The AAMC submitted comments to the Health Resources and Services Administration (HRSA) in response to the agency’s 340B Rebate Model Pilot Program. HRSA’s 340B Rebate Model Pilot Program allows for a minimum one-year test of rebate models limited only to drug manufacturers with Medicare Drug Price Negotiation Program Agreements for drugs on the Medicare Drug Price Negotiation Selected Drug List for 2026 [refer to Washington Highlights, Aug. 1].
The AAMC opposed the use of rebate models in the 340B program (PDF) and urged HRSA not to move forward with the use of these models. Comments highlighted the negative impacts rebate models would have on the 340B Program and AAMC members. The association’s greatest concerns with the pilot program include the insufficient implementation timeline, the absence of information on how HRSA will enforce 340B compliance under a rebate model, the lack of a clear process for disputing improperly rejected rebate requests, and the substantial administrative burden it would impose on 340B hospitals. Members of Congress echoed these concerns in a Sept. 9 bipartisan letter to Health and Human Services (HHS) Secretary Kennedy urging the administration to withdraw its plans for a rebate model [refer to related story].
Drug manufacturers have until Sept. 15 to apply for the pilot program. HRSA will issue approvals by Oct. 15 for implementation by Jan. 1, 2026.