# Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2022-00117 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** January 12, 2022 - **Citation:** 87 FR 1842 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 422 and 423 [CMS-4192-P] RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Proposed rule. SUMMARY: This proposed rule would revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance, Star Ratings, network adequacy, medical loss ratio reporting, special requirements during disasters or public emergencies, and pharmacy price concessions. This proposed rule would also revise regulations related to dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans. DATES: To be assured consideration, comments must be received at one of the addresses provided below, by March 7, 2022. ADDRESSES: In commenting, please refer to file code CMS-4192-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the “Submit a comment” instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4192-P, P.O. Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4192-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Marna Metcalf Akbar, (410) 786-8251, or Melissa Seeley, (212) 616-2329—General Questions. Jacqueline Ford, (410) 786-7767—Part C Issues. PartCandDStarRatings@cms.hhs.gov —Part C and D Star Ratings Issues. Marna Metcalf-Akbar, (410) 786-8251—D-SNP Issues. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. Acronyms ACC Automated Criteria Check ANOC Annual Notice of Change ARB At-Risk Beneficiaries BBA Bipartisan Budget Act CAHPS Consumer Assessment of Healthcare Providers and Systems CMS Centers for Medicare & Medicaid Services COI Collection of Information COVID-19 Coronavirus 2019 Disease C-SNP Chronic Condition Special Needs Plan DME Durable Medical Equipment D-SNP Dual Eligible Special Needs Plan EOC Evidence of Coverage FFS Fee-for-Service FIDE SNP Fully Integrated Dual Eligible Special Needs Plan HEDIS Healthcare Effectiveness Data and Information Set HHS Department of Health and Human Services HIDE SNP Highly Integrated Dual Eligible Special Needs Plan HOS Health Outcomes Survey HPMS Health Plan Management System HSD Health Service Delivery ICR Information Collection Requirement I-SNP Institutional Special Needs Plan MA Medicare Advantage MAC Medicare Administrative Contractor MACPAC Medicaid and CHIP Payment and Access Commission MA-PD Medicare Advantage Prescription Drug MCO Managed Care Organization MCMG Medicare Communications and Marketing Guidelines MACPAC Medicaid and CHIP Payment and Access Commission MedPAC Medicare Payment Advisory Commission MIPPA Medicare Improvements for Patients and Providers Act MLR Medical Loss Ratio MMA Medicare Prescription Drug, Improvement, and Modernization Act MMP Medicare-Medicaid Plan MOC Model of Care MOOP Maximum Out-of-Pocket NAMBA National Average Monthly Bid Amount NEMT Non-emergency Medical Transportation NMM Network Management Module OACT Office of the Actuary OMB Office of Management and Budget PACE Programs of All-Inclusive Care for the Elderly PBP Plan Benefit Package PDE Prescription Drug Event PDP Prescription Drug Plan PHE Public Health Emergency PRA Paperwork Reduction Act RFI Request for Information RFA Regulatory Flexibilities Act SAE Service Area Expansion SB Summary of Benefits SNP Special Needs Plan SSA Social Security Administration TPMO Third-Party Marketing Organization I. Executive Summary A. Purpose Over 27 million individuals receive their Medicare benefits through Medicare Advantage (MA or Part C), including plans that offer Medicare Prescription Drug Benefit (Part D) coverage. Over 24 million individuals receive Part D coverage through standalone Part D plans. The primary purpose of this proposed rule is to implement changes to the MA and Part D programs. The proposed provisions in this rule will reduce out-of-pocket prescription drug costs; improve price transparency and market competition under the Part D program; strengthen consumer protections to ensure MA and Part D beneficiaries have accurate and accessible information about their health plan choices and benefits; strengthen CMS oversight of MA and Part D plans; and improve the integration of Medicare and Medicaid programs for individuals enrolled in dual eligible special needs plans (D-SNPs). The proposed D-SNP provisions build on the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) (Pub. L. 111-148), the Bipartisan Budget Act (BBA) of 2018 (Pub. L. 115-123), CMS experience administering the MA and Part D programs, and the experiences of Medicare-Medicaid Plans (MMPs) to better align and integrate benefits for dually eligible beneficiaries. B. Summary of Major Provisions 1. Enrollee Participation in Plan Governance (§ 422.107) Managed care plans derive significant value from engaging enrollees in defining, designing, participating in, and assessing their care systems. 1 We are proposing to require that any MA organization offering a D-SNP must establish one or more enrollee advisory committees in each State to solicit direct input on enrollee experiences. We also propose that the committee include a reasonably representative sample of individuals enrolled in the D-SNP(s) and solicit input on, among other topics, ways to improve access to covered services, coordination of services, and health equity for underserved populations. We believe that the establishment and maintenance of an enrollee advisory committee is a valuable beneficiary protection to ensure that enrollee feedback is heard by managed care plans and to help identify and address barriers to high-quality, coordinated care for dually eligible individuals. 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 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. 2 Building on CMS's experience with other programs and model tests, we propose to require that all SNPs include standardized questions on housing stability, food security, and access to transportation as part of their health risk assessments. 2 Medicaid and CHIP Payment and Access Commission, “Report to Congress on Medicaid and CHIP,” June 2020. Retrieved from: https://www.macpac.gov/wp-content/uploads/2020/06/June-2020-Report-to-Congress-on-Medicaid-and-CHIP.pdf. Our proposal would result in SNPs having a more complete picture of the risk factors that may inhibit enrollees from accessing care and achieving optimal health outcomes and independence. We believe this knowledge would better equip the MA organizations offering these SNPs to meet the needs of their members. Our proposal would also equip MA organizations with person-level information that would help them better connect people to covered services and social service organizations and public programs that can help resolve housing instability, food insecurity, or transportation challenges. Our proposal also would have the benefit of standardizing these data elements collected through HRAs, which we believe would eventually facilitate better data exchange among SNPs (when an individual transitions from one SNP to another) as well as facilitate the care management requirements under section 1859(f)(5) of the Act. 3. Refining Definitions for Fully Integrated and Highly Integrated D-SNPs (§§ 422.2 and 422.107) Dually eligible individuals have an array of choices for how to receive their Medicare coverage. We propose several changes to how we define fully integrated dual eligible special needs plan (FIDE SNP) and highly integrated dual eligible special needs plan (HIDE SNP) to help differentiate various types of D-SNPs, clarify options for beneficiaries, and improve integration. We propose to require, for 2025 and subsequent years, that all FIDE SNPs have exclusively aligned enrollment, as defined in § 422.2, and cover Medicaid home health, durable medical equipment, and behavioral health services through a capitated contract with the State Medicaid agency. We propose to require that each HIDE SNP's capitated contract with the State apply to the entire service area for the D-SNP for plan year 2025 and subsequent years. Consistent with existing policy outlined in sub-regulatory guidance, we also propose to codify specific limited benefit carve-outs for FIDE SNPs and HIDE SNPs. We believe these proposals 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. We propose to 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) integrate materials and notices for enrollees. Where States choose to use this opportunity, it would help individuals better understand their coverage. Because Star Ratings are assigned at the contract level, this proposal would also provide the State 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 propose 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 would improve Federal and State oversight of certain D-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. We propose to 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) is 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 because of State limits on the amounts paid for Medicare cost-sharing and dually eligible individuals' exemption from Medicare cost-sharing. The proposal would result in more equitable payment for MA providers serving dually eligible beneficiaries. We project that our proposal would result in increased bid costs for the MOOP for some MA plans. A portion of those higher bid costs would 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 10-year cost estimate for the proposal is $614.8 million. 6. Special Requirements During a Disaster or Emergency (§ 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 limited depending on the type or scope of the disaster or emergency, while other situations, like the current 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. This proposal would clarify the period of time during which MA organizations must comply with the special requirements to ensure access for enrollees to covered services throughout the disaster or emergency period, especially when the end date is unclear and the period renews several times. We also propose to codify an additional condition for triggering the special requirements imposed by § 422.100(m)(1), specifically that there is a disruption in access to health care at the same time as the disaster or emergency. 7. Amend MA Network Adequacy Rules by Requiring a Compliant Network at Application (§ 422.116) We are proposing 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 would 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 one year ahead of the beginning of the contract as the proposed change for network adequacy rules would require. Therefore, the proposal 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 would no longer apply and MA organizations would need to meet full compliance. 8. Allow CMS To Calculate Star Ratings for Certain Measures for 2023 Given Impacts of the COVID-19 Public Health Emergency (§ 422.166) Due to the scope and duration of the COVID-19 public health emergency, we codified a change to the 2022 Star Ratings methodology in the interim final rule titled “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” (CMS-3401-IFC; 85 FR 54820), published in the Federal Register and effective on September 2, 2020, which included a change to our extreme and uncontrollable circumstances policy at 42 CFR 422.166(i)(11) to make it possible for us to calculate 2022 Star Ratings for MA contracts. We propose 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. 