U.S. GOVERNMENT PRINTING OFFICE

59–992CC WASHINGTON : 1999

ORGAN PROCUREMENT AND TRANSPLANTATION

NETWORK AMENDMENTS OF 1999

HEARING

BEFORE THE

SUBCOMMITTEE ON

HEALTH AND ENVIRONMENT

OF THE

COMMITTEE ON COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

FIRST SESSION

ON

H.R. 2418

SEPTEMBER 22, 1999

Serial No. 106–75

Printed for the use of the Committee on Commerce

(

COMMITTEE ON COMMERCE

TOM BLILEY, Virginia, Chairman

W.J. ‘‘BILLY’’ TAUZIN, Louisiana

MICHAEL G. OXLEY, Ohio

MICHAEL BILIRAKIS, Florida

JOE BARTON, Texas

FRED UPTON, Michigan

CLIFF STEARNS, Florida

PAUL E. GILLMOR, Ohio

Vice Chairman

JAMES C. GREENWOOD, Pennsylvania

CHRISTOPHER COX, California

NATHAN DEAL, Georgia

STEVE LARGENT, Oklahoma

RICHARD BURR, North Carolina

BRIAN P. BILBRAY, California

ED WHITFIELD, Kentucky

GREG GANSKE, Iowa

CHARLIE NORWOOD, Georgia

TOM A. COBURN, Oklahoma

RICK LAZIO, New York

BARBARA CUBIN, Wyoming

JAMES E. ROGAN, California

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

VITO FOSSELLA, New York

ROY BLUNT, Missouri

ED BRYANT, Tennessee

ROBERT L. EHRLICH, Jr., Maryland

JOHN D. DINGELL, Michigan

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RALPH M. HALL, Texas

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, Jr., New Jersey

SHERROD BROWN, Ohio

BART GORDON, Tennessee

PETER DEUTSCH, Florida

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

RON KLINK, Pennsylvania

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

THOMAS C. SAWYER, Ohio

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

KAREN MCCARTHY, Missouri

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

THOMAS M. BARRETT, Wisconsin

BILL LUTHER, Minnesota

LOIS CAPPS, California

JAMES E. DERDERIAN, Chief of Staff

JAMES D. BARNETTE, General Counsel

REID P.F. STUNTZ, Minority Staff Director and Chief Counsel

SUBCOMMITTEE ON HEALTH AND ENVIRONMENT

MICHAEL BILIRAKIS, Florida, Chairman

FRED UPTON, Michigan

CLIFF STEARNS, Florida

JAMES C. GREENWOOD, Pennsylvania

NATHAN DEAL, Georgia

RICHARD BURR, North Carolina

BRIAN P. BILBRAY, California

ED WHITFIELD, Kentucky

GREG GANSKE, Iowa

CHARLIE NORWOOD, Georgia

TOM A. COBURN, Oklahoma

Vice Chairman

RICK LAZIO, New York

BARBARA CUBIN, Wyoming

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

ED BRYANT, Tennessee

TOM BLILEY, Virginia,

(Ex Officio)

SHERROD BROWN, Ohio

HENRY A. WAXMAN, California

FRANK PALLONE, Jr., New Jersey

PETER DEUTSCH, Florida

BART STUPAK, Michigan

GENE GREEN, Texas

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

THOMAS M. BARRETT, Wisconsin

LOIS CAPPS, California

RALPH M. HALL, Texas

EDOLPHUS TOWNS, New York

ANNA G. ESHOO, California

JOHN D. DINGELL, Michigan,

(Ex Officio)

(II)

C O N T E N T S

Page

Testimony of:

Gibbons, Robert D., Professor of Biostatistics, School of Medicine, Department of Psychiatry, University of Illinois at Chicago, accompanied by

Mitchell W. Spellman, Professor of Surgery Emeritus and Dean of

Medical Services Emeritus, Harvard Medical School, and Susanne

Stoiber, Executive Officer, Institute of Medicine ....................................... 31

Irwin, Craig, President, National Transplant Action Committee ................ 45

Miller, Joshua, Division of Transplantation, Department of Surgery, University of Miami School of Medicine ............................................................ 40

Payne, William, Director, Liver Transplant Program, Fairview Medical

Center ............................................................................................................ 26

Rabkin, John M., Chief, Liver/Pancreas Transplantation Heptobiliary

Surgery, Oregon Health Sciences University ............................................. 51

Raub, William F., Deputy Assistant Secretary for Planning and Evaluation/Science Policy, Department of Health and Human Services ............. 20

Material submitted for the record by:

Center for Donation and Transplant, letter dated September 16, 1999,

to Hon. Michael R. McNulty ........................................................................ 94

Clarian Health, letter dated September 22, 1999, to Hon. Thomas J.

Bliley, Jr ........................................................................................................ 87

Fiske, Charles, prepared statement of ............................................................ 82

Gibbons, Robert D., Professor of Biostatistics, School of Medicine, Department of Psychiatry, University of Illinois at Chicago, letter to Hon.

Diana DeGette, enclosing response for the record ..................................... 99

Jacksonville Transplant Center:

Letter dated July 26, 1999, to Hon. Corrine Brown ............................... 94

Letter dated July 26, 1999, to Hon. Charles T. Canady ........................ 95

Letter dated July 26, 1999, to Hon. Tillie Fowler .................................. 95

Letter dated July 26, 1999, to Hon. Cliff Stearns .................................. 96

LifeCenter:

Letter dated August 6, 1999, to Hon. Rob Portman ............................... 89

Letter dated August 6, 1999, to Hon. John A. Boehner ......................... 90

Letter dated August 6, 1999, to Hon. Steve Chabot ............................... 91

LifeSource, letter dated July 29, 1999, to Hon. Bill Luther ......................... 91

Louisiana State University Medical Center, letter dated September 21,

1999, to Hon. Thomas J. Bliley, Jr .............................................................. 86

Meredith, Thomas L., letter dated June 24, 1999, to Hon. Ed Bryant ........ 97

Mississippi Organ Recovery Agency, Inc., letter dated July 14, 1999,

to Hon. Chip Pickering ................................................................................. 93

National Kidney Foundation, prepared statement of .................................... 85

Raub, William F., Deputy Assistant Secretary for Planning and Evaluation/Science Policy, Department of Health and Human Services, responses to questions of Hon. Diana DeGette .............................................. 100

Saint Louis University Hospital, letter dated September 21, 1999, to

Hon. Thomas J. Bliley, Jr ............................................................................ 89

Shands HealthCare, letter dated September 21, 1999, to Hon. Thomas

J. Bliley, Jr .................................................................................................... 88

Stark, Hon. Pete, a Representative in Congress from the State of California, prepared statement of ...................................................................... 84

Tennessee Donor Services, letter dated September 21, 1999, to Hon.

Ed Bryant ...................................................................................................... 98

Tennessee Transplant Society, letter dated August 2, 1999, to Hon. Bill

Frist ................................................................................................................ 94

University Hospital, The, letter dated September 3, 1999, to Hon. Steve

Chabot ............................................................................................................ 96

University Hospitals of Cleveland, letter dated August 26, 1999, to Hon.

Thomas C. Sawyer ........................................................................................ 93

University of Alabama at Birmingham, letter dated September 20, 1999,

to Hon. Thomas J. Bliley, Jr ........................................................................ 87

University of Florida, letter dated August 11, 1999, to Hon. Karen Thurman ................................................................................................................ 92

University of Medicine and Dentistry of New Jersey, letter dated September 20, 1999, to Hon. Thomas J. Bliley, Jr ........................................... 86

University of Texas, letter dated September 2, 1999, to Hon. Joe Barton .. 88

Weir, Bruce, President, Transplant Recipients International Organization, Inc., prepared statement of ................................................................. 84

(III)

(1)

ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK AMENDMENTS OF 1999

WEDNESDAY, SEPTEMBER 22, 1999

HOUSE OF REPRESENTATIVES, COMMITTEE ON COMMERCE, SUBCOMMITTEE ON HEALTH AND ENVIRONMENT, Washington, DC.

The subcommittee met, pursuant to notice, at 10 a.m., in room

2322, Rayburn House Office Building, Hon. Michael Bilirakis

(chairman) presiding.

Members present: Representatives Bilirakis, Burr, Bilbray,

Ganske, Coburn, Bryant, Brown, Waxman, Pallone, Green, Barrett,

and Eshoo.

Also present: Representative Klink.

Staff present: Marc Wheat, majority counsel; Clay Alspach, legislative clerk; and John Ford, minority counsel.

Mr. BILIRAKIS. The hearing will come to order. Good afternoon.

I am pleased to convene this hearing on H.R. 2418, the Organ Procurement and Transplantation Network Amendment of 1999. I was

pleased to introduce this bipartisan legislation with my colleague,

Gene Green of Texas.

Last summer this subcommittee held a joint hearing with the

Senate Labor Committee to review our Nation’s system for organ

allocation, and more specifically the changes proposed by the Department of Health and Human Services. The Department’s proposed changes to the Organ Procurement and Transplantation Network and the policies that it sets for all patients have been, to say

the very least, as we all know, controversial. A majority of the comments received by the Department were very critical of the regulation, and certainly we in Congress have heard from many experts

in the field about the consequences, unintended or otherwise, of the

Department’s regulations.

We will have the opportunity to hear a range of views on these

issues generally and H.R. 2418 in particular from our witnesses

today.

Of course, many of us have already heard directly from our constituents. Recently, I received a letter from Kathy Gibson, a 49-

year-old constituent who received two kidney transplants within

the past year. The second transplant, which was a success, followed

an unsuccessful first transplant using her husband’s kidney. Kathy

received her second kidney through Life Link Foundation, a nonprofit community service entity in Tampa that operates four of the

Nation’s 62 organ procurement organizations. She wrote to tell me

how grateful she was for Life Link’s assistance saying, ‘‘I have

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nothing but good things to say regarding my transplant team from

Tampa General Hospital and Life Link Transplant Institute. They

found me the gift of life.’’

H.R. 2418 was drafted with people like Kathy Gibson in mind.

The bill recognizes the decisions regarding organ procurement and

transplantation are best left to the medical community, as Congress intended in passing the National Organ Transplant Act of

1984. Those experts at the forefront of changes in the medical profession are best suited to adjust policies in light of new technology

and new medical understanding.

H.R. 2418 also addresses the underlying problem of an inadequate organ supply by promoting incentives to increase organ donation. For example, the bill includes innovative provisions to help

reduce the financial burden on living donors. As the National Kidney Foundation has noted, these provisions will help increase the

supply of organs needed for many men and women waiting for a

matching organ to be transplanted.

I want to welcome all of our witnesses. I appreciate their time

and effort in joining us and look forward to hearing their testimony. As you know, we changed the time for this from 2 to 2:30

for a very good reason. I appreciate your understanding in that regard.

I will now recognized the ranking member Mr. Brown for an

opening statement.

Mr. BROWN. Thank you, Mr. Chairman. I would like to also

thank today’s witnesses for joining us and a special thank you to

Representative Klink, who has joined us. He is not a member of the

subcommittee, but he has a special interest and knowledge of this

issue, especially in this western end of his State and his district.

I would like to commend you, Mr. Chairman, for bringing increased attention to a process within our health care system that

is critical to the lives of so many Americans, the process of allocating an obviously scarce number of donated organs for those individuals throughout the country waiting for and praying for them.

Your bill is intended to correct some important problems and forestall others. It addresses the lack of enforcement mechanisms to

ensure that network participants comply with quality standards. It

reflects a view I believe that we all share; that is, organ allocation

decisions be shielded from political bias.

However, Mr. Chairman, I am concerned that in an effort to wall

off organ donation allocation decisions from political influence, H.R.

2418 also shields the organ allocation contractor from the accountability and subordination to the public that it should have. The bill

appears to deny the Secretary of Health and Human Services the

right to exert any authority over any allocation decisions that are

scientific, clinical or medical in nature. The private contractor that

coordinates the organ allocation could not be challenged on decisions of that nature. Since no legitimate organ allocation decisions

are made outside the context of scientific, clinical and medical considerations, this effectively undercuts the Secretary’s oversight of

the contractor’s activities. The Secretary, charged with representing the public and the public interest, would be unable to

hold the organ allocation contractor to its contract.

3

Let’s explore a scenario, one we certainly hope would never happen. Let’s say a private contractor hired to allocate donated organs

determines, based on scientific and medical data, that malnourished children should be the last to receive donor organs because

malnourishment is correlated with the rejection of donor organs.

Even if that decision reflects the best science that medicine has to

offer, is it the right thing to do from a public policy perspective?

Obviously not. Malnourishment is not just correlated with rejecting

donor organs, it is also correlated, obviously, with poverty, with the

public agreeing to choose which child’s life to save based on family

income.

As I read it, under H.R. 2418 the public would in the end have

no say in that matter. The organ allocation contractor could implement the rule without—regardless of public policy implications and

without any public input. I am concerned that the organ allocation

contractor would have more power than the entity it contracts

with, particularly when the entity speaks on behalf of the public.

I question the wisdom of setting a precedent like this when, for

government contractor relationships, it advocates the government’s

responsibility and alleviates the contractor of accountability.

Mr. Chairman, I support the goal of ensuring an allocation system free of political bias and designed to deter internal breaches

of quality. But the system as a whole and those who administer it

must also be held accountable. The Institute of Medicine made a

recommendation that I think would reconcile the need for public

accountability and the importance of keeping politics out of organ

allocation decisions. They recommended the establishment of an external independent scientific review board that would be charged

with periodically assessing the organ allocation system. Starting

there we can achieve our goals without compromising the integrity

of the government/contractor relationship.

I look forward to hearing our witnesses’ perspectives on this

issues. I would like again to express my appreciation to the chairman for his efforts.

Mr. BILIRAKIS. I thank the gentlemen.

Dr. Ganske for an opening statement?

Mr. GANSKE. Thank you, Mr. Chairman. In the interest of hearing testimony from our first panel, I just want to say I appreciate

you having the hearing, and I look forward to the testimony.

Thanks.

Mr. BILIRAKIS. Mr. Waxman, opening statement?

Mr. WAXMAN. Thank you very much, Mr. Chairman. Only 5

months have passed since our last hearing on organ allocation, but

a great deal has changed. For some time I have been deeply troubled by the debate over the Department’s final rule. I have heard

outright misrepresentations and gross misinformation aimed at

scaring patients, communities of color and the poor into believing

that the administration wanted to make it harder for them to obtain organ transplants. UNOS has spent nearly $1 million lobbying

Congress, dollars which should have gone toward saving lives.

Today we finally have the cure for this lobbying and rhetorical

excess. The Institute of Medicine has provided us with a blueprint

for a more equitable and efficient organ allocation system. They

have reminded us that we must put patients, not UNOS, not transVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
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plant centers, not transplant surgeons, first. The IOM concluded

that the final rule should be implemented. They concluded that

HHS should exercise legitimate oversight responsibilities articulated in the final rule. They documented how weak oversight has

compromised accountability at all levels, and they found that

broader sharing of organs won’t hurt donation rates or close small

transplant centers.

The IOM report reveals a national organ allocation system badly

in need of reform, but H.R. 2418 ignores the IOM report. Patients

across the country say that this bill would only make things or

change things for the worse. It would strip the Secretary of her

oversight authority over UNOS. It would insulate UNOS from competition and accountability. It would grant sole authority over lifeand-death decisions to an organization that has fought to keep patient outcome data secret, shielded its decisionmaking from public

input, and enforced its policies in a politically expedient manner.

Today a patient seeking a transplant has practically no idea how

well our transplant centers are performing. The data is hidden

somewhere in UNOS. After years of resistance, UNOS has finally

made some patient outcome data available, but that data is for the

years 1988 to 1994. That means that patients are still in the dark

about the centers’ current performance.

Yesterday at our request the Department provided myself, Mr.

Dingell, Mr. Klink, and Mr. Stark with patient outcome data for

every transplant center in the country. This data is up-to-date and

was obtained under congressional mandate from UNOS. This data

shows that a patient’s chances of survival depends very much on

where you get your transplant. Depending on the transplant center, a patient’s likelihood of getting a liver transplant within a year

of listing can range anywhere from 25 to 70 percent. Depending on

the transplant center, if you are waiting for a liver transplant, your

likelihood of dying within a year of listing can range from 7 to 22

percent.

This new data would help transplant patients make better decisions, but this data is blinded and the transplant centers are only

identified by number. This afternoon I will formally request that

the Department provide us with the identities of the transplant

centers. When we receive this information, we will provide transplant patients with all of this recent information about every transplant center in the country, information which UNOS should have

made public a long time ago.

I want to thank you, Mr. Chairman, for holding this hearing. I

look forward to this afternoon’s testimony.

Mr. BILIRAKIS. I thank the gentleman.

Dr. Coburn for an opening statement.

Mr. COBURN. Thank you, Mr. Chairman. I am not going to be

able to stay for the whole hearing because of other obligations, but

I wanted to make a couple points as we talked about the IOM

study. The IOM study, the Institute of Medicine, is the same institute that said we shouldn’t track HIV by partner notification. They

are the same people who underestimated the sexually transmitted

disease epidemic in this country. Although they are valuable in

their input, what they say, in this physician’s eyes, is not always

100 percent accurate. I think that needs to be said without deVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
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meaning or taking discredit for the efforts of those in the Institute

of Medicine.

The second thing that I would say and offer is my own State has

done a great job in terms of increasing the number of transplant

organs available. I have a great deal of difficulty thinking that if

families in Oklahoma have a loved one who lives in Oklahoma, and

Oklahoma is working hard in their one good transplant center to

perfect and improve survivability, that Big Brother should not have

the right to tell Oklahomans that they can’t direct an organ for

their own State brothers and sisters.

That is what we are really talking about here. There is a States

rights issue and a personal issue that has been ignored in this

process. I raise that because it is a concern to me. I am not sure

that it will be heated, but it is an important thing if we really want

States to be active. And should all organ transplants be run by the

Federal Government? That is where we are headed, and I am not

sure that is a great idea. I am not sure it is great for innovation.

I am not sure it is great for patient longevity. I am not sure it is

great for people who are receiving transplants.

As a physician, I know transplant centers when they start don’t

have good rates. As they perfect and get better, they improve. So

I would just hope that we would consider those thoughts as we

hear this testimony and ask the questions. With that, I yield back

and thank you, Mr. Chairman, for this hearing.

Mr. BILIRAKIS. I thank the gentleman.

Mr. Green, for an opening statement.

Mr. GREEN. Thank you, Mr. Chairman, for scheduling this hearing on H.R. 2418 today. I am pleased to be an original cosponsor

because I believe it ensures that medicine and science instead of

Federal employees will develop our Nation’s organ transplant policy.

The Department of Health and Human Services released their

final rule on organ transplantation last year. They did so to equalize the waiting time differences for sicker patients around the

country. They claim that a national waiting list would reduce some

of the differences, which admittedly can be too long, and make the

organ transplantation process fair. However, a recent Institute of

Medicine report found that the current system is equitable for the

most severely ill patients. While their report also found that broader sharing between OPOs and States in regions would be better, it

is important to note that this initiative is already being implemented within the transplant community.

I agree with the intent of the promulgated HHS regulation. However, I believe that the regulation would leave small and mediumsize transplant centers at a significant operating disadvantage,

which would ultimately cause them to shut their doors, leaving

thousands of needy patients with few options.

The problem with organ allocation policy is not the way they are

allocated, but the number we have to allocate. Instead of trying to

force new regulations on a transplant community that has nearly

unanimously rejected them because they could harm patients, we

need to focus on ways to encourage more people to donate healthy

organs. I support creating the fair organ allocation system, not one

that so many patient groups, transplant surgeons, and organ proVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
6

curement organizations believe would do more harm than good. I

believe any policy needs to be dictated by the true experts in this

issue, the transplant community. That is why I am proud to be a

cosponsor. I would hope the administration recognizes the shortfall

of their rule and would reach out to the transplant community and

reach a compromise. Short of that, we have no choice but to pass

legislation.

Again, Mr. Chairman, I appreciate your willingness to address

this issue in a timely and equitable manner. I believe many of today’s witnesses will express many concerns raised to me by both

the Houston medical community and the Texas Medical Center in

Houston. Thank you.

Mr. BILIRAKIS. I thank the gentleman.

Mr. Bryant.

Mr. BRYANT. Thank you, Mr. Chairman, and I thank you for convening this hearing. I, too, am proud to be a cosponsor of H.R. 2418

because I believe it is a good bill and the right way to handle this

matter. I think we are here today because—in large part because

of HHS’s final rule on Organ Procurement and Transplantation

Network, which was published in April. Obviously, this has been

a controversial issue since the beginning. In fact, we have as a

Congress placed a 1-year moratorium on this. The moratorium is

about to expire.

I think many of us do have serious concerns about this rule for

several reasons; I think particularly its effect, potential effect, on

local transplantation and small transplant centers. I think that we

could go on, but I did want to incorporate as part of my statement

and I will at this time ask unanimous consent to put the full letter

that I am about to read a portion of——

Mr. BILIRAKIS. Without objection, so ordered.

Mr. BRYANT. [continuing] as well as the letter from the Tennessee Transplant Society, dated August 2, 1999.

Mr. BILIRAKIS. Without objection.

Mr. BRYANT. This is a letter—again, I will just take portions

out—from a gentleman who has a great deal of credibility in this

area. He is a donor father. His wife also was a kidney recipient.

He has been on numerous organizations involving transplants,

most particular a member of the national board of TRIO. He states

in a quite lengthy letter that the policies that have come out of the

National Organ and Transplant Act back in the mid-1980’s, while

not perfect, are good. He congratulates us or commends Congress

on our wisdom, primarily because ‘‘it established a private partnership between the medical community and the patient population

which is independent from undue political influence by government

operatives however well they might be intended. Difficult decisions

involving the allocation of scarce organ resources have been made

by informed private partnership rather than by a core of government attorneys and bureaucrats.’’

It goes on to say that there is a fear that a large transplant center with political clout would monopolize transplantation procedures by manipulating proposed rules dictated by HHS personnel.

Proponents may dismiss such concerns as paranoia, but these worries are indeed genuine and have been supported by the monopolistic track record of certain large centers. Those of us who have

7

had the opportunity to experience that could tell you that some of

the smaller regional transplant centers understand firsthand the

excellence and talent available in many locations throughout the

country. The benefit which I have seen countless times is under the

existing system, families are able to provide local support for patients that do not have to travel long distances to receive life-saving transplant operations.

He goes on, if I might add, to say that ‘‘I can report to you that

many of us who have been in the most difficult situation have been

acutely concerned that hope be provided first to those in need in

our local region. We do not want these precious gives to be treated

as just some other government-owned part, shipped across country

to a large center currently in favor with Federal rulemakers.’’

He closes by, ‘‘Keep transplantation a predominantly medical

issue with rules established by the existing partnership of medical

experts, patients, and donor families.’’

I agree with the sentiments of my constituent and would tell you

further that I do look forward to the witnesses that we have here

today. Like Dr. Coburn, I have another hearing that I have to jump

back and forth between, so I apologize. I may not be here for your

full testimony, I am going to try to come back and forth, but I

would like to make that my way of explanation.

Again, Mr. Chairman, thank you for what you are doing in this

area.

Mr. BILIRAKIS. I thank you, sir.

Mr. Pallone for an opening statement.

Mr. PALLONE. Thank you, Mr. Chairman. The National Organ

Transplant Act reauthorization is long overdue. Increasing the supply of organs for transplantation is a critical policy issue in this

Nation and an acute problem in my home State of New Jersey. The

Federal Government can help realize this goal in two broad ways.

First, it must maintain an equitable organ allocation system, and

second, it must develop a new and improved process for evaluating

the Nation’s organ procurement program. In my opinion, H.R. 2418

of which I am a cosponsor along with the chairman and Mr. Green,

ensures both of these points.

We must move swiftly to reauthorize the National Organ Transplant Act, and as we do so, however, we must keep some basic

principles in mind. The recently completed Institute of Medicine report recommends creation of organ allocation areas independent of

the current organ procurement organization population structure.

An optimal population size of approximately 9 million is suggested

for the organ allocation areas. They should be accomplished

through new regional sharing agreements, not through consolidation of OPOs. The report notes that achieving optimum results and

procuring organs for transplants is highly dependent on good working relationships at the local level among hospitals, OPOs, transplant centers and on others. The committee does not want its recommendations to detract from or interfere with present operations

where they are working effectively.

I want to say that New Jersey’s 6 transplant centers which service approximately 8.5 million residents already fits this model.

Congress specifically charged the Institute of Medicine with the

review of access to transplantation services for low-income popuVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
8

lations and racial and ethnic minority groups. This review included

an examination of the impact of State policies regarding payments

for services for patients outside of the States in which the patients

reside. The report states the most important predictors of equity in

access to transplant services lie outside the transplantation system;

that is, access health insurance and high-quality health care services. The fact is that many minority and ethnic groups and low-income groups do not have access to health insurance and high-quality health care services. This fact of life cannot be divorced from

a the review of how well organ donation transplantation works.

This critical area must be given as much consideration and note as

policies regarding allocations, or we will produce a caste system for

organ transplantation with only the rich being able to afford transplants.

The IOM report noted that Federal oversight of the national

transplant system is useful in some areas. I feel strongly that the

medical community must be free to make critical clinical decisions

regarding transplants, but I welcome Federal oversight in the area

of appeals, enforcement of national organ transplantation policy,

and imposition of sanctions when deemed necessary to further the

operation of the national transplant system.

I have learned from constituents in my area that many variables

affect organ donor rates. The current performance standards used

by the Federal Government do not accurately assess OPO performance because they are based on total population and not the number of potential donors. In New Jersey, for example, the number of

potential donors is significantly reduced by the State’s high incidence of cancer and AIDS. The diverse nature of New Jersey’s people also make organ donation education and procurement particularly challenging.

Adherence to the current performance standards without regard

to these operations which occur from one area of the country to another may needlessly lead to the termination of OPOs with strong

relationships in their communities which are addressing their coverage area donor potential in an effective manner.

Organ procurement organizations cannot fully concentrate on

programs to increase the supply of organs when they are burdened

by the mandate to meet unpredictable national average performance standards over a 2-year period. Such a short cycle does not

help. OPOs implement best practices to increase the organ supply.

The population-based performance measures used by HCFA has

been widely criticized by the Institute of Medicine, the GAO, the

Harvard School of Public Health and others as being significantly

flawed for assessing OPO performance. Mr. Chairman, unless overturned, these inappropriate measures may very well result in the

decertification of OPOs that are actually excellent performers. To

that end I support the inclusion of language in the reauthorization

calling on HHS to suspend the current OPO recertification process

until a fair process that relates to true performance are developed

in cooperation with the OPO community.

I believe that H.R. 2418 will allow organ procurement organizations the freedom to do their good work of educating and procuring

precious organs in an efficient manner, and therefore I look forward to working with you, Mr. Chairman, to directly help those

9

Americans in need of transplantation by passing this good bill.

Thank you.

Mr. Chairman, could I ask, I would like to ask unanimous consent to submit for the record a statement by Peggy Dreker of Kearny, New Jersey. Ms. Dreker is the cofounder of the New Jersey

chapter of the Transplant Recipients International Organization.

Her testimony recounts the hardship she and her family experienced when their 2-year-old son needed a liver transplant. And he

had—both she and her husband had to travel back and forth to

Pittsburgh for 3 years to save their son’s life. No offense to my

friend from Pennsylvania, Pittsburgh is actually a nice place, but

it is unfortunate they had to travel back and forth to Pittsburgh

during this time. Their testimony illustrates why we need to pass

H.R. 2418, and I would ask that it be included in the record.

Mr. BILIRAKIS. Without objection that is part of the record.

[The prepared statement of Peggy Dreker follows:]

PREPARED STATEMENT OF PEGGY DREKER, NEW JERSEY CHAPTER, TRANSPLANT

RECIPIENTS INTERNATIONAL ORGANIZATION

Good Morning, I am Peggy Dreker. I live in Kearny, New Jersey which is located

about 15 miles outside of New York City. I am the co-founder of the New Jersey

Chapter of TRIO, Transplant Recipients International Organization. I serve on the

Board of Directors of the New Jersey Organ and Tissue Sharing Network, the organ

procurement agency in New Jersey, and I am currently the Treasurer of that board.

I am here today in another role, that of a Mom who would like to share my experience with the transplant community. I am also here because I am concerned that

part of the new HHS regulations will hurt many potential recipients and many New

Jersey residents. I am concerned that these changes will limit patient access to

transplant services which can add a tremendous financial and family burden to the

transplant patient. I am also here today to tell you that the NJ chapter of TRIO

strongly supports HR 2418 sponsored by Congressman Bilirakis and cosponsored by

New Jersey’s Congressman Pallone.

I would like to share with you my story which is typical of many families that

have had family members transplanted and therefore, the tremendous need for local

services.

In December of 1984, when taking my six week old son Daniel, for a regular check

up, the pediatrician pointed out that he was bit jaundiced and recommended that

he have blood work done. He referred us to a pediatric gastroenterologist, Dr. Lucy

McLoughlin at United Hospital in Newark, New Jersey. Daniel was hospitalized immediately on Christmas Eve. One week later on new Year’s Eve, Daniel was diagnosed as having liver disease. In my mind I thought, OK, they know what the problem is and we are in a children’s hospital, let’s get this thing fixed quickly. I was

in for a rude awakening when Dr. McLoughlin informed us that the only way to

‘‘fix’’ Daniel’s problem was through a liver transplant. In 1985, I considered this just

another thing that needed to be done. Imagine my shock and surprise when I discovered that an organ would not be available ‘‘on demand’’ just because my son

needed it. I was appalled, and shocked but mostly scared. During this time we

began a relationship with the physicians and nurses that so lovingly cared for my

son and in turn for me. I was glad we had this relationship with the staff of the

hospital knowing a liver transplant would mean a long hospital stay. That’s when

the final blow came. The doctor informed us the closest place for Daniel to receive

his transplant was Children’s Hospital at the University of Pittsburgh. I was

shocked that as a life-long New Jersey resident, my husband and I both worked in

New Jersey and yet health care was not available in the State for my son. I immediately wrote to the Commissioner of Health in New Jersey who informed me that

transplant services were only available regionally and we were fairly lucky that

Pittsburgh wasn’t too far away from New Jersey.

While trying to deal with a sick infant in the intensive care unit, the real world

also went on. I decided to resign from my position working for the County. My employer had been very generous extending my maternity leave but I felt I could not

ask for an indefinite leave. This also meant that I would lose my medical coverage.

We had just purchased a home and were counting on our two incomes to pay the

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mortgage. This plan was shot. We also realized that many of Daniel’s expenses were

not being covered by our insurance which we always thought was so inclusive.

When Daniel was two months old he was placed on the national transplant list

from Children’s Hospital in Pittsburgh. Daniel weighed under eight pounds and was

literally starving to death. He was on a constant feeding tube and his color was

changing from a glow in the dark yellow to a sallow shade of green.

Getting a bit desperate, I decided to call the White House seeking help for Daniel.

We were referred to the Transplant Office headed by Michael Batten. The local

media in New Jersey/New York picked up on this correspondence and within two

days of Daniel’s arrival home we were besieged by the media. We decided to go

along with this attention hoping that it would raise awareness for Daniel’s plight.

A reporter from the New York Times followed us around for a week trying to put

a diary together of what it was like waiting to get a transplant. The local communities in the area rallied together to raise funds and awareness for Daniel. This was

a wonderful thing but it did take away from our privacy and family life. Little did

we know how important those funds would become.

In August of 1985, we received a call saying there was an organ available for Daniel. This was after a false alarm in June where we used up all our favors of a free

plane ride, ambulance and police escorts. In 1985, time was of the essence getting

to the transplant center. Within one hour, my husband arrived home for work, we

begged cash from anyone who had it, contacted the airline to get on a regular scheduled flight to Pittsburgh, and packed clothing for all of us not sure how long we

would be gone. We made arrangements with the local police department and the

State Police since we had under one hour to get to Newark Airport. All of this while

handling a sick infant who was still on a feeding pump, special formula and who

cried constantly. By the time we left our home, it finally dawned on me that we

were leaving a lot more than a house; I would have no family, no friends, no familiar physicians and nurses and no husband who would have to come back home

shortly to return to work. I would be handling Daniel’s health on my own. My first

view of the city of Pittsburgh was strapped on a stretcher in the back of speeding

ambulance with my tiny son on my chest sleeping.

On August 5, 1985 my son Daniel received the gift of life from a total stranger,

another infant who had died. Daniel’s surgery lasted well over 10 hours as we were

left standing in the waiting room of the hospital with everything we owned and no

place to stay. We ended up showering at the University of Pittsburgh dorms. Daniel

was blessed with the best medical and nursing care. Unfortunately, within three

days it was determined that Daniel would need another liver. By this time my husband had returned to work in New Jersey. My family drove the eight hours out to

Pittsburgh to locate a cheap furnished apartment for me to live. Paying rent is not

covered under your insurance. The community fund-raising money came in handy

for this. Daniel was hospitalized in Pittsburgh from August 5, 1985 through April

10, 1986 before he was released with the knowledge that a second transplant was

still needed. During this time, I would stay with Daniel in the hospital six days and

nights a week. On Saturday morning, my husband would fly out to Pittsburgh and

stay about 24 hours before returning back home. Daniel did not recognize him and

would cry whenever he walked into the room. The total feeling of isolation was relieved only by the wonderful nursing staff who quickly became my new family. During this long period of hospitalization we developed a dependence on the physicians,

as they developed a familiarity with my son on a daily basis. Six months later, when

my son was finally discharged, the sense of anxiety of leaving the transplant center

was upsetting. We were now back to using our original physicians back home in

New Jersey. At the time, my son was the first and only transplant patient Dr.

McLoughlin cared for. As of today, she cares for 40 post transplant children.

For the next 18 months, Daniel and I would fly back to Pittsburgh every three

weeks or so because of the tubes that were left in him while he was waiting for

another liver. Imagine if you can, traveling with a baby with a liver drain coming

out the right side, a feeding tube coming out of his nose and a broviac catheter coming from his neck. I would leave the plane in Pittsburgh airport, put Daniel in the

stroller, put the feeding pump on my shoulder, drag a set of luggage wheels with

a suitcase and a baby walker, and carry a pack with diaper, bottles and supplies

I needed if one of his tubes happened to break loose, which they frequently did. That

was just to get through the airport before I could hail a cab. I would then pack this

into the cab and head to the hospital. Thirty dollars later we arrived at the hospital.

By this time, Daniel was screaming and I had reached my wits end. This procedure

went on for the next year or more.

On October 26, 1987 we received a call that a second liver was available for Daniel. This time all the commercial flights from the three surrounding airports had

stopped for the evening. We ended up chartering a small private plane from a friend

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of a friend that we had never even met. We again packed up our things and tried

to put our lives on hold.

Daniel had been blessed with this second gift of life. Surgery went well. We quickly reverted back to our hospital routine as my husband left us again in Pittsburgh

to go back to work. We used the money raised by the communities to pay the rent

on our apartment so we still had that. Daniel spent about eight weeks in the hospital and another month in Pittsburgh before he was sent home on Christmas Eve

1987—three years after the original diagnosis.

