2023-07115.pdf

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/ . 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 (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 (HESS) Dashboard for targeted sub-groups. The commenter suggested that CMS publish the HESS and its research and findings to date so that stakeholders can review and comment. They also requested the results from CMS recent survey about the HESS and its utility, feasibility, ease-of-use, be published. And, that CMS stipulate a score or targeted proportional improvement which, if met, would signal that health equity results have been achieved, allowing for targeted improvement by each plan, rather than compared to a group average. Response: CMS thanks for commenter for their feedback and appreciates the interest regarding HESS research. Though outside of the scope of this rule, CMS points out that related information has already been published about the HESS.60 61 62 More information can be found in The Office of the Assistant Secretary for Planning and Evaluation (ASPE) May 2021 report on health equity measures.63Finally, an article on the development of the Medicare Advantage Health Equity Summary Score Dashboard is slated to be published in the March 2023 issue of American Journal of Managed Care. CMS believes the references included in the footnotes will provide the commenter with additional insight on the HESS. After consideration of the comments and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing our proposed change to 422.152(a)(5) without modification. B. Behavioral Health in Medicare Advantage (MA) ( 422.112, 422.113, and 422.116) 1. Introduction On March 1, 2022, President Biden announced a national strategy regarding behavioral health to strengthen system capacity and connect more individuals to care by ensuring that the nations health and social services infrastructure addresses mental health holistically and equitably.64Further, the 2022 CMS Strategic Framework describes CMS broad goals to expand coverage and enhance access to equitable health care services for those covered under CMS programs.65CMS is also prioritizing, as part of the agencys many cross-cutting initiatives, to improve access to behavioral health services and outcomes for people with behavioral health care needs.66 According to the Health Resources and Services Administration (HRSA), more than one-third of Americans live in designated Mental Health Professional Shortage Areas,67meaning these communities do not have enough providers to meet the needs of their population. Furthermore, according to the results from the 2020 National Survey on Drug Use and Health, published by SAMHSA, while overall 65 percent of people with serious mental illnesses (SMI) receive treatment,68people of color with SMI receive care at significantly lower rates. More specifically, while approximately 69 percent of white people with SMI received mental health care, for Black, Hispanic, and Asian people with SMI the rates were 55 percent, 56 percent, and 44 percent respectively.69The 2020 National Survey results also indicate that common reasons for not receiving treatment for SMI include: inability to afford the cost of treatment, not knowing where to go to receive services, and health insurance not covering services.70CMS included a request for information (RFI) in the proposed rule titled Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs published in the Federal Register January 12, 2022 (87 FR 1842) (hereinafter referred to as the January 2022 proposed rule), to solicit public comment regarding the challenges that exist with accessing behavioral health VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00049 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222168 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 71https://oig.hhs.gov/oei/reports/OEI-02-22- 00390.pdf. providers within MA plans. We sought stakeholders input concerning a range of topics, including the challenges related to building behavioral health networks for MA plans, accessing behavioral health providers for MA enrollees, and requesting suggestions on how to address issues with building adequate behavioral health networks within MA plans. We received a number of comments from stakeholders and explained in the December 2022 proposed rule how we used those comments in shaping our proposals. CMS continues to evaluate and seek ways to enhance our behavioral health policies to address the health care needs of those we serve. In order to support these goals, we are finalizing regulatory changes that focus on ensuring access to behavioral health services for MA enrollees. We solicited comment on our proposals. 2. Behavioral Health Specialties in Medicare Advantage (MA) Networks ( 422.112 and 422.116) Section 1852(d)(1) of the Act permits an MA organization to select the providers from which an enrollee may receive covered benefits, provided that the MA organization, in addition to meeting other requirements, makes such benefits available and accessible in the service area with promptness and in a manner that assures continuity in the provision of benefits. To implement and adopt related standards for this, CMS codified, with some modifications, network adequacy criteria and access standards that were previously outlined in sub-regulatory guidance in the Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program final rule, which appeared in the Federal Register on June 2, 2020 (85 FR 33796), hereinafter referred to as the June 2020 final rule. In that final rule, we codified, at  422.116(b), the list of 27 provider specialty types and 13 facility specialty types subject to CMS network adequacy standards. Although  422.116(b)(3) authorizes removal of a specialty or facility type from the network evaluation criteria for a specific year without rulemaking, CMS did not adopt in  422.116 a mechanism to add new provider types without rulemaking. We proposed to add to the list of provider specialties here to address access to behavioral health services more broadly than the current regulation. Currently, MA organizations are required to demonstrate that they meet network adequacy for two behavioral health specialty types, psychiatry and inpatient psychiatric facility services, under  422.116(b). Further, the regulation at  422.112 includes a number of requirements to ensure that MA enrollees have adequate access to covered services. Of note,  422.112(a)(1) requires MA organizations to maintain and monitor a network of appropriate providers that provides access to typically used services including, primary care providers, specialists, hospitals, skilled nursing facilities, home health agencies, ambulatory clinics and other providers. In response to the RFI in the January 2022 proposed rule, we received comments emphasizing the importance of network adequacy and ensuring adequate access to behavioral health providers in MA plans. Stakeholders responses to the RFI suggested that CMS expand the network adequacy time and distance standards for MA plans beyond those that we currently review through our network adequacy evaluations. Commenters suggested that we expand the standards to include other outpatient behavioral health physicians and health professionals, including those that treat substance use disorders (SUDs), as part of our evaluation of MA plan networks in order to better meet MA enrollees needs in accessing behavioral health care. Even though over one million Medicare beneficiaries had a diagnosis of Opioid Use Disorder (OUD) and more than fifty thousand experienced an overdose in 2021, fewer than 1 in 5 of these Medicare beneficiaries with a diagnosis of OUD receive treatment for their OUD.71Current standards of care for OUD include treatment through three Food and Drug Administration (FDA) approved medications (buprenorphine, naltrexone and methadone), along with other services to provide the best approach to treating SUD. Enrollees can access Medications for Opioid Use Disorder (MOUD) in various settings including in Opioid Treatment Programs (OTPs) and, at the time of the