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Medicare Coverage of Investigational Devices:  The Troubled Path Forward for Deep Brain Stimulation

P. Justin Rossi, BA1; Andre Machado, MD, PhD2; Michael S. Okun, MD1
[+] Author Affiliations
1Center for Movement Disorders and Neurorestoration, University of Florida, Gainesville
2Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio
JAMA Neurol. 2014;71(5):535-536. doi:10.1001/jamaneurol.2013.6042.
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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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