Advisory Committee
on Organ Transplantation (ACOT)
Hilton Rockville Hotel
Rockville, MD
May 15-16, 2007
May 15, 2007
Ms. Gail
Agrawal, Chairperson, welcomed the group and read a letter
from Larry Hagman, whose last meeting this was to be. Mr.
Hagman's letter described his inability to attend due to family
obligations and expressed how much he has enjoyed his ACOT
membership.
Mr. Remy
Aronoff, Executive Secretary, introduced Dr. Russ Wiesner,
the newest member, from the Mayo Clinic. Mr. Aronoff thanked
ACOT members for the work that everyone has done between meetings
and noted that this will be a very full agenda.
Public
Solicitation of Donors – Dr. Douglas Hanto
There
are important ethical aims in distributing scarce health care:
maximizing the benefits from a limited resource (utility),
and distributing the resource fairly or equitably among all
possible recipients (justice). These two goals will often
conflict, however, and trade-offs will be necessary, but they
must be kept in mind. This summary comes from Dr. Dan Brock
of Harvard Medical School, who is currently working with the
government in Thailand, looking at ways to provide limited
dialysis in that country.
Organ
donation can be thought of along a spectrum that spans from
altruism, solicitation, incentives, coercion and theft. The
concept of “sales” can occur along this spectrum in multiple
places, depending on your position regarding the ethics of
sales. Everyone is familiar with billboards that have been
used to advertise for a directed liver donation to that individual.
Decreased
organ donation allocation: organs are allocated in a non-directed
fashion, to patients on the United Network for Organ Sharing
(UNOS) waiting list. There are exceptions, such as when organs
are donated to family members or friends of those on the list;
or when a donor family responds to the public plea made by
a potential recipient, and directs the donor’s organ(s) to
that recipient. Solicitation allows one to jump the list,
which many feel violates fair principles. Therefore, the issue
of solicitation is more straightforward for deceased donors
than it is for live donation. It is important to remember,
however, that solicitation is permitted in both the Final
Rule (1999) and in the UAGA (1987).
Living
donation is, in contrast, largely unregulated; and there are
currently no allocation policies. Living donations have historically
occurred between friends and/or family members, which is ethical.
Policies for this sort of donation are set by the transplant
centers. Donations are increasing from anonymous non-directed
donors to the next appropriate person on the list. These “Good
Samaritan” donations do not violate national policies so long
as payment does not occur. Solicitation can involve unethical
and/or illegal practices, however. For this reason, the Health
Resources and Services Administration (HRSA) asked UNOS to
create guidelines about solicitation. It is relatively uncommon
at this moment, which presents an opportunity for the issue
to be addressed before it becomes a bigger problem.
The Organ
Procurement and Transplantation Network (OPTN) response outlined
in a paper written by Dr. Frank Delmonico and Walter Graham,
has been that it is:
1. developing
guidelines for the appropriateness of donor/donee relations
in directed donation from deceased donors; and 2. working
to deter media solicitations that are counter to the goals
of the National Organ Transplant Act (NOTA), but there is
no solution for a family that persists in directing donation(s)
They have
stated further that the OPTN cannot regulate or restrict how
relationships are developed for the purposes of living donation.
It is the goal, however, to prevent sales, remove financial
disincentives from donation, and reimburse donor expenses.
The OPTN will work to develop guidelines for the psychosocial
evaluation of all living donors. This does not really provide
transplant centers with practical answers on how to address
the real situations that arise, however.
An upcoming
paper by James Rodrigue, Ph.D. at Beth Israel Deaconess Medical
Center Transplant Center submitted to the American Journal
of Transplantation provides insight into acceptable donor
types. A survey of centers on acceptable donor types found
that only about 30 percent of programs view as acceptable,
a person solicited via the Web, newspaper or media. While
these donors are not necessarily viewed as acceptable, they
may not be refused.
Arguments
for solicitation of organ donors note that donors have autonomy.
Those who support this position say that one should be able
to give an organ to anyone one chooses, and a kidney may be
considered a private resource that may be disposed of as the
owner wishes. Supporters of solicitation note that the current
allocation system may be unfair to certain patients and may
favor some over others (in terms of geography, for example).
Solicitation may result in greater awareness about donation,
and hence generate more donations.
Opponents
of solicitation note that donor autonomy is not absolute and
must consider the fair rights of others. For example, one
must also consider the ethical, legal, and social obligations
of the transplant surgeon, nurses, and hospitals; they should
not be forced to participate in something they find unethical.
Solicitation of deceased donors bypasses the fair policies
of allocation and the person who is ethically entitled to
the organ. It permits discriminatory practices and favors
the well educated and those with financial resources. Solicitation
risks the exploitation of donors or recipients and may result
in the undetected buying and selling of organs. Finally, it
may divert organs to unsuitable candidates for transplantation.
Ideally,
we want to balance the rights of the donor who claims autonomy
with the rights of all of those who are waiting on the list.
When the balance shifts to those on the list, exclusively,
it ignores donor rights – which is not acceptable. But, alternatively,
we cannot go so far in the other direction that donor autonomy
has absolute preference. This would not work with a national
allocation policy (it’s like picking the flowers in the public
park; when everyone does it, it prevents the system from working
for the entire community). Dr. T. M. Wilkinson argues that
conditional organ donation should be acceptable; he cites
a United Kingdom situation in which a family would only permit
donation to a white person and argues that even such a discriminatory
donation can be altruistic and acceptable.
Some argue
that kidney donors want to be able to direct their donation
and will be less likely to donate if this right is removed.
This view is not supported by experiences at the University
of Minnesota, which requires Good Samaritan donor kidneys
to be given to the next patient on the waiting list (See AJT
2004;4:1110-6). A national conference on non-directed living
kidney donation supported non-directed donation to the list
(See JAMA 2000;284:2919-26). Dr. A. Spital reported
that 93% of willing donors to a stranger would still donate
if they could not direct their donation (See Transplantation
2003;76:1252-6). If we educate people, we can show that the
allocation system makes sense and they will accept it.
Is the
donor allocation system fair? UNOS is required to conduct
allocation in a way that balances justice, equity, and utility.
The system includes broadly representative committees that
develop, solicit public comment on, approve, and review allocation
policies. The system involves both public and governmental
accountability and oversight. The model used for deceased
donation can be applied, with modifications, to live donor
transplantation as well.
Does solicitation
increase awareness about donation, and donations themselves?
Media publicity does increase awareness about donation; anecdotally,
there are instances where people come forward as a result
of solicitation. But, there are no data on this. Stories used
for solicitation suggest that the people soliciting are exempt
from the criteria used for allocation to the list, but we
should remember that all people have stories. Consideration
should be given to putting people’s stories on UNOS Web site
so they reach the public outside of a solicitation setting.
Solicitation
may yield discriminatory practices: the donor can choose recipients
based on a discriminatory basis, which is unethical because
it places some at a disadvantage (e.g., those who are less
attractive or have less “compelling” stories). It is clear
that directed donation favors those with public relation skills
or other advantages (e.g., ability to use the media or Internet,
physical attractiveness). Internet access, for example, varies
greatly by age, socio-economic status, and geographic location.
