On February 10, 2026, the Health Resources & Services Administration (HRSA) rescinded its 340B Rebate Model Pilot Program. Shortly thereafter, HRSA issued (1) a Request for Information (RFI) to gather input regarding the potential future use of rebates in the 340B Program and (2) an Information Collection Request (ICR) on the estimated administrative burden of a future 340B rebate pilot program.
Last summer, the agency announced a pilot program that would allow 340B discounts for certain drugs to be provided as a rebate after the purchase rather than an upfront discount. The American Hospital Association, Maine Hospital Association, and four health systems filed a lawsuit challenging the pilot program. Multiple hospital associations also filed amicus briefs in support of the plaintiffs.
The Maine district court issued a preliminary injunction stopping the program from going into effect on January 1, 2026. HRSA appealed the preliminary injunction to the U.S. Court of Appeals for the First Circuit and asked the court to allow the rebate program to proceed while the court considered the injunction; the First Circuit denied HRSA’s request for a stay of the injunction. Both courts held that HRSA likely violated the Administrative Procedure Act when establishing the program.
HRSA and the plaintiffs then entered into negotiations which resulted in the First Circuit appeal being dismissed and the initial lawsuit being closed. Through the negotiations, the parties agreed that HRSA would rescind the existing 340B Rebate Model Pilot Program. If HRSA were to create a new pilot program, it would have to issue a new notice, solicit new applications, and wait 90 days following the announcement of any approval of drug manufacturer applications for the program to go into effect.
On February 13, 2026, HRSA filed a RFI seeking “comments on whether HRSA should implement a rebate model under the 340B Program and how best to operationalize any such rebate framework for stakeholders.” RFI comments are due by April 20, 2026. On February 25, 2026, HRSA released an ICR on the administrative burden of a rebate pilot program and comments are due by April 27, 2026.