# 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 COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2022-09375 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** May 9, 2022 - **Citation:** 87 FR 27704 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 417, 422, and 423 [CMS-4192-F, CMS-1744-F, and CMS-3401-F] RIN 0938-AU30, 0938-AU31, and 0938-AU33 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 COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Final rule. SUMMARY: This final rule will 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 final rule will also revise regulations related to dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans. This final rule finalizes certain 2021 and 2022 Star Ratings provisions that were included in two interim final rules with comment period (IFC) that CMS issued on April 6, 2020, and September 2, 2020; other policies from those interim final rules will be addressed in other rulemakings. DATES: Effective dates: These regulations are effective on June 28, 2022, except for amendatory instructions 27 and 36 (regarding the definition of “negotiated price” at §§ 423.100 and 423.2305), which are effective January 1, 2024. Applicability dates: The applicability date of the provisions in this rule is January 1, 2023, except as explained in SUPPLEMENTARY INFORMATION. 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. PartCandDStarRatings@cms.hhs.gov —Part C and D Star Ratings Issues. Marna Metcalf-Akbar, (410) 786-8251—D-SNP Issues. PartDPaymentPolicy@cms.hhs.gov —Part D Pharmacy Price Concession Issues. MLRreport@cms.hhs.gov —MLR Issues. SUPPLEMENTARY INFORMATION: Acronyms ACC Automated Criteria Check AHC Accountable Health Communities AKS Anti-kickback Statute ANOC Annual Notice of Change ARB At-Risk Beneficiaries BBA Bipartisan Budget Act CAHPS Consumer Assessment of Healthcare Providers and Systems CAI Categorical Adjustment Index 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 EGWP Employer Group Waiver Plan EOC Evidence of Coverage FAI Financial Alignment Initiative FDR First-Tier Downstream and Related Entity FFS Fee-for-Service FIDE SNP Fully Integrated Dual Eligible Special Needs Plan FQHC Federally Qualified Health Center HEDIS Healthcare Effectiveness Data and Information Set HHS Department of Health and Human Services HIDE SNP Highly Integrated Dual Eligible Special Needs Plan HIPAA Health Insurance Portability and Accountability Act of 1996 HOS Health Outcomes Survey HPMS Health Plan Management System HRA Health Risk Assessment HSD Health Service Delivery ICR Information Collection Requirement IRE Independent Review Entity I-SNP Institutional Special Needs Plan LOI Letter of Intent LTSS Long Term Services and Supports MA Medicare Advantage MAC Medicare Administrative Contractor MACPAC Medicaid and CHIP Payment and Access Commission MA-PD Medicare Advantage Prescription Drug 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 MMCO Medicare-Medicaid Coordination Office 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 PAHP Prepaid Ambulatory Health Plan PBP Plan Benefit Package PDE Prescription Drug Event PDP Prescription Drug Plan PHE Public Health Emergency PIHP Prepaid Inpatient Health Plan PRA Paperwork Reduction Act RFI Request for Information RFA Regulatory Flexibilities Act RHC Rural Health Clinic SAE Service Area Expansion SB Summary of Benefits SDOH Social Determinants of Health SHIP State Health Insurance Assistance Program SNP Special Needs Plan SSA Social Security Administration SSBCI Special Supplemental Benefits for the Chronically Ill TPMO Third-Party Marketing Organization Additional information regarding the applicability dates: The Star Ratings provision at § 422.166(i)(12) is applicable to the calculation of the 2023 Star Ratings released in October, 2022, as discussed in section II.D.2. of this final rule. The definition of “fully integrated dual eligible special needs plans (FIDE SNP)” in § 422.2 at paragraphs (2)(i) and (iii) through (v), (5), and (6) as discussed in section II.A.5 of this final rule are applicable beginning January 1, 2025. The definition of “highly integrated dual eligible special needs plans” in § 422.2 at paragraph (3), as discussed in section II.A.5.f. of this final rule, is applicable beginning January 1, 2025. The applicability date of the requirements at § 422.101, as discussed in section II.A.4. of this final rule, is January 1, 2024. The requirements at § 423.100, as discussed in section II.H. of this final rule, are applicable beginning on January 1, 2024. I. Executive Summary A. Purpose Over 29 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 23 million individuals receive Part D coverage through standalone Part D plans. The primary purpose of this final rule is to implement changes to the MA and Part D programs. This final rule implements 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 final rule also revises regulations related to dual eligible special needs plans (D-SNPs), other special needs plans, and Medicare cost contract plans. B. Summary of Major Provisions 1. Enrollee Participation in Plan Governance (§ 422.107) Managed care plans derive significant value from engaging enrollees in defining, designing, participating in, and assessing their care systems. 1 Through this final rule, we require that any MA organization offering a D-SNP establish one or more enrollee advisory committees in each State to solicit direct input on enrollee experiences. We also establish that the committee must include a reasonably representative sample of individuals enrolled in theD-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. Public comments on our proposal reinforced our belief 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. 1 Centers for Medicare & Medicaid Services. (n.d.). Person & Family Engagement Strategy: Sharing with Our Partners. Retrieved from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/Person-and-Family-Engagement-Strategy-Summary.pdf. 2. Standardizing Housing, Food Insecurity, and Transportation Questions on Health Risk Assessments (§ 422.101) Section 1859(f)(5)(A)(ii)(I) of the 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 § 422.101(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 literacy. Building on CMS's experience with other programs and model tests, and with broad support from public commenters, we are finalizing a requirement that all SNPs include one or more questions from a list of screening instruments specified in sub-regulatory guidance on housing stability, food security, and access to transportation as part of their health risk assessments (HRAs). However, based on public comments, we are not finalizing our proposal that all SNPs use the same specific standardized questions. Our final rule will 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 will better equip the MA organizations offering these SNPs to meet the needs of their members. Our final rule will also equip these MA organizations with person-level information that will help them better connect people to covered services, social service organizations, and public programs that can help resolve housing instability, food insecurity, or transportation challenges. 3. Refining Definitions for Fully Integrated and Highly IntegratedD-SNPs (§§ 422.2 and 422.107) Dually eligible individuals have an array of choices for how to receive their Medicare coverage. We proposed 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 increase integration for these types of D-SNPs. In this final rule, we are requiring, for 2025 and subsequent years, that all FIDE SNPs have exclusively aligned enrollment, as defined in § 422.2, and cover Medicare cost-sharing and three specific categories of Medicaid benefits: Home health services (as defined in § 440.70), medical supplies, equipment, and appliances (as described in § 440.70(b)(3)), and behavioral health services through a capitated contract between the State Medicaid agency and the Medicaid managed care organization that is the same legal entity as the MA organization that offers the FIDE SNP. In addition, we are requiring that, for plan year 2025 and subsequent years, each HIDE SNP have a service area that completely overlaps the service area of the affiliated Medicaid managed care plan with the capitated contract with the State. Consistent with existing policy outlined in sub-regulatory guidance, this final rule also codifies specific, limited carve-outs of the Medicaid long-term services and supports and Medicaid behavioral health services covered under the Medicaid capitated contract affiliated with FIDE SNPs and HIDE SNPs. We believe these policies will create better experiences for beneficiaries and move FIDE SNPs and HIDE SNPs toward greater integration, which we believe is a purpose of the amendments to section 1859(f) of the Act regarding integration made by section 50311(b) of the BBA of 2018. 4. Additional Opportunities for Integration Through State Medicaid Agency Contracts (§ 422.107) Section 164 of Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275) amended section 1859(f) of the Act to require that a D-SNP contract with the State Medicaid agency in each State in which the D-SNP operates to provide benefits, or arrange for the provision of Medicaid benefits, to which an individual is entitled. States have used these contracts to better integrate care for dually eligible individuals. In this final rule we codify new pathways through which States can use these contracts to require that certain D-SNPs with exclusively aligned enrollment (a) establish contracts that only include one or more D-SNPs within a State, and (b) use certain integrated materials and notices for enrollees. Where States choose this opportunity, it will help individuals better understand their coverage. Because Star Ratings are assigned at the contract level, this final rule will also provide a mechanism to provide States and the public with greater transparency on the quality ratings for the D-SNP(s), helping CMS and States better identify disparities between dually eligible beneficiaries and other beneficiaries and target interventions accordingly. We also codify mechanisms to better coordinate State and CMS monitoring and oversight of certain D-SNPs when a State has elected to require these additional levels of integration, including granting State access to certain CMS information systems. Collectively, our proposals will improve Federal and State oversight of certainD-SNPs (and their affiliated Medicaid managed care plans) through greater information-sharing among government regulators. 5. Attainment of the Maximum Out-of-Pocket Limit (§§ 422.100 and 422.101) In order to ensure that MA plan benefits do not discriminate against higher cost, less healthy enrollees, MA plans are required to establish a limit on beneficiary cost-sharing for Medicare Part A and B services after which the plan pays 100 percent of the service costs. Current guidance allows MA plans, including D-SNPs, to not count Medicaid-paid amounts or unpaid amounts toward this maximum out-of-pocket (MOOP) limit, which results in increased State payments of Medicare cost-sharing and disadvantages providers serving dually eligible individuals in MA plans. In this final rule we specify that the MOOP limit in an MA plan (after which the plan pays 100 percent of MA costs for Part A and Part B services) must be calculated based on the accrual of all cost-sharing in the plan benefit, regardless of whether that cost-sharing is paid by the beneficiary, Medicaid, other secondary insurance, or remains unpaid (including cost-sharing that remains unpaid because of State limits on the amounts paid for Medicare cost-sharing and dually eligible individuals' exemption from Medicare cost-sharing). The change will result in more equitable payment for MA providers serving dually eligible beneficiaries. We project that our requirement as finalized will result in increased bid costs for the MOOP for some MA plans. A portion of those higher bid costs will result in increased Medicare spending of $3.9 billion over 10 years. That cost is partially offset by lower Federal Medicaid spending of $2.7 billion and the portion of Medicare spending paid by beneficiary Part B premiums, which totals $600 million over 10 years. The net Federal 10-year cost estimate for the finalized requirement is $614.8 million. 6. Special Requirements During a Disaster or Emergency for Medicare Advantage Plans (§ 422.100(m)) In order to ensure enrollees have uninterrupted access to care, current regulations provide for special requirements at § 422.100(m) for MA plans during disasters or emergencies, including public health emergencies (PHEs), such as requirements for plans to cover services provided by non-contracted providers and to waive gatekeeper referral requirements. The timeframe during which these special rules apply can be very specific depending on the type or scope of the disaster or emergency, while other situations, like the PHE for COVID-19, may have an uncertain end date. Currently, the regulation states that a disaster or emergency ends (thus ending the obligation for MA plans to comply with the special requirements) the earlier of when an end date is declared or when, if no end date was identified in the declaration or by the official that declared the disaster or emergency, 30 days have passed since the declaration. This has caused some confusion among stakeholders, who are unsure whether to continue special requirements during a state of disaster or emergency after 30 days, or whether those special requirements do not apply after the 30-day time period has elapsed. In this final rule, we clarify the period of time during which MA organizations must comply with the special requirements. Under this final rule, MA organizations must ensure access for enrollees to covered services throughout the disaster or emergency period, including when the end date is unclear and the period renews several times, so long as there is a disruption of access to healthcare. 