Lexology April 25, 2024
The U.S. Centers for Medicare & Medicaid Services’ (CMS) annual Medicare Advantage and Part D final rule, published on April 23, 2024, will allow Medicare Part D Plans (PDPs) to change their biologics coverage policies in the middle of a plan year beginning in Calendar Year (CY) 2025 without a robust transition process for current branded biologic prescriptions. Among other key changes, the final rule will allow PDPs to immediately substitute all biosimilars, unbranded biologics, and authorized generics, not just those deemed “interchangeable.”
CMS based its final rule on existing substitution policy and two proposed rulemakings from December 2022 and November 2023, as well as various provisions of the Medicare Part D statute, as amended by the Inflation Reduction Act....
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