2023-07115.pdf

prior to applying the clustering methodology to determine the cut points. The combination of mean resampling (implemented with the 2022 Star Ratings and described at  422.166(a)(2)(i) and 423.186(a)(2)(i)) and Tukey outlier deletion will alleviate the impact of any extreme outliers. Thus, if a contract is impacted by an extreme and uncontrollable circumstance and as a result has a significantly lower score on a measure, the score will be removed if it is an extreme outlier. Removing extreme outliers will eliminate the concern that other contracts are inappropriately impacted by changes in scores for contracts impacted by disasters. By removing the 60 percent rule, we will also simplify the Star Ratings calculations and continue to allow measure-level Star Ratings to be calculated if all or most contracts qualify for an extreme or uncontrollable circumstance in the future. We proposed to amend  422.166(i)(9)(i), 422.166(i)(10)(i), 423.186(i)(7)(i), and 423.186(i)(8)(i) to remove the 60 percent rule beginning with the 2026 Star Ratings for non- CAHPS measures, including the HOS measures, even though the measurement period is slightly different for these measures. We solicited comments on this proposal. Comment: Most commenters supported the removal of the 60 percent rule. Response: CMS appreciates the support. Comment: A commenter recommended delaying implementation of the 60 percent rule until Tukey outlier deletion is implemented. Response: Starting with the 2024 Star Ratings, CMS will be including Tukey outlier deletion. Removing the 60 percent rule will begin with the 2026 Star Ratings. See section V.H. later in this rule for a discussion of the codification of the Tukey outlier deletion provision. Comment: A commenter was concerned that enrollees in affected contracts would be impacted by this change. Response: The removal of the 60 percent rule will only impact which contracts are included when we calculate the measure-level cut points. It will not impact which contracts receive the extreme and uncontrollable circumstances adjustment. For MA plans,  422.100(m) addresses special requirements for when a disaster or emergency is declared as described in  422.100(m)(2) and there is a disruption of access to health care as described in  422.100(m)(6). The changes in the Star Ratings extreme and uncontrollable circumstances adjustment will not change application of  422.100(m) and the beneficiary protections required under that regulation. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the revision at  422.166(i)(9)(i), 422.166(i)(10)(i), 423.186(i)(7)(i), and 423.186(i)(8)(i) to remove the 60 percent rule beginning with the 2026 Star Ratings for non- CAHPS measures as proposed without modification. 2. Health Outcomes Survey (HOS) Measures We adopted regulations for how Star Ratings would be calculated in the event of extreme and uncontrollable circumstances in the April 2019 final rule. We explained in the April 2019 final rule (CMS4185F) that for most measures, the extreme and uncontrollable circumstance adjustment applies for disasters from 2 years prior to the Star Ratings year (that is, a disaster that begins168during the 2020 measurement period results in a disaster adjustment for the 2022 Star Ratings). For Part C measures derived from HOS, the disaster adjustment is delayed an additional year due to the timing of the survey and 1-year recall period. That is, for measures derived from the HOS, the disaster policy adjustment is for 3 years after the extreme and uncontrollable circumstance. For example, we noted at 84 FR 1577215773 that the 2023 Star Ratings would adjust measures derived from the HOS for 2020 extreme and uncontrollable circumstances. We proposed to clarify in  422.166(i)(3)(iv) the timing for HOS measure adjustments for extreme and uncontrollable circumstances. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00176 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222295 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 169See the Announcement of Calendar Year (CY) 2022 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, page 97, which delayed the return of the Plan All-Cause Readmissions measure to the Star Ratings for an additional year due to the disruption to data collection posed by the COVID19 pandemic. We solicited comments on this proposal. Comment: All commenters supported our proposal to clarify the timing for HOS disaster adjustments. Response: CMS appreciates the support for clarifying the timing of the HOS measure adjustments for extreme and uncontrollable circumstances at  422.166(i)(3)(iv). Comment: A commenter suggested that CMS provide additional clarification on the recall period for HOS measures and the hold harmless timing for the adjustment for extreme and uncontrollable circumstances. Response: The measurement period or recall period is defined by the measure steward. NCQA is the measure steward for the three HEDISHOS measures derived from the HOS. As noted by the title of NCQAs technical manual for the 2021 HOS data collection, HEDIS MY 2020 Volume 6: Specifications for the Medicare Health Outcomes Survey, the measurement period is one year prior to data collection. Since 2020, HOS survey administration occurs in late summer through fall. HOS is currently fielded from late July through early November. For Part C measures derived from HOS, the disaster adjustment is three years after the extreme and uncontrollable circumstance. That is, contracts affected by an extreme and uncontrollable circumstance in the year prior to data collection are essentially held harmless and receive the higher of the previous or current years Star Rating for each HOS and HEDISHOS measure (and corresponding measure score) for the Star Ratings 3 years after the eligible extreme and uncontrollable circumstance. For example, contracts affected by an extreme and uncontrollable circumstance in 2021 will receive the higher of their 2023 or 2024 measure-level Star Rating (and corresponding measure score) for each HOS and HEDISHOS measure in the 2024 Star Ratings as described at  422.166(i)(3)(iv). After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the clarification at  422.166(i)(3)(iv) as proposed without modification. H. Calculation of Star Ratings ( 422.166(a)(2)(i) and 423.186(a)(2)(i)) In the