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Kidney Failure and the Federal Government (1991)

Chapter: Access to Kidney Transplantation

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Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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8
Access to Kidney Transplantation

This chapter presents an overview of kidney transplantation in the ESRD program and examines the restrictions of the Medicare entitlement for successful transplant recipients, the distribution of kidneys, and the limited supply of organs. Transplant reimbursement issues are addressed in Chapter 9.

There are a number of issues regarding kidney transplantation that the committee did not address. These include, among others, the performance of organ procurement organizations, the effects of required request on organ donation, and the scoring system for the distribution of organs. The committee focused its attention on a few issues (discussed in Chapters 7, 8, and 9) for two reasons: A large number of other organizations have many of the questions of kidney and other whole-organ transplantation under continuing study; and the rate-limiting factor in making transplantation more available to ESRD patients, as the committee believes it should be, is the shortage of suitable kidneys.

OVERVIEW

Kidney transplantation occupies a unique place in the treatment of ESRD. It is the preferred treatment for a majority of ESRD patients, there are fewer contraindications to transplantation today than ever before, and patient and graft outcomes have improved markedly in the past decade (Eggers, 1988; USRDS, 1990). The availability of donated kidneys, however, has consistently fallen short of both the estimated need and the actual demand for transplantation. Consequently, concerns over equitable distribution of donor kidneys among potential recipients have also been raised in recent years.

Kidney transplantation is the preferred treatment because, when successful, it restores a renal failure patient more nearly to a normal and satisfactory

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

quality of life than does dialysis. It relieves the individual of continued dependence on a machine or on repeated fluid exchanges. Transplant recipients, however, face a continuing threat that the transplanted kidney will be rejected and, therefore, must take immunosuppressive drugs to prevent rejection for the duration of their functioning transplant.

From Medicare's perspective, a successful transplant is cost-effective compared to dialysis. HCFA data show that the annualized Medicare expenditure for a dialysis patient was $32,000. Patients with functioning kidney grafts require a higher first-year per-capita expenditure of $56,000, but they cost Medicare only $6,400 on average in succeeding years. Given certain assumptions about patient and graft survival rates, it has been estimated that the cumulative dialysis and transplantation costs reach a break-even point in about 3 years. From then on transplantation provides a net financial gain to Medicare (P.W. Eggers, HCFA, personal communication, 1990).

Clinically, the reasons for not transplanting an ESRD patient have diminished in the past decade. ESRD patients with diabetes are no longer viewed as poor risks. Today, a diabetic transplant patient does better than a diabetic dialysis patient, but not as well as a nondiabetic transplant patient. Age limits on kidney transplantation have also diminished in clinical importance, although dispute exists about the ethics of using a scarce donated kidney to extend the life of an older ESRD patient when dialysis treatment is available. As an empirical matter, only 193 ESRD patients 65 years of age or older received transplants in 1988 and 178 in 1989 (UNOS, 1990b). This is 2 percent of all kidney transplants, a proportion that is small and likely to remain so.

The number of kidney transplant procedures performed annually has increased from about 3,200 in 1974 to 8,889 in 19891 (HCFA, 1990). These data, broken down by living-donor and cadaver-donor transplants, are shown in Table 8-1. The number of living-donor transplants has been stable, just under 2,000 procedures annually, over an extended period. Cadaver-donor transplants, which grew rapidly before 1986, have leveled off at approximately 7,000.

The number of all kidney transplants grew an average of 5.5 percent per year from 1974 through 1978, then at more than 10 percent annually from 1978 to 1986. Since 1986, however, no growth has occurred, and the numbers have actually decreased slightly. The total numbers of procedures for each year of the 1986-89 period, according to HCFA data, have been 8,976, 8,892, 8,932, and 8,882, respectively. During this time, the outcomes of kidney transplantation, measured by both patient and graft (or transplanted kidney) survival, have improved for living-donor and cadaver-donor transplant recipients (USRDS, 1990). One-year patient survival2 for living-related-donor (LRD) recipients increased from 78 percent in 1980 to 94 percent in 1988; for recipients of cadaver kidneys, the corresponding in

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

TABLE 8-1 Number and Type of Kidney Transplant Procedures (Medicare and Non-Medicare), by Donor Type, 1980–89

Donor

1981

1982

1983

1984

1985

1986

1987

1988

1989

Living

1,460

1,677

1,784

1,704

1,876

1,887

1,907

1,760

1,900

Related

1,704

1,830

Unrelated

56

70

Cadaver

3,445

3,681

4,328

5,264

5,819

7,089

7,060

7,116

6,982

TOTAL

4,905

5,358

6,112

6,968

7,695

8,976

8,967

8,932

8,882

 

SOURCES: HCFA, 1990; P.W. Eggers, HCFA, personal communication, 1990.

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

TABLE 8-2 One-Year Survival of Kidney Transplant Patients 1980, 1984, and 1988

Donor

1980

1984

1988

Cadaver

78.4

87.4

91.0

Living related

78.2

91.8

94.7

NOTE: Adjusted for age, race, gender, and primary diagnosis.

SOURCE: USRDS, 1990.

crease was from 78 percent to 91 percent (Table 8-2). One-year graft survival for living-donor transplants increased from 83 percent in 1980 to 88 percent in 1988; for cadaver transplants, the improvement was from 60 percent to 77 percent (USRDS, 1990). Much of the improved graft survival is attributed to the effectiveness of cyclosporine in preventing the rejection of transplanted kidneys.

