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December 14, 2022

CMS Issues MA and Part D Proposed Rule for 2024

Rule includes proposals aimed at streamlining prior authorization

On December 14, 2022, the Centers for Medicare and Medicaid Services (CMS) released the Medicare Advantage (MA) and Part D Proposed Rule for CY 2024. Among other policy proposals, the rule includes several proposed changes to utilization management programs in MA and greater flexibility to make changes to approved Part D formularies.

CMS is proposing revisions to the regulations governing when and how Medicare Advantage plans develop and use coverage criteria and utilization management policies to ensure that MA enrollees receive the same access to medically necessary care they would receive in Traditional Medicare. The rule also includes a proposal that would require that the physician or other health care professional used by the MA plan to review prior authorization requests must have expertise in the field of medicine that is appropriate for the service before the MA plan can deny coverage.

The rule includes several other changes to prior authorization protocol. First, CMS proposes that prior authorization policies for coordinated care plans may only be used to confirm the presence of diagnoses or other clinical criteria and/or ensure that an item or service is medically necessary. Second, CMS proposes that plans must provide a minimum 90-day transition period when an enrollee currently undergoing treatment switches to a new MA plan. Third, CMS proposes to require that all MA plans establish a Utilization Management Committee to review policies annually and ensure consistency with Traditional Medicare’s national and local coverage decisions and guidelines.

CMS is also proposing greater formulary flexibility for certain biological products and authorized generics. Specifically, CMS is proposing to allow Part D sponsors to immediately substitute: (1) a new interchangeable biological product for its corresponding reference product; (2) a new unbranded biological product for its corresponding brand name biological product; and (3) a new authorized generic for its corresponding brand name equivalent. CMS notes that current regulations allow a Part D sponsor that adds an equivalent generic drug, and otherwise meets requirements, to immediately remove a brand name drug from the formulary or change its preferred or tiered cost-sharing status. CMS is not proposing to allow Part D sponsors to immediately substitute biosimilar products.

The US Oncology Network will submit comments on the proposed rule prior to the deadline on February 13, 2023.

  • To read the CMS press release on the proposed rule, CLICK HERE.
  • To read the CMS factsheet on the proposed rule, CLICK HERE.
  • To read the proposed rule in its entirety, CLICK HERE.