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Audit Scope and Period

Audit quarter and date range are documented critical (required)

Contract pharmacy location(s) included in scope are identified critical (required)

Note (optional)

Claim population and sample methodology are documented critical (required)

Relevant 340B policies and SOPs were available for review

Yes No N/A

Prior audit findings and open corrective actions were reviewed critical (required)

Yes No N/A

Auditor name and review date are recorded critical (required)

Eligibility and Claim Integrity

Patient eligibility criteria were met for sampled claims critical (required)

Yes No N/A

Prescriber eligibility and relationship to covered entity were verified critical (required)

Yes No N/A

Medication dispensed was eligible for 340B accumulation under program rules critical (required)

Yes No N/A

Claim date, dispense date, and accumulator date align with the 340B eligibility record critical (required)

Yes No N/A

Claim documentation supports the billed NDC, quantity, and days supply

Yes No N/A

Any rejected or reversed claims were excluded from 340B accumulation critical (required)

Yes No N/A

Diversion Review

No evidence of dispensing to ineligible patients was found in the sample critical (required)

Yes No N/A

No evidence of duplicate patient profiles or duplicate claim records was found

Yes No N/A

Overrides, manual edits, or exception flags were reviewed for diversion risk critical (required)

Yes No N/A

Any out-of-pattern utilization or high-risk claim trends were investigated

Yes No N/A

Documentation supports that split-billing or accumulator logic prevented diversion critical (required)

Yes No N/A

Duplicate Discount Prevention

Medicaid carve-in or carve-out status was correctly applied for the audit period critical (required)

Yes No N/A

State Medicaid billing identifiers and claim submission rules were applied correctly critical (required)

Yes No N/A

Claims were screened to prevent duplicate discounts before 340B accumulation critical (required)

Yes No N/A

Any Medicaid managed care or third-party payer exclusions were documented

Yes No N/A

No duplicate discount exceptions were identified in the sample critical (required)

Yes No N/A

Controls, Documentation, and Corrective Actions

Contract pharmacy agreement and current business associate or operational documents are on file

Yes No N/A

Audit workpapers, claim extracts, and supporting evidence are retained critical (required)

Yes No N/A

Findings are categorized as deficiency, non-conformance, or critical item as applicable

Note (optional)

Corrective actions were assigned with owner and due date critical (required)

Follow-up review date is scheduled

Inspector attests that the audit was completed accurately and completely critical (required)

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Run: 340B Contract Pharmacy Quarterly Self-Audit Worksheet

Audit Scope and Period

Eligibility and Claim Integrity

Diversion Review

Duplicate Discount Prevention

Controls, Documentation, and Corrective Actions

Get your results