Cervical disc arthroplasty may be considered medically necessary when ALL of the following criteria are met:
The device is approved by the U.S. Food and Drug Administration (FDA);
The individual is skeletally mature;
The individual has intractable cervical radicular pain or myelopathy
which has failed at least 6 weeks of conservative nonoperative treatment, including an active pain management program or protocol, under the direction of a physician, with pharmacotherapy that addresses neuropathic pain and other pain sources AND physical therapy; OR
if the individual has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment;
Degeneration is documented by magnetic resonance imaging, computed tomography, or myelography;
Cervical degenerative disc disease is from C3 through C7; and
The individual is free from contraindications to cervical disc arthroplasty.
Simultaneous cervical disc arthroplasty at a second contiguous level may be considered medically necessary if the above criteria are met for each disc level, and the device is FDA-approved for 2 levels (eg, Mobi-C®, Prestige LP™).
Subsequent cervical disc arthroplasty at an adjacent level may be considered medically necessary when all of the following are met:
Criteria 1 to 6 above are met; and
The device is FDA-approved for 2 levels; and
The planned subsequent procedure is at a different cervical level than the initial cervical artificial disc replacement; and
Clinical documentation that the initial cervical artificial intervertebral disc implantation is fully healed.
Cervical disc arthroplasty is considered investigational for all other indications, including the following:
Disc implantation at more than 2 levels
Combined use of an artificial cervical disc and fusion
Prior surgery at the treated level
Previous fusion at another cervical level
Translational instability
Anatomic deformity (eg, ankylosing spondylitis)
Rheumatoid arthritis or other autoimmune disease
Presence of facet arthritis
Active infection
Metabolic bone disease (eg, osteoporosis, osteopenia, osteomalacia)
Malignancy.
