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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 nonradicular low back pain.
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. During the past 30 years, a variety of 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.
While artificial intervertebral discs have been used internationally for over 10 years, only two devices have received approval from the U.S. Food and Drug Administration (FDA). The CHARITÉ® and PRODISC-L® devices (Charité® and ProDisc ®-L) have received approval from the U.S. Food and Drug Administration (FDA). Because the long-term safety and effectiveness of these devices were not known, approval was contingent on completion of post-marketing studies. The 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; Charité is 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 radiographic studies. Other devices are currently under investigation in this country as part of the FDA process of approval, including the FlexiCore (Stryker Spine) and Maverick (Medtronic) devices.
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 such as laminectomy and/or decompression are not candidates for the artificial disc.
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.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
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.