Navigating 340B, Site-Neutral & Prior-Auth Rules After the 2025 Executive Order

On April 15 2025, President Trump signed the “Lowering Drug Prices by Once Again Putting Americans First” Executive Order (EO)—a sweeping directive that targets hospital drug pricing, 340B discounts, and payment differentials.

What the Order Says (in Plain English)

CMS must survey hospitals’ actual acquisition costs and propose rate changes within 180 days. Expect a revived 28.5 % cut to 340B drug reimbursement as early as FY 2027. Site-Neutral PaymentHHS to craft regulations that equalize Part B drug-administration fees across HOPDs and physician offices. Shift infusion volume to lower-cost clinics before rates converge.Medicare Drug-Price NegotiationEO directs expansion of the negotiation list and acceleration of timelines. High-spend oncology drugs likely added to the 2028 cohort.Prior-Authorization ReformCMS must publish a uniform electronic PA standard in 2026. Invest now in FHIR-ready PA APIs to stay compliant.

Timeline at a Glance

• Jul 2025: CMS issues 340B cost-survey methodology.

• Oct 2025: Proposed rule on site-neutral drug-administration fees.

• Jan 2026: Draft electronic PA standards open for comment.

• Apr 2026: Final 340B and site-neutral rules; 90-day implementation clock starts.

Action Steps for Revenue-Integrity Teams

Update 340B Modeling

Run margin scenarios assuming 28–30 % ASP-minus rates for covered outpatient drugs.

Optimize Site of Care

Begin steering low-acuity infusions (e.g., IV iron) to physician-office settings where costs already average 53 % lower than HOPDs.

Modernize Prior-Auth Tech

Adopt FHIR-compliant, real-time PA workflows; the EO’s mandate mirrors the pending CMS 0057-F rule.

Conclusion

The 2025 EO compresses timelines for long-debated reforms. Hospitals that simulate new 340B rates, re-site infusions now, and digitize PA workflows will cushion future revenue shocks while preserving patient access.