6/3/2026 – HRSA Sends 340B Rebate Model Prerule to White House for Review

Overview

Last week, HRSA sent a prerule document titled “Notice Regarding 340B Rebate Model Pilot Program” to the White House Office Management and Budget (OMB) for review. While the document’s content is unknown, this action suggests that the agency has not abandoned the rebate model pilot despite a groundswell of comments opposing the model.

Background

In February, HRSA published a Request for Information (RFI) and Information Collection Request (ICR) Federal Register notice seeking stakeholder input on a possible new pilot. Stakeholders submitted thousands of comments to HRSA, with the overwhelming majority of unique comments opposing a new pilot. Individual 340B providers, associations representing covered entities, and their allies expressed strong concern that a rebate program would substantially harm patient care, have a severe negative impact on entities’ finances, and impose a significant administrative burden on providers.

Congressional Input

Members of Congress also weighed in on the rebate model debate. The RFI and ICR notices elicited three separate sign-on letters from Congress. Led by Reps. Doris Matsui (D-CA) and Dusty Johnson (R-SD) in the House, more than 90 lawmakers signed a bipartisan “Dear Colleague” letter in March 2026 urging House appropriators to include language in the fiscal year 2027 appropriations to block federal funds from being used to implement a 340B rebate model.

A similar letter was sent in the Senate. A “Dear Colleague” letter opposing the model was sent in April 2026 by nine Democrats, including Sens. Peter Welch (D-VT), Chris Van Hollen (D-MD), and Amy Klobuchar (D-MN). The Senators, like their House counterparts, requested that a 340B rebate model pilot not be funded.

The third sign-on letter was submitted in support of the model. It was sent to the Secretary of HHS and CMS Administrator by members Reps. Diana Harshbarger (R-TN) and Earl L. “Buddy” Carter (R-GA) in April 2026. The letter was signed by a total of seven Republican members, one of whom – Rep. Exell (R-MS) – sent a separate letter changing his position to opposition after speaking with covered entities in his state.

The New Notice

The specifics of the new prerule notice are unknown. One possibility is that HRSA plans to propose guidance creating a new pilot and summarizing stakeholder comments in response to the RFI. Another possibility is that the agency is issuing a second RFI to seek additional information from stakeholders. In either case, the new notice suggests that HRSA is continuing to advance the model and that stakeholders will have another opportunity to submit comments.

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. Stakeholders meeting with OMB should be aware that the agency will publish on its website that a meeting occurred, who attended the meeting, and the documents shared with the agency before or during a meeting.

While the new prerule document was filed only a couple of months after the RFI and ICR, any new pilot is likely still many months away from taking effect. After federal courts struck down HRSA’s first rebate pilot scheduled to start January 1, the agency agreed to set the effective date for any new pilot no earlier than 90 days following approval of drug manufacturer applications for the pilot.

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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.