The Health Resources and Services Administration (HRSA) has approved a 340B Rebate Model Pilot Program that will significantly change how 340B discounts are accessed for covered entities for certain medications. The Rebate Model Pilot Program is voluntary for manufacturers, but if a manufacturer chooses to participate, covered entities will be required to participate for those specific drugs. The pilot is currently limited to nine drugs from eight manufacturers, with an anticipated effective date of January 1, 2026.
What does this mean for you as a covered entity?
The most significant change with the 340B Rebate Model Pilot Program is the shift from an upfront discount on medications to a post-sale rebate model. Covered entities will initially purchase drugs at the Wholesale Acquisition Cost (WAC) price through the existing 340B wholesaler account. The covered entity will then need to submit claims data through the manufacturer’s IT platform to receive a rebate afterwards. Manufacturers are required to pay approved rebates within 10 calendar days of receiving claims data submission.
Manufacturers participating in the pilot program are required to cover all IT and data submission costs and must ensure that all IT platforms utilized are HIPAA-compliant.
Covered entities will need to be prepared for the impact on cash flow to their organization before the rebate is received. It is recommended that covered entities monitor those drugs that will be affected by the pilot model and evaluate their internal data systems to ensure the ability to capture the necessary claim data fields for submission. Covered entities should also proactively work with their Third-Party Administrator(s) (TPAs) to determine the feasibility of managing the new pilot model for impacted medications.
Contact Us
Blue is closely tracking HRSA’s information releases and will share more guidance as information becomes available. If you have any questions in the interim, please do not hesitate to reach out to one of our 340B ACE-certified advisors.
Kyle Smith, CPA, 340B ACE, Director
Jason Prokopik, PharmD, 340B ACE, Senior Manager
