Proof of Compliance Efforts Is ‘Lifeboat’ in Justice Department Investigations, Expert Says
Healthcare inflation, widespread violations and successful prosecutions of manufacturers have created a “perfect storm” — an ideal environment for kickback investigations of the medical device and pharmaceutical industries, an industry expert said.
Prosecutors are focusing on relationships with providers, particularly consulting agreements with physicians, Michael Bell, attorney with Mintz Levin, said. Red flags include no-show jobs and high payments for minimal services.
When the first request for documents comes in, companies can shape the tone of the investigation and the result, Bell said, speaking during a Center for Business Intelligence webinar.
A company should be able to show the mechanisms it has in place to prevent the conduct under investigation. It should show that this was an anomaly, not a practice condoned by corporate culture or policy. “Your lifeboat is effective compliance,” Bell said.
Demonstrable compliance may prompt prosecutors to use their discretion not to prosecute or to prosecute for a lesser offense. It also may influence the Justice Department’s decision to pursue a case or offer a settlement, he said.