The 340B Summer Coalition was held earlier this month in Washington D.C. Julie Zadecky, a Pharmacist in the Program Performance and Quality Branch for the Office of Pharmacy Affairs was asked two questions regarding the OPA’s requirement for a 340B independent audit during her presentation on July 12, 2016:
Question 1: If a contract pharmacy does an annual or quarterly self-assessment for 340B compliance, will it satisfy the oversight requirement?
Question 2: Some split-billing software vendors offer a mock audit service annually. Will you consider this an external audit or would you still recommend a non-affiliated external audit annually?
Zadecky replied: “They both are an oversight; however, if it were my program, I would want it to be as thoroughly evaluated as possible. [For example], I know if I write a letter and I proof read that letter myself, I’m going to miss a lot of things. So, if you have a vested interest in what you are auditing and not finding, then you may miss some things. HRSA’s recommendation is to get an outside, independent audit performed. That way you can find as many issues [as possible] that you may not be aware of.”
HRSA has made it clear that it is an expectation for 340B covered entities to have an annual independent audit of their contract pharmacies. Covered entities should not take the wording “expectation” lightly because in the audit process, HRSA will ask when the last independent 340B audit of contract pharmacies was performed. HRSA set the expectation of an independent 340B external audit as a tool to ensure covered entities have adequate oversight of their contract pharmacy. Southwest Consulting Associates has written extensively regarding the independent external audit expectation which you can read about HERE.
SCA is working to publish additional information regarding takeaways from the Coalition and will post them on the blog in the coming weeks. If you have any questions regarding your 340B compliance with the independent external audit expectation, please contact Southwest Consulting Associates.
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