed earlier in this section, we also proposed for FY 2023 to exclude providers from our impact simulations whose change in simulated cost per day is outside 3 standard deviations from the mean. Based on an analysis of the data available for the proposed rule, we estimated that IPF outlier payments as a percentage of total estimated payments were approximately 3.2 percent in FY 2022.

Therefore, we proposed to update the outlier threshold amount to $24,270 to maintain estimated outlier payments at 2 percent of total estimated aggregate IPF payments for FY 2023. This proposed update was an increase from the FY 2022 threshold of $16,040. Comment.

Several commenters expressed concern about using CY 2021 data because of the impact of the asthma treatment PHE and suggested that CMS consider alternative methodologies for estimating the outlier percentage and setting the outlier fixed dollar loss threshold amount. Some commenters expressed their belief that the proposed trimming methodology is not sufficient to blunt asthma treatment's overstated impact on the IPF PPS outlier calculation. These commenters encouraged CMS to use an alternative inflation factor from a period before the asthma treatment PHE and to adjust cost-to-charge ratios (CCRs) to reflect the CCRs from prior to the asthma treatment PHE.

Another commenter suggested that CMS estimate the outlier percentage using multiple years of claims, or set the outlier fixed dollar loss threshold amount based on an average of outlier thresholds from multiple years. Another commenter suggested that the percent increase to the outlier fixed dollar loss threshold amount should be limited to no more than the market basket update percentage. Response.

We appreciate the suggestions from commenters regarding these alternative methodologies. We believe that the proposed trimming methodology sufficiently mitigates the significant increases in charges that we observed in the FY 2021 claims, which we noted would skew our estimate of outlier payments for FY 2022. We believe this methodology also appropriately accounts for the ongoing trends that we noted in previous analysis of FY 2020 claims for FY 2022âthat is, an overall increase in average cost per day and an overall decrease in the number of covered days.

In the FY 2022 IPF PPS final rule (86 FR 42624), we explained that we believed these trends were related to the asthma treatment PHE and noted that we would continue to analyze further data in order to better understand both the short-term and long-term effects of the asthma treatment PHE on IPFs. Because we observed these continued trends in FY 2021, we believe it is reasonable to expect that they will continue to some extent in FY 2023. Regarding the recommendation to use an inflation factor from a different time Start Printed Page 46863 period, we do not believe it would be appropriate to do so for this FY 2023 IPF PPS final rule.

We note that whereas the IPPS uses a charge inflation factor calculated based on historical IPPS charge data, the longstanding IPF PPS methodology uses a charge inflation factor calculated based on the latest available forecast of the IPF PPS market basket price proxies. As discussed in section IV.A.2 of this final rule, we believe the 2016-based IPF market basket increase adequately reflects the average change in the price of goods and services hospitals purchase in order to provide IPF medical services. Furthermore, as discussed in that same section of this final rule, the updated forecast for this FY 2023 final rule incorporates more recent historical data and reflects a revised outlook regarding the United States economy and expected price inflation for FY 2023 for IPFs.

Therefore, we believe it is more appropriate to use an inflation factor that is based on the latest available forecast of input price growth for IPFs, rather than a factor based on data from an earlier time period, as the commenters suggested. Regarding the alternative methodologies that commenters suggested for calculating the outlier threshold, we do not believe that averaging the proposed FY 2023 outlier fixed dollar loss threshold amount with the amounts from prior years, or limiting the increase to the outlier fixed dollar loss threshold amount, would be appropriate for this FY 2023 IPF PPS final rule. As discussed earlier in this section, the longstanding IPF PPS 2-percent outlier policy was established based on the regression analysis and payment simulations used to develop the IPF PPS.

We have previously explained that the 2-percent outlier policy strikes an appropriate balance between protecting IPFs from extraordinarily costly cases while ensuring the adequacy of the Federal per diem base rate for all other cases that are not outlier cases. Each year when we update the IPF PPS, we simulate payments using the latest available data to compute the fixed dollar loss threshold so that outlier payments represent 2 percent of total estimated IPF PPS payments. For this FY 2023 IPF PPS final rule, we have simulated payments using the latest available data, and these payment simulations indicate that an increase to the outlier fixed dollar loss threshold is necessary in order to maintain outlier payments at 2 percent of total payments.

We are concerned that the alternative methodologies that commenters suggested would not appropriately target outlier payments such that they remain at 2 percent of total IPF PPS payments. Regarding the suggestion that CMS use multiple years of claims to determine the outlier fixed dollar loss threshold amount, we reiterate that our longstanding methodology uses the best available data, which is typically the most recent available data, to update the outlier fixed dollar loss threshold amount. We believe the proposed methodology appropriately accounts for the trends in average cost per day and the number of covered days reflected in the IPF PPS claims, which we expect are likely to continue to some extent into FY 2023.

We believe the proposed methodology also incorporates more recent historical data and reflects a revised outlook regarding the United States economy and expected price inflation for FY 2023 for IPFs. Therefore, we are finalizing the use of the proposed methodology to calculate the FY 2023 IPF PPS outlier fixed dollar loss threshold amount. Comment.

MedPAC encouraged CMS to provide additional data about the increase to the outlier fixed dollar loss threshold amount for FY 2023. Response. As we noted in the proposed rule, two main trends that we observed in the FY 2020 claims continued in the FY 2021 claims.

First, we observed that average cost per day increased approximately 12 percent when comparing the simulated FY 2021 IPF PPS payments from the FY 2022 IPF PPS final rule to the simulated FY 2022 IPF PPS payments that we used to estimate the outlier percentage for this FY 2023 IPF PPS final rule. In the FY 2022 IPF PPS proposed rule (86 FR 19526), we explained that we estimate the costs per case based on the covered charges on each IPF claim and the IPF's most recent CCR. In that proposed rule, we noted that laboratory charges, which make up roughly one-third of the covered charges per IPF claim, increased approximately 6.8 percent between FY 2019 and FY 2020.

We found that laboratory charges continued to increase for the FY 2021 claims analyzed for this FY 2023 IPF PPS final rule. We found that laboratory charges per day in 2021 were approximately 12.7 percent higher than laboratory charges per day in 2019. We believe these increased laboratory charges are likely in response to the asthma treatment PHE, and as stated earlier, we believe it is reasonable to expect that these increased laboratory charges will continue to some extent in FY 2023.

The second continued trend that we observed was that the number of covered days decreased in the FY 2021 claims. As we discussed in the FY 2022 IPF PPS proposed rule (86 FR 19524), we observed a decrease in covered days of approximately 15 percent from the FY 2019 claims to the FY 2020 claims. Before applying the statistical trim for this FY 2023 IPF PPS final rule, the number of covered days in the FY 2021 claims was approximately 28 percent lower than the number of covered days in the FY 2019 claims used for FY 2022 final rulemaking.

This decrease in covered days corresponds with a decrease of approximately 27 percent in the total simulated FY 2022 IPF PPS payments compared to total simulated FY 2021 IPF PPS payments used for FY 2022 final rulemaking. After applying the statistical trim, covered days were approximately 32 percent lower than FY 2019, and total simulated FY 2022 IPF PPS payments that we used to estimate the outlier percentage for this FY 2023 IPF PPS final rule were approximately 30 percent lower than total simulated FY 2021 IPF PPS payments. Because we calculate the outlier fixed dollar loss threshold amount so that outlier payments represent 2 percent of total estimated IPF PPS payments, the decrease to the number of days and total estimated IPF PPS payments increases the percentage of outlier payments relative to total payments, which contributes to the upward trend in the outlier fixed dollar loss threshold amount.

In our simulated FY 2022 outlier payments using the FY 2022 IPF PPS outlier fixed dollar loss threshold of $16,040, we estimated that 9,169 cases will receive outlier payments, with a mean outlier payment amount per outlier case of $10,057.59. We observed that the distribution of simulated FY 2022 outlier payments is skewed right, which means that a large number of outlier cases receive relatively small amounts of outlier payments, and a smaller number of outlier cases receive relatively large outlier payments. Consequently, half of all simulated outlier cases receive outlier payments of $5,490.11 or less, and 1,231 cases receive outlier payments of $1,000 or less.

