Second Time’s the Charm: HRSA Revives the 340B Rebate Pilot By Abdie Santiago —

https://www.thefdalawblog.com/2026/08/second-times-the-charm-hrsa-revives-the-340b-rebate-pilot/?utm_source=rss&utm_medium=rss&utm_campaign=second-times-the-charm-hrsa-revives-the-340b-rebate-pilot On August 3, 2026, the Health Resources and Services Administration (HRSA) published a Federal Register notice announcing a revised 340B Rebate Model Pilot Program, stating that, for a defined set of drugs, “rebates will be used instead of upfront discounts.” It is HRSA’s second attempt at a rebate pilot in just over a year, and it arrives shortly after the D.C. Circuit’s decision in Novartis v. Kennedy, which held that rebate models are permissible under Section 340B but may not be implemented without approval from the Department of Health and Human Services (HHS). HRSA’s revised Pilot is the agency’s latest effort to exercise the authority the court recognized.