-HRSA Audits and Your 340B Program-Lessons Learned in the Field

As you are aware, your 340B Program is subject to HRSA audits. These can be random or targeted audits. As your number of contract pharmacies and child sites increase, so do your chances of being selected for an audit. Adverse findings are publicly posted on OPA’s website and may result in repayments to manufacturers and possible termination from the 340B Program.

HRSA has engaged the Bizzell Group to perform audits of 340B Programs. The Bizzell Group largely utilizes independent contractors consisting of pharmacists and experienced experts in the 340B Program. The quality of their audits continues to improve as the Bizzell Group increases their expertise in the program and their familiarity with the various operations of a 340B Program.

The requests for information, both pre-audit and during the audit, can be extensive, so it is important to be prepared with this information. We encourage you to have a multi-disciplinary team assembled to react to these requests on short notice. Here are some common requests to be aware of:

  • Regardless of your decision to carve-in or carve-out Medicaid, it is important to understand how your covered entity bills Medicaid fee-for-service for both in-state and out-of-state Medicaid. Differences in billing practices and the Medicaid Exclusion File will result in adverse findings.
  • If you are a hospital covered entity, it is important to know your hospital classification that qualifies your eligibility for the 340B Program and have this documentation readily available upon request.
  • You will be requested to provide copies of Medicaid FFS bills from sampled claims, as well as a sample Medicaid bill from all registered locations for the audit period that was not included in the sampling.
  • The auditor will request hard copies of prescriptions from all retail pharmacy samples – both in-house and contract – while the Bizzell auditor is on-site.

Our team of 340B experts have experienced HRSA audits firsthand and want to assist you in preparing for a HRSA audit. We are available to provide, on-site assistance, and respond to HRSA’s audit report and develop a Corrective Action Plan.

Please contact our Albany office at (229) 883-7878 or our Atlanta office (404) 220-8494 and request to speak to one of our Apexus Certified Experts.

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