On December 30, 2014, the Department of Health and Human Services Office of Inspector General (OIG) published its annual solicitation for the development and/or modification of safe harbor provisions under the Federal Anti-Kickback Statute. The OIG also requested recommendations for the development of new OIG Special Fraud Alerts (SFAs). The deadline to submit comments to the OIG pursuant to the solicitation is March 2, 2015. The OIG has requested that any response to the solicitation include a detailed explanation or justification for the development or modification of a safe harbor or issuance of a SFA, as well as any empirical evidence in support of the request.

While Section 1128B(b) of the Social Security Act is broad reaching and attaches criminal liability to individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration to induce or reward business reimbursable under Federal health care programs, certain regulatory safe harbors do exist to protect specific payment and business practices so as not to trigger liability under the Anti-Kickback Statute. Through its annual solicitation, the OIG seeks input from the health care industry on current practices and factual circumstances that could justify development or modification of the safe harbors. The OIG also periodically issues SFAs as a form of guidance to the health care industry on topics or practices that the OIG finds potentially fraudulent, and similarly seeks input from health care industry stakeholders as to new issues or areas of concern that could be appropriate for a SFA.