Si-Bone said a Medicare administrative contractor, Palmetto GBA, reversed its non-coverage policy on the medical device company’s iFuse spinal fusion device.
The decision opens coverage for the iFuse sacroiliac procedure to patients on a case-by-case basis in North Carolina, South Carolina, Virginia and West Virginia, according to a press release.
San Jose, Calif.-based SI-Bone said the iFuse device won 510(k) clearance from the FDA in 2008 and landed CE Mark approval in the European Union in 2010. Palmetto GBA is the 1st of the 8 regional Medicare contractors to lift the ban on iFuse coverage, the company said.
During the iFuse procedure, surgeons implant small titanium devices coated with a porous, titanium plasma spray designed to help decrease implant motion, provide immediate fixation and promote biological fixation for long-term fusion, according to the release.
“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. 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,” SI-Bonehealth outcomes & reimbursement vice president Michael Mydra said in prepared remarks.
Chris Walker contributed to this report.