Since Daniel’s ordeal, New Jersey has worked very hard establishing quality

transplant programs for its residents. The thought of returning back to a time

where accessibility to a transplant center could impede a person getting a transplant is appalling. The three years that my son and I lived away from home hurt

my family, my marriage, my finances and ended my career.

Today, Daniel is a healthy fifteen year old. In the last 15 years a lot has changed

in New Jersey.

There are now more transplant centers and pediatric transplant programs are

available. Someone in my position would not have to leave the state to get medical

care for a child.

I fear that the new HHS regulations on organ allocation will send us back to

1985, back to a time when there was not easy access to transplants for many people.

In New Jersey the state has allowed more transplant centers to open, but only when

there is a proven need. So there are not too many centers and they all have reasonable waiting lists. We also have worked hard at the New Jersey Organ and Tissue

Sharing Network to increase the number of organs procured. The New Jersey Organ

and Tissue Sharing Network does an excellent job in procuring organs and its potential yield from New Jersey’s population is very high. We need to continue this,

please don’t let it be taken away by regulations that threaten transplant services

to New Jersey residents and unfair federal agency review regulations that fail to

take into consideration population characteristics that inhibit donation. It just

doesn’t make sense to me to destroy a system that works so well, a system that provides good outcomes and that so many people rely on. People need transplant services in their states like they need cardiac services, obstetric services and cancer

care. Don’t set policy that consolidated transplant services to regional areas. Americans will suffer.

I am not the only one who feels this way. I am surrounded by people at the Sharing Network and organizations like TRIO where people, like me, have experienced

what it is like to have to go out of state. We are appalled by the HHS regulations

and strongly support HR 2418. In fact, the New Jersey Chapter of TRIO has actively opposed the HHS regulations, as have Arkansas, Ohio, Louisiana, New Mexico, Hawaii, Memphis/Nashville, South West Florida, Main and Rhode Island Chapters of TRIO. We support Congressmen Bilirakis and Pallone’s legislation that will

further enhance organ donation and transplantation for all Americans.

I know that the current system is not perfect and I think there are some aspects

of the new regulations that are good that have been incorporated in HR 2418. We

can not allow the unbridled hunger for organs by mega transplant centers to dictate

organ allocation schemes. It is the responsibility of the federal government to support policy that encourages the decentralization of transplant services so that Americans in need do not have to experience the hardships I endured with Daniel. Regular people like me need access to transplants, preferably close to home. HR 2418

supports this policy.

Thank you.

Mr. BILIRAKIS. I might add at this point the opening statement

of all members of the subcommittee will made a part of the record,

and would now recognize Ms. Eshoo for an opening statement.

Ms. ESHOO. Thank you, Mr. Chairman. I can’t help but think of

the joint hearing on this very issue that this committee had with

our Senate counterparts a year ago this last June, June 18, 1998.

So I want to thank you and salute you for having yet another hearing on this issue. It is a very important one. It is one of literally

life and death for people in our country, and it is a difficult issue

to take on, but one that deserves the kind of examination that you

are giving to it. So I thank you for having the hearing.

Very recently—my staff didn’t put this in the written open commentary, but I can’t help but think of it. Very recently a company,

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I think within the boundary of my congressional district, had online the sale or the posting of an organ online. It is a company that

does essentially public auctions. Now, the response to that was absolutely extraordinary and overwhelming. The company did say out

of respect, please don’t bid on this. But I think if we were to peel

away some of the veil of that in terms of its high profile in terms

of the news, what it underscores is not only the demand, but the

urgency.

Any one of us that would need to have an organ replaced in order

to live—just imagine that—would want to have that organ available right now. So what we are dealing with is how best and how

fairly to do this. As we speak, I am sure that people are going to

think, well, this one is from such and such a district, this is what

they have in their district, that is why they are saying it. We need

to rise above that because the American people obviously deserve

to have a system that is going to speak to the urgency at hand. In

fact, if this hearing lasts 2 hours, someone will die waiting for an

organ. That, too, underscores the urgency. A mere one-third of the

more than 60,000 Americans now on waiting lists will receive a donated organ this year. With today’s technology, really, people

shouldn’t be dying because they can’t get an organ in time. We

know that the system can’t feed the demand, so we have more to

do than what we are just dealing with here.

But of those organ that are donated, what is the best system,

how should they be disbursed, so to speak. I don’t want to sound

cold or bureaucratic about this, because we are talking about

human beings’ lives.

Last Congress we enacted a 1-year moratorium on the HHS proposed rule so that the Institute of Medicine, the IOM, could study

its potential effect. That study, released in July, resoundingly supported HHS’s proposed rule. They concluded that, ‘‘broader sharing

is likely to result in more of the most medically urgent patients receiving first attention when waiting for donated livers.’’

The IOM study goes on to refute many of the criticisms that were

raised about final rule. Broader sharing of organs does not require

a national waiting list. Treating more medically urgent patients

first does not mean wasting organs on patients too sick to benefit

from a transplant. Broader sharing does not mean reduced services

to minorities or closure of smaller transplant centers. The substantial health benefits of broader sharing would outweigh the marginal effects of cost.

We have the medical knowledge to do successful organ transplants. We need to make sure that we have in place a system,

match that, and have a record that we have a system that makes

the most of available organs.

Let me just close by saying the following: In the aftermath of the

joint hearing that we had with the Senate, I was a fairly new member of the committee. And the message that went out across the

country, the impact of just having the hearing, really astounded

me. It was yet another underscoring of the need to do better.

Some have heavily criticized the organization that is in place and

how they do their work. That is not what I am here for. I think

that all of us together, wherever we come from, whatever we have

in our districts, whatever take we have on this, have to really at

13

the end of the day be devoted to filling any kind of gap that exists.

So I am looking forward to hearing from the panelists today.

What I drew out of that hearing was that we do have some shortcomings. It is not for a committee or organization to do—it is not

good enough. I used to say when I was in local government, don’t

tell me about your organization, tell me how effective your organization is for the people I represent.

So with that, Mr. Chairman, I hope that the people that testify

will inform and enlighten us as to the results of the study and how

they can direct themselves toward what is being proposed. I think

they are steps in the right direction myself, and I appreciate your

having this hearing. I think it is timely and critical. Thank you.

Mr. BILIRAKIS. I thank the gentlelady.

Mr. Barrett.

Mr. BARRETT. Thank you, Mr. Chairman. I thank you also for

holding this very important hearing.

This is an issue that I think combines so many different human

elements and so many economic elements together at the same

time that it is bound to raise emotions on all sides. As Ms. Eshoo

said, I think all of us look at this issue a little differently depending upon where we come from, whether we have a large center,

small center, no center, or how close we are to a center.

But I look at the issue, and notwithstanding all of the emotions,

health issues, the urgency issues, I think frankly what we are talking about here is very much an economic issue. These centers are

big money-makers. And each one of us who has a center wants for

economic reasons to maintain the economic resource that we have

located in our own communities. There is nothing wrong with that.

For those people who represent large centers, I understand where

they are coming from. From people like myself, who come from

mid-sized centers, I trust that the people who represent the large

centers also understand where we are coming from.

In the end, of course, we want to do what is right for the patient.

But there is no correct answer written in the back of the book as

to what is the right answer for the patient.

The part of the country that I represent, the upper Midwest, does

very, very well in producing several things. Ironically, we are dealing with one on the floor right now. We do very well in producing

milk in the State of Wisconsin, as does Minnesota. There is another

product that we do very well in the Midwest, and that is organs.

For whatever reason, the people in our part of the country are very

generous when it comes to giving organs. I would like to think that

it is because we have this down-to-earth group of people who care

about other people and society and are willing to make that sacrifice. Others might have other explanations as to why that occurs,

but the fact is that if you look at Wisconsin and Minnesota in particular, we remain relatively high in the number of organs we

produce. Correspondingly, we have health care centers and transplant centers that use some of these organs.

I get back to the economic argument because I look at the report

from the Office of the Inspector General fostering equity in patient

access to transplantation, local access to liver transplantation,

where the inspector general says that 80 percent of the liver transplants are done in 35 cities in this country. So right now people are

14

traveling to cities, 35 different cities, to get organ transplants. Now

we are going to fight about which city they go to.

I am obviously of the school of thought to say, well, if we want

regions of the country to continue putting their emphasis on procuring organs, it makes sense not to penalize those regions of the

country that do a good job of procuring organs. We could have

taken another approach in our part of the country and instead of

trying to harvest organs, we could have tried to harvest a waiting

list and get as many people as we could on a waiting list so that

there would be a lot of sick patients that would be on our waiting

list. I personally think that that in the big picture is counterproductive. To say that what we should be doing is having the

transplant centers put all of their emphasis on developing waiting

lists, I think, is inevitably going to mean is they are going to put

less emphasis on recruiting new organs.

I certainly heard—or rather the analysis that said that people

don’t care whether they know who the person is who is receiving

the organ, that it doesn’t make any difference to them. Again, I

might be living in not exactly in Garrison Keillor country, but close

to it, where it does matter to people if they know somebody. We

have stories in our community about somebody who donated this

organ marrying someone who donated that organ, and there is this

nice little storybook ending from people who have met through this

network.

So it is not big east coast stuff, it is not big west coast stuff, it

is corny Midwest stuff, but I think it works.

I think what happens is that we should be putting more emphasis on increasing the supply of organs and stop fighting over where

people are going to go, because again, as the inspector general’s report says, 80 percent of the people are traveling. Let’s not fight

among the hospitals to develop waiting lists. Let’s work together to

get more people to give organs.

I would yield back the balance of my time.

Mr. BILIRAKIS. I thank the gentleman for his remarks.

Mr. Klink is not a member of this subcommittee, and that is the

only reason that we passed over him in his opening statement. The

rules state that I must do that. But in any case, he has a great

interest in this subject, as he does in most health care subjects,

and the Chair is pleased to invite him to make an opening statement if he wishes.

Mr. KLINK. I certainly thank the chairman for his courtesy. He

has always been very courteous. Even in this case where he knows

that he and I come down on different sides of this issue, he has

gone out of his way to allow my voice to be heard, and I appreciate

that.

If ever there was an issue that deserves to be protected from political maneuvering, it is indeed the issue of organ allocation. This

is one of the few issues that we in Congress will deal with where

there is no doubt about it, it is life or death. If you are the one that

is waiting for the organ, you either get the organ, or you die. There

is nothing abstract about it.

Regardless of how each of us approaches this issue, I hope that

all of us agree the best thing for everyone is to get this dispute out

15

of the annual appropriations process by for once and all establishing the rules for how our organ network should operate.

As I have seen this and I have studied it, there are two issues

that are before us today: One, how do we make the allocation system fair and equitable; and, two, who should be responsible for setting and enforcing the policies for sharing organs? Should it be

HHS or a government contractor?

While the bill before us today is a sincere attempt by two of my

dearest friends in the legislative body here to rewrite those rules,

I must respectfully speak against H.R. 2418 because it does nothing, I think, to make the system more equitable because it delegates too much policymaking authority to a largely unaccountable

government contractor. The fact is that every year people die unnecessarily because the current organ allocation system is broken.

Whether or not you get an organ that can save your life will depend on where you live. But under the current system, depending

on where the organ was harvested, it could be given to someone

with years to live while someone in the next town across the wrong

border may die while waiting for a transplant.

One of the most difficult organs to transplant is the liver. Pioneered at the University of Pittsburgh, upwards to 90 percent of

all of the liver transplant surgeons today were either trained at the

University of Pittsburgh or by doctors who were trained there. Yet

facilities like Pittsburgh and other highly regarded transplant centers which take on the most difficult and riskiest transplantations

are struggling because they have the longest transplant list in the

country.

While these centers are highly regarded, many of their patients

don’t come to them because of their reputation. The fact is that

many of the patients come there and only seek them out after they

have been turned down by their local transplant centers. There is

very strong evidence to suggest that many smaller transplant centers avoid the riskier transplants on the sicker patients because

they are more difficult and would adversely impact their reputation

should they not be successful. Without national standards for how

people get listed or how organs should be shared, the organs do not

follow the people that need them. This is not right, and it should

be fixed.

Ever since the rule was announced last April, its proponents

have argued that the Secretary should not be allowed to set organ

allocation policy because it involves a medical question that should

best be left to medical professionals in the transplant community.

I have to tell my colleagues that this argument causes me great

difficulty when I know that if we share organs more broadly, lives

would be saved.

I agree with the views of those in the transplant community

should be given great weight, but I disagree with the notion in this

bill that the Secretary should totally refer to a contractor on questions that are, ‘‘scientific, clinical, or medical in nature.’’ The biggest opponent of any change and the proponent of this bill is the

OPTN contractor, UNOS, who has a vested interest in not having

the Department of Health and Human Service looking over their

shoulders. Sadly, UNOS has budgeted upwards to $1 million of paVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00018 Fmt 6633 Sfmt 6602 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
16

tients’ fees to lobby against the proposed changes. That is money

that should have been spent saving lives.

The argument that the Secretary is unqualified to deal with medical questions causes me great difficulty when I know that every

year Medicare and Medicaid pay for more than 50 percent of the

transplants in this country. I think it would be highly irresponsible

for us as taxpayers to pay for those transplants without making

sure that the money is spent equitably. Not only would we be delegating sole authority over allocation policy to a private contractor,

which I think would be an unconstitutional delegation of legislative

authority, but as the agency that oversees most of our health policy, I don’t understand how the Secretary becomes less qualified to

deal with allocation policy than she is in making scientific, clinical,

or medical decisions as she oversees, Medicare, Medicaid, NIH, or

the FDA. As the ranking Democrat on Oversight and Investigation,

I fully agree with the Institute of Medicine that says ‘‘vigilant and

conscientious oversight and the review of programs and policies are

critically important to ensuring accountability on the part of the

OPTN, and that the HHS final rule appropriately places this responsibility with the Federal Government.’’

Again, I would close by saying that I must oppose H.R. 2418 as

it is currently written because I feel it fails to improve the allocation system, and it gives too much policy-setting authority to an

unaccountable Federal contractor while severely restricting the

Secretary’s authority to oversee the transplant network. People are

dying because they happen to live in the wrong zip code and because States don’t want to share their organs. Nowhere else in society would we allow a monopoly like this to continue. We have to

put an end to this craziness. The No. 1 priority of organ allocation

has to be medical necessity, not geography, period.

Mr. Chairman, again, I thank you so much. I yield back my time,

and I ask unanimous consent, to not prolong your hearing, I would

like to submit questions for the witness in writing.

Mr. BILIRAKIS. Without objection that will be the case. Of course,

written questions are always provided to the witnesses to be responded to.

[Additional statements submitted for the record follow:]

PREPARED STATEMENT OF HON. BARBARA CUBIN, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF WYOMING

Thank you, Mr. Chairman, for holding this important and timely hearing on

organ allocation. I think many people, myself included, are happy to see legislation

introduced that will address the problems associated with the 1998 proposed rule

on a new organ allocation policy.

I have grave concerns about Secretary Shalala’s proposed rule. The ‘‘sickest-patient-first’’ standard, applied on a national basis, would result in more deaths and

fewer successful transplants.

In rural states, where most of the population is spread over large areas and many

people live in rural communities, the number of transplants would drop, decreasing

access to care if the ‘‘sickest-patient-first’’ standard were applied.

A national list would give transplant programs in high-population areas access to

more organs. Regions with small populations would have fewer. The northwestern

region’s success in supplying quality, cost-effective transplants to all regions of the

country could be reversed under this standard.

I believe that decisions regarding organ procurement and transplantation policy

are best left to the medical community, patients, and donor families. Local and regional distribution areas have many advantages including giving people local access

to transplantation and shorter distances to travel with the transplant organ. Our

17

current allocation system achieves a balanced and fair distribution of organs for all

who await a life saving transplant.

I would like to commend the chairman, the subcommittee, and those involved in

the drafting of H.R. 2418. This bill recognizes the importance of maintaining the regional boundaries in the current organ allocation system, and ensuring that medical

experts ultimately make the decisions regarding organ transplantation.

I would like to thank our witnesses for appearing here today, and look forward

to hearing their testimony. Thank you, Mr. Chairman.

PREPARED STATEMENT OF HON. TOM BLILEY, CHAIRMAN, COMMITTEE ON COMMERCE

Thank you, Chairman Bilirakis, for convening this afternoon’s hearing on H.R.

2418, the Organ Procurement and Transplantation Network Amendments of 1999.

It has been well over a year since the Administration issued its regulation on the

Organ Procurement and Transplantation Network. Some claim that the regulation

changed the HHS Secretary’s oversight authority into a policy-making authority.

Policy control of the Network is not what Congress intended, and that is not what

the law permits.

The Organ Procurement and Transplantation Network was authorized by Congress to make decisions without political interference. The decisions they make safeguard the interests of not just those who are presently on a waiting list, but those

unknown persons who will be placed on a waiting list in the future.

Mr. Chairman, your bill would safeguard the independence of the Network. It also

would increase the level of accountability of the Network by mandating timely reports on the performance of transplant centers within the Network. The bill includes

an innovative enforcement mechanism that would mandate the payment of liquidated damages by transplant centers that try to cheat under the Network rules.

You are also to be applauded for the provision that would offer assistance for living

donors seeking to donate an organ to someone in another state.

It is evident that a great deal of work and consultation went into this bill, Mr.

Chairman, and I congratulate you for bringing H.R. 2418 to this stage in the authorizing process. I support your bill, Mr. Chairman, and I look forward to the testimony this afternoon and to a mark-up in the near future.

PREPARED STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF MICHIGAN

Mr. Chairman, a hearing on the subject of organ allocation is timely and I thank

you for scheduling it. I know that we have many other issues to discuss and hopefully resolve before this session ends.

Mr. Chairman, there are a lot of reasons why we must reach some kind of collective and durable agreement on the future course of organ allocation policy. Let me

name a few. First, patients need and deserve an allocation program that is efficient

and equitable. The ongoing struggle over the current organ allocation system is discouraging and harmful to the many persons across this country who are in need of

an organ transplant. Second, the professional transplant community consists of talented and dedicated professionals. Their views and concerns are important and need

to be weighed in any organ allocation policy we develop. Third, the public has an

important interest in organ allocation policy. I think the point is sometimes overlooked that when we speak of the proper role of the Secretary, we are ultimately

speaking of the public’s interest in this matter. The Secretary is a steward of the

public interest and is accountable as such. In my view, this is more so when we note

the fact that a third or more of all organ transplants are paid for with taxpayerfunded health insurance programs such as Medicare and Medicaid.

Some will argue that organ allocation is purely a matter of medicine and science

and that public officials have no business in such matters. This is a curious argument. We debate public policies on such medical and scientific issues as limits on

stem cell and cloning research, pain management, the scope and direction of public

research funded by the NIH, availability of FDA approved pharmaceutical products,

reimbursement for medical procedures, protection of human research subjects, and

so on. The argument that medicine and science are not proper areas for public scrutiny is a dangerous notion and therefore should be rejected.

Let me be specific. H.R. 2418 divorces the operations of a government contractor

from any meaningful oversight by or accountability to the Department of Health

and Human Services, the agency from which the contractor derives its authority to

operate an organ allocation system. Without that government contract, the Organ

Procurement and Transplantation Network would have no authority to operate. As

18

I have already noted, my concerns in this area are amplified by the fact that Medicare and Medicaid pay for a substantial percentage of all organ transplants. There

simply must be greater accountability of the Network to the Secretary than H.R.

2418 would provide.

I am also concerned that H.R. 2418 does not do enough to alleviate the shortage

of organs. One example that comes to mind is the cost of immunosuppressive drugs.

A major reason for long term failure of transplants is a lack of compliance with the

life long drug therapy that is required for transplant patients. The major reason for

a lack of compliance with immunosuppressive drug therapy is the lack of resources

to pay for them. The result is that the organ fails and another is needed. We should

examine this question and determine whether providing drug coverage for those

who need it would be cost effective and help reduce the shortage of organs.

We should also take a look at other ways to encourage donations. These include,

for living donors, extended leave, expanded reimbursement for costs beyond that

proposed in H.R. 2418, and expanded insurance coverage. More aggressive outreach

by medical, educational, and legal professionals, as well as other community leaders,

to promote awareness of the need for donations is also desirable.

Mr. Chairman, I support the concept of engaging in an effort aimed at trying to

resolve the issues that have been so divisive. I see encouraging signs of movement

from almost every direction. HHS has indicated that it is willing to repropose its

allocation regulation in an effort to deal with some of the criticisms leveled against

its earlier version. The study by the Institute of Medicine, particularly with respect

to the role of waiting times, may also have had an influence on the Department’s

thinking. The transplant community, for its part, has in some cases shown a recognition of the merit of broader regions for sharing organs. There is not a complete

meeting of the minds yet, but I sense that the differences may be smaller than a

year ago.

I am certainly willing to work with you and my colleagues on this. I thank the

witnesses for appearing here today, and look forward to continued progress in increasing the supply of organs and making their allocation more equitable.

PREPARED STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF GEORGIA

Thank you, Mr. Chairman for holding this important hearing regarding H.R.

2418, the Organ Procurement and Transplantation Network Amendments of 1999.

As a cosponsor of this legislation, I appreciate your efforts in addressing this issue

and encourage the subcommittee to support this bill which is important to my constituents and the State of Georgia.

As you know, this legislation reinforces the original intent of the National Organ

Transplant Act of 1984 that is responsible for developing and maintaining the medical criteria and standards for organ procurement and transplantation resting with

the medical community. It is my belief that properly trained physicians should be

responsible for transplant issues, and we must ensure that these functions remain

the sole discretion of the Organ Procurement and Transplantation Network (OPTN).

Furthermore, it is vital that we increase the supply of donated organs around the

country so that more people may receive transplants and we can achieve a just and

equitable allocation system. To that end, H.R. 2418 includes provisions that require

the OPTN to actively increase the supply of donated organs and authorize the Secretary of Health and Human Services to award grants related to increasing organ

donation. Finally, the bill strengthens patient confidentiality safeguards and mandates that transplant centers provide specific information to the patients.

If implemented, the Department of Health and Human Services’ Final Rule on

this matter will harm the state of Georgia. Currently, Georgians employ one of the

best organ procurement systems in the country that results in better access to

transplants. I fear that Georgians will no longer be as likely to donate their organs

if the Final Rule is implemented and find it troubling that my state would be punished for our successful organ procurement program.

Again, I appreciate your efforts in introducing this legislation. I look forward to

hearing from our witnesses and recommend that the subcommittee move ahead in

this process to pass H.R. 2418.

Mr. BILIRAKIS. The Chair calls the panel forward. Please come

forward.

Dr. William Raub is the Deputy Assistant Secretary for Planning

and Evaluation/Science Policy with the Department of Health and

19

Human Services. Dr. William Payne is the director of the liver

transplant program, Fairview Medical Center, Minneapolis, Minnesota. Dr. Robert G. Gibbons, professor of biostatistics, School of

Medicine, Department of Psychiatry, University of Illinois, Chicago;

Dr. Joshua Miller, Division of Transplantation, Department of Surgery, University of Miami School of Medicine; Mr. Craig Irwin,

president of the National Transplant Action Committee out of Portland, Oregon; and Dr. John M. Rabkin, chief of liver transplantation, Oregon Health Sciences University, Portland, Oregon.

Gentlemen, the committee welcomes you. Before we hear from

the first witness, I unfortunately have a negative statement to

make. I want to remind our witnesses, not only here but forevermore, that the committee expects to receive testimony 2 days prior

to the hearing. The purpose of this rule, I think it is kind of obvious, is to allow members and their staffs sufficient time to review

the statements and educate themselves on the testimony that will

be at the hearing.

The testimony from the administration was not received until 1

p.m. Today. Now, anyone tell me that that is unfair. That is unacceptable, and it shows, I think, blatant disrespect for the members

of the subcommittee. And I know that the administration had to be

aware that a hearing like this was going to take place because of

the controversy that is involved.

The committee noticed this hearing 1 week prior to the hearing

date, providing ample time for invited witnesses to produce testimony. And please, Dr. Raub, this is certainly no reflection upon

you personally, but I appreciate it if you would maybe pass the

word on to the Department to give us the courtesy of submitting

their testimony at least 2 days prior to the hearing. We have gotten

complaints from the minority, too, in this regard so it doesn’t come

just from the majority. I think that you can understand that.

Mr. Brown, did you have anything that you wanted to comment

in this regard?

Mr. BROWN. Only that I agree with your assessment, Mr. Chairman.

Mr. BILIRAKIS. All right. The committee ordinarily gives the administration witness 10 minutes to testify and the others 5 minutes. But I am going to—you are all busy people, have taken time

away from your schedules to be here. Anywhere between 5 and 10

minutes would be appreciated because I know that you have an

awful lot of valuable things to say to us.

Dr. Raub, we would ask you to kick it off, sir.

20

STATEMENTS OF WILLIAM F. RAUB, DEPUTY ASSISTANT SECRETARY FOR PLANNING AND EVALUATION/SCIENCE POLICY,

DEPARTMENT OF HEALTH AND HUMAN SERVICES; WILLIAM

PAYNE, DIRECTOR, LIVER TRANSPLANT PROGRAM, FAIRVIEW MEDICAL CENTER; ROBERT D. GIBBONS, PROFESSOR

OF BIOSTATISTICS, SCHOOL OF MEDICINE, DEPARTMENT OF

PSYCHIATRY, UNIVERSITY OF ILLINOIS AT CHICAGO, ACCOMPANIED BY MITCHELL W. SPELLMAN, PROFESSOR OF

SURGERY EMERITUS AND DEAN OF MEDICAL SERVICES

EMERITUS, HARVARD MEDICAL SCHOOL, AND SUSANNE

STOIBER, EXECUTIVE OFFICER, INSTITUTE OF MEDICINE;

JOSHUA MILLER, DIVISION OF TRANSPLANTATION, DEPARTMENT OF SURGERY, UNIVERSITY OF MIAMI SCHOOL OF

MEDICINE; CRAIG IRWIN, PRESIDENT, NATIONAL TRANSPLANT ACTION COMMITTEE; AND JOHN M. RABKIN, CHIEF,

LIVER/PANCREAS TRANSPLANTATION HEPTOBILIARY SURGERY, OREGON HEALTH SCIENCES UNIVERSITY

Mr. RAUB. Thank you, Mr. Chairman. Good afternoon, Chairman

Bilirakis, Congressman Brown, other members of the subcommittee. I am William Raub, Deputy Assistant Secretary for

Science Policy at the Department of Health and Human Services.

I appreciate your invitation to testify.

I will discuss H.R. 2418 and also will testify in general about national organ transplantation policies and the constructive discussions we have had with our colleagues in the transplant community

about those policies. With your permission, I will submit my full

statement for the record.

Thanks in part to the passage of NOTA in 1984, organ transplantation now is a routine and widely endorsed procedure. Many organizations and individuals deserve high praise for this achievement:

The United Network for Organ Sharing; surgeons, physicians,

nurses and other health professional who have committed themselves to the practice of transplantation medicine; laboratory and

clinical scientists who continue to generate new knowledge and

technology that drives transplantation medicine to ever greater

success; the staff of organ procurement organizations who work so

diligently to acquire and transport organs to transplant programs;

patients who provide invaluable insights as to how OPTN processes

might be improved; and most of all, organ donors and their loved

one whose decisions to share the gift of life enable transplantation

medicine to flourish.

Through the efforts of the Organ Procurement Transplantation

Network, organ transplantation has become available to more and

more chronically ill patients. Last year more than 21,000 Americans received organ transplants, but more than 4,000 people on

transplant waiting lists died because of the scarcity of donated organs. As these lists grow, many more will die as the system continues to strain under the demand for organs.

In light of this demand, we in the administration believe that our

first priority must be to increase organ donation. To that end, in

December 1997, the Department launched its organ and tissue donation initiative to foster partnerships between public and privatesector organizations, to enhance public education about the need

for donation, and to recruit potential donors. We believe that we

21

must work to ensure that the OPTN operates equitably and provides the best possible outcomes for patients.

This role for the Federal Government was recently affirmed by

the Institute of Medicine, ‘‘The Federal Government as well as the

transplantation community has a legitimate and appropriate role

to play in assuring that the organ procurement and transplantation

system serves the public interest, especially the needs and concerns

of patients, donors, and families affected by it. The IOM learned of

numerous instances in which weak governance tends to undermine

the effectiveness of the system. Weak oversight has compromised

accountability at all levels, permitted poor procedures for data collection and analysis to persist, and allowed the system to operate

without adequate assessment of performance.’’

Thus, in commending the OPTN for its accomplishments, we cannot ignore the persistent flaws and unfairness in the system. The

most medically urgent patients do not always receive priority. Patients with similar levels of disease may have different outcomes

depending on where they live or list. Distrust among transplant

surgeons and hospital administrators sometimes impedes broader

sharing of organs. True measures of equity to judge the OPTN do

not exist.

In recognition of a need for public sector oversight of the OPTN,

and in response to provisions of the Consolidated Omnibus and

Emergency Supplemental Appropriations Act of 1999, the Department has increased its efforts to assess the performance of transplant programs. With the assistance of staff from UNOS, the contractor for both the OPTN and the scientific registry, the Department staff analyzed OPTN outcome data for liver and heart transplants with respect to three critical issues: One, the likelihood that,

having been listed as a transplant candidate, a patient would receive an organ within 1 year; two, the likelihood that a patient will

die within 1 year of listing while awaiting transplantation; and

three, the likelihood that a patient would still be alive 1 year after

listing irrespective of whether he or she underwent a transplant

procedure.

After risk adjustment, that is adjustment for differences in the

mix of patients’ health status from program to program, the analysis revealed substantial differences in outcome from one transplant program to another. These findings warrant attention by the

OPTN. In the course of performing these analyses, the Department

staff identified gaps in the data currently collected by the scientific

registry; for example, additional clinical details about patients’ condition at the time of listing, which could improve risk adjustment,

and additional data on clinical complications, which could help in

assessing quality of life following transplantation.

The Department intends to encourage UNOS in its management

of the OPTN and its operation of the scientific registry to broaden

the scope of data collection and make increased use of program-specific performance analyses.

Many of the flaws in the OPTN are addressed in the final rule

issued by the Department in April, 1998, after extensive public

comment and 3 days of public hearings.

The rule requires the OPTN to develop policies that will result

in standard listing practices and medically based definitions of paVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00024 Fmt 6633 Sfmt 6602 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
22

tient status categories. The rule also requires policies that will encourage broader geographic sharing of organs so that the most

medically urgent patients receive transplants based on sound medical judgment. The rule leaves the policy decisions to the OPTN

with oversight by the Department.

I again quote from the IOM report: ‘‘Vigilant and conscientious

oversight and review of program policies are critically important to

ensuring accountability on the part of the OPTN and other participants in the organ procurement and transplantation system. The

final rule appropriately places this responsibility with the Federal

Government. The IOM believes that this is an important aspect of

the final rule and charge that should be pursued by the Federal

Government in close cooperation with the full range of participants

in the transplant community.’’

The Department concurs with the IOM. This is the balance we

sought in the rule.

Mr. Chairman, we have taken very seriously the charge we were

given by the Congress last year to work cooperatively with the

transplant community to clarify the intent and the effect of the

rule. We very much appreciate the many hours that those in the

community have spent meeting with us and their constructive approach in identifying apparent problems and potential solutions

through oral and written comments. In addition, we have carefully

reviewed the IOM report and recommendations and have met with

representatives of the IOM expert committee on two separate occasions. Also we are fortunate to have additional data pursuant to

the study provisions of the omnibus bill.

In response to these helpful comments and discussions, we have

committed to revise the rule in important areas. For example, we

intend to clarify the rule so that there is no doubt that the OPTN

will develop allocation policies. We intend to ease any lingering

concerns of the transplant community about the Secretary’s regulatory authority by instituting an independent advisory committee,

as recommended by IOM, to review major differences between the

Secretary and OPTN on policy matters.

Other areas of potential clarification or revision have been discussed in detail with transplant community representatives. I believe our revisions will address the major concerns we have heard

from the transplant community, yet maintain the essential framework of the rule requiring standardization of certain practices and

encouraging broader geographic sharing of organs.

Consistent with the law, it is our intent that the rule once revised go forward to address inequities in the system identified by

the Department and IOM. However, congressional review of the

OPTN is essential; and the Department looks forward to working

together with you, Mr. Chairman, and other Members of the Congress to develop legislation to reauthorize NOTA. Reauthorization

should primarily address the needs of patients and also maintain

the requirement of NOTA that there be a national, equitable system of organ allocation in the United States. We recommend that

reauthorization reinforce the role of the Federal Government in

overseeing the OPTN in accordance with the IOM recommendations and that the statute continue to leave management and policy

development of the OPTN in the private sector.

23

The Department is concerned that H.R. 2418 does not do enough

to preserve and strengthen many of the attributes of the OPTN

that have placed transplantation firmly within the medical mainstream. Indeed in some instances the bill takes a step backward.

The Department therefore opposes H.R. 2419 in its current form.

My full statement contains comments on specific provisions.

In summation, Mr. Chairman and members of the subcommittee,

the Department is committed to working with you and the members of the transplant community to create policies that improve

the quality of care and the equity of our organ allocation system.

While we have had our differences, our recent discussions with the

transplant community have been quite promising. We hope that

this spirit of cooperation can extend to our discussions on reauthorization of NOTA as well. Thank you for the opportunity to testify

today.

[The prepared statement of William F. Raub follows:]

PREPARED STATEMENT OF WILLIAM F. RAUB, DEPUTY ASSISTANT SECRETARY FOR

SCIENCE POLICY, OFFICE OF THE ASSISTANT SECRETARY FOR PLANNING AND EVALUATION, OFFICE OF THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES

Good afternoon, Chairman Bilirakis, Congressman Brown, and other members of

the Subcommittee. I am William Raub, Deputy Assistant Secretary for Science Policy at the Department of Health and Human Services. I appreciate your invitation

to be here today to discuss H.R. 2418, a bill to reauthorize the National Organ

Transplant Act (NOTA). I also will testify in general about national organ transplantation policies and the constructive discussions we have had with our colleagues

in the transplant community about those policies.

Thanks in large part to the passage of NOTA in 1984, the transplant network is

very different from the system that existed then. Organ transplantation is no longer

experimental; it is routine. The figurative handful of centers comprising the network

in 1984 has grown into an enterprise of 891 organ-specific transplant programs.

Technological advances allow excised organs to last much longer and to be transported much farther than they could fifteen years ago.

In many respects, NOTA and the transplant network it spawned have served patients well. We have an organized national system requiring a structured approach

to organ transplantation that did not previously exist. Allocation of scarce organs

is done more cooperatively than in the past. Advances in drugs for immunosuppression and techniques for lengthening cold ischemic time have resulted in high

survival rates for transplant patients.

