There is certainly no shortage of guidance available when it comes to managing a 340B program, but much of this information was established long before the wealth of knowledge and recommendations we see today were readily accessible. For many organizations, this can make preparing for and navigating HRSA audits increasingly challenging.
This is certainly the case for covered entities, who must work to ensure program integrity while also maintaining accurate records that document compliance with all aspects of 340B. Failure to comply may make the covered entity liable to manufacturers for repayments of discounts and can even cause the covered entity to be removed from the 340B Program.
This makes knowing how to prepare for and handle HRSA audits especially vital. Here are five things to do within 24 hours of receiving a HRSA audit notice of your 340B program in order to ensure a smooth and successful process.
Preparing for the audit
It’s first important to know the duration of the audit and how it will affect your day-to-day operations. In most cases, the HRSA audit is performed over the course of a 2-3-month period immediately following receipt of the audit notice. The expectation is that covered entities will maintain their 340B Program operations throughout this process.
Upon receiving notice:
- Ensure your Authorizing Official and Primary Contact have notified key stakeholders within the covered entity, such as Legal, Compliance, and other Leadership.
- Schedule the Welcome Call and complete the requested Information Request Form.
- Verify the recommended date of the audit provides no conflicts for your covered entity.
- Review the Document Request List and identify any requested items that the covered entity needs to develop or has questions about for the Bizzell Group.
- Notify key contacts external to the covered entity such as 340B Software Vendors, contract pharmacy partners, wholesalers, and other partners with your 340B program to ensure they are ready to provide support and guidance throughout the process.
Ensure a smooth and successful 340B program audit with support from Visante
For many organizations, navigating the complexities of a 340B program can be an overwhelming challenge for even the most advanced and experienced entities. Visante helps overcome this challenge by providing assistance to our clients throughout the duration of any HRSA audit, including preparation, document review, and analysis in advance of uploading to HRSA, executing, and following up throughout the process.
Visante is well-positioned to support our clients, given that we are independent, extraordinarily committed to our clients’ success, highly experienced with every type of covered entity and software/technology, and capable of identifying aspects other big firms may often overlook. In addition to having ACE certifications, our team members have extensive experience working in health systems and grantee covered entity types and have provided this support on a regular basis throughout their careers. We have built a level of experience and expertise we feel is important to share with covered entities.
We recognize that no two covered entities have the same needs or approach an issue the same way, which is why we strive to provide each client with the opportunity to evaluate a situation and to make the best decision based on what is right for them.
Contact us today to learn more about preparing for and completing a successful HRSA audit of your 340B program.