Staff Working Paper
Organ Transplantation: Potential Policy Recommendations
By Sam Crowe, PhD, and Eric Cohen
Since February 2006, the Council has been engaged in an in-depth
inquiry into the ethical and policy dimensions of organ donation,
procurement, allocation, and transplantation. This inquiry has been
conducted through ten Council sessions, staff meetings with numerous
experts, extensive outreach to key organizations, and multiple staff
working papers. It is clear that the Council has a unique contribution
to make to current debates and will publish a report of its findings in
the spring of 2007.
As with its previous reports, the heart of the Council's contribution
will be in the realm of the ethical, with a series of core chapters on
the ethics of deceased donation, living donation, and organ allocation.
The report will subject various perspectives in the current debate to a
probing inquiry; it will explore the ethical obligations and ethical
dilemmas that shape current practices; and it will try to elucidate the
deeper human goods and attendant imperatives that shape organ donation,
procurement, allocation, and transplantation-from the meaning of the
human body to the nature of human death to the aspirations and limits
of medicine. The result should be an ethical analysis that every member
of the Council can "own."
The Council's work is situated amid widespread concern about the
current system of organ procurement and allocation, as the gap between
organ demand and organ supply continues to widen. Some experts and
organizations are interested in controversial-some would say
"radical"-reforms: from promoting donation after uncontrolled cardiac
death to enacting a policy of presumed consent to permitting and
promoting organ markets. Motivated by a desire to serve the public
good, each of these potential reforms deserves to be considered and
analyzed on its moral merits. The Council's report will surely offer
such analysis in full, giving every position its due and acknowledging
the disagreements that exist both in the country and among Council
members.
As the Council explores these potential reforms, it will also
describe-and, where appropriate, defend-the moral framework that
governs the current system of organ donation, procurement, allocation,
and transplantation. These governing principles include the following:
- that organ transplantation is a good that serves health and saves
lives, which should be facilitated by public policy;
- that being a donor is a personal decision requiring voluntary consent,
a consent that cannot be presumed;
- that families, especially the families of the newly deceased, should
have their needs and wishes respected, especially during the final
moments of a loved one's life and in the first moments of mourning;
- that physicians and medical institutions have an obligation to ensure
that organ donation is safe, free from coercion, and, in the case of
deceased donors, only begins once the donor is rightfully declared
dead;
- that everyone on the organ waiting list should be treated fairly,
allocating organs according to principles of equity and utility that
apply universally to everyone;
- and that organ donors should be true donors, providing organs not for
pay or profit but as gifts of the body to those whose bodies are
failing.
This staff working paper explores a series of focused policy
recommendations that work within the general ethical framework of the
current system. These recommendations envision reforms that serve one
or more of the moral goals of the current system, without violating any
of the principles integral to its overarching moral framework. These
recommendations are offered as potential recommendations; they are
intended to spur and direct Council discussion and to assess where the
Council might pledge its support. For those recommendations that do
seem to have broad support, the staff will develop them further and in
greater detail.
There are nine potential recommendations, which are organized into four
thematic categories:
The first category includes four policies that aim at protecting the
health and well-being of the living donor and his/her family and at
easing the economic burden of living donation, especially for those
with limited resources. This includes providing all donors with a
legally protected unpaid leave of absence from work; providing donors
with tax credits to cover the direct costs associated with donation;
providing donors with life and disability insurance to protect donors
who die or become debilitated due to complications from donation; and
providing donors with supplementary health insurance to cover the
incremental additional health expenses connected to donation.
The second category includes one policy recommendation that aims at
improving the care of transplant recipients by making Medicare
immunosuppressive drug coverage for organ recipients lifelong.
The third category includes two policies that would better serve the
aims of equity and utility in organ allocation: first, by taking
measures to mitigate geographical inequities in organ allocation, and
second, by reforming the criteria that govern kidney allocation.
The fourth category includes two policies that aim at expanding the
supply of available organs within the moral framework of the current
system. This includes the promotion of ethically responsible criteria
for planned donation after cardiac death; and the promotion of paired
and list donation, understood as forms of creative gifting.
Category #1: Ensuring the Well-Being of Living Donors
Unpaid Leave of Absence for Organ Donation
On April 28, 2005, some members of the House of Representatives
introduced a bill called the "Living Organ Donor Job Security Act of
2005." The bill proposes to amend the Family and Medical Leave Act of
1993 to include a provision for organ donation.
