This is the first episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor in administering the 340B Program, including by publishing guidance and compliance tools to assist stakeholders in running their 340B operations. This first episode discusses best practices for resolving non-compliance under the 340B Program, how to determine whether an issue is a “material breach” of 340B requirements, HRSA’s self-disclosure process, and some of the most common compliance issues that arise.
