BlueCross BlueShield of Tennessee Medical Policy Manual

Artificial Intervertebral Disc

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

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.

SOURCES

BlueCross BlueShield Association. Evidence Positioning System. (5:2019). Artificial intervertebral disc: cervical spine (7.01.108). Retrieved September 5, 2019 from https://www.evidencepositioningsystem.com/. (46 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (5:2019). Artificial intervertebral disc: lumbar spine (7.01.87). Retrieved September 5, 2019 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.

Cui, X., Li, H-T., Zhang, W., Zhang, L-L., Luo, Z-P., & Yang, H-L. (2018). Mid– to long-term results of total disc replacement for lumbar degenerative disc disease: a systematic review. Journal of Orthopaedic Surgery and Research, 13 (26), doi: 10.1186/s13018-018-1032-6. (Level 2 evidence)

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)

Mu, X., Wei, J., Jiancuo, A., Li, Z & Ou, Y. (2018). The short-term efficacy and safety of artificial total disc replacement for selected patients with lumbar degenerative disc disease compared with anterior lumbar interbody fusion: A systematic review and meta-analysis. A Peer-Reviewed, Open Access Journal, 13 (12), e0209660. (Level 1 evidence)

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)

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. Comparative Effectiveness Review. (2019, April). Lumbar Total disc replacement for degenerative disc disease. Retrieved August 5, 2019 from www.Hayesinc.com/subscribers. (113 articles and/or guidelines reviewed)

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]

ORIGINAL EFFECTIVE DATE:  11/1/2003

MOST RECENT REVIEW DATE:  10/10/2019    

ID_BA

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