The Centers for Medicare & Medicaid Services (CMS) has released a proposed rule that would significantly enhance regulations around how Medicare Advantage (MA) organizations use internal coverage criteria, particularly relating to prior authorization and utilization management. The proposed changes, part of the Contract Year 2026 Policy and Technical Changes proposed rule published in late 2024, include key modifications to how MA plans would define, implement, and disclose their coverage criteria. They aim to ensure access to medically necessary care for MA enrollees.
Definition and Scope of Internal Coverage Criteria
Internal coverage criteria are newly defined as “any policies, measures, tools, or guidelines, whether developed by an MA organization or a third party, that are not expressly stated in applicable statutes, regulations, NCDs, LCDs, or CMS manuals and are adopted or relied upon by an MA organization for purposes of making a medical necessity determination” (§ 422.101(b)(6)(iii)). NCDs refer to National Coverage Determinations developed by CMS that apply nationwide, while LCDs refer to Local Coverage Determinations that apply to specific geographic areas.
Key Prohibitions and Limitations
Two major prohibitions are being proposed as follows:
- Coverage criteria cannot be implemented if they lack clinical benefit and exist solely to reduce utilization of the item or service (§ 422.101(b)(6)(iv)(A))
- Plans cannot use criteria to automatically deny coverage without individual medical necessity determination (§ 422.101(b)(6)(iv)(B))
New Public Disclosure Requirements
The proposed public disclosure requirements for MA organizations include that they must:
- Publish comprehensive lists of services using internal coverage criteria by January 1, 2026
- Make information freely available without login requirements
- Include vendor names when using third-party criteria; and
- Maintain website accessibility standards according to Section 504 of the Rehabilitation Act
Public Comment Process
Among other things, CMS is actively seeking feedback on whether to require a specific format and standard template for MA organization website postings and whether there are other prohibitions on internal coverage criteria that CMS should consider to support and promote access to medically necessary care.
Categories: DATA ACCESS & INTEROPERABILITY, DATA TRANSPARENCY
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