[Senate Hearing 118-706]
[From the U.S. Government Publishing Office]
S. Hrg. 118-706
THE COST OF INACTION AND THE URGENT
NEED TO REFORM THE U.S. TRANSPLANT SYSTEM
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH CARE
of the
COMMITTEE ON FINANCE
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
FIRST SESSION
__________
JULY 20, 2023
__________
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Finance
______
U.S. GOVERNMENT PUBLISHING OFFICE
61-416 PDF WASHINGTON : 2025
COMMITTEE ON FINANCE
RON WYDEN, Oregon, Chairman
DEBBIE STABENOW, Michigan MIKE CRAPO, Idaho
MARIA CANTWELL, Washington CHUCK GRASSLEY, Iowa
ROBERT MENENDEZ, New Jersey JOHN CORNYN, Texas
THOMAS R. CARPER, Delaware JOHN THUNE, South Dakota
BENJAMIN L. CARDIN, Maryland TIM SCOTT, South Carolina
SHERROD BROWN, Ohio BILL CASSIDY, Louisiana
MICHAEL F. BENNET, Colorado JAMES LANKFORD, Oklahoma
ROBERT P. CASEY, Jr., Pennsylvania STEVE DAINES, Montana
MARK R. WARNER, Virginia TODD YOUNG, Indiana
SHELDON WHITEHOUSE, Rhode Island JOHN BARRASSO, Wyoming
MAGGIE HASSAN, New Hampshire RON JOHNSON, Wisconsin
CATHERINE CORTEZ MASTO, Nevada THOM TILLIS, North Carolina
ELIZABETH WARREN, Massachusetts MARSHA BLACKBURN, Tennessee
Joshua Sheinkman, Staff Director
Gregg Richard, Republican Staff Director
______
Subcommittee on Health Care
BENJAMIN L. CARDIN, Maryland, Chairman
RON WYDEN, Oregon STEVE DAINES, Montana
DEBBIE STABENOW, Michigan CHUCK GRASSLEY, Iowa
ROBERT MENENDEZ, New Jersey JOHN THUNE, South Dakota
THOMAS R. CARPER, Delaware TIM SCOTT, South Carolina
ROBERT P. CASEY, Jr., Pennsylvania BILL CASSIDY, Louisiana
MARK R. WARNER, Virginia JAMES LANKFORD, Oklahoma
SHELDON WHITEHOUSE, Rhode Island TODD YOUNG, Indiana
MAGGIE HASSAN, New Hampshire JOHN BARRASSO, Wyoming
CATHERINE CORTEZ MASTO, Nevada RON JOHNSON, Wisconsin
ELIZABETH WARREN, Massachusetts MARSHA BLACKBURN, Tennessee
(II)
C O N T E N T S
----------
OPENING STATEMENTS
Page
Cardin, Hon. Benjamin L., a U.S. Senator from Maryland, chairman,
Subcommittee on Health Care, Committee on Finance.............. 1
Young, Hon. Todd, a U.S. Senator from Indiana.................... 3
Wyden, Hon. Ron, a U.S. Senator from Oregon...................... 4
Grassley, Hon. Chuck, a U.S. Senator from Iowa................... 6
WITNESSES
Goldring, LaQuayia, kidney transplant recipient and kidney
transplant candidate, Louisville, KY........................... 9
McCarthy, Molly J., vice chair and Region 6 Patient Affairs
Committee representative, Organ Procurement and Transplantation
Network (OPTN), and 3-time kidney transplant recipient,
Redmond, WA.................................................... 10
Wadsworth, Matthew D., president and CEO, Life Connection of
Ohio, Kettering, OH............................................ 12
Lynch, Raymond J., M.D., M.S., FACS, professor of surgery and
public health director, transplantation quality and outcomes,
the Pennsylvania State College of Medicine, Hershey, PA........ 14
Cryer, Donna R., J.D., founder and CEO, Global Liver Institute,
Washington, DC................................................. 16
ALPHABETICAL LISTING AND APPENDIX MATERIAL
Cardin, Hon. Benjamin L.:
Opening statement............................................ 1
Prepared statement........................................... 33
Cryer, Donna R., J.D.:
Testimony.................................................... 16
Prepared statement........................................... 34
Responses to questions from subcommittee members............. 35
Goldring, LaQuayia:
Testimony.................................................... 9
Prepared statement........................................... 39
Responses to questions from subcommittee members............. 40
Grassley, Hon. Chuck:
Opening statement............................................ 6
Lynch, Raymond J., M.D., M.S., FACS:
Testimony.................................................... 14
Prepared statement........................................... 42
Responses to questions from subcommittee members............. 44
McCarthy, Molly J.:
Testimony.................................................... 10
Prepared statement........................................... 46
Responses to questions from subcommittee members............. 57
Wadsworth, Matthew D.:
Testimony.................................................... 12
Prepared statement........................................... 59
Responses to questions from subcommittee members............. 71
Wyden, Hon. Ron:
Opening statement............................................ 4
Young, Hon. Todd:
Opening statement............................................ 3
Communications
American Society of Nephrology................................... 75
Association of Organ Procurement Organizations................... 78
Center for Fiscal Equity......................................... 84
Frank, Adam, M.D................................................. 87
Hollis, Mary Ann, family of...................................... 87
McGlone, Patrick................................................. 89
Mid-America Transplant........................................... 92
National Down Syndrome Society................................... 93
National Kidney Foundation....................................... 94
Organ Donation Consortium........................................ 96
Science in Donation and Transplant............................... 98
Society of Pediatric Liver Transplantation....................... 103
TransMedics, Inc................................................. 104
United Network for Organ Sharing................................. 109
THE COST OF INACTION AND THE
URGENT NEED TO REFORM THE
U.S. TRANSPLANT SYSTEM
----------
THURSDAY, JULY 20, 2023
U.S. Senate,
Subcommittee on Health Care,
Committee on Finance,
Washington, DC.
The hearing was convened, pursuant to notice, at 10:03
a.m., in Room SD-215, Dirksen Senate Office Building, Hon.
Benjamin L. Cardin (chairman of the subcommittee) presiding.
Present: Senators Wyden, Cortez Masto, Warren, Grassley,
Lankford, Young, and Blackburn.
Also present: Democratic staff: Martha P. Cramer, Staff
Director for the Subcommittee on Health Care of the Senate
Committee on Finance and Health Policy Advisor for Senator
Cardin; Michelle Galdamez, Legislative Aide for Senator Cardin;
and Carolyn A. Perlmutter, Legislative Aide for Senator Cardin.
Republican staff: Beth Nelson, Health Policy Director for
Senator Young.
OPENING STATEMENT OF HON. BENJAMIN L. CARDIN, A U.S. SENATOR
FROM MARYLAND, CHAIRMAN, SUBCOMMITTEE ON HEALTH CARE, COMMITTEE
ON FINANCE
Senator Cardin. Good morning. The Subcommittee on Health
Care of the Senate Finance Committee will come to order. I
first want to thank Senator Wyden and Senator Crapo for their
help in allowing us to move forward with this hearing today in
regards to transplants. I also want to acknowledge Senator
Young not only for his taking on the responsibilities for this
hearing, but also his leadership on this issue. And we thank
Senator Daines for his cooperation in allowing the subcommittee
to proceed with today's hearing.
Lastly, I want to thank Senator Grassley, who has been the
real champion on this issue for many, many years. He will be
joining us. He is at the Judiciary Committee right now, and he
will be joining us shortly, and at that time he will be
recognized for his opening statement.
In the United States, the need for organs is far greater
than those available. There are about 104,000 adults and
children on the national transplant wait list, and every 10
minutes another person is added to it. In 2020, the Senate
Committee on Finance did an investigation into the system and
documented significant failures.
Today, we discuss the path forward to a better system. My
constituents in Maryland have access to two excellent
transplant centers in our State. Maryland also has a Tier 1
Organ Procurement Organization, OPO, that is taking innovative
action to some of the most underserved areas like Baltimore
City, to encourage organ donation. This OPO has been among the
top ten performers nationwide. Access to transplants in
Maryland is far from perfect. Despite the high-performance
transplant ecosystem, due to the nature of the underlying
issues with the current transplant network, 148 people died
while on transplant waiting lists in Maryland last year. That
is unacceptable. Other States are not so lucky. Marylanders and
people across the Nation deserve better.
Nationally, 17 people die each day waiting for an organ
transplant. OPOs are ranked Tier 1, Tier 2, Tier 3 depending on
performance levels, Tier 3 being the lowest. According to the
Centers for Medicare and Medicaid Services in a 2023
performance review, 24 OPOs, or 42 percent, have been
classified in Tier 3.
Senators Wyden, Grassley, Young, and I have been leading
the Senate Finance Committee's investigation into the organ
transplant system for over 3 years, and each new line of
inquiry has exposed more and more failures, which are often
borne by the sickest patients in the Nation.
Specifically, our committee has uncovered transportation
and testing failures that have put patients' lives at risk;
outdated information technology underlying the network; a lack
of oversight by the current Organ Procurement and
Transplantation Network, OPTN, contractor, the United Network
for Organ Sharing (UNOS); and misuse of Medicare funds.
These disparities impact people throughout the country,
including those who are low-income, the uninsured, members of
racial and ethnic minorities, people with disabilities, and
rural populations. Even more concerning, the U.S. Digital
Service has found that UNOS is incapable of modernizing the
OPTN IT infrastructure. The stakes of neglecting the needs of
underserved communities could not be higher.
During the last administration, CMS put out an OPO final
rule, which will establish a performance tiering system that
triggers decertification, competition, and potential DSA
reassignment. HRSA has taken critical steps to modernize the
OPTN, but statutory changes are necessary to ensure that HRSA
is able to work with the better-equipped organizations to
ensure the OPTN is operating in an efficient and safe manner.
When lives are at stake, Congress cannot accept logistics
or poor administration as excuses. Last week we held a
roundtable with senior officials from the Center on Medicare
and Medicaid Services and HRSA. It was a productive
conversation, where we discussed efforts to modernize the organ
transplant system and increase transparency and accountability.
Currently, we have a system that works well for some, as
some of our witnesses will discuss today. But that is
insufficient. Where an individual lives or their ability to
afford travel to get care should not determine access to
lifesaving organs.
Today, we have the opportunity to hear from patients and
professionals who are working on key reforms. Our committee
will continue to address the biggest challenges facing our
Nation, including the transplant system. We demand better, and
we will not stop until we make it so.
With that, let me recognize Senator Young.
[The prepared statement of Senator Cardin appears in the
appendix.]
OPENING STATEMENT OF HON. TODD YOUNG,
A U.S. SENATOR FROM INDIANA
Senator Young. Thank you, Chairman Cardin, for your
leadership on this issue. I see Senator Wyden here, who has
shown exemplary leadership as it relates to this issue as well.
Senator Grassley, one of the real champions, as indicated, will
be joining us a bit later, as I understand.
Every day, 17 people die while on organ transplant waiting
lists, and another 13 are removed from the waiting list because
they have become too sick to receive a transplant. In total,
there are more than 100,000 Americans on the organ transplant
waiting list today, including nearly 1,200 in my home State of
Indiana.
These are not just statistics. These are lives. Organ
donation is a personal issue for me. My friend, Dave Gunny
McFarland from Jeffersonville, IN, died because his heart
transplant never came. We served together in the United States
Marine Corps, and I have gotten to know Gunny's wife Jennifer
over the years.
She has made it her mission to raise awareness about the
transplant process, and to help prevent others from facing a
similar fate. Because the organ transplant system is so
complex, most people do not know how it works, or if patients
are being protected.
Now, I began looking into this issue right after being
elected to the House of Representatives in 2010. In the early
2010s, I explored ways to try and incentivize some innovation
in this space. I had a silly idea to try and create a prize
concept to coax people into innovating in the kidney space. The
bureaucrats told me it would go nowhere.
I began working on organ procurement oversight and reform
in 2018. I told The Washington Post then, ``We can't continue
to allow thousands of Americans to die each year waiting for
lifesaving organs that we know are available, if only this
system were being managed by competent individuals operating in
the light of day.''
I was proud to help champion performance measures for Organ
Procurement Organizations, which the Centers for Medicare and
Medicaid Services adopted and finalized in 2020, and I joined
my colleagues Chairman Wyden, former Chairman Grassley, and
Senator Cardin in launching an investigation that same year.
I welcomed the announcement earlier this year that HRSA
will break up the Organ Procurement and Transplantation Network
monopoly, and I joined my colleagues to colead the Securing the
U.S. Organ Procurement and Transplantation Network Act,
bipartisan legislation that gives HRSA the tools to implement
common-sense reforms to act in patients' interests.
But there is still much work to be done, and our friends
and neighbors are still dying every day. It does not have to be
this way. A functional organ donation system could facilitate
tens of thousands more organ transplants every year.
