Medicare and State Health Care Programs: Fraud and Abuse; Clarification of the Initial OIG Safe Harbor Provisions and Establishment of Additional Safe Harbor Provisions Under the Anti- Kickback Statute

This final rule serves both to add new safe harbor provisions under the Federal and State health care programs' anti-kickback statute, as authorized under section 14 of Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, and to clarify various aspects of the original safe harbor provisions now codified in 42 CFR part 1001 (originally proposed in RIN 0991-AA74). Specifically, this final rule modifies the original set of final safe harbor provisions codified in 42 CFR 1001.952 to give greater clarity to that rulemaking's original intent. In addition, this final rule sets forth an expanded set of safe harbor provisions designed to protect additional payment and business practices from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.