Focused ultrasound has the potential to improve the quality of life and decrease the cost of care for many patients suffering with essential tremor. For this potential to be realized, focused ultrasound must be widely adopted as a standard of care, which requires evidence of safety and efficacy and sufficient reimbursement to allow healthcare institutions to acquire the equipment and train physicians to use it.
Robust evidence of safety and efficacy of focused ultrasound to treat certain patients with essential tremor has been achieved through a clinical trial, the results of which served as the basis for the July 2016 FDA approval for this indication. The study’s final data were published in the New England Journal of Medicine in August 2016.
While the level of reimbursement currently approved by CMS is less than desired by the neurosurgical community, it is hopefully sufficient to allow adequate numbers of patients to be treated during the next two years to generate the cost data that will allow CMS to adjust the level of payment.
Focused ultrasound to treat essential tremor is the first brain disorder to be approved by the FDA and the first to be reimbursed by Medicare. These approvals serve as the predicate to treat other brain indications including tumors, epilepsy, Parkinson's disease, and reversibly opening the blood brain barrier to enable delivery of a range of cutting-edge therapies for a variety of other neurological disorders that are in earlier stages of research and development.
We anticipate Medicare reimbursement for patient treatments will be available after the first of the year.