2023-07115.pdf

measures. The two-star level shifts were primarily upwards, but one contract did shift down two stars in the Medication Adherence for Cholesterol (Stains) measure. For the Medication Adherence for Diabetes Medication measure, 82 percent of MAPD contracts and 59 percent of PDP contracts retained the same star level. When a star level shift was observed for the Medication Adherence for Diabetes Medication measure, most MAPD and PDP contracts saw a one-star downward movement with the SDS risk adjustment applied to the measure. As previously noted, if CMS implements SDS risk adjustment for the three medication adherence measures, the measures would no longer be included in determining the Star Ratings CAI. Therefore, we also conducted an analysis to simulate calculating the CAI values without case- mix adjusting the three adherence measures for LIS/DE and disability; these simulated CAI values were used in the application of the simulated summary rating calculations. For most MAPD contracts, this resulted in a negative shift in the CAI adjustment values for the overall and Part D summary ratings, and in contrast, most PDPs had a positive shift in values. Additionally, the analysis found a minimal change in reward factor thresholds, ranging from 0.07 to +0.02 for mean percentile thresholds and 0.08 to +0.008 for variance percentile thresholds. In the analysis of the overall and Part D summary rating, 91 percent of MAPD contracts retained the same overall rating, 7 percent decreased by half a star, and 2 percent increased by half a star. We found that 81 percent of MAPD contracts retained the same Part D summary rating, 11 percent decreased by half a star, and 7 percent increased by half a star. The impact on PDP contracts was neutral or positive; 63 percent of PDP contracts retained the same Part D summary rating star level while 37 percent increased by a half a star. No PDP contracts had a decrease in their Part D summary rating. The Part C and Part D improvement measures were not recalculated for this simulation. The final 2021 Star Ratings for both improvement measures were used for the summary rating recalculations in the simulations to illustrate the impact of this proposed change to the three medication adherence measures. Additionally, the final 2020 Star Ratings for both improvement measures and for the three adherence measures were used for the CAI value recalculations in the simulations. It is possible that the simulated differences could vary if or when we are able to have two consecutive years of adjusted data for recalculating these components. Per  423.184(d)(2), the change to implement SDS risk adjustment for the three Part D medication adherence measures would be a substantive update. We signaled this potential update and solicited initial feedback on incorporating the SDS risk adjustment in the Advance Notice and Announcement of Calendar Year (CY) 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies. A majority of the comments submitted in response to the CY 2023 Advance Notice supported SDS risk adjustment for the medication adherence measures. Some of those comments also requested information on how the CAI will be affected by this update. We completed testing of the impact of the adjustment and are including the additional information about the simulations in this final rule, as summarized previously. If finalized, the legacy VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00148 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222267 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations medication adherence measures would remain in the Star Ratings and the updated medication adherence measures with the SDS risk adjustment would be on the display page for at least 2 years (beginning with the 2024 measurement year for the 2026 display page). Beginning with the 2026 measurement year and 2028 Star Ratings, CMS would then move the re- specified measures from display page to Star Ratings and the legacy measures would be removed under this proposal. In addition, to provide a more complete explanation of the changes in the specifications to the three medication adherence measures, the December 2022 proposed rule included a summary of non-substantive updates to the medication adherence measures. As noted in the proposed rule and in the Advance Notice of Methodological Changes for Calendar Year (CY) 2024 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, our intent was to implement the non-substantive changes regardless of whether we ultimately finalized changes to add risk adjustment for SDS factors to the three medication adherence measures. The non- substantive updates are to: (1) apply continuous enrollment (CE) instead of member-years (MYs) adjustment and (2) no longer adjust for stays in inpatient (IP) settings and skilled nursing facilities (SNFs). More information about the non-substantive updates is in section V.D.2.b. of this rule and in the Announcement of Calendar Year (CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies issued on March 31, 2023. We solicited comments on this substantive update to incorporate SDS risk adjustment for the medication adherence measures. In addition, we summarize here the comments received regarding the non-substantive updates that specifically reference the proposed substantive measure updates to the medication adherence measures. Comment: The majority of commenters supported the proposal to implement SDS risk adjustment for the Part D Star Ratings medication adherence measures. Commenters also expressed their support for CMSs efforts to promote health equity in the Star Ratings program. Commenters believed that including case-mix adjustment based on SDS characteristics would help improve health care quality for underserved individuals and incentivize plan sponsors to both seek and improve the care for additional vulnerable beneficiaries. Some commenters requested that SDS risk adjustment be carefully monitored to ensure overall quality shortcomings are not concealed. Response: CMS appreciates the support received for the proposal to incorporate SDS risk adjustment for the three medication adherence measures: Diabetes, Hypertension (RAS), and Cholesterol (Statins). We do not want to mask quality issues and intend to carefully monitor the SDS risk adjusted measure rates while they are on the display page for two years and after they are implemented in the Star Ratings. The stratified Medication Adherence patient safety reports and SDS risk adjusted measures provided to plan sponsors should incentivize plans to improve performance, provide high quality of care to Medicare beneficiaries, and identify disparities. Comment: A commenter requested clarification on whether implementing SDS risk adjustment for the three adherence measures is a substantive update. Response: The change to implement SDS risk adjustment for the three Part D medication adherence measures is a substantive update according to  423.184(d)(2) because it sufficiently changes the nature or scope of the three medication adherence measures and is not similar to any of the examples of non-substantive updates listed in  423.184(d)(1)(i) through (v). Therefore, the process for non-substantive updates does not apply. According to  423.184(d)(1)(i) through (v), examples of non-substantive updates