The 1993 Act declared that employees who have worked for at least
twelve months for a specific employer and who have worked for at least
1250 hours during that twelve month period may take an unpaid leave of
absence for twelve work weeks for a few specific conditions. These
conditions include the birth and care of a baby, the adoption and care
of a child, the care of a sick family member, or the recovery of the
employee from serious illness.
Only certain employers are covered by the 1993 Act. All public service
employers, all primary and secondary schools, and all employers who
have fifty or more employees for at least twenty of the calendar work
weeks must allow their employees to take this form of leave if needed.
Those private employers who regularly have less than fifty employees
are not bound by the law to permit this form of leave of absence.
The Living Organ Donor Job Security Act would amend the Family and
Medical Leave Act by including organ donation as one of the eligible
reasons for taking a legally protected leave of absence. The bill lists
six specific donation-related activities that the leave would cover:
tests to determine if the person is medically suitable to be a donor,
evaluations to determine if the person has the requisite mental health
to be a donor, pre-transplantation medical services, post-operation
services, travel during the total process, and recuperation time. The
bill does not specify the length of the leave of absence that would be
granted, but presumably the leave would be the same as the other
conditions already permitted.
It is worth noting that all federal government employees, government
employees of some states (Delaware, Maryland, Missouri, Ohio, Utah, and
Virginia), and government employees of the District of Columbia
currently may take thirty days of paid leave to be organ donors. The
Living Organ Donor Job Security Act would supplement this leave for
these federal and state employees by two months. But the bill neither
recommends that public sector donors should be paid during the extra
two months, nor proposes that private sector employees should be paid
at all.
The Council could recommend passage of this or a similar bill. Such a
law would build on the well-established practice of allowing employees
to take leave from work to perform life-giving or care-giving
activities, without requiring that employers pay employees who are not
working. Such a law would ensure that fear of job loss is not the
reason that a willing donor does not donate, without unduly burdening
private employers with mandates they may not be able to fulfill. It
thus balances, in a subtle way, the competing needs of employees and
employers.
In the context of organ donation, the law could be made more or less
specific-for example, by setting different periods of leave for
different types of organ donation, or by making clear that the period
of permissible leave can be broken up to account for pre-donation and
post-donation activities. But the overriding moral principle is clear:
living donors should not fear for their jobs in making the decision to
donate, and in this limited way, the public sector can protect living
donors from this concern.
2. Tax Credits to Compensate the Direct Costs of Donating
Section 274e of Title 42 of the U.S. Code states the following: "the
term 'valuable consideration' does not include the reasonable payments
associated with.the expenses of travel, housing, and lost wages
incurred by the donor of a human organ in connection with the donation
of the organ." This law in effect permits reimbursement for the
financial costs incurred during the donation process, but it does not
support any particular means of payment. A few states (Arkansas,
Georgia, Iowa, Minnesota, New Mexico, North Dakota, Oklahoma, Utah, and
Wisconsin) have created reimbursement programs, but as of now there is
no federal policy to compensate donors for their expenses.
In the spring of 2005, a few members of the House of Representatives
presented a bill entitled the "Living Organ Donor Tax Credit Act of
2005." The bill proposes to amend the Internal Revenue Code of 1986 to
include a nonrefundable personal tax credit for the financial costs of
living donation. The credit would cover un-reimbursed costs related to
the process of donation, offering a tax credit up to a maximum amount
of $5,000. Eligible expenses include the costs of transportation,
lodging, and any wages lost during the transplantation process. The
credit would only be given if an organ is actually removed.
The moral aim of such a policy is to reduce the financial impediments
to being an organ donor. For most people, living without pay and paying
for the travel and lodging expenses connected to donation is a serious
burden, making donation difficult and in some cases impossible. A
policy of reimbursement for expenses, using tax credits, would help
generous donors to be generous by easing the direct financial costs of
their act of organ gifting. Such reimbursement is not an incentive to
donate or a form of payment for donating, but a way to ensure that
donation does not lead to economic problems or even temporary
impoverishment for donors.
A policy of tax credits has certain specific advantages: it employs an
existing tax mechanism as the means of reimbursement; it works within
existing law on organ transplantation, requiring no alteration of the
valuable consideration statute; it focuses on specific expenses rather
than offering a general reimbursement; and it both protects organ
donors and promotes organ donation in a way that is entirely consistent
with the ethical framework that governs the current system. Taken
together, such a policy would provide assistance to those who "give the
gift of life" by giving of themselves, quite literally, to help another
in need. And, inasmuch as it expands the number of donors and thus
reduces the number of patients on dialysis, the economic positive might
outweigh the economic cost of the program.
The Council could recommend passage of a version of the tax credit law,
either in the form already proposed in Congress or with some
modification. As for potential modifications, it could recommend that
the size of the tax credit be either expanded or reduced. It could
recommend that eligibility for the tax credit depend on the personal or
family income of the donor, thus tailoring the program to assist donors
most in need. Or it could recommend that the size of the tax credit
depend on personal or family income (i.e., a larger credit for less
wealthy donors, a smaller credit for more wealthy donors). Whatever the
specifics, however, the overriding principle would be that the public
sector has a compelling moral interest in helping generous people be
generous; just as charitable donations are tax deductible, we could
make the financial costs of being a living organ donor reimbursable,
especially for those who stand to bear the greatest economic burden
from being a donor.
3. Limited Life and Disability Insurance for Living Donors
Like all surgery, living donation carries certain risks. Kidney
donation has a morbidity rate of 1-10% and a mortality rate of 0.03%;
partial liver donation has a 10% morbidity rate and 0.2% mortality
rate. While the risk is relatively low, the possibility that the donor
may become disabled or die is also real. For donors with dependents,
the fear of leaving their families in economic turmoil could become a
reason not to donate, and in those cases of mortality or debilitating
morbidity, poor families most of all could be left in financial ruin.
To ameliorate some of the economic risks associated with living
donation, the Council might recommend publicly-subsidized life and
disability insurance targeted especially to those with limited means.
The available insurance would only cover mortality and morbidity that
result directly from the act of donation, both in surgery and due to
post-operative complications. Such a policy would not be an inducement
to donate, but rather a form of protection for donors and their
families, allowing them better to cope in the event that the worst
imaginable scenarios become tragic realities.
In practical terms, the policy could be structured in various ways. It
might be similar to the insurance policies offered to members of the
armed forces, with donors paying a small fee to opt into the system and
the federal government paying out the policies in the case of
disability or death. Such policies could be available either to all
living donors or to all donors with annual incomes and net worth
beneath a certain eligibility threshold. There could be a single-rate
fee or the fee could be mean-tested to reduce or eliminate the cost for
the poorest donors. Eligibility could be tied to routine follow-up
care, thus requiring that donors care for themselves if the public
sector is going to help care for them and their families.
Alternatively, the law might offer tax breaks or other incentives to
entice private life and disability insurance companies to offer
insurance to living organ donors at a reduced price.
Regardless of its ultimate form, this policy recommendation would
probably require that the existing statute governing organ
transplantation be amended to clarify that the limited form of life and
disability insurance proposed here is not a form of valuable
consideration. Such a policy recommendation, however, would not shift
the moral framework that informs the existing law: namely, that organ
donation should be an act of generosity, not a form of commerce.
Rather, such a policy would remove a potential barrier to donation-fear
of impoverishing one's family-and it would ensure that donor families
are not left in economic ruin in the tragic event that their family
provider can no longer provide for them.
4. Supplementary Health Insurance for Living Donors
Even in the vast majority of cases, when organ donation proceeds
without major complications, there are often additional healthcare
expenses and minor complications incurred by donors, including expenses
that extend beyond the term of coverage by the organ recipient's
insurance policy. And, yet again, it is poorer donors, especially those
with high co-payment or high-deductible insurance policies, that stand
to bear the greatest additional burden.
To address this problem, the Council might recommend offering
publicly-subsidized supplementary health insurance for living donors to
cover the incremental, out-of-pocket costs connected to the act of
donation. This recommendation would be offered as a form of care for
donors intrinsically connected to the act of donation, and it would be
a way to ensure that donors take care of themselves-most notably, that
donors go for all of their necessary follow-up visits, rather than
avoiding extra doctor visits to avoid extra costs. Such a program could
also be tied to expanded follow-up studies of living donors. Like the
reimbursement program recommended above, it could take the form of tax
credits for extra medical costs incurred because of donation. It could
be available to all donors or targeted to donors below a certain
income-level.