7. Amend MA Network Adequacy Rules by Requiring a Compliant Network at Application (§ 422.116) We proposed to amend § 422.116 to require applicants to demonstrate that they meet the network adequacy standards for the pending service area as part of the MA application process for new and expanding service areas and to adopt a time-limited 10-percentage point credit toward meeting the applicable network adequacy standards for the application evaluation. Under our current rules, we require that an applicant attest that it has an adequate provider network that provides enrollees with sufficient access to covered services, and we will not deny an application based on the evaluation of the MA plan's network. Network adequacy reviews are a critical component for confirming that access to care is available for enrollees. As such, we believe that requiring applicants to meet network adequacy standards as part of the application process will strengthen our oversight of an organization's ability to provide an adequate network of providers to deliver care to MA enrollees. This change will also provide MA organizations with information regarding their network adequacy ahead of bid submissions, mitigating current issues with late changes to the bid that may affect the bid pricing tool. Finally, we understand that it may be difficult for applicants to have a full network in place almost 1 year ahead of the beginning of the contract as the proposed change for network adequacy rules will require. Therefore, the final rule includes a 10-percentage point credit towards the percentage of beneficiaries residing within published time and distance standards for new or expanding service area applicants. Once the contract is operational, the 10-percentage point credit will no longer apply and MA organizations will need to meet full compliance. We are finalizing our proposal, with one modification; to allow applicants to utilize Letters of Intent (LOIs) to meet network standards in counties and specialty types as needed. Once the contract is operational, MA organizations must have signed contracts with providers and facilities to be in full compliance. 8. Part C and Part D Quality Rating System Due to the scope and duration of the COVID-19 PHE, we adopted a technical change to the 2022 Star Ratings methodology for extreme and uncontrollable circumstances in the “Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” published in the Federal Register and effective on September 2, 2020 (hereafter referred to as the “September 2nd COVID-19 IFC”), 2 (CMS-3401-IFC; 85 FR 54820) at 42 CFR 422.166(i)(11) to make it possible for us to calculate 2022 Star Ratings for MA contracts. We proposed making a technical change at § 422.166(i)(12) to enable CMS to calculate 2023 Star Ratings for three Healthcare Effectiveness Data and Information Set measures that are based on the Health Outcomes Survey (87 FR 1842, January 12, 2022). Specifically, these measures are Monitoring Physical Activity, Reducing the Risk of Falling, and Improving Bladder Control. Without this technical change, CMS will be unable to calculate measure-level 2023 Star Ratings for these measures for any MA contract. We are therefore finalizing § 422.166(i)(12) without modification. In this final rule, we also respond to comments we received on the Medicare Advantage and Part D Star Ratings provisions in the interim final rules titled “Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” published in the Federal Register on April 6, 2020, with a March 31, 2020 effective date (hereafter referred to as the “March 31st COVID-19 IFC”) 3 (85 FR 19230) and the September 2nd COVID-19 IFC. As detailed in sections II.D.3. and II.D.4. of this final rule, we are finalizing most of the Star Ratings provisions from the March 31st COVID-19 IFC and the September 2nd COVID-19 IFC, but we are not finalizing several Star Ratings provisions in those interim final rules, regarding circumstances that did not happen, because they are moot. CMS will address other provisions from the interim final rules in other rulemakings. 2 www.federalregister.gov/documents/2020/09/02/2020-19150/medicare-and-medicaid-programs-clinical-laboratory-improvement-amendments-clia-and-patient . 3 www.federalregister.gov/documents/2020/04/06/2020-06990/medicare-and-medicaid-programs-policy-and-regulatory-revisions-in-response-to-the-covid-19-public . 9. Past Performance Methodology to Better Hold Plans Accountable for Violating CMS Rules (§§ 422.502 and 422.503) In a previous rulemaking cycle, CMS modified the past performance methodology, revising the elements that are reviewed to determine if CMS should permit an organization to enter into a new contract or expand an existing contract. The current regulatory language prohibits an organization from expanding or entering into a new contract if it has a negative net worth or has been under sanction during the performance timeframe. In this final rule, we include an organization's record of Star Ratings, bankruptcy issues, and compliance actions in our methodology going forward. 10. Marketing and Communications Requirements on MA and Part D Plans To Assist Their Enrollees (§§ 422.2260 and 423.2260, 422.2267 and 423.2267, 422.2274 and 423.2274) CMS has seen an increase in beneficiary complaints associated with third-party marketing organizations (TPMOs) and has received feedback from beneficiary advocates and stakeholders concerned about the marketing practices of TPMOs who sell multiple MA and Part D products. In 2020, we received a total of 15,497 complaints related to marketing. In 2021, excluding December, the total was 39,617. We are unable to say that every one of the complaints is a result of TPMO marketing activities, but based on a targeted search, we do know that many are related to TPMO marketing. In addition, we have seen an increase in third party print and television ads, which appears to be corroborated by State partners. Through this final rule, we will address the concerns with TPMOs by means of the following three updates to the communications and marketing requirements under 42 CFR parts 422 and 423, subpart V: (1) We define TPMOs in the regulation at §§ 422.2260 and 423.2260 to remove any ambiguity associated with MA plans/Part D sponsors responsibilities for TPMO activities associated with the selling of MA and Part D plans; (2) we add a new disclaimer that will be required when TPMOs market MA plans/Part D products (§§ 422.2267(e) and 423.2267(e)); and (3) we update §§ 422.2274 and 423.2274 to require additional plan oversight requirements associated with TPMOs, in addition to what is already required under §§ 422.504(i) and 423.505(i) if the TPMO is a first tier, downstream or related entity (FDR). CMS' January 2021 final rule, entitled “Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” (86 FR 5864) did not require notice and taglines, based on the HHS Office for Civil Rights repeal of certain notice and tagline requirements associated with section 1557 of the Affordable Care Act. In the months since the publication of this rule, CMS gained additional insight regarding the void created by the lack of these notification requirements. Based on the significant population (12.2 percent) of those 65 and older who speak a language other than English in the home and complaints CMS received through our Complaint Tracking Module, in this final rule we are finalizing a requirement that MA and Part D plans create a multi-language insert that will inform the reader, in the top fifteen languages used in the U.S., as well as any additional non-English language that is the primary language of at least 5 percent of the individuals in a plan benefit package service area, that interpreter services are available for free. As a note, CMS provides plans a list of all languages that are spoken by 5 percent or more of the population for every county in the U.S. As part of the finalized requirement, plans will be required to include the multi-language insert whenever a Medicare beneficiary is provided a CMS required material (for example, Evidence of Coverage, Annual Notice of Change, enrollment form, Summary of Benefits) as defined under §§ 422.2267(e) and 423.2267(e). We further note that existing statutes, including Section 504 of the Rehabilitation Act and 1557 of the Affordable Care Act, require the provision of any auxiliary aids and services required for effective communication for individuals with disabilities at no cost to the individual. Finally, in this final rule we are codifying a number of current sub-regulatory communications and marketing requirements that were inadvertently not included during the previous updates to 42 CFR parts 422 and 423, subpart V. 11. Greater Transparency in Medical Loss Ratio Reporting (§§ 422.2460 and 423.2460) To improve transparency and oversight concerning the use of Trust Fund dollars, we reinstate the detailed medical loss ratio (MLR) reporting requirements that were in effect for contract years 2014 to 2017, which required reporting of the underlying data used to calculate and verify the MLR and any remittance amount, such as incurred claims, total revenue, expenditures on quality improving activities, non-claims costs, taxes, and regulatory fees. In addition, the new MLR reporting templates will require additional details regarding plan expenditures so we can better assess the accuracy of MLR submissions, the value of services being provided to enrollees under MA and Part D plans, and the impacts of recent rule changes that removed limitations on certain expenditures that count toward the 85 percent MLR requirement. 12. Pharmacy Price Concessions to Drug Prices at the Point of Sale (§§ 423.100 and 423.2305) The “negotiated prices” of drugs, as the term is currently defined in § 423.100, must include all network pharmacy price concessions except those contingent amounts that cannot “reasonably be determined” at the point-of-sale. Under this exception, negotiated prices typically do not reflect any performance-based pharmacy price concessions that lower the price a sponsor ultimately pays for a drug, based on the rationale that these amounts are contingent upon performance measured over a period that extends beyond the point of sale and thus cannot reasonably be determined at the point of sale. We proposed to eliminate this exception for contingent pharmacy price concessions (87 FR 1842, January 12, 2022). We proposed to delete the existing definition of “negotiated prices” at § 423.100 and to adopt a new definition for the term “negotiated price” at § 423.100, which we proposed to define as the lowest amount a pharmacy could receive as reimbursement for a covered Part D drug under its contract with the Part D plan sponsor or the sponsor's intermediary (that is, the amount the pharmacy will receive net of the maximum negative adjustment that could result from any contingent pharmacy payment arrangement and before any additional contingent payment amounts, such as incentive fees). We proposed to allow plans the flexibility to determine how much of the pharmacy price concessions to pass through at the point of sale for applicable drugs in the coverage gap phase of the benefit. After consideration of the comments, we are modifying our proposal to apply the new definition of “negotiated price” to all phases of the Part D benefit, including the coverage gap phase. We are also amending the definition of “negotiated price” at § 423.2305 by revising paragraphs (1) and (2) of the definition of “negotiated price” for the Coverage Gap Discount Program to be consistent with the definition of “negotiated price” that we are adopting at § 423.100 (that is, the lowest possible reimbursement such network entity will receive, in total, for a particular drug). This policy takes effect 60 days after publication of the final rule and is applicable beginning on January 1, 2024. Part D sponsors will need to account for these changes in the bids that they submit for contract year 2024. In this final rule, we add a definition of “price concession” at § 423.100. Although “price concession” is a term important to the adjudication of the Part D program, it had not yet been defined in the Part D statute, Part D regulations, or sub-regulatory guidance. We define price concession to include any form of discount, direct or indirect subsidy, or rebate received by the Part D sponsor or its intermediary contracting organization from any source that serves to decrease the costs incurred under the Part D plan by the Part D sponsor. C. Summary of Costs and Benefits BILLING CODE 4120-01-P ER09MY22.000 ER09MY22.001 ER09MY22.002 ER09MY22.003 ER09MY22.004 BILLING CODE 4120-01-C D. Background We received approximately 6,179 timely pieces of correspondence containing one or more comments for the provisions addressed in this final rule from the proposed rule titled “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs” which appeared in the Federal Register on January 12, 2022 (hereafter referred to as the January 2022 proposed rule, 87 FR 1842). Comments were submitted by MA health plans, Part D sponsors, beneficiaries, MA enrollee and beneficiary advocacy groups, trade associations, providers, pharmacies and drug companies, States, telehealth and health technology organizations, policy research organizations, actuarial and law firms, MACPAC, MedPAC, Members of Congress, and other vendor and professional associations. The proposals we are finalizing in this final rule range from minor clarifications to more significant modifications based on the comments received. Summaries of the public comments received and our responses to those public comments are set forth in the various sections of this final rule under the appropriate headings. We received an overarching comment related to the proposed rule, which we summarize in the following paragraphs: Comment: A commenter expressed a concern about the timing of the provisions included in the proposed rule related to the deadline for bid submissions, especially related to proposals with contract year 2023 effective dates. The commenter noted that several proposals would require operational and technical changes for MA organizations as well as additional resource allocations, and, as such, welcomed additional time for implementation. The commenter suggested it could better align and collaborate with CMS in the future if given more time to fully understand and implement proposed changes. Response: We understand and appreciate the commenter's concerns and