U.S.
Department of Health and Human Services
Advisory Committee on Organ Transplantation
Recommendations 19-28
The Committee
met on May 22-23, 2003 and unanimously agreed on the following
ten consensus recommendations.
RECOMMENDATION
19: That the primary principle in organ donation be honoring
the donor's wishes and fulfilling the donor's intent. This
principle is known as donor designation.
ACOT
affirms the right of individuals to donate their organs and
tissues at death.
The
wishes of the decedent donor should not be overruled when the
organs and tissues are medically acceptable.
This
donor rights model acknowledges individual self-determination
and social responsibility in the exercise of choice to be a
donor.
This
Recommendation relates to donation only. Procurement, allocation
and transplantation are still governed by the rules of the OPTN
and medical judgment.
While
fulfilling donor wishes, procurement agencies and hospital staff
must continue to be sensitive to the needs of, as well as provide
active and adequate support and care for, the families involved.
The
legal system should provide an ongoing opportunity for persons
to make their wishes regarding organ and tissue donation known
and should facilitate the implementation of the donor's wishes.
The Secretary should continue to use his good offices to encourage
states in this regard.
Educational
initiatives should provide training to OPO and hospital staff
and information to the public about the primacy of donor wishes.
Currently, a mixed message is being disseminated, because members
of the public are encouraged to sign a donor card, but are also
told they may not be donors if they have not shared their wishes
with their families.
Donor
Designation. We refer above to the approach recommended
here as the honoring of the donor's wishes and the fulfilling
of the donor's intent. This practice of proceeding with donation
based on the pre-death decision of the donor has occasioned
multiple descriptions: first person consent, donor designation,
and donor authorization are most prominently employed. From
a legal perspective, the donation decision more appropriately
fits under the context of a "gift" rather than an "informed
consent." Moreover, we believe that the donor is making an autonomous
decision and not merely permitting or authorizing others to
fulfill the donor's wishes. For the sake of consistency and
clarity, therefore, we recommend that the term "donor designation"
be adopted as the preferred and more accurate description of
this practice
ACOT
notes that the approach recommended here has been endorsed by
the Association of Organ Procurement Organizations, and received
major support at a recent United Network for Organ Sharing consensus
conference. Additionally, the National Kidney Foundation, the
Coalition on Donation, the American Society of Transplantation,
and the American Society of Transplant Surgeons are all actively
considering endorsement of this approach.
RECOMMENDATION
20: That updated provisions of the Uniform Anatomical Gift
Act with respect to donor rights be fully implemented in all
states where the UAGA has been adopted, and that those or substantially
similar provisions be enacted in all other states.
In 1968,
the National Conference on Commissioners for Uniform State Laws
promulgated the Uniform Anatomical Gift Act (UAGA) that authorized
persons 18 years of age or older to make a gift of any part
of their bodies, such gift to take effect upon death. The Act
further provided that, this gift could not be rescinded by another
party without the donor's consent. Over the next decade, this
provision was adopted by the legislatures of all 50 states
In
1987, the National Conference on Commissioners for Uniform State
Laws promulgated amendments to the Uniform Anatomical Gift Act,
which had as their expressed purpose the encouragement of organ
donations. The specific language employed in the law is: "An
anatomical gift that is not revoked by the donor before death
is irrevocable and does not require the consent or concurrence
of any person after the donor's death." This amendment
to the UAGA was endorsed by the American Bar Association and
has so far been enacted in the following jurisdictions:
Many legal
scholars would contend that the original 1968 UAGA made clear
that a donor's anatomical gift does not require the consent
of anyone else. The amended 1987 UAGA removed any doubt about
that interpretation. Thus, according to the Act, as amended,
an anatomical gift is irrevocable at death.
Despite
the law, however, a telephone poll of OPOs indicated that a
majority would refuse an anatomical gift if the donor's family
objects, although it is not clear why. This practice could
be based on a concern about potentially adverse publicity and
the effect that might have on the overall rate of donation.
Alternatively, this practice might be based on a natural tendency
to exhibit greater respect for the wishes of living persons
present than for those of the decedent. OPOs may also feel
free to refuse an anatomical gift because the law imposes no
penalty for failing to comply with the donor's wishes. Another
possible reason could be an unfounded fear of legal liability
if the OPO acts on the donor's designation against the wishes
of the family.
