The 25 Areas HRSA Actually Examines in a 340B Audit
Most programs prepare for an audit by reviewing everything. HRSA doesn't examine everything — it examines a specific, repeatable set of areas. Knowing them changes how you spend your prep time.
HRSA audit findings cluster into six categories: eligibility and registration, patient definition, duplicate discount prevention, contract pharmacy, GPO prohibition and inventory, and program governance. Within those six categories sit the 25 specific test areas that show up again and again in adverse findings.
Why this matters for prep time
A program with limited internal bandwidth can't test everything before an audit notice arrives. Knowing which 25 areas actually get examined — and in what order findings typically surface — lets a compliance team prioritize the highest-risk items first, rather than spreading thin effort across a generic checklist.
Where programs get caught out
The most common gap isn't a missing policy — it's a policy that exists but doesn't match what's actually happening operationally. Patient definition policies in particular tend to drift from practice as referral patterns and service lines change, without anyone updating the written policy to match.
Grouped the way findings actually cluster.
Eligibility & registration, patient definition, duplicate discount prevention, contract pharmacy, GPO prohibition & inventory, and program governance.
Related pages
Next step
See where your own program stands.
The 15-minute scorecard covers the same six categories this post describes.