Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Low back pain.
Treatment:  Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level; insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level; Interspinous process distraction device (implantable)(Superion Procedure).

The insurer denied Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level; insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level; Interspinous process distraction device (implantable)(Superion Procedure).  The determination is upheld.

The patient has low back pain and secondary reports of neurogenic claudication.  An MRI by report describes multilevel degenerative changes, which result in mild central stenosis.

Insertion of interlaminar/interspinous process stabilization/distraction device (Vertiflex-Superion), without open decompression or fusion is proposed, and at issue is whether this is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

In this case, moderate-severe symptoms of intermittent neurogenic claudication are not described.  A lumbar MRI by report describes mild lumbar spinal stenosis; therefore, the Food and Drug Administration (FDA) approved indication for the Superion device is not present.  In addition, reliable evidence shows that the consensus among qualified objective experts regarding the inherent nature of the Superion device is that further clinical studies, clinical outcomes research, or clinical trials are necessary to determine its safety, efficacy and anticipated outcomes as compared with the standard means of treatment of the condition in question and is therefore not likely to be more beneficial than any standard treatment or treatments for the insured's disabling condition.

A report on the five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis reports benefits, but is limited to, patients with at least moderate symptoms of intermittent neurogenic claudication, secondary to a diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1-L5 [1].

A review of stand-alone interspinous spacer versus decompressive laminectomy for treatment of lumbar spinal stenosis is limited to studies which included patients with moderate to severe lumbar spinal stenosis [2].

A randomized, controlled Food and Drug Administration (FDA) investigational device exemption trial reports 4-year results in patients with moderate spinal stenosis [3].  FDA-approved Superion product labeling states (in part) "The Superion Indirect Decompression (IDS) System is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing.  The Superion IDS is indicated for those patients with impaired physical function, who experience relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain, who have undergone at least 6 months of non-operative treatment.  The Superion IDS may be implanted at one or two adjacent lumbar levels in patients in whom operative treatment is indicated at no more than two levels, from L1 to L5" [4].  The standard treatment of symptomatic, lumbar spinal stenosis is discussed in a comprehensive review of the topic, which states, "Lumbar spinal stenosis (LSS) affects more than 200,000 adults in the United States, resulting in substantial pain and disability.  It is the most common reason for spinal surgery in patients over 65 years.  Lumbar spinal stenosis is a clinical syndrome of pain in the buttocks or lower extremities, with or without back pain.  It is associated with reduced space available for the neural and vascular elements of the lumbar spine.  The condition is often exacerbated by standing, walking, or lumbar extension and relieved by forward flexion, sitting, or recumbency.  Clinical care and research into lumbar spinal stenosis is complicated by the heterogeneity of the condition, the lack of standard criteria for diagnosis and inclusion in studies, and high rates of anatomic stenosis on imaging studies in older people who are completely asymptomatic.  The options for non-surgical management include drugs, physiotherapy, spinal injections, lifestyle modification, and multidisciplinary rehabilitation.  However, few high quality randomized trials have looked at conservative management.  A systematic review concluded that there is insufficient evidence to recommend any specific type of non-surgical treatment.  Several different surgical procedures are used to treat patients who do not improve with non-operative therapies.  Given that rapid deterioration is rare and that symptoms often wax and wane or gradually improve, surgery is almost always elective and considered only if sufficiently bothersome symptoms persist despite trials of less invasive interventions.  Outcomes (leg pain and disability) seem to be better for surgery than for non-operative treatment, but the evidence is heterogeneous and often of limited quality." 

The determination is upheld.