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Jennifer Klein's Files
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ORGAN WPD
Page 1
Memo
To:
Jennifer Klein
From:
Susan Gyeszly
Subject: Transplant Organ Allocation
Date:
June 22, 1998
Overview
On March 26, 1998, HHS Secretary Shalala announced a new regulation to
improve the nation's organ allocation system. Public comment has been requested
until August 31, 1998 with the effective date of the rule October 1, 1998. The
regulation sets three broad performance goals for organ allocation. These include:
1. Standardized listing criteria for placing patients on waiting lists, using
objective and
measurable medical criteria;
2. Standardized criteria for determining medical status, also based on
objective and
measurable medical criteria, sufficient to differentiate patients
from least to most medically
urgent.
3. Organ allocation policies that give priority to those whose needs are most
urgent, with
the result that differences in waiting times for patients of like
medical status will be
reduced.
Background
HHS's Division of Transplantation (DOT) manages the Organ Procurement and
Transplantation Network (OPTN), whose primary function is to maintain a 24
hour-a-day national organ placement center to match donors and recipients. Since
1986, the DOT has administered a contract with the United Network for Organ
Sharing (UNOS), in Richmond, Virginia, for the operation of the OPTN.
UNOS Analysis of Proposed Organ Transplant Regulations
UNOS agrees with first two parts of the regulation which instruct UNOS to develop
national standards that would govern when doctors put patients on the waiting list
for a transplant and when patients are moved up in priority on that list. In fact, last
year UNOS instituted national guidelines for determining these items. However, the
organization disagrees with the third component that eliminates the current
local-based allocation system in favor of one national list based on medical urgency,
or "sickest first." They believe this will lead to several issues.
1. Longer waits, sicker patients, fewer lives save. UNOS believes that the
regulation will require a national list with a "sickest first" criteria, which means
patients will become sicker before they receive their transplant. Statistics show
ORGAN WPD
Page 2
that patients who are extremely ill when given a transplant have a higher rate of
failure. However, the HHS argues that while organs should be allocated according
to need, they have not devised a rigid directive that would require futile transplants.
In fact, they have included a directive stating that organ allocation policies must be
designed to avoid organ wastage and poor utilization. The regulation also calls on
the organ network, and thus UNOS, itself to develop the new allocation policies.
2. Local centers will close; organ donation will be affected. UNOS believes that by
centralizing into a national waiting list, the larger centers that have more patients
will perform more transplants, thus leaving smaller, local centers to fail. Also,
UNOS believes people are more willing to donate if they know that the organs will
stay in the area. However, the HHS feels that there is no evidence of this and
instead a 1994 survey found that "an overwhelming majority of donor families
state as their preference that organs go to the neediest patient regardless of
geography, so long as organs are not wasted.
3. Transplantation access for poor will decrease. If many of the smaller transplant
centers close, many transplant patients will be required to travel far from home.
This would be an added struggle to patients, one of five that are already on
Medicaid.
4. Transporting organ decreases success rates. By abandoning the local system of
organ allocation, organs will need to travel farther distances, leading to lower rates
of success.
5. Legal uncertainty for UNOS. The National Organ Transplant Act intended to
have organ transplantation policy in the private sector and the HHS regulation
assert executive branch control over the program without appropriate legislative
authorization.
6. Preemption of State Law. The new HHS regulations would preempt many state
laws that currently govern organ procurement and distribution. In fact, the
Washington Post reported on Jun 16, 1998 that four states (Wisconsin, Oklahoma,
Louisiana and South Carolina) have passed "organs-for-state-residents-first" laws.
Letter from Donna Shalala to members of Congress
In response to these criticisms, Secretary Donna Shalala wrote a letter to members
of Congress stating that the Department's new regulation does not mandate
specific organ allocation policies.
She also stated that the primary objective in issuing regulation is to assure that
patients receive organs based on standardized medical judgement and common
medical criteria, no matter where they live or in which transplant center they are
awaiting treatment. The change in policy stemmed from the fact that one of the
current shortcoming of the current allocation system is the wide span in average
ORGAN.WPD
Page 3
waiting times for those on translation waiting lists. In some areas of the nation,
patients wait at least 5 times longer for an organ that those in other areas. She
also enclosed a letter form Claude Earl Fox, M.D., Administrator of the Health
Resources and Services Administration. He stated that the current allocation
system is geographically biased and does not distribute organs on the basis of
medical urgency which violates the requirements of the National Organ Transplant
Act which calls for equitable system to distribute organs.
aged lenient White House treatment of
out demonstrated to the group's officials
to be struck, so that every country does
Loral's exports to China-raised the most
the public's growing awareness of how
not charge for the same frequencies.
ire among congressional Republicans.
much it depends on satellite communica-
The SIA is claiming a partial victory on
As a result, the House bill that would
tions.
the auction issue. The FCC auctioned off
bar satellite sales to China passed in two
Given the flurry of Capitol Hill activity,
some frequencies, but the SIA's lobbying
days with very limited debate. The SIA and
Mowry expects to register as a lobbyist,
effort, Mowry says, helped "stem the tide"
other business groups have urged the Sen-
something neither he nor two other SIA
by at least delaying future auctions. Legis-
ate to adopt a go-slow approach.
officials did before the recent crises. His-
lation that would prevent future auctions
The industry needs foreign launches to
torically, the heavy lifting had been done
has passed the House. A companion bill
meet the demand for satellite services, the
by the SIA's member companies and their
has not been introduced in the Senate.
SIA says. "The U.S. is poised to be a great
hired guns.
On one hot-button issue-whether the
exporter of technology and services,"
The SIA is taking a lead role in trying
federally chartered company COMSAT
Levin said. "We don't want people to over-
to block the Federal Communications
should be privatized-the SIA is unable to
react."
Commission (FCC) from auctioning off
take a position. Both COMSAT and pro-
The China episode and the PanAmSat
frequencies for satellite communications.
privatization rivals such as PanAmSat are
satellite's failure have forced the associa-
The SIA contends that the international
members. Legislation on the matter has
tion to rethink how it operates, SIA offi-
nature of satellites means that before the
passed the House and is pending in the
cials added. Outrage over the pager black-
FCC acts, international agreements need
Senate.
From the K Street Corridor
Organ-Sharing Fight
had, eprinted as the June 17 editions. of The New
York Times, The Wall Street and The Washington Post.
What the ad doesn't say, that the two-year old founda
The masty-battle over which patients should be to
is supported a group of companies known in lobby-
organ transplants pits doctor against doctor, top
cir as the Gang of Six," for their majorystak in
hospitals against regional ansplant centers and
China trade. They aresthe American International Group
Health and H um an Services Department (HH
Inc. the Boeing Co.: General Electric Co. General Motors
own contractor, the United Network for Organ
Corp. International Business Machines Corp.and Motor
Sharing (UNOS) At-issue is an HHS that would
Inc. The ad also doesn t disclose that some of the govern
hearts kidneys and the sic people, no
big shots- as former Secretaries, of State
where they live. Critics the regulation would
Lawrence S. Eagleburger Alexander Haig Jr. and Henry,
more deaths, increase costs and some trans
Kissinger, have done consulting on China issues
centers to close. Approximately 55,000 people are
andinvestments for several leading! corporations
the national waiting
Separately, the Business Roundtable reprinted a letter
squabble has reached Capitol Hill and each side is
from 119 of its CEOs to Members of Congress calling for
up its topiguns The Patient Access to Transplant
MFN renewal in the June 24 editions of The Post and The
lition, anewly ed group of regional transplant
Washington imes The adswere of a $2 million effort
has retained Martha M. Kendrick a partner Pat
that's expected to last for weeks.
Peter H. Stone
and B Stewart Scoyoc, president of Van
Associates Inc Meanwhile, UNOS, which based
Kichmond Va., has recently Black , Kelly, uggs
And the University of Pittsburgh Medical Gen
An Explosive Issue
regarded. as the nation s premier/transplan cen
signed former House Minority Leader-Rober
Tirewor manufac urers are complaining about what
TOT RAIL who's at Hogan & and Michael
they,say is be wildering of local and feder
CCV name partner at Wunder Knight, Levine
al.r egulations that govern their industry Deerfiel Ohio)
Forscey
W. John Moore
based Midwest Co., one of the bigge
in the country, has hired former Re pyLyle
Williams, Ohio, to take the to Capitol Williams
heerleading for China
wor with that Michael, another lobbyist with Interna
tional Capital Strategies Inc in Washington. Both are also
working closely with the American Fireworks Association
America multimillion ollar advertising
and the American otechnics Association
shtz that supports enewal of China' most favored-
The gulatory burdens threaten to put all the mom-
(MF status sand-backs the Clinton Admin
and pop-firewor out of business, Williams warns
policy of with China is getting a
Fireworks the Fourth of July all American, he says
from former President Carter and Ford,
The actual.incidents of injury are minimal and most are
top policy makers. The political heavy
caused by misuse Show us where people are
eighed in with and Open to Congres that
fingers blown off, There a bicy-
China Education Foundation recently
cles than using fireworks
Shawn Zeller
6/27/98 NATIONAL JOURNAL 1517
Jul-10-98 03:28pm From-HON ERNEST ISTOOK
2022267836
T-442 P.01/02 F-923
ERNEST J. ISTOOK, JR
5TM DISTRICT QKLAHOMA
119 CANNON BUILDING
WASHINCTON DC 20515-3605
(202) 225-2132
COMMITTEE
FAX (202) 226-1463
APPROPRIATIONS
SUDCOMMITTEES:
Congress of the United States
DISTRICT OFFICES
5400 N GRAND BOULEVARD
SUITE 505
TREASURY POSTAL SERVICE AND
CALAROMA CITY OK 73112
GENERAL GOVERNMENT
house of Representatives
(405) 942-3636
LABOR HHS. AND EDUCATION
FAX (405) 942-3792
NATIONAL SECURITY
FIRST COURT PLACE
Hashington. DC 20515-3605
Suite 205
BERTLEBVILLE. OK 74003
AT LARGE WHIP
(918) 336-5546
FAX (918) 336-5740
REPUBLICAN POLICY COMMITTEE
5TM . GRAND
To:
Debra Warman
PONCA C.TV. OK 74601
(405) 762-6778
FAX (405) 762-7049
ISTOOX@MAIL ROUSE cav
WH cand
456 28
FROM:
Dr. William A. Duncan
Appropriations Committee Associate
Education, Labor, Health & Human Services
Office Phone: (202) 225-2132 Personal Phone (202) 226-3454 Fax: (202) 226-1463
E-mail:
[email protected]
Pages:
Message:
Transplant
Langrage
49
50
1 rector of the Office of MDS Research shall transfer from
I 30, 1999, on the fual rule entitled "Organ Procurement
2 such account amounts necessary to carry out section
2 and Transplantation Network" published by the Depart
T-442 P.02/02 F-923
3 2353(d)(3) of the Public Health Service Act
} nient in the Federal Register on April 2. 1998 (63 Fed.
4
SEC. 210. Funds appropriated in this Act for the Na.
4 Reg. 16295 et seq.), and such rule shall not become effec.
5 tional Institutes of Health may be used to provide transit
5 tive before November 1, 1999.
