Written by Laura Dyrda
Obtaining reimbursement for new spine surgery technology isn’t a walk in the park. There are instances where a new technology receives FDA clearance, support from spine societies, a Category 1 CPT code and coverage by Medicare and Medicaid, and a number of articles detailing clinical evidence supporting use of the technology is published, yet commercial insurance companies still question the procedure.
“The coverage bar in the US has been set pretty high for reimbursement from commercial payers,” says Jeffrey Dunn, president and CEO of SI-BONE. “It appears that it’s not enough to have positive clinical evidence. In our particular case, there are over 30 peer-reviewed clinical publications specific to the iFuse Implant System® demonstrating safety and effectiveness. Among these publications are 12-month results from a Level I randomized controlled trial and 12-month results from a prospective multicenter single-arm study. Combined, these studies involve over 300 patients treated with iFuse and so far have demonstrated improved pain, patient function, and quality of life at 12 months post-implantation. All of our iFuse studies have been summarized in a systematic review or meta-analysis that was published in the International Journal of Spine Surgery in July 2015. There are also several U.S. retrospective publications, European publications, studies comparing iFuse to open SI joint fusion, all of which show positive improvements after the iFuse procedure. In addition, there are long-term outcome publications showing that positive results achieved at one year are sustained to 4 ½ and five years. Beyond what’s currently published, additional publications are expected in the coming months, including six-year single-center results, three-year multicenter results and 24-month results from two ongoing prospective multicenter trials, one of which is INSITE, the randomized controlled trial. You would think with this substantial body of clinical evidence showing consistent positive outcomes, along with positive coverage recommendations from NASS and ISASS that include well-defined inclusion and exclusion criteria saying minimally invasive SI joint fusion should be covered, that insurance companies would cover this procedure. But there are still many that aren’t.”
