Notification

Artificial Intervertebral Disc Insertion


Notification Issue Date: 10/16/2018

This version of the policy will become effective 01/14/2019.

The Description Section was updated to include information regarding the ActivL® Artificial Disc.

The following statement was added to the Policy Section:

Subsequent cervical artificial intervertebral disc implantation at an adjacent level is considered medically necessary, and therefore, covered when all of the following are met:

  • Criteria for cervical artificial intervertebral disc implantation listed above are met; AND
  • The device is FDA-approved for 2 levels (i.e., Mobi-C, Prestige LP); AND
  • The planned subsequent procedure is at a different cervical level than the initial cervical artificial disc replacement; AND
  • Clinical documentation that the initial cervical artificial intervertebral disc implantation is fully healed.

The following ICD-10 Diagnosis Codes were added to the policy: M50.120, M50.121, M50.122, M50.123


Medical Policy Bulletin


Title:Artificial Intervertebral Disc Insertion

Policy #:11.14.19l

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member’s contract.

CERVICAL ARTIFICIAL INTERVERTEBRAL DISC INSERTION

MEDICALLY NECESSARY
Artificial intervertebral disc insertion for the cervical spine, using an FDA-approved device, is considered medically necessary and, therefore, covered for the treatment of one cervical spine level from C3 to C7 in skeletally mature individuals when all of the following conditions are met:
  • The individual has symptomatic, intractable cervical degenerative disc disease (e.g., radicular neck and/or arm pain, functional/neurological deficit) or herniated disc, confirmed by radiographic studies.
  • The individual either
    • Has failed at least 6 weeks of conservative non-operative management, including active pain management program or protocol, under the direction of a physician, with pharmacotherapy that addresses neuropathic pain and other pain sources and a formal course of physical therapy OR
    • Has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment
  • The individual does not have a cervical anatomical deformity or compromised vertebral bodies at the treated level (e.g., ankylosing spondylitis, rheumatoid arthritis).
  • The individual has not had prior surgery at the treated level.
  • The individual has not had prior spinal fusion at an adjacent cervical level.

Simultaneous cervical artificial intervertebral disc implantation at a second contiguous level is considered medically necessary, and therefore, covered if the above criteria are met for each disc level, and the device is FDA-approved for 2 levels (i.e., Mobi-C, Prestige LP).

Subsequent cervical artificial intervertebral disc implantation at an adjacent level is considered medically necessary and, therefore, covered when all of the following are met:
  • Criteria for cervical artificial intervertebral disc implantation listed above are met; AND
  • The device is FDA-approved for 2 levels (i.e., Mobi-C, Prestige LP); AND
  • The planned subsequent procedure is at a different cervical level than the initial cervical artificial disc replacement; AND
  • Clinical documentation that the initial cervical artificial intervertebral disc implantation is fully healed.

Artificial intervertebral disc insertion with simultaneously performed (i.e., hybrid) spinal fusion surgery is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

All other uses for artificial intervertebral disc insertion for the cervical spine are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

LUMBAR ARTIFICIAL INTERVERTEBRAL DISC INSERTION

EXPERIMENTAL/INVESTIGATIONAL
Although the US Food and Drug Administration (FDA) has approved several artificial intervertebral disc devices for the lumbar spine, the Company has determined that the safety and/or effectiveness of artificial intervertebral disc insertion for the lumbar spine cannot be established by review of the available published peer-reviewed literature. Therefore, artificial intervertebral disc insertion for the lumbar spine is considered experimental/investigational by the Company and not covered.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, artificial intervertebral disc insertion for the cervical spine is covered under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met.

Artificial intervertebral disc insertion for the lumbar spine is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved several artificial intervertebral disc devices for use in the lumbar spine. The FDA has also approved several artificial intervertebral disc devices for use in the cervical spine.

Description

Artificial intervertebral disc insertion is an emerging technology intended for use in the cervical or lumbar spine to treat degenerative disc disease (DDD). DDD is a common cause of neck and/or low back pain. DDD is often defined as discogenic back pain with degeneration of the disc confirmed by individual history and radiographic studies. When conservative treatment for the disease (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], physical therapy) fails to relieve pain, a common surgical approach is spinal fusion. However, by surgically altering the biomechanics of the back, spinal fusion may also cause premature disc degeneration at adjacent levels, which results in increased pain and decreased range of motion (ROM). This is a notable concern for younger individuals. The artificial intervertebral disc insertion procedure (i.e., spinal arthroplasty or total disc replacement) was developed with the goal of avoiding the problems associated with spinal fusion surgery, which include a decreased ROM.

Artificial intervertebral disc insertion is intended to preserve ROM at the operative level once the diseased spinal disc is surgically removed, and an artificial disc is inserted between the adjoining vertebrae. The artificial disc generally consists of two metal endplates and a central, free component that moves within the disc space during spinal motion. Theoretically, the artificial intervertebral disc insertion procedure is designed to reduce or eliminate back pain and restore disc height while maintaining spinal curvature, flexibility, and load bearing. However, there are concerns that the use of an artificial disc increases the potential for implant failure due to device fracture, dislocation or wear, bone implant interface failure due to subsidence (i.e., sinking or settling in a bone), dislocation migration, or vertebral body fracture, and host response to the implant, which may include adverse events such as osteolysis, heterotopic ossification, and pseudotumor formation.

Clinical studies have indicated that successful outcomes are typically only achieved by well-trained surgeons. This underscores the difficulty associated with the artificial intervertebral disc insertion procedure, especially when compared to spinal fusion, which is often considered the established standard for the treatment of DDD and low back pain. Additionally, there remain concerns about the need for revision surgery following artificial disc insertion, which often requires the disc to be removed. It is considered to be more complicated than revision surgery following spinal fusion due to the need for the abdomen to be opened, which results in severe blood loss.

CERVICAL ARTIFICIAL DISC REPLACEMENT

Cervical DDD is typically caused by spinal spondylosis (i.e., degenerative osteoarthritis), which causes intervertebral disc deterioration of the cervical spine. Symptoms may include radicular arm pain, weakness, and paresthesias (i.e., abnormal sensation). The prevalence of cervical DDD that is secondary to spinal spondylosis increases with age, with an estimated 60% of individuals older than 40 years having radiographic evidence of cervical DDD. By 65 years of age, approximately 95% of men and 70% of women have at least one degenerative change evidenced by radiography.

Anterior cervical discectomy and fusion (ACDF) is considered the definitive surgical treatment for symptomatic cervical DDD, and the resolution of pain and neurologic symptoms has been demonstrated in 80% to 100% of individuals undergoing ACDF. However, cervical artificial disc replacement (CADR) has been proposed as an alternative to ACDF for the treatment of individuals with neck pain, arm pain, nerve irritation, and/or spinal cord irritation due to cervical DDD that has not improved with at least six weeks of conservative management alone. It is hypothesized that CADR has the potential to reduce the risk of adjacent level DDD above or below a fusion site and to preserve ROM. However, while the intended patient populations for CADR and ACDF are similar, CADR should be limited to the treatment of one cervical spine level in individuals with DDD, without cervical anatomical deformities or compromised vertebral bodies at the treated level (e.g., ankylosing spondylitis, rheumatoid arthritis). Additionally, individuals should not have had prior spinal fusion at an adjacent cervical level, which may compromise the effectiveness of CADR at the treated level.

The FDA has approved several artificial disc devices for the treatment of DDD of the cervical spine including, but not limited to, ProDisc®-C (Synthes Spine, Inc., West Chester, PA), Prestige® ST Cervical Disc System (Medtronic Sofamor Danek, Memphis, TN), BRYAN® Cervical Disc (Medtronic Sofamor Danek, Memphis, TN), PCM Cervical (NuVasive, Inc., San Diego, CA), Secure®-C (Globus Medical, Inc., Audobon, PA), and Mobi-C® (LDR Spine USA, Inc., Austin, TX). Due to concerns about the long-term safety and effectiveness of these devices, post-approval studies were required to assess long-term data. These devices are indicated for spinal arthroplasty at one cervical spine level from C3 to C7 in skeletally mature individuals with DDD. There are multiple ongoing clinical trials which assess artificial intervertebral disc devices for the use in the cervical spine. The current FDA approvals were based on randomized clinical trials using a noninferiority trial design in which cervical artificial intervertebral disc insertion was compared to a type of spinal fusion surgery. The available published peer-reviewed literature for Secure®-C, if any, is limited. In August 2013, the Mobi-C® cervical disc received FDA approval for use in both one-level and two-level CADR.

