By Purnank Gandhi, PharmD, Founder & CEO of GapRx

HRSA has approved rebate-model plans from 10 manufacturers, with an effective date of January 1, 2027. For affected drugs, your entity should prepare for a change in how it receives the 340B price benefit: purchase at wholesale acquisition cost (WAC), submit claims-level data, and receive a rebate after the claim is completed and validated.

This is a revised pilot, not the 2026 launch that was halted in court and vacated on February 10, 2026. HRSA announced the revised program on July 31, 2026, and published its notice on August 3. HRSA plans interim reporting and an evaluation by April 30, 2028.[^1][^2]

The most important practical point is that the pilot applies to specific NDC-11s, not simply to a drug’s brand name. Match the NDC-11s in your purchasing and dispensing records against each approved manufacturer plan.

The approved list: 10 manufacturers, 21 brand and formulation entries

Manufacturer	Approved pilot drugs
AbbVie	Imbruvica, Linzess, Vraylar
Amgen	Enbrel, Otezla, Otezla XR
Astellas	Xtandi
AstraZeneca	Farxiga
Bristol Myers Squibb (BMS)	Eliquis, Pomalyst
Boehringer Ingelheim	Jardiance, Ofev, Tradjenta
GSK	Breo Ellipta, Trelegy Ellipta
Merck	Januvia, Janumet, Janumet XR
Pfizer	Ibrance
Teva	Austedo, Austedo XR

That is 21 listed brand and formulation entries. Some reports count related formulations together and describe the cohort as 18 drugs. For operational planning, use the individual entries and, most importantly, the exact NDC-11s in the approved plans.

The pilot scope is limited to approved NDC-11s of selected drugs for Medicare’s 2026 and 2027 initial price applicability years, during their applicable price periods. Within that scope, it applies regardless of payer or indication. Drugs without an approved plan continue under upfront 340B pricing.[^2]

The list includes drugs used in diabetes, cardiology, respiratory care, and behavioral health, all important prescribing areas for FQHCs. Pay particular attention to your entity’s volume for Eliquis, Farxiga, Jardiance, Januvia, and Janumet.

What changes on January 1?

For affected products, your entity purchases at WAC and submits claims data after dispensing. The rebate is calculated as WAC minus the 340B ceiling price on the date of dispense, and is paid at the unit level. This is a retrospective process, not an upfront discount.

Continue purchasing through your existing 340B wholesaler accounts, with WAC loaded for the affected products. Do not move purchases to a separate WAC-only or GPO account. HRSA’s notice requires plans to allow orders through existing distribution mechanisms, including 340B wholesaler accounts with WAC pricing loaded.[^2]

The two deadlines are related, but they are not the same clock:

• You generally have 45 calendar days from the date of dispense to submit a claim, subject to permitted allowances for extenuating circumstances.
• The manufacturer must pay or provide a documented denial within 10 calendar days after a complete submission.
• If a submission is returned as incomplete, the 10-day payment clock restarts once corrected data is submitted.

So do not model this as “rebate in 10 days.” Model the full cash cycle: dispense, data preparation, submission, any correction, and payment. AHA has raised concerns that purchasing at WAC can create administrative costs and cash-flow pressure for providers.[^3]

Beacon registration is a separate workstream

All 10 approved manufacturers are using the Beacon Rebate Model Platform. Having an existing 340B ESP account does not automatically enroll your entity in Beacon.

For a new registration, prepare for organizational verification and ACH setup. Beacon may require Articles of Incorporation, the IRS CP 575 letter, a bank letter, and micro-deposit verification. Entities already registered may still need to reconfirm documents and complete updated bank verification for AbbVie, Amgen, Astellas, BMS, and Merck.

Astellas recommends completing registration by December 26, 2026, allowing up to five business days for documentation review. There is no program-wide registration deadline, but holiday schedules make early completion prudent.

Name a Beacon administrator, a backup, and a finance contact. Confirm who owns each step, including resolving failed verification, fixing a rejected file, and reconciling payments.

Manufacturer routing is not uniform

Beacon is the common platform, but the routes and existing obligations differ. Use the table below as a setup checklist, then confirm each instruction against the manufacturer’s current approved plan and notice.

Manufacturer	Routing and other requirements to map
AbbVie	Pilot-drug contract pharmacy claims are no longer accepted in ESP. Other products continue in ESP.
Amgen	Separate claims-data requirements under its Integrity Policy remain.
Astellas	Its Contract Pharmacy Policy continues to apply.
AstraZeneca	Continue Farxiga ESP reporting alongside Beacon.
Boehringer Ingelheim	Move pilot claims for purchases on or after January 1 to Beacon. ESP remains for non-pilot claims and contract pharmacy designations.
BMS	Provide explicit TPA authorization in Beacon. Do not assume an existing TPA relationship is sufficient.
GSK	Move contract and in-house claims to Beacon; ESP no longer accepts them. The ADAP exception is preserved.
Merck	Move pilot products to Beacon; other products stay in ESP. Its Program Integrity Initiative continues.
Pfizer	Confirm the approved plan’s requirements and map its affected NDC-11s to the correct submission route.
Teva	Complete separate Beacon registration even if your entity uses ESP or Second Sight. Contract pharmacy policy continues.

