AHA 340B Advocacy Alliance Bulletin August 8, 2025

AHA, others urge HRSA to extend timeline for comments and feedback on 340B pilot program

The AHA, joined by several other national groups representing 340B hospitals, today urged the Health Resources and Services Administration to extend the timeline for stakeholder comments, agency consideration, and manufacturer rebate plan submissions for its 340B Rebate Model Pilot Program.

“With the fundamental changes a rebate model will impose on all 340B stakeholders, it is impossible for the agency to meaningfully consider, in just seven days, all the feedback it will surely receive,” the groups wrote. “Moreover, drug companies have spent years developing and preparing for a rebate model, but the agency’s current timeline would give 340B hospitals far less time to prepare.”

Specifically, the groups asked the agency to allow comments until Sept. 15, require manufacturer submissions by Oct. 20, and approve any rebate model plans by Nov. 3.

HRSA July 31 announced the pilot program, which will provide certain drugmakers the option to effectuate access to 340B discounted pricing for certain drugs under a rebate model. The agency is currently accepting comments through Sept. 8 and has asked drug manufacturers to submit rebate model plans by Sept. 15.

In addition to the AHA, today’s letter was signed by America’s Essential Hospitals, American Society of Health-Systems Pharmacists, Association of American Medical Colleges, Catholic Health Association of the United States, Children’s Hospital Association and 340B Health.

The AHA will submit a separate comment letter on HRSA’s pilot program. For more details and AHA’s take on the program, see the Aug. 1 AHA Regulatory Advisory.