evekhm/cms_iom_500 huggingface dataset:
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apply the new requirement to all MA organizations, rather than only to MA organizations offering coordinated care plans by finalizing the revision at  422.100(n) instead of  422.112(b)(9). In addition, we are finalizing without modification the proposed policy that the MA organization must make information about its digital health literacy screening and digital health education programs available to CMS upon request. We are further finalizing our proposed language providing a non- exhaustive list of the information CMS may request from MA organizations under this policy. 5. Quality Improvement Program ( 422.152) In accordance with section 1852(e) of the Act, all MA organizations must have an ongoing Quality Improvement (QI) Program for the purpose of improving the quality of care provided to enrollees. Per  422.152(a), MA organizations must develop a QI plan that sufficiently outlines the QI program elements; have a chronic care improvement program (CCIP) that meets the requirements at  422.152(c) and addresses populations identified by CMS based on a review of current quality performance; and, encourage its providers to participate in CMS and HHS quality improvement initiatives. Section 422.152(c) provides that CCIPs must include methods for identifying MA enrollees with multiple or sufficiently severe chronic conditions that would benefit from participating in a CCIP; mechanisms for monitoring MA enrollees that are participating in the CCIP and evaluating participant outcomes, such as changes in health status; performance assessments that use quality indicators that are objective, clearly and unambiguously defined, and based on current clinical knowledge or research, and systematic and ongoing follow-up on the effect of the CCIP. Organizations must report the status and results of each program to CMS as requested. The intent of the CCIPs is to promote effective chronic disease management and improve care and health outcomes for enrollees with chronic conditions. Furthermore, CCIPs should support the CMS Quality Strategy; include interventions that surpass MA organizations inherent care coordination role and overall management of enrollees; engage enrollees as partners in their care; promote utilization of preventive services; facilitate development of targeted goals, specific interventions, VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00046 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM
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VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00046 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222165 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 49https://www.cms.gov/Medicare/Health-Plans/ Medicare-Advantage-Quality-Improvement- Program/5CCIP. 50Disparities in Health Care in Medicare Advantage by Race, Ethnicity and Sex, April 2022. 51Lindenauer, P.K., Lagu, T., Rothberg, M.B., Avrunin, J., Pekow, P.S., Wang, Y., Krumholz, H., & Hines, H. (2013). Income Inequality and 30-Day Outcomes After Acute Myocardial Infarction, Heart Failure, and Pneumonia: Retrospective Cohort Study. British Medical Journal. 52Trivedi, A.N., Nsa, W., Hausmann, L.R.M., Lee, J., Ma, A., Bratzler, D., Mor, M., Baus, K., Larbi, F., & Fine, M. (2014). Quality and Equity of Care in U.S. Hospitals. New England Journal of Medicine. 371(24):22982308. 53Polyakova, M., Udalova, V., Kocks, G., Genadek, K., Finlay, K., & Finkelstein, A.N. (2021). Racial Disparities In Excess All-Cause Mortality During The Early COVID19 Pandemic Varied Substantially Across States. Health affairs (Project Hope), 40 (2), 307316. https://doi.org/10.1377/ hlthaff.2020.02142. 54Rural Communities: Age, Income, and Health Status. Rural Health Research Recap. (2018). Rural Health Research Gateway.
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hlthaff.2020.02142. 54Rural Communities: Age, Income, and Health Status. Rural Health Research Recap. (2018). Rural Health Research Gateway. https://www.ruralhealthresearch.org/recaps/5. 552020 Update on the Action Plan to Reduce Racial and Ethnic Health Disparities. (2020). HHS Office of Minority Health. https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_ Disparities_ Dept-FY2020.pdf. 56Sexual Orientation Disparities in Risk Factors for Adverse COVID19-Related Outcomes, by Race/ Ethnicity. (2021, February 5). CDC. www.cdc.gov/ mmwr/volumes/70/wr/mm7005a1.htm. 57Poteat, T.C., Reisner, S.L., Miller, M., & Wirtz, A.L. (2020). COVID19 Vulnerability of Transgender Women With and Without HIV Infection in the Eastern and Southern U.S. medRxiv: The preprint server for health sciences, 2020.07.21.20159327. https://doi.org/10.1101/ 2020.07.21.20159327. 58Guth, M., Garfield, R., & Rudowitz, R. (2020). The Effects of Medicaid Expansion Under the ACA: Studies from January 2014 to January 2020. Kaiser Family Foundation. https://www.kff.org/medicaid/ report/the-effects-of-medicaid-expansion-under-the- aca-updated-findings-from-a-literature-review/. and quantifiable, measurable outcomes; guard against potential health disparities; and produce best practices.49 In accordance with 1852(e) of the Act, MA organizations are required to report quality performance data to CMS. MA organizations generally report such data through the Healthcare Effectiveness Data and Information Set (HEDIS), Health Outcomes Survey (HOS), Consumer Assessment of Healthcare Providers and Systems (CAHPS), and other related data collection tools. As codified at  422.152(b)(3) and
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Information Set (HEDIS), Health Outcomes Survey (HOS), Consumer Assessment of Healthcare Providers and Systems (CAHPS), and other related data collection tools. As codified at  422.152(b)(3) and (5), MA coordinated care plans are required to report on quality performance data which CMS can use to help beneficiaries compare plans; MA local and regional PPO plans must similarly report under  422.152(e)(2)(i). The areas of measurement include outcomes, patient experience, access, and process measures. In addition, CMS uses this information to develop and publicly post a 5-star rating system for MA plans based on its authority to disseminate comparative information, including about quality, to beneficiaries under sections 1851(d) and 1860D1(c) of the Act. To meet the needs of their enrolled special needs populations, MA special needs plans (SNPs) have additional QI program requirements, including the implementation of an approved model of care (MOC), which serves as the framework for meeting the individual needs of SNP enrollees, and the infrastructure to promote care management and care