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A roadmap for diagnostic labs: Federal regulations

  • Stark law. Congress intended this prohibition of self-referrals to reduce the risk of physicians referring to certain labs purely for financial gain. Any connection must fit within an exception, referred to as IOAS exception.  
  • Anti-Kickback Statues. This law prohibits “knowing and willful” payments to induce referrals. Safe harbors are available and offer protection, but only if the agreement satisfies all the requirements.
  • False Claims Act. Any business that submits claims for payment through Medicare or Medicaid is generally subject to the FCA. The government uses this law to better ensure labs do not file false or fraudulent claims. The filing of such claims can result in fines and suspension of future payments.
  • Eliminating Kickback in Recovery Act of 2018. Lawmakers passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act to address patient brokering in opioid treatment facilities. Unfortunately, a provision within this act extends to labs that may not even provide services related to substance abuse treatment, outlawing previously acceptable business practices.

Additional state regulations may also apply. Navigating the nuances of these regulations is no easy task. However, a failure to take compliance seriously can lead to allegations of criminal wrongdoing. Labs can take proactive steps to reduce this risk.