HRSA's Revised 340B Rebate Model Pilot, Explained

What is going on

On January 1, 2027, the 340B discount stops showing up at purchase for a small group of drugs. Covered entities will pay wholesale acquisition cost (WAC) up front and get the discount back later as a rebate. HRSA is clear that the pilot does not change the 340B ceiling price, covered entity eligibility or patient eligibility. It changes when and how you receive the benefit.

Why this is the second attempt

A first version was blocked by a federal court in Maine in December 2025 and vacated on February 10, 2026. After asking for public input, HRSA published a revised notice on August 3, 2026 (91 FR 48,883) and has since approved plans from 10 manufacturers covering 21 drugs. All start January 1, 2027, on the Beacon Rebate Model Platform.

The five steps of a rebate claim

1. Buy. Order pilot drugs through your existing 340B wholesaler account, where the manufacturer has loaded WAC. HRSA says not to order them through a WAC-only or GPO account if you plan to request a rebate.
2. Dispense. Dispense or administer the drug to an eligible 340B patient. The pilot applies regardless of payer.
3. Submit. Send the claims data to Beacon within 45 calendar days of the date of dispense. HRSA allows exceptions for extenuating circumstances.
4. Get paid or denied. The manufacturer must pay, or deny with documentation, within 10 calendar days of a complete submission. If a submission comes back incomplete, the clock restarts when you resubmit.
5. Reconcile. Match what you expected against what arrived.

The rebate equals WAC minus the 340B ceiling price on the date of dispense, paid per unit, so you no longer wait for a full package to accumulate.

Protections built into the revised pilot

• Manufacturers cannot deny a rebate over covered entity eligibility, diversion, Medicaid duplicate discounts or a perceived lack of WAC purchases. Those concerns go to HRSA.
• Covered entities submit only HRSA-approved data fields. Purchasing and encounter data are not allowed.
• Beacon is free for covered entities, and each manufacturer must post a quarterly 340B ceiling price file by NDC-11.
• HRSA could start removal proceedings against a manufacturer that denies or delays a significant share of transactions without justification. The notice gives 5% or more as an example.

Which drugs move to rebates

Only the specific NDC-11s listed in each approved manufacturer plan. All of them are drugs on Medicare's negotiated price list for 2026 or 2027, and every other covered outpatient drug keeps the upfront 340B price. You can see every manufacturer and drug, plus the negotiated drugs that were left out, in our 340B rebate pilot drug list.

For the changeover, plans must allow rebates on up to two unreplenished accumulated packages dispensed in the 15 calendar days before January 1. Those claims are still due within 45 days.

What to do before January 1

The money is the same, but the work is new. Register your organization and bank account in Beacon, check how much of your program the pilot drugs represent, and decide who will submit claims, work denials and confirm payments. Then plan to submit daily: 45 days is the deadline, not the target.

Where Aventi fits

Aventi is Beacon-ready for pharmacy and medical claims. We identify pilot claims, submit them, track status and reconcile each payment. The rebate module is included for our TPA clients and available on its own if you use another TPA.