LivaNova PLC (LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today issued a statement in regard to the U.S. Centers for Medicare & Medicaid Services’ (“CMS”) publication of a tracking sheet to reconsider its National Coverage Determination (“NCD”) for the Company’s Vagus Nerve Stimulation Therapy® (“VNS Therapy”) System for Treatment-Resistant Depression (“TRD”):
LivaNova has been engaged with CMS on this important issue and submitted a letter to CMS requesting a formal reconsideration of the NCD for VNS Therapy for patients with TRD. 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. The posting of the National Coverage Analysis (“NCA”) tracking sheet has opened the 30-day public comment period. Interested parties may comment on the NCA tracking sheet until June 29 as CMS brings greater attention to this important public health issue. Over the last decade, a significant body of new evidence has emerged showing that the addition of VNS Therapy is effective in reducing symptoms in patients with TRD. We look forward to working with CMS as they consider a change in Medicare coverage.
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London, LivaNova has a presence in more than 100 countries worldwide. The Company currently employs more than 3,500 employees. LivaNova operates as two business franchises: Cardiac Surgery and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.A.), respectively.
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