How many ESRD patients can potentially benefit from a kidney transplant? Stuart (1984) expressed the view that half the new ESRD patients in 1981 were good transplant candidates, and that improved immunosuppression might increase that figure to 75 percent. Of the over 44,000 new ESRD patients in 1988, nearly 14,000 were 65 years old or over and may be arbitrarily excluded for estimation purposes. If Stuart's assumptions are correct, perhaps 11,000 to 16,000 patients of the remaining 22,300 new ESRD patients might be suitable transplant candidates, well above the current actual number of procedures being performed.

If the estimated need exceeds the available supply, so does the actual demand for kidneys expressed by the length of patient waiting lists. The number of individuals on waiting lists doubled and then trebled in the 1980s from slightly over 5,000 in 1980 to 12,000 in 1987, nearly 14,000 in 1988, and over 16,000 by the end of 1989 (UNOS, 1990b). The 1989 end-of-year waiting list exceeded the total number of 1989 transplant procedures by almost twofold. The relationship between the growing number of wait-listed individuals and the number of transplant procedures is shown in Figure 8-1.

THE MEDICARE KIDNEY TRANSPLANT BENEFIT

Kidney transplantation is governed by two distinct bodies of statutory law. It is covered by Medicare as a treatment for ESRD pursuant to the ESRD provision of the Social Security Amendments of 1972. Medicare reimburses for organ procurement, the transplant procedure, physician fees, and one year of immunosuppressive drugs under this authority, for which HCFA is administratively responsible. In addition, the National Organ Transplant

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

FIGURE 8-1

Kidney Transplantation Procedures and ESRD Patients on Waiting Lists, 1980–88

SOURCE: HCFA, 1980–88.

Act of 1984 (Pub. L. No. 95-292) amended the Public Health Service Act to address the acquisition and distribution of whole organs, including kidneys, through the Organ Procurement and Transplantation Network (OPTN).

The kidney transplant benefit under Medicare has two limitations that may affect access to treatment and patient outcomes. First, the 1972 statute limited the eligibility of patients with successful transplant to 12 months after the procedure, unlike the lifetime entitlement of dialysis patients. This period was extended to 36 months in 1978.

One apparent consequence of the 3-year limit on Medicare eligibility is that nearly 50 percent of the successful kidney transplant recipients who reach the 3-year posttransplant mark have established eligibility for Social Security disability benefits (P.W. Eggers, HCFA, personal communication, 1990). Although more suited to return to work than dialysis patients, they establish and maintain disability status primarily to protect their entitlement to Medicare benefits. The certainty of modest but nontaxable disability benefits reportedly acts as a disincentive to return to uncertain employment, as does employer discrimination.

The second limit on the kidney transplant benefit is that immunosuppressive drugs, which the patient must take to prevent rejection of the transplanted kidney as long as it functions, are currently reimbursed on an outpatient basis for only one year after a successful transplant. These drugs are expensive

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

(Showstack et al., 1990). They were not reimbursed at all until the transplant provisions of OBRA 1986 (Pub. L. No. 99-509) authorized payment for one year, mainly in response to the high cost of cyclosporine. Had the Catastrophic Health Insurance Act of 1988 been implemented, this restriction would have been removed.

In 1990, the American Society of Transplant Surgeons (ASTS, 1990), in response to a request from the Subcommittee on Health and the Environment of the House Committee on Energy and Commerce, surveyed its members to determine the effect of Medicare's limited coverage of immunosuppressive drugs on patient compliance with prescribed drug regimens and on patient outcomes. There were 107 respondents from 84 transplant centers in 36 states and the District of Columbia. Of these 37 states, 2 had programs for full coverage of immunosuppressives, 14 had partial coverage (for all patients), 3 had Medicaid coverage only (for indigent patients), and 15 had no program. Overall, respondents estimated that nearly 47 percent of patients at these 84 centers had experienced difficulty meeting the financial burdens of medication costs. The cost of drugs was regarded as a major cause of noncompliance by nearly 85 percent of the individual respondents; over 80 percent believed that extending Medicare coverage of immunosuppressives beyond the current one year would have major or significant beneficial effect. The ASTS respondents estimated that 143 kidneys had failed because of economic-related noncompliance, although the methods of estimation were not indicated. The findings of this survey, if validated, argue for the removal of this economic barrier to effective medical care.

It is not known to what extent the lack of private health insurance to pay for immunosuppressive medication after the first year deters prospective transplant recipients. Some respondents to the ASTS survey, however, indicated that the prospective financial burden of immunosuppressive drugs had led some ESRD patients to refuse a transplant. The committee also heard anecdotal reports from surgeons who stated that they could not ethically advise a patient to undergo transplantation if he or she could not pay for the medications needed to ensure its success. However, no systematic studies of this issue have been made.

It is necessary to recognize that ESRD is only controlled—not cured—by kidney transplantation. Some transplant recipients later experience failure of the transplanted kidney from a recurrence of the initial disease. All transplant patients remain at risk of rejecting the transplanted kidney throughout their lives, and the drugs they must take to prevent rejection place them at risk of various other medical problems.

Thus transplant patients face a set of predictable and very real needs for medical insurance (Evans et al., 1990). If they lose their Medicare coverage, their transplant status may be regarded as a preexisting condition by prospective insurers and prevent them from obtaining private health insurance except at

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

very high individual rates. Transplant status may also act as a barrier to work by employers apprehensive about the dependability of the individual or their effect on the firm's health insurance premium. The limits of Medicare coverage for necessary medications may impinge on the success of the transplant or act as a disincentive to transplantation itself.

