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Run: 340B HRSA Audit Preparation Checklist

Use this 340B HRSA Audit Preparation Checklist to verify eligibility files, policy controls, utilization traceability, contract pharmacy oversight, and audit...

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Program Eligibility and Registration

Confirm documentation supporting covered entity status is available, including the entity type, site eligibility, and any supporting enrollment records.
Verify current and prior registration, recertification, and change records are organized for review.
Confirm the current authorizing official, primary 340B contact, and backup contact are documented and match internal records.
Verify the list of registered child sites and service locations matches the locations currently dispensing or administering 340B drugs.
Confirm written controls exist for provider eligibility, patient definition, and site-based dispensing or administration rules.

Policies, Procedures, and Governance

Verify policies and procedures are current, approved, dated, and controlled so the latest version is available during the audit.
Confirm written procedures address diversion controls and duplicate discount prevention, including responsible owners and review cadence.
Verify the replenishment methodology, accumulation logic, and inventory segregation controls are documented and understandable.
Confirm committee minutes, compliance reviews, or leadership oversight records are retained and show routine monitoring of 340B controls.
Verify responsibilities for pharmacy, compliance, finance, and leadership are documented, including escalation for suspected non-conformance.

Utilization Data and Transaction Traceability

Verify encounter, dispensing, and administration records are complete, dated, and retrievable for the requested audit period.
Confirm utilization reports can be traced back to source patient, encounter, and prescription records without unexplained variances.
Verify purchase orders, wholesaler invoices, and replenishment reports support the accumulation methodology used for 340B replenishment.
Confirm the system configuration, accumulation rules, and key parameters used to identify 340B-eligible transactions are documented.
Verify rejected claims, reversals, adjustments, and exception logs are retained with evidence of follow-up and resolution.

Contract Pharmacy Oversight

Confirm signed agreements are on file for each active contract pharmacy and include effective dates and scope of services.
Verify routine monitoring, audit results, or performance reviews are documented for each contract pharmacy arrangement.
Confirm contract pharmacy claims and dispensing data reconcile to covered entity source records and replenishment activity.
Verify controls exist to prevent Medicaid duplicate discounts and other prohibited overlaps where applicable.
Confirm the process for remediation, corrective action, and contract termination is documented and accessible.

Audit Readiness, Evidence, and Corrective Action

Verify policies, reports, contracts, and supporting evidence are stored in a logical, searchable repository for rapid retrieval.
Confirm recent internal or independent audit findings, if any, are documented along with management responses.
Verify any identified deficiencies have documented corrective actions, responsible owners, and target completion dates.
Confirm who receives HRSA requests, who coordinates responses, and how documents are approved before submission.
Overall readiness assessment for the 340B audit package.

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