Navigating Uncertainties in the 340B Drug Pricing Program

Summary

This article discusses 340B Drug Pricing Program (340B Program or Program) uncertainties related to the Health Resources and Services Administration's (HRSA's) ability to enforce many of the Program's core requirements. This article begins with an overview of the regulatory background that set the stage for recent 340B Program developments and then summarizes those key developments. This article includes practical guidance on how best to navigate 340B regulatory inflection points and favorably position your healthcare or life sciences clients for the future of the 340B Program.