evekhm/cms_iom_500 huggingface dataset:
2023-07115.pdf
and provide guidance on drug pricing and selection for Medicare Drug Price Negotiation Program. Response: We thank the commenters for their consideration. As previously stated, the regulatory definition that CMS is amending was adopted for use and currently applies only in the context of determining reinsurance payments under the Part D program. Guidance related to the IRA, including guidance on the selection of drugs for the Medicare Drug Price Negotiation Program, is being provided outside of this rulemaking. Specifically, we refer readers to the Initial Guidance for the Medicare Drug Price Negotiation Program issued on March 15, 2023 for further discussion of the topics raised by the commenters. After considering all of the comments received, CMS is finalizing as proposed the revisions to the definition of gross covered prescription drug costs at  423.308 and removing the two uses of the phrase actually paid and replacing the second use with paid. V. Medicare Advantage/Part C and Part D Prescription Drug Plan Quality Rating System (42 CFR 422.162, 422.164, 422.166, 423.182, 423.184, and 423.186) A. Introduction CMS develops and publicly posts a 5- star rating system for Medicare Advantage (MA)/Part C and Part D plans based on the requirement to disseminate comparative information, including information about quality, to beneficiaries under sections 1851(d) and 1860D1(c) of the Act and the collection of different types of quality data under section 1852(e) of the Act. The Part C and Part D Star Ratings system is used to determine quality bonus payment (QBP) ratings for MA plans under section 1853(o) of the Act and the amount of beneficiary rebates under section 1854(b) of the Act. Cost plans under section 1876 of the Act are also included in the Part C and Part D Star Ratings system, as codified at  417.472(k). We use multiple data sources to measure quality and performance of contracts, such as CMS administrative data, surveys of enrollees, information provided directly from health and drug plans, and data collected by CMS contractors. Various regulations, including  417.472(j) and (k), 422.152(b), 423.153(c), and 423.156, require plans to report on quality improvement and quality
2023-07115.pdf
contractors. Various regulations, including  417.472(j) and (k), 422.152(b), 423.153(c), and 423.156, require plans to report on quality improvement and quality assurance and to provide data which help beneficiaries compare plans. The methodology for the Star Ratings system for the MA and Part D programs is codified at  422.160 through 422.166 and 423.180 through 423.186, respectively, and we have specified the measures used in setting Star Ratings through rulemaking. In addition, the cost plan regulation at  417.472(k) requires cost contracts to be subject to the Part 422 and 423 Part C and Part D Quality Rating System. (83 FR 1652627). As a result, the policies adopted as final in this rule apply to the quality ratings for MA plans, cost plans, and Part D plans. We generally use Part C to refer to the quality measures and ratings system that applies to MA and cost plans. Where a cost plan covers Medicare Part D, it is treated like an MAPD plan and therefore must also report Part D measures. We are working to ensure that the Star Ratings program is aligned with the CMS Quality Strategy as that Strategy evolves over time. This includes reducing the weight of patient experience/complaints and access measures and codifying clarifications to the rules for calculating the Part C and D Star Ratings related to disasters and contract consolidations. The current CMS National Quality Strategy encourages the highest quality outcomes, safest care, equity, and accessibility for all individuals (https:// www.cms.gov/Medicare/Quality- Initiatives-Patient-Assessment- Instruments/Value-Based-Programs/ CMS-Quality-Strategy). In addition to focusing on a person-centric approach as individuals move across the continuum of care, the current CMS Quality Strategy aims to create a more equitable, safe, and outcomes-based health care system and, where feasible, works to align performance metrics, programs, and policy across CMS programs. In this final rule, we are finalizing a health equity index reward to further incentivize Part C and D plans to focus on improving care for enrollees with specified social risk factors (SRFs), and to support CMS efforts to ensure attainment of the highest level of health for
2023-07115.pdf
health equity index reward to further incentivize Part C and D plans to focus on improving care for enrollees with specified social risk factors (SRFs), and to support CMS efforts to ensure attainment of the highest level of health for all people. We are also finalizing the following measure updates: Remove the Part C Diabetes Care Kidney Disease Monitoring measure; Add the updated Part D Medication Adherence for Diabetes Medication, Medication Adherence for Hypertension (RAS Antagonists), Medication Adherence for Cholesterol (Statins) measures; and Add the Part C Kidney Health Evaluation for Patients with Diabetes measure. We are also finalizing several methodological changes: VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00145 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222264 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 139There are exceptions to this for some measures. For example, as adopted in the April 2018 final rule and used now, the measures from the CAHPS survey are based on the most recent data submitted from surveys of enrollees; the surveys ask about the experience of the enrollees over the last six months. The annual Medicare Part C & D Star Ratings Technical Notes (available online here: https://www.cms.gov/Medicare/ Prescription-Drug-Coverage/ PrescriptionDrugCovGenIn/PerformanceData) identify the measures and their data sources for each years Star Ratings. Reduce the weight of patient experience/complaints and access measures to further align the Part C and Part D Quality Rating System with other CMS quality programs; Add an additional basis for the subregulatory removal of Star Ratings measures; and Remove the 60 percent rule for the adjustment for extreme and uncontrollable circumstances (generally called the adjustment for disasters). Finally, we are also finalizing a series of technical clarifications of the existing rules related to adjustments for disasters and contract consolidations, as well as a technical amendment to  422.162(a)(2)(i) and 423.186(a)(2)(i) to fix a
2023-07115.pdf