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. 9. Past Performance Methodology To Better Hold Plans Accountable for Violating CMS Rules (§§ 422.502 and 422.503) In the 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 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. We are proposing to 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 and has received feedback from beneficiary advocates and stakeholders concerned about the marketing practices of third-party marketing organizations (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 are 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 rulemaking, we will address the concerns with TPMOs by means of the following three proposed updates to the communications and marketing requirements under 42 CFR parts 422 and 423, subpart V: (1) We propose to 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 propose to add a new disclaimer that would be required when TPMOs market MA plans/Part D products (§§ 422.2267(e) and 423.2267(e)), and (3) we propose an update to §§ 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 (FDRs). CMS' January 2021 final rule (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 Patient Protection and Affordable Care Act of 2010 (Affordable Care Act). In the months since the publication of this rule, CMS gained additional insight regarding the void created by the lack of 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, we propose to require MA and Part D plans create a multi-language insert that would inform the reader, in the top fifteen languages used in the U.S., 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. We propose to require the inclusion of 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). Finally, we propose 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 are proposing to 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, we are proposing the collection of 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) 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 are proposing to eliminate this exception for contingent pharmacy price concessions. We are proposing 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 are proposing 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 would 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). To implement the proposed change at the point of sale, Part D sponsors and their pharmacy benefit managers (PBMs) would load revised drug pricing tables reflecting the lowest possible reimbursement into their claims processing systems that interface with contracted pharmacies. The proposed changes would take effect on January 1, 2023, meaning, if finalized, Part D sponsors would need to account for the changes in the bids that they submit for contract year 2023. We are also proposing to 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 has not yet been defined in the Part D statute, Part D regulations, or sub-regulatory guidance. We are proposing to define price concession in a broad manner to include all forms of discounts and direct or indirect subsidies or rebates that serve to reduce the costs incurred under Part D plans by Part D sponsors. C. Summary of Costs and Benefits BILLING CODE 4120-01-P EP12JA22.000 EP12JA22.001 EP12JA22.002 EP12JA22.003 BILLING CODE 4120-01-C II. Provisions of the Proposed Rule 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. 3 3 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 coordination of Medicare and Medicaid services, across primary, acute, long-term, behavioral, and social domains; • Mitigate cost-shifting incentives, including total-cost-of-care accountability across Medicare and Medicaid; and • Create seamless experiences for beneficiaries. There is 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. Some States have carefully married MA dual eligible special needs plans (D-SNPs) with Medicaid managed care organizations (MCOs) to create integrated care programs for dually eligible individuals. Researchers have generally found positive results from such integrated care approaches. For example, a study in Minnesota showed that enrollees in fully integrated Medicare-Medicaid managed care plans had greater primary care physician use and lower inpatient hospital and emergency department use in comparison to service delivery when Medicare and Medicaid-funded services were delivered independently. The study also found that home and community-based service use was greater for the fully integrated Medicare-Medicaid managed care plans than the comparison population and nursing facility use was no greater. 4 A study in Oregon found that dually eligible individuals enrolled in plans with aligned financial incentives for Medicare and Medicaid experienced more improvement in their care relative to those enrolled in nonaligned Medicare Advantage and Medicaid managed care plans. 5 Other studies have found that integrated care programs foster high beneficiary satisfaction, 6 perform better than non-integrated plans on certain quality metrics, 7 and provide benefit flexibility needed to allow beneficiaries to continue living in the community. 8 Overall, 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. 9 4 Anderson, W.L., Feng, Z., & Long, S.K. Minnesota Managed Care Longitudinal Data Analysis, prepared for the U.S. Department of Health and Human Services Assistant Secretary for Planning and Evaluation (ASPE) (March 31, 2016). Retrieved from: https://aspe.hhs.gov/report/minnesota-managed-care-longitudinal-data-analysis. 5 Kim, H., Charlesworth, C.J., McConnell, K.J., Valentine, J.B., and Grabowski, D.C. “Comparing Care for Dual-Eligibles Across Coverage Models: Empirical Evidence from Oregon”, Medical Care Research and Review, (November 15, 2017) 1-17. Retrieved from: https://journals.sagepub.com/doi/abs/10.1177/1077558717740206. 6 Health Management Associates. Value Assessment of the Senior Care Options (SCO) Program (July 21, 2015). Retrieved from https://www.mahp.com/wp-content/uploads/2017/04/SCO-White-Paper-HMA-2015_07_20-Final.pdf. 7 Medicare Payment Advisory Committee. “Chapter 3, Care coordination programs for dual-eligible beneficiaries.” In June 2012 Report to Congress: Medicare and Health Care Delivery System (June 16, 2012). Retrieved from https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/reports/jun12_ch03.pdf. 8 Ibid. 9 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 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. The Medicare Payment Advisory Commission (MedPAC), Medicaid and CHIP Payment and Access Commission (MACPAC), and a wide array of health policy organizations have long pushed for greater CMS investment in integrated care. Over the last few years, MedPAC and MACPAC have written extensively on opportunities to promote integration through managed care policies. 10 10 Most recently, see MACPAC's June 2021 Report to Congress and MedPAC's June 2019 Report to Congress. 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, including specific responsibilities. 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. In two recent MA/Part D rulemakings, CMS has adopted regulations 11 to: (1) Promote better information sharing between States and D-SNPs; (2) unify appeals processes across Medicare and Medicaid for certain D-SNPs that are also capitated for Medicaid benefits; and (3) phase out “D-SNP look-alike” plans that enroll a high percentage of dually eligible individuals without meeting the requirements for D-SNPs. 12 11 For a discussion of codified requirements for information sharing between States and D-SNPs and unified appeals processes, see the final rule titled “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,” (84 FR 15710 through 15717 and 84 FR 15720 through 15744) at: https://www.federalregister.gov/documents/2019/04/16/2019-06822/medicare-and-medicaid-programs-policy-and-technical-changes-to-the-medicare-advantage-medicare. For a discussion of codified contract limitations on D-SNP look-alike plans, see the final rule titled “Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program,” (85 CFR 33805 through 33820) at: https://www.federalregister.gov/documents/2020/06/02/2020-11342/medicare-program-contract-year-2021-policy-and-technical-changes-to-the-medicare-advantage-program. 12 For a discussion of D-SNP look-alikes, 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 9025) at: https://www.govinfo.gov/content/pkg/FR-2020-02-18/pdf/2020-02085.pdf. 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. Maximizing the potential of D-SNPs to achieve these goals will require a sustained effort over multiple years, including— • Partnership with and technical assistance for States; • Technical assistance and support for providers and health plans, especially among the local not-for-profit plans that disproportionately serve Medicaid beneficiaries; • Monitoring and oversight that protects beneficiaries and promotes person-centered coordination of care; and • Federal rulemaking to raise the bar on integration without excessive disruption for enrollees. We are working to improve and increase options for more integrated care in a variety of ways, including through D-SNPs and Medicare-Medicaid Plans (MMPs). 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 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 2021, approximately 3.3 million dually eligible individuals (more than 1 of every 4 dually eligible individuals) were enrolled in 627 D-SNPs. 13 13 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 § 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 § 422.101(f), and contracts with State Medicaid agencies as described in section 1859(f)(3)(D) of the Act and at § 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). 14 14 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 (hereinafter referred to as the February 2020 proposed rule). 15 15 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. 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. Certain elements of the capitated model demonstrations vary by State, but all MMPs include— • A beneficiary advisory committee or governance board to provide ongoing input on plan operations; • An integrated set of member materials, including provider directories, beneficiary notices, and a single ID card; • Person-centered care planning, including HRAs and care plans; • Care coordination and assistance with care transitions; • Aligned Medicare and Medicaid plan enrollment and disenrollment effective dates; • Medicare provider network adequacy standards specific to the dually eligible individual population; • Integrated grievance and appeal processes at the plan level; • Joint oversight by CMS and the States through contract management teams; • Benefit flexibility, an integrated medical loss ratio (MLR), and other financing provisions intended to promote person-centeredness and mitigate incentives for cost-shifting across programs; and • A set of CMS core and State-specific quality measures, a subset of which are part of performance-based risk through a quality withhold on the payment to the MMP. CMS and States partnered with MMPs to create a seamless experience for beneficiaries, but MMPs operate as both MA organizations 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 July 2021, there are 39 MMPs in nine States serving approximately 400,000 members. 