June 2020 final rule, we finalized use of Tukey outlier deletion effective for the Star Ratings issued in October 2023 and subsequent years. (85 FR 3383336). In the rulemakings since that time, we have not proposed to eliminate the Tukey outlier deletion aspect of the Star Ratings methodology. In a final rule that appeared in the Federal Register on January 19, 2021, we noted how the Tukey outlier deletion provision had been adopted for the Part C and Part D Quality Star Ratings. (86 FR 5917). As we stated in May 2022 final rule (87 FR 27766), we will implement Tukey outlier deletion beginning with the 2024 Star Ratings to help improve stability of cut points and prevent cut points from being influenced by outliers. We further stated that with Tukey outlier deletion, extreme outliers will be removed from measure scores prior to clustering to prevent outliers from impacting cut points for all contracts. However, it appears that the sentence in  422.166(a)(2)(i) and 423.186(a)(2)(i) (Effective for the Star Ratings issued in October 2023 and subsequent years, prior to applying mean resampling with hierarchal clustering, Tukey outer fence outliers are removed.) was inadvertently removed from the codified regulation text. At no point did CMS propose removal of the Tukey outlier provision and CMS has, since its adoption in the June 2020 final rule, discussed implementation and application of the Tukey outlier provision when applicable. We proposed a technical amendment to fix this codification error from the May 2022 final rule. In addition, although the provision regarding application of the Tukey outlier deletion policy was originally at the end of paragraph (a)(2)(i) in each regulation, we also proposed a non-substantive technical change to move the sentence about removal of Tukey outer fence outliers earlier in  422.166(a)(2)(i) and 423.186(a)(2)(i) since Tukey outlier deletion is applied prior to the other steps. We believe that this makes the regulation text clearer. We solicited comments on this proposal. Comment: Some commenters were concerned that Tukey outlier deletion would result in disproportionate losses of QBPs among DSNPs. They cite an analysis performed by ZAHealth that found that the outlier policy would result in 14 percent of DSNP contracts losing their QBPs compared to 7 percent of non-DSNPs, and 27 percent of D SNPs losing rebate dollars compared to 20 percent of non-DSNPs. Response: We are unable to replicate the findings of ZAHealth. Based on our simulations, we do not believe that contracts with DSNPs will be disproportionately impacted by Tukey outlier deletion. Using the 2023 Star Ratings data, we examined the impact of introducing Tukey outlier deletion assuming no guardrails. In the simulation, approximately 8.2 percent of contracts with DSNPs and 9.5 percent of contracts without DSNPs would lose a QBP by their overall rating decreasing from 4 to 3.5 stars overall with Tukey outlier deletion compared to without Tukey outlier deletion. The percentage of contracts losing a QBP is slightly higher for non-DSNP contracts. In the simulation, 13.6 percent of contracts with DSNPs would have a decrease in rebates or lose rebates compared to 10.5 percent of contracts without DSNPs, a very small difference. Comment: A commenter stated that CMS should withdraw its proposed Tukey outlier deletion for the 2024 Star Ratings as it will create new hurdles for plans that are trying to improve their ratings. Another commenter supported Tukey outlier deletion but raised challenges in the industry implementing multiple changes in the Star Ratings over the next few years, while another commenter suggested CMS delay implementation. Response: Tukey outlier deletion is the only methodological enhancement to the 2024 Star Ratings. The only other changes for the 2024 Star Ratings are the addition of two new measures, Transitions of Care and Follow-up after Emergency Department Visit for Patients with Multiple Chronic Conditions measures, to the Part C Star Ratings that have been on the display page since the 2020 Star Ratings (2018 measurement year) finalized in the January 2021 final rule (86 FR 592126) and the return of the updated Plan All-Cause Readmissions measure finalized in the April 2019 final rule,169a measure that has been included in the Star Ratings program since the 2012 Star Ratings. CMS finalized the application of Tukey outlier deletion for non-CAHPS measures beginning with the 2024 Star Ratings in the CY 2021 final rule published in June 2020 so this is not a new enhancement and contracts have been on notice of this upcoming change. For the 2025 Star Ratings, there are no additional measures or methodological enhancements. The primary goal of setting cut points is to disaggregate the distribution of scores into discrete categories such that each grouping accurately reflects true performance. (85 FR 15752). Tukey outlier deletion supports this goal by helping stabilize VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00177 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222296 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 170See COVID19 interim final rule (IFC) (CMS 1744IFC) issued on March 31, 2020. measure-level cut points since they will not be influenced by one or more contracts with outlier scores. Tukey outlier deletion does not change what contracts need to do to improve. Interested parties have requested that CMS minimize changes in cut points from year to year; the implementation of Tukey outlier deletion supports this goal, so we do not believe that the implementation of Tukey outlier deletion needs to be delayed. Comment: A commenter stated that an agency must use the same procedures when they amend or repeal a rule as they used to issue the rule. Additionally, this commenter noted that CMS cannot make a change in the substantive rules that apply to Star Ratings without undertaking rulemaking and cannot rely on the Regulatory Impact Analysis used in 2020, given that other policies related to the mechanism for calculating the Star Ratings continue to evolve. Response: CMS proposed and provided public notice and an opportunity to comment on revising  422.166(a)(2)(i) and 423.186(a)(2)(i) to include the Tukey outlier deletion provision that was inadvertently removed from the regulation text in a May 2022 final rule.