for as many transplant recipients as possible is the new challenge for the next century.
The interest of the federal government in solid organ transplantation dates back to 1972, when passage of the Social Security Amendments authorized Medicare entitlements for patients with end stage renal disease (ESRD) and included funding for kidney transplantation. At the time, for most patients, dialysis was considered optimal therapy.3 Subsequent clinical developments led to a marked shift in the scientific underpinnings of the Medicare ESRD program, as data ever more convincingly confirmed the benefits of transplantation relative to dialysis. Medicare policies evolved to keep pace with these technological changes. However, recent clinical advances have again tilted the balance away from scientific and economic symmetry, particularly regarding issues related to long-term graft survival. In addition, funding considerations have previously focused only on kidney disease through the ESRD entitlements but in recent years, advances in transplantation of other solid organs have meant that recipients of other types of transplants are also affected by coverage policies. This changing environment challenges the rationale underlying current Medicare funding of transplantation. In this document, we will explore the scientific and clinical bases for current approaches to transplantation, and their relationship to other therapies (notably dialysis, for patients with ESRD). Successful transplantation has become inseparably linked to pharmacological immunosuppression that must be maintained for the life of the graft. By limiting payment for immunosuppressive drugs, current policies not only place a heavy burden on Medicare beneficiaries who have received transplants but continue to reflect the early impression that transplantation and pharmacological immunosuppression are temporary interventions.
In 1963, future Nobel laureate Joseph Murray noted: “At present there is good evidence that chemical suppressive agents may be temporarily effective, [but] many questions remain unsolved. The eventual status of these homografted kidneys, the length of time for which the drug must be continued, whether or not the possibility for rejection diminishes with the passage of time and whether the original kidney disease will develop in the homograft are all unsolved problems. The total immunological potential of the host is not known when one is considering the course of his future lifetime. However, this report permits a note of cautious optimism in a problem that 10 years ago was considered almost insoluble.”4
Transplantation has evolved in a very short time from a spectacular, experimental procedure to a commonplace event. Patients who previously faced near-