Organ Transplants
Ethical Issues
What are Organ Transplants?Cadaveric organ donation: Involves removing organs from a recently deceased donor.Living organ donation: Involves the donation of one of a paired organ (ex: kidneys) or a portion of an organ (such as a lobe of the liver or lung). The donor's organ system is still able to function after the donation. Living donors are often related to the patient, but that is not always the case.
HistoryIn 1954, the first successful kidney transplant was performed in the United States. It was a kidney from a living identical twin donor.
History cont.More than a half of a century after the very first transplant, more than 80,000 people whose death without a donor is certain are on waitlists in the United States waiting for a new lung, kidney, heart, or liver. The United Network for Organ Sharing reports that about half of these people will die without receiving the necessary organs. Human organs are a scarce medical resource and have many ethical issues concerning organ transplantation.
ConsentA donor card is the main signal for permission to collect an organ from a potential donor. Also there is an attempt to gain approval from a next of kin or other family members. If a family member isn’t present for that decision then recovery agencies would act solely on the donor card.
Donor Card ConcernsThere is fear and distrust that if you are a organ donor then less effort would be placed into saving your life if your death meant organs for others.Coercion takes place when signing up for a license, because everyone’s license is marked with the decision to be a organ donor or not.
Allocation ConcernsOrgan recipients are chosen from a long waiting list after they have been medically determined to be a eligible candidate. The criteria for these lists are weighed upon factors such as age range, causes of failure, and stage of organ failure.
An attempt to balance justice...The United Network for Organ Sharing policy tries to make the decision of organ donating fair by placing criteria on the donating circumstances. These circumstances include; the need for the organ and those with the possibility of the maximum outcome.
UNOS Criteria
Maximize the availability of transplantable organs.
Maximize patient and graft survival (allograft-human to human transplant).
Minimize the deaths while waiting for a transplant.
UNOS Criteria cont.
Maximize opportunity for patients with biological or medical disadvantages to receive a transplant.
Minimize the effects related to geography.
Allow convenient access to transplantation.
UNOS Criteria cont.Minimize overall transplantation costs.Provide for flexibility in policy making. Provide for accountability and public trust.
The UNOS Ethical PositionThe only ethically sound motivation for donation is humanity. They interpret humanity to be solidarity with the national community and the absence of personal benefit.
Racial BiasRacial bia.
Organ TransplantsEthical Issues What are Organ T.docx
1. Organ Transplants
Ethical Issues
What are Organ Transplants?Cadaveric organ donation:
Involves removing organs from a recently deceased
donor.Living organ donation: Involves the donation of one of a
paired organ (ex: kidneys) or a portion of an organ (such as a
lobe of the liver or lung). The donor's organ system is still able
to function after the donation. Living donors are often related to
the patient, but that is not always the case.
HistoryIn 1954, the first successful kidney transplant was
performed in the United States. It was a kidney from a living
identical twin donor.
History cont.More than a half of a century after the very first
transplant, more than 80,000 people whose death without a
donor is certain are on waitlists in the United States waiting for
a new lung, kidney, heart, or liver. The United Network for
Organ Sharing reports that about half of these people will die
without receiving the necessary organs. Human organs are a
scarce medical resource and have many ethical issues
concerning organ transplantation.
2. ConsentA donor card is the main signal for permission to
collect an organ from a potential donor. Also there is an attempt
to gain approval from a next of kin or other family members. If
a family member isn’t present for that decision then recovery
agencies would act solely on the donor card.
Donor Card ConcernsThere is fear and distrust that if you are a
organ donor then less effort would be placed into saving your
life if your death meant organs for others.Coercion takes place
when signing up for a license, because everyone’s license is
marked with the decision to be a organ donor or not.
Allocation ConcernsOrgan recipients are chosen from a long
waiting list after they have been medically determined to be a
eligible candidate. The criteria for these lists are weighed upon
factors such as age range, causes of failure, and stage of organ
failure.
An attempt to balance justice...The United Network for Organ
Sharing policy tries to make the decision of organ donating fair
by placing criteria on the donating circumstances. These
circumstances include; the need for the organ and those with the
possibility of the maximum outcome.
UNOS Criteria
3. Maximize the availability of transplantable organs.
Maximize patient and graft survival (allograft-human to human
transplant).
Minimize the deaths while waiting for a transplant.
UNOS Criteria cont.
Maximize opportunity for patients with biological or medical
disadvantages to receive a transplant.
Minimize the effects related to geography.
Allow convenient access to transplantation.
UNOS Criteria cont.Minimize overall transplantation
costs.Provide for flexibility in policy making. Provide for
accountability and public trust.
The UNOS Ethical PositionThe only ethically sound motivation
for donation is humanity. They interpret humanity to be
solidarity with the national community and the absence of
personal benefit.
Racial BiasRacial bias could effect the way organs are
distributed and there has been legislative attempts to reduce
discrimination involved in the donation of organs.
Uniform Anatomical Gift ActThe following act states that,
“Donation of an organ may not be made in a manner in which
4. discriminates against a person or class of persons on the basis
of race, national origin, religion, gender, or similar
characteristic.”
What are the racial differences?Biological:Hypertensive renal
disease in the black community. Different histocompatibility
complex antigens
Racial Differences cont.Social: A lower donation rate for
African-American than Caucasian.General distrust of the health
care system and medical workforce, that means that there is less
biologically compatible organs for that specific community and
race. Personal:Surveys show: 90% of Caucasians would accept
an organ if their lives would be saved by it, compared to only
70% of African-Americans said they would do the same.
Purchasing Human OrgansThe 1984 National Organ
Transplantation Act prohibits the purchase or sale of human
organs or tissue. Organ Commerce remains a controversial
topic. Notion of property is a major debated area
Notion of PropertyPeople think that if one has complete
ownership of their organs than they should be able to use them
for whatever purpose they choose, even if it means selling them.
The other side says that the body is a quasi-property, which
means that only the bodily fluids can be sold or purchased not
the solid organs.
5. Critics of Organ CommerceArguments include: Exploitation,
coercion, and violations of the sacredness of a human being.
Concerns include: The socially disadvantaged donating their
organs for money.Organ theft: Children have been kidnapped
and murdered and their organs have been sold on the
international market (black market).
Ethical Framework for Organ TransplantationEthical issues and
controversy arise because there is such a need for organs. Many
debates stem from fair distribution of the limited number of
organs and trying to find ways to increase the number of organs.
Prolonging life through transplantation is very sought-after, and
many people in the U.S. feel that the allocation system favors
those who are financially able to receive these organs.
Past behavior of recipientsThere is a ongoing debate about a
person’s past behavior leading to the need of a transplant and
whether or not these people should be eligible for a
transplant.Some of these behaviors include:AlcoholismSmoking
Drug AbuseObesityBecause of the limited supply of organs, the
recipient needs to be considered a “good investment.” If the
behavior is not going to change even after the transplant then
how fair is that to the people who need the transplant from
natural causes of a disease? The controversy is whether or not
the people with risky behavior should be eligible for
transplantation.
Facts:On average 17 patients die every day while awaiting an
6. organ. On average 110 people are added to the nations organ
transplant waiting list each day.In 2003 more than 19,000
transplants were performed. It is illegal to buy or sell organs in
the United States.
Moral and Ethical QuestionsShould those who have a better
chance for survival be given priority over other patients needing
transplants?Should parents of young children be given
priority?Should those whose lifestyle choices damaged their
existing organs be given a chance at an organ transplant?Should
everyone be required to indicate their wishes regarding organ
transplantation on either tax forms or drivers license?
Questions cont.Should consent to donate organs be presumed, so
that organs are donated unless a person specifically requests not
to donate upon death?Should organs be created through the use
of stem cells?Should hospital policies permit organs to be taken
from non-heart-beating donors (NHBD) to increase the number
of organs available?
Resourceshttp://www.bioethics.umn.edu/resources/topics/organ
_transplants.shtmlhttp://www.lhsc.on.ca/transplant/ethics.htmhtt
p://www.miracosta.edu/home/lmoon/OTpage.htmlhttp://www.m
olbio.princeton.edu/courses/mb427/2001/projects/01/ethics.htm
7. Organ Transplant and Donation
Stats for OregonOverall: 48 years and more than 5,000
transplants Annually: 200-plus transplantsTo date, the OHSU
Transplant Program has transplanted: 3,822 kidneys, 496 hearts,
570 livers, 126 pancreaes, and 24 lungs.
Heart TransplantStarted 1985Medicare certified 1988Total
transplants: 4961-year survival 91% Average length of stay post
13 daysAverage wait for transplant 24 days
Liver TransplantStarted 1988Medicare certified1993Total
transplants 8721-year survival 88%Average length of stay post
transplant, 10 daysAverage wait 108 days
KidneyProgram started 1959Medicare certified 1973Total
transplants 3,8283-year survival 86%Average length of stay
post transplant 6 daysAverage wait 476 days
Pancreas TransplantationProgram started 1987Total transplants
1271-year survival 88%Average lenth of stay post transplant 8
daysAverage wait 93 days
8. Some National StatsOrgan and Tissue Donation Statistics:The
national waiting list for organ donation is rising at the alarming
rate of a new name every ten minutes, with 97,504 people
currently on the list (10/5/07). In 2006, 28,293 individuals
received a life-saving organ transplant thanks to the generosity
of a donor.
