Deep-brain stimulation has proven to be one of the most successful technologies for treating neurological diseases and disorders. As we report on page 1 of this issue, there are several efforts underway to develop alternatives to DBS that would minimize surgical risks or eliminate the implantation process required for today’s devices.
This goal is laudable, in our view, but it should not interfere with ongoing clinical and research work with DBS, which promises to treat a wide range of new indications in the years ahead. Indeed, we should be expanding accessibility to DBS therapies. Unfortunately, there are still barriers—most notably, regulatory and reimbursement—confronting clinicians and patients who want to use DBS.
In a recent issue of JAMA Neurology, Michael Okun from the University of Florida and his colleagues argued that unfair practices by health insurers are interfering with off-label use of DBS. “Even when medical necessity has been documented and coverage preapproved, third party payers often refuse to reimburse the costs of off-label DBS, and notification of nonpayment frequently occurs after the procedure has been implemented,” the authors wrote. “Most commonly, payers deny reimbursement by referring to the terms and conditions of the policy: most policies in the U.S. stipulate that coverage of humanitarian or investigational therapies is provisional and may be covered on a discretionary basis.”
The authors shared their experience of 18 off-label lead placement procedures and 56 IPG or battery replacements during the previous 10 years, for conditions such as Tourette’s, Alzheimer’s, or OCD. Not counting the procedures covered by research grants, 72 percent of lead implantations and 63 percent of IPG procedures were denied reimbursement, despite preapproval in all cases. More than half of those denials were from government insurance providers. The financial uncertainty caused by this “bait and switch” process imposes significant burdens on patients and clinicians and hinders clinical trials that could help further our understanding of neurological diseases and new therapies to treat them.
Meanwhile, a pilot study of DBS for early-stage Parkinson’s disease reported by Vanderbilt University investigators at the meeting of the American Neurological Association showed that patients receiving DBS performed better over a period of several years. Yet the FDA still limits on-label DBS for PD for a period of several years after onset of symptoms.
Clearly, there is much to gain by expanding, not limiting, access to DBS for treatment of neurological disorders. Regulators and reimbursement agencies should recognize the value these therapies can offer to medicine and to neuroscience in the future.
Editor and Publisher