Danielle and Seth point out that “recent enforcement actions have made clear that fraud, waste, and abuse is a continual concern of regulating agencies for the healthcare space, including for clinical laboratories.” Reports from multiple government agencies – including the U.S. Department of Health and Human and Services, the Office of Inspector General and the U.S. Department of Justice – show that “[e]nforcement actions over the last several years have focused on medical necessity, payment to marketers, kickbacks, and general relationships between laboratories and referring entities/providers…A laboratory may want to stop and ask itself the broader question whether relationships are commercially reasonable, make objective sense, and assess the purpose of any proposed relationship. An investment in a laboratory’s compliance and auditing functions, ensuring that they are well designed, applied in earnest and in good faith, and provide an active, functional set of policies and procedures may be the best recipe to avoid disaster.” Read the article.