The 340B Rebate Model Pilot Is Coming Fast, and We’re Here to Help

By Tim L'Hommedieu, SVP of Pharmacy at Plenful. Connect with Tim on LinkedIn. 

The last two weeks, my phone has been ringing off the hook. Past colleagues and current Covered Entity partners are all trying to make sense of the 340B Rebate Model Pilot, a sweeping regulatory shift with a short runway that will reshape how health systems approach 340B, starting January 2026. 

I wanted to take a moment to summarize what we’ve learned about the 340B Rebate Model Pilot to date, and share a preview of what we’re building at Plenful to ease the transition for our Covered Entity partners.

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340B Rebate Model in a Nutshell: A Major Change, on a Tight Timeline

On July 31, 2025, HRSA’s Office of Pharmacy Affairs unveiled a pilot program that changes how the program will operate for the 10 drugs included in the CMS Medicare Drug Price Negotiation List. Instead of purchasing at the 340B price, Covered Entities will purchase these 10 drugs at a higher price and then submit claims to manufacturers for a post-purchase rebate.

A few key dates we’re closely watching:

‍The pilot starts January 1, 2026. Manufacturers must submit their participation plans by September 15th, with approvals expected from OPA by October 15th. That leaves Covered Entities little time to re-engineer workflows, train teams, and make sure the right systems are in place. 

For some organizations, this rebate model could create a major financial gap, as Covered Entities are required to “float” the cash to cover the incremental acquisition cost of the drugs until reimbursement is received from the manufacturer.

Despite ongoing litigation, I expect the 340B Rebate Model Pilot Program to proceed. This is because it addresses a challenge within the IRA’s Medicare Drug Price Negotiation Program. Specifically, manufacturers can offer the Maximum Fair Price (MFP) either at the point of purchase or through a retrospective refund via the MTF Payment Module (MTF PM). If a manufacturer opts for the retrospective refund, and the 340B price is lower than the MFP, a critical question arises: how will they differentiate claims eligible for MFP refunds from 340B claims, which do not require a refund? CMS clarified in its October 2, 2024 Final Guidance document they will not assume responsibility for nonduplication of discounts between the 340B price and MFP. The proposed 340B Rebate Model Pilot Program would provide manufacturers with the necessary data to distinguish between 340B and MFP refund claims. 

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What the Rebate Model Means for 340B Operations and Your Financial Planning Efforts

In this new model, you will pay a higher price upfront, then wait for the rebate, which is expected from manufacturers within 10 days of claim submission. 

That sounds manageable in theory, but in practice, it creates challenges in cash flow, reconciliation, and team workload.

Operationally, you’ll need to:

• Identify the 340B eligible claims across your systems
• Submit all 11 required data fields accurately, every time (if inaccurate, delays could occur as data is revised and resubmitted)
• Reconcile incoming rebate payments with your submissions to ensure nothing is missed or underpaid
• Track contracting nuances and other operational elements 

Large Covered Entities with well-resourced teams will feel the strain, and smaller organizations may forgo the 340B savings completely and exclude these drugs from their program. 

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Meet Plenful’s 340B Rebate Management Solution

As soon as the pilot was announced, we started working behind the scenes with our Covered Entity partners to design a 340B Rebate Management solution that’s built for the needs of pharmacy teams overseeing complex 340B programs.

Here’s what it will deliver:

• Automated data submission: Similar to our existing 340B Export Package for ESP and State reporting requirements, which reduces manual admin time by >95%, Plenful will organize and submit the 11 required data elements to manufacturers, reducing manual work and the chance for costly errors.
• Fast, accurate reconciliation and rebate validation: Leveraging similar logic as our existing Claim Capture and Rate Reconciliation use case, Plenful will validate rebate amounts to flag underpayments or errors and reconcile rebate payments to ensure timely reimbursement within the 10-day payback window.
• Clear financial visibility: Key financial metrics will be showcased within an executive dashboard, including estimated cash float, claims submitted and outstanding, manufacturer roll-ups, and monthly National Drug Code (NDC) roll-ups, all in one place. Our dashboards are highly customizable to highlight the metrics that matter most to your organization.
  
  

As rebate model guidance evolves, we’ll continue to stay close to the requirements and align feedback from our customer base to shape our 340B Rebate Management solution. This means leveraging automation to reduce tedious reporting work and empowering pharmacy leaders to have clear oversight of their financials. 

How can Plenful support your needs as you prepare for the rebate pilot? Let’s connect. I’m eager to hear what’s on your mind. 

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Ready to Learn More?

📅 Join us on August 20th for our 340B Platform Showcase webinar, where I’ll preview the rebate solution we’re rolling out ahead of the pilot, alongside our Founder and CEO, Joy Liu, and Product Solutions lead, Arvind Swaminathan.

RSVP here to join live. 

If you can’t make the webinar date, or would prefer a more personalized demo, we’d love to chat. Request a call with our team online here.

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