Advisory Committee
on Organ Transplantation (ACOT)
Spring Meeting
May 9 & 10, 2005
Doubletree Hotel and Executive Meeting Centers
Rockville, Maryland
Monday, May 9
Prior to the meeting, newly appointed ACOT members were sworn
in as members of the Committee in a private ceremony.
ACOT Ethics Training Video
Thom Balbier, Executive Director, ACOT
Mr. Balbier welcomed the group to the Washington area, and
noted the meeting would start after a short video presentation
on ethics training, which is required for certain Federal
employees and Special Government Employees (SGEs). Ms. Jennifer
Jordan, who had been scheduled to present this session, was
unable to attend the ACOT meeting.
The video covered ethical requirements for government consultants,
such as grant reviewers, advisory committee members, and other
SGEs. The video addressed how to assess conflicts of interest,
and described conflicts that might occur around financial
holdings of SGEs and their family members; acceptance of gifts;
and activities such as teaching, speaking and writing. Mr.
Balbier noted that ACOT members are asked to serve because
of their experience in organ donation and transplantation
and, as a general rule, the Committee has waivers approved
for all Committee members around their particular area of
expertise. Members only have to do the financial paperwork
once, unless there is a major change in assets or employment.
After the video, Mr. Balbier introduced Dr. Hans Sollinger
as the new chair of ACOT.
Welcome and Introductions
Hans Sollinger, Chair, AC
Dr. Sollinger thanked Mr. Balbier and expressed his appreciation
for all of the ACOT members (especially the mothers) who left
their families on Mother's Day in order to attend the meeting.
Dr. Sollinger welcomed the new members and noted the handout
providing information about the new members and their backgrounds.
Dr. Sollinger reminded the group that ACOT was formed in the
last year of Secretary Shalala's administration, and it met
for the first time under Secretary Thompson. ACOT has accomplished
a lot over the last four years — it has issued proposals
and recommendations that have had an enormous impact on U.S.
organ donation. Due to the Breakthrough Collaborative, there
has been an 11 percent increase in organ donation in the U.S.
Overall, it has been a very successful and productive four
years. Dr. Sollinger noted that, in his first meeting with
former Secretary Thompson, he had suggested that it was important
to focus on increasing donations (rather than addressing allocation
issues). He said he felt real progress has been made in this
area.
Update on Recent ACOT Developments
Thom Balbier, Executive Director, ACOT
Mr. Balbier updated the group on ACOT activities and reviewed
the meeting agenda. A notice of this meeting was published
April 11 in the Federal Register and included the
notice that there would be an opportunity reserved for public
comments over the next two days. He asked the group, when
discussing future agenda items, to think about the subcommittees
that exist, and consider what subcommittees might be established
in the future, or whether ACOT should have informal arrangements
like workgroups formed to consider special initiatives or
projects. He noted the success of the recently formed Workgroup
on CMS Regulations as an example.
New members should remember that service on ACOT is based
on an individual's experience. However, when voting, members
should consider the broad public policy interests, rather
than the interests of any particular organization with which
they may be affiliated. The ACOT, located on the Organ
Donor website now lists the expiration dates of all members'
terms. Mr. Balbier noted that several members' terms expire
in July, and asked those members to keep the November 3-4
meeting dates on their calendars because each ACOT member's
term continues until his or her replacement is named. New
appointments for ACOT were solicited by publication on March
4 in the Federal Register. There have been 64 nominations
received, but Mr. Balbier said that the appointments process
can be lengthy, and may not be completed in time for new members
to attend the November meeting.
He finished by stating that the Uniform Anatomical Gift Act
(UAGA) is close to 20 years old and there have been many changes
in the field since the UAGA was first crafted by the National
Conference of Commissioners on Uniform State Laws (NCCUSL).
Proposed amendments to the UAGA have been developed and are
currently being circulated for review within the NCCUSL Drafting
Committee on Amending the UAGA. HRSA staff has been participating
as observers with the Drafting Committee, which will report
its first draft of an amended UAGA to the NCCUSL at its annual
conference this July.
Report on DCD Consensus
Conference
Frank Delmonico, Medical Director, New England Organ
Bank
Dr. Delmonico presented on the National Conference on Donation
after Cardiac Death (DCD), which occurred in April 2005 with
the participation of many groups, including WHO, AMA, AOPO,
JCAHO, ASA, CCN, SCCM, and AST. He noted that the IOM has
issued a statement that DCD is an ethically proper approach
to recovering organs. The conference goal was to expand this
practice particularly with respect to quality end-of-life
care. He said that when life support is withdrawn, especially
in an ICU, there should be an opportunity for DCD so that
families can honor the deceased. The message that the conference
wishes to stress is to convey the social responsibility of
DCD and the appropriateness of determining death using circulatory
or brain criteria.
The conference consisted of six working groups on:
- Determining death by a cardiopulmonary criterion,
- Assessing medical criteria to predict DCD candidacy following
the withdrawal of life support,
- Protocols for successful DCD organ recovery and subsequent
transplantation,
- Initiating DCD in Donor Service Areas (DSA),
- Allocation of DCD organs for transplantation, and
- Media, public perceptions, and DCD.
Dr. Delmonico explained the findings, to date, of these workgroups.
He noted that DCD is increasing, but there are places where
none has occurred to date. Some OPOs and Donor Service Areas
(DSA) lack experience in this area and the group's objective
is to work with those areas to improve their experience and
start DCD policies and practice. It is important to get information
about this to the public and the media, so more people know
about it and know that DCD saves lives.
Dr. Delmonico said that the group wanted ACOT to endorse
the recommendations, support development of research studies,
and also to revisit Recommendation 14 (require hospitals as
a condition of participation, to establish DCD programs and
policies). Also, ACOT is asked to:
- Support the development of studies assessing the frequency
of auto-resuscitation in DCD patients and other patients
dying after withdrawal of life-sustaining therapy.
- Recommend standardized data and reporting parameters for
potential DCDs to the OPTN.
- Recommend that the OPTN modify data submission standards
to capture Phase I and Phase II data with a minute-by-minute
collection of data to assess systolic, diastolic, and mean
arterial blood pressure, the measurement of O2 saturation,
and urine output.
- Provide guidance on issues related to informed consent.
Discussion
Dr. Sollinger thanked Dr. Delmonico for the presentation
and for being such an eloquent spokesperson in this area.
He said that it's known that organs function well if the donor
is picked carefully and it's a major concern that so many
OPOs do not have DCD as a component of organ donation. As
a result, many donations are lost. In Dr. Sollinger's region,
they had to spend a lot of time traveling to donor hospitals
to talk to boards before the hospitals would add DCD protocols;
but still, some of the larger hospitals lack policies. He
agreed that having DCD policies should be a condition of participation
with CMS. Dr. Delmonico said that DCD has the support of the
community and JCAHO is very supportive. By every method of
reviewing practice, it's clear that DCD should be a component
of organ donation.
Mike Seely asked if the OPTN membership criteria have been
fast-tracked.
Dr. Delmonico responded that there will be a strategic plan
for OPTN in the fall and the goal is to include this. The
OPOs should have a policy and protocol for DCD. Mr. Seely
asked if, with respect to the 15,000 discards mentioned in
the presentation, there were any data on biopsies or cull
time as discard factors. Dr. Delmonico said that currently
a HRSA grant is looking at this question. In some cases, biopsy
is a factor, but there is a need for more data. There are
people who are on dialysis who could benefit from these organs.
Even if the function is not excellent, it's better than being
on dialysis for these patients.
Dr. Kahan said that in Madrid (Spain) they have on-site preparation
by the emergency team and have had good results. In the field,
one often finds better organs.
Dr. Delmonico agreed that the Spanish are ahead of us in
this area.
Dr. Young said that he found the same problem in Alabama.
They had to go to the ethics committee several times to show
them the data to get DCD approved. Because of the fear of
litigation, it is very hard to get hospitals on board. He
said that, if CMS had a regulation to make DCD a standard
of care, it would help. He suggested better education of medical
providers so they are on board as well. In many cases, the
medical providers have no idea about the benefits of DCD.
Susan Gunderson said that she was looking forward to seeing
these results. As an OPO that implemented DCD the week before,
she confirms that the process takes a long time. Having the
IOM report behind us has been really helpful, and this new
report will really help as well. Making DCD a CMS condition
of participation for donor hospitals will be beneficial. She
asked if there were any deliberations around ethics for caregivers
and the timing — this has been a thorny issue —
in terms of whether the caregiver doctor is also the one who
wants to pursue DCD.
Dr. Delmonico said there has to be a progression. It has
to be established that it is futile for treatment to be given.
People have to trust the doctors not to be overly pursing
the goal of organ donation. He stressed that the end of life
care is the main priority and this has to be paramount for
everyone concerned. When that is established, then the continuum
goes to the next phase, which happens after it's not feasible
to continue treatment. He asked ACOT members to please make
comments when they see the report.
Dr. Migliori said that the delayed function requiring dialysis
is striking and leads to higher costs. He noted that reimbursement
requirements will have to be adjusted. He said given that
the discard rates are unacceptable, is the fear of the cost
burden adding to discards? Dr. Delmonico said this was absolutely
the case. There is a question of whether, when a donor is
declared dead, there is a way to improve the organ function.
The University of Michigan is a leader in this, and there
is the possibility that organ functioning could be improved
by resuming oxygenation.
Dr. Sollinger said that one way to do this is to keep ischemia
time as short as possible. They are handling kidneys like
they are hearts in his hospital. They know up-front and the
recipient comes in and is ready to go — they are down
to 4-5 hours. Dr. Delmonico responded that, right now, it's
hard to consider allocation protocols that give preference
acceptance and that ACOT might wish to address this.
Ms. Turrisi said that ACOT has looked at adjusted versus
unadjusted data and one issue that has come up is that there
is a difference in outcomes (especially for livers) around
informed consent. She said it was desirable that ACOT recommendations
include support for the DCD conference findings. Dr. Delmonico
agreed that not all donors are the same. At the final phase,
where the surgeon decides, they have to decide about the risk
of failure. Profiling of the donor should have been discussed
with the patient and family.
Dr. Evans suggested that one should look at resource utilization
(e.g., hospital days) and do this early on as part of data
collection and tracking major resources that are used to see
how they fluctuate. Each individual institution can do that
internally. This can be part of the protocol to work with
SRTR and the data collection could start right now. Dr. Delmonico
said it would be helpful to the OPTN to have this as a recommendation
from ACOT that this can be put in their strategic plan discussion.
