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1 This document is scheduled to be published in the Federal Register on 01/12/2022 and available online at [Billing Code: , and on 4120-01-P]. DEPARTMENT OF HEALTH AND HUMAN SERVICES . Centers for Medicare & Medicaid SERVICES 42 CFR Parts 422 and 423. [CMS-4192-P]. RIN 0938-AU30. Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs AGENCY: Centers for Medicare & Medicaid SERVICES (CMS), DEPARTMENT of HEALTH and HUMAN SERVICES (HHS). ACTION: Proposed rule. SUMMARY: This proposed rule would revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance, Star Ratings, network adequacy, medical loss ratio reporting, special requirements during disasters or public emergencies, and pharmacy price concessions. This proposed rule would also revise regulations related to dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans.

2 DATES: To be assured consideration, comments must be received at one of the addresses provided below, by March 7, 2022. ADDRESSES: In commenting, please refer to file code CMS-4192-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to Follow the "Submit a comment" instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid SERVICES , DEPARTMENT of HEALTH and HUMAN SERVICES , Attention: CMS-4192-P, Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid SERVICES , DEPARTMENT of HEALTH and HUMAN SERVICES , Attention: CMS-4192-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

3 For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Marna Metcalf Akbar, (410) 786-8251, or Melissa Seeley, (212) 616-2329 General Questions. Jacqueline Ford, (410) 786-7767 Part C Issues. Part C and D Star Ratings Issues. Marna Metcalf-Akbar, (410) 786-8251 D-SNP Issues. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: Follow the search instructions on that Web site to view public comments. CMS will not post on public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual.

4 CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. Acronyms ACC Automated Criteria Check ANOC Annual Notice of Change ARB At-Risk Beneficiaries BBA Bipartisan Budget Act CAHPS Consumer Assessment of Healthcare Providers and Systems CMS Centers for Medicare & Medicaid SERVICES COI Collection of Information COVID-19 Coronavirus 2019 Disease C-SNP Chronic Condition Special Needs Plan DME Durable Medical Equipment D-SNP Dual Eligible Special Needs Plan EOC Evidence of Coverage FFS Fee-for-Service FIDE SNP Fully Integrated Dual Eligible Special Needs Plan HEDIS Healthcare Effectiveness Data and Information Set HHS DEPARTMENT of HEALTH and HUMAN SERVICES HIDE SNP Highly Integrated Dual Eligible Special Needs Plan HOS HEALTH Outcomes Survey HPMS HEALTH Plan Management System HSD HEALTH Service Delivery ICR Information Collection Requirement I-SNP Institutional Special Needs Plan MA Medicare Advantage MAC Medicare Administrative Contractor MACPAC Medicaid and CHIP Payment and Access Commission MA-PD Medicare Advantage Prescription Drug

5 MCO Managed Care Organization MCMG Medicare Communications and Marketing Guidelines MACPAC Medicaid and CHIP Payment and Access Commission MedPAC Medicare Payment Advisory Commission MIPPA Medicare Improvements for Patients and Providers Act MLR Medical Loss Ratio MMA Medicare Prescription Drug, Improvement, and Modernization Act MMP Medicare-Medicaid Plan MOC Model of Care MOOP Maximum Out-of-Pocket NAMBA National Average Monthly Bid Amount NEMT Non-emergency Medical Transportation NMM Network Management Module OACT Office of the Actuary OMB Office of Management and Budget PACE Programs of All-Inclusive Care for the Elderly PBP Plan Benefit Package PDE Prescription Drug Event PDP Prescription Drug Plan PHE Public HEALTH Emergency PRA Paperwork Reduction Act RFI Request for Information RFA Regulatory Flexibilities Act SAE Service Area Expansion SB Summary of Benefits SNP Special Needs Plan SSA Social Security Administration TPMO Third-Party Marketing Organization I. Executive Summary A.