6 subsidies in amounts consistent with the transportation
6
SEC. 214. None of the funds made available in this
7 subsidy programs authorized under section 629 of Public
Trainisplant
Notice
7 Act may be used to implement or enforce the provisions
8 Law 101-509 to non-FTE bearing positions including
Ry
8 described in section 482.110(c) or section 482.120(a)(8)
9 trainees, visiting fellows and volunteers.
9 of part 482 of title 42, Code of Federal Regulations, as
2022267836
10
SEC. 211. None of the funds appropriated in this Act
10 contained in the proposed rule issued on December 19,
11 may be made available to any entity under title X of the
11 1997 (62 FR 66726).
12 Public Health Service Act unless the applicant for the
12
SEC. 215. (a) Section 2003(c) of the Social Security
13 award certifies to the Secretary that it encourages family
13 Act (42 U.S.C. 1397b(c)) is amended by striking para-
14 participation in the decision of minors to seek family plan-
14 graph (8) and unserting the following:
15 ning services and that it provides counseling to minors on
15
"(8) $2,299,000,000 for the fiscal year 1998;".
16 how to resist attempts to coerce minors into engaging in
16
(b) The amendment made by this section takes effect
17 sexual activities.
17 immediately after the amendments made hy section 8401
18
SEC. 212. Subsection (b)(1)(H) of section 401 of the
18 of the Transportation Equity Act for the 21st Century
Jul-10-98 03:28pm From-HON ERNEST ISTOOK
19 Public Health Service Act (42 U.S.C. 281 (b)(1)(H)) is
19 take effect.
20 amended by striking "National Institute of Dental Re-
20
SEC. 216. The Consolidated Laboratory Building
21 search" and inserting "National Institute of Dental and
21 (Building 50) at the National Institutes of Health is here-
22 Craniofacial Research".
22 by named the Louis Stokes Laboratories.
23
SEC. 213 Notwithstanding any other provision of
23
This title may be cited as the "Department of Health
24 law, the Department of Health and Human Services shall
25 permit the submission of public comments until September
Reg
Allocation
Liver
24 and Human Services Appropriations Act, 1999"
J. 49-388
J. 48-368
THE WHITE HOUSE
July 4, 1998
Betty Lowe, MD
Medical Director
Arkansas Children's Hospital
800 Marshall Street
Little Rock, AK 72202-3591
Dear Betty:
Thank you for your letter about the new HHS solid
organ allocation policy. As you know, I have long admired the
transplantation work done at the Arkansas Children's Hospital.
The success of your heart transplant program is a testament to
the dedication and excellence of the medical staff.
I have asked Jennifer Klein on my staff to look into the
issues you raised about the new HHS policy. As you point out,
we need to strive to find a balance between creating fair
transplantation policies and ensuring that it is practical for
patients to get the organs they desperately need. Jennifer will
contact you to discuss this further and will continue to update
me on this issue.
Sincerely yours,
Hillary Hillary Rodham Clinton
ORGAN.WPD
Page 1
Memo
To:
Jennifer Klein
From:
Susan Gyeszly
Subject: Transplant Organ Allocation
Date:
June 22, 1998
Overview
On March 26, 1998, HHS Secretary Shalala announced a new regulation to
improve the nation's organ allocation system. Public comment has been requested
until August 31, 1998 with the effective date of the rule October 1, 1998. The
regulation sets three broad performance goals for organ allocation. These include:
1. Standardized listing criteria for placing patients on waiting lists, using
objective and
measurable medical criteria;
2. Standardized criteria for determining medical status, also based on
objective and
measurable medical criteria, sufficient to differentiate patients
from least to most medically urgent.
3. Organ allocation policies that give priority to those whose needs are most
urgent, with
the result that differences in waiting times for patients of like
medical status will be
reduced.
Background
HHS's Division of Transplantation (DOT) manages the Organ Procurement and
Transplantation Network (OPTN), whose primary function is to maintain a 24
hour-a-day national organ placement center to match donors and recipients. Since
1986, the DOT has administered a contract with the United Network for Organ
Sharing (UNOS), in Richmond, Virginia, for the operation of the OPTN.
UNOS Analysis of Proposed Organ Transplant Regulations
UNOS agrees with first two parts of the regulation which instruct UNOS to develop
national standards that would govern when doctors put patients on the waiting list
for a transplant and when patients are moved up in priority on that list. In fact, last
year UNOS instituted national guidelines for determining these items. However, the
organization disagrees with the third component that eliminates the current
local-based allocation system in favor of one national list based on medical urgency,
or "sickest first." They believe this will lead to several issues.
1. Longer waits, sicker patients, fewer lives save. UNOS believes that the
regulation will require a national list with a "sickest first" criteria, which means
patients will become sicker before they receive their transplant. Statistics show
ORGAN WPD
Page 2
that patients who are extremely ill when given a transplant have a higher rate of
failure. However, the HHS argues that while organs should be allocated according
to need, they have not devised a rigid directive that would require futile transplants.
In fact, they have included a directive stating that organ allocation policies must be
designed to avoid organ wastage and poor utilization. The regulation also calls on
the organ network, and thus UNOS, itself to develop the new allocation policies.
2. Local centers will close; organ donation will be affected. UNOS believes that by
centralizing into a national waiting list, the larger centers that have more patients
will perform more transplants, thus leaving smaller, local centers to fail. Also,
UNOS believes people are more willing to donate if they know that the organs will
stay in the area. However, the HHS feels that there is no evidence of this and
instead a 1994 survey found that "an overwhelming majority of donor families
state as their preference that organs go to the neediest patient regardless of
geography, so long as organs are not wasted.
3. Transplantation access for poor will decrease. If many of the smaller transplant
centers close, many transplant patients will be required to travel far from home.
This would be an added struggle to patients, one of five that are already on
Medicaid.
4. Transporting organ decreases success rates. By abandoning the local system of
organ allocation, organs will need to travel farther distances, leading to lower rates
of success.
5. Legal uncertainty for UNOS. The National Organ Transplant Act intended to
have organ transplantation policy in the private sector and the HHS regulation
assert executive branch control over the program without appropriate legislative
authorization.
6. Preemption of State Law. The new HHS regulations would preempt many state
laws that currently govern organ procurement and distribution. In fact, the
Washington Post reported on Jun 16, 1998 that four states (Wisconsin, Oklahoma,
Louisiana and South Carolina) have passed "organs-for-state-residents-first" laws.
Letter from Donna Shalala to members of Congress
In response to these criticisms, Secretary Donna Shalala wrote a letter to members
of Congress stating that the Department's new regulation does not mandate
specific organ allocation policies.
She also stated that the primary objective in issuing regulation is to assure that
patients receive organs based on standardized medical judgement and common
medical criteria, no matter where they live or in which transplant center they are
awaiting treatment. The change in policy stemmed from the fact that one of the
current shortcoming of the current allocation system is the wide span in average
ORGAN WPD
Page 3
waiting times for those on translation waiting lists. In some areas of the nation,
patients wait at least 5 times longer for an organ that those in other areas. She
also enclosed a letter form Claude Earl Fox, M.D., Administrator of the Health
Resources and Services Administration. He stated that the current allocation
system is geographically biased and does not distribute organs on the basis of
medical urgency which violates the requirements of the National Organ Transplant
Act which calls for equitable system to distribute organs.
Transcript of UNOS President's Speech at June 1998 Board Mehtg://www.unos.org/Newsroom/archive_other_speech_hunsicker_062398.htm
Return to Breaking News
Transcript of UNOS President Dr. Larry Hunsicker's
Speech At UNOS
Meeting of The Executive Board
June 23, 1998
DR. HUNSICKER: Well, it's been a quiet week in Lake Woebegone.
(Laughter.)
DR. HUNSICKER: With that comment, Garrison Keeler narrates all of the
major and minor crises and triumphs of his little town in either southern
Minnesota or northern Iowa, depending upon where you come from.
It has not been a quiet week in Lake Woebegone. I would also like to begin this
by remembering an ancient Chinese curse. May you live in interesting times.
(Laughter.)
DR. HUNSICKER: I've spent the last year in large measure speaking for
UNOS and the transplant community, speaking to the public about UNOS and
what we try to do in my role as your president and your representative to the
public.
Today, I am grateful to have the opportunity to pass this onto my successor,
Bill, and as I do this, I want to speak from myself to you, to my group in
transplantation, to give you some of the thoughts that I have had this past year.
In many ways, I might have preferred to say all of what I have to say in private,
but it is not appropriate for me to do that. I want to say that I accomplished
nothing of what I had intended to accomplish when I started my term. I had well
defined plans for the year. I knew exactly what I was going to accomplish.
I wanted to improve access to and use of UNOS data, and I spent the first part of
the year confronted with the PTR turn down controversy. I have been concerned
about the public image of UNOS, and I wanted in my year to improve the public
image and to improve the sense that UNOS was swirlingly surrounded by
controversy. I haven't succeeded in that.
I wanted to be, as I think each of the presidents before me has wanted to be, the
first UNOS president to succeed in focusing on donation rather than allocation. I
have spent the last part of my term dealing with issues largely of allocation.
We have heard already this morning from Watson where we should be spending
our time. I know Dr. Pfaff, like every prior president of UNOS, wants to spend
the predominate amount of his time dealing with donation issues, and I want to
join Watson and the other people who spoke to this, to ask that this community
can finally turn from the issues of allocation to the issues of donation.
We must turn from our rancorous debate about allocation to the only thing
which we can all join in and in the only thing that has the potential for solving
our problems.
I'm pleased that yesterday the board of directors endorsed the resolution of the
Council on Organ Availability to support strongly the HCFA conditions for
participation, which would institutionalize required referral, something which I
believe we all feel has the potential to make a real difference in donation.
We are pleased, Dr. Fox, to offer that support to HHS unequivocally.
Now, what you all want me to talk about is the UNOS/HHS business, the
relationships and other things related to the regulations. I'm commenting here,
since this is a public meeting, both to the community and to the Government.
I want to tell you there are two paths that we can take, and the first is the path of
confrontation. I'm a classic scholar. Some of you who may know me well
enough know this.
I will refer you to the story of the House of Atreus, in which the curse on that
1 of 6
07/09/98 13:50:24
Transcript of UNOS President's Speech at June 1998 Board Meehttg://www.unos.org/Newsroom/archive_other_speech_hunsicker_062398.htm
house went back so far to an original grievance that nobody could remember
what it was, but because of that grievance as it came down through the
generations, Clytaemnestra was bound in honor to kill her husband,
Agamemnon, and then Orestes and Electra, their children, were ordered by the
gods to avenge Agamemnon by killing their mother, Clytaemnestra.
Because of the matricide, Electra had to die and Orestes went mad, and so it
goes on. In a less classical tone, we could talk about the Hatfields and the
McCoys. Nobody remembers where it started. It's all lost in the mists of history,
but it determines where we are today.
This path leads from whatever ancient mythic distrust started between UNOS
and HHS, to regulations announced largely unilaterally, to outraged response, to
counter response and wound up at a congressional hearing.
A wiser head than mine observed those hearings, spoke with praise of Secretary
Shalala's dignity in handling her side, and had nice things to say about the way
UNOS handled its side. He concluded who won, no one won, neither side won,
transplantation lost.
