Do the Latest DOJ and OIG-HHS Compliance Program Effectiveness Guidance Documents Provide the Life Sciences Industry Anything New?

Our rapidly changing regulatory and enforcement environment is creating new compliance challenges. This makes the task of assessing compliance program effectiveness more acute.

In February 2017, the US Department of Justice (DOJ) issued new guidance—"Evaluation of Corporate Compliance Programs"— that lists 119 "sample questions" that the DOJ has frequently found relevant in determining whether to bring charges or negotiate plea and other agreements. Following that guidance, in March 2017 the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Health Care Compliance Association (HCCA) released "Measuring Compliance Program Effectiveness: A Resource Guide," that contains a list of 417 "measurement options" to measure program effectiveness.

Join us as we help you efficiently wade through these 500+ topics, issues and factors; help identify what is new; how to apply these factors; and which should be used. We also address how companies in the life sciences and healthcare sectors should apply these factors to specific topics and issues, particularly in the areas of payor interactions, healthcare provider consultants and speaker programs, and internal investigations and corrective actions.