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.)