That road is still open before us. There are congressional actions. There are
other things going on, and the road down that way lies to mutual assured
destruction or what has been known in the community as MAD.
Now, from the beginning, it has been my position that if the HHS leadership and
UNOS and the transplant community leadership could meet and talk things
over, we could find a way to come to work together.
We now have that opportunity, and we must use it wisely. The latest letters of
Dr. Fox and Secretary Shalala and what Secretary Shalala said at the testimony
on the 18th had lots of things to say but the central and only important part of
what these have had to say include the following comments:
Specific rules for allocation of organs should be made by and come from the
community, not from the Department. There will be flexibility about what the
final rules might be. Our system must strive to achieve fairness as much as
is
possible and as much as prudent, given medical realities, and the Secretary
explicitly said at the hearings that she wants to re-build the relationship between
HHS and the OPTN contractor or UNOS. These are certainly our objectives,
too.
How do we go from here? The images that came to me as I was thinking about
this were two. First is the dance, again, a classical thing, the tarantella, which is
a classic dance which is actually in its origins, supposedly the acting out by
dancers of the engagement between a male and a female spider, trying to decide
whether to kill and eat each other or to make love.
The other was the famous question about how porcupines make love, maybe a
little bit more vegetarian and a little bit less aggressive, and the answer is very,
very carefully.
(Laughter.)
DR. HUNSICKER: On the 8th of May, we had our first meetings with HHS
since the release of the regulations. Dr. Fox and some of his associates met with
Walter and me in a meeting that was at times very angry, but we came out at the
end with a conclusion that we absolutely just had to begin meeting ith one
another.
On the 8th of June, for the first time, senior leadership from HHS met with the
UNOS Executive Committee for a session in which UNOS expressed its?
spectrum of concerns about the regulation, so that all of the HHS leadership
would be able to hear from our communities what our concerns were, and a
beginning of a response came. This was not designed as a negotiation session, E
but-just an exchange of views.
On the 19th of June, the day after the hearings in which neither side won and
transplantation lost, HHS and the UNOS team began to discuss how we were
going to proceed now with our discussions.
2 of 6
07/09/98 13:50:24
Transcript of UNOS President's Speech at June 1998 Board Meehitt://www.unos.org/Newsroom/archive_other_speech_hunsicker_062398.htf
If I had them in my hand, I would have distributed the letters that we have both
written. They are still, I think, pending final approval. These letters will express
three things on both sides.
First, that what we have heard from the politics, from the hearings, from our
own community, is that we should work this out together, not in the political but
in the direct route, that we are in fact meeting to work this out and that both
sides are committed in good faith to see if these problems can be resolved.
We are going to be meeting frequently in July and August, and this may be part
of a subsequent discussion.
I want to make it clear that neither side in this negotiation is capable of speaking
unilaterally for everybody on its side. The HHS people clearly will have to go
back and clear whatever they say or review whatever they hear or want to
propose with the Secretary and with the President, and it is equally clear on our
side that the people who are discussing for UNOS well recognize that we cannot
speak unilaterally for the entire community.
I have suggested that there are two kinds of issues that will be coming up. One
are what I would call structural or relationship issues, which deal with how HHS
and the transplant community work with one another.
These are things that UNOS, even if I had the board of directors there, couldn't
speak for unilaterally because UNOS is not just an organization, it is the
crystallization of the transplant community, and it is perfectly clear that we
cannot give our assent to things until the surgeons, the physicians, the patient
groups, the OPO groups and the other groups know what's there and have signed
onto this.
We are your representatives. I believe this is well understood by HHS.
With respect to the allocation issues, I have argued strongly that it makes no
sense for us to try to save UNOS' allocation system by destroying it, and
therefore, I do not believe it is appropriate for me as the president or any
negotiating group to usurp the process for formation of allocation policy from
what has been established.
I will argue strongly that the allocation systems and the changes that will be
proposed or whatever should come through the usual UNOS process, which
means that what goes on in the other committees of UNOS will be part of this
tarantella, this negotiation, this coming to mutual understanding between the
transplant community and HHS.
I expect that all people representing UNOS will follow our commitment, your
leadership's commitment, that we will approach this in good faith to see if these
issues can be resolved.
I want to speak on three specific issues. One is the issue of fairness, equity. A lot
turns on this question, of what is fair. I am extremely proud as a member of
UNOS to be able to have behind me the ethical principles for organ allocation
developed over many years by UNOS. I would like to think that this should
serve as a template for how we proceed.
It is clear in our discussions with HHS and in our reading what is there that we
have not operationalized these principles. We have general principles but we
don't yet know how we as a community want to measure the question of
fairness.
I have asked Bill whether he would be willing to charge the organ specific
communities, this is his term now coming up, so it's not for me to say, but I
would like to see as a personal request, the organ specific committees commit
themselves, amongst other things, to discussion of how they would
operationalize the definitions of justice and utility.
This is well under way in the area of liver, where we have the leadership of the
liver committee that has gone a long way to saying these are the things we
should be looking at, but we need to do this in a very thoughtful way to make
certain that we have captured what we as a community believe constitutes both
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justice and utility, so that we agree in advance on the measures that we are going
to use, so that we can go to HHS and say, look, we need to broaden these things,
we have the consensus of the community that these factors should be
considered.
Waiting time. This is part of the same issue. Clearly, waiting time is not an
unique measure of equity. This has been part of our concern with HHS. They
know this. I think I'm not saying anything that worries them, particularly in one
hotly controversial area, which is liver status three patients.
It can be argued that waiting time doesn't have any direct relationship in large
measure because of the rolling in of status four patients, when we changed our
rules, because of different paces and all sorts of things.
It doesn't seem clear to me that waiting time under no circumstance is a
legitimate measure and we have to understand what is the proper role of waiting
time.
I asked what about kidneys. Well, kidneys are a very confusing situation. We
have highly sensitized patients and patients who may be listed prior to renal
failure, but we can correct for those things. Is waiting time not an issue? We
need to decide this as a community and we need to communicate these kinds of
things to HHS and to the community.
Caveats. We are concerned about keeping the smaller centers with shorter lists
open. There are lots of ways to do this. We can perpetuate a current system
where we can look for ways to phase changes in that would protect that. Both
UNOS and the United States have made it clear that they have no intention of
undercutting our regional system for organ transplantation. We need to find a
way to do this.
I want to emphasize in this respect that all of us, both UNOS and HHS alike, are
under political judgment. None of us are given the authority to speak for
transplant or the community unilaterally from on high. We only have insofar as
the public, the broader public, understands that we are acting properly in the
interests of the broader public.
A derivative issue from the issue of justice is the issue of whether we are
hearing appropriately from all parts of our community. I have had in my time
two concerns, one largely now met and one which I hope is well on the way to
being met.
The one that's being met is that we now have enfolded the OPO community
largely into the leadership of UNOS. That has been a success and I'm grateful to
see that.
We now have to also make certain that our patient and public and donor family
representatives are heard, not only at the board of directors. We have a third of
our Board of Directors representing that community.
We have to figure out how at the regional meetings and at the committee
meetings, the voice of the public can be heard, the voice of the patients, the
voice of the donor families, can be heard more clearly.
I personally have asked each of our public members and the leadership of the
public group to make certain that they recognize they have an equal obligation
as trustees of this corporation to speak out clearly on the issues of allocation or
whatever.
I would remind my medical breathren of the comments of Jim Childress who
says that while it may be that the medical realities belong especially to the
medical profession to understand, the allocation of organs is a resource
allocation issue in which we doctors have no special competence, but we must
in fact turn to the entire community to hear what we have to do.
One final thing, which is not related, and this is the area in which I have had my
most intense personal discomfort. That has to do with motivations attributed on
both sides to donor families in their willingness to donate.
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None of us has stood where the donor family -- well, many of us have stood
where the donor families have stood. Neither side in this debate has the right to
claim for their side the ethical strength of what those families have done.
At this point, to the extent that I have contributed to this, I want to apologize
personally to Thea as a living donor, to Margaret, Arlene, Ken, Lynn and
Scharleen for any way in which I have contributed to preempting for my side
what the donor families have done. We must not do this. We must not speak of
ownership of kidneys or organs or whatever. That's just simply not fair on either
side of this debate.
What I've heard from the donor families is that they want us to use these organs
with the love and wisdom, do a gift of love, which comes with astonishing grace
from unfathomable pain.
I spoke before about the political judgment that we all live under. I think we live
under, as we operate in this area, a much more awful kind of judgment.
As we deliberate how we are to use these gifts, we have to realize that we are
dealing with something truly holy. We all must keep this greater judgment
before us as we deliberate.
That's what I want to tell you. I want to say thank you to the community for its
bittersweet gift of the opportunity to represent you this year. I want to thank my
Executive Committee. I have been told I should not say "my" Executive
Committee, but I felt it as my family, my executive committee, who have shored
me up and helped me know when I was right and when I was wrong.
I want particularly to thank Bill, who has been staunch throughout this year, and
to whom I am now in the process of transferring both the responsibility and the
burden.
I want to thank the UNOS staff. I may not mention everybody here because I
did this literally between 2:00 and 4:00 this morning.
I want to thank John Persons, who is a man of iron, who stands quietly behind
the people at the head of the table here and keeps us from doing wrong things.
Doug Heiney and Sally Aungier, who led me through a year as chair of the
Membership and Professional Standards Committee when I came to that first
committee meeting not having the foggiest idea what was going on, as its
chairman.
I want to thank Cindy Sommers for her smile and her wisdom. Dave Burroughs,
who has yielded to almost every request I have made of him and said, yes, we
can find a way to do these things. Berkeley Keck, who stands quietly also in the
background and keeps us out of trouble with the year 2000 and in the process of
totally re-doing our computer system.
The regional personnel, and particularly Chris Williams, who really got started
with me in Region 8 and has now moved up to the Organ Center.
Juanita, who kept -- because I don't have to do it any more Walter and I
together, the Travel Department at UNOS who never tired of my repetitive
changes of schedules time and time again. In particular, my scientific folks. Pat,
who I still count in the scientific area. Mary D., Eric, and all the rest of you.
You know who you are and I can't go through all the names.
The whole crowd, from whence I came and where I hope to return when I finish
this term, Walter, who didn't want these things to happen in his time any more
than I wanted these things to happen in my mind, and who doesn't get to get off
the train this afternoon.
(Laughter.)
DR. HUNSICKER: Last year as he was winding up, Jim thanked his
colleagues, and I thought that was sort of nice. I must thank my colleagues. I
have been an absentee landlord. They have filled in for me, uncomplainingly,
taken my schedules, done my work for me back home so that I could be up here
doing this. I owe them and you owe them a remarkable debt. Of course, my
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family, and in particular, my wife, who is the still point in my turning world.
That's the news from Lake Woebegone, where men are strong and women are
good looking and where all of the children are above average.
(Applause.)
DR. HUNSICKER: We have the opportunity this morning to hear directly
from Dr. Fox, who in concordance with our agreement that we are going to
work this out, has interrupted his schedule. He should be today in Geneva, in a
much nicer place, not subject to attack by a potentially hostile crowd, but
amongst his cohorts at the International AIDS Conference. He broke that
schedule to come here and be with us this morning.