Many organizations and individuals deserve high praise for the achievements of

the Organ Procurement and Transplantation Network (OPTN): the United Network

for Organ Sharing (UNOS); surgeons, physicians, nurses, and other health professionals who have committed themselves to the practice of transplantation medicine;

laboratory and clinical scientists who continue to generate new knowledge and technology that drives transplantation medicine to ever-greater success; staff of the

Organ Procurement Organizations (OPOs), who work so diligently to acquire and

transport organs to transplant programs; patients, who provide invaluable insights

as to how OPTN processes might be improved; and, most of all, organ donors and

their loved ones, whose decisions to share the gift of life enable transplantation

medicine to flourish.

Their efforts have made organ transplantation available to more and more chronically ill patients. Last year more than 21,000 Americans received organ transplants. But more than 4,000 people on transplant waiting lists died because of the

scarcity of donated organs. As these lists grow, many more will die as the system

continues to strain under the demand for organs.

We in the Administration believe that our first priority must be to increase organ

donation. To that end, in December 1997, the Department launched its National

Organ and Tissue Donation Initiative to foster partnerships between public- and private-sector organizations to enhance public education about the need for donation

and to recruit potential donors. The centerpieces of this initiative are a rule, modeled upon legislation in Pennsylvania, requiring hospitals participating in Medicare

to expand their reporting of imminent deaths and deaths to OPOs and a new $5

24

million grant program to learn more about what works in organ donation. We are

pleased to report that organ donation increased by more than 5 percent last year

as a result of our collective efforts, and we are hopeful that the upward trend will

continue. Nevertheless, we recognize that the need for transplantation is growing

faster than the supply of organs and that continued emphasis on both organ donation and equitable organ allocation is necessary.

A second priority for the Administration is to ensure that the OPTN established

by NOTA works equitably and provides the best possible outcomes for patients. The

role of the federal government in this area was recently affirmed by the Institute

of Medicine (IOM), which was directed by Congress last year to study the national

organ transplantation network. Two months ago, IOM reported that:

The federal government, as well as the transplantation community, has a legitimate and appropriate role to play in ensuring that the organ procurement and

transplantation system serves the public interest, especially the needs and concerns of patients, donors, and families affected by it. The [IOM] learned of numerous instances in which weak governance tends to undermine the effectiveness of the system... Weak oversight has compromised accountability at all levels, permitted poor procedures for data collection and analysis to persist, and

allowed the system to operate without adequate assessment of performance.

As I said, the OPTN should be commended for its wonderful accomplishments.

Nevertheless, we cannot ignore the persistent flaws and unfairness in the system.

The most medically urgent patients do not always receive priority. Patients with

similar levels of disease may have different outcomes, depending on where they live

or list. Distrust among transplant surgeons and hospital administrators sometimes

impedes broader sharing of organs. True measures of equity to judge the OPTN do

not exist.

In recognition of the need for public-sector oversight of the OPTN and in response

to provisions of the Consolidated Omnibus and Emergency Supplemental Appropriations Act of 1999, the Department has increased its efforts to assess the performance of transplant programs. With the assistance of staff from UNOS, the contractor

for both the OPTN and the Scientific Registry, Department staff analyzed OPTN patient outcome data for liver and heart transplants with respect to three critical

issues:

the likelihood that, having been listed as a transplant candidate, a patient will

receive a organ within one year;

the likelihood that a patient will die within one year of listing while awaiting

transplantation; and

the likelihood that a patient will still be alive one year after listing, irrespective

of whether he or she underwent a transplant procedure.

After risk adjustment (i.e., adjustment for differences in the mix of patients’

health status from program to program), the analyses revealed substantial differences in outcomes from one transplant program to another. The principal findings

for liver transplants illustrate this:

ten percent of the programs have a risk-adjusted rate of transplantation within

one year of listing of 71 percent or more; whereas, for another ten percent of

the programs, the rate is 25 percent or less;

the likelihood of dying within one year of listing while awaiting a transplant

ranges from less than 8 percent to more than 22 percent; and

the likelihood of surviving one year after listing as a transplant candidate or a

recipient ranges from approximately 65 percent to almost 86 percent.

The analogous values for heart transplants are 36-72 percent (transplantation

within one year of listing), 9-23 percent (death within one year of listing while

awaiting a transplant), and 67-84 percent (survival for one year after listing irrespective of whether transplanted or not).

In the course of performing these analyses, Department staff identified gaps in

the data currently collected by the Scientific Registry—e.g., additional clinical details about patients’ conditions at the time of listing (which could improve risk adjustment) and additional data on clinical complications (which could help in assessing quality of life following transplantation). The Department intends to encourage

UNOS, in its management of the OPTN and its operation of the Scientific Registry,

to broaden the scope of data collection and make increased use of program-specific

performance analyses.

Although these findings warrant further study to determine the precise reasons

for such variances in patient outcomes, one thing is clear. Where a patient lives or

lists often does more to determine whether he or she gets a transplant than do medical considerations. Patients in like circumstances are being treated differently, in

25

clear contradiction of the premise of NOTA that we have an equitable national system of organ transplantation in the United States.

Many of the flaws that I have discussed are addressed in the final rule for the

OPTN that was issued by the Department in April, 1998, after extensive public comment and three days of public hearings. The rule requires the OPTN to develop policies that will result in standard listing practices and medically based definitions of

patient status categories. The rule also requires policies that will encourage broader

geographic sharing of organs so that the most medically urgent patients receive

transplants, based on the sound medical judgment of physicians under this general

rubric. The rule leaves the policy decisions to the OPTN with oversight by the Department.

In reference to the final rule, I again quote from the IOM report:

Vigilant and conscientious oversight and review of programs and policies are

critically important to ensuring accountability on the part of the OPTN and

other participants in the organ procurement and transplantation system. The

Final Rule appropriately places this responsibility with the federal government.

The [IOM] believes that this is an important aspect of the Final Rule and

charge that should be pursued by the federal government in close cooperation

with the full range of participants in the transplant community.

The Department clearly concurs with the IOM. There should be vigilant government oversight and close cooperation with the transplant community. This is the

balance we sought in the HHS rule.

Mr. Chairman, we have taken very seriously the charge we were given by the

Congress last year to work collaboratively with the transplant community to clarify

the intent and effect of the rule. We very much appreciate the many hours that

those in the community have spent meeting with us and their constructive approach

in identifying apparent problems and potential solutions through oral and written

comments. In addition, we have carefully reviewed the IOM report and recommendations and have met with representatives of the IOM committee on two separate occasions. As I have indicated, we are also fortunate to have additional data

pursuant to the study provisions in the omnibus bill.

In response to these helpful comments and discussions, we have committed to revise the rule in important areas. For example, we intend to clarify the rule so there

is no doubt that the OPTN will develop allocation policies. We intend to ease any

lingering concerns of the transplant community about the Secretary’s regulatory authority by instituting an independent advisory committee—as recommended by

IOM—to review major differences between the Secretary and OPTN on policy matters. Other areas of potential clarification or revision have been discussed in detail

with transplant community representatives. I believe our revisions will address the

major concerns we have heard from the transplant community yet maintain the essential framework of the rule requiring standardization of certain practices and encouraging broader geographic sharing of organs.

Consistent with the law, it is our intent that the rule, once revised, go forward

to address inequities in the system identified by the Department and IOM. However, congressional review of the OPTN is essential, and the Department looks forward to working together with you, Mr. Chairman, and other members of Congress

to develop legislation to reauthorize NOTA. Reauthorization should primarily address the needs of patients and also maintain the requirement of NOTA that there

be a national, equitable system of organ transplantation in the United States. We

recommend that reauthorization reinforce the role of the federal government in

overseeing the OPTN, in accordance with the IOM recommendations, and that the

statute continue to leave management and policy development of the OPTN in the

private sector.

The Department is concerned that H.R. 2418 does not do enough to preserve and

strengthen many of the attributes of the OPTN that have placed transplantation

firmly within the medical mainstream. Indeed, in some instances, the bill takes a

step backward. The Department, therefore, opposes H.R. 2418 in its current form.

The following paragraphs describe our principal concerns.

• While calling for a national system to match organs and individuals who need

organ transplants, the bill does nothing to decrease the reliance on arbitrary

geographic boundaries and the inequities that result. Commenting specifically

on allocation of livers, IOM concluded that ‘‘the fairness of the organ procurement and transplantation system, and its effectiveness in meeting its stated

goals, would be significantly enhanced if the allocation of scarce donated livers

were done over larger populations than is now the case.’’ Medical outcomes,

waiting time and the possibility of fatality should not depend on the geographic

location of a transplant program at which a patient is wait-listed.

26

• H.R. 2418 does not ensure that patients and referring physicians can obtain the

kinds of program-specific information they need to make decisions about whether, when, and where to seek transplantation. Although H.R. 2418 provides for

program-specific data on such items as the probability of receiving an organ

transplant, the waiting time for similarly situated patients, and the medical

outcomes for similarly situated patients, the bill does not specify that this information also be timely and easy to use. Out-of-date information can lead referring physicians and patients to make less than optimal decisions. • H.R. 2418 would erode the role of the federal government in providing oversight

of the OPTN. The OPTN, by its structure, is not able to incorporate into its activities the public policy considerations that underpin the NOTA. The Department believes that it must continue to be an active partner with the privatesector in striving to fulfill the goals of the OPTN. Indeed, the overarching purpose of the OPTN rule is to clarify the nature and extent of oversight by the

Department while ensuring a continued prominent role for transplantation professionals, patients / patient-advocates, and other organizations and individuals

in the private sector. • As you know, under the U.S. Constitution, a private entity cannot perform functions inherent to the federal government. Yet the bill does not stipulate that

binding policies for the OPTN be approved by the federal government. • Although H.R. 2418 requires that the Board of the OPTN have physician representation of no less than 50 percent, it makes no such percentage requirements for patients and donor families, who we believe should have a significant

representation on the Board.

In summation, Mr. Chairman and members of the Subcommittee, the Department

is committed to working with you and the members of the transplant community

to create policies that improve the quality of care and the equity of our organ allocation system. While we have had our differences, our recent discussions with the

transplant community have been quite promising. We hope that this spirit of cooperation can extend to our discussions on reauthorization of NOTA as well. Thank

you for the opportunity to testify today.

Mr. GANSKE [presiding]. Thank you, Mr. Raub. By the way, why

was your testimony so late?

Mr. RAUB. Sir, the invitation to the Department, as I understand

it, arrived at the end of last week. We worked very hard over

the——

Mr. GANSKE. The invitation I am told arrived last Tuesday.

Mr. RAUB. That is not my knowledge, sir, but I have no reason

to dispute your statement.

Mr. GANSKE. Okay. If it arrived last Tuesday, why did we not receive your testimony until today? Will you take personal responsibility and find out what the delay was?

Mr. RAUB. Yes, sir, I will.

Mr. GANSKE. Thank you. Dr. Payne?

STATEMENT OF WILLIAM PAYNE

Mr. PAYNE. Thank you, Mr. Chairman and distinguished members of the committee. It is an honor to testify today as the current

President of UNOS, the United Network for Organ Sharing. I am

Bill Payne, a liver transplant surgeon and Director of the Liver

Transplant Program at the University of Minnesota.

On behalf of UNOS I will be speaking in support of H.R. 2418.

First, however, I would like to provide a brief report on three major

improvements made since we last appeared before you.

In June, the UNOS board of directors voted to institute a major

change to the liver allocation policy by establishing region-wide

sharing for the most urgent patients. This new policy, which has

been in development for several years, addresses many of the concerns that have been raised with regard to allocation over the last

year.

27

Each year more than 4,000 people die needlessly because of the

organ shortage. I am pleased to report that UNOS recently completed a pilot test of its new critical pathway for organ donor management developed under our contract with HRSA. The study revealed a 10.4 percent increase in the number of organs recovered

per donor at pilot sites.

This is extremely important news. The organ supply has remained roughly the same for years despite everyone’s best efforts.

As this new organ recovery technique is implemented nationally we

expect a 10 percent increase, the largest in a decade.

Finally, UNOS recently unveiled an impressive array of new online data for patients and the public. By updating our Internet site

we have an all new section called ‘‘Transplant Patient Data

Source.’’ we are now providing the latest statistics on survival rates

on every transplant program in the country, the size of waiting

lists and waiting times at each center and OPO, and the supply of

donated organs nationally by State and by transplant center.

This unique research tool offers patients the critical information

they need to evaluate transplant centers in a user friendly format.

Consumer information and scientific data of this kind is unprecedented, available nowhere else in medicine. In fact, we recently

asked Arthur Andersen to conduct a study to evaluate the data

published by leading major health organizations. Arthur Andersen

polled 40 Federal public health agencies and national private

health care organizations and found that other than the small bone

marrow transplant registry, none of the organizations polled collects or analyzes center-specific data or health care-related outcome

data and makes it available to the public to the extent that UNOS

does.

With regard to H.R. 2418, I am proud to represent the UNOS

membership in strongly supporting this legislation. Mr. Chairman,

we very much appreciate your leadership on this issue and commend you for your hard work and the truly bipartisan support for

this legislation. We support this bill for many reasons.

First, the bill reinforces the original intent of NOTA. It was

Chairman Bliley and other members of this committee who designed the current public-private structure that keeps the delicate

medical decisionmaking with doctors and the medical community.

H.R. 2418 preserves the original intent of NOTA by restating that

the responsibility for developing, establishing and maintaining

medical criteria and standards for organ procurement and transplantation rests in the private sector and the medical community.

This inclusive and democratic policymaking process ensures that

transplantation policy reflects the consensus of the community

while addressing the issues facing practitioners and patients every

day.

Second, the bill also updates NOTA by providing new direction

in important areas such as enforcement, accountability, and patient

confidentiality. It provides several new means by which the network can enforce its policies. It also includes new requirements improving the network’s public accountability. Specific and detailed

data reporting requirements will now be mandated by law. The bill

also provides for a new periodic evaluation of the network’s perVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00030 Fmt 6633 Sfmt 6602 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
28

formance by the GAO to be submitted to Congress for review.

UNOS strongly endorses these new oversight measures.

The bill also ensures that in an effort to provide more information to the public, the confidentiality of patients pre and post transplant will not be compromised. We wholeheartedly support this important protection for patients.

Finally and perhaps most importantly, the bill provides new incentives for donation. Simply put, too few people give the gift of

life. The medical community struggles daily with families torn with

grief over the loss of a loved one who through fear or mistrust

choose not to allow organs to live on. This bill represents further

commitment by Congress to help us increase donation.

Mr. Chairman, we believe all of these provisions are great improvements to NOTA and that a reauthorization is timely and necessary. We urge the committee to pass it, and again thank you for

the opportunity to appear before you today. I would be happy to answer any questions you may have.

[The prepared statement of William Payne follows:]

PREPARED STATEMENT OF WILLIAM PAYNE, PRESIDENT, UNITED NETWORK FOR

ORGAN SHARING

Mr. Chairman, distinguished members of the Committee, it is an honor to be here

today to testify as the current President of the United Network for Organ Sharing,

or UNOS. My name is Bill Payne, and I am a liver transplant surgeon currently

serving as Chief of Staff at Fairview University Medical Center in Minneapolis,

Minnesota, where I also am Director of the Liver Transplant Program.

UNOS members elect a new president each June, and my predecessors have appeared before you in the past. Therefore, you know that UNOS has been the Organ

Procurement and Transplantation Network—the OPTN, or Network—since the passage of NOTA in 1986, and continues to operate this national Network under contract with the Department of Health and Human Services. Because we have testified before you in the past, I will only briefly recount who UNOS is and what we

do.

As a private membership organization, UNOS includes every transplant center

and organ procurement organization in the United States. The corporation qualifies

under federal law as a charitable, tax-exempt scientific and educational organization. Although we employ almost 200 full-time staff, the important clinical and scientific work of UNOS, as well as the critical establishment of national transplant

standards and policies, is accomplished by thousands of volunteers.

UNOS incorporates and embodies the entire organ transplant community in this

country. It comprises surgeons, physicians, nurses, ethicists, and allied health professionals, as well as patients, patient advocates, and donor family members, all of

whom have dedicated hundreds of thousands of hours to the operation of this critical life-saving Network.

It has been a year since UNOS last appeared before this Committee to testify on

issues relating to organ transplantation. And, as you know, much has happened

since then. I want to take this opportunity to inform you of several significant

changes that have been made since we appeared last. In the last year, UNOS has:

• Implemented new liver allocation policies;

• Increased the supply of organs; and

• Published new, extensive data for patients and the public.

NEW UNOS INITIATIVES

New Liver Allocation Policy

Today’s liver allocation policy is significantly different than when this issue was

last before the Committee. In June, the UNOS Board of Directors voted to institute

a dramatic change to the liver allocation policy that has been in development for

several years. The new policy establishes region-wide sharing for the most urgent

patients—the subset of patients doctors agree have the best chance of a successful

transplant. This policy is founded on broad community consensus because it

achieves the benefits of broader sharing while avoiding the problems that many

think are inherent in the distribution of livers over excessively large areas, such as

29

increased retransplants or decreased access at smaller centers. This action is a

major step toward the goal of broader sharing of livers and addresses many of the

concerns that have been raised with regard to allocation over the last year.

This new sharing policy is also consistent with the Institute of Medicine’s (IOM)

recent recommendation that livers be shared in areas with a base population of 9

million versus the much smaller organ procurement organization (OPO) service

areas. Since UNOS’ 11 regions range in population from 10 million to 40 million,

these areas are significantly larger than those recommended by the IOM. Needless

to say, we will still be examining the IOM’s recommendations to determine its advantages or disadvantages over the current system.

Increasing the Organ Supply

Regarding organ donation, I am pleased to report that UNOS has developed a

new technique that has the potential to increase the overall number of transplantable organs by more than 10 percent. As you know, the organ supply has remained

roughly the same for years, despite the best efforts of everyone involved in transplantation. UNOS recently completed a pilot test of the new UNOS Critical Pathway for organ donor management developed under our contract with the Health Resources and Services Administration (HRSA).

The study revealed that use of this new protocol resulted in a 10.4 percent increase in the number of organs recovered per donor at the test sites. The study also

demonstrated that use of the Pathway reduced costs and did not increase the time

spent in donor management. As the Pathway is implemented across the country, we

expect to see a nationwide increase in the organ supply on the order of 10 percent,

the largest increase in more than a decade.

New Data Available for Patients

Another significant change that has taken place since we were before the Committee last involves new information and data that we have made available to the

public. Two weeks ago, UNOS unveiled an online resource to provide the transplant

community and the public with unprecedented access to organ transplant information by utilizing the latest in Internet technology.

Available on our web site (www.unos.org/patients), Transplant Living is a new

site offering patients and their families a single, comprehensive source for everything they want and need to know to handle the often tough decisions involved in

obtaining an organ transplant. It is designed to help those who have just discovered

they need a transplant better understand the process, and help them feel they are

making the best choices for their care.

Among its many resources, the web site features Transplant 101, designed to be

a step-by-step guide for patients and their families for every stage of the organ

transplant process. There is helpful information on financing transplants, local support groups, instructions on how to get on waiting lists, as well as past experiences

from transplant recipients, professionals and family members of organ donors

The UNOS Internet site has been updated with a new section called, Transplant

Patient DataSource. This part of our web site provides the latest statistics on:

• Survival rates for every transplant program in the country;

• The size of waiting lists and waiting times at each center and OPO; and

• The supply of donated organs, nationally, by state, and by transplant center.

This unique research tool offers patients the critical information they need to

evaluate transplant centers when making decisions about obtaining a life-saving

organ. This kind of consumer information and scientific data is unprecedented because nowhere else in medicine is this level of detailed, institution-specific data

available.

UNOS is extremely proud to have been able to step into this leadership role in

medicine, not only for the United States, but for the entire world. Through our partnership with HHS, under our contracts with HRSA, and through other funding arrangements, we have been able to provide more extensive data for patients and the

public than any other public or private institution in medicine.

Ask yourself this question: If your doctor told you today that you had a life-threatening condition, could you find information about where you could receive treatment, and the track record at each hospital where it is provided? Could you learn

the number of similar cases and the results at each of those centers, including every

center’s survival rate?

Unless the treatment you need is an organ or bone marrow transplant, the answer is no.

30

Arthur Andersen Study

We recently asked the world’s leading information and management consulting

firm, Arthur Andersen, LLP, to conduct a study to evaluate the extent to which

leading major health organizations collect outcomes data and provide center-specific

information to the public.

Arthur Andersen polled 40 federal public health agencies and national private

health care organizations and found that other than the bone marrow transplant

registry, none of the organizations polled collect or analyze center-specific data or

healthcare-related outcome data, or make it available to the public to the extent

that UNOS does. Three of the organizations noted that they make efforts to track

other types of data, e.g. number of cases, case demographics, etc., but that the data

is not made publicly available.

We believe the findings of this survey by Arthur Andersen confirm the unique and

unprecedented depth of information UNOS now makes available to anyone interested in organ transplants.

UNet

Beyond the new, improved outreach to patients and their families, UNOS is

launching a similar, but secure, Internet-based transplant information resource to

help doctors and the transplant community match donors to recipients faster and

more efficiently. UNETsm replaces an older, less user-friendly computer system, and

should eliminate many of the time-consuming telephone calls and faxes required to

coordinate the donation, allocation, and transplantation of life saving organs.

UNETsm is scheduled to go online next week, offering physicians and organ centers

unprecedented, real-time access to the latest organ transplant information.

Both of these Internet-based efforts are a direct response to feedback and suggestions from UNOS’ network of patients, families, doctors and medical professionals.

With its lifesaving charter, UNOS continually evaluates different ways to improve

the system and help make donation and transplant data readily available.

NOTA REAUTHORIZATION

With regard to H.R. 2418, the bill that is before the Committee today, I am proud

to represent the UNOS membership in strongly supporting this legislation. As I

stated in my July 14, 1999 letter to you, Mr. Chairman, we very much appreciate

your leadership on this issue and commend you for your hard work in developing

this legislation and the bipartisan support it has received.

Since 1990, when NOTA was last reauthorized, many of us in the transplant community have been anxious about the state of transplantation, and the Federal government’s commitment to the public-private partnership established in NOTA. We

are enthusiastic about the prospect of NOTA reauthorization and the opportunity

to update and strengthen current law. Specifically, we support H.R. 2418 for the following reasons.

H.R. 2418 Reinforces the Original Intent of NOTA

It was Chairman Bliley and other members of this Committee who designed the

current public-private partnership that we now know as the Organ Procurement

and Transplantation Network. The beauty of this structure is that it keeps delicate

and informed medical decision making in the medical and transplant community

and out of the political realm.

We at UNOS, as the Network contractor since its inception, believe that the vision

of NOTA’s original authors has been a successful model of great service to patients.

The current system serves as a check and balance system, producing the best medical decisions and the best transplant policies for current and potential organ donors

and recipients.

H.R. 2418 preserves the original intent of NOTA by restating that the responsibility for developing, establishing and maintaining medical criteria and standards

for organ procurement and transplantation rests in the private sector and the medical community. With doctors, patients, donor families, procurement coordinators,

ethicists, government officials, and others participating in a democratic policy making process, transplantation policy can reflect a consensus of the community while

addressing the issues facing practitioners and patients every day.

H.R. 2418 Creates New Enforcement and Accountability Requirements

Within the framework of the original NOTA, H.R. 2418 updates NOTA by providing new direction in important areas such as enforcement, accountability, and

patient confidentiality.

Enforcement: Over the years, the transplant community has been concerned that

the Network lacked any real mechanisms to enforce its policies. H.R. 2418 provides

31

for several actions that the Network may take in this regard. This approach is contrasted with what many have regarded as the only enforcement mechanism available to the Network under current law: the severe penalty of a hospital or OPO losing its eligibility to be a Medicare provider (so severe a penalty that it is unlikely

to ever be invoked). The bill’s proposed intermediate actions include:

• Payment of damages by Network participants who are found to be non-compliant

with Network policies through a peer review process;

• Suspension of a transplant program’s ability to receive organs for transplantation;

and

• Public designation as a member not in good standing.

Accountability: In addition to new enforcement mechanisms, H.R. 2418 includes

new important requirements designed to make the Network more accountable to

Congress, the Secretary of Health and Human Services and the public. For the first

time, specific and detailed data reporting requirements will be mandated by law.

This ensures that the extensive data that UNOS has recently made available to the

public will always be available in the future. The bill also provides for a new periodic evaluation of the Network’s performance by the Comptroller General of the

United States, which shall be submitted to Congress for its review. Never before

have such oversight measures been required by law, and we support them.

Patient Confidentiality: As a significant new addition to NOTA, H.R. 2418 contains a specific provision to protect patient confidentiality. This provision ensures

that, in an effort to provide more information to the public regarding transplant

hospital waiting lists and outcomes, the confidentiality of patients—pre- and posttransplant—will be protected. Many people do not realize the depth of information

that patients must disclose to be placed on a waiting list to receive an organ transplant. As with any medical information, disclosure of this information—even if unintended—can have devastating effects on people lives. We wholeheartedly support

this important protection for patients.

H.R. 2418 Provides New Incentives for Donation

Perhaps most important are the bill’s provisions aimed at increasing donation. All

of us involved in organ transplantation struggle regularly with our frustration over

the shortage of donor organs. Each year, nearly 4,000 people die needlessly because

too few people give the gift of life. The medical community struggles daily with families torn with grief over the loss of a loved one, who, through fear or mistrust,

choose not to allow organs to live on.

We know that Congress is committed to helping us bridge the gap. There have

been several recent steps taken such as the passage of the Organ Donor Leave Act.

For the past several years, Congress has also been generous in appropriating more

funds dedicated to educating people about organ donation. This bill continues that

trend.

The bill also provides resources to HHS to seek out the ‘‘best practices’’ in organ

procurement so they can be duplicated around the country. I, for example, come

from a state that has a great success rate in recovering organs. These funds could

help facilitate information sharing and training between OPOs, hospital personnel

and others around the country, allowing for the best and most successful ideas to

be replicated.

Summary

Mr. Chairman, we believe all of these provisions are great improvements to NOTA

and that a reauthorization is timely and necessary. We support the bill and urge

the Committee to pass it. Again, thank you for the opportunity to appear before you

today.

Mr. GANSKE. Thank you. Mr. Gibbons?

STATEMENT OF ROBERT D. GIBBONS

Mr. GIBBONS. Good afternoon, Mr. Chairman and members of the

committee. My name is Robert Gibbons and I am a professor of biostatistics at the University of Illinois in Chicago, and also a member of the Institute of Medicine’s Committee on Organ Procurement

and Transplantation. With me today is another member from the

IOM committee, Dr. Mitchell Spellman, who is Professor of Surgery

Emeritus and also Dean of Medical Services Emeritus for Harvard

32

University Medical School. And also with me is Susanne Stoiber,

the Executive Officer of the Institute of Medicine.

We are pleased to have this opportunity on behalf of our fellow

committee members and the Institute of Medicine to talk to you

about our report on organ procurement and transplantation. Copies

of the report’s executive summary have been submitted for the

record and preliminary print of the full report has been available

to members of this subcommittee.

The IOM was asked by Congress to review the regulation published by the Department of Health and Human Services in April

1998. Congress asked IOM to review its potential effect on access

to transplantation services, organ donation rates, waiting times,

survival rates and cost of organ transplantation services.

Much of the public debate that led up to Congress asking for our

report centered on the observation that the time it takes to receive

a liver transplant varies greatly depending on the location of the

transplant center where the patient was placed on the waiting list;

namely, geographic heterogeneity. Our committee quickly discerned

that on the one hand this claim was highly overstated, but on another it diverted attention from very real and very important

issues.

The reason this view is misleading is that it aggregated data

across all the levels of severity of patients. Patients in liver Transplantation are broken down into four status groups depending on

the severity of their condition. The most severely ill patients, which

are called status 1 patients, have a life expectancy of approximately a week. By contrast, the less severely ill patients, status 3

patients and sometimes status 2B patients, may wait months or

even years for a transplant.

Among the status 1 patients, the severely ill patients, there is

very little variation in waiting time. On average these patients who

do get transplanted do so within 4 days. This is not the case for

the less severely ill patients who can wait months or possibly years

based on differing policies and practices among the transplant centers on when these patients are placed on the list.

It is these listing practices that gave the overall impression that

there were large heterogeneity in the median waiting times. Important to note is that more than 50 percent of the patients are, in

fact, status 3 patients accounting for the variation in the median.

In terms of our analysis, for a variety of reasons the IOM committee focused its attention on livers. We reviewed over 68,000

liver transplant records for every liver transplant patient on the

list from 1995 through 1999. This was a huge data base.

Attached to my testimony is a map showing the configuration of

the 63 organ procurement organizations, which I will call OPOs

from here on, covering the U.S. and its territories. The populations

covered by these OPOs varied from 1 million to 12 million people.

We determined in an important finding that OPOs serving larger

populations are associated with improved access overall for those

patients most in need of a transplant. The committee found specifically that for status 1 patients, those most severely ill patients

most in need of a transplant, they would receive transplants—they

wait a comparable period of time across the country, about 4 days

on average. However, transplantation rates do vary for patients

33

who are not as ill, with smaller OPOs having a larger proportion

of status 2B and status 3 patients receiving transplants relative to

the larger OPOs. Consequently patients who are less ill sometimes

receive transplants before more severely ill patients who are served

by a different organ procurement organization.

Based on the data available and our analysis, these differences

begin to disappear when the population served by the OPO reached

9 million people or more. For that reason, and because the probability of a suitable match between a donated liver and a status 1

patient increases as the size of the population covered increases,

we concluded that liver allocation areas should be established to

cover an area large enough to serve at least 9 million people.

There were many other findings by the committee, but I will

highlight a couple. Our analyses indicated that the longer that status 2B and status 3 patients are on the list, the lower their likelihood is that they will die or receive a transplant. This finding also

led the committee to the conclusion that the time on the waiting

list is not an appropriate criterion for allocating organs among the

less severely ill patients.

Finally, we also looked at existing sharing arrangements and we

found that the existing sharing arrangements did, as we would expect, increase status 1 transplantation rates and decrease the rate

of transplantation of the less severely ill patients without increasing their pretransplantation mortality rates.

There were several concerns expressed about the notion of broader sharing. The first was whether or not there would be a limitation on minority access or access to low-income patients. The committee did not find any evidence in support of these concerns.

Information available to the committee indicated that the smallest transplant centers are not a major source of access for racial

and ethnic minorities. Moreover, we found the evidence that small

centers would be forced to close under broader sharing arrangements to be inconclusive.

We also heard concern that distributing organs across a wider

area would discourage donation and again we found no evidence in

support of this idea.

Finally, we also found that broader sharing would significantly

increase the cost of transplantation and although it will increase

the cost, only marginally compared to the total expenditures for

transplantations.

Finally, the committee concluded that achieving the goals of the

National Organ Transplant Act requires an active Federal role in

review and oversight and this should be done in collaboration with

representatives of those involved in transplantation, including patients, donor families, physicians, nurses, OPOs and transplant

centers. At the heart of this there should be an independent scientific review board that should assist with policies and procedures, making sure that they are well grounded in medical science;

that there is a cohesive and strategic approach to the entire transplantation system; that the interests of transplant patients and

donor families are given paramount concern; and credibility and

trust are maintained with patients in the transplant community

and the general public.

Thank you.

34

[The prepared statement of Robert D. Gibbons follows:]

PREPARED STATEMENT OF ROBERT D. GIBBONS, PROFESSOR OF BIOSTATISTICS,

UNIVERSITY OF ILLINOIS AT CHICAGO

Good afternoon Mr. Chairman and members of the Committee. My name is Robert

D. Gibbons. I am a Professor of Biostatistics at the University of Illinois at Chicago

and a member of the Institute of Medicine (IOM) Committee on Organ Procurement

and Transplantation Policy. With me is another member of the IOM committee,

Mitchell W. Spellman, M.D., Ph.D. Dr. Spellman is professor of surgery, emeritus,

and dean for medical services, emeritus, at the Harvard Medical School. [Also with

me is Ms. Susanne Stoiber, the Executive Officer for the IOM.]

We are pleased to have this opportunity—on behalf of our fellow committee members and the Institute of Medicine—to talk about our report on organ procurement

and transplantation. Copies of the report’s Executive Summary have been submitted

for the record, and a preliminary print of the full report has been available to the

members of this Subcommittee. I have a short oral statement and Dr. Spellman and

I [OR, the three of us] will be pleased to answer any questions you may have about

the report.

THE COMMITTEE’S ASSIGNMENT

The IOM was asked by the Congress to review a regulation published by the Department of Health and Human Services (DHHS) in April 1998. That regulation set

forth various requirements and procedures to be followed by the Organ Procurement

and Transplantation Network (OPTN) in carrying out its responsibilities under the

National Organ Transplant Act (NOTA). The Congress suspended implementation

of the regulation and asked the IOM to review its potential effect on several important issues, including:

• Access to transplantation services by low-income populations and racial and ethnic minorities;

• Organ donation rates;

• Waiting times for organ transplants;

• Patient survival rates and organ failure rates; and

• Costs of organ transplantation services.

Our report examines each of these issues, and sets forth several conclusions and

recommendations.

THE INITIAL PUBLIC DEBATE

Much of the public debate, leading up to the Congress asking for our report, centered on the observation that the time it takes to receive a liver transplant varies

greatly, depending upon the location of the transplant center where the patient has

been placed on the waiting list. This geographic inequity was put forward as evidence that the current system is grossly inequitable. Our Committee quickly discerned, however, that this was not the best way to evaluate the data. One the one

hand, it overstated the inequities, for reasons I will briefly explain; but on the other

hand, it diverted attention from some very real and very important issues. The reason this view was misleading is that it aggregated the data for all patients awaiting

a liver transplant, instead of breaking the data down into the four status groups

into which patients are classified, depending on the severity of their condition. The

most severely ill patients—those having a life expectancy of a week or less—are in

status 1. There is very little variation in the waiting time for these patients; it is

a matter of a few days for those who receive a transplant. The least severely ill

patients— those in status 3—may wait months or even years for a transplant. Since

more than half of all patients on the waiting lists are in status 3, the data for these

patients are what determines the overall variation in median waiting times used in

the arguments noted above. But this tells us very little about the equity or effectiveness of the system, since differing policies and practices among transplant centers

on when status 3 patients should be placed on a waiting list means that these patients form a very heterogeneous group.

THE COMMITTEE’S ANALYSIS

For a variety of reasons, the IOM Committee focused its attention on livers. In

order to review the issues in greater depth, the Committee obtained, from the

OPTN, approximately 68,000 records covering all the patients awaiting a liver

transplant during the period from 1995 to 1999. Of particular interest were the consequences of the current OPTN policies on allocating donated organs among paVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00037 Fmt 6633 Sfmt 6621 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
35

tients, and the likely consequences of the changes in those policies called for by the

DHHS regulation.

Organ Procurement Organizations (OPOs) are statutorily created entities responsible for the procurement of donated organs and for coordinating the allocation of

those organs among patients on the waiting lists of transplant centers. Attached to

my testimony is a map, showing the configuration of the 63 OPOs covering the U.S.

and its territories. At the present time, with a few important exceptions, when these

OPOs obtain an organ donated for transplantation, they seek to allocate it to a patient located within their own defined geographical area. Only if they cannot find

a suitable patient within their own area do they seek to find a patient located in

one of the other—typically adjacent—OPO areas. The populations covered by these

OPO areas vary from approximately 1 million to about 12 million. We determined

that OPOs serving larger populations are associated with improved access

for those patients most in need of a transplant.

