LivaNova Recognizes Final Decision from the U.S. Centers for Medicare & Medicaid Services Regarding National Coverage Determination for VNS Therapy for Treatment-Resistant Depression

LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today recognized that the U.S. Centers for Medicare & Medicaid Services (CMS) finalized its National Coverage Determination (NCD) for the LivaNova Vagus Nerve Stimulation Therapy (VNS Therapy) System for Treatment-Resistant Depression (TRD). Per its final decision, CMS has modified the NCD for VNS Therapy for TRD to include feedback received during the comment period in a manner that aligns the Coverage with Evidence Development (CED) framework with current indications and standard of practice for clinical study design in this disease state. This final decision initiates coverage for Medicare beneficiaries through CED when offered in a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year, as well as the coverage of VNS Therapy device replacement. The CED also includes the possibility to extend the study to a prospective longitudinal study.

“As part of our commitment to improving the lives of patients around the world, LivaNova requested that CMS formally reconsider coverage for VNS Therapy for Treatment-Resistant Depression,” said Damien McDonald, Chief Executive Officer of LivaNova. “We applaud CMS for taking this considerable step to provide increased access to treatment through Coverage with Evidence Development. We are pleased that CMS has expanded the potential beneficiaries of this therapy by including patients with bipolar disorder, an important and underserved patient population. Further, CMS expanded its research questions to include response to treatment, providing a much better gauge of benefit in this very ill patient population. Overall, this decision will help the large number of people who suffer from TRD receive access to an affordable, potentially life-altering treatment option.”

In October 2017, LivaNova submitted a letter to CMS requesting a formal reconsideration of the NCD for VNS Therapy for TRD. In May 2018, CMS accepted the request and published a tracking sheet to initiate a national coverage analysis and opened a public comment period, marking the first time CMS had opened the NCD in 10 years. In November 2018, CMS released a Proposed Decision Memo proposing to cover VNS devices that are approved by the U.S. Food and Drug Administration for TRD through CED. After another public comment period, CMS issued its Final Decision Memo today.