I have asked him to come here so he can speak to everybody, and there are
chairs up here for his team, so that if he needs to consult, he can do that.
He has agreed to speak for a few minutes and then answer questions, both from
the board of directors and from the entire community.
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National Organ Transplantation Policy
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Health Resources and Services Administration
News Room
House Testimony: National Organ Transplantation Policy
Prepared Testimony of Claude Earl Fox, M.D., M.P.H.
Acting Administrator, Health Resources and Services Administration
Before the Human Resources Subcommittee
United States House of Representatives
April 8, 1998
Mr. Chairman and members of the Subcommittee, thank you for inviting the Department of Health and
Human Services to participate in this very important hearing on national organ transplantation policy. I
am Doctor Claude Earl Fox, Acting Administrator of the Health Resources and Services
Administration. I am accompanied by Doctor William Raub, the Secretary's Science Advisor and
Marc Smolonsky, Senior Policy Advisor in the Office of the Assistant Secretary for Legislation.
We are delighted to be here in Wisconsin, a State with an outstanding record of organ donation.
Wisconsin has some of the finest transplant surgeons in the country. And one of the great breakthroughs
in transplant technology, the Belzar UW solution, was developed in Wisconsin. This is an appropriate
issue for discussion here or anywhere else in the United States, because organ transplantation policy
affects all Americans, regardless of where they live.
As you know, the National Organ Transplant Act of 1984 created the national Organ Procurement and
Transplantation Network, commonly known by its acronym, OPTN. The OPTN is managed under a
contract with the Department by the United Network for Organ Sharing, or UNOS. The Act was
amended twice, in 1988 and 1990, each time with language clarifying that the OPTN should direct an
equitable nationwide distribution of organs. In the construction of a national organ allocation network,
Congress recognized that there is a shortage of organs available for transplantation, and that the shortage
was likely to continue into the foreseeable future. Congress further recognized that medical urgency and
equity should be the main criteria for access to available organs and that no one should be allowed to
unfairly game the system.
Prior to passage of the National Organ Transplant Act, the distribution of organs was often unfair.
Wealthy people or persons with special connections reportedly were able to manipulate the system so
that they received organ transplants instead of people who were sicker and had been waiting far longer.
Patients from foreign countries sometimes received life-saving transplants while Americans died. After
hearings and media reports had confirmed many of these allegations, Congress acted swiftly to establish
a national system.
HHS has the responsibility to oversee the OPTN to ensure that its policies conform to technological
advances and are consistent with the intent of the statute. Our reviews indicate that there are still many
challenges to optimal patient care. The greatest challenge is the shortage of organs available for
transplantation. About 4,000 people died in 1996 while waiting for a transplant that probably would
have saved their lives. The gap between the demand and supply of available organs for transplantation is
growing, and will continue to expand as medical innovations make transplantation an option for more
and more patients.
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Approximately 10,000 to 15,000 deaths in the United States each year could result in viable organ
donation. But only 5,500 cadaveric donors, one half to one third of potential organ donors, contribute
organs for transplantation. While the number of cadaveric organ donors has increased, from 4,084 in
1988 to 5,417 in 1996, the number of deaths among people on organ transplant waiting lists has also
grown. There were 1,507 deaths on the waiting list in 1988, a number that jumped to 4,022 in 1996.
Some 20,000 Americans received organ transplants in 1996, but more than 55,000 people were on the
waiting lists. Of those on the waiting lists, ten people will die every day, mainly because there are not
enough organs to meet their needs.
The Nation's failure to obtain optimal donation rates for transplantable organs is unquestionably the
biggest problem facing the transplant community. Addressing the shortage of organs is a priority of this
Administration. Last December, the Vice President announced a nationwide initiative to increase organ
donations. The initiative is focused on known barriers to donation by creating a national partnership of
public, private and volunteer organizations. The partnership emphasizes the need to share personal
decisions on organ donation with one's family. Even if an individual agrees during his or her lifetime to
be an organ donor, the agreement is not always honored without family consent. As part of the initiative,
HHS convened a conference on best practices last week, with experts from throughout the country
discussing successful solutions for increasing organ donations.
The initiative also includes proposed Medicare regulations designed to ensure that deaths are reported to
organ procurement organizations whenever there is potential for donation. HHS is working with
providers, consumers, organ procurement organizations, eye and tissue banks and hospitals to develop a
final regulation. The proposal is based on approaches that have been successful in other areas. For
example, organ donations increased dramatically in Pennsylvania as the result of a state law that requires
the reporting of deaths to organ procurement organizations. The Department estimates that the number
of donors nationwide could increase by 20 percent within two years of the publication of a final rule.
Organ procurement is one of the most sensitive issues in American society. Asking a family to donate an
organ from a loved one who just died is a wrenching task, which is done most effectively by people who
are trained organ procurement specialists. There are many heroic individuals who are in the business of
saving lives every day by convincing people to donate organs. But as a nation, we must do a better job.
Although the country's mixed record on organ donation is our primary concern, there are other problems
that pose vexing questions for the Department. How do we ensure that organs are allocated fairly and
with sufficient efficiency that available organs are used to prolong the lives of people in the greatest
need? How do we guarantee that the OPTN operates primarily in the interests of patients? Our best
answers to these questions are contained in the new regulations for the OPTN, which were published last
week.
Six principles underlie the regulations:
1. Transplant patients are best served by an organ allocation system that
functions equitably on a nationwide basis.
2. The Secretary of Health and Human Services should represent the public
interest by setting broad goals for the OPTN and by overseeing OPTN policy
development and operations with a view toward ensuring that the goals are
being addressed in a reasonable manner.
3. The OPTN must exercise leadership in performing its responsibilities under
the National Organ Transplant Act, in particular by devising the specific
policies assigned under the regulations, and by adapting its policies and
procedures to changes in medical science and technology.
4. Organs should be equitably allocated to all patients, giving priority to those
patients in most urgent medical need of transplantation, in accordance with
sound medical judgment.
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5. Thorough, timely, and easy to use information about transplant centers,
including center-specific performance data, is essential for measuring quality of
care and should be readily available to help patients and physicians in choosing
among transplant centers.
6. Potential conflicts of interest should be minimized for those who are
responsible for operation of the OPTN.
The statute that created the OPTN requires the Secretary of Health and Human Services to provide
timely information to patients, their families, and physicians about transplantation. Current OPTN
policies make it impossible to fulfill this requirement because the Department has been denied current
and thorough information. Under existing policies, for example, we cannot provide Americans with the
current one-year survival rates of patients and organ grafts. We cannot compare the performance of
transplant programs. Data available to patients today is four years old, so it is out of date. Given that the
data made public is outdated and incomplete, patients cannot review the performance of respective
transplant programs. We find this situation unacceptable and seek to obtain timely useful data for
patients through the pending regulation.
The pending regulation also addresses the issue of the broader sharing of organs and intends to spur
debate within the OPTN about the suitability of the current local-first policy for the allocation of organs.
We believe there is solid evidence that the current system is unfair and that patients may be dying
unnecessarily because they happen to live in the wrong place at the wrong time. Secretary Shalala
believes that everyone in need of a transplant should have equal access to an organ, regardless of where
they live or list.
We believe broader sharing of organs will reduce current geographic inequities in the OPTN. Our view
is supported by numerous prominent medical authorities and experts who have proposed broader sharing
of donated organs. For example, Dr. Lawrence Hunsicker, the current President of the United Network
for Organ Sharing, said in 1986:
"In principle, and to the extent technically and practically achievable, any
citizen or resident of the United States in need of a transplant should be
considered as a potential recipient of each retrieved organ on a basis equal to
that of a patient who lives in the area where the organs or tissues are retrieved.
Organs and tissues ought to be distributed on the basis of objective priority
criteria, and not on the basis of accidents of geography."
According to the American Medical Association's Code of Medical Ethics:
"Organs should be considered a national, rather than a local or regional
resource. Geographical priorities in the allocation of organs should be
prohibited except when transportation of organs would threaten their suitability
for transplantation."
In 1991, the HHS Inspector General reached the following conclusion:
"
current organ distribution practices fall short of congressional and
professional expectations," and that "there has been substantial progress in
developing a national organ distribution system grounded in uniform policies
and standards. However, organ distribution remains confined primarily within
the individual service areas of the Organ Procurement Organizations."
In passing the National Organ Transplant Act, Congress clearly intended that the OPTN act as a
nationwide system, free of geographic bias. In 1990, when Congress amended the statute to emphasize
the importance of a truly national allocation system, the Senate reported, "because the demand for
transplantable organs is expected to continue to be considerably greater than the supply, a fair and
equitable organ sharing system is critical to the future of a national transplant program that the public
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will support."
The OPTN has not met the mandate of the statute that created it. The allocation system is not fair, nor is
it a national network. By allocating organs primarily at the local level, OPTN policies give the sickest
patients a substantially lower chance of being promptly matched to a suitable organ. Current OPTN
policies create enormous geographic disparities in the time patients must wait to receive transplants. For
example, based on the latest data, if you live in New England and need a kidney transplant, you will wait
as long as three years. But in the upper portion of the southeast, a patient in need of a kidney transplant
will wait as little as 231 days.
We find the disparity in waiting times across the country to be unacceptable. Americans in need of organ
transplants will live or die on the basis of where they live. The policy that allows this to happen is
contrary to the intent of Congress and in violation of the American Medical Association's Code of
Ethics.
It would be illegal to deny an organ to patients solely because of their race, gender, or age. Yet organs
are denied to patients because of where they live. Geographic discrimination is no better than any other
sort of discrimination. It is flat out wrong and should no longer be tolerated.
The Department recognizes that there is tremendous controversy over the subject of organ allocation.
We understand that there is division in the transplant community about the distribution of organs, and
that while many want the current system changed, others do not. The OPTN must not be so paralyzed by
controversy and division that it does not act to change a system that is unfair to patients, and that may be
allowing patients to die unnecessarily. Through the pending regulation, the Department is putting
patients first. What is best for patients, in our view, overrides concerns about the individual needs of
transplant centers, whether they be large or small.
In its pursuit of justice for patients, the Department does not intend to substitute its own medical
judgment for the judgment of members of the OPTN-. Although the pending regulation requires changes
in current allocation policy, the regulation does not contain a specific policy. The regulation leaves it to
the OPTN to reform the policy and present its recommendations to the Secretary. I reiterate, HHS will
not be setting any new allocation policy; it is up to the medical experts of the OPTN to set the new
policy. We ask only that the policy conform to three basic performance goals: One, that criteria for
placing patients on waiting lists be standardized; two, that criteria for determining medical status of
patients be standardized; and three, that medical urgency, not geography, be the main criterion for
allocating organs.
The OPTN agrees with the first two performance goals. In fact, the network is already working toward
those aims. It is the third performance goal, the one that is designed to end discrimination in the
allocation system, with which the OPTN is struggling. But I am confident that if the OPTN puts patients
first, it will accomplish this goal as well.
I have described what the pending regulation will do. Now let me tell you what it will not do. The
regulation will not adversely affect patients who are on waiting lists at the time it takes effect. The
regulation states that no one currently on a waiting list will be disadvantaged by changes in the
allocation policy. The regulation will not deprive any locality of organs. Broader sharing will mean that
patients have more access to organs, not less. Our goal is that all patients be better off as a result of
policy reforms.
