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

An enrollee has requested authorization and coverage for Superion procedure. The Superion Interspinous Spacer is appropriate to treat skeletally mature patients with pain, numbness, and/or cramping in the legs secondary to a diagnosis of moderate degenerative lumbar spinal stenosis with imaging evidence of thickened ligament flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion Interspinous Spacer can provide relief for patients with impaired physical function who experience relief in flexion from symptoms of leg, buttock, and groin pain, who have undergone at least six months of conservative treatment. The Superion Interspinous Spacer may be implanted at one or two adjacent lumbar levels from L1 to L5. Contraindications for the Superion Interspinous Spacer include scoliosis and morbid obesity defined as a body mass index (BMI) greater than 40. Researchers concluded that patients submitted to interspinous process devices had significantly higher rates of reoperation. Medical literature reports that bony decompression by laminectomy remains the gold standard of surgery and the most common technique for lumbar spinal stenosis. Further, the authors commented that interspinous spacer devices do not result in improved patient health outcomes over conventional decompression and are associated with higher reoperation rates. Overall, current evidence-based medical literature does not support the spinal decompression device procedure over the gold standard of lumbar laminectomy for treatment of this patients medical condition. There is a lack of large peer-reviewed outcome studies with long-term follow-up to support the use of this device in this clinical setting. This patient presents with a long history of chronic low back pain with a diagnosis of lumbar spinal stenosis with neurogenic claudication. The records document that the pain interferes with her ability to perform activities of daily living. There is reported imaging evidence of moderate to severe spinal stenosis at L4-5 due to disc herniation. She has failed to improve with long-term reasonable and comprehensive conservative treatment. Clinical examination findings have not revealed any focal neurologic deficits. However, the patient has significant scoliosis and a BMI of 51.7, which are U.S. Food and Drug Administration (FDA) contraindications to placement of the Superion interspinous spacer. Given these findings, the requested Superion procedure is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested Superion procedure is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Final Result: The reviewers determined that the requested services are 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. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in orthopedic surgery and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.