November 2018 issue
November 30, 2018 | LivaNova plc, the London, U.K. manufacturer of vagus nerve stimulation systems, expressed optimism after the U.S. Centers for Medicare & Medicaid Services announced a proposed decision memo regarding its national coverage determination for the company’s VNS therapy for treatment-resistant depression. Within the memo, CMS proposes to change the NCD for VNS therapy for TRD to expand Medicare coverage. CMS could initiate coverage for Medicare beneficiaries through Coverage with Evidence Development when offered in a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year, with the possibility of extending the study to a prospective longitudinal study.
LivaNova intends to commence a clinical study that meets these requirements, once the NCD decision is finalized by CMS on or before Feb. 17, 2019. LivaNova said that it remains committed to providing additional treatment options for patients with depression and finds the proposed decision memo from CMS to be a positive step toward increased access to important therapies for these patients. 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 chronic or recurrent depression. With the release of its memo, CMS opened a 30-day public comment period. LivaNova encourages interested parties to comment on the proposed decision memo by Dec. 19, 2018 to be considered by CMS. All relevant information related to this process is available on the CMS website.
