The authors submitted this comment letter to the Centers for Medicare and Medicaid Services on July 1, 2024.
In an effort to lower the price of prescription drugs, the Inflation Reduction Act of 2022 established the Medicare Drug Price Negotiation Program to negotiate maximum fair prices (MFPs) for certain high-expenditure single source drugs and biologics. Richard Frank and Gerard Anderson recently commented on draft guidance by the Centers for Medicare and Medicaid Services (CMS) on the Medicare Drug Price Negotiation Program. The draft guidance specifically seeks input regarding the implementation of the Negotiation Program for initial price applicability year 2027 and manufacturer effectuation of the MFP in 2026 and 2027.
The authors comment on several proposed provisions of the guidance. Their comments are organized into the following groupings: 1) competitive entry standards; 2) payment and price components; 3) negotiation factors; and 4) negotiation process.
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Acknowledgements and disclosures
The authors thank Rachel Sachs for careful review of the comment letter. They also thank Amaya Allen and Caitlin Rowley for excellent research and editorial assistance.
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Commentary
Comments on the Medicare Drug Price Negotiation Program
July 8, 2024