HRSA Seeks Information from Stakeholders on Another Potential 340B Rebate Model

2/17/2026 – HRSA Seeks Information from Stakeholders on Another Potential 340B Rebate Model

HRSA has released a request for information (RFI) seeking input on a possible 340B rebate program. The RFI is addressed to 340B program stakeholders, including covered entities and manufacturers, and asks them to provide feedback on whether and how HRSA should implement a rebate model. HRSA said it plans to use the information collected to evaluate a rebate model’s financial and operational impacts on 340B stakeholders and its effects on patients’ access to drugs.

Areas where HRSA is seeking stakeholder input include:

Administrative, operational, financial, and medication access concerns;
Reliance interests in continuing to obtain 340B ceiling prices as upfront discounts and whether such reliance interests are reasonable considering the HHS Secretary’s express statutory authority to provide 340B ceiling prices as a “rebate or discount;”
Potential cash-flow impacts;
Proposed alternatives to a rebate model and measures to limit a rebate model’s scope;
How to balance stakeholder concerns about a rebate model against the agency’s goal of testing 340B rebates;
How to gather empirical data on the effectuation of 340B ceiling prices through rebates;
How to generate data related to other federal health care programs, including the Medicare Drug Price Negotiation Program (MDPNP); and
How to improve transparency and inform future policy decisions.

For some of the above items, HRSA requests detailed data. For example, HRSA seeks comments on “Costs to Covered Entities,” including the number of 340B transactions by the covered entity during the most recent fiscal year, an estimate of incremental administrative and operational costs the entity would incur under a rebate program, and a description of the methodology and assumptions used to develop those estimates. Other areas where HRSA requests detailed data include payment timing and potential cash flow impacts, rebate denials, data collection by covered entities, manufacturer efforts to avoid duplicate discounts (these questions appear to be intended for manufacturers), required reporting, and 340B program integrity and other potential benefits of a rebate pilot.

The RFI comes shortly after the federal government asked the District Court for the District of Maine to vacate HRSA’s previous rebate model guidance and agreed to new procedural requirements in order to pursue another rebate program. The same court had previously stopped the guidance from taking effect on January 1, finding that HRSA had violated the Administrative Procedure Act by failing to consider the rebate model’s impact on covered entities and not providing a reasonable explanation for changing its longstanding policy of requiring upfront 340B discounts. HRSA’s call in the RFI for detailed data suggests that the agency is paying heed to the court’s criticism of its approach to establishing the first rebate model.

The Office of Management and Budget reviewed and approved the RFI in only five days. While HRSA has not publicly committed to pursuing another rebate model, the quick pace of these recent developments suggests that the administration remains very interested in advancing a rebate program. The RFI initially was available for public inspection on the Federal Register website, and was published in the Federal Register today. The RFI will be subject to a 30-day comment period with a deadline of March 19.

HRSA has removed its previous rebate model guidance from its website and states that it is “reconsidering whether to implement a 340B Rebate Model Pilot Program.” The website now includes a link to the RFI.

HRSA’s previous rebate model guidance was limited to the first Medicare Part D drugs subject to the MDPNP. Since the RFI does not state that a new rebate program would be confined to those same drugs, the agency might be considering a rebate model that encompasses additional drugs. An additional fifteen drugs will become subject to the MDPNP on January 1, 2027.

Powers will continue to monitor developments regarding 340B rebates. Please contact Powers’ drug pricing team, or your lead Powers attorney, if you have any questions.