I will conclude by saying that the Department has solicited widespread public comment on this
regulation. It was published as an NPRM in 1994, and we received extensive public comments in
response. In December 1996, the Department conducted three days of public hearings on issues
pertaining to the regulation. Everyone connected to the transplant community, from patients to surgeons,
was invited to testify. The pending regulation has a 60-day public comment period and a delayed
effective date. Should the Department learn anything during the public comment period that requires
change, the effective date of the regulation can be delayed further to accommodate the changes. We
encourage public debate on the regulation, whether it be at a hearing like this one or within the confines
of the OPTN.
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Thank you for the opportunity to testify. I will be pleased to answer any questions you may have.
Go to: Top I Speeches and Testimony I HRSA News Room I HRSA I HHS
Questions/comments to HRSA's Office of Communications
Last Updated May 01, 1998
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Letter to Representatives, Senators
http://www.hrsa.dhhs.gov/osp/DSLETTER.htm.
MUMAN
HEALTH
THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, D.C. 20201
3
June 1, 1998
Hts gress
The Honorable
House of Representatives/United States Senate
Washington, D.C. 20515-3601
Dear Member of Congress:
Thank you for your interest in the Department's April 2, 1998, regulation governing the
Organ Procurement and Transplantation Network (organ network). I am deeply concerned
about recent efforts by the contractor that manages the network, the United Network for
Organ Sharing (UNOS), to misrepresent the provisions of the regulation. I have received
numerous letters from Members of Congress, transplant professionals, patients, and the
public that reflect the inaccuracies published by UNOS. I am especially distressed that UNOS
is needlessly frightening transplant patients about the HHS regulation. I appreciate having the
opportunity to set the record straight about the intent and effect of this important rule.
First, let me assure you that the Department's new regulation does not mandate specific
organ allocation policies. We believe strongly that policies requiring medical expertise and
judgment should be formulated by the organ transplant professionals who comprise the organ
network. Our regulation simply asks that the organ network establish new policies that will
be fairer to patients than the current system, especially to assure that allocation of organs will
be based on common medical criteria, not accidents of geography.
Certain specific claims made by UNOS must be challenged at the outset:
UNOS:
For example, UNOS maintains that we would require a new single national waiting list for
transplant patients. This is not true. To the contrary, we allow the organ network wide
latitude as it devises new policies that are both fair to patients and medically sound. Indeed, a
variety of alternatives have already been presented to UNOS by some of its own members.
UNOS also maintains that our regulation requires organs to be allocated to the very sickest
patients first, leading to poor utilization-of:organs. This is also untrue. While organs should
indeed be allocated with a primary emphasis on medical need, the regulation does not make
any rigid directive that would require futile transplants. In fact, the regulation explicitly
requires that organ allocation policies must be designed to avoid organ wastage and poor
utilization. Likewise, the regulation is quite clear in leaving to physicians and to the organ
network the difficult but necessary decisions that must be made when a patient may be too ill
to be successfully transplanted.
4
Finally the UNOS claim that fewer patients will be transplanted and fewer lives saved is
simply specious. The most important fact to understand is that the HHS regulation calls on
the organ network, and thus UNOS itself, to develop the new allocation policies. Therefore,
when UNOS predicts that negative consequences will result from the regulation, the truth is
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that such negative effects could only occur if UNOS itself chose an unsound policy. HHS
does not want such policies; our regulation does not call for such policies; in some instances,
the regulation actually prohibits policies with the consequences that UNOS is predicting; and
finally, when UNOS actually develops its allocation policies, I am certain that it will adopt
approaches that will serve patients, physicians and its own member transplant centers.
A primary objective in issuing our regulation is to assure that patients receive organs based
on standardized medical judgment and common medical criteria, no matter where they live or
in which transplant center they are awaiting treatment. Patients who need an organ transplant
should not have to gamble that an organ will become available within a particular arbitrary
geographic area, nor should they have to travel to faraway transplant centers simply to
improve their chances of getting an organ. Instead, patients throughout the country should
have a more equal chance of receiving an organ, based on their medical condition and the
judgment of their physician.
To achieve this result, the rule calls on the organ network to develop uniform medical
criteria for determining the severity of a patient's medical status and eligibility for placement
on a transplant waiting list. The rule also calls on the organ network to develop organ
allocation policies that will reduce the current geographic disparities in patients' access to
transplantable organs.
We have proposed these changes because we believe the current system is fundamentally
unfair. Consider the recent case of a Maryland child who was transplanted in Florida within a
week of listing there, though the child had been waiting for one year on the organ transplant
list at a California hospital, and then four years on the organ transplant list at a hospital in
Pennsylvania. No one -- especially those who cannot afford it should be required to list at
several transplant hospitals and fly long distances for surgery that could be provided closer to
home.
The most visible shortcoming of the current allocation system is the wide span in average
waiting times for those on transplantation waiting lists. In some areas of the nation, patients
wait at least 5 times longer for an organ than those in other areas. Less visible are the
resulting inequities among those who receive organs. Where waiting times are the shortest,
organs may go to patients who are less ill; while at the same moment, in areas where patients
wait longer, organs often are not offered to patients with greater medical need. In the worst
cases, patients die in areas where waiting times are long, while, at the same time, organs are
being made available to less ill patients in areas with shorter waiting times. And, for many
reasons, virtually all patients are on the waiting list of only one transplant center.
UNOS has not published a hospital-specific waiting time report, although one newspaper,
using UNOS data, computed these times. The results illustrate that disparities in waiting
times exist not only between different parts of the country, but also between transplant
centers within the same State. For example, the median waiting times for the two major liver
transplant centers in Kentucky were vastly different -- 38 days at one center, 226 at the
other. Similarly, in Louisiana, the median waiting time at one center was reported to be 18
days, while at another, it was 262 days. In Michigan, the numbers were 161 days and 401
days. Although these numbers do not tell the whole story, they certainly reflect that
unacceptable disparities in waiting times exist, even within States. I believe that basic fairness
to patients demands that these disparities be substantially reduced and that the transplant
community should ultimately develop the means to this end.
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It is regrettable that since we issued our regulations UNOS has launched a campaign that
factually misrepresents the Department's intent in issuing the rule and mischaracterizes its
provisions. As the organ network contractor, UNOS has a special responsibility to help
develop policies that reflect sound medical judgments concerning organ transplantation. Now
is the time for UNOS to be working productively to design policies to implement the rule
that incorporates the views of patients, the transplant community and the public. Instead,
UNOS has embarked on a misleading lobbying campaign that has confused the public and
caused fear among transplant patients and their families.
There is no doubt that the issues we are grappling with as we pursue equity in organ
allocation are complex and difficult. Members of Congress, and the public at large, have
important contributions to make as we seek to get it right. Unfortunately, rather than engage
in a fair and thoughtful debate, UNOS hasdecided to craft a set of fictional facts and choices
in order to make plausible the dire scenarios that are necessary for their lobbying campaign
to succeed. Perhaps most inappropriate has been the decision by UNOS to develop a
hypothetical allocation policy and dub it the "HHS policy." UNOS then modeled computer
runs on this hypothetical, using outdated 1991 transplant data, in order to predict undesirable
results. This effort merely creates a fiction and a distraction. It is not credible.
UNOS
UNOS also has claimed, without any factual support, that the rule will somehow reduce the
rate of organ donation. Simply put, there is no evidence that our regulation would have this
effect. A 1991 HHS Inspector General report, cited in the preamble to our regulation, notes
that "Americans do not think that keeping a [donated] organ in a specific locality is an
important goal in and of itself." And a 1994 survey by UNOS itself showed, again as stated
in our regulation's preamble, that the overwhelming majority of donor families state as
their preference that organs go to the neediest patient regardless of geography, so long as
organs are not wasted."
This Administration, with dozens of partners, is committed to increasing the rate of organ
donation by 20 percent within two years. Indeed, the urgency could not be greater. As you
know, some 55,000 persons are on organ transplant waiting lists today, up from 16,000 in
1988. More importantly, about 4,000 Americans died in 1996 -- more than 10 each day
while awaiting organ transplants. Increased organ donation is an absolute priority for all of
us, and we will work very hard to achieve our commitment.
A final point of special importance is the need to improve the availability of transplant data.
Useful, current transplant center-specific information needs to be available so that patients
and health care providers can make informed choices. Likewise, good data must be available
to HHS and to Congress in order to successfully carry out our oversight functions. The
organ network contractor needs to perform better in this area, and our regulation makes this
a requirement.
To offer a more detailed response to these and other issues that UNOS has raised, I am
enclosing a letter from Claude Earl Fox, M.D., the Administrator of the Health Resources
and Services Administration. I trust that you will find this information helpful.
Thank you again for your interest in this important subject. I believe we have made
remarkable progress in the field of organ transplantation. But, we can do even better. We can
help the organ network operate more effectively by establishing clear expectations through
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http://www.hrsa.dhhs.gov/osp/DSLETTER.htm
performance standards that serve the goals embodied in the National Organ Transplant Act.
And, with the and expertise of the transplant community, we can assure Americans that
organ allocation policies are equitable, and that those who need organ transplants will be
treated according to medical need, no matter where in the country they may be hospitalized,
or at which center they may be listed. I look forward to working closely with you to achieve
this important goal.
Sincerely,
/Donna E. Shalala
Enclosure
Go to home page for: DOT II OrganDonor.gov Il HRSA HHS
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http://www.hrsa.dhhs.gov/News-PA/organreg.itm
HHS NEWS
OPTN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOR IMMEDIATE RELEASE
Contact: HRSA Press Office
Thursday, March 26, 1998
301-443-3376
HHS RULE CALLS FOR ORGAN ALLOCATION
BASED ON MEDICAL CRITERIA, NOT GEOGRAPHY
Calls on Private Transplant Network to Develop Policies
NOTE: The public comment period for the Final Rule for the Organ Procurement and Transplantation
Network (OPTN) has been éxtended from June 1, 1998 until August 31,1998. Similarly, the effective date
of the Rule will be October, 1, 1998. These actions are based on Section 4002 of the Fiscal Year 1998
Supplemental Appropriations Act (Public Law 105-174).
HHS Secretary Donna E. Shalala today announced a new regulation to improve the nation's
organ transplantation system, to assure that allocation of scarce organs will be based on
common medical criteria, not accidents of geography.
The new rule calls on the Organ Procurement and Transplantation Network, the private
sector system created by the National Organ Transplant Act of 1984, to develop revised
organ allocation policies that will reduce the current geographic disparities in the amount of
time patients wait for an organ The rule also calls on the OPTN to develop uniform criteria
for determining a patient's medical status and eligibility for placement on'a waiting list. The
criteria will be aimed at assuring that patients with greatest medical need will receive scarce
:
organs based on medical judgment and common medical criteria, no matter where they live #
or in what transplant center they are awaiting treatment
"Patients who need an organ transplant should not have to gamble that an organ will become
available in their local area, nor should they have to travel to transplant centers far from
home simply to improve their chances of getting an organ," Secretary Shalala said. "Instead,
patients everywhere in the country should have an equal chance to receive an organ, based on
their medical condition and the judgment of their physicians.
