May 2014

Medicare Coverage of Investigational DevicesThe Troubled Path Forward for Deep Brain Stimulation

Author Affiliations
  • 1Center for Movement Disorders and Neurorestoration, University of Florida, Gainesville
  • 2Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio

Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Neurol. 2014;71(5):535-536. doi:10.1001/jamaneurol.2013.6042

Medicare coverage plays an important role in innovative device-based therapy in a market with increasing medical device costs and scarce financial resources. In January 2014, the Centers for Medicare and Medicaid Services (CMS) implemented changes to coverage policies for items and services associated with investigational device exemption (IDE) studies.1 Medicare’s changes centralize coverage decisions and establish 10 new ethical and scientific criteria for coverage determination. Despite revision, current policies risk curbing the advancement of an innovative treatment known as deep brain stimulation (DBS).

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