Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for a cervical artificial disc replacement surgery. Bono and colleagues note that according to guidelines for cervical artificial disc replacement (ADR) by the North American Spine Society, cervical ADR may be indicated for patients with radiculopathy related to single level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-C4 to C6-C7 with or without neck pain that has been refractory to conservative treatment, and for single level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-C4 to C6-C7 with or without neck pain that is severe enough to warrant surgical intervention. The authors note that cervical ADR is not indicated in symptomatic multilevel disease (two or more levels) that would require multiple level artificial disc replacement. In a prospective, randomized, controlled multicenter investigational device exemption clinical trial comparing cervical total disc replacement compared with anterior cervical discectomy and fusion for treatment of two-level symptoms degenerative disc disease, Radcliff and colleagues concluded that cervical total disc replacement and anterior cervical discectomy and fusion significantly improved general and disease-specific measures compared with baseline. However, the authors also noted that there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the two-level disc replacement patients versus anterior cervical discectomy and fusion control patients. In a prospective, randomized, controlled multicenter clinical trial on two-level symptomatic degenerative disc disease, Davis and colleagues found support for 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, Coric and colleagues concluded that anterior cervical surgery for contiguous two-level pathology was safe and effective, and 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) shows one to two mm bulge of the disc with mild narrowing of the neural foramen and patent central canal at C3-C4. The patient reports left-sided neck discomfort with pain radiating towards the shoulders and worsened by certain head positions. The records did not note associated tingling other than on the thumb and index finger on the left side, and there was no weakness, loss of dexterity, sensory loss, or obvious atrophy. On examination, the patient walked with a narrow based non-ataxic gait. His biceps reflex was absent on the left and 2+ on right and his triceps reflex was trace on the left and 2+ on the right. There was mild tenderness in both trapezius muscles and induration on the left side compared to the right. The patient was noted to be status post ADR at C5-C6 and C6-C7. In this clinical setting, there is a lack of evidence in the current medical literature supporting the use of ADR at three levels. Therefore, the requested cervical artificial disc replacement surgery is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested service is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.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.