Ten drugmakers were just approved for the 340B rebate pilot. Here is what January 1 actually looks like at a health center.

"Our wholesaler says we will be buying Eliquis at WAC starting in January. Is that right?"

It is right, and it is not only Eliquis. On October 1, 2026, HRSA posted the first ten approved manufacturer plans for the 340B Rebate Model Pilot Program, every one of them starting January 1, 2027 (HRSA, 340B Rebate Model Pilot Program). For the products on those plans, the 340B price stops arriving as a discount on the wholesaler invoice and starts arriving as a rebate, after you submit claim data and the manufacturer accepts it.

That is a workflow change, not a price change. The ceiling price is the same. What changed is who has to do what, in what order, to get it.

What actually changed, and for which drugs

The rules are in HRSA's notice at 91 FR 48883 (Aug. 3, 2026) (Notice Regarding 340B Rebate Model Pilot Program). The scope is narrow on purpose. The Pilot applies only to the selected drugs under the Medicare Drug Price Negotiation Program for initial price applicability years 2026 and 2027, limited to the NDC-11s on the CMS Selected Drug List, "regardless of payer or indication," during each drug's price applicability period. Every other 340B drug keeps the upfront discount.

The ten approved manufacturers and their listed products, as HRSA posts them: AbbVie (Imbruvica, Linzess, Vraylar), Amgen (Enbrel, Otezla, Otezla XR), Astellas (Xtandi), AstraZeneca (Farxiga), Bristol Myers Squibb (Eliquis, Pomalyst), Boehringer Ingelheim (Jardiance, Ofev, Tradjenta), GSK (Breo Ellipta, Trelegy Ellipta), Merck (Januvia, Janumet, Janumet XR), Pfizer (Ibrance), and Teva (Austedo, Austedo XR). That is 21 product names. For a health center, the ones that will show up in your dispensing data every day are Eliquis, Jardiance, Farxiga, Januvia, Trelegy, and Enbrel.

All ten plans name the same IT platform, the Beacon Rebate Model Platform. So the registration instructions landing in your inbox will come from one place, which is the one piece of good news in this post.

The mechanics, step by step

1. You keep ordering through your existing 340B wholesaler account. HRSA requires manufacturers to structure plans so purchases flow through existing distribution, with WAC prices loaded into the 340B account. Do not order Pilot drugs through a WAC-only or GPO account if you intend to claim the rebate. HRSA's own words: covered entities "should not order Pilot drugs through any other account."

2. You dispense or administer the drug.

3. You submit claim-level data for that dispense to the manufacturer's platform. The notice limits what can be asked to a fixed list of pharmacy and medical claim fields, covered below.

4. The manufacturer pays the rebate, equal to WAC minus the 340B ceiling price on the date of dispense, "paid at the unit level rather than by accumulation of a full package size."

Step 3 is the new job. The notice itself observes that "many covered entities, such as federally qualified health centers, lack the ability to operate their own in-house pharmacy," and run 340B through contract pharmacies and a third-party administrator. Until now the claims data that earns the price never had to leave the TPA. Now it goes to a manufacturer platform, in a defined format, on a clock.

The two clocks

45 days to submit. Section VIII.B.1 of the notice requires every plan to let covered entities submit data "at a minimum, up to 45 calendar days from date of dispense, with allowances for extenuating circumstances and other exceptions, including adjustments when a 340B status change occurs on a claim."

10 days to pay or deny. Section VIII.C requires rebates to be paid or denied, with supporting documentation, "within 10 calendar days of completed data submission." If a submission is returned as incomplete, the 10-day clock restarts when the complete data arrives.

Read those together and the lesson is simple. Data quality is now a cash-flow control. A claim with a missing prescriber ID does not get paid late. It gets sent back, and the clock starts over.

The cash-flow question your CFO will ask

HRSA's answer is in the preamble. The 10-day payment "is intended to precede the payment deadlines associated with standard wholesaler payment terms, thereby reducing or eliminating the need for covered entities to 'float' the WAC price," and so "HRSA expects the cash-flow impacts on covered entities to be minimal."

