ComplianceMay 3, 2025 9 min read
340B Compliance Audit Checklist: 12 Things HRSA Looks For
A practical 340B audit-readiness checklist covering eligibility, duplicate discounts, diversion, GPO prohibition, and policy documentation.
HRSA audits are no longer rare. With audit volume climbing and findings carrying real financial consequences, audit-readiness is now a year-round discipline — not a quarterly scramble.
The 12 most-cited focus areas
- Patient eligibility definition documented and applied consistently
- Provider eligibility (employed, credentialed, referral relationships)
- Location eligibility (registered child sites only)
- Prevention of duplicate discounts on Medicaid claims
- Prevention of diversion to non-eligible patients
- GPO prohibition compliance for hospitals
- Contract pharmacy agreements current and signed
- Written policies and procedures, reviewed annually
- Self-audits performed and findings remediated
- Inventory replenishment model documented
- TPA oversight and reconciliation procedures
- Recertification on file and accurate
Most findings trace back to gaps in documentation rather than intent. A strong internal audit cadence — paired with annual staff training — closes the majority of HRSA exposure.