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The Anti-Kickback Statute is one of the two main federal statutes that deal with remuneration related to improper referrals, with the other being the Stark Law. Although these two laws are similar, there are several important distinctions between the Anti-Kickback Statute versus the Stark Law. 

  • First, unlike the Anti-Kickback Statute which includes civil and criminal penalties, the Stark Law is exclusively a civil enforcement statute. 
  • Second, the Stark Law is narrower. Whereas the Anti-Kickback Statute applies to Medicare and any federal healthcare program, the Stark Law is limited only to designated health services (DHS) paid for by Medicare. 
  • Third, the element of intent is required for a violation of the Anti-Kickback Statute but not of the Stark Law, which is a strict liability statute. 
  • Fourth, the Anti-Kickback Statute applies to any referral source, i.e., not just physicians. However, a violation of the Stark Law must involve a referral relationship between a physician and an entity. 

The complex legal landscape governing these Anti-Kickback Statute issues coupled with the federal government’s commitment to prosecuting violators, and levying significant penalties against them, represents a lethal combination for healthcare organizations and personnel. With so much at stake financially and professionally, healthcare providers who receive notice of an Anti-Kickback Statute investigation—usually under a governmental request for records such as a subpoena or civil investigate demand—should immediately engage legal counsel who has healthcare litigation and Anti-Kickback Statute experience.

This is true even if the notice attempts to downplay the significance of the investigation by only requiring the production of documents or by suggesting another person or entity is the intended target. It is important to remember that regardless of what the notice says, it is being sent by a government agency or office that is tasked with criminally and civilly enforcing the laws and punishing all violators, regardless of the investigation’s initial scope or purpose.