We also observed that outlier payments are concentrated among certain types of IPFs. As shown in Table 3, in section VIII.C.2 of this final rule, teaching IPFs with more than 10 percent interns and residents to beds are projected to experience the largest decreases in estimated payments as a result of the increase to the outlier fixed dollar loss threshold amount, because these providers had a larger share of outlier cases than other provider types. We did not observe that changes in case Start Printed Page 46864 mix appear to be driving the increase in the outlier percentage.

In the simulated FY 2022 IPF PPS payments, we observed that approximately 79 percent of outlier cases are for DRG 885 (Psychoses), which aligns with the proportion of IPF PPS cases that typically receive that DRG. We estimate that the average outlier payment for cases with DRG 885 is $10,600.21, which is comparable to the average outlier payment for all cases. Final Decision.

After consideration of the comments received, we are finalizing our proposal to use the latest available FY 2021 claims, in accordance with our longstanding practice, to simulate payments for determining the final FY 2023 IPF PPS outlier fixed dollar loss threshold amount. We are also finalizing our proposal to exclude providers from our impact simulations whose change in simulated cost per day is outside 3 standard deviations from the mean. Based on an analysis of the March 2022 update of FY 2021 IPF claims and the FY 2022 rate increases, we continue to believe it is necessary to update the fixed dollar loss threshold amount to maintain an outlier percentage that equals 2 percent of total estimated IPF PPS payments.

We estimate that IPF outlier payments as a percentage of total estimated payments were approximately 3.2 percent in FY 2022. Therefore, we are updating the outlier threshold amount to $24,630 to maintain estimated outlier payments at 2 percent of total estimated aggregate IPF payments for FY 2023. This update is an increase from the FY 2022 threshold of $16,040.

3. Update to IPF Cost-to-Charge Ratio Ceilings Under the IPF PPS, an outlier payment is made if an IPF's cost for a stay exceeds a fixed dollar loss threshold amount plus the IPF PPS amount. In order to establish an IPF's cost for a particular case, we multiply the IPF's reported charges on the discharge bill by its overall CCR.

This approach to determining an IPF's cost is consistent with the approach used under the IPPS and other PPSs. In the FY 2004 IPPS final rule (68 FR 34494), we implemented changes to the IPPS policy used to determine CCRs for IPPS hospitals, because we became aware that payment vulnerabilities resulted in inappropriate outlier payments. Under the IPPS, we established a statistical measure of accuracy for CCRs to ensure that aberrant CCR data did not result in inappropriate outlier payments.

As we indicated in the November 2004 IPF PPS final rule (69 FR 66961), we believe that the IPF outlier policy is susceptible to the same payment vulnerabilities as the IPPS. Therefore, we adopted a method to ensure the statistical accuracy of CCRs under the IPF PPS. Specifically, we adopted the following procedure in the November 2004 IPF PPS final rule.

Calculated two national ceilings, one for IPFs located in rural areas and one for IPFs located in urban areas. Computed the ceilings by first calculating the national average and the standard deviation of the CCR for both urban and rural IPFs using the most recent CCRs entered in the most recent Provider Specific File (PSF) available. For FY 2023, we proposed to continue to follow this methodology.

We did not receive any comments on this proposal, and we are finalizing it as proposed. To determine the rural and urban ceilings, we multiplied each of the standard deviations by 3 and added the result to the appropriate national CCR average (either rural or urban). The upper threshold CCR for IPFs in FY 2023 is 2.0412 for rural IPFs, and 1.7437 for urban IPFs, based on CBSA-based geographic designations.

If an IPF's CCR is above the applicable ceiling, the ratio is considered statistically inaccurate, and we assign the appropriate national (either rural or urban) median CCR to the IPF. We apply the national median CCRs to the following situations. New IPFs that have not yet submitted their first Medicare cost report.

We continue to use these national median CCRs until the facility's actual CCR can be computed using the first tentatively or final settled cost report. IPFs whose overall CCR is in excess of three standard deviations above the corresponding national geometric mean (that is, above the ceiling). Other IPFs for which the MAC obtains inaccurate or incomplete data with which to calculate a CCR.

We proposed to continue to update the FY 2023 national median and ceiling CCRs for urban and rural IPFs based on the CCRs entered in the latest available IPF PPS PSF. We did not receive any comments on this proposal, and we are finalizing it as proposed. Specifically, for FY 2023, to be used in each of the three situations listed previously, using the most recent CCRs entered in the CY 2022 PSF, we provide an estimated national median CCR of 0.5720 for rural IPFs and a national median CCR of 0.4200 for urban IPFs.

These calculations are based on the IPF's location (either urban or rural) using the CBSA-based geographic designations. A complete discussion regarding the national median CCRs appears in the November 2004 IPF PPS final rule (69 FR 66961 through 66964). V.

Comment Solicitation on Analysis of IPF PPS Adjustments In the FY 2023 IPF PPS proposed rule (87 FR 19428 through 19429), we discussed the background of the current IPF PPS patient-level and facility-level adjustment factors, which are the regression-derived adjustment factors from the November 15, 2004 IPF PPS final rule. We briefly discussed past analyses and areas of concern for future refinement, about which we previously solicited comments. Finally, we described the results of the latest analysis of the IPF PPS and solicited comments on certain topics from the report.

As we discussed in the proposed rule, we have undertaken further analysis of more recent IPF cost and claim information. In conjunction with the FY 2023 IPF PPS proposed rule, we posted a report on the CMS website,[] which summarizes the results of the latest analysis. We noted that this updated analysis finds that the existing IPF PPS model continues to be generally appropriate in terms of effectively aligning IPF PPS payments with the cost of providing IPF services, but suggests that certain updates to the codes, categories, adjustment factors, and ECT payment amount per treatment could improve payment accuracy.

We requested comments on the results of our latest analysis as summarized in the report. In particular, we requested comments about the following topics, which are discussed in detail in the report. The report summarizes results of the analysis regarding patient-level characteristics, about which we requested comments.

++ The updated regression analysis suggests that certain technical changes to the DRG and comorbidity adjustment factors, consolidation of the age categories for the patient age adjustment, and changes to the adjustment factors for age and length of stay could be appropriate. ++ The analysis of ancillary costs for IPF stays with ECT suggests that a higher ECT payment amount per treatment could better align IPF PPS payments with the costs of furnishing ECT. ++ The analysis of the outlier percentage suggests that fewer IPF cases Start Printed Page 46865 qualify for outliers under the current 2 percent outlier target than were estimated when the IPF PPS was established.

We estimate that increasing the outlier percentage will increase the number of IPF cases that qualify for outliers, but will have distributional effects due to budget neutrality. The report summarizes the results of analysis regarding facility-level characteristics, about which we requested comments. ++ The updated regression analysis suggests that updating the adjustment factors for teaching facilities, rural facilities, and facilities with an ED could improve payment accuracy.

However, we estimate such changes could have positive and negative effects on payments for different types of IPFs. ++ The analysis of occupancy-related control variables included in the regression model indicates that these control variables are correlated with the rural adjustment factor, and that removal of these control variables from the model could result in an increase to the rural adjustment factor in the regression model. The report summarizes certain areas where we believe additional research is needed.

We requested comments about the results summarized in the report. We also requested comments about additional analyses that we should undertake to better understand how these issues affect the cost of providing IPF services, and how the IPF PPS could better account for these costs. ++ We analyzed the costs associated with social determinants of health, but found that our analysis was confounded by a low frequency of IPF claims reporting the applicable ICD-10 diagnosis codes.

We solicited public comments on the results of this analysis, and whether there are additional patient characteristics that affect the cost of providing IPF services that may not be consistently reported on claims. Additionally, we solicited public comments about how we could better identify such patient characteristics and their effects on costs. ++ We analyzed the costs associated with the percentage of low-income patients that IPFs treat, based on a construction of the Disproportionate Share Hospitals (DSH) percentage that is used in other payment systems using the data currently available for IPFs.

We solicited public comments about the results of this analysis, which suggest that the addition of an adjustment factor for disproportionate share intensity could improve the accuracy of IPF PPS payments. We received 10 comments in response to the FY 2023 IPF PPS pertaining to the report, the analysis of patient-level and facility-level adjustment factors, and areas of interest for further research. Commenters included MedPAC, state-level and national provider and patient advocacy organizations, and individual IPF hospitals and health systems.

We thank commenters for their detailed responses to this comment solicitation. We will take these comments into consideration to potentially inform future rulemaking. VI.

Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program A. Overarching Principles for Measuring Equity and Healthcare Quality Disparities Across CMS Quality ProgramsâRequest for Information Significant and persistent disparities in healthcare outcomes exist in the United States. Belonging to an underserved community is often associated with worse health outcomes.[] â[] â[] â[] â[] â[] â[] â[] â[] With this in mind, CMS aims to advance health equity, by which we mean the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.

CMS is working to advance health equity by designing, implementing, and operationalizing policies and programs that support health for all the people served by our programs, eliminating avoidable differences in health outcomes experienced by people who are disadvantaged or underserved, and providing the care and support that our beneficiaries need to thrive.[] We are committed to advancing equity in healthcare outcomes for our beneficiaries by supporting healthcare providers' quality improvement activities to reduce health disparities, enabling them to make more informed decisions, and promoting healthcare provider accountability for healthcare disparities.[] Measuring healthcare disparities in quality measures is a cornerstone of our approach to advancing health equity. Hospital performance results that illustrate differences in outcomes between patient populations have been reported to hospitals confidentially since 2018. The RFI in the proposed rule (87 FR 19429 through 19437) consisted of three sections.

The first section discussed a general framework that could be utilized across CMS quality programs to assess disparities in healthcare quality. The next section outlined approaches that could be used in the IPFQR Program to assess drivers of healthcare quality disparities in the IPFQR Program. Additionally, this section discussed measures of health equity that could be adapted for use in the IPFQR Program.

Finally, the third section solicited public comment on the principles and approaches listed in the first two sections as well as sought other thoughts about disparity measurement guidelines for the IPFQR Program. 1. Cross-Setting Framework To Assess Healthcare Quality Disparities CMS has identified five key considerations that we could apply Start Printed Page 46866 consistently across CMS programs when advancing the use of measurement and stratification as tools to address health care disparities and advance health equity.

The remainder of this section describes each of these considerations. a. Identification of Goals and Approaches for Measuring Healthcare Disparities and Using Measures Stratification Across CMS Quality Programs By quantifying healthcare disparities through measure stratification (that is, measuring performance differences among subgroups of beneficiaries), we aim to provide useful tools for healthcare providers to drive improvement based on data.

We hope that these results support healthcare providers' efforts in examining the underlying drivers of disparities in their patients' care and to develop their own innovative and targeted quality improvement interventions. Quantification of health disparities can also support communities in prioritizing and engaging with healthcare providers to execute such interventions, as well as providing additional tools for accountability and decision-making. There are several different conceptual approaches to reporting health disparities in the acute care setting, including two complementary approaches that are already used to confidentially provide disparity information to hospitals for a subset of existing measures.

The first approach, referred to as the âwithin-hospital disparity method,â compares measure performance results for a single measure between subgroups of patients with and without a given factor. This type of comparison directly estimates disparities in outcomes between subgroups and can be helpful to identify potential disparities in care. This type of approach can be used with most measures that include patient-level data.

The second approach, referred to as the âbetween-hospital disparity methodology,â provides performance on measures for only the subgroup of patients with a particular social risk factor. These approaches can be used by a healthcare provider to compare their own measure performance on a particular subgroup of patients against subgroup-specific state and national benchmarks. Alone, each approach may provide an incomplete picture of disparities in care for a particular measure, but when reported together with overall quality performance, these approaches may provide detailed information about where differences in care may exist or where additional scrutiny may be appropriate.

For example, the between-provider disparity method may indicate that an IPF underperformed (when compared to other facilities on average) for patients with a given social risk factor, which would signal the need to improve care for this population. However, if the IPF also underperformed for patients without that social risk factor, the measured difference, or disparity in care, (the âwithin-hospitalâ disparity, as described above) could be negligible even though performance for the group that has been historically marginalized remains poor. We refer readers to the technical report describing the CMS Disparity Methods in detail as well as the FY 2018 IPPS/LTCH PPS final rule (82 FR 38405 through 38407) and the posted Disparity methods Updates and Specifications Report posted on the QualityNet website.[] CMS is interested in whether similar approaches to the two discussed in the previous paragraph could be used to produce confidential stratified measure results for selected IPF QRP measures, as appropriate and feasible.

However, final decisions regarding disparity reporting will be made at the program-level, as CMS intends to tailor the approach used in each setting to achieve the greatest benefit and avoid unintentional consequences or biases in measurement that may exacerbate disparities in care. B. Guiding Principles for Selecting and Prioritizing Measures for Disparity Reporting We intend to expand our efforts to provide stratified reporting for additional clinical quality measures, provided they offer meaningful, actionable, and valid feedback to healthcare providers on their care for populations that may face social disadvantage or other forms of discrimination or bias.

We are mindful, however, that it may not be possible to calculate stratified results for all quality measures, and that there may be situations where stratified reporting is not desired. To help inform prioritization of the next generation of candidate measures for stratified reporting, we aim to receive feedback on several systematic principles under consideration that we believe will help us prioritize measures for disparity reporting across programs. (1) Programs may consider stratification among existing clinical quality measures for further disparity reporting, prioritizing recognized measures which have met industry standards for measure reliability and validity.

(2) Programs may consider measures for prioritization that show evidence that a treatment or outcome being measured is affected by underlying healthcare disparities for a specific social or demographic factor. Literature related to the measure or outcome should be reviewed to identify disparities related to the treatment or outcome, and should carefully consider both social risk factors and patient demographics. In addition, analysis of Medicare-specific data should be done in order to demonstrate evidence of disparity in care for some or most healthcare providers that treat Medicare patients.

(3) Programs may consider establishing statistical reliability and representation standards (for example, the percent of patients with a social risk factor included in reporting facilities) prior to reporting results. They may also consider prioritizing measures that reflect performance on greater numbers of patients to ensure that the reported results of the disparity calculation are reliable and representative. (4) After completing stratification, programs may consider prioritizing the reporting of measures that show differences in measure performance between subgroups across healthcare providers.

C. Principles for Social Risk Factor and Demographic Data Selection and Use Social risk factors are the wide array of non-clinical drivers of health known to negatively impact patient outcomes. These include factors such as socioeconomic status, housing availability, and nutrition (among others), often inequitably affecting historically marginalized communities on the basis of race and ethnicity, rurality, sexual orientation and gender identity, religion, and disability.[] Start Printed Page 46867 Identifying and prioritizing social risk or demographic variables to consider for disparity reporting can be challenging.

This is due to the high number of variables that have been identified in the literature as risk factors for poorer health outcomes and the limited availability of many self-reported social risk factors and demographic factors across the healthcare sector. Several proxy data sources, such as area-based indicators of social risk and imputation methods, may be used if individual patient-level data is not available. Each source of data has advantages and disadvantages for disparity reporting.

â¢ Patient-reported data are considered to be the gold standard for evaluating quality of care for patients with social risk factors.[] While data sources for many social risk factors and demographic variables are still developing among several CMS settings, the IPFQR Program will begin collecting mandatory patient-level data for certain chart-abstracted measures the FY 2024 payment determination and subsequent years (86 FR 42608). â¢ CMS Administrative Claims data have long been used for quality measurement due to their availability and will continue to be evaluated for usability in measure development and or stratification. Using these existing data allows for high impact analyses with negligible healthcare provider burden.

For example, dual eligibility for Medicare and Medicaid has been found to be an effective indicator of social risk in beneficiary populations.[] There are, however, limitations in these data's usability for stratification analysis. â¢ Area-based indicators of social risk create approximations of patient risk based on the neighborhood or context that a patient resides in. Several indexes, such as Agency for Healthcare Research and Quality (AHRQ) Socioeconomic Status (SES) Index,[] Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry (CDC/ATSDR) Social Vulnerability Index (SVI),[] and Health Resources and Services Administration (HRSA) Area Deprivation Index (ADI),[] provide multifaceted contextual information about an area and may be considered as an efficient way to stratify measures that include many social risk factors.

â¢ Imputed data sources use statistical techniques to estimate patient-reported factors, including race and ethnicity. One such tool is the Medicare Bayesian Improved Surname Geocoding (MBISG) method (currently in version 2.1), which combines information from administrative data, surname, and residential location to estimate patient race and ethnicity.[] d. Identifying Meaningful Performance Differences While we aim to use standardized approaches where possible, identifying differences in performance on stratified results will be made at the program level due to contextual variations across programs and settings.