The purpose of a noninferiority trial is to show that the experimental treatment is not clinically worse than (i.e., inferior to) the control treatment by a pre-specified margin, referred to as the noninferiority margin. A noninferiority trial is built on the assumption that the control has been proven effective. A superiority trial is a first choice for RCT trial design because it provides direct evidence of effect. In such a trial, the new treatment or device demonstrates a superior clinical result. A noninferiority trial should be a last choice for trial design because it offers indirect evidence of a treatment or device’s effectiveness. These studies lack robust effectiveness data because decisions on degree of inferiority margins can be complex or biased, appropriate sample size can be difficult, and the results can be misleading and misinterpreted. The appropriateness of utilizing a noninferiority trial design for artificial intervertebral disc insertion has been questioned because the control (i.e., spinal fusion) has not been adequately studied to determine which type of spinal fusion surgery (e.g., anterior lumbar interbody fusion, posterior fusion) is the most effective or whether spinal fusion surgery is more effective than conservative management alone.

Currently, the US Centers for Medicare and Medicaid Services (CMS) has not issued a national or local coverage determination for CADR.

PEER-REVIEWED LITERATURE
In a prospective, randomized, noninferiority clinical trial with a noninferiority margin of 10%, individuals who received the ProDisc®-C cervical disc were compared to those who underwent ACDF. For several reasons related to the primary composite endpoint (i.e., overall success rate) and the overall ProDisc®-C study design, it is difficult to discern a real health benefit from the ProDisc®-C cervical disc compared with fusion. The reported statistical superiority was based on ad-hoc analysis that was driven primarily by a single outcome measure (revision of fusion vs. removal of the implant). Furthermore, the study failed to demonstrate statistical superiority for the NDI, which is a clinically validated, multidimensional outcome measure of pain and disability caused by cervical DDD. Lastly, the study was not blinded, which has the potential to bias outcome assessments in favor of the novel ProDisc®-C treatment over the conventional fusion treatment. Ultimately, the FDA required a 7-year PAS to evaluate the long-term safety and effectiveness.

In a prospective randomized controlled trial, Nabhan et al. (2007) compared the safety and effectiveness of ProDisc®-C with ACDF. Thirty-three individuals with symptomatic soft disc herniation were randomized to CADR or ACDF (control group). These individuals were followed for 24 weeks and had a mean age of 45 years. Outcome measurements included segmental ROM postoperatively and neck and arm pain. The authors noted that segmental ROM was significantly better for extension and right-sided bending in the CADR group compared with the ACDF group (p < 0.05). However, there was a statistically significant difference between both groups for right-sided axial rotation. The authors concluded that while neck and arm pain results were comparable between the two groups, loss of cervical segmental ROM was significantly higher in the ACDF. The study is limited in its small sample size, short-term follow-up period, and lack of blinding.

In a prospective, randomized, noninferiority clinical trial with a noninferiority margin of 10%, individuals were randomized in a 1:1 ratio to ACDF (control group) or CADR with the BRYAN® cervical disc and were followed for 24 months. Outcome measurements included the NDI, the Neck Pain Score, and SF-36 scores. The authors demonstrated that CADR had statistically significant improvements when compared with ACDF (p < 0.05). The study is limited in its small sample size and short-term follow-up period. Additionally, the authors reported a low participation rate due to patient dissatisfaction with randomization, which may contribute to potential bias. The FDA required a 10-year PAS to evaluate the long-term safety and effectiveness of the BRYAN® Cervical Disc. Data will be collected at 5, 7, and 10 years. Furthermore, the FDA approval is contingent upon the completion of a 5-year enhanced surveillance study, which will more fully characterize adverse events when the device is used in a broader population.

In a prospective, multicenter, randomized FDA-approved IDE clinical study, individuals who underwent CADR with the PCM® cervical disc were compared to those undergoing ACDF with allograft and plate control and were followed for 2 years. A total of 416 individuals with a degenerated single-level cervical disc from C3-C4 or C7-T1 were enrolled in the clinical trial and 403 were ultimately treated. The mean age was 45 years old. Individuals were randomly assigned to be treated with either the PCM cervical disc or ACDF. Outcome measurements included NDI, VAS neck and arm pain scores, and patient satisfaction questionnaires. This was in addition to radiographic and clinical evaluations. Overall success was defined as at least 20% improvement in NDI with the absence of radiographic or major complications. At 24 months, overall success was achieved by 75.1% of PCM® individuals compared with 64.9% of ACDF individuals. The study is limited in its short-term follow-up period.

In a prospective, randomized controlled trial, Heller et al. (2009) evaluated the safety and effectiveness of CADR with the BRYAN® cervical disc compared with spinal fusion. Two hundred and forty-two individuals received the BRYAN® cervical disc and 221 individuals underwent one-level ACDF (control group). Study participants completed clinical and radiographic follow-up for up to 24 months after surgery. NDI was statistically significantly better in the CADR group compared with the ACDF group (p = 0.025). There was no statistically significant difference between the two groups with regard to revision surgery subsequent to the index procedure. Individuals who received the CADR returned to work nearly 2 weeks earlier than individuals undergoing fusion (p = 0.015). The authors concluded that CADR is a viable alternative to ACDF in individuals with persistent symptomatic, single-level cervical DDD. The study is limited in its short-term follow-up period and lack of blinding.

In a prospective randomized controlled trial, Murrey et al. (2009) compared the safety and effectiveness of ProDisc®-C with ACDF for the treatment of DDD at one level between C3 and C7. A noninferiority design with a 1:1 randomization of 269 individuals was used (106 ACDF; 103 ProDisc®-C). Outcome measurements included visual analog scale (VAS) pain and intensity scores, NDI, and the number of adverse events. Individuals were followed for up to 24 months, with similar demographics between the two groups. The authors noted that both the ACDF and CADR groups had statistically significantly better NDI and VAS scores (p < 0.0001). However, there was no statistically significant difference between the two treatment groups. At 24 months postoperatively, CADR individuals achieved a more than or equal to 4 degrees of motion or maintained motion relative to preoperative baseline measurements. The authors concluded that ProDisc®-C was a safe and effective treatment option for individuals with disabling cervical radiculopathy due to DDD. The study is limited in its short-term follow-up period and lack of blinding.

In a non-comparative, prospective study, Beaurain et al. (2009) evaluated the safety and effectiveness of the Mobi-C® device in 76 individuals with DDD at one or more levels. CADR was performed after radiological confirmation (e.g. CT, MRI) and failure of conservative treatment. Individuals older than 65 years of age or with osteoporosis were excluded. About 86.5% of study participants had no previous cervical surgery and 12.2% had previous fusion. Approximately 88% of study participants were operated with Mobi-C® at one level, while 12% were operated at two levels. Outcome measurements included NDI and VAS pain scores, in addition to ROM measurements pre- and post-operatively. Complications and re-operation rates were also assessed. The authors reported on intermediate 2-year follow-up results and analyzed occurrences of HO. Ultimately, only 58 individuals were evaluated at 2-year follow-up (i.e., 24% loss to follow-up). Of these study participants, 72% (n=42) met the successful outcome definition of pre-op NDI superior or equal to 30%, with a decrease of 15 points or more at 2-year follow-up. Mean NDI and VAS scores for both the arm and neck were statistically significantly reduced and ROM was preserved at index levels, with 85.5% of the segments remaining mobile at 2-year follow-up. In 72% of the study participants, HO was responsible for fusion at 6 of the 76 total levels. The authors concluded that the intermediate results of CADR were encouraging and that further studies were needed to determine the preservation of adjacent levels. The study is limited in its relatively short-term follow-up period, high loss to follow-up, heterogeneous study population, and lack of a comparative control group.

In a prospective randomized controlled trial, Garrido et al. (2010) evaluated the safety and effectiveness of BRYAN® cervical disc in CADR when compared with ACDF. Forty-seven individuals with single-level DDD were followed for 48 months. Outcome measurements included NDI, VAS neck and arm scores, the number of adverse events, and the number of revision surgeries. At 48 months, NDI improvement was higher for CADR when compared with ACDF. VAS neck and arm pain scores were higher for ACDF when compared with CADR. There were six revision surgeries in the ACDF group and only one revision surgery in the BRYAN® cervical disc group. Of the six revision surgeries for the ACDF group, three were for adjacent level DDD and one was for remote level DDD. The remaining two surgeries were performed on the same individual for pseudarthrosis (i.e., unresolved fracture). In the CADR group, the revision surgery was for adjacent level DDD. The authors concluded that at 48 months, CADR continued to compare favorably to ACDF and resulted in no degradation of functional outcomes. The study is limited in its small sample size and short-term follow-up period.

