Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program
Key claim: CMS proposes to codify the Medicare Drug Price Negotiation Program and establish new implementing policies under the Inflation Reduction Act of 2022, including a modification to the fixed combination drug policy.
Abstract
(Proposed Rule · Health and Human Services Department, Centers for Medicare & Medicaid Services) This proposed rule would codify the Medicare Drug Price Negotiation Program (“Negotiation Program”) and would establish certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program as required by the Inflation Reduction Act of 2022. This proposed rule would also propose a modification to the fixed combination drug policy.
Why this matters
The Medicare Drug Price Negotiation Program is the central mechanism by which the IRA lowers what Medicare and its beneficiaries pay for selected high-cost drugs. Codifying the program in regulation — and adjusting the fixed combination drug policy — shapes which products get pulled into a negotiated ceiling price and how manufacturers can respond through product reformulation, directly affecting Part D cost-sharing and plan formularies.