DESCRIPTION
Posterior decompression for spinal stenosis has been evolving toward increasingly minimally invasive procedures to reduce postoperative morbidity and spinal instability. Unlike conventional surgical decompression, the percutaneous mild® decompressive procedure is performed solely under fluoroscopic guidance (e.g., without endoscopic or microscopic visualization of the work area). This procedure is proposed for central stenosis only, without the capability of addressing nerve root compression or disc herniation, should either be required. The mild® decompressive procedure is proposed for use in the lumbar, cervical, and thoracic spinal regions.
In this procedure, the epidural space is filled with contrast medium under fluoroscopic guidance. Using a 6-gauge cannula 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 are conducted entirely under fluoroscopic guidance, with 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 for use near the lateral neural elements and are contraindicated for disc procedures.
POLICY
Image-guided minimally invasive spinal decompression is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
The available evidence is insufficient to determine the efficacy of mild® compared with placebo or to determine the efficacy of image-guided minimally invasive lumbar decompression compared with open decompression. Trials with relevant control groups could provide greater certainty on the risks and benefits of this procedure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. For individuals who have cervical or thoracic spinal stenosis who receive image-guided minimally invasive spinal decompression, no evidence was identified. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
SOURCES
Benyamin, R. & Staats, P. (2016). MILD® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE randomized controlled trial. Pain Physician, 19, 229-242. (Level 1 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (5:2023). Image-guided minimally invasive decompression for spinal stenosis (7.01.126). Retrieved January 26, 2024 from https://www.bcbsaoca.com/eps/. (14 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services.CMS.gov. (2017, June). NCD for percutaneous image-guided lumbar decompression for lumbar spinal stenosis (150.13). Retrieved March 14, 2017 from http://www.cms.gov.
Chopko, B. W. (2013). Long-term results of percutaneous lumbar decompression for LSS: Two-year outcomes. Clinical Journal of Pain, 29 (11), 939-943. (Level 3 evidence)
Deer, T.R., Grider, J.S., Pope, J.E., Falowski, S., Lamer, T.J., Calodney, A., et al. (2018). The MIST guidelines: the lumbar spinal stenosis consensus group guidelines for minimally invasive spine treatment. Pain Practice, 19 (3), 250-274. (Level 2 evidence)
Kreiner, D., MacVicar, J., Duszynski, B., & Nampiaparampil, D. (2014). The mild® procedure: a systematic review of the current literature. Pain Medicine, 15, 196-205. (Level 2 evidence)
Levy, R. M., & Deer, T. R. (2012). Systematic safety review and meta-analysis of procedural experience using percutaneous access to treat symptomatic lumbar spinal stenosis. Pain Medicine, 13 (12), 1554-1561. (Level 2 evidence)
Schomer, D. F., Solsberg, D., Wong, W., & Chopko, B. W. (2011). Mild® lumbar decompression for the treatment of lumbar spinal stenosis. Neuroradiology Journal, 24 (4), 620-626. (Level 2 evidence)
Staats, P. & Benyamin, R. (2016). MiDAS ENCORE: Randomized controlled clinical trial report of 6-month results. Pain Physician, 19, 25-37. (Level 2 evidence)
U. S. Food and Drug Administration. (2010, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K093062. Retrieved April 26, 2012 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Health Technology Assessment. (2023, March). Minimally invasive lumbar decompression device kit (Vertos Medical Inc.) for treatment of lumbar spinal stenosis. Retrieved January 26, 2024 from www.Hayesinc.com/subscribers. (43 articles and/or guidelines addressed)
ORIGINAL EFFECTIVE DATE: 12/11/2010
MOST RECENT REVIEW DATE: 3/14/2024
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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