On October 30th, the Health Resources and Services Administration (“HRSA”) announced the approval of eight of the nine proposed plans for the 340B Rebate Model Pilot Program.; Novartis drug, Entresto, being the lone plan not approved. This model will shift the discount on certain prescription drugs from an upfront price reduction to a post-purchase rebate from the manufacturer. The plans approved include the same drugs included in the Medicare Drug Price Negotiation Program, but in this instance are applicable to all payers, not just Medicare and both retail and clinical administrations:
Manufacturer | Selected Drug Name |
Bristol Myers Squibb | Eliquis |
Immunex Corporation (Amgen) | Enbrel |
Astra Zeneca AB | Farxiga |
Pharmacyclics (AbbVie) | Imbruvica |
Merck Sharp Dohme (Merck) | Januvia |
Boehringer Ingelheim | Jardiance |
Novo Nordisk Inc. | Novolog, Novolog Flexpen, Novolog Penfill, FIASP, FIASP Flextouch, FIASP Penfill |
Janssen Biotech, Inc (JJHSC) | Stelara |
Janssen Pharmaceuticals, Inc. (JJHCS) | Xarelto |
Covered entities will now be required to purchase the selected drugs above at Wholesale Acquisition Cost (“WAC”) price and submit claims data to a HRSA designated platform named, “Beacon.”
Pharmacy Claims Data Fields | Medical Claims Data Fields |
Date of Service | Date of Service |
Date Prescribed | Claim Line Number |
Rx Number | Claim Number |
Fill Number | Unit of Measure |
NDC-11 | NDC-11 |
Quantity Dispensed | Quantity |
Prescriber ID | Rendering Physician ID |
Service Provider ID | Service Provider ID |
340B ID | 340B ID |
Rx BIN | Health Plan Name |
Rx PCN | Health Plan ID |
Group Number ID (Optional) | Health Plan ID Qualifier (Optional) |
| HCPCS Code (Optional) |
| HCPCS Modifiers (Up to 4) (Optional) |
Upon review of this data, Beacon will request rebates based on eligible claims, which will be submitted to the manufacturers for review. If approved by the manufacturer, a rebate will be sent back to the covered entity through the Beacon platform that will be the difference between the WAC purchased and the 340B ceiling price. While all rebates must be made within 10-days, HRSA stated in its series of recently issued FAQs, that only a demonstrable trend of manufacturers routinely delaying payment beyond 10-days would trigger penalties and potential removal of the manufacturer from the program.
OPA is expected to publish a summary of all approved rebate model plans on its website, prior to the plans’ implementation. Additionally, manufacturers are required to communicate details of their plans directly to covered entities no later than 60 days prior to implementation of their respective plans, or by November 2, 2025. Accordingly, we recommend covered entities be on the lookout for additional communication from manufacturers in the coming days.
If you have any questions regarding these most recent changes in events, please reach out to Advis to consult how to approach this model for the upcoming year.
Published October 31, 2025