When the recipient can pay for the donor’s expenses, it favors
those who are better off and have a greater ability to cover
these costs for a donor.
If solicitation
becomes common, people may elect to solicit a stranger rather
than ask a family member for a donation because they may not
be willing to ask their family to make this sacrifice. This
could decrease donations. In fact, there are examples of this
happening. In India, family member donations dropped because
it was safer and easier to buy an organ than to ask a family
member for one. In Hong Kong, the living donation rate dropped
when Hong Kong rejoined China. In Egypt, live donor liver
transplants have nearly disappeared because people are going
to China to purchase deceased donor livers. Additional risks
from solicitation include illegal demands for payment and
the donor contacting the recipient at a later date for assistance.
For these reasons, preserving the anonymity of both donor
and recipient is preferred by many, unless the donor and recipient
wish to meet.
Solicitation
may divert organs to unsuitable candidates, to those who are
not appropriate recipients. The young man in Texas (who had
a billboard soliciting an organ) was not a good candidate,
and he died within a year of recurrent liver cancer. One wonders
what happened to the next person on the waiting list who did
not get the liver because it went to this young man.
In conclusion,
solicitation of deceased donors by recipients (or their agents)
should not be permitted. Solicitation of living donors may
involve unethical and illegal practices that place both donors
and recipients at risk, and should be discouraged. Non-directed
donation from a deceased or living donor to the first patient
on the waiting list is preferable, and unlikely to discourage
donation.
UNOS is
best positioned to, and should, regulate living organ donation
and allocation. The same principles used for non-directed,
deceased-donor allocation should be applied. Directed donation
from deceased and living donors to family members and persons
with preexisting emotional relationships should continue.
UNOS must create a policy that defines the acceptable preexisting
emotional relationships, and the OPTN Final Rule should be
amended to cover this. One must be willing to accept that
donor autonomy is not the end-all, be-all in this situation.
A common
comment made by supporters of solicitation is that no one
is disadvantaged by this. Such a statement assumes that the
directed donor would not have donated to the list, but evidence
suggests otherwise. Most would give to the next person instead
of the directed recipient. Supporters also note that we permit
directed donation by family and friends, so why not allow
this as well? The response is that there are unique relationships
and obligations among family members. If we didn’t permit
donations among relatives, it would cripple donation rates.
Finally, supporters of solicitation complain that those without
living donors are penalized by events they cannot control,
but the fact is that the presence -- or absence -- of special
qualities (e.g., moving story, attractive physical features,
social standing) should not determine allocation.
What are
the alternatives to solicitation? We should decrease financial
and other disincentives for live and deceased organ donation
(offer paid leave for donors; offer reimbursement for lost
wages and expenses for live donors; and provide first-person
person consent. We should work to increase altruistic live
donation (by related and unrelated donors) (e.g., ABO incompatible,
desensitization, paired kidney exchange, and “Good Samaritan”
non-directed donations). We need to keep working to increase
deceased donor donation through mechanisms that include the
Organ Donation and Transplantation Breakthrough Collaboratives
and presumed consent. We should use extended criteria organs
and donors after cardiac death and work on continuing improvement
in outcomes and xenografting.
Discussion
--
Dr. Solomon
asked if there is any research on the motivations of Good
Samarians.
Dr. Hanto replied that there is, mainly among blood or bone
marrow donors who want to help. There are also other individuals
with other motivations as well; a large number are screened
out of the donation process on the initial phone call. They
are “altruistic,” but they have psychological, medical, or
other reasons to be excluded on the initial phone call.
Dr. Solomon
asked if, since the Organ Donation and Recovery Improvement
Act allows financial reimbursement for expenses, there is
a concern about solicitation and/or incentives that stem from
this. The Act provides for reimbursement of donors for travel
and subsistence expenses and other incidental non-medical
expenses that the Secretary may authorize by regulation. HRSA
awarded an $8 million 4-year cooperative agreement to the
Regents of the University of Michigan to operate this program.
Dr. Hanto commented that such funding would remove a barrier
to donation.
Mrs. Boone
remarked that she felt it’s unethical to solicit donors into
a process that has no long-term follow-up on results for donors.
Dr. Hanto replied that the system has always been focused
on the safety of live donors, but there is an increasing concern
about the lack of long-term data on this population. The University
of Minnesota has some good data and looking long-term at this
issue. But, it’s hard to get donors to come back for follow-up
visits. Barriers to knowing these patients are safe include
reimbursement, patients failing to return for follow-up visits,
and the expense of coming back for follow-up. It’s a big focus
and priority of groups like UNOS and American Society of Transplantation,
especially live liver donors. Mrs. Boone noted that most of
the likely problems are not known to donors when they accept
the request to become a donor. They have no idea about the
quality of life issues, for example. Dr. Hanto stated that
most transplant programs try to talk about the risks and complications,
and this has been an increasing focus in the last few years.
A new video produced by the American Society of Transplant
Surgeons addresses living donor issues.
Dr. Migliori
said that Dr. Hanto’s conclusions hinge upon the determination
of an acceptable “pre-existing emotional development,” and
he asked what Dr. Hanto felt those parameters are. Dr. Hanto
responded that this will be hard to define in detail and it
will be necessary to do so generally and give examples. Certainly,
friends and relatives are acceptable. The struggle occurs
where the relationship exists solely for the purposes of donation.
That’s one extreme. (Matchingdonors.com
is an example of this). Yet, 40 percent of Americans say that
their closest relationships exist with people they relate
to on the Internet. They view these as friendships with emotional
content. One cannot prohibit how people forge friendships.
Another example is someone asking for a donation at church.
Our view has been that, where close relationships exist, solicitation
should be acceptable. Friendships within the workplace or
in a community (however that is defined: religious, geographic,
Internet, service) are usually seen as acceptable. These are
hard to define, however. The goal is to prevent exploitation
of both the donor and the recipient.
Ms. Conrad
agreed that, as a living donor herself, it’s like herding
cats to get donors to come back in for follow-up. Donors should
be able to get needed follow-up through their local doctors,
and have the results sent back to the Centers. She commented
that donors such as herself are healthy, and don’t want to
go back to the transplant center. The problem is one of resources;
we can’t just send a donor a letter saying, “go to the doctor.”
It takes more effort than that to get the information on donors.
Dr. Reyes
asked about the numbers of solicitations a year. Dr. Hanto
stated that it’s about 70-80 cases a year. The numbers are
relative and the social question is more critical. The small
number raises the question of whether they should direct attention
to prevent solicitation, or if we should just keep watching
the situation. Dr. Reyes remarked that it’s strange to imagine
that the Internet is not an acceptable solicitation venue,
but a church is. That’s not reflective of how people really
live; more people log in than go to church. It may be extreme
to prohibit such solicitation, and we may miss opportunities
to develop the field. Dr. Hanto agreed that solicitation has
received more publicity than are justified by the numbers,
but there is a risk that it can be a bigger problem. The field
took a strong stance against solicitation of deceased donors,
which was nipped in the bud. But, over the long-term, this
may be a new, bigger, problem. We don’t want a blanket policy
for something that’s not a big problem; but it is a problem
for some transplant centers.
