The Importance of 340B Auditing

The 340B program, as a whole, is becoming a highly scrutinized program. Although 340B covered entities have been audited since the program’s inception in 1992, the growing visibility and budgeting concerns of government programs have lead to an increase in both incidence and rigor by which HRSA and manufacturers perform audits.

In light of ever-increasing HRSA oversight, a key to the successful continuation of your 340B Program is audit-readiness. Successful preparation extends far beyond the simple implementation of an adherent program; your program must follow two basic tenets: transparency and traceability. Proper documentation, certification, policies, procedures and adherence to established guidelines must be constantly monitored to ensure continued compliance with any changing requirements.

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Therefore, ensuring a successful 340B program requires two major additional components:

  • Consistent & Comprehensive Internal Auditing Procedures – Many programs that were designed to meet the exact specifications required by HRSA can become non-compliant through both gradual degradation of implemented procedures through time and/or evolving government regulations. Meticulous, well-planned internal audit procedures ensure that actual practice coincides with current program requirements.
  • External, Independent Audits Performed by 340B Program Experts – Although establishing an effective internal audit procedure is an important first step to compliance, entities should also receive regular audits from an independent body. By contracting with a organization whose sole focus is 340B audit support, your organization is ensured (1) current knowledge of all compliance and regulatory changes, (2) exposure to actual HRSA audit procedures and areas of emphasis, and (3) identification of problem areas that may have been overlooked by established internal audit procedures.

In short, the inclusion of both internal and external independent audits are vital components to the success of your 340B program. Your dedicated Innova team can work with you to design procedures that maximize the value of your internal audits, ensuring time and efforts are not spent on unnecessary tasks and all necessary components receive appropriate attention. The team is also available to conduct comprehensive ‘mock’ audits that mimic a typical HRSA review, preparing your staff for a true audit event and identifying any potential issues that HRSA might uncover.

Innova….Building for Compliance