In a randomized controlled trial, Delamarter et al. (2010) reported on the 4-year follow-up results of the individuals enrolled in the FDA’s investigational device exemption (IDE) trial for the ProDisc®-C. The authors noted that ACDF may result in a higher risk for revision surgery. However, both CADR and ACDF groups show good clinical results at 4-year follow-up. Furthermore, they noted that the study is limited by the lower individual accountability at 48 months compared with at 24 months. They indicated that follow-up was ongoing. Therefore, the reported results should be considered preliminary, and no conclusions can be drawn until the entire study population has been evaluated. Large, long-term, randomized controlled trials are needed to demonstrate the long-term efficacy and safety of this device.

In a randomized, non-blinded, noninferiority trial with a noninferiority margin of 10%, the Prestige® ST cervical disc was compared to anterior cervical fusion (with allograft bone and plate stabilization). There were some noted concerns with the clinical trial, including the fact that the trial was non-blinded, which may have introduced bias because both the investigators and subjects knew which procedure was performed. At the time of the post-market approval (PMA) application, follow-up results were available on only half of the study participants, and only 75% of the 2-year follow-up results were reported in the published study. The FDA required a 7-year post-approval study (PAS) to evaluate the device’s long-term safety and effectiveness. In addition, a 5-year enhanced surveillance study was required to fully characterize the adverse events associated with the cervical disc device.

In a prospective, non-blinded, randomized controlled trial, Burkus et al. (2010) evaluated the long-term clinical outcomes in individuals undergoing anterior cervical surgery with the Prestige® device. Five hundred and forty-one individuals with cervical DDD were randomly assigned to CADR or spinal fusion (control group). Outcome measurements included Neck Disability Index (NDI) scores, health surveys, and neck and arm pain scores. Study participants were followed for up to 60 months. Of the 541 initial individuals , 271 (144 CADR and 127 spinal fusion) completed follow-up at 5 years. The overall rates of maintenance or improvement in neurological status in the CADR group were 91.6% 92.8%, and 95.0% at 24, 36, and 60 months, respectively, compared with 83.6%, 83.2%, and 88.9% in the control group (p = 0.006, 0.004, and 0.051). While rates of maintenance or improvement in the CADR group were not statistically significantly different at 60 months, the authors noted that rates for revision surgery at adjacent levels trended lower in the CADR group (8 individuals with 11 surgeries) compared with those in the spinal fusion group (13 individuals with 16 surgeries). These differences were not statistically different (p = 0.376). Regardless, the authors concluded that the Prestige® disc maintained improved clinical outcomes and segmental motion at 5-year follow-up. The study is limited in its high loss to follow-up, mid-term follow-up period, and lack of blinding. For the purposes of an implantable device, a 5-year follow-up is insufficient to assess durability, the biologic effects of wear, and the response of the prosthesis to its environment, particularly in the relatively young population in which this device is being used.

In a prospective comparative study, Peng et al. (2011) evaluated the safety and effectiveness of the Prestige® disc compared with ACDF. Twenty-one females and 19 males with a mean age of 43.9 years were followed for a mean of 2.9 years. Of these individuals, 62.5% had one-level replacement, 52.5% had myelopathy, and 47.5% had radiculopathy. Outcome measurements included NDI, cervical ROM, and radiography. The authors noted significant improvement in the NDI from a mean of 42.2 preoperatively to 16.4 at 6 months and 15.2 at 2 years (p < 0.05). There was no statistically significant difference in clinical outcomes between CADR and ACDF. The authors concluded that CADR resulted in improved clinical outcomes at 2-year follow-up and can restore segmental lordosis (i.e., inward curvature of the spinal column) and preserve segmental ROM up to 2 years postoperatively. The study is limited in its lack of randomization, small sample size, short-term follow-up period, and heterogeneous study population.

In a prospective study, Huppert et al. (2011) evaluated the safety and effectiveness of the Mobi-C® device at one-level compared with multi-level CADR. A total of 231 individuals with cervical DDD were evaluated at 2-year follow-up, with 175 undergoing one-level surgery and 56 at 2-levels or more. Outcome measurements included NDI, VAS pain scores, ROM, and participant satisfaction. Mean NDI and VAS scores for both groups were improved, though there was no statistically significant difference between the two groups. In the multi-level group, analgesic use was significantly higher and the occurrence of HO was significantly lower. There was no significant difference in participant satisfaction. Approximately 11% of individuals in the one-level group and 20% of individuals in the multi-level group required re-operation or had at least 1 complication. While the authors concluded that there was no statistically significant difference between one-level and multi-level CADR, they acknowledged that further studies were necessary to understand the impact of multi-level CADR, especially on adjacent segments. The study is limited in its relatively short-term follow-up period, high loss to follow-up, heterogeneous study population, and lack of comparisons with gold standard treatments.

In a retrospective study, Ding et al. (2012) evaluated the intermediate clinical and radiographic outcomes of CADR with BRYAN® cervical disc. Thirty-four individuals representing 38 discs underwent CADR and study participants were followed for an average of 49.4 months (32 to 69). Clinical and radiographic outcomes, adjacent segment degeneration, complications, and reoperations were determined. NDI and neck and arm VAS pain scores were all statistically significantly improved postoperatively (p < 0.05), but there were no statistically significant differences between the different follow-up time points. Approximately 23% of adjacent levels displayed mild degeneration at last follow-up. No revision surgeries were performed. The authors concluded that the BRYAN® cervical disc resulted in successful clinical outcomes; however, adjacent segment degeneration was observed. The study is limited in its retrospective study design, small sample size, and lack of a comparative group.

In a prospective randomized controlled trial, Zhang et al. (2012) evaluated the safety and effectiveness of the BRYAN® cervical disc during CADR with conventional ACDF (control group). A total of 120 individuals were randomized to CADR (n=60) or ACDF (n=60) and were followed for 24 months. Both groups had similar demographics including ROM, NDI, and VAS pain scores for the neck and arm. The CADR group had a statistically significantly longer operation time than the ACDF group (p < 0.001). ROM was maintained in the CADR group, but was reduced in the ACDF group. There was no statistically significant difference between the two groups with respect to NDI or VAS pain scores. One individual in the CADR group and four individuals in the ACDF group required revision surgery. The authors concluded that CADR yielded good clinical results while preserving ROM at the index level. The study is limited in its small sample size, short-term follow-up period, and lack of blinding.

In a prospective study, Wu et al. (2012) evaluated the safety and effectiveness of one-level CADR compared with two-level CADR in 87 consecutive individuals. Ultimately, data from 70 individuals, representing 98 levels, were obtained. There were 42 individuals in the one-level group and 28 individuals in the two-level group. Outcome measurements included NDI and VAS pain scores and study participants were followed for a mean of 46 months. While both groups had statistically significant improvements in NDI and VAS, there was no statistically significant difference between the two groups. HO was identified significantly more frequently in the two-level group than the one-level group (75% vs. 40.5%; p = 0.009). The authors concluded that clinical outcomes of both one-level and two-level CADR were similar at 46-month follow-up. However, there was a statistically significantly higher rate of HO in individuals undergoing two-level CADR. The study is limited in its non-randomized design, relatively short-term follow-up period, and lack of a comparative control group.

In a prospective randomized controlled trial, Delamarter and Zigler (2012) reported on the rates of secondary surgical intervention at both the index and adjacent levels for individuals treated with CADR or ACDF. Two hundred and nine individuals were randomized (103 CADR, 106 ACDF) and followed for 5 years. A secondary surgical intervention was defined as a reoperation. Of the study participants that were ultimately involved in the study, 5-year follow up rates were 72.7% for the CADR group (n=72) and 63.5% for the ACDF group (n=61). At 5-year follow-up, individuals who received the ProDisc®-C device had a statistically significant probability of not having a reoperation at the index and adjacent levels when compared with individuals who underwent ACDF (97.1% vs. 85.5%, p = 0.0079). There were no reoperations performed for implant breakages or device failures for the CADR group. For the ACDF group, the most common reason for reoperation at the index level was pseudarthrosis. For both groups, the most common reason for reoperation at the adjacent level was recurrent neck and/or arm pain. For the CADR group, three individuals had reoperations. One individual had a secondary surgical intervention to address persistent pain and two individuals were treated at the index and adjacent levels for persistent pain and adjacent level degeneration (ALD). The device was removed in two individuals and the levels were converted to anterior fusions. One device was left intact with a posterior foraminotomy and fusion with stabilization. The authors concluded that CADR results in decreased reoperation rates when compared with ACDF. The study is limited in its mid-term follow-up period and its high loss to follow-up, which may hinder the internal validity of the study.

