Partner and Chair of the Healthcare Litigation Practice, Andrew London, and Associate, Sam Hoff, will speak at The Mass League Health Center Compliance Academy Session on June 26. The session will explore the 340B Drug Pricing Program and recent changes in federal policy impacting when and how covered entities, including community health centers, can access these discounted drugs. They will discuss various aspects of the 340B program, including, but not limited to: the requirements for participation, the ADR process, audits of covered entities, the use of contract pharmacies, disputes regarding adoption of a rebate model, and the increased involvement in states in regulating access to 340B priced drugs.
During this session, participants will:
- Review the changing landscape of the 340B program, including the history of the program, current requirements for participation, and program growth.
- Understand the Alternative Dispute Resolution (ADR) process and HRSA’s authority to oversee disputes between covered entities and manufacturers.
- Learn about changing federal landscape regarding manufacturer restrictions on the use contract pharmacies and the current state of legal challenges.
- Evaluate the implications of manufacturer rebate policies, including ongoing litigation on rebates, and HRSA’s pilot program for the use of manufacturer rebates to provide 340B discounts in limited instances.
- Understand trends in state policies impacting the 340B program and discuss the potential for similar efforts in Massachusetts.
