Artificial Intervertebral Disc

Medical Policy: 07.01.03 
Original Effective Date: February 2005 
Reviewed: March 2012 
Revised: February 2007 

Benefit Application
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.

Description: 

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 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. 

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Prior Approval: 

Not applicable

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Policy: 

Artificial intervertebral discs are considered investigational for treatment of disorders of the cervical and lumbar spine.

Rationale:

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) is inadequate to evaluate long-term results, in particular any effect of the device on adjacent-level disc degeneration, device durability, adverse events, and revisability.  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.

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.

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Procedure Codes and Billing Guidelines: 

• 22856 Total disc arthroplasty, anterior approach,cervical
• 0092T Each additional interspace 
• 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
• 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 

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Selected References: 

• 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; November 2006; Target Report 852. Artificial intervertebral disc replacement for lumbar disc disease. Available: http://www.ecri.org.
• 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; 2009 Feb 25. 9 p. [ECRI hotline response]. Also available: http://www.ecri.org.
• 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; 2007 May 9 [updated 2010 Apr 6]. Artificial intervertebral disc replacement for lumbar degenerative disc disease. Available: http://www.ecri.org.
• 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; 2004 Mar 26 [updated 2010 Jul 2]. Artificial intervertebral disc replacement for symptomatic cervical degenerative disc disease. Available: http://www.ecri.org.
• 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. 2012 January 17. [Hotline Service]. Also available: http://www.ecri.org.
• 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. 2012 February 6. [Emerging Technology Evidence Reports). Also available: http://www.ecri.org.

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Policy History: 

Date                                        Reason                               Action

April 2011                              Annual review                     Policy renewed

March 2012                           Annual review                     Policy renewed

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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.

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