MEDICAL POLICY

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DESCRIPTION
SCOPE
BENEFIT APPLICATION
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REFERENCES
CODING
APPENDIX
HISTORY

Artificial Intervertebral Disc: Cervical Spine

Number 7.01.537

Effective Date March 25, 2014

Revision Date(s) 03/10/14; 01/14/13; 01/10/12; 09/13/11; 10/12/10; 10/13/09;10/14/08; 02/12/08; 4/10/07

Replaces 7.01.108

Policy

Cervical artificial intervertebral disc implantation with an FDA-approved prosthetic cervical disc (e.g., Bryan Cervical Disc , Prestige Cervical Disc System, ProDisc-C Total Disc Replacement,) may be considered medically necessary for treatment in adults with symptomatic cervical degenerative disc disease (DDD) when ALL of the following criteria are met:

  • The patient is skeletally mature; and
  • The replacement is performed at one level from C3-C7; and
  • Objective evidence in the clinical record documents cervical radiculopathy and/or myelopathy; and
  • The patient has actively tried and failed at least 6 weeks of conservative medical management such as:
  1. Activity modification
  2. Oral analgesics and/or anti-inflammatory medications
  3. Physical therapy with home exercise program

(The six-week conservative treatment period may be waived in cases of myelopathy with an acute onset of clinically significant signs requiring immediate treatment.)

Cervical artificial intervertebral disc implantation with a prosthetic cervical disc is considered investigational for the following:

  • In patients with isolated axial neck pain without cervical radiculopathy or myelopathy;
  • When requested adjacent to a prior fusion;
  • When more than one level is requested, (prosthetic intervertebral discs are FDA approved for one level only currently).
  • For all other devices not listed as medically necessary in the first medical policy statement above.

Related Policies

7.01.18

Automated Percutaneous and Endoscopic Discectomy

7.01.72

Percutaneous Intradiscal Electrothermal Annuloplasty (IDET) Annuloplasty and Percutaneous Intradiscal Radiofrequency Thermocoagulation

7.01.87

Artificial Intervertebral Disc: Lumbar Spine

7.01.93

Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty)

7.01.542

Lumbar Fusion

7.01.551

Lumbar Spine Decompression Surgery: Discectomy, Foraminotomy, Laminotomy, Laminectomy

Policy Guidelines

Coding

CPT

0092T

Total disc arthroplasty (artificial disc), each additional interspace (List separately in addition to code for primary procedure)

0095T

Removal of total disc arthroplasty (artificial disc), each additional interspace (List separately in addition to code for primary procedure)

0098T

Revision including replacement of total disc arthroplasty (artificial disc), each additional interspace (List separately in addition to code for primary procedure)

Definition of Terms

  • Arthroplasty – surgical procedure to replace a damaged joint with an artificial device.
  • Disc (intervertebral) – round flat “cushions” between each vertebra of the spine.
  • Radiculopathy – a progressive neurologic deficit caused by disc material or boney changes like spurs compressing a spinal nerve root. Symptoms may include pain radiating from the spine, a motor deficit, reflex change or EMG changes. In the cervical spine it is characterized as neck pain that radiates into the arm.
  • Myelopathy – refers to any neurologic deficit related to the spinal cord, usually caused by compression. In the cervical spine it is characterized as neck stiffness, arm pain, numbness in the hands, and weakness of the hands and legs.
  • Paresthesia – abnormal sensation of burning, prickling, pricking, tickling, tingling of the skin; often described as “pins and needles”.
  • Vertebrae – the individual bones of the spinal column that consists of the cervical, thoracic and lumbar regions that surround and protect the spinal cord.

NOTE: Artificial intervertebral discs for treating the lumbar spine are addressed in a separate medical policy (see Related Policies).

Description

Several prosthetic devices are currently available for artificial intervertebral disc arthroplasty (AIDA) of the cervical spine after the removal of a degenerated cervical disc. AIDA is proposed as an alternative to anterior cervical discectomy and fusion (ACDF) for patients with symptomatic cervical degenerative disc disease (DDD).

Background

Cervical 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 five 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 non-surgical interventions (e.g., rest, heat, ice, analgesics, anti-inflammatory agents, exercise). If symptoms do not improve or resolve after six weeks or more, or if they progress, surgery 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 relieve 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. 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.

