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DESCRIPTIONThese interspinous implants aim to restrict painful motion while otherwise enabling normal motion. The devices (spacers) distract the spinous processes and restrict extension. This theoretically enlarges the neural foramen in patients with spinal stenosis and neurogenic claudication.
The implant is inserted between the spinous processes through a small (4-8 cm) incision. The supraspinous ligament is maintained and assists in holding the implant in place. The surgery does not include any laminotomy, laminectomy or foraminotomy at the time of insertion. The implant acts as a spacer between the spinous processes, maintaining the flexion of that spinal interspace.
In November 2005, the X-STOP® Interspinous Process Decompression (IPD®) System (Kyphon - now part of Medronic Spine LLC) was approved by the FDA for "treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. It is approved for those who have had a regimen of at least 6 months of non-operative treatment and who have relief of their pain when in flexion. The device is approved for implantation at 1 or 2 lumbar levels in patients whose condition warrants surgery at no more than 2 levels.
The Wallis System (Abbott Spine) was introduced in Europe in 1986. The first generation Wallis implant was a titanium block, the second generation device is composed of a plastic-like polymer that is inserted between adjacent processes and held in place with a flat cord that is wrapped around the upper and lower spinous processes. The Wallis System is currently being tested in a FDA-regulated clinical trial. Also in a FDA-regulated clinical trial is the DIAM Spinal Stabilization System (Medtronic Sofamor Danek), which is a soft interspinous spacer with a silicone core. The DIAM system requires removal of the interspinous ligament and is secured with laces around the upper and lower spinous processes.
The Coflex implant (Paradigm Spine) is used in Europe but is not currently FDA approved. ExtendSure and CoRoent (both from NuVasive) were launched in Europe in 2005 and 2006.
POLICYInterspinous distraction devices are considered investigational as a treatment of neurogenic intermittent claudication.
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.
POLICY GUIDELINESThe coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY10/26/2006: Policy added
12/28/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions
9/18/2007: Policy reviewed, no changes
9/20/2007: Code Reference section updated. ICD-9 2007 revisions added to policy
5/14/2009: Policy reviewed. No changes.
6/26/2009: Removed unlisted CPT code 22899 from the non-covered table. All services incurred on 1/1/2008 and after should be filed using the new codes, 0171T and 0172T.
06/21/2011: Policy reviewed; no changes to policy statement. FEP verbiage added to the Policy Exceptions section.
01/18/2012: Policy reviewed; no changes.
04/02/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.107
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.