We requested comments on the benefits and limitations of the possible reporting approaches described below. Statistical approaches could be used to reliably group results, such as using confidence intervals, creating cut points based on standard deviations, or using a clustering algorithm. Programs could use a ranked ordering and percentile approach, ordering healthcare providers in a ranked system based on their performance on disparity measures to quickly allow them to compare their performance to other similar healthcare providers.

Healthcare providers could be categorized into groups based on their performance using defined thresholds, such as fixed intervals of results of disparity measures, indicating different levels of performance. Benchmarking, or comparing individual results to state or national average, is another potential reporting strategy. Finally, a ranking system may not be appropriate for all programs and care settings, and some programs may only report disparity results.

e. Guiding Principles for Reporting Disparity Measures Reporting of the results discussed above can be employed in several ways to drive improvements in quality. Confidential reporting, or reporting results privately to healthcare providers, is generally used for new programs or new measures recently adopted for programs through notice and comment rulemaking to give healthcare providers an opportunity to become more familiar with calculation methods and to improve before other forms of reporting are used.

In addition, many results are reported publicly, in accordance with the statute. This method provides all stakeholders with important information on healthcare provider quality, and in turn, relies on market forces to incentivize healthcare providers to improve and become more competitive in their markets without directly influencing payment from CMS. One important consideration is to assess differential impact on IPFs, such as those located in rural, or critical access areas, to ensure that reporting does not disadvantage already resource-limited Start Printed Page 46868 settings.

The type of reporting chosen by programs will depend on the program context. Regardless of the methods used to report results, it is important to report stratified measure data alongside overall measure results. Review of both measures results along with stratified results can illuminate greater levels of detail about quality of care for subgroups of patients, providing important information to drive quality improvement.

Unstratified quality measure results address general differences in quality of care between healthcare providers and promote improvement for all patients, but unless stratified results are available, it is unclear if there are subgroups of patients that benefit most from initiatives. Notably, even if overall quality measure scores improve, without identifying and measuring differences in outcomes between groups of patients, it is impossible to track progress in reducing disparity for patients with heightened risk of poor outcomes. B.

Approaches to Assessing Drivers of Healthcare Quality Disparities and Developing Measures of Healthcare Equity in the IPFQR Program This section presents information on two approaches for the IPFQR Program. The first section presents information about a method that could be used to assist IPFs in identifying potential drivers of healthcare quality disparities. The second section describes measures of health equity that might be appropriate for inclusion in the IPFQR Program.

A. Performance Disparity Decomposition In response to the FY 2022 IPF PPS proposed rule's RFI (86 FR 19494 through 19500), âClosing the Health Equity Gap in CMS Quality Programs,â some stakeholders noted that identifying which factors are contributing to the performance gaps may not always be straightforward, especially if the IPF has limited information or resources to determine the extent to which a patient's driver of health or other mediating factors (for example. Health histories) explain a given disparity.

An additional complicating factor is the reality that there are likely multiple social determinants of health (SDOH) and other mediating factors responsible for a given disparity, and it may not be obvious to the IPF which of these factors are the primary drivers. Consequently, CMS may consider methods to use the data already available in enrollment, claims, and assessment data to estimate the extent to which various SDOH (for example, transportation, health literacy) and other mediating factors drive disparities in an effort to provide more actionable information. Researchers have utilized decomposition techniques to examine inequality in health care and, specifically, as a way to understand and explain the underlying causes of inequality.[] At a high level, regression decomposition is a method that allows one to estimate the extent to which disparities (that is, differences) in measure performance between subgroups of patient populations are due to specific factors.

These factors can be either non-clinical (for example, SDOH) or clinical. Similarly, CMS may utilize regression decomposition to identify and calculate the specific contribution of SDOHs and other mediating factors to observed disparities. This approach may better inform our understanding of the extent to which providers and policy-makers may be able to narrow the gap in healthcare outcomes.

Additionally, provider-specific decomposition results could be shared through confidential results so that IPFs can see the disparities within their facility with more granularity, allowing them to set priority targets in some performance areas while knowing which areas of their care are already relatively equitable. Importantly, these results could help IPFs identify reasons for disparities that might not be obvious without having access to additional data sources (for example. The ability to link data across providers).

To more explicitly demonstrate the types of information that could be provided through decomposition of a measure disparity, consider the following example for a given IPF. Figures 1 through 3 depict an example (using hypothetical data) of how a disparity in a measure of Medicare Spending Per Beneficiary (MSPB) between dual eligible beneficiaries (that is, those enrolled in Medicare and Medicaid) and non-dual eligible beneficiaries (that is, those with Medicare only) could be decomposed among two mediating factors, one SDOH and one clinical factor. (1) low health literacy and (2) high volume of emergency department (ED) use.

These examples were selected because they are factors the healthcare provider could mitigate the effects of, if they were shown to be drivers of disparity in their IPF. Additionally, high volume ED use is used as a potential mediating factor that could be difficult for IPFs to determine on their own, as it will require having longitudinal data for patients across multiple facilities. In Figure 1, the overall Medicare spending disparity is $1,000.

Spending, on average, is $5,000 per non-dual beneficiary and $6,000 per dual beneficiary. We can also see from Figure 2 that in this IPF, the dual population has twice the prevalence of beneficiaries with low health literacy and high ED use compared to the non-dual population. Using regression techniques, the difference in overall spending between non-dual and dual beneficiaries can be divided into three causes.

(1) a difference in the prevalence of mediating factors (for example. Low health literacy and high ED use) between the two groups. (2) a difference in how much spending is observed for beneficiaries with these mediating factors between the two groups.

And (3) differences in baseline spending that are not due to either (1) or (2). In Figure 3, the `Non-Dual Beneficiaries' column breaks down the overall spending per non-dual beneficiary, $5,000, into a baseline spending of $4,600 plus the effects of the higher spending for the 10 percent of non-dual beneficiaries with low health literacy ($300) and the 5 percent with high ED use ($100). The `Dual Beneficiaries' column similarly decomposes the overall spending per dual beneficiary ($6,000) into a baseline spending of $5,000, plus the amounts due to dual beneficiaries' 20 percent prevalence of low health literacy ($600, twice as large as the figure for non-dual beneficiaries because the prevalence is twice as high), and dual beneficiaries' 10 percent prevalence of high-volume ED use ($200, similarly twice as high as for non-duals beneficiaries due to higher prevalence).

This column also includes an additional $100 per risk factor because dual beneficiaries experience a higher cost than non-dual beneficiaries within the low health literacy risk factor, and similarly within the high ED use risk factor. Based on this information, an IPF can determine that the overall $1,000 disparity can be divided into differences simply due to risk factor prevalence ($300 + $100 = $400 or 40 percent of the total disparity), disparities in costs for beneficiaries with risk factors ($100 + $100 = $200 or 20 percent) and disparities that remain unexplained (differences in baseline costs. $400 or 40 percent).

In particular, the IPF can see that simply having more patients with low Start Printed Page 46869 health literacy and high ED use accounts for a disparity of $400. In addition, there is still a $200 disparity stemming from differences in costs between non-dual and dual patients for a given risk factor, and another $400 that is not explained by either low health literacy or high ED use. These differences may instead be explained by other SDOH that have not yet been included in this breakdown, or by the distinctive pattern of care decisions made by providers for dual and non-dual beneficiaries.

These cost estimates will provide additional information that facilities could use when determining where to devote resources aimed at achieving equitable health outcomes (for example, facilities may choose to focus efforts on the largest drivers of a disparity). Start Printed Page 46870 b. Measures Related to Health Equity Beyond identifying disparities in individual health outcomes and by individual risk factors, there is interest in developing more comprehensive measures of health equity that reflect organizational performance.

When determining which equity measures could be prioritized for development for the IPFQRP Program, CMS may consider the following. Measures should be actionable in terms of quality improvement. Measures should help beneficiaries and their caregivers make informed healthcare decisions.

Measures should not create incentives to lower the quality of care. And Measures should adhere to high scientific acceptability standards. CMS has developed measures assessing health equity, or designed to promote health equity, in other settings outside of the IPF.

As a result, there may be measures that could be adapted for use in the IPFQR Program. The remainder of this section discusses two such measures, beginning with the Health Equity Summary Score (HESS), and then a structural measure assessing the degree of hospital leadership engagement in health equity performance data. (1) Health Equity Summary Score The HESS measure was developed by the CMS OMHâ[] to identify and to reward healthcare providers (that is, Medicare Advantage [MA] plans) that perform relatively well on measures of care provided to beneficiaries with social risk factors (SRFs), as well as to discourage the non-treatment of patients who are potentially high-risk, in the context of value-based purchasing.

