Advisory
Committee on Organ Transplantation (ACOT)
Spring Meeting
May 4 - 5, 2006
Doubletree
Hotel and Executive Meeting Center
Rockville, Maryland
Monday, May 4
Welcome
and Introductions
Hans
Sollinger, Chair, ACOT
Dr. Sollinger
called the meeting to order and introduced the new Executive
Secretary, Remy Aronoff. The eight new ACOT members introduced
themselves.
Public
Solicitation of Donors
Laurence
Chan, University of Colorado
Francis Delmonico, New England Organ Bank
Dr. Chan
presented on the topic of public solicitation of living donors.
He remarked that controversy is not new to organ transplantation,
dating to the first successful transplant in 1954 of a kidney
from one identical twin to another.
The evolving
role of the living donor results from the improved outcomes
among recipients, and increased demand, especially for kidneys.
The number of living donor transplants has increased, particularly
the number of those who are unrelated to the recipient. The
growing transplant list is a major reason to support living
donation.
Colorado
experienced a case of a live organ donation that had been
arranged through a commercial internet website. The surgical
director did not realize this was the source of the donation
and initially refused to perform the operation (the operation
was eventually performed). On December 14, 2004, the University
and its private, related hospitals issued a policy that, until
professional organizations, such as UNOS and ACOT, issue a
public statement on this issue, the hospital would not perform
living donor donations arranged through commercial internet
sites. There was a lot of controversy about this decision.
There
are many questions and concerns in this area. The Matching
Donors website contains statements which are not refined and
need clarifications. Originally, both donors and recipients
paid to be registered on the website — it costs $300/month.
Commercial sites present the risk of leading to organ marketing.
The National Organ Transplant Act does not permit "brokerage."
In March
2005, Dr. Sollinger visited Colorado to advise the hospital;
this interaction was continued at a meeting held in Chicago
in June 2005. There had been 13 patients transplanted in arrangements
made by commercial sites as of November 1, 2005. There is
variability in the statements of hospitals and other professional
organizations; they usually state that the donor has to understand
the risks and be prepared physically and psychologically to
engage in donation. Many hospitals have changed their policies
on this. There have been several publications in peer reviewed
publications on the subject.
In November
2005, the University of Colorado Hospital and Transplant Team
issued the following position statement on living donation.
- We
will be vigilant to ensure that the donor understands the
risks of donation, is physically and psychologically prepared
for donating and has come to the decision without undue
influence.
- We
want to ensure that organs are allocated fairly and that
a donor is not motivated by any financial incentives.
- The
National Organ Transplant Act (42 United States Code section
274e) makes it a crime to purchase or sell organs for profit.
This law is intended to prevent the commercial trafficking
in organs that occurs in other places in the world. The
law permits payment to the donor for travel expenses, housing
and lost wages because this is reimbursement for out-of-pocket
expenses and is not considered the payment of valuable consideration.
- The
Hospital and its transplant team will continue working to
ensure that the principles of equity, justice and informed
consent of the donor are maintained.
In March
2006, Colorado held its Controversies in Transplantation Conference.
Participants and topics included the founder of Matchingdonors.com
;
and representatives from UNOS. Discussions covered organ trafficking,
ethical issues (e.g., consent), and legal perspectives. The
hope is that Matchingdonors.com
will become a non-profit organization to mitigate the issue
of financial gain. Dr. Chan noted that the field needs to
care about the donors and to better understand their outcomes
so that true informed consent can be provided.
Next,
Dr. Delmonico gave his presentation on the same topic. He
showed a slide of a flyer seeking a liver donation for a New
England woman and a billboard seeking a liver donation for
a young man in the Southwest. He stated that it is telling
that people are so desperate they feel compelled to advertise
in this way. The young woman survived and is doing well, but
the young man died of metastatic disease. UNOS wishes to increase
the number of transplants and decrease waste. Live donor donation
is a new component for OPTN/UNOS, and live donation is very
central to the activities. A strategic plan to increase donations
is being implemented. Comments have been sought in the Federal
Register on applying OPTN's regulations to live donations
as well.
Dr. Delmonico
and Walter Graham, Executive Director of the United Network
for Organ Sharing (UNOS), published a paper with a plan on
solicitation in the American Journal of Transplantation.
The paper distinguishes between solicitations for live and
deceased donations and proposes that public solicitation and
directed donation for the latter would have a negative impact
on the equitable allocation system. It is important to ensure
that the most medically urgent person in the country gets
the organ. He stressed that this needs to be addressed by
the professional community. In terms of live donation, it's
not possible to prohibit people from forming relationships
and bonds over the internet, but there should be a very careful
psychosocial assessment required of both donor and recipient.
UNOS is
sponsoring a national conference in May to address the evaluation
of the motivation of non-traditional types of kidney donors.
Dr. Delmonico described the circumstances that would trigger
identification of a high-risk, non-traditional donor. These
include significant and on-going psychiatric issues; substance
abuse or mental health issues; a desire for medical care;
a relationship with the recipient; or other secondary gain.
In the latter cases, more intense evaluation than ordinarily
would be performed is needed.
JAMA
has issued a consensus statement on live organ donors that
has been included in CMS regulations for transplant centers.
Dr. Delmonico asked ACOT to reflect upon the proposal to make
a distinction between deceased and live donors. He noted that
he doesn't think that it's possible to prohibit what happens
when relationships develop over the internet, but it will
be necessary to ensure that evaluation is conducted and principles
are applied to the live donor.
Discussion
Dr. Sollinger
introduced the first discussion point: the distinction between
deceased vs. live donor solicitation. It is inappropriate
to pressure families who are in an emergency situation to
donate organs; we need to be careful to avoid solicitation
of deceased donor organs. Dr. Sollinger stated that the surgeon
carries the burden of policing these matters. He questioned
what an appropriate time-frame would be between someone seeing
a public solicitation, and making a later donation to the
person who advertised. Families should be encouraged to donate
to the person who most needs the organs, over someone who
has caught their eye in an advertisement. But, if a family
declines to do this, what does the doctor do? This happened
in New York last fall. Dr. Chan noted that there are no data
on this. He has found, sometimes, when you ask a family to
make an anonymous donation through the waiting list, they
are resistant. People want to have a connection with the recipient.
We need to compare the two groups of patients (directed vs.
to the list) and assess differences between them.
Tommy
Frieson asked about a case in which there's someone who needs
an organ and they advertise. There's a potential donor who
sees the ad and then an organ becomes available through death,
and the family directs the donation to the advertiser. They
weren't solicited, but they were directed in their
decision-making. They were prompted about organ donation and
decide to direct it to someone through the advertisement.
Dr. Delmonico said that the doctor and the OPO have a responsibility
to raise the issue of the people on the waiting list and their
needs.
Anita
Principe remarked that, in the New England case, the woman's
press background enabled her to promote her cause effectively.
When the UNOS system was explained to her, she got onto the
waiting list and received an organ through the allocation
system. It's all about explaining the system to families and
their loved ones. Dr. Delmonico raised other examples of how
far afield this can go: people following ambulances, approaching
families in emergency wards, and soliciting directed donations.
Kris Robinson asked if public billboards increase general
donations once people understand that there are others who
also need organs. Dr. Delmonico responded that we can't assess
this, and we shouldn't endorse it.
Staff
from the HHS Office of General Counsel noted that the current
law allows a person to direct an organ where they wish —
it's legal to direct to a solicited person rather than someone
on the list. If there's already a relationship between two
people, it's very clear that it's legal to direct a donation.
