COMPLIANCE GUIDANCE

Anti-kickback and Stark Law Compliance Tips

There have been a number of anti-kickback and physician self-referral (Stark) cases involving laboratories in recent years. Many laboratory compliance officers may need to focus compliance efforts on these laws and regulations. Here are a few reminders and tips that may be helpful when these laws are implicated.

  • If the anti-kickback laws are implicated, it is essential that any potential Stark implications are examined. Often, both are involved. One key element for Stark violation is that a physician or practitioner who can make referrals must be involved. Generally speaking—no physician, no Stark problem.
  • Note that these laws include more criteria than just the issues of fair market value and value and volume of referrals. Always examine all of the criteria for a safe harbor or a Stark exception.
  • When considering whether there is an anti-kickback violation, look for anything that ties or implies that remuneration is being given in consideration for, or in exchange for, referrals.
  • Exclusivity clauses in any agreements or language that requires the referral of other business in order to receive the remuneration are red flags.
  • To ensure you are in compliance with Stark, if your lab is paying physicians for any service, providing something for free or giving them anything of value, you must find an exception for it, and all of the criteria for the exception must be met.
  • For either of these laws, written agreements are required.
  • Finally, the consequences of violations of these laws are severe. If you are unsure that what you are being asked to approve is legal, seek the advice of counsel familiar with these laws and their application to the clinical laboratory setting.

For more compliance insight and discussion and analysis of the latest enforcement cases involving Stark and Anti-Kickback as well as False Claims violations, see G2 Intelligence’s Lab Compliance Essentials 2017: Managing Medicare Fraud & Abuse Liability Risk.

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