Expert Tip from SpendMend

Validating a covered entity’s eligible providers is a key component of demonstrating compliance during a HRSA audit.  There are three elements that covered entities need to be mindful of when addressing this key component of the 340B patient definition.

• Provider List – The HRSA audit data request list (DRL) #4 requests a list of the covered entity’s eligible providers during the audit period. This list should include provider names, national provider identifier (NPI) values, and indicate the provider’s affiliation with the entity (e.g., employed, contracted), along with the start and termination dates of the provider’s tenure.
• Provider Eligibility Documentation – For each transaction tested during a HRSA audit, the covered entity will need to provide documentation that validates the provider’s affiliation with the entity. This may be copies of employment agreements, provider contracts, or screenshots from an online provider credentialing database.  Because HRSA audits often test 60 or more transaction samples, advanced organization of these records can significantly reduce administrative burden during the audit.
• Provider Eligibility Discussion – During a HRSA audit, the auditor may request to interview the entity stakeholders responsible for maintaining provider eligibility documents in order to understand how the provider eligibility process is managed in the organization. This may require involvement from several teams, including the organization’s medical staff office, graduate medical education (GME) office, or other groups.

Remember, failure to demonstrate provider eligibility for a tested transaction during a HRSA audit can result in diversion findings, which may warrant a corrective action plan and possible manufacturer repayment.