A more expansive and more costly recommendation would be to make all
living donors eligible for public health insurance, perhaps through the
Medicare system. The trouble with offering public health insurance to
all living donors, however, is that it risks becoming an inducement to
donation rather than a form of proper care for donors. Some
individuals, lacking quality health insurance or worried about the high
cost of health insurance, might donate in order to become eligible for
publicly-provided healthcare. By contrast, a system of supplementary
health coverage, focused only on covering those costs and complications
related to the act of donation, would ensure that the existing system
of organ gifting is not undermined.
Such a targeted policy of supplemental insurance could be combined with
greater legal protections to guarantee that living donors are never
adversely affected in the private health-insurance market because they
were donors-such as prohibiting insurance companies from treating
donation itself or complications due to donation as cost-increasing
pre-existing conditions.
For donors without health insurance, the policy could require
transplant centers to investigate whether the potential donor is
eligible for Medicaid, and if so, to facilitate enrollment. For those
donors without insurance who are not eligible for Medicaid, the program
could cover the entire cost of care related to the act of donation,
either by reimbursing the donor or by paying the transplant center
directly.
Whatever specific form a policy of supplemental health coverage
ultimately takes, the principle guiding such a recommendation would be
clear: there is a moral obligation to ensure that living donors are
cared for. To permit and even encourage organ donation while leaving
donors at undue risk because they lack healthcare coverage is morally
irresponsible. As with life and disability insurance, such a policy
would probably require an amendment to existing law. This amendment
would clarify that providing limited supplemental health coverage is a
form of care for living donors inextricable from the act of donation,
not a form of valuable consideration or an inducement to donate. And,
once again, this shift in the law does not involve an alteration in the
moral aims that govern the law: namely, ensuring that organ donation is
always an act of generosity, motivated by beneficence rather than the
pursuit of profit.
Category #2: Improving Care for Transplant Recipients
5. Comprehensive Immunosuppressive Drug Coverage
To combat organ graft rejection, transplant recipients must take
immunosuppressive drugs for the rest of their lives. These drugs are
fairly expensive, costing on average $1,000 per month. Private health
insurance can defray much of the cost, but for those who do not have
private insurance, for those with only minimal coverage, and for those
with limited financial means, the out-of-pocket cost for these drugs
can be prohibitive. Many of those who would not be able to afford the
drugs on their own qualify for Medicare drug benefits-specifically,
those who are 65 and over, those who are legally considered disabled,
and those who have end-stage renal disease. The problem is that for the
third class of patients-those whose Medicare eligibility is tied to
their end-stage renal disease-Medicare only covers the cost of the
immunosuppressive drugs for three years.
In addition to the time limit on drug coverage, there are two other
significant limitations that affect Medicare eligibility for drug
coverage for transplant recipients. First, if a transplant recipient is
not eligible for Medicare at the time of the transplant, then the
recipient cannot receive immunosuppressive drug coverage through
Medicare even if the patient becomes of Medicare age or disabled.
Second, if the patient receives a transplant in a hospital that is not
Medicare approved, then the recipient cannot later receive
immunosuppressive drug coverage even if the patient would otherwise
qualify for it.
Currently, the Senate has a bill at the committee level called the
"Comprehensive Immunosuppressive Drug Coverage for Transplant Patients
Act of 2005." The bill would change the law by striking the three-year
time limit on Medicare drug coverage for transplant recipients who were
previously part of Medicare's end-stage renal disease program. It would
also provide immunosuppressive drug coverage for all individuals
covered by Medicare, regardless of whether or not they were eligible
for Medicare benefits when they had their transplant and regardless of
whether or not the transplant took place in a hospital approved by
Medicare.
The Council could pledge its support for such a policy, which makes
both economic and moral sense. First, lifetime immunosuppressive drug
coverage is less expensive than the alternative in most cases. If a
recipient's new kidney fails (this situation only applies to kidney
failure, but most of the organs transplanted are kidneys), then
Medicare will cover the cost of future dialysis and another kidney
transplant. Dialysis costs on average $4,000 per month, while a
transplant operation costs roughly $100,000. Compared to these costs,
the $1,000 per month for immunosuppressive drugs is minuscule.
