New CMS Guidelines for Drug Price Negotiation

Complications: Health Policy Unraveled

The Center for Medicaid & Medicare Services (CMS) recently released new guidelines that will affect the Medicare drug price negotiation process beginning in 2026.

In this episode of Complications: Health Policy Unraveled, host Stephanie Kennan provides a summary of the new CMS guidelines, including the new requirements for drug manufacturers and Part D dispensing entities, the timeline for negotiating new drug prices, and some of the challenges in navigating these new guidelines. Tune in to learn more about these new CMS guidelines.

Meet Your Host

Name: Stephanie Kennan

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

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Episode Highlights

[0:30] An overview of the new CMS drug price negotiation guidelines

[1:21] The limited effect of the Inflation Reduction Act on Medicare drug price negotiations

[1:39] The process of negotiating new maximum fair prices for drugs between Medicare and drug manufacturers.

[3:18] How the new guidelines mandate patient access to drugs

[5:28] Using a Medicare Transaction Facilitator to ensure the guidelines are followed by engaging in an exchange of information between drug manufacturers and CMS

[7:02] CMS’s procedures for receiving feedback on certain features of the new guidelines

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