MA organizations and Part D sponsors' willingness to work to meet the implementation date timeframes. In response to comments, we are modifying the date on which some of the new and amended regulations in this final rule become applicable. We describe these modifications in further detail in the respective sections of the rule. We also note that some of the public comments received for the provisions implemented in this final rule were outside of the scope of the proposed rule. As such, these out-of-scope public comments are not addressed in this final rule. The following paragraphs summarize the out-of-scope public comments. A commenter noted that long-term care provider-led institutional special needs plans (I-SNPs) offer a strong additional solution to States in integrated efforts, especially for long-term care services uses with complex, high risk needs. We received a few comments related to D-SNP look-alikes, which are addressed at § 422.514(d). A commenter requested that CMS consider reducing the threshold for a D-SNP look-alike from the current 80 percent of dually eligible individuals enrolled to 50 percent and requiring the Medicare program to inform individuals that they are enrolling in a non-integrated model where an integrated model exists. Without such action, this commenter expressed that D-SNP look-alikes could undermine progress on integration, leading to the erosion of D-SNP enrollment over time and additional beneficiary confusion. Another commenter requested that CMS reconsider its current policy for States without a D-SNP option for partial-benefit dually eligible individuals by either allowing these individuals to enroll in FIDE SNPs or excluding them from the 80-percent threshold calculation used to determine D-SNP look-alikes in these States. A few commenters encouraged CMS to consider applying other MMP design elements to D-SNPs. These included extending contract management teams to HIDE SNPs and FIDE-SNPs, D-SNPs with exclusively aligned enrollment, and/or D-SNPs with a meaningful proportion of enrollees who receive Medicaid benefits from a managed care plan affiliated with the D-SNP; requiring D-SNPs to develop single case agreement policies to enable enrollees to see out-of-network providers; applying MMP program audit rules and protocols to D-SNPs with exclusively aligned enrollment; and allowing beneficiaries to enroll in integrated plans on a monthly basis rather than the roughly quarterly enrollment opportunities under MA. MACPAC noted that while the provisions in the proposed rule promote integration in existing products, they do not necessarily increase the availability of integrated models or enrollment in integrated plans and urged CMS to look for ways to expand policies to promote integration beyond D-SNPs with exclusively aligned enrollment in future rulemaking. A commenter encouraged CMS to reconsider its approach to setting separate requirements for D-SNPs and Medicaid managed care plans and to align Federal regulations for FIDE SNPs with those that already exist for Medicaid managed care. A commenter recommended that CMS take steps to reduce limitations on data sharing between plans and States and provide additional guidance on creating a standardized and electronic method to integrate information in model materials. A few commenters recommended that CMS take steps to ensure that quality measurement is appropriately targeted to the populations served by each product and that measurement and related financial incentives do not disproportionately penalize D-SNPs for serving populations with greater risk factors. Other commenters urged CMS to require all States to adopt standardized, disability-informed quality measurement tools so that measures are collected and reported in a uniform format. A few commenters expressed concern related to quality measurement for D-SNPs more broadly. A commenter stated that because of the challenges inherent to serving younger dually eligible beneficiaries with disabilities who represent the most complex and at-risk Medicare members with the most social risk factors, plans serving this population have less quality bonus funding available to support supplemental benefits tailored to the population. A commenter suggested CMS consider revising the requirement that the D-SNP and Medicaid managed care plan contract holder must be the same legal entity in order to qualify as a FIDE SNP; instead, the commenter recommended using the same requirement that is used for HIDE SNPs that the contract holder is the same parent organization or another entity that is owned and controlled by its parent organization. A few commenters requested CMS consider additional financial policies. A commenter encouraged CMS to require States to ensure that the capitated payments for HIDE SNPs and FIDE SNPs are documented in the State Medicaid agency contract. Another commenter noted that the existing risk adjustment methodology is not sensitive to pick up all of the nuances for D-SNPs that largely serve populations with more complex care. A commenter requested that CMS consider clarifying elements of the cost-sharing billing process during an enrollee's Medicare deeming period, including prohibiting Medicare cost-sharing being billed to dually eligible individuals during the Medicare deeming period. A commenter requested guidance on how to handle cost-sharing for supplemental benefits that may overlap with what is provided by Medicaid. A commenter expressed concern regarding the complaint resolution process for dually eligible individuals, noting that it is fragmented and confusing when some issues are handled by State Medicaid agencies or plans while others are handled by CMS or MA plans. The commenter noted that “no wrong door” policies for enrollee concerns are critical to ensuring complaints are addressed. A commenter urged CMS to consider the limited availability of transportation options in rural communities when finalizing the proposed rule. A commenter expressed interest in additional research to better understand fluctuations within dual eligibility and what may cause a partial-benefit dually eligible individual to become a full-benefit dually eligible individual and encouraged CMS to assess whether integrated models can help prevent partial-benefit dual eligible individuals from necessitating full-benefit status. A commenter suggested that another approach to improving integrated care is to establish a single program that would provide dually eligible beneficiaries with their medical, long-term care, behavioral, and social needs. They further suggested the program allow States to contract with the administering entities, which would bear two-sided risk to ensure accountability and eliminate incentives for cost-shifting. A commenter expressed concerns about the MA program overall, including inadequate care provided to MA enrollees, low payments to providers, and high MA payment rates compared to the original Medicare fee-for-service (FFS) program. CMS received a number of comments regarding extending the COVID-19 disaster adjustments that all contracts received for the 2022 Star Ratings for measures other than HEDIS-HOS measures and reducing the weight applied to the patient experience/complaints and access measures for the 2023 Star Ratings. CMS received many comments regarding network adequacy requirements and policies that are outside of the scope of this rule. Some commenters indicated that CMS should consider reinstating previous network adequacy standards including returning to the 90 percent rate of beneficiary requirements within time and distance standards for micro, rural and counties with extreme access considerations, as well as including dialysis facilities as a specialty type evaluated for network adequacy under § 422.116(b). Many commenters recommended that CMS add criteria to our current network adequacy standards. For example, commenters recommended that CMS add new provider and facility specialty types, including sub-specialty types, to our list of those which are evaluated for network adequacy standards under § 422.116(b). Some commenters suggested that CMS increase the frequency in which network adequacy formal reviews are conducted or align the triennial network adequacy review timelines with the application timeline. A commenter suggested that CMS integrate network adequacy into Star Ratings measures. A few commenters suggested that CMS consider how increased use of telehealth-provided services will impact network adequacy, and that CMS should consider expanding the telehealth credit in certain county types such as rural counties. A few commenters recommended CMS establish policies to enhance information available in MA plan network directories. A commenter suggested that CMS consider changes and improvements to the network adequacy exceptions and criteria process. A commenter provided recommendations regarding how network adequacy standards should recognize and address the unique needs of enrollees in I-SNPs. A commenter recommended CMS develop network standards specific to the D-SNP population. Additional topics out of scope of this rule include requests to update timelines for release of the Reference and Sample Beneficiary Files, make MA organizations' network adequacy review data publicly available, and limit organization's ability to make changes to network providers throughout the contract year. CMS received some comments regarding special requirements during emergency and disasters that are out of scope for this rule. A commenter asked CMS to provide guidance about online or point-of-sale processing of Part B out-of-network claims during a disaster or emergency. Another commenter expressed concerns that these requirements do not apply to Part D drugs. A commenter suggested that we take a more holistic approach to past performance. The commenter suggested we review all contracts for past performance and not just applicants. We received several out-of-scope comments related to the provision on applying all pharmacy price concessions to the negotiated price at the point of sale. A few commenters urged CMS to address pharmacy benefit managers' (PBMs') formularies, specifically the preference for brand medications over generics due to the rebates and with respect to the use of biosimilars as they launch. Many commenters asked that CMS address the “reasonable and relevant” contracting terms and conditions between MA organizations/plan sponsors and pharmacies. A few commenters expressed concern with vertical integration of PBMs and pharmacies. A few commenters were concerned about the costs of COVID-19 tests and treatments. Some commenters stated that CMS should not make the changes associated with this Pharmacy Price Concessions rule when it should instead be working to wind down or officially incorporate policies put in place during the COVID-19 PHE. Some commenters stated that the proposal failed to address the root cause of high drug prices and offered recommendations for regulating the pharmaceutical industry. A few commenters stated that PBMs should not set drug prices and encouraged CMS to make sweeping reforms including a patient bill of rights and a pharmacy bill of rights. A few commenters stated that PBMs cannot engage in sub-capitation arrangements that require pharmacies to bear risk. Some commenters requested CMS re-evaluate its policy on U.S. Food and Drug Administration (FDA)-approved anti-obesity medications. Other commenters recommended that CMS do more to improve access to the Part D Low-Income Subsidy (LIS) program, noting the program's importance to improving health equity and the nearly three million beneficiaries who are eligible for the program but not enrolled. This commenter also requested that CMS track and report on the number of complaints received regarding Part D plans charging individuals enrolled in the full LIS program the higher plan copayment rather than the established LIS copayment. Unless otherwise noted, cites to regulations are to title 42 of the CFR. II. Provisions of the Proposed Rule and Analysis of and Responses to Public Comments A. Improving Experiences for Dually Eligible Individuals 1. Overview and Background Over 11 million people are concurrently enrolled in both Medicare and Medicaid. Beneficiaries who are dually eligible for both Medicare and Medicaid can face significant challenges in navigating the two programs, which include separate or overlapping benefits and administrative processes. Fragmentation between the two programs can result in a lack of coordination for care delivery, potentially resulting in: (1) Missed opportunities to provide appropriate, high-quality care and improve health outcomes; and (2) undesirable outcomes, such as avoidable hospitalizations and poor beneficiary experiences. Advancing policies and programs that integrate care for dually eligible individuals is one way in which we seek to address such fragmentation. 4 4 For example, see chapter 1 of Medicaid and CHIP Payment and Access Commission, Report to Congress on Medicaid and CHIP, June 2021, and chapter 12 of Medicare Payment Advisory Committee, June 2019 Report to the Congress: Medicare and the Health Care Delivery System. “Integrated care” refers to delivery system and financing approaches that— • Maximize person-centered 5 coordination of Medicare and Medicaid services, across primary, acute, long-term, behavioral, and social domains; 5 “Person-centered care” typically refers to focusing care on the needs of the individual and ensuring that a person's individual preferences, needs, and values guide care decisions. This is in contrast to approaches to care in which the specific diagnosis or illness drives care and treatment decisions. See the National Center on Advancing Person-Centered Practices and Systems for additional information: https://ncapps.acl.gov/home.html. • Mitigate cost-shifting incentives, including total-cost-of-care accountability across Medicare and Medicaid; and • Create seamless experiences for beneficiaries. We described at 87 FR 1849 through 1850 of the proposed rule a range of approaches to integrating Medicare and Medicaid benefits or financing for dually eligible individuals, including through demonstrations and existing programs. The most prevalent forms of integrated care use capitated financing, including capitation of health plans to cover the full range of Medicare and Medicaid services. The number of dually eligible individuals in integrated care or financing models or both has increased over time, now exceeding 1 million beneficiaries, but it remains the exception rather than the rule in most States. 