The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently announced its annual solicitation of proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the federal anti-kickback statute as well as for developing new OIG Special Fraud Alerts.

The criteria used by the OIG to determine whether to modify or establish a Safe Harbor are whether the change would affect:

  • Access to healthcare services
  • The quality of healthcare services
  • Patient freedom of choice among healthcare providers
  • Competition among healthcare providers
  • The cost to federal healthcare programs
  • The potential overutilization of healthcare services, and
  • The ability of health care facilities to provide services in medically underserved areas or to medically underserved populations

In addition, the OIG “will also consider other factors, including, for example, the existence (or nonexistence) of any potential financial benefit to health care professionals or providers that may take into account their decisions whether to (1) order a health care item or service or (2) arrange for a referral of health care items or services to a particular practitioner or provider.”

Comments must be submitted to the OIG by February 22, 2016.