The organ procurement organization (OPO) fulfills the request,
and no one would object to a situation like this. Every State
law provides that a person (or their authorizing agent) can
make a directed donation, and this is Federal law. Under law,
families are entitled to direct the donation where they will.
The Secretary of the Department of Health and Human Services
cannot change State law.
Nancy
Bridges asked about the high-risk, solicited donor-people
for whom individual characteristics may make the donation
a problem and cause problems (e.g., motivation). All of the
risks have analogies in other areas of medical practice; clinicians
deal with these in other areas, but translating them into
policy recommendations for the Secretary is difficult. Millie
Solomon noted that there are analogies about giving informed
consent; there are people who are in the gray zones (older
children giving consent; those with fluctuating cognitive
capacity). The capacity to make the decision is complicated
with an unrelated, non-traditional, and live donor-the higher
the risk, the higher the standard for decision-making needs
to be.
Ms. Principe
said that, when reviewing the donation process, one also has
to think about the recipient and his/her family. Transplantation
is a team approach that must involve social workers, psychiatrists,
etc. You may never know for sure and the key thing is to engage
in a multidisciplinary and team approach to the decision making
process.
Richard
Migliori expressed concerned about a two-class system based
on the recipient's economics. We don't want profiteering,
and we don't want money to play a role in who gets an organ.
Doctors and OPOs are not the police to enforce the fact that
no money has changed hands. There may be a need for a document
attesting to the fact that there is no monetary gain. Transplant
centers wonder about money being exchanged too; they may benefit
from such an attestation.
Lewis
Low noted that the definition of "public solicitation"
is important. Where family members are willing to donate,
it's a private solicitation; it can be extended to church
members, etc., where there is a previous relationship. Solicitations
may lead to relationships. Between these two, it's a gray
area. Dr. Chan answered that you need to know how sustained
and long-term the relationship. Colorado's legal department
is developing guidelines on this, in terms of length of time,
as there is no reference from professional organizations.
Jorge
Reyes commented that this has happened locally for a long
time, but the internet has exploded it and prompted successes
that complicate the issue. ACOT needs to define risks and
ensure that principles exist and are applied. Then the surgeon
and the OPO have to make the final decisions.
Rhonda
Boone asked if a transplant center is conducting solicitation
by encouraging donations and how, if there is no long-term
donor follow-up, can anyone give informed consent. Dr. Delmonico
responded that we can't say "Uncle Sam wants your organ"
and solicit, by public policy, organ donations. We make available
information if people want it. In the medical community, when
there's a family emergency, the question needs to be asked
if there is a donor in the family — not to coerce someone
into being a donor, but because it is a medical possibility.
Dr. Chan said he is passionate about this — so many
transplants occur, and there is no follow up; there is only
one grant to track follow-up. How can we have a registry and
not follow up on results?
The Organ
Procurement and Transplantation Network/UNOS will soon have
an adverse event recording process so that, if the donor dies
or needs his/her own transplant, it will be mandatory to bring
the fact to the Membership and Professional Standards Committee.
ACOT must relay the message about the need for long-term follow
up because one absolutely cannot get informed consent without
information about long-term impact. Dr. Sollinger agreed that
it was embarrassing that this doesn't exist. His center is
trying to gather information on it.
Dr. Sollinger
asked if ACOT members wanted to establish absolute guidelines
or a framework on directed donations. Ms. Rosenzwieg suggested
there could be categories of informed consent for different
risk categories; making a psycho-social assessment is very
complicated and it's unclear who makes that judgment. Dr.
Delmonico said it doesn't need to be set in stone, but could
be a recommendation that this happens. Dr. Solomon stressed
that the transplant community could say we won't accept live
donors for the highest risk transplant.
Dr. Bridges
said it would be useful for doctors to have it worded in a
way that it's an evolving area of practice and that the decision
is likely to be a judgment of the transplant team; make the
language supportive for the team. They are afraid of litigation
and need to know what is right (e.g., not being discriminatory)
as well as the fact that there's no way to make a final, concrete
determination.
Dr. Reyes
asked about the legal regulations for public solicitation.
Could organizations like Matchingdonors.com
be required to provide education when people register,
directing them to UNOS? The site would probably say that there's
no danger just from registering some one. The transplant centers
can't have all of the responsibility. UNOS could have its
own registry and undercut the other sites. Advertising on
the part of transplant centers has been a concern and should
be addressed in any recommendation(s) on solicitation.
Dr. Sollinger
will ask individuals to draft recommendations and bring them
back to the group on Friday. There seems to be agreement about
a crucial distinction between public solicitations of live
versus deceased donors. Public solicitation of deceased donations
needs to be assessed by the OPO on the scene; people should
not circumvent the donor list by replying to billboards and
other solicitations; and no money should be exchanged.
OPTN
Net Lifetime Survival Benefit Model
Mark
Stegall, Mayo Clinic
Dr. Stegall
presented a new model for allocating kidneys. In March 2006,
there were 65,338 people on the UNOS deceased donor kidney
waiting list. In 2005, 15,209 kidneys were transplanted, 9,188
of which came from deceased donors. The demand is growing
faster than supply. The median number of days in which 50
percent of the candidates have been transplanted varies by
blood type—people with AB (the easiest to transplant)
now wait up to two years; half of the Bs are still waiting.
The UNOS
Board charged the Kidney Allocation Review Subcommittee (KARS)
with reviewing kidney allocation and to impact mortality and
morbidity on the waiting list and increase the benefits from
kidney transplantation. Dr. Stegall described the outreach
process used to collect information and hold public hearings
on the subject. KARS was eventually combined with regional
representatives and the Kidney Transplantation Committee.
The current
system has limitations and inefficiencies; it is not being
optimized. Problems include the fact that kidneys with long
expectancies are going to recipients with short life expectancy;
the system is unpredictable about how long people wait; and
there is variability in terms of access to kidney transplantation.
The proposed
revised system would:
- Maintain
current priority for children (from donors under age 35)
- Maintain
expanded criteria donor (ECD) allocation (emphasize efficiency
with local usage and ranking based on waiting time)
- Clearly
identify candidates' position on the waiting list, and
emphasize their wait-list mortality and their transplant
benefit.
- Bring
patients who are close to the top of the list in and
have their work-ups current.
- Allocate
locally which allows a shorter ischemia time, and increases
acceptance.
- Alter
standard criteria donor (SCD) allocation with the emphasis
on transplant benefit with modifiers
The new
proposed SCD allocation has a goal of maximizing total number
of life years gained by candidates on the waiting list for
a deceased donor kidney. The Net Lifetime Survival Benefit
(NLSB) is calculated from estimated candidate survival time
with an SCD transplant, minus the estimated survival time
while staying on the waiting list without a transplant.
Survival
with end stage renal disease (ESRD) varies with age. For 50-60
year olds, patients do better with a transplant. The chart
indicates that 20-30 year olds do well on the waiting list,
and do better after a transplant. Over 30 years, the net life
saving benefit (NLSB) is greater for 20-year-olds than for
30-year-olds, and increases over length of time. Factors that
affect the NLSB include age, diabetes, ESRD, body mass index
(BMI), angina, gender, etc. The committee is assessing what
factors should be included; factors that are both important
and can be objectively measured will be included. The committee
excluded those that are unimportant or can't be measured such
as ethnicity, gender, calendar year of listing, insurance
status, angina, etc. The committee members are working on
definitions (e.g., diabetes) and exploring whether the factors
differ for diabetics, for kidney vs. kidney-pancreas patients,
etc. Unintended consequences were also considered and the
committee is currently addressing them.
