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January 2017

The Problem of Funding Off-label Deep Brain Stimulation: Bait-and-Switch Tactics and the Need for Policy Reform

Author Affiliations
  • 1Center for Movement Disorders and Neurorestoration, University of Florida, Gainesville
  • 2Department of Neurology, Georgetown University Medical Center, Washington, DC
  • 3Department of Neurology, University of Florida College of Medicine, Gainesville
JAMA Neurol. 2017;74(1):9-10. doi:10.1001/jamaneurol.2016.2530

Deep brain stimulation (DBS) is currently approved by the US Food and Drug Administration to treat Parkinson disease, essential tremor, and dystonia. However, so-called off-label use of DBS may be permissible under research-based or compassionate use guidelines to treat severe, medication-refractory cases of other neurological and psychiatric disorders such as Tourette syndrome and obsessive-compulsive disorder.

While affording promising outcomes, DBS surgery and its associated postoperative care is expensive. Mean initial surgical costs are US $65 000 per patient, and battery replacements can add an additional $10 000 to $20 000 in costs during the first 36 months postimplantation (depending on brain target and amount of electricity required).1 These costs can be daunting because governmental and commercial insurance providers are reluctant to subsidize off-label therapies. Coverage depends on preauthorization requests that require exhaustive documentation of a patient’s medical history and peer-to-peer review with an insurance provider’s medical director.

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