6 6 CMS Medicare-Medicaid Coordination Office FY 2020 Report to Congress, available at: https://www.cms.gov/files/document/reporttocongressmmco.pdf. An increasing number of dually eligible individuals are enrolled in managed care plans. The broader trend toward managed care presents opportunities for integrated care. It also presents risks for further fragmentation and complexity. In fact, while enrollment in integrated care has increased, it is also becoming increasingly likely that dually eligible individuals are in one sponsor's Medicaid managed care organization (MCO) and a competitor's D-SNP. The result: Duplicative health risk assessments (HRAs); multiple ID cards, handbooks, and provider and pharmacy directories; strong incentives for cost-shifting where possible; multiple care coordinators; more complex billing processes for providers; and similar other fragmented care, burdens, or increased costs. Section 2602 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (Affordable Care Act) established the Medicare-Medicaid Coordination Office (MMCO) within CMS to better align and integrate benefits for dually eligible individuals. Section 50311(b)(2) of the Bipartisan Budget Act (BBA) of 2018 amended that provision to also charge MMCO with— • Developing regulations and guidance related to the integration or alignment of policy and oversight under Medicare and Medicaid regarding D-SNPs; and • Serving as the single point of contact for States on D-SNP issues. At 87 FR 1850 of the proposed rule, we described recent MA/Part D rulemaking to enhance D-SNPs. Despite this recent work, additional actions are needed to maximize the potential of D-SNPs to deliver person-centered integrated care—and ultimately better health outcomes and independence in the community—for dually eligible older adults, people with disabilities, and people with end stage renal disease. We are working to improve and increase options for more integrated care in a variety of ways, including through D-SNPs. a. Dual Eligible Special Needs Plans Special needs plans (SNPs) are MA plans created by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) that are specifically designed to provide targeted care and limit enrollment to special needs individuals. Under section 1859(b)(6) of the Act, SNPs restrict enrollment to certain populations. The most common type of SNP is a dual eligible special needs plan, or D-SNP, in which enrollment is limited to individuals entitled to medical assistance under a State plan under title XIX of the Act. D-SNPs are intended to integrate or coordinate care 7 for dually eligible individuals more effectively than standard MA plans or the original Medicare fee-for-service (FFS) program by focusing enrollment and care management on this population. As of January 2022, approximately 4.0 million dually eligible individuals (more than 1 of every 4 dually eligible individuals) were enrolled in 729 D-SNPs. 8 7 “Care coordination” typically refers to the managing of care and sharing of information among medical and non-medical providers and supports across the spectrum primary, acute, behavioral health, long-term services and supports. See, for example, https://www.ahrq.gov/ncepcr/care/coordination.html , and Barth, S., Silow-Carroll, S., Reagan, Russell, M., Simmons, T. (2019) Care Coordination in Integrated Care Programs Serving Dually Eligible Beneficiaries—Health Plan Standards, Challenges and Evolving Approaches. Report to the Medicaid and CHIP Payment and Access Commission. https://www.macpac.gov/wp-content/uploads/2019/03/Care-Coordination-in-Integrated-Care-Programs-Serving-Dually-Eligible-Beneficiaries.pdf. 8 Centers for Medicare & Medicaid Services. SNP Comprehensive Report (January 2021). Retrieved from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html . Federal statute and implementing regulations have established several requirements for D-SNPs in addition to those that apply to all MA plans to promote coordination of care, including HRA requirements as described in section 1859(f)(5)(A)(ii)(I) of the Act and at 42 CFR 422.101(f)(1)(i), evidence-based models of care (MOCs) as described in section 1859(f)(5)(A)(i) of the Act and at 42 CFR 422.101(f), and contracts with State Medicaid agencies as described in section 1859(f)(3)(D) of the Act and at 42 CFR 422.107. The State Medicaid agency contracting requirement allows States to require greater integration of Medicare and Medicaid benefits from the D-SNPs in their markets. Most recently, section 50311(b) of the BBA of 2018 amended section 1859 of the Act to add new requirements for D-SNPs, beginning in 2021, including minimum integration standards, coordination of the delivery of Medicare and Medicaid benefits, and unified appeals and grievance procedures for integrated D-SNPs, the last of which we implemented through regulation to apply to certain D-SNPs with exclusively aligned enrollment, termed “applicable integrated plans.” These requirements, along with clarifications to existing regulations, were codified in the “Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021” final rule (84 FR 15696 through 15744) (hereinafter referred to as the April 2019 final rule). 9 9 See https://www.govinfo.gov/content/pkg/FR-2019-04-16/pdf/2019-06822.pdf . For a more comprehensive review of D-SNPs and legislative history, see the proposed rule titled “Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” (85 FR 9018 through 9021), which appeared in the Federal Register on February 18, 2020. 10 10 See https://www.govinfo.gov/content/pkg/FR-2020-02-18/pdf/2020-02085.pdf . b. Medicare-Medicaid Plans To test additional models of integrated care, we established the Medicare-Medicaid Financial Alignment Initiative (FAI) in July 2011 with the goal of improving outcomes and experiences for full-benefit dually eligible individuals while reducing costs for both States and the Federal Government. This State-Federal partnership is tested using authority under 1115A of the Act (as added by section 3021 of the Affordable Care Act) and further described below. Although the FAI includes two models, the model with the largest number of States participating is a capitated model through which CMS, the State, and health plans (called Medicare-Medicaid Plans or MMPs) enter into three-way contracts to coordinate the full array of Medicare and Medicaid services for members. Our proposed rule at 87 FR 1851 through 1854 summarized the key elements offered by MMPs under the capitated model demonstrations. As discussed in the proposed rule at 87 FR 1851, CMS and States partnered with MMPs to create a seamless experience for beneficiaries, but MMPs operate as both MA organizations offering Medicare Advantage Prescription Drug (MA-PD) plans and Medicaid managed care organizations. As such, unless waived by CMS, MMPs are required to comply with Medicaid managed care requirements under 42 CFR part 438, with MA (also known as Part C) requirements in title XVIII of the Act as well as 42 CFR part 422 and, with regard to the Medicare prescription drug benefit, Part D requirements in title XVIII of the Act and 42 CFR part 423. Section 1115A of the Act (as added by section 3021 of the Affordable Care Act) authorizes waiver of certain Medicare provisions and CMS used that authority to waive several Medicare requirements for the FAI. For States participating in the capitated model, CMS typically uses authority under section 1115(a), 1915(b), 1915(c), or 1932(a) of the Act to waive or exempt the State from certain provisions of title XIX of the Act or establish the authority to deliver Medicaid services through managed care. As of January 2022, there are 39 MMPs in nine States serving approximately 424,000 members. 11 11 MMP enrollment as of January 2022. See CMS Monthly Enrollment by Contract Report (January, 2022). Retrieved from https://www.cms.gov/research-statistics-data-and-systemsstatistics-trends-and-reportsmcradvpartdenroldatamonthly/enrollment-contract-2022-01 . As summarized at 87 FR 1851 through 1854 in our proposed rule, while an independent evaluation of the FAI is still underway, we have already gleaned several lessons regarding integrated, managed care from the capitated financial alignment model: • Enrollee participation in governance helps identify and address barriers to high-quality, coordinated care; • Assessment processes are a vehicle for identifying and addressing unmet needs, particularly those related to social determinants of health; • Medicare-Medicaid integration correlates with high levels of beneficiary satisfaction; • Carving in Medicaid behavioral health benefits helps promote better coordination of behavioral health and physical health services; • Integrated beneficiary communication materials can enhance the beneficiary experience; • Effective joint oversight of integrated managed care products is possible; • Integrated care and joint oversight provide a platform for quality improvement; • There is potential for market distortions in areas with multiple options targeting the same population; and • State investment is critical to successful implementation of integrated care either through MMPs or D-SNPs. Since the outset of the FAI, our shared goal with State partners has been to develop models that promote greater Medicare-Medicaid integration that, if successful, could be implemented on a broader scale. We proposed to incorporate into the broader MA program many of the MMP practices that successfully improved experiences for dually eligible individuals. 2. Summary of D-SNP Proposals Related to MMP Characteristics Many of the proposals in the proposed rule would incorporate certain MMP policies into the regulations governing D-SNPs or, in several cases, certain types of D-SNPs. We included a table (87 FR 1854) summarizing how our proposals relate to MMP policies. Section II.A.14 of this final rule includes an updated version of that table to reflect the policies adopted in this final rule. Comment: Several commenters, including MACPAC, described the challenges dually eligible individuals and their providers and families experience navigating separate and fragmented Medicare and Medicaid delivery systems. A commenter noted suboptimal care coordination can compromise patient care and increase overall program spending. A commenter noted younger dually eligible individuals face health inequities caused by institutional racism and other systematic disadvantages. A few commenters encouraged full integration and MACPAC cited recent Bipartisan Policy Center reports 12 urging full integration of Medicare and Medicaid services for all full-benefit dually eligible individuals. Another commenter emphasized that coverage of medical, behavioral health, and long-term services and supports should be aligned and integrated care should be grounded in the diversity of dually eligible enrollees, tailored to individuals' needs and preferences, prioritize care coordination, simplify eligibility and enrollment processes, minimize administrative burdens, and honor enrollee choice of plan and providers. 12 Bipartisan Policy Center, Guaranteeing Integrated Care for Dual Eligible Individuals (2021) and A Pathway to Full Integration of Care for Medicare-Medicaid Beneficiaries (2020). Response: We appreciate the comments and we agree that a fragmented delivery system raises major issues, as we discussed in the proposed rule (87 FR 1849 through 1850). We are committed to maximizing opportunities for integration through the proposals finalized in this rule and will continue to explore additional ways to better align the Medicare and Medicaid programs in the future. We acknowledge the comment about dually eligible individuals experiencing health inequities caused by institutional racism and other systematic disadvantages. Addressing such inequity is a major focus of CMS and other Federal agencies, based in part on Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (January 20, 2021). Comment: Numerous commenters supported the overall focus of the proposals to better integrate Medicare and Medicaid services, incrementally strengthen and improve integration for D-SNPs, advance health equity, and improve the beneficiary experience for older adults and people with disabilities. A few commenters indicated these proposals improve the potential for D-SNPs to provide person-centered care and support enrollees to remain independent and manage their health and daily activities. A few commenters indicated the proposals provide States with greater D-SNP coordination and oversight opportunities. A few commenters believed the proposals would tighten and clarify requirements for D-SNPs. A commenter indicated the proposals would help simplify D-SNP offerings, and another commenter noted support for the proposed rule's goal of strengthening consumer protections to ensure dually eligible individuals have access to accurate and accessible information about health plan choices and benefits. A few commenters believed the proposals would help engage enrollees in designing and participating in care. Another commenter indicated the proposals offer the potential for both administrative and clinical integration at the plan level. A commenter encouraged CMS to couple implementation of the final rule with guardrails to mitigate against potential unintended consequences. Another commenter encouraged CMS to quickly adopt regulations that reflect stakeholder recommendations in light of the rapid growth of D-SNPs. Several commenters expressed support for the package of D-SNP proposals as useful incremental steps toward furthering integrated care via D-SNPs. A commenter encouraged CMS to consider how steps taken now build towards a broader long-term vision for integrated care. Another commenter acknowledged that CMS did not want to be prescriptive but encouraged CMS to provide sufficient detail with regard to the array of D-SNP proposals when finalizing the rule given the recent growth in