16 16 MMP enrollment as of December 2020. See CMS Monthly Enrollment by Contract Report (December, 2020). Retrieved from https://www.cms.gov/research-statistics-data-and-systemsstatistics-trends-and-reportsmcradvpartdenroldatamonthly/enrollment-contract-2020-12. 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. Stakeholder engagement has been an important tenet of the FAI since its inception. We required participating States to work with a variety of stakeholders, including beneficiaries and their advocates, as a condition of demonstration approval and implementation processes. Some have cultivated robust and impactful advisory bodies. For example, Massachusetts developed a One Care Implementation Council, 17 at least half of whose membership is comprised of enrollees and/or their representatives, charged with tracking quality of services, providing support and input to the State, and promoting accountability and transparency. The three-way contracts used in the capitated financial alignment model require MMPs to establish enrollee advisory committees and/or recruit enrollees to governing boards to ensure plans regularly obtain enrollee input on issues of program management. These advisory committees often provide input on enrollee materials, access to covered services, outreach campaigns, and other topics. Not every advisory committee operates at the same level, and many MMPs have had to recalibrate their approaches to ensure robust participation over time, but all have made strides toward seeking out and incorporating enrollee feedback. We believe such mechanisms help MMPs improve the experiences of dually eligible individuals. 17 For more information on the One Care Implementation Council, see the Center for Consumer Engagement in Health Innovation at Community Catalyst & the LeadingAge LTSS Center @UMass Boston. “The One Care Implementation Council: Stakeholder Engagement Within a Duals Demonstration Initiative.” (June, 2018). Retrieved from https://www.healthinnovation.org/resources/publications/body/One-Care-Implementation-Council-Review-June-2018-1.pdf. • Assessment processes are a vehicle for identifying and addressing unmet need, particularly those related to social determinants of health. MMPs are required to offer care coordination services to each beneficiary, including an HRA of the enrollee's physical, psychosocial, and functional status which meet all minimum requirements for MA plans in section 1859(f)(5)(A)(ii) of the Act but often include additional elements to assess social risk factors. As of September 2020, MMPs had performed over 1.3 million HRAs, and in doing so identified significant unmet need among members, particularly related to food insecurity and housing instability. 18 For example, we commonly learn of HRAs identifying people with no regular source of care, untreated chronic conditions, unsafe living conditions, and/or imminent eviction or homelessness. By identifying these unmet needs through the HRA process, MMPs are then able to address them with interventions from care coordinators, connections to community organizations, and by incorporating goals and actions into beneficiary care plans. 18 MMP reported monitoring measure data. Measure data are provided for informational purposes only and do not constitute official evaluation results. Full measure specifications can be found in the reporting requirements documents, available at: https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/FinancialAlignmentInitiative/MMPInformationandGuidance/MMPReportingRequirements.html. • Medicare-Medicaid integration correlates with high levels of beneficiary satisfaction. MMP members report high levels of satisfaction with their MMPs through member experience surveys. When asked to rate their health plan on a scale from 0 to 10 (with 0 being the worst possible and 10 being the best possible), 91 percent of respondents rated their health plan and health care a 7 or higher in 2019, the most recent year for which data are available. 19 Sixty-six percent of all respondents rated their MMP a 9 or 10 in 2019, up from 59 percent in 2016. 20 These ratings have improved continuously (by five percentage points per year on average) since the MMPs started reporting such data in 2015 and are on par with ratings in the broader Medicare Advantage program. 21 19 Centers for Medicare & Medicaid Services. Enrollee Experiences in the Medicare-Medicaid Financial Alignment Initiative: Results through the 2019 CAHPS Surveys. (October 2020) Retrieved from https://www.cms.gov/files/document/faicahpsresults.pdf. 20 Ibid. 21 CMS analysis of MMP and Medicare Advantage CAHPS data 2015-2019. • Carving in Medicaid behavioral health benefits helps promote better coordination of behavioral health and physical health services. Behavioral health conditions are pervasive among dually eligible individuals. For example, nearly one-third of individuals who are dually eligible for Medicare and Medicaid have been diagnosed with a serious mental illness, such as schizophrenia, bipolar disorder, or major depressive disorder, a rate almost three times higher than for non-dually eligible Medicare beneficiaries. 22 Fragmented physical and behavioral health care, delivered across multiple providers and funding sources, can decrease access to care and lead to poor health status. 23 MMPs in all capitated demonstration States except for California and Michigan include Medicaid behavioral health benefits in their plan benefit package. In California, specialty mental health services and substance use disorder treatment covered by Medicaid are financed and administered by county behavioral health departments, and MMPs are required to coordinate with the counties for members served by both entities. Coordination between the MMPs and the counties has varied by county and has often been difficult; challenges include confusion for plans over county-level variation on which services are covered by the county or the MMP, limited behavioral health provider resources to participate in interdisciplinary care teams, and legal and communication barriers to sharing data between county providers and MMPs. 22 Congressional Budget Office. “Dual-Eligible Beneficiaries of Medicare and Medicaid: Characteristics, Health Care Spending, and Evolving Policies.” (June, 2013). Retrieved from: https://www.cbo.gov/sites/default/files/113th-congress-2013-2014/reports/44308dualeligibles2.pdf. This report classified Medicare enrollees as having a mental illness if they had a diagnosis from the previous year of schizophrenia; major depressive, bipolar, and paranoid disorders; or other major psychiatric disorders. 23 Medicaid and CHIP Payment and Access Commission. “Integration of Behavioral and Physical Health Services in Medicaid.” (March, 2016). Retrieved from: https://www.macpac.gov/wp-content/uploads/2016/03/Integration-of-Behavioral-and-Physical-Health-Services-in-Medicaid.pdf. • Integrated beneficiary communication materials can enhance the beneficiary experience. The Medicare and Medicaid programs have different, and sometimes inconsistent, requirements for how plans communicate with individuals. CMS and partnering States, however, require MMPs to provide a single set of integrated member materials designed to meet Federal and State requirements and convey information to members in a more streamlined fashion. CMS tested such materials with beneficiaries to maximize readability and understanding. • Effective joint oversight of integrated managed care products is possible. Through the FAI, we have shown it is possible to create a successful framework for joint State and CMS oversight and contract management. Contract management teams (CMTs) consisting of State Medicaid and CMS staff work hand in hand to assure compliance with the relevant Medicare, Medicaid, and State requirements and MMP three-way contract requirements, and to promote MMP performance in meeting the needs and preferences of beneficiaries. Through each CMT, State and CMS staff coordinate to jointly issue guidance and operational clarification and, as needed, may coordinate to issue joint CMS-State compliance actions. CMTs regularly meet with State ombudsman organizations, State-convened advisory groups, and may also meet with local stakeholders, such as beneficiary advocates, enabling more rapid problem-solving and real-time feedback on plan performance and beneficiary experience. 24 CMS has also developed and refined audit protocols specific to three-way contracts between CMS, the States, and the MMPs, and CMS and State staff coordinate to avoid scheduling conflicting Medicare and Medicaid audits that can cause a plan to split resources between two regulators. Based on feedback from States and MMPs and our own experiences for the last eight years, we believe these joint oversight processes, along with having performance data specific to the local MMPs, have improved communications and driven performance improvement. 24 RTI International, “Financial Alignment Initiative Massachusetts Once Care: Third Evaluation Report,” (April 2019), Retrieved from: https://innovation.cms.gov/files/reports/fai-ma-thirdevalrpt.pdf; RTI International, “Financial Alignment Initiative Michigan MI Health Link First Evaluation Report (Sept 2019), Retrieved from: https://innovation.cms.gov/files/reports/fai-mi-firstevalrpt.pdf; RTI International, “Financial Alignment Initiative MyCare Ohio: First Evaluation Report “(Nov 15 2018), Retrieved from: https://innovation.cms.gov/files/reports/fai-oh-firstevalrpt.pdf; RTI International, “Financial Alignment Initiative South Carolina Healthy Connections Prime: First Evaluation Report (Sept 2019), Retrieved from: https://innovation.cms.gov/files/reports/fai-sc-firstevalrpt.pdf. • Integrated care and joint oversight provide a platform for quality improvement. The capitated model demonstrations have shown it is possible to effectively incentivize innovation and investment for better serving the dually eligible population. MMPs and CMTs collaborate on continuous performance improvement. Like MA plans, MMPs report quality and performance data such as Consumer Assessment of Healthcare Providers and Systems (CAHPS) and Healthcare Effectiveness Data and Information Set (HEDIS) at the contract level. Because the MMP is the only plan under the three-way contract, CMS and the State have access to performance and quality data specific to each individual MMP. (This is similar to how States generally approach Medicaid managed care contracts and quality reporting. In contrast, a D-SNP may be one of many plan benefit packages under a single MA contract, making it difficult to get a true picture of a particular MA plan's performance.) CMS routinely shares State and national performance data on CAHPS and HEDIS metrics with States and MMPs to identify high and low performing plans. Through the CMTs, State and CMS staff have worked with MMPs to identify specific quality metrics to drive performance improvement and have developed specific quality and performance improvement projects at an MMP and/or demonstration level. These efforts have helped to drive significant year-over-year improvement in CAHPS and HEDIS measures. From 2016 to 2018, MMPs as a group improved performance on measures related to care coordination like Care for Older Adults (by an average of 17 percent across three separate measures) and Medication Reconciliation Post-Discharge (by 54 percent), and on key outcome measures like Controlling High Blood Pressure (by 16 percent) and Plan All-Cause Readmissions (17 percent reduction for beneficiaries age 65 and over). 