What FQHC Leaders Need to Know About HRSA’s New 340B Rebate Model Pilot Program
As health center leaders know, the 340B Drug Pricing Program has been a vital mechanism for stretching scarce federal resources to serve high-need communities. Now, a significant shift is underway. On July 31, 2025, HRSA announced a new pilot, the 340B Rebate Model Pilot Program, designed to test a rebate-based alternative rather than the traditional upfront discounted price model. (HRSA Announces Application Process for the 340B Rebate Model Pilot Program and Request for Public Comment | HRSA)
On October 30, 2025, it has been announced that the Office of Pharmacy Affairs (OPA) approved eight manufacturers for participation in the rebate model starting January 1, 2026. (340B Drug Pricing Program | HRSA)
What’s New: The Pilot Program Basics
The pilot will begin January 1, 2026, for manufacturers whose plans are approved by HRSA.
It covers a selected group of drugs that were part of the Medicare Drug Price Negotiation Program (for which maximum fair prices were negotiated) and whose manufacturers submit eligible plans.
Covered entities (including FQHCs) must continue to purchase through their 340B wholesale account for the selected drugs and then request rebates on dispensed units eligible under the model.
HRSA has published the limited set of required data fields for claims submissions and clarified that all auditable records must be maintained. Examples: Date of service, NDC-11, quantity dispensed, 340B ID, BIN/PCN for pharmacy claims.
Drugs Included (Initial List)
While the full list of participating manufacturers may still evolve, sources identify the following drugs as subject (at least initially) to the pilot:
Eliquis (Bristol Myers Squibb)
Enbrel (Immunex/Amgen)
Entresto (Novartis)
Farxiga (AstraZeneca)
Imbruvica (Pharmacyclics/AbbVie)
Januvia (Merck)
Jardiance (Boehringer Ingelheim)
NovoLog / Fiasp (Novo Nordisk)
Stelara (Janssen)
Xarelto (Janssen)
FQHCs that dispense or prescribe any of these products (or monitor pharmacy services that do) need to prioritize readiness.
Why This Matters for FQHCs
Operational & finance impact: Rather than receiving the upfront 340B discounted price at purchase, the model requires wholesale acquisition and rebate submission. That changes cash-flow timing and requires new operational steps.
Data and compliance burden: The need to collect detailed claims data, submit it in a timely fashion (often within 45 days of dispense), and reconcile rebates means added process risk.
Audit & documentation: HRSA will audit both covered entities and manufacturers under this pilot, so clean documentation, segregation of claims, and compliance with the model’s rules will be critical.
Dual-model environment: Since only select drugs are implicated initially, FQHCs may need to run two parallel workflows, one for “traditional” 340B discounted purchases and one for the new rebate model drugs. This adds more complexity to already complex systems.
Strategic positioning: Because this is a pilot, the outcome may influence broader 340B program design. FQHCs that are prepared can shape their role, protect their access, and mitigate risk.
Actionable Steps for FQHC Leadership
1.Assemble your cross-functional readiness team: Include pharmacy services, finance/accounting, compliance/HRSA registration, IT/data management, and contracts/vendor relations. Make sure each team understands the potential changes ahead.
2.Identify exposure
Review your current pharmacy inventory — including both onsite and contract pharmacy arrangements — to determine whether any of the nine drugs included in the pilot are dispensed or prescribed within your system.
Map your end-to-end process (purchase → dispense → claims → reimbursement) to identify where new steps may be needed to accommodate the rebate model.
Engage your pharmacy vendor or TPA to determine how they plan to support the rebate submission process and whether system upgrades are required.
Flag potential gaps in timing, data capture, or coordination with third-party partners that could affect eligibility or rebate timeliness.
3.Audit your data and systems
Confirm your EHR, pharmacy management, and billing systems can capture all required rebate data elements: NDC-11, 340B ID, prescriber ID, quantity dispensed, and BIN/PCN.
Test your ability to generate and submit complete rebate claim files within the required submission window (typically 45 days, depending on manufacturer).
Review your reporting capabilities.
Can you easily pull lists of eligible drugs, submission statuses, and rebate payments received?
Establish a reconciliation and tracking process that ensures all rebate claims are matched to payments and any denials are investigated promptly.
Adopt key performance indicators (KPIs) to monitor rebate program success, such as rebate claim error rate, payment turnaround time, and reconciliation completion percentage.
4.Update internal policies and vendor/partner contracts
Revise SOPs to reflect two workflows: standard 340B discount vs. rebate model.
Clarify responsibilities with wholesalers, TPAs, third-party pharmacy networks, and vendors:
Who handles reimbursement tracking?
Who maintains audit logs?
Build rebate submission and reconciliation tracking into your regular financial reporting cycles.
Communicate with pharmacy contract partners about how purchases will need to be routed through the 340B wholesaler account under the pilot model.
5.Monitor and communicate with stakeholders
Ensure your board and executive leadership understand the potential financial and operational impact.
Build regular updates into pharmacy and finance leadership meetings.
Assign responsibility for monitoring federal updates and sharing new information internally.
Monitor HRSA/OPA communication, including plan approvals, comment periods, and updated guidance.
6.Scenario-plan for implementation date (January 1, 2026)
Set internal deadlines (e.g., by end of Q1 2026) to fully test unique workflows.
Model cash-flow scenarios to understand how delayed rebates will affect operations and how to adjust for these changes
Develop a contingency plan for any vendor or system issues that could delay rebate submissions.
Ensure robust communication and regular cross-department check-ins to ensure alignment between pharmacy, finance, IT, and compliance teams as the pilot goes live.
Navigating Change Together
Change in the 340B space is nothing new, but preparation, communication, and collaboration remain the keys to success. As this rebate pilot moves forward, FQHCs that align finance, pharmacy, and compliance efforts now will minimize disruption and maintain program integrity. At Community Link Consulting, we’re committed to helping health centers navigate transitions like these with clarity and confidence so your team can stay focused on what matters most: caring for your community.
About the Author
Amy Brisson, Chief Strategy Officer
Community Link Consulting
Phone: 509-226-1393
Email: info@communitylinkconsulting.com
Amy combines over 15 years of progressive financial leadership experience with over 11 years of specialized FQHC industry expertise to guide health centers through complex federal policy transitions and compliance requirements. Her deep understanding of grants management, federal funding cycles, and community-based healthcare initiatives positions her as a trusted advisor for FQHCs navigating regulatory changes.
