Medical Policy: 07.01.03 

Original Effective Date: February 2005 

Reviewed: March 2021 

Revised: March 2021 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy 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 will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Disc degeneration is a complex biochemical process that occurs with the loss of normal water content within the disc resulting in the deterioration of the mechanical shock absorbing properties of the disc over time. This will lead to bulging and decreased disc height. The most frequent cause attributed to degenerative disc disease (DDD) is the natural aging process, although various associated factors may accelerate the process. Not all individuals with disc degeneration are symptomatic with pain.

 

Cervical artificial disc replacement

Cervical artificial disc replacement (CADR, also known as cervical total disc replacement and cervical arthroplasty) may be indicated for the following conditions:

  • Radiculopathy related to nerve root compression from one or 2-level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-4 to C6-7 with or without neck pain that has been refractory to medical or nonoperative management.
  • Myelopathy or myeloradiculopathy related to central spinal stenosis from one or 2 level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-4 to C6-7 with or without neck pain.

 

Lumbar artificial disc replacement

Total disc replacement, using an artificial intervertebral disc designed for the lumbar spine, is proposed as an alternative to spinal fusion in patients with degenerative disc disease leading to disabling symptoms. For individuals who have lumbar degenerative disc disease who receive a lumbar artificial intervertebral disc, the evidence includes randomized controlled trials with 5-year outcomes and case series with longer term outcomes. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Five-year outcomes for the ProDisc-L randomized controlled trial have provided evidence for the noninferiority of artificial disc replacement. We are awaiting long-term outcomes on device durability and noninferiority over time. 

 

Summary of Evidence

When conservative treatment of degenerative disc disease fails, a common surgical approach is spinal fusion; over 200,000 spinal fusions are performed each year. However, the outcomes of spinal fusion have been controversial over the years, in part due to the difficulty in determining whether a patient’s back pain is related to degenerative disc disease (DDD) and in part due to the success of the procedure itself. In addition, spinal fusion alters the biomechanics of the back, potentially leading to premature disc degeneration at adjacent levels, a particular concern for younger patients.

 

As an alternative, a variety of artificial intervertebral discs have been investigated over the past 30 years as an alternative to fusion. This approach, also referred to as total disc replacement or spinal arthroplasty, is intended to maintain motion at the operative level once the damaged disc has been removed, and to maintain the normal biomechanics of the adjacent vertebrae. It is hypothesized that artificial disc will maintain anatomical disk space height, normal segmental lordosis, and physiological motion patterns at the index and adjacent cervical levels. The potential to reduce the risk of adjacent-level degenerative disc disease above or below a fusion site has been the major rationale driving device development and use. To help ensure a good outcome, the patient has to have motion in their bending zone. If not, placing an artificial disc in a severely degenerative disc space is not going to help. Overall, a theoretic advantage of lumbar disc replacement compared with fusion is that a prosthetic disc could help preserve normal range of motion and spine mechanics. This could reduce the long-term degenerative changes in adjacent vertebral segments that have been observed following spinal fusion. However, the evidence currently suggests that the efficacy of this approach is likely similar to that of spinal fusion.

 

Practice Guidelines and Position Statements

The North American Spine Society's (NASS) Coverage Policy Recommendation (2019)

Cervical artificial disc replacement

Cervical artificial disc replacement (CADR, also known as cervical total disc replacement and cervical arthroplasty) may be indicated for the following diagnoses with qualifying criteria, when appropriate.

  1. Radiculopathy related to nerve root compression from one or 2-level degenerative disease (either herniated disc or spondylot- ic osteophyte) from C3-4 to C6-7 with or without neck pain that has been refractory to medical or nonoperative management.
  2. Myelopathy or myeloradiculopathy related to central spinal stenosis from one or 2 level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-4 to C6-7 with or without neck pain.

 

There is not significant evidence at this time to support its use for 3 or more levels or in the case of adjacent segment disease following an index fusion. CADR is contraindicated in the following scenarios.