"HHS does not want to choose which patients receive scarce organs. Those choices must be
made by transplant professionals," she said. "But this regulation will help assure that organs
are allocated on the basis of medical need, and that availability of organs will not be impeded
by arbitrary geographic lines."
In addition to today's action, the Clinton Administration last year launched a new National
Organ and Tissue Donation Initiative with public and private sector partners, aimed at
increasing organ donation by 20 percent within two years.
"The real answer to the problem of scarce organs is to increase the number of organ
donations," Secretary Shalala said. "Our national initiative is a serious new effort to bring
about more organ donation."
Under the regulation announced today, performance goals would be established to guide the
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OPTN as it modifies existing organ allocation policies. Under the current policies, matching
organs are usually made available to all listed patients in a local organ procurement area
before they are made available to other patients outside the area. This means less ill patients
in the local procurement may receive a transplant while patients with more urgent medical
need in another area continue to wait.
Under today's regulation, three new sets of criteria for organ allocation would be developed
by the OPTN. Development of the criteria would include public input and comment and final
HHS approval. Secretary Shalala emphasized that the regulation looks to transplant
professionals in the OPTN to develop the revised policies. "We are not substituting our
judgment for the judgment of medical professionals," she said. "We are asking them to make
the system fairer, and we are setting clear performance goals to guide their work." The in
<criteria to be developed by the OPTNare:
Problem
Criteria aimed at allocating organs first to those in the highest medical urgency status,
with reduced reliance on geographical factors. This should reduce disparities in waiting
times for patients at different transplant centers in different areas of the country.
Today, there is a wide variation in waiting times, with patients in some areas waiting
five times longer or more for an organ than in other areas. The new criteria would
UNOST
provide for wider sharing to assure organs were made available to patients with
greatest medical need.
Criteria to be followed in deciding when to place patients on the waiting list for an
organ. Today, each transplant center establishes its own criteria, with the result that
patients listed at one center may not be as ill as patients not yet listed at another center
with more stringent medical listing criteria. Under the regulation, the OPTN would
develop medically objective criteria to be used by all transplant centers.
By
Criteria for determining the status of patients who are listed. Medically objective,
uniform criteria would help ensure a "level playing field" in selecting among patients
and determining which have the greatest medical need. The OPTN is already
developing uniform criteria of this kind.
The final rule includes a.new 60-day comment period, and becomes effective 90 days after
publication in the Federal Register. The OPTN would have another 60 days to propose new
criteria for livers; and a year for development of criteria for other organs.
"Together, these new uniform criteria will add up to a fairer and more understandable
system, which will serve both patients and the transplant system better," Shalala said.
Other provisions of today's regulation include enhanced access to center-specific data about
transplant centers, measuring outcomes and helping patients and physicians to choose among
transplant centers; a broad definition of the composition of the OPTN membership and board
of directors; the process for HHS review of OPTN policies before they become mandatory
for OPTN members; and approval authority over the fees charged for registration on the
OPTN waiting list (currently $357, usually paid by an insurer, most often Medicare or
Medicaid.)
In 1996, some 20,000 Americans - about 55 each day - gained a new lease of a better life
through transplantation. However, more than 55,000 people are on the transplant waiting list
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nationwide, and some 4,000 people - 10 every day - die in the U.S. while awaiting a donated
organ.
The OPTN includes transplant centers and organ procurement organizations, as well as other
public, medical and professional organizations
The final rule is available on the World Wide Web at
http://www.hrsa.dhhs.gov/osp/dot/dotmain.htm.
####
Go to: News Releases I HRSA News Room I HRSA I HHS
Last updated: 05/29/98
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Fact Sheet forthe New Organ Donor Regulation
http://www.hrsa.dhhs.gov/News-PA/organfs.ltml
U.S. Department of Health & Human Services
Health Resources and Services Administration
5600 Fishers Lane, Rm. 14-45
Rockville, MD 20857
NEWS
Tel: 301-443-3376
Fax: 301-443-1989
FACT SHEET
Contact: HRSA Press Office
301-443-3376
Thursday, March 26, 1998
IMPROVING FAIRNESS AND EFFECTIVENESS
IN ALLOCATING ORGANS FOR TRANSPLANTATION
The Regulation || Key Principles || Major Provisions II Effective Date
Background
Since the enactment of the National Organ Transplant Act of 1984, American medicine has
been a world leader in organ transplantation. More people are benefiting from organ
transplants and their survival rates are steadily improving. In 1996, some 20,000
Americans--about 55 each day--gained a new lease on a better life through transplantation.
At the same time, the rapid development of transplant procedures and growth in the organ
transplant system have brought new challenges:
The demand for organs for transplantation far exceeds the supply. Some 4,000
people-- 10 people every day--die in the U.S. while waiting for a donated kidney, liver,
heart, lung or other organ.
In March 1998, approximately 54,500 people were on the national transplant waiting
list, and the list grows by about 500 each month.
Despite technological advances in preserving organs, the system for allocating scarce
organs (especially livers) remains weighted to local organ allocation, instead of broader
regional or national allocation according to medical need. A patient who is less ill in
one geographic area with a short waiting list may get a matching organ before a patient
whose condition is more medically urgent in another area with a longer waiting time.
Medical criteria for listing patients and assessing their status vary from one transplant
center to another, making it difficult to objectively compare the medical need of
patients awaiting organ transplantation in different centers and different areas of the
country.
While much data is available today, there is still a need to provide for more current and
usable data collection and dissemination to help patients and doctors in measuring
quality and making transplant decisions.
The Regulation
The National Organ Transplant Act of 1984 envisioned a national transplant system to be
operated by transplant professionals, with oversight by HHS to ensure an equitable allocation
system in the public's interest. The Act created the Organ Procurement and Transplantation
Network, a non-profit private sector network to be operated by a contractor to HHS.
Originally, OPTN membership and policies were voluntary. But with enactment of the
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Omnibus Budget Reconciliation Act of 1986 adding Section 1138 of the Social Security Act,
all hospitals that perform transplants and all organ procurement organizations (OPOs) were
required to abide by the rules and requirements of the OPTN in order to receive Medicare
and Medicaid reimbursement.
In December 1989, HHS issued a Federal Register notice indicating that all OPTN rules and
requirements would remain voluntary until the Secretary promulgated regulations to define
the roles and policy-making procedures of the OPTN and HHS. A Notice of Proposed Rule
Making containing these definitions was published on September 8, 1994.
After two extensive comment periods, including three days of special hearings in December,
1996, HHS today announced a final rule providing a framework for the operation of the
OPTN, and aimed at assuring that the Nation's organ procurement and transplantation system
operates for the greatest benefit of transplant patients. The regulation builds on medical
technology advancements; it looks to the medical community for leadership in policy
development, with participation by patients, donors and their families; and it sets
performance goals for fair and effective use of donated organs.
The rule, to be published in the Federal Register in March 1998, with a 60-day opportunity
for additional public comment, provides the framework within which the OPTN, its members,
and other participants in organ procurement and transplantation will operate. The rule, which
becomes effective 90 days after publication, sets requirements for the structure of and
membership in the OPTN; the OPTN policy making process, including the Secretary's
oversight role; standardized criteria for placing transplant candidates on a national waiting
list; identification of organ recipients; equitable organ procurement and allocation;
designation of transplant programs; review and evaluation of OPTN activities; and record
maintenance and reporting by the OPTN, OPOs and transplant hospitals.
Key Principles
Important principles underlying the final regulation include:
The Department's responsibility is to assure that the goals of the National Organ
Transplant Act are being realized for patients. The Department's role is to provide
broad oversight and performance goals to ensure an equitable allocation system that
operates in the best interest of patients.
The rule does not dictate medical practice, but provides a broad framework for the
OPTN's operation and activities. Within that framework and the goals of the law, the
OPTN has the freedom and flexibility to determine the most effective ways to put the
policies into practice nationwide. Individual physicians will continue to make decisions
regarding individual patients.
As far as medically feasible, there should be a "level playing field" in organ allocation.
Organs should be allocated based on patients' medical need and sound medical
judgment, with less emphasis on keeping organs in the local area where they are
procured. Patients should have an equal chance to receive an organ based on their
medical need, not the accident of geography. Efforts should be made to equalize
waiting times among different regions of the country.
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Standardized medical criteria should be used to determine the status of a person's
illness and when the person can be placed on a waiting list. The same medically
objective criteria should be used by all transplant centers. Uniform criteria can help
reduce regional variations and will help build trust among centers, physicians and
patients.
Patients, their physicians and the public should have timely, accurate and user-friendly
center-specific data on the performance of transplant programs to measure quality and
make transplant decisions.
Transplant decisions should always be based on sound medical judgment to avoid
wasting organs and ensure an efficient and effective system.
HHS policies must be guided by the interests of patients and the purposes of the law,
not the sometimes conflicting interests of different transplant centers
Major Provisions
The final regulation establishes a framework within which both the OPTN and the
Department will operate. It delineates the roles of each, providing a basis for the OPTN to
act and the Department to monitor and review these actions to ensure an equitable allocation
system that operates for the public's benefit. Major provisions include:
Policy Development--The OPTN Board of Directors is responsible for developing
organ allocation policies, with the advice of patients, families and the public. Proposed
policies may be reviewed by the Secretary, and if determined appropriate, published in
the Federal Register for public comment. Entities objecting to OPTN or Secretarial
policies may submit appeals to the Secretary in writing. In addition to policies for the
equitable allocation of organs, the OPTN's policy making role includes: policies on the
training and experience of transplant surgeons and physicians; policies for nominating
OPTN Board members; and other policies as directed by the Secretary.
Allocation of Organs--The OPTN Board of Directors is responsible for developing
organ-specific policies (including combinations of organs, such as for heart-lung
transplants) for equitable organ allocation among potential recipients. The rule sets
three broad performance goals for organ allocation:
-standardized listing criteria for placing patients on waiting lists, using
objective and measurable medical criteria;
-standardized criteria for determining medical status, also based on
objective and measurable medical criteria, sufficient to differentiate patients from
least to most medically urgent
problem
-organ allocation policies that give priority to those whose needs are most
urgent, with the result that differences in waiting times for patients of like
medical status will be reduced;
All of these goals, of course, are subject to considerations of practicality and sound
medical judgment to avoid futile transplants and wasted organs, and to promote the
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efficient management of organ placement.
The rule requires the OPTN board to focus first on appropriate revisions to its current
liver-allocation policy and propose a new liver allocation policy to the Secretary within 60
days of the regulation's effective date. Other organ-specific policies must be provided to the
Secretary within one year of the regulation's effective date.
Transition to New Policies--When the OPTN initially revises organ allocation
policies, it must propose transition policies so that people who are already on the
national waiting list for transplantation do not receive less favorable treatment than
under previous policies.
Board Composition--The rule modifies the composition of the OPTN Board of
Directors. At least six public members must come from fields such as behavioral
science, computer science, economics, ethics, heath care financing, law, policy
analysis, sociology, statistics or theology. Another eight members--at least 25 percent
of the board--must represent transplant candidates, transplant recipients, organ donors
and family members. No more than 50 percent of the members are to be transplant
surgeons or transplant physicians.
