California medical device maker Vertos Medical was dealt a blow this week when the Centers for Medicare & Medicaid Services issued a Proposed Decision Memo rejecting coverage for image-guided lumbar decompression surgery in treatment of lumbar spinal stenosis.
Medicare regulators largely questioned the available evidence for the efficacy of the minimally invasive procedure, saying that most of the clinical studies supporting the treatment come from Vertos itself or from physicians with financial ties to the company.
"In reviewing the evidence on [Percutaneous Image-guided Lumbar Decompression] we are confronted with weak studies, questions about missing information, questions about adverse events and conflicts of interest," according to the CMS memo. "After thoroughly reviewing the evidence for PILD for [Lumbar Spinal Stenosis], we have determined the evidence does not support a conclusion of improved health outcomes for our Medicare beneficiaries."
Vertos Medical largely rejected the agency’s conclusions, saying that it hopes to foster more discussion on the subject during the new public commenting period.
"We are disappointed by the conclusions drawn from the analysis and do not believe that they accurately reflect the clinical study experience of the 542 clinical study patients, the 16+ physician-reviewed published clinical journal articles, or the commercial experience of over 15,000 patients nationwide that have been treated with the mild procedure," the company told MassDevice.com.
Vertos in 2006 won FDA clearance for its mild tool kit, a set of minimally invasive surgical tools for performing spinal surgery to alleviate pain associated with lumbar spinal stenosis. The surgery is performed on an outpatient basis through an incision the company compared to the size of a baby aspirin, and the procedure requires no implants, no stitches and no general anesthesia, the company says.
The surgery combines an imaging machine and specialized instruments to help physicians target and remove excess tissue and restore space in the spinal canal.
CMS in April initiated its coverage review for PILD treatment, meeting with Vertos a couple of times over the course of this year and gathering public comments before issuing its proposal. The initial public comment period, with ended in May, generated more than 100 comments, the vast majority of which advocated coverage for PILD. The agency also received 5 comments from national physicians’ groups, 3 of which supported coverage, 1 against coverage and 1 "unclear in its position," according to the memo.
The agency has opened another comment period, to last until November 16, before the agency makes its final decision.