A HRSA audit does not have to be stressful. If you are prepared, it is simply a review of the work you are already doing. The key word is prepared.
Patient Eligibility Verification
HRSA will want to see that every 340B transaction is tied to an eligible patient with a qualifying encounter at your facility. Your system should be able to produce this documentation for any prescription in your program.
Common issues include outdated patient records, inconsistent eligibility checks, and gaps between your EHR and your 340B tracking system. Fix these before HRSA asks about them.
Contract Pharmacy Oversight
If you use contract pharmacies, HRSA will review your agreements, your reconciliation processes, and your oversight of contract pharmacy transactions. You need current, signed agreements with every contract pharmacy. You need regular reconciliation of claims data. And you need evidence that you are actively monitoring contract pharmacy compliance.
A contract pharmacy relationship without active oversight is a compliance liability.
Policies and Procedures
Your 340B policies and procedures should be current, comprehensive, and actually followed by your staff. HRSA does not just want to see that you have a policy manual. They want to see that your operations match what the manual says.
Review your policies annually. Update them when HRSA guidance changes. And make sure your staff knows where to find them and how to follow them.
Documentation Standards
Keep records of everything. Patient encounters, prescription fills, 340B claims, contract pharmacy reconciliation, staff training, internal audits. If it relates to your 340B program, document it.
HRSA auditors rely on documentation. If you cannot produce it, you cannot prove compliance.
Internal Audit
The best audit preparation is an internal audit. Run through the same review HRSA would conduct. Identify any gaps, fix them, and document the fixes. If HRSA finds an issue you have already identified and corrected, it demonstrates proactive compliance management.
An internal audit every six months is a good cadence for most safety net providers.
Ready to Take the Next Step?
MedMatrix provides full 340B audit preparation support for safety net providers. Schedule an internal audit and ensure your program is HRSA-ready. Contact us at info@medmatrix-rx.com to get started.