National Stats cont.An average of 18 men, women, and children
die each day waiting for an organ transplant; in 2006, there
were 5,423 people who died waiting. More than 1
million people benefit from tissue transplants each year.In
2006, A single tissue donor can improve the quality of life for
more than 50 people.
Donation
To donate in Oregon now you need to go to the web site and
register.
http://www.donatelifenw.org/resources/
Having it stated on your drivers license is not enough.
Make sure your family knows your wishes because they can
over turn what is stated.
Donation cont.The only state that will go only off your drivers
license is Minnesota and that is only in an emergency if family
is unavailable.You are able to state whether you want certain
organs to be donated or not.
9. Selling OrgansProponents for selling organs state that it is a
way to reduce the amount of people that on the waiting list by
increasing the amount of organs are available. If people get
paid for their organs more people will be willing to donate.
They say that 70% of the kidneys will fail over the 10 years, but
if there is an open market for organs there would be a much
better over look if there were better matched donors.
Selling organs cont.People that are extremely poor may look to
this as a way to help themselves get ahead. They may not be
informed about the risks involved, or may not understand what
risks are involved. Are this places doing all the testing on the
donor to ensure it will go to a proper recipient. And that the
donor has NO illnesses.
Bioethical issuesShould a person that has abused their body,
(drugs, alcohol) be placed on the list? Should there be
preferential treatment for people?Should someone that is HIV
positive be able to receive a transplant. If so, at what point in
their disease process should it be considered to late to get a
transplant. And should the organ only come from another person
that is HIV positive?Should there be a market for organs, after
all they do this for eggs, sperm, and blood products.
THE IMPACT OF
ROUTINE INQUIRY
LAWS ON
ORGAN DONATION
10. by Kathleen S. Andersen and Daniel M. Fox
Prologue: Health policy making regarding the emotionally
charged issue of organ donation has evolved quickly, attempting
to
keep up with new developments in medical technology. A key
policy
problem has been how to increase the supply of organs to
satisfy the
burgeoning demand. One proposal to which U.S. policymakers
have been attracted is that of routine inquiry (also called
required
request). This policy requires hospitals or their designees to ask
families of patients and/ or potential donors about their wishes
con-
cerning organ donation. Routine inquiry laws were enacted first
in
the states. The federal government, running close behind,
adopted
the policy in its 1986 Omnibus Budget Reconciliation Act,
which
supersedes state law. This paper reports survey data that assess
the
impact of these new state and federal routine inquiry laws on
organ
donation. Kathleen Andersen and Daniel Fox of the Center for
As-
sessing Health Services at the State University of New York
(SUNY) at Stony Brook began their research on routine inquiry
at
the request of the New York State Department of Health. They
as-
sisted the department in preparing its mandated evaluation of
the
first year of required request in New York. The two researchers
moved on from there, asking, “What are the other states doing?”
11. Andersen, a policy analyst at the center for nearly five years,
earned a master of public administration degree from Harvard
University’s Kennedy School of Government. Fox, who holds a
doc-
torate in history also from Harvard, is professor of humanities
in
medicine at SUNY-Stony Brook and director of the Center for
As-
sessing Health Services. His research interests also include
compar-
ative health systems, chronic disease, and policies regarding an-
other emotionally charged issue: acquired immunodeficency
syndrome (AIDS).
66 HEALTH AFFAIRS |Winter 1988
Since July 1985, forty-four states and the District of Columbia
havepassed routine inquiry laws to increase the supply of organs
andtissues for donation.1 These laws aim to increase the
potential donor
pool by requiring hospital personnel to request consent of
potential
candidates or their families for donation, or at least inform
people of the
option. How effective these laws have been is unknown, since
most of the
evidence is anecdotal and contradictory.
Until recently, efforts to increase the supply of organs and
tissues for
transplantation focused mainly on state legislation and
regulation. In
1986, however, acting on a recommendation of the national
Task Force
12. on Organ Transplantation, Congress required hospitals to
establish
written protocols to identify potential organ and tissue donors.
This
legislation supersedes state law but does not prevent states from
establish-
ing more stringent requirements.
This article describes the results of a survey conducted during
fall 1987
to find out which states have passed routine inquiry laws, how
those laws
have been implemented, and what their effects on organ
procurement
have been. The texts of the laws and proposed legislation
provided the
data for our analysis, supplemented by information obtained
through
interviews with legislative analysts and representatives of state
health
departments. We interviewed persons in the Office of Organ
Transplan-
tation and the Health Care Financing Administration (HCFA)
for in-
formation on current federal activity related to routine inquiry
protocols.
Following a summary of the origins of routine inquiry laws, the
article
describes how the states have enacted and implemented routine
inquiry
laws; how the Uniform Anatomical Gift Act has been amended
to
include routine inquiry; what actions the federal government
has taken
to improve organ procurement; and what the relationship
13. between
federal and state regulations is likely to be. We conclude with a
descrip-
tion of what is known about the effects of the laws in Oregon,
New York,
and California– three of the earliest states to enact them.2
Origins Of Routine Inquiry
Organ donation in this country relies on the concept of
encouraged
voluntarism. Either the donor must give consent or surviving
persons
close to the donor must authorize the donation in the absence of
a prior
decision; consent is not presumed. It is a system of “opting in”
rather than
“opting out.”
The legal structure of organ donation is state-based and
legislative. It is
built on the concept that binding organ donation is a creation of
state law
regulating the disposition of dead bodies in the interest of
public health
ROUTINE INQUIRY 67
and safety. Although there has never been a federal organ
donation law
that covers all states and territories, the Uniform Anatomical
Gift Act,
promulgated in 1968, provided a model that was modified by
each state.3
14. By 1973, the Gift Act was enacted in some form in all fifty
states. In
general, it authorizes an individual to donate all or any part of
his or her
body, and it specifies who can give consent to donation in the
absence of a
prior decision by the decedent. To facilitate implementation of
the act,
many states have adopted statutes that require drivers’ licenses
to serve as
donor cards, when signed by the holder. However, in 1986 less
than 20
percent of the population in any state carried such cards.4
Despite its adoption by all states, the act has not increased
donations to
the extent envisioned. Jeffrey Prottas reported that no organ
procure-
ment agency will remove organs solely on the approval of a
signed donor
card, although its presence may encourage family members to
consent to
donation.5 Paul Lee and Paul Kissner argued that the
shortcomings of the
Gift Act result from the unwillingness of transplant personnel to
exploit
its provisions fully because of liability concerns and bad
publicity, even
though the act has been uniformly upheld under litigation.6
In the early 1980s, advances in extrarenal transplantation and
the large
numbers of patients on transplant waiting lists stimulated a
reexamina-
tion of organ donation policy. Bioethicist Arthur Caplan
15. described a
policy of “required request” that could increase donations
simply by not
overlooking opportunities for requesting consent. He cited
public opin-
ion surveys that found strong public support for organ donation,
con-
firmed by the finding that over 60 percent of families gave
consent when
they were asked. Thus, he argued, if hospitals were required to
give
families the option to consent to donation, the supply of organs
and
tissues likely would increase. Unlike policies of presumed
consent or
marketing of organs, which present a number of ethical
problems,
required request would restrict voluntarism only for hospitals
and health
care providers, not for individual prospective donors and their
families.7
What The States Have Done
The speed with which routine inquiry and required request laws
have
passed indicates strong state support (Exhibit 1).8 Exceptions
are South
Carolina, South Dakota, and Utah, where state legislators
considered
proposed laws in 1986 and 1987 but failed to pass them. The
Vermont
legislature considered bills in 1987 and 1988 authorizing
hospitals to ask
nonemergency patients if they had signed an organ donor card,
but the
16. legislation did not pass. Only Idaho and Wyoming have taken
no action.
Structure of laws. Although there is agreement about the
purpose of
68 HEALTH AFFAIRS | Winter 1988
Exhibit 1
States That Have Passed Routine Inquiry Laws
1985
California
New York
Oregon
1986
Alabama
Arizona
Connecticut
Delaware
Florida
Georgia
Illinois
Indiana
Kansas
Kentucky
Louisiana
Maine
18. Pennsylvania
Rhode Island
Tennessee
Washington
West Virginia
Wisconsin
the laws, their structure varies. State laws differ primarily in the
degree of
hospital monitoring, the extent of health department
involvement in
implementation via regulations, whether hospitals are required
to re-
quest donations or only to inform families of the option, and the
con-
ditions under which exceptions to the requirement may be made.
Oregon, New York, and California provided models for the
states that
later passed similar legislation. The laws passed by Oregon and
New York
are the most alike. Each requires that, in the absence of prior
notice of
contrary intention, hospital personnel or their designees request
consent
for anatomical gifts from the families of potential donors. Each
request
and its outcome must be recorded in the medical record and on
the death
certificate. New York’s law requires that the hospital also
submit a
certificate of request with the death certificate. The state health
depart-
ments are responsible for setting implementation regulations.
