Si-Bone Receives Updated Coverage Decision

San Jose, Calif.-based Si-Bone Inc., developer of the iFuse implant system for the fusion of the sacroiliac (SI) joint, announced today that the Medicare Administrative Contractor (MAC) Palmetto GBA will begin covering minimally invasive surgery (MIS) SI joint fusion, including when performed using the iFuse system, effective immediately, on a case-by-case basis.

Specifically, Palmetto has removed the current procedural terminology (most often called CPT) code 0334T, which is used by physicians to report the iFuse procedure, from their list of non-covered services. Palmetto is one of eight Part A/B MACs in the United States and the first to make this decision. The change will enable Medicare beneficiaries to receive coverage for the iFuse procedure throughout the states of North Carolina, South Carolina, Virginia and West Virginia. This coverage decision by Palmetto was based on published clinical data demonstrating the safety, effectiveness and clinical value of the iFuse procedure, according to Si-Bone officials.

“To ensure Medicare beneficiaries have access to the latest effective, evidence-based treatments, Palmetto GBA now allows access to MIS SI joint fusion for patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions who fail conservative therapy,” said Michael Mydra, vice president of health outcomes and reimbursement. “By removing the procedure from the non-coverage list, Palmetto confirms that the procedure is consistent with generally accepted standards of medical practice in the medical community and is safe and effective.”

The company received original U.S. Food and Drug Administration (FDA) 510(k) clearance in November 2008 to market its iFuse Implant System (then called the SI Joint Fusion System) for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.

Clinical publications have identified the SI joint as a pain generator in up to 22 percent of low back pain patients. An article in Pain Medicine published in 2011 identified the SI joint as a low back pain generator in 43-61 percent of post-lumbar fusion, so-called “failed back surgery,” patients.¹ Initial treatment options for patients with SI 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 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. According to the company, the implants have “substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures.”

Reference:
1. DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732-9.