The 340B program has been a lifeline for many hospitals, community health centers, and others but a new pilot will have significant impacts.
With the Health Resources and Services Administration’s (HRSA) launch of the 340B rebate pilot program, providers participating in the 340B Drug Pricing Program face a new operational landscape.
Announced October 31, this pilot introduces a shift from traditional up-front discounts to a rebate-based model for select drugs. Understanding how this pilot works — and what adjustments it demands — will be crucial for providers serving vulnerable communities. The model will launch January 1, 2026.
Drug manufacturers rebate models, platforms
For decades, the 340B program has been a vital resource for hospitals, federally qualified health centers, and other covered entities. Through discounted pricing, covered entities have leveraged savings to expand patient services, provide uncompensated care, and provide access. The emergence of rebate models, however, means providers must adapt to a system where discounts are received after-the-fact, often requiring new workflows and data reporting processes.
Various drug manufacturers began piloting rebate or chargeback systems over the past few years. These approaches have required providers to submit claims and patient data, sometimes through third-party portals, to receive rebates for eligible purchases. These arrangements often equate to additional administrative steps, delayed receipt of savings, and questions about compliance and audit risk. Providers have voiced concerns about the burden of managing these processes, especially as the manufacturers are using different platforms or requirements.
HRSA 340B rebate pilot
When announcing the application for participation in this model, HRSA stated that the pilot was “to better understand the merits and shortcomings of the rebate model from the perspective of affected stakeholders, and to help shape any future 340B rebate models that align with the 340B statute and the Administration’s goals.”
Rebate processing
All rebate processing will be handled through the centralized Beacon platform. Each drug manufacturer has provided documents (also available on the Beacon platform) on their respected impacted drug(s) and what covered entities must do and know.
The Beacon platform is where to submit claims, track rebate status, and receive payments.
The rebate pilot will launch on
January 1, 2026.
Eight manufacturers were selected and received approval for rebate plans covering specific high-cost drugs: Eliquis, Enbrel, Farxiga, Imbruvica, Januvia, Jardiance, Stelara, Xarelto, and several NovoLog and Fiasp products. The drug Entresto will be under the rebate model beginning April 1, 2026.
Next steps: preparing for the model
Covered entities are required to order drugs included in the 340B Rebate Model Pilot Program through their current 340B wholesale account if they want to receive the rebate. They should not use a WAC or GPO, for example. Manufacturers should work with their distributor partners to confirm the WAC price is loaded in the 340B wholesaler account where purchases will be made by covered entities to then obtain a rebate.
System changes, logistics
For covered entities, the most immediate impact will be logistical. Instead of up-front 340B pricing, eligible entities will pay full price for covered drugs at the point of purchase, then submit utilization data through Beacon to receive rebates. Key items to consider:
- A rigorous tracking system for purchases and claims
- Tighter linkages between pharmacy and finance teams
- Careful attention to deadlines
- Focus on documentation to have records in case of dispute
- Evaluate internal systems for capabilities to capture and report necessary data
- Review the Beacon platform’s onboarding resources
- Work with 340B associations or coalitions to learn more
Cash flow preparation, communication
Another key consideration is cash flow. Since rebates are issued after the fact, there may be a lag between outlay of funds and receipt of 340B savings. Planning for this lag by making budgetary adjustments to absorb short-term impacts must be evaluated now and changes put in place early on.
Throughout this process and with all other changes stemming from this model, transparent communication across impacted departments and teams — finance, pharmacy, leadership — will be critical. This works to keep teams united and reduces the possibility of being caught off guard. Ongoing communication also works to maintain continuity of care during the model’s changes.
Use Beacon Support
The Beacon Support Center hosts an array of content including educational videos that range in topics from Account Registration to Data Submissions, step-by-step guides on using Beacon, downloadable data templates to streamline the data intake process, and articles that help further elucidate Beacon functionality. Visit the Beacon Support Center and the Resources page to learn more.
Beacon Support is also available via email, phone, or Beacon’s in-platform support messenger:
- Email: support@beaconchannelmanagement.com
- Phone (Monday to Friday 9 a.m. – 9 p.m. ET): 878-788-8907
- In-platform support messenger: For real-time responses from Beacon Support Monday to Friday 9 a.m. – 9 p.m. ET, use Beacon’s in-platform support messenger. This is available in the bottom right corner of the Beacon platform.
For inquiries outside of Monday to Friday 9 a.m. – 9 p.m. ET, users can email the support inbox or create a ticket using the in-platform messenger on Beacon.
How CLA can help with regulatory developments
The 340B rebate model pilot represents a significant shift. Preparing now for operational changes, strengthening internal workflows, and staying informed about any developments, you can continue to leverage the 340B program for the benefit of your patients and communities — even as the regulatory environment evolves.
If you need an advisor to answer questions, review your program, or develop program next steps, reach out today.