ACOT
specifically recommends that every OPO and hospital in a state
that has enacted the UAGA, as amended, should be educated in
the implications and enforcement of the UAGA. ACOT further recommends
that OPOs and hospitals in states that have not adopted the
amendments to the UAGA, or substantially similar provisions,
should work with their state legislatures to enact laws that
enforce the donor designation model.
Attached
to this Recommendation is Appendix 6 -- Donor Designation:
State Law and OPO Practice, which details, state by state,
the current law and OPO policy position in every state (and
three other U. S. jurisdictions) where such information could
be ascertained. The OPO policy position reflected in Appendix
6 is based only on a telephone poll, and thus might not reflect
recent changes in practice. ACOT is aware of and encouraged
that the National Conference on Commissioners for Uniform State
Laws will this summer be considering yet another revision to
the UAGA, so as to bring those provisions up to date with the
many changes in practice since 1987, including the 1998 Medicare
Conditions of Participation, which effectively superceded the
1987 language defining the obligations of hospitals to ask families
about donation.
Thus, ACOT
recommends that a comprehensive review and updating of the laws
governing anatomical gifts take place in each state and that
all states be encouraged to adopt laws intended to uphold the
intent of donors. The very most recent state reforms in
Virginia and Florida provide good models for other states.
The Virginia code, for example, declares: "An anatomical gift.regardless
of the document making such gift or donation, that is not revoked
by the donor before death is irrevocable and does not require
the consent or concurrence of any person after the donor's death."
Finally,
as the Virginia code provision implicitly recognizes, individuals
have a right to authorize or to decline donation. A donor may
revoke an authorization, or decide to donate, at any time before
death. Any revised law should also address how a donation can
be revoked. A recently enacted Florida provision, for example,
allows a person to change or revoke plans to donate organs by
telling at least two people, one of whom must not be a relative.
It should be clear, therefore, that the primary purpose of Recommendations
19 and 20 is to honor and support the intent of the donor, whatever
that intent may be.
RECOMMENDATION
21: That HHS direct the OPTN and SRTR to rename and broaden
the scope of the present cadaver donor registration form to
meaningfully capture whether
donor wishes are expressed prior to the time of death, to determine
whether donor wishes are being honored, and, if not, to ascertain
what conditions prevented the fulfillment of the donor's wishes.
The current
reporting of information on an individual potential donor's
decisions regarding donation is confusing and of limited value
for any analysis. For each organ donor, two questions address
a donor's wishes, but, because of the wording of the questions
and the limited rigorousness of the reporting, any analysis
of the reported data is necessarily inconclusive. The OPTN
form must be revised to completely capture necessary information.
For example, as the practice of honoring donor wishes has been
endorsed by ACOT, AOPO and other organizations, it is critical
to ascertain whether OPOs comply with this practice. The high
incidence of "Unknown" responses likely reflects the current
practice in many OPOs of not actively seeking this information
as part of the family consent discussion, but this must also
be investigated.
ACOT recommends
that the confusing and sometimes inappropriate terminology used
in this area needs to be brought up to date and applied consistently.
In this regard, we have made two specific recommendations.
The first was with respect to the phrase "Donor Designation,"
and we described our position in this regard in Recommendation
19. The second concerns the overbroad use of the term "cadaver."
Deceased
Donor. The current OPTN reporting form gathering information
on the donor is titled the "Cadaver Donor Registration Form."
Many in the donation and transplantation community regard the
term "cadaveric" as unduly harsh and disrespectful to the families
of donors. They have requested that professionals use the term
"deceased donor" wherever practicable. We support this change
in the OPTN form, and in all donation and transplantation nomenclature,
to "deceased donor."
RECOMMENDATION
22: That the use of split livers be encouraged as a matter
of national policy.
When
evaluating split liver transplantation as an option, the parameters
that should be considered include wait list mortality and survival
after split liver transplantation. On a national policy basis,
and based on the available outcomes data, ACOT believes that,
for adult/pediatric splitting, whenever it is technically feasible
to do so, splitting should be encouraged. Specifically, ACOT
encourages the OPTN Liver Committee to develop policy changes
that would maximize the use of split livers. Such a maximization
of utility would further respect the kindness of the donor or
donor family who generously provided the organ.
Everything
else being equal, the plain facts appear to be that a split
liver will not be as good for a patient as a whole liver, but
that a split liver is better than no liver at all. The overall
goal is to increase the number of donors and transplants so
that fewer people are forced to remain on the waiting list.
The best way to determine the relative risk of using split livers
is to compare survival after transplant with a split liver with
mortality on the waiting list. SRTR produced tentative yet impressive
data showing that, of 162 patients with a split liver, survival
at 2 years was actually 20 percent higher than had they remained
on the waiting list, which is comparable to the rate for whole
organ transplantation. Therefore, for centers with the ability
to split livers and pediatric recipients, splitting should be
encouraged.
Under the
present practice, if an organ can be split, but there is no
pediatric recipient in that region, it is not likely that a
center, in another region with a pediatric candidate for that
small segment, will be called. This is as opposed to the practice
in Europe, where good organs are considered two listed livers,
and two patient names are automatically issued. ACOT encourages
the OPTN Liver Committee to develop a change in policy to maximize
the use of splits, as many current policies do not achieve this
result. Rather than a separate list for patients willing to
accept a split liver, ACOT suggests that the OPTN develop a
list of patients who could benefit from such an organ and an
allocation scheme for distributing such organs among patients.
RECOMMENDATION
23: HHS should convene a consensus conference, involving key
members of the transplant community and insurance industry representatives,
with the goal of identifying a single reporting mechanism for
clinical outcomes data.
There is
a clear need to establish one standardized request for information
(RFI). Currently, transplant centers must fill out many forms
for insurance companies. UNOS developed a standardized form
for insurance companies at one point, but many insurance companies
have continued to request additional information. A standardized
RFI is presently available on the secure website hosted by the
SRTR, and is available to each transplant center. This form
is updated on a regular basis, but not all insurance companies
have accepted it.
The transplant
community reports that completing these forms is time consuming
and costly, and that insurance companies often ask for data
that transplant centers have already submitted. Completing
many often duplicative forms slows the process and diminishes
the capacity of centers promptly and efficiently to transplant
organs into patients. As a result of these information demands,
patients are not receiving transplants or are added to the list
too slowly.
On the other
hand, some insurance carriers argue that no existing RFI collects
sufficient information to satisfy their needs. Part of the purpose
of the proposed consensus conference would be an attempt to
identify which elements are missing from the standardized RFI,
so as to reduce the gap between what has been produced and what
is required by insurance carriers.
Many large
payers in California have adopted the UNOS RFI and collect other
information from the SRTR data. Therefore, a survey sent to
the major payers might obviate the need for a costly consensus
conference. Most payers with transplant program benefits have
a medical director who reviews the completed RFIs. These insurance
company medical directors could be asked about additional information
needed beyond what is available through the standardized UNOS
RFI or SRTR data.
ACOT believes
that HHS should review all options and, if necessary, convene
a consensus conference, possibly held under the specific auspices
of the OPTN, to resolve these issues.
RECOMMENDATION
24: That HHS issue a request for proposals for research to
define and collect from OPOs and transplant centers those donor
and recipient factors in extra-renal organ transplantation that
would better explain relative risk of graft loss after transplant.
ACOT has
determined that there is a need to better define, at an earlier
stage, those organs that have been variously categorized as
"marginal," "expanded," or "extended criteria donation (ECD)."
(We believe this latter term best describes the organs that
are being used with greater frequency today, and will refer
to them accordingly.) In particular, potential recipients need
to be informed of the risks and benefits of transplant from
such ECD donors at the time of listing, and not just when the
extended criteria organ becomes available. There is a need
to collect such data both to better inform patients about the
risks of accepting a particular organ, and to encourage facilities
to consider certain organs that they otherwise might not use.
This kind of information would inform everyone in the transplant
community and be used to inform the patient more fully.
These recommendations
focus on extra-renal organs, as specific criteria have already
been established for kidneys. The genesis of this recommendation
is that the Committee requested data on relative risk, and learned
that such data are not presently available.
