The Health Resources and Services Administration (HRSA) announced the revised 340B Rebate Model Pilot Program, which will provide qualifying drug manufacturers with a voluntary pathway to provide the 340B ceiling price to covered entities through rebates, rather than upfront discounts, for a limited set of covered outpatient drugs to bolster transparency and program sustainability and preserve access to care for underserved communities.
The revised Pilot follows extensive stakeholder engagement, including a Request for Information that generated more than 2,400 public comments, and reflects feedback received from hospitals, health centers, manufacturers, pharmacies, patient advocates, and other stakeholders.
Rebate plans for selected drugs during the applicable pricing periods will become effective on January 1, 2027.