  1. Infection
    • active at the site of proposed implantation OR
    • systemic infection
  2. Osteoporosis or osteopenia
  3. Instability defined as:
    • translation greater than 3mm difference between lateral flexion-extension views at the symptomatic level OR
    • 11 degrees of angular difference between lateral flexion-extension views at the symptomatic level
  4. Sensitivity or allergy to implant materials
  5. Severe spondylosis defined as:
    • greater than 50% disc height loss compared to minimally or non-degenerated levels OR
    • bridging osteophytes OR
    • absence of motion on flexion-extension views at the symptomatic site
  6. Severe facet joint arthropathy defined as:
    • Radiographic confirmation of facet joint disease or degeneration
  7. Ankylosing spondylitis
  8. Rheumatoid arthritis
  9. Previous fracture with anatomical deformity
  10. Ossification of the posterior longitudinal ligament (OPLL)
  11. Malignancy
    • active, in the cervical spine

 

Lumbar Artificial Disc Replacement

Lumbar Artificial Disc Replacement is indicated for patients with discogenic low back pain who meet ALL of the following criteria from the Lumbar Fusion Coverage Recommendation:

  1. Symptomatic single level lumbar disc disease at L3-L4, L4-L5 or L5-S1 level
  2. Presence of symptoms for at least 6 months or greater and that are not responsive to multi-modal nonoperative treatment over that period that should include a physical therapy/rehabilitation program but may also include (but not limited to) pain management, injections, cognitive behavior therapy, and active exercise programs
  3. Any underlying psychiatric disorder, such as depression, should be diagnosed and the management optimized prior to surgical intervention
  4. Primary complaint of axial pain, with a possible secondary complaint of lower extremity pain

 

Lumbar Disc Arthroplasty is NOT indicated in ANY of the following scenarios:

  1. Any case that does not fulfill ALL of the above criteria
  2. Presence of symptomatic degenerative disk disease at more than one level
  3. Presence of spinal instability with spondylolisthesis greater than Grade I
  4. Chronic radiculopathy (unremitting pain with predominance of leg pain symptoms greater than back pain symptoms extending over a period of at least one year)
  5. Osteopenia as evidenced by a DEXA bone mineral density T-score less than or equal to -1.0
  6. Poorly managed psychiatric disorder
  7. Significant facet arthropathy at the index level
  8. Age greater than 60 years or less than 18 years
  9. Presence of infection or tumor

 

International Society for the Advancement of Spine Surgery

In 2015, the International Society for the Advancement of Spine Surgery (IASS) published a policy statement on the lumbar artificial disc. The goal of the policy statement was “to educate patients, physicians, medical providers, reviewers, adjustors, case managers, and all others involved or affected by insurance coverage decisions regarding lumbar disc replacement surgery.” The authors of the policy statement were selected for their expertise and experience with the artificial lumbar disc and included one of the investigators for the Prodisc-L IDE trial and another for the ActivL IDE trial. RCT and long-term results that were favorable to the LADR were discussed. Postoperative pain patterns in 58 (33%) patients of 175 implanted with the ProDisc II showed facet joint pain in 22 (13%) and sacroiliac joint pain in 21 (12%). Another report describes late complications in 75 patients who had received an earlier generation SB Charité prosthesis. As all of the patients had been originally treated by other surgeons, the percentage of implant failure cannot be determined from this report. The mean interval between insertion and retrieval of the prosthesis was 8 years and 11 months (range, 3-16 years). The most frequent complications included subsidence (n=39), disc prosthesis too small (n=24), adjacent disc degeneration (n=36), degenerative scoliosis (n=11), facet joint degeneration (n=25), and metal wire breakage (n=10). The report indicated that good placement and good sizing of the disc prosthesis appeared problematic for many of the patients, adjacent-disc degeneration was seen in many patients, and polyethylene wear with inflammatory fibrous tissue containing wear debris was observed. The report concluded that wear mechanisms of 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 prosthesis can be difficult and dangerous. Therefore, long-term health outcomes following disc implantation in young active patients may become a clinically significant issue.