The Committee found that status 1 patients (those with the highest medical urgency for a transplant) who receive transplants wait for a comparable period of time

all across the country—about 4 days on average. Moreover, the transplantation

rates and the pre-transplantation mortality rates for status 1 patients do not vary

significantly from one OPO to another, despite substantial variations in the size of

the OPOs. (Size of OPO was defined either by the size of the population served or

the number of transplants performed within the OPO service area.) However, only

about one-half of the patients listed as status 1 receive a transplant.

Transplantation rates do vary for patients who are not as ill, with smaller OPOs

having a larger proportion of status 2B and status 3 patients receiving transplants

than larger OPOs. Consequently, patients who are less ill sometimes receive transplants before more severely ill patients who are served by a different organ procurement organization. Based on the data available to the Committee, these differences

begin to disappear when the population served by the OPO reaches 9 million or

more.

For that reason, and because the probability of a suitable match between

a donated liver and a status 1 patient increases as the size of the population covered increases, we concluded that liver allocation areas should be

established to cover an area large enough to serve at least 9 million people.

Nine million is as far as our available data could take us. Logic suggests that larger

areas would be even more effective in arranging a suitable match. These areas, however, should not be so geographically broad as to pose difficulties or delays in transporting organs, which could threaten the viability of the organ and the success of

transplantation. The allocation areas for organs other than livers will differ depending on how long they can survive outside the body.

It is important to note that improvements in the rates of transplantation for status 1 patients do not appear to come at the expense of other patients. Our analysis

indicated that the longer status 2B and status 3 patients are on the waiting list,

the lower is the likelihood that they will either die or receive a transplant. This

finding also lead the Committee to the conclusion that time on the waiting list is

not an appropriate criterion for allocating organs among status 2B and status 3 patients.

There are currently in effect several arrangements under which two or more

OPOs share donated organs on a statewide or regional basis, at least for status 1

patients. The Committee could make only a preliminary analysis of the data available for such sharing arrangements, but that analysis tends to confirm the Committee’s view that broader sharing is beneficial. The analysis shows that that such

sharing: (1) increases status 1 transplantation rates; (2) decreases status 2B pretransplantation mortality rates; and (3) decreases the rate of transplantation of status 3 patients without increasing their pre-transplantation mortality rates.

CONCERNS EXPRESSED ABOUT BROADER ORGAN SHARING

The Committee heard some people in the transplant community express concern

that broader sharing of organs might reduce access to organs for minorities and lowincome patients. This would be true, they stated, if broader sharing resulted in the

closure of some of the smaller transplant centers.

The Committee did not find any evidence to support these concerns. For low-income patients, regardless of their racial and ethnic backgrounds, there is an appropriate concern that they may not be referred to a transplant center for an evaluation for transplantation. This is because appropriate referral depends in large part

on whether they have access to health insurance and high-quality health services.

Once patients are referred for an organ transplant—again regardless of their race

36

or ethnicity—there appear to be no significant disparities either in their placement

on a waiting list or in access to transplantation.

Information available to the Committee indicated that the smallest transplant

centers are not a major source of access for racial and ethnic minorities. Moreover,

we found the evidence that small centers would be forced to close under broader

organ sharing to be inconclusive.

The Committee also heard concern that distributing organs across a wider geographic area would discourage donation and drive down organ donation rates.

Organ donation rates are affected by many variables, including cultural attitudes

about donation and transplantation, the age and race of the potential donor, the

progression of illness in the potential donor, the manner in which families of potential donors are approached, and the various policies and practices of hospital staff

and OPOs. The biggest shortcoming at present appears to be that many potential

donors are not identified and their families not approached about the possibility of

donation. The Committee found little evidence—if any—to support the notion that

families would decline to donate, or that health professionals involved in organ procurement would be less diligent in their efforts, if they knew a donated organ would

be used outside the donor’s immediate geographic area. The Committee believes current efforts to increase donation should be sustained and that broader allocation arrangements should be made in a way that does not undermine current effective

working relationships between OPOs and hospitals.

Another concern expressed to the Committee was that broader sharing would significantly increase the cost of transplantation. Based on data provided to the Committee by the General Accounting Office (GAO), as well as the published literature,

the Committee concluded that total expenditures associated with organ procurement

and transplantation are likely to increase as a result of broader sharing. OPOs and

transplant teams may both experience higher transportation costs. In addition, a

larger number of sicker patients will receive transplants and there will likely be

more re-transplants’ both of which would increase costs. The Committee was unable

to estimate the magnitude of the increase, but believes it would be marginal compared to the total expenditures for transplantation

FEDERAL OVERSIGHT AND REVIEW

The Committee believes that, when Congress passed the National Organ Transplant Act, it intended for there to be a cohesive, well-coordinated system encompassing all aspects of transplantation. The Committee also believes that we do not

have such a system at this time and that we cannot have such a system without

effective, comprehensive oversight. We therefore concluded that achieving the goals

of the National Organ Transplant Act requires an active federal role in review and

oversight, and that this should be in collaboration with representatives from all

those involved in transplantation, including patients, donor families, physicians and

nurses, OPOs, and transplant centers. The federal government, as well as the transplantation community, has a legitimate and appropriate role to play in ensuring

that the organ procurement and transplantation system serves the public interest,

especially the needs and concerns of patients, donors, and families affected by it.

At the present time, responsibilities are dispersed throughout the system, creating

impediments to oversight and review, permitting poor procedures for data analysis

and dissemination to persist, and allowing the system to operate without adequate

assessment of performance. The Committee acknowledges that many aspects of

organ procurement and transplantation require effective arrangements and decision

making at a local level. However, a more centralized mechanism for oversight and

review would improve the quality assurance that donors and recipients deserve.

This is not to say that the federal government should be making medical judgments

regarding individual patients, but rather that its responsibility is to ensure that the

policies that guide the operation of the system are equitable and well-grounded in

medical science. Vigilant and conscientious oversight and review of programs and

policies are critically important to ensuring accountability on the part of the OPTN

and other participants in the organ procurement and transplantation system.

To assist in this activity, there needs to be independent scientific review. The

Committee recommends that an independent, multidisciplinary advisory board be

appointed to assist in the oversight of the program. Such a board could help to assure that: (1) policies and procedures are well grounded in medical science: (2) there

is a cohesive, strategic approach to the entire transplantation system: (3) the interests of transplant patients and donor families are given paramount concern: and (4)

credibility and trust are maintained with patients, the transplantation community

and the general public.

37

In addition, the Committee concluded that better performance measures should

be developed for each of the components of the transplantation system, and that

data about the system should be reliably and regularly gathered, independently assessed, and made widely available. The Committee’s concerns about oversight and

review cut across the individual issues specified in its charge and relate in general

to all organ transplantation, not just liver transplantation.

COMMITTEE RECOMMENDATIONS

Based on its review and analysis of the data and information available to it, the

Committee reached the following recommendations:

Recommendation 1: Establish Organ Allocation Areas for Livers

The committee recommends that the DHHS Final Rule be implemented

by the establishment of Organ Allocation Areas (OAAs) for livers—each

serving a population base of at least 9 million people (unless such area

exceeds the limits of acceptable cold ischemic time). OAAs should generally be established through sharing arrangements among organ procurement organizations to avoid disrupting effective current procurement activities.

Recommendation 2: Discontinue Use of Waiting Time as an Allocation Criterion

for Patients in Statuses 2B and 3

The heterogeneity and wide range of severity of illness in statuses 2B

and 3 make waiting time misleading within these categories. For this

reason, waiting time should be discontinued as an allocation criterion

for status 2B and 3 patients. An appropriate medical triage system

should be developed to ensure equitable allocation of organs to patients in these categories. Such a system may, for example, be based on

a point system arising out of medical characteristics and disease prognoses rather than waiting times.

Recommendation 3: Exercise Federal Oversight

The Department of Health and Human Services should exercise the legitimate oversight responsibilities assigned to it by the National Organ

Transplant Act, and articulated in the Final Rule, in order to manage

the system of organ procurement and transplantation in the public interest. This oversight should include greater use of patient-centered,

outcome-oriented performance measures for OPOs, transplant centers,

and the OPTN.

Recommendation 4: Establish Independent Scientific Review

The Department of Health and Human Services should establish an external, independent, multidisciplinary scientific review board responsible for assisting the Secretary in ensuring that the system of organ

procurement and transplantation is grounded on the best available

medical science and is as effective and as equitable as possible.

Recommendation 5: Improve Data Collection and Dissemination

Within the bounds of donor and recipient confidentiality and sound

medical judgment, the OPTN contractor should improve its collection

of standardized and useful data regarding the system of organ procurement and transplantation and make it widely available to independent

investigators and scientific reviewers in a timely manner. DHHS should

provide an independent, objective assessment of the quality and effectiveness of the data that are collected and how they are analyzed and

disseminated by the OPTN.

References:

DHHS (U.S. Department of Health and Human Services). 1998b. Organ Procurement and

Transplantation Network; Final Rule (42 CFR Part 121). Federal Register 63(63):16296-16338.

GAO (U.S. General Accounting Office). 1997. Report to the ranking minority member, Committee on Labor and Human Resources, U.S. Senate. Organ Procurement Organizations: Alternatives Being Developed to More Accurately Assess Performance. GAO/HEHS-98-26. Washington,

D.C.: GAO.

IOM (Institute of Medicine). 1999. Organ Procurement and Transplantation Policy. Washington, D.C.: National Academy Press.

UNOS (United Network for Organ Sharing) 1999. Available at: www.unos.org. Accessed July

1, 1999.

38

Committee on Organ Procurement and Transplantation Policy

EDWARD D. PENHOET (Chair), Dean, School of Public Health, University of California at

Berkeley

NAIHUA DUAN, Statistics Group, RAND Corporation, Santa Monica (until May 6, 1999)

NANCY Neveloff DUBLER, Director, Division of Bioethics, Montefiore Medical Center, Professor of Bioethics, Albert Einstein College of Medicine, New York

CHARLES K. FRANCIS, President, Charles R. Drew University of Medicine and Science, Los

Angeles

ROBERT D. GIBBONS, Professor of Biostatistics, Departments of Biostatistics and Psychiatry, University of Illinois at Chicago

BARBARA GILL, Clinical Nurse Specialist, Abilene Cardiothoracic and Vascular Surgery of

Texas, Abilene

EVA GUINAN, Associate Professor of Pediatrics, Harvard Medical School, Boston

MAUREEN HENDERSON, Professor Emeritus of Epidemiology and Medicine, University of

Washington, Seattle

SUZANNE T. ILDSTAD, Director, Institute for Cellular Therapeutics, University of Louisville

PATRICIA A. KING, Carmack Waterhouse Professor of Law, Medicine, Ethics, and Public Policy, Georgetown University, Washington, D.C.

MANUEL MARTINEZ-MALDONADO, Vice Provost for Research and Professor of Medicine,

Oregon Health Sciences University, Portland

GEORGE E. MCLAIN, Assistant Chief of Anesthesiology, Martin Memorial Medical Center,

Stuart, Florida

DAVID MELTZER, Assistant Professor, Section of General Internal Medicine, Department of

Economics, and Harris School of Public Policy Studies, University of Chicago

JOSEPH E. MURRAY, Professor of Surgery, Emeritus, Harvard Medical School, Boston

DOROTHY NELKIN, University Professor, New York University Department of Sociology and

School of Law, New York

MITCHELL W. SPELLMAN, Director of Academic Alliances and International Exchange Programs, Harvard Medical International, Harvard Medical School, Boston

39

40

Mr. BILIRAKIS. Thank you very much. Dr. Miller, when did you

arrive? I was able to escape late yesterday after that storm which

swerved from dead on Pinellas County down to your area.

Mr. MILLER. We ducked and it missed us. It went around the

south tip of the State, so we were all fortunate.

Mr. BILIRAKIS. They are crazy, aren’t they? In any case, sir, you

are welcome. Please proceed.

STATEMENT OF JOSHUA MILLER

Mr. MILLER. I appreciate the opportunity to testify at this hearing on the important legislation that you have introduced, Mr.

Chairman, which would reauthorize programs relating to organ

procurement and transplantation. I am Dr. Joshua Miller, Codirector of the Division of Transplantation at the University of

Miami School of Medicine in Miami, Florida. I am appearing today

as the immediate past President of the American Society of Transplant Surgeons, the ASTS, a professional organization of surgeons,

physicians and scientists who during the past 25 years of our existence have pioneered and continue to advance the frontiers of lifesustaining organ transplantation.

ASTS members have the responsibility for directing transplantation clinical and research programs at America’s major medical

centers. As part of this responsibility, we helped forge the National

Organ Transplant Act, NOTA, into law in partnership with the

U.S. Congress over a decade and a half ago.

We were instrumental in conceiving an organ procurement and

distribution network and, in partnership with the Health Care Finance Administration of the Department of Health and Human

Services, helped to organize it and to put it into action during the

same period.

We are here now 15 years later to work with you in reauthorizing NOTA and providing a clear congressional guideline for how

that network can provide the maximum benefit to our patients as

we move into the 21st century.

Because of the explosive success of organ transplantation in the

latter part of the 20th century there are now more than 65,000

Americans, an additional 3,000 since I last testified before your

subcommittee in April, Mr. Chairman, with end-stage failure of

hearts, livers, lungs, pancreases, and kidneys awaiting life-saving

and life-sustaining transplants. This is a potentially explosive situation because as the number of patients on waiting lists climbs inexorably toward 100,000, concern and frustration over the allocation of these scarce organs is bound to grow. Our fear is that this

mounting public concern is leading to increased efforts to politicize

what is and ought to remain a medical decisionmaking process.

We strongly believe that Congress in enacting NOTA and establishing the Organ Procurement and Transplantation Network, the

OPTN, in the private sector under government contract intended

for this highly specialized and expert OPTN to make organ allocation policy based on sound medical and ethical principles and scientific data independent of political influence, and that is how it

has essentially operated these past 15 years.

But as you are aware, Mr. Chairman, several sections of the final

rule governing the OPTN published by the Secretary of Health and

41

Human Services a year ago April could be interpreted as setting

the stage for the Secretary of DHHS to make specific allocation policy. This effort by the Department was the result of the fairly recent intense criticism by a vocal minority of one very specialized

aspect of the OPTN, liver allocation. We have repeatedly expressed

our concerns to DHHS in the course of a number of meetings this

past summer. We have suggested changes in a rule that we largely

agree with, this rule that we largely agree with, changes designed

to prevent the baby that we jointly conceived from being thrown

out with the bath water, changes that among other things would

clarify that the Secretary must not dictate specific transplantation

practices or medical judgments. We were also greatly concerned

that the rule might unwittingly tamper with the very delicate but

very real local influences on organ donation that we discussed in

my last appearance before your committee.

We believe the legislation you have drafted makes it clear that

there is a most legitimate oversight role for DHHS in ensuring that

the policies which guide the operation of the system are adhered

to, and we support that oversight role for DHHS.

We would also like to submit for the record a white paper our

society issued just last Friday summarizing our views on the issues

that we have been discussing with DHHS and on some of the recommendations included in the report delivered to Congress in midsummer by the Institute of Medicine. We know Members of Congress have been provided with a variety of interpretations of this

IOM report both by DHHS and by the OPTN contractor, UNOS,

generally claiming vindications for their positions. And as is so

often the case, we believe the truth falls somewhere in between.

I would like to just mention two important points that the IOM

report makes what I believe go to the heart of our concern over

leaving medical decisions in the hands of medical professionals.

Throughout 1998 and right up through this summer, DHHS, in

urging Congress to allow the final rule to be imposed without

delay, contended that significant regional differences in the length

of time patients spend on waiting lists for livers demonstrated a

fundamental unfairness of the current system. The ASTS testified

before Congress more than a year ago as we repeatedly informed

the Department that there really were only small differences in

waiting times for patients in the most urgent categories and that

median waiting times for all liver patients as used by the Department were really not a good measure of fairness.

The Institute of Medicine after analyzing data, and as was just

mentioned, ‘‘Overall median waiting time, which has dominated the

policy debate, is a poor measure of differences in access to transplantation.’’

It further suggested that differences in waiting time for less urgent patients are so, ‘‘misleading’’—that was the word that the

IOM used, misleading—that it proposed waiting time no longer be

an allocation criteria in less urgent categories of liver patients.

The public focus on waiting time as the driver of the need for

quick fix, quick change in the allocation of livers is exactly the kind

of politicization of the medical decisionmaking process that concerns us.

42

And I would like to touch briefly on one other recommendation

of the IOM that we move toward a system of broader sharing of

livers for patients in most urgent need because we do believe that

this recommendation has merit. In fact, less than a month after the

IOM issued its report the OPTN put into effect a new policy of

broader regional sharing for status 1 liver patients, the most urgent category, and this was already in the due process pipeline.

This policy will hopefully ensure that those most critical liver patients to the best of our medical ability today have access to lifesaving organs. This I believe is indicative that the establishment

of allocation policies by the OPTN is a dynamic process through

which change does take place in response to new information and

analysis. Could this change have occurred earlier? Probably. Does

the current system function perfectly? Of course not. Is there room

for improvement in the performance of the current contractor? Absolutely. There is always room for improvement in the operation of

the network through refinements like those suggested in our legislation.

Our society’s interests lie in the structure and operation of the

network and its relationship to DHHS. Our interest is not to be

specifically protective of the incumbent contractor that is operating

the network. We also very much believe that the OPTN should be

responsive to independent external review and assessment. We

would favor strengthening the section you already included in the

legislation relative to General Accounting Office evaluations of the

network.

We have a small number of other changes we would be pleased

to discuss with you, Mr. Chairman, which we believe would further

strengthen the NOTA reauthorization effort. But again let me conclude my prepared remarks by thanking you for the leadership you

have demonstrated sponsoring this most important piece of legislation, and I would welcome any questions that I might be able to

answer.

Thank you.

[The prepared statement of Joshua Miller follows:]

PREPARED STATEMENT OF JOSHUA MILLER, AMERICAN SOCIETY OF TRANSPLANT

SURGEONS

I appreciate the opportunity to testify at this hearing on the important legislation

that you have introduced, Mr. Chairman, which would reauthorize programs relating to organ procurement and transplantation.

I am Dr. Joshua Miller, Professor of Surgery, Microbiology , Immunology and Pathology, and Chief of the Division of Kidney and Pancreas Transplantation, at the

University of Miami School of Medicine in Miami, Florida.

I am appearing today as the Immediate Past President of the American Society

of Transplant Surgeons (the ASTS), the professional organization of Surgeons, Physicians, and Scientists who, during the past 25 years of our existence, have pioneered and continued to advance the frontiers of life-sustaining organ transplantation. ASTS members have the responsibility for directing transplantation clinical

and research programs at America’s major medical centers.

As part of this responsibility we helped forge the National Organ Transplant Act

into law in partnership with the United States Congress over a decade and a half

ago. We conceived of an organ procurement and distribution network, and, in partnership with the Health Care Financing Administration of the Department of

Health and Human Services, helped organize it and put it into action during the

same period.

Now, we are here—15 years later—to work with you in reauthorizing NOTA and

providing clear Congressional guidelines for how that network can provide the maxVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00045 Fmt 6633 Sfmt 6621 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
43

imum benefit to the maximum number of patients as we move into the 21st Century.

Because of the explosive success of organ transplantation in the latter half of the

20th century, there are now more than 65,000 patients—an additional three thousand since I last testified before your Subcommittee in April—with end-stage failure

of hearts, livers, lungs, pancreases, and kidneys awaiting life-saving transplants.

This is a potentially explosive situation, Mr. Chairman, because as the number

of patients on waiting lists climbs inexorably toward and passes 100,000 Americans,

concern and frustration over the allocation of these scarce organs is bound to grow.

Our fear is that, inevitably, this mounting public concern over who-gets-an-organand-when will lead to increased efforts to politicize what is, and ought to remain,

a medical decision-making process.

We strongly believe that Congress, in enacting NOTA and establishing the Organ

Procurement and Transplantation Network in the private sector under government

contract, intended for the OPTN to make organ allocation policy based on sound

medical principles and scientific data independent of political influence. And that is

how it has operated these past 15 years.

But as you are aware, Mr. Chairman, several sections of the Final Rule governing

the OPTN published by Secretary of Health and Human Services Donna Shalala a

year ago April could be interpreted as setting the stage for the Secretary of DHHS

to make specific allocation policy.

We have repeatedly expressed our concerns over this to DHHS, in the course of

a number of meetings this past summer. We have suggested changes that, among

other things, would clarify that the Secretary must not dictate specific transplant

practices or medical judgments.

We believe the legislation you have drafted, Mr. Chairman, makes it clear there

is a legitimate oversight role for DHHS in ensuring that the policies which guide

the operation of the system are equitable, based on sound medical science, and are

adhered to. We support that oversight role for DHHS.

But we do want to again express our appreciation to you, Mr. Chairman, for making it clear in this legislation that the responsibility for ‘‘developing, establishing,

and maintaining medical criteria, and standards,’’ and policy concerning allocation,

belongs with the Network. And those policies should be modified by the Network,

as necessary, on the basis of sound medical science and developing medical practices.

We would also like to submit for the record, along with these remarks Mr. Chairman, a white paper our society issued just last Friday summarizing our views on

a variety of the issues we have been discussing with DHHS. It also contains our

views on some of the recommendations included in the report delivered to Congress

in midsummer by a Committee of the Institute of Medicine.

We know Members of Congress have been provided with a variety of interpretations of this IOM report, both by DHHS and by the OPTN contractor, the United

Network for Organ Sharing, among others, generally claiming vindication for their

positions. As is so often the case, we believe the truth falls somewhere between.

I would like to just mention a couple of important points that the IOM report

makes, however, that I believe go to the heart of our concern over leaving medical

decisions in the hands of medical professionals.

Throughout 1998 and right up through this summer, DHHS—in urging Congress

to allow the Final Rule to be imposed without delay—contended that significant regional differences in the length of time patients spend on waiting lists for livers

demonstrate a fundamental unfairness of the current system.

We suggested in testimony before Congress more than a year ago—as we repeatedly suggested to the Department—there really were only small differences in waiting time for patients in the most urgent categories, and that median waiting times

for all liver patients, as used by the Department, were really not a good measure

of fairness.

The Institute of Medicine—after analyzing years of data—concluded, and I quote:

‘‘Overall median waiting time, which has dominated the policy debate, is a poor

measure of differences in access to transplantation.’’ It further suggested that differences in waiting time for less urgent patients are so ‘‘misleading’’—that was the

word the IOM used-that it proposed waiting time no longer be an allocation criterion in less urgent categories of liver patients.

The public focus on waiting times as the driver of the need for quick change in

the allocation of livers is exactly the kind of politicization of the medical decisionmaking process that concerns us.

I would also like to touch briefly on another recommendation by the Institute of

Medicine—that we move toward a system of broader regional sharing of livers for

44

patients in most urgent need—because we do believe that this recommendation has

a great deal of merit.

The IOM committee concluded, after crunching the data, that the most urgent

liver patients—Status 1 patients—would be more likely to receive an organ expeditiously if contiguous OPOs were grouped into what it called Organ Allocation Areas

each serving a population base greater than nine million.

Less than a month after the IOM issued its report, the OPTN put into effect a

new policy of broader regional sharing for Status 1 liver patients—the most urgent

category—which hopefully will insure that these most critical liver patients have access to a life-saving organ sooner than might have been the case.

I believe this is indicative, Mr. Chairman, of the fact that the establishment of

allocation policies by the OPTN is a dynamic process through which change does

take place in response to new information and analysis, and changes in medical

science and medical practice.

Could this change have occurred earlier? Probably. Does the current system function perfectly? Of course not. Is there room for improvement in the performance of

the current contractor? Absolutely.

There is always room for improvement in the operation of the network through

refinements, like some suggested in your legislation.

And I might add that our Society’s interests lie in the structure and operation of

the network, the composition of the network and its relationship to DHHS, and the

composition and authority of the network board of directors and committees, which

establish policy for the network. Our interest is not to be specifically protective of

the incumbent contractor that operates the network.

We also very much believe that the OPTN should be responsive to independent

external review and assessment. We would favor strengthening the section you already included in the legislation, Mr. Chairman, relative to General Accounting Office evaluations of the network.

We have a small number of other changes we would be pleased to discuss with

you, Mr. Chairman, which we believe would further strengthen the NOTA reauthorization effort. But again, let me conclude my prepared remarks by thanking you for

the leadership you have demonstrated in sponsoring this most important piece of

legislation.

Thank you.

Mr. BILIRAKIS. Thank you, Mr. Miller. You heard the bells, and

the bad news is that there is no good news. The bad news is that

we have a 15-minute vote followed by two 5-minute votes, so we

are talking probably 35, 40 minutes. I would have liked to have

been able to get through at least the witnesses, but we just won’t

really have time to do that because I hate to cut you off at 5 minutes. So I am just going to have to ask you to be as patient—continue to be as patient as you have been. We are going to break

probably until about 4:30 or shortly thereafter.

Mr. GANSKE. Mr. Chairman?

Mr. BILIRAKIS. Yes?

Mr. GANSKE. I ask unanimous consent for 1 minute.

Mr. BILIRAKIS. One true 1 minute? Without objection.

Mr. GANSKE. Thank you, Mr. Chairman. As probably one of the

few Congressmen who has scrubbed with Dr. Starzl and also did

my general surgical training at the University of Oregon Health

Sciences Center, I have some understanding of this issue.

I am disturbed with the administration on this. I think you have

put your foot in a tar baby where you shouldn’t be. Mr. Chairman,

I see that on your bill you have cosponsors Gene Green, Bill Jefferson, Ken Bentsen, Peter Deutsch, Carlos Romero-Barcelo, Ralph

Hall, Bart Gordon, David Wu, Jim Clyburn, Frank Pallone, Martin

Frost, Sheila Jackson Lee, Jerry Kleczka, Peter DeFazio, Maurice

Hinchey, Earl Hilliard, Tammy Baldwin, and a whole bunch of Republicans, and guess what, Mr. Chairman? You can now put my

name on your cosponsor list. Thank you very much.

45

Mr. BILIRAKIS. I thank the gentleman and I believe that there

are some that are probably not on that list.

Thank you for that. Dr. Gibbons, you have heard some of the

comments made by Mr. Miller. I know that Dr. Payne, I am sorry

I was called out by a large group of people that wanted to see me

about another matter. That is the life up here but hopefully you

all can talk about some of the comments that you have heard. We

are trying to do the right thing. Granted, there is parochialism

here. There is no question about it. But at the same time I think

for the most part we do want to do what is right.

Well, anyhow, maybe you can have a little bit of interplay among

yourself until we return. Thank you.

[Brrief recess.]

Mr. BILIRAKIS. We are back. Mr. Irwin, President of the National

Transplant Action Committee. By the way, thanks again for your

patience and your understanding. Please proceed, sir.

STATEMENT OF CRAIG IRWIN

Mr. IRWIN. Thank you, Mr. Chairman. I am here today speaking

on behalf of not only The National Transplant Action Committee

but also TRIO, Transplant Recipients International Organization,

and MOTTEP, the Minority Organ Transplant and Tissue Education Program. Collectively we represent thousands of transplant

patients throughout the United States.

Unfortunately, Dr. Clyde Calendar of MOTTEP nor Mr. Bruce

Weir, President of TRIO, were able to be here today but I am

joined by Lisa Kory, President of TRIO.

I am here to speak in opposition to H.R. 2418, the Organ Procurement and Transplantation Network Amendments of 1999. This

legislation comes amid considerable debate over the rules promulgated by the Department of Health and Human Services last year.

Those rules are scheduled to go into effect on October 21.

Our three organizations believe that transplant patients and

their families must be the focus of our public policy in this area of

health care. Patients should be able to access critical information

about the transplant system and the quality of care in our Nation’s

transplant hospitals. Patients deserve to be treated fairly by the

organ allocation system. Some patients have choices among transplant centers, however, many don’t. A patient’s chance of finding

a suitable donor shouldn’t be a matter of who you are or where you

live. And patients and their families either directly or through

HHS deserve to have a significant role in the development of public

policies impacting the Nation’s transplant system.

These beliefs are consistent with the goals and intent of the National Organ Transplant Act. To quote the intent of Congress: The

organ procurement and transplantation network was created in

order to facilitate an equitable allocation of organs among patients.

The OPTN’s responsibilities are great and the purpose of the act

will be served only if the policies of the OPTN are sound and are

soundly developed. The allocation of organs may well be a life or

death decision for patients.

And although the act gives the contractor authority to develop

medical policies regarding the safe allocation and transportation of

46

organs, it does not give the contractor public policy authority. Instead it gives administrative authority to the Secretary.

Unfortunately, what has evolved is a patchwork system of organ

allocation designed to meet the expectations and needs of transplant centers instead of the patients. Many patients and advocates

who have worked hard to help others and have much to offer are

often left out of the OPTN policy setting process because of their

views. And critical data is often difficult to obtain and is often old

and useless.

I am pleased to hear of Mr. Waxman’s remarks regarding the

availability of comprehensive data, and we look forward to reviewing that data and making it available to patients around the country.

These problems have continued to surface throughout the years.

The concerns of patients have been echoed by the Congress and reflected by changes to the act in 1988 and 1990.

In 1990, Congress eased the minimum qualifications that must

be met by an entity seeking the OPTN contract stating that, ‘‘By

modifying this requirement, the committee intends to provide the

Secretary with the opportunity to seek out the best possible potential applicants for this critical role.’’

This change along with changes the committee has made to the

OPTN board of directors reflect deep concern on the part of the

committee in the manner in which the OPTN has functioned. That

same year, Congress amended the act to mandate that the OPTN

assist organ procurement organizations in the nationwide distribution of organs equitably among transplant patients.

The bill now before this committee represents a complete reversal from these patient-driven policies and statements. H.R. 2418

would make dramatic changes to the manner in which organs are

allocated to patients on the waiting list. New factors could now be

considered in addition to equity. Fairness would no longer be the

benchmark. Secretarial oversight would essentially be eliminated

with no recourse to change or amend policies which might be detrimental to patients. The right of patients and the public to become

members of the OPTN would be eliminated. There would be no further competition for the OPTN contract. UNOS would be the only

organization meeting the contract criteria.

H.R. 2418 contradicts the past actions by this committee. The bill

also ignores the recommendations of the recent report by the Institute of Medicine, which was required by Congress, submitted to

this committee. The report contains key recommendations impacting transplant patients. The IOM calls for more oversight, not less,

of the OPTN. In addition, the report calls for independent comprehensive review by a body reporting to the Secretary and not affiliated with the OPTN contractor.

The IOM concluded that broader sharing as called for by the regulation would have the net effect of saving more lives by increasing

transplantation rates for those with the greatest risk of dying, decreasing pre-transplant mortality rates for the next level of patients on the waiting list and decreasing the number of the healthiest patients transplanted without increasing their risk of dying.

Finally, the report dispels the many myths promoted by the opponents of the regulation, many of which we have heard today.

47

Paramount is the myth that minorities would be hurt by the regulations.

Although the IOM found that there is essentially parity and equity in liver allocation, the report also concluded that minorities

would not be hurt by the regulations. The HHS regulations will

move the system toward greater fairness and a more patient-driven

system. H.R. 2418 will move us in the opposite direction.

Mr. Chairman, when the committee last took up the reauthorization in 1993, you took exception to the full committee’s desire to

simply call for a study of organ allocation. You were quite eloquent

in recognizing that sick people will continue to die merely because

of UNOS-created geographic boundaries. You asked the Secretary

to do what the committee would not, operate the program closer to

the original congressional intent when the act was passed in 1984.

Mr. Chairman, you were right then. Your conclusions apply

equally today and your views have been validated by the IOM. On

behalf of the 65,000 patients now waiting for transplants in the

United States, we ask that you not change directions now.

Thank you.

[The prepared statement of Craig Irwin follows:]

PREPARED STATEMENT OF CRAIG IRWIN, PRESIDENT, NATIONAL TRANSPLANT ACTION

COMMITTEE

National Transplant Action Committee (NTAC) is a consumer advocacy organization founded in 1992. We currently have approximately 1500 members across the

United States. NTAC has been a leading advocate for organ transplant patients and

their families as directed by our Patient Public Policy Committee.

ANALYSIS AND COMMENT ON HR 2418

NTAC strongly opposes HR 2418, the ‘‘Organ Procurement and Transplantation

Network Amendments of 1999. The bill now before the Committee would make drastic changes to the National Organ Transplant Act (NOTA) and the management of

the nation’s Organ Procurement and Transplantation Network (OPTN).

1. The bill establishes the private contractor as an ‘‘independent partner’’ with the

federal government. It requires the Department of Health and Human Services

(HHS) to ‘‘cooperate’’ with the contractor as well as eliminates the oversight role of

HHS. It reduces the role of the Secretary to taking and reviewing comments but

grants no authority to HHS to protect or promote the public health interest through

an administrative role.

2. Eliminates the independent Scientific Registry

3. Gives the OPTN contractor greater authority over which information is released

to patients and the public. Grants the contractor new ‘‘authority’’ by which to withhold vital information from the public.

4. Excludes members of the public and patients from being members of the OPTN.

Membership is only permitted to ‘‘entities’’ in the transplant field.

5. The bill would eliminate the release of center specific data and replace it with

less helpful OPO specific data.

6. Gives the contractor broad judicial authority and the right to penalize transplant centers. Such penalties may include the withholding of organs from transplant

centers that do not adhere to network rules.

7. Administrative and procedural activities between the Secretary and the contractor would now have to be conducted on a mutually consensual basis. Gives the

contractor sole discretion over ‘‘scientific, clinical, and medical decisions’’ regardless

of the impact of such decisions on the public health interest.

8. Any subsequent contractor must be approved by the OPOs and transplant centers. Requires the OPTN contractor to have ‘‘experience’’ in organ transplantation.

9. Changes the criteria for the allocation of donated organs. Expands consideration of allocation policies to include issues of equity and ethics. It also eliminates

the requirement that organs be distributed on a ‘‘nationwide’’ basis ‘‘equitably

among patients on the waiting list.’’

NTAC believes that each one of these provisions would have an adverse impact

on organ transplant patients and the public’s health care interest. We support the

48

current National Organ Transplant Act and the Final Rule promulgated by HHS

governing the OPTN. We are concerned that HR 2418 is aimed at derailing the

HHS rules before they go into effect on October 21, 1999.

The OPTN is currently operated by the United Network for Organ Sharing

(UNOS) based in Richmond, VA. UNOS has operated the network since its inception

in 1986. HR 2418 as written would eliminate the Secretary’s discretion to contract

with the best possible candidate to operate the OPTN. Under the Bill, UNOS could

essentially operate the OPTN without regard to the public health interest and without oversight by HHS and still not jeopardize its standing as the OPTN contractor.

