SI-BONE has announced that Priority Health (Michigan, USA) published an update to its Lumbar Fusion Medical Policy No. 91590-R4 providing positive coverage for SI-BONE’s MIS sacroiliac joint fusion procedure. The policy states that the fusion procedure, which employs the iFuse implant system, may now be considered medically necessary for members with sacroiliac joint disruptions and degenerative sacroiliitis.
Priority Health is the third largest commercial insurer in Michigan, covering over half a million lives.
“This positive coverage decision from a leading commercial insurer is another welcome validation of the clinical benefits of the iFuse implant system for treating patients with sacroiliac joint dysfunction directly resulting from sacroiliac joint disruptions and degenerative sacroiliitis,” says Michael Mydra, vice president of Health Outcomes and Reimbursement for SI-BONE. “The growing body of clinical evidence and positive coverage policies, like that coming from Priority Health, once again confirm that the procedure represents an accepted standard of care in the medical community. We are pleased that a growing number of US patients seeking a minimally invasive surgical approach to pain relief from certain sacroiliac joint disorders will now have access to this unique treatment option.”
SI-BONE had previously announced positive coverage news from Medicare Administrative Contractors Novitas Solutions and Palmetto GBA, LLC earlier this year.
SI-BONE received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse implant system. The CE mark for European commercialisation was obtained in November 2010.
Clinical publications have identified the sacroiliac joint as a pain generator in up to 22% of low back pain patients. In addition, DePalma et al, Pain Medicine 2011, identified the sacroiliac joint as a low back pain generator in 43% to 61% of symptomatic post-lumbar fusion, so-called “failed back surgery,” patients. Initial treatment options for patients with sacroiliac joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.
The iFuse implant system is a commercially available device in the US and Europe. The iFuse procedure uses a small incision for delivery and implantation of titanium implants. The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and allow for biological fixation to support long term fusion. The iFuse system is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse implant.