19. In contrast, California’s law requires no involvement by the
state
health department and specifies no mechanism for recording the
out-
ROUTINE INQUIRY 69
comes of requests for organ and tissue donations. Hospitals are
required
to inform families of the option to consent to donation, rather
than to
request consent. The hospital also must notify an organ
procurement
agency when consent for donation is granted, but it is not
required to
notify the agency before the family is informed of the option of
donation.
The laws passed since 1985 fall into two groups: those that
require
hospitals to request anatomical gifts (Oregon and New York
models); and
those that require them to inform families of the option of
donation
(California model). Twenty-six states and the District of
Columbia have
required request laws; eighteen others require that hospitals
inform
families about organ donation. Georgia, Kentucky, and
Tennessee do not
require hospitals to approach the families. Instead, they are
required to
notify an organ procurement agency when they identify
20. potential donors.
It is unclear whether the difference between the two types of
laws
results in distinctly different practice and effects or is merely a
difference
in language. In some s tates– Rhode Island, for example– the
words
“request” and “inform” are both used to describe what the
hospitals
must do. However, other states may have chosen to require
hospitals to
“inform” to avoid forcing reluctant hospital employees to ask
for organ
donations at a time of great emotional stress for the families.
Health department involvement. The laws vary in the degree to
which
they require the involvement of state health departments in
implementa-
tion and oversight. Like Oregon and New York, sixteen other
states
require their health departments to establish any rules and
regulations
necessary to implement the law. Fifteen states require that their
health
departments establish rules for training hospital employees who
are
making the requests; ten of these states require that they also
establish
request procedures. In nine states and the District of Columbia,
health
departments must establish procedures to facilitate effective
coordina-
tion among hospitals and procurement agencies.
21. The regulations that health departments have established usually
reflect concerns of hospitals, physicians, and the transplant
community.
For example, in Illinois, the health department may issue a rule
that the
need for organs and tissues has been adequately met, and the
requirement
is suspended. This provision recognizes the hospitals’ concerns
that they
could be required to request unneeded donations.
Pennsylvania’s law
allows the health department to make exceptions to the
requirement for
hospitals that it deems unable to comply. Standards for training
the
persons who approach the families recognize the importance of
careful
preparation for handling an often difficult situation.
Requirements that
health departments help to draw up agreements between
hospitals and
transplant and organ procurement programs (Louisiana and
Ohio, for
70 HEALTH AFFAIRS | Winter 1988
example) address coordination problems.
Record keeping. Most routine inquiry laws require that hospitals
record the outcome of their encounter with the families of
potential
donors. The record provides both a way to monitor compliance
and
statistics for possible later evaluation. Twenty states require
22. that the
outcome be recorded in the patient’s medical record; six of
these require
additional documentation on death certificates or certificates of
request.
New York and Delaware require all three forms of reporting.
Michigan
requires that hospitals keep a log of requests and submit a
report to the
health department annually. Sixteen states do not specify record
keeping.
Legislation requiring health departments to compile statistical
reports
or to evaluate the effectiveness of routine inquiry protocols is
less com-
mon. New York and Nebraska require an initial report on
implementa-
tion. Michigan, Massachusetts, Tennessee, and New Mexico
require
annual reports on the number of requests made and organs
donated.
Monitoring compliance. How compliance will be monitored is
rarely
specified in the laws. Instead, it is usually part of the
regulations adopted
for implementation, especially where organ donor identification
proto-
cols are made a condition of hospital licensure. While New
York has
developed a detailed surveillance protocol and elaborate
reporting sys-
tem for monitoring compliance, California does not have a
separate
mechanism, relying instead on the hospital accreditation survey.
23. Respon-
dents from a number of states noted that surveillance is
unnecessary
because the hospitals support the legislation and will comply
voluntarily.
Only Kentucky specifies sanctions for failure to comply:
hospitals that do
not comply must pay a fine of $100–$500.
Notification procedures. Twenty-four of the states require
hospitals to
notify an organ procurement agency of a potential donor.
Because
workable agreements between procurement agencies and
hospitals are
crucial to the effectiveness of an organ procurement system, the
absence
of this requirement in the law may reduce its effectiveness.
Most states have specified exceptions to the requirement that
hospitals
request consent for donation or inform families of the option.
Almost all
laws state that hospital representatives are not required to
request consent
to donation if there is actual notice of the contrary intention of
the
decedent. Many allow exceptions if organ donation is contrary
to the
decedent’s religious beliefs, if approaching the family would
cause them
undue emotional stress, or if the donation would not be
medically
suitable and therefore not used.
Donor cards. Explicit in some laws, and implicit in those that
24. are
amendments to the Uniform Anatomical Gift Act, is the
hospital’s ex-
emption from the requirement if the potential donor previously
signed a
ROUTINE INQUIRY 71
donor card. However, even with a card, hospitals and
procurement agen-
cies rarely will proceed with organ procurement without
requesting
consent from the family. Thus, the effect of this exemption may
be
limited.
As the Conference of Commissioners on Uniform State Laws
notes in
its commentary to the act, discovering who has signed an
instrument of
donation is a logical first step before requesting consent to
donation.9 By
asking admitted patients if they have signed a donor card, the
hospital
obtains a record of consent to donation and has the opportunity
to
inform patients of the option in a routine manner. Few states
have
addressed this type of routine inquiry directly. In 1985, New
Jersey
enacted such a law, then passed a law in 1987 requiring request
for
donation. A spokesman in the department of health said that he
hoped
25. the earlier law would be repealed because he thought it
offended pa-
tients. Contrary to action taken by other states, the Vermont
legislature
in 1987 and 1988 considered but did not pass bills that would
authorize
hospitals to make inquiries of all nonemergency patients.
Hawaii’s 1988
revisions to its anatomical gift act include routine inquiry
requirements.
The Revised Uniform Anatomical Gift Act
In August 1987, the National Conference of Commissioners on
Uni-
form State Laws (NCCUSL) drafted a revised Uniform
Anatomical Gift
Act that incorporates new provisions to address some of the
shortcom-
ings of voluntary donation. The revised law was drafted after
most states
had passed routine inquiry laws and thus did not provide the
model that
the earlier law did. Even laws adopted by Alaska and Virginia
in 1988 did
not follow the new model act. Only Hawaii has amended its
existing law
to incorporate provisions of the new model.
In a preface to the revised model law, the NCCUSL cited a 1985
Hastings Center report on organ transplantation, which stated
that the
public policy instituted by the act “is not producing a sufficient
supply of
organs to meet the current or projected demand for them.”10
The report
26. identified nine inadequacies in the system, including the failu re
of
persons to sign written directives for organ donation, the failure
to
approach family members systematically, and the failure to
obtain ade-
quate informed consent from family members.
The 1987 Gift Act includes provisions on routine inquiry and
required
request. The routine inquiry provision would require hospitals
to ask
each patient admitted if he or she is an organ donor, to discuss
the option
to make an anatomical gift, and to record the patient’s decision
in the
medical record. The required request provision would require
hospitals
72 HEALTH AFFAIRS | Winter 1988
to discuss with the family of a dying patient the option of
donation if
there is no indication of the patient’s decision in the medical
record and if
the patient is a medically suitable candidate. The hospital would
record
the outcome of the request in the patient’s medical record and
notify the
recipient, if known, or an appropriate organ procurement
organization.
The commissioner of health in each state would be responsible
for
establishing regulations and / or guidelines for implementation.
27. The new routine inquiry and required request provisions ensure
in-
creased opportunities for requesting consent to anatomical gifts.
In addi-
tion, they also require emergency personnel to search for
information
indicating that a person who is dead or near death is a donor.
Federal Government Action
Federal action began with the passage of the National Organ
Trans-
plant Act in 1984. This act established a national Task Force on
Organ
Transplantation to examine “barriers to the improved
identification of
organ donors and their families and organ recipients.”11 The
task force
report of April 1986 recommended that the states that had not
already
done so adopt routine inquiry laws. It further recommended that
the
Joint Comm ittee on Accr ed itation of Healthcar e Or ganiz
ations
(JCAHO) require that hospitals have organ procurement
protocols as
part of their accreditation requirements, that the NCCUSL
develop
model routine inquiry legislation, and that HCFA require
hospitals to
have routine inquiry protocols as a condition of participation in
Medi-
care and Medicaid. Although the JCAHO has not adopted the
recom-
mendation, the NCCUSL did adopt model legislation in 1987.
28. Congress, in the Omnibus Budget Reconciliation Act (OBRA) of
1986, amended the conditions of participation to require that
hospitals
develop routine inquiry protocols. The requirements that
hospitals must
meet are identical to those of California’s routine inquiry law,
which the
task force had recommended as a model because it allows the
option to
grant or deny consent and gives hospital employees the option
not to
request donations if they are uncomfortable with that action.
