Medical Policy: 07.01.03
Original Effective Date: February 2005
Reviewed: April 2016
Revised: April 2016
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.
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.
The mid-term follow-up on four devices have been reported at this time. The trial results remain consistent, non-inferiority when compared to anterior cervical discectomy and fusion and reoperation.
The PCM and Secure C devices were granted FDA PMA in 2012, the Mobi-C prosthesis in 2013, and the Prestige LP Cervical Disc in 2014; but long-term studies are ongoing, and the data is still not published. Other artificial intervertebral discs have been developed and are currently being investigated in clinical trials. The FDA actively tracks devices whose approvals are contingent upon a post approval long-term study. Some contraindications from the FDA labels for the artificial intervertebral cervical disc devices include the following:
- Active systemic infection or infection at the operating site;
- Osteoporosis, defined as a DEXA bone mineral density T-score equal to or worse than 2.5;
- Marked cervical instability on neutral resting lateral or flexion/extension radiographs; translation greater than 3mm and/or greater than 11 degrees of rotational difference to either adjacent level;
- Moderate to advanced spondylosis characterized by bridging osteophytes, marked reduction or absence of motion, or collapse of the intervertebral disc space of greater than 50% of its normal height;
- Clinically compromised vertebral bodies at the affected level due to current or past trauma (e.g., by radiographic appearance of fracture callus, malunion, or nonunion);
- Symptoms necessitating surgical treatment at more than one level.
The North American Spine Society's (NASS)
Coverage Policy Recommendation (2014) Recommends use of cervical artificial intervertebral disc replacement (CADR) for:
- Radiculopathy related to single level degenerative disease (either herniated disc or spondyloticosteophyte) from C3-4 to C6-7 with or without neck pain that has been refractory to medical or non-operative management.
- Myelopathy or myeloradiculopathy related to single level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-4 to C6-7 with or without neck pain that is severe enough to warrant surgical intervention
NASS notes CADR is not indicated in the following scenarios:
- Symptomatic multi-level disease (2 or more levels) that would require multiple level CADR
- Adjacent level disease: degenerative disease adjacent to a previous cervical fusion
- Osteoporosis or osteopenia
- Sensitivity or allergy to implant materials
- Severe spondylosis
- Severe facet joint arthropathy
- Ankylosing spondylitis
- Rheumatoid arthritis
- Ossification of the posterior longitudinal ligament
- Malignancy – active in the cervical spine
Careful and appropriate patient selection is essential in ensuring optimal surgical outcomes.
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.
The use of cervical artificial disc is considered medically necessary when ALL of the following criteria is met:
- The individual has:
- intractable cervical radicular pain: (including neck and/or arm pain and functional or neurological deficit), or
- myelopathy due to a single-level abnormality localized to the disc space; and
- The individual is 18 years old or older; and
- Replacement of a degenerated cervical disc is limited to a single level from C3-C7; and
- The individual does not have a previously implanted cervical artificial intervertebral disc device at another cervical level; and
- An FDA-approved cervical artificial intervertebral device is used in accordance with FDA labeling and will be implanted using an anterior approach; and
- 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 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
- Patient has failed 6 weeks of conservative treatment including:
- 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.
- 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, 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 resting lateral or flexion/extension radiographs; with 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 due to current or past trauma (for example, radiographically confirmed fracture callous, malunion or nonunion) or anatomical deformity (for example rheumatoid arthritis, ankylosing spondylitis); and
- Moderate or severe spondylosis at the level 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 one level.
Cervical artificial intervertebral disc implantation is considered investigational when the criteria above are not met.
Cervical artificial intervertebral discs are considered investigational for those who have degenerative disk disease or herniated disc at more than 1 level.
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.
Cervical artificial intervertebral disc implantation in an individual with a previous fusion at another cervical level is considered investigational for all indications.
Artificial intervertebral discs are considered investigational for treatment of disorders of the lumbar spine.
At the present time, there is limited published information about the impact of cervical arthroplasty devices on clinical outcomes over the long term (5 or more years). While the early results are encouraging, given the natural history of the disease, 2-year follow-up (limited evidence on 4-year follow-up) they are inadequate to evaluate long-term results, in particular any effect of the device on adjacent-level disc degeneration, device durability, adverse events, and ability to revise. Longer term results are expected, given the FDA requirement for a 7-year post-approval clinical study of the safety and function of the device, and a 5-year enhanced surveillance study of the disc to more fully characterize adverse events in a broader patient population. The 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 to further define these adverse events. 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.