More data
are needed on the recipient data pool and donor data pool to
better define relative risk ratios from the point of transplant
and, especially, from the time of listing. However, ACOT did
not believe it appropriate or desirable simply to add questions
to the OPTN forms, which are already too long and cumbersome.
Instead, ACOT recommends that the Secretary issue a request
for proposals (RFP) for the larger centers to collaborate on
collecting data. This RFP could be issued by that the National
Institute of Allergy and Infectious Diseases (NIAID). Centers
could be chosen for these awards based on consistency in their
pre-operative evaluation and post-operative care to ensure that
the resulting information is robust. Kidney information from
the OPTN is so clear because of the large number of kidney transplants.
In other organs, where the numbers of cases of each type of
procedure are much more limited, standardization is needed in
the way patients are cared for so that other factors can be
isolated and identified within the database
Another
rationale for this research is that of utility. At present,
we know recipients are better off with an ECD kidney than if
they remain on dialysis. For other organs, limited comparable
information is available. Organs that do not meet a specific
degree of quality are not being used, or are assigned on a delayed
basis, so that they are, in effect, being wasted at a high rate.
The driving force for the use of such extended criteria organs
is to enlarge the pool of available organs so as to benefit
more people, i.e., to use organs that would otherwise be wasted,
and thus to save people who would die while waiting for an organ.
The overall goal of ACOT in this regard is to maximize resources.
If a center is willing to use ECD organs, and patients properly
understand the risks involved, these centers can be contacted
immediately and cold ischemic time can be reduced.
Once
the relative risk factors have been developed, the patients' expected survival, using ECD organs, would be calculated
based on the risk factors developed. Thus, one end result of
this research may be the establishment of a separate list of
patients willing to accept such ECD organs, as determined by
pre-set criteria.
This is
a scientific issue that will require additional resources to
address. This recommendation supports the need for better defining
the factors that define long-term outcomes, which will require
additional study and thus additional funding. HHS could issue
an RFP for further studies in these areas.
As a part
of this research, ACOT believes that, for every organ, the risk
ratio increase for adverse outcomes needs to be defined. The
SRTR should continue to study those statistical factors that
increase this risk and put it into the perspective of the end-stage
renal disease (ESRD) natural history on an ongoing basis. It
is apparent that the ECD definition is a fluid one. As other
aspects of transplantation medicine improve, overall outcomes
should improve as well.
RECOMMENDATION
25: That a minimum listing criterion, called the MELD score
critical level, should be established by the OPTN/UNOS liver
committee based on the MELD score that provides no significant
addition of life following transplantation relative to life
on the wait list. The MELD score critical level should be
reevaluated on a continuing basis, and changes made when appropriate.
Data
provided by the SRTR demonstrated that wait list mortality is lower than post-transplant
mortality for patients with low MELD scores (mid teens down
to 1). Accordingly, patients with low MELD scores, who account
for as many as one-third of the patients presently receiving
liver transplants, have an improved chance of staying alive
if they are not transplanted. This is an important finding and
the transplant community must pay a great deal of attention
to these data.
On
the basis of currently available data, ACOT concurs with the
recent recommendation of the OPTN liver committee that the OPTN
establish a MELD score of 10 as a lower limit for performing
transplantation. This lower limit should be referred to as
the MELD score critical level. Patients with such scores (i.e.,
below the MELD score critical level) have a good chance of doing
well while on the wait list and should not undergo transplantation.
Exceptions should be permitted, on an individual case-by-case
basis, when clinically indicated.
To date,
however, the length of follow-up for MELD is limited; the conclusions
about patients who receive no benefit from transplant are based
on about six months of follow-up. It is possible that, in the
longer term, these patients may experience some benefit, although
such data are not yet available, and present evidence indicates
otherwise. Therefore, further data collection and analyses are
essential. Even if patients with lower MELD scores eventually
prove to experience some benefit over time, the benefits to
patients with higher MELD scores are clearly much greater, and,
given the continuing organ shortage, transplantation should
be an option primarily for those with higher MELD scores.
