Navigating HRSA Audits with FQHC 340B Compliance

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Navigating HRSA Audits with FQHC 340B Compliance

HRSA, which stands for Health Resources and Services Administration, audits can be a daunting and stressful experience for health centers. The extensive documentation and scrutiny involved can be overwhelming, and the pressure to ensure compliance with HRSA's 340B Program requirements can be immense. However, there is a solution to alleviate this stress: having a partner to guide you through the entire audit process. This is where FQHC 340B Compliance comes in to be your support team from the moment you receive the HRSA audit letter through the site visit and beyond.

Key Items HRSA Requests

HRSA's audit request includes various items that demand careful preparation and documentation. Some of the key items that HRSA typically requests are:

1. Policies and Procedures: HRSA requires your entity's 340B policies and procedures. It is essential to review these documents to guarantee they contain all elements HRSA expects you to include, and that they align with your actual practices.

2. Narrative of Your Entity: You will need to provide an overview of your organization’s 340B Program, detailing inventory methods and billing and reporting practices.

3. 340B Drug Utilization Data: HRSA will request data on 340B drug utilization, including clinic-administered drugs, contract pharmacy data, and entity-owned pharmacy utilization.

4. 340B Purchase Records: Ensure you have comprehensive purchase records that align with your historical purchases reported on the 340B Prime Vendor Program (PVP) website. You should also maintain a detailed list of all of your wholesaler accounts.

5. Medicaid Billing Forms: Provide Medicaid billing forms for each site involved in Medicaid billing, ensuring accuracy in listing NPIs and compliance with state requirements.

Support Throughout the HRSA Audit

Our team at FQHC 340B Compliance can assist you at every stage of the HRSA audit.

1. Preparing for the Audit: We will help you compile all the necessary data for HRSA's review and assist you in uploading it to the HRSA portal.

2. Site Visit: During the site visit, our team will provide valuable guidance and support to your covered entity.

3. Audit Follow-Up: After the audit, our team will provide our initial reactions to the audit. Once the results are in, we will review those with you and assist with a corrective action plan, if necessary.

The Audit Process

When the auditor is on-site or conducting a remote visit, the pressure intensifies. It's essential to be well-prepared for this part of the process.

1. Opening Conference: This is your opportunity to meet with the auditor and set expectations for the day. Take the time to highlight the value of the 340B Program to your community and showcase how it supports critical services, such as managing the opioid crisis or running food pantries. 

2. Clarifying Questions: The auditor may ask for further details on your program, 340B policies and procedures, and billing processes to ensure compliance with Medicaid duplicate discount requirements. They may ask for more information about how your contract pharmacy programs, your entity-owned pharmacy programs, and your clinic-administered drugs are set up. In addition, they will also want to talk to your credentialing department and billing department to understand what safeguards are in place to make sure you comply with 340B Program expectations.

3. Sampling: Approximately 60 samples are selected from your 340B universe, which includes clinics, entity-owned pharmacies, and contract pharmacies.

4. Reviewing Eligibility: The auditor will test each sample for diversion and duplicate discount. For diversion, they’ll confirm that the individual is an active patient of your covered entity and that provider eligibility and medical record documentation support your entity’s responsibility of that patient’s care. To be sure that you comply with the Medicaid duplicate discount prohibition, they’ll determine if you are following the appropriate 340B billing procedures for any Medicaid Fee-For-Service (FFS) claims within your samples.

Preparing for Contract Pharmacy Audits

Managing contract pharmacy agreements is crucial for HRSA audits. Keep fully executed copies of these contracts readily accessible and confirm they meet HRSA's requirements. Due to the maintenance required for updating each site within the contract, it is highly recommended that your covered entity includes all-inclusive language stating that all locations of your covered entity are encompassed within that contract. This way, you will simply have to maintain your pharmacy locations as they change.

The Role of a Support Team

Navigating the complex HRSA audit process requires expertise, attention to detail, and a deep understanding of the 340B Program's intricacies. Having a support team that has successfully navigated numerous HRSA audits can make a significant difference ensuring a smooth experience for you. Our team at FQHC 340B Compliance has extensive auditing experience, and we are eager to assist you in preparing the necessary documentation, ensuring compliance with HRSA requirements, and providing guidance throughout the entire audit experience.

HRSA audits can be stressful for health centers, but you do not have to face them alone. Whether you're in the early stages of preparing for an audit or need assistance during the site visit, our team can guide you and help ensure your audit experience is successful. Don't hesitate to contact the FQHC 340B Compliance team for support. Your organization's compliance and success depends on it.


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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