Suggestions for Safe Harbor proposals face a deadline of February 27, 2018, according to a Federal Register announcement. The same deadline applies to suggestions for practices that should be discussed in a Special Fraud Alert.

Safe Harbors

The Office of Inspector General (OIG) requests recommendations for Safe Harbors because the Anti-kickback statute “is so broad” that “relatively innocuous commercial arrangements” can violate the law. In order to promote effective healthcare practices, the OIG may designate certain “payment and business practices” will not be treated as criminal offenses under the Anti-kickback statute or the basis for administrative sanctions.

Factors for Safe Harbors

When evaluating whether to create a Safe Harbor, the OIG will consider how the proposal affects

  • access to health care services,
  • the quality of health care services,
  • patient freedom of choice among health care providers,
  • competition among health care providers,
  • the cost to Federal health care programs,
  • the potential overutilization of health care services, and
  • the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations.

Special Fraud Alerts

The OIG also solicits recommendations of practices that should be discussed in a Special Fraud Alert. These Alerts allow the OIG to provide guidance to the healthcare industry about practices that could be considered fraudulent. The Alerts assist providers to be compliant with the law.

How to Submit

Recommendations for either Safe Harbors or Special Fraud Alerts may be submitted through the Federal eRulemaking Portal at
by regular, express, or overnight mail to Patrice Drew, Office of Inspector General, Regulatory Affairs, Department of Health and Human Services, Attention: OIG-125-N, Room 5541C, Cohen Building, 330 Independence Avenue SW., Washington, DC 20201.