Medical Policy: 07.01.63 

Original Effective Date: February 2014 

Reviewed: January 2018 

Revised: January 2018 

 

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-MILD) 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-MILD) 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. 

 

Less invasive surgical procedures include open laminotomy and microendoscopic laminotomy. In general, the literature comparing surgical procedures is limited. The literature has suggested that less invasive surgical decompression may reduce perioperative morbidity without impairing long-term outcomes when performed in appropriately selected patients.

         

Decompressive laminectomy, the classic treatment for LSS, unroofs the spinal canal by extensive resection of posterior spinal elements, including the lamina, spinous process, portions of the facet joints, ligamentum flavum, and the interspinous ligaments. Wide muscular dissection and retraction is needed to achieve adequate surgical visualization. The extensive resection and injury to the posterior spine and supporting musculature can lead to instability with significant morbidity, both postoperatively and longer term. Spinal fusion, performed at the same time as laminectomy or after symptoms have developed, may be required to reduce resultant instability. Laminectomy may also be used for extensive multilevel decompression.

 

Hemilaminotomy and laminotomy, sometimes termed laminoforaminotomy, are less invasive then laminectomy. These procedures focus on the interlaminar space, where most of the pathologic changes are concentrated, minimizing resection of the stabilizing posterior spine. A laminotomy typically removes the inferior aspect of the cranial lamina, superior aspect of the subjacent lamina, ligmentum flavum, and the medial aspect of the facet joint. Unlike laminectomy, laminotomy does not disrupt the facet joints, supra and interspinous ligaments, a major portion of the lamina, or the muscular attachments. Muscular dissection and retraction are required to achieve adequate surgical visualization.

 

Microendoscopic decompressive laminotomy (MEDL), similar to laminotomy, uses endoscopic visualization. The position of the tubular working channel is confirmed by fluoroscopic guidance, and serial dilators are used to dilate the musculature and expand the fascia. For MEDL, an endoscopic curette, rongeur, and drill are used for the laminotomy, facetectomy and foraminotomy. The working channel may be repositioned from a single incision for multi-level and bilateral dissections.

   

Posterior decompression for LSS has been evolving toward increasingly minimally invasive procedures in an attempt 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 indicated for central stenosis only, without the capability of addressing nerve root compression or disc herniation, should either be required.

 

Percutaneous image-guided minimally invasive lumbar decompression (IG-MILD) using a specially designed tool kit mild® has been proposed as an ultra-minimally invasive treatment of central LSS.  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 devices are not intended to be used near the lateral neural elements and are contraindicated for disc procedures.

 

Summary of Evidence

For individuals who have lumbar spinal stenosis, the evidence includes a randomized controlled trial (RCT; N=302) the MiDAS ENCORE study, a systematic review of a small RCT (N=38), a number of prospective and retrospective cohort studies and case series, and an ongoing observational study (MILD Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study; NCT03072927). The MiDAS ENCORE study compared minimally invasive lumbar decompression (MILD) procedure to epidural steroid injections in patients with painful lumbar spinal stenosis exhibiting neurogeneic claudication and having verified ligamentum flavum hypertrophy and who failed conservative therapy. Results at one year follow-up suggested reductions in pain and improvements in function in the MILD group versus the control group. The limitations related to this study included lack of patient blinding due to considerable differences in treatment protocols, resulting in a high risk of bias and a potentially higher non-responder rate for both groups versus standard-of-care due to adjunctive pain therapy study restrictions. Study enrollment was also not limited to patients that had never received epidural steroid injections (ESI). The Medicare Claims Study (NCT0307297) is an observational study, the control group includes all patients receiving interspinous process decompression (IPD) for the treatment of lumbar spinal stenosis with neurogenic claudication, and the treatment group includes all patients receiving MILD during the enrollment period. The study will compare incidence rates as well as harms associated with the MILD procedure. While image-guided minimally invasive lumbar decompression (IG-MILD) has been proposed as an alternative, less invasive treatment for central lumbar spinal stenosis, current clinical evidence is insufficient to permit conclusions about whether any beneficial effect from image guided minimally invasive lumbar decompression provides a significant advantage over surgical decompression. In addition, the complication rates and reoperation rates for this procedure compared with those of decompression surgery is unknown. There is a need for additional randomized controlled trials with sufficient follow up, sample size, and relevant comparative control groups to other established alternatives (i.e. surgical decompression) 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.

 

Practice Guidelines and Position Statements

No guidelines or position statements were identified.

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-MILD) is considered investigational for all indications.

 

While image-guided minimally invasive lumbar decompression (IG-MILD) has been proposed as an alternative, less invasive treatment for central lumbar spinal stenosis, current clinical evidence is insufficient to permit conclusions about whether any beneficial effect from image guided minimally invasive lumbar decompression provides a significant advantage over surgical decompression. In addition, the complication rates and reoperation rates for this procedure compared with those of decompression surgery is unknown. There is a need for additional randomized controlled trials with sufficient follow up, sample size, and relevant comparative control groups to other established alternatives (i.e. surgical decompression) 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.

 

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 March 11, 2016.
  • 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
  • Chopko BW. A novel method for treatment of lumbar spinal stenosis in high-risk surgical candidates: pilot study experience with percutaneous remodeling of ligamentum flavum and lamina. J Neurosurg Spin. Jan 2011;14(1):46-50. PMID 21142460
  • Chopko BW. Long-term results of percutaneous lumbar decompression for LSS: two year outcomes. Clin J Pain. Nov 2013;29(11):939-943. PMID 23446067
  • Benyamin RM, Staats PS, MiDAS Encore. MILD ® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE randomized controlled trial. Pain Physician May 2016;19(4):229-242. PMID 27228511

 

Policy History:

  • January 2018 - Annual Review, Policy Revised
  • 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.

 

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