In a follow-up publication of the same study, Zigler et al. (2013) evaluated the safety and effectiveness of CADR using the ProDisc®-C device when compared with ACDF. Outcome measurements included NDI, VAS neck/arm pain scores, a SF-36 health survey (a standardized questionnaire used to measure an individual's overall subjective health status), neurological examination, device success, adverse event occurrence, and patient satisfaction. At 5-year follow-up, the authors reported that individuals in the CADR group had statistically significantly less neck pain intensity and frequency. Both groups scored high VAS satisfaction scores at 5 years. There were no reports of device failures or implant migration with the ProDisc®-C device and individuals in the CADR Group maintained ROM at their index level. The authors concluded that at 5 years, CADR was a safe and effective treatment for single-level symptomatic cervical disc disease with clinical outcomes that are comparable to ACDF. The study is limited in its mid-term follow-up period and its high loss to follow-up.

In a prospective, randomized FDA IDE pivotal study, Davis et al. (2013) evaluated the safety and effectiveness of CADR with the Mobi-C® device compared with ACDF for the treatment of 2-level symptomatic DDD. The primary outcome measurement was a composite measure of success at 2-year follow-up. A total of 330 individuals were enrolled and randomized (225 received CADR; 105 received ACDF). At 2-year follow-up, 3% of individuals were lost to follow-up. Individuals in both groups showed statistically significant improvements in NDI and VAS pain scores. However, individuals undergoing CADR experienced statistically significant greater improvements in success and NDI. The reoperation rate was significantly higher in the ACDF group at 11.4% compared with 3.1% in the CADR group. Grade IV HO was present in 11 individuals undergoing CADR (5%) at 2-year follow-up. HO was not present in individuals undergoing ACDF. The authors concluded that on average, CADR was safe and effective compared with ACDF for the treatment of two-level symptomatic DDD. The study is limited in its relatively short-term follow-up period and potential risk for publication bias.

In a prospective, single-site study of two randomized clinical trials, Hacker et al. (2013) evaluated the safety and effectiveness of CADR using the Prestige® and BRYAN® devices compared with ACDF for the treatment of 94 individuals with cervical DDD. Nineteen individuals received the Prestige® device and 28 received the BRYAN® device. Outcome measurements included radiographical and clinical data scheduled postoperatively at 12, 24, 48, and 60 months. Adverse events were assessed as well. Late complications were defined as 24 months following surgery, and very late complications were defined as 48 months following surgery. Adjacent segment disease occurred at a similar rate for individuals undergoing both fusion and CADR. Five individuals in the CADR group returned for evaluation of neck and arm symptoms 48 after surgery. Of these, 4 had peridevice vertebral body bone loss and 1 had posterior device migration and presented with myelopathy. Three required revision surgery. The authors concluded that despite the similarity between CADR and ACDF, they are not equivalent procedures in regard to very late complications. The authors also noted that appropriate follow-up intervals for CADR have not yet been defined by clinical trials. Therefore, they suggested that significantly longer follow-up periods may be warranted for individuals undergoing CADR than those undergoing fusion.

In a prospective randomized controlled trial, Coric et al. (2013) evaluated the safety and effectiveness of CADR with conventional ACDF (control group) in individuals with single-level cervical radiculopathy. The results of two separate prospective randomized IDE trials (BRYAN® and Kineflex®-C) were combined to evaluate outcomes. Primary clinical outcome measurements included NDI, VAS pain scores, and neurological examination. A total of 74 individuals were randomized to CADR (n=41) or ACDF (n=33). Eighty-six percent of individuals (n=63) completed a minimum of 4 years follow-up. Average follow-up was 6 years (48 to 108 months). In both the CADR and ACDF groups, mean NDI scores had a statistically significant improvement at 6 weeks after surgery and remained statistically significantly improved throughout the minimum of 48 months (p < 0.001). ROM in the CADR group was statistically significantly greater when compared with the ACDF group. There were a total of three reoperations at the index or adjacent levels in the CADR group and there was one reoperation in the ACDF group. There were no statistically significant differences in overall reoperation rates. The authors concluded that both CADR and ACDF groups showed excellent clinical outcomes that were maintained over 48 months. The study is limited in its small sample size, heterogeneous treatment arms (BRYAN® and Kineflex®-C), and mid-term follow-up period.

In a retrospective study, Malham et al. (2014) evaluated the safety and effectiveness of the ProDisc®-C device in one-level (n=19) or two-level CADR (n=5). Outcome measurements included NDI and VAS pain scores. Complication and revision surgery rates were also noted. Average follow-up was 7.7 years. All outcome measurements had a statistically significant improvement. There were no episodes of device migration or subsidence, with a mean ROM of 6.4 degrees. Heterotopic ossification (HO) was present in 37% of individuals (n=7). Radiographic adjacent segment disease below the device developed in 21% of individuals (n=4), with three occurring in individuals who underwent two-level CADR. The authors concluded that CADR was a safe and effective procedure, though there was radiographic evidence of HO and adjacent segment disease on follow-up. The study is limited in its small sample size, retrospective study design, heterogeneous population, and lack of a comparative control group.

In a retrospective study, Fay et al. (2014) evaluated the safety and effectiveness of CADR using the BRYAN® cervical disc (n=37) compared with ACDF (n=40) in two-level cervical DDD. Seventy-seven consecutive individuals underwent two-level surgery and were followed for approximately 40 months. Outcome measurements included NDI and VAS pain scores. There were statistically significant improvements in all both NDI and VAS pain scores, though there was no significant difference between the groups. The authors concluded that clinical outcomes of two-level ACDF and CADR were similar 40 months after surgery; however, further studies were needed to truly establish the safety and effectiveness of surgery to treat multi-level DDD. The study is limited in its retrospective study design, relatively small sample size, and short-term follow-up period.

In a prospective randomized controlled trial, Hisey et al. (2014) evaluated the Mobi-C® device in CADR when compared with ACDF for treating single-level cervical DDD. A total of 245 individuals were treated (164 CADR; 81 ACDF) and followed for 24 months. The primary outcome measurement was overall success based on improvement in NDI, no subsequent surgical interventions, and no adverse events. Secondary outcomes included VAS assessing neck and arm pain, patient satisfaction, radiographic ROM, and adjacent level degeneration. Overall success rates were 73.6% for CADR and 65.3% for ACDF, which confirmed noninferiority (p < 0.0025). Operative level ROM in the CADR was maintained throughout follow-up and radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). The authors concluded that CADR with the Mobi-C® was a safe and effective treatment for single-level disc degeneration, producing similar outcomes when compared with ACDF. The study is limited in its relatively short-term follow-up period and potential for publication bias.

In a comparative study, Hey et al. (2013) evaluated the role of hybrid CADR and ACDF in 7 consecutive individuals. Outcome measurements included VAS, NDI, and complication rates, and individuals were followed for 2 years. Data from the 7 individuals who underwent the hybrid procedure were compared with a retrospective random selection of another 7 ACDF and 7 CADR individuals. The authors noted that the individuals who underwent the hybrid procedure returned to work faster when compared to either ACDF or CADR (p = 0.035). There were no significant differences in ROM or functional scores. The authors concluded that the hybrid procedure was comparable to ACDF and CADR in terms of safety and feasibility, though additional large, randomized controlled trials were warranted. The study is limited in its extremely small sample size, retrospective matching, and short-term follow-up period.

