This update summarizes some of the recent trends in compliance and regulatory enforcement for laboratories. It also serves as a reminder to implement and maintain robust compliance policies and procedures in order to face these challenges.
Whether you operated a traditional diagnostic lab, a toxicology lab, or one that performs high-complexity genetic and genomic testing, there were plenty of regulatory nightmares to keep.
Despite some regulatory flexibilities granted to clinical laboratories during the COVID-19 crisis, there are two separate federal anti-kickback laws labs must strictly adhere to.
Kathryn F. Edgerton is a Member of Mintz's Los Angeles office. Kathryn advises hospitals and other health-related organizations on a broad range of transactional, regulatory, and strategic issues.
In the post-COVID era, health care fraud and abuse issues will be aggressively and swiftly enforced by the government. The legal framework and regulations in the health care space can.