340B Rebate Model Pilot Program
As of noon on December 31, 2025, in accordance with the December 29, 2025, U.S. District Court for the District of Maine order in American Hospital Association et al. v. Kennedy et al., No. 25-cv-600 (D. Me.), HRSA’s Office of Pharmacy Affairs (OPA) is pausing the implementation of the 340B Rebate Model Pilot Program for all covered entity types at this time. Manufacturers who were approved for participation in the Pilot to effectuate 340B pricing through a rebate mechanism will now be required to continue to offer all of their covered outpatient drugs to 340B covered entities at the 340B ceiling price as an up-front discount. OPA will update stakeholders on developments regarding the Pilot as they arise.
Guidance to 340B providers in Washington
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 Washington 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.