 

American Academy of Orthopaedic Surgeons (AAOS)

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.

 

  • There are a few potential concerns, however. While artificial discs appear safe when used in experienced hands, they are not for everyone. Patients with multi-level lumbar pathology are less likely to benefit than patients with one-level of lumbar disc degeneration.
  • There are potentially serious operative risks that the patient needs to consider before opting for an artificial disc. No patient should consider this option without first trying high-quality non-operative treatments for at least six months. Patients should also be aware that the long-term outcomes of artificial discs are still not well-known and that revision surgery may be required down the road.

 

Regulatory Status

Mobi-C® Cervical Disc Prosthesis received premarket approval on August 7, 2013. (P110002). The Mobi-C® Cervical Disc Prosthesis consists of two metal (cobalt-chrome alloy2) endplates and a plastic (ultra-high molecular weight polyethylene) insert that fits between the endplates. The device is placed between two adjacent neck bones (cervical vertebrae) to replace a diseased cervical disc that is causing arm pain and/or weakness or numbness. The device is indicated The Mobi-C® Cervical Disc Prosthesis is intended for skeletally mature patients (people who have stopped growing) to replace a cervical disc in the neck (from C3-C7) following removal of the disc for conditions that result from a diseased or bulging disc at only one spinal level.

 

Mobi-C® Cervical Disc Prosthesis (two-level) received premarket approval of August 23, 2013. (P110009). The Mobi-C® Cervical Disc Prosthesis consists of two metals (cobalt-chrome endplates and a plastic (ultra-high molecular weight polyethylene) insert that fits between the endplates. The device is placed between two adjacent neck bones (cervical vertebrae) to replace a diseased cervical disc at two adjacent levels that are causing arm pain and/or weakness or numbness. The Mobi-C® Cervical Disc Prosthesis is intended for skeletally mature patients (people who have stopped growing) to replace two adjacent cervical discs in the neck (from C3-C7) following removal of the discs for conditions that result from diseased or bulging discs at two adjacent spinal levels.

 

ProDisc-C® Total Disc Replacement received premarket approval on December 17, 2007 (P070001). The device is indicated for skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or loss of disc height. The ProDisc-C® total disc replacement is implanted via an open anterior approach. Patients receiving the ProDisc-C® total disc replacement should have failed at least six weeks of non-operative treatment prior to implantation.

 

Prestige® LP Cervical Disc received premarket approval on July 24, 2014. Indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy with or without neck pain, or myelopathy due to a single-level abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, x-ray): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. In July 2016, the Prestige® LP received FDA approval for implantation at two levels.

 

Prestige® Cervical Disc System received premarket approval on July 16, 2007 (P060018). The device is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The PRESTIGE® device is implanted via an open anterior approach. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is 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.): 1) herniated disc, and/or 2) osteophyte formation. The safety and effectiveness of the device has not been established in patients who have not undergone at least six weeks of conservative treatment or had signs of progression or spinal cord/nerve root compression with continued non-operative care.

 

Bryan® Cervical Disc received premarket approval on May 12, 2009 (P060023). The device is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The Bryan® device is implanted via an open anterior approach. 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, and necessitating surgery as demonstrated using computed tomography (CT), myelography and CT and/or magnetic resonance imaging (MRI). Patients receiving the Bryan® Cervical Disc should have failed at least six weeks of non-operative treatment prior to implantation.

 

SECURE®-C Artificial Cervical Disc received premarket approval on September 28, 2012 (P100003) The SECURE®-C Artificial Cervical Disc is intended to be used in skeletally mature patients (people who have stopped growing) to replace a cervical disc in the neck (from C3-C7) following removal of the disc for conditions that result from a diseased or bulging disc (intractable radiculopathy3 or myelopathy4) at only one level.