Artificial intervertebral disc arthroplasty (AIDA) is proposed as an alternative to ACDF for patients with symptomatic cervical DDD. In AIDA, an artificial disc device is secured in the prepared intervertebral space rather than in 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 DDD above or below a fusion site has been the major rationale driving device development and use. Disc arthroplasty and ACDF for single-level disease have very similar surgical indications, primarily unremitting pain due to radiculopathy or myelopathy, weakness in the extremities, or paresthesia. 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.

Regulatory Status

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 (Medtronic Sofamor Danek) received FDA approval in May 2009, for treatment in skeletally mature patients with single-level cervical. An anterior approach is used for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. Intractable radiculopathy and/or myelopathy is 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, Radiologic studies to demonstrate the need for surgery include CT, myelography and CT, and/or MRI. Patients receiving the Bryan cervical disc should have tried and failed at least six weeks of non-operative treatment prior to implantation. As a condition for approval of this device, the FDA required the manufacturer to extend its follow-up of enrolled subjects to 10 years after surgery. The study will involve the investigational and control patients from the pivotal investigational device exemption (IDE) study arm, as well as the patients who received the device as part of the continued access study arm. In addition, the manufacturer must perform a 5-year enhanced surveillance study of the BRYAN® Cervical Disc to more fully characterize adverse events when the device is used in a broader patient population.

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 composed of stainless steel and 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., CT, MRI, X-rays, etc.): 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.

The ProDisc-C® implant (Synthes Spine) received FDA PMA approval in December 2007. ProDisc-C is indicated for skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease. Patients receiving this device should have tried and failed at least six weeks of non-operative (conservative) treatment. In clinical studies submitted for FDA approval, patients were not required to undergo conservative treatment if they had the presence of progressive symptoms or had signs of nerve root/spinal cord compression in the face of conservative treatment.

In more recent years, continued FDA approval requires completion of 2 post-approval studies. One study provides extended follow-up of the pre-market 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:

  • The PCM [porous-coated motion] Cervical Disc® (NuVasive) received FDA approval in 2012 (P100012). The PCM® is a semi-constrained device consisting of 2 metal (cobalt-chromium alloy) endplates and a polyethylene insert that fits between the endplates.
  • Secure®-C (Globus Medical) was approved in 2012 (P100003). The Secure®-C is a 3 piece semiconstrained device with 2 metal (cobalt chromium molybdenum alloy) endplates and a polyethylene insert.
  • The Mobi-C® (LDR Spine) received FDA approval in 2013. Mobi-C® is 3 piece semiconstrained device with metal (cobalt-chromium alloy) endplates and a polyethylene insert. The Mobi-C® is approved for 1 level (P110002) or 2 level (P110009) disc replacement

A number of other devices are under study in FDA IDE trials in the United States. Updates to the regulatory status of artificial intervertebral discs can be viewed online at the FDA website at URL address: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Enter the letters “MJO” in the search box next to Product Code.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This policy does not apply to Medicare Advantage.

Benefit Application

N/A

Rationale

Anterior Cervical Discectomy and Fusion (ACDF) involves an anterolateral surgical approach, decompression of the affected spinal level, discectomy, and placement 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.

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 a post-surgical external orthosis is usually not required. The surgical procedure and perioperative complications of AIDA are nearly identical to those of anterior fusion. (8) AIDA maintains anatomical disk space height, normal segmental lordosis, and physiological motion patterns at the index and adjacent cervical levels (8). This has been proposed to reduce the risk of adjacent-level degenerative disc disease (DDD) above or below a fusion site, and has been the major rationale driving device development and use. However, while biomechanical modeling studies have suggested that altered adjacent segment kinematics following fusion may lead to adjacent-level DDD, the clinical relevance of these changes has not been established. (2-4)

