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  • Writer's pictureLyssa Limbrecht

Developing an Effective Self-Auditing Plan

Updated: Dec 8, 2023

Most of you know that the 340B program is heavily scrutinized by lawmakers today. Their main concerns are the lack of transparency on how organizations use their savings and the vast differences between programs.

How can you overcome the present challenges and remain compliant? Conducting regular self-audits will ensure you stay HRSA compliant now and for years to come.

In this way, you can maximize your savings and continue providing underserved patients with quality, affordable healthcare.

Answering the following questions will help you assess whether or not you’re ready for an audit:

● Do you briefly review only your TPA records or complete full audits on your program's essentials?

● Will you pass an audit if HRSA notified you to complete one in 2 weeks?

● Have you set aside time to review and or modify your 340B policies and procedures, record-keeping process, OPAIS Database entry, etc.?

Without a doubt, if you can confidently answer these questions, you're well on your way to passing your HRSA audit. If not, that’s okay.

We’ll explore a few key areas you should focus on when conducting self-audits:

  1. Meet basic eligibility requirements, including compliance with the GPO prohibition.

  2. Clean up your OPAIS database. Make sure your information is accurate and up-to-date.

  3. Prevent drug diversion. Provide discounted drugs for 340B eligible patients only.

  4. Avoid duplicate discounts. Document and report to Medicaid how you’re billing.

How often should you conduct self-audits? We recommend you complete monthly self-audits of sample patients from your partner healthcare facilities, whether that's your contract pharmacies, off-site clinics, or elsewhere.

Of course, the sample size will vary depending on how complex your program is. However, including about 30 patients or 10% of your captured claims to review every month is a good start. Assess the following criteria:

● Patient eligibility

● Provider eligibility

● Location eligibility

● Medicaid billing

Also, if monthly audits are too excessive for your facility, quarterly reviews will work. In fact, HRSA expects organizations to complete at least quarterly internal audits.

We recommend that you do a comprehensive review of your HRSA database records every year before your annual recertification. What will you verify during this review? You’ll look at:

● All eligibility documents

● Registered child sites and contract pharmacies

● Contact Person & Authorizing Official information

● Ship-to & bill-to addresses

● and more

Make sure all the data you collect is accurate. Be sure to include your self-audit program process and requirements in your policies and procedures. And ensure that it highlights how you report and respond to findings.

Did you know HRSA recommends independent audits for all contract pharmacies? A best practice is to get an outsider’s perspective on whether your program is compliant or not at least once every year. You’ll learn more about your areas of weaknesses and how to improve.

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

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