The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Federal Register notice last week soliciting proposals and recommendations for developing new and/or modifying existing safe harbor provisions for the federal Anti-Kickback Statute (AKS) in accordance with section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987. The Federal Register notice also requests input for developing new OIG special fraud alerts. Topics considered by the OIG in 2013 for new safe harbor provisions included the following: free or reduced cost continuing medical education programs for health care providers, rewards programs for patient compliance, discounts on Medicare Part A-covered services offered by independent providers to skilled nursing facilities, complimentary patient transportation services, and compensation to individuals in clinical trials and the provision of services related to the clinical trials at no cost. The OIG also considered modifications to the following current safe harbor regulations in 2013: electronic health records, investments in group practices, investments in ambulatory surgical centers, obstetrical malpractice insurance subsidies, hospital recruitment payments to practitioners, space rental and employee compensation. All comments must be submitted to the OIG by February 25, 2014.
The OIG considers a number of factors when evaluating new safe harbor provisions, modifications to existing safe harbor provisions, and issuing new special fraud alerts. Specifically, the OIG considers the extent to which the proposal would affect an increase or decrease in: access to health care services, quality of health care services, patient freedom of choice among health care providers, competition among health care providers, cost to federal health care programs, potential overutilization of health care services, ability of health care facilities to provide services in medically underserved areas or to medically underserved populations, and whether there is any potential financial benefit to health care professionals or providers that may be taken into account in their decisions whether to order or arrange for a referral of health care items or services to a particular practitioner or provider.