Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 52-year-old male with degenerative disc disease and significant lower back pain. He has been evaluated by a neurosurgeon who recommended spinal stabilization. The patient has requested authorization for X-STOP implantation surgery.  The Health Plan considers the procedure experimental/investigational and has denied his request.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 requested procedure is 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 52-year-old male with a history of severe low back pain radiating to the right lower extremity. He believes his back condition was caused by an automobile accident in 1995. He has had flare ups in 1998, 2001 and most recently, 2004 and he takes Vicodin ES for pain relief. His request for X-STOP implantation surgery was denied by the Heath Plan citing the investigational/experimental nature of the procedure.The record provided for review included the reports of the treating providers and the results of EMG and nerve conduction studies of bilateral lower extremities in late 2003 and MRIs of the lumbar spine from January 2004 and December 2005. The patient was evaluated by a neurosurgeon who determined the patients postural pain was due to degenerative joint disease of the lumbar spine and a probable element of spinal instability. The patients provider indicated that decompression alone is not likely to resolve the patients problem and recommended that any surgical intervention include a stabilization procedure. He recommended multilevel discography if the patient wanted to consider the fairly major surgical reconstruction. His provider apparently determined that X-STOP implantation for the diagnosed L4-5 spinal stenosis was the treatment of choice.  The device used in this procedure is still being evaluated and concerns as to its long-term safety and efficacy remain. Based on the clinical factors involved, I have determined that the requested procedure is 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 3: The patient is a 52-year-old male with a long history of lower back pain and spinal stenosis.  He has been evaluated for surgical intervention and his provider recommends spinal stabilization along with decompression.  At this point, the patient wishes to proceed with X-STOP implantation surgery. The Health Plan has denied authorization and coverage for this 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. Therefore, traditional decompression surgery remains the standard of care for surgical treatment of spinal stenosis.  For the reasons stated, I have determined that the requested procedure is 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.