Additionally, a version of the HESS is under consideration for the Hospital Inpatient Quality Reporting (HIQR) program.[] The HESS composite measure provides a summary of equity of care delivery by combining performance and improvement across multiple measures and multiple at-risk groups. The HESS was developed with the following goals. Allow for âmultiple grouping variables, not all of which will be measurable for all plans,â allow for âdisaggregation by grouping variable for nuanced insights,â and allow for the future usage of additional and different SRFs for grouping.[] The HESS computes across-provider disparity in performance, as well as within-provider and across-provider disparity improvement in performance.

Calculation starts with a cross-sectional score and an overall improvement score for each SRF of race/ethnicity and dual eligibility, for each plan. The overall improvement score is based on two separate improvement metrics. Within-plan improvement and nationally benchmarked improvement.

Within-plan improvement is defined as how that plan improves the care of patients with SRFs relative to higher-performing patients between the baseline period and performance period, and is targeted at eliminating within-plan disparities. Nationally benchmarked improvement is improvement of care for beneficiaries with SRFs served by that MA plan, relative to the improvement of care for similar beneficiaries across all MA plans, and is targeted at improving the overall care of populations with SRFs. Within-plan improvement and nationally benchmarked improvement are then combined into an overall Start Printed Page 46871 improvement score.

Meanwhile, the cross-sectional score measures overall measure performance among beneficiaries with SRFs during the performance period, regardless of improvement. To calculate a provider's overall score, the HESS uses a composite of five clinical quality measures based on HEDIS data and seven MA Consumer Assessment of Healthcare Providers and Systems (CAHPS) patient experience measures. A provider's overall HESS score is calculated once using only CAHPS-based measures and once using only HEDIS-based measures, due to incompatibility between the two data sources.

The HESS uses a composite of these measures to form a cross-sectional score, a nationally benchmarked improvement score, and a within-plan improvement score, one for each SRF. These scores are combined to produce an SRF-specific blended score, which is then combined with the blended score for another SRF to produce the overall HESS. (2) Degree of Hospital Leadership Engagement in Health Equity Performance Data CMS has developed a structural measure for use in acute care hospitals assessing the degree to which hospital leadership is engaged in the collection of health equity performance data, with the motivation that organizational leadership and culture can play an essential role in advancing equity goals.

This structural measure, entitled the Hospital Commitment to Health Equity measure (MUC2021-106) was included on the 2021 CMS List of Measures Under Consideration (MUC List)â[] for acute inpatient hospitals and assesses hospital commitment to health equity using a suite of equity-focused organizational competencies aimed at achieving health equity for racial and ethnic minorities, people with disabilities, sexual and gender minorities, individuals with limited English proficiency, rural populations, religious minorities, and people facing socioeconomic challenges. The measure would include five attestation-based questions, each representing a separate domain of commitment. A hospital would receive a point for each domain where they attest to the corresponding statement (for a total of 5 points).

At a high level, the five domains cover the following areas. (1) strategic plan to reduce health disparities. (2) approach to collecting valid and reliable demographic and SDOH data.

(3) analyses performed to assess disparities. (4) engagement in quality improvement activities;â[] and (5) leadership involvement in activities designed to reduce disparities. The specific questions requested within each domain, as well as the detailed measure specification are found in the CMS MUC List for December 2021 at https://www.cms.gov/âfiles/âdocument/âmeasures-under-consideration-list-2021-report.pdf.

A hospital could receive a point for each domain where data are submitted through a CMS portal to reflect actions taken by the hospital for each corresponding domain (for a point total). If we were to consider this measure for the IPFQR Program, we would include it for this program on a future MUC list. CMS believes this type of organizational commitment structural measure may complement the health disparities approach described in previous sections, and support IPFs in quality improvement, efficient, effective use of resources, and leveraging available data.

As defined by AHRQ, structural measures aim to âgive consumers a sense of a healthcare provider's capacity, systems, and processes to provide high-quality care.ââ[] We acknowledge that collection of this structural measure may impose administrative and/or reporting requirements for IPFs. We requested feedback from stakeholders on conceptual and measurement priorities for the IPFQR Program to better illuminate organizational commitment to health equity. C.

Solicitation of Public Comment We requested information with the goal to describe key principles and approaches that we will consider when advancing the use of quality measure development and stratification to address healthcare disparities and advance health equity across our programs. We invited general comments on the principles and approaches described previously in this section of the rule, as well as additional thoughts about disparity measurement or stratification guidelines suitable for overarching consideration across CMS' QRP programs. Specifically, we invited comment on.

Identification of Goals and Approaches for Measuring Healthcare Disparities and Using Measure Stratification Across CMS Quality Reporting Programs ++ The use of the within- and between-provider disparity methods in IPFs to present stratified measure results ++ The use of decomposition approaches to explain possible causes of measure performance disparities ++ Alternative methods to identify disparities and the drivers of disparities Guiding Principles for Selecting and Prioritizing Measures for Disparity Reporting ++ Principles to consider for prioritization of health equity measures and measures for disparity reporting, including prioritizing stratification for validated clinical quality measures, those measures with established disparities in care, measures that have adequate sample size and representation among healthcare providers and outcomes, and measures of appropriate access and care. Principles for Social Risk Factor and Demographic Data Selection and Use ++ Principles to be considered for the selection of social risk factors and demographic data for use in collecting disparity data including the importance of expanding variables used in measure stratification to consider a wide range of social risk factors, demographic variables and other markers of historic disadvantage. In the absence of patient-reported data we will consider use of administrative data, area-based indicators and imputed variables as appropriate Identification of Meaningful Performance Differences ++ Ways that meaningful difference in disparity results should be Start Printed Page 46872 considered.

Guiding Principles for Reporting Disparity Measures ++ Guiding principles for the use and application of the results of disparity measurement. Measures Related to Health Equity ++ The usefulness of a HESS score for IPFs, both in terms of provider actionability to improve health equity, and in terms of whether this information would support Care Compare website users in making informed healthcare decisions. ++ The potential for a structural measure assessing an IPF's commitment to health equity, the specific domains that should be captured, and options for reporting this data in a manner that would minimize burden.

++ Options to collect facility-level information that could be used to support the calculation of a structural measure of health equity. ++ Other options for measures that address health equity. Consistent with what we stated in the proposed rule, we will not be responding to specific comments submitted in response to this RFI in this final rule, we will actively consider all input as we develop future policies that address these issues.

Any updates to specific program requirements related to quality measurement and reporting provisions would be addressed through separate and future notice-and-comment rulemaking, as necessary. Below is a summary of the comments we received in response to this request for information. We received the following comments in response to our request for information.

Comment. Many commenters expressed support for reporting stratified IPF measures, specifically recommending providing these data in confidential reports prior to public reporting. Some commenters described potential benefits of public reporting including improved transparency, increased provider accountability, and use of market forces to drive improvement.

Several commenters provided recommendations for developing a stratified reporting strategy, including focusing on data that cannot be calculated independently by IPFs, providing support to the public in interpreting the data, and analyzing the effects of potential confounders when developing reports. One commenter recommended that IPFs only be compared to other IPFs in between-provider analyses. Some commenters expressed concerns regarding stratified data reporting.

One commenter expressed that publicly reported stratified data could lead to the perception that it is acceptable for some subgroups to experience worse care. This commenter recommended the use of performance benchmarks or national thresholds instead of the between-provider disparity method. Several commenters expressed concern that the burden of collecting data for stratifying the chart-based measure outweighs the potential benefit of stratifying these measures, especially given small numbers of patients in each stratum and high overall performance on the measures.

Some of these commenters specifically stated that IPFs do not have widespread electronic health technology to support this data collection. Several commenters were concerned that there may be unintended consequences of reporting data based on a small sample and recommended that CMS establish a minimum sample size for subgroup reporting. Another commenter recommended using estimates of variability (that is, confidence intervals) when reporting data.

Another commenter observed that while stratification of claims-based measures is less burdensome, this reporting would exclude patients with private insurance coverage and rely on data, which are not self-reported. Some commenters recommended that CMS analyze the predictive power of drivers of health compared to the predictive power of the diagnosis requiring treatment prior to stratifying any measures by drivers of health. Another commenter recommended further analysis of regression decomposition prior to considering this technique in data reporting.