That is an expectation, not a guarantee, and it depends on two things you control and one you do not. You control how fast your team submits and how clean the submission is. You do not control your wholesaler's terms. If your wholesaler is net 15 on the 340B account and your submissions take three weeks, you are floating WAC. Model it with your actual terms and your actual Pilot volume before January, and do not accept "minimal" as the answer.

One transition accommodation is worth knowing. Plans must accommodate up to two unreplenished accumulated packages during implementation, with a 15-calendar-day grace period before the effective date. Claims are still due within 45 days of dispense.

What is protected, and what is not

Protected: a manufacturer may not deny a rebate based on covered entity eligibility, diversion, or Medicaid duplicate discount concerns. Those concerns go to HRSA, or through the statutory audit and administrative dispute resolution processes. Other denials require a documented rationale, and a rebate may not be denied for a perceived lack of WAC purchases. If you believe a denial is improper, HRSA's page gives the address: 340BPricing@hrsa.gov.

Also protected: all costs of the IT platform are borne by the manufacturer, and data received under the Pilot may not be used for any purpose other than those identified in the Pilot, which HRSA says extends to "any collecting, aggregating, sharing, or licensing of Pilot data by manufacturers or their technology platforms."

Not protected: there is no categorical carve-out for health centers. Section VIII.A.7 of the notice requires a plan to "describe whether an exception that would not apply broadly to all covered entities" exists, and names health centers only as an example of who such an exception might cover, not as an exempt class. Whether any of the ten approved plans actually contains a health center exception is inside the plan PDFs HRSA posted, and I have not read all ten. Read the ones for the drugs you dispense.

The data you will send, and the BAA question

The notice limits the fields a manufacturer may request. For pharmacy claims: date of service, date prescribed, Rx number, fill number, NDC-11, quantity dispensed, prescriber ID, service provider ID, 340B ID, Rx BIN, Rx PCN, and health plan ID qualifier if available. For medical claims: date of service, claim line number, claim number, unit of measure, NDC-11, quantity, rendering physician ID, service provider ID, 340B ID, health plan name, and health plan ID. Purchasing data and encounter-level data "are not permitted as part of the Pilot at this time." If a platform asks for more, that is a question for HRSA, not a field to fill in.

HRSA's position is that these fields are not protected health information, and that data de-identified under 45 CFR 164.514 is outside the Privacy Rule. It also says, in a footnote, that if a covered health care provider relies on the platform to de-identify PHI, "the platform would be acting as a HIPAA business associate of the provider and would be required to have a valid business associate agreement in place." So before the first file goes out, read your TPA agreement and decide, in writing, who is de-identifying what and whether a BAA with the platform is needed.

What to do in the next 60 days

1. Pull your dispensing and administration data for the 21 listed products and size the Pilot volume by NDC-11. If it is zero, you can stop here, and confirm it is still zero each quarter.

2. Confirm with your TPA whether it can produce every required claim field, for both contract pharmacy and in-house claims, and in what format.

3. Name the person who owns submission inside the 45-day window, and the person who watches the 10-day payment clock. Neither should be the person who reconciles the wholesaler invoice.

4. Read each manufacturer's 90-day notice as it arrives. Section VIII.A.2 requires plans to give covered entities "90 calendar days' notice" before implementation, so for a January 1 start, the notices are due now.

5. Get the quarterly ceiling price file from the platform, by 11-digit NDC, and give it to whoever does Medicaid billing and sliding fee calculations. The notice requires manufacturers to make it available for exactly that purpose.

6. Run the cash-flow model with your real wholesaler terms.

7. Decide the BAA question in writing.

Posture, not panic

Keep the Pilot in proportion. It covers a limited set of drugs, and it is contested. Covered entity groups sued over the 2025 version on December 1, 2025, a federal court in Maine granted a preliminary injunction on December 29, 2025, and HHS appealed. The notice recounts all of that itself. HRSA says it will publish an evaluation of the first year of operations by April 30, 2028. Build the workflow, keep the documentation, and do not rebuild your whole 340B program around a pilot.

Reach out if you want help sizing your Pilot exposure or reading the plan PDFs for the drugs you actually dispense.