Mock audit workflow · Not HRSA-affiliated

340B Audit Done Right.

End-to-end. Full control. Backed by state-of-the-art AI.

A structured mock audit workflow for covered entities. Organize documentation, identify gaps, track corrective actions, and export evidence bundles — without the 40+ hour DRL scramble.

Run your mock audit →See how it works

Not legal advice. Not HRSA-certified. A structured operational tool for covered entities.

63%
of HRSA-audited covered entities received adverse findings in FY2023
Source: Kodiak Solutions FY2023 HRSA Audit Summary
68%
of re-audited entities fail again — CAP execution is the gap
Source: ADVI 2025
#1 finding
Incorrect OPAIS records — in 51% of entities with adverse findings in FY2023
Source: Kodiak Solutions FY2023 HRSA Audit Summary
What You Get

A complete mock audit — structured exactly like HRSA would run it.

340B Auditor organizes your document collection, evaluates every requirement against HRSA's Data Request List, identifies gaps before HRSA does, and produces a report your compliance team can act on — with a corrective action plan already drafted.

Complements — doesn't replace — your existing 340B program. Your TPA, split-billing software, and compliance staff stay in place. We validate the evidence and configurations they already produce, and get you audit-ready.

What You Find Out

Six questions your compliance team can answer with confidence.

Are your OPAIS registrations accurate?

Every site, child site, and contract pharmacy is cross-checked against what HRSA has on file.

Is your patient definition defensible?

Provider roster completeness, referral prescriber eligibility, and encounter documentation are all evaluated.

Are your Medicaid elections consistent?

MEF carve-in/out elections are compared against your actual billing behavior to identify duplicate discount risk.

Is your contract pharmacy program documented?

Agreements, independent audits, and BIN/PCN carve-out configurations are all reviewed.

Are your policies current and complete?

All 14 required policy topics are checked for coverage, approval signatures, and review dates.

Does your purchasing comply with GPO rules?

Wholesaler account separation and GPO prohibition compliance are verified for applicable entity types.

Your Report

Findings your compliance team can act on immediately.

  • Every finding references the specific HRSA requirement it relates to
  • Severity ratings based on HRSA audit precedent — Critical, High, Medium, Low
  • Corrective action plan drafted for each finding
  • Evidence bundle organized by DRL section
  • PDF and Word versions for compliance and legal review
  • Portfolio executive report for multi-entity health systems

This complements your existing 340B program infrastructure.

340B Auditor works alongside your TPA, your consultant, and your internal audit program — not instead of them. It adds a structured, HRSA-aligned readiness layer that gives your team a clear picture of where you stand before an audit request arrives.