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HE 485W Bioethics for Public Health
please answers each of the following in a brief
paragraph.
l. Please explain why we should have cause for concern
regarding
the Bioethical issues facing us in today's modern contemporary
Society
2. When does an individuals' right to choose begin to threaten
the
autonomy of others? Likewise, when does the quest for
autonomy begin to threaten individual rights?
3. Please explain how genetic engineering and testing along
with
Bio-technology has the potential to promote discrimination.
4. Please describe the inherent social challenges in cloning
human
beings as we have discussed them in class or otherwise.
5. In your opinion, would it ever be appropriate for employers
to
screen for predetermined genetic disorders. Why and Why not?
6. Would it ever be ethical to withhold information from a
dying
patient? Why and Why not?
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 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
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.
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
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
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
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.
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
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?”
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
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
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
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
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
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
Maryland
Massachusetts
Michigan
Missouri
New Hampshire
Ohio
1987
Arkansas
Colorado
Iowa
Minnesota
Mississippi
Mo ntana
Nebraska
Nevada
New Jersey
New Mexico
North Carolina
North Dakota
Oklahoma
Texas
Washington, D.C.
1988
Alaska
Hawaii
Virginia
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.
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
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.
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
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.
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
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
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
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.
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.
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
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
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
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
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
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
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
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-
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
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
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
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
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
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
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.
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.
Undergraduate Economic Review
A publication of Illinois Wesleyan University
Vol. II – 2005-2006
Title “Free Kidney For Sale? Substitution, the Shortage, and
Procurement Policy”
Author Matthew E. Allen
Affiliation College of Saint Benedict / Saint John’s University
Abstract From 1989 to 2003 kidney transplant waiting lists have
grown 247%. The
effect of this growth and advances in kidney transplant
technology has
caused a shortage of available organs and the death of
thousands waiting
for their transplant. Current procurement policy based on
altruism has
failed to increase the supply of kidneys, yet many consumers
and
professionals are opposed to a market based system. This paper
will
examine the current altruistic procurement policy as well as
presumed
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
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
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-
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
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
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
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
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
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
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).
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
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
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
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
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
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
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
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
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
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
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.
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
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
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
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.
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
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
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
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
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
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
50,000
55,000
60,000
1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999
2000 2001 2002 2003
Time
N
u
m
b
er
o
f P
at
ie
n
ts
o
n
W
ai
tin
g
Li
st
s
an
d
T
ra
n
sp
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?
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
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)
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
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
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
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
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
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.
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
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
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
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
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).
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
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
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
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

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HE 485W Bioethics for Public H.docx

  • 1. HE 485W Bioethics for Public Health please answers each of the following in a brief paragraph. l. Please explain why we should have cause for concern regarding the Bioethical issues facing us in today's modern contemporary Society 2. When does an individuals' right to choose begin to threaten the autonomy of others? Likewise, when does the quest for autonomy begin to threaten individual rights? 3. Please explain how genetic engineering and testing along with Bio-technology has the potential to promote discrimination. 4. Please describe the inherent social challenges in cloning human beings as we have discussed them in class or otherwise. 5. In your opinion, would it ever be appropriate for employers to screen for predetermined genetic disorders. Why and Why not? 6. Would it ever be ethical to withhold information from a dying patient? Why and Why not?
  • 2. 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.
  • 3. 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).
  • 4. 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 discriminates against a person or class of persons on the basis of race, national origin, religion, gender, or similar characteristic.”
  • 5. 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. Critics of Organ CommerceArguments include: Exploitation,
  • 6. 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 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
  • 7. 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 Organ Transplant and Donation
  • 8. 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 Some National StatsOrgan and Tissue Donation Statistics:The national waiting list for organ donation is rising at the alarming
  • 9. 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. Selling OrgansProponents for selling organs state that it is a
  • 10. 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 by Kathleen S. Andersen and Daniel M. Fox Prologue: Health policy making regarding the emotionally
  • 11. 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?” 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
  • 12. 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 on Organ Transplantation, Congress required hospitals to establish written protocols to identify potential organ and tissue donors.
  • 13. 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 between federal and state regulations is likely to be. We conclude with a descrip-
  • 14. 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 By 1973, the Gift Act was enacted in some form in all fifty states. In
  • 15. 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 described a policy of “required request” that could increase donations simply by not
  • 16. 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 legislation did not pass. Only Idaho and Wyoming have taken no action.
  • 17. 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 Maryland Massachusetts
  • 18. Michigan Missouri New Hampshire Ohio 1987 Arkansas Colorado Iowa Minnesota Mississippi Mo ntana Nebraska Nevada New Jersey New Mexico North Carolina North Dakota Oklahoma Texas Washington, D.C. 1988 Alaska Hawaii Virginia Pennsylvania Rhode Island
  • 19. 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. In contrast, California’s law requires no involvement by the state
  • 20. 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 potential donors. It is unclear whether the difference between the two types of
  • 21. 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. The regulations that health departments have established usually reflect concerns of hospitals, physicians, and the transplant community.
