HRSA has launched a voluntary 340B Rebate Model Pilot Program for outpatient drugs on the 2026 CMS Medicare Drug Price Negotiation Selected Drug List.
This pilot lets qualifying manufacturers test post-purchase rebates instead of upfront discounts, helping HRSA evaluate a fair, transparent rebate process for covered entities.
Program Overview
To reimburse covered entities (after purchase) for the difference between a drug’s wholesale acquisition cost and its 340B ceiling price.
Eligibility stipulations
Applies only to NDC-11 drugs on the 2026 CMS Medicare Drug Price Negotiation Selected Drug List, regardless of payer. Only manufacturers with 2026 Medicare Drug Price Negotiation Agreements may apply.
Important dates
| September 2, 2025 | Public comment deadline. Submit via the Federal eRulemaking Portal (Docket HRSA–2025–111). |
| September 15, 2025 | Plan submission deadline. Submit up to a 1,000-word proposal emailed to 340BPricing@hrsa.gov. |
| October 15, 2025 | Approval notices go out. HRSA will notify approved participants by deadline. Approval letters will include detailed launch instructions on system requirements, reporting schedules, and compliance guidelines. |
| January 1, 2026 | Pilot begins. It runs through the 2026 applicability year, during which HRSA will provide ongoing technical support and collect performance data. |
Participation criteria highlights
- Manufacturers bear all IT platform costs and must give covered entities at least 60 days’ notice before launching the rebate model, including instructions for any new systems.
- IT platforms must secure data and protect patient-identifying information in compliance with HIPAA and other laws.
- All rebates must be paid—or documented if denied—within 10 calendar days of data submission.
Why this matters for everyone
Even if your organization isn’t eligible to join the pilot now, you need to understand what this program means for the future of 340B discounts.
Under this pilot, covered entities will now pay a drug’s wholesale price upfront and receive the 340B rebate later.
This cash‑flow gap can create real financial uncertainty. HRSA wants every stakeholder, initial eligibility or not, to help shape safeguards before launch.
What to send:
- Evidence‑based observations. Real utilization data, cost impacts, and workflow examples that show how post‑purchase rebates would play out in practice.
- Safeguard suggestions. Guardrails that protect cash flow for smaller covered entities and keep the rebate timeline realistic.
- Efficiency ideas. IT or reporting flexibilities that lower admin burden for manufacturers and providers.
- Extra metrics. Data points HRSA should track to measure success and spot issues early.
Submit comments by September 2, 2025. Visit https://www.regulations.gov/ and search for the docket using the number HRSA–2025–lll. Click the “Comment” button associated with the document to leave your feedback.
For any and all HRSA rebate program questions, contact Chantelle Britton, Office of Pharmacy Affairs, HRSA, at 340Bpricing@hrsa.gov or 301-594-4353.
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