Artificial Intervertebral Disc
DESCRIPTION
A variety of artificial intervertebral discs are being investigated as an alternative to spinal 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. The devices (e.g., BRYAN™, CHARITE™, MAVERICK™, PRESTIGE®, ProDisc™-C, PRODISC®-L) 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. This medical policy is intended to address the use of artificial intervertebral disc at all levels of the spine (i.e., cervical, thoracic, lumbar).
POLICY
Artificial intervertebral discs are considered investigational.
IMPORTANT REMINDER
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.
ADDITIONAL INFORMATION
There is a lack of well-designed, randomized, controlled trials to determine the safety, efficacy and long-term benefits regarding artificial intervertebral disc for cervical, thoracic and lumbar degenerative disc disease.
SOURCES
American Academy of Orthopaedic Surgeons. (2010, March). Cervical disc arthroplasty. A technology overview. Retrieved July 19, 2010 from http://www.aaos.org/research/overviews/cervicaldisc.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2010). Artificial intervertebral disc: Cervical spine (7.01.108). Retrieved August 10, 2010 from BlueWeb. (15 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2009). Artificial intervertebral disc: Lumbar spine (7.01.87). Retrieved June 22, 2010 from BlueWeb. (24 articles and/or guidelines reviewed)
BlueCross BlueShield of Tennessee network physicians. July - August 2009.
BlueCross BlueShield of Tennessee network physicians. March - May 2009.
Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Lumbar artificial disc replacement (LADR). (NCD 150.10, p. 2-72). Ingenix.
Daly, K. J., Ross, E. R., Norris, H., & McCollum, C. N. (2006). Vascular complications of prosthetic inter-vertebral discs. European Spine Journal, 15 (Suppl. 5), 644-649.
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2009, October). Artificial intervertebral disc replacement for symptomatic cervical disc disease. Retrieved June 22, 2010 from ECRI Institute. (31 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2009, October). Artificial intervertebral disc replacement (AIDR) for lumbar degenerative disc disease (DDD). Retrieved June 22, 2010 from ECRI Institute. (31 articles and/or guidelines reviewed)
Galbusera, F., Bellini, C. M., Zweig, T., Ferguson, S., Raimondi, M. T., Lamartina, C., et al. (2008). Design concepts in lumbar total disc arthroplasty. European Spine Journal, 17 (12), 1635-1650.
Goffin, J., van Loon, J., Van Calenbergh, F., & Lipscomb, B. (2010). A clinical analysis of 4- and 6-year follow-up results after cervical disc replacement surgery using the Bryan Cervical disc prosthesis. Journal of Neurosurgery. Spine, 12 (3), 261-269. (Level 2 Evidence - Industry sponsored)
Heller, J. G., Sasso, R. C., Papadopoulos, S. M., Anderson, P. A., Fessler, R. G., Hacker, R. J., et al. (2009). Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: Clinical and radiographic results of a randomized, controlled, clinical trial. Spine, 34 (2), 101-107. (Level 1 Evidence - Industry sponsored)
International Society for the Advancement of Spine Surgery. (2009, September). Position statement: Cervical total disc arthroplasty. Retrieved September 21, 2010 from http://www.isass.org/public_policy/sas_policy_statement_on_cdr.html.
