Corporate compliance officers in the healthcare and pharmaceutical industries are feeling a little uneasy these days over a wave of settlements with the Department of Health and Human Services that raise the specter of holding senior executives criminally liable for the compliance failures of others.
At issue is new language contained in many of the corporate integrity agreements that companies have inked with the HHS Inspector General’s Office. The language expands the scope of “certifying employees” who must provide written certification attesting to the effectiveness of the company’s corporate compliance program. Historically, such provisions only applied to the chief compliance officer. Now they are growing to include many more levels of corporate leadership, including the CEO and the board of directors.

