Punishing health care fraud--is the GSK settlement sufficient?

Source

Boston University School of Law, Boston, USA.

These measures can certainly be improved. For one thing, though all these provisions seem advisable, they are imposed only under a corporate integrity agreement, as opposed to official regulations, and expire in 5 years. Legislative reformers should consider whether the entire industry should be regulated on a level playing field, as opposed to through piecemeal agreements. In addition, individuals must be held responsible in appropriate circumstances. Models might include federal tax law, under which directors and officers of nonprofit corporations cannot be indemnified against fines imposed on them as individuals for particularly egregious violations.3 Key leaders can also be excluded from participation in federal health programs. The academic researchers involved in the controversy regarding the safety data for Avandia has thus far escaped sanctions as well.4

If the corporate fines are too small, the False Claims Act will need to be amended so that a higher percentage of the revenues derived from fraudulent activities is recouped. At the same time, federal law must insist on greater transparency for clinical trial results, so that negative safety data are not hidden from clinicians and regulators.

Finally, these types of fraud are hard to detect from the outside. Internal documents are often critical to these cases. Most of the time, these documents are provided by internal whistleblowers. In a recent survey, researchers identified several ways in which the whistleblower provisions of the False Claims Act could be strengthened to encourage whistleblowers to come forward and to protect them from retaliation.5 Whistleblowers should be encouraged, not punished for their testimony.

TimAllenMDJD

Saturday, October 13, 2012