The 2027 340B rebate pilot: 5 things worth knowing
HRSA's revised 340B Rebate Model Pilot takes effect January 1, 2027 for manufacturer plans HRSA approves. It applies only to selected drugs under Medicare's Drug Price Negotiation Program — most 340B sales continue under the upfront discount model.
Purchase at WAC→Dispense→Submit claim data→Paid or denied
01
Participation isn't optional for affected covered entitiesThe pilot is voluntary for manufacturers. Once HRSA approves a manufacturer's plan, it becomes mandatory for covered entities buying that manufacturer's 340B drugs.Know which approved plans apply to you.
02
45 days isn't a waiting periodApproved plans must let covered entities submit claim data for at least 45 calendar days from the date of dispense.It's a minimum window, not a delay. Submitting sooner shortens the cash cycle.
03
Incomplete data restarts the clockManufacturers pay or issue a documented denial within 10 calendar days of a completed submission. If a submission is returned for incomplete data, the clock restarts.Data completeness becomes a cash-flow question.
04
Rebate value is set on the day of dispenseThe rebate equals WAC less the 340B ceiling price on the day of dispense, paid at the unit level.Dispense-date accuracy drives the amount.
05
You should have visibility into rebate statusApproved plans must provide reconciliation reporting for submitted claims.Know what's submitted, paid, denied or outstanding.
Based on HRSA guidance as of September 16, 2026 1 of 3
2027 rebate pilot · field guide
The rebate pilot doesn't arrive alone
Medicare's negotiated prices phase in across the same years, and the two programs meet on the same claim. This is the shape of the next three years.
<5.5%of total 340B sales — the share represented by included products, 2025 data
2026
10 drugs, prices already in effectThe first negotiated maximum fair prices took effect January 1, 2026, covering 10 drugs under Medicare Part D.
2027
15 more drugs — and the rebate pilot beginsA second group of 15 Part D drugs takes effect January 1, 2027, the same date the 340B rebate pilot starts. Both land together.
2028
15 more — and Part B joins for the first timeA third group takes effect January 1, 2028. For the first time it includes drugs paid under Part B, alongside one earlier drug returning for renegotiation.
One price, not both
When a selected drug is also a 340B drug, the covered entity gets the lower of the two on a deduplicated basis — never the 340B price and the negotiated price on the same unit (Social Security Act §1193(d)(2)).
Ask: when a claim is paid on the wrong basis, who catches it and who corrects it?
Terms you'll hear
MFP — Maximum Fair Price. The price Medicare negotiates with a manufacturer for a selected drug.
MTF — Medicare Transaction Facilitator. CMS's platform moving claim and payment data between pharmacies, plans and manufacturers.
SDRA — Standard Default Refund Amount. The expected refund on a claim, generally WAC less the MFP.
Beacon MFP / Beacon 340B. The manufacturer-side portals used for MFP claim detail and, from 2027, for 340B rebate submission.
GFI — Good Faith Inquiry. The route for questioning a refund decision you believe is wrong.
Drug counts and effective dates per CMS, Medicare Drug Price Negotiation Program
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2027 rebate pilot · field guide
What to pressure-test before January 1, 2027
None of these have one right answer. The point is knowing yours before the date.
Cash
Which selected drugs represent meaningful purchase volume for us?
How much working capital could be outstanding between purchase and rebate receipt?
Who compares expected rebates against rebates received?
Data
Which required claim fields come from which systems?
How quickly after dispensing can we submit a complete claim?
Who owns a submission that comes back incomplete?
Operations
Who owns submission, reconciliation and exceptions?
When a rebate is delayed or denied, who investigates?
Who confirms which of our drugs are in scope on day one?
How do pharmacy and finance see the same picture?
Contract pharmacy? Ask your partners.
HRSA's notice is written primarily to covered entities, which retain ultimate responsibility for 340B compliance. Contract pharmacies should clarify operating responsibilities with their covered-entity partners before January 1, 2027.
What data do you need from us, and how soon?
Who submits — you, us, or someone on your behalf?
How will rebate status and exceptions be communicated?
Who follows up when submitted information is incomplete?
Easy to missApproved plans must publish a quarterly 340B price file for each 11-digit NDC.
HRSA says covered entities can use it to account for actual acquisition cost after rebate — for Medicaid billing and to assist with sliding fee scales or patient cost sharing.
Ask: who on our team owns this file?
2027 changes more than reconciliation.
Callara models what the rebate pilot and MFP do to your cash position, and flags where rebates are outstanding, from the dispensing history you already have.