HRSA Announces Application Process for the 340B Rebate Model Pilot Program and Request for Public Comment

U.S. Department of Health and Human Services
Health Resources and Services Administration For Immediate Release

July 31, 2025

HRSA News Room newsroom.hrsa.gov Contact: HRSA PRESS OFFICE Phone: 301-443-7070 Media Inquiries: Submit via this form Today, the Health Resources and Services Administration (HRSA) announced the availability of a voluntary 340B Rebate Model Pilot Program for drugs on the CMS Medicare Drug Price Negotiation Selected Drug List for year 2026 from qualifying manufacturers meeting specific criteria.

HRSA is introducing this pilot program to test the rebate model on these drugs in a methodical and thoughtful approach to ensure a fair and transparent 340B rebate model process.  HRSA is implementing this pilot to better understand the merits and shortcomings of the rebate model from the perspective of affected stakeholders, and to help shape any future 340B rebate models that align with the 340B statute and the Administration’s goals.

“The 340B Program provides vital healthcare access for high-need communities by allowing health care providers – also known as covered entities – to purchase medications at reduced prices,” said HRSA Administrator Tom Engels. “Today’s announcement of the availability of a Rebate Model Pilot Program addresses concerns we have received from both covered entities and manufacturers, while creating a measured approach to the process of approving manufacturer rebate models under the 340B Program. We look forward to receiving comments and working with everyone to ensure that the program operates with accountability, transparency and adherence to the 340B statute, allowing covered entities to stretch scarce resources as far as possible.”

For more information on how to submit a Rebate Model Pilot plan or to provide comments during the 30-day comment period please visit the 340B Program Notice: Application Process for the 340B Rebate Model Pilot Program Federal Register Notice (PDF - 240 KB).

Date Last Reviewed:

July 2025

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