Dr. Wiesner
raised the issue of directed donation to a celebrity, which
has a detrimental effect on the public’s perception of fairness.
Every time a celebrity is transplanted, there’s a question
about his or her priority on the list. The field has to be
squeaky clean.
Dr. Scantlebury
asked if, with regard to the large numbers who come forward
as potential donors for well-known people, there is a way
to think of these individuals as potential donors for others.
Can we capture them as donors for others who are on the list,
rather than being directed donors for one particular person.
If they are educated about the system, can they become non-directed
donors? Dr. Hanto felt that this should be encouraged and
that we should educate the anonymous donor so that he or she
is encouraged to donate to the next person on the list, or
participate in paired kidney donation. It’s more work, but
it’s a really an effective thing to do and is all about compatibility,
and who is on the list. The community can come together and
be uniform and hold the line that these donations have to
go to the next person on the list (as occurs at the University
of Minnesota), which will be hard. Or, we can develop a policy
to address this situation. There will be resistance because
of resources and conceptions of autonomy, as well as push-back
from libertarians. It may not be doable, but it has to be
on the table.
Ms. Principe
commented that she felt she would be remiss if she did not
underscore the need for education in this country about live
donations. It’s the key piece. When we do long-term follow-up,
in addition, we have to be careful that we embody all cultures
and perspectives and that whatever we develop is multicultural.
What works in Minnesota and Iowa may not work elsewhere in
terms of people’s approaches to life. A lot of things would
be prevented if we did a better job of educating the public.
If we get that out there, we can help resolve a lot of problems.
Ms. Rosenzweig
said that the whole reason we are having this conversation
is because we are dealing with something that is both scarce
and valued. She asked for clarification on understanding xenografting’s
pros and cons. Dr. Hanto is in the process of writing about
this. Many years ago, xenografting was the latest, greatest
thing, and a lot of money was invested in it. He thinks xenografting
should be revisited. Ultimately, it’s going to be the solution
for many patients. There has been a decrease in funding and
publications in the last decade, however.
Dr. Conti
said that the balance of utility and justice is important.
In the circumstance of a live donor without emotional connections,
do you think a six-month waiting period could decrease the
chances for exploitation? Dr. Hanto reported that he does
not know if there are data on this. He would be hesitant to
take this approach because it would be burdensome to enact
such a long waiting period. Some programs have some waiting
periods for high-risk donors (more like a month). It might
prevent some folks who could really benefit from an immediate
transplant from getting the organ.
Dr. Lorber
suggested that ACOT consider some of the presentation points
as potential action items. Since the committee had a long
discussion on the need for long-term donor follow-up and the
idea of mandating a registry, the issue of funding for such
a registry could be important as an objective and could really
help to understand how safe donation is. Dr. Hanto commented
that UNOS has done a few things; any death of a live donor
has to be immediately reported to UNOS, for example. There
is resistance to provide more data, on the part of transplant
centers and UNOS has decreased the amount of data it collects.
But, it’s important and we should do it. In addition, solicitation
is one key issue related to deceased donation and is still
technically permitted by the Uniformed Anatomical Gift Act
and the final rule. It’s not a big problem yet. Another important
discussion is about donor autonomy and how much is allowed.
This will frame the debate on where we go after that, and
will drive the eventual solution. Another issue is how to
define “pre-existing relationships” in a way that’s acceptable.
Dr. Scantlebury
raised the recent comment on Matchingdonors.com
that suggested transplant centers can list their patients
on the site and get reimbursed by CMS. Dr. Hanto commented
that the site sent an email soliciting the transplant programs
and surgeons to list potential recipients on Matching donors.com,
a marketing approach to add people to their list. Ms. Newton,
representing CMS, said that this statement was an assumption
on the part of Matchingdonors.com
,
and that CMS will release guidance on this soon.
Ms. Agrawal
asked if any members of the public had any questions.
Ms. Luebke
introduced herself as a kidney donor from 1994 and Nurse Practitioner
with the Living Donor Advocate Program. The nurses with the
Advocate Program have a few comments. They request that any
person speaking or publishing about living kidney donation
refrain from using terms such as “minimal risk to the kidney
donor,” or “being a kidney donor is minimal risk,” or “recognition
of the minimal risk to be a living kidney donor.” This language
minimizes the risks that donors are taking when, in fact,
they are the only ones taking a risk. In response to “minimal
risk,” Dr. Mark Alisio, a professor in the Department of Bioethics
at Case Western Reserve University, prepared this statement
for Ms. Luebke to read.
Minimal
risk is a term most commonly used in human subjects research
and is usually defined as (roughly) no greater than one
would encounter in the normal activities of everyday life.
Whether a study is “no risk,” “no greater than minimal risk,”
or “risk[y]” demarcates different criteria that must be
satisfied for the study to be approved. There is no Institutional
Review Board that would consider the removal of an organ
of a living human being “minimal risk,” and to characterize
live organ donation as such is grossly misleading.
Ms. Donna
Luebke noted that, in terms of protecting living donors when
they offer the donation, autonomy only goes so far.
Mrs. Vicky
Hurewitz said that she is encouraged by promoting the idea
of xenotransplantation. She has been coming to ACOT meetings
for five years, and has problems with living donations. She
would be very happy to be involved in promoting xenotransplantation
and asked how people could get involved and whether there
was an advocacy group working on this as a way of getting
the focus off the living donor. Dr. Hanto does not know of
anything at the moment. He is working on an editorial for
the American Journal of Transplantation, citing changes
in the research around this and calling for new energy on
this. The hope is that it will spawn interest in both the
private and public sectors. He welcomes help from everyone.
Myles
Kaye, a member of the public, spoke about the use of faith-based
groups for solicitation. This happened in his congregation,
the rabbi asked for someone to make a donation. The way he
presented it was that it was a “no brainer.” When such a message
comes from a religious leader, who is respected, it seems
so easy. Mr. Kaye wrote to the rabbi, recommending the need
to explain both sides of this and noting that there are problems
and complications connected with donation. When a religious
leader makes the request, one has to be very careful to make
sure that all aspects are explained. Dr. Hanto agreed; when
an influential person makes the request, it can lead to coercion.
He is also opposed to a solicitation in which Jewish people
are encouraged to donate to Jewish patients.
Ms. Robinson
cautioned about messages put into the public sphere: the message
about donation’s risks will be heard by others as well, so
we have to be cautious.
CMS
Organ Transplantation Regulation – Living Donation – Ms. Marcia
Newton
Ms. Newton
spoke on final regulations from CMS on new Transplant Center
Conditions of Participation in terms of living donation. Living
donation is mentioned throughout the regulation in many places
including data submission and comparing blood types. But,
today she spoke about specific protections for the health
of living donors.
In terms
of the definition of “adverse events,” CMS did not receive
any comments specifically on the definition, but it was clear,
from the comments CMS received, that there is concern about
this issue. In creating the Final Rule, CMS realized that
a death of a living donor might not be defined as an adverse
event. This was changed in the Final Rule, so such a death
would have to be both reported and investigated. (Final language
includes as an adverse event, “Serious medical complications
or death caused by living donation.”)