Cepoiu-Martin and colleagues (2011) performed a systematic review to qualitatively analyze the literature on the efficacy and effectiveness of artificial cervical disc arthroplasty (ACDA) and to highlight methodological and reporting issues of randomized controlled trials (RCT) reports on effectiveness of ACDA compared to cervical fusion. (5) They found 18 studies (13 case series, four RCT reports, and one nonrandomized comparative study) met the inclusion criteria for this review. The four RCTs and the nonrandomized comparative study concluded that the effectiveness of ACDA is not inferior to that of cervical fusion in the short term (up to 2-yr follow-up). The safety profile of both procedures appears similar. The case series reviewed noted improved clinical outcomes at 1 or 2 years after one or multiple-level ACDA. They concluded that ACDA is a surgical procedure that may replace cervical fusion in selected patients suffering from cervical degenerative disc disease. Within 2 years of follow-up, the effectiveness of ACDA appears similar to that of cervical fusion. Weak evidence exists that ACDA may be superior to fusion for treating neck and arm pain. They stated that future studies should report change scores and change score variance in accordance with RCT guidelines, in order to strengthen credibility of conclusions and to facilitate meta-analyses of studies.

Maldonado and colleagues (2011) studied the incidence of adjacent-segment degeneration (ASD) in a prospective cohort of patients who underwent cervical disc arthroplasty (CDA) as compared with anterior cervical discectomy and fusion (ACDF). (6) A prospective cohort of patients with single-level cervical degenerative disc disease from C3 to C7 who underwent CDA or ACDF between January 2004 and December 2006, with a minimum follow-up of 3 years. The patients were evaluated pre- and postoperatively with the visual analog scale (VAS), the neck disability index (NDI), and a complete neurological examination. Plain radiographic assessments included sagittal-plane angulation, range of motion (ROM), and radiological signs of ASD. One hundred and five patients underwent ACDF and 85 were treated with CDA. The postoperative VAS and NDI were equivalent in both groups. The ROM was preserved in the CDA group but with a small decreased tendency within the time. Radiographic evidence of ASD was found in 11 (10.5%) patients in the ACDF group and in 7 (8.8%) subjects in the CDA group. The Kaplan-Meier survival analysis for the ASD occurrence did not reach statistically significant differences (log rank, P = 0.72). They found preservation of motion in the CDA patients was not associated with a reduction of the incidence of symptomatic adjacent-segment disease and there may be other factors that influence ASD.(29)

Prestige Cervical Disc

Mummaneni and colleagues (2007) reported the results of a prospective randomized multicenter study in which the results of cervical disc arthroplasty were compared with ACDF in patients treated for symptomatic single-level cervical DDD. (7) Their study involved 32 sites and 541 patients who were enrolled and randomly assigned to one of two treatment groups: Patients (n=276) in the investigational group underwent arthroplasty with the PRESTIGE ST Cervical System; 265 patients in the control group underwent decompressive ACDF. Eighty percent of the arthroplasty-treated patients (223 of 276) and 75% of the control patients (198 of 265) completed clinical and follow-up examinations at routine intervals for two years after surgery. Analysis of all currently available post-operative 12 and 24 month data indicated a two point greater improvement in the neck disability index score in the investigational group than the control group. 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=0031). The mean improvement in the 36-Item Short Form Health Survey 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 reoperation was significantly lower in the investigational group (p=0.0492). The cervical disc implant maintained segmental motion averaging more than 7 degrees. In the investigational group, there were no cases of implant failure or migration. The FDA approved the Prestige Cervical Disc for single level cervical DDD based on the findings of this study on July 17, 2007. (8)

Three primary outcome variables were used in the Prestige trial: the Neck Disability Index (NDI), neurological status, and functional spinal unit height (FSU). The NDI is a validated multidimensional instrument that measures the effects of pain and disability on a patient’s ability to manage everyday life. (9) It is a modification of the Oswestry Low Back Pain Index, based on the response to 10 questions that focus on neck pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. The response to each question ranges from 1 to 5, with a lower numeric score representing a better pain and disability status for that variable. A total NDI score is obtained by adding individual question scores and dividing by the maximum total of 50 if all questions are answered. Therefore, NDI scores range from 0% to 100%, with a lower percentage indicating less pain and disability. The neurological status is a composite measure of motor function, sensory function, and deep tendon reflexes. It is used to judge if patients are within normal parameters for those categories based on physiological measurement. Neurological success in the Prestige trial was based on postoperative maintenance or improvement of condition as compared to preoperative status for each component. The anterior FSU height is a radiographic measure of interdiscal space. Comparison of the immediate postoperative FSU height with the 6-week postoperative value shows whether or not the disc space has decreased, which indicates graft or device subsidence has occurred.