Congress, in Pub. L. No. 95-292 of 1978, the National Organ Transplant Act of 1984, certain provisions of OBRA 1986, the Health Omnibus Programs Extension of 1988, and the Transplant Amendments Act of 1990, has consistently encouraged organ transplantation for more than a decade. The committee endorses these efforts and believes that the Medicare payment system should foster transplantation rather than discourage it.

The committee recommends that Congress eliminate the three-year limit on Medicare eligibility for ESRD patients who are successful transplant recipients and authorize an entitlement equal to that of ESRD patients who are treated by dialysis.

The committee also recommends that coverage of immunosuppressive medications for kidney transplant patients be made coterminous with the period of a patient's entitlement.

The implementation of these recommendations may increase program expenditures in the short run. An estimate of that effect is found as an appendix at the end of this chapter. However, kidney transplantation is more cost-effective than dialysis as a treatment for ESRD. In the long run, the Medicare program should incur lower costs from encouraging kidney transplantation.

DISTRIBUTION OF KIDNEY TRANSPLANTS

The scarcity of organs limits the number of transplant procedures performed, however, and creates two additional access problems: how to equitably allocate a scarce supply of kidneys, and how to increase the supply of donated organs.

The legal and institutional framework for the distribution and supply of kidneys goes beyond that of the ESRD program. In the early 1980s, Congress responded to a number of highly visible cases of individuals, including very young children, who needed either a heart or a liver transplant for continued survival. It enacted the National Organ Transplant Act of 1984, which authorized the creation of the National Task Force on Organ Transplantation; grant assistance to organ procurement organizations (OPOs); establishment on a contract basis of the OPTN; and a scientific registry for organ transplantation; and it outlawed the sale of organs. Congress thus expanded the scope of federal government concern with transplantation be-

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

yond kidneys to other whole organs (especially heart and liver) and to bone marrow transplantation.

The task force recommended coverage of immunosuppressive drugs (Task Force, 1985), the implementation of the OPTN, the establishment of a national system for sharing organs, the consolidation of OPOs, a requirement that hospitals ask all prospective candidates about organ donation as a condition of participation in Medicare, and the creation of a scientific registry (Task Force, 1986). The Health Resources and Services Administration (HRSA) of the Public Health Service (PHS) currently administers the contracts for the OPTN and the scientific registry.

Before the creation of the OPTN, the distribution of donated kidneys was determined by local transplant centers and OPOs on a voluntary basis, and by sharing arrangements among centers. Regional sharing organizations developed, the largest being the Southeast Organ Procurement Foundation (SEOPF). SEOPF originally organized UNOS as a way to permit national participation in its organ-sharing activities by transplant centers across the country.

After Congress authorized the creation of the OPTN in 1984, UNOS was reconstituted separately from SEOPF. It successfully bid on the OPTN contract proposal and has operated the network since 1986. It also successfully bid on the scientific registry. The OPTN, whose rules must be proposed according to ''notice and comment'' procedures and be approved by the Secretary of Health and Human Services (54 Fed. Reg. 51802, December 18, 1989), establishes the policies and procedures for organ sharing and is responsible for devising and operating a system for the equitable distribution of organs.

Ideally, allocation policies ought to reflect the public consensus that donated organs are a national and a community resource that should be given to those most in need and allocated by criteria that are equitable, easily understood, and developed with broad input from all affected constituencies. Current OPTN policies on the sharing of donated organs are determined according to criteria that are first local, then regional, and finally national. This means that the determination of where a donated kidney is to be used is made by the local OPO in conjunction with the transplant centers in its area.

Mandatory national sharing of organs is required, however, under a UNOS/OPTN rule when a six-antigen match or a phenotypic identical match exists between the donor organ and the prospective recipient. The outcomes of sharing based on such matches are so favorable in such cases, but the frequency so low, that mandatory sharing is needed to ensure access to a donated kidney.

Who receives kidney transplants? Data for 1989 (UNOS, 1990b) show the following distribution by age, gender, and race of transplant recipients.

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

TABLE 8-3 Distribution of Kidney Transplants (percent) by Age and Type of Transplant, 1989

Age Group (years)

Living Related

Cadaver

Total

Pediatric (0–18)

16

5

7

19–45

65

58

59

46–64

19

35

31

Elderly (over 65)

0.3

2.5

2

TOTAL

100

100

100

 

SOURCE: UNOS, 1990b.

Pediatric patients (0–18 years) accounted for 16 percent of LRD transplants and 5 percent of cadaver transplants, or 7 percent of the total; the 19–45 age group received 65 percent of LRD transplants and 58 percent of cadaver transplants, for 59 percent of the total; the 46–64 age group received 19 percent of LRD transplants and 35 percent of cadaver transplants, for 31 percent of the total; and those 65 years of age and over accounted for 0.3 percent of LRD transplants and 2.5 percent of cadaver transplants, or 2 percent of the total (Table 8-3). Men comprised 60 percent of transplant recipients in both LRD and cadaver-donor categories. Blacks received 12 percent of the LRD transplants and 22 percent of cadaver transplants, for 20 percent of the total.

Equitable distribution of kidney transplants has emerged as an important issue, especially with publication of a report from the DHHS Office of Inspector General (OIG, 1990) that examined organ distribution practices in the United States. This analysis, based largely on UNOS data on 17,556 individuals in the United States who were awaiting or had received a first kidney transplant between October 1, 1987, and March 31, 1989, addressed the relationship between congressional and executive branch expectations3 and actual practices. The OIG found three significant disparities in the access of individuals to cadaver kidney transplants, related to an individual's race, transplant center, and level of sensitization (reactivity to antigens).

