Posterior decompression for spinal stenosis has evolved toward increasingly minimally invasive approaches intended 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). The procedure is intended for the treatment of central stenosis only and does not address nerve root compression or disc herniation, if present. The mild® decompressive procedure has been proposed for use in the lumbar, cervical, and thoracic spinal regions.

During the procedure, the epidural space is accessed and filled with contrast medium under fluoroscopic guidance. A 6-gauge cannula, secured with a back plate, is used in conjunction with single-use instruments including a portal cannula, surgical guide, bone rongeur, tissue sculptor, and trocar to resect thickened ligamentum flavum and small pieces of lamina. Tissue and bone sculpting are performed entirely under fluoroscopic guidance, with contrast media added throughout the procedure to aid visualization of the decompression. The procedure may be repeated on the opposite side to achieve bilateral central canal decompression. 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 the mild® procedure compared with placebo or to determine the efficacy of image-guided minimally invasive lumbar decompression compared with open decompression. The limited availability of trials with relevant control groups precludes definitive conclusions regarding the risks and benefits of this procedure. As a result, the evidence is insufficient to determine whether the technology results in an improvement in the net health outcome. For individuals with cervical or thoracic spinal stenosis who undergo image-guided minimally invasive spinal decompression, no evidence was identified. Therefore, the evidence is insufficient to determine that the technology improves net health outcomes in these populations.

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. (5:2025). Image-guided minimally invasive decompression for spinal stenosis (7.01.126). Retrieved May 9, 2025 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)

Hayes, a symplr company. Medical Technology Directory. (2025, May). Percutaneous-image-guided lumber decompression via mild procedure (Vertos Medical Inc.) for lumbar spinal stenosis. Retrieved April 6, 2026 from www.Hayesinc.com/subscribers. (45 articles and/or guidelines addressed)

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.

Zhang, X. Y., Zhao, J. L., Wang, Y. J., Luan, J., Lin, H. Q., & Wang, D. (2025). The efficacy of the minimally invasive lumbar decompression (MILD®) procedure: a PRISMA-compliant systemic review and meta-analysis. Pain Physician, 28 (2), 71-81. (Level 1 evidence)

ORIGINAL EFFECTIVE DATE: 12/11/2010

MOST RECENT REVIEW DATE: 5/14/2026

ID_BA

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.

This document has been classified as public information.