2023-07115.pdf

We proposed to revise the current regulation text at  422.162(b)(3)(iv)(A)(1) and 423.182(b)(3)(ii)(A)(1) to clarify that the Part C and Part D improvement measures are not calculated for the first VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00146 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222265 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 140The measure, which has the HEDIS label Comprehensive Diabetes Care (CDC)Medical Attention for Nephropathy was retired after the 2021 performance period as noted here https://www.ncqa.org/wp-content/uploads/2022/07/ Summary-Table-of-Changes-HEDIS-MY-2022.pdf and does not appear in the list for the 2022 performance period. 141https://www.aspe.hhs.gov/reports/second- report-congress-social-risk-medicares-value-based- purchasing-programs. year after a contract consolidation in order to codify our current application of the ratings rules. We solicited comments on this proposal. Comment: All commenters supported this proposed provision. Response: CMS appreciates the support. After considering the comments we received and for the reasons outlined in the proposed rule, we are finalizing the clarification at  422.162(b)(3)(iv)(A)(1) and 423.182(b)(3)(ii)(A)(1) without modification. D. Adding, Updating, and Removing Measures ( 422.164 and 423.184) The regulations at  422.164 and 423.184 specify the criteria and procedure for adding, updating, and removing measures for the Star Ratings program. In the April 2018 final rule, at 83 FR 16532, we stated that we are committed to continuing to improve the Part C and Part D Star Ratings system and anticipated that over time measures would be added, updated, and removed. We also specified at  422.164(d) and 423.184(d) rules for measure updates based on whether they are substantive or non-substantive. The regulations, at paragraph (d)(1), list examples of non- substantive updates. See also 83 FR 1653437. Due to the regular updates and revisions made to measures, CMS does not codify a list in regulation text of the measures (and their specifications) adopted for the Part C and Part D Star Ratings program (83 FR 16537). CMS lists the measures used for the Star Ratings each year in the Medicare Part C & D Star Ratings Technical Notes or similar guidance issued with publication of the Star Ratings. We proposed measure changes to the Star Ratings program for performance periods beginning on or after January 1, 2024 unless noted otherwise. We also proposed a new rule for the removal of measures. 1. Diabetes CareKidney Disease Monitoring (Part C) Measure Removal We proposed to remove the Diabetes CareKidney Disease Monitoring measure because it has been retired by the measure steward.140NCQA, the measure steward, announced the retirement of the Diabetes CareKidney Disease Monitoring measure after measurement year 2021. As we stated in the Announcement of Calendar Year (CY) 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, since NCQA will no longer be collecting data for this Healthcare Effectiveness Data and Information Set (HEDIS) measure beginning with measurement year 2022, CMS will not have data for this measure to be included in the 2024 Star Ratings. The measure was included in the 2023 Star Ratings using data from measurement year 2021. We proposed to replace this measure with the Kidney Health Evaluation for Patients with Diabetes measure (described in section V.D.3. of this final rule). CMS proposed to permanently remove the Diabetes CareKidney Disease Monitoring measure starting with the 2024 Star Ratings because we will not have data to calculate the measure. We solicited comments on removing this measure from the Star Ratings program. Comment: All commenters supported the removal of the Diabetes Care Kidney Disease Monitoring measure from the Star Ratings program. Response: CMS appreciates the support. After considering the comments we received and for the reasons outlined in the proposed rule, we are finalizing the removal of the Diabetes CareKidney Disease Monitoring measure from the Star Ratings program. 2. Measure Updates In the April 2018 final rule, we specified at  422.164(d) and 423.184(d) rules for measure updates based on whether they are substantive or non-substantive. (83 FR 16534 and 16535). Where an update by the measure steward is substantive within the scope of  422.164(d)(2) and 423.184(d)(2), CMS will initially solicit feedback on whether to make substantive measure updates through the process described for changes in and adoption of payment and risk adjustment policies in section 1853(b) of the Act and then engage in rulemaking to make substantive changes to a Star Ratings measure. Per  422.164(d)(2) and 423.184(d)(2), CMS will place the updated measure on the display page for at least 2 years prior to using the updated measure to calculate and assign Star Ratings. This 2-year period for the updated measure to be on the display page may overlap with the period during which CMS solicits comment and engages in rulemaking. Further, the legacy measure may continue to be used in the Star Ratings during this period. a. Medication Adherence for Diabetes Medication, Medication Adherence for Hypertension (RAS Antagonists), Medication Adherence for Cholesterol (Statins) (Part D)Substantive Change CMS proposed to implement risk adjustment (also sometimes referred to as case-mix adjustment) based on sociodemographic status (SDS) characteristics, a substantive update, to the three Part D medication adherence measures for the 2028 Star Ratings (2026 measurement year). The adherence measures would be adjusted for the following beneficiary-level SDS characteristics: age, gender, low-income subsidy/dual eligibility (LIS/DE) status, and disability status. Health outcomes are affected by