Medical Policy: 07.01.63
Original Effective Date: February 2014
Reviewed: January 2015
Revised: January 2015
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 (MILD) is a percutaneous procedure for decompression of the central spinal canal utilized for pain relief in patients with lumbar spinal stenosis (LSS).
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 MILD procedure and the mild® system have been proposed as an alternative, less invasive treatment option for LSS. This procedure treats LSS by removing small, but adequate, portions of laminar bone and debulking the ligamentum flavum.
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 mild® system uses fluoroscopic guidance in a percutaneous procedure to achieve minimally invasive lumbar decompression for the treatment of lumbar spinal stenosis (LSS). The mild® system utilizes a specialized cannula and surgical tools for bone and tissue sculpting near the spinal canal. However, the devices are not intended to be used near the lateral neural elements and are contraindicated for disc procedures. This procedure is indicated for central stenosis only, without the capability of addressing nerve root compression or disc herniation that may also be present.
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 (MILD). 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.
Image guided minimally invasive lumbar decompression (MILD) 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 (MILD) and the mild® system. 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 (MILD) 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 ICD-9-CM diagnostic 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:
- CMS. 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 Pain. May 13, 2009.
- American Association of Neurological Surgeons (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 2010; 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 2010;13(4):369-378.
- ECRI. Product Brief. MILD Surgical Kit (Vertos Medical, Inc.) for Treating Lumbar Spinal Stenosis, November 2013.
- UpToDate. 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 2012; 15:451-460.
- PubMed. 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.gov
Date Reason Action
February 2014 New policy created
January 2015 Annual review Policy revised
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
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affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.