LCD L38033: Cervical Disc Replacement

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.

Neck pain is highly prevalent with approximately 15-20% of adults reporting at least 1 episode during any given year with degenerative disc disease (DDD) as a frequent cause. 1 Aging is the primary risk in developing DDD. As the United States (U.S.) population ages, the incidence of CDDD has increased in kind. Though the initial treatment is typically conservative, the frequency of cervical spine surgeries in the U.S. has increased substantially, with a retrospective study finding the annual number of fusions for cervical spondylotic myelopathy increasing from 3,879 in 2003 to 8,181 in 2013. 2 The study also found that the average age of all fusion patients increased from 58.2 to 60.6 years (p 2 Disc herniation, osteophytes, or an instability that compresses the cervical spinal cord can result in myelopathy, manifested by paresthesia, pain, or weakness of the arms or hands.

Anterior cervical discectomy and fusion (ACDF) has historically been considered the definitive surgical treatment for symptomatic DDD of the cervical spine. The goals of ACDF are to relieve pressure on the spinal nerves (decompression) and to restore spinal column alignment and stability. CDR is a new surgical strategy that has recently emerged as a possible alternative to ACDF, the more commonly used decompressive procedure in the cervical spine. In CDR, an artificial disc is secured in the prepared intervertebral space rather than an interbody cage and/or bone. Since an anterior plate is not required to stabilize the adjacent vertebrae and postsurgical orthosis is not usually required, it is hypothesized that CDR’s advantage is its ability to maintain anatomical disc space height, normal segmental lordosis, and physiological motion patterns at the index and adjacent cervical level with reduced risk of adjacent-level DDD, commonly seen above or below a fusion site. 3

CDR is equivalent to ACDF for surgical treatment of CDDD in select patient groups with the advantage of preserving motion.

Mummaneni, et al. (2007) reported the results of a prospective, randomized, multi-center study in which the results of CDR with the Prestige ® ST Cervical Disc System (Medtronic Sofamor Danek) were compared with ACDF. 4 Patients with symptomatic single-level CDDD who failed at least 6 weeks of conservative treatment, or had signs of progression or spinal cord/nerve root compression with continued non-operative care, were included in the study. DDD was determined to be present if a herniated disc and/or osteophyte formation were confirmed by history and radiographic studies (e.g., CT, MRI, x-rays). A total of 541 patients were enrolled at 32 sites and randomly assigned to 1 of 2 treatment groups: (i) 276 patients in the investigational group underwent anterior cervical discectomy and decompression and replacement with the Prestige ® ST Cervical Disc System; and (ii) 265 patients in the control group underwent decompressive ACDF. A total of 80% of the arthroplasty-treated patients (223 of 276) and 75% of the control patients (198 of 265) completed clinical and radiographic follow-up (FU) examinations at routine intervals for 2 years after surgery. 4 Analysis of available post-operative 12- and 24-month data indicated a 2-point greater improvement in the neck disability index (NDI) score in the investigational group than the control group. 4 The arthroplasty group also had a statistically significant higher rate of neurological success (p=0.005), as well as a lower rate of secondary revision surgeries (p=0.0277) and supplemental fixation (p=0.0031). 4 The mean improvement in the 36-Item Short Form Health Survey (SF-36) Physical Component Summary scores was greater in the investigational group at 12 and 24 months, as was relief of neck pain. The patients in the investigational group returned to work 16 days sooner than those in the control group, and the rate of adjacent-segment re-operation was significantly lower in the investigational group as well (p=0.0492, log-rank test). 4 The cervical disc implant maintained segmental sagittal angular motion averaging more than 7 degrees. In the investigational group, there were no cases of implant failure or migration. The authors concluded that the Prestige ® Cervical Disc maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success, improved clinical outcomes, and a reduced rate of secondary surgeries compared with ACDF. 4 The FDA approved the Prestige ® Cervical Disc (Medtronic Sofamor Danek, Memphis, TN) for the treatment of single-level CDDD (C3 to C7) in 2007.