Labs and lab executives can face liability under the Anti-Kickback Statute when they engage in (or attempt to engage in) prohibited financial relationships. Broadly speaking, the Anti-Kickback Statute prohibits health care entities from paying or accepting referral fees and other forms of 'remuneration' using funds received from federal payors (i.e., Medicare and Medicaid). It also outlaws attempts to pay or accept these forms of compensation, as it specifically includes 'offering' and 'soliciting' remuneration among its prohibitions.
The regulations promulgated under the Anti-Kickback Statute establish several 'safe harbors,' and defending against alleged Anti-Kickback Statute violations often involves proving that a safe harbor applies. But, if a lab has not specifically structured a financial relationship to satisfy a safe harbor's requirements, establishing safe harbor protection may not be possible.