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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for (1) four cervical levels (two levels approved by plan and two levels denied by plan) of artificial disc replacement (ADR) (CPT 22856) and (2) four lumbar levels (one level approved by plan, and three levels denied by plan) of ADR (CPT 0163T). In this clinical setting, four cervical levels of ADR are not likely to be more beneficial than any available standard treatment for this patients medical condition. In a prospective, randomized, controlled multicenter clinical trial on two-level symptomatic degenerative disc disease, Davis and colleagues noted findings supporting the use of cervical arthroplasty at two contiguous levels and demonstrated advantages over two-level anterior cervical discectomy and fusion. In an independent review of a prospective, randomized, controlled multicenter investigational device exemption clinical trial, Radcliff and colleagues concluded that total disc replacement was superior to anterior cervical discectomy and fusion for the treatment of two-level contiguous pathology at five years. In this case, magnetic resonance imaging (MRI) of the cervical spine noted multilevel cervical disc disease with consequent stenosis. The patient reported neck pain and left upper extremity radiculopathy. X-rays of the cervical spine reported moderate spondylosis without evidence for listhesis or segmental instability, with likely degenerative anterior and posterior interbody fusion at C2-C3. An examination reported normal cervical range of motion and Spurlings maneuver with left upper extremity radiculopathy into the lateral arm. The records noted upper extremity strength at 5-/5 in the left triceps and 4/5 in left finger extension, thumb extension, and hand intrinsics. While current medical literature supports the use of one-level and two-level cervical ADR there is a lack of evidence supporting the use of ADR at four levels. Therefore, (1) four cervical levels (two levels approved by plan and two levels denied by plan) of ADR (CPT 22856) are not likely to be more beneficial for treatment of the patients condition than any available standard therapy. In this clinical setting, four lumbar levels of ADR are not likely to be more beneficial than any available standard treatment for this patients medical condition. The U.S. Food and Drug Administration (FDA) approves ProDisc-L TDR in skeletally mature patients with degenerative disc disease (DDD) at one or two consecutive levels from L3 to S1. The FDA further notes that the patient should have no more than grade 1 spondylolisthesis at the involved level(s) and have failed at least six months of conservative treatment. The FDA notes that contraindications include active systemic or site infection, osteopenia or osteoporosis, bony lumbar spinal stenosis, isolated radicular compression syndromes especially due to disc herniation, and pars defect. In selecting patients for lumbar TDR, Buttner-Janz and colleagues report, With respect to safety, there was good agreement in the literature to exclude patients with osteopenia/osteoporosis or fracture. Risk of injury to vascular structures due to the anterior approach was often addressed by excluding patients with previous abdominal surgery in the area of disc pathology or increased age. The literature was very consistent on the primary indication for TDR being painful disc degeneration unresponsive to at least 6 months of nonoperative care. Literature investigating the impact of previous spine surgery was mixed; however, prior surgery was not necessarily a contra-indication, provided the patient otherwise met selection criteria. The literature was mixed on setting a minimum preoperative disc height as a selection criterion. There were no publications investigating whether some patients are better/worse candidates for specific TDR designs. Based on the literature a proposal for patient selection criteria is offered. In a follow-up at the five-year mark of 236 patients who underwent either ProDisc-L TDR or fusions, Zigler and colleagues noted that the TDR group had significantly better improvement on some scales, and while TDR patients avoid the stiffness of fusion and are more satisfied than fusion patients, both fusion and TDR were reasonable surgical options in this specific patient population. In this case, a sensory examination with light touch and proprioception was abnormal in the left lower extremity into the left lateral thigh, lateral leg, and dorsolateral foot. A left straight leg test was positive. During an examination that reported spine lumbar range of motion with extension and flexion of 25 degrees, the patient reported lumbosacral pain at an eight out of ten, even with pain medication. Notes reported lumbar pain and cervical radiculopathy. The patient continued to rate his pain throughout his low back at up to eight out of ten depending on his activity level and positioning, with associated numbness in his left leg from his hip to the top of his foot. The patient reported neck pain, stiffness, and soreness associated with limited range of motion, that radiated to the left arm down to his elbow. Computed tomography (CT) of the lumbar spine documented grade 1 left lateral listhesis of L4 relative to L5 and multilevel degenerative spondyloarthropathy resulting in bilateral bony neural foraminal stenosis, most severe at L4-5 and L5-S1. The records noted a clinical history of lumbar back pain, right foot drop, and left-sided paresthesias. In this clinical setting, there is a lack of published, large-scale, long-term peer-reviewed medical literature showing that ADR at four levels is an effective and safe treatment for the noted pathology. Therefore, (2) four lumbar levels (one level approved by plan, and three levels denied by plan) of ADR (CPT 0163T) are 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 (1) four cervical levels (two levels approved by plan and two levels denied by plan) of ADR (CPT 22856) and (2) four lumbar levels (one level approved by plan, and three levels denied by plan) of ADR (CPT 0163T) are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.