(Aug. 14, 2026) – HRSA Releases Notice About 340B Program Rebate Model
In 2025, the Health Resources and Services Administration opened the 340B Drug Pricing Program rebate model to certain manufacturers who volunteered to participate. HRSA later paused implementation due to litigation. HRSA has now released a notice advancing the 340B program rebate model, with implementation set to begin on Jan. 1, 2027. Manufacturers who wish to participate in the model must apply by Monday, Aug. 24.
The new model will require 340B providers to submit claims to participating manufacturers for purchases of 340B drugs designated as selected pilot program drugs. The manufacturer will then issue rebates to the 340B provider. When a claim is filed, manufacturers will not be permitted to deny a rebate based on suspected diversion, duplicate discounts between 340B and Medicaid, eligible issues with the provider or insufficient purchases of a drug at full price. Such issues remain subject to agency review, manufacturer audits and 340B Administrative Dispute Resolution processes.