25 Compared to MA plans as a group, MMPs improved at a higher rate on these measures over the same time period. MA plans as a group improved by an average of 5 percent across the Care for Older Adults measures (although only D-SNPs report those measures) and by 32 percent on the Medication Reconciliation Post-Discharge measure, while the Plan All-Cause Readmissions measure had a 16 percent reduction for beneficiaries age 65 and over. 26 Overall, MA plans saw no change to performance on the Controlling High Blood Pressure measure. 27 25 CMS analysis of the MMP performance on HEDIS data reported 2017-2019. 26 CMS analysis of Medicare Advantage performance on HEDIS data reported 2017-2019. 27 Ibid. • There is potential for market distortions in areas with multiple options targeting the same population. The MMP experience has shown that we can create a competitive market among MMPs with multiple choices for beneficiaries in the same service area and maintain high expectations for plans around care coordination and cost effectiveness. However, it has also shown the potential for beneficiary confusion and disruption in markets where MMPs are competing with other products targeting dually eligible individuals, including D-SNPs and, more recently, D-SNP look-alikes. For example, fully integrated D-SNPs (FIDE SNPs) served the same population as MMPs that were under New York's Fully Integrated Dual Advantage (FIDA) capitated model demonstration and the FIDE SNPs were offered by the same parent organization as the MMPs, creating confusion among beneficiaries and providers about each program's role. 28 Differences in Medicare capitation payments gave parent organizations a financial incentive to prioritize enrollment in FIDE SNPs over MMPs. 29 In addition to the financial challenges, the MMPs experienced low enrollment spread among a high number of MMPs 30 due to providers not wanting to meet prescriptive care coordination requirements and encouraging patients not to participate. In California, D-SNP look-alikes emerged following the State's decision to limit eligibility for D-SNPs to beneficiaries not otherwise eligible for MMPs. 31 In its June 2018 report to Congress, MedPAC describes broker commissions as another factor incentivizing enrollment in the D-SNP look-alike plans over the MMPs in States like California that prohibit MMPs from using brokers. 32 For a more thorough discussion of market dynamics in New York and California, see MedPAC's June 2018 report to Congress. 33 For a more comprehensive review of D-SNP look-alike plans, see pages 9019-9021 in the February 2020 proposed rule. 34 28 Medicare Payment Advisory Committee. “Chapter 9, Managed care plans for dual eligible beneficiaries.” In June 2018 Report to Congress: Medicare and Health Care Delivery System (June 15, 2018). Retrieved from https://www.medpac.gov/docs/default-source/reports/jun18_ch9_medpacreport_sec.pdf?sfvrsn=0. 29 Ibid. 30 Per MedPAC's June 2018 report, as of June 2017, 156,000 full-benefit dually eligible individuals were eligible to participate in FIDA, but only 4,708 individuals (3 percent) were enrolled among 14 MMPs. 31 Pursuant to Welfare and Institutions Code section 14132.277(d), for seven counties, DHCS only offered D-SNP contracts (that is, contracts between the State and the D-SNP that are required under 42 CFR 422.107 for an MA organization to offer a D-SNP) to plans that were approved as of 1/1/13 and new enrollment into those D-SNPs is limited to beneficiaries not otherwise eligible for Medicare-Medicaid plans. The State also did not permit existing D-SNPs to expand service area into the seven counties. 32 Medicare Payment Advisory Committee. “Chapter 9, Managed care plans for dual eligible beneficiaries.” In June 2018 Report to Congress: Medicare and Health Care Delivery System (June 15, 2018). Retrieved from https://www.medpac.gov/docs/default-source/reports/jun18_ch9_medpacreport_sec.pdf?sfvrsn=0. 33 Ibid. 34 As finalized in § 422.514 by the “Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, and Medicare Cost Plan Program” (85 FR 33796 through 33911) (hereinafter referred as the May 2020 final rule), CMS will no longer enter into a contract with a new D-SNP look-alike beginning in CY 2022 or an existing D-SNP look-alike beginning in CY 2023. • State investment is critical to successful implementation of integrated care either through MMPs or D-SNPs. True integration of Medicare and Medicaid requires long-term State participation. However, interest and capacity in pursuing integrated care for dually eligible individuals varies considerably from State to State, and sometimes from year to year. One of the many lessons from the MMP experience has been that standing up a demonstration of this scope requires significant State resources. However, even outside of MMPs, many of the features of integration also require significant State effort. States that have successfully utilized D-SNP contracts to integrate or align Medicare and Medicaid programmatic and administrative elements outside of the FAI have also invested in building State capacity, including establishing dedicated staff or contractors with Medicare knowledge and expertise, building technical capacity to integrate Medicare and Medicaid data, and creating analytic resources to support ongoing program operations and oversight. 35 For example, to maximize integration opportunities, D-SNP members may also enroll in the same organization's Medicaid plan. State investment in establishing enrollment and assignment processes to enable alignment of Medicare and Medicaid enrollment require upfront and ongoing monitoring resources. 35 A. Kruse and M. Herman Soper. State Efforts to Integrate Care for Dually Eligible Beneficiaries: 2020 Update. Center for Health Care Strategies, Inc., February 2020. Available at https://www.chcs.org/media/State-Efforts-to-Integrate-Care-for-Dually-Eligible-Beneficiaries_022720.pdf. 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. Below we propose 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 that follow would incorporate certain MMP policies into the regulations governing D-SNPs or, in several cases, certain types of D-SNPs. We describe those proposals in greater detail in this section of this proposed rule. Table 1 summarizes how our proposals relate to MMP policies. BILLING CODE 4120-01-P EP12JA22.004 BILLING CODE 4120-01-C 3. Enrollee Participation in Plan Governance (§ 422.107) CMS believes managed care plans derive significant value from engaging enrollees in defining, designing, participating in, and assessing their care systems. 36 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. 37 Federal regulations for other programs, such as the Programs of All-Inclusive Care for the Elderly and Medicaid managed care plans that cover long-term services and supports (LTSS) include requirements for stakeholder engagement and committees, including input from beneficiaries. We describe these requirements later in this section. 36 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. 37 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. Stakeholder engagement has been an important tenet of the FAI since its inception. As required by the three-way contracts between CMS, States, and MMPs, all MMPs established enrollee advisory committees. 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. While three-way contract terms differ by State, all three-way contracts require the enrollee advisory committees to meet at least quarterly, be comprised of enrollees, family members, and other caregivers that reflect the diversity of the demonstration population, and provide regular feedback to the MMP's governing board. MMPs have flexibility in conducting these meetings, including determining how to recruit and train enrollees, number of participants, discussion topics, and how feedback is disseminated and used. CMS's contractor Resources for Integrated Care partnered with Community Catalyst, a non-profit advocacy organization, to offer a series of webinars and other written technical assistance to help enhance MMPs' operationalization of these committees. 38 In their work, the Resources for Integrated Care and Community Catalyst identified some practices leading to successful enrollee advisory committees. These include MMP efforts to— 38 Resources for Integrated Care and Community Catalyst, “Member Engagement in Plan Governance Webinar Series”, 2019. Retrieved from: https://www.resourcesforintegratedcare.com/concepts/member_engagement. • Recruit enrollees through care coordinator referrals and community outreach events; • Listen to enrollee feedback; • Be responsive to enrollee feedback by identifying meaningful changes made because of comments shared and, if the plan is not able to implement a suggestion, providing a rationale; • Disseminate feedback to appropriate departments across the plan; • Promote consistent enrollee participation through supports like transportation to the committee meetings, meals, and a stipend; and • Provide ongoing training to enrollees to help them feel comfortable and empowered to provide feedback. 39 39 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. In late 2018, Federal and State officials led conversations with MMPs to gain a better understanding of the enrollee advisory committees, promising practices, challenges, and how plans are using the feedback received from enrollees and caregivers. A significant number of MMPs reported value from having an advisory committee and that the committee contributes to operational improvements through: (1) Understanding challenges with community resources and potential gaps in services; (2) improving enrollee communications, including printed materials and the website enhancements; (3) identifying barriers to medication adherence and what adherence tools might be most useful to enrollees; and (4) improving delivery of non-emergency transportation, dental, vision, and over-the-counter benefits. A few MMPs reported a neutral value of the advisory committee meetings, citing benefits from enrollee feedback but also challenges in enrollee participation and willingness to engage on issues beyond their personal circumstances. Overall, though, the MMPs reported the committees provided a valuable perspective that shapes the plan's approach to recovery, wellness, and overall access to health care as well as prioritize areas where additional assistance is needed for enrollees. More recently, MMPs have utilized enrollee advisory committees to gain insight into the effectiveness of specific enrollee materials. For example, some MMPs have shared redacted care plans with enrollee advisory committees for enrollee feedback. Other MMPs have shared draft influenza vaccination outreach materials with their enrollee advisory committees and used the quarterly meetings to discuss influenza prevention. During 2020 and 2021, MMPs have used these committees to discuss ways to educate enrollees about COVID-19 prevention and vaccines. We have had the opportunity to observe some of these meetings and found the dialogue between enrollees and their caregivers and the MMPs to be open and constructive, with all parties interested in sharing information, listening, and identifying solutions. Other programs overseen by CMS include similar committees or mechanisms for beneficiaries to provide feedback and have a role in plan administration. a. Participant Advisory Committees in PACE Organizations In addition to MMPs, Programs of All-Inclusive Care for the Elderly (PACE) organizations, per § 460.62(b), must establish participant advisory committees to advise the PACE organization governing body on matters of concern to participants. The majority of the 51,000 PACE participants are dually eligible individuals. 