Cervical Intervertebral Disc Replacement

Cervical intervertebral disc replacement or spinal arthroplasty is considered medically necessary when performed at one level (22856, 22861, 22864) in individuals with symptomatic cervical degenerative disc disease (722.0, 722.4) when ALL of the following criteria are met:

• An FDA approved device (e.g., Prestige®ST Cervical Disc, Bryan® Cervical Disc, and ProDisc™-C Total Disc Replacement) is used; and
• The operative level is C3 to C7; and
• The procedure is performed in a skeletally mature individual; and
• At least six weeks of conservative management has been tried and has failed.

Cervical intervertebral disc replacement is considered experimental/investigational when all of the above criteria are not met, when performed for conditions other than cervical degenerative disc disease (722.0, 722.4), and when performed at additional levels (0092T, 0095T, 0098T).  A participating, preferred, or network, provider can bill the member for the denied service.

Lumbar Intervertebral Disc Replacement

Lumbar intervertebral disc replacement or spinal arthroplasty (22857, 22862, 22865, 0163T, 0164T, 0165T), using an artificial disc, is considered experimental/investigational as a treatment for degenerative disc disease involving the lumbar vertebrae (722.52). The Food and Drug Administration (FDA) has granted approval for several lumbar artificial intervertebral replacement discs (e.g., Charité, ProDisc®-L).  Studies regarding lumbar artificial intervertebral disc replacement, however, are inadequate to permit scientific conclusions regarding the long-term safety, efficacy, and durability of the replacement disc. Additionally, concerns have been identified regarding long-term bone/implant interface, wear debris, metal ion concentration, and adjacent segment effects. Lumbar artificial intervertebral disc replacement is not covered and is not eligible for payment.  A participating, preferred, or network provider can bill the member for this service. 

Description

Degenerative disc disease (DDD) involves deterioration of the intervertebral disc that has been confirmed by patient medical history and radiographic studies.  DDD can lead to disc dehydration, annular tears, herniations and protrusions and/or loss of disc height or collapse.  This can result in chronic pain due to narrowing of the intervertebral space with resultant abnormal motion of the affected spinal segment, biomechanical instability of the spine, and nerve root compression which may cause symptoms of pain, numbness, tingling and weakness in the neck, shoulders and extremities. 

Spinal fusion or arthrodesis, is a common surgical approach to degenerative disc disease when conservative treatment (i.e., rest, pain medication, physical therapy) fails.  This process involves joining two or more vertebrae together to produce a more stable spine.  Bone grafting or metal hardware is used to perform a spinal fusion.  Fusion eliminates abnormal motion and instability of the spine by altering the biomechanics of the back.  It also restricts motion, which may cause potential premature disc degeneration at adjacent levels of the spine especially in younger patients.

As an alternative, artificial intervertebral discs have been developed for the treatment of degenerative disc disease.  Total disc replacement, or spinal arthroplasty, is intended to restore normal disc height, prevent compression of nerve roots, relieve pain, maintain motion at the affected level of the spine, maintain the normal biomechanics and prevent further disc degeneration of the adjacent vertebrae after the damaged disc has been removed.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP.  Medical Policy is not an authorization, certification, explanation of benefits, or a contract.  Benefits are determined by the Federal Employee Program.

National Blue Cross Blue Shield Association Medical Policy 7.01.87, Artificial Intervertebral Disc, 04/01/05

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Clinical Significance of Heterotopic Ossification in Cervical Disc Replacement: A Prospective Multicenter Clinical Trial, Neurosurgery, Vol. 57(4), 10/2005

The Treatment of Disabling Single-Level Lumbar Discogenic Low Back Pain with Total Disc Arthroplasty Utilizing the ProDisc Prosthesis: A Prospective Study with 2-Year Minimum Follow-Up, Spine, Vol. 30(19), 10/2005

Cervical Arthroplasty after Previous Surgery: Results of Treating 24 Discs in 15 Patients, Spine, Vol. 3(5), 11/2005