In terms
of selection of living donors, CMS focused on selection criteria
for determining their suitability for transplantation. CMS
received questions about the selection criteria being consistent
with the general principles of medical ethics. There is abundant
information about this, in the preamble and elsewhere. A Center
that performs living donor transplants must use written donor
selection criteria in determining the suitability of living
donors. The selection criteria must be consistent with general
principles of medical ethics. The Center must ensure the medical
and psychosocial evaluation of the living donor and must document
that the donor has received informed consent. In the Final
Rule, documentation of medical suitability was altered. It
was originally maintained in the transplant recipient’s records,
but this is personal information about the donor and keeping
it there would have violated Health Insurance Portability
and Accountability Act (HIPAA). Now this documentation is
only in the donor’s records.
There
are four requirements on living donor management. Centers
must:
- Have
written donor management policies for the donor evaluation,
donation, and discharge phases of living donation.
- Ensure
that each living donor is under the care of a multidisciplinary
patient care team coordinated by a physician throughout
the donor evaluation, donation, and discharge.
- Make
available social services furnished by a qualified social
worker available to living donors.
- Ensure
that nutritional services are available. (This and the requirement
for social services were added because End-Stage Renal Disease
(ESRD) regulations include these requirements.) All types
of donors are under one regulation now, including kidney
donors. The goal is that living donors should receive no
less, in terms of care, than the recipients.
The proposed
qualifications for social workers include a statement originally
from the ESRD regulations grandfathering in those who were
employed before 1976. CMS also included this language in the
Final Rule. (A qualified social worker must meet State licensing
requirements and have a Master’s degree from a graduate school
of social work accredited by the Council on Social Work Education;
or be working as a social worker in a transplant center on
the rule’s effective date; and have either two years as a
social worker, or one year as a social worker in a transplant
program.)
The dietician
must also be qualified – proposed qualification requirements
were changed in the final rule. CMS received comments that
it was proposing different qualification for dieticians in
dialysis versus transplant centers. These requirements are
much more aligned now.
Centers
must have a quality assurance and performance improvement
(QAPI) program. Specifically, for living donors, the regulation
lists activities transplant centers might want to include
in their AQPI programs, such as, selection, management, consent
practices and living donor rights. They must have a process
for identification, reporting, analysis, and prevention. Centers
must conduct analysis and have written policies to address
and document adverse events and use the analysis to effect
changes in policies and practices. Adverse events are reported
not to CMS, but to UNOS, the Joint Commission on Accreditation
of Healthcare Organizations (voluntarily), and State health
departments per individual State requirements. CMS notification
requires Centers to report outcomes that might affect their
Medicare approval.
CMS is
requiring that there be a living donor advocate or team, based
on ACOT’s second recommendation for such an independent living
donor advocate/team. CMS wanted to hear from the public on
this and received overwhelming support for the idea. CMS has
tried to be flexible and non-prescriptive in this area while
preserving the rights of the living donor and prospective
living donor. The living donor advocate or team must not be
involved in transplantation activities on a routine basis.
The advocate/team must demonstrate understanding of the possible
impacts on donor decision-making and ability to discuss with
prospective donors; and knowledge of living donation, transplantation,
medical ethics, and informed consent. The advocate or team
is responsible for representing or advising the donor; protecting
and promoting the interests of the donor; respecting the donor’s
decision; and ensuring the donor’s decision is informed and
free from coercion.
The informed
consent regulations are based on the ACOT’s first recommendation
on informed consent standards for living donors. Informed
consent policies must inform prospective living donors about
all aspects of and potential outcomes from living donation.
Elements of informed consent include informing prospective
donors that communication between the donor and center will
remain confidential and an explanation of the evaluation process.
Content must include an overview of the surgical procedure,
including post-operative treatment; availability of alternative
treatments for the prospective recipient; the potential medical
or psychosocial risks of the procedure; national and Center-specific
outcomes for recipients and donors, as available; the donor’s
health, disability, or life insurance issues; the prospective
donor’s right to opt out at any time; and the recipient’s
Medicare drug coverage issues.
Drug coverage
issues were included due to concerns over some transplant
Centers’ policies of offering transplants to Medicare recipients
at no cost in order to improve their transplant and/or experience
numbers and gain CMS approval. But, the beneficiary who has
a transplant in an unapproved facility loses his or her right
to immunosuppressant drugs under Part B; Part B coverage fills
in the gap in Part D coverage (that is the “doughnut hole.”)
Since loss of immunosuppressant drugs would be serious for
a beneficiary to give up, CMS wanted this to be addressed
specifically.
CMS received
a lot of questions about why it did not adopt all of the ACOT’s
recommendations on this. The reason is that the ACOT’s recommendations
here are very detailed. CMS took the elements it thought were
particularly important, but also attempted to allow flexibility
on the part of the Centers. Because they are hospital patients,
living donors also have other rights under Medicare regulations,
such as grievance processes and the right to a safe environment.
For more
information, see Centers
for Medicare & Medicaid Services web site for “Newly
Published Organ Transplant Regulation.” There are links to
the Final Rule in Federal Register format, a list of approved
transplant Centers, information required for applications
and information on where to submit applications.
Discussion
--
Ms. Agrawal
asked for clarification on how CMS measures compliance and
what happens for those that are non-compliant. Ms. Newton
replied that this was assessed by looking at outcome measures,
using data from the Scientific Registry of Transplant Recipients
(SRTR). In terms of process requirements, this is done by
using on-site surveys or future reviews. Non-compliance threatens
Medicare approval of the transplant Center (not of the hospital).
CMS can remove the Center’s approval without affecting the
hospital’s certification under Medicare.
Dr. Reyes
commented that, in terms of program approval, he had not been
aware that CMS had to approve a living donor program for these
organs. Ms. Newton clarified that these regulations are not
for approval of a living donor program, but for approval of
the organ program itself. Medicare does not regulate, certify,
or approve living donor programs, but a Center that has such
a program is bound by the requirements specific to living
donation. They have to be members of OPTN and follow their
allocation rules.
Dr. Hanto
asked about the advocates/teams, noting that most of the team
members are “involved in transplantation,” yet the Rule seems
to suggest that these team members cannot be involved in transplantation.
Are Centers being asked to go outside the staff for such team
members (e.g., hire a social worker) and, if so, how can they
ensure that the advocates have the requisite knowledge needed
to truly advocate? Ms. Newton said that this is a gray area,
about which CMS is intending to publish guidelines shortly.
A donor coordinator who is paid by the Center is acceptable.
Where it’s a problem is when the person is working with the
donor and the recipient at the same time. CMS is looking to
follow the regulation with more information. CMS has not found
a conflict with someone who does the medical evaluation and
the nephrectomy with living donors. They are looking for a
donor advocate who is not to be involved in donor transplant
activities.
