evekhm/cms_iom_500 huggingface dataset:
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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
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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
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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
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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
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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 2020 measurement year. NCQA, in collaboration with the National Kidney Foundation, developed a kidney health evaluation measure, and NCQA tailored the measure specifically for health plans. The KED NCQA measure assesses whether adults who have diabetes received an annual kidney profile evaluation, defined by an estimated Glomerular Filtration Rate (eGFR)143and a Urine Albumin- Creatinine Ratio (UACR) during the measurement year. This new measure aligns with recommendations from the American Diabetes Association and provides critical information for screening and monitoring of kidney health for patients with diabetes. This measure would replace the prior related measure, Diabetes CareKidney Disease Monitoring, which was removed beginning with the 2024 Star Ratings as the measure steward, NCQA, retired the measure beginning with the 2022 measurement year. CMS began reporting the KED measure on the display page for the 2022 Star Ratings. As provided at  422.164 (c)(3) and (4) and
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retired the measure beginning with the 2022 measurement year. CMS began reporting the KED measure on the display page for the 2022 Star Ratings. As provided at  422.164 (c)(3) and (4) and 423.184(c)(3) and (4), as new performance measures are developed and adopted they are initially posted on the display page for at least 2 years. We submitted the KED plan measure through the 2022 Measures Under Consideration process for review by the Measures Application Partnership, which is a multi-stakeholder partnership that provides recommendations to HHS on the selection of quality and efficiency measures for CMS programs, and the Measures Application Partnership provided support for this measure. The MIPS program had also submitted it to the 2021 Measures Under Consideration process and this measure will also be implemented for qualified health plans (QHPs).144 We solicited comments on adding this measure to the 2026 Star Ratings program. Comment: Most commenters supported adding the KED measure beginning with the 2024 measurement year and 2026 Star Ratings. A commenter stated that adding the measure will serve to increase early diagnosis and treatment of kidney disease, stop or slow disease progression for chronic kidney disease, and continue the agencys prioritization of the efficient management of end-stage renal disease. Response: CMS thanks the commenters for their support of our proposal to add this measure beginning with the 2026 Star Ratings. Comment: A commenter stated there is concern about not using the race- neutral eGFR when monitoring kidney health and recommended that CMS wait to implement the measure until the race-neutral eGFR is incorporated into the measure specifications. Response: The new race-neutral eGFR codes are already incorporated into the measure specifications. Currently, NCQA includes all codes for eGFR, including both new and old codes, to allow transition to the race-neutral eGFR. Starting with the 2023 measurement year, only the race-neutral eGFR will be included in the technical specification for the KED measure.145 Comment: A commenter suggested that CMS cover CPT code 80050 under Original Medicare given its inclusion in the KED measure code set since the commenter suggested not including it could create provider hesitation to order the test. Response: The KED measure assesses whether members 1885 with diabetes received an annual kidney health evaluation including both a uACR and an eGFR. The intent is that
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commenter suggested not including it could create provider hesitation to order the test. Response: The KED measure assesses whether members 1885 with diabetes received an annual kidney health evaluation including both a uACR and an eGFR. The intent is that any code that indicates that an eGFR was completed can count towards the measure. CPT code 80050 is one of several codes included in the value set for eGFR. Our proposal to add the KED measure to the Part C and Part D Quality Star Ratings program was not about whether and how Medicare covers all of the tests under CPT code 80050. Comments about the scope of services covered by Medicare are outside the scope of the proposal to add the KED measure to the Star Ratings. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the addition of the KED measure to the 2026 Star Ratings. Table 2 summarizes the additional and updated measures addressed in this final rule for the 2026 Star Ratings, unless otherwise noted. Due to the level of detail and changes in measure specifications, CMS does not list the measures and their specifications in the regulation text for the Part C and Part D Quality Star Ratings, but their final adoption and required use are addressed in this final rule. The measure descriptions listed in this table are high- level descriptions. The annual Star Ratings measure specifications supporting document, the Medicare Part C & D Star Ratings Technical Notes, provides detailed specifications for each measure. Detailed specifications include, where appropriate, more specific identification of a measures: (1) numerator, (2) denominator, (3) calculation, (4) timeframe, (5) case-mix adjustment, and (6) exclusions. The Technical Notes document is updated annually. The annual Star Ratings are produced in the fall of the prior year. For example, Stars Ratings for the year 2026 will be produced in the fall of 2025. If a measurement period is listed as the calendar year 2 years prior to the Star Ratings year and the Star Ratings year is 2026, the measurement period is referencing the January 1, 2024 to December 31, 2024 period. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00152 Fmt 4701 Sfmt 4700
