The 340B Rebate Model Pilot Program consists of a selected group of drugs of manufacturers who have submitted plans meeting specific criteria that HRSA has approved.
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The 340B Rebate Model Pilot Program consists of a selected group of drugs of manufacturers who have submitted plans meeting specific criteria that HRSA has approved. The Pilot Program will help to inform the development of a process for approving future models that are consistent with the 340B statute and the Administration’s goals. For more details on the Pilot Program, please visit the 340B Program Notice: Application Process for the 340B Rebate Model Pilot Program Federal Register Notice (PDF - 212 KB) and the HRSA press release.
Manufacturer 340B rebate model plan summaries
OPA has approved eight (8) plans for participation in the 340B Rebate Model Pilot Program with a January 1, 2026, start date. These plans all met the requirements as stated in the Federal Register Notice (PDF - 212 KB). The plans summarized below apply to all covered entity types.
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Under the 340B Rebate Model Pilot Program, covered entities must continue to make purchases through their 340B wholesaler account and must ensure they are only requesting rebates on the above drugs dispensed to 340B eligible patients after a purchase is made. Manufacturers should work with their distributor partners to ensure the WAC price is loaded in the 340B wholesaler account where purchases will be made by covered entities to then obtain a rebate.
Manufacturers should subsequently work with their distributors to obtain necessary data from the 340B wholesaler account to monitor purchases in that account. Covered entities and manufacturers should maintain auditable records for puchases made subject to the 340B Rebate Model Pilot Program. HRSA will continue to audit both covered entities and manufacturers to ensure compliance with statutory requirements. All approved manufacturer plans will issue rebates based at the unit level. HRSA approved the limited data fields below for covered entity submission in order to effectuate the rebate:
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) |