Dr. Hanto
pointed out that some of the examples just provided by CMS
actually violate CMS’ own regulations. The Rule says the staff
can’t be “involved in transplantation on a routine basis,”
and the staff at his facility is involved in transplantation
100 percent of their time. It’s their job. His facility has
separate teams, which may act as the donor team in one instance,
and the recipient team in another, switching back and forth.
Coordinator does mainly work with donor, but sometimes they
switch and work with recipient.
Ms. Newton
said CMS would look further at this. She felt that staff who
work with recipients most of the time and donors only part
of the time will naturally be more of a champion on the side
with which they work more frequently. If it’s not routine
for the donor advocate to work with recipients, that’s okay.
The goal is not for the advocate to be from a completely different
part of the hospital and not know about transplantation. CMS
wants the person to know about transplantation in order to
be able to provide help and counseling. A word other than
“routine” would have been preferable. It may be possible for
CMS to explain that the meaning was intended more like “primarily.”
CMS does not want the transplant surgeon, for example, to
be the donor advocate. Dr. Hanto agreed that you don’t want
someone who is involved in the recipients’ side to be the
donor advocate, as they would be likely to be too zealous.
It sounds like a donor coordinator, working in the Center
and its setting, with occasional involvement with recipients
is acceptable. Ms. Newton agreed.
Dr. Reyes
asked how CMS will use the community resources to develop
the guidelines. Ms. Newton replied that the OPOs will be involved,
as they have experience in this area as advocates. Dr. Lorber
commented that there is a danger in the balance between an
approach that provides advocacy for those who are thinking
about being donors, and forcing hospitals on the other hand
to use people outside the transplant center to provide this
advocacy. The balance could be created in which a member of
the transplant team assumes the role of donor advocate and,
for that combination of donor and recipient, the person has
nothing to do with the recipient. At another time, that person
could play the opposite role. As long as they are separated
it could work. Can you have true donor advocacy with a staff
person who doesn’t know transplantation?
Dr. Wiesner
asked about CMS using SRTR outcomes data and whether this
will be done independently. Ms. Newton commented that this
will be an independent decision. The contract is not with
SRTR and the decision about the survey and/or de-accreditation
will be made solely by CMS. There will be two surveys: management
of the wait list and keeping people informed on the list about
their status. Anything that is not an existing outcome measure
will be on the CMS survey.
Dr. Scantlebury
asked how CMS will assess structural compliance and raised
the issue of pain medications not being covered by the recipients’
insurance. Ms. Newton said she had been surprised by a case
in which the donor’s medication were not covered; she reiterated
that, if CMS pays for the transplant, the donor is to receive
services as if he was a beneficiary, related to the donation.
The donor’s medications should be covered. However, the medications
are not covered for the recipient if the individual hasn’t
purchased Part D, when the person is not an in-patient. In
terms of assessment, the surveys will be analyzed based on
how well the Centers are performing on the outcome measures.
CMS will stratify them and survey the under performing ones
first. CMS will look at each of the conditions and the evidence
that the standard is met. For informed consent, it would be
to look for documentation in the records and to ensure that
the Center has policies outlining how this is treated. Guidelines
will identify this for each area.
Mrs. Boone
asked why CMS did not make reporting to JACHO mandatory. Mrs.
Newton said that these indicators are sentinel events, so
they are voluntary. Death of a living donor must be reported
to UNOS, however.
Dr. Conti
commented that, in terms of the semantics around the advocate
having extensive knowledge and experience in transplantation
and in the Center, New York State’s regulations on liver donors
includes a well-balanced scheme for the team that effectively
describes the idea that CMS is attempting to reach.
Discussion
of Workgroup Draft Recommendations Resulting from the November
2006 Meeting
Medicare
Part D
Ms. Robinson
reported that the workgroup met to discuss Medicare Part D.
The workgroup believes there is more information available
for patients, providers, and pharmacists, which had been the
group’s biggest concern. Resources also are more available
from non-profits and other organizations, such as the National
Kidney Foundation. It is the workgroup’s recommendation that
ACOT continue watching and hearing from people about any problems
on which the committee can act. In terms of generic drugs
substitution, the group didn’t see a continuing problem. States
are beginning to take action and enforcing that the decision
is not to be made at the pharmacy level in terms of substituting
a generic drug. The workgroup requests that ACOT members be
contacted if problems occur, however. Thus, there is no action
item for ACOT to consider from the Medicare Part D workgroup.
Public
Solicitation
Dr. Scantlebury
reported that the workgroup on public solicitation of living
donors has met twice. The concern was over having a system
that would ensure the potential living donors are informed
about the consequences to his- or herself and to the allocation
system. Education is the key. It is the group’s recommendation
that a national resource center or other system be created
to ensure that education takes place; to establish such a
system for education and to conduct a long-term review of
living donor’s outcomes. There needs to be insurance that
the donors are not being put at risk. The recommendation is
as follows:
- The
ACOT recommends to the Secretary that he direct the OPTN
to develop and distribute within the transplant community,
particularly to transplant programs and OPOs, a set of practice
guidelines to be followed with respect to public solicitation
of organ donors. The objective of these guidelines is to
maintain the effectiveness and fairness of the existing
organ allocation system.
Dr. Scantlebury
noted that elements of the practice guidelines may include:
safeguards against monetary exchange between recipients and
donors; control of access to potential donor patient information
within intensive care units and emergency rooms; insuring
that publicly solicited donors are properly informed about
all potential consequences of a directed donation for themselves,
and for all patients who are waiting; protection against false
and misleading statements by those who solicit organs; application
of appropriate psychosocial evaluation of potential donors;
public education about the importance of supporting the existing,
fair allocation system; and a strategy for offering potential
donors an alternative when they are responding to a solicitation
for a celebrity who is not first on the waiting list.
Dr. Solomon
commented that the recommendation does not mention fairness
to the living donor, which was in the presentation. She suggested
adding a sentence: “and to protect the safety of the living
donor,” which was acceptable to the subgroup members.
- FINAL
RECOMMENDATION (public solicitation for
living and deceased organ donors): The ACOT recommends
to the Secretary that he direct the OPTN to develop and
distribute within the transplant community, particularly
to transplant programs and OPOs, a set of practice guidelines
to be followed with respect to public solicitation of organ
donors. The objective of these guidelines is to maintain
the effectiveness and fairness of the existing organ allocation
system and to protect the safety of the living donor.
A motion
to adopt the recommendation was made and seconded. There was
no discussion. The vote was unanimous.
Tissue
Regulation
Mr. Holtzman
reported that the work group has conducted several conference
calls and has several recommendations. There has been a lot
of coverage of this issue and some scandals around tissue
recovery, which affects the public’s trust in the transplantation
field. The group had consensus on creating barriers/requirements
to get into the tissue recovery business (e.g., license, certification,
accreditation). It is the group’s sense that one can currently
do tissue transplantation in your garage, if you want to,
and the members felt that there should be some licensure process.
It is estimated that 70 percent of tissues come from OPOs,
which are certified. A question is, does one need accreditation
from the OPO, American Association of Tissue Banks (AATB),
and the Eye Bank Association of America (EBAA). This should
be encouraged so that organizations do not have to do all
three. At the time being, it is not overly burdensome, but
it should be streamlined. It would be good practice and keep
bad players out of the business. Recommendations are as follows:
- Any
agency or organization that recovers organs and/or tissues
for human transplantation within the United States must
be registered, inspected and certified to do so by the U.S.