It's sophisticated and practical.
Dr. Evans continued that discharge data are already collected
and there are few standard donors any more. There is a continuum
of risk for all donors that have to be discussed with the
patients ahead of time. We should recommend what kind of informed
consent should be carried out (without being so specific)
and saying what should be done. With DCD, these conversations
have to happen well before the transplant occurs. We should
get away from DCD informed consent versus other kinds of informed
consent — we should talk, rather, about what the risks
are overall.
Ms. Turrisi agreed, but said there has to be documentation
of some sort that outlines what kind of consent and information
has been given to the patient and the families. She said she
didn't think we are always consistent in how and what we do
for patients and families. Her feeling is that informed consent
is critical — patients have a right to know and to choose.
Giving the elements of informed consent and guidelines on
the process for providers is important. The framework on paper
is important because there are many people who do it and their
abilities vary widely. The informed consent form should be
a guideline and not the be-all and end-all. Dr. Evans agreed,
but felt this should not be a Federal guideline.
Presentation
on the Collaborative's Yield Initiative
Dennis Wagner, Social Marketing Leader, DoT, HRSA
Virginia McBride, Public Health Analyst, DoT, HRSA
Jade Perdue, Public Health Analyst, DoT, HRSA
Virginia McBride updated ACOT on what has happened since
the last meeting. The purpose of the Collaborative is "saving
or enhancing thousands of lives a year by spreading known
best practices to the Nation's largest hospitals, to achieve
organ donation rates of 75% or higher in these hospitals."
Among the goals of the Collaborative are to increase the
annual number of deceased donor organs transplanted by 100
percent; to increase non-cardiac death donors by 333 annually;
and to increase annual cardiac death donors by 175 annually.
The collaborative is on-track to meet these goals.
Ms. Perdue reported on the Collaborative process, a deliberative
process that generates learning periods and tests changes
in order to achieve a goal. To date, the Collaborative has
identified best practices, held a National Learning Congress,
and begun working with two teams of hospitals on changing
their practices. The first round ended in September 2004 (95
hospitals and 43 OPOs); the second round included 131 hospitals
and 50 OPOs. With the third round, the Collaborative's participating
hospitals now account for 50 percent of all eligible donors
in the United States.
Ms. Perdue ended her presentation by asking Ms. Gunderson
and Mr. Seely to talk about what has been the biggest benefit
to the OPO or hospital from participating, and what is the
best idea to spread to hospitals. Ms. Gunderson reported that
the Collaborative has become a machine, it has energy and
momentum. The biggest benefit is that everyone is on the same
team now — the OPO, donor hospital, and the transplant
center. Also, the Collaborative has brought new tools and
thinking into this work.
Mike Seely reported that the key thing is the redefining
of relationships that propel us forward, breaking down barriers,
spreading hospital ownership of the process (so they are engaged).
There is more real-time discussion of events now; huddles
happen quickly, which keeps it at the forefront of people's
minds. We all own it together.
Dr. Higgins asked if there has been any assessment of where
the lowest donations rates are and if institutions from those
OPOs have been asked to participate in the Collaborative.
He noted that urban hospitals might benefit from these process
improvements. Ms. Perdue replied that she was not certain
if they have specific percentages in terms of urban hospitals.
They have looked at hospitals with the largest donor potential,
and these hospitals are included in the Collaborative.
Dr. Sollinger said he felt that the Collaborative's success
has come from it being so positive and being presented as
such a great thing to do. It is really very exciting and is
very appealing to people. A lot of the credit goes to the
staff of the Collaborative.
Mr. Wagner discussed the aim of the Collaborative and its
sub-goals. He also showed a short video on what has been done.
The video illustrated how the Collaborative has resulted in
a shift in attitude to one that affirms transplantation and
actively seeks donations. Mr. Wagner said that the 250 hospitals
in the Collaborative are among the largest in the United States.
Henry Ford, one participant, used to have a 22 percent conversion
rate and now has a 75 percent conversion rate sustained over
12 months. The big ones are getting good.
The participating organizations choose among best practices
to test changes that will help reach the goals. These include
actions to improve timely notification of the OPO that will
permit a successful donation to occur; increase donation rates;
reduce medical examiner denials, etc. High leverage changes
are overarching strategies that lead to 75 percent donation
rates. They include advocating organ donation as the mission;
involving senior leadership to get results; deploying a self-organizing
OPO/hospital team; practicing early referral and rapid response;
learning effective requesting; and implementing DCD. A 75
percent national conversation rate would yield 9,000 donors
per year. An increase in three organs per donor to almost
four organs translates into 36,000 transplant recipients.
There are 88,000 people on the waiting list and 6,000 deaths
on the list. Expanding donations could feasibly eliminate
deaths among those on the waiting lists.
Since the Collaborative started, the number of donors across
the Nation has increased to unprecedented records. The Collaborative
began in October 2003. In 2004, every month exceeded the best
number of donations of any previous year and set new donation
records for that month. In 2005, there have been even higher
numbers and we clearly have not reached the upper limits of
what is possible. There were 631 donors in April 2005, which
is a 15% increase over last year and is statistically significant.
Mr. Wagner concluded by recognizing Russ Hereford, from the
HHS Inspector General's office, who suggested they recognize
high performing hospitals. Ms. Gunderson said that getting
a medal of honor has amazing results. When you tell people
they will get an award it's very motivating. Her site had
lower rates for lungs and has increased lung yield dramatically
in just four months.
Discussion
Dr. Sollinger thanked the group and said that they have done
a lot of work with OPOs and hospitals. Next, the Collaborative
needs to work with — and ACOT needs to help with —
the surgeons. Successful surgeons are gung-ho, but there are
other surgeons who need to be motivated just like the OPOs
have been.
Dr. Migliori said that what has been achieved is very exciting.
The timing and magnitude really demonstrates that a collaborative
effort will yield results. The accomplishments here are nothing
short of spectacular as the growth rates in performance would
be respected and admired in any industry, public or private.
The Collaborative is grinding donors through, but another
issue is the discard levels at the end.
Dr. Freeman commented that the Collaborative is showing high
yields in bigger hospitals, and asked what was being done
to share these results with other hospitals without going
to meetings and such. Mr. Wagner said that this information
is in the public domain and the Collaborative also is working
on a "spread strategy." This is like a practice
that was originated by Ford and Nokia where one pumps changes
out to leaders (in this case, in OPOs) and then track their
use of practices. He said the Collaborative will track the
information and see if it's getting out there. The hospitals
report back if they are testing an idea, have implemented
it, are not using it, or found it did not work. The knowledge
management system (KMS) has a focus for pushing changes out
and tracking them. They are also drafting articles for JAMA,
Critical Care Nurse, book chapters, etc. The National Learning
Congress will host CEOs from large hospitals who will attend
a leadership track. ACOT's suggestion to engage JCAHO in the
Collaborative was a good one.
Dr. Freeman said that having a higher proportion of organs
coming from DCD will impact the yield. The fourth goal of
10 percent DCD may not improve the total number of organs
procured. Ms. McBride clarified that the goal is to increase
the numbers of DCD without a loss in gains among other donors.
The concern is one that the OPOs have expressed. However,
the U.S. national data do not bear out this concern (although
Dutch data do).
Dr. Zhu said that he is very impressed that statistically
significant improvement is being discussed. Are people looking
at rate of survival and patient outcome? Ms. McBride reported
that best practice among patient survival is being looked
at and that this is the next direction. Dr. Zhu suggested
that if you do more transplants, and have more organs, but
the outcomes are not improved, it would be a problem. Dr.
Sollinger said that the outcome would be that more people
are alive, and that's an improvement. With kidneys, we know
that when you do a transplant, people do better than when
they were on dialysis. When you transplant more people, there
are fewer people on dialysis, so there are fewer deaths.
Report on the Fair Treatment
Subcommittee
Kathy Turrisi, Program Administrator, Medical University
of South Carolina Transplant Center
Ms. Turrisi noted that only she and Dr. Young remain as members
of this Subcommittee, whose work grew out of the Subcommittee
on Expanded Criteria Donor (ECD) organs. One question has
been what defines an extra-renal ECD organ. The group asked
SRTR about this and would like to have this information in
language that we can all understand. She did not want just
primary graft function but wanted to see 1-3 year survival
rates.
The question the group considered was what defines relative
risk? It seems arbitrary and subject to change. When looking
at the CMS guidelines, the group also wondered about expected
vs. actual survival rates — and the importance of relative
risk for this. What is adjusted vs. unadjusted? The issue
is, when explaining things to patients, how can risk be explained
in a way that is easy to follow? There is a need to be clear
and consistent in our explanations. In terms of informed consent
for ECD organs (livers), there is a difference in survival.
Should the patient know this first? This is part of the informed
consent issue. As we become more public about outcomes, there
needs to be a better understanding and consistent interpretation
of what we're being held accountable for.
The Subcommittee wanted to know if there are algorithms for
doctors to use for ECD organs and with patients. The Subcommittee
wanted algorithms to help inform patients and for doctors
to use to decide if this is the best organ for the person
at that point in time. What can we do to help everyone provide
the best information to guide care? The Subcommittee asked
that SRTR be invited to the ACOT meeting to provide an overview
of their activities that would include an explanation of relative
risk, future plans, expected vs. actual survival — all
the things that create confusion.
SRTR Overview Presentation
Robert Merion, Professor of Surgery, University of Michigan;
Clinical Transplant Director, SRTR
Dr. Merion talked about center-specific reporting tools that
are available and mandated by law. His presentation also addressed
what SRTR provides in center-specific reports. He began by
differentiating SRTR from OPTN and describing the work each
conducts. In short, SRTR does activities around inferential
analysis and analytical data reports, some of which are mandated
by NOTA (e.g., reports for policy-making committees, annual
reports, OPO-specific reports, Membership and Professional
Standards Committee [MPSC] reports, etc.).
The data come primarily from OPTN in a monthly transfer.
SRTR does "person linking" so that one patient can
be followed across multiple transplants and states for longitudinal
tracking. These data are supplemented with others and then
cleaned and validated to create standard analysis files that
are used by biostatisticians and other analysts. Different
groups have different needs and interests in the data: patients
and families are interested in specific questions about what
will happen to them. Payers and MPSC want to know if the centers
are performing up to standards. The centers want to know what
choices their patients have.
