Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 58-year-old male with a history of low back pain with radiation to the right thigh, lateral calf and right groin. His symptoms are aggravated by lying supine and walking and relieved by sitting. Lumbar spine imaging studies confirm severe multi-level degenerative disc disease especially at L4-5 and L5-S1. Injection treatment and physical therapy provided no relief and surgical treatment has been recommended using the X-STOP procedure. The Health Plan has denied coverage for this procedure on the basis that it is considered investigational.The proposed procedure is experimental without established long-term safety and efficacy. Available data does not demonstrate an advantage to X-STOP interspinous process decompression over standard surgical procedures. The long-term safety profile is unknown. There is no clinical indication demonstrating the proposed procedure is the best treatment option for this patient. There are other treatments available. For these reasons, I have determined the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Physician 2:  The patient is a 58-year-old male with a history of radiating low back pain. He has multi-level degenerative disc disease at L4-5 and L5-S1. The patient has failed conservative therapies. The patient has requested authorization from his Health Plan for X-STOP implantation surgery. The Health Plan considers the procedure experimental and has denied authorization for the surgery.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. Furthermore, this patient has multi-level disease, which would be a contraindication to the use of the X-STOP device. 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 3:  The patient is a 58-year-old male with back and leg pain. He has attempted conservative care without sustained relief. Injections have not helped his pain. An MRI study revealed a disc herniation at L4-5 with degenerative disc disease at several levels. The patient wishes to undergo an X-STOP implantation procedure. The Health Plan has denied authorization for the procedure citing a lack of proven efficacy.The requested procedure does not appear to be appropriate in this case. The patient has radicular complaints with a disc herniation noted on the MRI. The X-STOP procedure is designed for spinal stenosis with pain on extension that is relieved by flexion. Thus, the proposed surgery is not consistent with the report of the patients complaints, clinical findings and MRI results. Furthermore, the X-STOP procedure is in its infancy and has not been adequately studied in peer-reviewed, controlled trials. 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.