Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

CMS Proposes Coverage With Evidence Development For Artificial Hearts

This article was originally published in The Gray Sheet

Executive Summary

CMS is proposing to pay for artificial hearts for the first time in 22 years, but only in certain clinical trials

You may also be interested in...



SynCardia Gets More Payment For Artificial Heart, Seeks To Grow Market

Having recently gained improved reimbursement for its CardioWest artificial heart, SynCardia Systems says its plans to make the device more portable could quadruple sales within two years of a U.S. introduction

SynCardia Gets More Payment For Artificial Heart, Seeks To Grow Market

Having recently gained improved reimbursement for its CardioWest artificial heart, SynCardia Systems says its plans to make the device more portable could quadruple sales within two years of a U.S. introduction

Artificial heart CED decision

CMS will nationally cover artificial hearts for patients with end-stage heart failure, but only if they are enrolled in an FDA-approved clinical trial that meets specified criteria, the Medicare agency announces May 1 in a coverage-with-evidence-development 1decision. The CED mirrors a February proposal (2"The Gray Sheet" Feb. 11, 2008, p. 8). The trials must address patient or facility characteristics that affect outcomes, average time to device failure, and/or the generalizability of the trial results to a broader population. The decision, which acknowledges the technology's promise, applies to SynCardia Systems' CardioWest temporary total artificial heart, approved in 2004, and Abiomed's AbioCor implantable replacement heart, approved in 2006. Artificial hearts had been explicitly non-covered by CMS since 1986

Related Content

UsernamePublicRestriction

Register

LL1134478

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