Dr. Merion then discussed risk adjustment and how this is
calculated. He used adults (aged over 18) and walked the group
through a comparison of survival rates for the national average
and a center's expected average given its patients. When calculating
expected outcomes, he noted that age matters for most organs
and used age greater and less than 45 years of age as an example.
Whenever expected survival is depends on a particular characteristic
of the patients, the risk adjustment takes into account the
varying types and characteristics of patients at a given center.
Likewise, with ECD kidney donors, the factors that affect
outcome are taken into account the components of ECD characteristics
for kidneys each has a relative risk or hazard ratio (donor
age, history of hypertension, elevated serum creatinine, and
cerebrovascular accident as the cause of death). The data
show the risk of failure by these different kinds of risk.
Ms. Turrisi asked if there was an ECD classification for
liver. Dr. Merion said that there is not a codified and accepted
definition of ECD liver, heart and lung, so the SRTR can't
use a separate flag for them, like they do for kidney. There
are factors that are likely to (and do) show up and these
components are in the model. DCD status is in the liver models
(except for the pediatric model).
Dr. Merion noted that risk adjustment includes demographics,
primary disease, donor cause of death, previous transplant,
life support, dialysis, creatinine levels, etc. There is a
very large pool of data to choose from. The documentation
of risk adjustment models is on the website. Dr. Merion also
talked about patients who are lost to follow up (LTFU) and
the resulting incomplete data. Transplant centers report transplant
failure and mortality, but the burdens to track long-term
are high. Now that the system for reporting is web-based,
the data are much better. They spend a lot of time looking
for data on deaths to make sure they know about the outcomes.
SRTR captures more than 99 percent of deaths.
Dr. Delmonico asked if a transplant center can have a 20
percent higher risk of graft failure, and if it's not a very
large center, what does this actually translate to in terms
of actual outcomes? Dr. Merion said that this fact is exactly
why SRTR reports data in a lot of different ways — you
can look at one or more of the outcomes and use what speaks
best to you. You could choose one metric to evaluate performance,
but SRTR doesn't. They use observed over-imputed values, and
several criteria. There is a User Guide Text with each center's
report that gives the expected rate and notes if the actual
rate is from chance or from something more significant. See
more information at the US
Transplant - Scientific Registry of Transplant Recipients
Web Site .
Centers are flagged when they have higher than expected numbers
of problems. A center is referred to MPSC if it gets flagged
on three criteria (more than three excess deaths, clinically
significant number of deaths (observed:expected ratio >1.5),
and statistical significance of the deaths). Only 7 –
10 percent of transplant centers have all three flags (this
varies by organ). Dr. Freeman asked what percent are not able
to be evaluated because of a lack of numbers — are there
a lot of small volume centers you can't look at? Dr. Merion
said he didn't know, but would follow up and report back.
Dr. Sollinger thanked Dr. Merion for the presentation, and
noted that people had asked their questions during the presentation,
so the group would move ahead to the next presentation.
Presentation of CMS
Proposed Regulation on OPOs and Transplant Centers
Marcia Newton, Senior Policy Analyst, CMS, DHHS
Ms. Newton presented an overview about how a regulation comes
into being and the specifics around transplant regulations.
She spent most of her presentation addressing the comments
that have been received so far by CMS on the proposed regulations.
On the proposed conditions for coverage, comments received
included that the proposal would diminish appeal rights by
eliminating two chances to be heard, since the entities would
be taken out of Part 498 and have only one appeal opportunity.
It would sacrifice due process in favor of speed and the CMS
hearing officer could be subject to agency influence.
On the recertification and competition process, Ms. Newton
noted that no one likes it. Comments include that CMS should
limit competition to OPO service areas that are opened due
to de-certification. Opening all areas to competition would
harm relationships formed under the Collaborative; ignore
regional variations in DSA culture; decrease donations due
to changeover to new OPO; and shift resources from OPO core
missions.
On performance measures, comments include that CMS should
count all organs recovered for research toward certification;
should consider using the SRTR methodology as part of outcome
measures; should not apply performance measures retroactively;
and should permit new entities to become OPOs.
On organ donor potential, comments include that CMS should
limit the definition of potential and not include DCD and
ECD; and should not count DCD in the numerators for the outcome
performance measures.
On cooperation with tissue banks, this was a major source
of form letters. Tissue banks wrote to say that OPO shouldn't
have to cooperate with banks that do not have OPO-consistent
policies. Comments also include that CMS should require OPOs
to include tissue banks in any training designated.
On administrating and governing, comments included that CMS
should establish requirements for OPO boards that the governing
board include lay and transplant professionals, that no more
than 50 percent of board members be from transplant hospitals,
and that boards should include families.
On human resources, comments included that CMS should hold
transplant centers, rather than OPOs, responsible for verifying
recovery surgeon's credentials, and should set standardized
training for OPO staff and set course content.
On the transplant coordinators certification, comments include
that CMS should require the same thing for procurement coordinators,
and should not establish a specific requirement for becoming
an "experienced" procurement coordinator.
On information management, comments include that organizations
should not have to maintain tissue and eye donations in their
records.
On consent, CMS is getting a lot of letters from tissue banks.
Comments include that CMS should not require OPOs to provide
information about tissue donation or ensure informed consent
for tissue donation; should not require OPOs to inform families
of potential tissue donors that tissue banks may be "for-profit"
entities.
On donor evaluation and management, she noted that the regulations
do not include a lot of information on DCD and ECD because
they were begun about four years ago, before the Collaborative
and DCD/ECD discussions began. Comments include that CMS should
require every OPO to have a DCD policy in every hospital.
On quality assurance, comments include that CMS should define
"adverse event" more clearly and clarify if information
on adverse events would be public information; and that CMS
should require OPOs to perform death records reviews on a
quarterly or monthly basis.
Ms. Newton also described the comments received on the Transplant
Centers regulations. She noted that CMS is proposing transplant
centers regulations in order to decrease confusion by codifying
requirements for all transplant center types into one regulation.
Right now, the regulations are all over the place and many
rules are in coverage decisions rather than in one regulation.
CMS wants to revise the current criteria to reflect improvements
in the transplant outcomes and to establish a mechanism for
re-approval of centers. In 1999, at a town hall meeting, CMS
was encouraged to draft regulations for transplant centers
because many people felt they were needed.
On procedures for re-approval, comments include that people
seem to like the proposed outcome measures.
On patient and living donor selection, comments include that
CMS should not limit psychosocial evaluations for prospective
transplant recipients to only being conducted by clinical
social workers, as patients may need further evaluation by
clinical psychologists or social workers; CMS should develop
and require uniform criteria for assessment of living donors.
On patient and living donor management, comments include
that CMS should mandate that coordination be done by a doctor
other than the one who will perform the recovery; a specialist
should do the follow up for that organ; CMS should not include
requirement for providing nutritional services to living donors;
other comments were in support of providing nutritional services;
the suggestion that CMS conform requirements for qualified
dieticians with those in the 2002 CMS regulations for nutritional
therapy; and support for social services being provided to
recipients, donors and families by social worker.
On rights, comments support establishing uniform standards
on rights.
On donor advocates, comments suggest that CMS should require
centers to provide living donors with an advocate who is an
RN, or a physician trained to be an advocate; and that the
donor advocate should not be a member of the transplant team.
On human resources, comments include that CMS should grandfather
in all transplant coordinators or all coordinators with five
years of experience; should provide alternative routes for
certification of coordinators; should require certification
of transplant coordinators; and should require that certification
be accomplished by ABTC.
On procedures for approval and re-approval, comments include
that CMS should require separate approval for centers that
do living donors, and should support re-approval of lung centers
every three years.
On alternative approval, comments include that CMS should
conduct a random survey of centers "to keep them on their
toes"; should survey centers only if they do not meet
the data submission and outcome requirements; and should not
use OPTN feedback to determine whether a center should be
surveyed — base on statistically significant data.
Discussion
Mrs. Boone asked questions about informing living donors
of the potential risk and securing informed consent. If there
is no organization that follows living donors over the long-term,
how is this information on the risks to be achieved? How can
we inform them when we don't know what happens to donors over
the long term?
Ms. Newton said there is a limit of the information we can
give to people until we have a living donor registry. CMS
used the most important things from ACOT's list of informed
consent components. We would expect transplant centers to
give their data to recipients and living donors.
Mr. Seely said that OPTN is starting to do this; it will
begin to fall into place as the OPTN serves as a central registry.
Dr. Delmonico said that the community is going to be reviewing
this and that OPTN is making a very, very careful review.
Documents on informed consent have been well established by
ACOT. Mrs. Boone reiterated that, without long-term follow
up of living donors, it will be hard to achieve true informed
consent. Dr. Delmonico said that Transplantation
just published a study on 50 years of live donors.
Dr. Kahan asked if there was public information on the data
collected on adverse events. Ms. Newton said that CMS hasn't
talked about this, but it's typically the kind of thing that
would be put into a final regulation, and CMS welcomes comments
on it. The intention is to give OPO coordinators an opportunity
to work with the OPO to see what happened and make sure it
doesn't happen again. A Medicare plan of correction is FOIA-able
but there is no personal patient information in it. Dr. Kahan
said that this is very important information to have in terms
of rapid trace-backs.
Dr. Robert Metzger asked about the rules, standards and regulations
for OPOs and transplant centers. Most are voluntary and only
become mandatory when the Secretary of HHS signs off on it.
The field is evolving and we need the freedom to move ahead.
He is concerned that if CMS adopts (as regulations) too many
OPTN standards, the field will be tied to them when the field
needs to move ahead. Dr. Sollinger concurred and said that
people are worried it will take another three to four years
to change something that will benefit the patients if the
field evolves. He cautioned CMS that it needs to be flexible
in the process.
Ms. Newton said that CMS wants the regulations to be very
high-level. An example is the requirement for the surgeon
and physician. At one point, CMS thought about taking all
of the OPTN requirements for training surgeons and physicians,
but decided in the end to just include that these providers
have to be identified and have the appropriate level of training
and experience. CMS knows that "appropriate" means
OPTN-approved. She continued that there are places where CMS
might be specifying requirements too far down. One of its
intentions was to give clout to the OPTN requirements. If
there is a change that needs to be made and it has the support
of the community, it won't take four years to occur.
Dr. Zhu said he had a comment on the technical aspect of
the policy. He talked to people over the break and did some
calculations, and it seems that the criteria favor small patient
volume. For larger centers, it's more disadvantageous. He
encouraged CMS to look at the criteria more carefully. Dr
Hui-Hsing Wong (from HRSA) said that they had done the calculations
on flagged centers and the system did not favor smaller centers
when put into practice.
Public Comment Period
Mr. Seely opened the public comment period and noted that
this is for public comment to ACOT, not to CMS, on the proposed
rules. He reminded the group that there is another public
comment period tomorrow afternoon before the full ACOT deliberations
on the Workgroup recommendations.
Katrina Crist of the American Society of Transplant Surgeons
(ASTS) spoke first. She said that the ASTS and the American
Society of Transplantation (AST) have established a joint
task force to review the CMS regulations. It is important
to point out that collectively, these two groups are comprised
of over 3,000 experts, scientific investigators, transplant
surgeons, transplant physicians and others that together represent
about 98 percent of the practitioners in the U.S. The task
force involved a diverse group of 15 surgeons and physicians
and was chaired by Mike Abecassis of Northwestern University.
The AST and ASTS have serious concerns about the CMS proposed
regulations. First, they are concerned about the standards
and processes to be used for initial approval. The proposed
initial approval process appears to deny any opportunity for
explanation, remediation, or survey for those centers that
fail to meet the proposed data submission and outcomes data.
This is a problem since neither the data submission nor the
outcome standards was intended to be used in this way, but
to be used rather as a "trigger" for further investigation
by OPTN. They think that CMS should defer the outcome requirements
until the OPTN review process has been concluded and should
only consider termination of a center if the OPTN reports
to the Secretary that the center is not in good standing with
the OPTN.
If CMS decides not to rely upon OPTN's review and remediation
process, the rules should be modified to provide an alternative
process for review and remuneration. CMS and OPTN requirements
need to be better coordinated.
Generally, they think the rules do not set forth standards
for re-approval. If CMS continues to believe that Medicare
conditions of approval for transplant centers should be independently
enforced through state survey agencies prior to the OPTN's
reporting a center to the Secretary as "not in good standing,"
a number of changes should be made to assure consistency between
CMS and OPTN requirements to the extent practicable and to
better coordinate the two processes. Finally, the proposed
rule fails to set forth the standards for re-approval with
enough specificity.
They met with Sean Tunis, Rachael Weinstein, Marcia Newton,
and others at CMS in March, and CMS was receptive to the concerns.
We hope that ACOT will bring our concerns to the attention
of the Secretary in your recommendations. The ASTS/AST has
23 pages of comments, and they are happy to share copies of
these comments with ACOT.
Vickie Hurewitz spoke next. She introduced herself as the
widow of Mike Hurewitz, who died in 2002 when he was a live
liver donor at Mount Sinai. She said that she came to the
ACOT meeting after about two years of not being active in
the live donor community. She said that she was disappointed
in how far things have not progressed in that time. The CMS
regulations, as they stand, do not include things that would
offer protections for her husband, nor for Danny Boone. Donor
selection criteria are needed that are imposed from outside
and adhered to. Mount Sinai had live donor criteria —
that included not accepting a donor over age 55 — but
they overrode their own criteria when it was in their interests.
Her husband was 57 when he was a donor. The reason the Feds
have not stepped up yet is because they have not been mandated
to do that. A law is needed that will protect living donors.
The main thing needed is more information: what has happened
to the 700+ live liver donors, to the people who are being
operated on now? Informed consent cannot be discussed until
it is known what happens with the donors over time. Her husband
was told that Mt. Sinai had done 200 operations and lost one
person, but that wasn't true. Nothing is in place to protect
the live donor. Mrs. Hurewitz said that she feels that it
is immoral to ask people to donate their organs — it's
an emotional situation and the transplant community needs
to protect the donors. The entire day has been about presentations
on data about the centers and how well they are doing. It's
unacceptable that there are no data, even now, about what
happens to the donors themselves.
Dr. Sollinger said that one of ACOT's former members has
a specific interest in this area, and he asked Dr. Delmonico
to respond. Dr. Delmonico reassured Mrs. Hurewitz and Mrs.
Boone — and other donor families — that we are
very concerned about live donors. He verified that NIH is
studying live donors and tracking live liver donors. In addition,
internationally, in September, there will be a conference
at which every live liver donor surgeon will come together
to discuss this issue. The community has — as a priority
— the interests of the live donor.
Dolph Chianchiano from the National Kidney Foundation spoke
next. The National Kidney Foundation has filed their comments
to CMS on OPOs and is working on their transplant centers
regulation comments. The Foundation is concerned that the
regulations do not encompass recommendations from ACOT for
living donors.
Paul Schwab from the Association of Organ Procurement Organizations
(AOPO) was the next speaker. In terms of addressing ACOT and
not CMS, their experience sees the CMS rules as affecting
transplant centers and OPOs. This is really a chance to have
an opportunity to look at the symmetry — or lack of
that — in the two regulations. For example, for OPOs
there is a new appeals process proposed. But, in the transplant
centers regulation, no process is proposed; the regulation
only includes a comment on what the process should be. In
OPOs, there is encouragement of outcome measures for DCD,
but this is not included in the transplant centers regulation.
The transplant centers regulation has outcome measures —
you can see the influence of Dr. Merion and SRTR — but
that's lacking in the OPO regulations. AOPO questions the
rationale behind the symmetry, and/or lack of it, between
the two regulations. The AOPO is in process of drafting our
comments and would like to highlight several things:
- AOPO is surprised that there is nothing in the regulations
on implementation data, although CMS says that no retroactive
rule-making is intended.
- AOPO is concerned about the effect on the Collaborative
of the competitive approaches outlined in the regulations.
We see an evidence-based approach in the Collaborative and
are concerned about undermining both the Collaborative and
the relationships that have been nurtured between the OPOs
and hospitals. We are concerned that the former predatory
culture and practices will return under these regulations.
- On the outcome measures, AOPO feels that five measures
are not actually multiple measures. There is just one outcome
measure, the first one. We propose multiple measures that
incorporate, as part of the outcomes, the SRTR data on outcome
rates so that one can go publicly and look at the OPO outcomes.
We think this is an important approach. We are not saying
that they have to meet these three areas only, but that
there is a midpoint. An OPO that is lower than expected
would be placed on improvement plan, but not de-certified.
- In terms of the appeals process, AOPO has a very long
response to it.
- We think that the regulation includes overly proscriptive
process standards. In the rule, in dealing with quality
assurance and improvement, CMS has used a process that has
worked with other providers; but a number of these practices
are already dated in the transplant field.
Dr. Sollinger asked for a copy of AOPO's response and Mr.
Schwab said he would be happy to provide that to ACOT.
Charles Alexander from the Transplant Resource Center of
Maryland spoke on behalf of National Association of Transplant
Coordinators (NATCO). He said that NATCO's assessment and
comments to ACOT are essentially in line with what Mr. Schwab
said. NATCO has concerns about the benefits of the Collaborative
being lost. Many business models show the benefits of collaboration
over competition. There were a few comments about the certification
process. Specifically, there is a mention of the CCTC certified
coordinator that is not mentioned in the regulation; it's
important on the OPO side and NATCO would like to see this
on the transplant center side as well. Transplant centers
need to have an advocate for living donors, and NATCO believes
there should be a patient advocate for living donors who is
not on the transplant team. In terms of the DSA, NATCO is
very encouraged by the Collaborative efforts. Organ procurement
organizations have been effective at pursuing donations. Regulations
should be congruent on the OPO and hospital sides in order
to maximize donations. SRTR and risk-adjustments need to be
accounted for; as a DSA, we should all be aiming at the same
direction.
Dr. Sollinger noted that the public comments were completed
and closed with a personal story. He said that he did a living
kidney donation a few days ago and everything went well. Before
he does a live donation, he said, he is always nervous. The
responsibility is so enormous. Despite the criticism that
not all the regulations are in place and executed yet, Dr.
Sollinger said that he is certain that there is a tremendous
awareness of the responsibility among the surgeons and centers
around the country when dealing with live donors. We all take
it very seriously. He wanted to mention this because he thinks
everyone feels the same way.
The public portion of the meeting concluded for the day and
the Workgroup began its meeting.
Meeting of the ACOT Workgroup on CMS Regulations
Mike Seely, Pacific Northwest Transplant Bank, Portland,
Workgroup Chair, ACOT
Mr. Seely thanked everyone for their efforts on the various
conference calls and noted that everyone had given good input.
The members have received the notes from the calls. He discussed
the charge to shape a comment to the Secretary, which shifts
the gears a little from the CMS discussion. The recommendations
are not going to CMS. The ACOT Workgroup does not have the
ability to write a 40-page document on the CMS regulations,
and the Secretary won't want to read all that.
He distilled the three recommendations discussed on the calls
to some samples for discussion. In the next 24 hours, these
recommendations will be revisited to see if they can be worded
better and to get a preliminary vote on the proposed recommendations.
The Workgroup can schedule another call to finalize the background
information once the recommendations are approved by the whole
Committee. He added that the group might want to add something
about living donations to be responsive to the issues that
were heard during the public comment period.
- Recommendation I: ACOT recommends that CMS eliminate the
proposed OPO regulation that creates open competition at
the end of every OPO re-certification cycle when all performance
and compliance measures have been met. The competitive framework
as proposed could have an untoward consequence of dampening
the demonstrated success of the Breakthrough Collaborative
and subsequently discourage the sharing of known best practices
among OPOs.
Dr. Freeman said that this recommendation is just what had
been discussed, but it should be framed positively —
see Federal Register page 6095 last column, where
CMS asks for alternative review criteria and sought comments
on the competition options. One of these alternatives is what
ACOT is recommending. It might be better to say "ACOT
strongly supports option X (whichever one it is)," putting
the recommendation in a positive framework.
Mr. Seely said that the bulleted discussion point that followed
could be integrated into the recommendation ("after de-certification,
a competitive framework would exist"). He suggested removing
the first sentence and saying that ACOT strongly supports
the alternative option for OPO recertification that utilizes
the highly restrictive process outlined on page 6095 of the
Federal Register. The discussion could address the
fact that there is no review process per se; there are issues
in the decertification process around the short time frame
and that the newly proposed appeals process is inconsistent
with appeals process, as Mr. Schwab (AOPO) had commented.
