LivaNova touts CMS reconsideration of VNS therapy treatment for TRD

LivaNova (NSDQ:LIVN) today announced that the US Centers for Medicare & Medicaid Services are reconsidering a National Coverage Determination covering the use of vagus nerve stimulation technology for treating treatment-resistant depression. CMS last considered covering VNS treatment for TRD in 2007, but declined the coverage due to “insufficient evidence.” “In 1999, CMS established coverage of vagus nerve stimulation for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. In 2007, CMS reconsidered the NCD and determined that, at that time, there was insufficient evidence to conclude that vagus nerve stimulation was reasonable and necessary for treatment resistant depression, and VNS for TRD was therefore non-covered,” CMS wrote in its newly posted tracking sheet. The agency is now reconsidering coverage at the urging of LivaNova, who recommended it based on a wealth of new data which emerged since CMS last declined covering VNS treatment for TRD. “In the intervening years since the NCD was considered in 2007, a significant body of new evidence has emerged about TRD and the role of VNS Therapy in its treatment. This compelling new evidence addresses the concerns expressed by the Centers for Medicare and Medicaid Services,” LivaNova wrote in its letter to CMS. LivaNova goes on to provide evidence it believes supports reconsideration of VNS therapy for TRD “as re...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Neurological LivaNova Source Type: news