Costs and insurance coverage associated with permanent mechanical cardiac assist/replacement devices in the United States.

Each year over 50,000 persons in the United States could potentially benefit from some form of permanent cardiac replacement or assistance. Approximately 7000 of these persons get on the waiting list for a transplant, and 2300 are transplanted. About 2000 patients are reportedly exposed to a mechanical cardiac assist device, most often as a bridge to transplant. The majority of persons who might benefit from cardiac replacement are never referred for treatment and, thus, the number of deaths on the waiting list is a misleading indicator of access to transplantation and overall patient mortality. The total economic burden associated with coronary artery disease and congestive heart failure now exceeds $140 billion each year, with approximately $700 million directly spent on heart transplant procedures alone. If a viable total artificial heart is devised to replace a failed heart, or a ventricular assist system to permanently assist a failing heart, direct aggregate expenditures alone are likely to be somewhere between $5.4 and $24.0 billion annually. Based on individual patient care costs, as well as aggregate national expenditures, insurers will be reluctant to pay for the permanent use of such devices, even though cost is reportedly not a consideration in coverage decisions. Today, medical benefits and added value are concepts that will shape the coverage determination process, as will increasingly liberal policies regarding payment for treatment costs in relationship to clinical trials. Nonetheless, resource allocation and rationing decisions loom large as strange "characters at play" on an international economic "stage," while being "directed" by worldwide health care needs.