HRSA Takes Steps to Pursue New 340B Rebate Model

2/11/2026 – HRSA Takes Steps to Pursue New 340B Rebate Model

HRSA announced its intention to pursue a new 340B rebate model last week through submission of a “Prerule” regarding “340B Drug Pricing Program Manufacturer Rebate Models” to the White House Office of Management and Budget (OMB). HRSA has not published details on the new rebate model.

HRSA’s submission of the prerule to OMB came one day after parties to the lawsuit challenging HRSA’s initial 340B Rebate Model Pilot Program asked the federal district court to vacate the agency’s guidance regarding the program and to send the rebate issue back to HRSA for further consideration. The court previously granted the hospital plaintiffs a nationwide preliminary injunction that stopped the Pilot Program from starting on January 1, 2026. A federal appeals court upheld the injunction.

In their request to return the rebate issue to HRSA, the parties outlined next steps they agreed HRSA would take if the agency decides to pursue a new rebate program, including:

Issuing a new notice that solicits new applications from pharmaceutical manufacturers,
Soliciting comments either before and/or concurrently with a new notice, and
Setting an effective date for no earlier than 90 days following the public announcement of any approval of a manufacturer application.

As is standard practice with any document under OMB review, OMB did not disclose the specifics contents of the prerule on its website. Despite the lack of public information about the document, this development signals that HRSA plans to pursue another rebate program. Additionally, given how rebates function, a new rebate program would undoubtedly require covered entities to buy drugs at non-340B prices and then apply to receive rebates on those drugs to bring their prices down to the 340B ceiling price. Although most rules and guidances reviewed by OMB are ultimately published, agency review is not a guarantee of eventual publication. While OMB is reviewing the proposal, interested parties can request a meeting with HRSA and OMB to discuss the proposal via the OMB website. RWC-340B is requesting a meeting with OMB to share the group’s strong concerns about 340B rebate models.

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.