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National Coverage Analysis (NCA) Tracking Sheet for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N)

Percutaneous image-guided lumbar decompression (PILD) describes a minimally invasive laminotomy/laminectomy procedure (interlaminar approach) for decompression of the lumbar spine for a primary diagnosis of lumbar spinal stenosis (LSS) under indirect image guidance (eg. fluoroscopic, CT) with or without the use of an endoscope. This procedure is proposed as a treatment for symptomatic LSS that is unresponsive to conservative therapy.

LSS is the narrowing of the space around the spinal cord and the spinal nerve roots. The most common symptom of LSS is back pain with neurogenic claudication, i.e., pain, numbness, or weakness in the legs that worsens with standing or walking and is alleviated with sitting or leaning forward. Degenerative spinal stenosis is often associated with age related changes in the spine. LSS is the most common reason for back surgery in adults over 65 years of age. The goal of surgical treatment is to decompress the spinal cord and/or nerve roots and alleviate the symptoms.

CMS is opening this national coverage analysis (NCA) to complete a thorough review of the evidence to determine if PILD for LSS is reasonable and necessary for coverage under the Medicare program. The scope of our review is inclusive of percutaneous lumbar laminotomy/laminectomy (interlaminar approach) for the decompression of neural elements (spinal cord, nerve roots), under indirect image guidance (eg, fluoroscopic, CT), with or without the use of an endoscope. NOTE: Endoscopically assisted laminotomy/laminectomy, which requires open and direct visualization, as well as other open lumbar decompression procedures for LSS are not within the scope of this NCA.

Outpatient Hospital Services Incident to a Physician's Service
Physicians' Services
Requestor Name(s)Internal
Formal Request Accepted and Review Initiated04/05/2013
Expected NCA Completion Date01/15/2014
Public Comment Period04/05/2013 - 05/05/2013
Proposed Decision Memo Released10/17/2013
Proposed Decision Memo Public Comment Period: 10/17/2013 - 11/16/2013 
Decision Memo Released01/09/2014
Comments for this NCA:View Public Comments
Lead Analyst(s)

April 5, 2013

CMS initiates this national coverage analysis of PILD for LSS. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days.

CMS is requesting public comment on the clinical evidence of health benefit outcomes, short term and long term, provided by this procedure in the Medicare population.

CMS considers all public comments, and is particularly interested in comments that include published clinical studies and other scientific information that provides evidence for improvement in short and long term outcomes related to this procedure.

Instructions on submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

October 17, 2013

Posted proposed decision memo

Original due date changed due to Government shutdown.

January 9, 2014

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