Americans deserve to know what the organ donation and
transplantation system and their government are doing to
increase organ donation and transplantation, as well as to
ensure patient safety. HHS and Congress must treat organ
donation reform with the urgency it deserves.
Lives are being lost, and we cannot stand by while some of
our most vulnerable neighbors die on the organ waiting list,
waiting for a call that never comes. We need strict enforcement
of the OPO rule, reform of the OPTN, and to ensure the entire
organ and transplantation system operates in the best interest
of patients.
We have taken initial steps, but we cannot stop there. I
look forward to hearing from our witnesses and learning from
their experiences and expertise of living and working within
the organ donation and transplant system on a daily basis.
I will not stop working on this issue until we increase the
availability of organs for patients in need and eliminate the
inefficiencies occurring in our organ donation system.
Thank you.
Senator Cardin. Thank you, Senator Young. The Senate
Finance Committee, under the leadership of Senator Wyden, has
been the moving factor in the investigations done that
uncovered so many of the mistakes and abuses that we have in
the current system. Senator Wyden has been our leader and
captain on this issue.
Senator Wyden?
OPENING STATEMENT OF HON. RON WYDEN,
A U.S. SENATOR FROM OREGON
Senator Wyden. Thank you, Chairman Cardin. And I just want
to note that one aspect of our service on the Finance Committee
is, we have always considered this the committee where you see
the NBA all-stars in the health-care arena. And certainly,
Chairman Cardin has been continuing that.
I am sitting in the seat this morning that was occupied for
many years by Senator Rockefeller, who was a great champion and
would be with us all the way in terms of cleaning up these
abuses that my colleagues have just mentioned.
I also especially want to thank our Republican colleagues,
Senator Grassley and Senator Young. This has been in the best
tradition of the Senate Finance Committee, with all these all-
stars we have in health-care policy working in a bipartisan
way, and I appreciate it.
I am going to be very brief. We have a terrific panel of
witnesses, and I am going to have to be in and out. I'll just
start by updating members and the public about our work, and
particularly moving forward with the Health Resources and
Services Administration to implement their modernization of
OPTN, the organ procurement network.
We are pleased with the bipartisan support that the bill
has gotten, and it has been good to see that UNOS is not
opposing the legislation. I can report to my colleagues and
people who are following this, I have had a number of
productive conversations with Chairman Sanders on this, and I
want everybody to understand, because I am not going to be able
to be here for the whole discussion.
This committee, on a bipartisan basis--as witnessed by my
colleagues here--we are going to be pulling out all the stops
to get the Senate to act on this issue as soon as possible. The
reason we are is because--both of my colleagues just mentioned
it. I think Senator Young used the word ``urgency.''
I cannot sum it up better than that, other than maybe a
capital ``U,'' because this is a matter of life and death for
too many Americans. There is not a moment to lose, friends,
with respect to getting this bill passed. And HRSA, the Health
Resources agency, is on track to begin the contract process
this fall. We are just going to be working here to complement
their effort.
Now, last week we hosted a meeting with officials from HRSA
and the Centers for Medicare and Medicaid Services to discuss
the administration's efforts to modernize the network, connect
more Americans with lifesaving organs, and particularly bring
more accountability and competition to the contracting process.
And three of us, Senator Grassley and others who attended,
we got the message loud and clear that the agencies want to
show a new emphasis on accountability and coordination. That
was very welcome.
A couple of other points, and one is, this hearing is going
to give us another chance to clear up some of the confusion
about what the legislation sets out to do and the rumors. And
if you listen to the rumors, I am telling you, they are trying
to basically run a kind of incumbent protection program and
smear this bill.
And Senator Grassley and I in particular, at this session,
asked questions with respect to our legislation and these so-
called rumors that the three of us are going to want to
privatize the system. I mean, if you listen to these rumors, it
would be like Congresspeople are trying to sell organs on the
side.
It was outrageous, the kind of stuff that we were hearing.
And here is what we were told by HRSA, the Health Resources
agency. ``No, the system is not being privatized, period.'' In
fact, HRSA notes that our bill will, for the first time,
mandate an independent board of directors to oversee OPTN,
separate from the contract holder.
Second, I asked HRSA to explain the boundaries that are
actually in place for a for-profit organization. How is it
going to work if they get a contract as part of OPTN? They said
that for-profit organizations would be held to strict Federal
standards for contractors. Let me quote again, ``limits on
profits and fees and comprehensive oversight, both before and
after the contract award.''
HRSA also made clear they intend for the section of the
contract concerning support for the independent OPTN board of
directors to be awarded to a nonprofit organization. So, to all
those people who are trying to spread these false and ugly
rumors about what this bill does, shame on you.
We are going to blow the whistle and make sure that the
American people know the facts. These colleagues will be here
this morning. I will be in and out. We are working in a
bipartisan way. And by the way, special credit to Senator
Grassley, who with me is the cochair of the Whistleblowers
Caucus. We know a little bit about people speaking out if there
are abuses. That is not the case here.
So, I will just wrap up by saying, ``Here is what is on
offer. We want to make sure that our country has the best-in-
class organ transplantation system in the world.''
And we found critical failures, looking in a bipartisan
way, from the current contract holder, especially when it comes
to matters such as information technology and logistics. So the
bill was written from top to bottom to ensure competition for
technical functions like those that will help the OPTN perform
to the highest level possible.
Thanks to my colleagues, and I have spoken to both of them
in recent days, and everybody understands. This is priority
business for the Senate Finance Committee, and there is not
going to be an ounce of partisanship here. We are going to stay
at it until we get this done, because the American people
deserve it. It is long overdue.
Senator Grassley, before you came--and I do not want to
make this a bouquet-tossing contest--I was talking about the
fact that you have been bulldogging this every step of the way,
and I really was grateful last week when we had the session to
go through the legislation, that we could all be together.
We appreciated your words, blowing the whistle on these
outrageous rumors that have been spread by some people who do
not really want change, that somehow this would privatize
things. So, thanks for all your good work, and you will see it
in the record that we are just so appreciative of your leading
this for so many years.
Senator Grassley. Can I respond by saying that I owe you a
big ``thank you,'' because we were finishing so much stuff I
started a long time ago. You were there helping me with every
letter and every move we made on it. So----
Senator Wyden. We are in it together, for the public.
Senator Grassley. Yes.
Senator Wyden. Thank you, Mr. Chairman.
Senator Cardin. Well, thank you, Senator Wyden. And thank
you for your commitment to keep this on track to get done. It
is very, very bipartisan. Senator Young and I have already
commented about Senator Grassley's leadership on this issue. We
have been mentored by Senator Grassley in regards to the need
for this committee's oversight on programs that we enact, and
he has taught us well.
