Managing the Finer Points of Parallel Investigations: Reconciling the Requirements of the False Claims Act and the Controlled Substances Act

March 15, 2023 3:30pm

Natalie Waites
Assistant Director, Fraud Section, Civil Division
U.S. Department of Justice

Matthew Feeley
Deputy Chief & Healthcare Fraud Coordinator, USAO SDFL Civil Division
U.S. Department of Justice

Jonathan M. Phillips
Partner
Gibson, Dunn & Crutcher LLP

Charles Graybow
Senior Compliance Counsel
Pfizer

Moderator:

Jolie Apicella
Partner
Wiggin & Dana LLP
Former AUSA, Chief of Healthcare Fraud, Eastern District of New York

Parallel investigations have unique considerations that must be considered when developing your legal, compliance and business strategies. Enforcement trends show that federal authorities target individual actors for criminal sanctions under the Controlled Substances Act, and target corporate entities for civil remedies, frequently under both the False Claims Act and the Controlled Substances Act. Parallel investigations have unique considerations that must be considered when developing your legal strategy. In this session, topics of discussion include:

  • Reviewing the CSA civil penalty and FCA framework to understand what actions may give rise to a claim under the Act;
    • Understanding CSA civil provisions
    • Learning the anatomy of an FCA lawsuit
  • Implementing effective and comprehensive FCA compliance measures and outlining best practices to maintain FCA compliance
  • Distinguishing between corporate and individual liability and knowing which factors can negatively or positively affect the other
    • When is it in the corporation’s interest to self-disclose and cooperate with investigations into individual actors within the corporation?
    • What are the privacy and self-incrimination considerations?
    • Understanding the new Monaco memo requirements
  • Knowing when to hire outside counsel to avoid conflicts of interest