Artificial Intervertebral Disc
Artificial intervertebral disc arthroplasty (AIDA) is proposed as an alternative to anterior discectomy and fusion (ACDF) for individuals with symptomatic degenerative disc disease. 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.
Cervical devices (e.g., BRYAN, PRESTIGE®, ProDisc™-C, Mobi-C®, SECURE®-C, PCM Cervical Disc®) use 2 metal endplates that are press fit into adjacent vertebrae and a central free component. This central component is held into place by the surrounding normal soft tissues (such as ligaments and the disc annulus), and shifts dynamically within the disc space during spinal motion. These devices are designed to restore disc height and normal physiologic motion.
The PRESTIGE® LP and MOBI-C® have received FDA approval for implantation at two cervical levels. Two-level implantation may occur simultaneously or one at a time (subsequently) after the individual has healed from the first implantation.
Cervical artificial intervertebral disc implantation is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Cervical artificial intervertebral disc implantation at more than two levels is considered investigational.
Lumbar or thoracic artificial intervertebral disc implantation for the treatment of degenerative disc disease, radicular pain and myelopathy is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Cervical artificial intervertebral disc implantation is considered medically appropriate if ALL of the following are met:
Procedure can include a single level or the addition of an adjacent level artificial intervertebral disc implantation if ALL of the following are met:
Skeletally mature individual
Cervical degenerative disc disease is from C3-C7
Degenerative disc disease confirmed by magnetic resonance imaging (MRI), computed tomography (CT) or myelography as indicated by ANY ONE of the following findings:
Intractable cervical radiculopathy
Intractable cervical myelopathy
Indicated for ANY ONE of the following:
Severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment
Failure of 6 weeks of conservative nonoperative treatment including, but not limited to, ALL of the following:
Under the direction of a physician
Pharmacotherapy that addresses neuropathic pain and other pain sources
Absence of ALL the following:
Combined use of artificial cervical disc and fusion
Prior surgery at treated cervical level
Previous fusion at another cervical level
Evidence of cervical instability as indicated by ANY ONE of the following:
Sagittal plane angulation of more than 11 degrees on lateral flexion-extension x-rays
Sagittal plane translation of more than 3.5 mm on lateral flexion-extension x-rays
Active systemic infection or localized infection at site of implantation
Anatomic deformity at affected level (e.g., ankylosing spondylitis)
Metabolic bone disease (e.g., osteoporosis, osteopenia, osteomalacia)
Rheumatoid arthritis or other autoimmune disease
Presence of facet arthritis
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
Overall, the available evidence remains insufficient to determine the effect of lumbar artificial intervertebral disc on net health outcome. At this time, the potential benefits of the artificial disc, such as faster recovery or reduced adjacent-level disc degeneration, have not been demonstrated. Evidence is insufficient to determine whether artificial lumber discs improve outcomes in the short term, and questions remain about potential long-term complications with these implants.
BlueCross BlueShield Association. Evidence Positioning System. (4:2018). Artificial intervertebral disc: cervical spine (7.01.108). Retrieved September 7, 2018 from https://www.evidencepositioningsystem.com/ (46 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (4:2018). Artificial intervertebral disc: lumbar spine (7.01.87). Retrieved September 7, 2018 from https://www.evidencepositioningsystem.com. (24 articles and/or guidelines reviewed)
Burkus, J., Traynelis, V., Haid, R., & Mummaneni, P. (2014). Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: clinical article. Journal of Neurosurgery: Spine, 21 (4), 516-528. (Level 2 evidence)
Centers for Medicare & Medicaid Services. CMS.gov. (2007, October). National Coverage Determination: (NCD) for lumbar artificial disc replacement (LADR) (150.10). Retrieved October 3, 2017 from https://www.cms.gov.
Davis, R., Nunley, P., Kim, K., Hisey, M., Jackson, R., Bae, H., et al. (2015). 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. Journal of Neurosurgery:Spine, 22, 15-25. (Level 2 evidence)
Furunes, H., Storheim, K., Brox, J.I., Johnsen, L.G., Skouen, J.S., Franssen, E., et al. (2017). Total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back and degenerative discs: 8-year follow-up of a randomized controlled multicenter trial. Spine Journal, 17 (10), 1480-1488. Abstract retrieved September 7, 2018 from PubMed database.
