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 evidence before an OPA review.
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Overview
This 340B HRSA Audit Preparation Checklist is a pre-audit inspection template for covered entities that need to confirm their program file is complete, current, and traceable before a HRSA Office of Pharmacy Affairs review. It is organized around the same evidence trail an auditor will follow: eligibility and registration, policies and governance, utilization and transaction traceability, contract pharmacy oversight, and readiness for document requests and corrective action.
Use it when you want to verify that your 340B records support the way the program is actually operating, especially after site changes, policy updates, pharmacy network changes, or a prior internal finding. It is also useful for recurring self-audits, mock audits, and leadership reporting. The checklist helps you spot missing approvals, inconsistent site listings, weak duplicate-discount controls, incomplete exception logs, and gaps between source records and replenishment logic.
Do not use it as a substitute for legal review or as a one-time cleanup tool after the audit starts. If your organization has not maintained current policies, documented roles, or reliable source data, the checklist will expose those deficiencies but will not fix them by itself. It is most effective when paired with a defined owner, a document repository, and a corrective action process that closes gaps before the auditor does.
Standards & compliance context
- This template supports HRSA 340B audit readiness by organizing the records auditors commonly request for eligibility, diversion prevention, and duplicate-discount prevention.
- It aligns with general compliance program practices used in healthcare and pharmacy operations, including documented policies, version control, oversight, and corrective action tracking.
- For contract pharmacy oversight, the checklist helps document agreements, monitoring, and reconciliation practices that are typically expected under 340B program governance.
- If your organization also operates under broader healthcare compliance or internal control standards, this checklist can be used as supporting evidence for audit trails and management review.
General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.
What's inside this template
Program Eligibility and Registration
This section confirms the covered entity, sites, and program contacts are properly registered and documented before any deeper audit review begins.
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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.
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HRSA 340B registration and recertification records are available
Verify current and prior registration, recertification, and change records are organized for review.
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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.
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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.
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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
This section shows whether the program has current written controls, clear ownership, and evidence of oversight rather than informal practices.
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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.
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Policies address diversion prevention and duplicate discount prevention
Confirm written procedures address diversion controls and duplicate discount prevention, including responsible owners and review cadence.
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Policies address inventory management and replenishment methodology
Verify the replenishment methodology, accumulation logic, and inventory segregation controls are documented and understandable.
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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.
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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
This section tests whether dispensing, purchasing, and replenishment records can be traced end to end without unexplained gaps.
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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.
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Utilization reports reconcile to source records
Confirm utilization reports can be traced back to source patient, encounter, and prescription records without unexplained variances.
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Purchase and replenishment records support 340B accumulation logic
Verify purchase orders, wholesaler invoices, and replenishment reports support the accumulation methodology used for 340B replenishment.
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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.
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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
This section verifies that outside pharmacy relationships are documented, monitored, and reconciled to the covered entity’s 340B records.
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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.
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Contract pharmacy compliance monitoring is documented
Verify routine monitoring, audit results, or performance reviews are documented for each contract pharmacy arrangement.
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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.
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Duplicate discount prevention controls are documented for contract pharmacies
Verify controls exist to prevent Medicaid duplicate discounts and other prohibited overlaps where applicable.
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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
This section ensures the audit package is organized, response-ready, and tied to owners and due dates for any open issues.
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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.
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Internal audit or mock audit results are available
Confirm recent internal or independent audit findings, if any, are documented along with management responses.
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Corrective action plans include owners and due dates
Verify any identified deficiencies have documented corrective actions, responsible owners, and target completion dates.
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Audit response contacts and document request workflow are defined
Confirm who receives HRSA requests, who coordinates responses, and how documents are approved before submission.
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Final readiness status
Overall readiness assessment for the 340B audit package.
How to use this template
- Start by loading the covered entity’s current registration, recertification, site, and authorizing official records into the checklist so the eligibility section can be verified against the live program footprint.
- Assign each section to the person who owns the evidence, such as pharmacy leadership, compliance, contract pharmacy operations, or internal audit, and set a due date for every open item.