Kim, H. K., Kim, M. H., Cho, D. S., & Kim, S. H. (2009). Surgical outcome of cervical arthroplasty using Bryan®. Journal of Korean Neurosurgical Society, 46 (6), 532-537. (Level 2 Evidence - Industry sponsored)
Kim, S. W., Limson, M. A., Kim, S. B., Arbatin, J. J., Chang, K. Y., Park, M. S., et al. (2009). Comparison of radiographic changes after ACDF versus Bryan disc arthroplasty in single and bi-level cases. European Spine Journal, 18 (2), 218-231. (Level 3 Evidence - Independent study)
Kim, S. W., Shin, J. H., Arbatin, J. J., Park, M. S., Chung, Y. K., & AcAfee, P. C. (2008). Effects of a cervical disc prosthesis on maintaining sagittal alignment of the functional spinal unit and overall sagittal balance of the cervical spine. European Spine Journal, 17 (1), 20-29. (Level 3 Evidence - Industry sponsored)
Mummaneni, P. V., Burkus, J. K., Haid, R. W., Traynelis, V. C., & Zdebkick, T. A. (2007). Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: A randomized controlled clinical trial. Journal of Neurosurgery, 6 (3), 198-209. (Level 1 Evidence - Industry sponsored)
Murrey, D., Janssen, M., Delmarter, R., Goldstein, J., Zigler, J., Tay, B., et al. (2009). Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease. The Spine Journal, 9 (4), 275-286. (Level 1 Evidence - Industry sponsored)
Nabhan, A., Ahihelm, F., Pitzen, T., Steudel, W. I., Jung, J., Shariat, K., et al. (2007). Disc replacement using Pro-Disc C versus fusion: A prospective randomised and controlled radiographic and clinical study. European Spine Journal, 16 (3), 423-430. (Level 3 Evidence - Independent study)
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/nicemedia/live/11157/48666/48666.pdf.
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/nicemedia/live/11081/44935/44935.pdf.
Park, J. H., Roh, K. H., Cho, J. Y., Ra, Y. S., Rhim, S. C., & Noh, S. W. (2008). Comparative analysis of cervical arthroplasty using Mobi-C® and anterior cervical discectomy and fusion using the Solis® -cage. Journal of Korean Neurosurgical Society, 44 (4), 217-221. (Level 2 Evidence - Independent study)
Peng-Fei, S., & Yu-Hua, J. (2008). Cervical disc prosthesis replacement and interbody fusion: A comparative study. International Orthopaedics, 32 (1), 103-106. (Level 4 Evidence - Independent study)
Technology Evaluation Center. (2007, June). Artificial lumbar disc replacement (Vol. 22, No. 2). Chicago: BlueCross BlueShield Association. (49 articles and/or guidelines reviewed)
Technology Evaluation Center. (2009, August). Artificial intervertebral disc arthroplasty for treatment of degenerative disc disease of the cervical spine (Vol. 24, No. 3). Chicago: BlueCross BlueShield Association. (38 articles and/or guidelines reviewed)
Traynelis, V. C. (2006). Cervical arthroplasty. Clinical Neurosurgery, 53, 203-207.
Tumialan, L. M., Ponton, R. P., Garvin, A., & Gluf, W. M. (2010). Arthroplasty in the military: A preliminary experience with ProDisc-C and ProDisc-L. Neurosurgical Focus, 28 (5), e18. (Level 4 Evidence - Independent study)
U. S. Food and Drug Administration. (2004, October). Center for Devices and Radiological Health. Premarket approval application (PMA). CHARITE™ artificial disc. P040006. Retrieved February 19, 2008 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040006b.pdf.
U. S. Food and Drug Administration. (2006, August). Center for Devices and Radiological Health. PRODISC® L total disc replacement. P050010. Retrieved February 19, 2008 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010b.pdf.
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/cdrh_docs/pdf7/P070001b.pdf.
U. S. Food and Drug Administration. (2007, July). Center for Devices and Radiological Health. PRESTIGE® cervical disc system. P060018. Retrieved February 19, 2008 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060018b.pdf.
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/cdrh_docs/pdf6/P060023b.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2009, April). Lumbar total disc replacement for degenerative disc disease. Retrieved June 22, 2010 from www.Hayesinc.com/subscribers. (53 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2010, August). Artificial disc replacement for cervical degenerative disc disease. Retrieved October 19, 2010 from www.Hayesinc.com/subscribers. (63 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 11/1/2003
MOST RECENT REVIEW DATE: 11/11/2010
ID_BT
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