CMS Proposes Coverage Decision for PILD, mild®
Percutaneous image-guided lumbar decompression for lumbar spinal stenosis is a non-covered service for Medicare beneficiaries, and if the Centers for Medicare & Medicaid Services (CMS) has anything to say about it (and they do), it will stay that way. The agency issued a proposed decision memo on Oct. 17, stating as much.
PILD is a posterior decompression of the lumbar spine, used as treatment for symptomatic LSS unresponsive to conservative therapy. Generally considered a non-invasive procedure, PILD requires the use of specially designed instruments and X-ray guidance to percutaneously remove a portion of the lamina and debulk the ligamentum. The expected health outcome is relief from pain, numbness, or tingling in the lower back, legs, or buttocks that prohibits a person’s ability to stand or walk.
CMS initiated this national coverage analysis (NCA) on April 5 and accepted public comment through May 5 to use as part of their review of evidence for whether PILD for LSS provides improved health outcomes. The proprietary procedure mild® was included in this review.
Clinical evidence CMS considered in their review was generally favorable. The following are excerpts from a small sample of the many studies CMS actually reviewed:
- “In keeping with other reports, the procedure appears to offer a safe and effective alternative to patients suffering from LSS.”
- “As a less-invasive alternative to decompression surgery, mild Lumbar Decompression has demonstrated comparable patient outcomes to standard decompressive laminectomy, with shorter procedure times, less blood loss, shorter hospital stays, and significantly better safety.”
- “In this study, the mild procedure was shown to be safe, with properly diagnosed patents experiencing significant improvement in mobility and significant reduction of pain at one year after the procedure.”
- “This clinical outcome assessment demonstrates that, for this patient series, the mild procedure provided significant pain relief at 1-year post-treatment and increased mobility for patients with symptomatic LSS.”
- “The findings from this double-blind, randomized, prospective study of ESI vs. the mild procedure in the treatment of LSS patients suffering from symptomatic neurogenic claudication indicate that mild provides statistically significantly better pain reduction and improved functional mobility vs. treatment with ESI.”
During the initial 30-day comment period, CMS received 114 comments—99 of which advocated coverage.
Despite the outpouring of support for PILD, CMS is standing by its decision for non-coverage. CMS explains, “In reviewing the evidence on PILD we are confronted with weak studies, questions about missing information, questions about adverse events and conflicts of interest. After thoroughly reviewing the evidence for PILD for LSS, we have determined the evidence does not support a conclusion of improved health outcomes for our Medicare beneficiaries.”
CMS is now seeking comments on their proposed decision that PILD for LSS is non-covered by Medicare. Comments can be made on the Medicare Coverage Database website and will be accepted through Nov. 16.