CMS Leadership on Historic Announcement of First Selected Drugs for Medicare

For the first time, Medicare is able to directly negotiate the prices of prescription drugs due to President Biden’s lower cost prescription drug law, the Inflation Reduction Act. Today, leaders of the Centers for Medicare & Medicaid Services (CMS) issued the following statements on the historic announcement of the first 10 drugs covered under Medicare Part D selected for negotiation under the Medicare Drug Price Negotiation Program. The negotiations with participating drug companies for the selected drugs announced today will occur in 2023 and 2024 with the negotiated prices effective beginning in 2026. In addition, CMS is announcing more information about patient-focused listening sessions on the selected drugs with interested parties that will occur in Fall 2023.

“Today marks a significant and historic moment for the Medicare program with the announcement of the first drugs selected for Medicare drug price negotiation,” said CMS Administrator Chiquita Brooks-LaSure. “Our goal with these negotiations is to improve access to some of the costliest drugs for millions of people with Medicare while driving competition and innovation.” 

“Promoting transparency and engagement continue to be at the core of how we are implementing the new drug law and the Medicare Drug Price Negotiation Program, and that is why we set out a process for the first round of negotiation that engages the public throughout,” said Meena Seshamani, MD, PhD, CMS Deputy Administrator and Director of the Center for Medicare. “Along with the announcement of the selected drugs, we announced CMS’ plans to host a patient-focused listening session for each selected drug to hear directly from patients and others.”

This announcement is one of a number of steps CMS previously detailed in the Medicare Drug Price Negotiation Program timeline for the first cycle of negotiation. Other key upcoming dates for implementation include:

• October 1, 2023: Deadline for companies with a drug selected for the Negotiation Program to choose whether to sign agreements to participate in the negotiation process for 2026.
• October 2, 2023: Deadline for participating companies with a drug selected for the Negotiation Program to submit manufacturer-specific data for CMS to consider in the negotiations. In addition, this is the deadline for the public to submit data on therapeutic alternatives to the selected drugs, data related to unmet medical need, and data on impacts to specific populations.
• Fall 2023: CMS will invite each participating drug company with a selected drug to engage in a meeting on its data submission. CMS will also hold a patient-focused listening session for each selected drug. The patient-focused listening sessions, which will include participation from patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties, will be held between October 30, 2023 and November 15, 2023. The listening sessions are subject to change, including postponement and/or cancellation.
• February 1, 2024: CMS sends an initial offer of a maximum fair price for a selected drug with a justification to each drug company participating in the Negotiation Program.
• August 1, 2024: The negotiation period ends.
• September 1, 2024: CMS will publish the maximum fair prices that have been negotiated for drugs selected for negotiation for 2026.

View the HHS press release.

View a fact sheet on the drugs selected for the Medicare Drug Price Negotiation Program, as well as more information about the patient-focused listening sessions.

More information on the patient-focused listening sessions is available at https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation-program-patient-focused-listening-sessions.

More information on the Medicare Drug Price Negotiation Program is available at https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation.