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.
Go to: Consensus
Recommendations 1-18 (November 2002)
Go to: Consensus
Recommendations 29-35 (November 2003)
Go to: Consensus
Recommendations 36-41 (November 2004)
Go to: Consensus
Recommendation 42 (May 2005)
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