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340B Rebate Model Pilot Program summary

340B Rebate Model Pilot Program summary

By: Sabrina Ho | 8/03/26

On August 3, 2025, the Health Resources and Services Administration (HRSA), through its Office of Pharmacy Affairs (OPA), published a revised 340B Rebate Model Pilot Program notice. This is HRSA's second attempt at a rebate model pilot. A 2025 version was withdrawn after covered entity stakeholders successfully enjoined it in federal court. The revised Pilot reintroduces a rebate mechanism for a limited set of drugs, responds at length to more than 2,400 comments HRSA received on its February 2026 Request for Information (RFI), and sets a compressed timeline for manufacturer submissions, with an effective date of January 1, 2027.

NRHA has created a summary of the program for members to access on NRHA Connect, the association's member network.

For more information on NRHA's regulatory comments, please see our Public Comments Page. For any additional questions, please contact NRHA's Government Affairs Team.

For questions on how to access and navigate NRHA Connect, or to join NRHA, please contact NRHA's membership team.

If you are not a member of NRHA and would like access to members-only resources, join here for access.

Meet the Author:

Sabrina Ho

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