340B Podcast Series, Episode 2: The Rebate Model with Clay Willis
In episode two of IntegriChain's 340B Series podcast, we're joined by Clay Willis, Partner of Advisory Services at IntegriChain. With years of hands-on experience guiding biopharma manufacturers and life sciences organizations through the 340B landscape, Clay unpacks key trends like duplicate discounts and the program's ongoing growth, along with practical strategies for managing and reducing 340B risk.
About this Episode
This episode dives into the 340B Rebate Model, how the industry got here, the latest developments, what the model does (and doesn't) solve for manufacturers, and what's on the horizon.
Clay traces the 340B Rebate Model back to late 2023, when the Centers for Medicare & Medicaid Services (CMS) named the first Maximum Fair Price (MFP) drugs under the IRA and manufacturers began weighing a rebate model against upfront discounts to manage duplicate discount risk. He covers the manufacturer lawsuits that followed HRSA's initial 340B Rebate Model Pilot Program, the court ruling that paused it in December 2025, and what a revised Pilot Program, version 2.0, could look like when it's expected to launch on January 1, 2027.
Episode Highlights
- Only 13 manufacturers can actually participate in the 340B Rebate Model Pilot Program, since the 25 eligible MFP-selected drugs are concentrated among a small group of manufacturers.
- The Pilot Program only covers MFP-related duplicate discount risk. It doesn't address duplicate discounts in Medicaid or commercial claims, or broader issues like contract pharmacy growth.
- A federal court paused the original Pilot Program in December 2025 over how HRSA rolled it out. HRSA is expected to release a revised version 2.0 in late summer 2026.
- Clay's takeaway: manufacturers should treat the Rebate Model as one tool for managing 340B risk, not a full solution to duplicate discount and program growth challenges.
FAQs
What is the 340B rebate model?
It's a way for manufacturers to pay 340B rebates instead of upfront discounts on MFP-selected drugs, aimed at reducing the duplicate discount risk created by Medicare drug price negotiation under the IRA.
Which manufacturers can participate in the 340B rebate model pilot program?
Only manufacturers with 2026 or 2027 MFP-selected drugs are eligible, and since several manufacturers hold more than one selected drug, just 13 manufacturers can take part.
When will the 340B rebate model pilot program version 2.0 launch?
Clay Willis expects HRSA to release version 2.0 requirements in late July or August 2026, with a possible launch on January 1, 2027, for manufacturers with 2026 and 2027 MFP-selected drugs.
Catch Up on the 340B Podcast Series
New to the series? Episode 1 covers one of the biggest shifts happening in 340B today: the move toward All Claims Collection, and what it means for manufacturers managing duplicate discount risk.