Artificial Hearts and Related Devices
VADs used for support of blood circulation postcardiotomy are covered only if they have received approval from the FDA for that purpose, and the VADs are used according to the FDA approved labeling instructions. Since there is no authoritative evidence substantiating the safety and effectiveness of a VAD used as a replacement for the human heart, Medicare does not cover this device when used as an artificial heart.
All of the following criteria must be fulfilled in order for Medicare coverage to be provided for a VAD used as a bridge to transplant:
05/1986 - Specified that artificial hearts not covered, either as permanent replacements or as temporary life-support systems. Also, ventricular assist devices (VADs) not covered when used as temporary life-support systems in patients awaiting heart transplants. Effective date 05/19/1986. (TN 7)
10/1993 - Provided coverage of FDA-approved VAD only when used in patients suffering from postcardiotomy ventricular dysfunction. Device intended for short use and not covered when used as bridge to cardiac transplantation. Effective date 10/18/1993. (TN 65)
11/1995 - Removed words "not covered" from title, and allowed exceptions for use of HeartMate IP LVAS for use as bridge to cardiac transplantation. Effective date 01/22/1996. (TN 82)
04/1997 - Clarified that VADs covered only if FDA approval received and used according to FDA-approved labeling instructions. Also deleted specific product names and hemodynamic criteria. Effective date 05/05/1997. (TN 94)
12/2000 - Allowed sites other than Medicare approved heart transplant centers to implant VADs in patients who are approved and listed as candidates for heart transplant by a Medicare approved heart transplant center. Also, implanting site must receive written permission from Medicare approved heart transplant center under which patient is listed prior to implantation of VAD. Effective and implementation dates 01/01/2001. (TN 134) (CR 1378)
This NCD has been or is currently being reviewed under the National Coverage
Determination process. The following are existing associations with NCAs, from the National
Coverage Analyses database.