Mr. Schwab remarked that the transplant centers regulation
does not propose any appeals process and the proposed rule
indicated that CMS is open to comments in this area. In the
OPO regulation, in contrast, what had been an appeals process
used by all Medicare suppliers is proposed to be eliminated
and replaced with an unarticulated process that raises questions
about due process. AOPO wants an initial review to be conducted
by an informed CMS staff member who would be a hearing officer.
Mr. Seely said that ACOT is concerned about the vagueness
of the review process (the two-tier review process), as well
as the truncated nature of the review process for OPO regulation
and for the transplant center review process.
Dr. Higgins asked if the group was concerned about the lack
of definition about compliance and certification. They have
heard changes in what outcome measures should be — all
of these things are uncharted in terms of performance measures.
Dr. Freeman suggested adding a statement about measurement
and OPO regulations. There is only one measure, the conversion
rate. The definitions of the denominator are provided (see
page 6099), and we should point out that CMS is using inappropriate
details. Viral septicemia is listed, but what does that mean?
He thinks CMS confused ECD with DCD. Ms. Gunderson said that
she had asked, and Ms. Newton said that ECD is not included
in the denominator in this regulation. Ms. Turrisi commented
that people are mixing up the OPOs and the transplant centers
regulations.
Dr. Freeman said that ACOT should point out that this is
a level of detail CMS should not get into in the regulations
because the regulations and the practice are going to change.
What an ECD is today will change over time, so it may be appropriate
or not to count them for OPO performance. The regulations
should not go into this level of detail.
Mr. Seely asked if we recommend that ECD donors not be counted,
then what should be the uniform definition of a donor. In
his OPO, 30 percent of the donors in 2004 were ECD. Do we
want it in the denominator or not? Dr. Freeman commented that
you will have a lot more organs than donors and will look
great.
Mr. Seely reminded the group of the major points they should
emphasize: (1) ACOT supports a limited competition re-certification
method; (2) CMS must have standard definitions for outcomes
and performance measures; and (3) ACOT recommends a certification
process that is thorough and provides ample opportunity for
review.
Mr. Schwab said HHS would argue that there is a definition
for the submission of data to OPTN currently performed by
the OPOs. On page 6099 of the Federal Register, in
the right-hand column, there is a set of criteria for organ
donors. CMS says there is no standard application and the
intent is to adopt the OPO definition.
Dr. Freeman reiterated that there should be room for evolution
of the field over time. He asked if the recommendation could
be worded to say we don't want the detail, but there should
be a review process and the denominator may be changed more
quickly. Ms. Turrisi added that it's questionable as to who
has input into making the changes. Dr. Freeman said this is
the crux of all of the regulations. Hopefully, all these definitions
and measurements will be changed, e.g., ECD didn't really
exist before. The ultimate issue is, if CMS goes to this level
of detail and writes current definitions and then the OPTN,
ACOT, or someone else comes up with new definitions, then
what? We end up with parallel processes and different definitions
which will cause problems. ACOT should point out where CMS
is dipping into levels of detail where this is likely to happen.
The denominator should be determined on a regular process.
ACOT can recommend that CMS take into account the inevitability
of changes of measures.
Ms. Gunderson said that OPOs are part of the OPTN and should
be at the table. Are the outcomes of the OPOs in the purview
of the OPTN? The OPTN doesn't have any jurisdiction over them,
and no control over the OPOs, which is creating this very
opportunity. CMS is supposed to be giving OPTN the teeth to
move ahead with oversight over OPOs and transplant centers.
Mr. Seely said that it doesn't make any sense to have all
these things in the numerator and not in the denominator.
Dr. Freeman suggested that CMS is at a different level in
terms of monitoring transplant centers. CMS is not as far
ahead in terms of monitoring OPOs. This is better managed
at the OPTN level than at the Federal level (e.g., by CMS).
Mr. Seely read the other draft recommendations:
- Recommendation II: ACOT recommends that inconsistencies
between the OPO and OTC proposed regulations that contain
conflicting incentives that will not promote better quality
and more frequent transplants be considered by CMS with
the goal of reconciliation. Regulation should be written
in a manner that anticipates and encourages the inevitable
innovation in procurement and transplant clinical and programmatic
practices that leads to enhancing quality of care.
- Recommendation III: Whereas the ACOT applauds and acknowledges
the incorporation of many OPTN processes and ACOT recommendations
in the proposed rules, the level of prescriptive language
in both regulations may be problematic in terms of the evolution
of transplantation. ACOT recommends that CMS and the OPTN
not be at cross-purposes where current proposals create
parallel review processes with potentially divergent or
contradictory results.
Ms. Gunderson stated that there isn't a lot of consistency
about this because there are questions about what the definition
means. It's hard to count it in the numerator and not the
denominator. The potential donor denominator comes from left
field and no one knows what this is. ACOT can recommend consistency
of using definitions that are being used in the field. Mr.
Alexander commented that, if you talk about ECD and DCD, the
ECD is not always over 70 and is not counted. There should
be a level playing field for measuring.
Mr. Seely noted that the group has concerns in several areas:
the regulations conflict with one another (e.g., OPTN, OPO);
performance measures; inconsistencies in data measurements;
there are very specific and prescriptive staffing requirements;
the appeals process is lacking for transplant centers for
the initial application; there are conflicting definitions
as far as DCD/ECD which are defined for risk adjustment for
OTCs, but not for OPOs.
Dr. Freeman said that some measures are totally arbitrary
— the greater than three rule, for example, the 1.5
ratio, likewise. Regulations have to acknowledge the inevitable
evolution of measurements and incorporate this so that CMS
stays in sync with OPTN. Dr. Conti said that there have to
be standards, and programs have to know what the standards
are. He asked how we incorporate flexibility to get there.
Mr. Seely commented that ACOT needs a statement that captures
this point so the Secretary will see it. The group can probably
put forth just two or three recommendations. Dr. Higgins agreed,
but noted that ACOT has to actually say something that will
be helpful to improve quality of transplantation and move
centers along to better practice.
Dr. Freeman suggested that ACOT recommend that CMS regulate
what it will and will not pay for. Transplantation is different.
ACOT is more like the OPTN in its ability to be responsive
and keep up on practice. Things change; it's inevitable. CMS
should be consistent with OPTN. Mr. Balbier said that it is
useful to suggest that the OPTN can monitor the centers, and
so forth, but there still needs to be oversight from the Federal
level. He reminded ACOT members of their responsibility to
make recommendations only to the Secretary, and not to the
OPTN, about organ transplantation matters.
Ms. Gunderson stated that, if regulations have to respond
to the evolving industry, then do we think that ACOT should
push to expand OPTN authority to enhance quality and do oversight
from other departments? Dr. Freeman answered that ACOT should
outline where the regulations are prescriptive of medical
practice and give CMS examples. The transplant centers regulation
includes several examples of things that OPTN has already
addressed, for example.
Mr. Balbier said that, if the Workgroup can come up with
draft recommendations to present to the full committee tomorrow,
and the full committee agrees with the language of the recommendations
(not necessarily including the introduction and discussion
points to be included in the letter to the Secretary), it
will be beneficial.
Ms. Turrisi said she wanted to add a recommendation about
living donors. ACOT has previously made some suggestions that
have not been implemented. The living donor registry needs
to be established so that we can track living donors. Transplant
regulations say that you have to inform about the short- and
long-term risks. ACOT recommended this previously and we should
note that, without the registry, this part of the living donor
regulations cannot be complied with.
Dr. Freeman said that there is a small Request for Proposals
(RFP) out on this, but it's not to create a central database
for living donors and is completely insufficient to meet the
need. Every group has recommended a donor registry similar
to what is captured about recipients. Mr. Balbier suggested
that making a living donor recommendation might be considered
outside the scope of responding to the proposed CMS regulations.
Ms. Turrisi responded that in order to do accurate informed
consent, as mandated by CMS, a better system for tracking
living donors has to be implemented. Ms. Gunderson called
the group's attention to the Federal Register, page
6181, far right column, where CMS says that you have to tell
patients outcomes for both donors and recipients. ACOT can
say that this information cannot be provided without a registry
of living donors.
Dr. Freeman noted that the government representatives told
the OPTN to stop thinking about living donors because it's
not in NOTA. This is a problem in terms of authorization.
UNOS could do this if it wanted to; they don't need a law
to tell them to do it. Mr. Seely said that this is precisely
ACOT's role, to recommend this sort of thing. We can recommend
that NOTA give expanded authority to the OPTN to address living
donations in a manner similar to what exists in terms of deceased
donations.
A sub-group of the Workgroup continued to draft language
for the proposed recommendations.
Tuesday, May 10, 2005
Dr. Sollinger welcomed the group back for the second day
of the ACOT meeting.
OPTN/UNOS Presentation
on Public Solicitation of Organs from Living and Deceased
Donors
Robert Metzger, President, United Network for Organ Sharing
Dr. Metzger thanked the committee for the opportunity to
present before ACOT on these important issues. The issue of
public solicitation of organs is growing in scope, but goes
back at least 25 years. In fact, President Reagan once made
a public appeal for a child who needed a liver. There are
many means for asking for organs that include talking to other
people, going through a church bulletin, using public means
like advertising. The newest means is through the Internet,
using the web as a way to solicit organs. It's being driven
by the fact that the waiting list is expanding and the number
of deceased donors cannot meet the need. The waiting time
is, on average, about five years.
There are several laws that allow public solicitation. Most
important, is the First Amendment, which grants freedom of
speech. The Uniform Anatomical Gift Act specifically allows
directed donations, and donations to a specific OPO or surgeon.
While NOTA prohibits buying and selling organs, people can
pay for travel and living expenses. The ethical issues include
autonomy and the donor's right to say where their organ should
go. Another factor is informed consent, which is a huge issue
for living donors. We also have to keep in mind equity, so
that similar patients get treated similarly, although some
recipients, like children, are treated differently. Dr. Metzger
noted there is very little included in NOTA around living
donors. He reported that, in the HRSA's new Request for Proposal
(RFP), the OPTN's authority on living donors will be expanded.
Much of Dr. Metzger's discussion involved the use of the
Internet to solicit organs and the site Matchingdonors.com
,
which charges a fee to be listed on its pages. The size of
the fee, $295/month, raises ethical concerns, although the
site has lowered its fees and said that one does not have
to pay to be listed. The major concern about public solicitation
for directed donors is that this subverts donations for people
who are more critically ill and who need the organ more desperately.
It undoes the purpose and role of the waiting lists. What
would be better would be to promote overall appeals of organs
for everyone, rather than selected donations.
