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DESCRIPTIONCervical degenerative disc disease (DDD) is a manifestation of spinal spondylosis that causes deterioration of the intervertebral discs of the cervical spine. Symptoms of cervical DDD include arm pain, weakness, and paresthesias associated with cervical radiculopathy. Disc herniation, osteophytes, kyphosis or instability that compress the spinal cord result in myelopathy, which is manifested by subtle changes in gait or balance, weakness in the arms or legs and numbness of the arms or hands, in severe cases. The prevalence of DDD secondary to cervical spondylosis increases with age. An estimated 60% of individuals older than 40 years have radiographic evidence of cervical DDD. By age 65, some 95% of men and 70% of women have at least one degenerative change evident at radiographic examination. It is estimated that approximately 5 million adults in the U.S. are disabled to an extent by spine-related disorders, although only a small fraction of those are clear candidates for spinal surgery.
Cervical DDD is initially treated conservatively using noninvasive measures (e.g., rest, heat, ice, analgesics, anti-inflammatory agents, exercise). If symptoms do not improve or resolve after 6 weeks or more, or if they progress, surgical intervention may be indicated. Candidates for surgical intervention have chronic pain or neurologic symptoms secondary to cervical DDD and no contraindications for the procedure.
Anterior cervical discectomy and fusion (ACDF) is currently considered the definitive surgical treatment for symptomatic single-level DDD of the cervical spine. The goals of ACDF are to relive pressure on the spinal nerves (decompression) and to restore spinal column alignment and stability. Resolution of pain and neurological symptoms may be expected in more than 80% to 100% of ACDF patients. ACDF involves an anterolateral surgical approach, decompression of the affected spinal level, discectomy, and emplacement of either autograft or allograft bone in the prepared intervertebral space to stimulate healing and eventual fusion between the vertebral endplates. A metal anterior cervical plate is attached to the adjoining vertebral bodies to stabilize the fusion site, maintain neck lordosis, and reduce the need for prolonged postoperative brace application that is needed following ACDF without an anterior plate. The choice of bone material for interbody fusion in ACDF has important clinical implications. Allograft bone has several drawbacks, including a small (albeit, unproven) risk of infectious disease transmission; possible immunological reaction to the allograft, and possible limited commercial availability of appropriate graft material. In contrast, the use of autograft bone in ACDF has potentially substantial morbidities at the harvest site, generally the iliac crest. These morbidities include moderate-to-severe, sometimes prolonged pain; deep infection; adjacent nerve and artery damage; and increased risk of stress fracture. Although there may be slight differences between autograft and allograft sources in the postoperative rate of union, clinical studies demonstrate similar rates of postoperative fusion (90%–100%) and satisfactory outcomes for single-level, anterior-plated ACDF, using either bone source. Thus, the choice of graft material involves a trade-off between the risks specific to autograft harvest versus those specific to use of allograft material. Biomechanical modeling studies have suggested that altered adjacent segment kinematics following fusion may lead to adjacent-level DDD, however, the clinical relevance of these changes has not been established.
Artificial intervetebral disc arthoplasty (AIDA) is proposed as an alternative to ACDF for patients with symptomatic cervical DDD. Disc arthroplasty and ACDF for single-level disease have very similar surgical conditions, primarily unremitting pain due to radiculopathy or myelopathy, weakness in the extremities, or paresthesia. In artificial intervertebral disc arthroplasty (AIDA), an artificial disc device is secured in the prepared intervertebral space rather than bone. An anterior plate is not placed to stabilize the adjacent vertebrae, and postsurgical external orthosis is usually not required. It is hypothesized that AIDA will maintain anatomical disk space height, normal segmental lordosis, and physiological motion patterns at the index and adjacent cervical levels. The potential to reduce the risk of adjacent-level degenerative disc disease (DDD) above or below a fusion site has been the major rationale driving device development and use. However, the chief complaint in AIDA candidates should be radicular or myelopathic symptoms in the absence of significant spondylosis. Patients with advanced spondylosis or hard disc herniations have a separate pathology and require a different surgical approach.
The Prestige ST Cervical Disc (Medtronic) received U.S. Food and Drug Administration (FDA) premarket application (PMA) approval as a Class III device on July 16, 2007. The Prestige ST Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy. The device is implanted via an open anterior approach. Intractable radiculopathy and/or myelopathy should be present, with at least one of the following items producing symptomatic nerve root and/or spinal cord compression as documented by patient history (e.g., pain [neck and/or arm pain], functional deficit, and/or neurological deficit) and radiographic studies (e.g., computed tomography, magnetic resonance imaging, X-rays): herniated disc and/or osteophyte formation. The FDA has required the Prestige disc manufacturer to conduct a 7-year post-approval clinical study of the safety and function of the device, and a 5-year enhanced surveillance study of the disc to more fully characterize adverse events in a broader patient population.
Another disc arthroplasty product, the ProDisc-C® (Synthes Spine) received FDA PMA approval in December 2007. As with the Prestige ST Cervical Disc, the FDA approval of ProDisc-C is conditional on 7-year follow-up of the 209 subjects included in the noninferiority trial (discussed in Rationale section), 7-year follow-up on 99 continued access subjects, and a 5-year enhanced surveillance study to more fully characterize adverse events when the device is used under general conditions of use. The post-approval study reports are to be delivered to the FDA annually.
The Bryan Cervical Disc (Medtronic Sofamor Danek) consists of 2 titanium-alloy shells encasing a polyurethane nucleus, and has been available outside of the United States since 2002. The Bryan Cervical Disc was approved by the FDA in May 2009 for treatment using an anterior approach of single-level cervical DDD defined as any combination of the following: disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy resulting in impaired function and at least one clinical neurological sign associated with the cervical level to be treated, and necessitating surgery as demonstrated using computed tomography (CT), myelography and CT, and/or magnetic resonance imaging. Patients receiving the Bryan cervical disc should have failed at least six weeks of non-operative treatment prior to implantation of the Bryan cervical disc.
In more recent years, continued FDA approval requires completion of 2 postapproval studies. One study provides extended follow-up of the premarket pivotal cohort out to 7 years. The second study provides 10-year enhanced surveillance of adverse event data. Continued approval is contingent on submission of annual reports, which include the number of devices sold, heterotopic ossification, device malfunction, device removal, or other serious device-related complications, and analysis of all explanted discs. The following have received FDA approval:
A number of other devices are under study in FDA IDE trials in the United States.
A related medical policy is Artificial Intervertebral Disc: Lumbar Spine.
POLICYArtificial intervertebral discs are considered investigational for treatment of disorders of the cervical spine, including degenerative disc disease.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
POLICY HISTORY10/26/2006: Policy added
1/4/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
12/5/2008: Policy reviewed, no changes
12/24/2008: Code reference section updated per the 2009 CPT/HCPCS revisions; deleted CPT code 22857 from policy
4/24/2008: Policy reviewed, no changes
04/30/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.
06/24/2010: Policy description updated regarding treatment approaches, available devices, and the FDA status of devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Definition of investigative service added to the Policy Guidelines.
12/13/2011: Policy reviewed; no changes.
11/28/2012: Policy reviewed; no changes to policy statement. Removed 0090T, 0093T, and 0096T from the Code Reference section as these codes have been deleted.
04/24/2013: Added ICD-9 procedure codes 84.61, 84.62, and 84.66 to the Code Reference section.
03/12/2014: Policy description updated regarding available devices. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.108
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.