the D-SNP landscape. Response: We appreciate the widespread support for our proposals. As discussed in the proposed rule (87 FR 1850), these proposals build on two recent MA/Part D rulemakings and our experiences with MMP policies. We believe this final rule will further the potential of D-SNPs to deliver person-centered integrated care—and ultimately better health outcomes and independence in the community—for dually eligible older adults, people with disabilities, and people with end stage renal disease. As we discuss later in this section under specific proposals, we will provide technical assistance, monitor implementation of the finalized provisions, and consider future rulemaking as needed to address any identified areas of concern. For example, information from CMS audits will help us monitor the extent to which MA organizations are meeting the enrollee advisory committee requirements at § 422.107(f), and we may consider more prescriptive requirements, as needed, based on implementation experience. We acknowledge the request for additional detail related to some of the D-SNP proposals. As we discuss in response to comments on specific proposals later in this section, we aim to strike a balance between providing MA organizations with flexibility in implementing various finalized requirements versus being more prescriptive. We explain our rationale further in responses to comments, including related to requirements for enrollee advisory committees at § 422.107(e), SDOH questions in SNP HRAs at § 422.101(f)(1)(i), and limited carve-outs of Medicaid behavioral health services and long-term services and supports (LTSS) at § 422.107(g) and (h). Comment: A number of commenters commended CMS for applying lessons learned from MMPs to D-SNPs and providing a long-term strategy for D-SNPs as an integrated plan option. A few commenters stated that the MMP demonstrations created a gold standard for integrated care and have given beneficiaries avenues for providing input on plan operations though beneficiary advisory committees; enhanced the beneficiary experience through integrated communications materials; scaled up person-centered care planning and care coordination including effectively combining medical and behavioral health benefits; and delivered a platform for incentivizing innovation and investment to improve quality of care for dually eligible individuals. Several commenters noted the achievements of particular States and MMPs in the FAI and expressed appreciation for the CMS goal of establishing a more permanent mechanism to sustain integrated programs beyond the demonstrations. MACPAC expressed support for CMS for proposals to promote integration by applying features of the MMPs operating under the FAI to D-SNPs. MedPAC encouraged CMS to extend some of the proposals that promote integration to HIDE SNPs too. A few commenters acknowledged the role of nonmedical benefits in providing care to complex populations and expressed appreciation for flexibilities in payment and benefit design. Response: We thank the commenters for the support for the proposals that incorporate many of the early lessons learned from the MMP experience into the broader MA program. We believe doing so will improve experiences for dually eligible individuals. Comment: A few commenters expressed support for the work of the CMS Medicare-Medicaid Coordination Office (MMCO) to improve care for dually eligible individuals, address needs around integration of care, focus on social determinants of health, and promote equity, while another commenter noted appreciation for MMCO efforts to lower health care costs for beneficiaries, States, and Federal Government. Response: We thank commenters for their support. Comment: Several commenters noted that Federal support would be an important component to helping States implement the necessary changes and to facilitate further integration of D-SNPs. These commenters noted that State officials often struggle with competing priorities, limited Medicare knowledge, and limited staff capacity to develop and implement integrated care initiatives for dually eligible individuals relative to their other responsibilities. A few commenters acknowledged the wide range of technical assistance that CMS has provided to date to help navigate the complexities of the policy environment and expand State ability to integrate and encouraged CMS to continue to bolster these resources for States should the proposals in this rule become final. Other commenters recommended that States would need additional Federal funding to enhance State capacity and to further incentivize integration. Response: We thank the commenters for this feedback and agree that States are an important partner in implementing many of the D-SNP proposals in this rule. We are committed to continue working closely with States to support their integration efforts and intend to utilize and build from the technical assistance resources we already have in place, including the Integrated Care Resource Center (see https://integratedcareresourcecenter.com ). Comment: A few commenters noted the importance of robust oversight to ensure that policies do not lead to higher spending without actually benefiting people with Medicare and supported the increased oversight of D-SNPs contained within the proposed rule. A commenter expressed concern as to whether there was sufficient demographic data, especially on disability and on social, racial, and economic status, or data on MA supplemental benefit spending, access, and eligibility for such oversight. Another commenter expressed concern that the Federal Government lacks the capacity to conduct adequate oversight without sharing responsibility with States. Response: We thank the commenters for these comments. We agree that oversight is an important component of providing person-centered, high quality care and will continue to work with stakeholders to ensure integrated programs do just that. We will consider opportunities for improving the types and quality of available data necessary to support such oversight in the future. We address issues related to expenditure data on MA supplemental benefits as part of MLR reporting in section II.G of this final rule. Comment: A few commenters supported the focus on the D-SNP model for deepening integration, pointing out the widespread availability and growing enrollment in D-SNPs and the ongoing investments by plans and States in supporting infrastructure. The commenter indicated the provisions included in the proposed rule were a logical alternative to other more radical integration proposals. A commenter specifically appreciated CMS's focus on the experience of D-SNP enrollees given the large number of enrollees in D-SNPs in certain States and the health care needs of these individuals. Response: We thank the commenters for this feedback. As we discussed in the proposed rule at 87 FR 1888, the integrated care landscape has changed substantially over the last 10 years. Key changes include Congress making D-SNPs permanent, establishing new minimum integration standards, and directing the establishment of unified appeals and grievance procedures. Changes in MA policy have also created a level of benefit flexibility that did not previously exist outside of the capitated model demonstrations, with MA plans increasingly offering supplemental benefits that address social determinants of health and LTSS. These changes make D-SNPs an attractive vehicle for integration for dually eligible individuals. Comment: A few commenters stated that the proposals do not go far enough to further integrated care. A commenter stated that the proposed changes do not address the main factors that determine long-term beneficiary satisfaction with integrated care, such as access to providers, easily understood marketing or other materials to help inform beneficiaries of their choices, and access to supplemental benefits. Another commenter stated that while the proposed policy changes promote integration in existing products, they do not necessarily increase the availability of integrated models or enrollment in integrated plans. Response: We appreciate the feedback from these commenters. We believe several of our proposals address factors that determine beneficiary satisfaction—see, for example, our proposal at § 422.107(e) related to using specified integrated materials—but we appreciate that there remain many other opportunities to improve experiences for dually eligible beneficiaries. We will consider whether there are additional opportunities to address these issues in the future. Comment: A few commenters supported the overall effort to promote care integration for dually eligible individuals but expressed concern about the potential for increased administrative burden for State Medicaid agencies, disruptions in care for members, and other operational challenges. A commenter expressed concern that some of the proposals would significantly curtail States' ability to customize programs that meet the specific needs of their State programs and constituents. Another commenter noted that the proposals are likely to be most impactful for States that are relatively far along in their integrated care strategies and recommended CMS continue its efforts through the Medicare-Medicaid Coordination Office and the Integrated Care Resource Center to promote integration for States newer to this policy area. A commenter was concerned that the operational aspects of some of the provisions would disadvantage new entrants to the MA market, particularly those that target underserved populations. Another commenter emphasized that CMS has an opportunity to ensure States do not use the proposed changes to hinder new market entrants who may offer more and better service to beneficiaries. Response: We thank the commenters for these comments and acknowledge the concerns they raise. It is important to note that none of the provisions in the proposed rule would impose new requirements on States; rather, States may choose whether or not to take advantage of any of the proposals finalized here. We are committed to continue working closely with States to support their integration efforts, regardless of how far along they are, and intend to utilize and build from the technical assistance resources we already have in place, including the Integrated Care Resource Center. While some proposals would impose new requirements of D-SNPs, we think on balance, the advantages of increasing the overall level of integration outweigh the potential downsides. Comment: A commenter recommended allowing MA organizations to offer D-SNPs without holding a Medicaid contract either directly or between the parent company and the State Medicaid agency. Response: We note that while State contracting policies may have prevented sponsors from offering D-SNPs in some markets, section 1859(f)(3)(D) of the Act requires a D-SNP to have a contract with the applicable State Medicaid agency. States are authorized to determine which D-SNPs they will contract with, as described in section 164 of the Medicare Improvement for Patients and Providers Act (MIPPA) (Pub. L. 110-274), which amended section 1859(f) of the Act to add the requirement for D-SNPs to have a contract with the State. Comment: A commenter recommended that CMS further define terms such as care coordination, person-centered care, and integrated care. This commenter believes further definition of these terms is important to gain trust among dually eligible individuals, especially those between the ages of 21 and 65 years old. Response: An important theme of our proposals is to improve experiences for dually eligible beneficiaries who are enrolled in D-SNPs. As part of that, we aim to streamline and simplify operations, including the terminology we use. We appreciate these suggestions and will consider them for the future. We believe that the terms care coordination, person-centered care, and integrated care are sufficiently clear in this final rule that additional regulatory definitions are not necessary. 3. Enrollee Participation in Plan Governance (§ 422.107) We believe managed care plans derive significant value from engaging enrollees in defining, designing, participating in, and assessing their care systems. 13 By soliciting and responding to enrollee input, plans can better ensure that policies and procedures are responsive to the needs, preferences, and values of enrollees and their families and caregivers. One of the ways managed care plans can engage dually eligible individuals is by including enrollees in plan governance, such as establishing enrollee advisory committees and placing enrollees on governing boards. Engaging enrollees in these ways seeks to keep enrollee and caregiver voices front and center in plan operations and can help plans achieve high-quality, comprehensive, and coordinated care. 14 As described at 87 FR 1855 through 1856 of the proposed rule, Federal regulations for other programs, such as the Programs of All-Inclusive Care for the Elderly (PACE) and Medicaid managed care plans that cover LTSS include requirements for stakeholder engagement and committees, including input from beneficiaries. 13 Centers for Medicare & Medicaid Services. (n.d.). Person & Family Engagement Strategy: Sharing with Our Partners. Retrieved from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/Person-and-Family-Engagement-Strategy-Summary.pdf . 14 Resources for Integrated Care and Community Catalyst, “Listening to the Voices of Dually Eligible Beneficiaries: Successful Member Advisory Councils”, 2019. Retrieved from: https://www.resourcesforintegratedcare.com/Member_Engagement/Video/Listening_to_Voices_of_Dually_Eligible_Beneficiaries. As required by the three-way contracts between CMS, States, and MMPs, all MMPs established enrollee advisory committees. As described at 87 FR 1854 through 1855 of the proposed rule, these enrollee advisory committees provide a mechanism for MMPs to solicit feedback directly from enrollees, assisting MMPs in identifying and resolving emerging issues, and ensuring they meet the needs of dually eligible individuals. 