Skadden Discusses Prosecutions of Medical Technology Companies

The CLS Blue Sky Blog

Jennifer L. Bragg Maya P. Florence William (Bill) McConagha

Partners John Bentivoglio, Jennifer Bragg, Maya Florence, Bill McConagha and counsel Karen C. Corallo outline how medical device and diagnostic and laboratory testing companies should expect close scrutiny from federal prosecutors, particularly where conduct poses a risk to patient health and safety, as federal spending on health care increases markedly in response to the COVID-19 pandemic. The authors analyze the U.S. Department of Justice's anticipated enforcement focus on usual kickback and False Claims Act issues and speaker program controls, and the government's range of efforts across the medical technology industry to monitor manufacturers, clinical laboratories, diagnostic testing companies and vendors of electronic health records software. Companies will likely need to update and adapt corporate compliance programs to address current and emerging risk areas in order to mitigate potential enforcement actions.