coordination (see  422.152(g)). As part of the initial MA SNP application and renewal requirements and through MOC submissions, SNPs provide to CMS a detailed profile of the medical, social, cognitive, and environmental aspects, the living conditions, and the co- morbidities associated with the SNP population, including information about health conditions impacting SNP enrollees along with other characteristics that affect health, such as population demographics (for example, average age, sex, gender, ethnicity), and potential health disparities associated with specific groups (for example, language barriers, deficits in health literacy, poor socioeconomic status, cultural beliefs/barriers, caregiver considerations, or other). SNPs must also capture limitations and barriers that pose potential challenges for accessing care and/or maintaining and improving SNP enrollee health status. Additionally, through health risk assessments (HRAs), SNPs identify the medical, functional, cognitive, psychosocial, and mental health needs of their enrollees, who are all special needs individuals, and address those needs in an individualized care plan for each enrollee. In the final rule titled Medicare Program; Contract Year 2023 Policy and Technical Changes
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and mental health needs of their enrollees, who are all special needs individuals, and address those needs in an individualized care plan for each enrollee. In the final rule titled Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID19 Public Health Emergency which appeared in the Federal Register May 9, 2022 (87 FR 27704), CMS finalized a new requirement for SNPs at  422.101(f)(1)(i), requiring the HRA tool to include one or more questions from a list of screening instruments specified by CMS in sub-regulatory guidance on the domains of housing stability, food security, and access to transportation beginning in 2024. We expect that this data collection would also provide information to MA organizations about potential health disparities among their enrollees. Persistent inequities in health care outcomes exist in the United States, including among populations enrolled in MA organizations.50Belonging to a racial or ethnic minority group, living with a disability, being a member of the LGBTQI+ community, having limited English proficiency, living in a rural area, or being near or below the poverty level, is often associated with worse health outcomes.51 52 53 54 55 56 57 Such disparities in health outcomes are the result of a number of factors and exist regardless of health insurance coverage type. Although not the sole determinant, poor health care access and provision of lower quality health care contribute to health disparities. Research has shown that the expansion of health insurance coverage, for example through Medicaid expansion under the ACA, and the resulting increased access to health care, is linked to reductions in disparities in health insurance coverage as well as reductions in disparities in health outcomes.58 In the final rule titled Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2023, which appeared in the Federal Register May 6, 2022 (87 FR 27208), CMS finalized a proposal to update the quality improvement strategy (QIS) standards for qualified health plan (QHP) issuers, requiring them to address health and health care disparities as a specific topic area within their QIS beginning in 2023. Examples of
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proposal to update the quality improvement strategy (QIS) standards for qualified health plan (QHP) issuers, requiring them to address health and health care disparities as a specific topic area within their QIS beginning in 2023. Examples of QIS activities that fall under the health and health care disparities topic area for QHPs can include language services, community outreach, cultural competency trainings, social needs- sensitive self-management recommendations, and increased demographic and disparities-related data collection; see the QIS Technical Guidance and User Guide for the 2023 Plan Year for more information. CMS is committed to advancing health equity for MA enrollees. Based on CMS definition of health equity and in alignment with similar CMS programs, we believe that MA organizations QI programs are an optimal vehicle to develop and implement strategies and policies designed to reduce disparities in health and health care, and advance equity in the health and health care of MA enrollee populations, especially those that are underserved. MA organizations have long focused on addressing health disparities through QI program requirements. By assessing cultural, language, health literacy, VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00047 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222166 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations financial, psychosocial & family support, community networks, and transportation needs, etc., and addressing those needs through a variety of QI program activities across their enrollee populations, MA organizations gain insight into their enrollee populations. Some of the specific QI activities include addressing barriers to health care, for example assisting enrollees with transportation to follow-up primary care visits post- hospitalization, linking enrollees to community resources, and improving care coordination and case management, especially for vulnerable and/or underserved enrollees. In addition to implementing QI activities for the broader enrollee populations, we are aware that some MA organizations have focused their QI activities on underserved groups. For example, to better serve these groups, several MA organizations have made efforts to improve their communication by providing cultural trainings for their staff, tailoring enrollee materials to ensure they