Dr. Stegall
addressed the benefits for different populations of the new
system. Kidney-pancreas patients, which make up a small percentage
of the list, have really great outcomes; older diabetics and
non-diabetics have worst outcomes, as they have a high waitlist
mortality and low post-transplant life expectancy. The model
also gives more weight to a year of life post-transplant versus
a year on dialysis. In the new sensitized patients' model,
all patients will be screened for human leukocyte antigen
(HLA); identify specificities and list unacceptable antigens
for all patients. Another issue is that the A2 to B system
has been shown to be successful in several places.
This will
be a national protocol and the goal is to present the final
proposal to the OPTN Board in December 2006.
Discussion
Dr. Sollinger
thanked Dr. Stegall for his work on this effort, and commented
that the model presents a statistical framework for what a
surgeon knows from experience. This is helpful from a conceptual
standpoint. The unintended consequences are real, but can
be addressed. There is a concern that the system might discriminate,
e.g., against obese people with a higher BMI or against older
people. Dr. Stegall responded that everyone is waiting longer
and there are too many recipients for the number of available
kidneys. The ECD kidney is a way to transplant people who
have been waiting for a long time, and some work well. Patients
who should be on an ECD list have not been identified.
Dr. Reyes
asked about using NLSB to create model end-stage liver disease
(MELD) scores for kidney candidates. Dr. Stegall responded
that almost every candidate benefits from kidney transplants.
Donor characteristics are put into the model, and benefits
specific to the donor are calculated. It's important to inform
the physician about life outcome from accepting a particular
organ or not. It will help in deciding about organs in particular
situations.
Ms. Principe
said that New York has many ECDs and asked if the definition
of the ECD donor will remain the same. Dr. Stegall said about
20 percent of kidneys are ECDs and the pool is expanding.
The criteria need to be revisited, but this should happen
later. ECD was created to increase acceptance of these kidneys,
which have a high discard rate because it takes a long time
to find a match. If the OPOs could find someone who wants
the kidney they could use it. ECD will be revisited later
and efficiency and benefits will be assessed.
Dr. Solomon
said that she is concerned that a model based on efficiency
and survival risks further disadvantaging already-disadvantaged
groups. It's utilitarian, which collides with equity. BMI,
for example, is connected with ethnicity and class. Not tracking
people by ethnicity complicates this. You have to be able
to track survival and outcomes by ethnicity and socio-economic
status (or by an socio-economic status proxy such as zip code).
Dr. Stegall responded that patients will be able to be tracked
by ethnicity using UNOS data, but this will not be a factor
in the model for selecting patients. Equity issues are being
examined. There are other surrogates that are being considered.
Of people on the list who are under age 40, 42 percent are
African American; under the new model, these patients would
have better outcomes than they do now, which is not discriminatory.
The simulations will tell us more and we'll report back.
CMS
Payment of Donation after Cardiac Death (CDC) Organ Acquisition
Costs
Howard
Nathan, Gift of Life Donor Program
Hans Sollinger, University of Wisconsin
Dr. Sollinger
began by noting that he fears that, if costs continue to rise,
hospitals will decline organs and limit the number of transplants
they perform. There are no data on the hospital (e.g., non-OPO)
side; it is almost impossible to get costs. At his facility,
the length of stay for a donation after cardiac death (DCD)
donor is about five days longer than with a traditional deceased
donation. He has talked with Bob Wolfe, Deputy Director, Scientific
Registry for Transplant Recipients, about collecting a sample
of approximately 200 DCD donors and asking UHS to compare
costs with an age-matched group. The committee members discussed
the possibility and agreed that this is worth pursuing.
Mr. Nathan
presented on the costs associated with organ acquisition.
He began by describing the Organ Donation Breakthrough Collaborative,
noting that there are 58 OPO service areas nationally, 52
of which are independent and have their own provider number
for Centers for Medicare and Medicaid Services (CMS) reimbursement.
(CMS reimburses for kidney organ procurement.) He defined
DCD and noted that both DCD and brain dead donations have
grown since the 1990s.
Mr. Nathan
described the difference between the processes and timing
for a potential brain dead versus DCD organ donor. Routine
care for brain dead patient before death goes on the patient's
bill. With a DCD, the family decides to withdraw care and
their costs essentially end at that point. The need to maintain
the patient for some time afterwards engenders costs. Realistically,
the OPOs should pay the costs for a DCD after the family decides
to withdraw care. Insurance companies are dependent on the
hospital billing department to send it over to the OPO, but
the system isn't perfect. Most OPOs do not have contracts
with hospitals and, therefore, have to negotiate bills. Hospitals
probably get higher reimbursement from OPOs than from insurance
companies. Some OPOs ask for the patient's and the donor's
bills and examine them both.
CMS is
primarily interested in renal costs; it controls and audits
each OPO annually. Direct acquisition costs are covered, as
well as other costs like G&A and education. About 40 percent
of the costs are indirect; about 21 percent are donor hospital
costs. CMS estimates a Standard Acquisition Charge (SAC) based
on all of these factors and promotes rules about what is reimbursable.
Fees vary across the country for kidney — from $16,000
to $32,000. Based on the current CMS standards, the line for
accruing costs stems from declaration of brain death and is
different for DCDs. The hope would be that no costs should
be sent to the family and that CMS reimburses OPOs for those
costs.
Discussion
The group
discussed various costs of organ retrieval, and the difficulties
in billing. The group discussed why hospitals are at liberty
to decide not to perform DCD, and the necessary process to
get DCD through CMS as a national policy. The Association
of Organ Procurement Organizations board of directors recently
passed a policy position on DCD.
Dr. Bridges
asked the group to consider public sentiment and understanding
about DCD. To push such a recommendation before the public
is ready could be very harmful for promoting organ donation.
Dr. Sollinger countered by noting he hasn't had a single complaint
about this from families. Dr. Scantlebury described resistance
from faculty administration and ethics committees, and expressed
her opinion that a lot of education is needed. Some felt that
ACOT should recommend that, if a hospital is a donor hospital,
it should also perform DCDs. Mr. Frieson said that getting
an attending physician to pronounce cardiac death is extremely
hard; if they don't die within 90 minutes, you have to bring
them back into the ICU. Dr. Low concurred that the comfort
level of nurses and doctors in the ICU is critical.
Dr. Solomon
reported that she hears that hospitals view this as a recommendation
from IOM, not a requirement. People fear that the process
of early evaluation and referral to an OPO may influence the
decision to withdraw treatment. Mr. Nathan noted that DCD
only occurs after the family decides to withdraw care and
there are standards of care around how this happens. Hospitals
already comfort families and help them decide. With DCD, donation
is only discussed after this happens; it's just one additional
thing to tell the family after they have made a decision.
Ms. Principe
noted that DCDs used to be performed before there was comfort
level around brain death. There has to be a mechanism to educate
the public about cardiac death. This option is a part of the
extension of end-of-life care and giving families an opportunity
to grieve and recover. Dr. Solomon said that all of these
worries are speculation and that ACOT could recommend an empirical
study that looks at the facts and helps shape our discussion.
Dr. Jim Burdick also suggested that the Breakthrough Collaborative
might help push this topic.
Ms. Conrad
suggested an ACOT recommendation that the OPO should be responsible
for the donor bill from the time of consent. Dr. Sollinger
said that this would be a point to be discussed in greater
detail at the next meeting.
Medicare
Part D and Transplant Recipients
Kris
Robinson, American Association of Kidney Patients
Ms. Robinson
described current CMS coverage for kidney transplants—most
patients receive Part B reimbursement. Key issues that complicate
the situation include the time-consuming process of confirming
Part D enrollment, confusion on the part of pharmacies about
billing, issues stemming from dual eligibility for Medicare
and Medicaid, lack of access to State assistance programs,
and issues surrounding share-of-costs and spend-down in select
States. These problems hamper patients from getting drugs
and may result in their losing their organs or not getting
a needed transplant. Ms. Robinson described what can be done
to assist patients and to educate pharmacists—solutions
include CMS implementing a Part D hotline to get help to patients
faster.
