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How to Stay HRSA Compliant Now and in the Future

Updated: Aug 11

Did you know that 60% of all HRSA audits on 340B programs since 2018 result in findings? Is your organization prepared to pass a surprise HRSA audit if they notified you to complete one within two weeks? If not, you still have time to improve your 340B program’s compliance.


Let’s take a step back.


How does the audit process even work? You’ll receive a notice from HRSA, followed by an “entrance conference” request by phone from an auditor. The auditor schedules an onsite audit and submits a “data request” to gather 340B-related documents for a six month period of time.


HRSA then performs the audit onsite and conducts an “exit interview” with you. Tensions run high during this time because you won't hear from HRSA until a few months and sometimes more than a year from the visit.


The truth is, many organizations struggle even with providing HRSA with the necessary documents within a set timeframe. This is why we recommend conducting regular self-audits, so you’ll provide HRSA with the right documents at the right time.


Here are some things to consider when reviewing and conducting your self-audit:


● Conduct audits on your contract/or in-house pharmacies every month

● Make sure your claims are for 340B eligible patients, providers, and locations

● Prevent duplicate discounts - understand your state’s Medicaid Carve-In/Carve-Out rules

● Ensure all OPA database information is accurate and up-to-date

● Create a 340B compliance committee to provide oversight for your 340B program

● Keep records of all of your self-audit findings and share them with your committee

● Consider outsourcing 340B experts to do an annual mock HRSA audit


Failing to meet HRSA compliance requirements results in the loss of time and money.


That’s why we highly recommend conducting monthly internal audits, whether that be self-audits or outsourcing to third-party auditors, to make sure your organization remains 340B compliant.


Get in touch with us to learn more about how Optimal340B can help your facility with your 340B Program.


Call us at 1-866-OPT340B(678-3402) , Schedule a time to chat or reach our CEO by email at Lyssa@optimal340B.com.




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