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The Department of Justice building Washington, D.C., The Department of Justice building in Washington, D.C.

As federal spending on health care increases in response to the COVID-19 pandemic, including spending on medical devices and diagnostic and laboratory tests, companies should expect close scrutiny from federal prosecutors, particularly where conduct poses a risk to patient health and safety. Few sectors within the health care space have received greater scrutiny from U.S. Department of Justice prosecutors than medical technology companies. We analyzed settlements with such companies (including device manufactures, laboratories and health technology vendors) from 2014 to 2019 and found the following: 67 companies reached settlements totaling more than $1.9 billion in fines, penalties and forfeitures. Kickbacks were the most common type of alleged misconduct, followed by unlawful promotional practices and quality and manufacturing problems. Corporate compliance programs—updated and adapted to address current and emerging risk areas—are essential in mitigating potential actions.

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