Good morning. I am Mark R. Yessian, Regional Inspector General for Evaluation and
Inspections in the U.S. U.S. Department of Health and Human Services (HHS). I am pleased to testify
at today's hearing on the effectiveness of organ allocation practices.
Our work in this area has led us to call for an organ allocation system that focuses on: (1) equity
among patients, not among transplant centers, and (2) common medical criteria, not the
circumstances of a patient's residence or transplant center affiliation.
I will concentrate my testimony on a report we issued 7 years ago. That report is relevant to
today's discussion because it makes the case for a more equitable organ allocation system that is
based on common medical criteria. The HHS rule issued on March 26, 1998 moves in a direction
that is responsive to the thrust of our findings and recommendations.
Background on the Report
Our 1991 report is entitled, The Distribution of Organs for Transplantation: Expectations and
Practices, and is attached. It was issued at a time when the national transplant waiting list had
grown to more than 20,000 people. That was less about one-third of the current level, but was
large enough to heighten concerns about the fairness of practices being used to allocate donated
organs for transplantation.
In the report, we focused on the organ distribution process, from the point that a cadaver organ is
procured to the point that it is transplanted. We concentrated on the distribution of kidneys
because at that time about 84 percent of those on transplant waiting lists were awaiting a kidney
transplant. When our report was issued in 1991, the Medicare program had just recently covered
liver transplants for adults and had certified only 20 liver transplant centers in the country.
The basic purposes of our inquiry were threefold: (1) to clarify expectations governing organ
distribution practices in the United States, (2) to determine the extent to which actual practices
were in accord with expectations, and (3) to offer recommendations that facilitated closer
accord between expectations and practices. We recognized the sensitivity of the issues under
examination and gave great emphasis to the presentation of objective, factual information that
could contribute to constructive policymaking.
Our methodology was based on four major lines of inquiry: (1) a statistical analysis of a data
base consisting of all individuals who were waiting for or received their first kidney transplant
between October 1, 1987 and March 31, 1989; (2) case studies of organ procurement
organizations and affiliated transplant centers in California, Florida, Wisconsin, and
Pennsylvania; (3) a review of key literature and Federal documents; and (4) interviews with
representatives of national organizations involved with organ transplantation, government
policymakers, public and private researchers, and transplant professionals.
In the sections below, I will present the three sets of expectations governing organ allocation that
we found were held by Congress and professional leaders. In each case, I will then contrast the
expectation with the actual practices that we found to be operative at the time.
Finally, I will review the recommendations we offered and their relevance to the current HHS
An Equitable System, With Each Person on a Transplant Waiting List Having an Equal
Opportunity to Receive a Transplant Subject to Established Medical Criteria.
There is a clear trail of congressional and professional expressions that provide the foundation of
this expectation. The National Organ Transplant Act of 1984 specified that an Organ
Procurement Organization (OPO) must have a system to allocate donated organs among
transplant centers and patients according to established medical criteria. In an accompanying
report, the Senate Labor and Human Resources Committee added the following:
An equitable policy and system is necessary so that individuals throughout our country can have
access to organ transplantation when appropriate and necessary.
Two years later, the Task Force on Organ Transplantation, established by the 1984 legislation,
defined this expectation more specifically, as follows:
The Task Force recommends that selection of patients both for
waiting lists and for allocation of organs be based on medical
criteria that are publicly stated and fairly applied. The Task
Force also recommends that the criteria be developed by a broadly
representative group that will take into account both need and
probability for success. Selection of patients otherwise
medically qualified should be based on length of time on the
In 1988, amidst some concerns that its initial expectations concerning equity were not being
adhered to, Congress amended the 1984 legislation to clarify that in allocating organs according
to established medical criteria, an OPO must focus strictly on the allocation among patients, not
transplant centers. In an accompanying report, the House Committee on Energy and Commerce
urged the HHS Secretary to monitor the allocation of organs closely to make sure that allocation
schemes remain based on equity among patients, not among transplant centers.