Some commenters expressed that stratification based on dual-eligibility creates bias due to state-level variation in Medicaid eligibility. One commenter recommended stratifying based on eligibility for the low-income subsidy (LIS) instead. One commenter cautioned CMS to ensure patient privacy is safeguarded, especially when reporting on small samples.

Many commenters expressed support for the collection of data (including race, ethnicity, language, and other factors) to support increased reporting of stratified data, though these commenters observed that there are not currently industry standards for most of these data and recommended developing standard terminology prior to proceeding. One commenter expressed that this data collection could improve provider interventions and performance in providing care. Some commenters recommended that CMS partner with other entities such as states and private payors to align data collection requirements.

Some commenters recommended that CMS evaluate use of claims to identify drivers of health, such as by using payment programs to incentive the use of ICD-10 Z Codes. One commenter observed that if CMS were to adopt a patient experience of care measure in this setting the same collection instrument could be used to collect self-reported demographic data. Other commenters supported use of proxy variables, such as indices or other data sets, when self-reported data are unavailable.

Some commenters supported further research into statistical imputation prior to use in stratification. Many commenters expressed concerns about potentially adapting the HESS for this setting. Some commenters observed that an aggregated score may not be actionable for many facilities, with one commenter recommending only reporting such a measure with all its component scores.

One commenter cautioned that in using a composite score a single risk factor could mask the effects of other risk factors. Another commenter stated that HESS scoring may not be practical for many smaller facilities, or facilities whose enrolled populations differ in drivers of health distribution patterns compared to typical MA plans. Several commenters expressed the belief that the measures underlying the HESS (HEDIS and CAHPS) are not applicable for the IPF settings.

Another commenter observed that calculation of a HESS-type measure would require standardized demographic data collection for all patients. One commenter recommended that if CMS were to develop a summary measure for quality reporting programs for settings other than IPFs, it should include behavioral health measures in the composite because socially at-risk groups often experience poor mental health outcomes. Many commenters supported the Degree of Hospital Leadership Engagement in Health Equity Performance Data measure concept.

Some of these commenters recommended that CMS adopt this structural measure before process or outcome measures related to health equity. However, several commenters provided recommendations or expressed concerns about this measure. Several commenters observed that the measure as specified would be difficult for many IPFs to report due to the requirement to use certified electronic health record technology (CEHRT).

One commenter expressed that there is no evidence that performance on this Start Printed Page 46873 measure is associated with improved patient outcomes. One commenter recommended adopting an audit procedure along with this measure. Another commenter recommended adding a different attestation measure on other efforts to gauge hospital data collection efforts (for example, the Leapfrog Hospital Survey).

Many commenters observed that there are measures of patient experience of care for other settings and that having such a measure in the IPF setting would improve public accountability and quality of care. A few commenters stated that a patient experience of care measure is necessary to improve the equity of care provided by IPFs. Several commenters stated that improving health equity would require government investment in addressing social needs, such as reducing financial barriers to access.

One commenter observed that having such an investment would reduce provider frustration with data collection requirements. Several commenters recommended linking payment to equity performance. These commenters specifically recommended the use of incentives to avoid unintended consequences for socially at-risk patients.

One commenter recommended the use of peer grouping (that is, comparing each provider's performance with providers with similar mixes of patients, that is, its âpeers,â to determine rewards or penalties based on performance) within value based purchasing (VBP) programs. Several commenters supported the suggested criteria for prioritizing equity measures and recommended additional criteria including building on existing health equity strategies, balancing administrative burden, allowing flexibility, relying on existing data sources, relying on measures that include self-reported data in the measure structure, providing timely feedback, expanding to include resource use measures, and aligning with states and other payors. Some commenters provided general feedback on the concept of using quality reporting programs to reduce healthcare disparities.

Several commenters observed that quality improvement initiatives are often initiated at the system level and therefore measurement should be at the system level to avoid duplicative reporting requirements. Another commenter expressed the belief that it would be appropriate to update the conditions of participation to address health equity. Other commenters recommended that any effort to use quality reporting to reduce healthcare disparities should include detailed definitions of all variables (for example, health outcomes, hospital leadership).

Response. We appreciate all of the comments and interest in this topic. We believe that this input is very valuable in the continuing development of the CMS health equity quality measurement efforts.

We note that in the FY 2023 IPPS/LTCH PPS proposed rule, we proposed several measures related to health equity for the Hospital Inpatient Quality Reporting (IQR) program. Specifically, we proposed the Hospital Commitment to Health Equity measure (87 FR 28492 through 28497) and two social drivers of health measures (87 FR 28497 through 28506). And we may consider these or similar measures for other quality reporting programs, such as the IPFQR Program in the future.

Additionally, we refer readers to the FY 2022 IPF PPS final rule in which we described our initial request for information on the concept of an equity summary score for the IPF setting and summarized the input we received (86 FR 42625 through 42632). We will continue to take all concerns, comments, and suggestions into account for future development and expansion of our health equity quality measurement efforts. If we determine that a measure, including a patient experience of care measure, a health equity measure, or any other measure is appropriate for the IPFQR program we will follow the pre-rulemaking process as described on our website ( https://www.cms.gov/âMedicare/âQuality-Initiatives-Patient-Assessment-Instruments/âQualityMeasures/âPre-Rulemaking).

For more information on our ongoing effort to address health equity, we refer readers to our recently released updated CMS Quality Strategy ( https://www.cms.gov/âMedicare/âQuality-Initiatives-Patient-Assessment-Instruments/âValue-Based-Programs/âCMS-Quality-Strategy) and our Framework for Health Equity ( https://www.cms.gov/âAbout-CMS/âAgency-Information/âOMH/âequity-initiatives/âframework-for-health-equity) in which we describe our five priorities for advancing health equity. VII. Collection of Information Requirements This final rule updates the prospective payment rates, outlier threshold, and wage index for Medicare inpatient hospital services provided by IPFs.

It also establishes a permanent mitigation policy for providers negatively affected by changes to the IPF PPS wage index. While discussed in section IV (Comment Solicitation on Analysis of IPF PPS Adjustments) of this preamble, the active requirements and burden associated with our hospital cost report form CMS-2552-10 (OMB control number 0938-0050) are unaffected by this rule. Therefore, this document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements.

Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). VIII.

Regulatory Impact Analysis A. Statement of Need This rule finalizes updates to the prospective payment rates for Medicare inpatient hospital services provided by IPFs for discharges occurring during FY 2023 (October 1, 2022 through September 30, 2023). We are finalizing our proposal to apply the 2016-based IPF market basket increase of 4.1 percent, less the productivity adjustment of 0.3 percentage point as required by section 1886(s)(2)(A)(i) of the Act for a total FY 2023 payment rate update of 3.8 percent.

In this final rule, we are finalizing our proposal to update the outlier fixed dollar loss threshold amount, update the IPF labor-related share, and update the IPF wage index to reflect the FY 2023 hospital inpatient wage index. Lastly, for FY 2023 and subsequent years, we will apply a 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, regardless of the circumstances causing the decline. B.

Overall Impact We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995.

Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C.

804(2)) Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and Start Printed Page 46874 equity). Section 3(f) of Executive Order 12866 defines a âsignificant regulatory actionâ as an action that is likely to result in a rule. (1) having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as âeconomically significantâ).

A regulatory impact analysis (RIA) must be prepared for major rules with significant regulatory action/s and/or with economically significant effects ($100 million or more in any 1 year). We estimate that the total impact of these changes for FY 2023 payments compared to FY 2022 payments will be a net increase of approximately $90 million. This reflects a $130 million increase from the update to the payment rates (+$140 million from the second quarter 2022 IGI forecast of the 2016-based IPF market basket of 4.1 percent, and â$10 million for the productivity adjustment of 0.3 percentage point), as well as a $40 million decrease as a result of the update to the outlier threshold amount.

Outlier payments are estimated to change from 3.2 percent in FY 2022 to 2.0 percent of total estimated IPF payments in FY 2023. Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined this rulemaking is âeconomically significantâ as measured by the $100 million threshold, and hence also a âmajorâ rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act). Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking.

Therefore, OMB has reviewed these final regulations, and the Departments have provided the following assessment of their impact. C. Detailed Economic Analysis In this section, we discuss the historical background of the IPF PPS and the impact of this final rule on the Federal Medicare budget and on IPFs.

