HRSA Audit Readiness: A Proven Checklist for 340B Success
HRSA audits can be daunting, but preparation is key. With more rigorous oversight in 2025 and increased scrutiny on contract pharmacy arrangements, covered entities must ensure they are fully audit-ready. The right preparation not only protects compliance but also preserves critical 340B savings that support patient care.
Step 1: Keep OPAIS Records Accurate and Up-to-Date
The Health Resources and Services Administration (HRSA) requires covered entities to maintain accurate and current records in the Office of Pharmacy Affairs Information System (OPAIS). Ensure that:
Child sites and contract pharmacies are properly registered.
Data is verified each quarter before deadlines.
Any organizational changes are promptly updated to avoid compliance risks.
Step 2: Conduct Regular Mock Audits
Simulating an HRSA audit allows your team to uncover gaps before regulators do. According to 340B Health, mock audits are among the most effective ways to prepare, as they:
Test the strength of policies and procedures.
Confirm that documentation is complete and retrievable.
Provide staff training in real-world compliance scenarios.
Step 3: Assemble a Comprehensive Document Packet
Successful audits hinge on having complete, well-organized records. Recommended inclusions are:
Policies and procedures for 340B program administration.
Detailed eligibility and claim validation records.
Contracts and agreements with TPAs and contract pharmacies.
Financial reports reflecting 340B savings allocation.
The Government Accountability Office (GAO) stresses the importance of auditable records to demonstrate program integrity.
Step 4: Use Real-Time Dashboards for Oversight
Manual tracking leaves room for errors. Platforms like Halo340B provide real-time dashboards that:
Highlight compliance risks before they escalate.
Track savings and missed claims.
Generate HRSA-ready reports for quick audit response.
By automating oversight, covered entities reduce the burden of manual preparation while increasing transparency.
How Halo340B Simplifies Audit Readiness
Halo340B’s compliance-first architecture empowers organizations to:
Validate eligibility independently from TPAs.
Recover missed claims through its Second Check Engine.
Access audit-ready documentation at the click of a button.
Gain peace of mind knowing compliance is continuously monitored.
