Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

A 57-year-old male enrollee has requested authorization and coverage for X-STOP interspinous decompression procedure (Interspinous Distraction Device) for treatment of the enrollees lumbar spinal stenosis with neurogenic claudication.  Findings:  Two physician reviewers found that the patient is a 57-year-old male with low back pain. A magnetic resonance imaging (MRI) of the lumbar spine describes moderate facet degeneration at T12-L1, without stenosis or disc protrusion. At L1-2, mild bulging, with degenerative osteophytes and facet degeneration were noted, with patent foramina. Similar degenerative changes were described at L2-3, with mild canal stenosis. At L3-4, there was disc bulging and protrusion, osteophytes, facet degeneration, and canal and foraminal stenosis, and similar changes were described at L4-5. The pars interarticularis was not well visualized, and spondylolysis was not excluded. At L5-S1, there was a Grade I anterolisthesis, as well as degenerative changes, stenosis, and a lack of clear visualization of the pars, with canal and foraminal stenosis. The impression was canal stenosis from L2 to L5-S1 with degenerative changes, and anterolisthesis at L4-5 and L5-S1, with degenerative disc disease and osteoarthritis, with possible pars defects. In a letter, the patients spine surgeon describes his evaluation. He notes a 212 year history of increasing buttock, anterior leg, and groin pain, with no relief from two epidural injections, physical therapy, and medications. X-rays were described as showing spondylolisthesis at L4-5 and L5-S1, with a lack of definite pars defect at L5-S1 on computed tomography (CT) scan. Severe stenosis was noted at L4-5 and L5-S1, with moderate stenosis at L3-4. On examination, he had kyphosis, with good forward motion, but only 10 extension and 20% of normal side bending. Patella reflexes were 1+, and absent at the Achilles bilaterally. No neurologic loss was noted. Surgery was discussed and planned to include decompression at L5 and S1, with interspinous process decompression system (X-STOP) insertions at L3-4 and L4-5. The patients request for coverage has been denied by the Health Plan as investigational and experimental. The X-STOP interspinous process decompression system was granted approval by the Food and Drug Administration (FDA) in 2005, with agreement for a follow-up study period, which is ongoing. Some studies have reported encouraging results, but due to the limited number and poor design, it is difficult to clearly define indications for the procedure at this time (Kabir, et al). Moreover, data comparing laminectomy and X-STOP is lacking, although some studies have demonstrated that lumbar laminectomy is actually more effective (Burnett, et al). Reports of problems with the X-STOP including failure when used for the treatment of stenosis caused by degenerative spondylolisthesis have also been described (Verhoof, et al). Overall, long-term follow-up to evaluate clinical outcomes is lacking (Zhao, et al). Thus, the requested procedure is not likely to be more beneficial than standard therapies in the management of this patients medical condition.