Discussion
Dr. Rosenzweig
asked about the need for patients and advocates to work with
CMS and to fix the drug plan, rather than focusing on the
State levels. Dr. Migliori thanked Ms. Robinson for her clear
explanation of the problems with the programs; the threats
to patients are very extreme when drugs are not available.
He also noted that immunosuppressant regimens are very specific
and it's troubling that patients appear to be expected to
shift between varying regimens because of pharmaceutical coverage.
Dr. Scantlebury agreed that it is an all-consuming process
to get drugs for her patients, most of whom are dual eligibles.
Ms. Robinson reported that every transplant surgeon with whom
she spoke had at least one patient who had lost their transplant
because they could not get access to immunosuppressant drugs
and medications.
Dr. Sollinger
asked what the committee can do about this. Ms. Robinson said
that a hotline specifically for transplants would be very
helpful — for patients, as well as pharmacists. The
Medicare number is often busy and staff who answer often lack
expertise in this area.
Collaboratives
Update: Next Steps
Dennis
Wagner, Division of Transplantation
Mr. Wagner
updated the group on the Breakthrough Collaboratives. There
is a much more robust community of practice today in the U.S.
working together in a more cohesive and transparent manner.
New practices are quickly identified and shared. In the old
system (before 2003), there were an average of 508 donors
per month; now the average is 614 per month. The new goal
is to achieve a mean of 750 donors per month.
It is
clear how to achieve and sustain 75 percent donation rates
— Iowa and Wisconsin have achieved this in their entire
donation area. Changes that make a difference include: advocate
organ donation as a mission; involve senior leadership to
get results; deploy a self-organizing OPO/hospital team; practice
early referral and rapid response; master effective requesting;
and implement donation after cardiac death.
The Organ
Transplantation Breakthrough Collaborative change practice
identified what occurred in the highest performing donation
service areas and found that (1) there is a culture of intent
to transplant as many organs per donor as possible; (2) relationships
are in place; (3) advanced practice in clinical management
rests with the hospital or the OPO; (4) the OPO pushes to
place organs; and (5) the transplant facilities pull in many
organs and use as many as possible. Each of these practices
can be facilitated by specific actions. Duke, for example,
sends a team to look at organs they might not otherwise use,
and ends up taking more of the organs as a result. It's more
costly, but it's worth it. Investment in resources yields
payoff. The results of the Action One period show that some
teams exceeded the goal. The successes resulted from taking
the appropriate time to optimize organ function and place
organs. These teams also involve critical care specialists
in donor management, and they have mutual accountability between
the OPO and facility to optimize organ use.
Mr. Wagner
described the Collaborative's future goals, which include
to:
- Conduct
the first combined Organ Donation and Transplantation Breakthrough
Collaborative,
- Launch
a Transplant Program and Management Initiative based on
experience from OPO redesign,
- Add
Transplant Collaborative Spread to the current program of
the Organ Donation Breakthrough Collaborative spread,
- Assist
the Coalition on Donation to apply collaborative methodology
to public education and outreach on organ donation, and
- Explore
application of the Collaborative methodology to improving
transplantation outcomes.
Mr. Wagner
stated that between 2003–2005, the Washington Regional
Transplant Consortium almost tripled the number of kidneys
transplanted at the Washington Hospital Center — from
24 to 78 kidneys.
Gift
of Life (GOL) Institute Update
Howard
Nathan, Gift of Life Donor Program
Mr. Nathan
discussed the fact that the education and training opportunities
for professionals are limited, once these professionals return
home. The Gift of Life Institute provides practical, day-to-day
learning. It started with an empty warehouse and now is a
building housing a call center, recovery suites, operating
rooms, training institute with practicum facilities, and more.
The call center handles 52,000 calls a year. The recovery
suite is an idea that came from St. Louis: a place to conduct
retrieval of organs from brain dead donors in the facility.
Many training and education activities occur on issues that
include gaining consent, ensuring best practices, clinical
practicum, DCD, etc. Funding was obtained by a $1.5 million
municipal bond.
Costs
Related to Desensitization Protocols
Francis
Wright, Texas Transplant Institute
Dr. Wright
presented on financial considerations with respect to transplantation
of sensitized renal patients. Sensitization is the presence
of HLA antibodies that causes incompatibilities with potential
donors; it traditionally has been measured by elevated panel
reactive antibodies (PRAs). Sensitization can result in patients
waiting longer or dying on the list.
On the
UNOS kidney waiting list, almost one-third of patients have
some level of sensitization. The ability to identify sensitization
has improved greatly over the last several years.
Two solutions
have been promoted: the "West Coast" solution is
to explore immunoglobulin to interfere with antibody production.
Dr. Wright described the second, "East Coast", approach;
this which removes circulating antibodies through plasmapheresis.
Dr. Wright described the benefits and problems associated
with plasmapheresis as well as the protocols for pre-transplantation,
admission, and post-transplantation. The costs for histocompatability
testing do not greatly differ from tests conducted for sensitized
patients on the waiting list. The plasmapheresis portion of
the treatment is dependent on IVIG preparation, however; and
there is a shortage of IVIG right now, which affects costs.
A typical case costs about $18-20,000 in total. Dr. Wright
discussed post-transplantation rejection rates and ways to
improve both costs and outcomes.
Several
funding sources exist including the Kidney Acquisition Cost
Center and use of the Ambulatory Patient Codes. There could
also be an adjustment in DRG rates/codes for desensitization
cases. Dr. Wright has been fairly successful in obtaining
coverage from private insurance for his patients. Dr. Wright
described future potential outcomes that will include increasing
living donor transplants and decreasing patients going on
the waiting list. He also suggested recommendations for moving
forward.
- HRSA
goals should include increasing living donor transplantation
- Approve
appropriate funding mechanisms for living donor desensitization
protocols (Kidney Acquisition Cost Center, APCs, DRG for
desensitization and renal transplant)
- Establish
a case registry to include appropriate data to track and
analyze results and improve outcomes
- Consider
proposals for application to deceased donor renal and extra-renal
transplantation
Discussion
Ms. Conrad
asked about the process for a deceased donor population. Dr.
Migliori asked about complication rates between the two protocols
(East vs. West Coast) and the long-term results for these
patients. Dr. Reyes asked about reimbursement and was told
that, at the present time, it is negotiated on an individual
basis. Dr. Bridges asked if data have been presented to the
FDA and CMS with a goal of getting a payment plan. Dr. Wright
does not know if the pharmaceutical industry has approached
the agencies yet. He noted that removal of language prohibiting
Medicare reimbursement for plasmapheresis has been helpful,
but that payment is now up to the individual payers. Mrs.
Boone asked if the process poses any additional risk to the
donors. Dr. Wright noted that the recipient is at higher risk
and he or she may have higher rate of rejection; but there
are no additional risks for the donor.
Public
Comment
Miles
Kaye (Rockville, MD) — Mr. Kaye identified that his
wife is a liver transplant recipient.
- With
respect to advertising for donors: While financial gain
is not allowed, he asked what precludes a donor from coming
back to the recipient later and asking for money. Financial
prohibitions need to address prior, current and future exchanges.
- He
conducts outreach and is often asked if health care facilities
let patients die in order to obtain an organ; the confusion
about this is profound in some communities.
- Medicare
Part D is really hard for people to understand. When he
has called the hotline, it has been hard to get through,
the caller waits a long time, and the staff can't answer
the questions. Hotline staff do not know about transplants
at all. Pharmacists have the same problem; they can't get
through and don't get answers. Pharmacies have cash flow
problems stemming from slow reimbursement that additionally
complicate their situations.
- He
mentioned the U. Cal Irvine situation and asked if ACOT
should comment that new controls need to be added to CMS
and UNOS to prevent a recurrence of this type of incident.
Note:
The "U. Cal Irvine situation" refers to serious
deficiencies in patient care involving onsite medical/surgical
coverage at UCI's liver transplant program; UCI's waitlist,
graft and patient survival for its liver transplant program;
and UCI's submission of documentation that contained potentially
false representations about the onsite coverage of certain
key personnel.
Tuesday,
May 5
Mr. Aronoff
presented a certificate and letter of appreciation from HHS
Secretary Michael Leavitt to Dr. Sollinger, who is concluding
his final meeting as ACOT member and chair.
Insurance
Coverage for Living Donors
Richard
Migliori, United Resources Network
Dr. Migliori
stressed that this presentation highlights his personal interpretation
of materials collected by him; it is not scientifically valid,
and only represents his views. He presented on issues of insurability
for donors. It is widely believed that donor needs are covered
and insurance documentation clearly indicates this should
be the case.
The clinical
capability of the U.S. medical industry is unmatched in the
world, which is expensive. Health insurance costs are rising.
Health care expenditures represent 17 cents out of every dollar
spent in the U.S., and costs are growing about 10 percent
a year. Increasingly, employers are not providing health insurance
to their employees. In terms of donor insurability, there
is a lot of confusion about insurance responsibility for donor
costs at transplant and afterwards. Donor insurability concerns
breed apprehension about donation; this confusion leads to
less optimal care and other problems for donors.
The North
American Transplant Coordinators Organization (NATCO) surveyed
liver and kidney centers in 2006 and found several interesting
things. For example:
- Four
centers require donors to show that they have their own
insurance at the time of transplantation, despite the fact
that donor costs are the responsibility of the recipient.
- Over
1/3 of centers have had donors decline to participate in
a donation because they fear future insurability.
- Only
46 percent of centers reimburse donors for their medications.
- Insurance
companies ask that bills be sent to donors (so they receive
a denial of payment) before they will pay, which creates
administrative work and scares the donors.
- Follow-up
care and coverage are inconsistent and centers end up paying
more than they should because of this confusion. Fifty-five
(55) percent of centers report that they absorb costs at
three months post-transplant, 47 percent do at one year.
- Nine
percent of programs report that absence of insurance affects
post-transplant care.
- Centers
feel that more donors would come forward if they were assured
that they would have financial and medical protections.
The Federal Government should ensure catastrophic care to
donors.
Dr. Migliori
examined insurance policies and found that coverage for donor
services are the responsibility of the recipient's policy;
this is spelled out in the policies very carefully. Group
insurance policies (which are normally employer-based) treat
a post-donation issue as a complication from a prior condition,
and pay it. Donors tend to be very healthy and the insurers
would rather get their premium than spend the time trying
to reject them. He noted that individual insurance coverage
is a little more restrictive. Typically, however, policies
accept donors as long as they have recovered with no other
significant medical conditions. Donors may buy an impairment
rider if they have had problems. The latter are those who
are likely to be at risk, although they can go back to recipient
insurance for coverage. If either the donor or recipient is
confused about insurance coverage, there can be delays or
care can be affected. This is a big concern.
Dr. Migliori
noted that donors are concerned about their insurability and
health care, exceeding their lifetime maximum limits on care,
and whether seeking care for complications will affect their
insurability. Donors also are worried about portability, fearing
that a new employee's plan won't cover effects of the donation.
They should not be burdened by this. In addition, these issues
crimp the availability of organs.
Dr. Migliori
presented a set of principles for discussion which include:
- Clarify
the coverage obligations of the insurers
- Clarify
treatment obligations of the centers
- Provide
a safety net for those impaired by previous donation.
Dr. Migliori
also presented solutions that would advance these principles,
including:
- Establish
coverage obligations for recipient insurer (e.g., life-long
coverage obligations for transplant-related complications;
one-year follow up coverage according to the American Society
of Transplant Surgeons)
- Mandate
center obligations to the donor (e.g., discharge medications
dispensing; elimination of donor insurance requirements;
guaranteed follow up and complication management; recommended
standards)
- Enable
Medicare eligibility for donors denied coverage due to impairment
resulting from donation.
Discussion
Mrs. Boone
thanked Dr. Migliori for his work on this subject and noted
that his ideas address many of the concerns she has experienced
and heard from other donor families. In turn, he thanked her
for advocating on behalf of donors, which directly led to
his presentation.
Dr. Rosenzweig
commented that she is skeptical of some of the solutions.
If we were going to change Federal law to prevent use of preexisting
conditions or denial of portability, how would it be enforced,
particularly after some time has passed. Dr. Migliori responded
that he is not advocating that, but rather is suggesting that,
in these rare cases, there needs to be protection through
the public arena. The bottom line is that people should not
be discriminated against because they have been an organ donor.
It is not at all clear that this ever happens, but it's a
fear that people have. Kidney recipients are or will become
Medicare recipients with ESRD; therefore, covering donors
more fully actually offsets funds that would be spent on the
recipient if they don't get a new kidney.
Dr. Solomon
asked about creating a change in practice; how to get a response
rate greater than 16 percent from centers so that standards
can be created and published. She has heard stories where
the transplant team itself didn't know about coverage for
donors and the consequences were bad. Dr. Migliori responded
that the low response rate has already identified a major
problem that needs to be addressed. Even if the problem among
all centers is actually less than indicated by the survey,
it's still an enormous issue that must be addressed. The solution
is in providing information to the donor at the same time
as the informed consent for the donation occurs.
Dr. Wright
commented from the floor that there is an insurance package
for kidney donors offering good coverage. It is underwritten
by American International Group, Inc., (AIG) and modeled after
the bone marrow field. It is administered through the American
Foundation for Donation and Transplantation, which collects
follow-up information on kidney donors. Two claims have been
paid to date. It can be purchased by individuals or by the
centers.
Ms. Principe
expressed concerns about mandating the center not to seek
information from the donor's policy. This should be directed
at the insurance companies, because they dictate the practices
and often won't proceed with payment until they get a letter
from the donor's company. Centers shouldn't even know the
policy from the donor, particularly given issues of confidentiality.
Dr. Migliori agreed wholeheartedly and noted that the insurers'
practice of billing the donor's policy and seeing what happens
is really problematic. Mrs. Boone described her situation
and said she doesn't know how the hospital acquired their
insurance coverage information, unless it was from the off-site
blood test procedure.
Dr. Migliori
suggested that ACOT consider the solutions he presented. Dr.
Scantlebury agreed that these are real issues ACOT needs to
consider.
Other
Living Donor Issues
James
Burdick, Division of Transplantation
Dr. Burdick
talked about other Federal efforts connected with donors.
The OPTN process for the registry and rules have been in place
for less than 20 years. There is a role for the Federal Government
to protect the living donor. Several activities are on-going
that will be helpful:
- OPTN
is going to begin to conduct two-year follow-up for every
program and every donor.
- NIH
is going to fund grants to explore long-term donor outcomes
for lung, liver and kidneys in terms of medical and quality
of life issues.
- HRSA
plans to conduct a national sample on intermediate follow-up
that will look at insurance, quality of life, and social
issues for patients.