 

PCM® Cervical Disc System received premarket approval on October 26, 2012 (P100012). The PCM Cervical Disc consists of two metal (cobalt-chrome alloy) endplates and a plastic (ultra-high molecular weight polyethylene) insert that fits between the endplates. The device is placed between two adjacent neck bones (vertebrae) to replace a diseased cervical disc2 that is causing arm pain and/or weakness or numbness. The PCM Cervical Disc is intended to be used in skeletally mature patients (people who have stopped growing) to replace a cervical disc from C3-C7 following removal of the disc for conditions that result from a diseased or bulging disc (intractable radiculopathy3 or myelopathy4) at only one level.

 

M6-C Artificial Cervical Disc received premarket approval on February 6, 2019 (P170036) Indicated for disc reconstruction following single-level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from C3 – C7. Degenerative cervical radiculopathy is defined as arm pain and/or a neurological deficit (numbness, weakness, deep tendon reflexes changes) with or without neck pain due to disc herniation and/or osteophyte formation and confirmed by radiographic imaging (computed tomography, magnetic resonance imaging, x-ray). The M6-C Artificial Cervical Disc is implanted via an anterior approach. Patients should have failed at least six weeks of conservative treatment or exhibit progressive neurological symptoms, which could lead to permanent impairment

 

ActivL® Artificial Disc received premarket approval on August 10, 2018 (P120024) The activL® Artificial Disc is intended for disc reconstruction between the fourth and fifth lumbar or fifth lumbar and first sacral vertebrae to treat symptomatic degenerative disc disease (DDD). The weight-bearing total disc replacement (TDR) system consists of two cobalt chromium alloy endplates and an ultrahigh-molecular-weight polyethylene inlay and is intended to match the rotational motion of the lumbar disc in response to physiologic motion.

 

ProDisc®-L received premarket approval on November 15, 2017 (P050010) The ProDisc®-L is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L3-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than grade 1 spondylolisthesis at the involved level. Patients receiving the PRODISC®-L Total Disc Replacement should have failed at least six months of conservative treatment prior to implantation of the PRODISC®-L Total Disc Replacement.

 

Products without current approval in the United States

  • The INMOTION® lumbar artificial disc (DePuy Spine) is a modification of the Charité® device with a change in name under the same premarket approval. The INMOTION® is not currently marketed in the United States.
  • The Maverick™ artificial disc (Medtronic) is not marketed in the United States due to patent infringement litigation.
  • The metal-on-metal FlexiCore® artificial disc (Stryker Spine) has completed the investigational device exemption trial as part of the FDA approval process and is currently being used under continued access.
  • Kineflex-L™ (Spinal Motion) is a 3-piece, modular, metal-on-metal implant. An FDA advisory committee meeting on the Kineflex-L, scheduled in 2013, but was canceled without explanation.

 

A number of other devices are under study in FDA Investigational Device Exemption (IDE) trials in the United States.

FDA Approved Cervical Artificial Disc Implants Approved vertebral levels
Prestige® ST Cervical Disc System Single level C3-C7
ProDisc-C® Total Disc Replacement Single level C3-C7
Bryan® Cervical Disc Single level C3-C7
Secure®-C Cervical Disc Single level C3-C7
PCM Cervical Disc Single level C3-C7
M6-C Artificial Cervical Disc Single level C3-C7
Mobi-C® Single level or two contiguous levels C3-C7
Prestige LP® Single level or two contiguous levels C3-C7

 

FDA Approved Lumbar Artificial Disc Implants Approved vertebral levels
ProDisc-L ® Lumbar Single level L3-S1
activL® Artificial Disc Single level L4-S1

 

Cervical Disc Prostheses Under Investigation in the U.S.