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 D-SNPs and to help identify and address barriers to high-quality, coordinated care for dually eligible individuals. Therefore, we proposed at § 422.107(f) that any MA organization offering one or more D-SNPs in a State must establish and maintain one or more enrollee advisory committees to solicit direct input on enrollee experiences. We also proposed at § 422.107(f) 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 proposed to establish the new paragraph at § 422.107(f) under our authority at section 1856(b)(1) of the Act to establish in regulation other standards not otherwise specified in statute that are both consistent with Part C statutory requirements and necessary to carry out the MA program and our authority at section 1857(e) of the Act to adopt other contract terms and conditions not inconsistent with Part C as the Secretary may find necessary and appropriate. We believe that a requirement for an MA organization offering one or more D-SNPs to establish one or more enrollee advisory committees is not inconsistent with either the Part C statute or administration of the MA program. While current law does not impose such a requirement, our experience with existing requirements for MMPs and PACE demonstrates that the use of advisory committees improves plans' ability to meet their enrollees' needs by providing plans with a deeper understanding of the communities the plans serve and the challenges and barriers their enrollees face, as well as serving as a convenient mechanism to obtain enrollee input on plan policy and operational matters. Our experience also suggests that advisory committees complement other mechanisms for enrollee feedback—such as surveys, focus groups, and complaints—with most advisory committees featuring longer-term participation by enrollees who can share their lived experiences while also learning how to best advocate over time for broader improvements for all enrollees. We believe the performance of all D-SNPs would benefit from this new requirement and that this requirement is therefore necessary and appropriate. While we described the proposed advisory committee at § 422.107(f) as an enrollee advisory committee consistent with the use of the term “enrollee” in MA regulations, we noted that “enrollee” under the proposed § 422.107(f) requirement for D-SNPs has the same meaning as “member” under the § 438.110 requirement for Medicaid plans to have a member advisory committee when LTSS are covered under a Medicaid managed care plan's contract. First, we proposed that the MA organization offering one or more D-SNP(s) in a State must have one or more enrollee advisory committees that serve the D-SNP(s) offered by the MA organization in that State. As proposed, an MA organization would be able to choose between establishing one single enrollee advisory committee for one or multiple D-SNPs in that State or by establishing more than one committee in that State to meet proposed § 422.107(f). Second, we proposed that the advisory committee must have a reasonably representative sample of enrollees of the population enrolled in the dual eligible special needs plan or plans, or other individuals representing those enrollees. At 87 FR 1856 of the proposed rule, we explained that, by using the phrase “representative sample” in the regulation text, we intended that D-SNPs incorporate multiple characteristics of the total enrollee population of the D-SNP(s) served by the enrollee committee, including but not limited to geography and service area, and demographic characteristics. For MA organizations that offer separate D-SNPs serving full-benefit dually eligible individuals and partial-benefit dually eligible individuals in the same State, we explained that our proposal would provide flexibility for MA organizations to solicit enrollee input through one or more committees where separate committees might represent specific eligibility groups. Finally, we proposed that the advisory committee must, at a minimum, solicit input on ways to improve access to covered services, coordination of services, and health equity among underserved populations, which is a CMS priority aligned with Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (January 20, 2021). Our proposal did not specify other responsibilities or obligations for the committee, but we encouraged D-SNPs to solicit input from enrollees on other topics would be part of the committee's responsibilities. At 87 FR 1857 of the proposed rule, we described how our proposal would relate to the requirement at § 438.110 for Medicaid managed care plans that cover long-term services and supports and how some organizations may satisfy our proposed requirement at § 438.110 with the same advisory committee. Citing our belief that D-SNPs should work with enrollees and their representatives to establish the most effective and efficient process for enrollee engagement, we did not propose Federal requirements as to the specific frequency, location, format, participant recruiting and training methods, or other parameters for these committees beyond certain minimum requirements. However, we solicited comments on whether we should include more prescriptive requirements on how D-SNPs select enrollee advisory committee participants, training processes on creating and running a successful committee, the committee responsibilities, additional committee topics, and whether we should limit the enrollee advisory committee proposed at § 422.107(f) to a subset of D-SNPs. We also solicited comments on whether our approach to allow MA organizations to meet the requirements in proposed §§ 422.107(f) and 438.110 through one enrollee advisory committee could dilute the § 438.110 requirement by detracting from the focus on LTSS enrollees. We noted that, if our proposal were finalized, we would update the CMS audit protocols for D-SNPs to request documentation of enrollee advisory committee meetings. Comment: Numerous commenters expressed strong support for our proposal to require that an MA organization offering one or more D-SNP(s) in a State have one or more enrollee advisory committees that serve the D-SNP(s) offered by the MA organization in that State. Many of these commenters noted direct input from enrollees helps to improve plan quality, operations, and care coordination to better serve its enrollees and can help advance health equity among dually eligible individuals. A number of commenters stated that their support for our proposal was informed by their experience with enrollee advisory committees implemented by MMPs, Medicaid managed care plans, and D-SNPs. Numerous commenters suggested that engagement of enrollees representing the diversity of the dually eligible population in a State is essential to providing meaningful person-centered care and effectively coordinating and integrating care across Medicare and Medicaid services in a manner that reflects individual's needs and preferences. A commenter shared their experience implementing D-SNP enrollee advisory committees, noting these committees are a chance to build trust with enrollees, improve plan processes, address health equity barriers, and empower enrollees as active contributors and co-designers of programs and policies. Some commenters appreciated that our proposal builds on existing Federal regulations that require enrollee advisory processes among Medicaid LTSS managed care plans and PACE and similar requirements for MMPs, which would create fewer differences for State staff managing multiple integration efforts and preserve flexibility in the design of these committees. MACPAC expressed its support for the proposal and welcomes CMS modeling the structure after the MMP committees to include beneficiaries, families, and other caregivers. Some commenters viewed the proposed committee requirement as an opportunity for States to cross-pollinate committee input and activities across D-SNPs that operate in their State. Other commenters appreciated the proposed requirement for the committee to encompass a representative sample of D-SNP enrollees within a State and noted that, because of this requirement, plans constructing these committees would take efforts to recruit participants from the diverse backgrounds of their enrollees. Response: We appreciate the widespread support we received for our proposal. These comments bolster our belief 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. We agree that the requirement that D-SNPs include a reasonably representative sample of members will incentivize them to consider diversity when recruiting for their enrollee advisory committees. Comment: A commenter applauded CMS's effort to create more mechanisms for enrollee input in plan operations and consult enrollees on issues related to health equity. But, this commenter believed requiring each SNP to establish and maintain a separate advisory committee could be redundant and duplicative with existing efforts. The commenter offered the example that, in many regions, coalitions or community groups already exist that can provide input on enrollee needs and stated that in some cases the existing coalitions or community groups are already prepared to inform plans about the challenges that impact their enrollees. This commenter recommended that CMS require all SNPs to have a mechanism to obtain diverse and representative enrollee input on plan policy and operations rather than requiring all D-SNPs to use the specific mechanism of enrollee advisory committees. Further, the commenter suggested that where community groups do not already exist, plans could then establish their own enrollee advisory committees. Response: We thank the commenter for this perspective. We would like to take the opportunity to clarify that our proposal would not apply to all SNPs but MA organizations with one or more D-SNPs in a State. While C-SNPs and I-SNPs could benefit from enrollee advisory committees and the type of engagement described by the commenter, and we encourage them to do so, we are not requiring it at this time. Our experience with such committees has been concentrated on plans exclusively or mainly enrolling dually eligible individuals, so we have chosen to apply this requirement to D-SNPs. Based on the D-SNP experience with such committees, we may consider future rulemaking to consider such a requirement for C-SNPs and I-SNPs. We recognize that coalitions and groups serving local communities can offer helpful perspectives to MA organizations and D-SNPs and our proposal does not preclude MA organizations and D-SNPs from engaging with other parties to gather feedback. But, our experience with existing requirements for MMPs and PACE demonstrates that the use of advisory committees improves plans' ability to meet their enrollees' needs by providing plans with a deeper understanding of the communities the plans serve and the challenges and barriers their enrollees face, as well as serving as a convenient mechanism to obtain enrollee input on plan policy and operational matters. Our experience also suggests that advisory committees complement other mechanisms for enrollee feedback—such as surveys, focus groups, and complaints—with most advisory committees featuring longer-term participation by enrollees who can share their lived experiences while also learning how to best advocate over time for broader improvements for all enrollees. We believe the performance of all D-SNPs would benefit from this new requirement, which is consistent with the existing requirement at § 438.110 for Medicaid plans to establish member advisory committees when those Medicaid managed care plans cover LTSS. Comment: Several commenters requested technical assistance for MA organizations and D-SNPs to help establish the proposed enrollee advisory committees. A few of these commenters stated that establishing robust enrollee advisory committees can be challenging. A commenter emphasized that the existence of an advisory committee is not itself a demonstration of enrollee input, but that these committees must be intentionally designed, integrated into overall program structures to be considered true enrollee engagement, and have decision-making authority. Another commenter requested that CMS provide technical assistance and guidance documents and/or training to plans, States, and consumer advocates on effective and standardized practices for these committees. A commenter suggested CMS leverage two existing resources on the topic of consumer engagement in enrollee advisory committees as technical assistance for plans regarding how to build a meaningful advisory committee. 15 15 Community Catalyst, “Meaningful Consumer Engagement: A Toolkit for Plans, Provider Groups and Communities,” March 2014. Retrieved from http://www.advancingstates.org/hcbs/article/meaningful-consumer-engagement-toolkit-plans-provider-groups-and-communities ; and Community Catalyst, “Supporting Meaningful Engagement through Community Advisory Councils,” August 2020. Retrieved from: https://www.healthinnovation.org/resources/publications/supporting-meaningful-engagement-through-community-advisory-councils . Response: We welcome this feedback and agree that technical assistance to support the design and implementation of enrollee advisory committees is important. CMS's contractor Resources for Integrated Care partnered with Community Catalyst, a non-profit advocacy organization, and offered a series of webinars and other written technical assistance to help enhance MMPs' operationalization of these committees in 2019. 