Department of Health and Human Services or its designee.
- Any
agency or organization that recovers organs and/or tissues
for human transplantation within the United States must
be accredited by Association of Organ Procurement Organizations
(organ), American Association of Tissue Banks (AATB), or
the Eye Bank Association of America (EBAA).
Ms. Robinson
noted that the second recommendation does not include inspection;
would accreditation take care of this or should it be added.
Clarification was that accreditation assumes an on-site inspection,
so it’s included. Ms. Principe asked how accreditation, an
important process, occurs at AOPO. Not all OPOs are accredited,
but 47 out of 58 are accredited. Mr. Holtzman commented that
he, personally, felt that they should all be accredited. The
process is very detailed and resembles JAHCO’s: three-year
process, with an on-site team, standards and management. AATB
also has a detailed, although different, process. His view
is that they should be combined, over time.
Dr. Vega
suggested, in the first sentence, adding “human” before “organs”
in both recommendations. He would also say “human transplantation
and/or implantation” to avoid confusion.
Dr. Conti
commented that the numbers just provided indicate that 20
percent of the OPOs are non-accredited. He asked if there
was to be a timeline for these facilities to become accredited,
or there is the risk of excluding these OPOs. Mr. Holtzman
responded that the OPOs should all be accredited, given the
stakes at hand. The workgroup members did not talk about timeframes,
but the recommendation will act as an impetus for the OPOs
to become accredited, and that’s part of the process. Dr Lorber
asked if the OPOs that are not accredited should be able to
comment on this requirement before this moves ahead; they
may have good reasons for not being accredited.
Ms. Levine,
HHS Office of General Counsel, cautioned that both recommendations
use “must” and asked if the workgroup was looking for the
Secretary to make this a legal requirement. She asked if the
recommendation will ask the Secretary to make this a regulation,
which would allow public comment and input, or if the group
is suggesting that the Secretary seek authority from Congress
to do this. Or, is the workgroup asking the Secretary to make
a statement encouraging OPOs to become members. Mr. Holzman
reiterated the consensus of the workgroup that this should
be mandatory. The public comment process would address the
need to get feedback, from both OPOs and other tissue banks
that are not accredited.
Dr. Burdick
asked if, by including organs, an OPO that does not recover
tissues would need more than CMS oversight that is currently
in place. Mr. Holtzman did not think that would be the case.
This recommendation is geared towards tissues, and recognizing
that there is no unified accreditation process. This may be
a question of semantics. The workgroup’s goal was to get all
of the agencies that are recovering tissues and ensure that
they are certified by the Federal Government. It is appropriate
for the Federal Government to regulate this because the activities
cross State lines.
Dr. Solomon
suggested removing “organs,” so that it applies to any agency
that recovers tissues. So, it would be: “Any agency or organization
that recovers tissues for human use”. “Use” is about blood
and bone marrow, so we should stay away from that.
Ms. Agrawal
noted that the first recommendation is aimed at creating an
entry requirement for the field. Revised suggestion:
#1-
ACOT recommends that the Secretary seek a procedure by which
any entity or organization that recovers tissues for human
implant within the U.S. must be registered, inspected, and
certified to do so by the U. S. Department. of Health and
Human services or its designee.
Dr. Laura
St. Martin, a representative from the FDA, commented that
the FDA regulates human tissues for transplantation. The FDA
is in the process of reviewing current regulations, which
have been in effect since May 2005. FDA is reviewing implantation
and effectiveness, and assessing how the FDA can resolve some
of the issues that have come to light. These discussions on
certification have occurred at the FDA, and are being considered.
ACOT should not have the impression that nothing has been
done, or that nothing will be done. The FDA has a registration
process in place and is investigating which facilities are
not registered but are doing recovery nonetheless. The scandals
have all been about illegal activity, and there are rules
in place for registration and inspection. If the word “organ”
were to be dropped from the recommendation, it becomes an
FDA issue. Dr. Reyes commented that this was the same issue
with vascular graphs; there’s a difference between implantation
and transplantation.
Dr. Low
asked if the recommendation was even necessary and if ACOT
should wait and see what the FDA does. Ms. Rosenzweig commented
that, if ACOT members believe it’s an issue, then the Committee
is adding its voice to the process in which the FDA is engaged;
it may help to have experts in the field speak on this issue.
Dr. Conti noted that ACOT has not, however, heard reports
from organ procurement organizations to assess why that 20
percent is not part of the AOPO; this would be necessary before
moving ahead on the recommendation.
Ms. Agrawal
suggested that ACOT could recommend that the Secretary express
his concern about the need for registration, certification,
and inspection for entities that are recovering tissues for
human implantation. This is about communicating with the FDA
as it goes through the process of looking at regulations,
because the scandals and problems affect organ donation as
well as tissues. Ms. Conrad commented that she supports the
process of making recommendations on this issue. The FDA had
an interim final rule for over a decade; the Final Rule still
does not speak to the structure, function and non-profit status
of tissue banks. There are still concerns in this area. Mr.
Holtzman stressed that the FDA does not look at issues such
as consent, quality, or who is entering the business. The
FDA has admitted that it does not know who is in the business
and the ACOT is trying to make a recommendation to the Secretary
in terms of creating a barrier for those in the tissue recovery
business who are not properly regulated. Mr. Holtzman prefers
to keep this issue on the floor at this point.
Dr. Solomon
suggested the following edit:
#1-
ACOT recommends that any entity or organization within the
United States that recovers tissues for human implantation
must be registered, inspected, and certified to do so by
the U.S. Department of Health and Human Services or other
oversight agency, including the Food and Drug Administration.
Dr. Reyes
noted that ACOT members do not have all of the needed information
yet. If ACOT makes a proposal to the Secretary, it should
be based on having all the information. ACOT should work with
the FDA on this issue. Ms. Agrawal expressed her sense that
the recommendation should go back to the workgroup, and for
those members to work with the FDA about what the FDA is doing
in this area.
Ms. Levine
commented that ACOT is concerned with organs; but because
tissue impacts organs donations so greatly, the subject is
within the scope of ACOT’s authority. The FDA is within the
Department of Health and Human Services, and the Secretary
has authority to regulate this issue, which he has delegated
to the FDA. She urged the members not to be too concerned
about the Secretary versus the FDA. There’s nothing to stop
ACOT members from having conversations with the FDA. Ms. Rosenzweig
seconded Dr. Solomon’s motion to change the recommendation.
Dr. Solomon expressed concern about the current language of
the recommendation which could give permission to a foreign
organization (e.g., Mexico) to bring tissue in to the U.S.,
so she withdrew that suggestion. Dr. Lorber commented that
anything used in the U.S. is already under the jurisdiction
of the FDA. He feels uneasy with what ACOT does not know and
encouraged the group to get more information before voting
on this recommendation. Dr. Wiesner stated that ACOT also
cares about tissue procured or used in the U.S. What is recovered
here is a big issue; but a tissue bank in Mexico sending things
into the U.S. is also a concern.