In a retrospective study, Park et al. (2013) evaluated the intermediate-term clinical and radiologic outcomes of CADR with Mobi-C®. The study population consisted of 75 individuals with cervical disc herniation, representing 85 disc levels. Mean follow-up was 40 months, with a minimum follow-up of 24 months. Outcome measurements included neck and arm pain scores and NDI. Cervical overall lordosis, segmental lordosis, and ROM were evaluated up to 24 months postoperatively. The mean numeric rating scale scores and NDI scores decreased significantly over 24 months. This represented an overall success rate of 86.7% according to Odom criteria. Mean segmental lordosis and motion increased and then decreased until 24 months. HO occurred in 67 levels at 12 months postoperatively, increasing to 80 levels at 24 months. The authors concluded that intermediate follow-up of CADR using the Mobi-C® device showed good clinical outcomes, though there was a trend toward reduced alignment and motion at 24 months. The overall HO occurrence was 94.1% at 24 months. The study is limited in its retrospective study design, lack of a comparative control group, and its relatively mid-term follow-up period.

In a literature review, Alvin and Mroz (2014) evaluated the available literature on CADR with Mobi-C®, with a focus on two-level device. Fifteen studies evaluating CADR with Mobi-C® were included in the review, with study design, sample size, length of follow-up, statistical analysis, quality-of-life outcomes, conflicts of interest, and complications being recorded. Only one study was a level 1B randomized controlled trial, with all included studies concluded a non-inferiority of one-level CADR with Mobi-C® when compared with ACDF. Only one study analyzed outcomes of one-level vs. two-level CADR with Mobi-C® and another evaluating two-level CADR with Mobi-C® when compared with two-level ACDF. The authors noted that in comparison with other CADR devices, the Mobi-C® device was associated with higher rates of HO. They concluded that one-level CADR with Mobi-C® was non-inferior, but not superior, to one-level ACDF for individuals with cervical DDD. Additionally, they noted that insufficient evidence exists for two-level CADR with Mobi-C® when compared to two-level ACDF and that while Davis et al. (2013) did conclude superiority of two-level CADR with Mobi-C®, there were questions about publication bias. Specifically, they noted that the HO rate in the Davis et al. (2013) paper was 4.9% and different significant from every other study included in the review (range: 27.7 % - 94.1%) The authors indicated that there was a need for unbiased, well-designed prospective studies with well-defined outcomes. The study is limited in the heterogeneous nature of the included studies.

In a follow-up to the initial prospective, randomized FDA IDE pivotal study, Davis et al. (2015) evaluated the noninferiority of two-level CADR using Mobi-C® (n=225) when compared to 2-level ACDF (n=105) at 4-year follow-up. At 24 months, the follow-up rate was 98.2% for the CADR group and 94.3% for the ACDF group. At 48 months, the follow-up rate was 89% for CADR and 81.2% for ACDF. Outcome measurements included NDI scores, patient satisfaction, and overall success. Both groups demonstrated significant improvement in NDI score, VAS neck pain, and VAS arm pain from baseline, with Mobi-C® meeting the noninferiority margin. Subsequent testing for superiority showed that CADR individuals had significantly greater improvement than ACDF with respect to NDI. CADR also resulted in significantly greater improvement in VAS neck pain at 6 months postoperatively, but not at 12, 24, 36, or 48 months. Arm pain scores did not different between the groups. The CADR group had lower reoperation rates when compared with ACDF. At 48 months, adjacent level degeneration was observed in 41.5% of CADR individuals and 85.9% of ACDF individuals among those with available radiographs. Clinically relevant HO was observed in 25.6% of CADR individuals. Post-hoc analysis of the data from Davis et al. (2013) and Davis et al. (2015) were reported by Bae et al. (2015). Comparisons between single-level and two-level CADR with Mobi-C® revealed no significant difference on clinical outcomes (NDI, VAS, Short-Form 12), major complication rates, or subsequent surgery rates (3% for single-level and 4% for two-level). Clinically relevant HO was observed in 23.8% of individuals who underwent single-level CADR and 25.7% of individuals who underwent two-level CADR.

In a literature review, Skovrlj et al. (2015) evaluated the current available literature regarding reoperations following CADR. The authors noted that with increasing numbers of individuals undergoing CADR and longer available follow-up data, complications related to the devices and/or aging spine are growing. The published rates of reoperation (mean 1.0%; range 0% to 3.1%), revision (mean 0.2%; range 0% to 0.5%), and removal (mean 1.2%; range 0% to 1.9%) following CADR were low and comparable to the published rates following ACDF. The authors indicated that there was minimal literature and no guidelines with respect to the approaches and techniques in revision and for the removal of implants following CADR. Additionally, they called for longer-term follow-up studies to assess implant survivorship and its effect on revision and removal rates.

LUMBAR ARTIFICIAL DISC REPLACEMENT

Artificial lumbar disc replacement is being studied as an alternative to lumbar spinal fusion for the treatment of low back pain due to lumbar DDD that has not improved with at least six months of conservative management alone. The FDA has approved several artificial disc devices for the treatment of DDD of the lumbar spine: including, but not limited to, Charité® (DePuy Spine, Inc., Raynham, MA), ActivL® (Aesculap, Inc., Center Valley, PA) and ProDisc®-L (Synthes Spine, Inc., West Chester, PA). Due to questions about the long-term safety and effectiveness of these devices, the approval was contingent on the completion of post-marketing studies. While these devices are indicated for spinal arthroplasty at one level in skeletally mature individuals with DDD, the Charité® is approved for use in levels L4 to S1, while the ProDisc®-L is approved for use in levels L3 to S1, and ActivL® is approved for use in levels L4-L5 or L5-S1. In March 2010, DePuy Spine announced that it had stopped production of the Charité® artificial disc. DePuy Spine also announced that the Charité® had been replaced by the InMotion artificial disc. The InMotion disc retains the Charité®'s essential features, but incorporates several minor modifications designed to facilitate insertion. There are multiple ongoing clinical trials which assess artificial intervertebral disc devices for use in the lumbar spine. The current FDA approvals were based on randomized controlled trials which used a noninferiority trial design in which lumbar artificial intervertebral disc insertion was compared with spinal fusion surgery.

Initially in March 2006, CMS published a preliminary national coverage determination (NCD) deeming the disc not reasonable and necessary. In May 2006, CMS decided to leave the determination up to local Medicare contractors for individuals under the age of 60 and issued an NCD in August 2007, which determined that the disc is not reasonable and necessary for individuals above 60 years of age.

PEER-REVIEWED LITERATURE
In a randomized controlled trial with a noninferiority margin of 15%, the Charité® lumbar disc was compared it with Bagby and Kuslich (BAK) spinal fusion (i.e., BAK fusion cage), a spinal fusion procedure that is no longer used. Individuals were randomized in a 2:1 ratio, with 205 receiving lumbar artificial disc replacement (LADR) and 99 undergoing spinal fusion (control group). Individuals were followed for up to 24 months. The Charité® artificial disc had a success rate of 63% compared with a success rate of 53% for BAK fusion. The Charité® artificial disc device study reported results using a composite measure of success, but for each outcome measurement, the study did not demonstrate statistically significant noninferiority to BAK spinal fusion. It was noted that there were other methodology issues with the study that made interpretation of the results difficult. Due to questions about the long-term safety and effectiveness of the Charité® device, the FDA required a 5-year PAS to evaluate the overall success of the device. Outcomes to be measured in the PAS included the rates of revision surgery and the absence of adverse events.

In a randomized, non-blinded clinical study with a noninferiority margin of 10%, the ProDisc®-L device was compared with circumferential fusion. Two hundred and forty-two individuals were followed for up to 24 months and were randomized in a 2:1 ratio, with 161 receiving LADR and 75 undergoing fusion (i.e., control group). Using an FDA-requested composite measure of outcome incorporating symptom improvement and the absence of complications, the ProDisc®-L group had a success rate of 53.4% and fusion had a success rate of 40.8%. Zigler et al. (2007) reported on the results of this study using alternative definitions of overall success, which resulted in a greater difference between the two groups (63.5% CADR vs. 45.1% fusion, p = 0.005). Study participation rates were not disclosed. The authors concluded that the ProDisc®-L was safe and effective for the treatment of single-level discogenic pain between L3 and S1. The study is limited in its short-term follow-up period. Although the ProDisc®-L was approved by the FDA based on the information provided by the manufacturer, the FDA advisory committee did not meet to review the data. Due to questions about the long-term safety and effectiveness of the ProDisc®-L device, the FDA required a 5-year PAS to evaluate the overall success of the device. Outcomes to be measured included the rates of revision surgery and the absence of adverse events.

