Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say Palmetto GBA considers 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:  
 
    1. The device is approved by the FDA AND 
 
    2. The Beneficiary is skeletally mature AND 
 
    3. The Beneficiary has EITHER 
        a. 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 
        b. Beneficiary has severe or rapidly progressive symptoms of nerve root or spinal cord compression 
requiring hospitalization or immediate surgical intervention, AND 
 
    4. 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 
    5. Cervical degenerative disc disease (CDDD) is from C3 to C7, AND 
 
    6. The Beneficiary is free from absolute contraindications to cervical disc replacement (CDR) which include: 
        a. Extreme obesity (BMI > 40 kg/m2) 
        b.  Significant cervical anatomical deformity 
        c. Allergy or sensitivity to implant materials (cobalt, chromium, molybdenum, polyethylene, titanium) 
        d. Active systemic infection or infection at the operating site 
        e. Osteoporosis or osteopenia 
        f. Marked cervical instability on resting lateral or flexion/extension radiographs demonstrated by 
translation greater than 3.5mm, and/or greater than 11o angular difference to that of either level adjacent the 
treated level 
        g. Severe spondylosis         h. Clinically compromised vertebral bodies at affected level 
 
    7. 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 two 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, Pagets 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. 
 
You can find this information in Medicare's Local Coverage Determination (LCD): Cervical Disc Replacement 
(L38033). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.