16 Oct Is Your 340B Program Audit-Ready? What Covered Entities Must Prepare for in 2025

The Audit Environment Is More Aggressive Than Ever

HRSA and manufacturer audits of 340B programs are not slowing down in 2025, and covered entities continue to face increasing scrutiny. In some cases manufacturers have pursued their own. Whether you’re a hospital, FQHC, or Ryan White clinic, you must be ready to defend every 340B claim, policy, and transaction.

At Ponaman Healthcare Consulting, we’ve supported over 150 clients through successful HRSA audits. Here’s what we’re seeing now—and what you should do to prepare.

What’s New in 2025?

Compared to previous years, 2025 audits have sharpened their focus in several key areas:

• Diversion tracking: Auditors are scrutinizing whether prescriptions actually qualify under 340B rules.

• Duplicate discount prevention: There is heightened interest in Medicaid billing practices and whether entities have proper carve-in or carve-out documentation.

• Eligibility verification: HRSA continues to require proof of patient/provider relationships for claims— and auditors are looking closely.

• Contract pharmacy oversight: Covered entities are expected to demonstrate direct oversight of their TPAs and pharmacy networks.

Common Pitfalls That Trigger Findings

Even well-intentioned programs can face findings for:

• Relying solely on TPA reports without internal review

• Having outdated or incomplete policies and procedures

• Inconsistent documentation of patient eligibility

• Lack of written agreements with contract pharmacies or referral providers

• Failing to update Medicaid Exclusion File entries regularly

What Every Covered Entity Should Have Ready

Don’t wait for an audit notice from HRSA to start preparing. Your organization should maintain the following at all times:

• Comprehensive 340B policies and procedures, reviewed and updated at least annually

• Clear documentation trailsthat tie every 340B claim to an eligible encounter

• Internal audit logsor self-audit reports showing ongoing compliance monitoring

• TPA oversight records, including regular reconciliations and contract reviews

• HRSA registration documentsand timely updates for any location or status change

How Ponaman Helps You Stay Audit-Ready

We work with covered entities nationwide to build audit-proof programs through:

• Full-scale mock HRSA auditsand gap analyses

• Tailored policy development and updates

• Staff trainingon 340B eligibility and documentation standards

• Support for TPA selection, oversight, and reconciliation

• Real-time audit support, including document prep and interview coaching

Final Thoughts

With HRSA enforcement tightening and drug manufacturers pushing back harder than ever, proactive audit readiness isn’t optional—it’s essential. A single finding can cost your organization in repayments, corrective actions, and reputational damage. 

Need help assessing your audit risk?Ponaman Healthcare Consulting is here to support you every step of the way.

👉 Schedule a compliance consultation today.