Overall, the available scientific evidence for lumbar arthroplasty remains insufficient to permit conclusions concerning the effect of this technology on net health outcomes. Current evidence is insufficient to determine whether artificial lumber discs are beneficial in the short term, and questions remain about potential long-term complications with these implants, especially considering the young patient population.
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
- 0375T Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), cervical, three or more levels
- The Medical Policy Reference Manual (MPRM) developed by the Blue Cross and Blue Shield Association Health Management Systems, based on the Technology Evaluation Center (TEC) criteria.
- Lemaire JP, Skalli W, Lavaste F et al. Intervertebral disc prosthesis. Results and prospects for the year 2000. Clin Orthop 1997; 337:64-76.
- Hochschuler SH, Ohnmeiss DD, Guyer RD et al. Artificial disc: preliminary results of a prospective study in the United States. Eur Spine J 2002; 11(suppl 2):S106-10.
- ECRI, Technology Assessment Resources Guide for Emerging Technologies. Artificial intervertebral disc, replacement for degenerative disc disease. March 2004.
- Blue Cross Blue Shield Association Technology Evaluation Center (TEC). 2005. Artificial Vertebral Disc Replacement. TEC Assessments, 20(1):1-18.
- TARGET [database online]. Plymouth Meeting (PA): ECRI Institute External SiteNovember 2006; Target Report 852. Artificial intervertebral disc replacement for lumbar disc disease.
- Sasso RC, Foulk DM, Hahn M. Prospective, randomized trial of metal-on-metal artificial lumbar disc replacement: initial results for treatment of discogenic pain. Spine 2008 Jan 15;33(2):123-31.
- Sasso RC, Smucker JD, Hacker RJ et al. Artificial disc versus fusion: a prospective, randomized study with 2-year follow-up on 99 patients. Spine 2007 Dec 15;32926):2933-40; discussion 2941-2.
- Nabhan A, Ahlhelm F, Shariat K et al. The ProDisc-C prosthesis: clinical and radiological experience 1 year after surgery. Spine. 2007 Aug 15;32(18):1935-41.
- Blue Cross Blue Shield Association Technology Evaluation Center (TEC). 2008. Artificial Intervertebral Disc Arthroplasty for Treatment of Degenerative Disc Disease of the Cervical Spine. TEC Assessments, 22(12):1-24.
- Blue Cross Blue Shield Association Technology Evaluation Center (TEC). 2007. Artificial Lumbar Disc Replacement. TEC Assessments; 22(2):1-24.
- ECRI Institute. Artificial Intervertebral Disc Replacement for Lumbar Degenerative Disc Disease. Plymouth Meeting (PA): ECRI Institute External Site2009 Feb 25. 9 p. [ECRI hotline response].
- Blue Cross Blue Shield Association Technology Evaluation Center (TEC). (2009). Artificial intervertebral disc arthroplasty for treatment of degenerative disc disease of the cervical spine. TEC Assessments, 24(3):1-28.
- Chou R, Loeser JD, Owens DK, et al; American Pain Society Low Back Pain Guideline Panel. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine 2009; 34(10):1066-77.
- Chou R, Baisden J, Carragee EJ, et al. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine 2009; 34(10):1094-109.
- Health technology forecast [database online]. Plymouth Meeting (PA): ECRI Institute External Site2007 May 9 [updated 2010 Apr 6]. Artificial intervertebral disc replacement for lumbar degenerative disc disease.
- Delamarter RB, Murrey D, Janssen ME et al. Results at 24 month from the prospective, randomized, multicenter investigational device exemption trial of ProDisc-C versus anterior cervical discectomy and fusion with 4-year follow-up and continued access patients. SAS Journal 2010; 4: 122-128.
- Health technology forecast [database online]. Plymouth Meeting (PA): ECRI Institute External Site2004 Mar 26 [updated 2010 Jul 2]. Artificial intervertebral disc replacement for symptomatic cervical degenerative disc disease.
