By Virgil Dickson | June 1, 2018
The CMS is considering
paying for a type of brain stimulation therapy for Medicare beneficiaries
suffering from treatment-resistant depression.
Vagus nerve stimulation (VNS) therapy involves implanting a battery-powered neurostimulator in a patient's skull to send mild pulses of electrical energy to the brain.
VNS therapy costs up to $30,000 per person in the U.S., according to Inkwood Research, a Boston-based research firm. This includes the cost of the device itself, surgery and other hospital charges.
As many as 5 million people have treatment-resistant depression, according to the National Institute of Mental Health.
The CMS had previously paid for VNS in depression patients starting in 1999. But the agency eliminated the coverage in 2007 due to insufficient evidence showing VNS successfully treated their symptoms.
LivaNova, a medical device company that manufactures a VNS product, sent a formal request for coverage late last year. It cited a March 2017 study published in the American Journal of Psychiatry that showed patients with treatment-resistant depression who were treated with vagus nerve stimulation as well as medication and therapy had better outcomes than those who received just drugs and therapy.
"These patients are in desperate need of treatment options and we believe that the weight of scientific evidence provided in this formal request for reconsideration supports coverage of VNS therapy as a treatment option," LivaNova officials said in a letter.
The CMS will accept comments on the request until June 29. It plans to issue a proposed decision by November and finalize its decision by next February.
Vagus nerve stimulation (VNS) therapy involves implanting a battery-powered neurostimulator in a patient's skull to send mild pulses of electrical energy to the brain.
VNS therapy costs up to $30,000 per person in the U.S., according to Inkwood Research, a Boston-based research firm. This includes the cost of the device itself, surgery and other hospital charges.
As many as 5 million people have treatment-resistant depression, according to the National Institute of Mental Health.
The CMS had previously paid for VNS in depression patients starting in 1999. But the agency eliminated the coverage in 2007 due to insufficient evidence showing VNS successfully treated their symptoms.
LivaNova, a medical device company that manufactures a VNS product, sent a formal request for coverage late last year. It cited a March 2017 study published in the American Journal of Psychiatry that showed patients with treatment-resistant depression who were treated with vagus nerve stimulation as well as medication and therapy had better outcomes than those who received just drugs and therapy.
"These patients are in desperate need of treatment options and we believe that the weight of scientific evidence provided in this formal request for reconsideration supports coverage of VNS therapy as a treatment option," LivaNova officials said in a letter.
The CMS will accept comments on the request until June 29. It plans to issue a proposed decision by November and finalize its decision by next February.
Virgil Dickson reports from
Washington on the federal regulatory agencies. His experience before joining
Modern Healthcare in 2013 includes serving as the Washington-based correspondent
for PRWeek and as an editor/reporter for FDA News. Dickson earned a bachelor's
degree from DePaul University in 2007.
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