Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program

What it does

This rule finalizes and codifies the Medicare Drug Price Negotiation Program ("Negotiation Program") and establishes certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program ("Part D Program") as required by the Inflation Reduction Act of 2022. This final rule also finalizes a proposed policy for specific fixed combination drugs that are new formulations.

The Centers for Medicare & Medicaid Services's summary, as published in the Federal Register.

What changed in the regulation

2 parts of Title 42 of the Code of Federal Regulations:

42 CFR 423, 42 CFR 429

Compared with

The Centers for Medicare & Medicaid Services has published 24 final rules in 2026 so far, compared with 12 in all of 2025.

Counted by the Tribune from Federal Register records since Jan. 1, 2025.

Before this

1 earlier Federal Register document under regulation identifier 0938-AV90 since Jan. 1, 2025.

• June 16, 2026 Proposed rule. Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program

What happens next and when

Effective date: These regulations are effective on December 5, 2026.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Title 42 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register