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Nov 15 -- The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (HHS), invited comments by January 5, 2024 regarding a proposed rule to revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, dual eligible special needs plans (D–SNPs), utilization management, network adequacy, and other programmatic areas. This proposed rule also includes proposals to codify existing sub-regulatory guidance in the Part C and Part D programs.

The primary purpose of this proposed rule is to amend the regulations for the Medicare Advantage (Part C) program, Medicare Prescription Drug Benefit (Part D) program, Medicare cost plan program, and Programs of All-Inclusive Care for the Elderly (PACE). This proposed rule includes a number of new policies that would improve these programs beginning with contract year 2025 and proposes to codify existing Part C and Part D sub-regulatory guidance. Please note that the new marketing and communications policies in this rule are proposed to be applicable for all contract year 2025 marketing and communications, beginning September 30, 2024. This proposed rule also includes revisions to existing regulations in the Risk Adjustment Data Validation (RADV) audit appeals process and the appeals process for quality bonus payment determination that would take effect and apply 60 days after publication of a final rule. Revisions to existing regulations for the use and release of risk adjustment data would also take effect and apply 60 days after publication of a final rule. A limited number of the provisions in this rule are proposed to be applicable beginning with coverage on and after January 1, 2026.

Additionally, this proposed rule would implement certain sections of the following Federal laws related to the Parts C and D programs:

-- The Bipartisan Budget Act (BBA) of 2018.
-- The Consolidated Appropriations Act (CAA), 2023.

Summary of the Major Provisions of Proposed Rule

1. Improving Access to Behavioral Health Care Providers -- We propose regulatory changes that would improve access to behavioral health care by adding certain behavioral health provider specialties to our MA network adequacy standards.

2. Special Supplemental Benefits for the Chronically Ill (SSBCI) -- We are proposing regulatory changes that would help ensure that SSBCI items and services offered are appropriate and improve or maintain the health or overall function of chronically ill enrollees.

3. Mid-Year Enrollee Notification of Available Supplemental Benefits -- In addition, over the past several years, the number of MA plans offering supplemental benefits has increased. The benefits offered are broader in scope and variety and we are seeing an increasing amount of MA rebate dollars directed towards these benefits. At the same time, plans have reported that enrollee utilization of many of these benefits is low. It is not clear whether MA plans are actively encouraging utilization of these benefits by their enrollees. We propose requiring MA plans to notify enrollees mid-year of the unused supplemental benefits available to them.

4. Enhance Guardrails for Agent and Broker Compensation

5. Annual Health Equity Analysis of Utilization Management Policies and Procedures -- We are proposing regulatory changes to the composition and responsibilities of the Utilization Management (UM) committee. We propose to require that a member of the UM committee have expertise in health equity. We also propose that the UM committee conduct an annual health equity analysis of the use of prior authorization.

6. Amendments to Part C and Part D Reporting Requirements -- We are proposing to affirm our authority to collect detailed information from MA organizations and Part D plan sponsors under current regulations, in keeping with the Biden-Harris administration's focus on improving transparency and data in Medicare Advantage and Part D. This proposal would lay the groundwork for new data collection to be established through the Paperwork Reduction Act (PRA) process, which would provide advance notice to interested parties and be subject to public comment. An example of increased data collection could be service level data for all initial coverage decisions and plan level appeals, such as decision rationales for items, services, or diagnosis codes to have better line of sight on utilization management and prior authorization practices, among many other issues.

7. Enhance Enrollees' Right To Appeal an MA Plan's Decision To Terminate Coverage for Non-Hospital Provider Services

8. Additional Changes to an Approved Formulary—Substituting Biosimilar Biological Products

9. Increasing the Percentage of Dually Eligible Managed Care Enrollees Who Receive Medicare and Medicaid Services From the Same Organization

10. For D–SNP PPOs, Limit Out-of-Network Cost Sharing -- We are proposing to limit out-of-network cost sharing for D–SNP preferred provider organizations (PPOs) for specific services. The proposed rule would reduce cost shifting to Medicaid, increase payments to safety net providers, expand dually eligible enrollees' access to providers, and protect dually eligible enrollees from unaffordable costs.

11. Contracting Standards for Dual Eligible Special Needs Plan Look-Alikes -- Under existing regulations, CMS does not contract with and will not renew the contract of a D–SNP look-alike—that is, an MA plan that is not a SNP but in which dually eligible enrollees account for 80 percent or more of total enrollment. We are proposing to lower the D–SNP look-alike threshold from 80 percent to 70 percent for plan year 2025 and 60 percent for plan year 2026.

12. Standardize the Medicare Advantage (MA) Risk Adjustment Data Validation Appeals Process -- We propose regulatory language to address gaps and operational constraints included in existing RADV appeal regulations.

Press release: https://www.cms.gov/newsroom/press-releases/biden-harris-administration-proposes-protect-people-medicare-advantage-and-prescription-drug
FRN: https://www.federalregister.gov/d/2023-24118 [155 pages]

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