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

Registration + Arrival Refreshments

Co-Chairs’ Opening Remarks

Heather Hurst
Global Director, Global Ethics & Compliance Officer
Cook Medical

Richard S. Liner
Senior Assistant General Counsel
Bayer

Keynote Address

What the Adoption of OIG Speaker Program Guidance into the PhRMA Code Will Mean for the Industry

Julie Ritchie Wagner
Head of Global Ethics, Compliance & Enforcement Legal Policy
Pharmaceutical Research and Manufacturers of America (PhRMA)

Compliance Executive Perspectives on the Latest OIG Pronouncements and the Evolving PhRMA Code: Thoughts on Speaker Programs, Kickback Risks and Forecasts for Future Fraud and Abuse Guidance

Arbella Cherkis
Ethics & Compliance Director, US Specialty
GSK

Tracy Palmer Berns
SVP, Chief Compliance & Quality Assurance Officer
Ionis Pharmaceuticals, Inc.

Katherine DeKam
Chief Compliance Officer
Acumed

The recent PhRMA Code update, which largely echoes the OIG’s Special Fraud Alert regarding health care speaker programs, raises significant concerns about companies offering or paying remuneration in connection with speaker programs in violation of health care fraud and abuse laws. This session will explore key considerations for modifying business models to address PhRMA code changes, as well as:

• Identifying and addressing high-risk activities of speaker programs
• Critical steps in operationalizing and executing compliant speaker programs
• Compliance pitfalls that medical device and pharma companies should be most mindful of in the aftermath of the OIG Special Fraud Alert
• Recent investigations and their impact on monitoring promotional programs
• Exploring other recent OIG pronouncements and opinions, and analyzing forecasts for future OIG fraud and abuse guidance

Networking Break

Analyzing DOJ Enforcement Priorities in Light of Recent OIG Guidance and Initiatives for the Life Sciences Industry

Allan Medina
Acting Senior Deputy Chief
U.S. Department of Justice, Criminal Division, Fraud Section

David Derusha
Assistant U.S. Attorney
U.S. Attorney's Office for the District of Massachusetts

Amanda Page Masselam Strachan
Assistant United States Attorney
Chief, Health Care Fraud Unit
U.S. Attorney's Office, District of Massachusetts

Moderator:

Jane H. Yoon
Partner
Paul Hastings LLP

• Understanding what the latest DOJ enforcement activity reveals about its interpretation of the OIG Guidance to date, as well as its anticipated impact on future enforcement
• Analyzing the OIG’s role in False Claims Act (FCA) enforcement: examining enforcement tools that OIG is utilizing in FCA matters
• Addressing shifting enforcement priorities as we proceed into our second year of the Biden Administration and how industry can prepare for what’s coming down the pike

Networking Luncheon

Navigating the Latest Fraud & Abuse Risks Associated with Payer Relationships, Value-Based Arrangements and Market Access Agreements

Richard S. Liner
Senior Assistant General Counsel
Bayer

Vladimir Jeune
Associate General Counsel – Market Access and Operations
EMD Serono, Inc.

Andrew Ruskin
Partner
K&L Gates LLP

• Understanding where to look for inducement and kickback concerns in your payer relationships and interactions
• Fraud and abuse compliance pitfalls to avoid when setting up payer contracts
• Analyzing the latest risks associated with value-based contracting and best price reporting
• Examining recent CMS guidance on how manufacturers can report multiple “best prices” for value-based purchasing arrangements under the Medicaid Drug Rebate Program (MDRP)

Break

Evaluating the Potential Fraud and Abuse Risks Associated with Personalized Medicine

John D. W. Partridge
Partner
Gibson Dunn & Crutcher LLP

Jennifer Bragg
Partner, Life Sciences and Health Care; Litigation
Skadden, Arps, Slate, Meagher & Flom LLP

Anna Laakmann
Senior Counsel - Global Commercial Operations
Amgen

• Exploring the latest federal fraud and abuse pitfalls inherent in certain precision medicine arrangements
• Analyzing OIG’s recent advisory opinion highlighting pharmaceutical company kickback risks associated with incorporating free genetic testing into their marketing plans
• Understanding how donations and financial relationships with patient advocacy groups in precision medicine collaborations may trigger certain fraud and abuse risks
• Evaluating recent OIG guidance on when a pharmaceutical manufacturer may provide financial assistance to a patient prescribed a personalized medicine drug
• Assessing the fine line that precision device companies must walk in providing product support to HCPs without it being qualified as “inducement”
• Comprehending the false claims implications of promoting certain precision medicines
• How to proceed in making claims about precision therapies when some patients receiving the medication have a genetic predisposition and some do not

Establishing Best Practices for Interacting with Health Care Professionals to Ensure Ethical Business Conduct and Fraud & Abuse Risk Mitigation

Heather Hurst
Global Director, Global Ethics & Compliance Officer
Cook Medical

Adam Yoffie
Senior Corporate Counsel, Litigation & Government Investigations
Bristol Myers Squibb

Matt Wetzel
Partner
Goodwin Procter LLP

Moderator:

Nathaniel (Nate) Mendell
Partner
Morrison & Foerster LLP

• Setting company standards for building ethical relationships with healthcare professionals
• Analyzing the evolving industry standard for HCP interactions
• Addressing the Advanced Medical Technology Association’s revisions to its Code of Ethics on Interactions with Health Care Professionals: understanding the impact on how device manufacturers and HCPs interact
• What the new DOJ enforcement policy means in practice for interactions with HCPs
• Best practices for confronting incidences of bribery
• Examining the impact of recent cases and enforcement priorities
• Exploring how the pandemic continues to impact the way companies promote their products to HCPs and compliance pitfalls to avoid amid this new environment

Conference Concludes