Dr. Zhu
stated his understanding is that ACOT is concerned with regulating
procurement or use in the U.S. If it’s used in the U.S., it
should be regulated; but outside of the U.S. use cannot be
regulated. Ms. Robinson asked if members could see the multiple
revisions presented on a clean hard copy, after lunch. Mr.
Aronoff asked ACOT members what additional information they
were seeking. Dr. Lorber said that this could include the
possible legitimate, contrary views on certification and regulation
that might impact how ACOT moves on this subject. Dr. Reyes
added that ACOT also needs to work with the FDA to get a sense
of what it is including in what it is doing, i.e., how will
the ACOT recommendation impact tissue importation. Ms. Agrawal
closed the discussion by sending the recommendation back to
the workgroup, and asked that the group consider this recommendation
later after further discussion and revision by the workgroup,
in collaboration with FDA.
Ms. Agrawal
noted the workgroup has commented that its members cannot
do a significant amount of work before tomorrow to address
the issue. Consideration may be given to the recommendation,
if time allows, on the morning of May 16.
Economic
Impact of Transplantation – Dr. Mark Schnitzler
Dr. Schnitzler
discussed the current state of affairs with respect to the
economics of transplants. He spoke first about measuring benefits,
and then moved on to discuss the health economic valuation
of a benefit, economically. He then discussed the four major
solid organ modalities (kidney, liver, lung, and heart). Most
work has been done in kidneys.
Economists
are not concerned only about money but are interested primarily
in value. In transplantation and in medicine, there are specific
ways to measure value and the transplant community is principally
interested in extending life, or making quality-of-life improvements.
Relatively speaking, how much we pay for something is a matter
of interest to us and, when something becomes too expensive,
people change their behavior. We are interested in the cost
of caring for a person with a transplant versus not transplanting
them at all.
In terms
of the effect of transplant, Dr. Schnitzler showed a chart
displaying the survival benefit of dialysis versus kidney
transplant. The graph showed expected transplant survival
and the expected non-transplant survival. The difference between
survival with and without transplant is the survival benefit
of transplant. One needs many years of data to create such
a comparison but, when the data are available, survival can
be predicted with great accuracy. Does transplantation extend
life? The expected liver transplant benefit was assessed by
projecting the 5-year data out to 40 years; the result is
a giant area between expected survival on the waiting list
compared to transplant. The gain is16-17 years of life benefit,
which is large compared to the benefit of other prominent
medical interventions.
Looking
at life-year benefit by organ, the new lung allocation system
may show better effects. Heart and liver transplants are highly
beneficial, as are kidney-pancreas transplants. For solitary
pancreas transplant in the absence of kidney transplant, the
issue is quality-of-life because people survive well on the
list and do equally well when transplanted. The average total
benefit per donation (if all seven organs are used) is 55
years of additional life from one deceased donor; and average
(2002) utilization of organs produces a benefit of 31 years
of life. These are large benefits.
Dew, et
al, (Transplantation, 1997) reviewed the quality-of-life
issue and found that, among 14,000 patients, pre- versus post-transplant,
for all studies, for all organs, quality-of-life is improving
on a global scale. Further improvements are likely, as care
has improved in the last 10 years.
What are
we paying for this benefit, and how much do we pay for a unit
of benefit? Value = cost/outcomes. We need a framework, though.
If something is cost-effective, we have to have a benchmark
to decide when something then becomes too expensive. Last
year, a New England Journal of Medicine article (David
W. Cutler, Ph.D.) gave us an interesting general reference
by looking at the effect of medical spending on increases
in life span in the U.S overall. The author separated out
groups, including age groups, and looked at how much money
is spent to gain additional life years in the different age
cohorts. From 1960 to 2000, the cumulative change in total
life expectancy has increased 10 percent for newborns; and
by 24 percent for 65-year-olds, mainly as a result of improvements
from cardiovascular disease. For each year of life extension,
$50,000 is being spent for each newborn and $150,000 for an
older person aged 65 years.
How do
transplant modalities fit into Medicare? Extensive literature
and research has been done on kidney transplantation. The
research clearly indicates that transplant is cheaper than
dialysis. One exception is the Mendeloff article (2004), which
argued that it breaks even. This is interesting because it’s
the only study that’s different. In terms of the cost savings
for a kidney transplant, Medicare breaks even on the investment
within 4 to 6 years.
Looking
at the impact on kidney donor selection, expanded criteria
donor (ECD) and donation after cardiac death (DCD) organs
account for significant growth in transplant volume, and a
deceased donor is slightly more expensive. There is minimal
increase in standard criteria donor (SCD) and living donor
transplants. The financial structure of kidney transplantation
is changing and the average expense of a dialysis patient
on Medicare is much more than a transplant case. Extensive
data exists for kidney transplantation, thus, refined statements
can be made about different events and characteristics and
the costs associated with them. Transplantation is cheap if
the kidney is stable and functioning; it is more expensive
if there is graft failure. Returning patients to dialysis
after graft failure is very expensive.
Examples
of detailed cost information available for kidney transplant
range from delayed graft function (DGF) to gastrointestinal
(GI) complications. DGF costs are expensive with the costs
being about $134,000 more expensive for DGF patients than
for patients without DGF. GI complications are also expensive.
The average health care costs were 53.3 percent higher for
kidney transplant patients experiencing GI side-effects in
the first year post-transplant who discontinued Mycophenolate
Mofetil (MMF) therapy, compared with patients remaining on
MMF who were free of GI side-effects ($22,694 versus $14,799).
Even when MMF was continued, GI side-effects increased costs
by $4,601.
Another
question is whether there is an effect from pumping kidneys,
and what are the costs of doing this. Average accumulated
costs for ECD pumped versus unpumped kidneys indicate that
pumped kidneys net a savings of $6,000 over the 12 months
post-transplant. This data could be used to decide to use
the pump or not—doing so has costs. If it is used in ECD kidneys,
then the kidney is more likely to be used, which affects supply.
Have we
gotten better, and/or improved outcomes? Kidney data show
a pattern in reducing the length of stay for the transplant
hospitalization in the period from 2001 to 2004, especially
in marginal organs compared to standard ones. Medicare’s cost
of care is declining.
The data
available for livers is much less extensive than what is available
for kidneys. Is liver transplant cost-effective at a threshold
of some expense? While this is likely, it has not been shown
from the perspective of the Federal Government.
Numerous
studies have suggested that liver allocation by the Model
for End-Stage Liver Disease (MELD) scores increases transplant
center costs. It is possible, but not clear that MELD also
increases costs post-transplant. We are using older donors,
more split livers, and more DCD organs. In terms of donor
risk for marginal donors, there is a learning curve for livers
and the marginal donor’s length of stay has been affected.
We are learning how to handle these recipients.
