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

Nature of Statutory Criteria/Case Summary: An enrollee has requested L4-5 artificial lumbar disc replacement surgery for treatment of the enrollee, who has a history of axial low back pain and moderate chronic disc degeneration. Findings: Three physician reviewers found that the patient has a history of axial back pain. Spine magnetic resonance imaging documented moderate to chronic disc degeneration with associated vertebral body endplate changes. There was a 3 mm broad-based central disc protrusion with an annular fissure. In combination with congenitally short pedicle configuration and mild facet arthropathy, this contributed to a mild degree of central canal narrowing. There was mild bilateral foraminal narrowing without focal nerve root displacement. The other lumbar spine levels were normal. The neurosurgical report cited complaints of radicular neck pain and low back pain that at times travels down the right posterior thigh and lateral leg to the ankle with associated foot cramping. The patient reported that her low back pain was much more severe than her radiating right lower extremity pain, and increased more with sitting than standing. Conservative treatment had included physical therapy and lumbar epidural steroid injections. Lower extremity neurologic exam documented 4+/5 right extensor hallucis longus strength, 5-/5 right ankle dorsiflexion strength, decreased right dorsal foot sensation, and positive right straight leg raise. Lumbar spine examination documented antalgic gait, moderate to severe midline and lumbar paraspinal tenderness at the lumbosacral junction, and decreased range of motion. Lumbar spine imaging was reviewed and showed single level degenerative disc disease and disc protrusion at L4/5 causing a small amount of retrolisthesis and mild to moderate bilateral neuroforaminal and lateral recess stenosis. The diagnosis included bilateral low back pain with bilateral sciatica. At issue in this case is whether the requested L4-5 artificial lumbar disc replacement surgery is likely to be more beneficial for treatment of the patients medical condition than any standard available treatment. The Health Plan has denied the requested procedure as investigational. The medical literature does not indicate the effectiveness of the requested procedure over the available standard therapy in this patients case. This patient presents with severe low back and leg pain with functional difficulty. Clinical examination findings have evidenced motor deficits and sensory loss consistent with imaging evidence of degenerative disc disease at the L4-5, mild central canal and neuroforaminal narrowing. Detailed evidence of reasonable and/or comprehensive non-operative treatment protocol trial and failure has been submitted. However, artificial lumbar disc replacement is not supported in the lumbar spine in radicular compression syndromes. The Food and Drug Administration (FDA) approval for the ProDisc-L total disc replacement states that this device is indicated for spinal arthroplasty in patients who are skeletally mature, have degenerative disc disease at one level in the lumbar spine from L3 to S1, have no more than grade 1 spondylolisthesis at the involved level, and have had no pain relief after at least six months of non-surgical treatment. FDA exclusions include bony lumbar spinal stenosis, and isolated radicular compression syndromes especially due to disc herniation. Standard indications for single level lumbar artificial disc replacement have not been met in this clinical setting. Given the signs and symptoms of lumbar radiculopathy, artificial disc replacement is not supported despite single level lumbar pathology. Therefore, the requested L4-5 artificial lumbar disc replacement surgery is not likely to be more beneficial than available standard modalities for treatment of this patient.Final Result: Three reviewers determined that 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.Credentials/Qualifications: All three physician reviewers 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.