1. Budgetary Impact As discussed in the November 2004 and RY 2007 IPF PPS final rules, we applied a budget neutrality factor to the Federal per diem base rate and ECT payment per treatment to ensure that total estimated payments under the IPF PPS in the implementation period would equal the amount that would have been paid if the IPF PPS had not been implemented. This budget neutrality factor included the following components.

Outlier adjustment, stop-loss adjustment, and the behavioral offset. As discussed in the RY 2009 IPF PPS notice (73 FR 25711), the stop-loss adjustment is no longer applicable under the IPF PPS. As discussed in section IV.D.1 of this final rule, we are updating the wage index and labor-related share, as well as applying the 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, in a budget neutral manner, by applying a wage index budget neutrality factor to the Federal per diem base rate and ECT payment per treatment.

Therefore, the budgetary impact to the Medicare program of this final rule will be due to the market basket update for FY 2023 of 4.1 percent (see section IV.A.2 of this final rule) less the productivity adjustment of 0.3 percentage point required by section 1886(s)(2)(A)(i) of the Act and the update to the outlier fixed dollar loss threshold amount. We estimate that the FY 2023 impact will be a net increase of $90 million in payments to IPF providers. This reflects an estimated $130 million increase from the update to the payment rates and a $40 million decrease due to the update to the outlier threshold amount to set total estimated outlier payments at 2.0 percent of total estimated payments in FY 2023.

This estimate does not include the implementation of the required 2.0 percentage point reduction of the productivity-adjusted market basket update factor for any IPF that fails to meet the IPF quality reporting requirements (as discussed in section IV.B.2. Of this final rule). 2.

Impact on Providers To show the impact on providers of the changes to the IPF PPS discussed in this final rule, we compare estimated payments under the IPF PPS rates and factors for FY 2023 versus those under FY 2022. We determined the percent change in the estimated FY 2023 IPF PPS payments compared to the estimated FY 2022 IPF PPS payments for each category of IPFs. In addition, for each category of IPFs, we have included the estimated percent change in payments resulting from the update to the outlier fixed dollar loss threshold amount.

The updated wage index data including the labor-related share and the 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year. And the market basket update for FY 2023, as reduced by the productivity adjustment according to section 1886(s)(2)(A)(i) of the Act. To illustrate the impacts of the FY 2023 changes in this final rule, our analysis begins with FY 2021 IPF PPS claims (based on the 2021 MedPAR claims, March 2022 update).

As discussed in section IV.E.2 of this final rule, we are excluding providers from our impact simulations whose change in estimated cost per day is outside 3 standard deviations from the mean. We estimate FY 2022 IPF PPS payments using these 2021 claims, the finalized FY 2022 IPF PPS Federal per diem base rates, and the finalized FY 2022 IPF PPS patient and facility level adjustment factors (as published in the FY 2022 IPF PPS final rule (86 FR 42608)). We then estimate the FY 2022 outlier payments based on these simulated FY 2022 IPF PPS payments using the same methodology as finalized in the FY 2022 IPF PPS final rule (86 FR 42623 through 42624) where total outlier payments are maintained at 2 percent of total estimated FY 2022 IPF PPS payments.

Each of the following changes is added incrementally to this baseline model in order to isolate the effects of each change. The final update to the outlier fixed dollar loss threshold amount. The final FY 2023 IPF wage index, the 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, and the FY 2023 labor-related share.

The final market basket update for FY 2023 of 4.1 percent less the productivity adjustment of 0.3 percentage point in accordance with section 1886(s)(2)(A)(i) of the Act for a payment rate update of 3.8 percent. Our column comparison in Table 3 illustrates the percent change in payments from FY 2022 (that is, October 1, 2021, to September 30, 2022) to FY 2023 (that is, October 1, 2022, to September 30, 2023) including all the payment policy changes. Start Printed Page 46875 Start Printed Page 46876 3.

Impact Results Table 3 displays the results of our analysis. The table groups IPFs into the categories listed here based on characteristics provided in the Provider of Services file, the IPF PSF, and cost report data from the Healthcare Cost Report Information System. Facility Type.

Location. Teaching Status Adjustment. Census Region.

Size. The top row of the table shows the overall impact on the 1,417 IPFs included in the analysis. In column 2, we present the number of facilities of each type that had information available in the PSF, had claims in the MedPAR dataset for FY 2021, and were not excluded due to the trim on providers whose change in estimated cost per day is outside 3 standard deviations from the mean.

In column 3, we present the effects of the update to the outlier fixed dollar loss threshold amount. We estimate that IPF outlier payments as a percentage of total IPF payments are 3.2 percent in FY 2022. Therefore, we adjusted the outlier threshold amount to set total estimated outlier payments equal to 2.0 percent of total payments in FY 2023.

The estimated change in total IPF payments for FY 2023, therefore, includes an approximate 1.2 percent decrease in payments because we expect the outlier portion of total payments to decrease from approximately 3.2 percent to 2.0 percent. The overall impact of the estimated decrease to payments due to updating the outlier fixed dollar loss threshold (as shown in column 3 of Table 3), across all hospital groups, is a 1.2 percent decrease. The largest decrease in payments due to this change is estimated to be 3.4 percent for teaching IPFs with 10 percent to 30 percent interns and residents to beds.

In column 4, we present the effects of the budget-neutral update to the IPF wage index, the labor-related share (LRS), and the 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year discussed in section IV.D.2 of this final rule. This represents the effect of using the concurrent hospital wage data as discussed in section IV.D.1.a of this final rule. That is, the impact represented in this column reflects the update from the FY 2022 IPF wage index to the FY 2023 IPF wage index, which includes basing the FY 2023 IPF wage index on the FY 2023 pre-floor, pre-reclassified IPPS hospital wage index data, applying a 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, and updating the LRS from 77.2 percent in FY 2022 to 77.4 percent in FY 2023.

We note that there is no projected change in aggregate payments to IPFs, as indicated in the first row of column 4. However, there are distributional effects among different categories of IPFs. For example, we estimate the largest increase in payments to be 0.8 percent for Pacific IPFs, and the largest decrease in payments to be 0.5 percent for New England IPFs.

Overall, IPFs are estimated to experience a net increase in payments of 2.5 percent as a result of the updates in this final rule. IPF payments are therefore estimated to increase by 2.5 percent in urban areas and 2.9 percent in rural areas. The largest payment increases are estimated at 3.7 percent for freestanding urban for-profit IPFs, IPFs located in the West South Central region, and IPF hospitals with 25 to 49 beds.

4. Effect on Beneficiaries Under the FY 2023 IPF PPS, IPFs will continue to receive payment based on the average resources consumed by patients for each day. Our longstanding payment methodology reflects the differences in patient resource use and costs among IPFs, as required under section 124 of the BBRA.

We expect that updating IPF PPS rates in this final rule will improve or maintain beneficiary access to high quality care by ensuring that payment rates reflect the best available data on the resources involved in inpatient psychiatric care and the costs of these resources. We continue to expect that paying prospectively for IPF services under the FY 2023 IPF PPS will enhance the efficiency of the Medicare program. 5.

Regulatory Review Costs If regulations impose administrative costs on private entities, such as the time needed to read and interpret this Start Printed Page 46877 final rule, we estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will be directly impacted and will review this final rule, we assume that the total number of unique commenters on the most recent IPF proposed rule will be the number of reviewers of this final rule. For the FY 2023 IPF PPS final rule, the most recent IPF proposed rule was the FY 2023 IPF PPS proposed rule, and we received 396 unique comments on this proposed rule.

We believe that the number of past commenters on the most recent IPF proposed rule would be a fair estimate of the number of reviewers of this final rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this final rule. It is possible that not all commenters reviewed the FY 2023 IPF PPS proposed rule in detail, and it is also possible that some reviewers chose not to comment on that proposed rule.

We solicited comments on this assumption and did not receive any comments on it. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of the proposed rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. Using the May 2021 mean (average) wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this final rule is $115.22 per hour, including fringe benefits and other indirect costs ( https://www.bls.gov/âoes/âcurrent/âoes119111).

Assuming an average reading speed of 250 words per minute, we estimate that it would take approximately 64 minutes (1.07 hours) for the staff to review half of this final rule, which contains a total of approximately 32,000 words. For each IPF that reviews the final rule, the estimated cost is $123.29 (1.07 Ã $115.22). Therefore, we estimate that the total cost of reviewing this final rule is $48,822.84 ($123.29 Ã 396 reviewers).

