Every 340B audit ends the same way: pass or fail. But for many health systems, that outcome feels like a coin toss—because 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.
Continuous 340B compliance requires constant documentation upkeep across multiple sources—shared drives, spreadsheets, email threads, and siloed databases. HRSA publicly outlines what’s required, but reconciling that list with your internal files 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, forced repayments, and potential loss of program eligibility. And without the savings 340B delivers, many hospitals face the real risk of financial insolvency or even bankruptcy. 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, and turn a reactive scramble into a proactive, manageable process.
Manual 340B compliance isn’t feasible
Most covered entities rely on ad hoc systems: shared drives, siloed files, and outdated checklists. 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Policies may be outdated.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 the right DSH percentage. 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 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:
- Analyze: Eliminate guesswork by consolidating your 340B data into one centralized repository. From policies and PSAs to cost reports and OPAIS entries, everything is tagged, searchable, and easily reviewed.
- 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.
- Oversee: Stay ahead of change with daily OPAIS synchronization. 340BCheck immediately flags issues like address mismatches, terminated sites, and new contract pharmacies. Version control and historical snapshots ensure you can verify what was in place 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.
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.