The proposed rule would write the negotiation programme into regulation and set new policies for it and for the Medicare prescription drug benefit, including a change to the fixed combination drug policy.
Washington, 16 June 2026 — The Centers for Medicare & Medicaid Services issued a proposed rule that would codify the Medicare Drug Price Negotiation Program and establish certain new policies for that programme and for the Medicare Prescription Drug Benefit Program, as required by the Inflation Reduction Act of 2022.
The proposed rule also proposes a modification to the fixed combination drug policy. It is a proposed rule, not a final one, and was issued by the Centers for Medicare & Medicaid Services rather than by the Food and Drug Administration.
Source documents
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Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program
- Identifier
- Federal Register document 2026-12059
- As the record states
- 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.
- Document number
- 2026-12059