340B HRSA Audit Preparation Checklist

Pre-audit inspection checklist to verify 340B program eligibility documentation, policies, utilization records, contract pharmacy oversight, and corrective action readiness before a HRSA Office of Pharmacy Affairs audit.

Program Eligibility and Registration

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

Policies, Procedures, and Governance

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

Utilization Data and Transaction Traceability

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

Contract Pharmacy Oversight

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

Audit Readiness, Evidence, and Corrective Action

• Audit evidence binder or repository is organized and searchable
  Verify policies, reports, contracts, and supporting evidence are stored in a logical, searchable repository for rapid retrieval.
• Internal audit or mock audit results are available
  Confirm recent internal or independent audit findings, if any, are documented along with management responses.
• Corrective action plans include owners and due dates
  Verify any identified deficiencies have documented corrective actions, responsible owners, and target completion dates.
• Audit response contacts and document request workflow are defined
  Confirm who receives HRSA requests, who coordinates responses, and how documents are approved before submission.
• Final readiness status
  Overall readiness assessment for the 340B audit package.