Throughout the years, patients, transplant centers, the Administration, and the

public have raised concerns about the manner in which UNOS has operated the

OPTN. These concerns have been echoed by Congress and reflected in amendments

to the National Organ Transplant Act in 1988 and 1990. Although the Act has not

been formally amended since 1990 congressional hearings in 1993 and 1995 have

resulted in similar actions attempting to address troubling concerns over UNOS activities.

Timely, accurate, and useful information is critical to the public, policy makers,

and especially transplant patients. UNOS has shown a blatant disregard for the

public interest in this area and has resisted attempts to obtain vital information.

In 1997 a request for data on organs turned down by transplant centers was made

available only after an exhaustive process that culminated in a Freedom of Information Act request. Only then did UNOS make the data available. In its attempt to

block the information UNOS used similar defenses to those proposed in HR 2418.

However, no patients were ever identified, directly or indirectly, as a result of the

data release. Information currently available with respect to center specific performance and OPO performance is outdated when it is published. The current HHS regulations would require the OPTN contractor to update its data every six months.

The UNOS governance and policy setting process is highly politically charged and

greatly influenced by transplant center self interest. There is no opportunity given

for public testimony at UNOS board meetings or committee meetings. Public members and patient advocates are excluded from participating in UNOS because of

their viewpoints. Recently, the UNOS patient affairs committee attempted to censure a UNOS public member because his positions and public statements were critical of the organization.

Not only is the UNOS policy setting process corrupted, its enforcement of policies

is based upon political expedience and appeasement. Recently, the UNOS board of

directors implemented a policy to create regional sharing for liver transplant candidates in the most urgent health care status. However, transplant centers in Wisconsin refused to abide by the new policy, adversely affecting patients in nearby Illinois. UNOS currently has at its disposal some of the same penalties available to

it that are created in HR 2418. However, instead of enforcing its policy, UNOS

opted to endorse a special agreement insisted on by the Wisconsin transplant centers.

However, the most critical decisions impacting organ transplant patients center

on the allocation of donated organs. As stated in a Congressional conference report

‘‘The Organ Procurement and Transplantation Network (OPTN) was created by the

1984 Act in order to facilitate an equitable allocation of organs among patients.’’

‘‘The allocation of organs may well be a life-or-death decision for patients.’’ (Senate

Report 100-310, P.L. 100-607). In 1990 UNOS changed liver allocation rules to

eliminate the priority status given to the most medically urgent patients on the national waiting list. The policy was enacted before public comment was sought. Since

then, organ allocation has been hotly debated in the organ transplant community.

The organ allocation issue is exacerbated by the fact that there are approximately

65,000 patients on the national waiting list and the number of transplants has continued to hover around only 20,000. Over ten patients die each day waiting for organs.

The manner in which UNOS has managed the policy setting process in this critical illustrates the shortcomings of the current system and UNOS’s ability to promulgate policies that serve the public interest. After exhaustive debate and efforts

on the part of patients and the public UNOS began considering the liver allocation

issue. The result was a policy where patients with chronic liver diseases would be

eliminated from the highest priority status. It was only after HHS intervention and

overwhelming public outcry at a three-day hearing that the policy was reversed.

Recommendations made by the UNOS Liver and Intestine Committee to expand

liver allocation in order to improve equity were ignored by the UNOS board, which

focused on regional and local interests instead of promulgating a fair public policy.

In the meantime, patients have needlessly died as a result of UNOS’s failure to act

in a responsible manner.

49

These issues highlight the grave concerns with the function of the OPTN and the

manner in which UNOS has managed the transplant network. Throughout the

years, Congress has acted to limit the authority of the OPTN contractor, attempted

to improve the internal operation and management of UNOS, and has called upon

HHS to exert greater authority of the Act and the OPTN to protect the public interest. In 1990 Congress eased the minimum qualifications that must be met by deleting a prior requirement that an entity seeking the OPTN contract must not be engaged in any activity unrelated to organ procurement. The Committee Report stated

‘‘By modifying this requirement, the Committee intends to provide the Secretary

with the opportunity to seek out the best possible potential applicants for this critical role.’’ The Committee went on to state ‘‘This change, along with changes the

Committee has made in the OPTN board of directors, reflect deep concern on the

part of the Committee in the manner in which the OPTN has functioned.’’ The Congress should continue to be concerned.

It is in this context that NTAC opposes the proposed OPTN reauthorization bill.

We believe that UNOS has failed to carry out the mandates of the National Organ

Transplant Act and that undue political influence and rampant self-interest characterize the UNOS process. The welfare of patients should be at the forefront of the

OPTN policy setting process but that is not the case.

In lieu of HR 2418, we believe that the Committee should give serious consideration to the recent report of the Institute of Medicine on Organ Procurement and

Transplantation. Congress requested the report as part of a one-year delay in the

HHS regulations.

The IOM has emerged from its deliberations in support of the final rule which,

together with its own recommendations, ‘‘could go a long way toward facilitating the

development of improved principles of [organ] allocation and improving what everyone agrees should be a patient-centered system.’’

HIGHLIGHTS OF THE IOM COMMITTEE REPORT:

1. Impact of the Final Rule on Access

The IOM Committee found that the Final Rule would not adversely impact patient access to organ transplantation. It has been claimed that small transplant centers would close as a result of changes to the nation’s organ allocation system imposed by the Final Rule. ‘‘The committee was not persuaded’’ by the arguments stated by the opponents of the Final Rule. In fact, the IOM report states that, ‘‘there

is some preliminary information that counters the argument that broader sharing [of

organs] under the Final Rule would adversely affect small transplant centers.’’

‘‘Broader organ sharing may well increase the prospects that a patient listed at a

low-volume transplant center will obtain a suitable matching organ.’’

The committee also examined the impact of the Final Rule on minorities and lowincome populations. The committee found that ‘‘African Americans do not receive

kidney transplants as quickly as whites’’ and that the rule would not exacerbate this

problem. The committee also found that ‘‘broader sharing of organs resulting from

implementation of the Final Rule is not likely to have a significant adverse effect on

those who are dependent on Medicaid for their health care.’’

2. Impact of the Final Rule on Organ Donation

The IOM committee found no evidence to support claims that organ donation

rates would decrease as a result of the Final Rule, stating that ‘‘the committee found

no convincing evidence to support the claim that broader sharing would adversely

affect donation rates or that potential donors would decline to donate because an

organ might be used outside the immediate geographic area. In fact, there is some

evidence suggesting that broader sharing is associated with increased rates of donation.’’

3. Analysis of Waiting Times

Disparities in waiting times for liver transplant candidates have been at the center of a heated debate over the allocation of scarce donor organs. Therefore, the

Committee concentrated its research on the current liver allocation policies. The

IOM Committee concluded that aggregate-waiting time is not a good measurement

of the equity and effectiveness of the transplant system. However, the Committee

made other key observations about the transplant system.

a. The system is basically fair for the sickest patients (Status 1). However, the

IOM Committee recommends improvements: ‘‘Although the current system appears

equitable, with respect to status 1 patients receiving transplants at similar rates

among OPOs and having similar mortality and outcomes, the equity of the current

system might be improved for all patients if it were possible to identify a minimum

OPO population size or transplant volume that would promote both greater consistVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00052 Fmt 6633 Sfmt 6621 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
50

ency in transplantation rates across OPOs and a higher rate of transplantation for

needier patients.’’

b. Some of the healthier patients on the waiting list do not die while on the list

nor do they move up in priority, suggesting that some patients are inappropriately

put on the list for a liver transplant. The IOM found that there are patients on the

waiting list who ‘‘have little likelihood of receiving a transplant and are also at little

risk of dying.’’

c. More ‘‘healthier’’ patients die on the waiting list in OPOs with smaller transplant centers. ‘‘Of concern was evidence of a statistically significant increase in the

risk of pretransplant mortality in those OPOs with smaller transplant volumes.’’ Relatively healthy patients in small-volume OPOs ‘‘had a significantly increased risk

of pretransplant mortality while on the waiting list.’’

d. Larger OPOs transplant the sickest patients while smaller OPOs and transplant centers transplant a greater percentage of healthier patients. The IOM concluded that ‘‘smaller OPOs, by generally transplanting more status 2B and 3 patients

than larger OPOs, may contribute to a situation in which more severely ill patients

are required to wait longer for organs at increased risk of death.’’

e. There are fewer patients waiting in smaller OPOs so that they can transplant

healthier patients. ‘‘Although smaller OPOs have lower transplantation rates than

larger OPOs, their listing rates are even further reduced relative to larger OPOs.’’

‘‘This means that smaller OPOs are able to allocate organs to patients farther down

their shorter waiting lists than are larger OPOs.’’

f. Increased sharing of organs would save more lives. ‘‘A reasonable improvement

in the current allocation scheme could be achieved by creating allocation areas of sufficient size to shift some of the transplants from status 3 to statuses 1 and 2.’’ ‘‘It

seems apparent that patients on liver transplant waiting lists will be better served

by an allocation system that facilitates broader sharing within larger populations.’’

Greater sharing will have the effect of ‘‘increasing transplantation rates for status 1

patients, decreasing pretransplantation mortality for status 2B patients, and decreasing transplantation rates for status 3 patients without increasing mortality.’’ The net

effect is that more lives would be saved through broader sharing of donor organs

to those patients with the greatest need.

4. Patient survival

The IOM found that the medically acceptable ischemic time (time that organs can

travel without a blood supply) for donated livers was 12 hours. However, more significantly, the IOM Committee found that larger transplant centers had better patient survival rates than smaller centers, despite the fact that larger centers also

transplant the sickest patients. ‘‘Patients located in smaller-volume OPOs had increased risk of posttransplant mortality relative to those in larger-volume OPOs.’’ In

reviewing UNOS data the IOM Committee found that ‘‘several of the transplant centers doing 25 or fewer liver transplants had 1-year graft survival rates significantly

lower than expected, given the health status of their patients.’’

5. Costs

The IOM Committee concluded that increased sharing would have a slight increase in the overall costs of liver transplantation. However, the committee stated

‘‘The committee was unable to estimate the magnitude of the increase, but believes

that it would be marginal compared to the total expenditures for transplantation.

The committee also believes the health benefits of implementing broader sharing will

be substantial and outweigh any net increase in expenditures.’’

6. Federal Oversight

The report of the IOM Committee supports the HHS Final Rule, ‘‘In the end, the

committee emerged from its deliberations generally supportive of the Final Rule.’’ In

addition, the committee called for more, not less, federal government oversight of

the nation’s organ transplant system. ‘‘Weak [government] oversight has compromised accountability at all levels, permitted poor procedures for data collection

and analysis to persist, and allowed the system to operate without adequate assessment of performance.’’

The report recommends that HHS ‘‘should exercise the legitimate oversight responsibilities assigned to it by the National Organ Transplant Act in order to manage

the system of organ procurement and transplantation in the public interest.’’ Furthermore, the committee recommended ‘‘a process for periodic, independent and comprehensive review by a body reporting to the Secretary and not affiliated with the

OPTN contractor is needed to help provide objective information and advise for the

future directions of the system.’’ The board would include ‘‘a broad spectrum of medical and scientific experts, including epidemiologists and health services researchers,

51

as well as representatives from the community of transplant patients and donor families.’’

CONCLUSION

National Transplant Action Committee opposes HR 2418 and hopes that the Committee will not vote in favor of legislation which we believe will have a devastating

impact on organ transplant patients throughout the United States. We encourage

the Committee to focus on sound public policies as opposed to parochial self-interests. We hope that the HHS regulations will be permitted to move forward and that

a fair and equitable system soon becomes established for the 65,000 Americans currently waiting for transplants in our nation’s hospitals.

Mr. BILIRAKIS. Thank you, Mr. Irwin. Dr. Rabkin.

STATEMENT OF JOHN M. RABKIN

Mr. RABKIN. Mr. Chairman, distinguished members of the committee, I am John Rabkin. I am a surgeon and the Chief of Liver

Transplantation at the Oregon Health Sciences University. I am

here today on behalf of the 31 organ transplant programs and

1,300 patients that currently make up the Patient Access to Transplantation or the PAT Coalition. I respectfully request submission

into the hearing record along with my testimony the August 28,

1998, PAT Coalition comments on the health and human services

final rule and a recent PAT Coalition policy paper from this September which delineates our views on several critical issues in the

legislative and regulatory debate.

The PAT Coalition strongly supports H.R. 2418, the Organ Procurement and Transplantation Amendments of 1999, the reauthorization of the National Organ Transplant Act, or NOTA, introduced

by Representatives Bilirakis, Pallone and Green. We appreciate

their commitment to this issue and that of Commerce Committee

Chairman Tom Bliley and other members of this committee.

The PAT Coalition urges Congress to pass this legislation because we feel strongly that enactment of this bill is the best way

to settle controversy over organ transplantation resulting from the

HHS rulemaking. Moreover, we think it is imperative to stem the

erosion of public faith in the transplant system which has occurred

since HHS issued its controversial rule in April 1998.

We believe that the current organ transplant system is fair and

that it does a good job of acquiring and allocating organs for transplantation. We all must recognize the extremely dynamic aspects

of the transplant system as medical developments occur on practically a daily basis. Like any system, there is and always will be

room for ongoing improvement and this is how our current system

operates. A recent study by the Institute of Medicine came to the

same conclusion, ‘‘The committee found that the current system is

reasonably equitable for the most severely ill status 1 liver patients

since the likelihood of receiving a transplant is similar across organ

procurement organizations, or OPOs, for these patients.’’

The IOM study contradicted the underlying rationale for the controversial final rule on organ allocation proposed by the Department of Health and Human Services. In an analysis of 68,000 liver

patient records, the IOM panel said, ‘‘The overall median waiting

time that patients wait for organs, the issue that seems to have

brought the committee to the table in the first place, is not a useful

statistic for comparing access to or equity of the current system of

52

liver transplantation, especially when aggregated across all categories of liver transplant patients.’’

HHS always maintained that reducing these regional differences

in waiting time was the primary goal of the rule on organ allocation. The PAT Coalition has actively supported the two moratoriums on the HHS final rule implemented by Congress because we

think that the final rule usurps the authority of the transplant

community under NOTA to determine organ transplant policy.

Stated most simply, Congress in NOTA vests the private sector

OPTN with the authority to determine organ allocation policy.

We strongly support this NOTA directive and agree with Congress that the private sector entity is far better equipped than the

government to make medical policy judgments and adapt to changing technological developments and scientific and medical advances.

NOTA simply does not provide the Secretary with authority to

substitute her judgment if she or her staff disagree with a medical

transplant community with respect to policymaking, yet the Secretary’s final rule usurps this authority by regulatory fiat and

claims the ability to reverse OPTN policy.

Among our other concerns we also recognize that the transplant

policy suggested in the final rule would result in more of our patients dying while waiting for transplant and a significantly higher

rate of retransplantation and possible organ wastage. We are also

concerned that the core HHS policy is a design to direct more organs to a few larger transplant centers, which would result in a

loss of access to transplantation services for those patients who

could not travel long distances for financial or family reasons.

The rule itself applies to all organs and cannot withstand medical scrutiny. For example, another serious effect of this policy

would be to increase the cold ischemic time, or the time that organs

are stored outside of the body, since organs would travel farther to

the large centers. The IOM study pointed out, ‘‘That a 4.2 percent

reduction in retransplantation by using livers with lower ischemic

times would necessitate less retransplantation and would mean

that 170 additional patients could receive a liver transplant.’’

The HHS policy is also short sighted in its wholesale preemption

of State laws regarding organ transplantation. Many of the beneficial policies that have served to improve organ procurement and

donation were based on State laws such as the organ donor checkoff on driver’s licenses. The HHS preemption fails to recognize that

fact. In addition, this preemption clearly exceeds the authority

granted by Congress.

During the moratorium period we have worked actively with the

transplant community to try to form a consensus on how best to

deal with the HHS position. We have been involved in discussions

with HHS officials who have promised the transplant community

a revised proposal that would take into consideration our objections

to the final rule. We are still waiting for a response from HHS as

the clock ticks down on the current moratorium scheduled to expire

October 21.

We are also still waiting for the HHS to publish an analysis of

the thousands of public comments filed in response to the final

53

rule. We understand that more than 85 percent of these comments

stated strong opposition or concerns about the rule.

The best solution to the problem is for Congress to reiterate the

long-held statutory premise that organ transplant policy should be

left to the private sector transplant community through passage of

new authorizing legislation. Short of that, Congress should continue the moratorium until a new authorization bill can be passed.

H.R. 2418 recognizes that scientific and medical decisions about

organ transplant policy should be left to the private sector transplant community rather than to the Federal Government bureaucracy, a concept that the PAT Coalition enthusiastically supports.

The legislation’s construct has worked successfully historically and

we continue to believe that the private sector is better equipped

than the government to sort through the complex medical, specific,

and ethical challenges presented by organ transplantation.

H.R. 2418 correctly places a strong emphasis on the real solution

to the organ shortage problem, which is increasing organ donation.

With your permission, Mr. Chairman, I would like to submit a report of Kansas State University researcher and professor of psychology James Shanteau’s recent summary of research on what motivates people to donate organs and a press release article which

expressed serious concern that the HHS new organ policy may result in a donation decline.

Mr. BILIRAKIS. Without objection, that is made a part of the

record Dr. Rabkin. Proceed.

Mr. RABKIN. Thank you, Mr. Chairman. Most importantly, H.R.

2418 would restore the public’s confidence in the transplant system. Congress should expeditiously take this positive step forward

building on a truly unique and successfully working transplant system and pass H.R. 2418, the organ procurement and transplantation network amendments of 1999. We appreciate the opportunity to testify here today. Thank you.

[The prepared statement of John M. Rabkin follows:]

PREPARED STATEMENT OF JOHN M. RABKIN, OREGON HEALTH SCIENCES UNIVERSITY

REPRESENTING THE PATIENT ACCESS TO TRANSPLANTATION COALITION

Mr. Chairman, distinguished Members of the Committee, I am John M. Rabkin,

M.D., a surgeon and Chief of Liver Transplantation at the Oregon Health Sciences

University.

I am here today on behalf of the 31 organ transplant programs and 1300 patients

that currently make up the Patient Access to Transplantation (PAT) Coalition. I respectfully request submission into the hearing record, along with my testimony, a

recent PAT Coalition policy paper (September 1999) which delineates our views on

several critical issues in the legislative and regulatory debate.

The Patient Access to Transplantation (PAT) Coalition supports H.R. 2418, the

‘‘Organ Procurement and Transplantation Network Amendments of 1999,’’ the reauthorization of the National Organ Transplant Act (NOTA), introduced by Reps.

Bilirakis, Pallone, and Green. We appreciate their commitment to this issue and

that of Commerce Committee Chairman Tom Bliley, and other Members of this

Committee.

The PAT Coalition urges Congress to pass this legislation because we feel strongly

that enactment of this bill is the best way to settle the controversy over organ transplantation resulting from the HHS rulemaking. Moreover, we think it is imperative

to stem the erosion of public faith in the transplant system that has occurred since

HHS issued its controversial Rule in April 1998.

We believe the current organ transplant system is fair and does a good job of acquiring and allocating organs for transplantation. We all must recognize the extremely dynamic aspects of the transplant system as medical developments occur on

practically a daily basis. Like any system, there is, and will always be, room for onVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00056 Fmt 6633 Sfmt 6621 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
54

going improvement, and there are several proposals that the PAT Coalition supports

to increase the numbers of transplants.

A recent study by the Institute of Medicine came to the same conclusion: ‘‘The

committee found that the current system is reasonably equitable for the most severely ill (Status 1) liver patients, since the likelihood of receiving a transplant is

similar across organ procurement organizations (OPOs) for these patients.’’

The IOM study contradicted the underlying rationale for the controversial Final

Rule on organ allocation proposed by the Department of Health and Human Services. In an analysis of 68,000 liver patient records, the IOM panel said ‘‘the ‘overall

median waiting time’ that patients wait for organs—the issue that seems to have

brought the committee to the table in the first place—is not a useful statistic for

comparing access to or equity of the current system of liver transplantation, especially when aggregated across all categories of liver transplant patients.’’ HHS always maintained that reducing regional differences in waiting times was the primary goal of the rule on organ allocation.

The panel also found that enlarging the current organ allocation areas—a broader, regional sharing concept that the PAT Coalition generally supports—would improve the chances of Status 1 and 2 patients being transplanted.

The PAT Coalition has actively supported the two moratoriums on the HHS Final

Rule implemented by Congress because we think that the Final Rule usurps the authority of the transplant community under NOTA to determine organ transplant

policy. Stated most simply, Congress in NOTA vests the private sector OPTN with

the authority to determine organ allocation policy. We strongly support this NOTA

directive and agree with Congress that the private sector entity is far better

equipped than the government to make medical policy judgments and adapt to

changing technological developments and scientific and medical advances. NOTA

simply does not provide the Secretary with authority to substitute her judgment if

she or her staff disagree with the medical transplant community with respect to policymaking—yet the Secretary’s Final Rule usurps this authority by regulatory fiat

and claims the ability to reverse OPTN policy.

Among our other concerns, we also recognize that the transplant policy suggested

in the Final Rule would result in more of our patients dying while waiting for a

transplant, and a significantly higher rate of retransplantation and possible organ

wastage. We are also concerned that the core HHS policy is a design to direct more

organs to a few larger transplant centers, which would result in a loss of access to

transplantation services for those patients who could not travel long distances for

financial or family reasons.

The Rule itself applies to all organs and cannot withstand medical scrutiny. For

example, another serious effect of this policy would be to increase the ‘‘cold ischemic

time’’ for organs since organs would travel farther to the large centers. The IOM

study pointed out that ‘‘a 4.2 percent reduction in re-transplantation . . . by using livers with lower ischemic times would necessitate less re-transplantation and would

mean that 170 additional patients could receive a liver transplant.’’

The HHS policy is also shortsighted in its wholesale preemption of state laws regarding organ transplantation. Many of the beneficial policies that have served to

improve organ procurement and donation are based on state laws, such as the organ

donor check-off on driver’s licenses. The HHS preemption fails to recognize that fact.

In addition, this preemption clearly exceeds the authority granted by Congress.

During the moratorium period, we have worked actively with the transplant community to try to form a consensus on how best to deal with the HHS position. We

have been involved in discussions with HHS officials who have promised the transplant community a revised proposal that would take into consideration our objections to the Final Rule. We are still waiting for a response from HHS as the clock

ticks down on the current moratorium scheduled to expire October 21, 1999. We also

are still waiting for HHS to publish an analysis of the thousands of public comments

filed in response to the Final Rule. We understand that more than 85% of these

comments stated strong opposition or concerns about the Rule.

The best solution to the problem is for Congress to reiterate the long held statutory premise that organ transplant policy should be left to the private sector transplant community through passage of new authorizing legislation. And, short of that,

Congress should continue the moratorium until a new authorization bill can be

passed.

H.R. 2418, the ‘‘Organ Procurement and Transplantation Network Amendments

Act of 1999’’ recognizes that scientific and medical decisions about organ transplant

policy should be left to the private sector transplant community rather than to the

federal government bureaucracy, a concept that the PAT Coalition enthusiastically

supports. The legislation’s construct has worked successfully historically, and we

continue to believe that the private sector is better equipped than the government

55

to sort through the complex medical, scientific, and ethical challenges presented by

organ transplantation.

H.R. 2418 correctly places a strong emphasis on the real solution to the organ

shortage problem: increasing organ donation.

But most importantly, this bill would restore the public’s confidence in the transplant system and would serve to recognize the contributions made by the donors,

patients, OPOs, doctors and volunteers who have actively participated in the development of a transplant system that results in 21,000 life-saving transplants each

year.

Since the passage of NOTA in 1984, the number of people receiving organs has

increased annually and survival rates are steadily improving.

Congress should expeditiously take a positive step forward, building on a truly

unique and successfully working transplant system, and pass H.R. 2418, the ‘‘Organ

Procurement and Transplantation Network Amendments of 1999’’.

We appreciate the opportunity to testify here today.

Thank you.

PATIENT ACCESS TO TRANSPLANTATION COALITION

POLICY PAPER

September 1999

The Patient Access to Transplantation (PAT) Coalition supports an organ allocation system that balances fairly ‘‘equity’’ with ‘‘utility.’’ Organ allocation policy must

seek to achieve the greatest good for the greatest number of people. Organ allocation

policy must avoid futile transplantation, excessive retransplantation, decreased viability of organs and other waste adversely affecting the supply of organs.

Local access to transplantation must be preserved both for the sake of patients

nationwide, especially minorities and medically underserved populations, and in

order to improve donation.

NOTA

The PAT Coalition strongly supports NOTA’s current delineation of authority. The

National Organ Transplant Act (NOTA), as initially passed by Congress and as

amended, establishes and clearly delegates policymaking authority to the Organ

Procurement Transplantation Network (OPTN), a private sector entity comprised of

physicians, patients and other transplant community representatives.

• NOTA’s legislative history explicitly provides that the private sector OPTN should

decide medical criteria for allocating organs, and should resolve issues regarding the fair distribution of organs.

• NOTA grants the Secretary oversight authority. Under NOTA, the Secretary is responsible for contracting with the OPTN and for soliciting comments on the

OPTN’s performance of its duties.

• The PAT Coalition strongly supports retention of medical decisionmaking in the

private sector, and opposes HHS’ involvement in developing, modifying or

vetoing organ allocation policy unless specifically directed under statute.

PREEMPTION

NOTA currently does not contain federal preemption statutory language. The Secretary’s Final Rule should avoid any attempt to preempt by regulation authority of

the states or authority in the area of organs which the Congress has not granted

explicitly to the Department. The federal preemption issue should be reserved for

NOTA reauthorization. Otherwise, HHS invites a lawsuit on the preemption issue.

HHS ROLE

The Pat Coalition supports a strong federal leadership role in organ donation. Intractable problems in allocation can never be fully resolved as long as the dire shortage of available organs remains and we urge the federal government to assume affirmative responsibility and make this its highest and primary priority. To that end

the PAT Coalition supports:

• Substantial increases in federal funding available for organ donation initiatives,

including a national educational campaign which covers living donor organ donation as well.

• Direct financial support and matching grants to states who are willing to mount

donor education and awareness campaigns within their states, establish donor

56

registration programs, and test other innovative approaches such as contributions for funeral expenses.

• Substantial increases in the National Institutes of Health (NIH) budget for targeted institute intramural and extramural research initiatives directed at increasing donations and making scientific and medical progress in organ transplantation (e.g., NIDDK, NHLBI, etc.).

• Continual expansion of the HRSA extramural research support funding to test,

evaluate and replicate creative research projects developed nationwide, including a directive to cover living donation initiatives.

• Seed money to explore the feasibility and logistics of establishing a national organ

donor registry.

The PAT Coalition supports the oversight role given to the Secretary of Health

and Human Services in the National Organ Transplantation Act (NOTA) regarding

oversight of the Organ Procurement Transplantation Network (OPTN). HHS has no

policy role in organ allocation.

• The PAT Coalition supports strong enforcement of OPTN policies by the OPTN.

The Department may exercise its oversight responsibilities to seek input on the

OPTN’s exercise of this authority.

• Any independent review board created to assist or advise the Secretary (as suggested by the IOM) must be fully autonomous and independent. The appointment, composition and responsibilities of any such group must be wholly independent of any political process and the Department and Administration. We

do not support using the Federal Advisory Committee Act (‘‘FACA’’) construct

because it would vest the Secretary with appointment authority and the role of

a committee or advisory board chartered under this authority would be advisory

and non-binding. This review group should not be charged with any policymaking responsibilities which belong in the private sector OPTN.

LISTING CRITERIA AND PRACTICES

The PAT Coalition believes that the private sector medical community, including

surgeons, transplant physicians and scientists, should be solely responsible for development and ongoing refinement, where appropriate, of organ-specific listing and

de-listing criteria based on standardized medical assessments.

• In balancing equity and utility considerations, the PAT Coalition recognizes that

transplantation of the ‘‘sickest’’ patient is not always the best or most appropriate use of an organ, given higher survival rates and lower retransplantation

rates of less sick patients.

• The PAT Coalition supports an independent process of prospective and ongoing

concurrent review of patient status and application of medical listing and

delisting criteria through chart review of all transplant centers within a given

region.

• The PAT Coalition supports imposition of significant monetary penalties by the

OPTN to enforce standardized listing and de-listing practices, and adherence to

OPTN policy.

REGIONAL SHARING

The PAT Coalition supports broader regional sharing of organs based on private

sector initiatives and arrangements. The PAT Coalition supports flexibility in the

size of the population base utilized to achieve broader regional sharing, such as a

population range of 6-11 million lives. Working relationships and arrangements between and among transplant centers in specific regions must drive the development

of broader sharing. We do not perceive a ‘‘cookie cutter’’ approach to broader sharing

will succeed because successful sharing must be based on relationships, which reflect regional considerations and availability of transplant centers and other resources within these regions. The PAT Coalition opposes development of a national

waiting list and any centralized allocation system administered or structured by the

federal government.

IMPORTANCE OF LOCAL ACCESS

• The PAT Coalition continues to believe that the policy mandated by HHS will impair access to transplantation services, especially for low-income and minority

patients. Lack of access to organs may drive some regional transplant centers

out of business, inflicting a fundamental blow to patient access and patient

choice. Any Final Rule adopted by HHS must ensure access to transplantation

and prevent unnecessary transplant center closings. The OPTN must assure

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that allocation policies developed will not harm patient access to local transplantation services.

• The PAT Coalition concurs with the independent research finding that for a significant number of individuals, there is a greater willingness of people to donate

if they can be assured that their organs will remain in their own local community or at least in their state (source: 12 years of independent research conducted by Kansas State University researcher James Shanteau).

ADDITIONAL CONCERNS

• OPO performance and effectiveness must be measured in a more meaningful way.

HHS should develop alternative and outcome performance measures for OPOs

as recommended by the General Accounting Office and endorsed by the Institute of Medicine.

• The Medicare and Medicaid statutes should be amended to ensure coverage to

transplantation for beneficiaries who are uninsured. Such costs should not be

borne by transplant centers.

• Models should be developed and disseminated nationally from careful screening

of procurement and utilization practices and subsequent clinical outcomes.

CONGRESSIONAL OVERSIGHT

The PAT Coalition supports strong Congressional oversight of both the federal Department of Health and Human Services and the Organ Procurement Transplantation Network (OPTN). To that end, the General Accounting Office (GAO) should

be charged with periodic oversight reviews of both the Health Resources Services

Administration (HRSA) and Health Care Financing Administration (HCFA) program responsibilities and the OPTN contractor.

Mr. BILIRAKIS. Thank you very much, Doctor. There is a package

here, testimony of the National Kidney Foundation and various letters—Shands Health Care and University of Texas, et cetera,

which has been handed to the minority, and I would ask unanimous consent that it may be made a part of the record. Without

objection. That will be the case.

I very much appreciate Dr. Rabkin emphasizing so very much

the donation area, because without adequate organs being donated

we can have all the allocation systems in the world, change this,

change that, and it is just not adequate.

And that is what concerns me an awful lot. Granted we are concerned about allocation and that sort of thing. And Mr. Barrett said

it as—I am not going to paraphrase and I may even be wrong in

paraphrasing, but he referred to the people in his area wanting to

know basically who was getting the organ and at least that there

would be an easier donation type of a situation if they knew that

it was sort of local, if you will, or at least regional. And I have

made those comments before and I feel very strongly about that.

I don’t have any trouble putting myself in the shoes of the public

back in my region in terms of—and we do well, particularly in Florida, we do well as far as donations are concerned. And someone

said something about if it ain’t broke don’t fix it, and that concerns

me.

I want that to be a part of the record because I know Mr. Irwin

referred to prior comments on my prior positions on my part.

But I will tell you and anyone who says differently is lying in my

opinion, that we are, as I said earlier, parochial. We have to be.

We represent people in our congressional district. And I dare say

that if the University of Pittsburgh were not at the forefront of this

national allocation system, that some of the people in Pennsylvania

and eastern Ohio might maybe not change their positions but at

least look at it a little more objectively. And the same thing is true

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if Florida and the University of Florida and Miami and whatnot

had a different position, that certainly would have an effect on me,

and I am going to be the first one to admit that.

But we are concerned about equitable—to use the terms that I

think Mr. Irwin used—equitable allocation. And we are concerned

about the sickest receiving the organs as against those who are not

in that category.

I understand that the IOM report concluded the current system

of liver allocation is not only fair for the sickest patients, but to everyone in urgent need of a transplant receives—and I believe Dr.

Rabkin touched on this—receives one, status 1 and 2A.

And if that is the case, it makes me wonder, Secretary Shalala

in a January 20, 1999, press release said: ‘‘These findings make

clear that changes are urgently needed to produce better and fairer

outcomes for our Nation’s organ transplant patients’’ and that, ‘‘further delay can only needlessly injure patients.’’

And yes, the IOM, which has been quoted so very much by the

administration and by others and certainly has made the news, basically is being held out as having said that unfairness exists and

that sort of thing. So Dr. Gibbons, would you care to expand?

Mr. GIBBONS. Love to. Let me first state that there is a difference

between equitable and optimal.

Mr. BILIRAKIS. Equitable and?

Mr. GIBBONS. And optimal.

Mr. BILIRAKIS. Okay.

Mr. GIBBONS. Our findings were that the status 1 patients were

treated equitably in the sense that there was not significant variability across the organ procurement organization for those status 1

patients, meaning that the rates of transplantation were fairly

similar and there weren’t these large geographic heterogeneous distributions. This was not true for the status 2B and 3 patients.

There was considerable variability from one OPO to the other and

beyond just that, the smaller OPOs were transplanting large numbers more of these less severely ill patients relative to the larger

organ procurement organizations.

Mr. BILIRAKIS. Are the sickest patients receiving the organs even

though—I mean, and if that is the case, are some of those organs,

many of those organs, whatever the proper term is, coming from

outside of those regions?

Mr. GIBBONS. That is an excellent point. First of all, all status

1 patients are not receiving organs. By our comments about it

being equitable it means that the rates are fairly similar, but only

54 percent of the status 1 patients are ever receiving an organ

across the country.

Now, what happens to the other 46 percent, which is a very important question? 8 percent of those status 1 patients die while

waiting for an organ. Again, those rates are comparable across the

system.

Mr. BILIRAKIS. Doctor, forgive me, are you saying that appropriate organs are available in other regions and that they are being

used for people who are nowhere near as sick and for that reason

these category 1 people are not receiving the organs?

Mr. GIBBONS. That is one of the reasons, yes, sir.

Mr. BILIRAKIS. That is one of the reasons.

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Mr. GIBBONS. Absolutely.

Mr. BILIRAKIS. And you pointed—you have detailed that in your

report in terms of evidence of that and that sort? I am not trying

to be difficult, don’t get me wrong, I just want to be sure. I know

that you have used terms like ‘‘inconclusive’’ and that sort of thing,

and I just want to know is this conclusive? I am assured in Florida

particularly, Mr. Miller can speak to this—nobody is under oath

here—but I am assured that many organs are shipped, if that is

the proper term, out of the State to be used by recipients who are

sicker. Is this true, Mr. Miller? If it is not true, please feel free——

Mr. MILLER. Well, it just so happens that we have a very, very

busy transplant program in Florida, many status 1 patients. So if

I were to say what the net would be, the balance of trade for status

1s would probably be into the State. On the other hand, were there

a status 1, let’s say, in Emory in Atlanta, and we have the donor

in Miami, that status 1 would be sent to Atlanta.

