Thursday, July 14, 2011

Off-label Investigations: Recent Actions, Settlements and Enforcement Trends

is being presented by John E. Kelly & Cori Annapolen Goldberg, Partner & Senior Associate, with Fulbright & Jaworski L.L.P and airs on Wednesday, August 17th, 2011. For more details, or to register please visit our site at www.fxconferences.com

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.