Minimally Invasive Spine Technique Gets Second Look By CMS
This article was originally published in The Gray Sheet
The Medicare agency is reconsidering coverage of percutaneous image-guided lumbar decompression for lumbar spine stenosis in response to a request by device manufacturer Vertos. The firm's goal is to lift current clinical trial conditions for coverage of the procedure.
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Vertos Medical asked the US Medicare agency to reconsider its 2014 decision that limits coverage of percutaneous image-guided lumbar decompression for lumbar spine stenosis to certain clinical trials. The agency ruled Dec. 7 that it will stick with the trial-limited policy, but expanded it to include longitudinal studies.
Spinal device makers, who objected to CMS’ proposal for outright noncoverage of percutaneous image-guided lumbar decompression, are pleased with the agency’s final decision to cover PILD when provided in a clinical study through coverage with evidence development.
Manufacturers seek more input on trial designs and objectives when CMS takes the "coverage-with-evidence-development" route to national Medicare coverage.