In the 1984 legislation, Congress did single out one group that it felt needed special attention if it
were to receive a fair opportunity for a transplant. In calling for the Organ Procurement and
Transplantation Network (OPTN) to develop a national list of individuals who need organs@
and a national system . . . to match organs and individuals on the list, it indicated that particular
attention should be given to individuals whose immune system makes it difficult for them to
receive organs. In calling for this special attention to highly sensitized individuals, it
implicitly recognized that for these individuals, the opportunity to receive a medically suitable
organ increases as the size of the available pool of donors increases.
A National System Adhering to Uniform Policies and Standards.
Congress called for the OPTN to establish one nationwide list of individuals awaiting
transplantation and a national system that would allow for donated organs to be quickly matched
with medically suitable candidates on that list. Yet, it did not mandate national distribution per
SE. It specifically stated that a national list and a national system could be established in regional
centers instead of one central location.
The Task Force, in its final report, reinforced the importance of a national system with uniform
policies and standards by which all will abide. The Task Force noted that while diverse practices
and protocols were to be expected during the pioneering years of transplantation, at
this point in the evolution of organ transplantation, sufficient data have been developed to allow
for the establishment of certain standards of practice. (This observation was 12 years ago, in
A Cooperative System Based on the Best Interests of Patients Waiting for Transplantation.
This expectation is obvious enough. But it is important to set forth because cooperation among
diverse parties is so integral to the transplant field. From the earliest efforts to enlist support of
potential donors and donor hospitals to the post transplant efforts to improve patient outcomes,
successful performance requires the cooperative efforts, often under strict
time pressures, of a wide range of professionals. These include but are no
means limited to transplant coordinators, nurses, social workers, neurologists, nephrologists,
transplant surgeons, immunologists, and OPO administrators. While each of these participants
have their own particular interests, they must work together effectively as trustees of organs for
all the persons awaiting a transplant.
It was in recognition of the complex nature of this collaborative effort that Congress called for
the unusual approach of a private body, the OPTN, having a strong role in shaping the national
system. Congress and professional leaders saw the OPTN and, to a lesser degree, the OPOs as
forums for developing approaches buttressed by broadly based consensus.
In our 1991 report, we pointed out that while progress had been made, actual practices fell well
short of each of the above-noted expectations. I point out those shortfalls below.
The access of patients to donated organs remained unequal in some important respects.
One important inequality was that among transplant centers. For the period we studied, the
median patient waiting time for a first kidney transplant ranged from a low of less than 1 month
at one center to a high of 71 months at another. Among the 202 centers we reviewed, the median
waiting time at 79 was less that 6 months for non-highly sensitized patients; at 15 it was
over 18 months. Such wide variations existed even among centers in the same OPO service
A second major inequality was with respect to race. We documented that blacks on kidney
waiting lists waited almost twice as long as whites for a first transplant, 13.9 months compared
with 7.6. This differential remained even when blood type, level of sensitization, and age were
taken into account. It was especially significant because blacks have much higher rates of kidney
failure. We examined various possible causes for the wide difference, but did not have any
Finally, we found that highly sensitized patients had considerably less access to transplants than
did others on waiting lists. During the 18 month period we examined, the median time that
highly sensitized patients waited for donated kidneys was almost 4 times that of all others, 32. 4
months compared with 8.6.
What stood out in our considerations of equitable access was that in OPO service areas, few
transplant centers had joined together to develop a common list of transplant candidates and to
distribute donated organs to those candidates on a first come first served basis, subject to medical
criteria. Some had formed a common list, but the sharing criteria they developed were apt to
devote more attention to the distribution of organs among centers than among patients. Along
this line, many transplant centers participated in an OPO approved arrangement whereby for each
pair of cadaver kidneys they retrieved, they kept one for one of their own patients
and gave one to a common pool. The kidney donated to the pool was then made available to
another transplant center in the service area, usually in accord with some rotational arrangement
This practice did not appear to us to be fair from the perspective of the overall pool of patients
awaiting a transplant. Also unfair from that broader perspective was that individuals seeking a
transplant could register at different centers both within and across OPO service areas,
thereby increasing their own chances of a transplant but reducing those others who did not have
the resources and/or information to get themselves multiple-listed.
