Earlier this year, the Office of Inspector General (OIG) put smaller life sciences companies on notice that they should put in place a risk assessment process as part of their corporate compliance program. In its corporate integrity agreement (CIA) with EndoGastric Solutions, Inc. (EGS), the OIG required EGS to establish a risk assessment process to allow the company to:
- Identify and assess risks associated with the sale, marketing, detailing, advertising and promotion of products reimbursed by government health care programs
- Devise and implement specific measures to mitigate identified risks
The risk assessment requirement in the EGS CIA is one more example of the OIG clearly signaling that its expectations with respect to smaller company corporate compliance programs are not significantly different than its expectations of Big Pharma compliance programs.