patient-related and external factors such as existing clinical conditions and SDS. Currently, the three medication adherence measures (Diabetes, Hypertension, and Cholesterol) are included in the determination of the Star Ratings Categorical Adjustment Index (CAI) because they are not excluded by the criteria established in  422.166(f)(2) and 423.186(f)(2); for example, the measures are not case-mix adjusted for socioeconomic status (SES). The CAI was implemented in the 2017 Star Ratings to adjust for average within- contract disparity in performance associated with the percentages of beneficiaries who receive LIS/DE and/or have disability status. The CAI was initially developed as an interim analytical adjustment to address concerns about disparities while longer- term solutions were explored, including engaging with measure stewards to examine if re-specification is warranted for measures used in the Star Ratings. The methodology for the CAI was codified at  422.166(f)(2) and 423.186(f)(2); the factor is calculated as the mean difference in the adjusted and unadjusted ratings (overall, Part D for MAPDs, and Part D for PDPs) of the contracts that lie within each final adjustment category for each rating type. In addition, the National Quality Forum (NQF) convened an expert panel in 2014 and recommended that performance-based measures should be risk adjusted for SES and other socio demographic factors in 2017. On June 28, 2020, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) submitted a second Report to Congress;141ASPE is required under section 2(d) of the Improving Medicare Post-Acute Care Transformation (IMPACT) to study the effects of certain VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00147 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222266 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations SRFs of Medicare beneficiaries on quality measures and measures of resource use in Medicare value-based purchasing programs. CMS contracted with the Pharmacy Quality Alliance (PQA), the steward of these measures, to examine the medication adherence measures for potential risk adjustment. PQA recommended SDS risk adjustment for the Medication Adherence for Diabetes Medication, Medication Adherence for Hypertension (RAS Antagonists), and Medication Adherence for Cholesterol (Statins) measures. PQA recommended and endorsed the following changes related to SDS in their Measure Manual: All three adherence measures should be risk adjusted for SDS characteristics to adequately reflect differences in patient populations. The measures should be adjusted for the following beneficiary-level SDS characteristics: age, gender, LIS/DE status, and disability status. The measures should be stratified by these four beneficiary-level SDS characteristics (listed in the prior bullet) to allow health plans to identify disparities and understand how their patient population mix is affecting their measure rates. The PQA measure specifications were endorsed by NQF in the 2019 Spring cycle (NQF endorsed #0541) (CMIT ID: 0043601CPARTD for Diabetes, 0043701CPARTD for Hypertension, and 0043501CPARTD for Cholesterol). CMS has included stratifications by age, gender, LIS/DE status, and disability status in the Medication Adherence patient safety reports to Part D sponsors beginning with the 2019 measurement year. We proposed to implement risk adjustment for the medication adherence measures based on the PQA specifications, which would be reflected in the Star Ratings. Additionally, because the medication adherence measures will be risk adjusted based on SDS characteristics (that is, for age, gender, LIS/DE status, and disability status), the medication adherence measures will be excluded from the CAI adjustment per  422.166(f)(2)(ii)(A) and 423.186(f)(2)(ii)(A). We found in our analysis that implementing the SDS risk adjustment to the patient safety reports can be very time consuming and should be incorporated at one period of time. Therefore, since we proposed to implement the SDS risk adjustment to the medication adherence measures (which will remove these measures from the Star Ratings CAI determination), we intend to incorporate the SDS risk adjustment operationally to the medication adherence measures reported by CMS to Part D sponsors in the last monthly patient safety report for the measurement year. In developing this proposal, we considered how this change might affect Star Ratings for MAPD and PDP contracts. We calculated SDS risk adjusted medication adherence measure rates using year of service (YOS) 2019 measurement year data and recalculated the CAI values excluding these three adherence measures. We then recalculated the overall and Part D summary ratings using the SDS risk adjusted medication adherence measure rates, revised CAI values, the final 2021 Star Ratings for other measures, and the reward factor. In our analysis, we found that the threshold shifts for measure- level cut points with SDS risk adjustment were minimal for both MA PD and PDP contracts, ranging from 2 to +1 percentage point(s) for MAPD contracts and about 2 to +3 percentage points for PDP contracts. We found that for both MAPD and PDP contracts, approximately 6070 percent of contracts retained the same star level across the Medication Adherence for Hypertension (RAS Antagonists) and Medication Adherence for Cholesterol (Statins) measures. When a star level shift was observed, most of the MAPD and PDP contracts shifted by one-star level and usually shifted upwards when the SDS risk adjustment was applied to the adherence measures. One percent of MAPD contracts shifted two-star levels for the Medication Adherence for Hypertension (RAS Antagonists) and Medication Adherence for Cholesterol (Stains) 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