On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited universe of drugs, a fundamental change to the manner in which discounts are provided to covered entities under the 340B Drug Pricing Program (the “340B Program”).
The 340B Rebate Pilot would allow qualifying manufacturers to make available to covered entities 340B-discounted prices through retrospective rebates, rather than the upfront discounts that traditionally have been extended on 340B drug purchases.1 The Pilot is limited to the universe of drugs included in the Inflation Reduction Act (“IRA”) Medicare drug price negotiation program, but applies to those drugs regardless of payer. The first round of the Pilot, kicking off in 2026, will be limited to qualifying manufacturers with IRA drug price negotiation agreements for initial price applicability year 2026. Drugs will be subject to the Pilot for a minimum of one year. HRSA indicates that the 340B Rebate Pilot is intended, among other purposes, to address 340B and IRA Maximum Fair Price deduplication.
The Office of Pharmacy Affairs (“OPA”) is seeking public comment on the 340B Rebate Pilot, with comments due by August 30, 2025. Manufacturers that wish to apply must submit plans for participation to the agency no later than September 15, 2025, with agency approvals to be made by October 15, 2025 for an effective date of January 1, 2026.
Overview of 340B Rebate Pilot. Under the Pilot, a covered entity would pay upfront for a covered drug at its standard acquisition cost (i.e., wholesale acquisition cost (“WAC”)) and later receive a post-purchase rebate reflecting the difference between the acquisition cost and the 340B ceiling price.
The 340B statute explicitly references the prospect of rebates;2 however, HRSA has taken the position that manufacturers must receive departmental approval before implementing rebate approaches.3 HRSA said it is launching the 340B Rebate Pilot “to test the rebate model…in a methodical and thoughtful approach to ensure a fair and transparent 340B rebate model process for all stakeholders involved.”4 The agency specified various criteria a manufacturer must satisfy in its plan to participate in the Pilot. Among other requirements, HRSA said that a manufacturer should ensure 340B rebates are not denied due to concerns about covered entity compliance with the statutory diversion or duplicate discount requirements and, instead, “the manufacturer should raise those concerns directly with OPA or utilize the 340B statutory mechanisms, such as audits and administrative dispute resolution (ADR), for addressing such issues.”5
OPA plans to assess the 340B Rebate Pilot, including evaluation of data and reports received from participating manufacturers and feedback from covered entities regarding the effectiveness of the limited rebate models. The agency said it seeks to “better understand the merits and shortcomings of the rebate model from stakeholders’ perspectives,” and, in the future, “OPA may consider expanding the rebate pilot to other drugs purchased under the 340B Program.”6
Public Comment Request. OPA has requested public comment on the following aspects of the Pilot:
- Flexibilities to maximize efficiency and efficacy for participating manufacturers;
- Additional safeguards to mitigate adverse, unintended consequences for covered entities;
- Data or reporting elements to improve implementation and evaluation of the Pilot; and
- Potential implementation issues (e.g., logistical and administrative burdens) not accounted for in the Pilot design.
