Safe Harbors to the Federal Anti-Kickback Statute in Orthopedics: A Rapid Review

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.

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.

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.

Out of 123 screened records, 17 sources were used to explore the AKS in terms of orthopedic practice. 18 additional sources were included to supplement this analysis. This study identified gray zones in orthopedics: consulting agreements, royalty arrangements, ASC investment terms, and industry funded travel. High-risk arrangements are often targeted by regulators when compensation is high, as demonstrated by recent multi-million dollar DOJ settlements.

AKS safe harbors provide vital protection but demand meticulous, ongoing documentation of compliance. As value-based care expands, orthopedic surgeons must ensure that modern, integrated business models are structured strictly around clinical justification and independent medical judgment, actively insulating patient care from personal financial incentives.