OPA Announces 340B Rebate Model Pilot Program

On July 31, 2025, HRSA’s Office of Pharmacy Affairs (OPA) announced a voluntary 340B Rebate Model Pilot Program (Pilot Program). Currently, under the 340B program, covered entities purchase outpatient drugs at a discounted price from drug manufacturers. Under the Pilot Program, covered entities purchase select drugs at a higher price upfront and then later receive a post-purchase rebate from drug manufacturers. OPA states that the Pilot Program is intended to address, (1) 340B and Maximum Fair Price (MFP) deduplication, which involves duplicate discounts when both the 340B program and the MFP under the Inflation Reduction Act (IRA) offer price reductions on the same drug; (2) 340B Medicaid duplicate discounts, which occurs when there is a duplicate discount for a drug that qualifies for both a 340B discount and a Medicaid rebate; and (3) diversion, which involves unauthorized distribution of drugs obtained through the 340B program.

The voluntary Pilot Program will last for a minimum of one year. The scope of the 340B Rebate Model Pilot Program is limited to the NDC-11s included on the CMS Medicare Drug Price Negotiation Selected Drug List subject to an MFP under the IRA. However, the Pilot Program will apply to the selected NDC-11s regardless of payer. The first call to submit plans for participation in the Pilot Program to OPA is limited to drug manufacturers with Medicare Drug Price Negotiation Program Agreements with CMS. Qualifying manufacturers’ plans are due by September 15, 2025, and OPA will approve plans by October 15, 2025, for an effective date of January 1, 2026. OPA lists several requirements that qualifying manufacturers’ plans must contain, including:  

1. Assurance that all costs for data submission through an Information Technology (IT) platform be borne by the manufacturer and no additional administrative of running the rebate model shall be passed onto the covered entities; 
2. Allowance of 60 calendar days’ notice to covered entities and other impacted stakeholders before implementation of a rebate model, with instructions for registering any IT platforms; 
3. Allowance for covered entities to order the selected drugs under existing distribution mechanisms (e.g., 340B wholesaler accounts with pre-rebate prices loaded) to ensure purchases flow through existing infrastructure; 
4. Assurance that covered entities are allowed to submit and report data for up to 45 calendar days from date of dispense, with allowances for extenuating circumstances and other exceptions, including adjustments when a 340B status change occurs on a claim; 
5. Specification if rebates are paid at the package level, or at the unit level; 
6. Assurance that all rebates are paid to the covered entity (or denied, with documentation in support) within 10 calendar days of data submission; and 
7. Assurance 340B rebates are not denied based on compliance concerns with diversion or Medicaid duplicate discounts. Drug manufacturers should provide a rationale and specific documentation for reasons claims are denied (e.g., deduplication for MFP or 340B rebate provided to another covered entity on the same claim). If a manufacturer has concern regarding diversion or Medicaid duplicate discounts, the manufacturer should raise those concerns directly with OPA or utilize the 340B statutory mechanisms, such as audits and administrative dispute resolution, for addressing such issues.  

OPA is accepting public comment on the Pilot Program until August 30, 2025. OPA is looking for comments specifically addressing: 

1. Additional flexibilities to maximize efficiency and efficacy for participating manufacturers; 
2. Additional safeguards to mitigate adverse, unintended impacts for covered entities; 
3. Additional data or reporting elements that should be required to improve implementation and evaluation of the pilot program; and 
4. Potential implementation issues not yet sufficiently accounted for in the pilot design (e.g., logistical or administrative burdens). 

OPA will assess the Pilot Program using data and reports from manufacturers and other stakeholder feedback. OPA seeks to understand the “merits and shortcomings” of a rebate model through the Pilot Program. OPA may subsequently consider expanding the rebate Pilot Program. OPA’s official announcement, titled “340B Program Notice: Application Process for the 340B Rebate Model Pilot Program,” can be found here.