Secondary outcome measures include the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) mental (MCS) and physical (PCS) component summaries, neck and arm pain status, patient satisfaction, patient global perceived effect, gait assessment, foraminal compression test, adjacent level stability and measurements, return to work, and physician’s perception.

Both data sources for the Prestige disc trial showed equivalent results. Thus, 81% of both groups showed at least a 15-point improvement for the Neck Disability Index (NDI), demonstrating noninferiority to fusion, but not superiority. Similarly, the FSU height measure also demonstrated evidence of noninferiority, but not superiority. By contrast, the neurological status showed non-inferiority and statistical superiority for the disc compared to fusion. This contributed to the overall success composite endpoint demonstrating superiority for the disc compared to fusion. The majority of secondary outcome measures for the disc were deemed noninferior to ACDF, but none was statistically superior. Perioperative results and adverse events were similar in both groups, with very few serious complications.

Sixty-month follow-up of participants in this clinical trial were reported by Burkus et al in 2010. (10) All participants were followed up in this FDA-regulated post approval study. Outcomes at 60 months were reported on approximately half of the original randomized controlled trial (RCT) participants. The majority of the remaining patients had not yet reached that point in their follow-up, rather than being lost to follow-up. About 18% of all participants were actually lost to follow-up at 60 months. The NDI improved by 38.4 points for the Prestige disc compared to 34.1 for ACDF (p=0.022). For most other clinical outcomes, the Prestige disc was similar to ACDF, with no significant difference between groups in improvement in neck pain score (56.0 vs. 52.4) or arm pain score (52.5 vs. 47.7, both respectively). There was a trend for greater neurologic success in the Prestige disc group (95% vs. 89%, p=0.051). Need for additional surgery was similar between the 2 procedures, and there was no significant difference in the percentage of patients requiring adjacent-level surgery (2.9% vs. 4.9% for ACDF). No implant migration was observed at up to 60 months. Bridging bone was observed in 3 of 94 patients (3.2%) with the Prestige disc

Bryan Cervical Disc

Sasso and colleagues (2007) randomized 115 patients in a 1:1 ratio to a Bryan artificial disc replacement (56 patients) or an anterior cervical fusion with allograft and a plate (59 patients). (11) The purpose of the study was to examine the functional outcome and radiographic results to determine the role of the Bryan artificial cervical disc replacement for patients with 1-level disc disease. This study pooled data from three centers involved in the U.S. FDA Investigational Device Exemption trial evaluating the Bryan artificial cervical disc. The mean NDI before surgery was comparable 47 (Bryan) and 49 (control). Twelve-month follow-up NDI was 10 (Bryan) and 18 (control) (P=0.013). At two-year follow-up, NDI for the Bryan group was 11 and the control group is 20 (p=0.005. The mean arm pain VAS before surgery was 70 (Bryan) and 71 (control). At one-year follow-up, Bryan arm pain VAS was 12 and control (23) (P=0.031). At two year follow-up, Bryan arm pain VAS was 14 and control was 28. The mean neck pain VAS before surgery was 72 (Bryan) and 73 (control). One-year follow-up Bryan arm pain was 12 and control 23. At two-year follow-up, Bryan arm pain VAS was 14 and control 28. The authors concluded that the Bryan artificial disc replacement compared favorably to ACDF for the treatment of patients with 1-level cervical disc disease. At the two-year follow-up, there were statistically significant differences between the groups with improvements in the NDI, the neck pain and arm pain VAS scores and the SF-36 physical component score.

Heller and colleagues (2009) assessed the safety and efficacy of cervical disc arthroplasty using the Bryan Cervical Disc. (12) They designed a prospective RCT for patients with cervical disc disease. Ultimately 242 patients received the investigational device (Bryan Cervical Disc), and 221 patients underwent a single-level anterior cervical discectomy and decompression and fusion as a control group. Patients completed clinical and radiographic follow-up examinations at intervals for two years after surgery. Results reported at 12 and 24 month postoperative data showed improvement in all clinical outcome measures for both groups. However 24 month after surgery, the investigational group patients treated with the artificial disc (Bryan) had a statistically greater improvement in the primary outcome variables: Neck disability index score (P=0.025) and overall success (p=0.010). With regard to implant or implant/surgical procedure associated serious adverse events, the investigational group had a rate of 1.7% and the control group, 3.2%. Patients who received the artificial cervical disc returned to work nearly two weeks earlier than the fusion patients. The authors concluded two-year follow-up results indicate that cervical disc arthroplasty is a viable alternative to cervical discectomy and fusion.

