340B Rebate Pilot: Preparing for HRSA’s 2026 Pilot
Beginning January 1, 2026, HRSA’s 340B Rebate Pilot will fundamentally change how covered entities access drug discounts. Instead of receiving immediate price reductions, providers will pay manufacturers upfront and wait for reimbursement through rebates.
This shift creates new risks for cash flow, compliance, and patient care. At The Craneware Group, we’re helping 340B-eligible organizations anticipate the impact now — so you’re ready when the pilot begins.
A New Era for 340B: What the Rebate Pilot Means for Covered Entities
HRSA’s rebate pilot is the most significant change to the 340B Program in decades. Covered entities will need to:
- Pay more up front, straining budgets and patient services
- Wait longer for reimbursement through rebate submissions
- Manage new documentation requirements and manufacturer interactions
Preparation isn’t optional. It’s essential to maintaining 340B compliance and protecting access for patients who rely on this program.
The Risks Ahead: Denials, Delays, and Financial Strain
Our analysis of real-world provider data revealed the scale of the challenge:
- $700M in upfront costs advanced to manufacturers in year one, based on a representative sample of covered entities
- Get ready for payor-style behaviors -- delays and denials are expected
- Hidden compliance and documentation gaps that could jeopardize rebates
Without preparation, these risks can ripple directly into operations and patient funding.
The Craneware Group’s Provider-First Approach
As the leader in healthcare revenue cycle management and 340B program compliance, The Craneware Group partners only with providers — never manufacturers.
- Neutrality matters: we advocate exclusively for covered entities
- Decades of experience: defending revenue against denials and compliance pressure
- Proven results: trusted by top U.S. hospitals to safeguard scarce resources
When disruption hits, you need a partner who prioritizes your mission, not manufacturer interests.
340B Rebate Pilot Checklist: 5 Steps to Readiness
Every covered entity should act now on these priorities before January 1, 2026:
- Model your exposure — quantify how much cash flow could be tied up in rebates
- Secure your 340B data integrity — ensure accurate, auditable submissions
- Plan for cash flow strain — prepare reserves to bridge delayed reimbursements
- Prepare for denials — build workflows to challenge rebate rejections with data
- Choose the right partner — work with experts in 340B audit readiness and revenue protection
Steady Support Through Transition and Beyond
When the rebate model takes effect, you don’t have to face the risks alone. The Craneware Group is ready to help providers:
- Protect operating cash flow during rebate recovery delays
- Use data and documentation to defend against denials
- Navigate evolving requirements with compliance-first technology
Your mission is patient care. Ours is ensuring financial sustainability so you can keep care accessible.
Our Advocacy: The Craneware Group’s Response to HRSA
The Craneware Group submitted a formal response to HRSA on behalf of covered entities, urging for:
- More time to implement requirements
- Greater clarity on manufacturer interfaces
- Stronger protections against abuse and denials
[Read our full HRSA comment letter]