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.
On January 9, 2014, CMS posted its final National Coverage Determination (NCD 150.13) covering PILD for beneficiaries with LSS when provided in a prospective, randomized, controlled clinical study meeting certain conditions under the Coverage with Evidence Development (CED) determination. Clinical studies must be designed using current validated and reliable measurement instruments and clinically appropriate comparator treatments, including appropriate medical or surgical interventions or a sham controlled arm, for patients randomized to the non-PILD group.
Two studies have been approved:
Study Title: A Prospective, Multi-center, Randomized Controlled Double-Blind Trial Evaluating the VertiFlex® Totalis™ Direct Decompression System versus a Sham Surgical Procedure in Patients with Lumbar Spinal Stenosis
Sponsor: VertiFlex®, Inc.
Clinicaltrials.gov Number: NCT02079038
CMS Approval Date: 05/22/2014
Study Title: MILD® Percutaneous Image-Guided Lumbar Decompression versus Epidural Steroid Injections in Patients Diagnosed with Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication.
Sponsor: Vertos Medical
Clinicaltrials.gov Number: NCT02093520
CMS Approval Date: 05/06/2014
CMS has received a complete formal request for a reconsideration of the January 9, 2014 PILD NCD which limits coverage to prospective, randomized, controlled clinical studies. The request is based on, and the analysis is limited to, published results of the CMS approved CED studies.
CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.