But, there
remain questions about the extent to which clinical outcomes
have improved with high Donor Risk Index (DRI) organs, over
time, and whether increased center experience will reduce
the risk of high DRI organs. We do not know that all high
DRI liver transplants are cost-effective. We also need to
know if clinical outcomes have improved with high DRI organs
over time. The economic impact of high DRI organs may be significant:
- There
may be an increase in global contracts with long post-transplant
coverage periods, and/or an emphasis on shifting financial
risk from payers to providers for DCD and other high DRI
donors.
- Regulatory
reform may be needed to ensure that transplant centers are
adequately reimbursed. The “push” of the HHS Organ Donation
and Transplantation Breakthrough Collaboratives will stall,
if there is no “pull” for marginal donors. The “pull” will
be weak if centers consistently loose money on marginal
donor transplants which is likely the case today.
As we
turn to lung transplantation, even less is known. The literature
is tremendously variable on the cost-effectiveness of lungs.
It is possible that lung transplant is not uniformly cost-effective.
However, the new lung allocation system may have improved
outcomes and reduced costs, perhaps yielding more favorable
cost-effectiveness ratios. With hearts, there is more literature.
The numbers vary, but they are within the range of cost-effectiveness.
Looking
at cost curves, an analysis (by Schnitzler) of costs before
and after transplant yields several examples with slope of
costs is lessened after transplant. For kidney transplants,
there is a steep slope of costs before transplantation (the
costs shown are for a private health plan). Projecting pre-transplant
costs forward indicates that the break-even point for kidney
transplantation occurs quickly because patients are much less
expensive after transplant than on dialysis. The private insurers
in Dr. Schnitzler’s example pay approximately three times
more than Medicare for the care of patients before kidney
transplant, thus financial break-even occurs sooner for private
insurers (than for Medicare), making it beneficial for the
private insurers.
Heart
transplant costs in the private insurance sample show a huge
increase of costs just prior to and through the end of the
transplant hospitalization. These costs lessen dramatically
when the patient leaves the hospital. Thus, there is great
potential for cost savings in heart transplant by adding organs
and reducing the average duration of wait. In the 4 months
before the transplant occurs and until the patient is stabilized,
costs total approximately $600,000. If the wait can be shortened,
these costs can be substantially reduced.
In the
lung transplant sample, private insurance spent $1.1 million
from listing through 4 years post-transplant. If waiting time
can be reduced, this again has the potential to save a great
deal of money because much of the costs are incurred in the
last months of the wait.
Liver
transplantation is less expensive for private insurance prior
to transplant than kidney transplants. This is mainly due
to the absence of maintenance therapy for end-stage liver
disease patients while patients with end-stage renal disease
have dialysis. It is unlikely that liver transplant is cost
saving due to the low pretransplant costs. However, liver
transplantation is almost certainly cost-effective due to
the large survival benefits.
HR 710
was introduced in January 2007 to address the possibility
that paired kidney donation might be interpreted as violating
the National Organ Transplant Act. The bill clarifies issues
such as that paired donation is explicitly legal. The bill
was passed after the Congressional Budget Office (CBO) released
an analysis stating that kidney transplants save public money,
as much as half a billion dollars over time. The lesson is
that it is very useful if the field can demonstrate the cost
saving aspect of transplantation.
In summary,
solid organ donation extends lives. Kidney transplant produces
cost savings. Non-renal transplants may offer cost savings,
but more data are needed. Kidney economic data have facilitated
passage of the donor swap law, several extensions of immunosuppression
benefits, discussions of LD compensation, facilitated assessment
of machine preservation and other technologies, aided in the
assessment of ECD/DCD financial implications, and demonstrated
the economic value of avoiding complications. Yet, the field
is far behind kidneys in the other organs.
The big
economic question turns around the economic effects of organ
supply expansion. If there are cost savings from organ supply
expansion, who are the beneficiaries (e.g., Medicare, Medicaid,
the VA, private payers, and/or patients)? What is an appropriate
investment in organ supply expansion? And, finally, are we
under-investing in this expansion?
Discussion
–
Dr. Reyes
asked about the lack of cost-benefit analysis in livers versus
kidneys and if this resulted from the use of dialysis in kidney
failure (whereas liver patients tend to die more quickly).
Another way of asking the question is if it is more cost-effective
if the patient dies quickly. Dr. Schnitzler responded that
huge amounts of money are spent on patients who die and that
it’s the dialysis that makes it happen for kidneys. There
also are other expensive support devices that are not available
for livers.
Dr. Wiesner
asked if there had been an assessment of livers before and
after the use of MELD. Dr. Schnitzler replied that globally
there’s very little information on liver patients. Studies
have looked at transplantation pre- and post-MELD. These are
almost all single center studies that have shown that post-MELD
costs are higher. This could be a time effect, however.
Mr. Frieson
commented that it is more expensive with ECD and DCD donors,
and asked if medical directors ought to look at selective
criteria for the donors? Dr. Schnitzler replied that, if a
Center is running on the bottom line alone – and is not concerned
with volume (in other words, they are only doing profitable
transplants), then yes. He has not met any surgeons like that.
But it is possible that they exist and that they would skip
ECD/DCD, and take SCD offers. Centers make more profit on
patients who remain on the waiting list than from those who
are transplanted.
Dr. Migliori
said that, in looking at the costs of the last 12 months of
life, it is amazing how much it costs if the patient is not
transplanted. As an insurer, however, it’s not about the economics.
The insurer’s obligation is to apply evidence-based medicine.
Congress needs to know this, so it can understand the benefits
and the specific dollars that would be spent.
Ms. Conrad
asked Dr. Schnitzler to expand on the remark that we are grossly
under-investing and why he had not said, instead, that we
are over-spending? The answer was that this is a good investment
and should be expanded. The Organ Transplantation Breakthrough
Collaborative costs several million dollars, about $1,000
per organ, and is the sort of effort to improve acquisition
rates to which Dr. Schnitzler was referring.
Ms. Rosenzweig
suggested that the cost savings argument could be applied
to the concept that Medicare should provide immunosuppressant
drugs. The CBO has stated that it will cost money to cover
immunosuppressants, so a convincing argument that doing so
will save money is needed. The CBO scored the bill as a half
billion dollar savings, which was given to Part D. This was
a missed opportunity to invest those savings into beneficial
activities connected with organ transplantation. Dr. Scantlebury
suggested looking at the costs to the system of patients returning
to dialysis at 36 months for the Medicare system compared
to private payers, as the latter might offer immunosupressants.
The problem is that private payers do not really know who
is uninsured or not, while we do know who the Medicaid beneficiaries
are.
Kidney
Allocation Policy Under Development – Dr. Leichtman
For the
last 3 years, the OPTN has been working on integrating a measure
of incremental Life Years from Transplant (LYFT) into the
SCD kidney allocation system. It held a year of hearings,
which identified three principal concerns: the shortage of
donor organs; the possibility of improving the allocation
algorithm; and geographic constraints. The OPTN Board of Directors,
noting that HRSA was working through its “Collaboratives”
on initiatives to improve donor availability and that issues
of geography might be so divisive as to prevent the development
of consensus around a new allocation system, directed the
OPTN Kidney Committee to concentrate its efforts upon developing
a new kidney allocation system, The kidney committee considered
multiple alternative allocation strategies, and decid |