40 40 CMS, Medicare Advantage, Cost, PACE, Demo, and Prescription Drug Plan Contract Report—Monthly Summary Report (Data as of June 2021). Retrieved from: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Monthly-Contract-and-Enrollment-Summary-Report. CMS initially required PACE organizations to establish consumer advisory committees as part of the Federal regulations codifying the PACE program in a November 1999 interim final rule with comment period (IFC) for PACE (64 FR 66234). The November 1999 IFC noted that consumer participation through advisory committees is a “well accepted community organization vehicle to maximize the involvement of consumers in a program designed to serve them” and that through the use of a consumer advisory committee consumers are also “likely to feel a greater stake in the operation of the program” (64 FR 66242). The original regulation, codified at § 460.62, required PACE participants and participant representatives to comprise the majority of committee membership, but there was no Federal requirement relating to how frequently PACE organizations were required to convene the committees. In a December 2006 final rule (71 FR 71244 through 71337), we made minor revisions to the PACE consumer advisory committee regulation text at § 460.62, including changing the name to participant advisory committee (71 FR 71265). We also clarified in the preamble that the final rule was not specifying the size of the participant advisory committee but that we expected each committee to be representative of the size and population of the PACE organization's participants. The requirements at § 460.62 allow PACE organizations flexibility in determining the frequency, scope, and participation on these advisory committees. Through its many years of experience overseeing PACE organizations, CMS has learned that PACE organizations value the participant advisory committees as an important way to receive direct feedback from PACE participants to improve program policy and operations. Attendance at participant advisory committees may include PACE organization leadership, including executive directors and PACE center directors. Since PACE participants visit the PACE center at least once per week, feedback provided by PACE participants at the participant advisory committees is generally focused on challenges with transportation between the PACE center and their residences and preferences for meals and activities provided at the PACE center. Per § 460.62(c), PACE organizations must have a participant representative on their governing body. These participant representatives act in part as a liaison of the participant advisory committee to the PACE organization governing body and the participant advisory committee, presenting issues from the participant advisory committee to the governing body. The link between the participant advisory committee and the governing body helps to elevate issues raised by participants to PACE organization leadership. b. Member Advisory Committees in Medicaid Managed Care Plans Medicaid managed care plans that cover long-term services and supports (LTSS) are also required to solicit active member and other stakeholder input through the use of a member advisory committee. Recognizing that stakeholder engagement is an important member protection and is critical to the success of Medicaid managed LTSS programs, CMS requires certain Medicaid managed care plans providing LTSS to establish and maintain a member advisory committee. Per 42 CFR 438.110, as adopted in the “Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability” final rule (81 FR 27655 through 27658) (hereinafter referred to as the May 2016 final rule), when LTSS are covered under a risk contract between a State and a Medicaid managed care plan (that is a Medicaid managed care organization (MCO), prepaid inpatient health plan (PIHP), or prepaid ambulatory health plan (PAHP)), each Medicaid managed care plan must establish a member advisory committee. The committee must include at least a reasonably representative sample of the LTSS population, or other individuals representing those members, covered under the contract with the Medicaid managed care plan. CMS designed this requirement in a way that gives managed care plans covering LTSS flexibility to work with their stakeholder communities to establish the most effective member engagement process. c. Proposal for D-SNP Enrollee Advisory Committees 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 propose 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 propose 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 propose 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 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. Further, this requirement would be consistent with the existing requirement at § 438.110 for Medicaid plans to establish member advisory committees when those Medicaid managed care plans cover LTSS. While we describe 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 note 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. We believe that D-SNPs should work with enrollees and their representatives to establish the most effective and efficient process for enrollee engagement. 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 choose not to 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. Further, our proposal includes flexibility for MA organizations in how they structure their enrollee advisory committee(s). 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 41 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. 41 Resources for Integrated Care and Community Catalyst, “Engaging Members in Plan Governance”, 2019. Retrieved from: https://www.resourcesforintegratedcare.com/node/433#PlanGov. First, we propose 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. Under our proposed rule, 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 propose 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. By using the phrase “representative sample” in the regulation text, we intend D-SNPs to 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. An MA organization that offers separate D-SNPs in multiple counties in a State could decide to convene one enrollee advisory committee to solicit feedback across the membership of all these D-SNP plans as long as that committee's participants reasonably represent the totality of the D-SNP membership. Alternatively, this MA organization could convene an enrollee advisory committee for each D-SNP in each county where the D-SNP is offered. The MA organization could also choose to implement a combination of the aforementioned approaches, such as establishing an enrollee advisory committee that solicits enrollees from a D-SNP offered in one county and establishing an enrollee advisory committee with enrollees representing D-SNPs offered in more than one county. For example, a MA organization that offers separate D-SNPs in Broward, Hillsborough, and Orange counties in Florida could establish one enrollee advisory committee that convenes membership representative of these distinct regions of Florida via virtual communications methods, or it could establish separate enrollee advisory committees in each county, or it could implement some combination of these approaches. Similarly, for MA organizations that offer separate D-SNPs serving full-benefit dually eligible individuals and partial-benefit dually eligible individuals in the same State, proposed § 422.107(f) provides flexibility for MA organizations to solicit enrollee input through one or more committees where separate committees might represent specific eligibility groups. Ensuring that the enrollee advisory committee is representative of the covered population of the D-SNP(s) that are served by the committee is key to achieving the goals of requiring an enrollee advisory committee. Finally, we propose 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). CMS encourages D-SNPs to consider the CMS Office of Minority Health Disparities Impact Statement as a potential tool to improve health equity for underserved populations among their enrollment. 42 Our proposal does not specify other responsibilities or obligations for the committee, but we encourage D-SNPs to solicit input from enrollees on other topics will be part of the committee's responsibilities. 42 CMS Office of Minority Health, Health Equity Technical Assistance. Retrieved from: https://www.cms.gov/About-CMS/Agency-Information/OMH/equity-initiatives/Health-Equity-Technical-Assistance. Specifically, we propose the following amendments to § 422.107: • Revise the section heading from “Special needs plans and dual eligible: Contract with State Medicaid Agency” to “Requirements for dual eligible special needs plans” to reflect how, as amended, § 422.107 will address D-SNP requirements, such as the enrollee advisory committee, in addition to the State Medicaid agency contracts and their content; and • Add new paragraph (f) to require that any MA organization offering one or more D-SNPs in a State must establish and maintain one or more enrollee advisory committees that serve the D-SNPs offered by the MA organization, with at least a reasonably representative sample of the population enrolled in the dual eligible special needs plan or plans, or other individuals representing those enrollees, and solicit input on, among other topics, ways to improve access to covered services, coordination of services, and health equity for underserved populations. An MA organization that offers one or more D-SNPs and offers (or is under a parent organization that offers) one or more Medicaid managed care plans that cover long term services and supports—including the MA organizations associated with all FIDE SNPs and most HIDE SNPs—would be subject to our proposal and § 438.110. In some circumstances, especially among FIDE SNPs and HIDE SNPs, we expect that organizations could meet the requirements in our proposal and § 438.110 through one enrollee advisory committee. Section 438.110(b) requires the member advisory committees to include at least a reasonably representative sample of the LTSS populations covered, but it does not preclude the membership of other enrollees as well. Therefore, an advisory committee could, in some cases, be reasonably representative of both the LTSS population and the D-SNP, even if enrollment in the D-SNP is not limited to LTSS users. Some State Medicaid agency contracts, such as those in Idaho, Massachusetts, Minnesota, New Jersey, and Pennsylvania, already require member advisory committees for FIDE SNPs that operate in those States in compliance with § 438.110, because the MCOs affiliated with those FIDE SNPs cover LTSS. Therefore, based on our review of State Medicaid agency contracts, we expect that a number of FIDE SNPs and HIDE SNPs affiliated with Medicaid managed care plans that cover LTSS already operate enrollee advisory committees that would comply with our proposal and § 438.110. The proposed regulation permits an organization that operates a D-SNP that is affiliated with a Medicaid managed care plan to use one enrollee advisory committee to meet both the requirement under § 438.110 and the requirement proposed at § 422.107(f), when all the criteria in both regulations are met and the State permits this arrangement. In other circumstances, it may not be feasible for an organization to operate a single enrollee advisory committee that meets the requirements of our proposal and § 438.110. Those organizations would need to operate multiple enrollee advisory committees. 