After over six months of legal uncertainty, HRSA has issued a revised rebate model pilot impacting Medicare Fair Price drugs.
On July 31st, the Health Resources & Service Administration (HRSA) reissued its controversial 340B Rebate Model Pilot. This action comes after a federal court placed HRSA’s previous attempt to introduce a rebate model pilot on hold at the end of 2025. HRSA proposes to begin its rebate model pilot on January 1, 2027.
The proposal is much the same as HRSA’s previous iteration with the exception that Medicare Fair Price (MFP) drugs selected for both 2026 & 2027 are now impacted.
Covered entities will be required to buy the affected products at Wholesale Acquisition Cost (WAC) up front and must then submit standardized dispense data within 45 days of the dispense via the 340B rebate platform to manufacturers for validation.
Manufacturers would then have 10 days to pay a rebate equal to the margin between the WAC price and the 340B ceiling price or deny a claim with rationale and documentation. HRSA contends that this process is necessary to prevent duplication between MFP and 340B discounts.
The proposal asks manufacturers of the affected products to submit their rebate plans by August 24, 2026. HRSA says it plans to notify manufacturers by September 24, 2026.
As with the last iteration, this newly revised rebate model pilot introduces significant cash flow and operational concerns for covered entities. Covered entities should begin to evaluate the financial impacts of buying the impacted MFP products upfront at a WAC price as well as the potential risk of rebate denials to cash flow and overall 340B savings.
Covered entities must also consider the additional staff time that will be required to process and submit data and manage rebate denials on an ongoing basis.
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
Alyssa Kramer, PharmD, 340B ACE, Manager