There
has been a Federal Register notice on OPTN's policies
that living donations have the same standards and enforceability
as deceased donations. He noted that there is a desire to
provide grants to cover expenses for low income donors; this
was unsuccessful last year but efforts to create it will be
on-going.
Discussion
Ms. Conrad
said that she was surprised that, when she donated her kidney,
travel and lodging were not covered by insurance and the donor
had to pay out-of-pocket. She noted that the Medicare system
is benefiting because the recipient did not have to go on
dialysis which saved a lot of money. Dr. Conti suggested pursuing
Medicare eligibility for all live donors.
Dr. Sollinger
noted that we have been waiting for these changes for a long
time, but he expressed pleasure that the transplantation field
is paving the way for donors. Mrs. Boone responded that this
makes her feel a lot better, that things can change, even
though it takes a while. She wondered why there has been a
delay in doing long-term follow up. Dr. Burdick responded
that the delay results from funding issues: he noted that
it is hard for federal programs to be inventive and do new
things when funds are being cut. The federal government is
engaged in a very constructive process, begun by the community,
to reduce the amount of information that transplant programs
have to send to OPTN. So, it would be necessary to justify
the collection of more information from centers, and to clarify
exactly what is to be collected. The NIH effort will help
define the best information to collect, which will help in
advocating for funding on this.
The
Institute of Medicine Study
James
Childress, University of Virginia
Dr. Childress
served as chair of IOM's Committee on Increasing Rates of
Organ Donation. He presented on the findings of the IOM study
— Organ Donation: Opportunities for Action
— to be released this week. He discussed the IOM's task
and the guiding perspectives and principles used by the IOM
group. He stressed that fairness is important in both benefits
and burdens. IOM also looked at the effects on disadvantaged
groups. Recommendations to support organ donation include:
- A Systems
Approach
- Expanding
the Population of Potential Donors
- Promoting
and Facilitating Individual and Familial Decisions to Donate
Organs
- Presumed
Consent
- Incentives
for Deceased Donation
- Ethical
Considerations in Living Donation
There
are about 12,000 potential donors in the U.S. each year, of
which about half are actual donors. Circulatory determination
of death (including DCD) presents a larger pool of 22,000
potential donors, of which only 270 were donors in 2003. Dr.
Childress discussed the difference between controlled and
uncontrolled death and how this affects the donor pools. IOM
is very interested in increasing donation after circulatory
determination of death (DCDD) by funding demonstration projects,
increasing other initiatives to encourage the practice, maintaining
opportunities for organ donations, and increasing research
on organ quality and enhanced organ viability.
IOM also
looked at ways to increase the public understanding and appreciation
of organ donation, and presented the committee's findings
on issues of presumed consent. Evidence suggests that the
U.S. public is not yet informed enough about donation to implement
the practice of presumed consent; and it might, therefore,
harm overall donation efforts. IOM suggests, instead, that
public support be built to create a society where it's presumed
that one will be a donor.
IOM considered
financial and non-financial incentives to donation. IOM suggests
that the U.S. should not adopt financial incentives (which
raise issues of commodification) at this time nor should the
U.S. institute preferential access to future services for
donors and/or their families. While IOM was not asked to look
at living donors, the committee did consider the impact of
living donation on the field.
Discussion
Mr. Frieson
asked about DCDD and issues of family consent and legal/ethical
issues. Dr. Childress described past and successful pilots,
notably at the Washington Hospital Center in the 1990s. The
DC City Council passed regulations to promote this practice,
in fact, and Virginia and Florida also have such supporting
laws. It will be important to have demonstration projects
to assess the success of the idea. Mr. Frieson noted that,
given Thursday's conversation about DCDD and the profession's
lack of comfort with this practice, it seems like DCDD would
face the same issues. Dr. Childress reported that the public
is pretty comfortable with DCDD, since it is how most people
are declared dead. The public is less comfortable with neurologic
death, while hospitals are more comfortable with neurologic
death.
Ms. Robinson
reported that pilot studies indicate that financial incentives
— like travel expenses and funeral expenses —
are popular. Dr. Childress noted the distinction between the
removal of financial barriers, which is for living donors
and is fair, compared to deceased donors, for which it is
unnecessary and probably unneeded.
Dr. Reyes
asked about requiring hospitals to have DCDD policies at this
time. Dr. Solomon reported that several IOM reports have suggested
this. The question discussed yesterday was whether this should
be a CMS requirement, but Dr. Childress stated that this question
had not been discussed by the IOM committee. Dr. David Vega
said that hospitals are overwhelmed by their trauma patients
and do not have the capacity to perform the activities required
to keep organs viable. Dr. Childress said this is exactly
why a demonstration project is necessary—to test it
before we move ahead.
Regulated
Payment for Organs
Arthur
Matas, University of Minnesota
Dr. Matas
reminded the group of the growth in the waiting list for organs,
which results in increased median waiting time for kidney
donations and deaths among those on the waiting list. Overall,
the percent that die on the waiting list has increased from
6 to 8 percent. These deaths are not, as one might think,
among the most elderly people on the list. The mean age is
54, and most of them are unsensitized. The argument for sales
of living donor organs stems from the 5-10 year wait for organs,
the increased number of deaths among those on the list, and
the fact that the projected supply cannot meet the demand.
It is agreed by everyone that there should not be financial
disincentives for donation.
In order
to debate sales, we must all debate the same sales systems.
What has been happening is that supporters and detractors
describe different systems. Dr. Matas proposes a specific,
regulated system of payment that provides a fixed price (that
has no tax implications) to the donor with allocation based
on a fixed algorithm.
In terms
of a regulated system, payment to donors does not need to
be monetary. It can be composed of access to health insurance,
a tax benefit, life insurance, etc. Many organizations have
supported sales, including the International Forum for Transplant
Ethics. Prohibition of sales of one's own body interferes
with an individual's autonomy and conflicts with our social
standards of individual liberty. It is legal to donate other
parts of the body, such as sperm or eggs, and monetary self-interest
alone is neither illegal nor uncommon. Sales currently occur
in an unregulated factor, and legalization can minimize this.
Organ sales are economically feasible for the health care
system. Over 20 years, the expected savings to the health
system of getting a kidney vs. staying on dialysis are about
$95,000. It is, therefore, cost neutral to pay the vendor
up to this amount (minus costs for administrating the system).
An argument
against sales has to make the distinction between sales and
donation. Dr. Matas presented current arguments against sales
and his response to these objections. Dr. Matas described
other regulated sales systems which occur today and touched
on the issue of commodification. He noted that experiences
in sperm and egg donation have indicated that commodification
isn't actually an issue for these donors and that people understand
that their humanity is not the same as their body part ("I
am not my kidney"). A sales system allows the individual
to decide for him or herself what to do with his or her own
body through a system that provides screening and regulation.
Those who have issues with their body integrity do not, in
the end, need to become donors.
Another
common argument against sales is that it will hurt the poor,
that financial considerations will override their judgment.
Yet, selling on the part of the poor is not exploitive if
everyone benefits and the vendor is making an autonomous decision
that can improve his/her own quality of life. The system can
be regulated to ensure that informed consent is intensive
and the donation is voluntary. There is a difference between
choices that are hard and choices that are voluntary. To deny
low income people this option implies that they are incapable
of making decisions. If we consider financial pressure on
a donor, then we have to consider also that there is emotional
pressure that exists for donors, too. Prohibiting low income
people from selling their organs doesn't really help them,
and leaves them poor. Finally, we allow low income people
do lots of things and engage in activities rich people won't
do (like join the military or work in mines) that have greater
risks than organ donation.
