LivaNova PLC (NASDAQ:LIVN) Files An 8-K Other EventsItem 8.01 Other Events
On May 30, 2018, the Centers for Medicare & Medicaid Services (“CMS”) published a tracking sheet to reconsider the National Coverage Determination (“NCD”) for LivaNova PLC’s (“LivaNova” or the “Company”) Vagus Nerve Stimulation Therapy® (“VNS Therapy”) System for Treatment-Resistant Depression (“TRD”).
This decision by CMS follows LivaNova’s submission of a letter to CMS requesting a formal reconsideration of the NCD for VNS Therapy, NCD 160.18, specifically for TRD. 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.
The posting of the National Coverage Analysis (“NCA”) tracking sheet, https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=292&TimeFrame=7&DocType=All&bc=AAAAIAAAQAAA&, 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.
Following the 30-day comment period and up to six months later, CMS will release a Proposed Decision Memorandum. The proposed decision could result in any of the following possibilities or variations thereof:
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1. |
CMS may confirm its NCD |
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2. |
CMS may reverse its NCD |
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3. |
CMS may remove the national non-coverage language from its NCD and allow its local Medicare Administrative Contractors (“MACs”) to make coverage decisions |
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4. |
CMS may use a coverage with evidence development (“CED”) framework to expand coverage for patients with TRD while additional evidence is being collected |
Once the Proposed Decision Memorandum is released, CMS will open another 30-day public comment period, after which, the agency will render a final decision on the NCD for VNS Therapy for TRD.
Item 9.01 Financial Statements and Exhibits
(d)Exhibits.
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Exhibit |
Description |
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99.1 |
Press Release issued by LivaNova PLC dated May 30, 2018 |
EXHIBIT INDEX
LivaNova PLC ExhibitEX-99.1 2 ex991pressreleasemay302018.htm LIVANOVA PRESS RELEASE Exhibit EXHIBIT 99.1NEWS RELEASELivaNova Comments on the U.S. Centers for Medicare & Medicaid Services’ Reconsideration of its National Coverage Determination forVNS Therapy for Treatment-Resistant DepressionLondon,…To view the full exhibit click here
About LivaNova PLC (NASDAQ:LIVN)
LivaNova PLC is a medical technology company. The Company operates through three segments: Cardiac Surgery, Cardiac Rhythm Management (CRM) and Neuromodulation. The Cardiac Surgery business unit is engaged in the development, production and sale of cardiovascular surgery products, including oxygenators, heart-lung machines, perfusion tubing systems and systems for autotransfusion and autologous blood washing. The CRM business unit develops, manufactures and markets products for the diagnosis, treatment and management of heart rhythm disorders and heart failure. CRM offers products, including leads and delivery systems, and information systems. The Neuromodulation business unit designs, develops and markets neuromodulation-based medical devices for the treatment of epilepsy and depression. Through the Neuromodulation business unit, the Company markets its implantable VNS Therapy systems that deliver vagus nerve stimulation therapy for the treatment of epilepsy and depression.