Goffin et al. reported four- and six-year follow-up from phase I and phase II trials of the Bryan disc in 2010. (13) The total potential patient population for long-term follow-up was 98 patients (89 with 1-level and nine with 2-level); 59 of the patients were at least six years postoperative. Although 4 patients from the phase I study declined to participate in the extended follow-up study, their results were included in the safety data. Mean neck pain at four and six years postoperatively was 2.2 and 2.0, respectively. Mean arm pain at four and six years was 2.4 and 2.3, respectively. Six patients experienced events that were believed to be related to the device, including minor device migration, device removal, hoarseness and vocal cord paralysis, while three of the six cases involved pain or neurological symptoms. The prosthesis was removed from one patient at six years after the index surgery because of progressive spinal cord compression due to recurrent posterior osteophyte formation. About 90% of patients were classified as having excellent or good outcomes at four and six years. The success rate estimated by Kaplan-Meier analysis was 94% at seven years following surgery.

ProDisc-C

The FDA’s approval of the ProDisc-C (14) was based upon the results of a non-inferiority clinical trial involving 209 patients at 13 clinical sites (15). One hundred three patients were treated with ProDisc-C and 109 with ACDF. Patients were assessed pre-operatively and post-operatively at prior to discharge, six weeks, three, six, 12, 18, and 24 months. Overall patient success at 24 months was defined as improvement in Neck Disability Index (NDI), maintenance or improvement in neurological status, no surgery to modify the original implant, and no adverse events related to the surgical treatment. The most commonly treated level was C5-C6 (ProDisc-C = 56.3%; Fusion = 57.5%). NDI and SF-36 scores were significantly less compared to pre-surgery sores at all follow-up visits for both groups. VAS neck pain intensity and frequency as well as VAS arm pain intensity and frequency were statistically lower at all follow-up time points compared to pre-operative levels (p<0.0001) but were not different between treatments. Neurologic success (improvement or maintenance) was achieved at 24 months in 90.9% of ProDisc-C and 88.0% of Fusion patients (p=0.638). There was a significant difference in the number of secondary surgeries with 8.5% of Fusion patients needing a re-operation, revision or supplemental fixation within the 24 month post-operative in comparison to 1.8% of PRO Disc-C (p=0.033). At 24 months there was a significant difference in medication usage with 89.5% of ProDisc-C patients not on strong narcotics or muscle relaxants, compared to 81.5% of Fusion patients.

Prestige LP Artificial Cervical Disc Replacement

Peng and colleagues (2011) report on the results of Prestige LP artificial cervical disc replacement (ADR) and motion preservation.(16) Forty patients with 59 Prestige LP ADR were analyzed. Cervical range of motion, Neck Disability Index, Visual Analogue, Short Form-36, Modified American Academy of Orthopedic Surgeons, and Japanese Orthopedic Association scores and radiographs were evaluated. Clinical results were compared with anterior cervical discectomy and fusion. Mean age was 43.9 years. Mean follow-up was 2.9 years. Of the patients, 62.5% had single level replacement – mainly C5-6. There was significant improvement in the AAOS and Visual Analogue scores at 6 months and 2 years. There was significant improvement in the Neck Disability Index from a mean of 42.2 pre-operation to 16.4 at 6 months and 15.2 at 2 years. There was significant improvement in all aspects of the Short Form-36 scores except general health at 6 months and 2 years. There was no significant difference in the clinical outcomes between ADR and anterior cervical discectomy and fusion. Segmental and global alignment was maintained at 6 months and 2 years. Dynamic radiographs showed significant segmental motion with a 6 month’s mean motion of 11.1 degrees, and a 2-year mean motion of 13.9 degrees. The authors report showed significant improvement in clinical outcomes at 2 years.

Complications

Heterotopic ossification (HO) is a well-known complication after total hip and knee arthroplasty. But limited studies have focused on prevalence of HO following cervical total disc arthroplasty (CTDA) and the published data show controversial results. A meta-analysis was performed by Chen et al in 2012 (17) to investigate the prevalence of HO following CTDA. Statistical heterogeneity across the various trials was tested using Cochran's Q, statistic and in the case of heterogeneity a random effect model was used. Tests of publication bias and sensitivity analysis were also performed. The data showed that the pooled prevalence of HO was 44.6% (95% confidence interval (CI), 37.2-45.6%) 12 months after CTDA and 58.2% (95% CI: 29.7-86.8%) 24 months after CTDA, while the advanced HO was 11.1% (95% CI: 5.5-16.7%) and 16.7% (95% CI: 4.6-28.9%), respectively. A significant heterogeneity was obtained. There was no publication bias and individual study had no significant effect on the pooled prevalence estimate.5 The results showed a higher prevalence of HO was observed following CTDA, although HO was reported to be unrelated to the clinical improvement. It suggests that cervical disc replacement should be performed cautiously before obtaining long-term supporting evidence.(18)

There are a limited number of studies for bilevel cervical total disc replacement.

Practice Guidelines and Position Statements

The 2011 guidelines from the North American Spine Society (NASS) on the diagnosis and treatment of cervical

radiculopathy from degenerative disorders give a grade B recommendation that anterior cervical decompression

with fusion and total disc arthroplasty are suggested as comparable treatments, resulting in similarly successful

short-term outcomes, for single-level degenerative cervical radiculopathy.(19)

The United Kingdom’s National Institute for Health and Care Excellence (NICE) issued guidance on the artificial cervical disc in 2010. (20) NICE concluded that

“Current evidence on the efficacy of prosthetic intervertebral disc replacement in the cervical spine shows that this procedure is as least as efficacious as fusion in the short term and may result in a reduced need for revision surgery in the long term. The evidence raises no particular safety issues that are not already known in relation to fusion procedures. Therefore this procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit. This procedure should only be carried out in specialist units where surgery of the cervical spine is undertaken regularly. NICE encourages further research into prosthetic intervertebral disc replacement in the cervical spine. Research outcomes should include long-term data on preservation of mobility, occurrence of adjacent segment disease and the avoidance of revision surgery.”

The 2009 guidelines from the American Association of Neurological Surgeons (AANS) address anterior cervical discectomy (ACD) and anterior cervical discectomy and fusion for the treatment of cervical degenerative radiculopathy and cervical spondylotic myelopathy. These guidelines do not address the artificial cervical disc. (21,22)

Medicare National Coverage

There is no national coverage decision on artificial intervertebral discs for the cervical spine.

