Statement by CMS Admin Brooks-Lasure on drugmakers participating in the IRA's Medicare Drug Price Negotiation Program

via the Centers for Medicare & Medicaid Services (CMS):

For the first time, Medicare is able to directly negotiate the prices of prescription drugs due to President Biden’s prescription drug law, the Inflation Reduction Act. Today, Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure issued the following statement on the announcement that the drug companies that manufacture all 10 drugs selected for the Medicare Drug Price Negotiation Program for the first cycle have chosen to participate in the Negotiation Program. The negotiations with participating drug companies for the selected drugs will occur in 2023 and 2024 with the negotiated prices effective beginning in 2026. 

“We look forward to engaging with the drug manufacturers of the selected drugs that have decided to participate in the Medicare Drug Price Negotiation Program,” said CMS Administrator Chiquita Brooks-LaSure. “Our goal is to ensure access to innovative treatments and therapies for people that need them when they need them. Medicare will negotiate in good faith consistent with the requirements of the law on behalf of people with Medicare.” 

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. CMS published the list of 10 drugs covered under Medicare Part D selected for the first cycle of negotiation on August 29, 2023. October 1, 2023, was the 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. Participating companies with a drug selected for the Negotiation Program had by October 2, 2023, to submit manufacturer-specific data for CMS to consider in the negotiations. Additionally, October 2, 2023, was 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.

Other key upcoming dates for implementation include:

• 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 list of the manufacturers of the selected drugs that have decided to participate in the Medicare Drug Price Negotiation Program. This list may be updated in the future.

View a fact sheet on the process for the first round of negotiations with participating manufacturers for Initial Price Applicability Year 2026. 

More information on the patient-focused listening sessions is available here. 

More information on the Medicare Drug Price Negotiation Program is available here.