Expert Tip from Avita Care Solutions


TIP: Establishing controls and performing regular monitoring is crucial to prevent and identify noncompliance with 340B program requirements.

The 340B program is complex. Covered entities need to have processes and controls in place to assess their ongoing compliance with HRSA policies, regulations, and guidance, in addition to their self-established policies and procedures. Best practices include an annual review of eligibility criteria and documents to ensure sufficient documentation to demonstrate compliance with all requirements, regularly maintaining and periodically reviewing the 340B OPAIS database to confirm accuracy, and routinely monitoring purchasing and inventory management.

Failure to conduct monitoring and implement remedial action when necessary can result in significant administrative and financial challenges for covered entities. This may impact their ability to address the needs of underserved communities adequately. Engaging a reputable 340B services provider that offers a tailored and holistic compliance strategy can help covered entities stay well-disciplined while focusing on the most important priority: patients and their well-being.

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