OIG Exclusion Guidance Will Serve As Warning to Company Officials

Individual officers and managing employees at a device company can be labeled a criminal and banned from the industry because of someone else’s misconduct, according to a new guidance from HHS’ Office of Inspector General (OIG). The Social Security Act permits OIG to exclude individual officers and managing employees from participation in federal healthcare programs because of company misconduct — even if they are unaware of it. Since there is no knowledge element required, “OIG has the authority to exclude every officer and managing employee of a sanctioned entity,” OIG says in the guidance on implementing its exclusion authority.
Devices & Diagnostics Letter