340B rebate denials: the 10-day clock, what manufacturers can't deny, and how to dispute
Starting January 1, 2027, the HRSA 340B Rebate Model Pilot Program has covered entities buy selected drugs at a non-340B price, submit claims data to Beacon, and receive the 340B discount as a rebate. Manufacturers must pay or deny each rebate, so every covered entity needs a way to catch denials, understand the reason, and get them fixed. Aventi Health is an independent 340B TPA built for the rebate era: rebate submissions, denial tracking and reconciliation run inside the same system of record as your contract pharmacy and split billing data.
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What is a 340B rebate denial?
A 340B rebate denial is a manufacturer's decision not to pay the rebate on a claim a covered entity submitted through Beacon. Under the pilot, rebates equal the wholesale acquisition cost (WAC) minus the 340B ceiling price on the date of dispense, and any denial must come with a documented rationale. Manufacturers also have to document and report denied claims to HRSA, including the reason for each denial and the status of any dispute.
The 10-day pay-or-deny clock
45 days to submit
Covered entities submit claims data to Beacon within 45 calendar days of the date of dispense, with exceptions for extenuating circumstances and 340B status changes.
10 days to pay or deny
Manufacturers must pay or deny, with documentation, each rebate within 10 calendar days of a complete data submission.
Incomplete data restarts the clock
If a submission is returned as incomplete, the 10-day clock starts again once all required data is submitted, so clean claims data gets you paid faster.
Reasons a manufacturer can't use to deny a 340B rebate
HRSA's pilot rules limit what a manufacturer can deny a rebate for. These concerns have to go to HRSA, the statutory audit process or 340B Administrative Dispute Resolution (ADR) instead of being handled by withholding the rebate:
Covered entity eligibility
Not a permitted reason to deny a rebate under the pilot.
Diversion
Not a permitted reason to deny a rebate under the pilot.
Medicaid duplicate discounts
Not a permitted reason to deny a rebate under the pilot.
Perceived lack of WAC purchases
Not a permitted reason to deny a rebate under the pilot.
Denials that need documentation
Other denials require a documented rationale. Examples in HRSA's notice include avoiding duplication with the Medicare maximum fair price (MFP) and a rebate already paid to another covered entity for the same claim. If HRSA finds a manufacturer denying a significant share of claims (for example, 5 percent or more) without acceptable justification, it can start removing that manufacturer from the pilot.
How to dispute a denied or unpaid 340B rebate
Step 1: Contact the manufacturer and Beacon
If a rebate is denied or not paid within 10 calendar days, contact the manufacturer's point of contact listed in its approved plan and the Beacon platform to resolve it.
Step 2: Report it to HRSA
If the issue isn't resolved after good-faith efforts, report it to HRSA through the 340B Rebate Unavailable form or by emailing 340BPricing@hrsa.gov.
Step 3: Use 340B ADR if needed
Disputes that still can't be resolved can go through the 340B Administrative Dispute Resolution process.
What you need to report a denied rebate
- Unique claim identifier
- Claim submission date
- 340B ID
- NDC-11 purchased
- Date of service (dispense date)
- Quantity
- Unit WAC price
- Unit 340B price
- Rebate amount
- Date the rebate was rejected
- Rejection reason, if given
Aventi keeps these fields on every rebate claim, so the information for a dispute is ready when you need it.
Preventing 340B rebate denials starts with clean claims data
Conforming claim units
Aventi prepares pharmacy and medical rebate claims for Beacon with conforming claim units, so submissions aren't returned as incomplete.
Real-time claim capture
Claims are captured in real time and tied to eligible dispense records, so they reach Beacon inside the 45-day window.
Denial tracking
Denied, unpaid and short-paid rebates are tracked with their status by manufacturer and pharmacy, so they can be corrected and resubmitted where allowed.
Because rebate claims live in the same system of record as contract pharmacy and split billing, there are no end-of-month true-ups, and denials show up next to the rest of your 340B data instead of in a separate spreadsheet.
How Aventi reconciles rebate paymentsSee how 340B TPAs compare
Specialty pharmacy rebate denials
Specialty and infusion drugs are often the highest-value rebates at stake. Aventi has exclusive integrations and a gateway with BioPlus, Accredo and Optum, plus many other specialty pharmacies, so specialty dispense data reaches rebate claims on time and complete instead of arriving late or by hand.
An independent 340B TPA built for the 2027 rebate era
Aventi Health has run 340B programs for 7 years and works with more than 300 covered entities. Rebate submissions run inside the same platform as contract pharmacy and split billing, so denials, payments and reconciliation are part of your system of record. Rebate claim submission is included for Aventi TPA clients and is $750 per covered entity per month for covered entities that use another TPA.
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Catch 340B rebate denials before they cost you
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