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DESCRIPTIONTotal disc replacement, using an artificial intervertebral disc designed for the lumbar spine, is proposed as an alternative to fusion in patients with persistent and disabling degenerative disc disease.
When conservative treatment of degenerative disc disease fails, a common surgical approach is spinal fusion; more than 200,000 spinal fusions are performed each year. However, outcomes with spinal fusion have been controversial, in part due to the difficulty in determining if 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 spine biomechanics, potentially leading to premature disc degeneration at adjacent levels, a particular concern for younger patients. During the past 30 years, various artificial intervertebral discs have been investigated as an alternative approach 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.
Potential candidates for artificial disc replacement have chronic low back pain attributed to degenerative disc disease, lack of improvement with non-operative treatment, and none of the contraindications for the procedure, which include multilevel disease, spinal stenosis or spondylolisthesis, scoliosis, previous major spine surgery, neurologic symptoms, and other minor contraindications. These contraindications make artificial disc replacement suitable for a subset of patients in which fusion is indicated. Patients who require procedures in addition to fusion (eg, laminectomy, decompression) are not candidates for the artificial disc.
Use of a motion-preserving artificial disc increases the potential for various types of implant failure. They include device failure (device fracture, dislocation, or wear), bone-implant interface failure (subsidence, dislocation-migration, vertebral body fracture), and host response to the implant (osteolysis, heterotopic ossification, and pseudotumor formation).
While a number of artificial intervertebral discs in the lumbar spine have been used internationally, only three devices (activL®, Charité®, and ProDisc®-L) have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process. Because the long-term safety and effectiveness of these devices were not known, approval was contingent on completion of post-marketing studies. The activL® (Aesculap Implant Systems), Charité® (DePuy), and ProDisc®-L (Synthes Spine) devices are indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level; activL® and Charité® are approved for use in levels L4–S1; and the ProDisc®-L is approved for use in levels L3–S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographs. The INMOTION® lumbar artificial disc (DePuy Spine) is a modification of the Charité® device with a change in name under the same premarket approval. Production under the name Charité® was stopped in 2010. The INMOTION® is not currently marketed in the United States. The Maverick™ artificial disc (Medtronic) is not marketed in the United States due to patent infringement litigation. The metal-on-metal FlexiCore® artificial disc (Stryker Spine) has completed the investigational device exemption trial as part of the FDA approval process and is currently being used under continued access. (Artificial intervertebral discs for treating the cervical spine are considered separately in the Artificial Intervertebral Disc Cervical Spine medical policy.) Kineflex-L™ (Spinal Motion) is a 3-piece, modular, metal-on-metal implant. An FDA advisory committee meeting on the Kineflex-L was scheduled for July 2013, but was cancelled without explanation.
POLICYArtificial intervertebral discs of the lumbar spine are considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY11/2003: Approved by Medical Policy Advisory Committee (MPAC)
1/21/2004: Code Reference section completed, CPT code 22899 added non-covered codes
7/21/2005: Reviewed by MPAC, remains investigational, Sources updated
9/15/2005: Code Reference section updated, ICD-9 procedure code 84.60, 84.61, 84.62, 84.63, 84.64, 84.65, 84.66, 84.67, 84.68, 84.69 added
10/18/2005: Code Reference updated, codes 0090T - 0092T added. Note added to code 22899: Use code 22899 to report artificial intervertebral disc prior to 7-1-2005. For services 7-1-2005 and after, use codes 0090T - 0092T.
3/08/2006: Coding updated. CPT4 2006 revisions added to policy
12/13/2006: Policy reviewed, no changes
1/4/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
5/16/2007: Policy reviewed, description updated. Clarified policy statement to include lumbar spine. Added "Lumbar Spine" to policy title. Code reference section updated; CPT codes 0090T, 0092T, 0093T, 0095T, 0096T, and 0098T removed
12/5/2008: Policy reviewed, no changes
12/24/2008: Code reference section updated per the 2009 CPT/HCPCS revisions
04/12/2010: Policy description updated regarding FDA-approval status of devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section. Removed the following codes as they were deleted on 12/31/2006: 0091T, 0094T, and 0097T. Also, deleted unlisted CPT code 22899; this code was only to be used to report artificial intervertebral disc procedure prior to 07/01/2005.
12/29/2010: Policy reviewed; no changes.
12/13/2011: Policy reviewed; no changes.
11/28/2012: Policy reviewed; no changes.
03/11/2014: Policy reviewed; no changes.
03/17/2015: Policy description updated regarding devices. Policy statement unchanged.
08/21/2015: Code Reference section updated to add ICD-10 codes and to remove ICD-9 procedure codes 84.60, 84.61, 84.62, 84.63, 84.66, 84.67, and 84.69.
05/31/2016: Policy number A.7.01.87 added.
08/15/2016: Policy description updated regarding devices. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.87
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
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