As a matter of fact, Dr. Payne just testified that the new algorithm for status 1 sharing was already in the pipeline as the Institute of Medicine was deliberating. So there was a more broader

sharing of status 1s——

Mr. BILIRAKIS. You said that. I suspect that Dr. Payne said that,

too, and I apologize for not hearing his testimony. But Dr. Gibbons

heard that. Is that true, were these changes in the pipeline during

the times that you were deliberating and working up your report?

Mr. GIBBONS. There were changes that were made during the

course of—towards the end of our report that were to some degree

consistent with our recommendations. Our recommendations were

broader sharing all across the board, not just for status 1 patients.

Also, what you are saying and what Dr. Miller is saying is completely consistent with our findings; that is, those States and those

regions that started to institute broader sharing of one form or another had an increase, a statistically significant increase, in the

overall transplantation rates of status 1 patients, making it more

optimal, despite the fact that it was already quite equitable. There

are status 1 patients who are not receiving organs, and there are

small organ procurement organizations in existence that are transplanting much higher rates of 2Bs and 3s that could ultimately go

to status 1 patients in other organ procurement organizations within the limits of cold ischemic time.

Mr. BILIRAKIS. My time is well up. We might—depending on how

many more people return, we might go a second round here.

Mr. Brown.

Mr. BROWN. Thank you, Mr. Chairman.

Dr. Rabkin, in your testimony you said that the organ transplant

policy should be left to the private sector transplant community.

You basically argue, if I understand transplantation, communities

should make virtually all or basically all allocation distribution decisions, correct?

Mr. RABKIN. I think if you define the transplant community as

it is currently structured, the answer yes would be correct.

Mr. BROWN. How would you define it?

Mr. RABKIN. Well, the transplant community currently doesn’t

just consist of transplant surgeons and transplant physicians. It includes, most importantly, patients, patient families, donor families.

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It includes members of the community. So I think it is a very broad

net. But I think all of these individuals have an interest and a

knowledge and a commitment to the transplantation process. They

understand the nuances, and they therefore—what has historically

happened is they have derived an allocation policy that has been

very effective and has brought transplantation to the point that it

is today. It is a dynamic process, continuously evolving and improving.

Mr. BROWN. If those transplants are paid by Medicare or Medicaid, FEHP, the Federal health system, does that change the position that you take in terms of who should make these decisions?

Mr. RABKIN. By the same token that we don’t discriminate on a

payor to decide who gets a transplant. It doesn’t matter who is paying for it who should be making the decision on who should get a

transplant.

The answer is no. We are trying to help as many patients as we

can with the limited resources that we have available.

Mr. BROWN. So with these decisions, spending taxpayer dollars,

there should be no real public role of government and of representing taxpayers when taxpayers are paying huge amounts of

money in a very profitable system, a system that has huge—all

kinds of for-profit entities in this system, from doctors being very

well paid to hospitals using it as profit centers, for-profit hospitals

and in some cases not-for-profit hospitals, for other kinds of people

in this allocation system which you describe very well. There

should be no role for taxpayer government involvement in these decisions?

Mr. RABKIN. No. That is not, in fact, what we believe. There is

a role for government oversight.

What I stated was that the allocation policy is a medical decisionmaking policy. It is similar to all other policies that take place

currently in other medical fields. There is not a government bureaucracy deciding necessarily who gets treated with a particular

illness and in what fashion. I think that there is a level of decisionmaking and oversight that does take place at the Federal level, but

the allocation policy per se needs to be in the hands of the transplant community.

Mr. BROWN. Even though the allocation decisions affect large

numbers of people, even people that—affects large numbers of people beyond perhaps what you very narrowly define as the transplant community, those decisions shouldn’t be overseen by the HHS

or shouldn’t be formed or formulated in any way by HHS?

Mr. RABKIN. I am not sure I really understand your question. I

think that I have stated as best I can state that I try to segregate

what we feel ought to be left in the hands of the transplant community, which is really the medical decisionmaking involved, as opposed to some of the——

Mr. BROWN. Let me take another direction for a moment. Adding

that UNOS in this bill has an appropriation of $6 million, so there

is always government involvement when it comes to paying for it,

the section, page 15 of the bill, this is my concern. I don’t disagree

with you in terms of the medical decisions. Clearly, the physicians

and the nurses and the hospitals and the transplant—the patients

all should have major roles in all of this. But on page 15, there is

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a section on gifts. ‘‘this section does not prohibit the network from

accepting gifts of money or services including gifts to carry out activities to provide for increase in organ donation.’’

On page 20 of the bill, ‘‘Prohibition against organ purchases,’’ insert after, ‘‘does not include—does not include’’—inserting after,

‘‘does not include the following: A benefit, the exchange of which

is expressly contemplated by organ distribution policies, demonstration projects.’’ it goes on and on and on.

My concern and a concern of a lot of us on both sides is the enormous profits that come from the terrific services that you as surgeons and the people that work with you—enormous profits generated in many cases. What drives this whole issue in part, I am

not sure that we—I am not sure that we have protected the public

when things like gifts are expressly allowed. Those gifts could take

the form—some cases a gift to encourage people to donate perhaps,

but in other cases gifts to steer people into major centers or to encourage—maybe if I am a wealthy potential beneficiary, recipient

of a transplant, then I make a gift to a hospital and get moved up

on the list, or my family does. We have to be extremely careful

that—while you certainly want to do the right thing from your testimony, all of you do, that are physicians and nonphysicians alike,

we need to be especially careful to not allow the for-profit drive in

this to overwhelm what should become good public policy.

Did you want to say something, Mr. Irwin, just a minute ago?

Mr. IRWIN. I just wanted to comment that I believe there are two

levels of decisionmaking that go on here, or policy setting. One certainly is medical. From our perspective I don’t think that we have

an issue with that. For the most part, the medical allocation policies that distinguish status 1 patients from 2As, 2Bs, and 3s we

feel is pretty well thought out. The problem is the public policy

issue. With that medical criteria, how big of an attachment area do

you use?

The problem with the system today is you have—because of a

varying number of factors, you have relatively small allocation

areas where relatively healthy patients are being transplanted,

where sicker patients are not being transplanted in fairly close

proximity, which really is contrary to the medical allocation decision that the sickest patients should be given priority.

The other concern that we have in our experience is just the way

these decisions are made by the OPTN contractors’ board. There

seems to be a lot of self-interest that comes out in the discussions

at the board level to the point where sometimes recommendations

from committees that explore this issue are overlooked or overruled

despite the fact from our perspective they make pretty good sense

from a public policy perspective.

Mr. BROWN. Thank you, Mr. Chairman.

Mr. BILIRAKIS. I thank the gentleman.

Mr. Bryant.

Mr. BRYANT. Thank you, Mr. Chairman. I apologize to this panel

for being a little bit late. We were involved in another committee,

and I have missed some of the testimony. For that reason I would

ask Mr. Irwin, if you have a microphone handy there, you represent NTAC. Is that the correct——

Mr. IRWIN. Yes, the National Transplant Action Committee.

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Mr. BRYANT. Does NTAC in any way coordinate its activities

with the University of Pittsburgh?

Mr. IRWIN. Mr. Bryant, we coordinate our activities with a lot of

institutions and patients around the country. We have—we speak

with and work with Mount Sinai Medical Center, with the University of North Carolina. We have received a contribution last year

from Jackson Memorial Hospital in Miami. I work with Stanford

and University of California, San Francisco. And yes, we coordinate

our activities with all of these institutions, including the University

of Pittsburgh.

Mr. BRYANT. Thank you.

Mr. Chairman, if I could, with unanimous consent I have a sixpage document that is various memoranda from the University of

Pennsylvania and a one-sheet, two-sided letter from Mr. Livingston, our former Member, former Chairman of the Appropriations

Committee. I would like to——

Mr. BILIRAKIS. Is that University of Pennsylvania or Pittsburgh?

Mr. BRYANT. It could be Pennsylvania, UPMC. I think that is

University of Pittsburgh.

Mr. BILIRAKIS. Okay. In any case, without objection, but that is

a part—well, I am not sure. Anyhow, that is part of the record.

Mr. BRYANT. Thank you.

[The information referred to follows:]

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Mr. BRYANT. The concern I had, quite frankly, Mr. Irwin, is that

in this confidential memorandum, it is discussing various strategies in lobbying Congress and getting people to write letters, which

I assume would be taking a position consistent with the University

of Pittsburgh.

It mentions that Charlie and Craig mentioned it is more critical

than ever for legislators to hear from their constituents. And then

Craig and Charlie have identified the following members of the

House and Senate Appropriations Committees as initial targets because of their views in the district.

So it looks to me like you have been coordinating strategies that

I assume would make NTAC consistent with taking the position

consistent with the University of Pittsburgh?

Mr. IRWIN. Certainly, Mr. Bryant. The same thing is happening

on the other side of this issue with the opposition.

Mr. BRYANT. I have no doubt. I just want to be transparent.

Mr. IRWIN. In addition, I would like to state that we do have

membership around this country, and we rely on volunteers and

that membership to also help us in a variety of areas.

Mr. BRYANT. Does—do you—you are an active lobbyist for the

year 1998. During this particular year, and including the year that

you wrote the letter about former Chairman Livingston, were you

officially lobbying? Were you registered as a lobbyist in 1998?

Mr. IRWIN. The National Transplant Action Committee has not

filed as a lobbyist. The work that I do I do through a private company. And as directed by law, this is a company that I started with

Mr. Charlie Fisk that does a variety of services in the transplant

field. As appropriate, we have filed papers with respect to the lobbying act.

Mr. BRYANT. For year 1998?

Mr. IRWIN. Mr. Bryant, off the top of my head, I can’t tell you

exactly. I think we filed in 1997 because we did have some considerable expenditures, but I know in the last year I can’t tell you

whether or not we met the criteria or not.

Mr. BRYANT. Could you tell me if either you or Mr. Fisk are

being paid by the University of Pittsburgh to testify?

Mr. IRWIN. No. I have never been paid by the University of Pittsburgh to testify.

Mr. BRYANT. And Mr. Fisk?

Mr. IRWIN. No.

Mr. BRYANT. Dr. Raub, if I might ask you some questions also.

At last year’s hearing there was a great deal of concern that the

regulations would force the closure or have a severe negative impact or small and medium-size transplant centers who are performing these vital services. The Secretary at that time assured

this committee that she would make certain that regulation would

not have that effect. Specifically, the Secretary was asked by Senator Frist, ‘‘Would you be willing to provide assurances and regulation if possible that you are not asking the UNOS or whoever the

contracting agency might be for a policy that would result in the

center’s closing,’’ end of question.

The Secretary responded, ‘‘The answer is yes. As best I can tell,

the IOM report was less than convincing that these regulations

would not have such an impact citing conflicting studies.’’

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My question is are you willing to give this subcommittee the

same assurances that the Secretary did last year?

Mr. RAUB. Sir, the final rule as published in April includes the

provision that, when the OPTN develops the proposed allocation

policies, it take into account and make an assessment of the likely

impact on those small centers. The basis of that provision is to fulfill the Secretary’s assurance. It is not our desire to close small centers.

Mr. BRYANT. That would be then—you feel that would adequately protect the small centers?

Mr. RAUB. We do, sir.

Mr. BRYANT. Mr. Chairman, is my time up?

Mr. BILIRAKIS. It is. If you would like an extra minute or so, with

unanimous consent, we will be glad to grant it. I do want to finish.

Hopefully, we will finish up before the vote comes up on the last

amendment on this particular bill on the floor. Please proceed if

you would like.

Mr. BRYANT. If I could have unanimous consent for one additional question?

Mr. BILIRAKIS. Without objection.

Mr. BRYANT. Dr. Raub, we are all aware of the substantial debate generated by the Department’s April 2, 1998, final rule. I understand that you have conducted a series of meetings with the

transplant community aimed at identifying a reasonable compromise all parties can live with. It is also my understanding that

as part of the process, the Department has indicated on several occasions its intent to reissue modifications to the April 2, 1998, final

rule, but has not yet actually done so. Specifically, your letter of

August 30, 1999, to the transplant community stated that ‘‘I intend

to move vigorously in cooperation with the transplant community

to put a modified final rule in place—’’and this is important—‘‘and

to bring about the changes in the regulation that could and should

be made.’’

Why then, when we find ourselves less than 1 month from the

expiration of the current moratorium, has the Department not yet

issued anything in writing to indicate the proposed modifications of

the final rule? Are we running out of time?

Mr. RAUB. Sir, in considering the public comment, the IOM report, and the meetings with the representatives of the transplant

community, the Department has made several determinations. One

is that the core principles and provisions as embodied in the rule

are sound. Second, these interactions have helped us identify a

number of areas where some refinement or revision or other clarification in the rule would make it better and would be responsive

to many of the concerns. I indicate two examples in my prepared

testimony.

Third, the intent of the Department, by the time of the date of

the end of the moratorium, is to have those revisions in place and

be prepared for that revised rule to go forward.

Mr. BRYANT. If I might follow up, on a time line, when would we

see this?

Mr. RAUB. I can’t state a precise time line other than that our

intent is to meet the end of the moratorium and to have these revisions in place at that time.

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Mr. BRYANT. Can you identify for this subcommittee those aspects of the rule that you plan to change?

Mr. RAUB. Just elaborating on one of the examples in the testimony, both the IOM report and a number of the public comments

indicate a desirability of some sort of scientific expert independent

advisory panel. We believe that is an intriguing idea. We are considering the number of variants that have been proposed for that.

We are looking at that in the context of the Federal Advisory Committee Act. That is an area that we are pursuing very seriously.

Also, our colleagues on the outside have pointed to the various

sentences in either the rule or the preamble that have caused them

to conclude, incorrectly, that the rule calls for a national list, that

it overrides the decisions of physicians with respect to which patients to transplant. We are looking hard at that language. That

was not the intent of it. To the extent that we identify an ambiguity and can clarify that, we will do so.

Mr. BRYANT. Thank you, Mr. Chairman.

Mr. RABKIN. Mr. Chairman, would it be out of order for me to

just ask a question?

Mr. BILIRAKIS. Who asked that? A question of whom, of Dr.

Raub?

Mr. RABKIN. Yes.

Mr. BARRETT. Mr. Chairman, there is 10 minutes until the next

vote.

Mr. BILIRAKIS. If you are going to ask questions, sir, without—

this is out of the ordinary, but do it quickly. And respond to

very——

Mr. BARRETT. I would like to object until we are done with our

questioning, if I could.

Mr. BILIRAKIS. Okay. The objection is heard, so you can’t do it.

Mr. Barrett.

Mr. BARRETT. Thank you, Mr. Chairman. I don’t mean to be

rude. If we have time, I would be happy to let you do it.

Mr. Irwin, you begin your testimony by saying you are a consumer advocate of the National Transplant Action Committee as a

consumer advocacy organization; is that correct?

Mr. IRWIN. Yes.

Mr. BARRETT. What percentage of your funds comes from consumers?

Mr. IRWIN. Off the top of my head, I couldn’t tell you.

Mr. BARRETT. Would it be fair to say that over 90 percent comes

from hospitals?

Mr. IRWIN. Not that much.

Mr. BARRETT. Can you give me a ballpark figure?

Mr. IRWIN. It is like moving—a moving target. What I can tell

you is we recently did a fund-raiser in our community with about

200 volunteers that raised about $30,000. I would say maybe 60

percent.

Mr. BARRETT. Dr. Rabkin, the Patient Access Coalition, I assume

the lion’s share of your money comes from hospitals as well?

Mr. RABKIN. That is correct.

Mr. BARRETT. I say that because we are all on our best behavior,

and we are all trying to be nice to each other, but we are fighting

about money, and we shouldn’t forget that.

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I would like to sort of invite you in and have you sit with me

and pretend for a moment that I am a hospital administrator that

is affected by this rule. We have been spending $200,000 on an

organ procurement outreach network in our community. This new

rule comes down that says from here on in the organs will not stay

in our region, they will be shipped across the country. Correct me

if I am wrong, but as I am sitting here with my surgeons, my

nurses, and my other hospital administrators, I am going to say,

zero out that $200,000 in organ procurement, that is no longer a

priority. Put that $200,000 into developing a waiting list of the

most critical patients. Won’t I do that, Dr. Raub?

Mr. RAUB. I see that as a possible decision, sir, but I couldn’t

state it with certainty that it would or wouldn’t be.

Mr. BARRETT. Dr. Gibbons, what would you do if you were administrator of that hospital? Would you put money into organ procurement, or would you put it into developing a waiting list, if you

were running a hospital?

I am asking what you would do. Data shmata. What would you

do?

Mr. GIBBONS. I only do data, sir.

Mr. BARRETT. You look remarkably like a human being, so I am

asking you what you would do if you were the hospital administrator.

Mr. GIBBONS. If I were the hospital administrator, sir, I would

note that increased broader sharing has actually increased donation rates, and that to ship an organ across the country doesn’t

make an awful lot of sense given cold ischemic times and the——

Mr. BARRETT. $200,000, where would you put that money, putting patients on a waiting list or procuring organs that might by

shipped across the country?

Mr. GIBBONS. I would put it into procuring organs because I don’t

believe that those organs would be shipped across the country. I

think broader sharing is a good thing, and 9 million people is not

so large that it reaches——

Mr. BARRETT. Okay. Mr. Gibbons.

Mr. GIBBONS. That is me.

Mr. BARRETT. Mr. Irwin, what would you do?

Mr. IRWIN. It doesn’t make sense to try to buildup your waiting

list if you don’t have the donors to service it.

Mr. BARRETT. But aren’t we putting together a beautiful system

for a free rider in pure economic terms, someone who says, well,

I am not going to worry about organ procurement because I gain

nothing. I gain nothing from organ procurement—in the most selfish way. Maybe in the global picture we do, but I am concerned

about my center here. And so the ticket to success under this system is to develop a waiting list.

Wouldn’t we agree with that, the ticket to guaranteeing patients

under this new system—guaranteeing patients under this new system is not getting organs, the ticket is getting sick patients. So if

I am a rational economic actor, I am going to be putting my effort

into getting sick patients. I think that has a devastating impact on

the supply of organs.

Mr. IRWIN. If you still want to hear from me, let me make a couple of comments.

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First of all, organ donation rates certainly vary throughout the

country. I don’t see any evidence that transplant centers or OPOs

with larger waiting lists are less aggressive or more aggressive in

trying to find donors. I think everybody in this system works hard

to maximize organ donation.

Second of all, I think you will find that in many cases patients

who do end up—who are sick patients who end up in a larger center, they are there because they are turned down by another center

who doesn’t have the expertise or the willingness to transplant

them.

Third of all, I think if you look at the data, transplant centers

that do transplant fairly sick patients in many cases have survival

rates that are on a par or even better than transplant centers that

transplant healthy patients.

Mr. BARRETT. If I may, Mr. Chairman, I know that time is short.

I also want to make this point. This is from Mr. Irwin’s testimony

commenting on the IOM study. Quoting, ‘‘Broader sharing of organs resulting from implementation of the final rule is not likely

to have a significant adverse effect on those who depend on Medicaid for their health care.’’

I don’t read that as a ringing endorsement that we are going to

improve access to the poor. That is one of the things that we have

had discussions here. To say that it is not going to have a significant adverse effect certainly leaves the door open that it is going

to have an adverse effect. With minorities in particular, the committee found, ‘‘that African-Americans do not receive kidney treatments as quickly as whites,’’ and that the Department’s rule would

not exacerbate this problem. It doesn’t say it will improve the problem, it simply says it is not going to make the problem worse.

So again, I think as we talk about minorities, about the underserved, that no one should leave this room thinking that the Department’s rule is somehow helping minorities and the poor based

on IOM’s own statement.

I would yield back the balance of my time.

Mr. BILIRAKIS. Mr. Green.

Mr. GREEN. Thank you, Mr. Chairman, and I will be as quick as

I can.

My first question is for Dr. Miller and Dr. Payne. I am concerned

that OPOs have not shown a willingness to share organs with

other OPOs or States within their closed region unless they do not

have any match within their own area. This practice is—the Institute of Medicine found it could have a negative impact on all patients who may lose the opportunity to receive a life-saving organ

based solely on their location.

In your testimony, you mentioned that the OPTN had already

begun to implement some of the IOM recommendations as they relate to organ sharing. Would you comment in greater detail on the

steps that have been taken? Are there plans to take or encourage

or require broader sharing of organs by OPOs within reasonable

geographic boundaries?

Remember, I am from Texas. We are pretty big. We have three

OPOs in our own State, and geographically there is no relation to

their areas.

75

Mr. MILLER. Dr. Payne is going to be able to do this better than

I. I would like to comment, though, if I might. The reason is he is

the president of UNOS this year. I think that is important. That

is where this process occurs.

However, we have felt the impact and are going to feel more of

this impact because of broader sharing, and it has to do with the

most urgently ill patients needing it. It is going to be regionalized

rather than localized so that in a region—for instance, we are in

a very large region in Florida that consists of Florida, Alabama,

Georgia, Louisiana, Mississippi. We are talking about a large region that has much more than 9 million people. That region has

developed methodologies now to attempt to share status 1—liver

status 1 patients.

May I make one comment about this local effect on organ donation, because there has been actually statements made by both the

esteemed Congressmen here as well as some of my colleagues at

this table that have actually put words into the IOM’s mouth, so

to speak. IOM came out with a statement that was very perceptively stated by Congressman Bilirakis, our chairman, that said

that it was inconclusive as to whether there would be an effect or

not on local organ retrieval or closure of local programs. Inconclusive. They did not say that there would not be an effect.

Now, if you were to ask experts in this field, the majority of the

American Society of Transplant Surgeons feel that there would be

an effect. We came out with a white paper about that. That word

is very important because it is a word that is used by—if you will

forgive me—statisticians who do not wish to make mistakes. It is

very important that they don’t.

Mr. BILIRAKIS. Doctor, would you submit that white paper for the

record?

Mr. MILLER. It has been submitted, and we will do so again. It

was our first paper on this when the——

Mr. BILIRAKIS. Please do so. The staff is not certain.

[The information referred to follows:]

PREPARED STATEMENT OF THE AMERICAN SOCIETY OF TRANSPLANT SURGEONS

ON EFFORTS TO RESOLVE THE CONTROVERSY OVER THE ORGAN PROCUREMENT AND

TRANSPLANTATION NETWORK

Introduction:

On October 21, 1998, a Congressionally ordered moratorium went into effect on

implementation by the U.S. Department of Health and Human Services (DHHS) of

the Final Rule published by HHS Secretary Donna Shalala in the Federal Register

on April 2, 1998 (42 CFR Part 121). This one-year moratorium is scheduled to end

on October 21, 1999 unless further extended by the U.S. Congress. In imposing the

moratorium, Congress asked the Institute of Medicine (IOM) and the General Accounting Office to conduct a study of current policies of the Organ Procurement and

Transplantation Network (OPTN) and the potential impact of the Final Rule. An

IOM Committee was formed to conduct this study in early 1999, and it published

a report, entitled ‘‘Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule,’’ on July 20, 1999.

The American Society of Transplant Surgeons (ASTS), as the professional organization representing the surgeons, physicians and scientists who lead the transplant

programs at the major medical centers across the United States, is committed to the

continuing refinement of organ allocation policies to meet the needs of our patients.

During the past 18 months, we have expressed both strong support for and strong

opposition to various aspects of the Final Rule. We have met repeatedly with leaders

of DHHS, have testified on this subject at hearings conducted by the U.S. Senate

76

and the U.S. House of Representatives, and have both testified before and provided

voluminous written information to the Institute of Medicine during its deliberations

in the spring of 1999.

We believe, based on numerous conversations, that an increasingly broad consensus exists among members of the transplant professional community on many

of the most contentious aspects of the Final Rule. We believe if a new Final Rule

were to be published today, it would not contain some of the elements that ASTS

has most vigorously opposed. DHHS itself has stated that it intends to publish some

number of unspecified changes to the Final Rule at some unspecified time prior to

implementation. We are increasingly apprehensive, however, that the transplant

community—and Members of the U.S. Congress, which is concluding its 1999 Session—will not see the proposed changes in a timeframe that would enable Congress

to again legislatively defer implementation of the Final Rule if the changes are not

found to be sufficiently responsive to our concerns.

While we do not propose in this position paper to repeat all of the points ASTS

has made in published position statements and testimony, we would like to highlight the major concerns we have been discussing with DHHS—and our views on

recommendations of the IOM Committee. We also urge Secretary Shalala to immediately publish the changes she proposes to make in the Final Rule. Given that the

one-year moratorium is near an end and we still have not seen any proposed

changes, we believe that when publication of changes by DHHS finally does occur,

a reasonable period of time for consideration of, and reaction to, these changes by

the transplant community—and Members of Congress—prior to implementation is

both fair and essential.

NOTA and Secretarial Authority:

The most difficult area to resolve in our discussions with representatives of DHHS

has been the question of Secretarial authority. We strongly believe the National

Organ Transplant Act (NOTA), which was passed by Congress in 1984 and established the OPTN in the private sector under government contract, intended for the

OPTN to make organ allocation policy based on sound medical principles and scientific data independent of political influence. This important principle is reaffirmed

in the NOTA reauthorization legislation introduced this summer in the U.S. House

by Chairman Michael Bilirakis and we hope that the legislative consideration of

NOTA Reauthorization will move forward in the coming year.

Let us be clear that ASTS supports preservation of the Secretary’s legitimate

oversight role. Three of the five specific recommendations included in the IOM Committee’s report addressed the area of oversight and review. The committee concluded

that ‘‘oversight and review of the nation’s organ procurement and transplantation

system needs to be enhanced to improve the system’s accountability to the public

and to ensure that it operates effectively in the public interest.’’ We endorse Recommendation 8.1 (Exercise Federal Oversight) and we stand ready to assist DHHS

in defining and updating performance standards for the OPTN, OPOs and transplant centers.

We simultaneously recognize and support the responsibility of the OPTN to make

specific organ allocation policy based on sound medical principles and scientific data.

We have expressed to DHHS our concerns that sections 121.4 (b) and (d) could be

interpreted as setting the stage for the Secretary of DHHS to make specific allocation policy, and have suggested changes in these sections to clarify the respective

roles. DHHS’s oversight responsibility should be to ensure that the policies that

guide the operation of the system are equitable, based on sound medical science,

and are adhered to. However, the Secretary must not dictate specific transplant

practices or medical judgments. The OPTN’s responsibility is to make specific policy

concerning allocation and to modify that policy on the basis of sound medical science

and developing medical practices.

Independent Scientific Review:

We believe IOM Recommendation 8.2, that the Department ‘‘establish an external

independent, multidisciplinary scientific review board,’’ has great merit. We agree

with the committee that the organ allocation system should be reviewed periodically

by an independent body separate from the OPTN. Obviously, a number of key issues

remain to be addressed, including the makeup of this board, how members would

be appointed, and what issues the board would review.

To be truly independent, we believe it important that the independent scientific

review panel not be appointed at the sole discretion of the Secretary, and since this

panel will be reviewing issues of medical judgment, we believe it imperative that

this panel consist of not more nor less than 50 per cent transplant surgeons and

physicians active in the field of transplantation. We believe an appropriately comVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00079 Fmt 6633 Sfmt 6621 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
77

posed body could bring medically sound resolution to difficult or contentious problems through careful objective review. We would then expect the Secretary and the

OPTN to work together to develop solutions based upon recommendations of this

body. We are prepared to suggest appropriate scientific experts to participate in

these reviews.

Standardized listing and de-listing criteria:

The transplant community currently recognizes the need for standardized listing

criteria, de-listing criteria and criteria for determining medical status. It is clearly

within the purview of the OPTN to develop these criteria, and to continually refine

them based upon changes in clinical care resulting from advances in medical

science. We believe the Final Rule should instruct the OPTN to develop standardized listing and de-listing criteria, and to develop a process for both prospective and

retrospective review for compliance. It should also provide a mechanism for funding

prospective review, such as an increase in listing fees. In this area, we would expect

that DHHS would be in a position of enforcing sanctions for non-compliance, and

we urge that the language of the Final Rule be changed to clearly reflect this.

Evaluation and Enforcement:

We totally agree that allocation and other policies, such as standardized listing

and de-listing criteria, must be enforced. However, as noted in section 121.10, the

only enforcement currently specified would involve relatively harsh penalties, including termination of a transplant hospital’s participation in Medicare or Medicaid,

or termination of a transplant hospital’s reimbursement under Medicare or Medicaid.

We believe the Rule should direct the OPTN to make recommendations on graduated enforcement options, and work with DHHS to develop a process for corrective

action prior to imposition of severe sanctions. Among the issues to be addressed is

due process, including at what level of enforcement Secretarial approval is required

prior to imposition of penalties.

Organ specific allocation policies:

We have previously emphasized the important principle that different organ

transplants require different allocation policies. The IOM report is careful to make

recommendations about liver transplantation only. Objective criteria of disease severity may be relevant to organs in which there is no suitable life support system,

such as livers or hearts. These types of criteria may have no relevance to other

organ transplants, such as kidneys or pancreata, for which there are suitable support techniques. We urge the Secretary to review the Final Rule and indicate that

other principles may apply to such organs.

Reducing Socio-Economic inequities:

We are encouraged by the IOM report’s conclusion that ‘‘the most important predictors of equity in access to transplant services lie outside the transplantation system—that is, access to health insurance and high-quality health care services. Thus

we are concerned that Section 121.4, subsection (3) of the final rule may seem to

place a too-heavy burden on transplant hospitals and OPOs. Specifically, we propose

that subsection (3) be changed to: ‘‘(i) Ensuring that patients in need of transplant

are listed without regard to source of payment. (ii) Procedures for transplant hospitals to make reasonable efforts to obtain from other sources . . .’’

OPTN Board Composition:

The final rule in Section 121.3 mandates an OPTN Board with a minimum of 30

members. Two seats are specifically allocated to transplant surgeons and two to

transplant physicians. It provides that ‘‘transplant candidates, transplant recipients,

organ donors and family members’’ shall comprise ‘‘at least 25 percent’’ of Board

members; and that transplant surgeons and transplant physicians shall comprise

‘‘no more than 50 percent.’’ We strongly believe that because of the technical and

scientific as well as ethical and social problems continuously occurring in this field,

transplant physicians and surgeons should comprise no more nor less than 50 percent of the membership of the Board.

Allocation of Organs:

In 1998, DHHS contended that differences in the median time that patients spent

waiting for a transplant at various centers demonstrated a fundamental unfairness

of the current allocation system, and argued on that basis for immediate implementation of the Final Rule.

ASTS has always taken the position that waiting times as used by DHHS were

not a good indicator of fairness, and totally agree with the data analysis performed

78

by the IOM Committee which clearly indicates that waiting time is not a reasonable

measure of equity of allocation for patients nor is the disparity of overall median

waiting time a reasonable measure of fairness of the current system.

But while we do not believe that waiting times as currently used are an appropriate performance measure, we are not—in the absence of a better methodology—

prepared to totally endorse the IOM Recommendation to ‘‘discontinue use of waiting

time as an allocation criterion for patients in Status 2B and 3.’’ We believe waiting

times might continue to be one consideration in the triage of liver patients in Status

2b and 3 when all other medical criteria are equal.

Thus, we recommend that certain sections of 121.8 be revised. As we have previously stated, neither time waiting nor medical urgency can be considered absolute

measures of equity for allocation of all types of organs for transplantation. For these

reasons, we would suggest that the final rule contain general principles of equity,

and suggest that it be left to the OPTN to develop the specific policies that achieve

equity.

Record Maintenance and Reporting Requirements:

We endorse IOM Recommendations 8.3 (Improve Data Collection and Dissemination). We strongly agree that physicians, patients and the public should have access

to accurate, understandable, and timely information regarding performance of the

OPTN, OPOs and transplant centers. However, the provisions in Section 121.11

mandating that updated data be made available to the public ‘‘no less frequently

than every six months . . . and shall be presented no more than six months later

than the period to which they apply’’ are not currently realistic. We propose that

data be collected annually. The one-year border will likely lead to more accurate and

efficient reporting. We also propose that data made available within one year after

the period to which it applies, but that it be made available more quickly at a time

when implementation of improved systems make this possible. Within two years of

the date of implementation of the Final Rule, we believe it should be possible to

make data available no more than six months later than the period to which the

data applies.

It is extremely important that the Secretary assure that any release of data be

done in a manner that preserves the confidentiality of individual patients and donors. Understanding that organ transplantation is performed infrequently even in

the busiest centers, identification of the date and location of a procedure could simultaneously identify the donor and recipient. Thus, in some circumstances, appropriate coding of some information may be necessary.

Organ Allocation Units:

We believe that Recommendation 1 (Establish Organ Allocation Areas for Livers)

is deserving of further study and would urge the Secretary—even prior to issuance

of the Final Rule—to direct the OPTN to present an analysis on those areas where

broader geographic sharing is now in effect and possibly even conduct tests in certain geographic areas based on this recommendation. Although the report of the

IOM committee found no evidence that supports the concerns that wider sharing—

or disassociating organ retrieval from organ allocation—would lead to decreased donation or closure of small programs, further study is required before such a conclusion can be drawn. There is no question that several OPOs serving relatively small

population areas have achieved some of the best donation rates, while other OPOs

do not have comparable rates of donation. This would suggest that local factors may

well influence organ donation, a very complex and delicate system, and that changes

should be made with extreme care. Therefore, to the extent that steps are taken either to broaden organ allocation areas or disassociate organ retrieval from organ donation, we recommend that any change in policy be reviewed by the OPTN within

one year, and at yearly thereafter, for its impact on patient outcomes, organ donation rates and transplant center volumes. We suggest that the OPTN might also undertake studies to determine whether the same principle of population-based allocation areas might improve the system of allocation of other organs.

DHHS and OPTN:

The report of the IOM committee clearly supports complementary roles of DHHS

and the OPTN in the transplant system. Unfortunately, a variety of issues have led

to substantial discord between the two organizations. While we understand the positions of the two parties and have commented on them previously, we believe it is

critical to the transplant community that these disputes be ended. We are encouraged by Secretary Shalala’s announcement that DHHS is prepared to make alterations in the Final Rule, and urge her to publish those changes for consideration

by the transplant community and the U.S. Congress at the earliest possible date.

79

September 16, 1999

Mr. BILIRAKIS. Please proceed, Mr. Green. I am sorry for interrupting.

Mr. GREEN. Dr. Payne?

Mr. PAYNE. My comments regarding wider sharing——

Mr. GREEN. Wider sharing within the region. I am not familiar

with southeast Texas, but I am in the Southeast of the United

States but understand Texas and sharing within the region, if not

nationally.

