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The U.S. Centers for Medicare & Medicaid Services (CMS) proposes that Percutaneous Image-guided Lumbar Decompression (PILD) for lumbar spinal stenosis (LSS) is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act. Therefore, CMS proposes that PILD for LSS is non-covered by Medicare.
The scope of the national coverage analysis (NCA) included a review of evidence on whether the procedure in question provides improved health outcomes in Medicare beneficiaries. This included Vertos Medical’s proprietary mild® procedure. CMS initiated this NCA in early 2Q13 and met with Vertos in 2Q and 3Q13.
Per Vertos Medical press releases, the efficacy and safety of mild have been demonstrated in 11 clinical trials and 16 physician-reviewed clinical journal articles. The brief outpatient procedure is performed through an incision the size of a baby aspirin and requires no general anesthesia, no implants and no stitches.
CMS cited several fundamental limitations of the evidence that supported conclusions that disagree with those of the studies that have been used to support claims of clinical benefit:
• Absence of diagnostic consensus leads CMS to question whether enrolled study subjects indeed have LSS, and if so to what degree
• Absence of diagnostic consensus constrains any significant consensus on treatment
• General reliance on case series rather than robust randomized sham controlled clinical trials with explicit protocol driven criteria further limits the persuasiveness of the evidence
CMS noted that these limitations are particularly challenging with back pain, in light of the subjective nature of patients’ symptoms and the failure to adequately account for the biases and confounding that arise from placebo effects/spontaneous symptom improvement.
CMS summarized, “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.”
Comments on the proposed decision are slated for collection through mid-November, after which CMS will respond in a final decision memorandum.
REFERENCES
Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N), October 17, 2013, CMS.gov
Vertos Medical, Inc. press releases, www.vertosmed.com