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. As a result, we are not proposing specific prescriptive requirements for how D-SNPs must interact with and use these enrollee committees. However, we solicit comments on our proposal, including 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 responsibilities of the enrollee advisory committees, and additional topics for enrollee input, and whether we should limit the enrollee advisory committee proposed at § 422.107(f) to a subset of D-SNPs. We also solicit 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. Consistent with PACE, if our proposal is finalized, we would update the CMS audit protocols for D-SNPs to request documentation of enrollee advisory committee meetings. As we learn about the implementation experiences of these committees, if proposed § 422.107(f) is finalized, we would consider more prescriptive requirements in the future, if needed. 4. Standardizing Housing, Food Insecurity, and Transportation Questions on Health Risk Assessment (§ 422.101) Section 1859(f)(5)(A)(ii)(I) of the Act requires each SNP to conduct an initial assessment and an annual reassessment of the individual's physical, psychosocial, and functional needs using a comprehensive risk assessment tool that CMS may review during oversight activities, and ensure that the results from the initial assessment and annual reassessment conducted for each individual enrolled in the plan are addressed in the individual's individualized care plan. We codified this requirement at § 422.101(f)(1)(i) as a required component of the D-SNP's MOC. In practice, we allow each SNP to develop its own HRA, as long as it meets the statutory and regulatory requirements. 43 In the final rule titled “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) (hereinafter referred to as the January 2021 final rule), we noted that D-SNPs also receiving capitation for Medicaid services may combine their Medicare-required HRA with a State Medicaid-required HRA to reduce assessment burden for enrollees (86 FR 5879). Certain social risk factors can lead to unmet social needs that directly influence an individual's physical, psychosocial, and functional status. 44 This is particularly true for food insecurity, housing instability, and access to transportation. The following are examples of actions that CMS has taken since 2014 to address social risk through the identification and standardization of screening for risk factors: 43 In the CY 2016 Call Letter (an attachment to the Announcement of Calendar Year (CY) 2016 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies) released on April 6, 2015, CMS encouraged SNPs to adopt the components in the CDC's “A Framework for Patient-Centered Health Risk Assessments” tool but did not mandate their use. Specifically, CMS encouraged the use of elements that identify the medical, functional, cognitive, psychosocial and mental health care needs of enrollees. 44 Hugh Alderwick and Laura M. Gottlieb, “Meanings and Misunderstandings: A Social Determinants of Health Lexicon for Health Care Systems: Milbank Quarterly,” Milbank Memorial Fund, November 18, 2019, https://www.milbank.org/quarterly/articles/meanings-and-misunderstandings-a-social-determinants-of-health-lexicon-for-health-care-systems/. • IMPACT Act of 2014. The Improving Medicare Post-Acute Care Transformation Act of 2014 Section 2(a) (Pub. L. 113-185), hereinafter referred to as the IMPACT Act, amended the Social Security Act (the Act) by adding section 1899B to the Act. Section 1899B(b)(1) of the Act requires, in part, that the Secretary require certain post-acute care (PAC) providers to submit standardized patient assessment data with respect to certain categories of data. CMS finalized several standardized patient assessment data requirements, including on social determinants of health. 45 45 See the “Medicare and Medicaid Programs: CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements” final rule (84 FR 39151 through 39161) as an example. In the interim final rule with comment period (IFC) “Medicare and Medicaid Programs, Basic Health Program and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program” (85 FR 27550 through 27629), CMS delayed the compliance dates for these standardized patient assessment data under the Inpatient Rehabilitation Facility (IRF) Quality Reporting Program (QRP), Long-Term Care Hospital (LTCH) QRP, Skilled Nursing Facility (SNF) QRP, and the Home Health (HH) QRP due to the public health emergency. In the “CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting Requirements for Long-Term Care Facilities” final rule (86 FR 62240 through 62431), CMS finalized its proposals to require collection of standardized patient assessment data under the IRF QRP and LTCH QRP effective October 1, 2022, and January 1, 2023 for the HH QRP. • Accountable Health Communities (AHC) Model. The AHC Model, which is being tested under section 1115A of the Act, tests whether systematically screening for health-related social needs and referrals to community-based organizations to resolve identified unmet needs will improve healthcare utilization and reduce costs. Over a five-year period, organizations implementing the AHC Model, known as Bridge Organizations, are screening community-dwelling Medicare and Medicaid beneficiaries to identify their health-related social needs and providing navigation assistance to connect those beneficiaries with community services. 46 Some Bridge Organizations are also engaging key stakeholders in community-level continuous quality improvement activities to align the community service capacity with the community's service needs. For purposes of the model, the CMS Innovation Center developed the AHC Health-Related Social Needs (HRSN) Screening Tool. The tool asks 10 standardized questions that identify a patient's HRSNs in five core domains: Housing instability, food insecurity, transportation problems, utility help needs, and interpersonal safety. 47 48 The first AHC Model evaluation report, assessing model implementation from 2017 to 2020, 49 demonstrated high prevalence of social risk factors among eligible high-need beneficiaries. Food insecurity was the most commonly reported social risk factor. 46 CMS Innovation Center, “Findings at a Glance: Accountable Health Communities: Evaluation of Performance Years 1-3 (2017-2020).” Retrieved from: https://innovation.cms.gov/data-and-reports/2020/ahc-first-eval-rpt-fg. 47 CMS Innovation Center, “The Accountable Health Communities Health-Related Social Needs Screening Tool.” Retrieved from: https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf. 48 There are now Logical Observation Identifiers Names and Codes (LOINC) terms available for the AHC HRSN Screening Tool, as of June 2021. For more information, see: https://loinc.org/loinc/96777-8/. 49 RTI International, “Accountable Health Communities (AHC) Model Evaluation First Evaluation Report,” Dec 2020. Retrieved from: https://innovation.cms.gov/data-and-reports/2020/ahc-first-eval-rpt. Many dually eligible individuals contend with multiple social risk factors such as food insecurity, homelessness, lack of access to transportation, and low levels of health literacy. 50 Nonetheless, we have not previously required that SNP HRAs specifically collect information about these issues. We believe requiring SNPs to include standardized questions about social risk factors is appropriate in light of the impact these factors may have on health care and outcomes for the enrollees in these plans and that access to this information will better enable SNPs to design and implement effective models of care. 50 Medicaid and CHIP Payment and Access Commission, “Report to Congress on Medicaid and CHIP,” June 2020. Retrieved from: https://www.macpac.gov/wp-content/uploads/2020/06/June-2020-Report-to-Congress-on-Medicaid-and-CHIP.pdf. We propose to amend § 422.101(f)(1)(i) to require that all SNPs (chronic condition special needs plans, D-SNPs, and institutional special needs plans) include one or more standardized questions on the topics of housing stability, food security, and access to transportation as part of their HRAs. These questions will help SNPs gather the necessary information in order to conduct a comprehensive risk assessment of each individual's physical, psychosocial, and functional needs as required at § 422.101(f)(1)(i) and will inform the development and implementation of each enrollee's comprehensive individualized plan of care as required at § 422.101(f)(1)(ii). Rather than include the specific questions in regulation text, we propose that the questions be specified in sub-regulatory guidance. This would afford us some flexibility to modify questions to maintain consistency with standardized questions that are developed for other programs while still providing MA organizations with clear requirements; we intend to provide ample notice to MA organizations of any changes in the questions over time. Should we finalize our proposal, SNPs would comply with the new requirement added to § 422.101(f) by including in their HRAs the standardized questions on these topics that we would specify in sub-regulatory guidance. At a minimum, we intend to align selected questions with the Social Determinants of Health (SDOH) Assessment data element 51 established as part of the USCDI v2, when finalized and where applicable. 51 For more information, see: https://www.healthit.gov/isa/taxonomy/term/1801/uscdi-v2. While we are proposing that the regulation text specify that the wording of individual questions would be established through sub-regulatory guidance, we provide here examples of the questions on these topics used in other Medicare contexts to provide better context on the proposed requirement and to solicit public comment. These examples include the transportation question in the post-acute care patient/resident instruments and the housing and food insecurity questions from the AHC Model HRSN Screening Tool: 52 52 For the Accountable Health Communities Health-Related Social Needs Screening Tool, see https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf. The PAC assessment utilized the same transportation question as the AHC HRSN Tool. Housing. What is your living situation today? 