Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis
Guidance for a Medicare National Coverage Determination (NCD) which allows coverage of PILD for LSS under Coverage with Evidence Development (CED) with certain conditions.
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: January 30, 2020
PILD for LSS is a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. This is a procedure proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. This procedure is generally described as a non-invasive procedure using specially designed instruments to percutaneously remove a portion of the lamina and debulk the ligamentum flavum. The procedure is performed under x-ray guidance (e.g., fluoroscopic, CT) with the assistance of contrast media to identify and monitor the compressed area via epidurogram.
On January 9, 2014, CMS issued a Medicare National Coverage Determination (NCD) which allows coverage of PILD for LSS under Coverage with Evidence Development (CED) with certain conditions. The NCD that requires a prospective, randomized, controlled clinical trial (RCT) design is available on our website at /medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=269.
On December 7, 2016, CMS expanded this NCD to allow coverage of PILD for LSS under CED in a prospective longitudinal study using an FDA-approved/cleared device that successfully completed a CMS-approved RCT with certain conditions. The NCD that requires a prospective longitudinal study design is available on our website at /medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=284.
As part of CED, we are identifying below the Medicare approved clinical trials which have been reviewed and determined to meet the requirements of coverage.
Clinical Study Approvals
Study Title: MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Sponsor: Vertos Medical
Clinicaltrials.gov Number: NCT03072927
CMS Approval Date: 02/16/2017
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
HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.
DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.