HRSA Approves Plans From 10 Drugmakers for 2027 340B Rebate Pilot

By 340B Auditor LLC · October 1, 2026 · 6 min read

HRSA has posted approved 340B rebate plans from ten drug manufacturers, with every manufacturer on the current list scheduled to begin January 1, 2027. All ten will use the Beacon Rebate Model Platform. For covered entities purchasing the affected drugs, that means preparing to pay wholesale acquisition cost (WAC) and collect the 340B discount afterward. ^[1]

The practical question is how that payment will make its way back to your organization. Someone will need to submit the claim, resolve missing information, match the rebate to the right transaction, and follow up when the money does not arrive. Pharmacy may see the change first, but finance, billing, and the people managing your data need a place in the conversation now.

Which manufacturers and drugs are included?

HRSA's approval table lists the following manufacturers and products. Each row has a January 1, 2027 start date and identifies Beacon as the platform. The product links below open the plans posted by HRSA. ^[1]

Use this list to start your review, then match the approved 11-digit National Drug Codes (NDC-11s) against your purchasing and dispensing records. A brand name alone is not enough to configure a purchasing system. The pilot is limited to approved selected drugs for Medicare's 2026 and 2027 initial price applicability years, during their applicable pricing periods. Within that scope, it applies regardless of payer or indication. Drugs without an approved rebate plan continue under upfront 340B pricing. ^{[1] [2]}

The 340B account stays. The payment timing changes.

HRSA directs covered entities to keep purchasing pilot drugs through their existing 340B wholesaler accounts, with WAC loaded for the affected products when the plan takes effect. Buying through a separate WAC-only or group purchasing organization (GPO) account is not the ordering route HRSA describes for a pilot rebate. The rebate equals WAC minus the 340B ceiling price on the date of dispense and is paid at the unit level. ^[1]

That distinction deserves a conversation with the wholesaler before January. An account can still be labeled “340B” while the amount due on an affected purchase increases. Finance will need to understand that change, the expected rebate receivable, and how a payment will be reconciled.

The pilot is voluntary for manufacturers. Covered entities should not assume that means they can choose to retain upfront discounts for an approved product. AbbVie's Imbruvica plan, for example, states that the ceiling price will be available through rebates only. Entity-specific exceptions require a separate review: GSK's plan allows AIDS Drug Assistance Program (ADAP) covered entities already receiving 340B discounts through rebates to continue their existing rebate processes. ^{[5] [6]}

Two clocks will matter to your team

Claims submission: HRSA describes a 45-calendar-day window from the date of dispense, with allowances for extenuating circumstances and changes in a claim's 340B status. The manufacturer plans explain how to request those allowances. Payment: the federal notice requires payment or a documented denial within ten calendar days of a completed submission. When a submission is returned as incomplete, the payment clock restarts after the necessary data is submitted. ^[2]

The ten-day standard does not mean the cash-flow gap begins and ends ten days after a drug is purchased. Inventory timing, the dispense date, submission timing, and corrections all affect when money returns. Our recommendation is to model that full cycle using your own purchasing volume and payment terms.

There is also a detail to clarify before building a payment calendar. AbbVie's posted Imbruvica plan describes payment within ten calendar days excluding federal holidays, while HRSA's notice states ten calendar days without that qualifier. We have not established how that difference will be reconciled. Ask for written clarification from the manufacturer or HRSA rather than treating the two formulations as interchangeable. ^{[2] [5]}

Beacon registration is only the first step

Manufacturers must cover the cost of the submission platform. Your team will still need a workable process for extracting data, correcting claims, and reconciling payments. HRSA limits the submission fields and says purchasing data and encounter-level data are not permitted as part of the pilot at this time. It also provides separate pharmacy and medical claims field lists. ^{[1] [2]}

Previous registration may not finish the job. AbbVie's Imbruvica plan says covered entities registered during the 2025 pilot effort must reconfirm documentation and provide an updated bank letter, with additional micro-deposits to verify payment details. Assign someone who can coordinate with finance and complete that work before claims begin flowing. ^[5]

Check where each product's claims belong, too. GSK's plan directs Breo Ellipta and Trelegy Ellipta claims to Beacon beginning January 1, while other GSK products continue through 340B ESP under its separate policy. A manufacturer can have more than one reporting process. Ask your third-party administrator (TPA) to show you the product-level routing and how it prevents missed or duplicate submissions. ^[6]

Build a way to resolve unpaid claims

HRSA prohibits denying pilot rebates based on concerns about covered-entity eligibility, diversion, or Medicaid duplicate discounts, or a perceived lack of WAC purchases. Those concerns must go through HRSA or the applicable statutory review processes. Other denials require supporting reasons and documentation. These limits do not remove a covered entity's underlying compliance obligations. ^[2]

That protection does not mean every submitted claim will be paid. Missing data, duplicate rebate requests, and coordination with Medicare's maximum fair price (MFP) require attention. BMS's plan, for example, allows a 340B rebate denial for certain claims already approved for an MFP rebate when the MFP is below the applicable 340B ceiling price. Keep the actual denial reason with the claim record so your team can distinguish a data correction from a dispute. ^[8]

HRSA tells covered entities to work first with the manufacturer and platform vendor, then raise unresolved issues with 340BPricing@hrsa.gov after good-faith efforts. Its page still labels the planned rebate-unavailable form link as forthcoming. An internal log of submission dates, responses, payment amounts, and follow-up will make that escalation more useful. ^[1]

A revised pilot with a familiar concern

The earlier pilot, intended to start in January 2026, was halted by litigation. HRSA says the original notices and approvals were vacated on February 10, 2026. The agency announced the revised program July 31, followed by the August 3 Federal Register notice. These are approvals under that revised framework. ^{[1] [3]}

HRSA says the approach will improve transaction visibility, program integrity, and coordination with Medicare drug pricing. In its July 31 response, the American Hospital Association warned that the revised program would create substantial administrative costs and cash-flow pressure for hospitals. Those are competing assessments of a program whose operational results are still ahead. HRSA plans interim reporting and an evaluation by April 30, 2028. ^{[3] [4] [1]}

What to put on this week's agenda

Start with the work that will make January easier:

1. Find your exposure. Match approved NDCs to recent utilization and purchases. Identify the affected sites, pharmacies, payers, and any applicable entity exceptions.
2. Confirm the people and accounts. Name a Beacon administrator, a backup, and a finance contact. Verify registration and payment setup, including anything left over from the earlier pilot.
3. Walk through a sample transaction. Have pharmacy, the TPA, and finance trace the record from dispense through the intended submission and reconciliation process. Record missing fields and who will correct them.
4. Plan for the money in between. Estimate the additional purchase outlay and the effect of submission delays or returned claims. Set a review schedule for unpaid rebates.
5. Prepare the year-end transition. HRSA provides a limited accommodation for up to two unreplenished accumulated packages during the 15-calendar-day period before implementation. Merck's plan applies that limit per NDC-11 and excludes dispenses already used to obtain 340B pricing. Review each applicable plan before clearing accumulations. ^{[2] [7]}
6. Check the billing handoff. Confirm how quarterly ceiling-price files will reach the people responsible for Medicaid billing and sliding-fee calculations. HRSA directs covered entities to work with their state Medicaid agencies on appropriate billing practices. ^[1]

A useful first meeting should end with named owners and a tested path for a claim. The goal is for the pharmacy team to know what gets purchased, the data team to know what gets submitted, and finance to know what should come back.

For help reviewing the affected products, testing your records, or preparing the supporting procedures, contact 340B Auditor.