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some MA organizations have focused their QI activities on underserved groups. For example, to better serve these groups, several MA organizations have made efforts to improve their communication by providing cultural trainings for their staff, tailoring enrollee materials to ensure they are linguistically and culturally appropriate, and hiring plan staff and establishing contracts with providers who are bilingual. Some MA organizations have implemented specific interventions that target blood pressure control, or improved rates for various cancer screenings in targeted groups. These types of activities can improve the health of and health care for MA enrollees. To improve the quality of care and health outcomes for MA enrollees and support the first pillar in the 2022 CMS strategic plan for advancing health equity, CMS proposed to amend the MA QI program regulations at  422.152(a). Specifically, we proposed to amend  422.152 by adding a new paragraph (a)(5), to require MA organizations to incorporate one or more activities into their overall QI program that reduce disparities in health and health care among their enrollees. We believe that many MA organizations are already addressing disparities and gaps in care for underserved populations through a variety of quality initiatives. Rather than limit these activities to specific QI program requirements such as the CCIPs, we proposed that MA organizations would be required to incorporate one or more activities that reduce disparities in health and health care across the broad spectrum of QI program requirements. MA organizations may implement activities such as improving communication, developing and using culturally appropriate materials (to distribute to enrollees or use in communicating with enrollees, community outreach, or similar activities. MA organizations should design activities so that they meet the needs of their particular enrollees, and therefore CMS is not prescriptive in the types of activities MA organizations must implement to meet this proposed new requirement. However, MA organizations must ensure that all their designed activities are broadly accessible irrespective of race, ethnicity, national origin, religion, sex, disability, or gender. These activities may be based upon health status and health needs, geography, or factors not listed in the previous sentence only as appropriate to address the relevant disparity in health or health care. Furthermore, adopting this requirement for MA organizations as part of their required QI programs aligns with health equity efforts across CMS policies and programs. We summarize the comments received on the proposal at  422.152(a)(5) and provide our responses to those comments in
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organizations as part of their required QI programs aligns with health equity efforts across CMS policies and programs. We summarize the comments received on the proposal at  422.152(a)(5) and provide our responses to those comments in this section of this rule. Comment: CMS received several comments expressing overwhelming support for requiring MA organizations to incorporate one or more activities that reduce disparities in health and health care among MA enrollees into their QI program, and recommended that CMS finalize the provision as proposed. Many of the commenters believed that MA plans QI programs are an important vehicle to develop and execute activities designed to reduce disparities, and advance equity in the health and health care of MA enrollees. Commenters commended CMS for its continued efforts to advance health equity for those who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality. Commenters also believed that closing health care gaps will enable every individual to achieve optimal health through the delivery of equitable health services. Additionally, each of the commenters conveyed a strong commitment to promote health equity and quality of care in the MA program. Response: CMS thanks the commenters and agrees that MA organizations are uniquely positioned to address disparities in health and health care, and that QI programs are an important vehicle for improving quality and health outcomes for MA enrollees. CMS appreciates MA organizations commitment to promote health equity and quality of care in the MA program. Comment: Some of the commenters conveyed that they were already addressing disparities in care for underserved populations through a variety of quality initiatives. Another commenter conveyed that the examples provided in the proposed rule, that is, improving communication, developing, and using linguistically and culturally appropriate materials, hiring bilingual staff, and engaging in community outreach, were good examples of actions that have helped reduce disparities in communities across the country. Response: CMS thanks the commenters and appreciates the initiatives that organizations have already undertaken to reduce barriers to care, improve care coordination and access to preventive services and community resources. CMS believes these initiatives will help to promote health equity among all MA enrollees. Comment: A few commenters requested that CMS allow MA organizations to have broad discretion regarding the types of activities they can implement to meet the new QI program requirement. Furthermore, they noted this will allow plans to respond to the needs of the communities they serve, define appropriate QI activities and
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that CMS allow MA organizations to have broad discretion regarding the types of activities they can implement to meet the new QI program requirement. Furthermore, they noted this will allow plans to respond to the needs of the communities they serve, define appropriate QI activities and promote meaningful efforts to address disparities. A commenter also requested that CMS not limit MA organizations to those QI activities currently being implemented by QHPs. Response: We appreciate the comments and reiterate that the requirement we proposed and are finalizing is not prescriptive in the types of activities MA organizations must or can implement to meet this new requirement. CMS also points out that the QHP activities described in the preamble were meant to serve as examples, not required activities. CMS firmly believed that plans should tailor QI program activities to meet the needs of their enrollees. However, CMS reminds MA plans that they must ensure these activities are broadly accessible irrespective of race, ethnicity, national origin, religion, disability, sex, or gender. Comment: A commenter requested that CMS explicitly state that QI program activities can include, as an element of the QI program (that is, CCIP, QI Initiative, etc.), nutrition services such as food, prepared meals, and groceries. Response: CMS appreciates the comment and again notes that we are generally not being prescriptive in the types of QI program activities MA organizations must or can implement to meet this new requirement. However, CMS believes that nutrition services are one of many activities that could help to advance health outcomes in MA enrollees, and as such has included VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00048 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222167 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 59https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/Downloads/ mc86c04.pdf. 60https://pubmed.ncbi.nlm.nih.gov/31713030/ .
