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, MAVERICK™, PRESTIGE®, ProDisc™-C, Mobi-C®) 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. Medical Policy Reference Manual. (4:2017). Artificial intervertebral disc: cervical spine (7.01.108). Retrieved October 3, 2017 from BlueWeb. (46 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2017). Artificial intervertebral disc: lumbar spine (7.01.87). Retrieved October 3, 2017 from BlueWeb. (25 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)

ECRI Institute. Health Technology Information Service. Health Technology Assessment Evidence Report. (2012, September). Artificial intervertebral disc replacement for treatment of cervical disc disease. Retrieved February 17, 2014 from ECRI Institute. (290 articles and/or guidelines reviewed)

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)

Huppert, J., Beaurain, J., Steib, J., Bernard, P., Dufour, T., Hovorka, I., et al. (2011). Comparison between single- and multi-level patietns: clinical and radiological outcomes 2 years after cervical disc replacement. European Spine Journal, 20, 1417-1426. (Level 4 evidence)

Jackson, R., Davis, R., Hoffman, G., Bae, H., Hisey, M., Kim, K., et al. (2016). Subsequent surgery rates after cervical total disc replacement using a Mobi-C cervical disc prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial withy 5-year follow-up. Journal of Neurosurgery:Spine, Published online January 22, 2016;DOI: 10.3171/2015.8.SPINE15219. (Level 2 evidence)

National Institute for Health and Clinical Excellence (NICE). (2010, May). Interventional procedure guidance: 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). Interventional procedure guidance: 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, Published online March 25, 2016; 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., and Vandepeer, M. (2014, March) Lumbar artificial intervertebral disc replacement: a systematic review. ANZ Journal of Surgery, 84 (3), 121-7. 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. (2014, December; last update search December 2015). Artificial disc replacement for cervical degenerative disc disease. Retrieved August 24, 2015 from www.Hayesinc.com. (139 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2015, August; last update search August 2016). Lumbar total disc replacement for degenerative disc disease. Retrieved August 24, 2015 from www.Hayesinc.com. (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 . (90 articles and/or guidelines reviewed)

Yue, J., Garcia Jr., R., and Miller, J. (2016, May) The activL® Artificial Disc: a next-generation motion-preserving implant for chronic lumbar discogenic pain. Medical Devices: Evidence & Research, 9, 75-84. (Level 5 evidence)

ORIGINAL EFFECTIVE DATE:  11/1/2003

MOST RECENT REVIEW DATE:  11/9/2017

ID_BA

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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