Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for artificial disc replacement surgery by anterior approach (CPT code 22857). The U.S. Food and Drug Administration (FDA) has approved ProDisc-L total disc replacement for spinal arthroplasty 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 be skeletally mature with no spinal growth remaining, have a condition in which pain is caused by wear-and-tear on a spinal disc at one or two consecutive levels in the lumbar spine from L3 to S1, 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, allergy or sensitivity to implant materials, isolated radicular compression syndromes especially due to disc herniation, and stress fracture in the lumbar spine. 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 total disc replacement being painful disc degeneration unresponsive to at least six 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 total disc replacement designs. In a follow-up at the five-year mark of 236 patients who underwent either ProDisc-L total disc replacement or fusions, Zigler and colleagues noted that the total disc replacement group had significantly better improvement on some scales, and while total disc replacement patients avoid the stiffness of fusion and are more satisfied than fusion patients, both fusion and total disc replacement were reasonable surgical options in this specific patient population. In this case, the patient is being treated for lumbar radiculopathy and disc degeneration. Her surgical history included L4-L5 microdiscectomy and bilateral resection of L5-S1. The records note that the patient has persistent low back pain and radiating left lower extremity pain despite conservative care measures. A sensory examination with light touch and proprioception was abnormal in the left lateral leg and foot and strength was as five out of five in the bilateral lower extremities. Magnetic resonance imaging (MRI) of the lumbar spine showed recurrence of lumbar disc herniation and degenerative disc disease at L4-L5, while computed tomography (CT) showed mild-to-moderate posterior disc bulge without significant facet arthropathy, and mild right and mild-to-moderate left neural foraminal narrowing and patent central canal at L4-L5. While the patient has undergone previous discectomy at the requested level of L4-L5, current medical literature indicates that this is not a contra-indication. In this case, given that the submitted records documented subjective and objective deficits corroborated by imaging studies, and the trial and failure of conservative care, the requested service is medically indicated. Therefore, artificial disc replacement surgery by anterior approach (CPT code 22857) is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested service is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert 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.