  • Kineflex C Spinal Motion FDA IDE
  • Freedom® AxioMed FDA IDE
  • Simplify Simplify Medical FDA IDE
  • IDE: investigational device exemption

 

Prior Approval:

Not applicable

 

Policy:

The use of cervical artificial disc, single-level or two contiguous levels, is considered medically necessary when ALL of the following criteria is met:

  1. The individual has one of the following:
    • Radiculopathy related to nerve root compression from one or 2 level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-4 to C6-7 with or without neck pain), or
    • Myelopathy due to a single-level or two-level degenerative disease from C3-4 to C6-7 related to central spine stenosis; or
  2. The individual is 18 years old or older; and
  3. Replacement of a degenerated cervical disc is limited to two levels (Mobi or Prestige LP Cervical Disc devices for two level only) from C3-C7; and
  4. The individual does not have a previously implanted cervical artificial intervertebral disc device at another cervical level; and
  5. The individual does not have a previous fusion at any surgical level ;and
  6. An FDA-approved cervical artificial intervertebral device is used in accordance with FDA labeling and will be implanted using an anterior approach; and
  7. Imaging studies (for example, computed tomography [CT], magnetic resonance imaging [MRI], myelography and CT, x-rays, etc.) confirm one or more of the following at the disc space(s) identified on neurological exam:
    • Herniated nucleus pulposus; or
    • Osteophyte formation; or
    • Not more than 50 percent loss of disc height as compared to adjacent levels; and
  8. Patient has failed 6 weeks of conservative treatment including (This criteria must be met for the current episode of pain (within 6 months)):
    • Physical Therapy and Medical management with steroids (oral and epidural) or
    • Physical Therapy and an active pain management program with pharmacotherapy that addresses neuropathic pain
      • These criteria must be met for the current episode of pain (the management and interventions for pain should have occurred over the last 6 months).
        • The need for conservative treatment is not necessary if signs/symptoms of compression/stenosis require immediate attention due to neurological changes.
  9. The individual is free from contraindications to cervical artificial intervertebral disc implantation including, but not limited to those on the FDA label and all of the following:
    • Active systemic infection or infection localized to the site of implantation; and
    • Osteoporosis or osteopenia's, either previously diagnosed or defined as dual energy X-ray absorptiometry (DEXA) bone density measured T-score less than or equal to 2.5; and
    • Marked cervical instability on neutral lateral or flexion/extension radiographs (may be documented as greater than 3mm translation or greater than 11 degrees of angular difference to either adjacent level); and
    • Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma (for example, radiographically confirmed fracture callous, malunion or nonunion) or anatomical deformity (e.g., ankylosing spondylitis); and
    • Moderate or severe spondylosis at the level(s) to be treated, characterized by any of the following:
      • Bridging osteophytes; or
      • Loss of greater than 50% normal disc height; or
      • Absence of motion less than 2 degrees; and
    • Symptoms of cervical degenerative disc disease at more than two levels and
    • Absence of metabolic bone disease (e.g. Paget’s disease, osteomalacia) and
    • No presence of facet arthritis or degeneration and
    • Absence of allergy to any of the device materials and
    • Absence of rheumatoid arthritis and
    • Absence of malignancy within the cervical spine and
    • Absence of tobacco use in the last 4 weeks 

 

Not all cervical artificial discs have FDA labeling for contiguous two-level degenerative disc disease. Only cervical artificial discs FDA labeled for contiguous two-level disease are proven and medically necessary for this indication. The MOBI-C and the Prestige LP Cervical Disc are the only artificial discs FDA-approved for use at both one and two contiguous levels.

 

Cervical artificial intervertebral disc implantation is considered investigational when the criteria above are not met.

 

Cervical artificial intervertebral disc implantation in an individual with a previous fusion at another cervical level (so if the new request would result in more than 2 contiguous disc replacement levels or more than two level disease from C3 to C7) it is considered investigational for all indications.