Some suggest
that the health care relationship will be harmed by organ
sales but there is no evidence to support this. In other instances
with sales, people (surrogate mothers) get great care, for
example. Some think that religious organizations might object,
but separation of church and state necessitates that churches
and other religious organizations not dictate public policy.
Additionally, it is thought that donation must be altruistic,
but it's not clear why this should be so. Finally, people
fear that the system could be abused if donors lie about health,
but screening will prevent this. Doctors and donors can game
the system now, anyway, and the possibility of abuse is not
a reason not to do something.
Public
surveys have indicated that the public supports organ sales,
while doctors and nurses are more likely to oppose it. There
are, of course, practical considerations to such a system
which include: setting a minimum age for donors; establishing
a geographic area for vendors; providing long-term care; providing
long-term follow up; providing payment; verifying donor's
status; handling logistics; designating a price; and drawing
the line at kidneys (because we know the most about these
donors). The practical concerns do not mean it's not worth
pursuing. Dr. Matas presented his principles for ethical sales.
Discussion
Dr. Solomon
asked that we have an ethical analysis on the other position
to balance the debate and Dr. Sollinger agreed to do this.
The ACOT members unanimously agreed to continue this discussion.
Dr. Solomon
remarked that the proposed sales system does not address the
IOM concerns about fairness. The proposal makes a libertarian
argument about autonomy, but there is precedence where society
trumps autonomy, as with physician-assisted suicide. This
has been rejected by the community despite a social commitment
to individual rights. Dr. Matas agreed that the debate should
be aired and on the table. He noted that bioethical and practical
issues are more critical than rights issues. He asked if there
are issues that trump the fact that people are dying on the
list.
Ms. Robinson
noted that patient organizations are interested in exploring
this issue. Patients who need organs do not want to stay on
the list and do not want to die. She stressed that wealthy
people are able to do lots of things that poor people can't
do — like get fertility treatments — and that
consent of the vendor is what's most important.
Dr. Scantelbury
stated that she connects a regulated sales system with the
web-based connections. If we can regulate such a system, and
compensate people in ways that may not be cash, we can help
with the problems raised yesterday. Access to other routes
is fairer than having only those who can pay $300 to be registered
in a commercial registry.
Dr. Leffell
asked if payment would result in increases in the number of
living donors. Dr. Matas responded that the previous presentation
on coverage stressed potential donors' concerns about their
insurability — such a plan could help overcome those
fears and ensure good, long-term care. Further, any system
would evaluate people just like we do now, so only the appropriate
donors would be accepted. It might be necessary to evaluate
a possible donor twice over a period of time to overcome the
fear of people misrepresenting themselves.
Dr. Bridges
reminded the committee that we don't really know the long-term
outcomes for donors and we do provide health care or protections
to today's altruistic donors. She suggested that, if the system
served these donors better with support services, health care
and information, it would encourage more people to participate
as voluntary donors. Dr. Bridges said that it's not clear
that vendors can be evaluated as stringently as well as someone
who comes forward because of families or other connections.
Dr. Matas disagreed, stating that finding a donor through
a church flyer or message at an office does not differ from
someone who comes in because of a billboard. Data do not indicate
that there is any difference between these types of donors,
although further study would be helpful here.
Dr. Conti
noted that he is uncomfortable because everyone benefits from
the system currently, e.g., surgeon, the facility, everyone
except the donors.
Tissue
Regulation
Mike
Seely, Pacific Northwest Transplant Bank
Mr. Seely
presented on the committee's recommendations on the framework
for tissue regulation and oversight. He described the committee's
past discussion and process to create the recommendations.
The focus is on potential Federal oversight, although there
is currently the potential for State oversight. The committee
looked at regulation of solid organs, tissue, and whole body
donations and examined the goals of preserving the public
trust, meeting transplant needs, assuring public safety, and
advancing science. Risk-benefits vary among these tissues.
Solid
organ oversight
- There
are oversight bodies and entities (i.e., UAGA, CMS, NOTA,
OPTN/UNOS, CoPs, HRSA, FDA)
- There
are quality oversight entities (i.e., AOPO, accreditation,
CMS Quality Audit, UNOS Audit, FDA Audit)
Tissue
- There
are oversight bodies and entities (i.e., UAGA, FDA, CoPs)
- There
are quality oversight entities (i.e., AATB accreditation,
EBAA Accreditation, FDA Audit, ISO 9000)
- Public
safety is emphasized
Whole
body
- There
is one oversight body (i.e., UAGA)
- QI
protocols set by universities
- Essentially
there is no oversight or regulation (only Maryland may have
mortuary rules)
- Has
been recent controversy in body trade and sales of body
parts
In Mr.
Seely's community, unregulated companies are providing free
cremation for those who donate their bodies. It is not clear
what the bodies are being used for (e.g., the Army has used
bodies to test land mines). There should be a mechanism of
accountability that addresses who the receives the bodies,
and that they comply with public health issues. In New York,
there was a scandal recently about in stolen body parts. In
response, Senators Charles E. Schumer and Patrick Leahy have
introduced a bill, The Safe Tissue Act (S. 2609); but it does
not, in Mr. Seely's opinion, go far enough to protect individual
rights and public safety, and is limited in scope.
Mr. Seely
suggested that ACOT recommend that Congress adopt a better
proposal that will really address the problem. The suggested
committee recommendations are to:
- Conduct
a review of overall regulatory framework for solid organ,
tissue and whole body donation.
This should be undertaken by an independent, professional
organization like the Institute of Medicine and have, as
its goals, preserving the public trust, addressing transplant
needs, assuring public safety, and advancing science.)
- Propose
options for strengthening the existing regulatory oversight.
In so doing, consider alternative models for regulatory
oversight (e.g., inspection and control; accreditation);
incorporate insights gained from other regulatory approaches;
and identify proposed changes for Federal and State attention.)
Discussion
Dr. Migliori
asked if this subject is part of ACOT's mission, and if there
is any impact from illegal/illicit traffic on the available
organ pool. Mr. Seely responded that it is appropriately part
of ACOT's mission. His organization gets many calls from members
of the public who are outraged about body tissue abuses. Some
people have gotten rid of their donor cards as a result of
these incidents. People do not differentiate between transplant
centers, tissue facilities, and these unregulated entities.
Ms. Conrad agreed, and reported that, as an OPO director,
she gets calls weekly from people who want to donate whole
bodies and all she can do is refer them elsewhere. There is
a lack of information about how the bodies are used, the consent
processes, and assessing good standards.
Mr. Seely
proposed that ACOT could ask the IOM to look at this issue.
Then the appropriate groups can shape legislation based on
these findings. Dr. Sollinger stated that a strategy for proceeding
will be developed and presented.
DoT
Clinical Interventions and Social and Behavioral Interventions
Grant Programs
Jade
Perdue, Division of Transplantation
Ms. Perdue
presented on the Division of Transplantation (DoT) activities
and ways to improve the number of organs donated and transplanted.
Under NOTA, there is a new amendment that the Secretary can
make grants to increase donation and recovery rates. There
are currently three grant programs that fund projects around
social enhancement of donation, OPO/hospital accountability
through best practices, and clinical interventions (CIOP).
CIOP does not support certain types of programs because HHS
seeks interventions that can be immediately directed to the
outpatient area.
Eleven
three-year grants have been funded and it's hoped there will
be three to five projects funded in FY07. DoT staff recently
met with NIH staff to discuss grants management and found
that the Institutes have longer project periods (4-10 years)
and offer multiple opportunities to apply. DoT will start
to offer technical assistance mid-year to grantees and hopes
to work with NIH on forwarding promising projects for future
funding of implementation of best practices.
