Cervical Disc Replacement

Jurisdiction: JM Part B. States: North Carolina, South Carolina, Virginia, West Virginia. Type: Active LCD

This A/B MAC considers United States Food and Drug Administration (FDA)-approved prosthetic cervical discs reasonable and necessary for the treatment of Medicare Beneficiaries with symptomatic cervical degenerative disease or herniated disc at a single level when all of the following criteria are met: The device is approved by the FDA AND The Beneficiary is skeletally mature AND The Beneficiary has EITHER: Intractable cervical radicular pain or myelopathy which has failed at least 6 weeks of conservative non-operative treatment, including physician-directed pain management (e.g., pharmacotherapy addressing neuropathic pain and physical therapy) OR Beneficiary has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical intervention, AND The Beneficiary must have clinical evidence of corresponding nerve root or spinal cord compression documented by computed tomography (CT), myelography, or magnetic resonance imaging (MRI), AND Cervical degenerative disc disease (CDDD) is from C3 to C7, AND The Beneficiary is free from absolute contraindications to cervical disc replacement (CDR) which include: Extreme obesity (BMI > 40 kg/m 2 ) Significant cervical anatomical deformity Allergy or sensitivity to implant materials (cobalt, chromium, molybdenum, polyethylene, titanium) Active systemic infection or infection at the operating site Osteoporosis or osteopenia Marked cervical instability on resting lateral or flexion/extension radiographs demonstrated by translation greater than 3.5 mm, and/or greater than 11° angular difference to that of either level adjacent the treated level Severe spondylosis Clinically compromised vertebral bodies at affected level Two-level procedures performed simultaneously may be considered reasonable and necessary if there is objective clinical evidence of radiculopathy, myelopathy or spinal cord compression at 2 corresponding contiguous levels. A CDR device FDA-approved for 2 levels is required. CDR is considered investigational for all other indications and conditions including: Disc replacement at 2 non-contiguous levels or 3 or more levels Combined use of an artificial cervical disc and fusion Prior surgery at the treated level Previous fusion at another level Any anatomical deformity (e.g., ankylosing spondylitis, trauma) Any autoimmune disease or rheumatoid arthritis Moderate to severe facet joint arthropathy at the involved level Metabolic bone disease (e.g., osteoporosis, Paget’s disease, osteomalacia, osteogenesis imperfecta) or taking medications known to potentially interfere with bone/soft tissue healing (e.g., steroids) Malignancy Chronic renal failure Optimal outcomes of CDR procedures depend on the knowledge, skill and experience of the provider. Consequently, the provider performing the procedure must be capable of demonstrating documented training and experience relevant to cervical spine surgery. Services will be considered medically reasonable and necessary only if performed by appropriately trained providers. All CDR procedures must be performed by a licensed qualified physician A licensed qualified physician for these services is defined as: Having trained and acquired expertise within the framework of an accredited residency or fellowship program in the applicable specialty/subspecialty (e.g., neurosurgery, orthopedic spine) or must reflect equivalent education, training and expertise endorsed by an academic institution in spine surgery or by applicable specialty/subspecialty society, and Is able to provide evidence of proficiency in the performance and management of CDR and CDDD.