In AKS, what is the role of safe harbors?

• A. They may apply if specific conditions are met to protect certain arrangements from liability.
• B. They remove all risk regardless of conditions.
• C. They apply only to pharmaceutical payments.
• D. They are not applicable to Medicare.

Answer: (A)

Safe harbors under the Anti-Kickback Statute are explicit criteria that, when fully satisfied, provide a defense against liability for certain health care arrangements involving federal programs. This means they may apply if specific conditions are met to protect those arrangements from liability, which is exactly what the best choice states. They’re not a blanket guarantee and don’t remove all risk; you must structure and document the arrangement to meet all the criteria. Safe harbors cover a broad range of arrangements, not just pharmaceutical payments, and apply to programs like Medicare and Medicaid.