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.
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.
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 (two studies have been approved). CMS is soliciting public comment relevant to the request. They are particularly interested in comments that include scientific evidence and that address the breadth of the request. The comment period runs from 4/13/16 to 5/14/16.
Submit comments here.
View the current National Coverage Determination.