Artificial Intervertebral Disc: Cervical Spine

POLICY NUMBER

A.7.01.108

DESCRIPTION

Several prosthetic devices are currently available for cervical disc arthroplasty. Cervical disc arthroplasty is proposed as an alternative to anterior cervical discectomy and fusion for individuals with symptomatic cervical degenerative disc disease.

Cervical Degenerative Disc Disease

Cervical degenerative disc disease is a manifestation of spinal spondylosis that causes deterioration of the intervertebral discs of the cervical spine. Symptoms of cervical degenerative disc disease 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, and, in severe cases, leads to weakness in the arms or legs and numbness of the arms or hands. The prevalence of degenerative disc disease secondary to cervical spondylosis increases with age. An estimated 60% of individuals older than 40 years have radiographic evidence of cervical degenerative disc disease. By age 65, 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 United States are disabled to an extent by spine-related disorders, although only a small fraction of those are clear candidates for spinal surgery.

Treatment

Anterior cervical discectomy and fusion has historically been considered the definitive surgical treatment for symptomatic degenerative disc disease of the cervical spine. The goals of anterior cervical discectomy and fusion are to relieve pressure on the spinal nerves (decompression) and to restore spinal column alignment and stability. Resolution of pain and neurologic symptoms may be expected in 80% to 100% of anterior cervical discectomy and fusion patients. Anterior cervical discectomy and fusion involves an anterolateral surgical approach, decompression of the affected spinal level, discectomy, and placement of a PEEK (polyetheretherketone) or titanium interbody cage plus 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 anterior cervical discectomy and fusion without an anterior plate. Although there may be slight differences between autograft and allograft sources in the postoperative rate of union, clinical studies have demonstrated similar rates of postoperative fusion (90% to 100%) and satisfactory outcomes using either bone source. Studies have suggested that altered adjacent segment kinematics following fusion may lead to adjacent-level degenerative disc disease and need for secondary surgery.

Cervical disc arthoplasty is proposed as an alternative to anterior cervical discectomy and fusion for patients with symptomatic cervical degenerative disc disease. In cervical disc arthroplasty, an artificial disc device is secured in the prepared intervertebral space rather than an interbody cage and/or bone. An anterior plate is not used to stabilize the adjacent vertebrae, and postsurgical external orthosis is usually not required. The cervical disc arthroplasty was designed to maintain anatomic disc 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 above or below a fusion site has been the major reason driving device development and use. Disc arthroplasty and anterior cervical discectomy and fusion have very similar surgical indications, primarily unremitting pain due to radiculopathy or myelopathy, weakness in the extremities, or paresthesia. However, the chief complaint in cervical disc arthroplasty candidates should be radicular or myelopathic symptoms in the absence of significant spondylosis or spondylolisthesis.

In 2007, the Prestige® ST Cervical Disc (Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process as a Class III device. The Prestige® ST Cervical Disc is composed of stainless steel and is indicated in skeletally mature patients for reconstruction of the disc from C3 through C7 following single-level discectomy. The device is implanted using 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 required Medtronic (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 to more fully characterize adverse events in a broader patient population.

Another disc arthroplasty product, the ProDisc-C® (Synthes Spine), was approved by the FDA through the premarket approval process in 2007. As with the Prestige ST Cervical Disc, the FDA approval of ProDisc-C was made conditional on the 7-year follow-up of the 209 subjects included in the non-inferiority trial, 7-year follow-up of 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 ProDisc C Vivo is currently marketed by Centinel Spine.

More recently, continued FDA approval requires the completion of two post-approval 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 the submission of annual reports, which include the number of devices sold, heterotopic ossification, device malfunction, device removal, other serious device-related complications, and analysis of all explanted discs.

Devices with FDA approval for use in the United States are described in the table below. These devices are for 1 site or 2 contiguous sites. There are no devices approved for non-contiguous sites. FDA Product Code: MJO

Cervical Disc Prostheses Approved for Use in the United States

FDA: U.S. Food and Drug Administration; MRI: magnetic resonance imaging; PEEK: polyetheretherketone.

A related medical policy is Artificial Intervertebral Disc: Lumbar Spine .

POLICY

Cervical disc arthroplasty may be considered medically necessary when ALL of the following criteria are met:

1. The device is approved by the FDA;

2. The individual is skeletally mature;

3. The individual has intractable cervical radicular pain or myelopathy

   1. which has failed at least 6 weeks of conservative non-operative 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

   2. if the individual has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment;

4. Degeneration is documented by magnetic resonance imaging, computed tomography, or myelography;

5. Cervical degenerative disc disease is from C3 through C7; and

6. 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 (ie, Mobi-C®, Prestige LP™).

Subsequent cervical disc arthroplasty at an adjacent level may be considered medically necessary when all of the following are met:

1. Criteria 1 to 6 above are met; AND

2. The device is FDA-approved for 2 levels; AND

3. The planned subsequent procedure is at a different cervical level than the initial cervical artificial disc replacement; AND

4. 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.

POLICY EXCEPTIONS

Federal 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 GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

10/26/2006: 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.

12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 0375T and 22858.

08/18/2015: Medical policy revised to add ICD-10 codes.

04/29/2016: Policy description updated regarding devices. Policy statement added that cervical artificial intervertebral disc implantation may be considered medically necessary when certain criteria are met. Investigational statement revised to change "artificial intervertebral discs" to "cervical artificial intervertebral disc implantation" and to list investigational indications. Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to add medically necessary codes table. The following codes moved from investigational to medically necessary: CPT codes 22856, 22861, 22864 and Procedure codes 0RR30JZ, 0RR50JZ, 0RW30JZ, 0RW50JZ, 0RW33JZ, 0RW34JZ, 0RW53JZ, 0RW54JZ, 0RP30JZ, and 0RP50JZ. Removed deleted CPT code 0092T from the Code Reference section. Effective 05/01/2016.

05/31/2016: Policy number A.7.01.108 added.

12/30/2016: Policy description updated regarding devices. First medically necessary statement criteria updated to remove "limited to a single level" for cervical degenerative disc disease. Added policy statements that simultaneous cervical artificial intervertebral disc implantation at a second contiguous level and subsequent cervical artificial intervertebral disc implantation at an adjacent level may be considered medically necessary if certain criteria are met. Investigational policy statement criteria updated to change "disc implantation at more than 1 level" to "disc implantation at more than 2 levels" and to remove "multilevel disc disease." Code Reference section updated to move CPT codes 22858, 0095T, and 0098T from investigational to medically necessary. Effective 01/01/2017.

05/01/2017: Policy description updated regarding devices. Policy statements unchanged.

05/08/2018: Policy description updated regarding outcome measures. Policy statements unchanged.

05/09/2019: Policy description updated. Policy statements unchanged.

12/19/2019: Code Reference section updated to make note of deleted CPT code.

05/28/2020: Terminology updated throughout policy to change "artificial intervertebral disc arthroplasty of the cervical spine" to "cervical disc arthroplasty." Policy description updated regarding devices.

07/14/2021: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted CPT code 0375T.

05/27/2022: Policy description updated regarding devices. Policy statements unchanged.

05/10/2023: Policy description updated regarding devices. Policy statements updated to change "patients" to "individuals."

05/16/2024: Policy description updated to change "patients" to "individuals." Policy statements unchanged.

05/07/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.108

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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