Southwest Consulting Associates (SCA) hosted a webinar in October which focused on recent audit findings relating to 340B audits conducted by HRSA as well as 340B external audits conducted by SCA. More specifically, SCA touched on areas HRSA is reviewing during an audit, what is being found, as well as provided some best practices that could be used in the management of a covered entity's 340B program. In this blog, we will share the most important takeaways regarding both HRSA audits and suggested best practices.
But first, did you know...HRSA has increased the quantity of audits performed within a given year by more than 400% since 2012. In 2012, 51 audits were completed and in 2015, HRSA will have hit their expected goal of more than 200. Knowing what to expect from a HRSA audit could make all the difference as you would expect the increasing audits trend to continue.
Takeaways From HRSA Audit Experience
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If selected for a HRSA audit, the covered entity will be asked to provide 340B policies & procedures, the Medicare cost report with Trial Balance, a crosswalk connecting the child sites on the HRSA database to the reimbursable line on the cost report, the Medicaid Provider Enrollment Verification letter and all contract pharmacy agreements. They will also ask for 6-months of hospital and contract pharmacy data along with several data listings including, but not limited to, all sites that purchase or provide 340B drugs and all accounts used to purchase drugs.
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HRSA requests a lockable room when they come on-site equipped with internet access, whiteboard, computer and projector. We suggest having 2 computers and projectors so that HRSA can move through records quickly. The covered entity will also need to provide someone to navigate through EHR (or two if you use SCA’s suggested setup).
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Once on-site, HRSA will conduct an opening conference, provide prescription samples they want to review and a list of providers they want to see proof of facility relationship. An employee’s payroll record or contract with the hospital will establish proof of relationship. HRSA will also tour the main hospital pharmacy and walk through inventory management, split-billing and contract pharmacy process on the whiteboard. Don’t forget the record review sample! HRSA will want to see the location of the encounter, verify outpatient status, identify the provider is eligible and look at the payer.
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HRSA WILL WANT TO SEE YOUR SELF-AUDIT DOCUMENTATION ON-SITE SO IT IS EXPECTED THAT YOU ARE CONDUCTING SELF-AUDITS AND MAINTAINING THE DOCUMENTATION!
Best Practices
During your self-audit, you should be reviewing your high cost drug prescriptions. This is the one drug sample you know HRSA will review upon audit.
Be sure actual practice reflects what is stated in your policies and procedures and regularly review them with staff as HRSA may ask you to explain a practice as a part of their audit.
Your policies and procedures should include how your facility determines to use a 340B drug on a patient in a mixed use setting, non-covered outpatient drugs and material breach thresholds with a process for self-disclosure.
SCA plans to hold additional webinars on the 340B Drug Pricing Program in the future and will announce them on our blog. These webinars will give you additional insight into the 340B program landscape, SCA’s external audit program and also what SCA consistently finds when performing external audits for their clients. Be sure you stay in-the-know and subscribe to our blog so that you will be informed about future webinars. And if you missed our blog on the 2015 HRSA audit findings, you can read that HERE.