53 53 Adapted from National Association of Community Health Centers and partners, National Association of Community Health Centers, Association of Asian Pacific Community Health Organizations, Association OPC, Institute for Alternative Futures. (2017). PRAPARE. http://www.nachc.org/research-and-data/prapare/. • I have a steady place to live • I have a place to live today, but I am worried about losing it in the future • I do not have a steady place to live (I am temporarily staying with others, in a hotel, in a shelter, living outside on the street, on a beach, in a car, abandoned building, bus or train station, or in a park) Food. Some people have made the following statements about their food situation. Please answer whether the statements were OFTEN, SOMETIMES, or NEVER true for you and your household in the last 12 months. Within the past 12 months, you worried that your food would run out before you got money to buy more. 54 54 Adapted from Hager, E.R., Quigg, A.M., Black, M.M., Coleman, S.M., Heeren, T., Rose-Jacobs, R., Cook, J.T., Ettinger de Cuba, S.E., Casey, P.H., Chilton, M., Cutts, D.B., Meyers A.F., Frank, D.A. (2010). Development and Validity of a 2-Item Screen to Identify Families at Risk for Food Insecurity. Pediatrics, 126(1), 26-32. doi:10.1542/peds.2009-3146. • Often true • Sometimes true • Never true Within the past 12 months, the food you bought just didn't last and you didn't have money to get more. • Often true • Sometimes true • Never true Transportation. Has lack of transportation kept you from medical appointments, meetings, work, or from getting things needed for daily living? 55 55 National Association of Community Health Centers and partners, National Association of Community Health Centers, Association of Asian Pacific Community Health Organizations, Association OPC, Institute for Alternative Futures. (2017). PRAPARE. http://www.nachc.org/research-and-data/prapare/. • Yes, it has kept me from medical appointments or from getting my medications • Yes, it has kept me from non-medical meetings, appointments, work, or from getting things that I need • No Our proposal would result in SNPs having a more complete picture for each enrollee of the risk factors that may inhibit accessing care and achieving optimal health outcomes and independence. We believe that these questions are sufficiently related to and provide information on enrollees' physical, psychosocial, and functional needs to be appropriate to include the HRA. Having knowledge of this information for each enrollee would better equip MA organizations to develop an effective plan of care for each enrollee that identifies goals and objectives as well as specific services and benefits to be provided. Our proposal would also equip SNPs with person-level information that would help them better connect enrollees to covered services (for example, non-emergency medical transportation, when capitated by Medicaid or covered as a supplemental benefit) and to social service organizations and public programs that can help resolve housing instability, food insecurity, transportation needs, or other challenges. Coordinating care along these lines is consistent with the obligations under § 422.112(b)(3) for MA organizations that offer coordinated care plans. We are not explicitly proposing that SNPs be accountable for resolving all risks identified in these assessment questions, but § 422.101(f)(1)(i) requires that the results from the initial and annual HRAs be addressed in the individualized care plan. Results of the HRAs do not require SNPs to provide housing or food insecurity supports, but having the results means that SNPs would need to consult with enrollees about their unmet social needs, which may include homelessness and housing instability, for example, in developing each enrollee's care plan. A SNP could demonstrate this in several ways, consistent with its MOC. For example, a SNP may make a referral to an appropriate community partner, consistent with the individual's goals and preferences, to assist in meeting these needs. The SNP may also adapt communication methods to fit the individual's circumstances and take steps to maximize access to covered services that may meet the individual's needs and preferences, especially for supplemental benefits that may help with housing instability, food insecurity, or transportation. SNPs currently report to CMS the number of completed HRAs, and, as part of the Medicare Part C Program Audit Protocols for SNP Care Coordination, we currently review a sample of HRAs and ICPs. 56 However, we do not currently collect specific data elements from HRAs for all SNP enrollees, in part because the data elements vary from plan to plan. By standardizing certain data elements, our proposal would make those data elements available for collection by CMS from the SNPs for all enrollees. (States can also use their contracts with D-SNPs at § 422.107 to require reporting of these data elements in the HRA to the State or its designee.) While we continue to consider whether, how, and when we would have the SNPs actually report data to CMS, we believe having such information could help us to better understand the prevalence and trends in certain social risk factors across SNPs and further consider ways to support SNPs in promoting better outcomes for their enrollees. We believe standardizing these data elements could also eventually facilitate better data exchange among SNPs (such as when an individual changes SNPs). 56 For more information, see: https://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-and-Part-D-Compliance-and-Audits/ProgramAudits. We understand that some States may separately require that Medicaid managed care plans collect similar information, potentially creating inefficiencies and added assessment burden on dually eligible individuals who are asked similar, but not identical information, in multiple HRAs. We believe that the benefit gained by all SNPs having standardized information about these social risk factors outweighs this potential risk. These questions build on other work across CMS. Where States are interested in requiring assessment questions, we recommend that States consider conforming to the standardized questions we implement for use under this proposed rule and, for integrated care programs, ensuring that plans do not need to ask the same enrollees similar or redundant questions. However, we also seek input from States about what questions they are using and how we can best minimize assessment burden while ensuring that SNPs and States are capturing actionable information on social risk factors. We are considering several alternatives to our proposal. We are considering requiring fewer or more assessment questions on additional topics related to social risk factors or different combinations of questions from the post-acute care patient/resident assessment instruments and AHC Model HRSN Screening Tool. For example, we are considering requiring that SNPs use the post-acute care patient/resident assessment instruments questions on health literacy (“How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?”) and social isolation (“How often do you feel lonely or isolated from those around you?”). We believe these would provide valuable insight but are not proposing to require HRAs to include standardized questions in these areas out of parsimony. We focused on the proposed areas since there is a large evidence base suggesting they have a particularly significant influence on the physical, psychosocial, and functional needs of the enrollees. 57 For example, our experience with the FAI demonstrations has shown that lack of transportation can have a large impact in securing needed health care services. Our proposal would not preclude SNPs from asking additional questions related to these areas as long as the minimum standardized questions (specified in CMS sub-regulatory guidance pursuant to the regulation) are included as part of the HRA. 57 See Kushel MB, Gupta R, Gee L, Haas JS. Housing instability and food insecurity as barriers to health care among low-income Americans. J Gen Intern Med. 2006;21(1):71-7. doi: 10.1111/j.1525-1497.2005.00278.x. We considered soliciting comment in this preamble on different examples of questions on housing, food, and transportation other than the examples included above, such as the housing-related questions from the U.S. Department of Veteran Affairs' Homelessness Screening Clinical Reminder 58 or the housing-, food-, and transportation-related questions from the Medicare Current Beneficiary Survey. 59 We also considered simply proposing that all HRAs address certain domains (for example, housing), without authorizing CMS to specify the standardized questions to be used. However, we believe the benefit of flexibility for SNPs is outweighed by the challenges posed by use of multiple different questions used by different SNPs across the country. Having different questions that touch on the same topics in different ways would pose difficulties for interoperability, comparability, and reporting on these risk factors. We are considering specifying that the new questions only apply to certain enrollees and not others. For example, we are considering whether the questions on housing insecurity would be relevant for enrollees in congregate housing. However, because people may move between settings, including from an institutional placement to the community, we believe that such a proposal would add complexity without obvious benefit. 58 For more information, see the U.S. Department of Veteran Affairs, VA National Center of Homelessness Among Veterans March 2014 Research Brief “Using a Universal Screener to Identify Veterans Experiencing Housing Instability” at https://www.va.gov/HOMELESS/Universal_Screener_to_Identify_Veterans_Experiencing_Housing_Instability_2014.pdf. 59 For more information, see https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/MCBS. Finally, due to the processes associated with developing HRA tools, approval of MOCs, and MOC implementation, we would not enforce this requirement until contract year 2024. However, we are also considering whether to have our proposed requirement take effect at a later date, such as contract year 2025, to allow MA organizations more time to work our proposed new questions into their existing SNP HRAs. We welcome comments on our proposal and these potential alternatives including adding questions regarding health literacy, social isolation, or other areas. We also welcome comments on when CMS would need to issue sub-regulatory guidance providing the specific questions to be included in the HRA to ensure that MA organizations would have sufficient time to incorporate the required questions. 5. Refining Definitions for Fully Integrated and Highly Integrated D-SNPs (§§ 422.2 and 422.107) Dually eligible individuals have an array of choices for how to receive their Medicare coverage, including Original Medicare with a standalone prescription drug plan, non-SNP MA plans, multiple types of SNPs, and Programs of All-inclusive Care for the Elderly. Those choices can be complex and, for some, overwhelming. An average Medicare beneficiary will have access to 54 MA plans in 2022, excluding MMPs and PACE, compared to 39 MA plans in 2020. 60 In one extreme example, dually eligible individuals in Los Angeles have over 85 choices for Medicare coverage for 2022, including 70 MA plans, nine D-SNPs, two FIDE SNPs, and five MMPs—more Medicare options to choose from than Medicare-only beneficiaries. 61 60 Information from 2022 Landscape Source Files. Retrieved from https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn. Excludes EGWPs. 