How CMS’s 2025 Medicare Outpatient Rule Could Disrupt 340B Funding and What Covered Entities Need to Know
The Centers for Medicare and Medicaid Services (CMS) has released a proposed rule for the 2025 Medicare Hospital Outpatient Prospective Payment System (OPPS) that could have sweeping implications for 340B covered entities. The proposal includes payment policy revisions that not only impact reimbursement but also set the stage for increased oversight and operational adjustments for hospitals that participate in the 340B Drug Pricing Program.
What the CMS Proposal Includes
According to the Rural Wisconsin Health Cooperative, the new CMS rule seeks to continue making lump sum remedy payments to certain hospitals that were underpaid for 340B drugs between 2018 and 2022. More critically, it proposes significant adjustments to how 340B-acquired drugs will be reimbursed in the future. If finalized, the 2025 OPPS rule will:
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Maintain ASP+6% as the reimbursement rate for 340B drugs, aligning with Medicare statute
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Codify previous court decisions that CMS’s prior reimbursement cuts were unlawful
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Clarify hospital eligibility and reporting requirements
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Introduce mechanisms for transparency and compliance, particularly for newly participating entities
These proposed adjustments may limit flexibility for covered entities and require them to carefully track both drug acquisition and patient eligibility.
Why This Matters for 340B Hospitals
Hospitals that depend on the savings generated from the 340B program could see a tightening of how those funds are received and managed. The updated rule introduces new complexities around reporting and compliance, which could increase administrative burden. Smaller rural hospitals and safety-net providers—already stretched thin—may face the greatest challenges.
It’s also important to note that CMS is using this rule to realign its policies with court rulings, indicating that regulatory scrutiny of the 340B program is intensifying. Hospitals must be prepared to adapt to stricter documentation and oversight practices.
How American Exchange Can Help
With policy shifts like these, having a trusted partner is more important than ever. American Exchange helps 340B covered entities navigate compliance, optimize enrollment processes, and manage reporting with minimal disruption. We offer customizable solutions that reduce administrative strain and increase program savings.
Don’t let regulatory changes derail your mission.
Visit https://enroll.americanexchange.com/demo to schedule a demo and see how American Exchange can support your compliance and patient engagement strategies.
Source:
Rural Wisconsin Health Cooperative. “CMS Proposes Changes That Would Impact 340B Covered Entities.” July 2025. Available at: https://rwc340b.org/cms-proposes-changes-that-would-impact-340b-covered-entities/