The analysis showed that, on average, blacks waited almost twice as long as whites for their first kidney transplant, the median waiting time being 13.9 months compared to 7.6 months. The longer waiting time for blacks is not confined to a few regions, transplant centers, or procurement organizations, but is widespread. Medical considerations involving blood type, level of sensitization, and age accounted for little of the difference. The reasons for this disparity in waiting time are not known.

Second, transplant centers vary greatly in median waiting time. The time for a first kidney transplant ranged from less than 1 month at one center to

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

71 months at another. Among the 202 centers reviewed by the OIG, the median waiting time for 79 centers was less than 6 months for patients with low sensitization levels; 15 centers had waiting times over 18 months, however, and the other centers fell between. These wide variations existed among centers in the same OPO service area.

Finally, highly sensitized patients (i.e., highly reactive to a wide range of antigens) had considerably less access to donated organs than did others on transplant waiting lists. Their median waiting time was 32.4 months compared with 8.6 months for all others.

The causes of these observed imbalances are only partly understood. Regarding age, the original point system adopted by UNOS in 1987 for allocating organs inadvertently had a negative effect on pediatric ESRD patients by giving points for time on a waiting list; this is now being remedied. Currently, donor kidneys from individuals 10 years old or younger must be offered to prospective pediatric transplant recipients 15 years old or younger. The procuring transplant center may use such a kidney in an adult if no pediatric candidate is available. In 1989, the UNOS Board of Directors asked for an analysis of the points required to ensure that patients under age 10 would receive transplants within 1 year and that those under age 5 would receive transplants within 6 months (UNOS, 1990a).

Gender differences in transplantation rates are not well explained but may be due in part to level of sensitization. Proportionately more women are highly sensitized than men, mainly because of pregnancy, and this could affect waiting times as well as transplantation rates.

Racial differences in kidney transplantation have caused much discussion (Callender, 1989), especially as a result of the OIG's report. Given the importance of the equitable distribution of kidneys, it is worth summarizing the several facets of this complex issue: Black individuals account for 28 percent of the incident ESRD patient population, even though they represent only 12 percent of the U.S. population; their incidence of renal failure is nearly four times that of whites. Regarding kidney transplantation, black ESRD patients represent about 30 percent of those on waiting lists but wait nearly twice as long to obtain a kidney as do whites; they receive over 22 percent of cadaver transplants and 12 percent of LRD transplants (UNOS, 1990b). They donate slightly over 8 percent of cadaver donors (UNOS, 1990b). Finally, aggregate data indicate that the graft survival rate among blacks is lower than that among whites, although a number of major centers report no difference in outcomes. For 1988, one-year cadaveric graft survival (first graft only) was 78 percent among whites and 73 percent among blacks; LRD graft survival was 89 and 87 percent, respectively (USRDS, 1990).

The equity issue arises from the differences between the proportion of blacks in the ESRD population and those receiving a transplant and the

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

longer time blacks wait for a transplant. Regarding the latter, the explanatory hypotheses include "subconscious bias" (AMA, 1990); a UNOS/OPTN organ allocation point scoring system that, until recently, favored sharing when a higher match between donor and recipient antigens existed than when fewer mismatches were present; and economic factors such as income and private health insurance.

The point scoring system warrants further explanation. In 1987, UNOS adopted a point system to determine priorities for allocating organs. This initial system emphasized both the geographic area in which a kidney was procured and the waiting time of the potential recipient. In addition, the system also emphasized human leukocyte antigen (HLA) tissue typing and matching. The immunologic characterization of individuals in terms of HLA at the A, B, and DR loci, however, has been worked out more extensively for the white population than for the black population. Since organ sharing for transplantation depends on this HLA typing system, a partial explanation for longer waiting times, as well as for actual transplant rate differences among races, is that the original UNOS point system favored more thoroughly HLA-characterized individuals, i.e., whites.

The UNOS point scoring system was modified in 1989 to give more weight to the absence of antigen mismatches. In addition, the current contract (No. 240-90-0064) between the DHHS and UNOS, as with the OPTN, calls for a monitoring effort "to identify and explain significant variations in waiting times among racial and ethnic groups" and to promote measures to eliminate such differences. Finally, the Transplant Amendments Act of 1990 called for a study by the General Accounting Office to determine "the extent to which the procurement and allocation of organs have been equitable, efficient, and effective."

In addition to the level of sensitization, the UNOS point scoring system, and race, economic factors have also been suggested as sources of disparities in access to transplantation. However, income and health insurance as economic barriers to transplantation have not yet been adequately addressed. Among the few published studies, Held and co-workers (1988) found that patients treated in predominantly white dialysis units or in units located in high-income counties are almost twice as likely to receive a transplant as patients treated in predominantly black units or those in low-income counties. The units located in the bottom-third income areas having an average annual family income of $16,000 or less in 1983 had an average transplant rate of 6.3 percent. In comparison, the rate for the top third of units by income area (average family income of $23,500) was 9.6 percent. Most important, the association of income with transplantation appears to be independent of race.

Evans and co-workers (1990) recently reported on the insurance status of patients receiving renal transplants. In a sample of 225 transplant patients,

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

they found that 74 percent had private insurance coverage, directly or through their spouses, and 99 percent had either public or private insurance coverage. Although little is known about the adequacy of the coverage, the benefit packages for transplant recipients are consistent with those available to the general population; patients are apparently not excluded from coverage for major services such as outpatient prescription drugs.

A few patients lost private health insurance after transplantation, mostly because of job loss or change. It was unclear what percentage of those losing employment opted for policy conversion from group to individual coverage. Evans and co-workers concluded that the insurance status outlook for the vast majority of kidney transplant recipients was favorable. Not examined, however, was whether the lack of private health insurance acted as a barrier to transplantation.

