LivaNova PLC has initiated a process with the U.S. Centers for Medicare and Medicaid Services $(CMS)$ to reconsider national Medicare coverage for its VNS Therapy™ in unipolar patients with treatment-resistant depression $(TRD.UK)$. This development marks a significant step in LivaNova's efforts to secure broader access to this therapy. The reconsideration request is backed by strong 24-month clinical outcomes from the RECOVER study, demonstrating the durability and effectiveness of VNS Therapy. Five critical articles analyzing primary and select secondary endpoint data from the study have been published or accepted by peer-reviewed journals, fulfilling the Coverage with Evidence Development (CED) requirement for publicly accessible results. This comprehensive data presentation aims to support the company's submission for coverage reconsideration by CMS.
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