6 Purpose Over 27 million individuals receive their Medicare benefits through Medicare Advantage (MA or Part C), including plans that offer Medicare Prescription Drug Benefit (Part D) coverage. Over 24 million individuals receive Part D coverage through standalone Part D plans. The primary purpose of this proposed rule is to implement changes to the MA and Part D programs. The proposed provisions in this rule will reduce out-of-pocket prescription drug costs; improve price transparency and market competition under the Part D program; strengthen consumer protections to ensure MA and Part D beneficiaries have accurate and accessible information about their HEALTH plan choices and benefits; strengthen CMS oversight of MA and Part D plans;. and improve the integration of Medicare and Medicaid programs for individuals enrolled in dual eligible special needs plans (D-SNPs). The proposed D-SNP provisions build on the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) (Pub.)

7 L. 111-148), the Bipartisan Budget Act (BBA) of 2018 (Pub. L. 115-123), CMS experience administering the MA. and Part D programs, and the experiences of Medicare-Medicaid Plans (MMPs) to better align and integrate benefits for dually eligible beneficiaries. B. Summary of Major Provisions 1. Enrollee Participation in Plan Governance ( ). Managed care plans derive significant value from engaging enrollees in defining, designing, participating in, and assessing their care We are proposing to require that any MA organization offering a D-SNP must establish one or more enrollee advisory committees in each State to solicit direct input on enrollee experiences. We also propose that the committee include a reasonably representative sample of individuals enrolled in the D-SNP(s) and solicit input on, among other topics, ways to improve access to covered SERVICES , coordination of SERVICES , and HEALTH equity for underserved populations. We believe that the establishment and maintenance of an enrollee advisory committee is a valuable beneficiary protection to ensure that enrollee feedback is heard by managed care plans and to help identify and address barriers to high-quality, coordinated care for dually eligible individuals.

8 2. Standardizing Housing, Food Insecurity, and Transportation Questions on HEALTH Risk Assessments ( ). Section 1859(f)(5)(A)(ii)(I) of Social Security Act (hereafter known as the Act) requires each special needs plan (SNP) to conduct an initial assessment and an annual reassessment of the individual's physical, psychosocial , and functional needs. We codified this requirement at (f)(1)(i) as part of the model of care requirements for all MA SNPs. Certain social risk factors can lead to unmet social needs that directly influence an individual's physical, psychosocial , and functional status. Many dually eligible individuals contend with multiple social risk factors such as homelessness, food insecurity, lack of access to transportation, and low levels of HEALTH Building on CMS's experience with other programs and model tests, we propose to require that all SNPs include standardized questions on housing stability, 1 Centers for Medicare & Medicaid SERVICES . ( ). Person & Family Engagement Strategy: Sharing with Our Partners.

9 Retrieved from Instruments/QualityInitiativesGenInfo/ 2 Medicaid and CHIP Payment and Access Commission, Report to Congress on Medicaid and CHIP, June 2020. Retrieved from: food security, and access to transportation as part of their HEALTH risk assessments. Our proposal would result in SNPs having a more complete picture of the risk factors that may inhibit enrollees from accessing care and achieving optimal HEALTH outcomes and independence. We believe this knowledge would better equip the MA organizations offering these SNPs to meet the needs of their members. Our proposal would also equip MA. organizations with person-level information that would help them better connect people to covered SERVICES and social service organizations and public programs that can help resolve housing instability, food insecurity, or transportation challenges. Our proposal also would have the benefit of standardizing these data elements collected through HRAs, which we believe would eventually facilitate better data exchange among SNPs (when an individual transitions from one SNP to another) as well as facilitate the care management requirements under section 1859(f)(5) of the Act.

10 3. Refining Definitions for Fully Integrated and Highly Integrated D-SNPs ( and ). Dually eligible individuals have an array of choices for how to receive their Medicare coverage. We propose several changes to how we define fully integrated dual eligible special needs plan (FIDE SNP) and highly integrated dual eligible special needs plan (HIDE SNP) to help differentiate various types of D-SNPs, clarify options for beneficiaries, and improve integration. We propose to require, for 2025 and subsequent years, that all FIDE SNPs have exclusively aligned enrollment, as defined in , and cover Medicaid home HEALTH , durable medical equipment, and behavioral HEALTH SERVICES through a capitated contract with the State Medicaid agency. We propose to require that each HIDE SNP's capitated contract with the State apply to the entire service area for the D-SNP for plan year 2025 and subsequent years. Consistent with existing policy outlined in sub-regulatory guidance, we also propose to codify specific limited benefit carve-outs for FIDE SNPs and HIDE SNPs.