Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 65-year-old male with spinal stenosis at L4-5. He was evaluated by multiple spine specialists. They recommended X-STOP decompression surgery, which the patient subsequently underwent in May 2006. The Health Plan considers the procedure experimental/investigational and therefore has denied the patients request for reimbursement for the procedure.The X-STOP is a titanium spacer surgically placed between the spinous processes of the vertebra for the treatment of spinal stenosis. Its indication for use is very narrow. Clinical trials are ongoing to determine its true efficacy. Based on a review of the literature, it remains an unproven experimental and investigational device and its actual clinical value has yet to be established. Therefore, I have determined that the procedure at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2:  The patient is a 65-year-old male who had surgical decompression with an X-STOP in May 2006 for spinal stenosis at L4-5 with left sciatica. His condition had not responded to conservative treatment with epidural injections. The patient has requested reimbursement for the X-STOP procedure, which has been denied by the Health Plan.Based on the submitted materials including the June 2006 report from the patient, the reports of the treating physicians and consultants, the MRI report of April 2006, the operative report of May 2006, the numerous publications concerning the X-STOP device and the November 2005 letter from the Department of Health and Human Services documenting the pre-market approval for the X-STOP interspinous process decompression system, the X-STOP procedure was a medically reasonable treatment option for this patient. There was sufficient evidence of the procedures efficacy available to warrant its use in this case. Therefore, I have determined that the procedure at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3:  The patient is a 65-year-old male with a long history of lower back pain and spinal stenosis.  He was evaluated for surgical intervention and his provider recommended spinal stabilization along with decompression. The patient underwent X-STOP implantation surgery in May 2006. The Health Plan has denied coverage for the procedure on the basis that its efficacy has not been established in this clinical context.At this time, there is no data demonstrating that X-STOP implantation is clearly superior to traditional decompression in the surgical management of spinal stenosis. Studies related to the long-term safety and efficacy of the procedure are still pending. Open laminectomy remains the standard of care for surgical treatment of spinal stenosis.  For these reasons, I have determined that the procedure at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.