Hospital
employees are required to identify potential donors, provide
next-of-kin
with opportunities for donation, and refer potential donors to
organ
pr ocurement agencies.12
Medicare /Medicaid participation. On July 31, 1987, HCFA
issued
proposed rules for the new conditions of participation, with the
final
rules scheduled to go into effect October 1, 1987. However,
implementa-
tion was postponed several times. According to a HCFA
spokesperson,
the delay was caused by requirements of the Gramm-Rudman
budget
ROUTINE INQUIRY 73
reduction legislation and by difficulties in completing the
29. regulations to
designate organ procurement agencies eligible for Medicare
reimburse-
ment. The final rule became effective March 31, 1988 and does
not differ
from the proposed rule, which states that a hospital may
continue to
participate in Medicare and Medicaid only if it establishes
written proto-
cols to identify potential organ donors that: (1) assure that
families of
potential donors are made aware that they have an option to
donate
organs or tissue and an option to decline to donate; (2)
encourage
discretion and sensitivity with respect to the circumstances,
views, and
beliefs of the families of potential donors; and (3) require that
an organ
procurement agency designated by the secretary of health and
human
services, under 1138(b)(1)(F), be notified of potential donors.13
Compliance with the regulations will be monitored by the state
survey
agency for Medicare, in most cases the group that reviews the
hospital for
its JCAHO accreditation. A HCFA spokesperson said that the
Medicare
reviewers will honor the state’s licensure requirements as long
as the
hospital meets Medicare’s minimum standards.
While the proposed rules focused on both organ and tissue
donors, the
final rule states that “except for the requirement that families be
30. aware of
their option to donate tissue, the requirements of our regulations
do not
apply to donated tissues but only to vascular organs.”14 This
restriction
was adopted to avoid imposing a heavy burden on procurement
agencies
to serve as the contact point for all organ and tissue donations.
The organ
donor protocols are intended to aid the networks of organ
procurement
agencies authorized by the 1986 legislation. Hospitals must
identify
potential donors and then notify the regional organ procurement
agen-
cies eligible for Medicare reimbursement. Since tissue banks are
not part
of the network, tissue donations are not a focus of the federal
require-
ments.
Many of the state laws require hospitals to request consent for
dona-
tion from all potential donors, tissue as well as solid organ.
Some states
have more stringent requirements in such provisions as the
training of
requesters and standards for compliance. According to Linda
Sheaffer,
director of the Office of Organ Transplantation, the new federal
require-
ments supersede the states’ routine inquiry laws; states,
however, may
establish more stringent requirements.
States’ responses. Most of the state routine inquiry laws will
31. meet
HCFA’s rules. Anticipating the new rules, eight states enacted
laws that
are identical or very similar to them. Each state would meet the
initial
r eq u ir ement– a written protocol. Similarly, they all would
meet the
requirement that families be informed of the option to donate or
to
decline donation. How well the state laws would meet the
requirement .
74 HEALTH AFFAIRS| Winter 1988
that hospitals encourage sensitivity in dealing with families
depends on
the performance criteria HCFA chooses to measure compliance.
It is
likely, however, that at least the twenty-three laws that require
special
training for hospital employees who discuss donation with the
families
would meet the requirement, as would the thirty that allow
exceptions to
the requirement when there is known opposition by the decedent
or
family. Notifying an organ procurement agency of a potential
donor is a
requirement of twenty-three states.
The HCFA regulations would seem to make further action
redundant
for states without routine inquiry legislation. An attorney with
the
32. NCCUSL told us that required request and routine inquiry are
now dead
issues, both because most states have already passed laws and
because
HCFA’s regulations will supersede laws with fewer
requirements. The
model Gift Act legislation the NCCUSL adopted in August
1987,
however, incorporated the HCFA requirements and could be
used by
states wishing to adopt more comprehensive organ donation
laws.
That HCFA regulations were forthcoming did not deter some
states
from introducing routine inquiry legislation. Alaska passed a
law in 1988
that requires hospitals to request consent for anatomical gifts,
and to
coordinate recoveries with tissue banks, eye banks, and
procurement
agencies. A legislative analyst there reported strong support for
the bill,
even though the closest organ transplant program is in Seattle.
He was
unaware of the proposed Medicare requirements.
Virginia also adopted legislation in spite of the Medicare
regulations. In
1985, as part of its authorization act for hospital licensure
regulations,
Virginia required hospitals to establish protocols for organ
procurement.
In 1987, according to a representative of the department of
health, a
legislative study group recommended that Virginia enact a more
33. stringent
routine inquiry law. Our respondent said that the 1985
regulation was
intended to warn hospitals and physicians of interest in
establishing
routine inquiry protocols. However, it has not succeeded in
increasing
donations. When asked why Virginia would introduce routine
inquiry
legislation once the Medicare regulations are implemented, he
responded
that a strong state law is needed to ensure compliance by
physicians, many
of whom have opposed routine inquiry. The legislature passed a
stronger
routine inquiry amendment in March 1988. In keeping with
recommen-
dations of the Virginia Transplant Council and hospital
association, the
law requires hospitals to establish protocols for offering
families of
potential organ and tissue donors the opportunity for donation.
Hawaii adopted an expanded anatomical gift act in 1988 that
incorpo-
rated the changes recommended by the NCCUSL. The rationale
given
in the conference committee report for the amendment is that
the
ROUTINE INQUIRY 75
changes would improve existing law and aid the state’s effort to
increase
34. the supply of organ and tissue donations. No mention is made of
the
HCFA regulations.
The federal organ procurement protocol regulations have met
with
little opposition, mainly because they duplicate action already
taken by
the states. In only a few states will hospitals have to adopt
written
protocols solely as a result of the HCFA regulations. The
regulations are
less comprehensive than many states’ laws, especially
concerning identifi-
cation of tissue donors. While the federal regulations establish a
mini-
mum routine inquiry requirement in all states, the largest effects
on organ
procurement may come from the tougher state laws.
Initial Effects Of Routine Inquiry Laws
Data about the effects of the routine inquiry laws are difficult to
obtain
because of the short time the laws have been in place and the
limitations
of the states’ reporting systems. To assess the initial effects of
routine
inquiry, we looked at what has happened in New York, Oregon,
and
California, the states that first implemented the laws.
New York has the most information available because its law
required
the state health department to report to the legislature on the
effects of
35. the required request law by July 1987. In 1986, heart donations
increased
by 94 percent, livers by 96 percent, and kidneys by 23 percent.
There was
a 58 percent increase in eye donors.15
The Oregon Organ Donor Program, a consortium of the
procurement
agencies, reported that following implementation of the law on
February
1, 1986, the number of eyes donated doubled “almost
overnight,” and
that rate continued into 1987. There was also a 20–25 percent
increase in
donations of bone and skin. Donations of kidneys, however,
decreased in
1986, increasing during the first three quarters of 1986 but then
declining
during the last quarter because of an unexplained drop in
mortality.
During 1987, kidney donations went up 12 percent. Although
there was
some increase in donations of extrarenal organs, the
consortium’s spokes-
person said that it is difficult to attribute the increase to the
routine
inquiry law alone, because the addition of new extrarenal
transplant
programs in the region may have been a factor. The Oregon
Organ
Donor Program began a pilot study in August 1987 to obtain
better
information about the effects of the law.
Organ procurement agencies in Los Angeles and San Francisco
re-
36. ported findings similar to Oregon’s. The director of the
Regional Organ
Procurement Agency in Los Angeles stated that during the first
year of
routine inquiry the number of referrals increased, but the
number of
76 HEALTH AFFAIRS | Winter 1988
donors stayed about the same. In 1987, local referral calls
dropped by
over 500. He cited a decline in the number of trauma deaths as a
possible
explanation. However, he also thought that the procurement
agency may
be losing referrals because hospital representatives are not
approaching
the families at the right time or in a manner likely to result in
consent for
donation. He encourages the hospitals affiliated with his
procurement
agency to call for assistance rather than approach the families
themselves.
Finally, he suggested that public education may have a greater
effect in
increasing donations than the routine inquiry requirement.
The procurement agency at the University of California-San
Fran-
cisco Medical Center also has not seen large increases in
donations. As in
Oregon, some of the increases may be due to other factors, such
as better
donor management and the opening of more transplant centers
37. in the
area. The staff member interviewed cited problems with data
accuracy
and the lack of a formal study as reasons for the difficulty in
evaluating
routine inquiry. The lack of a mechanism for monitoring
compliance is
also a problem, but one that may be partially alleviated when
the
Medicare regulations go into effect. She also stressed the need
for better
training of hospital representatives and increased education of
the public.
Although New York has enjoyed the largest increases in
donations, it
also has had a number of implementation problems, most
notably with
cumbersome reporting requirements. The health department
concluded
that the certificate of request form that hospitals were required
to
complete and attach to the death certificate whenever a request
for
donation was made has not worked. Health department staff
discovered
that the small number of forms returned was due in part to
funeral
directors who, finding the unfamiliar form attached to the death
certifi-
cate, simply threw it away. The department recommended that
the form
be eliminated, since surveillance and documentation could be
accom-
plished through other means.16 However, at the same time that
New York
38. was trying to eliminate the certificate of request, New Jersey
was enacting
a routine inquiry law that made it a reporting requirement.