A scarce
national resource should be allocated only to people who would
benefit from it. Some people are too well to benefit, while
others are too sick. In the future, it is likely that the
upper limits of MELD will also be more clearly defined, i.e.,
the point where the severity of illness is so great that transplantation
would be futile, yielding poor outcomes. ACOT therefore encourages
the OPTN liver committee continually to reassess the MELD score
critical level, always balancing and considering the potential
benefit to individual patients and the appropriate use of a
scarce national resource.
RECOMMENDATION
26: That Section 105 of Senator Frist's bill (S. 573 ) be
endorsed, so as to make clear that the term " valuable consideration,"
in the National Organ Transplant Act of 1984, does not include
familial, emotional, psychological, or physical benefit to an
organ donor or recipient.
The
National Organ Transplant Act of 1984 (NOTA) [Pub. L. 98-507,
98 Stat. 2344 (1984), 42 U.S.C. Sections 273-274], contains
a specific criminal prohibition [NOTA Section 301] against any
person receiving "valuable consideration" in exchange for a
human organ [42 U.S.C. Section 274e]. Section 301 of
the National Organ Transplant Act (NOTA), as amended, reads
as follows:
Prohibition
of organ purchases
(a) Prohibition
It shall
be unlawful for any person to knowingly acquire, receive, or
otherwise transfer any human organ for valuable consideration
for use in human transplantation if the transfer affects interstate
commerce.
(b) Penalties
Any person
who violates subsection (a) of this section shall be fined not
more than $50,000 or imprisoned not more than five years, or
both.
(c) Definitions
For purposes
of subsection (a) of this section:
(1) The
term "human organ" means the human (including fetal) kidney,
liver, heart, lung, pancreas, bone marrow, cornea, eye, bone,
and skin or any subpart thereof and any other human organ (or
any subpart thereof, including that derived from a fetus) specified
by the Secretary of Health and Human Services by regulation.
(2)
The term "valuable consideration" does not include the reasonable
payments associated with the removal, transportation, implantation,
processing, preservation, quality control, and storage of a
human organ or the expenses of travel, housing, and lost wages
incurred by the donor of a human organ in connection with the
donation of the organ.
(3) The
term "interstate commerce" has the meaning prescribed for it
by section 321(b) of Title 21.
42 U.S.C.
§ 274e (emphasis supplied).
Over the years, questions have arisen over the scope and intent of the phrase
"valuable consideration," and, given that this is a criminal
prohibition, ACOT deems it important to clarify that neither
the intent of the drafters nor the present use of this term
applies to other than financial exchanges. On March 7, 2003,
Malcolm E. Ritsch, Jr., acting as General Counsel to the United
Network for Organ Sharing (UNOS), drafted an opinion letter
which persuasively argued that NOTA Section 301 did not apply,
for example, to such beneficial arrangements as intended
recipient exchanges or paired exchanges.
Given the growth of this field, however, and the desirability of such continued
innovations as paired exchanges, as well as the fact that no
private legal opinion can bind the government or substitute
for legislative clarification, ACOT strongly supports the efforts
of Senate Majority Leader William Frist as expressed in the
legislation which he has introduced in the United States Senate.
Specifically, ACOT endorses Section 105 of proposed S. 573:
Sec.
105. Technical Amendment Concerning Organ Purchases.
Section 301(c)(2) of the National Organ Transplant Act (42 U.S.C. 274e(c)(2)
is amended by adding at the end the following: "Such term does
not include familial, emotional, psychological, or physical
benefit to an organ donor, recipient, or any other party to
an organ donation event."
RECOMMENDATION
27: That HHS support legislation providing for elimination
of the current three-year time limit on Medicare coverage for
immunosuppressive drugs for the ESRD population.
Although
Medicare does not generally pay for self-administered outpatient
prescription drugs, Congress has specifically mandated that
the program cover "prescription drugs used in immunosuppressive
therapy" furnished to an individual who received an organ transplant
eligible for coverage by the Medicare program. Historically,
the Medicare immunosuppressive drug benefit was limited first
to a one-year period, but legislation enacted in 1993 expanded
the benefit to 30 months of coverage from 1995 to 1997, and
then to 36 months of coverage beginning in 1998.
