340B Rebate Model Pilot Program
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).
Guidance to 340B providers in Commonwealth of the Northern Mariana Islands, the Territory of Guam, and Hawaii
Public health emergency declaration by the Secretary
We recognize that circumstances surrounding disaster relief efforts warrant flexibility for entities eligible for participation in the 340B Program. Therefore, eligible entities in Commonwealth of the Northern Mariana Islands, the Territory of Guam, and Hawaii may immediately enroll for the 340B Program during the Public Health Emergency Declaration by the Secretary, rather than having to wait for the normal quarterly registration period. We believe this will enable these entities to meet the needs of the residents affected by these disasters.
Contact: If you are in the listed states and would like to enroll, email the 340B Prime Vendor Program or call 1-888-340-2787.