2023-07115.pdf

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 treated as a new measure and will receive a weight of 1 for the first year in the Star Ratings. In subsequent years, an updated measure is assigned the weight associated with its category. (See 86 FR 5919 and 87 FR 79616). Therefore, being consistent with the Star Ratings policy, during the first year the SDS risk adjusted adherence measures will be in the Star Ratings with a weight of 1, but then beginning with the following Star Ratings year, the weight will increase to 3, as these measures are categorized as intermediate outcome measures. Comment: Some commenters appreciated the lead time provided for implementation of the proposed update and the advance notification that the SDS risk adjustment would be included in the last monthly patient safety report of the measurement year. A commenter noted that the lead time allows them to find solutions to automate the process internally. Only a couple of commenters suggested that SDS risk adjustment be provided to plans prior to year-end or possibly monthly to give plans an understanding of the impact of these adjustments. Response: We appreciate the comments submitted on the proposed rule; however, CMS is unable to provide monthly patient safety reports with SDS risk adjustment. As CMS noted previously, implementing the SDS risk adjustment to the patient safety reports is very time consuming and labor intensive. As a result, we are unable to provide this information on a monthly basis because of the tight production timelines for the monthly patient safety reports. We intend to apply the SDS risk adjustment for the final medication adherence patient safety reports of the measurement year which is typically in July of the following calendar year. During the display page transition period, CMS will assess the feasibility of providing the medication adherence patient safety reports with SDS risk adjustment at an additional time period prior to the determination of the final rates. Comment: Commenters requested that CMS publish detailed methodology and analysis results for the SDS risk adjustment. One commenter requested additional analysis examining contracts that were impacted by the SDS risk adjustment. Response: Thank you for the additional requests to increase transparency about the SDS risk adjustment. As a reminder, CMS provides detailed contract-level reports and user guides to Part D plan sponsors for each of the current Part D patient safety measures. Similarly, we will update the medication adherence measure report user guides to reflect the implementation of the SDS risk adjustment and provide SDS risk adjustment methodology. As we align with the PQA,142CMS will continue to monitor the SDS risk adjusted medication adherence measures while on the display page and will conduct further analyses if needed. We will also explore adding additional information to the reports provided to plan sponsors to help understand the non-adjusted and SDS risk adjusted rates. Comment: We received one comment encouraging CMS to adopt the PQA Proportion of Days Covered (PDC) Medication Adherence combined measure and to apply the case-mix adjustment to that measure. Response: The PQA endorsed the PDC composite health plan measure in 2022. CMS defers to the measure steward, PQA, regarding questions on the composite health plan measure specifications and evaluation for risk adjustment. CMS would need to propose through rulemaking to add PQAs composite health plan measure as a new measure to the Part C and Part D Quality Star Ratings system. CMS will consider testing the new PQA measure in the future as part of our continued oversight and maintenance of the Star Ratings program. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00150 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222269 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations Comment: A commenter expressed concerns that the medication adherence performance measures used by plans to evaluate pharmacies may not be risk adjusted and recommended that CMS implement standardized pharmacy performance measures. Additionally, a commenter expressed concerns of potential downstream implications of the SDS risk adjustment update to the adherence measures on the pharmacy community and that Part D sponsors will structure reimbursement to penalize pharmacies if PDC thresholds are not achieved. A commenter was concerned that plans would game the measure by having their pharmacies auto-ship prescriptions. Response: These comments are out of scope for the proposed SDS risk adjustment to the Star Ratings medication adherence measures used to evaluate Part D plan performance. The SDS risk adjusted medication adherence measures are endorsed by the PQA and used by CMS at the plan-level, not the pharmacy-level. We encourage the PQA and industry to continue to work together on developing a set of pharmacy performance measures through a consensus process and Part D sponsors to adopt such measures to ensure standardization, transparency, and fairness. CMS is not addressing the proposals around auto-ship policies in this final rule. Comment: Commenters expressed concern that removing the IP/SNF stay adjustment may undermine or counteract the proposed SDS risk adjustment updates, may not simplify the measure, or that implementing SDS risk adjustment for the adherence measures and removing the adherence measures from the CAI may provide additional complexity to these calculations which may disadvantage some populations with more IP/SNF stays. A commenter was concerned about the disproportionate impact of removing the IP/SNF stay adjustment on plans with enrollees with frequent or prolonged IP stays even after adjusting for LIS status; the commenter also requested more data. Response: CMS understands these concerns about removing the IP/SNF stay adjustment in the context of adding the SDS risk adjustment. As noted in the proposed rule, we conducted testing on the impact of the combined changes of the SDS risk adjustment and removing the IP/SNF stay adjustment. Our testing indicated that applying both the SDS risk adjustment and the IP and SNF stay adjustments added complexity to the measure and created concerns about the accuracy of the SDS risk adjustment. As a reminder, the IP/SNF stay adjustment does not align