Fighting health care fraud has been one of the current administration’s top law enforcement priorities. The past few years have seen bold and pointed steps by the Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) as well as federal lawmakers intent on proving the government’s commitment to the crackdown on health care fraud.

In the last two years, the DOJ has pursued and recovered a record amount of taxpayer dollars lost to health care fraud – more than in any other two-year period in the Department’s history. A major part of these recent recoveries comes from settlements involving off-label marketing and promotions by drug and device manufacturers. In 2009, DOJ announced the largest federal health care fraud takedown in U.S. history, which included the largest criminal fine ever imposed in the U.S. for any matter. The reason for the investigation and takedown? Off-label marketing.

With the government’s aggressive crackdown on health care fraud and abuse, it is imperative that companies arm themselves with the knowledge to identify risk areas and to protect themselves against government investigations that could cost billions in fines, penalties, and legal fees. This presentation looks at recent health care fraud and abuse as it relates to off-label marketing, and ways in which companies can protect themselves from undue scrutiny.

This audio conference covers:

• FDA labeling requirements
• What constitutes off-label marketing?
• Manufacturer liability
• Significant health care reform legislation and enforcement trends (FDCA, FCA, PPACA and the Federal Anti-Kickback Statute, HEAT initiative)
• Recent and pending government investigations
• Most profitable and other recent settlements
• Strategies for avoiding liability and limiting risk in government investigations

About the speakers:

John E. Kelly is a partner in Fulbright & Jaworski L.L.P.'s Washington, DC office. He is a member of the firm's Health Care and White Collar and Government Investigations practice groups and focuses on matters involving health care and health care litigation (criminal and civil), The Foreign Corrupt Practices Act (FCPA), corporate and government investigations, and regulatory and compliance issues. Prior to joining Fulbright, John had a distinguished career as a federal prosecutor with the Department of Justice where he held a number of leadership positions including serving as the Assistant Chief for Health Care Fraud of the Fraud Section, U.S. Department of Justice, Criminal Division. In that role, John supervised attorneys and specialized in investigating and prosecuting health care fraud matters nationwide. John obtained extensive trial and investigation experience as an Assistant United States Attorney and as an Assistant District Attorney in the State of New York.

Cori Annapolen Goldberg joined the Washington D.C. location of Fulbright & Jaworski L.L.P. in 2007. As a senior associate, she focuses her practice on health law matters, food and drug law issues, government and internal investigations, and white collar criminal defense. She has worked with clients including hospitals, academic medical centers, medical device manufacturers, pharmaceutical companies, physicians, and other health care providers. Her practice includes the representation of health care clients in compliance matters, including internal investigations and self-disclosures. Cori advises her clients on a broad array of topics including corporate compliance issues, the Anti-Kickback Statute, the Stark Law, and various food and drug law regulations. She also represents large corporations in investigations by the U.S. Department of Justice, the U.S. Securities and Exchange Commission and other federal and state agencies. Prior to joining Fulbright, Cori served as a judicial law clerk to Judge Clayton Greene, Jr. on the Court of Appeals of Maryland.

Who should attend?

• In-house Counsel
• Compliance Officers
• Regulatory Attorneys
• Sales Professionals
• Marketing Professionals