The AAMC joined the American Hospital Association, 340B Health, and other hospital groups in an Aug. 8 letter (PDF) to HRSA Administrator Thomas Engels requesting that the agency extend the timeline for implementing their proposed 340B Rebate Model Pilot Program [refer to Washington Highlights, Aug. 1]. Under the current timeline, HRSA has requested comments from interested parties by Sept. 8 and that manufacturers submit their rebate model plans by Sept. 15 — leaving the agency just one week to synthesize stakeholder feedback and make any necessary changes to the pilot program.
In their letter, the hospital groups underscored that the proposed pilot program represents a “fundamental shift” in 340B program operations, moving from a front-end discount to a retrospective rebate. In light of the magnitude of this proposed change, the hospitals urged the agency to extend the comment period until Sept. 15 and give manufacturers until Oct. 20 to finalize their submissions. This extended timeline, the signatories argued, would allow the agency time to gather and consider meaningful feedback from stakeholders.
The AAMC previously articulated concerns with 340B rebate models in a letter to Health and Human Services Secretary Robert F. Kennedy Jr. [refer to Washington Highlights, May 30].