Re: National Coverage Analysis (NCA) 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 recent request for reconsideration of the National
Coverage Analysis (NCA) for Percutaneous Image-Guided Lumbar Decompression (PILD) for Lumbar
Spinal Stenosis (LSS).
We have reviewed the six month study data cited for the reconsideration and we do not believe it
supports a change in the CMS decision of January 2014, covering the procedure only for approved
clinical trials. We will be interested to see the full twelve months of data and until that time, do not
support a change in coverage policy for the device. Although some neurosurgeons have been trained in
the technique of percutaneous image-guided lumbar decompression (PILD) for the treatment of
symptomatic Lumbar Spinal Stenosis (LSS), overall our field of neurosurgery has not embraced the use
of this procedure due to concerns regarding its effectiveness as compared to our current surgical
options. The literature continues to be predominantly industry funded and we continue to have concerns
that the technique is not indicated in patients with a significant element of bony stenosis, lateral recess
stenosis, or foraminal stenosis. While the literature suggests that the PILD procedure appears relatively
safe, the improvements in the patients in previous studies did not meet a minimally acceptable outcome
based on the definitions. We continue to have concerns about the characteristics of patients who would
benefit from this procedure and the degree to which these patients would benefit as compared to current
treatment options. We believe that CMS should wait for the full 12 months of data before reconsidering
its non-coverage policy for this procedure.
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