1. What is changing on January 1, 2026?

Two new federal initiatives take effect:

The 340B Rebate Model Pilot and Medicare’s Maximum Fair Price (MFP) Program.

For the rebate pilot, covered entities will purchase selected drugs at WAC and submit claims through the Beacon platform to receive 340B rebates equal to WAC minus the ceiling price.

For MFP, pharmacies send eligible Medicare Part D claims to the Medicare Transaction Facilitator (MTF) through Beacon to receive reimbursement based on the negotiated MFP amount.

Covered entities do not register for the MTF unless they own the dispensing pharmacy.

2. Which drugs are included in the pilot?

Ten Medicare-negotiated drugs make up the initial 2026 pilot list. These are the only drugs eligible for 340B rebates in year one. Additional products will be added annually through 2029.

Manufacturers are expected to adjust WAC pricing as early 2026 progresses, which may influence rebate outcomes.

3. What actions are required before launch?

Covered entities should:

• Enroll eligible in-house pharmacies in the MTF by November 15, 2025

• Register on Beacon and complete banking verification

• Coordinate participation with contract pharmacies

• Review accumulations and replenish 340B stock prior to January 1

• Prepare workflows for WAC purchasing and rebate reconciliation within Beacon

4. What is the Beacon Platform?

Beacon is the central system for both MFP refunds and 340B rebate submissions.

For rebate pilot drugs, using Beacon is mandatory. Claims must be submitted within 45 days of dispense. Only complete, finalized claims should be sent; reversals are handled using negative quantities.

Beacon is the sister platform to ESP and both systems perform cross-verification for eligibility and pricing.

5. Will we still use 340B ESP?

Yes. ESP remains in place for all manufacturer-required products except the pilot drugs, which must be sent to Beacon.

Covered entities must maintain ESP participation for manufacturers that require data submission to retain 340B pricing for non-pilot drugs.

6. How are rebates calculated and paid?

Rebate = WAC minus the 340B ceiling price at the time of dispense.

Beacon issues payment within 10 days of claim submission.

Denials occur for incomplete data, late submissions, duplicate claims, or incorrect quantities.

HRSA confirmed that rebates process at the unit level, with no requirement to wait for a full package accumulation.

7. How do MFP refunds interact with 340B rebates?

The 340B rebate always takes priority.

If a claim qualifies for a rebate, the MFP refund is reversed automatically through the MTF ledger to prevent duplicate discounts.

Contract pharmacies must understand that a claim cannot receive both an MFP refund and a 340B rebate.

8. What data elements are required for rebate submission?

Contract pharmacy rebate submissions require:

• 340B ID

• Date prescribed

• Date of service

• RX and fill number

• NDC-11

• Quantity

• Prescriber ID

• Service provider ID

• BIN and PCN

Cash claims may use “CASH” as the BIN and PCN.

Accurate quantities and fill numbers are essential, as incorrect values lead to reversals and lost rebate opportunities.

9. How should entities bill Medicaid?

Covered entities should bill at the expected 340B price, assuming the rebate will later be applied.

Manufacturers publish ceiling price files quarterly within Beacon, which should be reviewed regularly.

States permitting carve-in may require additional guidance.

10. What if an entity fails to register?

Without Beacon registration, no rebates can be paid.

Without MTF enrollment, MFP refunds cannot be processed.

The HRSA Rebate Model Pilot applies to all covered entity types and settings for the included pilot drugs.

11. Are contract pharmacy restrictions changing?

No. Existing manufacturer restrictions remain in effect.

Beacon verifies eligible 340B IDs and sites before issuing rebates.

Covered entities must continue sending required data to ESP to maintain price access for non-pilot drugs.

12. How should leadership prepare financially?

• Expect higher upfront spend due to WAC purchasing

• Review cash flow and consider reserves

• Increase wholesale credit limits where possible

• Train staff on Beacon workflows

• Strengthen reconciliation processes for invoices, rebates, and claims

• Track operational issues for HRSA or OPA feedback

13. What unknowns remain?

Pending HRSA decisions include:

• Manufacturer participation questions

• Contract pharmacy involvement for certain NDCs

• Future guidance related to program oversight

14. How can Pillr Health support covered entities?

Pillr Health is registered as a PSAO and can transmit data to Beacon automatically using a provided token.

We help review Beacon rejections, support claim resubmissions, and streamline workflows for both MFP and rebate submissions.

15. How are accumulations handled for dispenses made before January 1, 2026?

Each manufacturer has its own one-time transition policy for unreplenished accumulations made in late 2025.

The policies vary by product and deadline.

Examples include:

• Some allow rebates for unreplenished dispenses dating back to October 2025

• Others limit rebates to a single package

• Deadlines for submitting retroactive claims range from January 31 to February 15, 2026

• A few manufacturers will consider exceptions on a case-by-case basis

16. What if two covered entities submit a rebate for the same claim?

The first covered entity to submit the claim receives the rebate.

17. How should covered entities prepare for HRSA audits?

Entities should ensure:

• Accurate eligibility documentation and cost report support

• Full routing and distribution records

• Complete data submission, including prescribing and dispensing logs

• Preparedness for discrepancies related to eligibility or routing

• Awareness of new HRSA focus areas, including orphan drugs and sub-grantee arrangements