On July 31, 2026, the Health Resources and Services Administration (HRSA) posted a Notice Regarding 340B Rebate Model Pilot Program in the Federal Register to announce the availability of a revised 340B Rebate Model Pilot Program (Pilot). Consistent with HRSA’s 340B statutory authority, the Pilot provides a rebate mechanism through which qualifying manufacturers may effectuate the 340B ceiling price for certain drugs sold to covered entities.
The Pilot is limited to a select group of drugs and is open to qualifying manufacturers that submit plans meeting specific criteria. For more details on the Pilot and how qualifying manufacturers can submit a plan to OPA, please visit Notice Regarding 340B Rebate Model Pilot Program (PDF - 445 KB).