The Complex World of Annual Audits Made Simple with FQHC 340B Compliance

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Working With Our Team for All Your Auditing Needs

FQHC 340B Compliance’s annual audit services set us apart in our industry. We offer external audit services as educational consultative services. During the process, we will educate you about the documents we request so that in the event of a HRSA audit, your team will know specifically what you are looking for. Upon receiving all the documents, typically, our audit service takes about 4 to 6 weeks to complete. During the review of your entity, we review your contracts with your contract pharmacies and complete an optimization of contract pharmacies that you may be able to add to your program. We will review your authorizing official and your primary contact to ensure all the information is correct. In addition to that, we check your contract pharmacies against your contracts to make sure that the data on your contracts is accurate, up-to-date, and matches with OPAIS. We will also review your grantee site information to make sure that it matches the HRSA electronic handbook. Another common finding in HRSA audits is duplicate discounts. During our review, we will review 100% of your claims. In addition, if your Medicaid fee-based patients will utilize 340B drugs, also known as carving-in, we will review your medical billing forms as well. Diversion is another common finding in HRSA audits. During our review, we will check all of your claims for diversion when they relate to eligible providers, eligible locations, and having audible records. If we discover findings during the process, we will work with the entity to correct them. This ensures that those will already be corrected in the event of a HRSA audit. Our external audits aim to prepare the entity so that you are confident in your entity’s program in the event of a HRSA audit.

Do Your Policies & Procedures Match Your Practices?

It is important to note that the HRSA auditors will review your policies and procedures, so evaluating what your team says everyone is doing within your organization will be beneficial. In this case, the audit will hold you accountable. As part of our annual external audit, we will go through and review in detail what you have described in your policies and procedures and make sure that these documents align with your practices. It's vital that you're not overpromising how your 340B Program is operating. Although it is important to have a compliant program, if you promise to deliver on unachievable standards, you may actually set yourself up for a difficult time in a HRSA audit.

The Ins & Outs of HRSA Audits & the 340B Program

Conducting an audit each year is a perfect time for your health center to learn the details of HRSA audits. Our team is able to give you updates on our findings in the most recent audits with the HRSA auditors and inform you about new trends and developments over the last year so that you can continue to improve your entity and program. Understanding how HRSA’s audits operate is crucial so you can be best prepared when you may be selected in the future. Another benefit of the annual external audit is that it helps your team prepare for what it is like to be in a HRSA audit. You will be responsible for pulling all of the data and gathering your contracts and your policies and procedures so they are all in one place. By doing this, you are eliminating a potentially stressful situation and setting your team up for success. The annual audit is a great time to receive one-on-one education about the 340B Program. Our team walks you through the difference between your legal requirements and what HRSA expects. Within the 340 statute are particular requirements: the covered entities, participation in the Program, diversion, and duplicate discount. Diversion is included to ensure that 340B drugs are only sold to patients of the covered entity. We do not offer a 304B discount when a Medicaid rebate is received, which is why it is imperative to check for duplicate discounts.

In addition, the Office of Pharmacy Affairs also presents a lot of expectations to covered entities of the Program. These do not have the same legally binding authority that the information in the statute does. Therefore, it is important for covered entities to understand where they are regulated by the Office of Pharmacy Affairs and where this office expects the covered entity to set up their policies and procedures to align with the intent of the 340B Program. Our team will help you understand the difference and successfully set up your program operations to ensure compliance with the Office of Pharmacy Affairs’s expectations.

With the FQHC 340B Team, Nothing Slips Through the Cracks

Conducting an annual review of your program is the best way to make sure that you are ready for a HRSA audit. While reviewing your 340B purchases, our team requests that you run a historical purchase report from the 340B PVP website. This reveals any accounts where you've been purchasing 340B drugs that you were unaware of. During the review for duplicate discounts, we also look at your Medicaid billing forms. We look at these forms to ensure that you are using the correct modifiers, as well as the correct NPI numbers. During the review of your entity, we will check OPAIS’s Medicaid exclusion file to double-check that all your grantee sites’ NPIs are listed if you do carve in. It is common for our team to find inaccuracies in your Medicaid exclusion file. When we discover these inaccuracies, we can work with your billing staff to ensure that these are prevented in the future. To add, during the review of your audit, our team requests a prescriber list. Your prescriber list start and termination date should reflect the dates your team accessed it on the electronic medical record. In the review of your policies and procedures, we will look at the elements that HRSA looks for in the data request list. If those elements are not present in your policies and procedures, we will provide you with templates to update them.


Let’s Rewrite the Script: External Audits Do Not Have to Be Scary

For some health centers, external audits can be scary and intimidating because an audit typically penalizes you for something you've done wrong. However, in the 340 space, an independent external audit is actually intended to help you because it is a consultative experience. Our report solely goes to management, and we do not report to anyone outside your organization. Additionally, it's a great area for you to add new practices or improve upon current ones. This is an excellent opportunity for an expert audit team to review and give your team constructive and consultative feedback. Our goal is to be a trusted resource for community health centers, particularly regarding audits. Reach out to our team today to discus show our team can serve you with our external audit services.


FQHC 340B Compliance is the dedicated partner for Federally Qualified Health Centers seeking assistance with the 340B Program. Their mission is to provide the necessary resources to secure and optimize the 340B Program, enabling health centers to offer more comprehensive services to those in need. With a focus on improved compliance and oversight, they act as more than just consultants or automated systems, tailoring their services to meet your health center's unique needs. Visit their website, call (760) 780-7469, or email to learn more about FQHC 340B Compliance and how they can help your health center thrive.

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