Future
opportunities include:
- IOM
recommendations to fund innovative system changes or modify
clinical interventions program to address DCDD
- NIH/DoT
participation in research symposium
- National
conference call on needed growth
- ACOT
sub-committee focus
DoT seeks
feedback from ACOT on ideas for areas of funding that will
have the best impact and for suggestions about the most important
step DoT can take to determine the focus of the CIOP.
Discussion
Dr. Low
stressed that anything ACOT can do to encourage this work
will be appreciated and helpful. Dr. Sollinger asked if the
DoT funds are available to most transplant professionals,
and Ms. Perdue described the distribution processes used for
the request for proposal (RFP). He suggested that a technical
assistance session could be held at the upcoming World Transplant
Congress (July 23-27). Dr. Bridges suggested that the OPOs
are the most appropriate entities for the funding. In the
clinical transplant community, not everyone knows how to formulate
a question and create a study. Technical assistance can help
these individuals write a grant and submit it, and DoT provides
this.
Mr. Frieson
suggested working with faith-based groups, as churches have
huge health fairs that reach thousands of people. (His denomination's
national meeting had a health fair attended by 40,000 people).
The Government could fund materials to be distributed to these
groups.
Dr. Mary
Ganikos described a new DoT grant program to assist States
that do not have a statewide organ donor registry and those
States that do have a statewide donor registry which do not
have enrollment capability through the motor vehicle licensing
offices to develop and implement, in collaboration with all
OPOs with service areas in that State and representatives
of the eye and tissue banks in that State, a statewide registry
of residents who wish to be an organ and tissue donor.
Past
ACOT Recommendations
James
Burdick, Division of Transplantation
Dr. Burdick
presented past recommendations from ACOT. Recommendations
have been made on the subject of education, the Breakthrough
Collaborative, reimbursement policies among HRSA and CMS,
medical examiners, and disparities in transplant rates. He
reported in greater detail on the most recent recommendations
(starting with #36) and updated the group on the progress
to date. Dr. Rosenzweig asked for a written record of the
recommendations and their implementation. Dr. Burdick promised
to distribute this.
Disease
Reporting and the Sentinel Network
Laura
St. Martin, Division of Transplantation
Dr. St.
Martin noted that organ transplant-transmitted infections
are rare, but can have serious outcomes. The goals of the
reporting systems are included to identify all affected recipients
in order to assess their condition and intervene with care;
to remove all donor materials that have not been transplanted
from the pool; to help investigate incidents; and to prevent
future incidents.
OPTN/UNOS
Policy 4.0 was revised and approved after public comment in
2004. It created a list of diseases and medical conditions
to be communicated to the transplant center, if known to be
present in the donor. Dr. St. Martin described mechanisms
to implement the reporting system as well as the OPO and OPTN
responsibilities. The OPTN will forward a final report from
the OPO to HRSA. To manage the reporting process, the Disease
Transmission Advisory Group has been created as a subcommittee
of the OPTN/UNOS Operations Committee. It has an evolving
role but its tasks include reviewing current disease transmission
reporting policies, developing disease reporting forms, reviewing
case reports, and recommending revisions to the OPTN/UNOS
Policy 2.0 and 4.0.
There
is also a Center for Disease Prevention and Control (CDC)-led
project, which grew out of a June 2005 workshop on organ and
tissue safety. Priorities were developed at this workshop
that included the need for clear mechanisms for adverse event
reporting, a notification algorithm, etc. While organ and
tissue mechanisms may be created, the mechanisms should be
able to communicate and share information between them. In
2005, the CDC issued an application to fund a Transplant Transmission
Sentinel Network to do this, and the 3-year cooperative agreement
was awarded to UNOS. UNOS has formed an alliance with many
relevant organizations (i.e., AOPO, AATB, EBAA, AST, and ASTS)
to do this work. The Network is in early stages but will hold
a meeting on June 6, 2006.
Discussion
Dr. Bridges
asked if the information to be collected from OPTN caser report
forms will go into the SRTR or other database. Dr. St. Martin
commented that it's yet to be determined where the data will
be housed. Staff is currently meeting with transplant centers
about the need for the data collection and its use. Dr. Zhu
commented that it's important to have a clear plan for data
collection and analysis. Dr. Matthew Kuehnert, Assistant Director
for Blood Safety, CDC, expressed the CDC's excitement about
the effort and seeks ACOT's comments on the effort.
Future
Subject Areas for ACOT Meetings
Hans
Sollinger, Chair, ACOT
Dr. Sollinger
recounted ACOT's history, which began with former Secretary
Donna Shalala and grew out of the allocation battle. He recommended
that new ACOT members should receive training how the process
works and how recommendations get developed and promoted.
He also suggested that introductions be made for everyone
in the room so new members can learn who is who.
Proposed
ACOT Recommendations for the Secretary to be addressed:
- Support
a public education campaign to educate the public about
what DCDD is, and its importance and potential impact on
organ transplantation. DCDD protocols should be mandated
to exist at all hospitals.
- Ensure
lifetime immunosuppressive medications for recipients of
organ transplants as a cost effective method of post-operative
care.
- Work
to ensure catastrophic insurance coverage for living organ
donors for donation related complications
- Dr.
Sollinger noted that this already exists; see earlier
notes from Thursday.
- Establish
a dedicated Medicare Drug Coverage Hotline for transplant
recipients.
- Investigate,
with the help of ACOT, if there are specific issues that
resonate with the public and influence them not to become
donors (i.e., public is not ready for mandated DCD, organ
sales, etc).
- Another
issue is whether negative publicity on organ and tissue
donation have a measurable influence on organ donation?
ACOT members could do research, suggest how research
could be done, and/or suggest who could do it.
- Investigate
ACOT's role in guiding priority research areas such as outcomes
of live donor recipients.
- Difference(s)
between solicitation for a live donor and a diseased donor.
This could be conducted through a subcommittee and presented
as a recommendation at the next meeting.
- Other
issues that ACOT could discuss:
- Payments
for donors and recipients for ECD; costs for OPO and
costs for hospitals
- SRTR
study to analyze costs based on available UHC data
- Desensitization:
do effective therapies indicate that a new DRG is needed
to cover these costs, and what is the feasibility of
living related donor versus deceased donor?
- Some
members felt there was not enough scientific evidence
of the therapies' effectiveness to suggest moving
ahead with advocacy for payment.
- ACOT
can have SRTR conduct an analysis on this question
- At
two meetings in the future, summarize current state
of art about this issue.
- Regulated
payment for live donors: pros and cons of a pilot study.
Public
Comment
- The
National Kidney Foundation applauds the IOM report and urges
ACOT to adopt the recommendations from the IOM.
- Dianne
LaPointe Rudow from NATCO talked about living donor insurance
and noted that it's important to clarify CMS regulations
in this area and what goes on the cost report. Administrators
actually debate this issue; for example, whether a hernia
two years later should be included in the cost report. It's
very important to clarify these regulations. Also, when
we look at follow-up, screening for complications has to
be conducted, too. Finally, complications are not just medical.
Data indicate there are mental health problems that occur
after a donation. Donors have psychiatric care needs that
must be paid for both while they are at the transplant center
and when they return home.
- Mary
Ganikos, Ph.D., reported that the Division of Transplantation
is providing technical assistance to TV screenwriters about
organ and tissue donation. Also, a Gallop survey is coming
out soon that compares current views with 1993 opinions
on financial incentives, presumed consent, etc.
Dr. Sollinger
thanked those individuals offering comments and adjourned
the meeting.
The next
meeting of the ACOT will be held on November 2-3, 2006.
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