Understanding the 340B Audit Process
December 2016 - Vol. 13 No. 12 - Page #2

Q&A with Maureen Testoni, JD, and Amanda Nagrotsky, JD
340B Health

Pharmacy Purchasing & Products (PP&P): How are covered entities notified of an impending audit?

Maureen Testoni & Amanda Nagrotsky: The audit process is initiated when the Health Resources & Services Administration (HRSA) sends an engagement letter notifying a covered entity of its selection for a 340B audit. HRSA typically contacts the covered entity within 1-2 weeks of the audit notice to coordinate the date of the audit and review other details. Shortly thereafter, HRSA sends a data request to the covered entity describing information that must be provided to the auditor(s).

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