 

Lumbar Artificial Disc Replacement

The use of lumbar artificial disc, single-level, is considered medically necessary when ALL of the following criteria is met:

  1. Member with discogenic low back pain and has symptomatic single level lumbar disc disease at L3-L4, L4-L5 or L5-S1 level. Single-level disc degeneration has been confirmed on complex imaging studies (i.e., computerized tomography [CT] scan, magnetic resonanace imaging [MRI]. Symptoms must be congruent with image findings.
  2. Presence of symptoms for at least 6 months or greater and that are not responsive to multi-modal nonoperative treatment over that period that should include a physical therapy/rehabilitation program but may also include (but not limited to) pain management, injections, active exercise programs
  3. Any underlying psychiatric disorder, such as depression, should be diagnosed and the management optimized prior to surgical intervention
  4. Primary complaint of axial pain, with a possible secondary complaint of lower extremity pain
  5. Member is 18-60 years old
  6. Absence of tobacco use in the last 4 weeks
  7. Absence of previous fusion or artificial disc

 

Lumbar Disc Arthroplasty is considered not medically necessary in ANY of the following scenarios:

  1. Any case that does not fulfill ALL of the above criteria
  2. Presence of symptomatic degenerative disk disease at more than one level
  3. Presence of spinal instability with spondylolisthesis greater than Grade I
  4. Chronic radiculopathy (unremitting pain with predominance of leg pain symptoms greater than back pain symptoms extending over a period of at least one year)
  5. Osteopenia as evidenced by a DEXA bone mineral density T-score less than or equal to -1.0
  6. Poorly managed psychiatric disorder
  7. Significant facet arthropathy at the index level
  8. Age greater than 60 years or less than 18 years
  9. Presence of infection or tumor at the lumbar level
  10. Combined use of an artificial cervical disc and fusion

 

Artificial intervertebral discs are considered investigational for treatment of disorders of the thoracic spine.

 

Hybrid Surgery

Hybrid constructs in a single procedure, involving cervical fusion with cervical artificial intervertebral disc implantation is considered investigational for all indications. Concurrent or planned sequential artificial cervical disc replacement with cervical spinal fusion are investigational for the management of neck pain, spinal disorders, and all other indications at all times.

 

Rationale:

At the present time, there is limited published information about the impact of cervical arthroplasty devices on clinical outcomes over the long term. The rates of device failure and the need for reoperations due to device failure or malfunction are not well defined. Reports of device failure that occur at time periods longer than the average follow-up in the clinical trials highlights the need for longer term studies. Most studies indicate that device effectiveness is supported by preserved ROM, which is one of the primary goals of the device, Reduction in adjacent level degenerative disc disease (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 fusion. At this time there needs to be further study on the high rate of ossification, device longevity, and the clinical significance of adverse events in the long term. There will need to be reevaluation of the value in the procedure once rates of device failure and reoperation rates in the long-term are known.

 

For individuals who have lumbar degenerative disc disease who receive a lumbar artificial intervertebral disc, the evidence includes randomized controlled trials with 5-year outcomes and case series with longer term outcomes. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Five-year outcomes have provided evidence for the noninferiority of artificial disc replacement. The superiority of artificial disc has not been proven at this time. Questions remain regarding artificial disc longevity, and key outcomes including improvement of adjacent disease.

 

Overall, the available scientific evidence for thoracic arthroplasty remains insufficient to permit conclusions concerning the effect of this technology on net health outcomes. Current evidence is insufficient to determine whether artificial lumbar and thoracic discs are beneficial in the short term, and questions remain about potential long-term complications with these implants, especially considering the young patient population. Currently, use of cervical total disc replacement adjacent to a previous fusion is a common but off label procedure, referred to as above as a hybrid procedure. While hybrid procedures may be thought of as efficacious, they have not yet been studied in a rigorous manner.

 

Tobacco Use

Evidence shows that tobacco use is considered a risk factor for poor healing. Tobacco use (e.g., cigarettes, cigars, pipes, vaping, or smokeless tobacco in the form of chew or snuff) within the previous 4 weeks is a contraindication for the procedure. If the patient utilizes tobacco, tobacco cessation should be encouraged.

