Si-Bone said today it won a positive local coverage determination from Kentucky and Ohio Medicare administrative contractor CGS Administrators for its minimally invasive surgical sacroiliac iFuse Implant joint.
The reimbursement decision will take effect Feb. 1, 2016, San Jose, Calif.-based Si-Bone said. CGS is the 6th MAC to provide coverage for the joint fusion device.
“This is a welcomed decision by CGS Administrators and not only continues to validate the safety and effectiveness of the iFuse Implant System, but also creates access for numerous Medicare beneficiaries in need of this treatment,” Si-Bone health outcomes & reimbursement veep Michael Mydra said in prepared remarks.
The coverage inclusion is based on clinical publications reporting on the safety and effectiveness of the iFuse, which detail that it “consistently show improved pain scores with fewer complications than open fusion in patients with non-infectious, non-traumatic related SI pain,” Si-Bone said.
The company’s joint fusion device is the only MIS SI joint fusion device cleared by the FDA with an indication for improving pain, function and quality of life, the company said.
In November, Si-Bone won FDA 510(k) clearance for its minimally invasive iFuse implant system designed for fusion of the sacroiliac joint.
The device is cleared for treating certain disorders of the sacroiliac joint, and its indication includes a statement that treatments with the device “improved pain, patient function and quality of life at 12-months post implantation,” San Jose, Calif.-based Si-Bone said.
The post Si-Bone touts midwest Medicare reimbursement win appeared first on MassDevice.
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