The Health Resources and Services Administration (HRSA) recently took steps to repropose a 340B rebate model. On May 27, 2026, it sent a prerule notice regarding the model to the White House Office of Management and Budget (OMB) for review. It also recently issued an information collection request (ICR), which provides insight into how the agency intends to operationalize a rebate-based approach that could materially alter how hospitals and other covered entities access 340B savings.
The recently released ICR, along with one released earlier this year, are part of HRSA’s efforts to cure Administrative Procedure Act issues that resulted in a federal court finding the initial 340B Rebate Model Pilot Program impermissible before its scheduled start date of January 1, 2026.
Which Drugs Would Be Included in the 340B Rebate Model Pilot?
If finalized, the pilot will apply to manufacturers participating in the Medicare Drug Price Negotiation Program for initial price applicability years (IPAY) 2026 and 2027. While the notice does not list the drugs directly, it confirms that only those negotiated drugs tied to these manufacturers will be included in the early phase, suggesting a targeted but high-profile set of therapies aligned with broader federal drug pricing reforms.
This is an expansion from just the 2026 drugs subject to price negotiation in the original rebate model. Forvis Mazars estimates that 30% of 340B rebates will be subject to the revised rebate model when HRSA releases it.
What Are the Requirements for Providers & Drug Manufacturers?
Critical policy and operational questions remain outstanding. HRSA indicates that data submission standards, frequency, and technical specifications will be defined in a future Federal Register notice. It is also unclear how quickly rebates will be processed, what dispute resolution mechanisms will look like, and how the model will address complexities such as contract pharmacy arrangements, duplicate discount prevention, and coordination with Medicaid and Medicare claims. In addition, stakeholders have raised concerns about data privacy and the transmission of claims-level or potentially patient-level information to manufacturers, which may require new compliance frameworks and contractual safeguards.
How Should Hospitals Prepare for a 340B Rebate Model?
While the rebate model would begin as a limited pilot, it also indicates a significant structural shift in the 340B program toward greater transaction-level accountability and manufacturer involvement. Hospitals should begin assessing their financial exposure, data capabilities, and operational readiness now.
Covered entities will need to set up a “rebate cycle” to capture and submit the necessary data within timely filing requirements. 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.
How Forvis Mazars Can Help With 340B Performance
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 a 340B rebate model may affect your organization or how you can prepare, please reach out to our team today.