340B Rebate Model Pilot Program Update
From Health Resources & Services Administration:
On February 10, 2026, in American Hospital Association et al. v. Kennedy et al., No. 25-cv-600 (D. Me.), the U.S. District Court for the District of Maine vacated and remanded to HHS the 340B Rebate Model Pilot Program Application Notice, 90 Fed. Reg. 36,163 (Aug. 1, 2025), the Corrected 340B Rebate Model Pilot Program Application Notice, 90 Fed. Reg. 38,165 (Aug. 7, 2025), and the approvals of applications from drug manufacturers submitted pursuant to those notices (announced between October 30 and November 14, 2025).
HHS is reconsidering whether to implement a 340B Rebate Model Pilot Program consistent with its statutory authority. HRSA is issuing a Request for Information (RFI) to gather input from interested parties regarding the potential use of rebates to effectuate the ceiling price under the 340B Program.
From American Hospital Association:
The Department of Health and Human Services Feb. 5 in a court filing said it would scrap its current 340B Rebate Model Pilot Program and potentially restart the administrative process for such a program.
These moves come after the 1st U.S. Circuit Court of Appeals Jan. 7 denied the government’s motion for a stay in a lawsuit filed by the AHA, the Maine Hospital Association, and four safety-net health systems challenging the 340B Rebate Model Pilot Program. The 1st Circuit ruling followed a Dec. 29 decision from the U.S. District Court of Maine granting a preliminary injunction blocking implementation of the 340B Rebate Model Pilot Program, which was scheduled to go into effect Jan. 1.