Subject: Proposed National Coverage Determination (NCD) for Percutaneous Image guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R)
Dear Ms. Jensen,
On behalf of the American Association of Neurological Surgeons (AANS), the Congress of Neurological
Surgeons (CNS), and the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves, we
appreciate the opportunity to comment on the recently released proposed national coverage
determination (NCD) for percutaneous image-guided lumbar decompression (PILD) for lumbar spinal
stenosis (LSS) patients experiencing neurogenic claudication. We share the agency’s dedication to
patient safety, and as such, we provide the following comments.
PILD represents novel technology in the treatment of patients with lumbar stenosis who experience
neurogenic claudication. As such, we agree on the need to evaluate this technology in a prospective
randomized trial. The current literature on this procedure at this time appears discordant. Some
industry-sponsored trials have demonstrated clinical efficacy while others have shown limited clinical
efficacy requiring reoperation. Mekhail and colleagues report a series of 58 patients who underwent
the procedure demonstrating benefit at six weeks from the procedure. However, in another industry sponsored trial, Wilkinson and Fourney found limited efficacy at six months with 60 percent of the
patients in their series of 24 requiring reoperation in that time frame. The authors hypothesize a placebo
effect and increased narcotic use as a potential explanation for the short term benefit. A reoperation rate
of 60 percent is concerning.
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