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the January 1, 2024 to December 31, 2024 period. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00152 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222271 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 4. Measure Removal ( 422.164(e)(1) and 423.184(e)(1)) CMS proposed adding a new rule for measure removal. We proposed that CMS would have the authority to remove a measure from calculations of Star Ratings when a measure steward other than CMS retires the measure. CMS continually reviews measures that are used in calculations of Star Ratings. As codified at  422.164(e)(1) and 423.184(e)(1), CMS may remove a measure when either (1) the clinical guidelines associated with the specifications of the measure change such that the specifications are no longer believed to align with positive health outcomes; or (2) a measure shows low statistical reliability. See also 83 FR 1653316537. In both of these circumstances, as codified at  422.164(e)(2) and 423.184(e)(2), CMS will announce the removal of any measure in advance of the measurement period through the process described for changes in and adoption of payment and risk adjustment policies in section 1853(b) of the Act. We proposed adding a rule at  422.164(e)(1)(iii) and 423.184(e)(1)(iii) to allow removal of a Star Ratings measure, without separate rulemaking, when a measure steward other than CMS (for example, NCQA or PQA) retires a measure. Under the proposal, which we are finalizing, CMS will have the authority to remove the measure from calculations of Star Ratings through the process described at  422.164(e)(2) and 423.184(e)(2). When a measure steward such as NCQA retires a measure, they go through a process that includes extensive review by their various
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described at  422.164(e)(2) and 423.184(e)(2). When a measure steward such as NCQA retires a measure, they go through a process that includes extensive review by their various measurement panels and they solicit public comment regarding proposed measure retirements so health plans, purchasers, consumers, and other stakeholders have an opportunity to weigh in on the relevance and scientific soundness of any changes to the measurement set. This change will allow CMS to respond more quickly to measure removals by external measure stewards to ensure that measures included in Star Ratings are clinically meaningful, reliable, and up-to-date. We solicited comments on this proposal. Comment: Commenters supported CMS having the authority to remove Star Ratings measures when an external measure steward retires a measure from its program. A couple of commenters stated they would like to see CMS continue to communicate to plans which measures will be removed. Response: CMS appreciates the support to be able to quickly remove Star Ratings measures when an external measure steward retires a measure. This will ensure that measures included in the Star Ratings program are clinically meaningful, reliable, and up-to-date. CMS agrees that transparency is important. Prior to removing any measure, CMS will announce the removal in advance of the measurement period, as required by  422.164(e)(2) and 423.184(e)(2), through the process described for changes in and adoption of payment and risk adjustment policies in section 1853(b) of the Act, that is, through the Advance Notice and Rate Announcement. Comment: A commenter raised the concern that there will be a gap in the 2024 Star Ratings program for immunization measures, including influenza and pneumococcal vaccinations, since NCQA is retiring these measures from the HEDIS measurement set. Response: CMS understands this concern and wants to clarify that the influenza measure used in the Star Ratings program will continue to be VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00153 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ER12AP23.008</GPH>ddrumheller on DSK120RN23PROD with
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4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ER12AP23.008</GPH>ddrumheller on DSK120RN23PROD with RULES222272 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 146Announcement of Calendar Year (CY) 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (cms.gov). 147Anhang Price, R, Elliott, MN, Zaslavsky, AM, Hays, RD, Lehrman, WG, Rybowski, L, Edgman- Levitan, S, & Cleary, PD (2014). Examining the role of patient experience surveys in measuring health care quality. Medical Care Research and Review, 71(5), 522554. Anhang Price, R, Elliott, M., Cleary, included in the 2024 Star Ratings because the Star Ratings influenza measure is different than the NCQA HEDIS measure being retired. The HEDIS measure for influenza is limited to Medicare members who are 65 or older. For the Star Ratings, the influenza vaccination measure is currently assessed for a sample of Medicare members through the Medicare CAHPS survey and covers all Medicare members, regardless of age. Pneumococcal vaccination is also assessed for a sample of Medicare members through the Medicare CAHPS survey and reported on the display page. As noted in the 2023 Rate Announcement146and 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, any substantive changes to the current influenza vaccination measure or the addition of a more comprehensive immunization measure would need to be proposed through rulemaking. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the additional rule at  422.164(e)(1)(iii) and 423.184(e)(1)(iii) as proposed without modification. E. Patient Experience/Complaints and Access Measure Weights ( 422.166(e)(1)(iii) and (iv), 423.186(e)(1)(iii)