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:
-
Alaska
-
Arizona
-
Arkansas
-
California
-
Colorado
-
Connecticut
-
Delaware
-
Florida
-
Georgia
-
Hawaii
-
Idaho
-
Illinois
-
Indiana
-
Iowa
-
Kansas
-
Louisiana
-
Minnesota
-
Missouri
-
Montana
-
Nevada
-
New
Hampshire
-
New
Mexico
-
North
Dakota
-
Oregon
-
Pennsylvania
-
Rhode
Island
-
South
Dakota
-
Tennessee
-
Utah
-
U.S.
Virgin Islands
-
Vermont
-
Virginia
-
Washington
-
West
Virginia
-
Wisconsin
Additionally,
the following states have retained the 1968 language, but
adopted separate provisions that convey the intent of the
1987 language to honor the donor's designation:
-
Kentucky
-
New
Jersey
-
North
Carolina
-
Ohio
-
South
Carolina
Accordingly,
it should be noted that 39 of the 50 states effectively have
donor designation provisions.
Remaining
jurisdictions — ones that only have the 1968 language
— are:
-
Alabama
-
District
of Columbia
-
Guam
-
Maine
-
Maryland
-
Massachusetts
-
Michigan
-
Mississippi
-
Nebraska
-
New
York
-
Oklahoma
-
Texas
-
Wyoming
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 web
site 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:
-
ESRD
Beneficiaries: If Medicare eligibility is based
solely on the recipient's end-stage renal disease (ESRD)
status, coverage of immunosuppressive drugs ends three
years after the transplant, when the recipient's overall
Medicare entitlement ends.
-
Aged
and Disabled Beneficiaries: Many transplant recipients,
particularly non-kidney recipients, were not Medicare-eligible
when they received their transplant. When they later become
Medicare-eligible, through age or disability, they do
not receive the benefit because the statute requires them
to be Medicare-eligible at the time of transplant.
-
Medicare
Beneficiaries Previously Transplanted in Non-Medicare
Approved Facilities: Transplant recipients covered
by private or other non-Medicare insurance are not necessarily
transplanted in Medicare-approved facilities. When they
later qualify for Medicare, through age or disability,
they also do not receive the immunosuppressive benefit
because the statute covers only those transplanted in
a Medicare-approved facility.
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.
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