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DESCRIPTIONImage-guided minimally invasive lumbar decompression (IG-MLD) describes a novel percutaneous procedure for decompression of the central spinal canal in patients with lumbar spinal stenosis (LSS). In this procedure, a specialized cannula and surgical tools (mild®) are used under fluoroscopic guidance for bone and tissue sculpting near the spinal canal.
In LSS, the space around the spinal cord narrows, compressing the spinal cord and the nerve roots. The most common symptom of LSS is back pain with neurogenic claudication, i.e., pain, numbness, or weakness in the legs that worsens with standing or walking and is alleviated with sitting or leaning forward. Compression of neural elements generally occurs from a combination of degenerative changes including ligamentum flavum hypertrophy, bulging of the intervertebral disc, and facet thickening with arthropathy. Spinal stenosis is often linked to age-related changes in disc height and arthritis of the facet joints. LSS is one of the most common reasons for back surgery and the most common reason for lumbar spine surgery in adults over 65 years of age. The goal of surgical treatment is to “decompress” the spinal cord and/or nerve roots.
For patients with LSS, surgical laminectomy has established benefits in reducing pain and improving quality of life. Less invasive surgical procedures have been developed, such as open laminotomy and microendoscopic laminotomy. Limited evidence on the comparative efficacy of these procedures suggests that less invasive procedures may achieve a roughly similar benefit with less adverse effects. The present policy addresses posterior decompression of central LSS with a percutaneous treatment that is performed under fluoroscopic guidance.
Percutaneous IG-MILD using a specially designed tool kit (mild®) has been proposed as an ultra-minimally invasive treatment of central LSS. In the procedure, the epidural space is filled with contrast medium under fluoroscopic guidance. Using a 6-gauge cannula that is clamped in place with a back plate, single use tools (portal cannula, surgical guide, bone rongeur, tissue sculpter, trocar) are used to resect thickened ligamentum flavum and small pieces of lamina. The tissue and bone sculpting is conducted entirely under fluoroscopic guidance, with additional contrast media added throughout the procedure to aid visualization of the decompression. The process is repeated on the opposite side for bilateral decompression of the central canal. The devices are not intended to be used near the lateral neural elements and are contraindicated for disc procedures.
Alternative posterior decompressive surgical procedures include:
The mild® tool kit (Vertos Medical) initially received 510(k) marketing clearance as the X-Sten MILD Tool Kit (X-Sten Corp.) from the U.S. Food and Drug Administration (FDA) in 2006, with intended use as a set of specialized surgical instruments to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
Vertos mild® instructions for use state that the devices are not intended for disc procedures but rather for tissue resection at the perilaminar space, within the interlaminar space and at the ventral aspect of the lamina. These devices are not intended for use near the lateral neural elements and remain dorsal to the dura using image guidance and anatomical landmarks.
Note: The abbreviation MILD has also been used for microscopic muscle-preserving interlaminar decompression, which involves a small skin incision at the interspinous level and partial drilling of the spinous process, with decompression performed under microscopic visualization.
Also, see the Interspinous Distraction Devices (Spacers) medical policy.
POLICYImage-guided minimally invasive lumbar decompression is considered investigational.
POLICY EXCEPTIONSFEP Subscribers Only: Image-guided minimally invasive lumbar decompression for central stenosis without nerve root compression or disc herniation is considered medically necessary.
Federal 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 GUIDELINESInvestigative 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/22/2010: Approved by Medical Policy Advisory Committee
04/20/2011: Policy reviewed; no changes.
04/26/2012: Policy reviewed; policy statement unchanged. Policy exceptions revised to state the following: FEP Subscribers Only: Image-guided minimally invasive lumbar decompression for central stenosis without nerve root compression or disc herniation is considered medically necessary.
07/29/2013: Policy reviewed; no changes to policy statement. Added CPT code 0275T to the Code Reference section.
07/02/2014: Policy reviewed; description updated regarding surgical laminectomy. Policy statement unchanged.
07/30/2015: Code Reference section updated for ICD-10.
09/15/2015: Policy reviewed. Policy statement unchanged. Investigative definition updated in Policy Guidelines section.
05/31/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.126
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.