Second, premature transplant failure, when caused because the recipient
stops taking immunosuppressive drugs, is not only expensive but tragic
and wasteful. To continue with the kidney example, the normal lifespan
of a transplanted kidney is on average 8 to 12 years. When recipients
who cannot afford the immunosuppressive drugs begin losing their
transplanted kidneys at 4 to 5 years, these recipients lose on average
3 to 8 years of a good functioning kidney, and often are added once
again to the waiting list. Given Medicare's large role in caring for
those with end-stage renal disease through its dialysis program,
providing lifelong immunosuppressive drug coverage seems like a wise
investment: ensuring that the sick take care of themselves, and
preventing the avoidable return to dialysis for patients who stop
taking their medications because they cost too much.
Category #3: Improving Organ Allocation
6. Mitigating the Role of Geography
Utility and equity are the central moral ideals that govern the
existing system of allocating organs to those on the public waiting
list. The practical application of these moral ideals is a complicated,
ongoing process, rooted in both certain historical realities about how
organ transplantation took shape in the United States and in certain
clinical realities about the viability and compatibility of human
organs.
Both procuring and allocating organs originated as local practices,
shaped by and directed to the needs of local and later regional
communities. In 1984, the passage of the National Organ Transplantation
Act by Congress signaled a new phase in the evolution of allocation
policy: organ transplantation was embraced as a medical innovation of
national-rather than local or regional-significance, as was the need
for a more ordered, principled approach to securing and distributing
the precious resource of human organs. Subsequent legislative and
regulatory initiatives, by Congress and the Department of Health and
Human Services, have served to articulate and to buttress three
ethically relevant norms: first, in organ allocation, the operative
sense of community should be the national (rather than local or
regional) community; second, organs should be allocated in ways that
achieve their best, most efficient usage; and third, beyond effective
usage, the most important criterion in allocating human organs should
be patient need.
In recent years, there has been laudable progress in the effort to
bring the system of allocation into conformity with these norms. For
example, reforms in the allocation algorithms for livers and lungs have
tilted the balance of criteria toward urgency of patient need and, as a
result, there are now fewer deaths on the waiting list for these organs
and geographic disparities have been lessened. Nonetheless, so-called
"accidents of geography" remain; where a person is registered as a
transplant candidate continues to be a potent factor in determining
whether one ultimately receives an organ or not. To the extent that
organ viability is critical to the efficient, effective use of these
scarce resources, geography will remain a constraining factor in the
allocation of human organs, especially hearts. Yet the geographical
inequities that persist in current practice are not dictated entirely
by the demands of utility. In some cases, the most worthy recipient,
judged by criteria of physiology, age, medical urgency, or waiting
time, is not getting an available and viable organ, or is waiting much
longer for such an organ, simply because they live in the wrong place.
Clearly, there are significant challenges and obstacles that mark the
path toward greater geographical equity in the system. Moreover, the
original and now traditional practice of procuring and allocating
organs within the same local community is deeply entrenched, in part,
because it has served legitimate community needs-and served them
well. For sound ethical reasons, however, the nation has embraced
geographical equity as the most defensible basis for allocating human
organs. In deference to this ideal, the Council could urge UNOS and the
Department of Health and Human Services to continue to explore and
institute reforms that would ensure that allocation serves the needs of
patients, unfettered by accidents of geography.
7. Greater Equity and Utility in Kidney Allocation
At present, the factor weighed most heavily in kidney allocation,
beyond physiological compatibility between donors and recipients, is
waiting time. While this criterion serves equity in an obvious sense,
giving waiting time such a high importance in allocation risks
undermining utility and equity in other crucial ways. To begin with, it
means that the value of receiving an organ is diminished by waiting for
years on dialysis in order to receive it; the result is that we are
getting fewer quality years out of the organs we transplant. We are
also transplanting organs to a comparatively older rather than younger
set of patients with renal failure. The Council could recommend
reforming the kidney allocation system to give greater relative weight
to other factors. Such factors might include:
Age of Recipient: Already, we give priority in kidney allocation
to pediatric patients. The Council could recommend expanding this
principle to benefit comparatively young, non-pediatric patients-for
example, by assigning points for age in a sliding scale, such that as
age increases, the points in the algorithm assigned for age decrease.
