On Feb. 13, the Health Resources and Services Administration (HRSA) released a request for information (RFI) on the impact of implementing the 340B Rebate Model Pilot program. The RFI does not include any specific proposals to modify the program, which the agency originally finalized in 2025 and was subsequently delayed due to litigation [refer to Washington Highlights, Oct. 31, 2025]. HRSA’s rebate program would apply to ten approved drugs and require providers to purchase these drugs at significantly higher list prices and then apply for rebates from drug manufacturers. This is a significant departure from the upfront discount on covered drugs the program has offered for over 30 years. The RFI is open for comments for 30 days, with comments due by March 19.
As part of this RFI, HRSA is seeking input from 340B stakeholders on multiple aspects of the proposed 340B rebate model. Specifically, the agency seeks input on current administrative costs under the upfront 340B discount model compared to a potential rebate model; anticipated staffing impacts, systems, and infrastructure investments necessary to implement a rebate model; and the impact of a rebate model on payment timing and cash flow for covered entities. Additionally, HRSA also requests feedback in a number of areas related to operational and compliance considerations, including the process for rebate denials, covered entities’ data collection related to the 340B program, drug manufacturers’ current system for avoiding duplicate discounts, required reporting for manufacturer compliance, and rebates’ impact on integrity of the 340B program.
The RFI follows the U.S. District Court of Maine’s decision to issue a preliminary injunction on Dec. 29, 2025, against the 340B Rebate Pilot Program, prohibiting implementation of the nine individual rebate program applications [refer to Washington Highlights, Jan. 9]. The court had indicated that HRSA failed to follow Administrative Procedure Act requirements and needed to fully document and consider the impact of the pilot program on providers’ reliance interest, including the impact of administrative costs and the cost of “floating” the full price of covered drugs. The AAMC had partnered with other hospital associations to submit an amicus brief in the case, supporting the plaintiffs’ motion for a temporary restraining order [refer to Washington Highlights, Dec. 12, 2025].