A study by Dialysis Clinic, Inc.-Cincinnati (DCI-C), a dialysis unit that has a strong commitment to transplantation, compared transplantation and dialysis patients in terms of prior private health insurance (Pollack and Pesce, 1990). Of the 124 patients in the University of Cincinnati Medical Center/DCI-C system on December 31, 1975, 79 were transplant patients and 45 were dialysis patients. Only 10 percent of the transplant patients lacked private health insurance, but over half of the dialysis patients lacked such insurance. Among the 14 new patients who received transplants preemptively (i.e., were not dialyzed before receiving transplants) during the 1976–89 period, all had private health insurance. These data suggest that transplant patients are more likely to have private health insurance than are dialysis patients.

Although no national data are available on the private health insurance status of prospective transplant candidates, it is possible that the availability of private insurance affects the willingness of a prospective patient and of a transplant center to conduct the procedure. This issue, unaddressed and thus unanswered, deserves more study.

The underlying problem of equitable distribution of kidney transplants is to define equity in a way that resolves the conflict between the expected outcome of the transplant procedure and the desired social objective of nondiscrimination. Two issues require continuing attention: that social bias not exclude some individuals; and that rejection as a transplant candidate for legitimate medical factors—such as hypersensitized patients who are likely to reject the transplanted kidneys, AIDS patients, intravenous drug users—not be equated with social discrimination.

The committee believes that the differential distribution of organs by ethnic group, gender, and income should be analyzed by UNOS, HCFA, and HRSA on a continuing basis to determine the reasons for differences in kidney transplant rates and to devise remedies where appropriate.

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

SUPPLY OF DONOR ORGANS

The major factor limiting access to transplantation is the shortage of available kidneys. The annual rate of increase in kidney transplant procedures exceeded 10 percent from 1978 to 1986, but, as indicated earlier, no growth has occurred since 1986. Compared to this historical rate of increase, the "loss" of transplants over the 1987–89 period is approximately 5,900. Had the rate slowed to 5 percent annually, the "loss" would still be over 2,900 procedures. The effect of no growth has been substantial. During this time, the number of individuals on the UNOS-monitored kidney transplant waiting lists increased to 16,360 by the end of 1989 (UNOS, 1990a).

It has long been argued that the number of donated organs falls far short of the potential. Over the years, there have been numerous efforts to estimate the potential supply of organ donors. Among the more frequently cited studies are those of Bart et al. (1981a,b) from the Centers for Disease Control. During the 1975–79 period, Bart and his colleagues conducted two studies. The first was a pilot study in Georgia and the second a multisite study that involved organ procurement in Georgia, Kansas, and Missouri. Using criteria for ideal donors, the CDC estimated that the potential supply of kidney donors in the United States was 43 donors per million population (pmp); using more relaxed criteria of donor acceptability, the CDC estimated a potential of 116 donors pmp. Their most reasonable estimate placed the potential donor supply at 55 pmp.

A commonly cited figure, regarded as overly optimistic on the basis of recent studies, is that of 25,000 potential donors per year (AMA, 1981). A recent study of the brain death and organ donor potential for Pennsylvania estimated that the potential pool was between 38.7 and 55.2 donors pmp, depending on the stringency of criteria of organ suitability. The study estimated that, overall, 32 to 38 percent of all potential donors are realized as actual donors (Nathan et al., 1990). The Kentucky Organ Donation Agency estimated that the statewide potential was 173 for a figure of 48 donors pmp, of which 22 percent were collected in 1990 (Garrison et al., 1990). Each donor, of course, contributes two kidneys, less some loss to various factors. Actual acquisition may be one-third to one-half the potential pool, depending on the estimate of the pool.

What factors may be depressing the supply of organs? There are a number of candidate answers but few conclusive data. The factors that have been suggested include the AIDS epidemic, the advance of trauma care, and improved traffic safety. Most OPOs began rejecting potential donors who were at high risk of AIDs in 1985 and 1986, just as the number of transplants plateaued. Estimates of potential donors denied because of

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

the risk of AIDs are 2 percent by the Tennessee OPO (L. Skelly, Tennessee Donor Services, personal communication, 1990) and 5 percent by the Delaware Valley OPO (Nathan et al., 1990).

Apparently, this results primarily from hospitals using the risk of AIDS to rule out the referral of potential donors to OPOs. Arthur Caplan (University of Minnesota, personal communication, 1990) has estimated 10 to 20 percent of potential donors are eliminated in this manner as a consequence of an expansive interpretation of risk. This range is consistent with similar estimates from San Francisco, Los Angeles, and New York City OPOs. Clearly, a careful assessment of the effects of AIDS on donation is needed.

In the matter of trauma care, 12 states had trauma centers in 1987, whereas 25 states have them today. It is believed that trauma centers save many lives, although the exact numbers are unknown (J. Morris, Vanderbilt University, personal communication, 1990). It has been estimated that advances in trauma care are able to decrease preventable deaths by about 25 percent. It is not clear, however, what effect these advances have had on organ donation.

The effect of traffic safety measures on organ donation is often mentioned but seldom analyzed. The number of traffic fatalities in the United States fell from 51,093 in 1979 to 42,589 in 1983, then increased to 47,087 in 1988; they have remained steady in the 46,000 to 47,000 range since 1986 (DOT, 1990). UNOS, however, is unable to indicate the percentage of donors who are traffic fatalities. At the margin, state and federal legislation on seat-belt use, drunken driving, minimum drinking age, and motorcycle helmet use all have reduced highway fatalities among young people, and thus may have affected the size of the potential donor pool. Air-bag use might also reduce the potential donor pool in future years.

The 55-mph speed limit is believed to have saved 2,000 to 4,000 lives per year. However, it was enacted in 1974 and any negative effects would probably have been realized long ago. If anything, the more recent authorization of a 65-mph speed limit would offset this effect. In 1987, 38 states adopted the 65-mph speed limit, and 2 states adopted it in 1988 (DOT, 1989). In the states that retained the 55-mph speed limit, fatalities remained essentially stable from 1986 to 1988.

What is known about the willingness to donate? Surveys indicate that the public's awareness of transplantation is high, but its enthusiasm for donation is lower, and individuals are more willing to donate a relative's organ than their own (Manninen and Evans, 1985; Evans and Manninen, 1988) (Table 8-4). Although public education is needed to maintain this high level of awareness, such efforts may now need to focus on promoting the discussion of transplantation by families as a way to encourage donation.

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

Table 8-4 Percentage of Responses to Organ Transplantation/Donation Surveys, 1983, 1984, and 1987

 

Year of Public Opinion Survey

Question

1983

1984

1987

Awareness of transplantation

94.0

93.0

98.7

Received information on donation

69.1

N/A

84.1

Willingness to donate own organs

50.0

45.0

49.3

Willingness to donate relative's organs

53.0

85.0

62.5

Carry organ donor card

19.2

17.02

4.6

Approached about organ donation

NA

14.0

14.9

Given consent for organ donation

NA

NA

1.7

NOTE: NA = not available.

SOURCE: Evans and Manninen, 1988.

The public's willingness to donate organs may be influenced by the newspaper and television publicity that transplantation receives. There may be a negative effect of adverse publicity, such as that about anencephalic donation or cross-species transplants (Evans and Manninen, 1988). The news value of organ transplantation may also be of limited or declining interest to newspapers and television. These dramatic procedures received substantial television coverage from 1983 through 1986, as public attention focused on the plight of a small number of individuals, often children. President Reagan made personal pleas for specific individuals, and made Air Force One available in certain notable cases. Network television programs, such as Nightline, 20-20, and the MacNeil-Lehrer Report, covered the drama of transplantation extensively (Rettig, 1989). Data developed by the IOM ESRD study staff suggest that the novelty of organ transplantation may have worn off and that the story may be less newsworthy.4

The attitudes of professional caregivers generally favor donation (Prottas and Batten, 1988). Recent studies, however, show substantial ignorance among neurosurgeons about brain death, a critical factor affecting organ

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

donation which highlights the need for professional education (Youngner et al., 1989).

The hypotheses about why the supply of kidneys has not increased also include the disruptive effects of the policy interventions of the mid-1980s (Rettig, 1989; UNOS, 1990b). These interventions include the implementation of the OPTN; the requirement of a single OPO for each SMA; the requirement that individual OPOs join the OPTN network in order to be reimbursed by Medicare for organ donation costs; the requirement that hospitals establish a written policy ensuring that all prospective donors or their next-of-kin are asked about their willingness to donate organs as a condition of Medicare participation; and complex rules governing the distribution of organs that have been adopted by UNOS.

The requirement that hospitals have written protocols for asking about organ donation, although well intentioned, may have altered the character of the request for organ donation. Cadaver donation involves a complex process between the attending physicians and nurses caring for the recently deceased potential donor, the organ procurement professionals, and the family of the deceased. The initial encounter with the family is critical. It is most effective when made by professionals who show respect to the family and communicate a sensitivity that acknowledges their grief. However, if the requester is uncomfortable or lacks answers to important questions, the result is often refusal. The initial effect of required request appears to be that the process of asking for a donation became a bureaucratic requirement for all hospitals that adversely affected donation. The development of new and productive relationships among all parties is now being worked out (UNOS, 1990b).

Data show that the performance of OPOs varies substantially (UNOS, 1990b). The rate of kidney procurement ranged from 4.1 to 52.1 pmp in 1988, and from 3.7 to 58.0 pmp in 1989; the averages for these years were 30.8 and 30.3 pmp, respectively. Now, substantial attention is being directed to increasing the average rate and raising rates that are below the mean. Within the IOM committee, Held expressed the view that consolidation of multiple OPOs into a single OPO per region reduced competition and depressed the incentive to obtain organs.

OBRA 1986 required that OPOs meet performance standards prescribed by the Secretary of DHHS. The Secretary established a standard that an OPO recover 23 kidneys pmp and transplant 19 patients pmp. In 1988, however, Congress required that each OPO must "reasonably expect to procure organs from not less than fifty donors per year." This 50-donor standard provoked substantial controversy, since it was the basis of Medicare recertification. Congress, in April 1990 (Pub. L. No. 101-274), delayed the requirement until January 1, 1992; then, in OBRA 1990, it repealed the rule and again delegated authority for performance standards to the Secretary.

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

Conclusions and Recommendations

The committee wishes to underline the urgency of increasing the organ donor supply as the central issue in making kidney transplantation available to increasing numbers of ESRD patients. However, numerous changes in the system of organ donation have been made in recent years for the purpose of increasing the supply of organs, and their results have often been disappointing. Renewed efforts to increase the supply of donated organs should be balanced, therefore, by careful design, testing, and data acquisition regarding all proposed interventions, and by extensive professional and public discussion about the social, cultural, and religious values that are involved in donation.

The committee believes that increasing the supply of donated kidneys for transplantation should receive very high priority, both from the medical community and from the federal government. It recommends that the Secretary of DHHS exercise continuing leadership on this matter. The equitable allocation of a scarce supply of organs will proceed more easily if the number to be distributed is increasing.