In a retrospective comparative study, Shim et al. (2007) evaluated the clinical and radiologic outcomes of the Charité® and ProDisc®-L devices. Among a total of 61 individuals (33 Charité®, 24 ProDisc®-L) who underwent LADR, 57 individuals were available for follow-up at 3 years. Clinical and radiologic data included ODI, VAS pain scores, ROM, progression of facet degeneration (PFA), and ALD. There was no statistically significant difference between the two groups in ODI or VAS improvement. ALD above the index level was seen in 19.4% of the Charité® and 28.6% of the ProDisc®-L devices. PFA was seen in 36.4% of the Charité® and 32% of the ProDisc®-L devices. Segmental ROM of the replaced segments was well-preserved, but ROM of L5 to S1 of the ProDisc®-L was significantly less than that of the Charité®. The authors concluded that while the clinical outcomes of both LADR disc devices were promising, the facet joint of the index level and the disc at the adjacent level showed an aggravation of the degenerative process in a significant number of study participants, regardless of the device used. This raises concerns about the potential late consequences of LADR, especially regarding facet arthrosis and adjacent segment disease. The study is limited in its small sample size, heterogenous study population, mid-term follow-up period, and lack of a comparative control group.

In a prospective randomized controlled trial, Guyer et al. (2008) reported on the 5-year follow-up from the FDA IDE study of the Charité® disc device. Of the 375 individuals enrolled in the initial Charité® IDE trial, 90 individuals who received the Charité® artificial disc and 43 individuals who underwent BAK fusion (control group) were followed for 5 years. These study participants were refractory to non-operative treatment and were followed for the treatment of single-level DDD from L4 to S1. Outcome measurements included VAS pain scores, validated Oswestry disability index (ODI, a self-report questionnaire that examines perceived levels of disability in 10 everyday activities of daily living), patient satisfaction, radiographic ROM, and segmental translation. Overall success was 57.8% in the Charité® group and 51.2% in the BAK group. The authors noted that there were no statistically significant differences in clinical outcomes between the two groups, though the Charité® group had a statistically significantly lower rate of long-term disability when compared with the BAK group. The study is limited in its small sample size, mid-term follow-up period, and high loss to follow-up. The study has limited internal validity because only 30% of the original participants were included in the follow-up, some individuals were lost to follow-up, and not all of the centers that participated in the original FDA IDE study participated in this follow-up. Taking these limitations into consideration, the ability to interpret this study is questionable.

In a retrospective study, Park et al. (2008) evaluated the radiographic changes at the adjacent levels and facets after LADR using the ProDisc®-L device. Thirty-two individuals representing 41 LADR were followed for a minimum of 26 months postoperatively. The degree of disc and facet degeneration at the index and adjacent levels were observed using radiography. PFA was observed in 29.3% of LADR (n= 12), with PFA observed in 2 levels (4.3%) and 3 levels (6.4%). All cases of PFA occurred only in those with preoperative grade 1 degeneration. The authors concluded that while degenerative changes in the discs and facets were minimal at approximately 2 years of follow-up, in 29.3% of LADR segments, facet joints presented with PFA. The study is limited in its small sample size, short-term follow-up period, and lack of a comparative control group.

In a prospective study, Katsimihas et al. (2010) reported the clinical and radiographic results of the Charité® type III disc after an average of 55 months follow-up. Sixty-four individuals received the Charité® disc at either L4 to L5 or L5 to S1. The primary indication for surgery was discogenic low-back pain confirmed by provocative discography. Assessment included pre- and post-operative validated individual outcome measures and radiographic review at 3, 6, and 12 months, and yearly thereafter. Fifty-seven individuals were available for complete follow-up. Their mean age was 39 years (21 to 59). A statistically significant improvement was demonstrated between all the mean pre- and post-operative intervals for the ODI, a VAS pain score for the back and leg, and the SF-36 health survey. Implant subsidence was present in 44 of 53 individuals with an L5 to S1 disc arthroplasty. The authors concluded that the 2- to 7-year follow-up of this cohort of individuals demonstrated satisfactory clinical and radiographic results in a carefully selected population and that the radiographic assessment confirmed preservation and maintenance of motion at the replaced disc during the period of follow-up. The study is limited in its small sample size, mid-term follow-up period, and lack of a comparative control group. Although the reported results by Katsimihas et al. were promising, case series provide little evidence of efficacy because without randomized controls, outcomes can be influenced by participant selection, placebo effects, or natural history. Large, long-term, randomized controlled trials are needed to demonstrate the long-term efficacy and safety of this device.

Zigler and Delamarter (2012) reported on the 5-year results of the FDA-mandated PAS to evaluate the safety and effectiveness of the ProDisc®-L device in LADR. Two hundred and thirty-six individuals were treated (161 LADR, 75 fusion) and followed for 5 years. The primary outcome measurement was a 10-component success end point. Secondary outcome measurements included neurological status, secondary surgery, ODI, SF-36, and VAS pain and satisfaction. At 5 years, the overall follow-up rate was 81.8%. A noninferiority margin of 12.5% was utilized. Results indicated that both LADR and fusion treatment groups maintained statistically significant improvement of ODI at 5 years compared with baseline (p < 0.0001). Revision surgeries at the index level were performed in 12% of fusion individuals and 8% of LADR individuals . ROM within the LADR group remained within the normal range, though it decreased by approximately 0.5 degrees from years 3 to 5. VAS pain scores decreased from preoperative values by 48% in both treatment groups at 5 years. The authors concluded that participants in both groups maintained significant improvement at 5 years, with LADR providing statistically significantly better improvement in ROM. The study is limited in its mid-term follow-up period. A noninferiority margin of 12.5% was utilized with no description of why an increased margin was used when compared with the initial study, which had a margin of 10%. Results showed noninferiority, but not superiority of LADR, with 53.7% of ProDisc®-L individuals and 50.0% of fusion individuals achieving overall success at 5 years. This change in overall success among individuals undergoing ProDisc®-L between 2 and 5 years (63.5% to 53.7%, respectively) indicates a possible decrement over time with LADR. This underscores insufficiency of a 5-year follow-up.

Zigler et al. (2012) also reported on the 5-year results of FDA-mandated PAS to evaluate the adjacent-level degenerative changes in with single-level disease who underwent LADR with the ProDisc®-L device compared with circumferential fusion (control group). Among the initial two hundred and thirty-six participants, 75 fusion), 123 LADR participants and 43 fusion participants were available for follow-up at 5 years. And of the participants in the 5-year follow-up group, 161 completed baseline and 5-year radiographic data needed to assess ALD change. This represented a patient participation rate of approximately 68%. ALD was characterized by radiography and a composite score including disc height, endplate sclerosis, osteophytes, and spondylolisthesis (i.e., vertebra which has slipped out of proper position onto the bone below). At 5-year follow-up, changes in ALD were observed in 9.2% of LADR participants and 28.6% of fusion participants (p = 0.004). Among the participants without preoperative ALD, new findings of ALD at 5 years were apparent in only 6.7% of LADR participants and 23.8% of fusion participants (p = 0.008). Adjacent level surgery leading to revision surgery was reported for 1.9% of LADR participants and 4.0% of fusion patients, though this was not a statistically significant difference (p = 0.6819). Among the LADR patients, ROM had a statistically significant decrease from 7.3° to 6.0° (p = 0.0198) and disc height had a statistically significant increase from 7.9 to 12.5 (p < 0.0001). Among the fusion group, disc height increased from 7.4 to 9.7 (p < 0.0001). The authors concluded that at 5 years after the index surgery, LADR maintained ROM and was associated with a statistically significantly lower rate of ALDs than in participants treated with circumferential fusion. The study is limited in its mid-term follow-up and high loss to follow-up. Comparisons to spinal fusion were specific to circumferential fusion, a combination of interbody and postero-lateral fusion. Therefore, the results may not necessarily be generalizable to other forms of spinal fusion (e.g., ACDF). In fact, the authors noted that the results may not be applicable to all LADR or to other types of fusion procedures. Lastly, the authors indicated that the results of this study were obtained with a post hoc analysis of data, which may hinder the potential validity of the results.