Organ distribution remained heavily controlled by individual transplant centers and confined
primarily within the individual service areas of organ procurement organizations.
Notwithstanding some progress in developing a national system grounded in uniform policies
and standards, the actual distribution of organs from donors to recipients remained highly
localized. This local orientation, we found, applied in two very important respects. First of all,
through the OPTN's local use policy, transplant centers were allowed to retain almost
all of the organs that they had retrieved. They entered into cooperative agreements with an OPO
or other centers only at their own will. If they so wished, they could make arrangements
concerning the distribution of organs with a donor hospital and/or an OPO in a service area other
than the one in which they were located.
Secondly, as follows from this local use policy, most organs procured within a service area never
left that area. Only about 22 percent of kidneys retrieved were shared nationally.
Among some transplant centers and professionals, a sense of local ownership towards organs
they had procured impeded the development of an equitable national system for distributing
It is this sense of local ownership, we found, that sustained the keep one-share one arrangements,
whereby a transplant center that retrieved an organ kept one for one of its patients and donated
one to the common pool. It also sustains the renal payback system, whereby a transplant center
that provided a perfect match kidney to the national pool was entitled to a
payback kidney from the receiving transplant center.
Such practices contributed substantially to the uneven playing field across the country, with
access to organs being much greater in some geographic areas and in some transplant centers
than at others. Many transplant professionals, we noted, would justify this unequal situation by
noting that any system that sought to level the playing field across regions or transplant centers
would discourage donations since, they alleged, families were more likely to donate if they knew
the organ is being used in the local area.
In our review, we found no statistical basis for this contention. In fact, we found that in a national
public opinion poll commissioned by the OPTN itself, over 75 percent of the respondents
disagreed with the statement that donor organs should go to someone in the area where the donor
A number of transplant surgeons we learned also disagreed with the notion of local ownership.
One, who was also the medical director of an OPO, commented as follows in a letter sent to the
Establishing a payback system also creates the illusion that a
kidney is the property of a given OPO. Clearly, we need to foster
the notion that organs for transplantation are a national
resource which should be used in the most efficient and
successful manner possible. They are not anyone's individual
We found the mismatch between expectations and reality significant enough for us to make a
number of strong recommendations to HHS. In making the recommendations, we recognized that
many organ allocation decisions are essentially medical in nature and ought to be made by
medical professionals on the basis of the best available evidence and objective criteria. At the
same time, we held that in a situation of scarcity, where there are not nearly enough available
organs to satisfy the need, some of the broad allocation decisions are essentially national in
nature and must be guided by publicly accountable institutions--the Congress and the Executive
Thus, we grounded our specific recommendations on actions that could be taken to help close the
gap between actual practices and the expectations clearly set forth by Congress. We did not seek
to impose our own or others judgments about what those expectations should be.
Below, I present the recommendations we made that are most pertinent to the
March 26, 1998 HHS rule:
Issue regulations to require that each OPO (1) establish a single, unified list of patients awaiting
transplantation and (2) distribute donated organs to those patients on a first come first served
basis, subject to established medical criteria.
It was time, we argued, to preclude transplant centers from operating as if they own the organs
that they or others have procured. Each center, we recommended, should have to register its own
transplant candidates on one unified list maintained by the OPO. Each cadaver organ that then
becomes available for transplantation in that service area (except for those mandated by the
OPTN to be distributed nationally) would be offered to patients on that list in the order that they
have registered. (Patients should not be allowed to improve their chances of a transplant by
registering at more than one transplant center.) The only basic exceptions here would be those
warranted in accord with established medical criteria.