References

  1. Goffin J. Complications of cervical disc arthroplasty. Semin Spine Surg 2006; 18(2):87-98.
  2. Anderson PA, Sasso RC, Riew KD. Update on cervical artificial disk replacement. AAOS Instr Course Lect 2007; 56:237-46.
  3. Phillips FM, Garfin SR. Cervical disc replacement. Spine 2005; 30(17 Suppl):S27-33.
  4. Wigfield C, Gill S, Nelson R et al. Influence of an artificial cervical joint compared with fusion on adjacent-level motion in the treatment of degenerative cervical disc disease. J Neurosurg 2002; 96(1 Suppl):17-21.
  5. Cepoiu-Martin M, Faris P, Lorenzetti D, et al. Artificial cervical disc arthroplasty: a systematic review. Spine (Phila Pa 1976). 2011 Dec 1;36(25):E1623-33. Last accessed February, 2014
  6. Maldonado CV, Paz RD, Martin CB. Adjacent-level degeneration after cervical disc arthroplasty versus fusion. Eur Spin 2011; 20 Suppl 3:403-7.
  7. Mummaneni PV, Burkus JK, Haid RW et al. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine 2007; 6(3):198-209.
  8. Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther 1991; 14(7):409-15.
  9. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health. Report of United States Clinical Study Results (G010188) -- Prestige® Cervical Disc System. Last accessed February, 2014.
  10. Burkus JK, Haid RW, Traynelis VC et al. Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial. J Neurosurg Spine 2010; 13(3):308-18.
  11. Sasso RC, Smucker JD, Hacker RJ et al. Artificial disc versus fusion: a prospective, randomized study with 2-year follow-up on 99 patients. Spine. 2007 Dec 15;32(26):2933-40; discussion 2941-2
  12. Heller JG, Sasso RC, Papadopoulos SM et al. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine (Phila Pa 1976). 2009 Jan 15;34(2):101-7
  13. Goffin J, van Loon J, Van Calenbergh F et al. A clinical analysis of 4- and 6-year follow-up results after cervical disc replacement surgery using the Bryan Cervical Disc Prosthesis. J Neurosurg Spine 2010; 12(3):261-9.
  14. U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health (CDRH). ProDisc-C Total Disc Replacement. Summary of Safety and Effectiveness Data PMA No. 070001. Rockville, MD: FDA; December 17, 2007. Last accessed February, 2014.
  15. Murrey, D, Janssen M, Delamarter R et al. Results of the Prospective, Randomized, Multi-Center Food and Drug Administration Investigational Device Exemption Study of the ProDisc-C Total Disc Replacement versus Anterior Discectomy and Fusion for the Treatment of 1-Level Symptomatic Cervical Disc Disease. The Spine Journal 2008.
  16. Peng CW, Yue WM, Basit A, et al. Intermediate Results of the Prestige LP Cervical Disc Replacement: Clinical and Radiological Analysis with Minimum Two-Year Follow-up. Spine (Phila Pa 1976). 2011 Jan 15;36(2):E105-11.
  17. Chen J, Wang X, Bai W et al. Prevalence of heterotopic ossification after cervical total disc arthroplasty: a meta-analysis. Spine J 2012; 21(4):674-80.
  18. Hayes, Inc. Hayes Medical Technology Directory. Artificial Disc Replacement for Cervical Degenerative Disc Disease. Lansdale, PA: Hayes, Inc.; December 2012.
  19. Bono CM, Ghiselli G, Gilbert TJ et al. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J 2011; 11(1):64-72.
  20. National Institute for Health and Clinical Excellence (NICE). Prosthetic intervertebral disc replacement in the cervical spine. 2010. Available online at: http://publications.nice.org.uk/prosthetic-intervertebral-discreplacement-in-the-cervical-spine-ipg341 Last accessed February 2014
  21. Matz PG, Holly LT, Groff MW et al. Indications for anterior cervical decompression for the treatment of cervical degenerative radiculopathy. J Neurosurg Spine 2009; 11(2):174-82.
  22. Mummaneni PV, Kaiser MG, Matz PG et al. Cervical surgical techniques for the treatment of cervical spondylotic myelopathy. J Neurosurg Spine 2009; 11(2):130-41
  23. Blue Cross and Blue Shield Association (BCBSA). Artificial Intervertebral Disc: Cervical Spine. Medical Policy Reference Manual, Policy 7.01.108, 2014.
  24. Reviewed by practicing neurosurgeon, September 2009.
  25. Reviewed by practicing orthopedic surgeon specializing in spine surgery, September 2009; September 2010.
  26. Resources
  27. Benzel EC. Cervical disc arthroplasty compared with allograft fusion. J Neurosurg Spine 2007; 6(3):197.
  28. Fraser JF, Hartl R. Anterior approaches to fusion of the cervical spine: a meta-analysis of fusion rates. J Neurosurg Spine 2007; 6(4):298-303.
  29. Galler RM, Sonntag VKH. Bone graft harvest. Barrow Quarterly 2003; 19(4):13-9. Last accessed February, 2014.
  30. Malloy KM, Hilibrand AS. Autograft versus allograft in degenerative cervical disease. Clin Orthop Rel Res 2002; 394:27-38.
  31. McAfee PC. Cervical and lumbar disc replacement – the ease of revision. Business Briefing: U.S. Orthopedics Review 2006. Last accessed January 2, 2013.
  32. Samartzis D, Shen FH, Goldberg EJ et al. Is autograft the gold standard in achieving radiographic fusion on one-level anterior cervical discectomy and fusion with rigid anterior plate fixation? Spine 2005; 30(15):1756-61.
  33. Sears WR, McCombe PF, Sasso RC. Kinematics of cervical and lumbar disc replacement. Semin Spine Surg 2006; 18(2):117-29.
  34. Suchomel P, Barsa P, Buchvald P et al. Autologous versus allogeneic bone grafts in instrumented anterior cervical discectomy and fusion: a prospective study with respect to bone union pattern. Eur Spine J 2004; 13(6):510-5.
  35. Yue WM, Brodner W, Highland TR. Long-term results after anterior cervical discectomy and fusion with allograft and plating. Spine 2005; 30(19):2138-44.
  36. Agency, and Other Authoritative Publications
  37. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Artificial Intervertebral Disc Arthroplasty for Treatment of Degenerative Disc Disease of the Cervical Spine. TEC Assessments. 2008; Volume 22, No 12.
  38. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Artificial Intervertebral Disc Arthroplasty for Treatment of Degenerative Disc Disease of the Cervical Spine. TEC Assessments 2013; Volume 28, Tab 7.
  39. Washington State Health Care Authority Health Technology Assessment. HTA Final Report Artificial Discs Replacement (ADR). September 19, 2008, Last accessed February, 2014.
  40. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health. Post Market Approval (P100003b) – SECURE®-C Cervical Artificial Disc. Last accessed February, 2014.
  41. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health. Post Market Approval (P100012) – PCM Cervical Disc System. Last accessed January 2, 2013.
  42. U.S. Food and Drug Administration (FDA) Center for Devices and Radiologial Health. Summary of Safety and Effectiveness Data: (P110002b) Mobi-C. 2013. Last accessed February, 2014.

