Navigating 2025 340B Compliance: Tips for Covered Entities
If your organization participates in the 340B Drug Pricing Program, you’re likely feeling the pressure in 2025. Increased HRSA audit activity, manufacturers pushing for restrictions, and shifting contract pharmacy policies are challenging covered entities like never before.
At Ponaman Healthcare Consulting, we work closely with covered entities to help them maintain 340B compliance and efficiency—even as the rules evolve.
What’s New in 2025?
Several key developments are shaping the 340B landscape this year:
- Manufacturer restrictions continue to limit access to 340B pricing at contract pharmacies, requiring covered entities to prove data sharing and direct patient relationships.
- Duplicate discount prevention is under the microscope. HRSA and in some states, Medicaid agencies are tightening enforcement, especially for carve-in states.
- Third-party administrator (TPA) accountability is a growing concern. More covered entities are being cited for poor oversight of their TPAs, especially when it comes to diversion and eligibility tracking.
Why It Matters
A single HRSA audit finding can have serious consequences, including:
- Repayment obligations to manufacturers
- Required corrective actions
- Increased scrutiny and damaged partnerships
Even worse, non-compliance can impact patient access, especially for safety-net providers relying on 340B savings to fund outreach, speciality care and community services.
How Ponaman Can Help
Whether you’re a DSH hospital, FQHC, or another covered entity, Ponaman Healthcare Consulting offers the expertise you need to navigate these challenges.
We provide:
- Pre-audit preparation and mock HRSA audits to identify gaps before HRSA does
- Program integrity reviews to identify and correct risks like diversion or duplicate discounts
- Policy and procedure development to align with current HRSA expectations
- Support managing manufacturer data requests and contract pharmacy documentation
We also offer TPA oversight consulting—helping you ensure your vendors are working with you, not putting your compliance at risk.
Get Ahead of the Next Audit
In 2025, it’s not enough to participate in 340B. Programs must be proactive, compliant, and audit-ready—at all times.
Ponaman has guided more than 150 covered entities through HRSA audits, with a track record of helping clients minimize findings and preserve program benefits.
Let Ponaman Healthcare Consulting help you build a stronger, defensible 340B program.
Contact us now to schedule a 340B compliance review.
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