Age Relationship of Donor and Recipient: Under the current
allocation system, organs from 20 year old deceased donors are
sometimes transplanted into 60 year old recipients. The Council could
recommend developing a policy requiring that donors and recipients be
of a certain proximate age: for example, a 50 year old on the waiting
list could be eligible for organs only from donors within a decade of
his or her age (i.e., 40 to 60 year olds).
Long-Term Benefit: The Council could recommend giving greater
relative weight to donors who stand to benefit the longest from
receiving a kidney transplant.
Net Benefit: The Council could recommend giving greater relative
weight to donors who would likely receive the greatest net benefit from
a kidney transplant compared to continuing with dialysis. Such a net
benefit calculation could also take into account the comparative
quality of life on dialysis versus life after transplantation.
Each of these proposed reforms of course invites its own criticisms and
problems-including the problem of shifting from the current system to a
reformed system. Any system of allocating a scarce resource stands to
benefit some and thus disadvantage others. But there are sound reasons
to conclude that the current system is not the only way, or the best
way, to serve the goals of utility or equity in kidney allocation, and
that it will serve these goals even less well as the size of the
waiting list continues to grow. In particular, by giving some relative
preference to the young, a reformed allocation system would attempt to
ameliorate some of the inequities of nature (such as getting end-stage
renal disease in one's twenties) in addition to maximizing the benefits
received from transplanted organs; it would not discriminate against
the old, but recognize that in allocating a scarce resource, we need to
do so based on some moral understanding of whose claims are the
weightiest.
Category #4: Encouraging Ethically Responsible Ways to Increase the
Organ Supply
8. Encourage Ethically Responsible Donation after Cardiac Death (DCD)
In certain, well-defined clinical circumstances, doctors and family
members decide that continued life-sustaining treatment no longer
benefits the life the patient still has. Some of these patients are
potential organ donors, and the number of cases of planned donation
after cardiac death (commonly called "controlled" DCD) has been slowly
increasing in recent years: in 1994 there were only 11 donations after
planned cardiac death, whereas in 2004 there were 366. Those 366
deceased donations produced 689 kidneys, 233 livers, 47 pancreata, and
10 lungs. This expansion could become much larger if the large number
of centers that do not have protocols in place for planned DCD are
encouraged to develop them. The Council could recommend a morally
responsible expansion of this practice-both to ensure that wherever it
is done, it is done responsibly, and to encourage a morally sound way
to increase the organ supply.
Donation after planned DCD should only be practiced within an explicit
hospital policy framework governed by clear moral criteria. A morally
sound hospital policy would include the following: (1) The decision to
withdraw interventions must be made independently of the decision to
donate. (2) Donors must receive the same end-of-life palliative care as
non-donors. (3) The hospital should provide the potential donor's
family with the option of being present when life support is withdrawn
and, in general, take every measure to permit family and friends to say
goodbye in a dignified way. In addition, families should not incur any
additional costs related to donation. (4) Procurement teams must wait
the recommended amount of time (2-5 minutes) after the permanent
cessation of heart function before beginning the removal of the organs.
(5) The medical staff overseeing withdrawal of interventions must not
hasten the patient's death, even if the organs might become
un-transplantable. (6) If patients do not die quickly enough to become
donors, a procedure should be in place to return these patients to the
intensive care unit to die in a peaceful and respectful way. In
general, the desire to expand the practice of DCD procurement should
not encourage hospitals to proceed without transparent policies in
place that ensure consistent and ethical practice.
Several moral arguments can be marshaled in support of encouraging
planned DCD. First, it would increase the organ supply in a way that
is entirely consistent with current ethical standards: the donors
and/or the families freely consent to donation; the donors are dead
before becoming donors; and every possible effort can be taken to
respect the needs and wishes of the donor's family in the last moment
of life and first moments of mourning. Second, it would extend the
opportunity for individuals and families to donate in situations in
which they are currently unable to do so. And third, establishing clear
protocols for planned DCD would help to ensure that a bright line is
maintained between those patients who are already dead by neurological
criteria and those who are still alive though severely neurologically
compromised. If DCD preparedness provides another responsible means for
facilitating donation after death, then the temptation to use nearly
dead patients as a source of organs should be diminished.