Assessment of Adjacent-Segment Disease in Patients Treated with Cervical Fusion or Arthroplasty: A Prospective 2-Year Study, Journal of Neurosurgery of the Spine, Vol. 3(6), 12/2005

Intervertebral Prosthesis Versus Anterior Lumbar Interbody Fusion: One-Year Results of a Prospective Non-Randomized Study, Acta Orthop Belg, Vol. 72(1), 01/2006

Prospective Randomized Controlled Study of the Bryan Cervical Disc: Early Clinical Results from a Single Investigational Site, Journal of Neurosurgery of the Spine, Vol. 4(1), 01/2006

Charité Total Disc Replacement – Clinical and Radiographical Results After an Average Follow-Up of 17 Years, European Spine Journal, Vol. 15(2), 02/2006

Complications with Cervical Arthroplasty, Journal of Neurosurgery of the Spine, Vol. 4(2), 02/2006

Lumbar Total Disc Arthroplasty in Patients Older Than 60 Years of Age: A Prospective Study of the ProDisc Prosthesis with 2-Year Minimum Follow-Up Period, Journal of Neurosurgery of the Spine, Vol. 4(2), 02/2006

Lumbar Total Disc Arthroplasty Utilizing the ProDisc Prosthesis in Smokers Versus Nonsmokers: A Prospective Study with 2-Year Minimum Follow-Up, Spine, Vol. 31(9), 04/2006

Revisability of the Charité Artificial Disc Replacement: Analysis of 688 Patients Enrolled in the U.S. IDE Study of the Charité Artificial Disc, Spine, Vol. 31(11), 05/2006

Design Limitations of Bryan Disc Arthroplasty, Spinal Journal, Vol. 6(3), May-June 2006

Mobility of Lumbar Segments Instrumented with a ProDisc II Prosthesis: A Two-Year Follow-Up Study, Spine, Vol. 31(15), 07/2006.

Clinical Results of Total Lumbar Disc Replacement with ProDisc II: Three-Year Results for Different Indications, Spine, Vol. 31(17), 08/2006

Early Clinical and Radioliogic Outcomes of Cervical Arthroplasty with Bryan Cervical Disc Prosthesis,” Journal of Spinal Disorders & Techniques, Vol. 19(7), 10/2006

Polyethylene Wear Debris and Long-Term Clinical Failure of the Charité Disc Prosthesis: A Study of 4 Patients, Spine, Vol. 32(2), 01/2007

Segmental Malalignment with the Bryan Cervical Disc Prosthesis-Does it Occur? Journal of Spinal Disorders & Techniques, Vol. 20(1), 02/2007

Clinical and Radiographic Analysis of Cervical Disc Arthroplasty Compared with Allograft Fusion: A Randomized Controlled Clinical Trial, Journal of Neurosurgery of the Spine, Vol. 6(3), 03/2007

Long-Term Results of One-Level Lumbar Arthroplasty: Minimum 10-Year Follow-Up of the Charité Artificial Disc in 106 Patients, Spine, Vol. 32(6), 03/2007

A Radiostereometric Analysis of the Bryan Cervical Disc Prosthesis, Spine, Vol. 32(8), 04/2007

Charité Versus ProDisc: A Comparative Study of a Minimum 3-Year Follow-Up, Spine, Vol. 32(9), 04/2007

Hybrid Testing of Lumbar Charité Discs Versus Fusions, Spine, Vol. 32(9), 04/2007

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Survival and Clinical Outcome of SB Charité III Disc Replacement for Back Pain, Journal of Bone and Joint Surgery (British), Vol. 89(6), 06/2007

Sasso RC, Smucker JD, Hacker RJ, Heller JG.  Artificial Disc Versus Fusion: A Prospective, Randomized Study with 2-Year Follow-Up on 99 Patients. Spine. 2007;32:2941-2.

