Medical Policy: 07.01.63 

Original Effective Date: February 2014 

Reviewed: January 2017 

Revised: January 2017 

 

Benefit Application:

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.

 

Description:

Image-guided minimally invasive lumbar decompression (IG-MLD) is a 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.  Image-guided minimally invasive lumbar decompression (IG-MLD) is proposed as an alternative to existing posterior decompression procedures.  

 

Lumbar spinal stenosis (LSS) is a condition in which the space around the spinal cord narrows and causes compression of the spinal cord and its nerve roots. The most common  symptoms of LSS is back pain with neurogenic claudication i.e. pain, numbness, or weakness in the lower extremities that often worsens with standing or walking and is alleviated by 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 among the most common reasons for back surgery and the most common reason for lumbar spine surgery in adults over the age of 65. The goal of surgical treatment is to “decompress” the spinal cord and/or nerve roots. 

   

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 microendoscopic decompression laminotomy), the percutaneous image-guided minimally invasive lumbar decompression (IG-MLD) using a specially designed tool kit (mild®) has been proposed as an ultra-minimally 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 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 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.

 

Summary

For individuals with severe symptoms that have not been alleviated by rest or conservative therapy, lumbar laminectomy is often considered the gold standard for lumbar spinal stenosis (LSS). While image-guided minimally invasive lumbar decompression (IG-MLD) has been proposed as an alternative, less invasive treatment for central lumbar spinal stenosis, there is a lack of adequately designed peer reviewed literature or guidance from relevant medical societies to establish its safety and effectiveness. There is a need for additional randomized controlled trials with sufficient follow up, sample size, and relevant comparative control groups to other established alternatives to determine the appropriateness of image-guided minimally invasive lumbar decompression for the treatment of central lumbar spinal stenosis. The evidence is insufficient to determine the effects of the technology on net health outcomes. Therefore, this procedure is considered investigational. 

 

Regulatory Status

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.

 

Prior Approval:

Not applicable.

 

Policy:

 

See also medical policy 07.01.39 Miscellaneous Surgical Treatment of Back Pain

 

Image-guided minimally invasive lumbar decompression (IG-MLD) is considered investigational for all indications.

 

For individuals with severe symptoms that have not been alleviated by rest or conservative therapy, lumbar laminectomy is often considered the gold standard for lumbar spinal stenosis (LSS). While image-guided minimally invasive lumbar decompression (IG-MLD) has been proposed as an alternative, less invasive treatment for central lumbar spinal stenosis, there is a lack of adequately designed peer reviewed literature or guidance from relevant medical societies to establish its safety and effectiveness. There is a need for additional randomized controlled trials with sufficient follow up, sample size, and relevant comparative control groups to other established alternatives to determine the appropriateness of image-guided minimally invasive lumbar decompression for the treatment of central lumbar spinal stenosis. The evidence is insufficient to determine the effects of the technology on net health outcomes. Therefore, this procedure is considered investigational.

 

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

 

Selected References:

  • CMS Decision Memo for Percutaneous Image Guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N).
  • American Pain Society 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.
  • CMS (NCD) for Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis (150.13).
  • 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 
  • UpToDate 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
  • Levy RM, Deer TR. Systematic safety review and meta-analysis of procedural experience using percutaneous access to treat symptomatic lumbar spinal stenosis. Pain Med 2012 Dec;13(12):1554-61. PMID 23136978
  • 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. PMID 20119461
  • Deer TR. Kim CK. et. al. Study of percutaneous lumbar decompression and treatment algorithm for patients suffering from neurogenic claudication. Pain Physician 2012 Nov-Dec;15(6):451-60. PMID 23159960
  • Mekhail N, Vallejo R, Coleman MH, et. al. Long term results of percutaneous lumbar decompression mild for spinal stenosis. Pain Pract 2012 Mar;12(3):184-93. PMID 21676166
  • Lingreen R, Grider JS. Retrospective review of patient self-reported improvement and post procedure findings for mild (minimally invasive lumbar decompression). Pain Physician 2010 Nov-Dec;13(6):555-60. PMID 21102968
  • Kreiner DS, MacVicar J, Duszynski B, et. al. The mild procedure: a systematic review of the current literature. Pain Med 2014 Feb;15(2):196-205. PMID 24308292
  • Staats PS, Benyamin RM; MiDAS ENCORE Investigators.  MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6 Month Results. Pain Physician 2016 Feb;19(2):25-38. PMID 26815247

 

Policy History:

  • January 2017 - Annual Review, Policy Revised
  • January 2016 - Annual Review, Policy Revised
  • January 2015 - Annual Review, Policy Revised
  • February 2014 - New Policy

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 practice and are neither employees nor agents of Wellmark or its 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.