16 In the proposed rule at 87 FR 1855, we outlined some of the best practices leading to successful enrollee advisory committees. We also noted in the proposed rule (87 FR 1888) that we intend to continue—focusing now on D-SNPs—many of the technical assistance and quality improvement activities that we initially developed for MMPs, including— 16 Resources for Integrated Care and Community Catalyst, “Member Engagement in Plan Governance Webinar Series”, 2019. Retrieved from: https://www.resourcesforintegratedcare.com/article/member-engagement/ . • Learning communities; • Direct work with beneficiary advocates and other stakeholders; • Targeted efforts to improve outcomes and reduce disparities; and • Capacity building on topics like person centeredness, disability-competent care, dementia, and behavioral health. We expect these topics to also include a focus on enrollee advisory committees. Comment: We received numerous comments in favor of more prescriptive requirements and numerous comments in favor of a less prescriptive approach consistent with our proposal. Among those in favor of more prescriptive requirements, numerous commenters requested that we provide clarification or further requirements on selection processes for enrollee advisory committees and what we consider to be a reasonably representative sample of the population enrolled in the D-SNP. Several commenters suggested that a reasonably representative sample should include enrollee characteristics such as race, ethnicity, language, disability status, sexual orientation and gender identity, receipt of LTSS or behavioral health services, geography and service area. A few commenters suggested that we establish percentage thresholds, such as a majority of committee participants are dually eligible individuals or a majority of participants are non-white or non-English speaking. A commenter recommended that enrollee advisory committees be composed of a majority of participants based on the proportional representation of enrollees with lived experiences and demographic identities, including disability, while other commenters requested we provide specific parameters on how D-SNPs might meet the definition of “representative sample”. Some commenters requested that we specify a minimum number of participants for the enrollee advisory committees. A commenter recommended that CMS establish a threshold for volume of D-SNP enrollees that a single committee could represent, suggesting one committee per D-SNP or per a certain number of D-SNP enrollees across plans (for example, 20,000). This commenter also recommended that D-SNPs be required to notify eligible enrollees of the opportunity to participate. Another commenter suggested we relax the representative sample requirement, as it is difficult for D-SNPs to engage all populations enrolled to include representation on advisory committees. Another commenter requested that CMS direct MA organizations to work with stakeholders, such as patient advocacy groups, to ensure enrollee advisory committees include a diverse and comprehensive patient population. MACPAC expressed that these committees should be developed by plans in partnership with advocates and should be representative of the people served by integrated programs. A few commenters noted that CMS should require D-SNPs to allow caregivers, personal care attendants, interpreters, and others to attend to help enrollees participate. In making its case for more prescriptive requirements, a commenter remarked that an analysis of MMP advisory committees indicates that, despite requirements in most States that committee membership reflects the diversity of the member body, the lack of guidance on what diversity means or how to properly recruit leads to under-representation of minority enrollees in committees. According to the commenter, not defining “reasonable sample” of individuals enrolled in D-SNPs increases the risk that the committee does not adequately represent the D-SNP enrollees. Response: We appreciate the commenters' suggestions for additional specificity in requirements for establishing enrollee advisory committees for MA organizations with one or more D-SNPs in a State. Given the variation in State Medicaid program, D-SNPs, and dually eligible populations across States and localities and the existence of enrollee advisory committees established under § 438.110, we continue to believe that D-SNPs should work with enrollees and their representatives to establish the most effective and efficient process for enrollee engagement. We appreciate comments regarding the need for more prescriptive requirements with respect to enrollee advisory committee diversity, and the need to more specifically define a reasonable sample of D-SNP enrollment such that committee representation is an accurate reflection of overall enrollment. We recognize that a key finding from the 2019 report “The Role of Consumer Advisory Councils in the Financial Alignment Initiative” 17 was the need for improved diversity of enrollee advisory committee participation. The first annual report for the Massachusetts Financial Alignment Initiative demonstration found that attracting and retaining diverse stakeholder participation in the Implementation Council was a challenge. 18 The second annual report indicated the Implementation Council was able to recruit additional members, and one Implementation Council member noted that “the resulting diversity was both exciting and challenging”. 19 While we are choosing to be nonprescriptive in how a reasonable sample is defined for the purposes of our new requirement, we may consider more prescriptive requirements based on information regarding how MA organizations implement committees and comply with the requirement that the D-SNP enrollee committees be reasonably representative of the enrolled population. Future technical assistance will include promising practices for how plans can build a diverse committee membership. 17 Center for Consumer Engagement in Health Innovation, “An Exploration of Consumer Advisory Councils within Medicare-Medicaid Plans Participating in the Financial Alignment Initiative”, 2019, Retrieved from: https://www.healthinnovation.org/resources/publications/an-exploration-of-consumer-advisory-councils-within-medicare-medicaid-plans. 18 RTI, “Financial Alignment Initiative Annual Report: One Care: MassHealth Plus Medicare, First Annual Report,” September 2016 (updated July 2017). Retrieved from: https://innovation.cms.gov/files/reports/fai-ma-firstevalrpt.pdf. 19 RTI, “Financial Alignment Initiative: Massachusetts One Care Second Annual Report,” April 2019. Retrieved from https://innovation.cms.gov/files/reports/fai-ma-secondevalrpt.pdf. Comment: We received some comments from organizations requesting that we specify how often the enrollee advisory committees must meet. A few of these commenters encouraged CMS to establish minimum frequency requirements but did not specify a meeting interval. Several commenters recommended that we require enrollee advisory committees to meet at least twice per year, and a commenter suggested quarterly convenings. A few of these commenters expressed concern that, without a minimum required frequency, plans would opt for annual meetings, which the commenters indicated would have limited value. A few commenters encouraged CMS to set training requirements for MA organizations and D-SNPs as they establish these committees. A commenter emphasized that CMS require D-SNPs to establish a process to train D-SNP staff on collecting and incorporating advisory committee feedback into plan operations and informing participants how enrollee feedback was used. We also received a comment that States should be given the authority to specify and require training components as part of their contracting with plans. Some commenters encouraged CMS to provide more specifics related to training for enrollee advisory committee participants. A few of these commenters recommended requirements to ensure MA organizations educate enrollee advisory committee participants about the responsibilities of these committees and ways to meaningfully engage in them, including providing an understanding of D-SNP program design and organizational structure. A commenter suggested that CMS include a requirement that the enrollee advisory committee receives training on key health and health care disparity concerns that affect the population served by the D-SNP and a robust module be provided on disability inclusion in health care, emphasizing intersectional identities. This commenter also suggested that D-SNPs provide the committee basic information about the right to request reasonable accommodations and policy modifications, an overview of the D-SNPs' transparency and accountability mechanisms, and local and State agencies and commissions with overlapping responsibilities and interests. A few of the commenters suggested that CMS create standards for training processes but did not provide further details. A few commenters suggested that CMS require enrollee advisory committees to incorporate other parameters. A commenter recommended that enrollees, not State authorities, should lead the committee process. Another commenter stated that CMS should consider other required feedback mechanisms for enrollee input beyond the proposed committee structure, which—in their view—could have a limited number of participants or may not include those who have voiced concerns about the plan. Another commenter suggested that CMS require MA organizations to implement best practices to ensure enrollee advisory committee participant retention and equity. A few commenters urged CMS to issue additional sub-regulatory guidance concerning its expectations of MA organizations and D-SNPs in establishing these enrollee advisory committees. Some commenters suggested specific topics the committee should be required to focus on beyond the health equity topic included in the proposed rule. A few commenters recommended that the committees focus on concerns and priorities of the enrollees themselves. A commenter supported additional topics be shared with committee participants for their input but did not name any particular topics. Another commenter did not specify any additional topics but suggested that the D-SNPs provide information to alert the enrollee advisory committee participants of the scope of potential topics, such as through a non-exhaustive list of topics other advisory committees have tackled. A few additional commenters identified specific topics for consideration, such as medication adherence, D-SNP collection of self-identified functional limitation data, and addition of self-identified functional limitation data fields to electronic patient records. Response: We appreciate the commenters' suggestions for additional specificity in requirements for establishing enrollee advisory committees. We continue to believe that giving D-SNPs flexibility in structuring the enrollee advisory committees will permit D-SNPs—and the enrollees participating on the advisory committees—to tailor these committees based on the local needs of enrollees. As we stated in the proposed rule, our experience with MMPs establishing and maintaining enrollee advisory committees demonstrates that these plans have found the committees useful and carefully consider feedback provided by enrollees to inform plan decisions without prescriptive Federal requirements for the committees. We expect the evolution and adoption of telecommunications technology, including as experienced during the COVID-19 public health emergency, will mean that the most effective modalities for enrollee input may change over time. Therefore, we are not finalizing any additional Federal requirements as to the specific frequency, location, format, participant recruiting and training methods, or other parameters for these committees beyond certain minimum requirements; however, we may consider more prescriptive requirements in future rulemaking based on D-SNP experience with enrollee advisory committees. Comment: Numerous commenters emphasized the importance for transparency of these enrollee advisory committees and ensuring D-SNPs are held accountable for adhering to established requirements. Several commenters suggested that MA organizations create a feedback loop for advisory committees to see how their feedback is being considered and implemented and to share this information with enrollee advisory committee participants. A few commenters welcomed information on how CMS would evaluate the effectiveness of the enrollee advisory committees, including any expected measurable outcomes, to better understand how well the committees are achieving policy goals. Another commenter requested that CMS consider whether there may be additional Federal and State benefits to compiling the findings of these enrollee advisory committees since this information may help inform future policy duration for not only MA plans and SNPs but also for the original Medicare FFS program. Response: We appreciate the request for monitoring of enrollee advisory committees against the requirements outlined at § 422.107(f) and the interest in information gathered through these convenings. We are not requiring that MA organizations publicly distribute enrollee advisory committee meeting agendas or materials since these committees will be addressing challenging topics related to plans and their enrollees, including potentially market-sensitive information related to potential changes in future plan benefits. We are concerned that requiring plans to make these agendas and materials publicly available could interfere with committee effectiveness. We noted in the proposed rule that, if our proposal were finalized, we would update the CMS audit protocols for D-SNPs to request documentation of enrollee advisory committee meetings. Information from CMS audits will help us monitor the extent to which MA organizations are meeting the enrollee advisory committee requirements at § 422.107(f), and we may consider more prescriptive requirements, as needed, based on implementation experience. Comment: Numerous commenters supported the flexibility CMS offered in the structure of the proposed enrollee advisory committees and urged CMS to require a less prescriptive approach to the enrollee advisory committees, consistent with the proposed rule. Many of these commenters favored a minimum set of requirements to give D-SNPs the flexibility to implement and manage enrollee advisory committees that best meet the needs of the local population and obtain meaningful input. Several commenters stated that the design flexibilities encourage the development of enrollee advisory committees to best reflect the different types of D-SNPs (that is, fully integrated dual eligible (FIDE) SNPs, highly integrated dual eligible (HIDE) SNPs, coordination-only D-SNPs 20 ) currently in place and the complexity of the dually eligible populations enrolled, which can differ from one locale to another. Some commenters noted that this flexibility would allow plans that currently offer D-SNPs in multiple States to build a foundation for an advisory committee that can be modeled and then refined to address specific needs of populations represented in each committee. Several commenters urged CMS not to be prescriptive with enrollee advisory committee requirements, especially for plans that already have such committees in place. These commenters emphasized that flexible enrollee advisory committee requirements would allow plans to build on experience and existing enrollee feedback approaches to best reflect the nuance and complexity of the D-SNP plans offered and populations served by those plans. Other commenters noted that this flexibility allows MA organizations already implementing such committees to continue existing operations without major changes, and the flexibility would allow plans to avoid overlapping or duplicative requirements from CMS and States as well as avoid beneficiary confusion. In supporting this perspective, a commenter explained that its experience offering FIDE SNPs, HIDE SNPs, and coordination-only D-SNPs across multiple States suggested wide variation in the specific benefits covered and populations served. Another commenter expressed concern that an overly prescriptive approach would reduce the flexibility for innovation and could stifle some of the positive strides already underway among managed care plans. 