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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).
Rossi PJ, Machado A, Okun MS. Medicare Coverage of Investigational DevicesThe Troubled Path Forward for Deep Brain Stimulation. JAMA Neurol. 2014;71(5):535-536. doi:10.1001/jamaneurol.2013.6042