The 340B program could be facing one of its most significant shifts in decades. HRSA has officially proposed a pilot program that would allow drug manufacturers to offer rebates, rather than the traditional upfront discounts, for a select group of drugs.

While the proposal is narrow in scope, it opens the door for broader conversations around how the 340B program may evolve in response to industry pressure, legal rulings, and the Inflation Reduction Act (IRA).

What Is the 340B Rebate Pilot?

The proposed rebate pilot would only apply to drugs selected under the IRA’s Medicare Drug Price Negotiation Program, beginning with the 10 drugs identified for 2026. Unlike past rebate proposals by manufacturers, HRSA’s pilot includes strict guardrails and requires pre-approval before implementation.

Key elements of the proposal include:

• Scope: Applies only to drugs included in the IRA price negotiations, beginning with 10 drugs in 2026 and expanding to 15 in 2027 (see tables below).
• Manufacturer Action: Interested manufacturers must submit detailed plans to HRSA by September 15, 2025.
• Timeline: HRSA will make approval decisions by October 15, 2025 with an effective start date of January 1, 2026.
• Rebate Payment: Manufacturers would be required to pay the difference between the drug’s Acquisition Cost and the 340B ceiling price within 10 days of claims submission.
• Data Submission: Rebates would be limited to 11 elements of pharmacy claims data, including:
  
  • Date of service
  • Date prescribed
  • Prescription number
  • Fill number
  • 11-digit NDC
  • Quantity dispensed
  • Prescriber ID
  • Service provider ID
  • 340B ID
  • Prescription BIN
  • Processor Control Number (PCN)
• Restrictions: Manufacturers cannot deny claims based on concerns like drug diversion or duplicate discounts. However, claims can be denied to comply with IRA rules, such as avoiding overlapping discounts with the Maximum Fair Price (MFP).

At RxTrail, we’re keeping a close eye on how this pilot unfolds and what it could signal for the future of the 340B program. While the initial impact may be limited, the long-term implications could be significant, especially if rebate models become more common. We're here to help you stay informed, prepared, and confident in your program strategy. If you'd like to walk through how this may relate to your organization or want to explore what readiness could look like, our team is always here to support you.

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