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CMS 4201-P Proposed Rule: The Big Five Takeaways

Updated: Jan 18, 2023



CMS 4201-P Proposed Rule Big 5 Takeaways

On December 14, 2022, CMS issued a proposed rule that puts forth revisions to regulations governing Medicare Advantage (MA or Part C), the Medicare Prescription Drug Benefit (Part D), Medicare cost plans and Programs of All-Inclusive Care for the Elderly (PACE). The proposed rule includes policies that would improve beneficiary protections and shore up guardrails that help CMS work to best meet the needs of beneficiaries.


In addition, the proposed policies would increase access to care, including behavioral health services, and promote equity in coverage and care. Comments to the proposed rule are due February 13, 2023.


The following is just a small summary of notable takeaways from this proposed rule:


1. Ensuring Timely Access to Care: Utilization Management Requirements

Proposed changes include revisions to when and how plans develop and use coverage criteria and utilization management policies; namely, in situations when no applicable Medicare criteria establishes coverage, plans must include current evidence in widely used treatment guidelines or clinical literature made publicly available.


The proposed rule also would streamline prior authorization requirements, including adding continuity of care requirements and requiring enrollees to be granted prior authorization approval valid for the full course of treatment.


2. Protecting Beneficiaries: Marketing Requirements

As has been a trending issue in MA over the last two years, this proposed rule also addresses potentially misleading marketing in the name of ensuring accurate and necessary information for beneficiaries to make coverage choices that best meet their needs.


CMS has made numerous proposals in the name of marketing, including prohibiting television ads that do not mention specific plan names, or which use “words and imagery” that may confuse beneficiaries in a way that may be misleading, or confusing, and prohibiting sales presentations, scope of appointments, and business reply cards that follow educational events.


3. Advancing Health Equity

CMS continues to move the needle of advancing health equity with several proposals including further clarifying requirements for plans to provide culturally competent care by expanding the list of populations that require it and requiring plans to offer digital health education to enrollees.


4. Improving Access to Behavioral Health

CMS reaffirmed plan responsibilities to provide behavioral health services by adding Clinical Psychologists, Licensed Clinical Social Workers, and Prescribers of Medication for Opioid Use Disorder as specialty types for which CMS will set adequacy minimum standards.


5. Improving Drug Affordability and Access in Part D

CMS has proposed greater formulary flexibility for certain biological products and authorized generics with proposals to permit plans to immediately substitute a new interchangeable biological product for its corresponding reference product, new unbranded biological product for its corresponding brand name biological product, and new authorized generic for its corresponding brand name equivalent.


In Conclusion

The administration has demonstrated an ongoing focus on health equity and genuine marketing continues to be a priority to plans as they roll out strategies from this Proposed Rule 4201-P. Our distinguished team of experts collaborated to provide an in-depth analysis of this new proposal.


Unsure where to start? Our team expects many of the proposals in this rule to be codified as final and has outlined a strategic path on what health plans should be thinking of and planning for in 2023 and beyond. Contact us today to get started.




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