Dr. Sollinger noted that he recently received an email from
a hospital administrator saying that Matchingdonors.com
sent a memo asking that centers willing to accept their donations
agree to being listed on the site (i.e., Matchingdonors.com
).
Dr. Metzger noted that he thought everyone in ASTS got that
memo last week. After the Bob Hickey (website-arranged) transplant,
both ASTS and AST issued statements on Internet solicitation.
They are now working on a joint statement on Internet solicitation.
The groups are being lambasted on the Internet for not recognizing
the web as a bona fide means of communication and community-building
no different from a church bulletin or interpersonal solicitation.
Dr. Metzger stated that it is paramount that neither person
be exploited and said that, absent a meaningful personal relationship
between the donor and recipient, the OPTN system should be
used instead of this kind of directed donation.
Ultimately, the transplant community needs to look at the
issue of transplants facilitated by the Internet and accept
that the web is a form of communication, that people do have
relationships facilitated by the Internet. It may increase
donations because people feel connected. On Living
Donors Online ,
for example, there are 260 pages of archived materials from
people who are willing to donate. UNOS is soliciting public
comment and will be holding a meeting to get input on this
issue and on ways to facilitate living donations. The OPTN/UNOS
Website may be useful in helping those who want to donate,
or the group might work with Living
Donors Online .
Discussion
Dr. Sollinger said that he is glad this is coming up, and
said it was going to be a huge issue. He put himself in the
position of a patient; if someone said he had to wait five
years, he'd put myself on a website and hope for the best.
When you are sick, things change. Dr. Kahan said that Houston
has had these types of billboards and people are very concerned
about it. In his center, which is the largest in the country,
there is a major problem with recipient families trolling
the ICU waiting rooms and soliciting donors from critically
ill patients' families there, talking them into directed donations.
His center's approach has been to limit these donations to
a second degree relative (e.g., cousin) and to talk with the
ICU families about equity issues and encouraging them to use
the regular allocation process. They also exercise a lot of
caution over the donors, and even Google them to get a little
background.
Dr. Kahan continued that another problem is patients going
overseas to get an organ through websites like medcare. For
this group, if you pay $14,700, they will fly a patient to
an undisclosed site (China) for an operation and aftercare.
ACOT and OPTN have the responsibility to warn people about
this. Dr. Kahan stated that in Houston they see these patients
all the time. The recipients have not been worked up, there
are no records, the records are in Chinese, and it's a big
risk (and ethical problem) taking organs from Chinese prisoners.
The organs have not been evaluated, and people think their
follow-up care is going to be covered in the U.S. but it's
not. Dr. Metzger agreed that this is a real concern and stressed
that he hoped ACOT would act on this.
Dr. Sollinger commented that this just reflects how desperate
people are. He feels that UNOS should quickly move to be the
Website that helps people and connects them. It will happen
anyway so why not have people with the best background and
authority make the connections and charge either very little
or nothing. If there are hundreds of thousands of people who
want to donate for nothing, who can be screened at reputable
hospitals, we may be able to solve our donor shortage problem.
It can be good, so long as we screen people well, do the surgery
at a good hospital, provide good care, and no money changes
hands.
Dr. Freeman said it's important to distinguish between deceased
and living donor solicitation. It's clear that the public
does not understand the difference between the two issues.
He feels that directed deceased donation is a subversion of
the system that is designed to be fair and ethical. In his
opinion, ACOT should not condone directed deceased donations.
ACOT can also recommend that the OPTN create a matching donor
live Website, but this has not happened because of OPTN's
reluctance stemming from a lack of explicit authorization
through NOTA. It's not clear if HRSA can do this without NOTA
authorization. Dr. Metzger reported that UNOS has approval
from HRSA to do this and is moving ahead.
Mr. Balbier reminded the group that, in terms of making a
recommendation to the OPTN, ACOT's role is to make recommendations
to the Secretary of HHS, not to the OPTN. Dr. Freeman stressed
what Dr. Sollinger said, that this should happen quickly and
ACOT should recommend that the Secretary encourage the OPTN
to develop a system quickly.
Ms. Turrisi added that the recommendation should be to tighten
the safeguards for living donors so that they get the right
information. ACOT has talked about the lack of a living donor
registry as being important; and we don't want to have people
regret the gift because they didn't have all the information.
Dr. Metzger agreed, saying that's why they wanted to do the
Website because they can provide helpful information to people.
Dr. Young commented that the desperation is really critical
and that everyone needs to be respectful of the situation
people are in. ACOT should also recommend to the Secretary
that a system be created to track the living donors and follow
up with them, to make sure they get insurance, information,
and medical care.
Dr. Kahan asked the group to bear in mind two principles:
first, anonymity. The Websites foster known donors, and it's
important to preserve anonymity or people become indebted.
Second, equity: If we have a Website and only a fraction of
the recipients can afford $9 a month to be listed, it's not
equitable. The donor pool has to be open to all if it's done
through the OPTN. At his center, they keep the donor and recipient
separate and don't introduce them. Both anonymity and equity
have to be preserved in any system.
Mrs. Boone asked who is really in charge of living donations.
If there is no organization that is in charge, how do we create
such a thing? She said that someone has to make the rules
and see they are followed. Dr. Metzger answered that, at present,
it's with the transplant centers. In the newly awarded HRSA
contract, the OPTN will get more clout to monitor and create
more definitive criteria. Dr. Sollinger reminded the group
that one may as well ask who is in charge of heart transplantation
— it's always the transplant center. Transplants have
more oversight and Federal control than other fields of medicine,
however.
Mrs. Boone asked if ACOT can recommend to the Secretary that
there needs to be changes in law to get this done. Dr. Sollinger
said that, once the NIH data are available, there will be
a site where you can see morbidity and mortality among live
donors with a mandatory five-year follow up and reporting.
He said he is really interested in the kidney donors after
5-10 years.
Dr. Sollinger asked if the ACOT members agreed to send a
message to the Secretary to recommend rapid and intense communication
with the OPTN regarding establishment of a donor recipient
matching program that will be the authorized site for live
donor matching. Dr. Freeman added the caveat that this includes
important information about both the risks and benefits of
being a donor. Dr. Young moved to accept the recommendation,
and Mr. Turrisi seconded the motion.
Dr. Kahan said there should not be a charge to someone who
wants to register as a potential live donor, either for assessment
or surgery. Dr. Higgins reinforced Dr. Kahan's point, saying
that anonymity makes donations more equitable for people who
can't afford it. Ms. Rosenzweig commented that many people
are on the websites not for monetary gain, but because they
have a real passion to connect with a person and help them.
Once you take that connection away from them, then there isn't
the same response. While she supports the recommendation,
she cautioned that this won't be the end of it. People want
to know their recipient and vice versa. We will end up with
multiple websites and we either have to live with it or try
to stop it. Of course, it can't really be stopped.
Dr. Freeman said the group needed to be clear about what
it's talking about. Matchingdonors.com
connects people who want to know their recipient, and
a list of donors maintained by the OPTN will not accomplish
this nor make these websites go away. He also said that donors
ultimately make their own decision. Saying the donors are
being "protected" gives the impression that they
are being exploited and unknowingly putting themselves at
risk.
Mrs. Boone disagreed, saying that her experience was one
of organ transplantation at its very worst. Her family needed
protection from this. Her husband was misled and misinformed
and, after he died, the experience was a nightmare in terms
of the response of the surgeons. Thankfully, few people have
this experience, but "protection" is exactly the
right word until we can be assured that living donors get
all the information they need.
Mr. Seely asked for a moment of order and to have the recommendation
read again.
Dr. Kahan said the recommendation is "to ask the OPTN
to consider establishing a Website that would serve as a clearinghouse
for referral of potential donors and potential pairs of donor-recipients."
Dr. Sollinger clarified that it would be that "ACOT urges
the Secretary of HHS to interact with the OPTN in an urgent
fashion to establish a website which facilitates the matching
of donors and recipients."
Ms. Agrawal asked if ACOT was about to ask the Secretary
to approve a known living donor-recipient match at a time
when we don't know how well developed the informed consent
process is or what the outcomes are. She stated she was not
sure if the government has all the pieces in place to speak
to this yet. Dr. Sollinger proceeded to call for a vote, which
occurred with 10 in favor, 7 opposed and 2 abstaining.
OPTN/UNOS Update on Kidney
Allocation Review Subcommittee
Robert Metzger, President, United Network for Organ Sharing
Dr. Metzger gave a brief presentation on kidney allocation,
noting that the list has 62,000 people on it. Most kidneys
are allocated at donor service areas; when not used nationally,
a kidney is allocated at the local level based on a number
of points on the DR match. He showed maps of donation service
areas and local allocation maps. UNOS tries to give organs
with the best benefits; it has just implemented a new lung
allocation system and is looking at the goals of the kidney
allocation system. UNOS is looking at the allocation systems
to follow the lead from liver and lungs and to improve morbidity
and mortality of patients on the waiting list.
Dr. Metzger showed information on the causes of kidney allograft
loss after the first year post-transplant. The question is
whether kidneys are being put into patients who will have
a long life with that organ. The hope is that the Breakthrough
Collaborative will increase donations, but he noted that there
is a need for improvements in dialysis, which will also decrease
the need for transplants. The field has settled on doing dialysis
three times a week but might benefit from looking at doing
dialysis daily in the future.
UNOS held a special board meeting in March on the kidney
allocation system; and new goals are being discussed. They
are looking at efficiency, which is a big problem in kidney
allocation. With new technology, they hope to have a system
so that the coordinators won't have to make a call on every
offer. They want to do blast updates to larger groups of centers
so then they won't have to call every center with someone
on the list.
Discussion
Dr. Sollinger said he remembered a paper co-authored by Dr.
Kahan, from 1995-6, predicting that the national kidney sharing
would result in .3 percent in improvement outcomes; in other
words, a negligible improvement. He said he thought Kahan
et al were right; that is, shipping kidneys all over the country
has been a major headache for transplant centers and has led
to delays and conflicts with operating groups. Sollinger's
OPO has considered hiring a lawyer to look at UNOS regulations
so they are not in violation of any of the hundreds of pages
of guidelines.
Dr. Kahan said that his hospital had a problem because it
was shipping so many kidneys out and there was a lot of negative
reaction for that. The changes are long overdue although it's
going to be difficult. Where the OPO is not functioning well,
they are accumulating a large number of patients.