Many suggestions have been made about how to increase the supply of organs. Public and professional education, recommended consistently over the years, should be continued, but working assumptions should be reexamined and efforts possibly refocused, and the effects on increasing the availability of organs should be monitored closely.

The process by which the families of potential donors are asked to consider donation must be improved. This might involve requiring that hospitals refer potential donors to OPOs, instead of requiring that hospitals make requests to families of potential donors. Thus, access of skilled OPO personnel to prospective donors and their families would be increased.

Living donation should be encouraged, especially from related donors but also in appropriate cases from emotionally bonded unrelated individuals.

Efforts to increase minority donation, especially among the black community, should receive strong support. Attention also should be given to the composition of OPO staff, to ensure the selection of competent personnel skilled in the organ donation process and sensitive to the values and attitudes that different ethnic groups may have toward donation.

The families of prospective donors should not be penalized for donation. In addition to paying medical expenses for living donors, consideration should be given to paying for time off work, perhaps at the daily rate for workmen's compensation or local jury duty.

The possibilities for improving donor hospital participation in the donation process should be analyzed. The medical management of prospective

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

donors deserves attention (Darby et al., 1989), and the associated financial costs of such management should also be analyzed. It may be appropriate to consider reimbursing donor hospitals for the workup and maintenance of prospective donors and making an allowance for professional education within the hospital.

Congress, in the Transplant Amendments Act of 1990, expanded the PHS grant program to include organizations other than OPOs. HRSA should now use this opportunity to develop a research effort focused on practical ways to increase the supply of available organs.

In the context of the above efforts, it is essential that a clear estimate of the potential national donor pool be developed against which success can be measured.

The committee recommends that the Centers for Disease Control conduct a national study of the potential donor pool, with attention to the estimated effects of AIDS, improved trauma care, traffic safety legislation, and other pertinent factors.

Two highly controversial ideas are likely to receive continuing public discussion and debate. These are consideration for donation and presumed consent. Consideration, or payment for donation, has been barred by the 1984 National Organ Transplant Act. But rewarded gifting, or a modest death benefit to the family of a donor, are ideas that have been raised and deserve thoughtful discussion (Peters, 1991).

Presumed consent, now used in several European countries, vests in the government the authority to take organs unless an individual has explicitly expressed himself to the contrary. On technical grounds, it is argued, this may facilitate the acquisition of more organs. This arrangement would alter the relationship of the state to the individual in the United States in fundamental ways, however, and the values involved should be thoroughly discussed in an open, public arena before public policy is changed.

NOTES

1.  

These data are based on HCFA's Annual Facility Surveys. UNOS (1990b) figures for 1987, 1988, and 1989 are slightly higher but show the same general pattern.

2.  

One-year survival is defined here as the survival probability from the date of the transplant procedure to one year later.

3.  

Strictly speaking, ''expectations'' are not synonymous with legislative intent as determined by an analysis of statutory law, the conference committee report, the statements of the House and Senate floor managers, and the reports of the relevant congressional committees.

4.  

The ESRD study staff examined newspaper coverage of organ transplantation in the New York Times, Wall Street Journal, Washington Post, Los Angeles Times, Chicago Tribune, and Boston Globe, from 1983 through 1989. News coverage was extensive in all newspapers except the Wall Street Journal. It was very limited before late 1982, grew in 1984 and 1985, appears to have peaked in 1986 and 1987, and declined thereafter. Most articles in

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

   

the mid-1980s dealt with heart transplantation. The New York Times, for example, devoted much more space to heart than to liver transplantation; the three regional papers, however, gave heart and liver transplantation approximately equal coverage from 1985 to 1987.

REFERENCES

AMA (American Medical Association, Council on Scientific Affairs). 1981. Organ donor recruitment. JAMA 246:2157–2158.

AMA (American Medical Association, Council on Ethical and Judicial Affairs). 1990. Black-white disparities in health care. JAMA 263:2345–2346.

ASTS (American Society of Transplant Surgeons). 1990. Survey on Present Status of Reimbursement for Immunosuppressive Drugs.


Bart KJ, Macon EJ, Whittier FC, Baldwin RJ, Blount JH. 1981a. Cadaveric kidneys for transplantation. Transplantation 31:379–382.

Bart KJ, Macon EJ, Humphries AL, Jr, et al. 1981b. Transplantation 31:383–387.


Callender CO. 1989. The results of transplantation in blacks: Just the tip of the iceberg. Transplantation Proc 21:3407–3410.


Darby JM, Stein K, Grenvik A, Stuart SA. 1989. Approach to management of the heartbeating "brain dead" organ donor . JAMA 261:2222–2228.

DOT (U.S. Department of Transportation). 1989. The Effects of the 65 mph Speed Limit Through 1988. Washington, D.C.

DOT. 1990. National Highway Traffic Safety Administration, Fatal Accident Reporting System.


Eggers PW. 1988. Effect of transplantation on the Medicare End-Stage Renal Disease program. N Engl J Med 318:223–229.

Evans RW, Manninen DL. 1988. U.S. public opinion concerning the procurement and distribution of donor organs. Transplantation Proc 5:781–785.

Evans RW, Manninen DL, Dugan MK, et al. 1990. The Kidney Transplant Health Insurance Study: Final Report. Seattle, Wash.: Battelle Memorial Institute.


Garrison RN, Bentley FR, Raque GH, et al. 1990. There is an answer to the organ donor shortage. Paper presented at 76th Annual Clinical Congress of the American College of Surgeons, San Francisco, October.


HCFA (Health Care Financing Administration). 1990. End Stage Renal Disease Program Quarterly Statistical Summary. August 2.