In the Medicare, Medicaid, and
SCHIP Benefits Improvement and Protection Act of 2000 ("BIPA"),
Congress eliminated the 36-month limitation for Medicare aged
and disabled transplant recipients who were Medicare-eligible
at the time of transplant and received a transplant in a Medicare-approved
facility. However, some
gaps in coverage remain:
Given the life-saving nature of transplantation and the immunosuppressive regime
that follows transplantation, there is widespread agreement
that the present practice of cutting off payments for such necessary
medications for the ESRD population after three years causes
great harm, and often results in the waste of scarce organs
and mortality for persons otherwise saved through transplantation.
Several bills pending in Congress would rectify this problem by amending Title
XVIII of the Social Security Act to eliminate the three-year
time limit on immunosuppressive drug coverage for individuals
who are eligible for Medicare solely due to their ESRD status.
These include: S.178, the Comprehensive Immunosuppressive Drug
Coverage for Transplant Patients Act of 2003, introduced by
Senators Durbin and DeWine; S. 191, the Immunosuppressive Drug
Coverage Act of 2003, introduced by Senator DeWine; and H.R.
2223, the House companion to the Durbin/DeWine bill, introduced
by Representative Camp.
The
principles enunciated in these legislative proposals have been
discussed for years within the transplant community. Lack
of coverage for immunosuppressive medications (which cost up
to $25,000 annually) may force transplant recipients to ration
their supply, greatly increasing the chance of organ rejection.
A 2001 study published in the American Journal of Transplantation
found that low-income kidney recipients had significantly greater
graft loss after Medicare coverage of immunosuppressive medications
ended. This finding was especially significant to poor and
minority populations, because 75 percent of the approximately
13,000 individuals who receive kidney transplants each year
fall into the low-income category, defined in the study as those
making less than $36,000 annually.
Such a graft
loss will lead to either death or re-transplantation. Re-transplantation
is almost as bad since it prevents an organ from being used
by somebody else on the waiting list. Further, many kidney
patients do not even consider the possibility of going through
transplantation (including the possibility of using a living
donor) because of the lack of coverage for anti-rejection drugs.
Instead, they opt to remain on kidney dialysis (which Medicare
pays for indefinitely, regardless of age, at a cost of approximately
$50,000 per year). There is substantial economic evidence,
therefore, that providing continuing Medicare coverage for immunosuppressive
drugs will actually save costs in the long run for CMS and funding
agencies as a whole.
In addition, supporting patient and graft survival through continuing Medicare
coverage for immunosuppressive drugs respects the kindness of
the donor or donor family who generously provided the organ.
With more than 80,000 Americans on transplant waiting
lists, it is senseless to risk a successful transplant and donor's
gift because of Medicare limitations on immunosuppressive drug
coverage.
RECOMMENDATION
28: That HHS support legislation providing for elimination
of the current requirement that recipients must have been Medicare
eligible when they underwent organ transplantation, in a Medicare
approved facility, to later receive the immunosuppressive drug
benefit when they become Medicare eligible through age or disability.
This feature
is contained in some of the legislative proposals enumerated
above in Recommendation 27, as well as in separate bills introduced
by Representative LaTourette (H.R. 588, the Medicare Fairness
for Organ Transplant Recipients Act of 2003) and Representative
Cardin (H.R. 26, the Medicare Payment Restoration and Benefits
Improvement Act of 2003).
An example
will clarify the intent of this proposal. This recommendation
refers to the patient who receives a liver at age 58, or a heart
at age 23, and has insurance other than Medicare. Often, such
recipients are able to return to work as a result of transplantation,
and will then receive medical and prescription coverage through
their employers. If a patient has other coverage for immunosuppressive
medication, then that coverage should remain primary and Medicare
coverage should be secondary, so that the burden on Medicare
is not increased too greatly. This would follow the traditional
pattern for coordination of benefits. During their years of
employment, they will pay federal taxes and contribute to FICA.
If, however, upon retirement or disability, Medicare becomes
their primary insurer, then they may lose the ability to pay
for transplant-related medications. As was stated above with
respect to Recommendation 27, this could result in untoward
harm to individuals, as well as a waste of donor organs.