U.S. Attorney’s Office Roundtable: The Enforcers Speak

March 12, 2015 3:00pm

David S. Schumacher
Assistant United States Attorney
District of Massachusetts

Keith V. Morgan
Assistant U.S. Attorney and Deputy Chief, Civil Division
District of Columbia, U.S. Department of Justice

David L. Kirman
O’Melveny & Myers LLP

Zachary Cunha
Assistant United States Attorney
District of Rhode Island (Providence, RI)

Jacob T. Elberg
Chief, Health Care & Government Fraud Unit
U.S. Attorney's Office, District of New Jersey


Jack W. Pirozzolo
Sidley Austin LLP

DOJ announced it has no intentions on letting up on its pursuit of fraud and abuse in this industry, to the contrary, it has indicated criminal prosecutions will be on the rise. With new government regulations and guidance for enforcement priorities, don’t miss this unique opportunity to hear directly from the enforcers as they share their insights and touch on:

  • Identifying the types of sales and marketing activities that raise red flags for state enforcers and have potential to trigger an investigation
    • FCA violations
    • Off-label promotion
    • Anti-Kickback
  • Are the AdvaMed and PhRMA codes considered the industry standard by which your organizations’ actions will be measured?
  • What they are looking for in reporting?
  • When does the DOJ pursue parallel criminal and civil investigations?
  • When does the DOJ pursue prosecution of individuals?
    • How does that impact cooperation from corporations?
  • When to voluntarily disclose
  • What changes should be expected in upcoming consent decrees and Corporate Integrity Agreements?
  • cGMP prosecutions and other categories of enforcement actions the enforcers see on the horizon