 

Required Documentation

  • Clinical notes that document the requesting surgeon personally evaluated the individual before submitting a request for surgery (except in cases of malignancy, trauma, infection or rapidly progressive neurologic symptoms)
  • Detailed documentation of extent and response to non-operative conservative therapy, if applicable, including outcomes of any procedural interventions, medications used and physical therapy/physiatrist notes
  • Copy of radiologist’s report(s) for diagnostic imaging (MRIs, CTs, etc.) completed within the past 12 months. Imaging must be performed and read by an independent radiologist.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric, (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 22856 Total disc arthroplasty, anterior approach,cervical
  • 22864 Removal of total disc arthroplasty, anterior approach, single interspace; cervical
  • 0095T Each additional interspace 
  • 22861 Revision of total disc arthroplasty, anterior approach, cervical
  • 0098T Each additional interspace
  • 22857 Total disc arthroplasty (artificial disc,) anterior approach, including discectomy to prepare interspace (other than for decompression), lumbar, single interspace
  • 22858 Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection); second level, cervical (List separately in addition to code for primary procedure)
  • 22862 Revision including replacement of total disc arthroplasty (artificial disc) anterior approach, lumbar, single interspace
  • 22865 Removal of total disc arthroplasty (artificial disc), anterior approach, lumbar, single interspace
  • 0163T Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), lumbar, each additional interspace
  • 0164T Removal of total disc arthroplasty, anterior approach, lumbar, each additional interspace
  • 0165T Revision of total disc arthroplasty, anterior approach, lumbar, each additional interspace
  • 22899 Unlisted procedure, spine

 

Selected References:

  • Burkus JK, Traynelis VC, Haid RW, Jr., et al. Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article. J Neurosurg Spine. Oct 2014;21(4):516-528. PMID 25036218
  • Davis RJ, Nunley PD, Kim KD, et al. Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results. J Neurosurg Spine. Nov 7 2014:1-11. PMID 25380538
  • North American Spine Society. NASS coverage policy recommendations: Cervical artificial disk replacement. 2015.
  • Baisden J. North American Spine Society (NASS). Cervical artificial disc replacement: defining appropriate coverage positions. 2014.
  • Guyer RD, Pettine K, Roh JS, et al. Five-year follow-up of a prospective, randomized trial comparing two lumbar total disc replacements. Spine (Phila Pa 1976). Jan 2016;41(1):3-8. PMID 26335669
  • Zigler J, Garcia R. ISASS Policy Statement - Lumbar Artificial Disc. Int J Spine Surg. 2015;9:7. PMID 25785243
  • ECRI Institute. (2016). Mobi-C Artificial Cervical Disc (Zimmer Biomet) For Treating Two Level Degenerative Cervical Disc Disease. Plymouth Meeting, PA: ECRI Institute.
  • Zou S, Gao J, Xu B, et al. Anterior cervical discectomy and fusion (ACDF) versus cervical disc arthroplasty (CDA) for two contiguous levels cervical disc degenerative disease: a meta-analysis of randomized controlled trials. Eur Spine J. 2016 Jun 17. [Epub ahead of print]
  • Zhang J, Meng F, Ding Y, et al. Hybrid surgery versus anterior cervical discectomy and fusion in multilevel cervical disc diseases: a meta-analysis. Medicine (Baltimore). 2016; 95(21):e3621.
  • Skovrlj B, Lee DH, Caridi JM, et al. Reoperations following cervical disc replacement. Asian Spine J. 2015;9(3):471-82.
  • Hoff EK, Strube P, Pumberger M, et al. ALIF and total disc replacement versus 2-level circumferential fusion with TLIF: a prospective, randomized, clinical and radiological trial. Eur Spine J. Mar 7 2015. PMID 25749689
  • Staub LP, Ryser C, Roder C, et al. Total disc arthroplasty versus anterior cervical interbody fusion: use of the Spine Tango registry to supplement the evidence from randomized control trials. Spine J. Feb 2016;16(2):136-145. PMID 26674445
  • U.S. Food and Drug Administration. Summary of Safety and Effectiveness: Prestige LP Cervical Disc. PMA Number P090029/S003. 2016
  • Radcliff K, Coric D, Albert T. Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine. Mar 25 2016:1-12. PMID 27015130
  • Hu Y, Lv G, Ren S, et al. Mid- to long-term outcomes of cervical disc arthroplasty versus anterior cervical discectomy and fusion for treatment of symptomatic cervical disc disease: a systematic review and meta-analysis of eight prospective randomized controlled trials. PLoS One. 2016;11(2):e0149312. PMID 26872258
  • Wuertinger C, et al. Motion preservation following total lumbar disc replacement at the lumbosacral junction: a prospective long-term clinical and radiographic investigation. Spine J 2017 June 30. [Epub ahead of print].
  • Ament JD, et al. Cost-effectiveness of cervical total disc replacement vs fusion for the treatment of 2-level symptomatic degenerative disc disease. JAMA Surg 2014 Dec;149(12):1231-9.
  • Ding F, Jia Z, Zhao Z, et al. Total disc replacement versus fusion for lumbar degenerative disc disease: a systematic review of overlapping meta-analyses. Eur Spine J. Mar 2017;26(3):806-815. PMID 27448810
  • Zigler J, Gornet MF, Ferko N, et al. Comparison of lumbar total disc replacement with surgical spinal fusion for the treatment of single-level degenerative disc disease: a meta-analysis of 5-year outcomes from randomized controlled trials. Global Spine J. 2018;8(4):413-423. 
  • Zigler J, Ferko N, Cameron C, Patel L. Comparison of therapies in lumbar degenerative disc disease: a network metaanalysis of randomized controlled trials. J compar effectiv res. 2018;7(3):233-246. 
  • Laugesen LA, Paulsen RT, Carreon L, et al. Patient-reported Outcomes and Revision Rates at a Mean Follow-up of 10 Years After Lumbar Total Disc Replacement. Spine (Phila Pa 1976). Nov 1 2017;42(21):1657-1663. PMID 28368983 
  • Washington State Health Care Authority, Health Technology Clinical Committee. Artificial disc replacement - Re-review. Final Findings and Decision. Olympia, WA: Washington State Health Care Authority; March 17, 2017. 
  • ECRI Institute. ActivL Artificial Disc (Aesculap, Inc.) for Lumbar Disc Arthroplasty. Plymouth Meeting (PA): ECRI Institute; 2018 Aug 01. (Custom Product Brief). 
  • Mobi-C Artificial Cervical Disc (Zimmer Biomet) for Treating Degenerative Cervical Disc Disease. Plymouth Meeting (PA): ECRI; 2020 Apr 10. (Custom Product Brief).
  • North American Spine Society, Lumbar artificial disc replacement (2019). NASS coverage policy recommendations.
  • Xu S, Liang Y, Zhu Z, Wang K, Liu H. [Effectiveness evaluation of Prodisc-C prosthesis for more than 10 years follow-up after total cervical disc replacement]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2019 Apr 15;33(4):393-402. Chinese. doi: 10.7507/1002-1892.201810109. PMID: 30983184.

 

Policy History:

  • March 2021 - Annual Review, Policy Revised
  • March 2020 - Annual Review, Policy Revised
  • March 2019 - Annual Review, Policy Revised
  • March 2018 - Annual Review, Policy Revised
  • March 2017 - Annual Review, Policy Revised
  • April 2016 - Annual Review, Policy Revised
  • August 2015 - Interim Review, Policy Revised
  • May 2015 - Annual Review, Policy Revised
  • February 2015 - Annual Review, Policy Revised
  • February 2014 - Annual Review, Policy Renewed
  • March 2013 - Annual Review, Policy Renewed
  • March 2012 - Annual Review, Policy Renewed
  • April 2011 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.