Mr. PAYNE. If I could just preface the answer with a little explanation about OPO boundaries, because I would hate for UNOS to

be saddled with the present OPO boundaries. Those boundaries

were established by HHS at the point that they were established

through HCFA. They were approved by HCFA. So those OPO

boundaries were out of the purview of UNOS at the time.

Mr. GREEN. My concern, though, is that the goal, I think, was to

regionalize it; not nationalize it, but regionalize it.

Mr. PAYNE. One of the first policies that UNOS adopted that extended sharing beyond OPO boundaries was that of identically

matched kidneys. That truly is a national program where if a kidney is made available anywhere in the country, and it is a so-called

perfect match with anybody on the waiting list, every effort is

made to get it to that particular patient. If more than one patient

is identified, the patient waiting the longest gets that organ. That

is a long-standing program that is available and takes it—expands

all OPOs in the country. That is an extraregional sharing agreement.

Mr. GREEN. That is for kidneys. That sounds like what HHS

might be wanting to do. I am a cosponsor of the bill, and I am concerned about what may happen in my own State.

Mr. PAYNE. The point there is that there is efficacy in doing that.

There is demonstrated improvement in outcome, so there is an effort made to do that, plus it is possible to do that with kidney

transplants because the cold ischemic time that we heard about is

not as critical in kidneys. They can go longer, so you have the time

to do it. In a liver transplant, it is much more difficult to set up

some sort of that broad sharing scheme.

So there have been stepwise attempts in regions around the

country to broaden sharing agreements across OPOs. Many of

them, they have been permitted by UNOS. Now, most recently the

policy that has been put in place nationally is that it will mandate

regional sharing, meaning the 11 UNOS administrative regions for

status 1 liver transplant recipients. Again, that is because of the

effectiveness of that for that particular patient population. Those

patients have a demonstrated benefit.

Earlier on, Dr. Gibbons was talking about the differences between equity and effectiveness, and in that case there is a real effective change in going from that 4 days that people average down

to 2 days. Everybody moves together. There is no change in equity.

Everybody waits the same amount of time, but everybody wins in

terms of effectiveness in terms of that patient.

Mr. GREEN. Thank you, Mr. Chairman. I see my light on. Since

we haven’t had a call for a vote, I have one question——

80

Mr. BILIRAKIS. Without objection, I have no problem with you

asking that additional question.

Mr. GREEN. Thank you, Mr. Chairman.

Dr. Raub, you mentioned that proposed provisions, we won’t have

to wait much longer. But again, this legislation and Congress is

going to have to act before October. It concerns me that we don’t

have those revisions now so that we can look at them and see what

may need to be done. But that leads into, both for the administration and UNOS and the rest of the panel, that we have been dealing with this in delaying the effectiveness of the final rule. There

has been—in earlier hearings there was effort to have both sides

sit down and work together to see how we could come up with

something that would be, and to this date I guess we haven’t.

Has there been efforts between the administration and HHS and

UNOS and the various groups to actually sit down and see how

this could be worked out?

Mr. RAUB. Sir, repeated discussions and meetings have been held

with both oral and written comments. As I indicated in my testimony, the Department has considered very seriously all of those

comments and has identified some areas where, while not modifying the core principles or provisions of the rule, we think some

refinements would improve it. And we are working hard to get

those formulated before the moratorium date ends.

Mr. GREEN. Thank you, Mr. Chairman. Any other comments

from—everyone else has a dog in the fight, so to speak.

Mr. MILLER. The American Society of Transplant Surgeons has

met with the Department very recently. My colleague, the president of the society, Dr. Busuttil, met with Dr. Fox.

We are concerned that we will not see this rule until the very

last minute. There may be language in the rule that still might be

improved upon. This is of great concern to us.

Mr. RABKIN. Mr. Green, I would like to echo that thought and

say that after having such a long period where we have had an opportunity to meet with the HHS and failed up to this date to have

any concrete proposal for change, it troubles us as well in the PAT

Coalition that we will not have the opportunity to weigh in and

make suggestions for refinement. As an example, Dr. Raub pointed

out that the IOM suggested an independent panel to be set up to

look at some of these issues. In fact, then he went on to mention

implementing the Federal Advisory Committee Act.

Well, the problem that we would immediately recognize is that

under that act it is directly under the Secretary’s discretion, it is

advisory, and, frankly, we don’t understand how that would add

any benefit if it is not an independent panel. I think if you read

the IOM report, they are very explicit, it needs to be an independent panel. So again, as an example, if the HHS comes forward

at the 11th hour with a proposal, but has these nuances of the interpretation that it would be put forward in policy, that would be

clearly objectionable to the members of the PAT Coalition.

Mr. GREEN. Thank you, Mr. Chairman.

Mr. BILIRAKIS. Well, Mr. Green, you brought up a point certainly

that I have been concerned with. We had all hoped—again, we are

an ivory tower here. We use that term an awful lot, but it is true.

We are required to make these tough choices and these tough deciVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00083 Fmt 6633 Sfmt 6602 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
81

sions when, in fact, people are better capable of doing it than we

are.

So this is why we had hoped that the transplant surgeons, HHS

would get together and work something out, and you haven’t. I

haven’t been privy to those conversations, but frankly, in my mind,

I really wonder whether HHS is willing to bend at all or just dead

set on their ways. Again, I am not trying to belittle any efforts that

HHS made in trying to work out these things and not resolving it

and not having to pass legislation to do something that you all

should be able to do, particularly when we hear of a bending on

the part of UNOS in terms of some of these areas that have been

pointed out.

Can you, Dr. Raub—would you furnish to the committee a copy

of those areas that you are contemplating changing that Mr. Bryant went into that somewhat? Will do you that?

Mr. RAUB. Yes, sir.

Mr. BILIRAKIS. Can do you that within the next couple of days?

Mr. RAUB. I will do it as soon as we can, sir.

Mr. BARRETT. Mr. Chairman, just for my education, the 1-year

moratorium, when does that expire? Do we know the day that expires?

Mr. BILIRAKIS. October 21.

Mr. BARRETT. I just want to say that I share the concern that

we are going to see that about the same time we saw the Department’s testimony.

Mr. BILIRAKIS. Well, Dr. Raub, you indicated you have been

working on this. Is there any reason why you can’t furnish at least

where you are at this point within the next few days? You will furnish it when you can. That might not be until late October.

Mr. RAUB. Some of the items are still in the early stages of

crafting.

Mr. BILIRAKIS. The moratorium is almost over, and they are still

in the early stages of drafting. I sometimes wonder if—well, sir, we

need that information. I frankly think that the industry out there,

the transplant industry, needs that information, and I think they

need it long before to give them an opportunity—I mean, I don’t

think that they should be left with what we have been here today,

not having seen the testimony until an hour before the hearing

started.

I say that with all due respect, but you should also realize that—

well, I am going to ask that that information, whatever is available—and whatever isn’t available, I guess you can’t furnish—be

submitted to this committee within—let’s say within 7 days of

today?

Need 48 hours? Why?

I am told that you have that information, and you are—all right,

48 hours. I am going to ask that it be furnished in 48 hours. I don’t

think that we should have to go through any legal proceedings or

whatnot in order to get that.

Can you do that, what you have?

Mr. RAUB. I will convey that request, sir.

Mr. BILIRAKIS. Please, Dr. Raub, do that. We want to do this the

right way, the nice way.

82

All right. A vote is being called on the floor. We have a number

of questions—oh, yes. A statement here submitted by Charles Fisk;

a statement here by Bruce Weir, Transplant Recipients International Organization, Inc., and a statement by Congressman Pete

Stark. I would ask as the Chair unanimous consent those be made

a part of the record.

There are a number of questions as per always, as per usual that

have not been asked, and we would like to furnish those to you in

writing and request that you respond to them as quickly as you

can, because, again, we are trying to do the right thing. I know

there has been more adversarial taking place at that table there

than frankly usually takes place up here, but believe it or not, we

are trying to do the right thing. Whatever information you furnish

to us could be helpful.

The hearing is adjourned.Thank you. Thank you for your patience.

[Whereupon, at 5:45 p.m., the subcommittee was adjourned.]

[Additional material submitted for the record follows:]

PREPARED STATEMENT OF CHARLES FISKE, UNOS GENERAL PUBLIC MEMBER

Mr. Chairman and Members of the Subcommittee: Thank you for allowing me to

submit written testimony on the reauthorization of the National Organ Transplant

Act. I came before this committee in April of 1990 and also April of 1993 to address

issues about the national transplant system. My involvement in organ transplantation began in 1982 when my then nine-month old daughter, Jamie needed a liver

transplant. At that time there was not much of a system in place for matching donors with recipients. In addition liver transplants had not been performed on anyone as young as Jamie and since there were only two liver transplant centers in

the country our family faced a difficult ordeal. Jamie was successfully transplanted

in November at age eleven months at the University of Minnesota Hospital.

The following Spring (April 1983) we came before then, Congressman Al Gore who

was conducting hearing on the problems transplant patients faced. In the fall of that

year Senator Orrin Hatch held hearings to learn of the ordeals that we and other

families encountered while waiting for an organ to be found in time. Senator Hatch

was familiar with Jamie’s situation since the donated liver came from Jesse Bellon

of Alpine, Utah. In 1984, President Reagan signed the National Transplant Act calling for a Task Force to study the issue. The task force concluded that a single national system would ensure that these national resources—donated organs—could be

effectively allocated fairly to all needing an organ transplant. Since then, I have

been actively involved in the issue and served on the UNOS (United Network for

Organ Sharing—the federal contractor) Board of Directors for four years. Currently,

I am one of only nine UNOS general public members. My observations and conclusions today are similar in some respects to my testimony previously presented before this same committee. We’ve come far but still have a long way to go to encourage the transplant system to be responsive to patients no matter who they are or

where they live. The implementation of the HHS transplant regulations will take

the care of patients to the next level. Passage of H.R. 2418 will be a step backwards

in this process and should not be passed. Congress has directed that the single national system be response to all medically urgent patients especially those with the

least access.

Congress must again encourage and demand that the National Transplant System

reflect the needs of the patient population first before serving the unique interests

of any transplant center. I’ve always advocated that the system be fair so that those

patients who are medically most urgent receive first attention. Patients should not

have to chase organs but rather be assured that when their time comes for transplantation they, given their medical status, will have a fair chance of receiving an

organ. Currently the system is based on local preference so that the available organ

is given locally even if there is another more medically urgent patient in the next

local area. If the organ can’t be used it is distributed regionally and then nationally.

Recently UNOS passed a resolution to have organs shared with status one patients

(most medically urgent with seven days to live) within each of the eleven regions

in the country. This is a good first step. Allocation determined primarily through

geographic boundaries rather than medical urgency makes little sense especially if

83

those organs can be safely transported greater distances. The wider allocation of organs needs to be expanded to include status 2A and 2B patients as well. There has

been a marked increase in the number of transplant centers. As a result, with more

patients needing transplantation the supply of available organs cannot meet the

current demand.

Congress needs to require that the national transplant system take the following

steps:

1) There should be greater oversight on the system to protect patients from the

self-interests of transplant centers. The UNOS Board is comprised of many individuals who represent various transplant centers throughout the country. Often they

are voting on policies that directly affect the financial interests of their own institutions. On the one hand the contractor is a membership organization and on the

other a regulatory body. Over the course of years this has been a difficult task for

the contractor. Greater oversight would assure the general public that the system

is in operating the best interest of all patients whether they lived in New England

or on the West Coast. That oversight involves the establishment of specific standards that not only protect the public but also assure the transplant community that

there is a mechanism in place to encourage compliance with public policy directives.

Only the Secretary can issue public policy that has the effect of law. Much of current debate over the NOTA reauthorization has to do with the confusion between

the development of public policy and the practice of medicine. The current contractor and a number of transplant centers have determined that all transplant

issues are considered the practice of medicine and are unwilling to respond positively to standards that have been established for the public policy purposes. Much

energy has been spent circling the wagons to keep the Department at bay when in

reality the public strongly supports a system that meets the needs of its most medically urgent. The transplant system is not the private domain of a certain select

group within the transplant community but directly connected to all our citizens on

whom we depend for organ donation. It is the general public through its patient registration fees and tax dollars that is fueling the system. To suggest that the National System can fairly operate on its own is both unrealistic and shortsighted. The

recent border war over organ allocation between Wisconsin and Illinois is a prime

example of special interests winning out over patients’ interests.

2) The most medically urgent patients must receive organs first. Distribution for

organs for the most urgent category could be realistically done beyond the boundaries of our current systems at both the local level and the regional level. The recently completed Institute of Medicine studies found that the current system now

operating could be greatly improved so that organs may be reaching to most medically urgent. The Institute of Medicine did find that the less urgent patients (Status

3) were being transplanted at the expense of those who are most medically urgent

(Status 1)

3) Data should be made available in a timely fashion. This data is not the private

property of the federal contract and should be accessible to physicians and patients

who make decisions on which center to approach for treatment. Data must be used

to help drive public policy decisions so that parochial interests of the various transplant centers cannot come before the interests of patients.

4) Patient registration fees should reflect the cost of helping run the transplant

system rather that fuels the special interest and lobby efforts of the contractor.

5) Greater steps need to be taken so that the ‘‘green screen’’ (no dollars, no transplant) affect is adequately understood as a major impediment preventing some patients from receiving care.

Congress has the ability to require this be done. The public needs to have confidence in the system so that when organs are distributed each patient can receive

an organ in a timely fashion when their turn becomes available.

I’ll submit copies of my prior testimonies from 1990 and 1993. Issues that were

raised then are yet to be resolved. I would urge this Committee to look forward not

only in fully supporting the HHS regulations but also encouraging the current contractor to take the immediate steps necessary to put an allocation system in place

that is responsive to current needs of the general public. The clear and astute recommendations that have come forward from the recently published Institute of Medicine report on the transplant system have supported the Department’s efforts to encourage the contractor to be more responsive to the needs of patients. Once the

changes have been enacted a full reauthorization of NOTA is in order. A more comprehensive bill to include the recommendations of the IOM report, the OIG report

(August 1999) and the April 1998 HHS regulations should be considered in the

spring of 2000.

Again I thank the Committee for the opportunity to present this information and

I am available at anytime to review this matter with you.

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PREPARED STATEMENT OF BRUCE WEIR, PRESIDENT, TRANSPLANT RECIPIENTS

INTERNATIONAL ORGANIZATION, INC.

I am submitting this testimony today on behalf of a vital segment of the national

transplant system that has been, and still is, quite under-represented...the patients.

In April of 1998, the Secretary of the Health and Human Services (HHS) issued

a ‘‘Final Rule’’ that addressed certain areas in the present system that need improvement (allocation of organs, oversight of the system, to name a couple).

United Network of Organ Sharing (UNOS), who holds the contract of the Organ

Procurement and Transplant Network (OPTN), decided to fight these changes and

the two sides became polarized. No gain for either side; and even worse...the patients lost. Many of the changes would have helped a patient’s chances of being

transplanted sooner. When things got to an impasse, UNOS then successfully lobbied Congress to issue a moratorium for one year, asking the Institute of Medicine

(IOM) to study the Rule and the issues having been raised to see if the Rule had

any merit. The IOM Report was issued on July 20, 1999 and generally supported

the reasons the ‘‘Final Rule’’ was issued and debunked the untruths spread by its

opponents. The moratorium expires October 21, 1999.

The very Congress that ordered the moratorium, not having yet studied or evaluated the IOM report, is now embarking on a mission to rewrite the law that established the OPTN, how it operates and what, if any oversight and authority the Secretary of HHS might or should have over the national organ transplant system.

What I have seen of the proposed changes only heightens my concerns. This bill

is greatly skewed in favor of OPTN and lessens the power and authority of HHS.

There needs to be balance. This bill would create imbalance.

I urge you all to seriously consider whether this is the time to even consider such

changes. Transplant centers may feel these changes are necessary to help insure

their future. This is not the time for patients—for while they are waiting, they have

no future.

PREPARED STATEMENT OF HON. PETE STARK, A REPRESENTATIVE IN CONGRESS FROM

THE STATE OF CALIFORNIA

Mr. Chairman: Thank you for holding this hearing today which will help educate

Members concerning the need for a more effective and fair system of organ allocation.

Every day 10 people die in this country waiting for an organ transplant. At least

65,000 Americans are currently awaiting an organ transplant. There is no disagreement about the problem—there aren’t enough organs to meet the needs of patients.

This Congress, I introduced legislation, H.R. 941, the ‘‘Gift of Life Congressional

Medal Act of 1999.’’ This legislation encourages donations thereby making more organs available for potential donation. I hope Members would consider this effort to

increase donations.

In April of last year, after extensive public debate, the Department of Health and

Human Services issued regulations intended to provide oversight for the nation’s

organ transplant system and to help guide the transplant community to create a

fairer transplant system. The FY ’99 Appropriations bill included a moratorium on

the regulations until October 21 of this year. Congress also directed the Institute

of Medicine (IoM) to report on the current organ allocation system.

The Secretary’s regulation will let medical people make medical decisions about

the best way to allocate the limited number of donated organs within a framework

that, as set forth by the IoM, will improve the function of the system. The Secretary’s regulation is urgently needed by patients across the country.

I believe there is a great deal of evidence of the need for timely implementation

of the Secretary’s regulations concerning organ allocation policies.

For example, a recent report from the HHS Office of Inspector General found that

the Secretary’s new transplant rules would not impose new hardships on patients

from small communities who need transplants. According to the OIG, most transplant centers are clustered around major cities and it is a ‘‘myth’’ that most Americans now have access to transplants virtually in their backyard. Thus the regulation

won’t hurt ‘‘local access’’ because such local access doesn’t truly exist.

Also, the Institute of Medicine has issued its report with conclusions that are very

supportive of the Department’s regulations. The IoM supports having the Federal

government exercise its legitimate oversight responsibilities under the National

Organ Transplant Act, instead of allowing a federal contractor essentially make the

rules. The report also declares that the current system would be significantly enVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00087 Fmt 6633 Sfmt 6621 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
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hanced if the allocation of scarce organs were done over larger populations than is

now the case.

The IoM report stated that ‘‘Vigilant and conscientious oversight and review of

programs... are critically important to ensuring accountability on the part of the

OPTN and other participants in the organ procurements and transplantation system.’’ The report also concluded that the Department’s Final Rule appropriately

places oversight responsibility with the federal government. Yet H.R. 2418 would set

allocation policies different than those contained in the Department’s regulations.

Among other flaws, H.R. 2418 provides unreasonable protections for the current

contractor (UNOS), removes the Secretary’s legitimate oversight authority over the

program, while simultaneously making data less available to the public. It is a significant step backward from even current law. And, in its delegation of power to private parties, it is probably unconstitutional.

I can think of no better way to put patients first than to make the system fair

for all. This issue is about putting patients first—not putting transplant bureaucracies first.

Mr. Chairman, armed with the strong support of the IoM report, Congress should

oppose another moratorium and should not enact H.R. 2418.

PREPARED STATEMENT OF THE NATIONAL KIDNEY FOUNDATION

On behalf of the thousands of individuals who are on waiting lists for an organ

transplant, we wish to thank you for introducing legislation to reauthorize the National Organ Transplant Act (NOTA). The Mission of the National Kidney Foundation (NKF) is to prevent kidney and urinary tract diseases, improve the health and

well-being of individuals and families affected by these diseases and increase the

availability of all organs for transplantation. NKF represents 30,000 lay and professional volunteers from all walks of life and every part of the country.

The NKF has long held that NOTA should be reauthorized in an effort to expand

organ donation and we are pleased that H.R. 2418 addresses the problem of the

shortage of organs available for transplant in this country. In addition, we are supportive of the effort to clarify the responsibility for developing, establishing, and

maintaining medical criteria and standards for organ procurement and transplantation as a function of the OPTN. Further, we believe that the transplant community at large should play an integral role in the development of these policies. The

NKF agrees that the OPTN shall make available timely information on outcomes

at specific transplant centers, as you have provided for in Sec. 3(d)(2), so as to help

transplant candidates make informed choices.

Research supported by the NKF Council of Nephrology Social Workers shows that

unreimbursed expenses serve as a disincentive to living organ donation. As such,

we are very appreciative and supportive of Sec. 5 of H.R. 2418, ‘‘Payment of Travel

and Subsistence Expenses Incurred Toward Living Organ Donation.’’ However, we

urge you to remove the provision that the donor must reside in a different State

than the recipient. Certain expenses, such as the need for temporary day care, are

incurred regardless of where the donor resides and a transplant center instate could

be at a greater distance from the donor than one in a State different from that in

which the donor lives. We also urge you to remove the provision that restricts payments to situations in which the annual income of the organ recipient is less than

$35,000. It is our belief that it is more appropriate for States, transplant centers,

organ procurement organizations and voluntary health agencies to determine who

should be eligible for assistance in each particular instance. Furthermore, any

means test might be more appropriate for the donor rather than the recipient. We

also believe Sec. 4(c) will be useful toward increasing organ donation, specifically

as this would facilitate demonstration projects on the efficacy and acceptability of

financial incentives to families for cadaveric organ donation.

We have additional specific suggestions regarding H.R. 2418. With regards to the

composition of the OPTN Board of Directors (Sec. 3(a)), we believe a more specific

designation is warranted for transplant recipients, candidates for transplants, donors and donor families, rather than the ‘‘reasonable proportion’’ cited in the bill

language, and we recommend that transplant surgeons and transplant physicians

should comprise not more than 50% of the members of the OPTN Board. We also

suggest that ‘‘transplant patients’’ be added in the list of groups with which the

Comptroller General be required to consult in preparation of the General Accounting

Office’s evaluation of the Network (Sec. 3(i)(2)).

Thank you for holding this hearing and for the opportunity to provide written testimony. We look forward to working with you to improve the efficiency and effectiveness of our nation’s organ procurement and transplant system.

86

LOUISIANA STATE UNIVERSITY MEDICAL CENTER

OFFICE OF THE CHANCELLOR

September 21, 1999

The Honorable THOMAS J. BLILEY, JR.

Chairman

House Commerce Committee

2125 Rayburn House Office Building

Washington, D.C. 20515-0106

DEAR CHAIRMAN BLILEY: I am writing on behalf of the Louisiana State University

Health Sciences Center to express my deep concern that implementation of the

DHHS Final Rule regarding organ allocation will jeopardize access to life-saving

organ transplants needed by Louisiana’s working poor and indigent. These are the

very patients most dependent upon our institution’s organ transplantation programs. However, H.R. 2418, the ‘‘Organ Procurement and Transplantation Network

Amendments of 1999’’ appears to be in the best interest of these patients as it would

provide them with continued access to organ transplantation. Introduced by Chairman Michael Bilirakis of the Health and Environment Subcommittee, Congressman

Gene Green and Congressman Frank Pallone, H.R. 2418 is supportive not only of

the organ transplantation programs at the LSU Health Sciences Centers in New Orleans and Shreveport, but also of most other medical centers across the country. For

example, the bill specifies that functions ‘‘scientific, clinical or medical in nature’’

are within the ‘‘sole discretion’’ of the Organ Procurement and Transplantation Network (OPTN). Further, it restricts the Secretary of the Department of Health and

Human Services from using provisions in the Social Security Act to exert broad

oversight authority relative to the OPTN. These two provisions would effectively

prevent DHHS from going forward with its OPTN Final Rule which, as I have stated, is not in the best interest of many of our patients.

As you know, Congress, through the appropriations process, thus far has blocked

DHHS from implementing the Final Rule. However, on October 21, 1999, the current congressional moratorium will expire. My colleagues and I feel it is imperative

for the future well-being of our patients that H.R. 2418 be considered by the appropriate authorizing committees in Congress.

Sincerely,

JOHN C. MCDONALD, M.D., Professor and Chairman

Department of Surgery, LSU Health Sciences Center-Shreveport

PHILIP BOUDREAUX, M.D., Professor of Surgery, LSUMC

Division of Transplantation, President, Louisiana Organ Procurement Agency

cc: Louisiana Congressional Delegation

The Honorable Richard Ieyoub

Mervin L. Trail, M.D.

Bonnie J. Hymel

UNIVERSITY OF MEDICINE & DENTISTRY OF NEW JERSEY

OFFICE OF THE VICE PRESIDENT

September 20, 1999

The Honorable THOMAS J. BLILEY, JR.

Chairman, House Commerce Committee

2125 Rayburn House Office Building

Washington, DC 20515-0106

DEAR CHAIRMAN BLILEY: As Acting Chief Executive Officer of UMDNJ-University

Hospital in Newark, New Jersey, I am writing to lend my institution’s strong support to the passage of H.R. 2418, the ‘‘Organ Procurement and Transplantation Network Amendments of 1999.’’ Introduced by Chairman Michael Bilirakis of the

Health and Environment Subcommittee and cosponsored by Congressman Frank

Pallone of New Jersey, this legislation supports the interests of New Jersey’s sole

transplant program and other programs throughout the country. Provisions contained within the bill would effectively prevent DHHS from going forward with its

OPTN Final Rule, which we strongly oppose as it threatens the continued viability

of our outstanding liver transplant program.

As you know, the moratorium blocking DHHS from implementing the final rule

is scheduled to expire on October 21 without any measure of compromise or consensus having been reached between the transplant community and the Administration. We believe that a strong show of support for H.R. 2418 in the House will send

still another clear signal to the Secretary and the Administration that the Final

87

Rule as written is not acceptable and that DHHS should seek to accommodate the

concerns held by most transplant centers throughout the nation.

Accordingly, I urge you to support H.R. 2418 and ask that you encourage your

colleagues to do the same.

Sincerely,

DANIEL L. MARCANTUONO, FACHE

Acting Chief Executive Officer

CLARIAN HEALTH

September 22, 1999

The Honorable THOMAS J. BLILEY, JR.

Chairman

House Commerce Committee

2125 Rayburn House Office Building

Washington, D.C. 20515-0106

DEAR CHAIRMAN BLILEY: On behalf of Clarian Health Partners located in Indianapolis, Indiana, I am writing in support of H.R. 2418, the ‘‘Organ Procurement and

Transplantation Network Amendments of 1999.’’ Introduced by Chairman Michael

Bilirakis of the Health and Environment Subcommittee, along with Congressmen

Gang Green and Frank Pallone, this legislation is supportive of the interests of the

organ transplantation programs at Clarian Health Partners and at most other medical centers across the country. For example, the bill specifies that those functions

that are ‘‘scientific, clinical or medical in nature’’ are within the ‘‘sole discretion’ of

the Organ Procurement and Transplantation Network (OPTN). Further, it restricts

the Secretary of the Department of Health and Human Services from using provisions in the Social Security Act to exert broad oversight authority relative to the

OPTN. These two previsions would effectively prevent DHHS from going forward

with its OPTN Final Rule, which Clarian Health and others strongly oppose.

As you know, Congress through the appropriations process has thus far blocked

DHHS from implementing the Final Rule. However, on October 21, 1999, the current congressional moratorium will expire, and we feel it is imperative that this legislation be afforded the opportunity to be considered in the appropriate authorizing

committees in Congress. We believe a strong show of support for H.R. 2518 in the

House will send a clear signal to the Administration that the Final Rule is not acceptable and that DHHS should seek to accommodate the concerns held by most

transplant centers by modifying the regulations. Accordingly, I would urge you to

support H.R. 2418, and also ask that you encourage your colleagues to do the same.

Thank you for your consideration.

Sincerely,

BRUCE M. MELCHERT

Vice President, Government Affairs

THE UNIVERSITY OF ALABAMA AT BIRMINGHAM

OFFICE OF THE PRESIDENT

September 20, 1999

The Honorable THOMAS J. BLILEY, JR.

Chairman

House Commerce Committee

2125 Rayburn House Office Building

Washington, D.C. 205OS15-0106

DEAR CHAIRMAN BLILEY: On behalf of the University of Alabama at Birmingham

(UAB), I am writing in support of H.R. 2418, the ‘‘Organ Procurement and Transplantation Network Amendments of 1999’’ introduced by your colleague Michael

Bilirakis, Chairman of the Health and Environment Subcommittee. As you know,

this legislation is supportive of the interests of the organ transplantation programs

at UAB and at most other medical centers across the country. It specifies that those

functions that are ‘‘scientific, clinical or ethical in nature’’ are within the ‘sole discretion’’ of the Organ Procurement and Transplantation Network (OPTN). Further, it

restricts the Secretary of the Department of Health and Human Services from using

provisions in the Social Security Act to exert broad oversight authority relative to

the OPTN. These two provisions would effectively prevent DHHS from going forward with its OPTN Final Rule, which we and others strongly oppose.

As you know, Congress through the appropriations process has thus far blocked

DHHS from implementing the Final Rule. However, on October 21, 1999, the curVerDate 20-MAR-2000 08:56 Mar 21, 2000 Jkt 061837 PO 00000 Frm 00090 Fmt 6633 Sfmt 6621 E:\HEARINGS\59992.TXT pfrm07 PsN: 59992
88

rent congressional moratorium will expire, and we feel it is imperative that this legislation be afforded the opportunity to be considered in the appropriate authorizing

committees in Congress. Accordingly, I would urge you to lend your strong support

to H.R. 2418. In this regard, I am pleased to report that we anticipate all of the

House members from Alabama will be supportive of this important legislation.

Sincerely,

W. ANN REYNOLDS

President

THE UNIVERSITY OF TEXAS

HEALTH SCIENCE CENTER AT SAN ANTONIO

September 2, 1999

The Honorable JOE BARTON

2264 Rayburn HOB

Washington, DC 20515-4306

DEAR REPRESENTATIVE BARTON: I am writing to request that you become a cosponsor of Representative Michael Bilirakis’s bill, H.R. 2418, which relates to transplant oversight by the Secretary of Health. I feel strongly that the government

should have oversight of this process, but should not dictate the process as is suggested in the final rule, written by Secretary Shalala. I also feel that a dramatic

overhaul of the current system is not in the interest of patients waiting for implantation in the United States. The current system works well. It can be improved

upon, and UNOS has been taking progressive steps, including the recent sharing

of organs, regionally for Status I patients, which are consistently improving the system.

The recent Institute of Medicine study indicated the current system was a good

system, and suggested small changes to modify it, rather than a traumatic change,

which in my opinion would be a total disaster. Most of Secretary Shalala’s effort

to change the system his been based on the political consideration of the inequality

of waiting times, and the Institute of Medicine’s study clearly concluded that waiting times should not be a measure of transplant equity. Therefore, I urge you to

please not support the final rule, which is supported by Secretary Shalala, and I

request that you call Representative Bilirakis’s office, 202-225-5735 to add your

name as a cosponsor on this bill.

Best regards,

GLENN HALFF, M.D.

Associate Professor of Surgery,

Director, Division of Organ Transplantation

SHANDS HEALTHCARE

September 21, 1999

The Honorable THOMAS J. BLILEY, JR.

Chairman

House Commerce Committee

2125 Rayburn House Office Building

Washington, D.C. 20515-01066

Dear Chairman Bliley: On behalf of Shands HealthCare at the University of Florida, I am writing in support of H.R. 2418, the ‘‘Organ Procurement and Transplantation Network Amendments of 1999.’’ Introduced by Chairman Michael Bilirakis of

the Health and Environment Subcommittee, along with Congressmen Gene Green

and Frank Pallone, this legislation is supportive of the interests of the organ transplantation programs at Shands and at most other medical centers across the country. For example, the bill specifies that those functions that are ‘‘scientific, clinical

or medical in nature’’ are within the ‘‘sole discretion’’ of the Organ Procurement and

Transplantation Network (OPTN). Further, it restricts the Secretary of the Department of Health and Human Services from using provisions in the Social Security

Act to exert broad oversight authority relative to the OPTN. These two provisions

would effectively prevent DHHS from going forward with its OPTN Final Rule,

which Shands and others strongly oppose.

As you know, Congress through the appropriations process has thus far blocked

DHHS from implementing the Final Rule. However, on October 21, 1999, the current congressional moratorium will expire, and we feel it is imperative that this legislation be afforded the opportunity to be considered in the appropriate authorizing

committees in Congress. We believe a strong show of support for H.R. 2418 in the

89

House will send a clear signal to the Administration that the Final Rule is not acceptable and that DHHS should seek to accommodate the concerns held by most implant centers by modifying the regulations. Accordingly, I would urge you to support

H.R. 2418, and also ask that you encourage your colleagues to do the same.

Sincerely,

J. RICHARD GAINTNER, M.D.

Chief Executive Officer

SAINT LOUIS UNIVERSITY HOSPITAL

September 21, 1999

The Honorable THOMAS J. BLILEY, JR.

Chairman

House Commerce Committee

2125 Rayburn House Office Building

Washington, D.C. 20515-0106

DEAR CHAIRMAN BLILEY: On behalf of Saint Louis University Hospital, I am writing in support of H.R. 2418, the ‘‘Organ Procurement and Transplantation Network

Amendments of 1999.’’ Introduced by Chairman Michael Bilirakis of the Health and

Environment Subcommittee, along with Congessmen Gene Green and Frank

Pallone, this legislation is supportive of the interests of the or,an transplantation

programs at Saint Louis University Hospital and at most other medical centers

across the country. For example, the bill specifies that those functions that are ‘‘scientific, clinical or medical in nature’’ are within the ‘‘sole discretion’’ of the Organ

Procurement and Transplantation Network (OPTN). Further, it restricts the Secretary of the Department of Health and Human Services from using provisions in

the Social Security Act to exert broad oversight authority relative to the OPTN.

These two provisions would effectively prevent DHHS from going forward with its

OPTN Final Rule, which Saint Louis University Hospital and others strongly oppose.

As you know, Congress through the appropriations process has thus far blocked

DHHS from implementing the Final Rule. However, on October 21, 1999, the current congressional moratorium will expire, and we fell it is imperative that this legislation be afforded the opportunity to be considered in the appropriate authorizing

committees in Congress.

We believe a strong show of support for H.R. 2418 in the House will send a clear

signal to the Administration that the Final Rule is not acceptable and that DHHS

should seek to accommodate the concerns held by most transplant centers by modifying the regulations. Accordingly, I would urge you to support H.R. 2418, and also

ask that you encourage your colleagues to do the same.

Sincerely,

JAN BLOMFIELD

Administrator for Transplant Services, Saint Louis University Hospital

LIFECENTER

August 6, 1999

Representative ROB PORTMAN

United States Representative, Ohio

238 Cannon Building

Washington, DC 20515

RE: NOTA Reauthorization

DEAR REPRESENTATIVE PORTMAN, I am the Executive Director of Ohio Valley

LifeCenter (LifeCenter). LifeCenter is the federally designated, non-profit organ procurement organization serving the Cincinnati area. Recently, Congressmen Bilirakis, Pallone, and Green introduced a bill to reauthorize the National Organ Transplant Act (NOTA). I would like to bring to your attention the importance of this bill

to the Greater Cincinnati area. As you are aware, there has been considerable focus

on the issue of organ allocation in the United States. At the heart of the matter

is who is most capable of deciding national implant policy: those involved in the

field or the federal government

The bill has several key components:

• Increase organ donation.

90

• Reaffirm that authority for transplant policy decisions and medical/scientific judgment/decision-making reside in the transplant community, with the government’s role being one of oversight.

• Preserves the Organ Procurement Transplant Network (OPTN) as a private entity.