Senator Grassley, thank you for your leadership on this
issue. You are recognized.
OPENING STATEMENT OF HON. CHUCK GRASSLEY,
A U.S. SENATOR FROM IOWA
Senator Grassley. Okay. Well, thank you, Chairman Cardin.
Today, we are here to visit about the urgent need to reform the
transplant system, and the deadly cost to patients and generous
donor families due to decades of inaction.
In 2005, I started the investigation of the deadly failures
of UNOS and the monopoly tasked with managing the U.S. organ
donation system. Since then, more than 200,000 patients have
needlessly died on the organ waiting list. There is a reason
that I call UNOS ``the fox guarding the hen house.''
For nearly 2 decades, UNOS has concealed serious problems
about the Nation's Organ Procurement Organizations, known as
OPOs, instead of working to uncover and correct the corruption.
This human tragedy is even more horrific because many of these
deaths were preventable. They were the result of a corrupt,
unaccountable monopoly that operates more like a cartel than a
public servant.
Our bipartisan investigation was started when I was
chairman of the committee, and I already referred to Chairman
Wyden's efforts in this working with me. We uncovered kidneys
lost in airports, technology systems that regularly go down,
and the cover-up of patient deaths. It uncovered a history of
misinformation and lobbying against accountability and
transparency for the local OPOs it's supposed to oversee.
We also are aware of ongoing threats to whistleblowers and
patient advocates. Instead of amending its bylaws to protect
these brave individuals, UNOS has continued its longstanding
practice of intimidation and retaliation. This is unacceptable.
Tens of thousands of organs go to waste every year,
exploiting generous donor families, while organ procurement
executives travel on luxury private jets to five-star resorts.
Investigative reporting has revealed anticompetitive behavior
designed to block new entities from the competitive bidding
process for new contracts, entities that have the technology
and skill desperately needed to save our lives.
Our Nation's organ procurement system is a deadly failure.
In recent years, UNOS has attempted to disguise its failures by
misrepresenting alleged record increases in organ donations.
Unfortunately, these increases are the results of public health
tragedies, including the opioid epidemic, which has ravaged our
rural communities.
It's time that we put an end to UNOS's attempts to use the
Nation's drug crisis to juice up its members, to try and show
the system is working. Simply put, the system is not working.
For too long, UNOS has run a system that benefits the
executives who run it, collecting taxpayer-funded perks and
paychecks. It has been more than 20 years since Forbes called
UNOS, quote, ``the Federal monopoly that's chilling the supply
of transplantable organs and letting Americans who need them
die needlessly,'' end of quote.
Our bipartisan investigation was clear. UNOS failed our
fellow Americans, and disproportionately so with respect to
older people or to people of color and rural residents. The
solution is also clear. Congress must pass our bipartisan bill,
S. 1668. Patient lives are at stake.
I yield. Thank you, Mr. Chairman.
Senator Cardin. And, Senator Grassley, thank you for your
statement. More importantly, thank you for your leadership.
In response to Senator Wyden, our topic, I think, very much
underscores the point that you made: the cost of inaction and
the urgent need to reform the U.S. transplant system.
We have an excellent panel who have experienced firsthand
the challenges in our transplantation system. So we are very
pleased to have all of our witnesses here today to help us in
this regard. Your entire statements will be made part of our
record, and you will be permitted to proceed as you wish.
I am going to introduce the five of you in the order in
which you will be speaking, and I will start with Miss LaQuayia
Goldring, who is from Bardstown, KY. She is a premedical
graduate from the University of Louisville. She is a previous
kidney transplant recipient and current kidney transplant
candidate.
She received the Lisa Allgood Excellence in Kidney Disease
Education award from the National Kidney Foundation, awarded to
those focused on improving the care and outcome for those
affected, as well as communicating risk factors and
implementing outreach efforts. Her first publication appeared
in STAT News, highlighting the failures of our U.S. organ
donation system and Black and Brown individuals seeking
transplants.
She will be followed by Ms. Molly McCarthy, a three-time
kidney transplant recipient. She grew up in northwest Illinois
and received her first transplant in 1991 at the University of
Iowa, her second at the University of Wisconsin, and her third
at the University of Washington.
She is in her fifth year as a volunteer with the OPTN
Patient Affairs Committee, serving for the last 3 years as vice
chair of the committee.
Our third witness is Mr. Matthew Wadsworth. He is the
president and CEO of Life Connection of Ohio, which serves
families and saves lives through organ donation in northwest
and west-
central Ohio. Before taking the reins of Life Connection of
Ohio, he served as the vice president of clinical affairs at
Nevada Donor Network. Under his leadership, Nevada Donor
Network doubled its performance within 3 years.
And next, we will hear from Dr. Ray Lynch, who is a
professor of surgery and public health sciences and the
director of transplantation quality and outcomes at Penn State
Health's Milton S. Hershey Medical Center.
He is a transplant surgeon whose research focuses on
improving access to organ procurement and transplantation care.
His work has formed the basis for objective metrics for
assessing the effectiveness of Organ Procurement Organizations.
Our fifth witness is Ms. Donna Cryer, who is the founder
and chief executive officer of Global Liver Institute, the
largest patient-led liver health nonprofit. She has channeled
her experience as a patient with inflammatory bowel disease
with a 28-year liver transplant into professional advocacy
across her career in law, policy, consulting, public relations,
clinical trial recruitment, and nonprofit management.
She has been awarded the Distinguished Advocacy Award by
the American Association for the Study of Liver Diseases, and
the Founder Award from Global Genes, among many of the
accolades for her pioneering patient advocacy.
So we will start with Ms. Goldring.
STATEMENT OF LaQUAYIA GOLDRING, KIDNEY TRANSPLANT RECIPIENT AND
KIDNEY TRANSPLANT CANDIDATE, LOUISVILLE, KY
Ms. Goldring. Hello, and good morning, Chairman Cardin,
Ranking Member Young, and members. Thank you for this
opportunity to testify before you today. My name is LaQuayia
Goldring. I am currently dependent upon the U.S. organ donation
system to save my life while I await a second kidney
transplant. In the meantime, the system is continuing to fail
me badly.
As a toddler, at the age of three I was diagnosed with a
rare kidney cancer that took the function of my left kidney,
and when I was 17 I went back into complete renal failure, and
I received a first kidney transplant at that time.
