CMS Drug Pricing Negotiations Timeline

CMS Drug Pricing Negotiations Timeline

The Centers for Medicare & Medicaid Services (CMS) is conducting a program that focuses on drug pricing negotiations, effective in 2026.

Here is a list of the drugs that CMS is including in their price negotiations:

Here’s a summarized timeline and breakdown of the upcoming events:

Fall 2023: Data Submission and Patient-Focused Listening Sessions
  • CMS invites each participating drug company with a selected drug for a meeting regarding data submission.
  • From Oct. 30 to Nov. 15, CMS holds patient-focused listening sessions for each selected drug.
  • These sessions will involve patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties.
  • The dates for these listening sessions are subject to change, including the possibility of postponement and/or cancellation.
Feb. 1, 2024: Initial Offer for Maximum Fair Price

CMS sends an initial offer of a maximum fair price for a selected drug to each drug company participating in the Negotiation Program, along with a justification for the proposed price.

Aug. 1, 2024: End of Negotiation Period

The period during which CMS and drug companies can negotiate the prices for the selected drugs concludes on this date.

Sept. 1, 2024: Publication of Negotiated Prices                                          

CMS will publicly release the negotiated maximum fair prices for the drugs that were selected for the 2026 negotiation.

The timeline provides a clear framework for drug companies and other stakeholders to understand the process and key dates associated with the CMS drug pricing Negotiation Program. This initiative appears to emphasize transparency and patient involvement, ensuring that multiple perspectives are considered in determining fair drug prices.

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Timothy Powell, CPA, CHCP

Timothy Powell is a nationally recognized expert on regulatory matters, including the False Claims Act, Zone Program Integrity Contractor (ZPIC) audits, and U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) compliance. He is a member of the RACmonitor editorial board and a national correspondent for Monitor Mondays.

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