20 Coordination-only D-SNPs are D-SNPs that neither meet the FIDE SNP nor HIDE SNP definitions at § 422.2. Response: We thank the commenters for their perspectives. Based on our experience with enrollee advisory committees operated by MMPs and PACE, we believe that D-SNPs should work with enrollees and their representatives to establish the most effective and efficient process for the enrollee advisory committees. Permitting flexibility for the enrollee advisory committees gives MA organizations—and enrollees themselves—more opportunity to establish committees that best meet the needs of enrollees. State Medicaid agencies have broad authority to include more prescriptive parameters for enrollee advisory committees in their contracts with D-SNPs and could adopt some of the commenters' suggestions appropriate to their State through these State Medicaid agency contracts. As discussed in the proposed rule at 87 FR 1857, some State Medicaid agencies already do this in applying § 438.110. Though we are choosing to be nonprescriptive on meeting frequency, location, format, enrollee recruitment, training, and other parameters, we encourage D-SNPs to adopt identified best practices 21 to ensure advisory committee meetings are accessible to all enrollees, including but not limited to enrollees with disabilities, limited literacy (including limited digital literacy), and lack of meaningful access technology and broadband. We note that compliance with Federal law related to accessibility and effective communications for persons with disabilities is a requirement under other statutes such as Section 504 of the Rehabilitation Act. We also clarify that the enrollee advisory committees are not meant to preclude MA organizations and D-SNPs from gathering enrollee feedback through other means. As we discussed at 87 FR 1856, our experience with existing requirements for MMPs and PACE suggests that advisory committees complement other mechanisms for enrollee feedback—such as surveys, focus groups, and complaints—with most advisory committees featuring longer-term participation by enrollees who can share their lived experiences while also learning how to best advocate over time for broader improvements for all enrollees. 21 Resources for Integrated Care and Community Catalyst, “Engaging Members in Plan Governance”, 2019. Retrieved from: https://www.resourcesforintegratedcare.com/article/member-engagement/ . Comment: Some commenters requested that CMS clarify what documentation we will request as part of CMS audit protocols with respect to enrollee advisory committees. Other commenters suggested we audit enrollee advisory committees on the accuracy of committee representation of the D-SNP enrollee membership, meeting frequency and committee feedback to the D-SNP. Response: Information requested as part of the CMS audit protocols may be similar to that reported by MMPs as part of the reporting requirement (for example, dates of meetings held, number of enrollees invited, number of enrollees in attendance). As described in section IV.B.1.b., prior to implementation of new audit protocols (under OMB control number 0938-1395; CMS-10717), we will make them available to the public for review and comment under the standard PRA process, which includes the publication of 60- and 30-day Federal Register notices. Comment: Several commenters questioned whether D-SNPs could delegate the facilitation or operation of enrollee advisory committees to first tier, downstream, or related entities. Response: There is nothing in rule that precludes a D-SNP from delegating the facilitation or operation of an enrollee advisory committee to a first tier, downstream, or related entity. Notwithstanding any relationship(s) that the D-SNP has with first tier, downstream and related entities, the MA organization maintains the ultimate responsibility for adhering to and otherwise fully complying with all terms and conditions of its contract with CMS, per § 422.504(i). All requirements with respect to the enrollee advisory committee are still applicable in the event a D-SNP delegates facilitation or operation of the enrollee advisory committee. Comment: In addition to D-SNP enrollee advisory committees, some commenters recommended CMS require States to create centralized, cross-plan advisory councils, similar to the implementation councils currently in place for the Massachusetts and Rhode Island demonstrations under FAI. Commenters suggested these councils be comprised of majority of D-SNP enrollees and their caregivers, and expressed that such councils could provide additional transparency and insight into D-SNP policy and operations. A commenter suggested CMS provide Federal funding for these State-level advisory councils, and another commenter suggested an implementation council was best positioned to liaise and collaborate with other similar health services and LTSS/HCBS (home and community-based services) county and State-level committees including Olmstead committees, Money Follows the Person advisory committees, and Medicaid advisory committees. Response: While we acknowledge the utility of a centralized advisory council, and commend the important work of the Massachusetts One Care Implementation Council in particular, we defer to States to decide whether to implement broader advisory councils in order to solicit feedback more broadly on their Medicaid managed care programs and the D-SNPs that operate in the State. Comment: A commenter opposed the approach of allowing MA organizations to meet the requirements proposed in §§ 422.107(f) and 438.110 through one enrollee advisory committee, acknowledging that, although there is overlap in the enrollees served, there are important distinctions in the populations and topics relevant for each stakeholder group. Response: While we appreciate the commenter's perspective that there are important distinctions in the populations served, and that there may be distinct topics for each group, there may also be instances in which populations align and therefore separate enrollee advisory councils may be duplicative. We believe the best approach is to be nonprescriptive and allow one enrollee advisory committee to satisfy both requirements in the instances in which the minimum requirements for §§ 422.107(f) and 438.110 are both met. States may choose to apply distinct requirements via their State Medicaid agency contracts and their Medicaid managed care contracts, such that plans would need distinct enrollee advisory committees for different plan populations. Comment: Many commenters suggested we delay the implementation of the enrollee advisory committee provision to contract year 2024 or suggested a phased-in approach that would require FIDE and HIDE SNPs to implement the enrollee advisory committees starting in contract year 2023, with less integrated D-SNPs implementing in contract year 2024. Commenters indicated the need for additional time to develop outreach strategies, coordinate with States, and develop reasonable representation recruitment strategies. A commenter noted D-SNPs will need more than a few months to ensure membership represents the different enrollee perspectives impacted by access, infrastructure, clinical needs, economic status, and prevalence of social supports. Response: While we acknowledge commenters concerns around potential operational challenges to establishing and convening an enrollee advisory committee, we are nonprescriptive on meeting committee frequency, location, format, participant recruitment and training methods. For this reason, we do not believe a contract year 2023 implementation timeframe is unreasonable. Given the implementation timing of this rule, D-SNPs will have approximately 6 months prior to the effective date of January 1, 2023, to develop an enrollee advisory committee, and we are nonprescriptive regarding when in calendar year 2023 the committee must meet, as well as the number of meetings and meeting frequency. Further, the regulation permits use of one committee per State, allowing for D-SNPs to start with a single committee and develop more nuanced committees over time. Additionally, while we have committed to providing technical assistance to D-SNPs in this area, a number of resources on establishing meaningful enrollee advisory committees are currently available via the Resources for Integrated Care. 22 22 Resources for Integrated Care “Engaging Members in Plan Governance”, Retrieved From: https://www.resourcesforintegratedcare.com/article/member-engagement/ . Comment: Numerous commenters requested clarification on how D-SNPs could reimburse enrollee advisory committee members for their time and expertise, and suggested D-SNPs be able to offer stipends, transportation or transportation reimbursement for in-person meetings, and food and drink. Response: We acknowledge the advantages of reimbursing enrollee advisory committee participants for their time and expertise, and prior technical assistance in this area 23 has cited incentives as a best practice to recruit and retain enrollee advisory committee members. We clarify that enrollee participation in an advisory committee is neither a marketing activity nor a personal enrollee health-related activity that would fall under § 422.134, so the authorities and limits that are specific to those activities under MA regulations would not apply. However, MA organizations are prohibited from providing cash, gifts, prizes, or other monetary rebates as an inducement for enrollment or otherwise by sections 1851 and 1854 of the Act. D-SNPs should ensure that any incentives be structured to avoid an inadvertent impact on enrollee eligibility for public benefits. In addition, the provision of stipends, transportation reimbursement, or anything else of value to D-SNP enrollees serving on the enrollee advisory committee potentially implicates the Federal Anti-kickback Statute (AKS), found in section 1128B(b) of the Act. Whether any particular arrangement violates the AKS would be based on the specific facts and circumstances. D-SNPs must ensure that the provision of reimbursement to these members complies with the AKS and other applicable law. We will provide future technical assistance to D-SNPs on this issue to help avoid unintended consequences related to plan compliance or enrollee eligibility for public programs. 23 Resources for Integrated Care “Engaging Members in Plan Governance”, Retrieved From: https://www.resourcesforintegratedcare.com/article/member-engagement/ . Comment: A number of commenters expressed concerns about operationalizing an enrollee advisory council for a D-SNP that has low enrollment. Commenters cited concerns about D-SNPs' ability to meet the reasonably representative sample if overall plan enrollment is too small, particularly for a newly established plan or a plan operating in a rural service area. These commenters suggested CMS either set a minimum enrollment threshold or allow for advisory committees to cross geographies (for example, via multi-State consumer advisory councils). A few commenters recommended we set the minimum D-SNP enrollment threshold at 1,000 enrollees for the establishment of enrollee advisory committees. A commenter requested we consider exempting new plans from this requirement, while another recommended small plans be able to meet the requirement via focus groups, surveys, or other methods. Response: While we appreciate the commenters' recommendations with respect to low-enrollment D-SNPs and the challenges low D-SNP enrollment might present in operationalizing a consumer advisory committee, we do not agree that the reasons cited create a significant barrier for MA organizations to meet the new requirement. First, we would like to clarify that an MA organization offering one or more D-SNP(s) in a State must have one or more enrollee advisory committees that serve the D-SNP(s) offered by the MA organization in that State. As proposed and finalized here, an MA organization would be able to choose between establishing a single enrollee advisory committee for one or more D-SNPs in that State or by establishing multiple committees in that State to comply with § 422.107(f). Thus, in situations where an MA organization operates more than one D-SNP in a State, the MA organization can, unless State Medicaid agency contracts dictate otherwise, establish one or more committees that encompass multiple D-SNPs in a State, which should help to address concerns related to low enrollment in any given D-SNP. Second, a number of MMPs that participated in FAI had low enrollment (that is, fewer than the suggested 1,000 enrollee threshold) and were able to operationalize meaningful enrollee advisory committees. Third, we are nonprescriptive in this requirement regarding how an MA organization recruits committee membership, the timing, frequency or number of advisory meetings an MA organization must cond [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2022-09375. Public record. Not legal advice.