- Cepoiu-Martin M, Faris P, Lorenzett D, et al. Artificial Cervical Disc Arthroplasty: A Systematic Review. Spine. 2011. 36;25. P. E1623-E1633.
- Huppert J, Beaurain J, Steib JP, et al. Comparison between single- and multi-level patients: clinical and radiological outcomes 2 years after cervical disc replacement. Eur Spine J. 2011 Feb 20.
- ECRI Institute. Synthes ProDisc-C for Cervical Disc Replacement. Plymouth Meeting (PA): ECRI Institute External Site2012 January 17. [Hotline Service].
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Artificial Intervertebral Disc Arthroplasty for Treatment of Degenerative Disc Disease of the Cervical Spine. TEC Assessments November 2011; Volume 26, No. 5.
- ECRI Institute. Artificial intervertebral disc replacement for symptomatic cervical disc disease. Plymouth Meeting (PA): ECRI Institute External Site2012 February 6. [Emerging Technology Evidence Reports).
- Boselie TF, Willems PC, van Mameren H, de Bie R, Benzel EC, van Santbrink H. Arthroplasty versus fusion in single-level cervical degenerative disc disease. Cochrane Database Syst Rev. 2012 Sep 12;9:CD009173. doi: 10.1002/14651858.CD009173.pub2.
- ECRI Institute. Artificial intervertebral disc replacement for cervical disc disease. Evidence report. September 2012. Plymouth Meeting (PA): ECRI Institute External Site2012 September.
- Zechmeister I, Winkler R, Mad P. Artificial total disc replacement versus fusion for the cervical spine: a systematic review. Eur Spine J. 2011 February; 20(2): 177–184. Published online 2010 October 10.
- 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. 2014.
- Hacker FM, Babcock RM, Hacker RJ. Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site. Spine (Phila Pa 1976). Dec 15 2013;38(26):2223-2226. PMID 24335628
- Tu TH, Wu JC, Huang WC, et al. Heterotopic ossification after cervical total disc replacement: determination by CT and effects on clinical outcomes. J Neurosurg Spine. Apr 2011;14(4):457-465. PMID 21294610
- Coric D, Kim PK, Clemente JD, et al. Prospective randomized study of cervical arthroplasty and anterior cervical discectomy and fusion with long-term follow-up: results in 74 patients from a single site. J Neurosurg Spine. Jan 2013;18(1):36-42. PMID 23140129
- Phillips FM, Lee JY, Geisler FH, et al. A Prospective, Randomized, Controlled Clinical Investigation Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion: 2-Year Results From the US FDA IDE Clinical Trial. Spine (Phila Pa 1976). Jul 1 2013;38(15):E907-918. PMID 23591659
- Nandyala SV, Marquez-Lara A, Fineberg SJ, Singh K. Comparison of revision surgeries for one-to-two level cervical TDR and ACDF from 2002 to 2011. Spine J. 2014 Dec 1;14(12):2841-6. doi: 10.1016/j.spinee.2014.03.037.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Artificial intervertebral disc arthroplasty for treatment of degenerative disk disease of the cervical spine. TEC Assessments 2013.
- Yi S, et al. The predisposing factors for the heterotopic ossification after cervical artificial disc replacement. Spine J 2013 Sep;13(9):1048-54.
- Bakar D, Lubelski D, Abdullah KG, Mroz TE. Artificial cervical disc arthroplasty versus anterior cervical discectomy and fusion. A systematic review. Curr Orthop Pract. 2014;25(1):9-13.
- 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
- Garcia R, Jr., Yue JJ, Blumenthal S, et al. Lumbar total disc replacement for discogenic low back pain: two-year outcomes of the activL multicenter randomized controlled IDE clinical trial. Spine (Phila Pa 1976). Dec 2015;40(24):1873-1881. PMID 26630435
- 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
- Lu SB, Hai Y, Kong C, et al. An 11-year minimum follow-up of the Charite III lumbar disc replacement for the treatment of symptomatic degenerative disc disease. Eur Spine J. Sep 2015;24(9):2056-2064. PMID 25895882
- Zigler J, Garcia R. ISASS Policy Statement - Lumbar Artificial Disc. Int J Spine Surg. 2015;9:7. PMID 25785243
- 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. 2015;22(1):15-25.
- 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.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.