340B Contract Pharmacy Quarterly Self-Audit Worksheet

Quarterly internal inspection worksheet for reviewing 340B contract pharmacy claims for diversion, duplicate discounts, and documentation completeness.

Audit Scope and Period

• Audit quarter and date range are documented
• Contract pharmacy location(s) included in scope are identified
• Claim population and sample methodology are documented
• Relevant 340B policies and SOPs were available for review
• Prior audit findings and open corrective actions were reviewed
• Auditor name and review date are recorded

Eligibility and Claim Integrity

• Patient eligibility criteria were met for sampled claims
• Prescriber eligibility and relationship to covered entity were verified
• Medication dispensed was eligible for 340B accumulation under program rules
• Claim date, dispense date, and accumulator date align with the 340B eligibility record
• Claim documentation supports the billed NDC, quantity, and days supply
• Any rejected or reversed claims were excluded from 340B accumulation

Diversion Review

• No evidence of dispensing to ineligible patients was found in the sample
• No evidence of duplicate patient profiles or duplicate claim records was found
• Overrides, manual edits, or exception flags were reviewed for diversion risk
• Any out-of-pattern utilization or high-risk claim trends were investigated
• Documentation supports that split-billing or accumulator logic prevented diversion

Duplicate Discount Prevention

• Medicaid carve-in or carve-out status was correctly applied for the audit period
• State Medicaid billing identifiers and claim submission rules were applied correctly
• Claims were screened to prevent duplicate discounts before 340B accumulation
• Any Medicaid managed care or third-party payer exclusions were documented
• No duplicate discount exceptions were identified in the sample

Controls, Documentation, and Corrective Actions

• Contract pharmacy agreement and current business associate or operational documents are on file
• Audit workpapers, claim extracts, and supporting evidence are retained
• Findings are categorized as deficiency, non-conformance, or critical item as applicable
• Corrective actions were assigned with owner and due date
• Follow-up review date is scheduled
• Inspector attests that the audit was completed accurately and completely