Since the 340B Genesis case was resolved in November 2023, there has been widespread confusion regarding the definition of a patient. The significance of the case lies in its potential to assist 340B covered entities in achieving or maintaining compliance, as well as in identifying new avenues for expanding their 340B programs.

This presentation seeks to offer clarity and alternative interpretations of the definition of a patient. We will explore 340B compliance concerning the definition, along with other compliance issues linked to this definition. Additionally, we will provide an overview of the Genesis debate and court case, highlighting the ruling’s outcome.