Public Access to Data--The rule pays special attention to public access to data. When
the Secretary determines that information will serve the public's interest, the Secretary
may release it. The rule requires that outcome data be updated every six months and be
available no more than six months later than the period to which they apply. The data
shall include the characteristics of individual transplant programs as well as rates of
non-acceptance of organs and waiting times, and other data useful to patients, their
families and physicians in making transplant decisions.
Review and Evaluation--The Secretary or her/his designee may review and evaluate
member OPOs and transplant hospitals where there is evidence of non-compliance with
the OPTN rule or actions that risk patients' health or compromise public safety.
Sanctions may include removal of transplant program designation, termination of the
transplant hospital's participation in Medicare or Medicaid, or termination of an OPO's
Medicare and Medicaid reimbursement.
EFFECTIVE DATE--These regulations are effective 90 days after publication in the
Federal Register. Comments on this rule are invited. To assure consideration, comments must
be received within 60 days after date of publication in the Federal Register.
ADDRESSES: Written comments should be addressed to Jon L. Nelson, Associate Director,
Office of Special Programs, Health Resources and Services Administration, Parklawn
Building, 12420 Parklawn Drive, Rockville, MD 20857. All comments received and
referenced background materials will be available for public inspection and copying at the
above address, weekdays (Federal holiday excepted) between 9 a.m. and 4 p.m.
A copy of this rule and selected background materials is posted on the Health Resources and
Services Administration's Division of Transplantation Web site at
http://www.hrsa.dhhs.gov/osp/dot/dotmain.htm.
####
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UNOS Rationale for objectives
http://www.unos.org/Newsroom/archive_other_regsanalysis_052798.htmftop
Return to OPTN Regulation News
UNOS Analysis of Proposed Organ
Transplant Regulations
The federal government's proposed organ transplant regulations would direct
UNOS to make three significant changes in transplant medicine. UNOS agrees
with two of those, and in fact has already made them. The third, though well
intended, would do more harm than good.
To ensure that all patients have a fair chance at getting a transplant, the
regulations instruct UNOS to develop national standards that would govern (1)
>thesave ock
when doctors put patients on the waiting list for a transplant and (2) when
patients are moved up in priority on that list. Historically, different doctors in
different areas have made different judgements about these matters.
In fact, UNOS recognized the need to address these two issues some time ago and
has already acted. UNOS last year instituted national guidelines for determining
when someone goes on the waiting list and when the person moves up on the list.
Transplant doctors have already begun reviewing each other's cases to ensure
that these guidelines are being observed unless there are sound medical reasons
not to.
The lawyer who heads the American Bar Association's biomedical ethics
coordinating group, Robyn Shapiro, has told Congress that these two steps should
help ensure that patients in every part of the country have equal access to
transplants. And Ms. Shapiro has urged the federal government to determine
what effect these guidelines have over time before making radical changes in the
transplant system.
problem
But the proposed federal regulations demand another severe step, eliminating the
current locally-based organ allocation system in favor of one national list based
on medical urgency, or "sickest first." The transplant community fears this new
policy will result in several disturbing realities:
AGAINST b/c
Longer waits, sicker patients, fewer lives saved. The HHS
regulations will require a national list with a "sickest
first" criteria. This means that patients will become
sicker before they receive their life-saving transplant.
Statistics show that patients who are extremely ill
when given a liver transplant have a higher rate of
transplant failure and may need a second or third
transplant to survive. The transplant community
believes, and statistical studies verify, the current
system of giving priority to the most urgent patients
locally, maximizes both the number of patients who
have the opportunity for transplantation and
long-term survival rates.
Local centers will close; organ donation will be affected. By
centralizing the system into a national waiting list,
the new regulations will reallocate donated livers
away from the vast majority of the country's 120
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transplant centers and shift them to about a
half-dozen regional surgical centers. This would
force many smaller transplant programs to close
their doors, depriving their communities of
life-saving medical technology and highly skilled
doctors. Because the current system is locally based,
many transplant centers and community activists
have been able to build local awareness and
initiatives that have increased organ donation. If the
system is converted to a national system, this local
incentive and personal exposure to the benefits of
organ donation will be lost. Under the current
system, the sickest patients receive a transplant in
2-6 days no matter where they live.
Transplantation access for poor will decrease. Almost one of
every five transplant patients is on Medicaid. If, as a
result of this new policy, a large percentage of the
country's smaller transplant centers close, many
transplant patients and their families will be forced
to travel far from home during an already traumatic
time. While families who have the means to have one
spouse quit work or make arrangements for child
care, may not be affected, these additional travel
expenses and logistical nightmares could make it
impossible for some poorer patients to get liver
transplants.
Transporting organs decreases success rates. As the
number of hours a liver goes without a blood supply
is increased, the likelihood of a successful
transplantation significantly decreases. By
abandoning the local system of organ allocation, the
take where W organ heeded
amount of time it takes to transport organs from one
region of the country to another will be significantly
TO
increased. Medical technology has not yet advanced
to the point where transport time can be ignored as
a factor in the success of transplantation.
Legal Uncertainty for UNOS. The clear intent of NOTA
was to have organ transplantation policy
development and implementation based in the
private sector. The HHS regulations assert executive
branch control over the program without the
appropriate legislative authorization. If Congress
wishes to change NOTA and the role of HHS it
should be done through the regular legislative
process.
Preemption of State Law. The new HHS regulations
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would preempt many state laws governing organ
procurement and distribution. For example,
Louisiana law states that organs donated or
acquired in the state shall not leave the state for
transplantation.
In sum, the government's proposed transplant regulations could result in
potentially tragic human consequences. UNOS has demonstrated its eagerness to
work with the government to improve transplant medicine and to rectify serious
problems in the proposed regulations. But UNOS cannot concur with policies that
are not in the best interest of patients.
Copyright © 1998, United Network for Organ Sharing all rights reserved.
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Description of Services
http://www.hrsa.dhhs.gov/ospydot-desd htm
HRSA
HEALTH RESOURCES AND SERVICES ADMINISTRATION
HHS
background
OFFICE OF SPECIAL PROGRAMS
Description of Services
The Division of Transplantation's (DOT) principal responsibilities include the management of the Organ
Procurement and Transplantation Network (OPTN), the Scientific Registry of Transplant Recipients
(SRTR), and the National Marrow Donor Program (NMDP) contracts, public education to increase
organ/tissue donation and technical assistance to organ procurement organizations (OPOs).
DOT maintains working relationships with professional organizations in the field of transplantation and
fosters relationships with public and private organizations to promote the concept of donation. Such
relationships have led to contracts targeted toward minority populations; national meetings bringing
together a cross-section of transplant professionals; coordination of a national exhibit program; a
recognition program paying tribute to America's organ donors; adoption of resolutions by private sector
groups in support of organ/tissue donation, and a Surgeon General's Workshop on Increasing Organ
Donation.
Through its contract with NMDP, DOT supports the recruitment of minority volunteer marrow donors,
maintenance of the Donor Registry, patient advocacy, and professional education on marrow
transplantation.
Organ Procurement and Transplantation Network (OPTN)
Since 1986, DOT has administered a contract with the United Network for Organ Sharing (UNOS) in
Richmond, Virginia for the operation of the OPTN. The primary function of the OPTN is to maintain a
national computerized list of patients waiting for organ transplantation and a 24 hour-a-day computerized
organ placement center to match donors and recipients. Its purpose is to ensure equitable access to
organs by critically-ill and medically-qualified patients and to guarantee that scarce organs are recovered
and used safely and efficiently. The computer currently maintains the status of more than 54,000 potential
recipients. In 1996, about 19,000 transplants were performed on patients on this waiting list.
OPTN membership includes all 275 transplant centers, 63 organ procurement organizations, 156
histocompatibility laboratories, and other members representing the general public, voluntary health
organizations and related medical and professional organizations.
Scientific Registry of Transplant Recipients
DOT also has a contract with UNOS to maintain the Scientific Registry of Transplant Recipients. The
Registry includes information on all recipients of kidney, heart, liver, heart-lung, lung and pancreas
transplants since October 1, 1987. The Registry also tracks all transplant patients from the time of
transplant through hospital discharge, and then annually until graft failure or death
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Description of Services
http://www.hrsa.dhhs.gov/osp/dot/desc.ltml
Education
DOT has responsibility for conducting public and professional education initiatives to improve awareness
of organ and tissue transplantation as a successful treatment option and, ultimately, to increase donation
in the United States. Often in collaboration with private sector groups related to transplantation, DOT
conducts a variety of activities such as exhibits, seminars, and special events to inform the public at large
about the critical need for organ donors and to apprise professionals about ways they can help promote
the concept of donation. DOT also collaborates with organizations such as the American Association of
Motor Vehicle Administrators to promote the concept of donation. DOT expands its educational impact
by collaborating with numerous other private sector organizations and assisting them in conducting organ
donor awareness activities.
National Marrow Donor Program
DOT oversees the National Marrow Donor Program (NMDP), a nonprofit organization headquartered in
Minneapolis, MN. NMDP began search operations in 1987 with 49 donor centers, 10 transplant centers
and fewer than 10,000 donors listed on the Registry. The first two transplants facilitated by the NMDP
took place in December 1987.
Currently, NMDP is a network of 106 (8 foreign) donor centers, 109 (13 foreign) collection centers, 95
(20 foreign) transplant centers, 11 recruitment groups and a Coordinating Center that helps patients
suffering from Leukemia or other blood diseases find matching volunteer unrelated marrow donors for
transplants. The NMDP also is a research organization, studying the effectiveness of unrelated marrow
transplants and related treatments. It currently has relationships with transplant centers and/or donor
registries in Argentina, Australia, Austria, Brazil, Canada, Denmark, France, Germany, Great Britain,
Hong Kong, Israel, Italy, Japan, the Netherlands, Norway, Russia, Spain, Sweden and Switzerland.
As of 1996, there are 1,946,824 potential donors registered with the NMDP, and at any given time, an
average of 2,500 active searches is under way. On average, 81 transplants are performed monthly, and
more than 4,052 patients have received NMDP-facilitated transplants since 1987.
NMDP has undertaken a national effort to increase the number of potential donors from four ethnic
groups: African Americans, Asian/Pacific Islanders, Hispanics and Native Americans.
Go to home page for: HRSA|| HHS
Send all questions, comments and suggestions to [email protected]
Return to the DOT Homepage
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Quickfacts!
http://www.hrsa.dhhs.gov/osp/dot/quicks.htm
HRSA
HEALTH RESOURCES AND SERVICES ADMINISTRATION
HHS
OFFICE OF SPECIAL PROGRAMS
Quickfacts!
Solid Organ Transplantation
The United Network for Organ Sharing national patient waiting list for organ transplant contains over
58,000 registrations. On March 18, 1998 there were:
38,760 registrations for a kidney transplant.
10,059 registrations for a liver transplant
367 registrations for a pancreas transplant.
88 registrations for a pancreas islet cell
1,653 registrations for a kidney-pancreas transplant
95 registrations for an intestine transplant
4,020 registrations for a heart transplant
235 registrations for a heart-lung transplant
2,756 registrations for a lung transplant
58,033 TOTAL
NOTE: UNOS policies allow patients to be listed with more than one transplant center (multiple listing), and thus the number
of registrations may be greater than the actual number of patients.
