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DESCRIPTIONInterspinous and interlaminar implants (spacers) stabilize or distract the adjacent lamina and/or spinous processes and restrict extension to reduce pain in patients with lumbar spinal stenosis and neurogenic claudication. Interspinous spacers are small devices implanted between the vertebral spinous processes. After implantation, the device is opened or expanded to distract (open) the neural foramen and decompress the nerves. Interlaminar spacers are implanted midline between adjacent lamina and spinous processes to provide dynamic stabilization either following decompressive surgery or as an alternative to decompressive surgery.
Interspinous spacers are devices implanted between vertebral spinous processes. Interlaminar spacers are implanted between adjacent lamina and have 2 sets of wings that are placed around the inferior and superior spinous processes. These implants aim to restrict painful motion while enabling normal motion. The devices (spacers) distract the laminar space and/or spinous processes and restrict extension. This procedure theoretically enlarges the neural foramen and decompresses the cauda equina in patients with spinal stenosis and neurogenic claudication. Other types of dynamic posterior stabilization devices are pedicle screw/rod-based devices and total facet replacement systems; these are not covered in this policy.
One type of interspinous implant is inserted between the spinous processes through a small (4–8 cm) incision and acts as a spacer between the spinous processes, maintaining the flexion of that spinal interspace. 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, thus reducing the risk of epidural scarring and cerebrospinal fluid leakage. Other interspinous spacers require removal of the interspinous ligament and are secured around the upper and lower spinous processes. Interlaminar implants are inserted between the adjacent lamina and spinous processes. These may be referred to as interlaminar implants or an interspinous U.
In 2005, the X-STOP® Interspinous Process Decompression (IPD®) System (Kyphon, now part of Medtronic Spine) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process 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 patients with moderately impaired physical function who have had a regimen of at least 6 months of non-operative treatment and who have relief of their pain when in flexion. In 2015, Medtronic discontinued sales and distribution of the implant.
In 2015, the Superion® Interspinous Spacer (ISS VertiFlex) was approved by FDA through the premarket approval process. The Superion ISS, as stated in the premarket approval, is to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without grade 1 spondylolisthesis, confirmed by x-ray, magnetic resonance imaging, and/or computed tomography evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion® ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain, and who have undergone at least 6 months of nonoperative treatment. The Superion® ISS may be implanted at one or 2 adjacent lumbar levels in patients in whom treatment is indicated and at no more than 2 levels, from L1 to L5.
In 2012, the coflex® Interlaminar Technology implant (Paradigm Spine) was approved by the FDA through the premarket approval process (P110008). It is a single-piece U-shaped titanium alloy dynamic stabilization device with pairs of wings that surround the superior and inferior spinous processes. This device was previously called the Interspinous U.
The coflex® is indicated for use in 1- or 2-level lumbar stenosis from the L1-L5 vertebrae in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).
The FDA lists the following contraindications to use of the coflex®:
The FDA labeling also contains multiple precautions and the following warnings:
"The coflex® Interlaminar Technology should only be used by surgeons who are experienced and have undergone hands-on training in the use of this device. Only surgeons who are familiar with the implant components, instruments, procedure, clinical applications, biomechanics, adverse events, and risks associated with the coflex® Interlaminar Technology should use this device. A lack of adequate experience and/or training may lead to a higher incidence of adverse events.
Data has demonstrated that spinous process fractures can occur with coflex® implantation. Potential predictors for spinous process fractures include:
If a spinous process fracture occurs during the surgical procedure, the surgeon should assess if sufficient bone stock exists for Coflex® implantation."
Continued FDA approval of the coflex® is contingent on annual reports of 2 post-approval studies to provide longer-term device performance and device performance under general conditions of use. One study will provide 5-year follow-up of the cohort in the pivotal investigational device exemption trial. The second will be a multi-center trial with 230 patients with follow-up at 5 years that compares decompression alone versus decompression plus coflex®.
The Wallis® System (originally from Abbott Spine; currently from Zimmer Spine) was introduced in Europe in 1986. The first generation Wallis implant was a titanium block; the second generation device is a plastic-like polymer that is inserted between adjacent processes and held in place with a flat cord wrapped around the upper and lower spinous processes. The Wallis System is currently being tested in an 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. Other clinical trials underway at U.S. centers are studying the In-Space (Synthes) and FLEXUS™ (Globus Medical) devices; the comparator in these trials is the X-STOP device.
ExtendSure and CoRoent (both from NuVasive) were launched in Europe in 2005 and 2006. The NL-Prow™ (Non-Linear Technologies), Aperius® (Medtronic Spine), and Falena® (Mikai) devices are in trials in Europe.
POLICYInterspinous distraction devices are considered investigational as a treatment of neurogenic intermittent claudication.
Use of an interlaminar stabilization device following decompressive surgery is 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 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.
10/15/2013: Policy title changed from "Interspinous Distraction Devices (Spacers)" to "Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)." Policy description re-written regarding devices. Added the following investigational policy statement: Use of an interlaminar stabilization device following decompressive surgery is considered investigational.
07/11/2014: Policy reviewed; description updated. Policy statements unchanged.
08/27/2015: Code Reference section updated for ICD-10.
09/15/2015: Policy description updated regarding devices. Policy statements unchanged. Investigative definition added to Policy Guidelines section.
05/31/2016: Policy number added.
08/15/2016: Policy description updated regarding devices. Policy statements unchanged.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.107
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.