OIG Seeks Public Recommendations for New Safe Harbors to the Anti-Kickback Statute

On December 17, the Department of Health and Human Services Office of Inspector General (OIG) issued its annual solicitation for proposals and recommendations from the public regarding the development of new safe harbors under the anti-kickback statute, 42 U.S.C. § 1320a-7b(b) (“the AKS”).

Safe harbors under the AKS are intended to shield from criminal penalties certain financial arrangements that could potentially induce improper patient referrals. Current safe harbors can be found at 42 CFR § 1001. Factors considered by OIG in reviewing recommendations for new safe harbors include whether the proposal will result in an increase or decrease in:

• Access to health care services;
• The quality of services;
• Patients' freedom of choice among providers;
• Competition among providers;
• The cost to federal health care programs;
• Potential overutilization of services; and
• The ability of providers to provide services in underserved areas or for underserved populations.

OIG also examines the existence of any financial benefit to providers that may affect their decision to provide services or refer services to another provider.

OIG has not yet adopted any of the proposals for new safe harbors submitted in response to the 2007 solicitation, but has adopted certain proposed safe harbors in previous years. OIG is continuing to study and evaluate several proposals that were submitted in fiscal years prior to 2007, in order to gather more data and experience on their necessity and potential for fraud and abuse.

All comments must be received by OIG by February 17, 2009.