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NASS issues coverage recommendations for interlaminar stabilization device
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The North American Spine Society recently developed coverage policy recommendations for lumbar interspinous devices used without fusion and decompression.
The coverage recommendations state interspinous devices are not indicated for cases with “degenerative spondylolisthesis of grade 2 or higher, degenerative scoliosis or other signs of coronal instability [or] dynamic instability as detected on flexion-extension views demonstrating at least 3 mm of change in translation ... ” The devices are also not indicated for a fusion not indicated based on NASS coverage recommendations for lumbar fusion or for a laminectomy not indicated by the NASS coverage recommendations for lumbar laminectomy.
According to the recommendations document, “[M]ore recently [interspinous] devices have been used in conjunction with direct decompression via laminectomy. Some devices, such as coflex [Paradigm Spine], according to the FDA labeling and available published data, are specifically approved for use in this manner.”
Paradigm Spine’s coflex device, a lumbar motion-preservation solution for pain relief and stability in patients with moderate to severe lumbar spinal stenosis, is included in that category of device, according to a company press release. The NASS recommendations only apply to devices used in combination with a direct decompressive procedure, which is currently is only the coflex.
“The NASS coverage policy recommendation for coflex is a major milestone for validating our technology and allows us to reach more private payors in the U.S. market,” Marc Viscogliosi, chairman and CEO of Paradigm Sine, said in the release.
“I think with this coverage recommendation, as well as [with] all of the coverage recommendations that NASS had developed, [the goal] is to develop some criteria that allow responsible use of technology and of surgical techniques,” Christopher M. Bono, MD, former NASS president, told Healio.com/Orthopedics. “In this case, with this particular device, I think that if one reads the actual coverage recommendation ... they define a specific type of patient with lumbar stenosis and spondylolisthesis in whom there is clear evidence of mechanical back pain, which is a small percentage of patients that are undergoing laminectomy decompression for stenosis.”
Bono said NASS members were interested in this class of device, and there were many follow-up studies produced on the coflex device. With the increasing and longer-term evidence, NASS felt it was appropriate to develop a coverage recommendation.
According to Bono, there are specific patients in whom an interspinous device with laminectomy without fusion may be an alternative treatment to instrumented fusion.
“[The] take away should not be that this is a blanket approval for the use of these devices in anyone undergoing the laminectomy for spinal stenosis.” – by Monica Jaramillo
Reference s :
www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations
Disclosure: Bono reports no relevant financial disclosures.