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, Aug. 8 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.
鈥淲ith 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,鈥 the groups wrote. 鈥淢oreover, drug companies have spent years developing and preparing for a rebate model, but the agency鈥檚 current timeline would give 340B hospitals far less time to prepare.鈥
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 through Sept. 8 and has asked drug manufacturers to submit rebate model plans by Sept. 15.
In addition to the AHA, Aug. 8's letter was signed by America鈥檚 Essential Hospitals, American Society of Health-Systems Pharmacists, Association of American Medical Colleges, Catholic Health Association of the United States, Children鈥檚 Hospital Association and 340B Health.
The AHA will submit a separate comment letter on HRSA鈥檚 pilot program.