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Guidance/Guidance/Manuals/Downloads/ mc86c04.pdf. 60https://pubmed.ncbi.nlm.nih.gov/31713030/ . 61https://journals.lww.com/lww-medicalcare/ Fulltext/2022/06000/Measuring_ Inconsistency_ in_Quality_ Across_ Patient.9.aspx. 62https://pubmed.ncbi.nlm.nih.gov/36038518/ . 63https://aspe.hhs.gov/sites/default/files/private/ pdf/265566/developing-health-equity-measures.pdf. 64https://www.whitehouse.gov/briefing-room/ statements-releases/2022/05/31/fact-sheet-biden- harris-administration-highlights-strategy-to- address-the-national-mental-health-crisis/. 65https://www.cms.gov/files/document/2022- cms-strategic-framework.pdf. 66https://www.cms.gov/files/document/cms- behavioral-health-stategy.pdf. 67https://data.hrsa.gov/topics/health-workforce/ shortage-areas. 68https://www.samhsa.gov/data/sites/default/ files/reports/rpt35325/NSDUHFFRPDFWHTMLFiles2020/2020PDFW102121.pdf. 69https://www.samhsa.gov/data/sites/default/ files/reports/rpt35324/2021NSDUHMHChartbook102221B.pdf. 70https://www.apa.org/monitor/2020/07/ datapoint-care. meals (on a limited basis) as an allowable supplemental benefit for which all enrollees may be eligible, provided they meet the criteria set forth in Chapter 4 of the Medicare Managed Care Manual.59Additionally, CMS has included meals beyond a limited basis as an allowable benefit under Special Supplemental Benefits for the Chronically Ill
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may be eligible, provided they meet the criteria set forth in Chapter 4 of the Medicare Managed Care Manual.59Additionally, CMS has included meals beyond a limited basis as an allowable benefit under Special Supplemental Benefits for the Chronically Ill (SSBCI), provided that the requirements in  422.102(f) are met regarding the chronically ill enrollees that are eligible for the benefits and that the item or service covered as an SSBCI have a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollee. We note that any benefits (including meals) provided to enrollees must be included in their bids and be offered in a manner consistent with applicable regulations and criteria for providing such benefits. Furthermore, we note that plans may not offer meals through a QI program instead of through regular supplemental benefits or SSBCI. Comment: A few commenters encouraged CMS to exercise appropriate oversight to ensure that MA organizations are implementing activities that are reducing disparities, clearly and measurably. A few commenters also recommended that MA organizations seek to identify disparities through data collection and stratification of enrollees by various subpopulations. Similarly, other commenters conveyed that they already had mechanisms in place to identify disparities in health and health care access among their members, investigate root causes, and develop reduction strategies. Response: CMS appreciates the comments and recognizes that some MA organizations already have mechanisms in place to identify disparities and address gaps in care. CMS notes that MA organizations have tools to assist them in gaining insight into their enrollee populations, such as CCIP initiatives, claims data, HRAs, detailed profiles of SNP enrollees and identification of barriers to accessing care, as required by the MOC, etc., and can use this data to identify gaps in care and tailor QI program activities accordingly. Lastly, we note that various aspects of the QI program require that MA organizations have processes in place to evaluate participant outcomes, the effectiveness of QI programs, report the status of CCIP results to CMS as requested, report quality performance data, etc. CMS current oversight efforts include these requirements, and therefore, we do not believe it is necessary to impose additional means of oversight. Comment: Another commenter supported the increased focus on health equity and requested that CMS provide guidance regarding measuring disparity reduction, such as the use of the Health Equity Summary Score