Federal Health Care Programs: Fraud and Abuse; Statutory Exception to the Anti-Kickback Statute for Shared Risk Arrangements

In accordance with section 216 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, this interim final rule establishes two new safe harbors from the anti- kickback law (section 1128B(b) of the Social Security Act) to provide protection for certain managed care arrangements. The first safe harbor protects certain financial arrangements between managed care plans and individuals or entities with whom they contract for the provision of health care items and services, where Federal health care programs pay such plans on a capitated basis. The second safe harbor protects certain financial arrangements between managed care plans (including employer-sponsored group health plans) and individuals or entities with whom they contract for health care items and services with respect to services reimbursed on a fee-for-service basis by a Federal health care program provided that such individuals and entities are placed at substantial financial risk for the cost or utilization of items or services furnished to Federal health care program beneficiaries. Each of these safe harbors set forth standards that will result in the particular arrangement being protected from criminal prosecution and civil or administrative sanctions under the anti-kickback provisions.