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Medicare Negotiation Final Guidance: No More ‘Gag’ Rules, But Other Changes Fall Short Of Hopes

 
• By Cathy Kelly

CMS sends a warning to Medicare Part D plans that beneficiaries should have ‘meaningful’ formulary access to drugs with negotiated prices. However, the guidance does not broaden potential exclusions from negotiation for orphan drugs, to the disappointment of stakeholders.

Manufacturers Will Be Free To Publicly Discuss Negotiation Process • Source: Shutterstock

The Centers for Medicare and Medicaid Services has withdrawn prohibitions barring manufacturers from publicly disclosing aspects of the Medicare drug price negotiation process in its final guidance on the first round of negotiations, released on 30 June.

The guidance is an important milestone in the implementation of the price negotiation program, which will begin this fall for prices that go into effect in 2026. (Also see "Medicare Rx Negotiation Horizon: The Key Dates Ahead Of 2026 Rollout Of The Pricing Program" - Pink Sheet, 22 April, 2023

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