340B Rebate Model Pilot Program—High Level Summary
The 340B Rebate Model Pilot Program requires covered entities to purchase select drugs at wholesaler acquisition cost (WAC) and then receive a rebate from the manufacturer for the difference between the WAC and the 340B ceiling price.
Program Scope
- The pilot is limited to the ten NDCs selected under the Medicare Drug Price Negotiation Program (MDPNP).
- The program applies to all payor types, not just Medicare.
- Following evaluation and stakeholder feedback, OPA may consider expanding the rebate model to include additional 340B drugs.
Participation Requirements
- Manufacturer participation is voluntary.
- Covered entity and pharmacy participation is mandatory.
- Manufacturers must submit plans to HRSA for approval prior to implementing a rebate model.
Manufacturer Plan Requirements (per HRSA)
- Manufacturers cover all costs related to IT platforms; no additional administrative costs may be passed to covered entities.
- Selected drugs must be available through existing distribution mechanisms (e.g. 340B wholesaler accounts).
- Covered entities have 45 calendar days to submit and report data for rebates.
- Rebates (or denials) must be issued within 10 calendar days of data submission.
- Manufacturers cannot deny claims based on compliance concerns.
- Data requirements from manufacturers are limited by HRSA.
Implementation Details
- Beacon 340B will be the preferred technology platform.
- A Beacon 340B Rebate Welcome Package is available HERE.
- Pharmacy dispense data must be submitted to Beacon 340B.
- WAC pricing for the selected ten drugs will be loaded into 340B wholesaler accounts (340B pricing will not be visible).
Timeline
- Manufacturers plans were due by September 15th.
- HRSA approvals were expected October 15th, but the government shutdown delayed release. They are available now on Beacon.
- Program launch date: January 1, 2026.
Intersection of MFP and 340B Rebates
- Beacon has communicated that the 340B rebate will be prioritized over the MFP rebate.
- The 340B Rebate Model pays the rebate to the covered entity.
- The MDPNP Model pays the MFP rebate to the pharmacy (dispensing entity).
Additional Resources