D. Alternatives Considered The statute does not specify an update strategy for the IPF PPS and is broadly written to give the Secretary discretion in establishing an update methodology. We continue to believe it is appropriate to routinely update the IPF PPS so that it reflects the best available data about differences in patient resource use and costs among IPFs as required by the statute.

Therefore, we are finalizing our proposal to update the IPF PPS using the methodology published in the November 2004 IPF PPS final rule. Applying the 2016-based IPF PPS market basket update for FY 2023 of 4.1 percent, reduced by the statutorily required productivity adjustment of 0.3 percentage point along with the wage index budget neutrality adjustment to update the payment rates. And finalizing a FY 2023 IPF wage index which uses the FY 2023 pre-floor, pre-reclassified IPPS hospital wage index as its basis.

Additionally, we are applying a 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year. Lastly, we are excluding providers from our simulation of IPF PPS payments for FY 2022 and FY 2023 if their change in estimated cost per day is outside 3 standard deviations from the mean. E.

Accounting Statement As required by OMB Circular A-4 (available at https://www.whitehouse.gov/âwp-content/âuploads/âlegacy_âdrupal_âfiles/âomb/âcirculars/âA4/âa-4.pdf), in Table 4, we have prepared an accounting statement showing the classification of the expenditures associated with the updates to the IPF wage index and payment rates in this final rule. Table 4 provides our best estimate of the increase in Medicare payments under the IPF PPS as a result of the changes presented in this final rule and based on the data for 1,417 IPFs with data available in the PSF, with claims in our FY 2021 MedPAR claims dataset, and which were not excluded due to the trim on providers whose change in estimated cost per day is outside 3 standard deviations from the mean. Lastly, Table 4 also includes our best estimate of the costs of reviewing and understanding this final rule.

F. Regulatory Flexibility Act The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions.

Most IPFs and most other providers and suppliers are small entities, either by nonprofit status or having revenues of $8 million to $41.5 million or less in any 1 year. Individuals and states are not included in the definition of a small entity. Because we lack data on individual hospital receipts, we cannot determine the number of small proprietary IPFs or the proportion of IPFs' revenue derived from Medicare payments.

Therefore, we assume that all IPFs are considered small entities. The Department of Health and Human Services generally uses a revenue impact of 3 to 5 percent as a significance threshold under the RFA. As shown in Table 3, we estimate that the overall revenue impact of this final rule on all IPFs is to increase estimated Medicare payments by approximately 2.5 percent.

As a result, the estimated impact of this final rule is a net increase in revenue across almost all categories of IPFs. Therefore, the Secretary has determined that this final rule will have a positive revenue impact on a substantial number of small entities. In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals.

This analysis Start Printed Page 46878 must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. As discussed in section VIII.C.2 of this final rule, the rates and policies set forth in this rule will not have an adverse impact on the rural hospitals based on the data of the 210 rural excluded psychiatric units and 57 rural psychiatric hospitals in our database of 1,417 IPFs for which data were available.

Therefore, the Secretary has certified that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals. G. Unfunded Mandates Reform Act (UMRA) Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation.

In 2022, that threshold is approximately $165 million. This final rule does not mandate any requirements for state, local, or tribal governments, or for the private sector. This final rule will not impose a mandate that will result in the expenditure by state, local, and Tribal Governments, in the aggregate, or by the private sector, of more than $165 million in any 1 year.

H. Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. This final rule does not impose substantial direct costs on state or local governments or preempt state law.

This final regulation is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.) and has been transmitted to the Congress and the Comptroller General for review. Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &.

Medicaid Services, approved this document on July 25, 2022. Start List of Subjects Administrative practice and procedureHealth facilitiesMedicarePuerto RicoReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services amends 42 CFR part 412 as set forth below.

Start Part End Part Start Amendment Part1. The authority citation for part 412 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

1302 and 1395hh. End Authority Start Amendment Part2. Section 412.424 is amended by revising paragraph (d)(1)(i) to read as follows.

End Amendment Part Methodology for calculating the Federal per diem payment amount. * * * * * (d) * * * (1) * * * (i) Adjustment for wages. CMS adjusts the labor portion of the Federal per diem base rate to account for geographic differences in the area wage levels using an appropriate wage index.

(A) The application of the wage index is made on the basis of the location of the inpatient psychiatric facility in an urban or rural area as defined in Â§â412.402. (B) Beginning October 1, 2022, CMS applies a cap on decreases to the wage index, such that the wage index applied to an inpatient psychiatric facility is not less than 95 percent of the wage index applied to that inpatient psychiatric facility in the prior fiscal year. * * * * * Start Signature Dated.

July 25, 2022. Xavier Becerra, Secretary, Department of Health and Human Services. End Signature End Supplemental Information.

Start Preamble Start where to buy ventolin online Printed Page 46846 Centers for Medicare &. Medicaid Services (CMS), Department of Health and Human Services (HHS). Final rule where to buy ventolin online.

This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This final rule establishes a permanent mitigation policy to smooth the impact of year-to-year changes in IPF payments related to decreases in the IPF wage index. In addition, this final rule includes responses to where to buy ventolin online public comments received on the results of the data analysis of the IPF Prospective Payment System (PPS) adjustments.

These changes will be effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2022, through September 30, 2023 (FY 2023). Lastly, this final rule includes public comments where to buy ventolin online received in response to requests for information that appeared in the FY 2023 IPF PPS proposed rule. Effective October 1, 2022.

Start Further Info The IPF Payment Policy mailbox at [email protected] for general information. Mollie Knight (410) 786-7948 or Eric where to buy ventolin online Laib (410) 786-9759, for information regarding the market basket update or the labor-related share. Nick Brock (410) 786-5148 or Theresa Bean (410) 786-2287, for information regarding the regulatory impact analysis.

Lauren Lowenstein (410) 786-4507, for information regarding where to buy ventolin online the inpatient psychiatric facilities quality reporting program. End Further Info End Preamble Start Supplemental Information Availability of Certain Tables Exclusively Through the Internet on the CMS Website Addendum A to this final rule summarizes the FY 2023 IPF PPS payment rates, outlier threshold, cost of living adjustment factors (COLA) for Alaska and Hawaii, national and upper limit cost-to-charge ratios, and adjustment factors. In addition, the B Addenda to this final rule shows the complete listing of ICD-10 Clinical Modification (CM) and Procedure Coding System (PCS) codes, the FY 2023 IPF PPS comorbidity adjustment, and electroconvulsive therapy (ECT) procedure codes.

The A and B Addenda are available where to buy ventolin online online at. Https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âInpatientPsychFacilPPS/âtools.html. Tables setting forth the FY 2023 Wage Index for Urban Areas Based on Core-Based Statistical where to buy ventolin online Area (CBSA) Labor Market Areas and the FY 2023 Wage Index Based on CBSA Labor Market Areas for Rural Areas are available exclusively through the internet, on the CMS website at https://www.cms.gov/âMedicare/âMedicare-Fee-for-Service-Payment/âIPFPPS/âWageIndex.html.

I. Executive Summary A. Purpose This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs) where to buy ventolin online for discharges occurring during Fiscal Year (FY) 2023 beginning October 1, 2022 through September 30, 2023.

B. Summary of the Major where to buy ventolin online Provisions 1. Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) For the IPF PPS, we are finalizing our proposal toâ Establish a permanent mitigation policy in order to smooth the impact of year-to-year changes in IPF payments related to decreases to the IPF wage index.

Adjust the 2016-based IPF market basket update (4.1 percent) for economy-wide productivity (0.3 percentage point) as required by section 1886(s)(2)(A)(i) of the Social Security Act (the Act), resulting in a final IPF payment rate update of 3.8 percent for FY 2023. â¢ where to buy ventolin online Make technical rate setting changes. The IPF PPS payment rates will be adjusted annually for inflation, as well as statutory and other policy factors.

This final where to buy ventolin online rule updates. ++ The IPF PPS Federal per diem base rate from $832.94 to $865.63. ++ The IPF PPS Federal per diem base rate for providers who failed to report quality data to $848.95.

++ The ECT payment per where to buy ventolin online treatment from $358.60 to $372.67. ++ The ECT payment per treatment for providers who failed to report quality data to $365.49. ++ The labor-related share from 77.2 percent where to buy ventolin online to 77.4 percent.