Oregon also noted problems with reporting requirements. The
dispo-
sition of the request is supposed to be recorded on the death
certificate,
but because the death certificate is completed by funeral
directors who
do not know what happened, the system does not work. During
the 1987
legislative session, a move to change the requirement failed to
pass. The
proposal was supported not only by the funeral directors but
also by the
eye banks, which rely heavily on the good will of funeral
directors.
Compliance with the laws in the three states is generally
reported to be
good. In New York, the health department’s hospital
surveillance pro-
gram has monitored implementation of the regulations through
hospital
ROUTINE INQUIRY 77
surveys conducted from January to May 1987. The survey of
150 hospi-
tals (about two-thirds of the total) found that all but twenty
hospitals had
implemented protocols. Oregon reported problems with very
small rural
39. hospitals. A staff member in the health department’s bureau of
health
facilities said that compliance is monitored through what he
called a
“nonmonitoring” system, adding that in a small state one does
not need to
coerce people to comply, especially with a requirement that is
perceived
as good policy. Neither is there a formal monitoring system in
place in
California. A respondent in the health department’s licensing
division
said that the only monitoring they would do would be to review
a copy of
the protocol at the time of the hospital’s accreditation survey.
Two years
after implementation, no monitoring had begun.
Conclusions
Routine inquiry legislation has had a brief and inconclusive
history.
Rarely has a policy been embraced so quickly by the states and
then been
almost immediately federalized. Part of the explanation for the
popular-
ity of routine inquiry may have been that it is exhortation rather
than
regulation; it encourages action that cannot easily be monitored,
much
less evaluated. Whether routine inquiry remains a symbol of the
moral
resolve of the states and the nation or is a first step in the
direction of a
more stringent standard– presumed consent to donation–
remains to be
40. seen. For the present, we can only observe that there is a
national
consensus that the opportunity to donate organs should not be
thwarted
by presumptions about the feelings of survivors.
By itself, routine inquiry is not likely to affect significantly the
supply
of organs after early attention by the media. Moreover, we know
very
little about the results of increased supply. Future research
should exam-
ine the outcomes of organ transplant policy and the
effectiveness of the
systems through which it operates. Research to date has focused
instead
mainly on the adequacy of elements of the process; for example,
the
effectiveness of hospital-based as opposed to independent organ
procure-
ment organizations. Our evaluation of routine inquiry is yet
another
evaluation of process. We need to know much more about the
results of
recent changes in policy that are intended to make
transplantation more
available, efficient, and equitable. Only then will it be possible
to debate
rationally how much ought to be allocated for these procedures.
78 HEALTH AFFAIRS | Winter 1988
NOTES
41. 1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Forty-four states and the District of Columbia had passed these
laws as of September
1988. In descriptions of these laws, the terms “routine inquiry”
and “required request”
are sometimes used interchangeably. Routine inquiry usually
refers to laws that require
hospitals to ask patients if they have signed a donor card and to
42. record that information
in their medical record, and / or to inform the families of
deceased patients of their
option to consent to donation. Required request is a narrower
term, usually referring
only to those laws that require hospitals to request consent to
donation.
We gathered data for New York at the request of the State
Health Department for their
legislatively mandated study of the law’s implementation.
P.P. Lee and I? Kissner, “Organ Donation and the Uniform
Anatomical Gift Act,”
Surgery 100 (1986): 867–875.
A.L. Caplan, “Requests, Gifts, and Obligations: The Ethics of
Organ Procurement,”
Transplantation Proceedings 18 (1986): 49–56.
J.M. Prottas, “The Structure and Effectiveness of the United
States Organ Procure-
ment System,” Inquiry 22 (1985).
Lee and Kissner, “Organ Donation.”
Caplan, “Requests, Gifts, and Obligations.”
While we were conducting the research for this article, the
Office of Organ Transplan-
tation, Department of Health and Human Services, contracted
with Maximus for an
“Evaluation of Methods Used by States to Expand the Number
of Organ and Tissue
Donors” (April 1988). We reviewed the executive summary
after this article had been
submitted for publication. They reviewed much of the same data
we did and had
similar findings about the implementation of routine inquiry.
There are some minor
discrepancies in the numbers in both studies, because of
differences in definition and in
stages of implementation when the two studies were conducted.
43. National Conference of Commissioners on Uniform State Laws,
“Uniform Anatomi-
cal Gift Act (1987).”
The Hastings Center, “Ethical, Legal and Policy Issues
Pertaining to Solid Organ
Procurement” (October 1985), quoted in “Uniform Anatomical
Gift Act (1987).”
Task Force on Organ Transplantation, Organ Tranplantation
Issues and Recommenda-
tions (Washington, D.C.: U.S. Department of Health and Human
Services, 1986).
Ibid.
U.S. Department of Health and Human Services, Health Care
Financing Administra-
tion, “Proposed Rules: Organ Procurement Organizations and
Organ Procurement
Protocols,” Federal Register (31 July 1987): 28666–28677.
U.S. Department of Health and Human Services, Health Care
Financing Administra-
tion, “Medicare and Medicaid Programs, Organ Procurement
Organizations and Or-
gan Procurement Protocols, Final Rule” Federal Register (1
March 1988): 6526–6547.
New York State Department of Health, Office of Health
Systems Management,
Division of Health Care Standards and Surveillance, “The
Implementation of the
Required Request Law: A Report to Governor Cuomo and the
Legislature Including a
Study of Transplant Services in New York State,” July 1987.
Ibid.
Write a paper about “Organ Transplantation” Identify the issue,
discuss and all relevant considerations to the individual and
society. APA format with a minimum of 3 references included.
44. Bioethics Topic
· Organ Transplantation: Which of several matched donors
should receive a particular organ?
These some references about the topic
·
http://www.nejm.org/doi/full/10.1056/NEJMp1307220?query=fe
atured_nephrology
·
http://www.nejm.org/doi/full/10.1056/NEJMp1308078?query=fe
atured_nephrology
· http://donatelife.net/statistics/
· http://www.zdnet.com/article/printable-organs-breakthrough-
3d-printed-stem-cells/
· http://www.livescience.com/39885-3d-printing-to-deliver-
organs.html
· https://www.thelundreport.org/content/new-law-expected-
promote-organ-donation
· http://www.donatelifenw.org
· http://www.bbc.com/news/world-asia-china-33854244
In addition, there are several case-based scenarios with
discussions. Links to additional readings and related websites
are included at the end of topic.
· Advance Care Planning
· Advance Directives
· Breaking Bad News
· Complementary Medicine
· Confidentiality
· with an Emphasis in Pediatrics
· Do Not Resuscitate Orders
· during Anesthesia and Urgent Procedures
· End-of-Life Issues
· Ethics Committees and Consultation
45. · Futility
· HIV and AIDS
· Informed Consent
· in the Operating Room
· Interdisciplinary Team Issues
· Law and Medical Ethics
· Maternal / Fetal Conflict
· Mistakes
· Neonatal ICU Issues
· Parental Decision Making
· Physician Aid-in-Dying
· Physician-Patient Relationship
· Professionalism
· Public Health Ethics
· Research Ethics
· Resource Allocation
· Spirituality and Medicine
· Student Issues
· Termination of Life-Sustaining Treatment
· Truth-telling and Withholding InformationFurther Bioethics
Resources
· Bioethics Related Websites
· Readings by Topic
· Related Websites by Topic
· Professional Societies & Organizations
n engl j med 353;14 www.nejm.org october 6, 2005
The new england journal of medicine
1533
book reviews
46. kidney for sale by owner: human
organs, transplantation,
and the market
By Mark J. Cherry. 258 pp. Washington, D.C., Georgetown
University Press, 2005. $26.95. ISBN 1-58901-040-X.
hen i first became aware of com-
mercialism as a possibility in organ trans-
plantation, I, like most everybody here . . . was
very opposed to it and thought it a terrible thing.
More recently, I am not so sure. I think the issue is
much more complex than it appears to be at first.
. . . I wonder who decided that it was morally
wrong. . . . Who is it that sits on these boards
and makes these decisions?”
This quotation from Kidney for Sale by Owner, re-
flecting a nephrologist’s comments at a conference,
perhaps summarizes the thoughts of a growing seg-
ment of the general public, as well as some medical
professionals. Whereas federal law and societal
standards prohibit individual adults from buying
and selling solid organs for transplantation, our
current ethical views on the commercialism of or-
gan donation have recently been challenged, in part,
by several living-donor transplantations in which
donor–recipient pairs were linked through for-
profit Internet sites. The sudden application of free-
market economics to organ donation has forced
physicians, patients, ethicists, and regulatory bodies
to reconsider this complex issue.
47. Kidney for Sale by Owner, written by Mark J. Cherry,
a philosopher with expertise in bioethics, is a time-
ly and important contribution to the current dis-
course. The book seems to have two goals: to re-
view the ethical basis for the current proscription
on organ sales, and to provide a philosophical and
societal framework by which organ sales could be
considered morally acceptable.