In a prospective study, Lebl et al. (2012) assessed the in vivo modes of wear and fixation of LADR with the ProDisc®-L device. Explanted devices were prospectively collected during a 7-year period from 2005 to 2011. The authors noted that inferior clinical outcomes and LADR failure may occur because of suboptimal component fixation, wear properties, and impingement in a subset of patients. Nineteen ProDisc®-L devices from 18 participants were explanted following an index LADR at L4 to L5 (n=6), L5 to S1 (n=11), and unknown levels (n=2). Reasons for device removal included pain (n=8), prosthesis subluxation/migration (n=4), end plate collapse/subsidence (n=3), polyethylene dislodgement (n=3), and unknown reasons (n=2). Mean length of implantation was 13.0 ± 3.9 months. The surface area of bony ongrowth was 9.6 ± 2.9% (0% to 52.5%). LADR burnishing (i.e., deformation due to rubbing) was observed posteriorly consistent with component impingement in extension in 53% of devices (n=8). This was more common than anterior (n=3) and lateral patterns (n=3). The authors concluded that metallic end plate burnishing was evident in a large percentage of clinically failed ProDisc®-L devices and that long-term follow-up studies are necessary to evaluate the effects of observed backside wear (i.e., non-articulating surface erosion), third-body wear (i.e., hard particles embedded into the device), and end plate impingement on clinical outcomes. The study is limited in its small sample size.

In a retrospective study, Park et al. (2012) evaluated the effectiveness of LADR using the ProDisc®-L device in participants with DDD. Thirty-five participants were followed for a mean of 6 years. The authors noted that while early clinical results of LADR have indicated successful outcomes, few studies have studied therapeutic effectiveness in the long term. Participants were examined preoperatively and at 3 months, 1 year, 2 years, and more than 5 years postoperatively. Outcome measurements included VAS pain scores, ODI, SF-36, and sporting activity scale scores. At the final follow-up, questions about surgery satisfaction and patient willingness to undergo the same treatment were ascertained. Results indicated that 71.4% of participants (n=25) achieved clinical success. Outcome scores were statistically significantly improved postoperatively. However, improvements were observed to be statistically significantly lower at the final follow-up visits when compared with post-operative visits at 1 or 2 years. The authors concluded that while LADR may be a safe and effective treatment for lumbar DDD, outcome measurements were statistically significantly lower at the 5-year endpoints than at earlier follow-up. Therefore, longer-term follow-up studies are warranted as there may be a potential decreasing trend in successful outcomes for LADR.

In a prospective non-randomized study, Siepe et al. (2014) evaluated the safety and effectiveness of one- and two-level LADR in 201 individuals with intractable low back pain without any deformities or instabilities. Ultimately, 181 individuals were included in the study, with a mean of 7.4 years follow-up [5 to 10.8 years]. Outcome measurements included VAS, ODI, and participant satisfaction rates. Complication and reoperation rates were also assessed. VAS scores demonstrated a slight statistically significant improvement from baseline, but also had statistically significant deterioration from 48 months onward (p < 0.05). While 63.6% of participants reported a highly satisfactory outcome, 13.7% were not satisfied. The overall complication rate was 14.4% (n=26). The incidence of revision surgery for general and/or device-related complications was 7.2% (n=13). Two-level LADR demonstrated a statistically significant improvement of VAS and ODI compared to baseline (p < 0.05), however, were significantly inferior to one-level LADR. The authors concluded that LADR demonstrated satisfactory mid- to long-term results, with acceptable complication and reoperation rates. The study is limited in its lack of a comparative control group and heterogeneous treatment design.

In 2018, Zigler et al published a systematic review with a meta-analysis of 6 randomized controlled trials (n = 1,417). The authors used a network meta-analysis to compare activL® with other total disc replacement (TDR) systems (Charite®, ProDisc-L®), lumbar fusion (interbody, circumferential), and patient rehabilitation for treating degenerative disc disease (DDD). Studies reported on Oswestry Disability Index (ODI) success, back pain scores, reoperation rates, and patient satisfaction at 2-year follow-up. The analysis indicated that the activL® Artificial Disc reduced back pain and improved the ability to perform daily tasks more than ProDisc-L® or Charite® TDRs; reoperation rates and employment status were similar. Athough the TCTs included in this systematic review have a low risk of bias, the evidence comparing activL® with lumbar fusion (interbody, circumferential) does not permit conclusions because comparisons in the meta-analysis are indirect, and the studies used various instruments to assess ODI and back pain. Therefore, unlike the evidence comparing activL® to Charite® and ProDisc-L® TDRs, the strength of evidence comparing activL® to lumbar fusion is very low and does not permit conclusions. The findings from this analysis warrant confirmation in additional long-term (> 3 years) RCTs comparing activL® with other discs and RCTs comparing activL® with lumbar fusion, however none are ongoing.

SUMMARY
Cervical Artificial Intervertebral Disc Insertion

Spinal fusion is considered the definitive surgical treatment for symptomatic cervical DDD for the resolution of pain and neurologic symptoms. However, CADR has been proposed as an alternative surgical treatment as it has the potential to reduce the risk of adjacent level DDD above or below a fusion site and to preserve ROM. There are admitted concerns about the robustness of the evidence supporting the effectiveness of FDA-approved cervical artificial disc devices. Many studies are of small sample size and short-term follow-up (e.g., 2 years or less). In fact, the American Academy of Orthopaedic Surgeons (AAOS) noted that while CADR may be an option for a select patient population, long-term follow-up is minimal. While randomized controlled trials supporting the effectiveness of CADR exist, the majority are designed as a noninferiority trial. A noninferiority design provides indirect evidence of a cervical disc device’s effectiveness, especially when the control group (i.e., spinal fusion) constitutes a variety of treatment methods (e.g., ACDF, posterior fusion, circumferential fusion, minimally invasive surgery). Additionally, most studies indicate that device effectiveness is supported by preserved ROM, which is one of the primary goals of the device, though may be considered a secondary outcome of clinical significance. Reduction in adjacent level DDD is a primary outcome of clinical importance; however, the published evidence is limited in indicating reductions in adjacent level DDD, especially when compared with ACDF.

Long-term studies should be conducted to assess the adverse events related to CADR. Adverse events may include adjacent segment degeneration, device failure, dysphagia (i.e., difficulty in swallowing), and HO. Performance and durability are key considerations given the relatively young age of the individuals who receive CADR. These individuals could conceivably outlive the disc lifespan. While the precise cause of HO is unknown, Jin et al. (2013) indicate that the incidence of HO can be up to 49% in Bryan®, 80% in PCM®, and 60% in the Prestige®-C discs. Yi et al. (2010) concluded that HO can potentially reduce the life of implants to an average of only 27 months and that HO can occur in up to 40.6% of patients. Therefore, it is a major concern as it undermines the preservation of ROM, a primary intended function of CADR. Future studies should address the potential difficulty of revising a failed implant.

In a 2010 guideline, the National Institute for Health and Clinical Excellence (NICE) concluded that the current evidence on the effectiveness of CADR indicates that it is at least as effective as spinal fusion in the short-term and may result in a reduced need for revision surgery in the long-term. They note that the adverse events related to CADR are also seen in spinal fusion. However, they do indicate that CADR should be performed by surgeons experienced in artificial disc replacement. They also recommended that further research be performed to assess long-term data on the preservation of mobility, the occurrence of adjacent segment disease, and the avoidance of revision surgery.

In a 2012 health technology assessment, ECRI assessed the safety and effectiveness of CADR. They included 55 studies based on rigorous study selection criteria. Outcomes were defined by a 2-year end point. ECRI conducted a meta-analysis of the data and determined that based on short-term outcomes (i.e., < 2 years), CADR and ACDF had similar levels of success in terms of neck/arm pain, disability, quality of life, and work status. ROM was determined to be better with CADR at the treatment level (high recommendation; evidence is convincing). Reoperation rates were lower with CADR (moderate recommendation; evidence is somewhat convincing) and neurological deterioration was lower when compared with ACDF (low recommendation; evidence is tentative). In the long-term (i.e., > 2 years), both CADR and ACDF provided similar levels of disability scores. Additionally, ROM was better for CADR at the treatment level (high recommendation) while reoperation rates (moderate recommendation) and neurological deterioration (low recommendation) were lower with CADR. ECRI noted that the evidence was inconclusive regarding long-term neck and arm pain outcomes for CADR.

In a 2014 guideline, the North American Spine Society (NASS) noted that CADR may be indicated for radiculopathy related to single-level DDD from C3-4 to C6-7 with or without neck pain that has been refractory to medical or non-operative management. Additionally, they noted that CADR may be warranted for myelopathy when it is severe enough to warrant surgical intervention. NASS noted that CADR was not indicated for symptomatic multi-level disease (i.e., 2 or more levels) that would require multiple level CADR, adjacent level disease, infection, osteoporosis, instability, severe spondylosis (i.e., greater than 50% disc height loss, bridging osteophytes, absence of motion on flexion-extension views at the symptomatic site), ankylosing spondylitis, rheumatoid arthritis, previous fracture with anatomical deformity, ossification of the posterior longitudinal ligament, or malignancy.