• Requires that administrative/procedural functions of the OPTN be established by

mutual agreement through a contract between the OPTN and HHS.

• Updates NOTA to reflect recent medical advances in the field of transplantation.

LifeCenter fully supports this bill. I would request that you consider being a cosponsor of this much-needed legislation.

Last year, Congress enacted a one-year moratorium on the organ allocation regulations proposed by the Department of Health and Human Services. This moratorium expires in October. This would be to the detriment of those Greater Cincinnati

residents awaiting a life-saving organ transplant. The expiration of this moratorium

heightens the need for NOTA reauthorization or, at the very least, an extension of

the moratorium.

Please feel free to contact me, if I can provide additional information or assistance.

Sincerely,

DAVID D. LEWIS

Executive Director

LIFECENTER

August 6, 1999

Representative JOHN A. BOEHNER

United States Representative, Ohio

1011 Longworth HOB

Washington, DC 20515

RE: NOTA Reauthorization

DEAR REPRESENTATIVE BOEHNER, I am the Executive Director of Ohio Valley

LifeCenter (LifeCenter). LifeCenter is the federally designated, non-profit organ procurement organization serving the Cincinnati area. Recently, Congressmen Bilirakis, Pallone, and Green introduced a bill to reauthorize the National Organ Transplant Act (NOTA). I would like to bring to your attention the importance of this bill

to the Greater Cincinnati area. As you are aware, there has been considerable focus

on the issue of organ allocation in the United States. At the heart of the matter

is who is most capable of deciding national implant policy: those involved in the

field or the federal government

The bill has several key components:

• Increase organ donation.

• Reaffirm that authority for transplant policy decisions and medical/scientific judgment/decision-making reside in the transplant community, with the government’s role being one of oversight.

• Preserves the Organ Procurement Transplant Network (OPTN) as a private entity.

• Requires that administrative/procedural functions of the OPTN be established by

mutual agreement through a contract between the OPTN and HHS.

• Updates NOTA to reflect recent medical advances in the field of transplantation.

LifeCenter fully supports this bill. I would request that you consider being a cosponsor of this much-needed legislation.

Last year, Congress enacted a one-year moratorium on the organ allocation regulations proposed by the Department of Health and Human Services. This moratorium expires in October. This would be to the detriment of those Greater Cincinnati

residents awaiting a life-saving organ transplant. The expiration of this moratorium

heightens the need for NOTA reauthorization or, at the very least, an extension of

the moratorium.

Please feel free to contact me, if I can provide additional information or assistance.

Sincerely,

DAVID D. LEWIS

Executive Director

91

LIFECENTER

August 6, 1999

Representative STEVE CHABOT

United States Representative, Ohio

129 Cannon Building

Washington, DC 20515

RE: NOTA Reauthorization

DEAR REPRESENTATIVE CHABOT, I am the Executive Director of Ohio Valley

LifeCenter (LifeCenter). LifeCenter is the federally designated, non-profit organ procurement organization serving the Cincinnati area. Recently, Congressmen Bilirakis, Pallone, and Green introduced a bill to reauthorize the National Organ Transplant Act (NOTA). I would like to bring to your attention the importance of this bill

to the Greater Cincinnati area. As you are aware, there has been considerable focus

on the issue of organ allocation in the United States. At the heart of the matter

is who is most capable of deciding national implant policy: those involved in the

field or the federal government

The bill has several key components:

• Increase organ donation. • Reaffirm that authority for transplant policy decisions and medical/scientific judgment/decision-making reside in the transplant community, with the government’s role being one of oversight. • Preserves the Organ Procurement Transplant Network (OPTN) as a private entity. • Requires that administrative/procedural functions of the OPTN be established by

mutual agreement through a contract between the OPTN and HHS. • Updates NOTA to reflect recent medical advances in the field of transplantation.

LifeCenter fully supports this bill. I would request that you consider being a cosponsor of this much-needed legislation.

Last year, Congress enacted a one-year moratorium on the organ allocation regulations proposed by the Department of Health and Human Services. This moratorium expires in October. This would be to the detriment of those Greater Cincinnati

residents awaiting a life-saving organ transplant. The expiration of this moratorium

heightens the need for NOTA reauthorization or, at the very least, an extension of

the moratorium.

Please feel free to contact me, if I can provide additional information or assist- ance.

Sincerely,

DAVID D. LEWIS

Executive Director

LIFESOURCE

July 29, 1999

The Honorable BILL LUTHER

House of Representatives

Washington, DC 20510

DEAR REPRESENTATIVE LUTHER: On behalf of LifeSource, the Organ Procurement

Organization serving Minnesota, I am writing to ask your support for legislation reauthorizing the National Organ Transplant Act (NOTA). This bill, H.R. 2418, was

introduced on July 1, 1999. Your leadership in signing on as a co-sponsor of this

legislation is important in maintaining the organ procurement and transplantation

system.

The bill seeks to increase organ donation, and it reaffirms that authority for

transplant policy decisions and medical/scientific decision-making will reside in the

transplant community. This will maintain the appropriate administrative oversight

of the Department of Health and Human Services while allowing the patients and

medical professional to develop appropriate donation and allocation policies. The bill

will also maintain the Organ Procurement and Transplantation Network’s (OPTN)

status as a private entity and will update NOTA to reflect medical advances in the

field of transplantation. NOTA has not been re-authorized since 1990.

I also anticipate that additional language will be proposed via amendment which

will address the process for designation and certification of Organ Procurement Organizations by the Health Care Financing Administration. LifeSource and other

members of the OPO community, supported by findings of the General Accounting

Office, believe that the current process and standards used to assess OPO performance are flawed and should be discontinued until a new process is developed. I am

92

enclosing a letter to Jeffrey L. Kang, M.D., M.P.H., HCFA, from the Association of

Organ Procurement Organizations which further outlines OPO concerns.

We believe it is vitally important that the NOTA reauthorization move forward

at this time and encourage you to sign on as a cosponsor. Please do not hesitate

to contact me if I can provide any additional information.

Sincerely,

SUSAN GUNDERSON

Chief Executive Officer

UNIVERSITY OF FLORIDA

COLLEGE OF MEDICINE

August 11, 1999

The Honorable KAREN THURMAN

440 Cannon HOB

Washington DC 20515

ATTN: Jeff Cohen

RE: Institute of Medicine Report

DEAR CONGRESSWOMAN THURMAN: I have reviewed Congressman William Coyne’s

letter dated July 29, 1999 that he sent to his colleagues in Congress regarding his

interpretation of the Institute of Medicine’s (IOM) report on organ allocation. Congressman Coyne’s interpretation of the report is a rather limited one and does not,

in the opinion of most transplant professionals, truly represent the content of that

report. I thought it might be helpful to you and your staff to clarify some of these

issues.

The most important point that Congressman Coyne fails to understand is that the

IOM determined that geographic differences and waiting times are ‘‘not an appropriate measure of the fairness of the system.’’ The claims made by the proponents

of the HHS regulation are that waiting times vary from region to region. While this

is true, it reflects the listing practices of centers in those regions and not the availability of organs. In fact, the waiting time for liver transplantation for all Status

1 patients is remarkably similar in every UNOS Region across the country (two to

four days). The IOM clearly recommends that the use of waiting time as an allocation criterion for statuses 2B and 3 be discontinued. The IOM noted that the heavy

emphasis placed on waiting times by HHS created the perception that the system

was unfair.

The IOM report does not, as Congressman Coyne states, suggest that the Health

and Human Services (HHS) regulations should be implemented. The IOM in fact determined that the liver organ allocation system is ‘‘reasonably effective and equitable’’ and that no system will ever function perfectly when the need for organs

vastly exceeds the demands. The IOM does suggest that sharing of livers for the

Status 1 (sickest patient) Category be done over areas consisting of approximately

9,000,000 people. This is, however, similar to the geographically based system already in place. In fact, all of the UNOS Regions currently share livers for this patient status category. No changes need to be effected in order to fulfill this recommendation.

Congressman Coyne neglected to mention that the IOM found that the institution

of these regulations would increase the overall cost of transplantation. Congressman

Coyne’s letter states that the IOM concluded that the new regulations would not

cause small transplant centers to close or negatively impact access for minority populations. The IOM was unable to come up with any firm evidence based conclusions

regarding these issues, but they did recognize that a consensus existed in the transplant community that the implementation of these regulations would lead to these

problems.

In summary, the findings of the IOM challenge the medical basis of the regulations suggested by the HHS. While they do endorse a note for federal oversight, I

do not believe that it is their intention that anyone other than the medical community determine the rules for organ allocation.

I do not believe that Congressman Coyne’s interpretation of the IOM report accurately reflects the content of that report. I hope that this letter is helpful and I

would be happy to discuss this with you at your leisure.

Thank you for your ongoing concern regarding the organ allocation issue.

Sincerely,

ALAN REED, MD

Associate Professor of Surgery

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UNIVERSITY HOSPITALS OF CLEVELAND

26 August, 1999

Congressman THOMAS C. SAWYER, Ohio

1414 Longworth House Office Building

Washington, DC 20515

DEAR CONGRESSMAN SAWYER: I am writing you to urge you to extend the moratorium on the HHS Organ Procurement and Transplantation Network Final Rule.

As you know Secretary Shalala and HHS have repeatedly sought to implement

rules that would effectively nationalize organ acquisition. While effectively spun as

a means to equalize access and ameliorate regional inequities, the real purpose of

the proposed rule is to restore oligopoly in transplantation to a few centers, such

as The University of Pittsburgh, which have seen volume disappear, have suffered

financially, and which seek to repair that damage through use of friends and lobbyists to obtain governmental relief. The citizens of Ohio among others will see access

to transplantations reduced as a result and those without means may lose it altogether.

The Institute of Medicine was asked to provide an evaluation of this controversial

issue, and issued their report earlier this month.

Recently a letter from Secretary Shalala to Members of Congress cast the Institute of Medicine report—a neutral assessment of the problem—as an endorsement

of her position.

It is nothing of the sort. In fact the IOM report is evenhanded. It notes that there

are no real differences in waiting limes for the sickest liver patents—the core argument of the Secretary’s position and the casus belli of the dispute—but that there

are differences among less ill patents, and that these could be erased by establishing

catchment areas of 9 million or so. This is similar to what we have already in Ohio,

and we can live with it. But it is not an endorsement for the very broad catchment

areas necessary to afford the few HHS-favored centers what they seek. What the

Secretary wants on their behalf is in effect a private bill.

Failure to extend the moratorium is certain to lead to a massive export of organs,

recipients and ultimately skilled professionals from Ohio to other states. I cannot

see how this pernicious policy change is in the interest of Ohioans and I think it

both unwise and unfair.

Sincerely,

D. ALLAN GRAY, Senior Vice President and General Manager

Medical/Surgical Services, University Hospitals of Cleveland

MISSISSIPPI ORGAN RECOVERY AGENCY, INC.

July 14, 1999

Representative CHIP PICKERING

427 Cannon House Office Bldg.

Washington, D.C. 20515

Re: Organ Procurement and Transplantation Network Amendments of 1999

DEAR REP. PICKERING: As you are aware over the last two years there has been

much discussion of the organ allocation process and who determines distribution of

this scarce resource. Since the inception of the Organ Procurement and Transplant

Network (OPTN), the United Network for Organ Sharing (UNOS) has been charged

with overseeing allocation of organs for transplant in the United States. UNOS has

done an excellent job over the years dealing with the very difficult task of determining how the precious gift of life of an organ transplant should optimally be

shared to ensure maximal lives saved.

Currently Representative Michael Bilirakis (FL), Chair of the Subcommittee on

Health and the Environment of the House Commerce Committee, is looking for cosponsors for legislation he is introducing to ensure that efforts continue to allocate

organs optimally. This legislation will ensure that Mississippians will continue to

have fair and equitable access to transplantation. If this legislation is not passed,

many Mississippians may die of organ failure and never get the opportunity of

transplant, particularly minority Mississippians and those in the lower socioeconomic strata.

Please support this legislation that should enable every Mississippian in need access to transplantation.

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Please call if we can be of any further service or answer any questions.

Sincerely,

KEVIN STUMP,

Executive Executor

SHIRLEY SCHLESSINGER, M.D.

Medical Director

CENTER FOR DONATION & TRANSPLANT

September 16, 1999

Hon. MICHAEL R. MCNULTY

House of Representatives.

2161 Rayburn

Washington, DC 20515

DEAR CONGRESSMAN MCNULTY: I am writing to ask for your support in cosponsoring the National Organ Transplant Reauthorization Bill, H.R. 2418. It is my understanding that there will be a hearing on this bill on September 22. For additional

information or to be added as a cosponsor, the contact person in Congressman Bilirakis’s office is Michael Reilly. The phone number is 202-225-5755.

As in the past, thank you for your support.

Sincerely,

FRANK TAFT

Director

TENNESSEE TRANSPLANT SOCIETY

August 2, 1999

The Honorable BILL FRIST

SD-567 Dirksen Senate Office Building

Washington, DC 20510-4205

DEAR SENATOR FRIST: The Tennessee Transplant Society (TTS) consists of all

seven transplant centers, all of the transplant professionals (physicians, nurses,

transplant coordinators), and all organ procurement organizations within the state

of Tennessee. At the July 26 meeting of the TTS, there was a vote taken following

discussion of the Institute of Medicine (IOM) Report and the continuing saga of the

HHS final rule regarding the allocation of organs for transplant. The IOM report

did not support the basic premise of the HHS rule, that is, waiting times for patients needing transplant are valid measure and should be equalized.

The Tennessee Transplant Society unanimously requests you to cosponsor Congressman Billrakis’ Bill H.R. 2418 ‘‘Organ Procurement and Transplantation Network Amendments of 1999.’’ Additionally, if it does not look like H.R. 2418 is gong

to pass in this session of Congress, we would strongly encourage you to support an

extension of the moratorium on the implementation of the HHS final rule (current

effective date 10/1/99) while we study the ideas brought forward in the IOM report.

Sincerely yours,

C. WRIGHT PINSON, M.D., M.B.A.

President

JACKSONVILLE TRANSPLANT CENTER

July 26, 1999

The Honorable CORRINE BROWN

2444 Rayburn House Office Building

Independence Ave. and S. Capitol St., SW

Washington, DC 20510

DEAR REPRESENTATIVE BROWN: I write regarding H.R. 2418 (Organ Procurement

and Transplant Patient Network amendments of 1999), a Bill before the House of

Representatives. Since I serve patients in your District, I encourage your support

of this Bill.

H.R. 2418 allows for the general functions of day-to-day organ donation and transplantation to continue throughout America. It maintains the truly excellent administrative structure and self governance of the Organ Procurement and Transplantation Network. Important in the latter is the fact that the Board governing the

Network is inclusive not just of medical professionals, but of patients and public

members. Further, the Bill establishes a workable and reasonable relationship of

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oversight between the Secretary of Health and Human Services and the Network

contractor.

Important new features of the Bill relate to access to transplantable organs and

tissues, recognition that organs and tissues from certain animal sources may soon

be applied to human disease, and enabling sections on provision of benefits for

cadaveric organ donation should demonstration projects to increase organ donation

be developed around survivor benefits. Finally, an important aspect of the Bill is

that expenses of living organ donors be reimbursed through mechanisms similar to

other aspects of organ transplant reimbursement.

May I thank you in advance for considering support of this important Bill which

may so positively affect your constituents and my patient.

Sincerely,

THOMAS G. PETERS, M.D.

Clinical Professor of Surgery, University of Florida HSCJ

JACKSONVILLE TRANSPLANT CENTER

July 26, 1999

The Honorable CHARLES T. CANADY

2432 Rayburn House Office Building

Independence Ave. and S. Capitol St., SW

Washington, DC 20510

DEAR REPRESENTATIVE CANADY: I write regarding H.R. 2418 (Organ Procurement

and Transplant Patient Network amendments of 1999), a Bill before the House of

Representatives. Since I serve patients in your District, I encourage your support

of this Bill.

H.R. 2418 allows for the general functions of day-to-day organ donation and transplantation to continue throughout America. It maintains the truly excellent administrative structure and self governance of the Organ Procurement and Transplantation Network. Important in the latter is the fact that the Board governing the

Network is inclusive not just of medical professionals, but of patients and public

members. Further, the Bill establishes a workable and reasonable relationship of

oversight between the Secretary of Health and Human Services and the Network

contractor.

Important new features of the Bill relate to access to transplantable organs and

tissues, recognition that organs and tissues from certain animal sources may soon

be applied to human disease, and enabling sections on provision of benefits for

cadaveric organ donation should demonstration projects to increase organ donation

be developed around survivor benefits. Finally, an important aspect of the Bill is

that expenses of living organ donors be reimbursed through mechanisms similar to

other aspects of organ transplant reimbursement.

May I thank you in advance for considering support of this important Bill which

may so positively affect your constituents and my patient.

Sincerely,

THOMAS G. PETERS, M.D.

Clinical Professor of Surgery, University of Florida HSCJ

JACKSONVILLE TRANSPLANT CENTER

July 26, 1999

The Honorable TILLIE FOWLER

106 Cannon House Office Building

Independence Ave. and S. Capitol St., SW

Washington, DC 20510

DEAR REPRESENTATIVE FOWLER: I write regarding H.R. 2418 (Organ Procurement

and Transplant Patient Network amendments of 1999), a Bill before the House of

Representatives. Since I serve patients in your District, I encourage your support

of this Bill.

H.R. 2418 allows for the general functions of day-to-day organ donation and transplantation to continue throughout America. It maintains the truly excellent administrative structure and self governance of the Organ Procurement and Transplantation Network. Important in the latter is the fact that the Board governing the

Network is inclusive not just of medical professionals, but of patients and public

members. Further, the Bill establishes a workable and reasonable relationship of

oversight between the Secretary of Health and Human Services and the Network

contractor.

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Important new features of the Bill relate to access to transplantable organs and

tissues, recognition that organs and tissues from certain animal sources may soon

be applied to human disease, and enabling sections on provision of benefits for

cadaveric organ donation should demonstration projects to increase organ donation

be developed around survivor benefits. Finally, an important aspect of the Bill is

that expenses of living organ donors be reimbursed through mechanisms similar to

other aspects of organ transplant reimbursement.

May I thank you in advance for considering support of this important Bill which

may so positively affect your constituents and my patient.

Sincerely,

THOMAS G. PETERS, M.D.

Clinical Professor of Surgery, University of Florida HSCJ

JACKSONVILLE TRANSPLANT CENTER

July 26, 1999

The Honorable CLIFF STEARNS

2227 Rayburn House Office Building

Independence Ave. and S. Capitol St., SW

Washington, DC 20510

DEAR REPRESENTATIVE STEARNS: I write regarding H.R. 2418 (Organ Procurement

and Transplant Patient Network amendments of 1999), a Bill before the House of

Representatives. Since I serve patients in your District, I encourage your support

of this Bill.

H.R. 2418 allows for the general functions of day-to-day organ donation and transplantation to continue throughout America. It maintains the truly excellent administrative structure and self governance of the Organ Procurement and Transplantation Network. Important in the latter is the fact that the Board governing the

Network is inclusive not just of medical professionals, but of patients and public

members. Further, the Bill establishes a workable and reasonable relationship of

oversight between the Secretary of Health and Human Services and the Network

contractor.

Important new features of the Bill relate to access to transplantable organs and

tissues, recognition that organs and tissues from certain animal sources may soon

be applied to human disease, and enabling sections on provision of benefits for

cadaveric organ donation should demonstration projects to increase organ donation

be developed around survivor benefits. Finally, an important aspect of the Bill is

that expenses of living organ donors be reimbursed through mechanisms similar to

other aspects of organ transplant reimbursement.

In your capacity as a member of the Commerce Committee, may I ask that you

especially regard this Bill as an important step in serving patients in need of an

organ transplant. I stand ready to provide further information or assistance to your

office should that be necessary. May I thank you in advance for positively considering H.R. 2418.

Sincerely,

THOMAS G. PETERS, M.D.

Clinical Professor of Surgery, University of Florida HSCJ

THE UNIVERSITY HOSPITAL

September 3, 1999

The Honorable STEVE CHABOT

United States Representative, Ohio

129 Cannon Building

Washington, DC 20515

RE: House Bill: H.R. 2418

DEAR REPRESENTATIVE CHABOT: I am the Administrator of Transplant Services at

The Health Alliance of Greater Cincinnati. Recently, Congressmen Bilirakis,

Pallone, and Green introduced House Bill H.R. 2418 to reauthorize the National

Organ Transplant Act (NOTA). I would like to bring to your attention the importance of this bill to the Greater Cincinnati area. As you are aware, there has been

considerable focus on the issue of organ allocation in the United States. At the heart

of the matter is who is most capable of deciding national transplant policy: those

involved in the field or the federal government?

The bill has several key components:

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• Increase organ donation.

• Decrease disincentives for living organ donation.

• Reaffirm that authority for transplant policy decisions and medical/scientific judgment/decision-making resides in the transplant community with the government’s role being one of oversight.

• Preserves the Organ Procurement Transplant Network (OPTN) as a private entity.

• Requires that administrative/procedural functions of the OPTN be established by

mutual agreement through a contract between the OPTN and HHS.

• Updates NOTA to reflect recent medical advances in the field of transplantation.

Last year, Congress imposed a one-year moratorium on the organ allocation regulations proposed by the Department of Health and Human Services. This moratorium expires October 21, 1999. Enactment of the HHS organ allocation regulation

would be detrimental to the Greater Cincinnati residents awaiting a life-saving

organ transplant. The expiration of this moratorium heightens the need for NOTA

reauthorization or, at the very least, an extension of the moratorium.

I fully support the House Bill H.R. 2418. I am requesting that you consider being

a cosponsor of this important and critical legislation.

Please contact me for additional information or assistance at (513) 584-1811.

Sincerely,

EDWARD Y. ZAVIA, M.B.A.

Administrator, Transplant Services

405 OWENDALE DRIVE

ANTIOCH, TN 37013

June 24, 1999

The Hon. ED BRYANT

408 Cannon House Office Bldg

Washington, D.C. 20515

DEAR MR. BRYANT, I am writing to you today concerning important pending legislation which will affect organ and tissue transplantation policy in the United States

for years to come. I speak from the perspective of a donor father (both of my sons

were organ donors following tragic accidents in 1990-91) and as the spouse of a kidney recipient in 1994. Tragically, my wife has since passed away, but I have been

so energized by her determination and courage throughout her wait of over 25

months for an organ that I have been actively involved in organ donation matters

since that date. Specifically, I have been a member of the national Board of Directors of Transplant Recipients International Organization (TRIO) and also the President of the Music City (Nashville area) TRIO local chapter. In addition, I have

worked extensively with Rotary International, the National Kidney Foundation

(NKF), Tennessee Donor Services (TDS), the Minority Organ Tissue Transplant

Education Program (MOTTEP) and several other organizations to promote increased

organ donation awareness.

I provide you with this detailed background information so that you can understand the depth of my frustration concerning the ongoing debate in the Congress

over national transplantation policy. While there is general agreement that the existing policies developed by the National Organ and Transplant Act during the mid80’s are not perfect, it is the feeling of most of the ‘‘non-professionals’’ within the

transplant community (recipients, donor families, and those currently waiting) that

the system in operation today has served us well. It has proven to be remarkably

adaptive to changing conditions as medical advances have taken place, and has resulted in a transplantation record that is the envy of the world. This has taken

place primarily because of the wisdom of the Congress to establish a private partnership between the medical community and the patient population which is independent from undue political interference by government operatives, however well

intentioned. Difficult decisions involving the allocation of scarce organ resources

have been made by this informed private partnership, rather than by a corps of government attorneys and bureaucrats.

I do not want to sound harsh in the above assessment, but it is imperative that

you understand that the current system has indeed served us well, and that any

improvements should be made on the margins by legislation to strengthen, rather

than dismember, the Organ Procurement Transplant Network (OPTN). This really

should not become a partisan issue, as both sides should have an intense interest

in insulating the organ transplant process from the political whims of whichever

party is in control of the Executive Branch or the Congress. It is critical that you

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insist that the current ‘‘firewall’’ be maintained so that transplantation policies are

predictable, just, and institutionally immune from political tampering.

I would also like to address comments which have been made publicly by those

purporting to represent all transplant patients and donor families. This is simply

a myth. There are, in fact, many different viewpoints throughout this large and diverse community. As you can imagine, there are some who view the current system

as ‘‘unfair’’ and in need of massive government intervention, if not outright total

control. It is my experience that these folks, however vocal, are in a distinct minority, but their opinions are nonetheless real.

What I see is a vast majority of those Americans who are interested in transplant

matters wanting the existing partnership of medical professionals and transplant

patients to remain in charge of transplant policy. Those who argue otherwise as

‘‘spokespersons’’ for transplant groups simply do not represent the views of

the majority of their membership. I say this with absolute certainty in the case

of Transplant Recipients International Organization (TRIO), because as a Board

member I asked repeatedly that our entire membership be polled on this key issue,

and such never happened.

When we did poll our local chapter here in Tennessee, the results were overwhelming in support of the current non-political, private partnership (the OPTN).

[The actual vote was 131-4]. In speaking with other TRIO chapter Presidents, I

noted differing levels of support due to local factors, but the overall fact is that there

is NOT unanimity in support of either side. Some of the other organizations which

purport to speak for the transplant community (e.g., National Transplant Action)

are simply ad hoc ‘‘fronts’’ which have been chartered by interested parties to lobby

for passage of proposed HHS regulations which will financially favor them. The bottom line is that no one speaks for the entire transplant community and that there

are mixed feelings about the issue throughout the U.S. I can report, however, that

the vast majority of the TRIO members to whom I have personally spoken are opposed to government intervention and want the existing system to have simple improvements.

There is also a fear that large transplant centers with political clout will monopolize transplantation procedures by manipulating proposed rules dictated by FMS

personnel. Opponents may dismiss such concerns as paranoia, but these worries are

indeed genuine and have been supported by the monopolistic track record of certain

large centers. Those of us who have had the opportunity to experience the expertise

of some of the smaller, regional transplant centers understand first hand the excellence and talent available in many locations throughout the country. The benefit,

which I have seen countless times, is that under the existing system families are

able to provide local support for patients who do not have to travel long distances

to receive life saving transplant operations.

As a two-time donor father I would like to comment personally on one aspect of

organ donation which is frequently misstated by proponents of a ‘‘national’’ system.

It is often stated by these people that donor families ‘‘do not care where organs of

their loved ones go.’’ This may be correct in some cases, but I can report to you that

many of us who have been in this most difficult situation have been acutely concerned that hope be provided first to those in need in our local region. We do not

want these precious gifts to be treated as just some other government owned part

shipped cross country to a large center currently in favor with federal rulemakers.

Obviously there are many other issues which are associated with this pending legislation, but I encourage you to focus on one thought: patients do not want a working, viable process with a proven track record to be dismembered and displaced by

policies dictated by government bureaucrats subject to political pressure. Keep

transplantation a predominantly medical issue with rules established by the existing partnership of medical experts, patients, and donor families.

Sincerely,

THOMAS L. MEREDITH

TENNESEE DONOR SERVICES

September 21, 1999

The Honorable ED BRYANT

United States Representative

408 Cannon House Office Building

Washington, DC 20515-4207

Attention: Carrie Dawson, Legislative Aide

DEAR REPRESENTATIVE BRYANT: Tennessee Donor Services (TDS) is the federally

designated Organ Procurement Organization (OPO) serving the vast majority of

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Tennessee. On September 22, 1999 the House Commerce Committee will conduct

hearings on H.R. 2418, the National Organ Transplant Act (NOTA) Reauthorization

Bill. The bill has a significant number of bipartisan sponsors,

Last year, Congress extended a moratorium on the implementation of a federal

rule that would have had a serious negative impact on the centers and patients we

serve. This moratorium is set to expire October 21, 1999. On behalf of transplant

centers, transplant physicians, donor families, and recipients that we serve, I request your support and urge you to cosponsor H.R. 2418, ‘‘Organ Procurement and

Transplantation Network Amendments of 1999.’’

H.R. 2418 protects the integrity of organ procurement organizations and transplant centers all across the country. It reiterates the original intent of the National

Organ Transplant Act of 1984 which was to create a national system that promotes

and supports a central network in the private sector serving all of the citizens of

the United States,

H.R. 2418 is unanimously supported by all Tennessee OPOs and ten transplant

centers. In the area served by TDS, H.R. 2418 has the support of Vanderbilt University Medical Center, St. Thomas Hospital, Centennial Medical Center/Parkview, UT

Medical Center, Johnson City Medical Center and Erlanger. H.R. 2418 is also

unanimously supported by Mid-South Transplant Foundation and its affiliated centers.

We also encourage you to send a letter to the Secretary of HHS asking that the

final rule be withdrawn in the meantime. If the Secretary fails to do so, we urge

you to extend the moratorium until such time as a solution in the best interests

of the patients we serve can be achieved.

Please contact Michael Reilly with Congressman Bilirakis’ office at (202) 225-5755

to be added as a cosponsor, I thank you for your support of H.R. 2418. You may

contact me at (615) 327-2247, if you have any questions or need additional information.

Sincerely,

LAWRENCE D. COCHRAN

Executive Director

UNIVERSITY OF ILLINOIS AT CHICAGO

Chicago, Illinois

The Honorable DIANA DEGETTE

1339 Longworth Building

U.S. House of Representatives

Washington, DC 20515-0601

DEAR CONGRESSWOMAN DEGETTE: Thank you for your letter requesting additional

information in connection with the testimony I gave recently at a hearing of the

Subcommittee on Health and the Environment relating to organ procurement and

transplantation. I apologize for not getting back to you sooner; however, I have

moved offices and mail has been delayed in reaching me.

You asked several questions relating to liver transplantation for pediatric patients, particularly in response to recent studies done by researchers at Pittsburgh

Children’s Hospital and the Medical University of South Carolina. Those studies apparently raised questions whether pediatric patients are receiving appropriate access to donated livers.

The Institute of Medicine Committee that prepared the report ‘‘Organ Procurement and Transplantation’’ was not specifically requested to investigate the issue

of pediatric patients’ access to transplantation and we did not do so. We did not

have copies of the research you cite and I have not read them. Some of our analysis

of transplant waiting times and mortality does, however, bear on one of the points

raised in your letter and I am happy to share that with you.

According to your letter, the research studies you cited found that children are

‘‘55% more likely to die waiting for an organ transplant than adults.’’ (Presumably

this refers to liver transplants.) Our analysis yielded somewhat different conclusions. Although the most severely ill (status 1) children, aged 0-5, had a significantly lower rate of transplantation than status 1 adults, they also had a lower rate

of pretransplant mortality. This finding suggests young children in status 1 are capable of living longer than adults in this status as they wait on the list. Less severely ill (status 2B) children (aged 0-5) actually had a higher rate of transplantation than status 2B adults and the least severely ill (status 3) children in all ages

(aged 0-17) had transplantation rates that were significantly higher than adults. In

both of these status groups, there was no difference between children and adults

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in their pretransplant mortality rates. In addition, age was not a significant determinant of post-transplantation mortality.

There could be a variety of reasons why our findings differ from those cited in

your letter, but without having read those studies I cannot pinpoint what they

might be. The time period covered by the data, the comprehensiveness of the data,

and whether patients were classified by severity of illness would be some of the

things to look at. Our analysis reflects the experience of all liver transplant patients

who were on waiting lists anywhere in the nation from the start of 1998 through

the first quarter of 1999 and we stratified these patients by severity of illness (status level).

Finally, I would note that the recommendation of the IOM Committee that donated livers be allocated over larger populations would appear to improve the likelihood that a suitable organ would be found for a child awaiting a transplant. Furthermore, the Committee’s recommendation to eliminate waiting time as a criterion

for allocating organs to status 2B and status 3 patients and to substitute more

medically relevant criteria to bring about a better match (e.g. pediatric versus adult)

would also appear to benefit children.

I hope this information is useful to you in your review of this important issue.

Sincerely,

ROBERT D. GIBBONS, Professor of Biostatistics

University of Illinois at Chicago

IOM Organ Procurement and Transplantation Committee Member

cc: The Honorable Michael Bilirakis

RESPONSES OF WILLIAM F. RAUB, DEPUTY ASSISTANT SECRETARY FOR PLANNING AND

EVALUATION/SCIENCE POLICY, DEPARTMENT OF HEALTH AND HUMAN SERVICES, TO

QUESTIONS OF HON. DIANA DEGETTE

Question: Recent studies by researchers at Pittsburgh Children’s Hospital and the

Medical University of South Carolina reveal some rather disturbing trends with respect to pediatric transplantation. The studies indicate that: Two-thirds of liver donations by children go to adults; and Pediatric liver donations have increased

through the 1990’s. And yet—The number of children who received a donated liver

from another child decreased dramatically from 1990 to 1996; and, Children are

55% more likely to die while waiting for an organ transplant than adults.

According to American Medical News, ‘‘Europe has virtually eliminated deaths of

children while on liver waiting lists by giving them priority over adults for pediatric

organs . . .’’

The Administration’s Final Rule, H.R. 2418, and the IOM report all fail to directly

address this issue.

To all the members of the panel, what are we as a nation doing to address this

growing and unacceptable problem for children in need of organ transplantations

and what additional steps need to be taken to reduce pediatric mortality rates?

Response: The current liver allocation conventions of the Organ Procurement and

Transplantation Network (OPTN) give priority to children 18 years of age and

under, who account for 10 percent of transplant candidates. The 1998 HHS regulation made clear that the Department intended the OPTN to address the special

needs of children as it developed fairer allocation policies:

‘‘. . . current OPTN policies take into account the special medical needs of children. The Secretary endorses this approach and expects that the OPTN will

continue to take these needs into account as it develops new medical criteria

and allocation policies.’’ (63 FR 16315; also discussed at 63 FR 16304)

The recent amendments to that regulation reaffirm this intention:

‘‘The Department wishes to emphasize, however, that these changes are not intended to limit the ability of the OPTN to address special situations such as

the unique needs of young children.’’ (64 FR 56657)

Based on the OPTN’s actions, the guidance provided in the HHS regulations, and

our expectations for continued improvement in split-liver techniques (whereby an

adult donor liver that is too large for a child can be divided surgically to transplant

two individuals in need of a smaller liver), the Department is optimistic that children will have a growing new source of opportunities for transplantation.

Children have the following outcomes under current OPTN liver allocation policies: they receive liver transplants at a higher rate (60%) than do adults (45%); their

survival at one year with or without transplant (21%) is similar to all other age

groups; and they die awaiting a transplant at a slightly lower rate (12.5%) than do

adults on the waiting lists (14%).

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Despite these generally favorable data, room remains for improvement. The Department—through its efforts to increase organ donation generally (its National

Organ and Tissue Donor Initiative), its research to improve transplantation procedures, and its oversight of the OPTN—will continue to strive to meet the needs of

children 18 years of age and under who are candidates for liver or other organ

transplantation. The Department intends to highlight this issue as it seeks comments from the public and advice from the Advisory Committee on Organ Transplantation on new allocation policies developed in response to the amended HHS

regulation.