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.

Complying with Breach Notification Provisions of the HITECH Act

is being presented by Kate Borten, President, of The Marblehead Group and airs on Thursday, June 17th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

The HITECH Act’s requirement for breach notification is the first national law – and the most sweeping – to call for the notification of individuals whose Protected Health Information (PHI) has been breached. The law and subsequent HHS rule are enforceable now, and organizations that incur a breach and fail to fulfill all of the standards are subject to both state and federal penalties.

This audio conference summarizes the breach notification requirements under the HITECH Act, highlighting areas that are particularly challenging for organizations, such as defining incidents and determining harm. It explains how breach notification steps fit into the mandated incident response plan and the need for proactive planning. Additionally, the speaker draws upon several real-life case studies to highlight important lessons learned.