Vagus Nerve Stim Gets New Chance To Prove Its Worth For Depression
The US Centers for Medicare and Medicaid Services loosened its long-running noncoverage policy for vagus nerve stimulation for treatment-resistant depression a little bit, with a tightly controlled coverage-with-evidence-development policy. Device-maker LivaNova hopes to launch a Medicare-covered study later this year.
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LivaNova's RECOVER trial will randomize about 1,000 patients with treatment-resistant depression to either LivaNova’s vagus nerve stimulation therapy or a sham therapy and follow them for at least a year.
The US Centers for Medicare and Medicaid Services' proposed national coverage policy for vagus nerve stimulation for depression would allow coverage only in a randomized controlled trial, stipulating multiple caveats on patient choice and endpoints. Manufacturer LivaNova says it is preparing to launch a qualifying study.
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