The author first takes us through the fundamen-
tal arguments for the prohibition of organ sales,
which are largely centered on exploitation and vio-
lation of human dignity. He then explores the basic
philosophical framework by which organ sales
could be morally acceptable, drawing on relevant
threads from Immanuel Kant, John Rawls, and
theological teaching. In this exposition, Cherry,
who is an authority in the field of organ donation,
reviews philosophical questions concerning per-
sonal autonomy and the concept of self as they re-
late to the sale of one’s organs. Although this book
is clearly written, the general medical reader will
probably find portions of this discussion, such as
“The Body, Its Parts, and the Market: Revisionist
Interpretations from the History of Philosophy,” to
be arcane and somewhat difficult to read.
The remainder of the book presents a balanced
view of the practical aspects of developing an organ
market. Cherry describes the negative societal ef-
fects of an organ market, including the potential
reduction in charitable organ donation, harmful
effects of exploitation of donors, and whether a
for-profit organ market would erode medical and
48. scientific standards in the field of transplantation.
He then reviews the potential positive societal ef-
fects: increased numbers of organs available for
transplantation; increased expression of personal
autonomy from organ donation; and achievement
of societal goals through income generated from
organ sales.
Cherry gives us a comprehensive, balanced re-
view of the philosophical and practical aspects of
adopting a market-driven system for organ sales.
Transplantation professionals, bioethicists, and the
public will find Kidney for Sale by Owner invaluable
for framing discussions of this complicated topic.
With thousands of patients dying each year while
on the list for transplants, our society should ex-
plore every reasonable means to increase the avail-
ability of donor organs. This book challenges our
current views on the commercialism of organ dona-
tion and argues that from an ethical, medical, and
societal viewpoint, the current prohibition of organ
sales may cause more harm than good.
James F. Trotter, M.D.
University of Colorado Health Sciences Center
Denver, CO 80262
[email protected]
“
w
The New England Journal of Medicine
Downloaded from nejm.org on March 2, 2011. For personal use
only. No other uses without permission.
50. consent and a hypothetical open market approach. With the use
of data
from the United Network of Organ Sharing and the United
States Renal
Data System, I will discuss the economic and moral dilemmas
of the
shortage and argue for a market based procurement policy.
Free Kidney For Sale? 3
Outline
Introduction
I. Dialysis, Transplant, and Substitution
A. Why are Transplant and Dialysis Substitutes
i. Microeconomic theory
ii. Health economic theory
B. My Empirical Finding and Other’s Findings
i. Limitations
ii. Regression results
iii. Explanation of the numbers
II. The Shortage
A. The Size of the Shortage
i. National Shortage
51. B. Why is it increasing
i. Technology influences
ii. Third-party-payers
iii. Current procurement policy
C. The effects of the Shortage
i. Loss of life
ii. Dialysis treatment costs
iii. Monetary costs
iv. Black market activity
III. Required Request and the Current Procurement System
A. Is Required request working
i. History and efforts to procure organs
ii. Review of required request literature
IV. Alternative
Solution
s
A. Presumed Consent
i. Definition
ii. Discuss property rights with presumed consent
iii. Ethics of presumed consent
52. B. Open Market
i. Define the market and set constraints
ii. Review literature on market based organ procurement
V. Ethical Concerns for Open Market Operations
A. Coercion of the poor
B. Transplant accessibility to the poor
C. Premature termination of care
VI. Conclusion
Free Kidney For Sale? 4
Introduction
Technology in the Healthcare Industry is unique in that one
must weight better-
53. quality outcomes and longer life against the costs of producing
those results. Kidney
transplant and dialysis treatment have been introduced and
developed over the last half
century and have had large benefits and costs. Specifically, the
first successful kidney
transplant was performed in 1954 between identical twins
(Barney & Reynolds, 1989).
Since then the development of immunosuppressive drugs have
increased survival rates of
transplant recipients and increased the number of individuals on
waiting lists for
transplant. Unfortunately the increase in the demand for
kidneys has not been met with
an increase in supply, and today 65,226 people are waiting for a
kidney transplant
(OPTN, 2005). This shortage of transplantable organs has lead
54. to significant social costs
that have not been corrected by the altruistic policy that guides
organ procurement today.
The current policy of altruism or volunteerism is the by-product
of property rights
established in the two guiding statutes on transplantation and
organ procurement. The
Uniform Anatomical Gift Act (UAGA) of 1968 enabled people
to formally document
their wish to donate their body or organs for transplantation and
research after death.
This act is “grounded in the idea that volunteerism would
supply a sufficient amount of
organs for transplant while promoting altruism and protecting
patient self-determination”
(Barney & Reynolds, 1989). Soon after the draft of the UAGA,
all fifty states passed
55. versions of the law to be held and abided by in the procurement
and transplant of organs.
The second influential statue is the National Organ
Transplantation Act (NOTA) passed
by Congress in 1984. Within this legislation, the buying or
selling of human organs
became illegal. NOTA states: “It shall be unlawful for any
person to knowingly acquire,
Free Kidney For Sale? 5
receive or otherwise transfer any human organ for valuable
consideration for use in
human transplantation if the transfer affects interstate
commerce.” Interestingly, NOTA
does allow compensation for blood donation and reasonable
payments for obtaining and
56. processing a donated organ such as travel, housing, and lost
wages costs (Altinanahtar,
Alper, B.A., M.A., May 2004). NOTA also organized the
current system of Organ
Procurement Organizations into the Organ Procurement
Transplant Network (OPTN) and
placed the United Network for Organ Sharing as the regulatory
body in the procurement
and disbursement of organs.
UAGA and NOTA further specify the policy that has been
present since the first
kidney transplant in 1954: organ donors are unable to receive
compensation for donation.
The purely altruistic approach to organ procurement and the
developments in medical
technology have increased the shortage of donable organs
57. drastically. In this paper I will
observe the developments in technology that have made kidney
transplant the more
attractive treatment for End Stage Renal Disease (ESRD). I will
discuss the costs
associated with transplant and dialysis and the reasons for their
substitutability. Three
policies will be examined; the current altruistic/required request
policy, presumed
consent, and a hypothetical open market approach. The ethical
implications of each
policy will be discussed, and I will propose that a market
solution will both correct the
shortage and reduce costs.
This paper will rely heavily on microeconomic theory and
health economic theory
58. in its discussion of open market policy and the substitution of
transplant and dialysis.
This reliance is necessary because open market operations have
never been implemented,
thus no empirical data exists to study its effects. In addition, the
amount of data that is
Free Kidney For Sale? 6
available for kidney transplants/costs and dialysis
treatments/costs free of charge is
inadequate. Still, the arguments made and the statistical data
should not be unrecognized
or seen as useless. The issue of the organ shortage is a large
medical, economic, and
ethical problem. The assumptions behind open market
operations and substitution
59. clustered with medical market observations will serve as a
foundation for working toward
correcting the shortage of kidney organs.
I. Dialysis, Transplant, and Substitution
Before discussing the theoretical assumptions of substitution in
the medical
market, I would like to elaborate on ESRD and the various
treatments that are available
for patients suffering from this disease. ESRD occurs when the
kidneys fail, thus
creating a creatinine buildup because the body is unable to filter
and excrete it properly.
Individuals with ESRD have three treatment options available to
them; Hemodialysis,
Peritoneal Dialysis, or Transplant (Bryant, 2005).
60. Hemodialysis is not a synthetic kidney, but it performs the
blood filtering function
of a healthy kidney. A patient undergoing hemodialysis must be
hooked up to a machine
three times a week for periods of three to four hours per
treatment. The machine acts as a
filter passing urine, while retaining suspended proteins. This
treatment requires a
surgical procedure where a fistula is created to accommodate
the sixteen gauge needle
that must be directly inserted into the patient’s vein (Bryant,
2005).
Peritoneal Dialysis (CAPD or CCPD) is a less evasive
treatment which requires
no medical assistance and can be performed at home. This
treatment works inside the
body using the peritoneal membrane to retain a reservoir of
61. dialysis solution which is
exchanged via catheter every four to six hours. It is important
to recognize that
Free Kidney For Sale? 7
peritoneal dialysis does have an increased probability of
infection and is more machine-
dependant, but it does allow the patient daytime freedom
because the treatment can be
administered during sleep due to an automated cycler (Bryant,
2005).
The third and final option for ESRD patients is transplant.
With the introduction
of immunosuppressive drugs, which fight the body’s instinct to
destroy foreign objects
such as the new kidney, transplant survival rates have increased
62. substantially. Patients
must be on these immunosuppressive drugs for the duration of
their post-transplant life
and initial costs for transplant are quite high. The main
problem with transplant is the
shortage of available organs; the patient may never get the
organ that he or she needs so
desperately (Bryant, 2005).
