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Compliance Considerations

(1) In considering how to resolve its exclusion authority, how does OIG assess future risk to the Federal health care programs and their beneficiaries posed by persons who have specifiedly engaged in civil health care fraud and are entering into an FCA settlement?

OIG applies published criteria to assess future risks and places each party to an FCA settlement into one of five categories on a risk spectrum developed by OIG. OIG uses its exclusion authority differently for parties in each category. To develop a risk assessment, we apply the published criteria to information that we have reviewed in the context of the resolved FCA case. Because our assessment of the risks posed by an FCA defendant may be relevant to various stakeholders, including patients, family members, and providers, OIG makes information publicly available about where an FCA defendant falls on the risk spectrum.

(2) What are some factors to consider when assessing the level of fraud and abuse risk posed by an arrangement that implicates the Federal anti-kickback statute?

Congress set forth a number of factors to consider when developing safe harbors; End of
Translation Click to Translate text after this point while not binding with respect to any assessment of an arrangement that implicates the Federal anti-kickback statute (other than in the establishment or modification of safe harbors (see section 1128D(a)(2) of the Act, 42 U.S.C. 1320a–7d(a)(2)), they are instructive for assessing risk under the Federal anti-kickback statute. For example, OIG’s advisory opinions frequently consider factors such as overutilization, increased costs to Federal health care programs, corruption of medical decision making, patient steering, and unfair competition. One of OIG’s Compliance Program Guidance documents reiterates these factors by highlighting the following questions to help guide an assessment of any problematic arrangements or practices identified:

  • Does the arrangement or practice have the potential to interfere with, or skew, clinical decision making?
  • Does the arrangement or practice have the potential to increase costs to Federal health care programs or beneficiaries?
  • Does the arrangement or practice have the potential to increase the risk of overutilization or inappropriate utilization?
  • Does the arrangement or practice raise patient safety or quality of care concerns?
  • Does the arrangement or practice raise concerns related to steering patients or providers to a particular item or service?

The health care community—and its partners—should be mindful of these types of factors and questions when structuring and reviewing arrangements that implicate the Federal anti-kickback statute. An affirmative answer to one or more of these questions is a red flag signaling an arrangement or practice may be particularly susceptible to the harms caused by fraud and abuse.

Last updated March 22, 2023