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Resolving 340B noncompliance can be a time-consuming task for 340B participants — and one of the greatest challenges in managing a 340B program. This guide outlines the five steps to successfully navigate resolving compliance issues requiring repayment to manufacturers, from discovery to resolution, and includes a solution to help streamline the refund process.

Step #1: Discovering 340B Program Noncompliance

Program noncompliance can be detected in four ways: self-audit, HRSA audit, manufacturer good faith inquiries or audits, and through normal day-to-day operations. Compliance issues are most commonly identified through self-audits conducted either by an internal audit department, pharmacy department, or an outside contractor hired by a covered entity.

“A compliance issue such as incorrect 340B accumulation quantities may be caused by systemic failures such as a data feed transmission error. In my experience as a 340B team member, we had analysts dedicated to reviewing specific program areas to monitor our program for noncompliance on an ongoing

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For 340B covered entities (CEs), a Health Resources and Services Administration (HRSA) audit is an inevitability. While you won’t be able to predict when HRSA comes calling, you can bank on sooner or later being one of the 200 CEs HRSA audits every year. That’s why Cloudmed recommends keeping your organization’s policies and procedures aligned with current 340B program guidance and expert interpretations. When the audit comes, you want to be one of the CEs with a clean outcome, not one of those saddled with findings that could jeopardize your program.  

A critical component of a compliant 340B program is having your policies and procedures in good order before the audit. They must identify how you ensure key compliance measures are met for the 340B program, including patient definition, care setting, and other factors.  

Beyond setting the applicable policies and procedures, you must ensure you