Organ transplantation criteria represent insurer dilemma.

In its simplest form, technology assessment, as used for coverage decision making, involves an analysis of published data regarding the safety and effectiveness of a technology, either on its own merits or in comparison with a competing technology. However, while the medical literature, and thus technology assessments, typically focus on a well-defined population, a positive coverage policy almost immediately creates pressure for broadening patient selection criteria. A variant on this phenomenon is the patient selection criteria for organ transplantation. These criteria are based not only on the scientific merits of the procedure but also on frequently ill-defined notions of the most appropriate allocation of a scarce resource, which in turn is determined by supply and demand at individual transplant centers.

In these cases, the payer may defer to the patient selection criteria of the individual transplant center. However, the situation arises when a patient, rejected at one transplant center, "shops" and finds another center that has more favorable selection criteria. How, then, can the payer resolve these discrepancies and establish consistent policy guidelines? Should allocation of scarce donor organs be part of a technology assessment and coverage decision? The case of liver transplantation will be used here to illustrate the insurer's dilemma.

In the early days of liver transplantation, patients with primary liver cancer were considered ideal candidates from a purely technical point of view. In contrast with patients with cirrhosis, these patients have more normal sized livers, are in good physical shape, and do not have associated bleeding problems. Although their liver transplantations are technically successful, these patients often succumb to recurrent tumor. The five-year survival of transplant recipients with liver cancer is around 35 percent, in contrast to an approximately 70 percent survival rate for liver transplant recipients as a whole. Faced with an organ donor shortage, some transplant centers are reluctant to accept these patients.

Should payers adopt the same policy and thus implicitly participate in the role of allocator of scarce resources? If so, the basis of denial on the part of an insurer is murky. Insurers typically make coverage decisions on the basis of medical necessity and/or a procedure's investigational status, not on the basis of the relative merits of allocating scarce resources. In oncology circles, a 35 percent success rate in patients with a dire disease with no other curative treatment options, such as hepatoma, would be cause for celebration. An increasing number of insurers are now providing coverage for high-dose chemotherapy and autologous bone marrow transplant for patients with metastatic breast cancer. Although long-term survival rates are not yet available, the overall cure rate for these treatments is probably less than the cure rate for liver transplant recipients with hepatoma.

Transplant policies for patients with hepatitis B are similarly variable. In patients who are antigen-positive, recurrent disease is the rule. At the University of Pittsburgh liver transplant program, the five-year survival rate of transplant recipients with antigen-positive hepatitis B is 45 percent, compared to 63 percent in recipients who are immune to the virus. Many institution offered liver transplants to patients with hepatitis B when there were fewer transplant programs and thus a larger supply of donors per program. Now, the scarcity of donors has prompted transplant institutions to rethink their patient selection criteria, and some institutions no longer accept patients with antigen-positive hepatitis B.

The patient selection criteria may reflect not only the scarce supply of donors but also the research agenda of some transplant programs. For example, in past years, the University of Pittsburgh has transplanted some 700 livers annually, but this figure has decreased to about 350 transplants because of the growing number of institutions that offer liver transplantation in the University of Pittsburgh's procurement areas. Institutions that enjoy a relative local monopoly on donors have not been forced to make such choices. If an insurer accepts the University's criteria, to a certain extent it is implying that Pittsburgh's local organ supply problem can be extrapolated to all transplant centers.

Politics also plays a role in the development of an institution's selection criteria. Patients rejected at Institution X may be accepted at Institution Y because Institution Y is interested in maintaining an adequate volume of transplants. A patient may be rejected at Institution X because that institution is interested in accepting good prognosis patients in order to improve its survival statistics and thus become a candidate for an insurer's Institute of Excellence program.

How, then, are payers supposed to sift through all these variables and come up with some consistent policy toward liver transplantation? While many aspects of liver transplantation may be considered investigational, it is unlikely that insurers will stop paying for what was considered a benefit in the past. Furthermore, the investigational status is not based on a lack of data - the five-year survival rate of various categories of liver transplants is known - but is primarily a function of scarce organs. If organs were plentiful, liver transplantation for antigen-positive hepatitis B and hepatoma probably would be considered standard therapy.

Institutes of Excellence serve a variety of purposes - increasing the number of patients receiving services from a select group of institutes increases volume and thus theoretically improves the quality of care and the increased volume then makes possible a discounted fee arrangement. Another possible role for an Institutes of Excellence program is that it would enable insurers to delegate the difficult issue of patient selection criteria to a limited number of institutions and to minimize patient "shopping." Such an approach would represent a compromise. A national consensus from the transplant community regarding appropriate patient selection criteria would be ideal, but there is no mechanism currently available to produce a national consensus from varying local factors. If Institutes of Excellence are a compromise solution, insurers must thoroughly understand the institutes' patient selection criteria and the local factors that drive them.

Elizabeth Brown, MD is Director, Technology Assessment, Aetna Health Plans, Aetna Life and Casualty, Chicago, Ill. The opinions expressed in this article are those of the author and not necessarily those of Aetna Health Plans.