340B Contract Pharmacy Quarterly Self-Audit Worksheet
Use this quarterly worksheet to review 340B contract pharmacy claims for diversion, duplicate discounts, and missing documentation. It helps you document scope, test sampled claims, and assign corrective actions in one audit trail.
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Built for: 340b Covered Entities · Hospital Pharmacy · Federally Qualified Health Centers · Community Health Centers · Contract Pharmacy Operations
Overview
This worksheet is a quarterly self-audit template for reviewing 340B contract pharmacy claims and the controls around them. It is built to help a covered entity document what was reviewed, which claims were sampled, and whether the evidence supports compliant accumulation, dispensing, and Medicaid duplicate discount prevention.
Use it when you need a repeatable internal review of contract pharmacy activity, especially after a policy change, a new pharmacy relationship, a carve-in or carve-out update, or a prior audit finding. The structure follows the way a reviewer would actually work: define the audit scope, test claim integrity, look for diversion indicators, confirm duplicate discount controls, and close with documentation and corrective actions.
Do not use this template as a substitute for legal counsel, a formal external audit, or a one-time incident investigation that requires a separate root-cause process. It is also not the right tool for unrelated pharmacy quality checks, inventory counts, or general revenue cycle audits. Its value is in making 340B-specific testing visible and repeatable, so the team can spot deficiencies such as unsupported eligibility, reversed claims that were still accumulated, duplicate patient records, or weak Medicaid exclusion documentation before they become recurring non-conformances.
Standards & compliance context
- This template supports internal monitoring aligned with 340B program expectations for preventing diversion and duplicate discounts, while leaving final legal interpretation to the covered entity and counsel.
- The duplicate discount section is designed to help document Medicaid carve-in or carve-out decisions and claim screening practices consistent with state Medicaid billing rules and 340B program requirements.
- The documentation and corrective action fields support audit readiness under common healthcare compliance and quality management practices, including ISO-style corrective action tracking.
- If your organization uses contract pharmacy arrangements, retain agreements, operational documents, and workpapers in a way that supports review by regulators, auditors, or the covered entity's compliance team.
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
Audit Scope and Period
This section matters because it defines exactly what was reviewed, when it was reviewed, and which claims and locations were included in the audit trail.
- 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
This section matters because it tests whether each sampled claim is supported by patient, prescriber, medication, and timing evidence before 340B accumulation.
- 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
This section matters because it looks for signs that a 340B drug was dispensed outside eligible use or that the claim workflow allowed hidden duplication.
- 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
This section matters because it verifies the controls that keep Medicaid claims from being counted twice through both the state program and 340B accumulation.
- 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
This section matters because it captures the evidence, classifies findings, and turns audit results into tracked remediation.
- 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
How to use this template
- 1. Enter the audit quarter, date range, contract pharmacy locations in scope, and the claim population or sample method before you begin testing.
- 2. Gather the current 340B policies, SOPs, prior audit results, open corrective actions, claim extracts, and accumulator or split-billing reports needed to support the review.
- 3. Test each sampled claim against patient eligibility, prescriber relationship, eligible medication status, dispense and accumulator date alignment, and billed NDC, quantity, and days supply.
- 4. Review diversion indicators by checking for ineligible patients, duplicate profiles, manual overrides, exception flags, and out-of-pattern utilization that needs follow-up.
- 5. Verify duplicate discount controls by confirming Medicaid carve-in or carve-out status, billing identifiers, payer exclusions, and claim screening before 340B accumulation.
- 6. Record findings, assign corrective actions with owners and due dates, attach supporting evidence, and schedule the follow-up review date before closing the worksheet.
Best practices
- Use a risk-based sample that includes high-volume claims, manual overrides, and any pharmacy or payer combinations that have triggered prior findings.
- Photograph or export supporting evidence at the time of review so the workpapers show exactly what was tested, not a later reconstruction.
- Treat reversed and rejected claims as a separate check, because they can be mistakenly included in accumulation if the workflow is not tightly controlled.
- Verify Medicaid status and payer exclusions against current state billing rules for the audit period, not against a generic policy summary.
- Look for duplicate patient profiles and duplicate claim records before you conclude that a claim pattern is clean, since those issues can mask diversion risk.
- Document why a claim was selected or excluded from the sample so the audit trail is clear during follow-up or external review.
- Escalate any unresolved exception flags to the 340B program owner immediately, especially when the same issue appears across multiple quarters.
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 contract pharmacy quarterly self-audit worksheet cover?
It covers the core controls a covered entity should test each quarter for contract pharmacy activity: audit scope, claim integrity, diversion review, duplicate discount prevention, and corrective actions. The worksheet is built to document sampled claims, supporting records, and any exceptions found. It is meant for internal review of contract pharmacy operations, not for a full enterprise compliance program audit.
How often should this worksheet be used?
This template is designed for quarterly use, which matches the cadence implied by the title and helps teams catch issues before they accumulate across multiple claim cycles. Some organizations also use it after a contract pharmacy change, a Medicaid carve-in or carve-out update, or a prior finding that needs closer monitoring. If your risk profile is higher, you can add interim spot checks without changing the core quarterly format.
Who should complete the audit?
A compliance, pharmacy operations, or internal audit reviewer should complete it, with input from the 340B program owner and contract pharmacy staff as needed. The reviewer should be able to trace claims, understand accumulator logic, and verify supporting documentation. If the auditor is also involved in day-to-day claim processing, add an independent review step to reduce bias.
Does this worksheet address duplicate discount prevention requirements?
Yes. The duplicate discount section is intended to verify Medicaid carve-in or carve-out status, state billing identifiers, claim screening, and exclusions for Medicaid managed care or other payer situations that can create risk. It does not replace legal review of state-specific billing rules, but it gives you a structured way to document that the controls were checked. That makes it easier to show how the covered entity prevented duplicate discounts during the audit period.
What are the most common mistakes this audit catches?
Common issues include missing proof that the patient was eligible under the covered entity relationship, mismatches between dispense dates and accumulator dates, and claims that were reversed or rejected but still appeared in a 340B population. Teams also miss duplicate patient profiles, manual overrides, and incomplete documentation for Medicaid exclusions. Those are the kinds of findings this worksheet is meant to surface before they become repeat deficiencies.
Can I customize the sample size and claim selection method?
Yes. The audit scope section includes space to document the claim population and sample methodology, so you can define random, risk-based, or targeted samples based on your program design. Many teams customize the worksheet to reflect high-risk pharmacies, high-dollar claims, or prior findings. Just keep the method consistent enough that quarter-to-quarter results are comparable.
How does this fit with split-billing or accumulator software?
The worksheet is designed to test whether split-billing or accumulator logic is working as intended, not to replace the software itself. You can use it to confirm that claim dates, dispense dates, and accumulator dates align and that exception flags were reviewed. If your system exports claim extracts or audit logs, those can be attached as supporting evidence in the documentation section.
What should I do if the audit finds a deficiency or critical item?
Record the issue clearly, classify it as a deficiency, non-conformance, or critical item based on your internal framework, and assign an owner and due date for corrective action. Then schedule a follow-up review so the same issue is re-tested in the next cycle or sooner if the risk is significant. The goal is to show that findings were not just noted, but tracked to closure.
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