Sasso RC, Smucker JD, Hacker RJ, Heller JG.  Clinical Outcomes of Bryan Cervical Disc Arthroplasty: A Prospective, Randomized, Controlled, Multicenter Trial With 24-Month Follow-Up. Journal of Spinal Disorders & Techniques. 2007;20:481-91.

Auerbach JD, Jones KH, Fras CI, Balderston JR, Rushton SA, Chin KR.  The Prevalence of Indications and Contraindications to Cervical Total Disc Replacement. Spine. November 2007. Accessed August 28, 2008.

Rabin D, Pickett GE, Bisnaire L, Duggal N. The Kinematics of Anterior Cervical Discectomy and Fusion Versus Artificial Cervical Disc: A Pilot Study. Neurosurgery. 2007;61:100-4.

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Sears WR, Sekhorn LH, Duggal N, Williamson OD. Segmental Malalignment With the Bryan Cervical Disc Prosthesis – Does it Occur?? Journal of Spinal Disorders & Technology.  2007;20:1-6.

Cunningham BW, McAfee PC, Geisler FH, Holsapple G, Adams K, Blumenthal SL, Guyer RD, Cappuccino A, Regan JJ, Fedder IL, Tortolani PJ. Distribution of in vivo and in vitro range of motion following 1-level arthroplasty with the CHARITE artificial disc compared with fusion. Journal of Neurosurgery of the Spine. 2008;8:7-12.

Guyer RD, Geisler FH, Blumenthal SL, McAfee PC, Mullin BB. Effect of age on clinical and radiologic outcomes and adverse events following 1-level lumbar arthroplasty after a minimum 2-year follow-up. Journal of Neurosurgery of the Spine. 2008;8:101-7.

Geisler FH, Guyer RD, Blumenthal SL, McAfee PC, Cappucino A, Bitan F, Regan JJ. Effect of previous surgery on clinical outcome following 1-level lumbar arthroplasty. 2008;8:108-14.

Punt IM, Visser VM, van Rhijn LW, Kurtz SM, Antonis J, Schurink GW, van Ooij A. Complications and reoperations of the SB Charite lumbar disc prosthesis: experience in 75 patients. European Spine Journal. 2008;17:36-43.

Sasso RC, Best NM, Metcalf NH, Anderson PA. Motion analysis of bryan cervical disc arthroplasty versus anterior discectomy and fusion: results from a prospective, randomized, multicenter, clinical trial. Journal of Spinal Disorders & Techniques. 2008;21:393-399.

Rabin D, Bertagnoli R, Wharton N, Pickett GE, Duggal N. Sagittal Balance Influences Range of Motion: An in Vivo Study with the ProDisc-C. Spine. July 2008. Accessed August 28, 2008.

Anderson PA, Sasso RC, Riew KD. Comparison of Adverse Events Between the Bryan Artificial Cervical Disc and Anterior Cervical Arthrodesis. Spine. 2008;33:1305-12.

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Riina J, Patel A, Dietz JW, Hoskins JS, Trammell TR, Schwartz DD. Comparison of Single-Level Cervical Fusion and a Metal-On-Metal Cervical Disc Replacement Device. American Journal of Orthopedics. 2008;37:E71-7.

Sasso, RC, Best NM. Cervical Kinematics After Fusion and Bryan Disc Arthroplasty. Journal of Spinal Disorders & Techniques. 2008;21:19-22.

Kim SW, Shin JH, Arbatin JJ, Park MS, Chung YK, McAfee PC. Effects of a Cervical Disc Prosthesis on Maintaining Sagittal Alignment of the Functional Spinal Unit (FSU) and Overall Sagittal Balance of the Cervical Spine. European Spine Journal. 2008;17:20-9.

Murrey D, Janssen M, Delamarter R, Goldstein J, Zigler J, Tay B, Darden B. Results of the prospective, randomized, multi-center food and drug administration investigational device exemption study of the Pro-Disc®-C Total Disc Replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disease. 2008. (Article in press).