A. Why are Transplants and Dialysis Substitutes
Economists assume that when consumers make choices, such as
choosing dialysis
or transplant, they act rationally. This is to say that consumers
are risk adverse, price
minimizing, and benefit maximizing beings. Along with this
logic, consumers are
63. assumed to choose a good or service as long as the good or
service’s marginal benefit is
greater than or equal to its marginal cost.
Certain constraints must be placed on this behavior. The
rational choice model
considers a world with two goods and measures the amount of
goods that a person will
consume in bundles or a particular combination of the two
specified goods. The bundles
available to the consumer are constrained by that consumer’s
income in the form of a
budget line, which is the set of all bundles that exactly exhaust
the consumer’s income.
Indifference curves are then used to identify when a consumer
is indifferent to a set of
bundles. The indifference curve that lies above the budget
64. constraint is preferred to those
Free Kidney For Sale? 8
that are on the budget constraint and the indifference curve on
the budget constraint is
preferred to those under it. With the use of budget constraints
and indifference curves, a
consumer’s utility choices can be derived (Frank, 2003).
This microeconomic model is transferable to health economics
and patient
decisions. In the medical industry, patients are deciding
between different treatments that
give themselves the best health outcome within a certain income
range. However, the
presence of third-party-payers gives the patient an extremely
large “income” and the
65. price of treatment becomes less likely to affect decisions of
treatments (Henderson,
2002). The influence of third-party-payers in ESRD began with
the 1979 amendment to
the Social Security Act which allowed the federal government
to pay for 80 percent of
treatment costs (both dialysis and transplant) for kidney disease
(Blair & Kaserman,
1991). Private insurance has also increased its coverage in
transplant costs, which has
further clouded the consumer’s sensitivity to price. The
presence of third-party-payers
lowers the out-of-pocket costs for the consumer. When you are
not paying the bills, there
is little incentive to reduce demand or act rationally when
considering the price of
66. transplant and dialysis (Henderson, 2002). The impact of third-
party-payers will have a
direct impact on the analysis of the rational choice theory for
dialysis and transplant.
Finally, in the medical care industry, treatments that lead to the
same outcome are
considered substitutes. As described above, the influence of
third-party-payers makes
consumers extremely insensitive to price and makes demand for
medical treatments
extremely price inelastic. Appropriately, the high costs of
dialysis treatment and kidney
transplant are infinitesimal when considering the possible health
advantages to these
treatments. Patients will focus more on the time involved to
administer dialysis treatment
67. Free Kidney For Sale? 9
or the physical strain from kidney surgery and weigh the health
benefits with these costs
rather than monetary expenses.
B. Empirical Analysis and Findings
When using the rational choice model in considering dialysis
and transplant there
must be a few modifications. First, the consumer cannot use
both treatments or consume
a half of a transplant. They must consume X dialysis treatments
(dialysis is an on going
procedure) or one transplant. This will lead the analysis to a
corner solution, or when the
consumer does not consume one of the goods. Second, because
68. of third-party-payments
from Medicare and private insurance the cost of each treatment
will not largely decide
which treatment a patient chooses. Therefore, patients will
migrate to the treatment that
offers the best outcomes. I argue that, because of the medical
advances in kidney
transplant such as the immunosuppressive drug cyclosporine in
1979, along with newer
drugs, Prograft and Cellcept, and the costs of dialysis apparent
in the hours wasted each
week connected to a dialysis machine, the majority of ESRD
patients would prefer
transplant (Bryant, 2005). Finally, utility and demand for
dialysis treatment is overstated.
Patients are pushed into receiving dialysis because there is a
shortage of transplantable
69. kidneys; because of this, dialysis treatment can be considered
an imperfect substitute
because the results do not have the same quality. As I argued
above, the majority of
patients want transplant except for those who feel they could
not undergo the trauma of
surgery. However, this majority is moved to a lower
indifference curve and receives less
utility because they must be treated with dialysis.
Free Kidney For Sale? 10
Figure 1.1
70. Dialysis
I0
I1
Transplant
Figure 1.1 illustrates the argument in graphical form. Notice
that each indifference curve,
I0 and I1, leads to a corner solution because the patients can
only consume dialysis or
transplant, not both. Patients want to be on the indifference
curve I0 because they believe
transplant has the most health and lifestyle benefits. However,
the majority of these
patients who demand transplant are moved to indifference curve
I1 because of the
shortage of organs available for transplant. I1 is less preferable
to these people because it
is below I0, where their utility is maximized.
71. To study the shortage of kidneys and the substitution effects of
dialysis treatment,
I turned to the United Network of Organ Sharing (UNOS) and
the United States Renal
Data System (USRDS). These groups provide transplant and
renal data free of charge to
the public for educational and research purposes. Although I
found sufficient data for my
undergraduate research and argument of substitution and the
resulting shortage, I must
rely heavily on the theory behind the numbers. There is no such
thing as a free lunch;
Free Kidney For Sale? 11
thus, the data set from UNOS and USRDS is smaller than a data
set from a subscription
72. based supplier. More importantly, although the data set is
diminutive, the results convey
the theory on which I rely.
My sample for analysis stretched from 1996 to 2002 for
transplant “patient years
at risk,” and dialysis Medicare payments per “patient years at
risk.” To determine the
substitution of kidney transplant for dialysis treatment, I named
transplant my dependent
variable with dialysis and time as my independent variables. I
then performed a
regression of these three variable’s natural logs to determine the
cross-price-elasticity of
transplant and dialysis. Cross-price-elasticity is the percentage
change in the quantity
demanded of one good caused by a one percent change in the
73. price of the other. The
results of this ratio if below zero are compliments, and if above
zero are substitutes.
The following are my results:
Regression output confidence interval
variables
coefficients
std.
error t (df=4) p-value
95%
lower
95%
upper
intercept -87.3694 5.0388 -17.339 .0001 -101.3593 -73.3796
74. LN of Dialysis Pmts 0.0873 0.0825 1.059 .3495 -0.1417
0.3164
Time in years 0.0486 0.0028 17.598 .0001 0.0410 0.0563
Data Source: (USRDS, 2005)
Though my sample was relatively small, only covering seven
years, the results can be
explained by the budget constraint and indifference curve model
that I presented above.
With a 10% increase in the price of dialysis there will be an
increase in quantity
demanded for transplants of 8.73%. As apparent by the t-
statistic, less than the absolute
value of two and a p-value stating a 34.95% chance that the
results occur because of
random chance this coefficient suggests an increase in the price
of dialysis treatment
would not be reason for increased demand for transplantation.
75. This result does not come
Free Kidney For Sale? 12
as a surprise when considering third-party-payers. The out-of-
pocket payment for the
patients would increase by very little relative to the increase in
the total price of the
treatment. Therefore, an increase in the price of either
treatment will not have a large
effect on the demand of the substitute good. Also, in figure 1.1,
I argued that most ESRD
patients would prefer transplantation, thus wanting to be on
indifference curve I0, but the
shortage of organs moves the patients to indifference curve I1,
consuming dialysis.
Consequently, no matter what the cost of dialysis, the majority
76. of ESRD patients will
have to consume dialysis. This explains the poor significance
of a rise in the price of
dialysis affecting the quantity of transplants demanded.
II. The Shortage
A shortage occurs when the price of the good is set below the
equilibrium level.
Thus, shortages occur when a price ceiling, the most a good can
be sold for, is set below
the equilibrium price and quantity. When looking at the
transplant market, we can assert
that the zero price for kidneys, which must be maintained by
transplant centers, is a price
ceiling. Under the current policy, procurement organizations
have been unable to supply
77. the number of organs that are needed for those wanting kidney
transplants. This
relationship is shown in figure 1.2 where D0 is the demand for
kidney transplants and S is
the supply for transplant. Notice that the demand curve is fairly
steep, indicating that
consumption is inelastic because of third-party-payers. Also
notice that the supply is
fixed at Q0S because the price of kidneys is zero and selling
above that price is illegal.
With the price set at zero, a shortage is created shown by Q0D –
Q0S, noted by the bold
line.
Figure 1.2
78. Free Kidney For Sale? 13
This shortage will persist as long as there is a price ceiling on
the price of kidneys. Later
in this paper I will show how this shortage will be decreased
and potentially eliminated
by the institution of an open market.
A. The Size of the Shortage
The present shortage of kidneys is the result of the zero price
that is placed on
them. Since 1989 there has been an enormous increase of 247%
in the number of
patients on the waiting list and a small increase of 74% in the
number of organs supplied
79. by living and dead donors. However, when looking at this
problem, the actual number of
kidneys demanded is compressed because many doctors will not
allow patients who want
a kidney to be on the waiting list because they do not meet
certain medical criterion to be
a candidate for transplant, though they would be a candidate if
there was a large enough
supply of organs. Graphically the shortage of kidneys is
represented by:
Figure 1.3
D0
S
Q0S Q0D
Price
80. Quantity
Free Kidney For Sale? 14
The Shortage of Kidneys
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
83. la
n
ts
P
er
fo
rm
ed
National Waiting List Transplants performed
Source: www.optn.org
This graph shows the upward trend of the waiting list and the
meager incline of
transplants performed. But why is the gap widening?