include those that: narrow the denominator or population covered by the measure with no other changes; do not meaningfully impact the numerator or denominator of the measure; update the clinical codes for quality measure; provide additional clarifications such as adding additional qualifiers that would meet the numerator requirements, clarifying documentation requirements, or adding additional instructions; or adding additional data sources. As required by  423.184(d)(2) for substantive updates to measures, CMS solicited initial feedback to incorporate the SDS risk adjustment in the Advance Notice and Announcement of Calendar Year (CY) 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies and received support on this substantive update. Comment: Several commenters opposed the proposal to apply SDS risk adjustment for the medication adherence measures. Commenters were concerned about the complexity of the SDS risk adjustment, that it contradicts CMSs expressed interest to simplify the Part C and D Star Ratings, that it could make tracking individual performance complicated for plans, and that it could make it difficult for beneficiaries to understand when comparing plans. Others were concerned SDS risk adjustment would create multiple standards by which plans are measured or that there is no definition of success or ceiling for medication adherence ratings. One commenter noted that the removal of the Part C Medication Reconciliation Post-Discharge measure will have a negative impact on adherence since the measure is an intervention to ensure adherence and that these changes to implement SDS risk adjustment would dissuade sponsors from enrolling sicker populations associated with poor adherence. Response: While risk adjustment does add complexity, CMS does not have concerns about applying the SDS risk adjustment and has tested this change. The update to implement SDS risk adjustment aligns with the PQAs recommendations as the measure steward. We will work to provide technical and non-technical information as appropriate about the updated measures for plans, beneficiaries, and other interested parties to help understand the specifications and to make comparisons. We will continue to provide contract-level and beneficiary- level information to Part D sponsors through the patient safety reports to assist plans with tracking their performance improvement efforts on medication adherence measures. Additionally, the medication adherence measures are intermediate outcome measures, while the other Part D patient safety measures included in the Star Ratings are process measures and not recommended for SDS risk adjustment by the PQA. Therefore, we are aligning with the PQA and implementing the SDS risk adjustment on only the three medication adherence measures. We remind commenters that the thresholds for the medication adherence measure rates in the Medicare Part D Star Ratings are not predetermined. They are based on the distribution of data for the year the data are collected. CMS uses the clustering methodology in accordance with  423.186(a)(2) to determine thresholds for the medication adherence measures. Additionally, the Part C Medication Reconciliation Post- Discharge measure will continue to be measured as part of the Transitions of Care (Part C) measure. Comment: Commenters expressed concerns surrounding the adherence measures being excluded from the CAI adjustment and unintended harm or impacts to sponsors with high VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00149 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222268 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 142Risk-Adjusted Adherence Measures: https://www.pqaalliance.org/index.php?option=com_dailyplanetblog&view=entry&year=2020&month=04&day=23&id=8:risk- adjusted-adherence-measures. enrollment of beneficiaries with SRFs. One commenter requested CMS to continue adjusting the three adherence measures through the CAI. Some commenters opposed implementation of SDS risk adjustment since the SDS characteristics are already accounted for in the CAI. Response: Currently, the Star Ratings CAI adjusts for the average within- contract disparity in performance for LIS/DE and/or disability status. The SDS risk adjustment for the adherence measures adjusts for additional beneficiary-level SDS characteristics: age, gender, LIS/DE status, and disability status. The CAI is designed to adjust for the impact of SES on measure scores and ratings when the measures do not already include an adjustment to account for SES or similar sociodemographic factors. Because case- mix adjustment (that is, risk adjustment) of a measure adjusts scores to account for certain respondent characteristics not under the control of the health or drug plan, adjusting again for the same or similar factors through the CAI is duplicative and unnecessary. CMS has encouraged and supported measure stewards to continue examining their measures for possible re-specification to include case-mix adjustment as appropriate. The PQA updated the measure specifications for the three adherence measures to include the SDS risk adjustment to account for SDS characteristics of age, gender, LIS/DE status, and disability status that may impact beneficiary health outcomes. As noted in the preamble, the PQA medication adherence measure specifications with the SDS risk adjustment were endorsed by the NQF. Per the Star Ratings rules, the medication adherence measures must be excluded from the CAI adjustment per  423.186(f)(2)(ii)(A) once the measure is already case-mix adjusted for beneficiary-level SDS characteristics: age, gender, LIS/DE status, and disability status. With the updated measure-level specifications, the adherence measures no longer needed to be included in the CAI since the measure scores are already adjusted for differences in the enrollee case mix across contracts. Comment: One commenter requested that the risk adjustment for the three adherence measures be introduced earlier in the 2026 Star Ratings. A commenter was concerned with program stability of moving the risk adjusted measures to the display page for two years and then reintroducing the measures to the Star Ratings with a triple weight. A few commenters suggested decreasing the weight of the adherence measures when incorporating the new methodology for program stability. Response: We appreciate the feedback we received. Measures with substantive updates are on the display page for a minimum of two years prior to becoming a Star Ratings measure and therefore cannot be introduced into the Star Ratings earlier per  423.184(d)(2). CMS will keep the three legacy adherence measures in the Star Ratings during the period when the updated adherence measures are placed on the display page. CMS and sponsors will have the opportunity to monitor the three updated measures rates while on the display page. New measures to the Star Ratings program are assigned a weight of 1 for their first year in the Star Ratings and then in subsequent years, the weight associated with the measure weighting category would be used. When substantive updates are made to an existing measure in the Star Ratings, the updated measure is then added to the display page for at least 2 years prior to its introduction to the Star Ratings. For weighting purposes, a substantively updated measure is