David Meltzer, Robert D. Gibbons, Naihua Duan and other
members of the Institute of Medicine Committee on Organ Procurement
and Transplation
Although no significant disparities for organ
transplant rates for the sickest patients exist on a regional, gender
or racial basis under the current Organ Procurement Transplantation
Network (OPTN) policy, the needs of the most critically ill patients
are not met; organs that could be used to treat the most severely ill
are sometimes used for the less severely ill because patients are "too sick to transplant." Moreover,
there is need for a more cohesive and attentive federal oversight
for the nation's organ transplant system and an independent review
board to improve the quality and amount of information available to
patients, providers and potential donors.
These are some of the key findings concluded
by the Institute of Medicine (IOM) review of current OPTN policies
and the potential impact of the US Department of Health and Human Services
(DHHS) "Final Rule" on the
allocation of scarce organs, which calls for organs to be assigned
to the most critical patients regardless of geography. University of
Chicago researcher, David Meltzer, along with colleagues Robert D.
Gibbons, Naihua Duan and other members of the IOM Committee on Organ
Procurement and Transplantation were among the investigators.
IOM Researchers determined that the DHHS Final Rule policy would not
contribute to increased costs, force the closure of small transplant
centers, adversely affect minority and low-income patient access, discourage
organ donation, and result in fewer lives saved as critics suggest.
Findings
The IOM committee studied 33,000 patients on waiting lists for liver
transplants between 1995 and 1999. They found that under current policy,
organs that could be used for the most severely ill are in fact used
for the less severely ill. About half (52.4%) of status 1 patients were
transplanted; 9.2% died while waiting. Differences in waiting times and
mortality rates by organ procurement organization (OPO) are associated
with the size of the OPO service region and whether the OPO participates
in a sharing arrangement with other OPOs.
The researchers found little difference in waiting times for the most
critical patients. They also found no disparities by race or gender,
indicating that the system is equitable for women and minorities once
they are on the list. There were broader ranges of waiting times among
all status 3 patients, but this is attributed to differences in when
they are placed on the list. Less critical patients tend to be placed
on transplant lists as early as possible in hope of early allocation.
The recommendation offered by the researchers is that waiting time should
not be a transplant criterion for patients who are not at risk for imminent
death.
The size of the OPO was a key determinant in whether the most critical
patients received transplant. More transplanted organs go to status 2B
and 3 patients in smaller OPOs (fewer than 4 million patients in the
service region) than in larger ones (9 million or more). This suggests
that under the current system, the needs of the most severely ill patients
are not well met. The researchers recommend that at least 9 million people
be included in an organ transplant region to maximize the chance that
the most severely ill patients receive a transplant.
Some OPOs participate in statewide and regional sharing arrangements,
most typically for status 1 patients. Researchers find that these sharing
networks work. Compared with non-sharing OPOs, organizations in sharing
arrangements with at least one other OPO had a transplant rate for status
1 patients of 52% vs. 42%, wait times of 3 days vs. 4, and a pre-transplant
mortality rate of 9% vs. 7%. Additionally, sharing was not associated
with closure of smaller centers and was associated with higher donation
rates.
The IOM report's findings do not support objections to the DHHS Final
Rule. Under the current system, the needs of the most critically ill
patients are not met. Furthermore, no evidence suggests that distributing
organs across broader geographic areas would cause smaller centers to
close, reduce donation rates, or adversely affect access for minorities
or the economically disadvantaged. The main obstacles to organ transplant
for minorities and the poor are actually outside of the transplant system:
lack of access to health insurance and to high quality health care services.
Background
In April 1998, DHHS published the "Organ Procurement and Transplantation
Network, Final Rule" to assure that allocation of scarce organs would
be based on "common medical criteria not accidents of geography." The
principles underlying the Final Rule are more effective federal
oversight, increased public access to information, consistent medical
listing information, an emphasis on medical need and reduced geographical
disparities in waiting times.
In response to controversy over the rule in the transplant community,
Congress suspended its implementation in October 1998 for one year to
allow further study of the potential impact of the regulation. DHHS republished
the Final Rule, incorporating findings from the IOM report. Congress
has further delayed implementation of the Final Rule to spring 2000.
Additionally, the House Committee on Commerce has approved a bill (HR
2418) that supports opponents of the Final Rule and does not consider
the IOM recommendation for enhanced government oversight.
More than 62,000 Americans are currently waiting for an organ transplant,
and a new name is added to the transplant wait list every 16 minutes.
Organ donation rates, however, have not kept up with growing demand,
and 4,000 Americans die each year waiting for a transplant. Since the
enactment of the National Organ Transplant Act of 1984, the number of
organ recipients in the U.S. has increased annually. In 1998, the year
Congress commissioned the IOM review, more than 21,000 Americans received
organ transplants.
Policy Briefs are designed to highlight key policy
implications and to broaden the dissemination of policy-related
research. These Briefs are funded by the Irving B. Harris Graduate
School of Public Policy Studies at the University of Chicago.
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a copy of this study.
For more information, contact Jamie Rosman at (773) 702-2287 or HarrisSchool@uchicago.edu.