existing rules related to adjustments for disasters and contract consolidations, as well as a technical amendment to  422.162(a)(2)(i) and 423.186(a)(2)(i) to fix a codification issue. Unless otherwise stated, the changes will apply (that is, data will be collected and performance measured) for the 2024 measurement period and the 2026 Star Ratings. In addition, we proposed in the December 2022 proposed rule other policies to amend the Part C and D Star Ratings but are not addressing those proposals in this final rule; those other proposals will be addressed in a subsequent, second final rule. Any policies we proposed in the December 2022 proposed rule that are addressed in that subsequent rule would apply (that is, data will be collected and performance measured) for no earlier than the 2025 measurement period and the 2027 Star Ratings. CMS appreciates the feedback we received on our proposals. In the sections that follow, we summarize the comments we received on each proposal we are finalizing and provide our responses. B. Definitions ( 422.162 and 423.182) We proposed to add the following definition for Part 422, Subpart D (for Part C plans) and Part 423, Subpart D (for Part D plans) in paragraph (a) of  422.162 and 423.182, respectively. Health equity index means an index that summarizes contract performance among those with specified SRFs across multiple measures into a single score. We received no comments on this proposed definition in paragraph (a) of  422.162 and 423.182 and are finalizing it without modification for the reasons in the proposed rule. This new definition is relevant for our policies discussed in section V.F. of this final rule and will be used in that context. C. Contract Ratings ( 422.162(b) and 423.182(b)) 1. Contract Type In the April 2018 final rule (83 FR 16440) at  422.162(b) and 423.182(b), we codified the methodology for calculating the same overall and summary Star Ratings for all plan benefit packages (PBPs) offered under each MA-only, MAPD, or PDP contract. As different organization or contract types offer different benefits, the overall and summary Star Ratings differ across contract types
2023-07115.pdf
and summary Star Ratings for all plan benefit packages (PBPs) offered under each MA-only, MAPD, or PDP contract. As different organization or contract types offer different benefits, the overall and summary Star Ratings differ across contract types when the set of required measures differs. For example, non-SNP contracts do not currently submit the following measures and, therefore, their overall and Part C summary ratings do not include them: SNP Care Management, Care for Older Adults Medication Review, and Care for Older AdultsPain Assessment. We proposed to amend  422.162(b)(1) and 423.182(b)(1) to add a sentence at the end to clarify that the overall and summary Star Ratings are calculated based on the measures required to be collected and reported for the contract type being offered for the Star Ratings year. This is our current practice and how the Star Ratings have historically been calculated. For example, the 2023 Star Ratings were calculated for the 2023 contract year using data primarily from measurement year 2021.139The 2023 Star Ratings were published on Medicare Plan Finder in October 2022 to provide comparative quality performance information about plans for people with Medicare to use in making enrollment decisions for the 2023 calendar year. If a contract offered a SNP PBP in measurement year 2021, but is no longer offering a SNP PBP for the 2023 contract year, the 2023 Star Ratings excluded the SNP-only measures and the contract was rated as Coordinated Care Plan without SNP. This is our current (and historical) process and how the proposed regulatory clarification would be applied. We solicited comments on this proposal. Comment: A commenter expressed support. 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)(1) and 423.182(b)(1) regarding the scope of measures used in calculating the overall and summary ratings without modification. We are also finalizing a revision related to adoption of the health equity index and future removal of the reward factor, which is discussed in more detail in section V.F. of this final rule. 2. Contract Consolidations The process for calculating measure scores for contracts that consolidate is specified as a series of steps at
2023-07115.pdf
and future removal of the reward factor, which is discussed in more detail in section V.F. of this final rule. 2. Contract Consolidations The process for calculating measure scores for contracts that consolidate is specified as a series of steps at  422.162(b)(3) and 423.182(b)(3). As described in the April 2018 final rule (83 FR 16528 through 16531), we use the enrollment-weighted means of the measure scores of the consumed and surviving contract(s) to calculate the measure-level ratings for the first and second years following the contract consolidation. For all contracts, under  422.164(f)(4) and 423.184(f)(4), the Part C and Part D improvement measures compare current contract-level measure scores with scores from the prior year across all measures included in the improvement measures calculations. Given there are no comparable prior year measure-level scores available for contracts in the first year of the consolidation, historically we have not calculated the Part C and D improvement measures for the first year after a consolidation. We proposed to amend  422.162(b)(3)(iv)(A)(1) and 423.182(b)(3)(ii)(A)(1) to clarify the calculation of the Part C and Part D improvement measures for contracts that consolidate. For the first year after a consolidation, we proposed to clarify that the Part C and Part D improvement measures will not be calculated for the consolidated contract. The prior year measure-level scores only include data from the surviving contract; using those as the comparison point for a consolidated contract would not be an accurate comparison because it does not include any information about performance of the consumed contract(s). For the second year after a consolidation, the improvement measure is calculated using the enrollment-weighted measure scores for the current and prior year because scores for both years are available for the consolidated contract. This is our current (and historical) process and how the proposed regulatory clarification would be applied. 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
2023-07115.pdf
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
2023-07115.pdf
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
2023-07115.pdf
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
2023-07115.pdf
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
2023-07115.pdf
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