This approach, we emphasized, would make for more equitable access for patients within OPO
service areas. It would reinforce the notion of equity among patients rather than among transplant
centers and would establish a system more in accord with congressional intent.
Issue regulations to require that each transplant center and donor hospital in an OPO service area
adhere to the centralized organ distribution policies of the OPO governing that area.
Transplant centers, we indicated, should not be allowed to violate the first come first served
approach by making organ distribution arrangements, as some did, with donor hospitals and/or
OPOs outside their own service area. We sought to reinforce the point that OPOs, not transplant
centers, be regarded as the engines of the organ distribution system. They should have the
authority to shape and oversee distribution policies in their service areas, in accord with guiding
Federal requirements, and they should be held accountable for the exercise of this authority. In
overseeing the distribution of organs, they must assure that the focus is on the equitable
access of patients, not transplant centers.
Support the development of medical practice guidelines addressing organ
We fully recognized that without more uniform and explicit medical criteria, equitable access as
we call for would be difficult to achieve. Widespread differences among professionals in the field
have inhibited the development of such criteria. The differences relate to the degree of
emphasis that should be given in allocating organs to such matters as age, sensitivity level, and
HLA matching. Even more fundamentally, they relate to the criteria that determine whether or
not one is a suitable candidate for a transplant and should be placed on a list in the first place.
Different practices in placing candidates on waiting lists clearly affected the equity we aimed for
with our first come first served recommendations.
For these reasons, we urged the Department to support the development of transplant practice
guidelines, based on medical outcomes, that would serve as an authoritative and useful reference
point for practicing professionals and for oversight bodies responsible for assuring that organs
are in fact being distributed equitably.
Fund a demonstration effort incorporating the following two
features: (1) the establishment of a single, unified waiting list
including all patients awaiting an organ transplant in a number
of OPO service areas and (2) the mandatory distribution of
donated organs to those patients on a first some first served
basis, subject to established medical criteria.
We recognized that even with the development of equitable, patient-based allocation systems
within OPO service areas, the unequal patient access across service areas would not be
diminished. Thus, we called for demonstration efforts that would develop larger pools of donors.
Such efforts could enhance equity across the established regions, allow greater opportunities for
highly sensitized patients, and enable better overall understanding of the pros and cons of
operating larger scale distribution systems. The demonstration effort, we believed, would foster
progress toward the national system envisioned by Congress.
Update and Conclusion
Since 1991, some progress has been made in closing the gaps we identified between expectations
and practices. The OPOs now must establish a single unified list of patients awaiting transplants
and use it as the basis for allocation, in accordance with OPTN rules. Further, the differential in
black-white waiting times for cadaver kidneys appears to have been reduced somewhat. The
OPTN has served as a vital forum for addressing issues and making decisions that contributed to
this progress in organ allocation practices.
At the same time, there is still much room for progress, as is most clearly exemplified by the
substantial differences that remain in waiting times across OPO service areas. Further, with three
times as many individuals awaiting a transplant as there were 7 years ago, it is even more
imperative that Congressional expectations of the organ allocation system and actual
practices be in close accord. The increased scarcity heightens the urgency of the situation and, we
believe, the importance of public guidance on how best to deal with the situation. Our
recommendations offered general directions on how that might be done. The March 26 HHS rule
follows along the same line, presenting broad directions for the OPTN and medical
professionals to apply, using the best of the medical evidence available to them.
By calling for performance goals for standardized criteria for listing patients on transplant
waiting lists, for standardized criteria for medical status of those on waiting lists, and for organ
allocation policies that give priority to those whose needs are most urgent, with less attention to
geographic factors, the HHS rule provides an opportunity for continued progress toward the kind
of system we called for 7 years ago. The OPTN, of course, has a key role to play in carrying out
It remains essential, we believe, for HHS and for the OPTN to exert leadership to help develop
organ allocation systems that are grounded in (1) equity among patients, not transplant centers
and (2) in common medical criteria, not the circumstances of a patient's residence or transplant