New positive commercial payor policy covering coflex for the surgical treatment of lumbar spinal stenosis

Coflex interlaminar stabilisation device (Paradigm Spine)

Paradigm Spine, a company specialising in the treatment of lumbar spinal stenosis, has announced the issuance of a broad coverage medical policy from BlueCross BlueShield of South Carolina covering its coflex device for the surgical treatment of lumbar spinal stenosis.

The coverage policy is entitled “Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)”, and is dated August 2018. BlueCross BlueShield of South Carolina is the largest commercial payor in South Carolina.

Lumbar spinal stenosis, affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (50 years and above) often associated with significant leg and back pain, numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for lumbar spinal stenosis include a decompression that removes bone and soft tissue and may also require a fusion to stabilise the spine. The coflex device (Paradigm Spine) is a non-fusion, motion-preserving stabilisation implant, that has pre-market approval (PMA) from the US Food and Drug Administration (FDA) for the treatment of lumbar spinal stenosis and is used in conjunction with a decompression, or used in lieu of a spinal fusion.

The BlueCross BlueShield medical policy defines Interspinous spacers as, “devices implanted between vertebral spinous processes.” The commercial insurance coverage document continues: “Interlaminar spacers are implanted between adjacent lamina and have two sets of wings that are placed around the inferior and superior spinous processes. These implants aim to restrict painful motion while otherwise enabling normal motion. The devices (spacers) distract the laminar space and/or spinous processes and restrict extension. This procedure theoretically enlarges the neural foramen and decompresses the cauda equina in patients with spinal stenosis and neurogenic claudication. Other types of dynamic posterior stabilisation devices are pedicle screw/rod-based devices and total facet replacement systems; these are not covered in this policy.

“One type of interspinous implant is inserted between the spinous processes through a small (4-8 cm) incision and acts as a spacer between the spinous processes, maintaining the flexion of that spinal interspace. The supraspinous ligament is maintained and assists in holding the implant in place. The surgery does not include any laminotomy, laminectomy, or foraminotomy at the time of insertion, thus reducing the risk of epidural scarring and cerebrospinal fluid leakage. Other interspinous spacers require removal of the interspinous ligament and are secured around the upper and lower spinous processes. Interlaminar implants are inserted between the adjacent lamina and spinous processes following decompressive surgery. These may be referred to as interlaminar implants or an interspinous U.”

As an interlaminar device, coflex is covered under these recommendations.

Marc Viscogliosi, Chairman and CEO, comments on this most recent policy coverage: “With more than 90 peer-reviewed published articles, including landmark long-term follow-up clinical studies, spine medical society guidelines, and now with additional commercial insurance coverage, it is wonderful to be able to expand patient access to the coflex technology.”


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