Create a routing list by NDC-11, manufacturer, effective date, dispensing channel, submission platform, and responsible vendor. That list should make it clear which transactions go to Beacon, which remain in ESP, and where additional manufacturer-specific data or authorization is required.

Denials, MFP, and the year-end transition

HRSA’s notice says pilot rebates cannot be denied based on covered-entity eligibility, diversion, Medicaid duplicate discounts, or a perceived lack of WAC purchases. Those concerns belong in HRSA oversight or statutory review processes. Other denials should have documented reasons, so preserve submission records, status changes, manufacturer responses, and follow-up.

Do not assume one manufacturer’s MFP process applies to another. BMS says an MFP refund below the 340B ceiling price can make a claim ineligible for a 340B rebate. AbbVie describes possible denials when MFP is lower. Teva says it pays the rebate and adjusts the MFP refund through the Medicare Transaction Facilitator. Confirm the applicable terms in each approved plan.

The year-end accommodation is narrow. HRSA provides for up to two unreplenished accumulated packages during the 15-calendar-day period before implementation. Manufacturer instructions can add important detail: Merck applies the exception per NDC-11 and excludes dispenses already used for 340B pricing. GSK describes a 15-day pre-start dispense window and a 15-day post-start submission period. Get written confirmation of cutoffs before configuring an exception.

There is also a timing detail to resolve with manufacturers. AbbVie and Teva describe the 10-calendar-day payment period as excluding federal holidays, while HRSA’s notice says 10 calendar days without that qualifier. Ask for written clarification before setting expected-payment dates.

Beacon READINESS: a practical FQHC action plan

Use the time before January 1 to work through these steps with pharmacy, finance, compliance, IT, and your TPA:

• R, Review exposure: Run an NDC-11 report across purchases and dispenses. Quantify affected volume by drug, site, and payer.
• E, Enroll and verify: Complete Beacon organizational checks, bank documentation, ACH micro-deposits, and any required TPA authorization.
• A, Assign owners: Name the platform administrator, backup, finance contact, and people responsible for file corrections and denial follow-up.
• D, Dollar-model the impact: Forecast WAC purchases, rebate receivables, payment timing, and working-capital needs. See GapRx’s rebate readiness framework and CFO decision framework.
• I, Identify each route: Build and validate the NDC-11 routing list, including Farxiga’s ESP reporting and Amgen’s separate data requirements.
• N, Navigate a sample claim: Walk one transaction from dispense through submission, correction, payment, and ledger reconciliation. Record who fixes each exception.
• E, Exercise the templates: Test separate pharmacy and medical claims templates, required fields, units, identifiers, and NDC-11 matching. HRSA does not permit purchasing data or encounter-level data in the pilot at this time.[^2]
• S, Set the transition control: Document the two-package accumulation exception, and get written confirmation of manufacturer-specific dates.
• S, Synchronize Medicaid and patient-pricing workflows: Brief the state Medicaid billing handoff and update ceiling-price files used for sliding-fee calculations.

For a fuller overview of the mechanics, read How the 340B Rebate Model Works and 2027 340B Rebate Model Requirements.

Escalate issues and keep an audit trail

Start by working with the manufacturer and Beacon. Beacon support is available at support@beaconchannelmanagement.com or 1-878-788-8907. After good-faith efforts to resolve an issue, escalate to HRSA at 340BPricing@hrsa.gov. Maintain an internal log of submission dates, responses, payments, follow-ups, and unresolved claims.

The list is official, but implementation details still require careful review. Confirm manufacturer-specific instructions against each manufacturer’s posted approved plan, particularly where ESP routing, contract pharmacy terms, MFP treatment, payment timing, and transition cutoffs differ. GapRx supports covered entities with manufacturer compliance and 340B ESP management. Schedule a 340B strategy call to review your entity’s NDC exposure, workflows, and cash-flow readiness.

This article is for informational purposes only and is not legal advice. Manufacturer-specific requirements may change; confirm current instructions against the posted approved plan and seek appropriate professional advice.

Sources

[^1]: HRSA: Revised 340B Rebate Model Pilot Program
[^2]: Federal Register: Notice Regarding 340B Rebate Model Pilot Program, August 3, 2026
[^3]: American Hospital Association: Fact Sheet on the 340B Rebate Model
[^4]: Manufacturer implementation notices distributed through Beacon, October 1–2, 2026. Confirm current details in each manufacturer’s posted approved plan.