Gornet, M. F., Burkus, J. K., Shaffrey, M. E., Arqires, P. J., Nian, H., and Harrell, F. E, Jr. (2015). Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study. Journal of Neurosurgery: Spine, 23, 558-573. (Level 3 evidence)
Laugesen, L.A., Paulsen, R.T., Carreon, L., Ernst, C., & Andersen, M. (2017). Patient-reported outcomes and revision rates at a mean follow-up of 10 years after lumbar total disc replacement. Spine, 42 (21), 1657-1663. Abstract retrieved September 7, 2018 from PubMed database.
National Institute for Health and Clinical Excellence (NICE). (2010, May). Prosthetic intervertebral disc replacement in the cervical spine. Retrieved June 22, 2010 from http://www.nice.org.uk.
National Institute for Health and Clinical Excellence (NICE). (2009, July). Prosthetic intervertebral disc replacement in the lumbar spine. Retrieved June 22, 2010 from http://www.nice.org.uk.
Radcliff, K., Coric, D., & Albert, T. (2016). 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. Journal of Neurosurgery: Spine, 25, 213-224. (Level 2 evidence)
Radcliff, K., Coric, D., & Albert, T. (2016). 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. Journal of Neurosurgery: Spine, doi: 10.3171/2015.12.SPINE15824. (Level 2 evidence)
Technology Evaluation Center. (2014, April). Artificial intervertebral disc arthroplasty for treatment of degenerative disc disease of the cervical spine (Vol. 28, No. 13). Retrieved July 22, 2014 from http://www.bcbs.com (50 articles and/or guidelines reviewed)
Technology Evaluation Center. (2014, January). Artificial lumbar disc arthroplasty (Vol. 28, No. 7). Retrieved March 6, 2014 from http://www.bcbs.com (25 articles and/or guidelines reviewed)
Thavaneswaran, P., & Vandepeer, M. (2014). Lumbar artificial intervertebral disc replacement: a systematic review. ANZ Journal of Surgery, 84 (3), 121-127. Abstract retrieved October 3, 2017 from PubMed database.
U. S. Food and Drug Administration. (2006, August). Center for Devices and Radiological Health. PRODISC® L total disc replacement. P050010. Retrieved June 14, 2012 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2007, December). Center for Devices and Radiological Health. ProDisc™-C Total Disc Replacement. P070001. Retrieved February 19, 2008 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2009, May). Center for Devices and Radiological Health. BRYAN® cervical disc. P060023. Retrieved July 9, 2010 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2015, June). Center for Devices and Radiological Health. Mobi-C® cervical disc.P110002/S012. Retrieved September 3, 2015 from http://www.fda.gov.
U.S. Food and Drug Administration. (2016, July). Center for Devices and Radiological Health. Prestige LP cervical disc P090029/S003. Retrieved September 8, 2016 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2015, August; last update search July 2018). Lumbar total disc replacement for degenerative disc disease. Retrieved September 7, 2018 from www.Hayesinc.com/Subscribers. (110 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, August). Single-level artificial disc replacement for cervical degenerative disc disease. Retrieved October 3, 2017 from www.Hayesinc.com/Subscribers. (90 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, October). Multilevel artificial disc replacement for cervical degenerative disc disease. Retrieved September 7, 2018 from www.Hayesinc.com/Subscribers. (90 articles and/or guidelines reviewed)
Zigler, J.E., Blumenthal, S.L., Guyer, R.D., Ohnmeiss, D.D., & Patel, L. (2018). Progression of adjacent-level degeneration after lumbar total disc replacement: results of a post-hoc analysis of patients with available radiographs from a prospective study with 5-year follow-up. Spine, doi: 10.1097/BRS.2647 [EPUB ahead of print]
MOST RECENT REVIEW DATE: 11/8/2018
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