Unfortunately, in 2015, I went back into kidney failure. And at
that time, I was not ready for another transplant, but I did
not have a choice but to go back on dialysis. I have been
waiting 9 agonizing years for a transplant, dependent upon a
dialysis machine 5 days a week just to be able to live.
I was told that I would receive a kidney transplant within
3 to 5 years, but yet I am still waiting. I am undergoing
monthly surgeries just to be able to get my dialysis access to
work, so that I can continue to live until I get a transplant.
The UNOS wait list is not like 1 to 100, where everybody
thinks you get a number. I am never notified on where I stand
on the list or when I will get the call. I have to depend on an
algorithm to make the decision of what my fate will be.
Every day that I am waiting, I am closer to becoming one of
the 30 Americans who die waiting for an organ transplant. I
know this all too well, because that is why I have had to take
matters into my own hands and start searching for a living
kidney donor by starting a social media campaign.
I have lost multiple family members and friends to organ
failures, and I have seen more funerals than success stories,
and I do not want to be the next. The reason it is so hard for
me to get a transplant is because the government contractors
running the organ donation system are failing and corrupt.
I grew up in rural Kentucky, where the organ procurement
systems, the OPOs, are now failing like many in our country,
where over 20,000 organs every year are not recovered and
instead they go lost or they are wasted. More than one in four
kidneys are thrown in the trash as generous families have
offered to donate.
It is even worse for people who are labeled minority, or
people who are Brown and Black. Our kidney functions are
wrongly calculated based on race, and it delays our access to
transplant. OPOs are less likely to show up for us when it is
time to get authorization for you to be a donor. The treatment
that we get is less urgent and less caring, and they are less
compassionate toward us.
I know this firsthand, as my grandmother was an organ
donor, and we had to personally reach out to the OPO just to
show up. These failures lie at the feet of the monopoly UNOS.
Patients like me go completely forgotten in a system that is
failing us every day as more and more of us continue to die.
Just a few weeks ago, a donor family had reached out to me
to be a directed kidney donor, meaning they chose me
specifically for a kidney transplant. But unfortunately, due to
the errors in the UNOS technology, I was listed as inactive--
and this was a clerical error. All that they told me was this
was a clerical error and they could not figure out why I was
inactive. But when it came down to it, I am active on the
transplant list.
This was not a one-off event. UNOS technology is unsecure
and unreliable, and it crashes hourly. During that time,
transplant candidates are not getting phone calls. While
kidneys continue to go lost, lives continue to be lost in the
process. Every time this happens, patients like me continue to
die.
You cannot even imagine how this feels every time I lose a
family member because of UNOS's failures. Every time I lose a
friend or every time I look in the mirror I see that I am
standing with one foot in the grave and one foot hoping to be
able to live to see another day, waiting on a call that may
never come.
As the email from the OPO CEO board member once said,
justifying the policy proposal that systematically hurt
minorities based on where we live, that we are dumb expletives
for living in the South and rural America, as though we can
choose where we live as we wait for a transplant.
But this is never the case. While they are using taxpayer
dollars to get specific trips, large salaries, going on golf
tournaments and vacations in beach houses, patients who look
like me are getting coffins. But there are never any
consequences for them, because the government has never held
them accountable.
The government has completely failed me, as well as many of
us sitting here today. The only solution to replacing failing
OPOs is to get rid of UNOS--not tomorrow, not 2 years from now,
but today. My fate lies in the hands of the Senate. My fate,
like many other Americans, lies in the hands of you and all
your constituents, and I am just asking that you all stand
behind this legislation as we move forth, and that all of
Congress stands together to pass this new legislation, so more
lives can be saved and less will be put in coffins.
Thank you.
[The prepared statement of Ms. Goldring appears in the
appendix.]
Senator Cardin. Ms. Goldring, thank you very much for your
testimony. You have heard us mention the numbers that are out
there, but there is nothing like seeing the individual who is
impacted by that. Each number is a person. So, I thank you for
sharing your story with us. It is powerful.
Ms. Goldring. Thank you, sir.
Senator Cardin. Ms. McCarthy?
STATEMENT OF MOLLY J. McCARTHY, VICE CHAIR AND REGION 6 PATIENT
AFFAIRS COMMITTEE REPRESENTATIVE, ORGAN PROCUREMENT AND
TRANSPLANTATION NETWORK (OPTN), AND 3-TIME KIDNEY TRANSPLANT
RECIPIENT, REDMOND, WA
Ms. McCarthy. Good morning, Chairperson Cardin, Ranking
Member Young, and the members of the committee. I am grateful
for the opportunity to speak with you today. My name is Molly
McCarthy, and I am an exceedingly grateful three-time kidney
transplant recipient, after having had my first transplant 32
years ago.
I am one of the fortunate ones. I have made it, despite the
broken and corrupt system that we have been saddled with, and I
am all too aware that many patients are not as fortunate. I
received two living donations, one from my mom and the other
from my dad, an option that so many patients just do not have.
Eleven years ago, I received my third transplant from a
generous, deceased donor, and while I am very healthy now, I am
acutely aware that I may need another transplant in the future,
and whether that happens is dependent on what Congress does
now.
I am here today to plead with you to please pass S. 1668.
The reason why is as simple as it is heartbreaking. The Federal
monopoly contractor managing the organ donation system, UNOS,
is an unmitigated failure, and its leadership spends more time
attacking critics than it does taking steps to fix the system.
I have seen this firsthand in my 5 years as a patient volunteer
with the OPTN, and 3 years ago I stepped into the role of vice
chair of the Patient Affairs Committee, or PAC.
I thought this would be a great opportunity for me to
demonstrate my gratitude by representing and advocating for the
patient voice to be included in national policy. I could not
have been more wrong. What I have observed is that UNOS at best
treats patients as props; at worst, it outright lies to us and
then uses us as a shield against much-needed oversight and
reform.
UNOS knows enough not to lie to Congress, so it lies to its
patients instead, and then launders those lies through us. It
is no wonder to me that Forbes called UNOS a cartel in 1999.
For the last year, much of my work with PAC has consisted
of writing to congressional offices to fact-check UNOS
misinformation, which I would like to take the opportunity to
do today. For example, UNOS leadership has created a systematic
effort to misrepresent the facts, regularly celebrating recent
increases in organ donations as evidence of their success and a
well-working system.
The reality, however, is that this growth is driven
entirely by the opioid epidemic, skyrocketing gun deaths, as
well as other increases in suicides and fatal car accidents.
