Patient Assistance Programs: Enforcement Trends and Regulatory Challenges

On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and related regulatory considerations. The conversation covers the legal framework governing these programs, including the Anti-Kickback Statute (“AKS”), Civil Monetary Penalties Law (“CMPL”), and False Claims Act (“FCA”). They focus on recent settlements and agency actions, and highlight key factors that influence regulatory outcomes for patient assistance programs.