Lexology May 28, 2024
Morgan, Lewis & Bockius LLP

The Centers for Medicare & Medicaid Services on May 3, 2024, released its draft guidance on administration of the Medicare Drug Price Negotiation Program for initial price applicability year 2027. The program—established by the Inflation Reduction Act and currently in active negotiations with manufacturers of the first 10 drugs selected for initial applicability year 2026—grants CMS the authority to negotiate with manufacturers of certain high expenditure drug products that represent substantial Medicare spend for the maximum price the Medicare program will pay for such drugs.

Overview of Negotiation Process

As described in detail below, the Centers for Medicare & Medicaid Services (CMS) proposes that the second cycle of the negotiation program proceed in the following manner:

Qualifying Drugs

As the...

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