Coding

Codes

Number

Description

CPT

0092T

Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), each additional interspace, cervical

 

0095T

Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace., cervical

 

0098T

Revision including replacement of total disc arthroplasty (artifical disc), anterior approach, each additional interspace, cervical

 

22856

Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), single interspace, cervical

 

22861

Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical

 

22864

Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical

 

22899

Unlisted procedure, spine

ICD-9 Procedure

80.50

Excision or destruction of intervertebral disc, unspecified

 

80.51

Excision of intervertebral disc

 

84.60

Insertion of spinal disc prosthesis, not otherwise specified

 

84.61

Insertion of partial spinal disc prosthesis, cervical

 

84.62

Insertion of total spinal disc prosthesis, cervical

ICD-10-PCS
(effective 10/01/14)

0RR30JZ

Open replacement of cervical vertebral disc with synthetic substitute

 

0RR50JZ

Open replacement of cervicothoracic vertebral disc with synthetic substitute

Type of Service

Surgery

 

Place of Service

Hospital

 

Appendix

N/A

History

Date

Reason

04/10/07

New policy. Add to Surgery Section.

08/23/07

Codes Updated

10/14/08

New PR Policy. Policy updated with literature search. Policy statement updated to allow artificial disc replacement as medically necessary when certain conditions are met. Previous Investigational statement deleted and added Medically Necessary and Investigational statements. Policy description, rationale and references updated. Status changed from BC to PR. Codes 80.5 and 80.51 added.

01/13/09

Codes 22856, 22861, 22864 added; effective 1/1/09.

10/13/09

Replace Policy. Policy updated with literature search. Rationale and References updated.

10/12/10

Replace Policy. Policy updated with literature search. Rationale and References updated.

09/15/11

Replace Policy – Policy updated with literature search. No change to policy statement.

01/10/12

Replace Policy – Policy updated with literature search. Policy statement clarified to allow myelopathy without need for conservative treatment. Rationale and References updated.

04/17/12

Related Policies updated: the title of 7.01.18 now includes endoscopic discectomy.

01/29/13

Replace policy. Investigational statement amended to include” as they are not FDA approved for more than one level”. Two new devices added to description section. Rationale updated and References 29 – 34 added.

04/17/13

Update Related Policies – Add 7.01.542.

09/30/13

Update Related Policies. Change title to 7.01.72.

12/03/13

Coding Update. Add ICD-10 codes.

03/25/14

Replace policy. Policy updated and rationale reformatted with a literature review through November 2013. Moved skeletally mature criteria from the Regulatory Status section to the medical policy statement. Added investigational statement: For all other devices not listed as medically necessary in the first medical policy statement above. Added Definition of Terms to Policy Guidelines. Mobi-C prosthetic device added to Regulatory Status. Added Practice Guidelines and Position Statements. References reformatted, numbers 19-23 added; others renumbered/removed. Policy statement changed as noted. Code 84.66 removed per ICD-10 mapping project; this code is not utilized for adjudication of policy. ICD-9 diagnosis code removed from the policy; this does not affect adjudication.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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