Held PJ, Pauly MV, Bovbjerg RR, Newmann J, Salvatierra O. 1988. Access to kidney transplantation: Has the United States eliminated income and racial differences? Arch Intern Med 148:2594-2600.


Kjellstrand CM. 1988. Age, sex, and race inequality in renal transplantation. Arch Int Med 148:1305–1309.


Manninen DL, Evans RW. 1985. Public attitudes and behavior regarding organ donation. JAMA 253:3111–3115.


Nathan HM, Jarrell BE, Broznik B, et al. 1990. Estimation and Characterization of the Potential Organ Donor pool in Pennsylvania: Report of the Pennsylvania Statewide Donor Study. Paper presented at the annual meeting of the American Society of Transplant Surgeons, Chicago, June.


OIG (Office of Inspector General, U.S. Department of Health and Human Services). 1990. The Distribution of Organs for Transplantation: Expectations and Practices. Washington, D.C. Draft report, August.


Peters TG. 1991. Life or death: The issue of payment in cadaveric organ donation. JAMA 265:1302–1305.

Pollack VE, Pesce A. 1990. Analysis of data related to the 1976–1989 patient population:

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

Treatment characteristics and patient outcomes. Report prepared for the Institute of Medicine ESRD Study Committee. Cincinnati: Dialysis Clinic, Inc.-Cincinnati.

Prottas JM, Batten HL. 1988. The health professional in organ procurement: Attitudes, reservations and their resolutions. Am J Public Health 6:642–645.

Rettig RA. 1989. The politics of organ transplantation: A parable of our time. J Health Politics Policy Law 14(1):91–227.


Showstack J, Katz P, Amend W, Salvatierra O. 1990. The association of cyclosporine with the 1-year costs of cadaver-organ kidney transplants. JAMA 264:1818–1823.

Stuart FP. 1984. Need, supply, and legal issues related to organ transplantation in the United States. Transplantation Proc 1:87–94.


Task Force on Organ Transplantation. 1985. Report to the Secretary and the Congress on Immunosuppressive Therapies. Washington, D.C.: U.S. Department of Health and Human Services.

Task Force on Organ Transplantation. 1986. Organ Transplantation: Issues and Recommendations. Washington, D.C.: U.S. Department of Health and Human Services.


UNOS (United Network for Organ Sharing). 1990a. Annual Report for 1988 and 1989. Richmond, Virginia.

UNOS. 1990b. Annual Report on the Scientific Registry for Organ Transplantation and the Organ Procurement and Transplantation Network, 1988 & 1989. Washington, D.C.: U.S. Department of Health and Human Services.

USRDS (U.S. Renal Data System). 1990. Annual Data Report. National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md.


Youngner SJ, Landefeld S, Coulton CJ, Juknialis BW, Leary M. 1989. "Brain death" and organ retrieval: A cross-sectional survey of knowledge and concepts among health professionals. JAMA 261:2205–2210.

Suggested Citation:"Access to Kidney Transplantation." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

APPENDIX

Estimated Additional Medicare ESRD Program Expenditures Required for Removing the 3-Year Eligibility Limit of Transplant Patients and the 1-Year Limit on Payment for Immunosuppressive Drugs, 1990–1995

 

Removal of 3-Year Limit on Eligibility

Removal of 1-Year Limit on Payment for immunosuppressive Drugs

Year

Estimate of Former Beneficiariesa

Estimate of Expenditures for Former Beneficiariesb

Estimate of Expenditure for Former Beneficiariesc

Estimate of Current Beneficiariesd

Estimate of Expenditures of Current Beneficiariese

Estimated Total Additional Expendituresf

1990

12,000–14,000

$80–95

$60–70

25,000

$125

$265–290

1991

13,000–16,000

90–110

65–80

27,000

140

295–330

1992

14,000–18,000

100–130

70–90

29,000

150

320–370

1993

5,000–20,000

110–145

80–105

31,000

160

350–410

1994

16,000–22,000

120–160

90–120

33,000

180

390–460

1995

17,000–24,000

130–180

95–130

35,000

190

415–500

a These estimates are of persons with a functioning kidney transplant who, under the current 3-year eligibility limit, would have ceased to be eligible for Medicare benefits or during the reference year. These do not include persons who would have maintained their Medicare eligibility by establishing Social Security disability status.

b This estimate assumes an average annual expenditure per beneficiary with a functioning kidney transplant, after the first year, of $6,800 for a 1987 base year, increased by 2 percent for each subsequent year.

c This estimate is based on an average annual expenditure of $5,000 per patient for immunosuppressive drugs times the number of former beneficiaries (column 1).

d This estimate is of current beneficiaries with a functioning kidney transplant no longer eligible for payment for immunosuppresive drugs.

e This estimate is based on $5,000 per year for immunosuppressive drugs times the number of current beneficiaries (column 4).

f This estimate is the sum of columns 2, 3, and 5. It does not include any estimates of costs saved by persons not returning to dialysis, nor of persons choosing the leave disability as a result of guaranteed medical benefits.

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Since 1972, many victims of endstage renal disease (ESRD) have received treatment under a unique Medicare entitlement. This book presents a comprehensive analysis of the federal ESRD program: who uses it, how well it functions, and what improvements are needed.

The book includes recommendations on patient eligibility, reimbursement, quality assessment, medical ethics, and research needs.

Kidney Failure and the Federal Government offers a wealth of information on these and other topics:

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This book will have a major impact on the future of the ESRD program and will be of interest to health policymakers, nephrologists and other individual providers, treatment site administrators, and researchers.

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