- Walk the checklist against source documents, confirming that policies are approved, utilization reports reconcile to dispensing and purchasing records, and contract pharmacy files match active agreements.
- Record every deficiency with a clear description, supporting evidence, owner, and remediation date, then flag any item that could affect diversion or duplicate-discount prevention as urgent.
- Assemble the final audit binder or repository in the same order as the checklist so the response team can retrieve documents quickly when HRSA requests them.
- Review the completed checklist with leadership, close out corrective actions, and schedule the next internal mock audit or readiness review.
Best practices
- Tie every checklist item to a named evidence source, such as a policy file, registration record, utilization report, or contract pharmacy agreement.
- Verify that registered child sites and service locations match the actual operational footprint before the audit window opens.
- Document the accumulation methodology and split-billing settings in plain language so reviewers can follow how 340B inventory is separated from non-340B inventory.
- Retain exception logs, reversals, and reconciliation notes for the full audit period instead of relying on memory or email threads.
- Review duplicate-discount prevention controls for both in-house dispensing and contract pharmacy activity, since gaps often appear in one channel but not the other.
- Photograph or export evidence of missing approvals, outdated versions, or unresolved discrepancies at the time they are found so the remediation trail is complete.
- Use a single owner for the final readiness status to prevent conflicting answers during the audit response.
What this template typically catches
Issues teams running this template most often surface in practice:
Common use cases
Frequently asked questions
What does this 340B HRSA Audit Preparation Checklist cover?
It covers the core documents and controls a covered entity should verify before a HRSA Office of Pharmacy Affairs audit. The checklist walks through eligibility and registration, approved policies, utilization traceability, contract pharmacy oversight, and audit-response readiness. It is designed to surface missing evidence, weak controls, and unresolved exceptions before the auditor asks for them.
Who should use this checklist?
It is typically run by the 340B program manager, pharmacy leadership, compliance, revenue integrity, or internal audit, with sign-off from the authorizing official or compliance owner. Contract pharmacy and IT/inventory system stakeholders may need to supply records and system settings. If your organization uses split-billing or multiple service locations, the checklist works best when one owner coordinates inputs across teams.
How often should this audit preparation checklist be completed?
Most organizations use it before a scheduled HRSA audit, after major program changes, and on a recurring internal cadence such as quarterly or semiannually. It is also useful after adding a child site, changing a contract pharmacy, updating inventory methodology, or remediating a prior finding. The right cadence depends on program complexity and the volume of dispensing and purchasing activity.
Does this checklist replace a formal 340B compliance program?
No. It is a readiness tool, not a substitute for a written compliance program, ongoing monitoring, or legal review. It helps confirm that the evidence you already maintain is organized, current, and traceable enough to support an audit. You still need documented policies, defined roles, and routine monitoring outside the audit window.
What regulatory areas does this template align with?
It is built around HRSA 340B audit expectations and common compliance practices for covered entities and contract pharmacies. Depending on your setting, it may also support broader pharmacy compliance, internal control, and record-retention expectations. The checklist is not a legal opinion, but it helps organize the evidence auditors usually request.
What are the most common pitfalls this checklist helps catch?
Common issues include outdated registration records, missing policy approvals, weak patient definition controls, incomplete utilization traceability, and contract pharmacy files that do not reconcile to covered entity records. Teams also miss exception logs, reversal documentation, or clear escalation paths for suspected diversion or duplicate discounts. This checklist is meant to expose those gaps before they become audit findings.
Can this checklist be customized for split-billing or multiple contract pharmacies?
Yes. It is especially useful when you need to document accumulation logic, inventory settings, and reconciliation across multiple dispensing channels. You can add site-level tabs, pharmacy-specific evidence fields, or separate review owners for each location. That makes it easier to prove consistency across the program footprint.
How does this compare with an ad hoc document request process?
An ad hoc process usually starts after the audit notice and forces teams to hunt for records under time pressure. This checklist creates a repeatable pre-audit workflow so missing items are identified early and assigned for correction. The result is a cleaner evidence package, fewer last-minute gaps, and a clearer response path if the auditor requests follow-up.
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