  • 22. 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 that the outcome be recorded in the patient’s medical record; six of these require
  • 23. 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. Respon- dents from a number of states noted that surveillance is unnecessary
  • 24. 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 are amendments to the Uniform Anatomical Gift Act, is the hospital’s ex-
  • 25. 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 the earlier law would be repealed because he thought it offended pa- tients. Contrary to action taken by other states, the Vermont
  • 26. 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 identified nine inadequacies in the system, including the failu re of persons to sign written directives for organ donation, the failure
  • 27. 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. The new routine inquiry and required request provisions ensure in-
  • 28. 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. Congress, in the Omnibus Budget Reconciliation Act (OBRA) of 1986, amended the conditions of participation to require that
  • 29. 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 regulations to designate organ procurement agencies eligible for Medicare reimburse-
  • 30. 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 aware of their option to donate tissue, the requirements of our regulations do not
  • 31. 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 meet HCFA’s rules. Anticipating the new rules, eight states enacted laws that
  • 32. 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 NCCUSL told us that required request and routine inquiry are now dead issues, both because most states have already passed laws and
  • 33. 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 stringent routine inquiry law. Our respondent said that the 1985 regulation was
  • 34. 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 the supply of organ and tissue donations. No mention is made of the HCFA regulations.
  • 35. 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 the required request law by July 1987. In 1986, heart donations increased by 94 percent, livers by 96 percent, and kidneys by 23 percent.
  • 36. 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- ported findings similar to Oregon’s. The director of the Regional Organ Procurement Agency in Los Angeles stated that during the first
  • 37. 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 in the area. The staff member interviewed cited problems with data accuracy
  • 38. 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 was trying to eliminate the certificate of request, New Jersey was enacting a routine inquiry law that made it a reporting requirement.
  • 39. 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 hospitals. A staff member in the health department’s bureau of health facilities said that compliance is monitored through what he
  • 40. 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 seen. For the present, we can only observe that there is a national consensus that the opportunity to donate organs should not be
  • 41. 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 1. 2.
  • 42. 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 record that information in their medical record, and / or to inform the families of deceased patients of their
  • 43. 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. National Conference of Commissioners on Uniform State Laws, “Uniform Anatomi- cal Gift Act (1987).”
  • 44. 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. Undergraduate Economic Review A publication of Illinois Wesleyan University
  • 45. Vol. II – 2005-2006 Title “Free Kidney For Sale? Substitution, the Shortage, and Procurement Policy” Author Matthew E. Allen Affiliation College of Saint Benedict / Saint John’s University Abstract From 1989 to 2003 kidney transplant waiting lists have grown 247%. The effect of this growth and advances in kidney transplant technology has caused a shortage of available organs and the death of thousands waiting for their transplant. Current procurement policy based on altruism has failed to increase the supply of kidneys, yet many consumers and professionals are opposed to a market based system. This paper will examine the current altruistic procurement policy as well as presumed 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.
  • 46. 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 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
  • 47. 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 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
  • 48. 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- 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
  • 49. 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 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
  • 50. 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 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
  • 51. 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 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
  • 52. 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 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
  • 53. 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 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
  • 54. 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 clustered with medical market observations will serve as a foundation for working toward correcting the shortage of kidney organs. I. Dialysis, Transplant, and Substitution
  • 55. 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). 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
  • 56. 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 dialysis solution which is exchanged via catheter every four to six hours. It is important to recognize that Free Kidney For Sale? 7
  • 57. 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 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
  • 58. 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 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
  • 59. 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 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
  • 60. 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 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
  • 61. 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 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
  • 62. 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 Free Kidney For Sale? 9 or the physical strain from kidney surgery and weigh the health benefits with these costs rather than monetary expenses.
  • 63. 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 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
  • 64. 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 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
  • 65. 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 Dialysis I0 I1 Transplant Figure 1.1 illustrates the argument in graphical form. Notice that each indifference curve,
  • 66. 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. 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
  • 67. 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 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
  • 68. 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 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:
  • 69. 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 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
  • 70. 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. 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
  • 71. 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 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.
  • 72. 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 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
  • 73. 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 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
  • 74. 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 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
  • 75. 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 Quantity Free Kidney For Sale? 14 The Shortage of Kidneys
  • 77. 2000 2001 2002 2003 Time N u m b er o f P at ie n ts o n W
  • 79. 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? 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
  • 80. (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 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
  • 81. 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) 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
  • 82. 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 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
  • 83. 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 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
  • 84. 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 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
  • 85. 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 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
  • 86. 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 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
  • 87. 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. 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
  • 88. 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 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
  • 89. 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 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
  • 90. 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 supply of donable organs. III. Required Request and the Current Procurement System The current procurement system is based on a volunteerism and altruistic
  • 91. 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 transplant. A. Is required request working? Economic researchers have studied required request from the day it was
  • 92. 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). 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.
  • 93. 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 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
  • 94. 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 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
  • 95. 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 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
  • 96. 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