Dr. Metzger said that UNOS needs to look at the burden of
disease for people. There is a DSA Task Force, which has held
its first conference call and will meet during May to look
at monitoring DSAs for productivity, exploring best practices
for OPOs, and bringing them into monitoring for the OPTN.
UNOS is setting up criteria they need to meet and helping
them get up to speed. The CMS and OPO regulations will hopefully
do the same thing.
Public Comment
Angela Tagliaferri from Cleveland Ohio spoke first. Ms. Tagliaferri
said that she had not planned to speak but wanted to talk
about living donations. She is not the spouse of, or doctor
of, or relative of, a living donor. She is a living donor
herself. She commented that there needs to be something in
place like the website, and agrees with Ms. Agrawal's comment
about nothing being in place to take care of people like her.
After her surgery in 2001, she went back in to have her incision
looked at and was told she was okay and they just sent her
home. She couldn't get anyone to take care of her and had
to beg the Cleveland Clinic to look at her. There needs to
be a push — as fast as possible — to put something
into place to take care of people like her because no one
does. She said that if ACOT and the community are going to
push living donations, then they have to make sure someone
takes care of the living donors.
Dr. Sollinger commented that no one disagrees with Ms. Tagliaferri.
As a practical matter, at his center, they would look at the
patient whenever he or she showed up with a problem. Ms. Tagliaferri
might have a different insurance company and his hospital
might not accept it, though. This is a real problem we have
to get around. Live donors should have life-long coverage
of some kind.
Mrs. Boone asked the group if they had any idea how many
live donors become uninsurable because the donation is seen
as a pre-existing condition. Dr. Sollinger stressed that this
is a huge problem and that ACOT should communicate this. There
is a lot of concern on the patient and donor side, as well
as on the medical side, that there should be life-long care
for donors.
Vickie Hurewitz, widow of Mike Hurewitz who died as a result
of a liver donation operation, spoke next. Mrs. Hurewitz said
that before anyone opens up living donations to the public
(without relational connections), there needs to be a law
to protect or regulate living donations. It is not fair to
ask people to do this without there being a law in place.
If UNOS needs to take a position, they should take the moral
high ground and say they are working to get laws in place
to protect the living donors. Until such a law is in place,
UNOS should say it can't support wide open donation. When
the vote on the recommendation was taken, she noticed that
the surgeons voted yes, and the non-surgeons voted no. Surgeons
cannot be objective; they are trained to conduct surgery and
their view is very different. The decision should be taken
from them and put in the hands of ethicists.
There were no addition public comments and the panel broke
for a break.
Discussion
When the meeting reconvened, Dr. Sollinger apologized and
noted that protocol was not followed in making and voting
on the recommendation. ACOT can vote on a recommendation only
when all public comments have been heard. He wanted to go
back to the recommendation and rephrase it to incorporate
the public discussion. He said that he listened very carefully
to Vickie Hurewitz's comments and they needed to be addressed
in the recommendation.
The proposed revised recommendation was projected for the
ACOT members' review:
- The ACOT recommends to the Secretary
that the OPTN be asked to consider all issues associated
with the development of a registry for matching living donors
and recipients, paying particular attention to informed
consent and the monitoring of long-term outcomes of the
donors.
Mr. Seely moved to reconsider the old recommendation; Dr.
Freeman seconded the motion. ACOT voted unanimously to withdraw
the original recommendation. Mr. Seely then moved to consider
the revised recommendation, and Dr. Zhu seconded it.
Ms. Gunderson suggested changing the proposed language to
read "OPTN be asked to expeditiously consider... "
Mr. Seely read the final recommendation:
- The ACOT recommends to the Secretary
that the OPTN be asked to expeditiously consider all issues
associated with the development of a registry for matching
living donors and recipients, paying particular attention
to informed consent and the monitoring of long-term outcomes
of the donors.
Dr. Sollinger called for a vote, which was unanimous in favor
of the new recommendation.
Presentation on
IOM Committee on Increasing Rates of Organ Donation
James Childress, University of Virginia, Institute of
Medicine Committee Chair
The presentation concerned the initial discussions from IOM
on increasing rates of organ donation. Dr. Childress noted
that this is very early in the process. The IOM Committee
has had one meting and benefited from hearing from several
people, including Ms. Agrawal. Ms. Cathy Liverman is the IOM
senior program officer working with the study and Dr. Childress
noted that she has been a great resource.
The statement of task is for the IOM Committee to convene
an expert committee to examine issues surrounding organ donation
and to evaluate the ethical implications of proposals to increase
deceased organ donation. The purpose of this study is to provide
advice to the Secretary of Health and Human Services in support
of legislative requirements of the Organ Donation and Recovery
Improvement Act.
The Committee will examine a broad range of proposals to
identify ethical implications; evaluate their impact on donation
efforts, public perception, and, especially, on disadvantaged
or disproportionately affected groups; and make recommendations
about how proposals can be effectively implemented to reduce
ethical problems.
The Committee tasks are to:
- Conduct a review of proposals and efforts to increase
organ donation including but not limited to educational
activities, media campaigns, financial incentives, presumed
consent laws, and presumptive consent approaches. Various
kidney exchange arrangements, including living donor and/or
deceased donor organs, will also be included. This will
include a literature review, as well as a review and evaluation
of grants funded by the Health Resources and Services Administration's
Division of Transplantation, interviews with grantees, and
review of donation efforts by other organizations such as
the Coalition on Donation. Various organ procurement organizations
also will be included.
- Examine the potential impact (cost or savings and benefit)
of increasing deceased organ donation rates in the United
States.
- Evaluate the ethical implications of the proposals or
efforts and identify which proposals are considered ethically
acceptable or ethically controversial by ethical, religious,
and moral standards commonly found in the United States.
- Further evaluate the ethically controversial proposals.
These include, but are not limited to: proposals for reimbursement
for funeral expenses; proposals to use a life insurance
vehicle to increase commitment to organ donation and registries;
proposals for tax credits/deductions; proposals for direct
payment to donors or families; presumed consent proposals;
first person consent proposals and other proposals that
the background research may discover. For the ethically-controversial
proposals, the committee will:
- Evaluate and address the impact that these proposals
may have on existing donation efforts and public perceptions
regarding organ donation.
- Evaluate and address the impact that these proposals
may have on specific groups such as ethnic minorities
(specifically African-Americans), the socioeconomically
disadvantaged, those likely to be disproportionately
affected by the proposal, and on living donors.
- Make recommendations about whether particular alterations
can be made to various proposals to reduce ethical problems.
- Provide recommendations regarding the cost-effectiveness,
feasibility, and practicality of implementing such proposals.
- Provide recommendations on evaluation methods for
grants issued to increase organ donation based on the
experiences of other social/behavioral campaigns or
marketing efforts.
The goal is to release the report in Spring 2006. The IOM
Committee won't have any information to present before the
Fall ACOT meeting because it will be in the process of drafting
the report. Dr. Childress noted that there was an opportunity
for members of the public to speak at the August meeting and
the committee eagerly solicits submission of written materials
at any point. More information is available at The
Institute of Medicine web site .
Discussion
Dr. Kahan congratulated Dr. Childress for taking on this
issue. Many people have been looking at this issue for years,
so the goal of issuing a report in 18 months is really quite
a charge. It's frightening because the issues are so multifaceted
and there is so much material. It's an awesome burden. Dr.
Childress responded that the committee is well aware of this
and does not have any pre-conceptions about where it will
come out on any of these matters. It may only be able to offer
pros and cons and point to the need for more evidence. The
committee is not going to rush to judgment. However, if there
is more information needed, then that will be called for in
the report.
Dr. Freeman asked if the issue of public solicitation will
be addressed. Dr. Childress confirmed that it would be, especially
as one possible way to increase rates of donation. Dr. Zhu
noted that three of the committee's panels will address incentives.
It seems, for donors, that a huge area of concern is access
to follow-up care and insurance coverage. Is this going to
be part of the IOM's examination? Dr. Childress said that
one thing they were going to consider was removing disincentives
such as the lack of follow-up care, informed consent, etc.
Mr. Schwab said that the last 19 months have shown increases
in organ donations due to impacting health care providers
(e.g., the Collaborative). There are ethical issues involved.
AOPO is recommending that reimbursement be provided to hospitals
earlier (e.g., before brain death). He asked if the committee
will look at ways to influence health care providers. Dr.
Childress affirmed that the committee will look at system
changes on both the micro and macro levels and asked for people
to let the committee know what these are and provide input.
Mr. Hagman asked if there has been input from insurers on
this issue. Dr. Migliori also suggested that the insurance
industry has to be connected and that the real issue is the
on-going insurability of the living donor. Insurance covers
the donation itself, and the recipient, but there is a need
to address the living donor and the pre-existing condition
issue. Mrs. Boone stated that it would be good to address
this at the next ACOT meeting.
Dr. Freeman noted that there had been a plan to survey donors
about their insurance issues, although it hasn't gotten off
the ground yet. The IOM and anyone else who looks at it will
see there's no information available. He said that we need
to learn how often donors subsequently are turned down for
coverage and what happens to them down the line. Ms. Turrisi
pointed out that ACOT has discussed this before. She did a
survey of insurance companies and there have been recommendations
made before. There is a question whether living donors should
be covered by long-term Medicare if they are denied by other
insurers.
Dr. Migliori noted that insurance law and regulation always
follows technology. The fact that there is the capacity to
do living/unrelated donations means that the insurance industry
has to focus on it broadly. The IOM should clearly address
this.
Ms. Newton said that there is no CMS coverage policy for
living liver donors. CMS did an informal survey and most Medicare
contractors do seem to cover it. Dr. Sollinger remarked that,
considering how much the government saves by getting people
off of dialysis, CMS should cover this and it's worth paying
for the donation. He suggested putting this issue as central
for the next ACOT meeting. Mrs. Boone asked to also discuss
other quality of life issues that matter for living donors.
Report and Draft
Recommendation on the Workgroup on CMS Regulations
Mike Seely, Pacific Northwest Transplant Bank, Portland,
Workgroup Chair, ACOT
Mr. Seely said that the Workgroup had looked at both the
transplant centers and OPO regulations. They had met over
several conference calls and heard a presentation from CMS's
Marcia Newton on the regulations that familiarized the members
with the proposed regulations.
