The US Centers for Medicare and Medicaid Services is maintaining its coverage-with-evidence-development (CED) approach to percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis, but will expand the coverage policy to include longitudinal studies. CMS issued its National Coverage Analysis decision memo for the PILD procedure Dec. 7.
In 2014, CMS agreed to cover PILD for patients enrolled in an approved clinical trials that meet certain criteria. (Also see "Spine Firms Laud CMS’ Decision To Cover Percutaneous Lumbar Decompression In Trials" - Medtech Insight, 20 January, 2014.) In March, Vertos Medical Inc. requested that CMS consider lifting the evidence-development requirements in the coverage policy in light of the results of data from MiDAS ENCORE, a 302-patient randomized trial comparing epidural steroid injections to PILD with Vertos' mild system. The mild system consists of a set of proprietary instruments for minimally invasive, fluoroscopically-guided PILD in an outpatient procedure
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