Every 340B audit ends the same way: pass or fail. But for many health systems, that outcome feels like a coin toss. Even with experienced teams and diligent processes, it’s hard to know whether you’re truly audit-ready. 

In fact, 46% of 340B audits had adverse findings in 2024, meaning the auditor identified a compliance issue that required corrective action and could trigger repayments. 

So what does audit ready actually mean?

Being 340B ‘audit-ready’ means that you can quickly produce comprehensive, current, and time-stamped documentation for the entities, pharmacies, and time periods under review.

Continuous 340B compliance (aka audit-readiness) requires constant documentation upkeep across multiple sources, including shared drives, spreadsheets, email threads, and siloed databases. It helps that the HRSA publicly outlines what’s required, but operationalizing readiness to meet the requirements of that list with your internal files and processes is manual, time-consuming, and inconsistent. Health systems frequently assume their documentation is complete, only to discover hidden gaps during HRSA audits or manufacturer inquiries.

These blind spots create serious risk, adverse findings, corrective action plans, forced repayments, and potential loss of program eligibility. And without the savings 340B delivers, many hospitals face a real risk of financial insolvency. Without a centralized way to monitor 340B audit readiness, teams are stuck reacting to issues instead of preventing them.

By contrast, teams that adopt a dedicated 340B compliance solution like 340BCheck gain continuous insight into their audit posture, flag deficiencies as they arise, identify trends before they escalate to material breach, and turn a reactive scramble into a proactive, manageable process.

Manual 340B compliance isn’t feasible

Most covered entities rely on ad hoc systems. Without a standardized, centralized method for storing and validating compliance documentation, even routine self-audits become error-prone and incomplete.

• Policies may be outdated. 
• Agreements may be missing critical fields. 
• Cost reports might not reflect child sites accurately

And when multiple teams touch the process, version control becomes nearly impossible to maintain. Add to that the fast-changing nature of contract pharmacy arrangements, state medicaid requirements, and OPAIS data, and the chance of overlooking critical details increases exponentially.

Staff spend weeks manually tracking down documentation, often without knowing whether the version they have is accurate or audit-ready. 

Meanwhile, leadership operates with a false sense of security; until HRSA finds a discrepancy or a manufacturer flags a violation.

To protect your 340B eligibility—and by extension, your financial viability—you need a unified system that brings clarity, accountability, and confidence to every aspect of your 340B audit preparation.

Shifting from Reactive to Proactive

The only way to gain confidence in your 340B audit preparation is to digitize and consolidate your program. 340BCheck helps compliance teams to:

1. Analyze: Eliminate guesswork by consolidating your 340B data into one centralized repository. From policies and PSAs to cost reports and OPAIS data review, everything is tagged, searchable, and easily reviewed.
2. Audit: Use guided workflows and scalable templates to conduct continuous self-audits. The transactional audit dashboard tracks each review by user and date, and exports “proof-of-audit” documentation for HRSA—without exposing sensitive results.
3. Oversee: Stay ahead of change with daily OPAIS synchronization, the HRSA database that lists your registered sites and contract pharmacies. 340BCheck immediately flags issues like address mismatches, terminated sites, and new contract pharmacies. Version control and historical snapshots ensure you can verify the status at any point in time.

By investing in technology that embeds these capabilities into your 340B compliance program, you eliminate last-minute scrambles, maintain an unbroken audit trail, and build genuine confidence in your 340B readiness.

340B Audit Checklist

Ready to evaluate your own 340B compliance program? This checklist, which is an eight point executive distillation of Apexus best practices, includes all essential elements for audit preparation, helping you maintain continuous compliance systematically rather than scrambling when auditors arrive.

1. Establish Governance:
   • Assign a program owner and backup. Maintain comprehensive written policies covering eligibility, diversion prevention, duplicate discount prevention, and oversight.
2. Validate OPAIS and Registrations
   • Confirm parent, child sites, and all contract pharmacies are correctly listed in OPAIS with accurate names and addresses. Document the latest recertification and any change requests.
3. Prove Eligibility
   • Keep evidence that patient, provider, and location are eligible for every 340B claim. Retain Medicare Cost Report or grant documents supporting eligible locations.
4. Prevent Duplicate Discounts
   • Document carve‑in or carve‑out by state and site. Maintain current Medicaid billing policies and proof your process prevents duplicate discounts. [1]
5. Reconcile Inventory and Purchasing
   • Document split‑billing or replenishment logic. Keep auditable purchase, invoice, accumulation, and dispensing records that reconcile at the NDC level.
6. Oversee Contract Pharmacies
   • Maintain signed PSAs with audit rights and data‑sharing. Perform quarterly internal audits and annual independent audits for each pharmacy. Track corrective actions to closure.
7. Centralize Documentation and Proof‑of‑audit
   • Store policies, PSAs, OPAIS exports, MEF evidence, audit logs, CAPs, cost reports, and training records in one system with version control. Keep an exportable proof‑of‑audit packet ready.
8. Monitor Continuously and Prep the DRL Pack
   • Sync OPAIS routinely, track expirations and CAPs, and run scheduled self‑audits. Keep a ready‑to‑send HRSA DRL folder with required policies

Next steps to maintaining continuous 340B compliance

Flying blind risks hidden gaps, unexpected penalties, and corrective action mandates. But with a modern compliance platform that centralizes your documents, maps them to HRSA requirements, and flags issues in real time, you gain the visibility to steer clear of pitfalls.

Here’s how to take the first step:

• Assess where your current documentation lives and how it’s maintained
• Identify weak points in your self-audit process and version control
• Evaluate whether your compliance data is accessible, up to date, and audit-ready
• Explore how 340BCheck can help you Analyze, Audit, and Oversee with confidence

Proactive audit readiness protects more than compliance—it protects your entire 340B margin. Don’t put it at risk when you don’t have to. 

Frequently Asked Questions

For comprehensive information please refer to https://www.340bpvp.com/hrsa-faqs.

FAQ 1: What Does HRSA Look For In A 340B Audit

Answer: HRSA typically checks that you can prove eligibility, prevent diversion, prevent duplicate discounts, and produce complete documentation that matches your day to day operations.

FAQ 2: What Documentation Should We Have Ready If We Get A DRL

Answer: Have current and historical policies, OPAIS records, eligibility support like cost reports, contract pharmacy agreements and audits, split billing documentation, NDC level purchase and dispense records, and any CAPs and training records.

FAQ 3: Why Do Teams Feel “Audit Ready” Until The Audit Actually Starts

Answer: Because documents are scattered across systems and versions change, teams miss gaps until they have to produce proof for a specific site pharmacy or time period.

FAQ 4: How Can We Reduce Audit Risk Without Creating More Manual Work

Answer: Standardize and centralize documentation, keep version control, monitor OPAIS changes, run routine self audits, and maintain an exportable audit packet.