2/27/2026 – HRSA Publishes Notice Contemplating Expanding 340B Rebate Model to 13 Manufacturers and Extends Rebate RFI Comment Deadline
HRSA published two Federal Register Notices (FRNs) about another potential 340B rebate model pilot program (rebate model). HRSA published part of an information collection request (ICR) outlining a possible rebate model involving the 13 manufacturers whose drugs have negotiated Medicare discounts for 2026 and 2027. HRSA also published an FRN extending its comment period on its request for information (RFI) from 30 to 60 days. HRSA does not commit to implementing a new rebate model in either FRN.
Rebate Model ICR
HRSA’s FRN for its ICR proposes and seeks comment on a potential HRSA rebate model. Comments on the ICR are due by April 27, 2026.
In the FRN, HRSA estimates that the rebate model would apply to 14,600 covered entities, suggesting that HRSA foresees the pilot applying to all covered entity types. The FRN estimates that each covered entity would spend an average of 260 hours per year on complying with the rebate model requirements. In the FRN, HRSA justifies its low burden estimate for the rebate model by stating that the covered entity data:
will be comparable to data already being collected and maintained by covered entities through existing third-party vendor relationships or data that is already being provided to manufacturers with respect to certain contract pharmacy policies, in-house pharmacy claims requests, and data elements provided for claims with drugs dispensed under the Medicare Drug Price Negotiation Program.
The FRN states that under a potential rebate model, covered entities would be required to provide specific data to participating drug companies to request rebates. HRSA states that it anticipates future guidance would define required “claims level data elements for 340B-eligible dispenses.”
Notably, the FRN proposes to expand the rebate model to include the 13 manufacturers subject to the 2026 and 2027 Medicare negotiated discounts in those years; however, it does not affirmatively state that the rebate pilot would be limited to the Medicare maximum fair price (MFP) drugs. The 13 manufacturers subject to 2026 and 2027 MFP are:
- AbbVie
- Amgen
- AstraZeneca
- Bausch
- Boehringer Ingelheim
- Bristol Myers Squibb
- GlaxoSmithKline
- Johnson & Johnson
- Merck
- Novartis
- Novo Nordisk
- Pfizer
- Teva
This FRN is part of a larger submission HRSA is required to make to the Office of Management and Budget prior to implementing a rebate model. HRSA asks for public input focused on:
- the need for the rebate model;
- accuracy of HRSA’s burden estimation of compliance with the rebate model;
- how to enhance the quality, utility, and clarity of the information to be collected; and
- any use of technology to minimize the burden of the rebate model.
The Rebate Model RFI
HRSA extended its due date for comments on its rebate model RFI to April 20, 2026. The RFI was originally published on February 17, 2026, with comments due on March 19, 2026. Powers Alert released on February 17, 2026 explained this RFI and included a link to the original FRN. The new FRN states that the extension “will provide stakeholders additional time to submit meaningful comments for HRSA’s review in evaluating operational, financial, and potential impacts on access to drugs for patients under a rebate model.”
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.