The Organ Donation
Breakthrough Collaborative is actively working to help develop and
spread ethically sound protocols for planned DCD. The primary thrust of
the Collaborative's efforts aim at educating and training hospitals,
organ procurement organizations, and transplant center staff. The
Collaborative is also supporting research that aims at achieving higher
transplantation success rates with organs procured after cardiac death
by spreading information about better surgical techniques, better organ
preservation, and better matching with potential recipients.
The efforts of the Collaborative are in sync with actions being taken
by UNOS and other groups to provide incentives and requirements to
hospitals to expand the practice of DCD. UNOS adopted a resolution in
August 2006 to include in its bylaws a requirement that all
participating organizations have a DCD protocol in place by January 1,
2007. The organizations that would be subject to this requirement
include all organ procurement organizations and all transplant
hospitals, where procurements also take place. The requirement would
not force all potential donor hospitals to have protocols because the
OPTN has no jurisdiction over these centers. A requirement to develop
DCD protocols in every hospital is currently being considered by the
hospital accreditation body, the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO). A Council endorsement of ethically
responsible planned DCD could mean lending its weight to some of these
efforts.
9. Encourage Paired Donation and List Donation
Paired donation and list donation are creative forms of organ gifting,
allowing living donors who are not biologically compatible with their
intended recipients to work together with one another, or in
conjunction with the public waiting list, to make donation possible in
cases when otherwise it would not be. A paired donation generally
involves two living donors and two intended recipients: Donor A gives
to Intended Recipient B, and Donor B gives to Intended Recipient A.
Paired donations can also occur among multiple pairs of donors and
recipients. A list donation occurs when Donor A desires to give a
kidney to Intended Recipient A who is not biologically compatible.
Instead, Donor A gives a kidney to someone on the kidney waiting list,
and in exchange Recipient A receives a compatible kidney from the list
more quickly than if Donor A did not donate to the list.
Paired donation and list donation can be combined and used together in
what is called a "chain exchange." Chain exchanges, in their simplest
form, entail two pairs (A and B) that do not qualify for paired
donation, meaning that both donors do not match the recipients of the
opposite pair. Instead, only the donor of pair A matches the recipient
of pair B. In a chain exchange, the donor of pair A gives a kidney to
the intended recipient of pair B, and the donor of pair B in turn gives
a kidney to the general kidney list. The intended recipient of pair A
then moves up the waiting list for kidneys.
Paired donation and list donation are not new ideas. Transplant
surgeons in some centers have been doing them for the past few years.
The first documented list donation occurred in 2001 at the New England
Program for Kidney Exchange. There have been an estimated 55 list
donations carried out in the United States. The Johns Hopkins'
Comprehensive Transplant Center performed the first simple paired
donation in the United States in 2001 and the first triple kidney
donation in August 2003. In total, there have been an estimated 125
transplants using paired donations in the United States.
In February 2006, a few Senators introduced a bill called the "Living
Kidney Organ Donation Clarification Act." The bill would clarify under
law that paired donation and list donation do not involve the giving of
kidneys for valuable consideration. The bill is currently with the
Committee on Health, Education, Labor, and Pensions.
Beyond clarifying the legality of these practices, there are two main
ways that a policy promoting paired and list donation could be
implemented. First, Congress could grant the OPTN extensive control
over paired and list donation. The OPTN would then most likely create a
national paired donation registry and clear rules to ensure that list
donations do not unfairly disadvantage those who are already at the top
of the waiting list, especially those with rare blood types. This
approach would presumably bring many potential donors to the registry,
and would unify the registry policy and living organ donation policy
more generally.
The second approach would be to provide federal assistance directly to
transplant hospitals to help them to develop or to expand paired and
list donation programs without OPTN interference. This option would
include offering grants for paired donation registries to cover
registry costs, such as the salary for transplant coordinators, public
education expenditures, and ongoing research. This option would help
private organizations to explore further the different ways of running
patient registries without the bureaucratic oversight that would be
part of the OPTN system.
The Council could both recommend passage of the Living Kidney Organ
Donation Clarification Act and encourage the creation of expanded and
ethically responsible national/local protocols for paired donation and
list donation. Such a recommendation would help facilitate this
creative form of gifting, allowing generous potential donors to become
actual donors. Through these measures, the bonds of community could be
both widened and deepened, binding individuals to one another through
mutual acts of generosity.
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