Numbers of Transplants Performed, January - December 1996
850 kidney-pancreas transplants
11,099 kidney alone transplants (3,173 from living donors)
172 pancreas alone transplants
4,058 liver transplants
2,342 heart transplants
39 heart-lung transplants
805 lung transplants.
45 intestine transplants
19,410 TOTAL
Based on UNOS Scientific Registry data as of April 23, 1997. Double kidney, double lung, heart-lung and kidney-pancreas
transplants are acounted as one transplant.
Number of Donors Recovered, 1996
5,416 cadaveric
3,524 living
8,940 TOTAL
As of November 12, 1997, UNOS membership included the following:
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Quickfacts!
http://www.hrsa.dhhs.gov/osp/dot/quicks.htm
275 Transplant Centers
3 Consortium Members
54 Independent Organ Procurement Organizations (OPOS)
58 Histocompatibility Laboratories
12 Voluntary Health Organizations
9 General Public Members
29 Medical/Scientific Organizations
440 TOTAL
NOTE: Of the 275 transplant centers, 12 have in-house OPOs and 102 have in-house histocompatibility labs
Currently, 275 medical institutions in the United States operate an organ transplant program. These
transplant centers can be separated into organ specific programs that include the following:
251 Kidney Transplant Programs
124 Liver Transplant Programs
124 Pancreas Transplant Programs
20 Pancreas Islet Cell Transplant Programs
33 Intestine Transplant Programs
158 Heart Transplant Programs
95 Heart-Lung Transplant Programs
91 Lung Transplant Programs
NOTE: Data subject to change due to future data submission or correction.
Go to home page for: HRSA|| HHS
Send all questions, comments and suggestions to [email protected]
Return to the DOT Homepage
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06/18/98 16:20:13
MEMO
To:
Jennifer Klein
From:
Susan Gyeszly
Subject: Transplant Organ Allocation
Date:
June 22, 1998
Overview
On March 26, 1998, HHS Secretary Shalala announced a new regulation to improve the nation's
organ allocation system. Public comment has been requested until August 31, 1998 with the
effective date of the rule October 1, 1998. The regulation sets three broad performance goals for
organ allocation. These include:
1. Standardized listing criteria for placing patients on waiting lists, using objective and
measurable medical criteria;
2. Standardized criteria for determining medical status, also based on objective and
measurable medical criteria, sufficient to differentiate patients from least to most medically
urgent.
3. Organ allocation policies that give priority to those whose needs are most urgent, with
the result that differences in waiting times for patients of like medical status will be
reduced.
Background
HHS's Division of Transplantation (DOT) manages the Organ Procurement and Transplantation
Network (OPTN), whose primary function is to maintain a 24 hour-a-day national organ
placement center to match donors and recipients. Since 1986, the DOT has administered a
contract with the United Network for Organ Sharing (UNOS), in Richmond, Virginia, for the
operation of the OPTN.
UNOS Analysis of Proposed Organ Transplant Regulations
UNOS agrees with first two parts of the regulation which instruct UNOS to develop national
standards that would govern when doctors put patients on the waiting list for a transplant and
when patients are moved up in priority on that list. In fact, last year UNOS instituted national
guidelines for determining these items. However, the organization disagrees with the third
component that eliminates the current local-based allocation system in favor of one national list
based on medical urgency, or "sickest first." They believe this will lead to several issues.
1. Longer waits, sicker patients, fewer lives save. UNOS believes that the regulation will
require a national list with a "sickest first" criteria, which means patients will become sicker
before they receive their transplant. Statistics show that patients who are extremely ill when given
a transplant have a higher rate of failure. However, the HHS argues that while organs should be
allocated according to need, they have not devised a rigid directive that would require futile
transplants. In fact, they have included a directive stating that organ allocation policies must be
designed to avoid organ wastage and poor utilization. The regulation also calls on the organ
network, and thus UNOS, itself to develop the new allocation policies.
2. Local centers will close; organ donation will be affected. UNOS believes that by
centralizing into a national waiting list, the larger centers that have more patients will perform
more transplants, thus leaving smaller, local centers to fail. Also, UNOS believes people are more
willing to donate if they know that the organs will stay in the area. However, the HHS feels that
there is no evidence of this and instead a 1994 survey found that "an overwhelming majority of
donor families state as their preference that organs go to the neediest patient regardless of
geography, so long as organs are not wasted.
3. Transplantation access for poor will decrease. If many of the smaller transplant centers
close, many transplant patients will be required to travel far from home. This would be an added
struggle to patients, one of five that are already on Medicaid.
4. Transporting organ decreases success rates. By abandoning the local system of organ
allocation, organs will need to travel farther distances, leading to lower rates of success.
5. Legal uncertainty for UNOS. The National Organ Transplant Act intended to have organ
transplantation policy in the private sector and the HHS regulation assert executive branch control
over the program without appropriate legislative authorization.
6. Preemption of State Law. The new HHS regulations would preempt many state laws that
currently govern organ procurement and distribution. In fact, the Washington Post reported on
Jun 16, 1998 that four states (Wisconsin, Oklahoma, Louisiana and South Carolina) have passed
"organs-for-state-residents-first" laws.
Letter from Donna Shalala to members of Congress
In response to these criticisms, Secretary Donna Shalala wrote a letter to members of Congress
stating that the Department's new regulation does not mandate specific organ allocation policies.
She also stated that the primary objective in issuing regulation is to assure that patients receive
organs based on standardized medical judgement and common medical criteria, no matter where
they live or in which transplant center they are awaiting treatment. The change in policy stemmed
from the fact that one of the current shortcoming of the current allocation system is the wide span
in average waiting times for those on translation waiting lists. In some areas of the nation, patients
wait at least 5 times longer for an organ that those in other areas. She also enclosed a letter form
Claude Earl Fox, M.D., Administrator of the Health Resources and Services Administration He
stated that the current allocation system is geographically biased and does not distribute organs on
the basis of medical urgency which violates the requirements of the National Organ Transplant
Act which calls for equitable system to distribute organs.
AR CHILDREN HOSP CEO
Fax 501-320-4777
Jun 15 '98
11:26
P. 01/02
ces jenklein
ARKANSAS
HOSPITAL
AGAINST b/c
800 Marshall Street. Little Rock. Arkansas 72202-3591. (501) 320-1100 or TDD (501) 320-1184
Bates.
M.D.
I
Chief Executive Officer
Only major centers Survive
Lowe.
M.D.
2
Arkansas residents
Gilmore. M.S., M.H.A.
June 11, 1998
, Chief Operating Officer
more willing in-state
ordon, L.C.S.W.
any and
Mrs. Hillary Rodham Clinton
2
ISChemic time
ACH Foundation
The White House
ingfield
Officer
Washington, DC 20500-2000
4
UNOS collaborated with
Moore
Government
Relations
Dear Hillary:
concerned groups
Officer
Directors
The new HHS solid organ allocation policy, which directs the removal of regional
Moore
considerations from organ allocation, is very distressing to the medical staff at
Jr.
Arkansas Children's Hospital. As you know, our cardiology department, including
heart transplantation, is one of our largest and most outstanding services. Although
Erwin
III
the policy refers to livers only, the Secretary has stated that this same perspective
(i.e., applying a single rule that organs should go to the sickest patients on a
mauchi,
M.D.
national waiting list) will be applied to heart and kidney allocation as well. We
Shults
agree that organs should go to the sickest patients, but certain practical aspects of
Jr.
organ transplantation also need to be considered.
Bates,
M.D.
Cranford
Cress
Arkansas Children's Hospital and other smaller programs are at risk in a national
Drilling
M.D.
organ donation environment. Very large centers will compete more effectively for
Grace
scarce organs because they have more patients on the waiting list at any given time.
(iman
Hoover
Only the major centers in large metropolitan areas will survive, resulting in heart
larion
Humphrey
Jackson
transplants only for those able to afford the travel and hotel costs for long periods
Joshua
of time as they wait for an organ. Most of our patients have little or no
eith
transportation, finding it difficult to make regular clinic visits even to ACH, a
Letthiser.
M.D.
M.D.
primary reason for our statewide local clinics. Usually, the child's illness has
lackey
already depleted the family's resources, and the parents would not be able to seek
Cielland
Nabholz
the transplant needed for their child. I know that access to health care for rural
citizens has been a concern of yours for a long time, and this action seems to be
therford
counterproductive to that goal.
midt
We feel strongly that Arkansas residents would be more willing to donate organs
Ward,
M.D.
B. Whiteside III
knowing that they would save the lives of Arkansas patients. The notion that
organs are going to patients who don't urgently need them is incorrect. No patient
is put on the waiting list until their medical condition has reached the acuity that
demands a transplant.
lan, Jr.
lodham
Clinton
ckman
A critical issue in heart transplantation is the ischemic time (the time from excision
White
of the organ to transplantation). The ischemic time is even more important in
CHILDREN HOSP CEO Fax 501-320-4777
Jun 15 '98 11:27
P.02/02
pediatric patients, many of whom have congenital structural abnormalities, which
complicate the transplant surgery and make it more time-consuming. Studies have
shown a direct correlation between longer ischemic time, greater risk of death, and
later complications.
In cadaver donations, the heart necessarily is the last organ to be harvested. If the
patient's other organs are being allocated to centers long distances away, the heart
harvest must wait until each transplant team travels for hours to excise the
it
particular organ allocated to them. By the time the heart is harvested, viability of
the donor heart is at risk. The delays inherent in this complicated chain of events
are a major concern of our heart transplant team.
UNOS has collaborated with all concerned groups (physicians, attorneys, ethicists,
donor families, and organ procurement specialists) in establishing equitable policies
for organ allocation. Our Cardiology Department Chairman, Dr. Robert Morrow,
has served on the UNOS thoracic organ committee, which has spent countless
hours trying to determine an equitable distribution system. These policies are
constantly under revision in response to both professional and lay input. No policy
will be perfect, but we feel that the existing policy and, more importantly, the
inclusive UNOS process, is the best for now.
Betty Bitty Lowe,
Sincerely yours, Lary
Professor Pediatrics, UAMS
Medical Director, ACH
Harvey and Bernice Jones Distinguished
Chair in Pediatrics, ACH
BAL/sam
P.S. The Arkansas Children's Hospital heart transplant program has performed 56
transplants since 1990. Forty-three patients are alive at present and our survival
rate since October 1997 is 95%. This service is an extraordinary asset to the health
care system of the state and region.
July 4, 1998
Betty Lowe, MD
800 Marshall Street
Little Rock, AK 72202-3591
Dear Betty:
Thank you for your letter about the new HHS solid organ allocation policy. As
you know, I have long admired the transplantation work done at the Arkansas
Children's Hospital. The success of your heart transplant program is a testament
to the dedication and excellence of the medical staff.
I have asked Jennifer Klein on my staff to look into the issues you raised about
the new HHS policy. As you point out, we need to strive to find a balance
between creating fair transplantation policies and ensuring that it is practical for
patients to get the organs they desperately need. Jennifer will contact you to
discuss this further and will continue to update me on this issue.
Sincerely,
Hillary Rodham Clinton