with current PQA measure specifications that were endorsed for the adherence measures. CMS and plan sponsors will have the opportunity to monitor their measure scores while the SDS risk adjusted medication adherence measures are on the display page for two years. The patient safety report user guides provided to Part D plan sponsors will include more information to describe how the SDS risk adjustment is applied to help sponsors understand the calculations. Comment: A few commenters suggested additional updates to the medication adherence measure specifications to: (1) apply the IP/SNF stay adjustment prior to or as part of the SDS risk adjustment; or (2) exclude beneficiaries who reside in long-term care (LTC) facilities. For the second suggestion, the commenter stated that exclusion of LTC residents is appropriate because such enrollees generally have a potential higher disease burden and their medications are actively monitored, and because inclusion of LTC residents could skew the performance rates on the measure based on other enrollees. Some commenters were concerned that the SDS risk adjustment would not directly account for IP/SNF stays or would not offset the removal of IP/SNF stay adjustment from the adherence measures since many of the reasons for IP/SNF stays may be unrelated to the SDS characteristics included in the risk adjustment. Response: As finalized in this rule, CMS will implement SDS risk adjustment for the following beneficiary-level SDS characteristics: age, gender, LIS/DE status, and disability status, as developed and endorsed by the PQA (the measure steward) and endorsed by NQF, for the three medication adherence measures. The PQA medication adherence measure specifications do not adjust for IP/SNF stays or exclude beneficiaries who reside in LTC. We will consider additional updates made by the measure steward in the future. For further details regarding the non-substantive updates to the medication adherence measures, refer to the Announcement of Calendar Year (CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies which was published on March 31, 2023. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the implementation of the SDS risk adjustment to the three medication adherence measures (Medication Adherence for Diabetes Medication, Medication Adherence for Hypertension (RAS Antagonists), and Medication Adherence for Cholesterol (Statins)). We will first display the updated SDS risk adjusted medication adherence measures for the 2024 measurement year (2026 display page). Then, the updated SDS risk adjusted measures will replace the existing medication adherence measures beginning with the 2026 measurement year (2028 Star Ratings). The IP/SNF stay adjustment will be removed from the medication adherence measures starting with the 2026 measurement year (2028 Star Ratings). CMS will implement the CE to the medication adherence measures starting with the 2024 measurement year (2026 Star Ratings). Publishing the display measures for at least two years will allow Part D sponsors and CMS additional experience with contract- specific results using the new measure specifications. b. Medication Adherence for Diabetes Medication, Medication Adherence for Hypertension (RAS Antagonists), Medication Adherence for Cholesterol (Statins) (Part D)Non-Substantive Changes As discussed in the December 2022 proposed rule, our analysis of the proposed substantive changes (to add risk adjustment for SDS for the three adherence measures) included two non- substantive changes to the adherence measures, based on the current PQA measure specifications, which are endorsed by NQF. While we did not need to propose non-substantive changes through rulemaking, given that we intend to make the non-substantive changes to the measures along with the proposed substantive changes to risk adjust the adherence measures, we described the non-substantive updates as well in the preamble to the proposed rule in order to provide a full picture of the changes to these measures. However, implementing these non- substantive updates was not dependent on finalizing the SDS risk adjustment proposal and was included 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. These specification changes are non-substantive in accordance with  423.184(d)(1) because they narrow the denominator population or do not change the target population or intent of the measure: (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 VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00151 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222270 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 143NCQA added the new Logical Observation Identifiers Names and Codes (LOINC) for the new race-free eGFR equations to the KED value sets. 144https://www.cms.gov/files/document/final- 2022-call-letter-qrs-qhp-enrollee-survey.pdf. 145Measurement year 2023 Technical Specifications Update available under Volume 2: https://www.ncqa.org/hedis/measures/. (SNFs). The comments that we received that were solely about the non- substantive updates are addressed in the Announcement of Calendar Year (CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, which was issued by CMS on March 31, 2023. As noted in section V.D.2.a., comments on the interaction or overlap of the substantive changes and the non-substantive changes to the three medication adherence measures are addressed as part of our discussion of the substantive changes. 3. Measure AdditionKidney Health Evaluation for Patients With Diabetes (KED) (Part C) We are committed to continuing to improve the Part C and Part D Star Ratings system by focusing on improving clinical and other health outcomes. Consistent with  422.164(c)(1) and 423.184(c)(1), we continue to review measures that are nationally endorsed and in alignment with the private sector. (83 FR 16521, 16533). For example, we regularly review measures developed by NCQA and PQA. CMS proposed to adopt the new measure described in this rule, which was developed by NCQA. The Kidney Health Evaluation for Patients with Diabetes (KED) measure has been collected from MA (including MA-only and MAPDs) and cost plans since the 2020 measurement year. We proposed to add the KED measure beginning with the 2024 measurement year and 2026 Star Ratings. This measure was introduced as a HEDIS measure for the