Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

CMS Proposes National Noncoverage Of VNS Therapy For Depression

This article was originally published in The Gray Sheet

Executive Summary

CMS plans to reject Cyberonics' request for national Medicare coverage of its VNS therapy for treatment-resistant depression, an action that would also end the firm's ability to seek coverage from local Medicare carriers

You may also be interested in...



CMS denies coverage for VNS Therapy depression indication

Medicare agency issues national noncoverage determination for Cyberonics' VNS Therapy vagus nerve stimulation implant for treatment resistant depression (TRD) on May 4. The action follows a Feb. 5 noncoverage proposal (1"The Gray Sheet" Feb. 12, 2007, p. 10). The agency "has determined that there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment resistant depression," CMS says. Last July, Cyberonics had requested coverage for TRD patients who either have been previously treated with or have refused treatment with electroconvulsive therapy, or have been previously hospitalized for depression. As a result of the depression reimbursement setback, Cyberonics has elected to refocus on its core business - which is centered on VNS Therapy's epilepsy indication...

CMS denies coverage for VNS Therapy depression indication

Medicare agency issues national noncoverage determination for Cyberonics' VNS Therapy vagus nerve stimulation implant for treatment resistant depression (TRD) on May 4. The action follows a Feb. 5 noncoverage proposal (1"The Gray Sheet" Feb. 12, 2007, p. 10). The agency "has determined that there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment resistant depression," CMS says. Last July, Cyberonics had requested coverage for TRD patients who either have been previously treated with or have refused treatment with electroconvulsive therapy, or have been previously hospitalized for depression. As a result of the depression reimbursement setback, Cyberonics has elected to refocus on its core business - which is centered on VNS Therapy's epilepsy indication...

Interim Postmarket Data Release May Compromise Trials – FDA Panel

Members of FDA's Neurological Devices Panel questioned the wisdom of asking sponsors to present interim results of ongoing post-approval trials during a meeting Jan. 26

Latest Headlines
See All
UsernamePublicRestriction

Register

MT024479

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel