Will CMS Reverse Its Stance on LivaNova & #039;s VNS for Depression?

A device that previously received an unfavorable coverage decision for treatment-resistant depression from the Centers for Medicare & Medicaid Services will get a second shot after more than a decade. CMS said it will reconsider its national coverage determination for LivaNova's Vagus Nerve Stimulation (VNS) Therapy for treatment-resistant depression (TRD). LivaNova's implantable VNS devices are FDA approved for both drug-resistant epilepsy and treatment-resistant depression, but CMS currently only covers VNS for drug-resistant epilepsy. Although the outcome of the reconsideration process remains to be seen. At least two analysts think the agency will most likely provide coverage with evidence development, which would make VNS available to patients enrolled in a registry. London-based LivaNova said it has been engaged with CMS on this issue and submitted a letter requesting a formal reconsideration of the coverage decision. "The company is encouraged that CMS has taken this initial step, which may provide access to this important therapy for TRD that has been a Medicare non-covered indication for more than a decade. A change in the Medicare coverage status of VNS Therapy for TRD that ensures adequate patient access to this important therapy would be a positive outcome for patients and physicians." VNS is a type of brain stimulation therapy that uses a small battery-powered generator, similar to a pacemaker, to send mild pulses of electrical energy to the brain. An ex...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news