Medical Policy: 07.01.63
Original Effective Date: February 2014
Reviewed: January 2016
Revised: January 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Image guided minimally invasive lumbar decompression (IGMLD) is a percutaneous procedure for decompression of the central spinal canal utilized for pain relief 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.
Lumbar spinal stenosis (LSS) is a condition in which the space around the spinal cord narrows and causes compression of the spinal cord and spinal nerves. This compression may cause symptoms such as pain, numbness, and weakness of the lower extremities that often worsen with standing or walking and are alleviated by sitting or leaning forward. Back pain may or may not be present. LSS if often linked to age-related changes in disc height and arthritis of the facet joints and is often seen in individuals over the age of 65. It is a common reason for spinal surgery, with the goal of surgery being decompression of the spinal cord and/or nerves. Decompressive surgery is usually recommended for individuals with severe symptoms that haven’t been relieved by other treatments. The IGMLD procedure has been proposed as an alternative, less invasive treatment option for LSS.
In contrast to traditional spinal surgery treatment for LSS, (e.g. decompression laminectomy, a procedure requiring extensive resection of the posterior spinal elements and wide muscular dissection and retraction, or other spinal surgeries such as hemilaminotomy or microendscopic decompression laminotomy), the percutaneous IG-MLD procedure using a specially designed tool kit (mild®) has been proposed as an ultraminimally invasive treatment of central LSS. This procedure is indicated for central stenosis only, with the capability of addressing nerve root compression or disc herniation. In this procedure, the epidural space is filled with contrast medium under fluoroscopic guidance. Using a 6-guage 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.
In general, the literature comparing surgical procedures is limited. Due to the unknown impact on health outcomes, randomized controlled trials in appropriate patients are needed to compare this procedure to the established alternatives. Although some studies have been initiated, no evidence is available at this time to evaluate the efficacy of image guided minimally invasive lumbar decompression (IGMLD). Therefore, this procedure is considered investigational.
The mild® tool kit (Vertos Medical Inc., San Jose, CA) initially received 510(k) marketing clearance as the X-Sten MILD Tool Kit (X-Sten Corp.) from the US Food and Drug Administration (FDA) on December 19, 2006, as a class II device 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. A subsequent approval for the Vertos Medical mild® Device Kit (Vertos Medical Inc.) was given by the FDA on February 4, 2010.
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.
See also medical policy 07.01.39 Miscellaneous Surgical Treatment of Back Pain
Image guided minimally invasive lumbar decompression (IGMLD) is considered investigational for all indications.
Based on peer reviewed literature the evidence is insufficient to determine the safety and efficacy of image guided minimally invasive lumbar decompression (IGMLD) and the mild® tool kit. The literature comparing surgical procedures is limited and due to the unknown impact on health outcomes, further randomized controlled trials are needed to compare this procedure to established alternatives. Therefore, image guided minimally invasive lumbar decompression (IGMLD) is considered investigational for all indications.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 0275T Percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy) any method under indirect image guidance (e.g. fluoroscopic, CT),with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; lumbar
Wellmark's policy is based on:
- CMSExternal Site. Decision Memo for Percutaneous Image Guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N).
- American Pain Society’s Guideline for Interventional Procedures and Surgery for Low Back PainExternal Site. May 13, 2009.
- American Association of Neurological SurgeonsExternal Site (AANS). Patient Information: Minimally Invasive Spine Surgery (MIS), January 2009.
- Retrospective Review of Patient Self Reported Improvement and Post Procedure Findings for mild® (Minimally Invasive Lumbar Decompression). Richard Lingreen, M.D., Jay S. Grider, D.O., PhD. Pain Physician 2010External Site; 13:555-560.
- MiDAS I (mild® Decompression Alternative to Open Surgery): A Preliminary Report of a Prospective, Multi-Center Clinical Study. Bohdan Chopko, M.D., PhD, David L. Caraway M.D. Pain Physician 2010External Site;13(4):369-378.
- ECRIExternal Site. Product Brief. MILD Surgical Kit (Vertos Medical, Inc.) for Treating Lumbar Spinal Stenosis, November 2013.
- UpToDateExternal Site. Subacute and Chronic Low Back Pain: Surgical Treatment. Roger Chou, M.D. Topic last updated June 6, 2013.
- The Microendoscopic Decompression of Lumbar Stenosis: A review of the Current Literature and Clinical Results. Albert P. Wong, Zachary A. Smith, Rohan R. Lall, Lacey E. Bresnahan and Richard G. Fessler. Volum 2012, doi:10.1155/2012/325095.
- Prospective Study: Study of Percutaneous Lumbar Decompression and Treatment Algorithm for Patients Suffering from Neurogenic Claudication. Timothy R. Deer, M.D., Christopher K. Kim, M.D., Richard G. Bowman II, M.D., Matthew T. Ranson, M.D. and Brian Scott Yee, D.O.. Pain Physician 2012External Site; 15:451-460.
- PubMedExternal Site. Long Term Results of Percutaneous Lumbar Decompression mild® for Spinal Stenosis. March 2012.
- National Guideline Clearinghouse, Work Loss Data Institute, Low Back – Lumbar & Thoracic (Acute & Chronic), December 4, 2013. Also available at www.guideline.govExternal Site
- CMS National Coverage Determination (NCD) for Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis (150.13). Also available at www.cms.gov
- National Guideline Clearing House. North American Spine Society, Diagnosis and Treatment of Lumbar Spondylolisthesis. Also available at North American Spine Society (NASS) 2014, p.119
- UpToDateExternal Site. Lumbar Spinal Stenosis: Treatment and Prognosis, Kerry Levin M.D., Topic last updated October 15, 2014.
- PubMed. Deer TR, Kapural L, New Image Guided Ultra-Minimally Invasive Lumbar Decompression Method: The Mild Procedure. Pain Physician 2010 Jan-Feb:13(1): 35-41
- PubMed. Brown LL, A Double Blind, Randomized, Prospective Study of Epidural Steroid Injection VS. the MILD ® Procedure in Patients with Symptomatic Lumbar Spinal Stenosis. Pain Pract 2012 Jun:12(5):333-41
- PubMed. Wilkinson JS, Fourney DR, Failure of Percutaneous Remodeling of the Ligamentum Flavum and Lamina for Neurogenic Claudication, Neurosurgery 2012 Jul;71(1): 86-92
- PubMed. Chopko BW, Long-Term Results of Percutaneous Lumbar Decompression for LSS: Two Year Outcomes, Clin J Pain 2013 Nov;29(11):939-43
- PubMed. Durkin B, Romeiser J, Shroyer AL, et. al. Report from a Quality Assurance Program on Patients Undergoing the MILD Procedure, Pain Med 2013 May;14(5):650-6
- PubMed. Deer T, Minimally Invasive Lumbar Decompression for the Treatment of Spinal Stenosis of the Lumbar Spine, Pain Manag 2012 Sep;2(5):457-65
January 2016 - Annual Review, Policy Revised
January 2015 - Annual Review, Policy Revised
February 2014 - New Policy
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.