Medical Policy: 07.01.03
Original Effective Date: February 2005
Reviewed: March 2021
Revised: March 2021
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 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.
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 (CADR, also known as cervical total disc replacement and cervical arthroplasty) may be indicated for the following conditions:
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.
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.
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.
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.
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:
Lumbar Disc Arthroplasty is NOT indicated in ANY of the following scenarios:
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) 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.
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.
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.
The use of cervical artificial disc, single-level or two contiguous levels, is considered medically necessary when ALL of the following criteria is met:
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.
The use of lumbar artificial disc, single-level, is considered medically necessary when ALL of the following criteria is met:
Lumbar Disc Arthroplasty is considered not medically necessary in ANY of the following scenarios:
Artificial intervertebral discs are considered investigational for treatment of disorders of the thoracic spine.
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.
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.
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.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric, (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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