There remain concerns about device longevity and associated adverse events, especially in a relatively young patient population. However, the current evidence suggests that CADR preserves ROM and may offer lower reoperation rates and decreased neurological deterioration. Mid-term results (e.g., 4 to 5 years) suggest that CADR is not inferior to spinal fusion, which is currently the established treatment for DDD. Based on clinical input, the available peer-reviewed literature, and the FDA-approved indications, CADR at one cervical level from C3 to C7 may be considered medically necessary for individuals with symptomatic cervical DDD, refractory to conservative management (e.g., NSAIDS, physical therapy), who have not had prior surgical treatment or cervical anatomical deformities at the treated level, which may compromise the device’s integrity.

For individuals who have cervical radicular pain or myelopathy who receive 2-level artificial intervertebral disc arthroplasty (AIDA) of the cervical spine, the evidence includes RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. At 2- and 4-year follow-ups, the first artificial cervical disc approved for 2 levels (Mobi-C) was found to be superior to ACDF for NDI scores, NDI success rates, reoperation rates, and overall success composite outcome. At 5 years, trial results were consistent with the continued superiority of 2-level AIDA for clinical outcomes and lower cumulative reoperation rates. Adjacent segment degeneration with Mobi-C was found in a significantly lower percentage of patients compared to 2-level ACDF patients. FDA approval for the Prestige LP was based on superiority to 2-level ACDF in overall success at 2 years. The increase in overall success rates at 2 years has been maintained for those patients who have reached the 5- and 7-year follow-ups. Based on this evidence, it can be concluded that 2-level AIDA with either of these FDA-approved discs is at least as beneficial as the established alternative. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

Lumbar Artificial Intervertebral Disc Insertion

According to the AAOS, lumbar fusion surgery remains the gold standard for individuals with persistent lumbar spine pain refractory to conservative nonsurgical management. LADR has been proposed as an alternative surgical treatment to the various types of spinal fusion. It is theorized that LADR may have the potential to reduce adjacent level lumbar DDD and preserve ROM.

The current available published peer-reviewed literature does not clearly establish the clinical efficacy of artificial intervertebral disc replacements for a number of reasons. Much of the published data on artificial discs comes from case study reports, which are low in the hierarchy of evidence. The few completed randomized controlled trials of artificial disc devices were conducted as part of the FDA-required premarket approval process, using a noninferiority trial design and comparing a specific artificial intervertebral disc to a specific type of spinal fusion surgery. Presently, there are no randomized controlled trials that compare the various types of spinal fusion surgery or that compare spinal fusion surgery to conservative management alone.

In August 2007, CMS issued a NCD for LADR. CMS determined that the procedure was not reasonable and necessary for individuals over 60 years of age. For Medicare beneficiaries younger than 60, CMS decided to leave the determination up to local Medicare contractors.

In a 2009 health technology assessment, ECRI evaluated the safety and effectiveness of LADR for lumbar DDD. At the time, ECRI indicated that the evidence base was limited due to lack of blinding, long-term follow-up, and comparisons to relevant control groups. In fact, some studies compared LADR with outdated methods of spinal fusion. LADR devices have many labeled contraindications (e.g., osteopenia, osteoporosis, radicular compression syndrome), which indicates that only a select population would benefit from device implantation. This further limits the already small sample size of most LADR studies, which in turn, increases the difficulty in estimating the number of adverse events associated with device implantation.

In a 2013 Cochrane systematic review, Jacobs et al. evaluated the effect of LADR for chronic low back pain due to lumbar DDD compared with fusion or other treatment options. The authors noted that among the seven randomized controlled trials included within the systematic review, there was a high risk of bias due to sponsoring and the absence of any blinding. Of these seven studies, six compared LADR with fusion (n=1301). All studies used ODI and VAS scores as outcome measurements. The authors indicate that the differences in clinical improvement were not beyond generally accepted boundaries for clinical relevance. The prevention of ALD and/or facet joint degeneration was not properly assessed. Radiological results were poorly reported across the studies and the definition of failure was varied or unclear, especially with respect to device-related failures. Therefore, the authors concluded that the number of adverse events associated with LADR that may occur in the long-term has not yet been researched. They advised that the clinical community should be prudent before adopting LADR.

Questions remain regarding the biologic effects of wear and the response of the prosthesis to its environment, particularly in the relatively young population in which these lumbar artificial intervertebral disc devices may be used. In addition, the effect of artificial disc on the progression of adjacent level DDD, which takes years to develop, is unknown. Complications associated with LADR devices are emerging with longer-term follow-up. Several recent studies have suggested that the facet joint at the index level and the disc at the adjacent level may show aggravation of the degenerative process in a significant number of patients. Other studies describe late complications which may include vertebral body fractures, persistent pain, device migration and failure, numbness, and degenerative scoliosis. Studies indicate that the wear mechanisms on artificial discs may be similar to artificial hips and knees and that due to nearby vascular structures and scar tissue from the original surgery, retrieval of an artificial disc device can be difficult and dangerous. Especially in a relatively young and active patient population for which LADR is intended, these long-term health outcomes may become a clinically significant issue.

Overall, the current available published peer-reviewed literature remains limited and insufficient to permit conclusions regarding the long-term safety and effectiveness of artificial intervertebral disc insertion for the lumbar spine. Current guidelines and a meta-analysis of the available published peer-reviewed literature indicate that CADR may offer lower reoperation rates, decreased neurological deterioration, and preserved ROM. However, several meta-analyses and systematic reviews have concluded that the current evidence to support LADR remains inadequate in demonstrating clinical significance. While some randomized trials have concluded that LADR is non-inferior to fusion, the potential benefits that would make non-inferiority sufficient to demonstrate clinical benefit have not been established. Because the artificial intervertebral disc is meant to last the lifetime of an individual, long-term randomized controlled trials evaluating the safety, effectiveness, and durability of these devices are needed.
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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY


0095T, 0098T, 0164T, 0165T, 22856, 22858, 22861, 22862, 22864, 22865


EXPERIMENTAL/INVESTIGATIONAL

0163T, 0375T, 22857



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

M50.020 Cervical disc disorder with myelopathy, mid-cervical region, unspecified level

M50.021 Cervical disc disorder at C4-C5 level with myelopathy

M50.022 Cervical disc disorder at C5-C6 level with myelopathy

M50.023 Cervical disc disorder at C6-C7 level with myelopathy

M50.120 Mid-cervical disc disorder, unspecified

M50.121 Cervical disc disorder at C4-C5 level with radiculopathy

M50.122 Cervical disc disorder at C5-C6 level with radiculopathy

M50.123 Cervical disc disorder at C6-C7 level with radiculopathy

M50.220 Other cervical disc displacement, mid-cervical region, unspecified level

M50.221 Other cervical disc displacement at C4-C5 level

M50.222 Other cervical disc displacement at C5-C6 level

M50.223 Other cervical disc displacement at C6-C7 level

M50.320 Other cervical disc degeneration, mid-cervical region, unspecified level

M50.321 Other cervical disc degeneration at C4-C5 level

M50.322 Other cervical disc degeneration at C5-C6 level

M50.323 Other cervical disc degeneration at C6-C7 level



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Related Documents


Policy History

Revisions for 11.14.19l:
01/14/2019This version of the policy will become effective 01/14/2019.

The Description Section was updated to include information regarding the ActivL® Artificial Disc.

The following statement was added to the Policy Section:

Subsequent cervical artificial intervertebral disc implantation at an adjacent level is considered medically necessary, and therefore, covered when all of the following are met:
  • Criteria for cervical artificial intervertebral disc implantation listed above are met; AND
  • The device is FDA-approved for 2 levels (i.e., Mobi-C, Prestige LP); AND
  • The planned subsequent procedure is at a different cervical level than the initial cervical artificial disc replacement; AND
  • Clinical documentation that the initial cervical artificial intervertebral disc implantation is fully healed.

The following ICD-10 Diagnosis Codes were added to the policy: M50.120, M50.121, M50.122, M50.123


Effective 10/05/2017 this policy has been updated to the new policy template format.



Version Effective Date: 01/14/2019
Version Issued Date: 01/14/2019
Version Reissued Date: N/A

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