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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Cervical Artificial Disc Replacement (CPT 22856).Coric and colleagues completed an independent review of a prospective, randomized, controlled multicenter investigational device exemption clinical trial. Their results supported the use of anterior cervical surgery for contiguous 2-level pathology as safe and effective. They concluded that total disc replacement was superior to anterior cervical discectomy and fusion for the treatment of 2-level contiguous pathology at five years. Radcliff and colleagues completed a prospective, randomized, controlled multicenter investigational device exemption clinical trial comparing cervical total disc replacement with anterior cervical discectomy and fusion for treatment of 2-level symptoms degenerative disc disease. They concluded that cervical total disc replacement and anterior cervical discectomy and fusion significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus anterior cervical discectomy and fusion control patients. Zhu and colleagues studied the clinical and radiographic outcomes of 23 multilevel cervical myelopathy (MCM) patients treated with a hybrid technique combining cervical anterior corpectomy and fusion (ACF) with cervical artificial disc replacement. The results revealed that this hybrid technique is both technically feasible and effective for the treatment of MCM. However, future comparative studies will be required to determine the potential benefits and pitfalls of this hybrid technique.I this case, the patient presents with complaints of severe right-sided neck pain radiating into her arms with numbness and weakness. The patient reports that her pain is incapacitating. Records reflect that she previously had 2-level artificial disc replacement at C4/5 and C5/6. Current imaging demonstrates a disc herniation/protrusion at the C6/7 level extending into the right neural foramen. There is also electrodiagnostic evidence of acute and chronic bilateral C6/7 radiculopathy. The patient has reportedly failed to achieve sustained improvement with conservative treatment including activity modification, medications, physical therapy, and epidural steroid injections. The patient has requested authorization and coverage for C6/7 artificial disc replacement (ADR). ADR at three contiguous cervical levels is not supported by current evidence based medical guidelines or high-quality peer reviewed literature. There are clinical trials that now support 2-level contiguous cervical ADR. There is also some literature support for hybrid ADR and fusion surgery at 3 levels with more comparative studies recommended. However, there is no evidence in the literature that there is large volume high quality support for the use of ADR at 3 levels. Therefore, the requested cervical artificial disc replacement at C6/7 would not be considered the standard of care for this patients adjacent segment disc herniation. Accordingly, the requested Cervical Artificial Disc Replacement (CPT code 22856) is not medically necessary for the patients medical condition.Final Result: The reviewer determined that the requested service is not medically necessary for 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.