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Day 1 - Thursday, March 18, 2021
Day 1 - Thursday, March 18, 2021
12:45 |
Opening Remarks from the Conference Co-ChairsKatherine DeKam Seth H. Lundy |
1:00 |
Practical Analysis of a Game Changer: Interpreting the November 2020 Special Fraud Alert on Speaker ProgramsKatherine DeKam Seth H. Lundy While falling short of declaring speaker programs by pharmaceutical and medical device companies as being in strict violation of the Anti-Kickback Statute (AKS), the Office of Inspector General (OIG)’s recent guidance affirms the agency’s strong reservations about such programs. This guidance outlines several “suspect characteristics” that would give rise to liability under the AKS, leading industry to seriously re-evaluate how it conducts speaking events. This session will address:
Be prepared to turn on your audio and video and engage in conversation with our esteemed chairs! |
1:45 |
Prosecutorial Perspectives on Recent Settlements, OIG’s Guidance, and Enforcement Priorities for 2021Jolie Apicella Lee M. Cortes, Jr. Amanda Masselam Strachan Allan Medina Moderator:David H. Resnicoff Join a panel of esteemed prosecutors in discussion of:
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2:45 |
The Real-Life Lessons from the Novartis, Gilead, and Biogen Settlements: Key Liability Risks Relating to Speaker and Patient Assistance ProgramsSean C. Cenawood William A. Sarraille In evaluating their own compliance measures, drug manufacturers must be cognizant of the deficiencies that led to recent, big-ticket enforcement actions. This session will examine three major settlements from the past year, each relating to violations of both the AKS and the False Claims Act (FCA), with an analysis of important lessons learned:
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3:45 |
1:1 Peer-to-Peer Networking |
3:55 |
Break |
4:15 |
IN-HOUSE COUNSEL PANELPerspectives on Staying Compliant in the Context of the Pandemic, Managing Interactions with HCPs, and Keeping up with Evolving Regulatory RequirementsStephen Chien Richard S. Liner Rebecca L. Orttel Moderator:Katie McDermott
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5:15 |
What the Newest AKS Safe Harbors Mean for Pharmaceutical and Medical Device ManufacturersMichael K. Loucks James Stansel Julie Ritchie Wagner In late 2020, OIG finalized a series of safe harbors to the AKS. This session will analyze their implications and ambiguities:
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6:00 |
Closing Remarks & Briefing Adjourns |