Over the past five years, the 340B Drug Pricing Program has been the subject of scrutiny from federal and state policymakers and drug manufacturers. Regulations regarding transparency, oversight, and how the program works have continued to evolve, including several key developments in just the last few months. In this article, we explore these recent developments and how covered entities can quickly respond and adapt to the changes.
340B Rebate Model
In August 2025, the Health Resources and Services Administration (HRSA) announced a voluntary 340B Rebate Model Pilot Program, in which approved manufacturers would provide 340B prices to covered entities through rebates, rather than upfront discounts. This represented a major change in how the program has operated since it began in 1992. The pilot was limited to a defined set of drugs selected for Medicare price negotiation under the Inflation Reduction Act of 2022 (IRA) and was scheduled to begin January 1, 2026.
However, on February 10, 2026, the U.S. District Court for the District of Maine vacated and remanded the pilot, effectively overturning HRSA’s Federal Register notice and manufacturer approvals due to the failure to follow requirements of the Administrative Procedure Act (APA). As a result of the ruling, manufacturers must continue providing 340B pricing through upfront discounts.
Following the court’s decision, HRSA announced that it is reconsidering whether it can implement a rebate‑based approach within its existing statutory authority. In February 2026, the agency issued a Request for Information (RFI) seeking stakeholder input on rebates, with a comment deadline extended to April 20, 2026. Covered entities should interpret the RFI as a signal that the concept of a rebate model is under active federal review. The American Hospital Association (AHA) also reports that HRSA has suggested it may expand the rebate model to all drugs selected for Medicare price negotiation under the IRA through 2027.1
CMS Drug Acquisition Cost Survey & Outpatient Drug Pricing
As part of the 2026 Outpatient Prospective Payment System (OPPS) final rule, CMS finalized plans to conduct a hospital drug acquisition cost survey, collecting National Drug Code (NDC)‑level data for outpatient drugs acquired between July 1, 2024 and June 30, 2025. The survey includes both 340B and non-340B drugs.
The survey is intended to satisfy statutory requirements reinforced by the U.S. Supreme Court’s 2022 decision in American Hospital Association v. Becerra, which found that CMS failed to appropriately survey hospitals before adjusting OPPS rates. CMS has indicated that survey results may inform outpatient drug payment policy beginning in calendar year 2027, though the agency has not committed to specific payment changes.
For 340B covered entities, the survey represents a renewed federal focus on acquisition cost data as a policy input. Covered entities should give careful consideration to the costs they submit and how they may affect future payments.
Child Site Registration Requirements
On March 3, 2026, a federal district court issued a ruling overturning HRSA’s child site registration requirement. Before the ruling, these off-site facilities had to appear on a hospital’s Medicare cost report and be registered and listed in the Office of Pharmacy Affairs Information System (OPAIS) before they could purchase drugs at 340B prices. The decision marks a return to pandemic-era flexibilities and eliminates delays in providing cost-effective treatments at these sites.
Federal 340B Oversight & Program Integrity
Oversight of the 340B program remains an area of ongoing scrutiny. In October 2025, the U.S. Government Accountability Office (GAO) reported that the number of covered entity sites more than doubled between 2013 and 2023, significantly expanding the program’s footprint. While the GAO acknowledged improvements in HRSA’s audit activity and program monitoring, it also noted that many prior recommendations related to eligibility verification, duplicate discount oversight, and audit remediation remain unimplemented.
The GAO further observed that HRSA has indicated a need for additional statutory authority to fully address certain oversight gaps. These findings reinforce that federal attention to program integrity is likely to continue, even as broader policy debates remain unresolved.
State 340B Policy Momentum
States have continued to play an increasingly active role in shaping how the 340B program operates in practice. Two related state‑level trends have emerged in parallel: continued legislative efforts to preserve contract pharmacy access and a growing emphasis on provider-focused 340B reporting and transparency requirements.
Continued Expansion of Contract Pharmacy Access Laws
States continue to advance legislation to protect covered entities’ ability to access 340B pricing for contract pharmacies. In addition, there have been multiple favorable court rulings for covered entities. For example, in February 2026, the 5th U.S. Circuit Court of Appeals upheld Louisiana’s contract pharmacy statute. This outcome, along with the U.S. Supreme Court’s 2024 ruling in PhRMA v. McClain on Arkansas’s contract pharmacy statute, has provided additional momentum for states considering comparable legislation. Covered entities in states that do not have contract pharmacy protections in place should consider actively engaging with their state representatives and associations to put forth legislation.
Increasing Focus on Provider‑Level 340B Reporting
Alongside contract pharmacy access legislation, states have begun to place greater emphasis on provider reporting and transparency obligations related to the 340B program. A growing number of states have enacted or proposed laws requiring certain covered entities to report information on 340B participation, savings, or use of funds to state agencies.
These reporting requirements vary in scope but reflect a common policy objective: increasing visibility into how 340B benefits are used at the provider level. Some statutes apply broadly to all 340B providers, while others are limited to hospital covered entities or tied to specific state oversight functions. Legislative activity in this area has accelerated in recent sessions, suggesting that reporting and transparency will remain an area of active state interest. Covered entities should gauge their ability to meet reporting standards and understand how they are utilizing 340B savings.
How Forvis Mazars Can Help 340B Covered Entities
Taken together, the rebate model RFI, drug acquisition cost survey, federal litigation, and state legislative activity signal a complex policy environment rather than a restructuring of the 340B program. For covered entities, the near‑term landscape will be defined by continued uncertainty, incremental change, and close attention from regulators and courts alike.
Our team at Forvis Mazars has extensive experience supporting compliance and performance improvement for 340B covered entities. If you have questions about the evolving policy environment and how it may affect your organization, please reach out to our professionals today.
- 1“HRSA extends deadline to April 20 for comments on 340B rebate model RFI and suggests expanded number of drugs to be included,” aha.org, February 25, 2026.