Intervertebral disc replacement or spinal arthroplasty (22857, 22862, 22865, 0090T-0098T, 0163T, 0164T, 0165T), using an artificial disc, is considered experimental/investigational as a treatment for degenerative disc disease involving the cervical, thoracic, and/or lumbar vertebrae (722.4, 722.51-722.52, 722.6). The Food and Drug Administration (FDA) has granted approval for several lumbar artificial intervertebral replacement discs (e.g., Charité, ProDisc®-L), and for several cervical replacement discs (Bryan®, Prestige®ST, ProDisc™-C).  Studies regarding artificial intervertebral disc replacement are inadequate to permit scientific conclusions regarding the long-term safety, efficacy, and durability of the replacement disc. Additionally, concerns were identified regarding long-term bone/implant interface, wear debris, metal ion concentration, and adjacent segment effects.  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, and/or loss of disc height or collapse.  This can result in chronic pain due to resultant abnormal motion of the affected spinal segment, biomechanical instability of the spine, and nerve root compression. 

Spinal fusion 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 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

Complications of Artificial Disc Replacement-A Report of 27 Patients with the SB Charité Disc”, Journal of Spinal Disorders & Techniques, Vol. 16, No. 4, 04/2003

Neurological Complications of Lumbar Artificial Disc Replacement and Comparison of Clinical Results with Those Related to Lumbar Arthrodesis in the Literature: Results of a Multicenter, Prospective, Randomized Investigational Device Exemption Study of Charité Intervertebral Disc”, Journal of Neurosurgery: Spine, Vol. 1, 09/2004

Clinical Outcomes with the PRESTIGE II Cervical Disc: Preliminary Results from a Prospective Randomized Clinical Trial, Neurosurgery Focus, Vol. 17(3), 09/2004

Long-Term Outcome after Implantation of the PRESTIGE I Disc in an End-Stage Indication: 4 Year Results from a Pilot Study, Neurosurgery Focus, Vol. 17(3), 09/2004

Lumbar Total Disc Replacement.  Seven to Eleven Year Follow-Up, Journal of Bone and Joint Surgery in America, Vol. 87(3), 03/2005

Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of Lumbar Total Disc Replacement with the Charité Artificial Disc Versus Lumbar Fusion: Part II: Evaluation of Radiographic Outcomes and Correlation of Surgical Technique Accuracy With Clinical Outcomes, Spine, Vol. 30(14), 07/2005

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

Revision and Explanation Strategies Involving the Charité Lumbar Artificial Disc Replacement, Spine, Vol. 32(9), 04/2007

Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease, Spine, Vol. 32(11), 05/2007

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