He reminded the group of the context for this effort, that
ACOT make recommendations to the Secretary, rather than to
CMS. ACOT is looking at the issue from a global level, and
the detailed perspective is being received by CMS through
many public comments. The Workgroup has developed three proposed
recommendations for ACOT's consideration. After the meeting,
the Workgroup will keep shaping the draft to include background
and attachments for the Secretary.
The Workgroup felt that, in light of the discussion over
the past few days, nothing in NOTA explicitly supports the
living donation issue. It was felt that living donor informed
consent provisions cannot be fulfilled without a registry
and this cannot happen without amending NOTA. It was hoped
that ACOT's previous recommendations had been better implemented
by now. Without any mention of living donations in NOTA, the
OPTN does not have any obligation or authority to take leadership
in this area.
Mr. Seely read the Workgroup's proposed Recommendation I:
- Pursuant to ACOT recommendations 1 and 3, ACOT recommends
that legislation be pursued to amend NOTA to expand the
role of OPTN relative to oversight of living donors and
establishment of a living donor registry.
Dr. Freeman said that comes from the fact that, in the transplant
centers regulation proposal, there are a lot of criteria that
don't really exist uniformly. The issue is that the proposed
rules cannot be met without this action happening first. Mr.
Balbier read ACOT's recommendations 1 and 3.
- ACOT Recommendation
1: That the following ethical principles and informed
consent standards be implemented for all living donors.
a) A set of ethical principles of consent required to being
a live organ donor; b) An informed consent document understandable
to all potential donors; and c) Certain standards of disclosure
and elements of informed consent be included in this document.
- ACOT Recommendation
3: That a database of health outcomes of all live
donors be established under the auspices of the United States
Department of Health and Human Services.
Mr. Seely commented that if NOTA is silent on living donors,
we need to find a way to give authority and oversight for
this to the OPTN. Ms. Rosenzweig said that the proposed recommendation
reads "legislation be pursued" and asked what that
process would entail. She is not clear how ACOT wants to proceed
with obtaining this objective. Mr. Seely said that there needs
to be a legislative fix to make the law work. ACOT can word
it differently, but it needs to be legislatively mandated.
Ms. Rosenzweig said that one option is to go back to Congress
and ask to amend NOTA or to pass something new. Alternatively,
one could look at financing for care and that would need Congress
to act upon it. Mr. Seely responded that NOTA would have to
be revised for any funding to come about. Writing the rules
came about because of legislative action, and the same process
needs to put forth an amendment to NOTA for this to happen.
Mr. Balbier suggested it might be better for the recommendation
to read that ACOT wants the "Secretary of HHS to propose
legislation to expand the role of..." This could happen
either by changes in appropriation or authorization. Dr. Migliori
asked, given the recommendations related to transplant centers,
what was the intent? Who would provide oversight? Mr. Seely
responded that it was more like a vacuum — there is
a discussion of living donations, but the authorization is
missing. Dr. Freeman added that the Workgroup didn't want
to get into the details of the regulations. There are living
donor standards that aren't even included in these regulations.
Logistically, there isn't a way to do the informed consent
without tracking. The regulations state that the donors must
be informed of the long-term risks, but there isn't a way
to do this right now. ACOT is suggesting that OPTN take over
living donation oversight so it's not prescriptive.
Ms. Agrawal said that she and Mark McGinnis, OGC, were not
persuaded that NOTA needed to be amended to reach this goal.
There is a mild concern that ACOT should not express an opinion
that the Secretary doesn't have the authority to do something
that he is already doing or is proposing in the regulations.
Legal counsel can help determine what it is that needs to
happen to make it occur. Dr. Freeman said that the concern
has been that the OPTN hasn't acted yet because it does not
feel it has the authority — maybe this is being reinterpreted,
which would be good.
Mr. Seely read the proposed Recommendation II:
- Regulations should be written in a manner that anticipates
and encourages the inevitable innovation in procurement
and transplant clinical and programmatic practices that
leads to the enhancement of quality of care.
He noted that this stemmed from discussions about innovation
in transplantation and the fact that ACOT does not want to
prevent or limit innovation. This is aimed at the prescriptive
language in the regulations. The regulations lack reliance
on the existing network that allows for timely concordance
between changing practice and policy, e.g., the ABO issue.
Dr. Young asked if there will there be examples of the discrepancies
given, and Mr. Seely affirmed that there would be.
Mr. Seely read the proposed Recommendation III:
- ACOT acknowledges that DSA performance is dependent on
shared accountability among OPOs, donor hospitals, and transplant
centers. The competitive framework, as proposed, will almost
certainly have an untoward consequence of undermining this
accountability by dampening the demonstrated successes,
such as the HHS Organ Donation Breakthrough Collaborative,
and discouraging the sharing of known best practices among
OPOs.
He said this came from the support for the proposed highly
restrictive competitive process in which only service areas
of OPOs which did not meet the conditions for coverage would
be opened for competition. Performance measures have to include
multiple measures of performance. The appeals mechanism does
not include enough due process and administrative protection.
Dr. Sollinger said that these issues are dangerous and could
really tear the country apart if implemented. ACOT has to
really push this. There are underperforming OPOs, but this
is not the way to fix the problem. Ms. Turrisi said that this
recommendation goes to both the OPO and the transplant centers
issues.
Ms. Agrawal cautioned that the text does not read as recommendations
in the format of "ACOT recommends that the Secretary
of HHS" does or does not do something. They need to be
in the proper form.
Dr. Conti suggested phrasing the recommendation to begin:
"ACOT recommends that the Secretary restrict the competitive
model to those OPOs who are determined to be underperforming"
and then add the other language in the rationale. Ms. Agrawal
offered to help with the formulation of final language outside
the ACOT meeting.
Mr. Seely said that the preliminary vote is on the basic
recommendations and, if approved in concept, the Workgroup
would have a final conference call to finalize the language
for the three recommendations and the transmittal letter to
the Secretary, and then send everything to the full committee
for a final review. Dr. Sollinger moved to approve the recommendations
conceptually as presented, Dr. Conti seconded the motion.
Public Comment
Vickie Hurewitz asked about the recommendation on living
donors in terms of what she can do as an advocate. If the
law has to be amended in Congress, should she speak to her
Representative? She asked how she can weigh in as a citizen
before the Secretary of HHS. Ms. Agrawal responded that any
member of the public can comment on the regulations and has
the opportunity to do so. Mrs. Hurewitz asked how this process
can be speeded up. Dr. Sollinger agreed that the process seemed
slow to everyone, but congratulated Mrs. Hurewitz on having
worked to improve and hasten the process.
The members voted on each recommendation in turn and all
were approved unanimously.
Dr. Sollinger thanked the Workgroup for its efforts. He has
looked at documents of other societies, and the common theme
seems to be that the groups are concerned that the OPTN is
being taken out of the loop. He said that former Secretary
Thompson had signed an amendment to the final rule stating
that the Secretary will only get involved if there is a high
degree of non-compliance that is not being addressed by the
OPTN. The goal is to avoid having an HHS Secretary come in
and undo the OPTN process. It was intended to put a barrier
between the Secretary and the OPTN.
Mr. McGinnis, OGC, stated that he was unaware of any amendment
to NOTA or the final regulations, and he would have cleared
any such document(s). He stated that there had been discussions
about giving the OPTN more authority to set its own rules
rather than going through full rule-making like it is now,
but that did not happen before Secretary Thompson left office.
Dr. Sollinger asked that the issue of an amendment to the
final rule be clarified before the next meeting.
Future Agenda Items
Hans Sollinger, Chair, ACOT
Dr. Sollinger stated that ACOT will continue to work on the
ACOT recommendations to the CMS regulations as a high priority.
Agenda items for the next meeting will include an update on
the work of the Breakthrough Collaborative and consideration
of the issue of a live donor registry and insurance coverage.
Dr. Migliori was asked to survey the insurance companies about
live donors and report on his findings. ACOT also will revisit
the dot com issue.
Dr. Higgins proposed that ACOT examine deceased donor organ
utilization because it appears timely to discuss this again
with respect to the Collaborative. The fact that there are
high levels of discards goes to the root of what the Collaborative
is trying to do in terms of increasing the number of organs
per donor. Mr. Seely stated that an OPO's performance is often
tied to surgeons' attitudes and the Collaborative hasn't addressed
that yet. If the surgeons are lethargic, they will fail. Perhaps
ACOT can look at this with the help of the Collaborative and
compare low-performing OPOs with their surgical staff's attitudes.
Mr. Balbier reminded the group that all of the ACOT recommendations
are on the Organ Donor Website.
Mrs. Boone said that she had recently petitioned the Medical
Care Commission of North Carolina about living donations.
She met with the North Carolina Secretary of Health and they
have established a workgroup. North Carolina now is three
days away from approving the document the workgroup created,
which gives guidelines for living donations. The State is
the second to do this, after New York. She suggested that
the chair of the workgroup be asked to make a presentation
to ACOT.
Public Comment
Miles Kaye said that he wanted to comment on one of Dr. Evans'
earlier remarks, made during Dr. Delmonico's presentation.
He has spoken before many transplant support groups and is
an ambassador for an OPO. His wife is a recipient of a liver
from a deceased donor. He said there is only limited and inconsistent
information given to living donors and their recipients. The
timing of getting this information is critical for ECD and
SCD recipients. When facing death, can a patient really be
involved in making the decision to accept or reject an ECD
organ? Would a desperate person reject any organ? We need
to be careful; we need standardization about the information
that is provided and the timing of when the information is
given to ESRD patients. Mr. Kaye also questioned whether a
patient can handle being involved in any decision to accept
or reject a specific organ at that point.
He also addressed Dr. Kahan's statement on anonymity. In
his experience, all recipients are grateful to donor families
and their donors. He has not met any recipient who didn't
want to thank the donor family. His wife wants to thank her
donor. Dr. Merion made a presentation on the SRTR models and,
as a layperson he was concerned that most of the charts refer
to one-year survival rates. Is the message being sent that
we're only looking for one year survival? We need to see one-,
three-, five-year rates, as well as extended survival rates,
especially with respect to the costs to patients, the transplant
centers, the government, and insurance companies.
Finally, Dr. Metzger referred to the "lesser" results
seen among those who are over 65. Mr. Kaye was sorry his wife
had to leave for another appointment because he wanted ACOT
members to see a positive, 40-month post-transplant, 71-year-old
liver transplant recipient from a deceased donor. He closed
by thanking the members for their time and efforts for all
ESRD patients.
Dr. Sollinger thanked Mr. Kaye and adjourned the meeting.
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