All UNOS is celebrating are national tragedies, not evidence of
a well-run system. Arguably worse, people who speak out have
been bullied, threatened, and retaliated against. I personally
have been warned by the UNOS board that it is unhappy with my
criticism, and that there may be consequences if I continue to
speak out.
I am a three-time patient. How do they say that to me?
Further, I have been called by a board member, telling me to
stop focusing on system outage and down time of the UNOS tech
system. He told me that having down time was not a big deal at
all. The donors are dead anyway.
That comment speaks volumes to me about the lack of empathy
and respect UNOS has for donor families. UNOS has failed to
oversee OPOs. As a patient, I cannot fathom why any Tier 3 OPO
is allowed to operate. Our lives depend on this business, and
CMS must immediately replace failing OPOs with the successful
OPOs that are getting the job done.
There is no shortage of evidence that this system is
broken. What I hope to convey today is that the problems are
far worse than publicly known, and the rot goes far deeper.
While we may never know the true toll of the gross negligence
and abuse of the government's own organ contractors, we at
least know the solutions.
CMS needs to move urgently to open data for OPOs. They must
replace these failing OPOs without caving to industry pressure
to weaken standards, and close the dangerous pancreas loophole
that allows OPOs to pad their numbers, misrepresent their
results, and jeopardize patient lives.
Two, Congress needs to break up the UNOS monopoly by
passing S. 1668, ensuring that HHS uses its authority to
replace UNOS as its contractor. Before my last transplant, my
family and I waited 6 agonizing years, and watching your
hearing last August, we realized that potentially years of that
wait were unnecessary.
Patients deserve an effective, safe, transparent, and
equitable organ donation system. Speaking as a patient, and
after having had an inside glimpse into the culture and
operating model, I have zero confidence that we will ever see
improvement if UNOS has any role whatsoever in the transplant
system.
Thank you.
[The prepared statement of Ms. McCarthy appears in the
appendix.]
Senator Cardin. Well, Ms. McCarthy, thank you for your
courage to come forward and to share with us the information
that you have observed.
Mr. Wadsworth?
STATEMENT OF MATTHEW D. WADSWORTH, PRESIDENT AND CEO, LIFE
CONNECTION OF OHIO, KETTERING, OH
Mr. Wadsworth. Chairman Cardin, Ranking Member Young, and
members of the committee, my name is Matthew Wadsworth, and I
serve as the president and CEO of Life Connection of Ohio, the
Organ Procurement Organization responsible for facilitating
organ donations in northwest and west-central Ohio.
My job is to help as many patients as possible receive
lifesaving transplants. Most days, I try to do that through
continually improving practice at our OPO. But to effect
meaningful change at scale, we need Federal policy reforms. The
current system is broken.
OPOs have geographic monopolies, which has made too many
sluggish and complacent at the expense of patients' lives.
There are absolutely no guard rails in place to ensure that
OPOs are adequately serving patients, and many of them are not.
And yet the Centers for Medicare and Medicaid Services has
never once decertified an OPO for performance failures.
In recent years, it appears things may finally be starting
to change. CMS finalized two regulations in 2020 to hold OPOs
accountable for the first time in 40 years. Three years later,
CMS still has not taken the steps to provide OPOs with any
guidance on how the rules will be enforced, or any indication
that it will support meaningful competition to ensure that
patients are only served by the best OPOs.
Furthermore, CMS has remained silent on waivers filed by
hospitals that want to work with higher-performing OPOs now,
instead of waiting until 2026. Additionally, CMS has not taken
any apparent steps to close a dangerous loophole in the rule,
which gives OPOs credit for recovery of pancreata that are
never transplanted, pancreata labeled for research, which many
OPOs have begun to flagrantly exploit--evidenced by over a 400-
percent increase in the number of pancreata placed for research
under this new rule.
This means that OPOs that are failing at their central
task--recovering organs for transplant--can avoid
accountability by simply recovering one organ and labeling it
``research.'' The fact that executives in our industry lack the
moral compass not to exploit this loophole is perverse. I am
deeply appreciative of this committee for investigating this
particular abuse.
This should be proof positive of a perhaps self-evident
notion. OPOs respond to their incentive structure.
Unfortunately, those incentives are currently entirely
misaligned with what patients need. This is not only regulatory
but financial. The OPO industry, including OPO boards, are
often rife with financial conflicts of interest, which means
OPOs all too often spend taxpayer resources on special interest
projects, rather than investing in organ recovery.
Another issue that deserves urgent attention is the lack of
safety guard rails. There is not even a standardized process
for declaring brain death across the country. The reality is
that the quality of care a donor patient and a donor family
receives depends on where in the country that person dies.
The fact the organ procurement system has been so broken
for 40 years speaks directly to the complete abandonment of
patients by the organization at the top of the system, UNOS.
Even now, more than 3 years into this committee's investigation
of UNOS's failures, UNOS has transitioned from an organization
that's inept, possibly incompetent, to one that takes an active
role in preventing patients from being transplanted.
Take for example recent reporting in The Washington Post
that UNOS is proposing changes to its terms of service, to
disallow external organizations from conducting data-driven
research into the most effective ways to place organs for
transplantation, even as our organ discard rates skyrocket.
UNOS only appears to be doing this to interfere with the
business of a potential competitor for its contract, showing
that, once again, the system has been held hostage by a
terrible actor, one which values its own contract far above the
lives of patients whom we are meant to serve.
This is a perfect microcosm of the problem. At every turn,
UNOS stifles innovation and hides its deadly failures, all to
keep its monopoly contract. There are three things the
Department of Health and Human Services needs to do immediately
to ensure that patients receive safe and high-quality organ
procurement care.
One, prepare to enforce the OPO rule without weakening or
delaying it, including closing the pancreas for research
loophole, publishing guidance for how the rule is going to be
enforced, and requiring the publication of OPO process data.
Two, break up the OPTN contract and allow for competition.
Patients need to be served by the best in areas such as
technology, logistics, data analytics, business development,
and process improvement. And three, eliminate board and
financial conflicts that exist in our industry that prevent
OPOs and any OPTN contractors from investing their dollars in
areas that grow donation and transplantation.
I commend this committee for introducing legislation to
finally break up this monopoly, and I stand ready to work with
you in any way possible to ensure that this bill passes. It is
the only way this industry will be able to save more patients'
lives.
Thank you.
[The prepared statement of Mr. Wadsworth appears in the
appendix.]
Senator Cardin. Thank you very much for your testimony,
particularly as it relates to accountability and competition.
We appreciate it very much.
Dr. Lynch?
