Is Off-Label Use of BMP in Pediatric Spine Surgery Now a Standard of Care?

Abstract

I was recently involved in a battle with an adult patient’s private insurance company over hospital payment for the off-label use of bone morphogenetic protein (BMP) during a routine L5-S1 anterior lumbar interbody fusion procedure. The U.S. Food and Drug Administration (FDA) indication for use of BMP at the L5-S1 level mandates utilization of a specific threaded titanium interbody cage; I had instead used a polyetheretherketone (PEEK) cage1. The insurance company insisted that any use of BMP outside of the strict FDA criteria was experimental and there would be no reimbursement. I argued that the widespread off-label use of BMP in adult spine fusion surgery, by definition, makes such use a standard of care in the U.S. One recent study, I pleaded, suggested that up to 85% of BMP use in 2009 was off-label2. The insurance company countered with recent studies that suggested high complication rates with the use of BMP in …