On August 1, 2025, the Health Resources and Services Administration (HRSA) released a federal register notice announcing its long-anticipated 340B rebate model guidance, which implements a relatively narrow pilot program focusing on drugs subject to Medicare drug price negotiations for 2026. While the pilot program is voluntary for manufacturers, covered entities will need to submit the required data to access the 340B price via rebate on selected drugs under approved manufacturer plans.
The notice states the pilot model is intended to address the 340B and Inflation Reduction Act (IRA) maximum fair price (MFP) deduplication. The model requirements mention that rebates should not be denied based on compliance concerns with diversion or Medicaid duplicate discounts.
Below are key details on the rebate model pilot program to help covered entities prepare.
When Does the 340B Rebate Model Pilot Program Start?
Manufacturers interested in participating were required to submit an application to HRSA by September 15, 2025. On October 30, 2025, HRSA announced it had approved the applications for nine drugs—Eliquis, Enbrel, Farxiga, Imbruvica, Januvia, Fiasp, Jardiance, Stelara, and Xarelto—which will operate through Beacon Channel Management. Of the 10 drugs subject to Medicare price negotiations for 2026, Novartis’ Entresto is the only one currently excluded from the rebate model pilot.
Assuming participating manufacturers can meet the pilot’s requirement to provide covered entities 60-days notification in advance of the pilot’s start date, the model will begin on January 1, 2026. It will apply to all covered entity types.
What Data Will 340B Covered Entities Need to Submit?
HRSA notes manufacturers should allow covered entities up to 45 calendar days from the date the drug is dispensed to submit data to claim a rebate. HRSA’s October 30 announcement noted that covered entities will be required to submit medical claims data in addition to the pharmacy claims data included in the August federal register notice. Below is the complete list of required data:
| Pharmacy Claims Data | Medical Claims Data |
|---|---|
| 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) |
Participating manufacturers must pay all rebates to the covered entity (or deny them with supporting documentation) within 10 calendar days of data submission. The HRSA notice does not mention a specific appeals process to address situations when manufacturers initially deny requests for rebates. However, it does note that covered entities can raise concerns with the Office of Pharmacy Affairs (OPA) regarding issues with rebate delays, denials, or other administrative or logistical issues related to the rebate model. Given the lack of a clearly defined appeals process, it will be important for covered entities to submit the data accurately the first time. In addition, if covered entities do need to raise concerns with OPA, they will be well served to have supporting data to facilitate a productive discussion.
How Can 340B Covered Entities Prepare for the Rebate Model Pilot Program?
The rebate model pilot program is far narrower in scope than what manufacturers attempted to implement in fall 2024. However, there is still potential for cash flow disruption to covered entities. Covered entities have limited time to set up a “rebate cycle” to capture and submit the necessary data within timely filing requirements. While pharmacy claims data may be relatively easy for covered entities to collect and submit, the medical claims data will likely be more difficult. In addition to 340B capabilities, covered entities will need experience managing rebates and setting up systems of control to manage workflows.
This will not be as simple as submitting a rebate request. Establishing a consistent, easily repeatable process based on program requirements will be critical to securing the rebates to which a covered entity is entitled. Adjustments to the drug ordering process also will be important to support success. Automating timely and accurate data capture and reporting will be critical as well. The rebate model also will require follow-up, as not all rebates may be approved on the first submission.
As part of setting up the rebate cycle, covered entities should establish infrastructure to capture data related to performance for each manufacturer, including:
- Timely Processing: How often the manufacturer pays rebates within 10 days.
- Denial Rates: How many claims the manufacturer denies by claims count, dollar value, and percentage of both dollars and claims count. If there is an administrative or legal avenue to appeal initially denied claims, covered entities also will want to track the rate of overturned denials and costs associated with appeals.
- Administrative Expense: How much the covered entity spends on staffing, legal, IT support, and other costs necessary to manage the rebate cycle.
- Key Performance Indicators (KPIs): Developing organizational KPIs for the rebate cycle will be critical to maintaining 340B savings.
In addition to using this data to improve rebate cycle performance, covered entities should consider sharing it with HRSA and elected officials to support an accurate, data-informed evaluation of the pilot program. The notice states that HRSA may allow for an expansion of the rebate model based on an assessment of the pilot program.
Maintaining and sharing accurate data on the participation costs for covered entities is especially important. When manufacturers apply for the pilot program, they must provide assurances that they will bear all costs for data submission through an IT platform. The federal register notice also states that no additional administrative costs for running the rebate model will be passed to covered entities. Providing HRSA and policymakers a full picture of the costs associated with this pilot program will help them understand how rebate models may reduce covered entities’ funds available to expand access for safety net populations, which is contrary to the purpose of the 340B program.
How Forvis Mazars Can Help
Our 340B professionals at Forvis Mazars are committed to helping healthcare organizations achieve regulatory excellence and financial discipline by understanding and adapting to the impact of evolving HRSA regulations on covered entities. If you have questions about how the proposed 340B Rebate Model Pilot Program may affect your organization or how you can prepare, please reach out to our team today.