Orthopedic reviews
Safe Harbors to the Federal Anti-Kickback Statute in Orthopedics: A Rapid Review
By Couris T, Lehmann P, Cappiello P and 2 others.
Abstract
Introduction
Orthopedic surgery relies on complex collaborations across ambulatory surgery centers (ASCs), device industries, and value based care models. However, a lack of specialty-specific guidance leaves orthopedic surgeons vulnerable to Federal Anti-Kickback Statute (AKS) violations. This review maps how legal safe harbors apply directly to modern orthopedic business arrangements.
Objective
The purpose of this review is to summarize the federal Anti-Kickback Statute safe harbors most relevant to orthopedic practice, clarify how they apply to common orthopedic business arrangements, identify high-risk arrangements in orthopedic practice, and to demonstrate practical compliance strategies.
Methods
A rapid review of PubMed, PMC, and Google Scholar was conducted from inception to October 29, 2025. This search was supplemented with official federal materials, Office of Inspector General (OIG) advisory opinions, and Department of Justice (DOJ) enforcement actions to synthesize a narrative compliance framework for orthopedic practice.