Published online by Cambridge University Press: 10 March 2009
From the perspectives of coverage and reimbursement, heart transplantation has been a serious concern of policymakers in the U.S. since 1980, the year it was decided that a comprehensive study was required before the Health Care Financing Administration (HCFA), the federal agency responsible for the administration of the Medicare program, would be able to decide the status of the procedure (14;15;30;35). It was well acknowledged that the issues surrounding this decision were complex and that initial attempts to resolve the underlying coverage issue seemed to be too narrowly construed. It was at this time that the late Patricia Roberts Harris, then Secretary of the Department of Health and Human Services (DHHS), declared that DHHS would require new technologies to pass muster on the basis of their “social consequences” before “financing their wide distribution” (30). In a very special sense, although not appreciated at the time, a new era of health care technology assessment was ushered in, as Harris proclaimed that the then-conceived study of heart transplantation should serve as the “prototype” of technology assessment.