61 Ibid. Our own terminology is complex too. While we have defined terms through rulemaking in § 422.2, there remains nuance and variation that may make it difficult for members of the public—and even the professionals who support them—to readily understand what may be unique about a certain type of plan or what a beneficiary can expect from any FIDE SNP, for example. We propose several changes to how we define FIDE SNPs and HIDE SNPs that we believe will ultimately help to differentiate various types of D-SNPs and clarify options for beneficiaries. Our proposals would lay the groundwork for potential future improvements to Medicare Plan Finder and other communications to help beneficiaries better understand their options for integrated coverage of Medicare and Medicaid benefits. a. Exclusively Aligned Enrollment for FIDE SNPs Section 422.2 defines the term “fully integrated dual eligible special needs plan,” most recently updated in the May 2020 final rule. Under the current definition, FIDE SNPs are plans that: (i) Provide dually eligible individuals access to Medicare and Medicaid benefits under a single entity that holds both an MA contract with CMS and a Medicaid managed care organization (MCO) contract under section 1903(m) of the Act with a State Medicaid agency, (ii) under the capitated Medicaid managed care contract, provide coverage, subject to some limited flexibility for carve-outs, of primary care, acute care, behavioral health, and LTSS, and coverage of nursing facility services for a period of at least 180 days during the plan year; (iii) coordinate delivery of covered Medicare and Medicaid benefits using aligned care management and specialty care network methods for high-risk beneficiaries; and (iv) employ policies and procedures approved by CMS and the State to coordinate or integrate beneficiary communication materials, enrollment, communications, grievance and appeals, and quality improvement. The current definition of a FIDE SNP does not require that the MA contract limit enrollment to the individuals who are enrolled in the affiliated MCO. One benefit of FIDE SNP designation for the MA organization is that the MA plan may qualify for a frailty adjustment as part of CMS's risk adjustment of its MA capitation payments under section 1853(a)(1) of the Act and § 422.308(c); FIDE SNPs with a similar average level of frailty (as determined by the Secretary) as the PACE program may qualify for the frailty adjustment, which may result in increased aggregate payment from CMS. Section 422.2 also defines the term “aligned enrollment” as referring to when a full-benefit dually eligible individual is an enrollee of a D-SNP and receives coverage of Medicaid benefits from the D-SNP or from a Medicaid MCO that is: (1) The same organization as the MA organization offering the D-SNP; (2) its parent organization; or (3) another entity that is owned and controlled by the D-SNP's parent organization. When State policy limits a D-SNP's membership to individuals with aligned enrollment, § 422.2 refers to that condition as exclusively aligned enrollment. Exclusively aligned enrollment is an important design feature for maximizing integration of care for all the D-SNP's enrollees. It facilitates the use of integrated beneficiary communication materials (because all beneficiaries in the D-SNP are also in the companion Medicaid MCO), clarifies overall accountability for outcomes and coordination of care, and makes feasible the requirement (effective January 1, 2021) that the plan use unified grievance and appeals procedures for both Medicare and Medicaid benefits. All MMPs operate with exclusively aligned enrollment, and several States require exclusively aligned enrollment for FIDE SNPs that operate in the State by including this requirement in the State Medicaid agency contract that is required for D-SNPs by § 422.107(b). However, the current regulatory definition of FIDE SNP permits certain forms of unaligned enrollment between Medicare and Medicaid coverage. That is, a beneficiary may be in one parent organization's FIDE SNP for coverage of Medicare services but a separate company's Medicaid managed care plan (or in a Medicaid FFS program) for coverage of Medicaid services. In 2021, there are 69 FIDE SNPs in 12 States, enrolling 264,146 beneficiaries as of January 2021. 62 Fifty-seven of those 69 FIDE SNPs have exclusively aligned enrollment. Only Arizona, Pennsylvania, and Virginia currently contract with FIDE SNPs without requiring exclusively aligned enrollment. 62 CY 2021 data is from CMS review of CY 2021 State Medicaid agency contracts submitted by FIDE SNPs. 2016 data is from Verdier, J., A. Kruse, R. Lester, et al. 2016. State contracting with Medicare Advantage dual eligible special needs plans: Issues and options. Washington, DC: Integrated Care Resource Center. Retrieved from https://www.integratedcareresourcecenter.com/sites/default/files/ICRC_DSNP_Issues__Options.pdf. We propose to amend the definition of “fully integrated dual eligible special needs plan” at § 422.2 with a new paragraph (5) that requires, for 2025 and subsequent years, that all FIDE SNPs have exclusively aligned enrollment. Our proposed change would move FIDE SNPs toward greater integration in the provision of Medicare and Medicaid benefits for dually eligible individuals and make the options available to these beneficiaries simpler to understand. Requiring all FIDE SNPs to have exclusively aligned enrollment would simplify the ways we, States, and benefit counselors communicate about FIDE SNPs by eliminating some of the confusing scenarios related to unaligned enrollment that our current definition permits. It would allow all enrollees to have their Medicare and Medicaid benefits explained under the FIDE SNP clearly, which is made more difficult when some enrollees are, but others are not, also enrolled in the affiliated Medicaid MCO. Our proposed change promotes higher levels of Medicare-Medicaid integration by ensuring that that all FIDE SNPs can deploy integrated beneficiary communication materials and unify appeals and grievance procedures for all the Medicare and Medicaid benefits covered through the FIDE SNP and affiliated Medicaid MCO; such unified procedures are not feasible when some FIDE SNP members do not receive the Medicaid benefits from the same organization. Under our proposed definition, all FIDE SNPs would (1) be capitated for Medicaid services, with some permissible exceptions proposed at § 422.107(g) and (h) and discussed later in this section, for all of their enrollees, and (2) based on meeting the definition of applicable integrated plans in § 422.561, operate unified appeals and grievance processes and continue delivery of benefits during an appeal. Ultimately, we believe this change in the definition of a FIDE SNP will help simplify options and provide a better plan experience for dually eligible beneficiaries, as they will be able to receive all their covered Medicare and Medicaid benefits through one organization. In the absence of a State Medicaid policy change (to require or facilitate exclusively aligned enrollment) in Arizona, Pennsylvania, or Virginia, our proposal would result in 12 plans losing FIDE SNP status. However, our proposal would not prohibit those States and plans from operating as they currently do but would simply mean that the affected plans would be HIDE SNPs rather than FIDE SNPs beginning January 1, 2025. (A HIDE SNP is another type of D-SNP defined at § 422.2 which we describe in more detail in section II.A.5.d. of this proposed rule.) A consequence of this would be that these plans would not qualify for the frailty adjustment, as described in § 422.308(c)(4); however, only six of the 12 potentially-affected FIDE SNPs qualify for the frailty adjustment in 2021 because only those six plans have a similar average level of frailty (as determined by the Secretary) as the PACE program. States may also choose to require, through their State Medicaid agency contracts under § 422.107, that MA organizations create separate plan benefit packages (that is, separate D-SNPs), with one for exclusively aligned enrollment and the other for unaligned enrollment, the former of which would meet our proposed criteria and allow the organization to maintain FIDE SNP status for a share of its current FIDE SNP enrollment while using one or more new, separate D-SNPs for the unaligned enrollment. MA organizations would need to submit a request to CMS for a crosswalk exception under § 422.530(c)(4)(i), which we are proposing in section II.A.6.a. to redesignate from § 422.530(c)(4), for such enrollment transitions. Finally, because the definition of aligned enrollment is specific to full-benefit dually eligible individuals, our proposal would newly preclude partial-benefit dually eligible individuals from enrolling in FIDE SNPs. Like with unaligned enrollees, enrollment of partial-benefit dually eligible individuals, who receive no Medicaid benefits other than coverage of Medicare premiums and—in some cases—Medicare cost-sharing, precludes a D-SNP from clearly communicating the Medicaid benefits available through the FIDE SNP or using unified appeals and grievance procedures for adjudication of both Medicare and Medicaid benefits. For CY 2021, however, no FIDE SNPs enroll partial-benefit dually eligible individuals. As such, we do not believe this would have any meaningful impact for plans currently operating as FIDE SNPs. Moving forward, we believe that the benefits to be achieved with FIDE SNPs having exclusively aligned enrollment for Medicare beneficiaries eligible for full Medicaid benefits, as proposed here, and the associated greater levels of integration in the provision and coverage of benefits and plan administration outweigh the potential negative effects for partial-benefit dually eligible individuals, who would be limited to enrollment in HIDE SNPs, coordination-only D-SNPs, other MA plans, or the original Medicare FFS program. b. Capitation for Medicare Cost-Sharing for FIDE SNPs and Solicitation of Comments for Applying to Other D-SNPs Section 1902(a)(10)(E) of the Act directs States to pay providers for Medicare coinsurance and deductibles for dually eligible individuals in the Qualified Medicare Beneficiary (QMB) program. Under section 1905(p)(3) of the Act, “Medicare cost-sharing” includes costs incurred with respect to a dually eligible individual in the QMB program, 63 “without regard to whether the costs incurred were for items and services for which medical assistance [Medicaid] is otherwise available under the plan.” For QMBs, Medicare cost-sharing amounts include Medicare Parts A and B premiums, coinsurance, and deductibles, and at State option, Medicare Advantage (MA) premiums. Section 1902(n)(2) of the Act permits the State to limit payment for Medicare cost-sharing to the amount necessary to provide a total payment to the provider (including Medicare, Medicaid State plan payments, and third-party payments) equal to the amount a State would have paid for the service under the Medicaid State plan. 64 About 8.8 million dually eligible individuals are enrolled in the QMB program. 65 Some States also elect to cover all Medicare cost-sharing for Medicare beneficiaries eligible for full Medicaid benefits who are not QMBs. This election means the State pays Medicare cost-sharing for a non-QMB full-benefit dually eligible individual even if the Medicare service is not covered under the Medicaid State plan. Absent such an election by the State, the State would pay the Medicare cost-sharing for non-QMB full-benefit dually eligible individual only if the Medicare service, such as inpatient hospitalization, is also covered u [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%3A2022-00117. Public record. Not legal advice.