August 5, 2025
HRSA Announces Application Process for the 340B Rebate Model Pilot Program and Request for Public Comment
The Health Resources and Services Administration (HRSA) recently 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.
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