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National Coverage Analysis (NCA) Tracking Sheet for Artificial Hearts (CAG-00322N)

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CMS has a longstanding noncoverage policy regarding the use of artificial hearts when used as a permanent replacement for the human heart or as a temporary replacement for patients awaiting heart transplantation.  These uses are often termed destination therapy and bridge to transplantation. 

An artificial heart is an implanted prosthetic device that replaces the heart.  As part of the artificial heart implantation, a substantial part or all of the biological heart is removed. The artificial heart differs from a ventricular assist device (VAD) which is attached to the intact native heart at the ventricle.  Because the heart remains intact it remains possible for the native heart to recover its function after being assisted by a VAD.  Since the artificial heart requires the resection of the ventricles, the native heart is no longer intact and recovery is not possible. 

SynCardia Systems, Inc.’s CardioWest temporary Total Artificial Heart was approved by the FDA in 2004 for use as bridge to transplantation in cardiac transplant eligible candidates at risk of imminent death from biventricular failure.  SynCardia has submitted a request for CMS to cover artificial hearts when used in accordance with the FDA approval. 

In addition to reviewing the use of artificial hearts as bridge to transplantation as requested by SynCardia, CMS will review other indications for which artificial hearts are approved for use by the FDA.  CMS is aware of one other artificial heart currently on the market, through an humanitarian device exemption.  Therefore, CMS initiates this national coverage analysis for the artificial heart when used for bridge to heart transplantation and for destination therapy. 

In particular, CMS is interested in public comments that relate to the following:

1) Medical evidence (e.g., published, peer-reviewed articles) about artificial hearts when used for bridge to transplantation or destination therapy

2) Hospital requirements (staffing, equipment, experience, transplant status, etc.)

3) Surgeon and team training requirements (proctoring, experience, etc.)
Prosthetic Devices
Requestor Name(s):  SynCardia Systems, Inc.
Requestor Letter(s):  View Letter
Formal Request Accepted and Review Initiated:  08/01/2007
Expected NCA Completion Date:  05/01/2008
Public Comment Period:  08/01/2007 - 08/31/2007
Proposed Decision Memo Released:  02/01/2008
Proposed Decision Memo Public Comment Period: 02/01/2008 - 03/02/2008 
Decision Memo Released:  05/01/2008
Comments for this NCA::  View Public Comments
Lead Analyst(s): 
  • JoAnna Baldwin
Lead Medical Officer(s): 
  • Madeline Ulrich, MD, MS
August 1, 2007

CMS opens this reconsideration of the NCD on the artificial heart. The formal request is to remove the current non-coverage for artificial heart and to cover the artificial heart when used in accordance with its FDA approval. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.

Instructions on submitting comments can be found at http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage.
November 14, 2007

Posted comments [PDF, 10MB] received.

View comments received through the website.
February 1, 2008

The proposed decision memorandum is now available for 30 days of public comment. The comment period will end on March 2, 2008.

To submit a comment, please use the orange "comment" button at the top of the page.
March 24, 2008

Posted comments [PDF, 5MB] received.

View comments received through the website.
May 1, 2008 The final decision memo is now posted.
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