84. B. Why is it increasing
As seen by the waiting list data presented in the previous
section the shortage of
kidneys is increasing at alarming rates, 247% since 1989
(UNOS, 2005). The reason for
this shortage is explained by three phenomena.
The first is a growth in technology. Medicine is always
changing because of
advances in drugs and procedures, thus causing a problem of
higher costs for the same
treatment but better results. Kidney transplant has evolved
since its birth in the middle of
the twentieth century beginning with transplantation only being
possible between patients
who were genetically related. At that time, rejection of the
85. organ was extremely likely,
http://www.optn.org/
Free Kidney For Sale? 15
so patients had to bring in potential living donors to the hospital
with them for the
operation. If the patient could not find a suitable donor, there
would be no operations,
hence, no shortage (Altinanahtar, Alper, B.A., M.A., May
2004). With the introduction
of the immunosuppressive drugs, cyclosporine in 1979 and new
drugs Prograft and
Cellcept, rejection rates decreased drastically and survival rates
increased, making
transplant the procedure of choice for ESRD patients (Bryant,
2005)
86. The increase in third-party-payments has also increased the
shortage of kidneys.
With the amendment of Medicare in 1979 increasing Medicare
payments for kidney
disease and private insurance shifting transplant from an
experimental coverage
procedure to a regular procedure, the financial burden of
transplantation became less of
an issue for ESRD patients when deciding between dialysis and
transplantation. Since
the high initial cost of transplant was cut down by private
insurance and Medicare
payments, patients have moved toward transplant as the
preferred treatment which has
increased the demand for transplant and increased the shortage.
Finally, the shortage has increased because of the failure of the
current
87. procurement system. The amount of cadaver organs has
increased only slightly since
1986 with living donors showing the same results (Blair &
Kaserman, 1991). This low
rate of growth is due to a paradox which has been written about
at length. The number of
deaths from car accidents, which yields the most suitable donor
suppliers, has decreased
with the increased usage of helmets and seatbelts. Campaigns
against drunk driving have
also reduced the number of car accidents along with decreasing
the amount of donor-
eligible subjects (Annas, June 1988). Though the number of
organs harvested is not
increasing at levels that are needed, the decrease in traffic
accident deaths is a great
88. Free Kidney For Sale? 16
accomplishment and should be looked at as a positive. To
counteract this stagnation of
cadaver and living organ donation, the National Organ
Transplant Act of 1984 increased
federal funding for the procurement of organs, but various
educational campaigns have
failed to reduce the gap between supply and demand
significantly.
C. The effects of the Shortage
The rapid increase in the demand for kidneys juxtaposed with
the slow increase in
the supply for kidneys has caused large social costs on the
United States. The failure of
89. instituting the proper policy to procure organs has caused
monetary and non-monetary
costs.
The most obvious of these costs is loss of life. Each year a
multitude of patients
die from kidney failure. The Organ Procurement and Transplant
Network documents the
number of patients on waiting lists removed because of death,
below is death removal
data from 1995-2004:
All Region Death Removals from Waiting Lists
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
3,723 4,247 4,811 5,505 6,971 6,639 7,195 7,257 7,008 6,727
Source: www.optn.org
The above numbers should be considered relative estimates
because they do not include
90. the large number of patients that are unable to be placed on
kidney waiting lists. These
patients include those that do not meet the specifications that
nephrologists must use to
decide who is most in need or would most benefit from a
transplant. With this in mind,
the costs of life are not only those that are on waiting lists for
donation but those that are
unable to be placed on waiting lists because they are inadequate
candidates for the
“precious” and “scarce” kidney.
http://www.optn.org/
Free Kidney For Sale? 17
Less obvious costs are those associated with dialysis treatment.
Since many
91. patients with ESRD are unable to receive a transplant they must
consume dialysis,
making dialysis more of an imperfect substitute than a treatment
that yields the same
results as transplant. Dialysis costs are apparent in the time
needed to be hooked up to
the machine, which occurs for three hours per treatment about
three to four times per
week (Bryant, 2005). If transplant was available to these
patients, the time lost while
undergoing dialysis could be filled with more productive
activities benefiting the
individual and society. Finally, patients must undergo surgery
to accommodate the
sixteen gauge needle which must be directly inserted into a
vascular artery for treatment.
92. During each treatment the skin covering this fistula must be
broken, which provides
further discomfort.
Monetary costs are also apparent because of the shortage of
kidneys. Paul Eggers
has compared the costs of dialysis treatment to transplant
treatment in multiple studies.
Each time he has found that transplant is less costly relative to
dialysis over time.
Dialysis costs remain stable over the time of treatment, while
transplant has a very high
initial cost but lower maintenance costs, assuming there are no
complications to the
procedure (Eggers, 1992). His study further supported the
belief that transplant was less
costly than dialysis treatment over time. The high initial cost of
transplant was recovered
93. in about 4 ½ years with a ten year savings of $42,000 (Eggers,
1992). The shortage of
organs prevents the United States Medicare system from
collecting the savings that it
could if less dialysis was used and more organs were available
to ESRD patients.
Lastly, a black market for kidneys has developed because of
this shortage. If
patients waiting for kidneys in the United States cannot get
them, they can go abroad and
Free Kidney For Sale? 18
buy a kidney from individuals that are willing to sell them.
Individuals in countries such
as the United States, Canada, Italy, Australia, Japan, and Saudi
Arabia have been found
94. buying kidneys from people in poorer countries such as
Romania, Philippines, Peru,
India, and China (Scheper-Hughes, 2005). Buyers are willing to
pay a large range of
prices for their kidney, from $750 to $30,000. With the
institution of an open market for
cadaver organs, this black market for living donors would
potentially decrease.
The shortage of kidneys is causing loss of life, large Medicare
payments,
productivity and quality of care deficiencies, and a black market
for kidneys. As waiting
lists grow and more patients are diagnosed with ESRD these
costs will escalate.
Knowing this we must look at the current procurement systems
efforts and effects on the
95. supply of donable organs.
III. Required Request and the Current Procurement System
The current procurement system is based on a volunteerism and
altruistic
framework. In the 1970s and 1980s deaths from the shortage of
kidneys were on the rise,
and there was a need to implement a policy that would help the
procurement of organs.
The answer was required request. This policy required
physicians or nurses to request for
donation from the family members or guardians at the time of
death (Caplan & Welvang,
February 1989). This policy kept the altruistic ideology of
autonomy and giving, while
increasing the amount of organs that were available to
96. transplant.
A. Is required request working?
Economic researchers have studied required request from the
day it was
implemented. Education has been the most important part of
required request. United
Free Kidney For Sale? 19
States policy makers have two central assumptions which
govern organ donation. First,
physicians and nurses fail to ask families to donate, and
secondly, families donate if
asked (Siminoff, Laura A., PhD, Arnold, Robert M., MD,
Caplan, Arthur L., PhD,
Virnig, Beth A., PhD, & Seltzer, Deborah L., BA, July 1995).
97. These assumptions have
been challenged with a study performed by Siminoff, Arnold,
Caplan, Virnig, and Seltzer
which examines why required request has not increased organ
procurement.
Their study found that 83% of healthcare professionals
correctly identify donable
organs, and families of donor-eligible patients were approached
about donation 73% of
the time (Siminoff, Laura A., PhD et al., July 1995). From
these findings, the assumption
that physicians and nurses do not approach donor eligible
patients seems to be
misleading. More interestingly, Siminoff and her colleagues
found that, of the families
that were approached for organ donation, only 46.5% agreed to
donate. This too goes
98. against the assumption that if families are asked they will agree
to donate (Siminoff,
Laura A., PhD et al., July 1995).
Many of the reasons families fail to consent are unclear. With
95% of Americans
stating that they are aware of transplant and about 75% wanting
to donate an organ after
their death, the low percentage of families willing to allow
donation comes as a surprise.
Research has been mixed regarding the “donation experience.”
Some families find the
approachment process to be comfortable, while others believe it
to be a very real
affirmation of the death of their loved one (Siminoff, Laura A.,
PhD et al., July 1995).
This is evidence that the altruistic ideal is not at fault, but
99. rather the approachment
process. It still is not known when the best time to confront
families about donation.
However, it is clear that a family’s knowledge of a patient’s
wishes to donate before their
Free Kidney For Sale? 20
death is central to the procurement of organs (Siminoff, Laura
A., PhD et al., July 1995).
Education seems to be the answer to these difficulties and
continues to be the platform
which procurement organizations use to increase the likelihood
of donation.
Another study by Virnig and Caplan also examined the poor
performance of
required request procurement efforts. This study also found
100. that required request support
was very high among medical professionals and their request
efforts were just as robust;
however, the refusal rates were extremely large. Though the
study found that required
request did not have much of an impact on procurement, it did
find that the effects of this
law helped hospitals become more effective in identifying
donor-eligible patients (Virnig
& Caplan, October 1992). Considering these results, required
request has not failed
entirely. Though organ increases have not been evident,
required request has forced
hospitals to become efficient in identifying and approaching
potential donors.
IV. Alternative