STATEMENT OF RAYMOND J. LYNCH, M.D., M.S., FACS, PROFESSOR OF
SURGERY AND PUBLIC HEALTH DIRECTOR, TRANSPLANTATION QUALITY AND
OUTCOMES, THE PENNSYLVANIA STATE COLLEGE OF MEDICINE, HERSHEY,
PA
Dr. Lynch. Chairman Cardin, Ranking Member Young, and
members of the committee, my name is Raymond Lynch. I am a
liver and kidney transplant surgeon and a professor of surgery
and public health at Penn State Health and Penn State College
of Medicine in Hershey, PA. Thank you for the opportunity to
speak today.
In my career, I have had the privilege of recovering organs
from more than 200 generous deceased donor patients. I have
performed hundreds of organ transplants, and I am the principal
investigator on an NIH-funded study to enhance organ
procurement care for United States veterans.
I am here because Congress has the ability to take action
to save my patients' lives. I ask the committee to take
concrete steps to make organ procurement and transplant safer
and more effective for all patients by supporting legislation
that permits authentic competition for the OPTN contract,
allowing specialized, highly skilled organizations the
opportunity to move our transplant system into the 21st
century; by ensuring that CMS and HRSA collect and report data
on how OPO workers provide clinical care; and by ensuring that
CMS enforces the current OPO performance threshold without
delay or dilution.
I want to differentiate between organ donation, which is
the altruistic decision of the donor patient and their family,
and organ procurement, which is the clinical care provided by
OPO staff. This is what turns the gift of donation into the
usable organs for transplant.
Organ procurement is a clinical specialty. It is the last
medical care that many patients will ever receive. It is
reimbursed by the Federal Government, and it is administered by
OPOs that are each the only provider in the territory to which
they hold Federal contracts.
Right now, patient care delivered by OPOs is some of the
least visible in American health care. I cannot tell you how
many patients were evaluated by OPO workers in the U.S. in
2022. I cannot tell you how many patients were examined, or how
many families were given information about donation, or how
many times an OPO worker even showed up to a hospital to do
this clinical duty.
This lack of information about what OPO providers actually
do for patients is the root cause of the variability in rates
of organ procurement around the country. My research has shown
that what we call OPO performance is a measurable restriction
on the supply of organs that results in the unnecessary deaths
of patients with organ failure. For example, if the lowest-
performing OPOs from around the country had just reached the
national median over a recent 7-year period, there would have
been 4,957 more organ donors, yielding an estimated 11,707
additional organs for transplant.
Because many OPOs operate in a low-quality data environment
and without appropriate oversight, almost 5,000 patients did
not get adequate organ procurement care, and nearly 12,000
other patients did not receive lifesaving transplants. Patients
like Ms. Goldring, Ms. McCarthy, and Ms. Cryer carry the burden
of the failures in the system.
OPO clinical work is currently not visible, it is not
benchmarkable, and it is not able to be adequately evaluated,
analyzed, or compared. However, much of the hidden data about
how OPOs provide care to patients is known to one entity, and
that entity is UNOS.
The front-line OPO providers who administer procurement
care are some of the most dedicated and hardworking in
medicine. Instead of offering these workers assistance, UNOS
has instead advocated for a deadly status quo, where
fearmongering takes the place of action to address quality of
care.
Even worse, UNOS claims recent increases in organ donors as
a measure of its own success. I have published peer-reviewed
research that reveals the primary driver of the large portion
of these increases to be the opioid epidemic. Between 2009 and
2018, 94.6 percent of the increase in the number of donors came
from patients who died from a drug-related cause.
This does not lessen the value of these donor patients'
gifts, but it does make the appropriation of their tragic
deaths as a success story for government contractors a lot
harder to stomach. UNOS is not capable of managing a safe,
effective, and innovative transplant system.
I know many of us have served to the best of our ability on
UNOS committees. I emphasize I direct my critical comments to
UNOS leadership and their network of cronies. In spite of our
best efforts, UNOS's incompetence prevents patients from
becoming organ donors or receiving transplants.
We need a new network of highly skilled specialist
organizations, each attending to areas of expertise in the
management of the OPTN contract. I ask you to listen to
patients, to researchers, and to front-line health-care workers
at OPOs, transplant centers, and community hospitals. I ask you
to remove this burden from the patients and put a new OPTN
contractor to work. My patients' lives depend on it.
Thank you.
[The prepared statement of Dr. Lynch appears in the
appendix.]
Senator Cardin. Dr. Lynch, again I thank you for your
willingness to come forward with this information. It is very
helpful to us.
Ms. Cryer?
STATEMENT OF DONNA R. CRYER, J.D., FOUNDER AND CEO, GLOBAL
LIVER INSTITUTE, WASHINGTON, DC
Ms. Cryer. Thank you, Mr. Chairman, Ranking Member, and
committee members, for your bipartisan support and commitment
to saving the lives of the more than 100,000 Americans waiting
today for an organ transplant, by passing legislation to break
up the deadly Federal organ transplantation monopoly.
My name is Donna Cryer, and I am the CEO of the Global
Liver Institute. I founded this organization to ensure that
other patients and their families would have the same
lifesaving opportunity I had, because we know too many do not.
It seems I have waited decades to give this testimony, and
I know only by the grace of God am I alive to give it. Since my
own lifesaving liver transplant nearly 3 decades ago, I have
worked in the organ donation and transplantation field and seen
the system from all angles: as a patient, as a lawyer, as a
nonprofit executive, as a Federal Government appointee, and
having served in several roles as a UNOS staffer and volunteer.
And so, I know that the fault for thousands of unnecessary
deaths and so much dysfunction lies squarely with the United
Network for Organ Sharing, the Federal organ donation and
transplantation monopoly contractor which has held this
contract since 1986. I applaud this committee's investigation
for helping us, all of us here and so many others around the
country, to pull back the curtain finally and show every
American citizen the corruption that lies beneath this.
My first role at UNOS was as a patient affairs specialist,
which gave me views into policy, education, communications. I
even drafted the board minutes, so I know about the
conversations that were going on. Years later, as a member of
UNOS's Membership and Professional Standards Committee, or
MPSC, I was charged with reviewing patient safety lapses and
generating remediation plans.
I hoped this was finally a place where I could make a
difference. But as the Senate Finance Committee's investigation
has revealed, UNOS executives joke that ``it's like putting
your kids' art work up at home. You value it because of how it
was created, not whether it's well done.''
This is consistent with my firsthand experience. The joke,
I guess, is that UNOS knowingly leaves patients unsafe and
unprotected. I fail to see the humor.
