A Manager's Guide for HRSA 340B Audits, Program Integrity, and Compliance
The 340B program is complex, and maintaining accurate records is essential for success! If you're a program manager, you know this all too well. But are you confident your records would stand up to a Health Resources and Services Administration (HRSA) audit? Let's review what you need to know about maintaining auditable records for 340B compliance.
340B Program Changes for Covered Entities
In the past couple of years, the 340B drug pricing program has seen some changes in record-keeping and program requirements. Edward Vargas, founder of Virtue 340B, points out a significant update: "One of the data elements on the HRSA data request list is to provide proof of an independent audit of your contract pharmacies." You must show evidence that an external auditor has reviewed your contract pharmacy operations.
But why are these records so important? Simply put, they're your defense against potential program removal. Vargas warns, "The most severe penalty would be removal from the 340B program." He adds that in past years, some covered entities did, in fact, lose their eligibility and had to repay manufacturers for compliance violations under section 340B, as outlined in the HRSA Office of Pharmacy Affairs.
The good news? Severe penalties have become less common in recent years. Vargas explains, "We've seen less and less of it. And it's primarily due to the 340B industry's acceptance of engaging third-party administrative vendors to help facilitate the program." Read More >
Since our inception in November 2022, Virtue has swiftly risen as a trailblazer in 340B compliance. We perform mock audits that simulate HRSA's rigorous reviews, helping covered entities identify risks and areas of non-compliance before actual audits. Our tailored approach, driven by seasoned healthcare professionals and 340B experts, evaluates program operations, policies, and controls. We ensure integrity and transparency by adhering to the International Standards for Professional Internal Auditing. Offering top-tier audit services at competitive rates, we make comprehensive 340B compliance accessible, transforming compliance challenges into manageable steps and optimizing program performance. Our commitment to excellence and expansion remains unwavering as we strive to become the best-in-class provider in the 340B industry.
