Fraud & Abuse in the Sales and Marketing of Drugs & Medical Devices

Opening Remarks from the Conference Co-Chairs

Katherine DeKam
Chief Compliance Officer
Acumed

Seth H. Lundy
Partner
King & Spalding LLP

Practical Analysis of a Game Changer: Interpreting the November 2020 Special Fraud Alert on Speaker Programs

Katherine DeKam
Chief Compliance Officer
Acumed

Seth H. Lundy
Partner
King & Spalding LLP

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:

• OIG’s objections to events held at restaurants and/or a significant period of time after a product is authorized
• Points of divergence from industry practices and what companies will need to change
• Considerations for resuming in-person speaker programs after the pandemic

Be prepared to turn on your audio and video and engage in conversation with our esteemed chairs!

Prosecutorial Perspectives on Recent Settlements, OIG’s Guidance, and Enforcement Priorities for 2021

Jolie Apicella
Chief, Health Care Fraud Unit
United States Attorney’s Office, Eastern District of New York

Lee M. Cortes, Jr.
Chief, Health Care Fraud Unit
United States Attorney’s Office, District of New Jersey

Amanda Masselam Strachan
Chief, Health Care Fraud Unit
United States Attorney’s Office, District of Massachusetts

Allan Medina
Chief, Health Care Fraud Unit
Criminal Division, Fraud Section, Department of Justice

Moderator:

David H. Resnicoff
Partner
Riley Safer Holmes & Cancila LLP

Join a panel of esteemed prosecutors in discussion of:

• What the enforcement activity of the past year reveals about the state of industry compliance with fraud and abuse laws
• Insight on how the DOJ is interpreting OIG’s Special Fraud Alert and its anticipated impact on future enforcement
• Types of industry practices under ongoing scrutiny
• Potential shifts in enforcement priorities under the Biden administration as some of the regulatory infrastructure dismantled under Trump is rebuilt

The Real-Life Lessons from the Novartis, Gilead, and Biogen Settlements: Key Liability Risks Relating to Speaker and Patient Assistance Programs

Sean C. Cenawood
Partner
Dentons

William A. Sarraille
Partner
Sidley Austin

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:

• Novartis’ $678 million settlement with the DOJ and corporate integrity agreement with OIG (in July 2020) over payments to care practitioners who spoke at Novartis events to induce them to prescribe the firm’s drugs
• Gilead’s $97 million settlement with the DOJ (in September 2020) resulting from use of a foundation as a conduit to cover the co-pays of Medicare patients taking a Gilead drug
• Biogen’s $22 million settlement with the DOJ (in December 2020) over allegations that it paid kickbacks to patient assistance charities in order to induce them to use its drugs

1:1 Peer-to-Peer Networking

Break

IN-HOUSE COUNSEL PANEL

Perspectives on Staying Compliant in the Context of the Pandemic, Managing Interactions with HCPs, and Keeping up with Evolving Regulatory Requirements

Stephen Chien
Global Compliance Lead, Senior Associate General Counsel
Gilead Sciences

Richard S. Liner
Senior Assistant General Counsel
Bayer Pharmaceuticals

Rebecca L. Orttel
Chief Counsel, U.S. Market and Global Health Law COE; Chief of Staff, Americas Region
Medtronic

Moderator:

Katie McDermott
Partner
Morgan, Lewis & Bockius LLP

• Compliance considerations surrounding sponsorship requests for virtual events in the COVID context and continued virtual interactions post-pandemic
• Conducting audits of compliance issues that may have gone unnoticed during the pandemic or that relate to measures taken in unusual times
• Evaluating when and how manufacturers can assist providers in setting up telemedicine arrangements that would enable patient access to their products, without violating of the AKS
• Overcoming compliance challenges as sales efforts resume with greater intensity
• Understanding how manufacturers and medical device companies can transition toward value-based contracting arrangements in compliance with the AKS
• Evaluating the potential for fraud in interaction with pharmacies – e.g., manufacturer involvement in completing prior authorization forms to ensure drug coverage; contacting pharmacy patients for resale reminders; obtaining data from pharmacies

What the Newest AKS Safe Harbors Mean for Pharmaceutical and Medical Device Manufacturers

Michael K. Loucks
Partner
Skadden, Arps, Slate, Meagher & Flom LLP

James Stansel
Executive Vice President & General Counsel
PhRMA

Julie Ritchie Wagner
Senior Assistant General Counsel
PhRMA

In late 2020, OIG finalized a series of safe harbors to the AKS. This session will analyze their implications and ambiguities:

• Debating the impact of eliminating the safe harbor for rebates paid by manufacturers to pharmacy benefit managers (PBMs)
• Assessing changes to protections for engaging healthcare providers through consulting agreements
• Expanded protection for drug and medical device companies for bundled product and service warranties

Closing Remarks & Briefing Adjourns