Meeting all compliance requirements is your main goal during a HRSA audit. Preparation is key to your success and execution during the audit is paramount. Macro Helix is a proven leader in 340B program management and has helped more than 350 covered entities to navigate through 340B program audits.
Q. What is a HRSA audit and how can you prepare?
A. When an entity enrolls in the 340B Drug Pricing Program, they are subject to program audits by HRSA to ensure the covered entity is fulfilling all compliance requirements by maintaining accurate and auditable records. HRSA audits are not intended to be punitive; however, some audits may involve manufacturer repayment. Instead, these audits are designed to be educational and help covered entities identify potential compliance gaps in their policies or processes. Nearly 60-70% of audited covered entities have at least one finding. Some of the most common findings include Medicaid-related discrepancies, such as duplicate discounts, inaccurate Medicaid Exclusion File (MEF) listings, or inaccurate 340B OPAIS database entries and diversion. Audit readiness and preparation are key but should not be limited to just auditing your 340B dispenses. Compliance activities should also include but are not limited to:
• Verifying all aspects of your covered entity’s 340B OPAIS database listing, especially Medicaid elections.
• Ensuring you have all pharmacy services agreements (PSAs) match your OPAIS listing and that they are readily available.
• Regularly review and update your covered entity’s policies, procedures, and 340B program scope.
• Establishing controls for preventing diversion and duplicate discounts for all areas that utilize 340B.
• Developing a cross-functional committee to increase oversight of your 340B program.
Q. What happens during a HRSA audit?
A. HRSA audits are conducted onsite at the covered entity, except in the event of a public health emergency or any other extenuating circumstances where travel may be restricted. The duration of the onsite visit varies from 1 to 2 days. The auditor will conduct a thorough “deskaudit” of all the documentation the covered entity is required to submit before the onsite visit.
When the auditor is onsite, they will meet with the pertinent staff involved in the covered entity’s 340B program and may request to tour an eligible location such as a clinic or outpatient pharmacy. Also, the covered entity will be required to perform audit tracers on 340B dispenses, purchases and patient billing to Medicaid to demonstrate 340B eligibility. Results of the HRSA audit will be reviewed and finalized several weeks after the onsite audit and will be provided to the authorizing official.
Q. How can your 340B program management software help with program compliance?
A. The goal of a 340B program management software is to help simplify the complexities of the 340B program through data management, qualification customization and support to help you stay compliant and audit ready. Program management software like Macro Helix’s 340B ArchitectSM offers you the ability to configure the software to meet your definition of a patient while providing an additional layer of oversight and monitoring to your existing processes. In addition to software, ongoing support is essential. A trusted partner like Macro Helix can make all the difference in ensuring you are HRSA audit ready. Throughout the year, our team of audit specialists proactively reviews all settings and configurations. We leverage our 340B audit knowledge and experience to help covered entities during a HRSA audit. We understand audits are stressful and we provide virtual or onsite assistance during the visit. We are here to support you.
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Contact us today to talk to an Audit Specialist
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