What I experienced firsthand was that at MPSC, decisions
were made by a small cabal of industry insiders protecting each
other, routinely ignoring or excusing aberrant and dangerous
behaviors. The patient in me was traumatized. The lawyer in me
was wondering at what point would HHS staff in the room do what
they were supposed to do, and oversee the overseers. When would
they step in and act? They never did.
We can change that today. UNOS has been well aware for
decades of severe, often fatal risks to patients and has worked
far harder to cover them up than to fix them. There is no
reason to believe UNOS has changed since then. Many of the same
executives are not only still there, but they have been
promoted.
For example, the current CEO, Maureen McBride, has been
there since 1995. How is that a change agenda? We have the
opportunity today though to create a different future for
patients and families. Transplantation is often painted as
complex, but a very few simple steps would make the system
significantly safer and equitable, and would elevate the
quality of organs available.
Congress needs to pass the Securing the U.S. Organ
Procurement and Transplantation Network Act, period. Secondly,
there are acts that CMS can take, long-awaited acts that they
can take. Some examples are simply to enforce regulations, to
hold OPOs accountable for their performance, and to do so
without caving to industry lobbying pressure to weaken these
standards in any way.
Openly publish OPTN process data; require that all staff
interacting with patients have some baseline clinical training
or licensure--that should not be too much to ask for; and
require that adverse patient events are publicly reported.
Innovation and reform will never come from the same people
paid lavishly to perpetuate the status quo. They will push back
as they always do, and arguments will be made that change is
disruptive. But I assure you that nothing is more disruptive
than dying.
At my sickest point, doctors stood outside the ICU and told
my mother that I only had 7 days to live. Right now, 210 people
are estimated to die in the next 7 days. They will not be saved
by empty promises that reforms will come years down the line.
They need you, Senators, to act today.
Thank you.
[The prepared statement of Ms. Cryer appears in the
appendix.]
Senator Cardin. Well, thank you, Ms. Cryer, for your
testimony, and laying it on the line with us. The five of you
have presented very powerful testimony, and there is consensus
among the five of you of what we need to do.
It really does reinforce our initial thoughts on
legislation that we filed that would open up competition. Your
assessment that the OPOs are not being held accountable, too
many on Tier 3--one is too many, and as a result we do not have
the outreach and procurement that we should have in our
communities, which is costing people's lives.
The inability of UNOS to modernize--you are not alone on
that. The United States Digital Service found that UNOS is
incapable of modernization. And then the lack of transparency:
we do not have the data; we do not have the information. Ms.
Goldring, the fact that you cannot get adequate information as
to where you are on a list is unacceptable. The anxiety of that
issue alone, and the pain it causes you and how it affects your
health, is something that cannot be tolerated moving forward.
So normally I have a lot of questions I want to ask; I want
to ask a couple. But you have really reinforced, I think, our
views of the need for our legislation, but more importantly
also the need for accountability.
CMS needs to enforce the rule that was adopted that would
hold OPOs accountable, and decertifications if they do not meet
the test, and opening up competition that all of you have
talked about being so important that we have. All of that is
just so important, and of course without the data, we get----
Our investigation showed that there were transportation
delays, that the IT was down for a period of time. And if you
are down for a couple of hours, that is, if I understand it--
maybe I will ask Dr. Lynch this about the timing, how important
it is to get immediate time information here.
So if you delay, if IT is down, or the transportation--you
cannot track where the organ is--what impact does that have on
a successful transplant?
Dr. Lynch. Life and death.
Senator Cardin. That is a pretty direct answer, and that
has happened over and over again. Or organs not properly
sampled from the point of view of disease. What impact does
that have?
Dr. Lynch. Potentially life and death, Senator.
Senator Cardin. Yes, and these are mistakes that are
routinely being made--too often. We have been told that the
error rates on transportation are higher than we have on the
private companies where you can just go to the neighborhood and
you can track your packages better than you can track organs in
this country.
I guess I will ask a question on transparency. You have all
talked about it, but that is an area that I find incredible,
that you cannot get the data and information about a lot of
this because it is just not available. Is that what I am
hearing?
Mr. Wadsworth. I will answer that. Speaking to the recent
reporting in The Washington Post--I mean, UNOS is obstructive
to it. The idea that we would not use this data, aggregate it
and use it to drive process improvement, to save patients'
lives, I cannot understand that. We have the ability to do it.
Let us analyze it so we can do better.
Senator Cardin. And then, the IT modernization. We all have
modernized our IT except for this area. I do not understand why
there has not been the progress made. You have, Mr. Wadsworth,
made specific recommendations, and we made note about that, and
all of you have.
I can tell you that we will be working on a dual track.
One, legislation, but two, also accountability and enforcement
by HHS, which we--that is the reason why we had our roundtable
discussion last week with HRSA and HHS, CMS: to make it clear
that we expect enforcement.
HRSA is responsible to make sure that we have
accountability, and we do not have accountability in the
current system, that is clear. It is the general consensus that
UNOS has failed. We recognize that, and that has to be first
and foremost.
Secondly, we do need independent boards, and I know they
are moving forward on that point, and we do not want to have
conflicting boards. Third, transparency, and fourth,
competition, and then accountability for those that are not
performing.
Senator Young?
Senator Young. Well, thank you for your riveting testimony,
especially to our patients, but really to everyone. I thank
you. This is very helpful in generating additional attention
towards this issue and helping us effect change.
You know, since I got involved in this issue, I was told
time and time again from UNOS, from HHS, from other interested
parties, that somehow management principles did not apply. They
could not be applied to this endeavor of procuring organs and
matching them up with individuals for lifesaving treatments.
This was different.
It turns out that the basic management principle ``if you
cannot measure it, you cannot manage it'' also applies to this
setting. What is different is UNOS has had a monopoly, and we
do not allow monopolistic behavior in other areas. But we have
allowed it far too long in this area. We have seen it manifest
itself in lost lives, anxious individuals, and incredible
professionals who are trying to do the best they can within the
system.
Dr. Lynch, you have really broken a lot of ground in
measuring what we can, right, and indicating what needs to be
measured more effectively. I thought it was really compelling
when you were talking about this clinical practice that is so
opaque.
It seems to me there is an incredible opportunity, if we
can get this legislation passed, to shine some light on that
practice and to begin measuring, and therefore more effectively
managing, this entire enterprise. So I see the possibilities
here, and I am excited about those.
Dr. Lynch, there seems to be overwhelming evidence that
there are significantly more organs available for donation
today than are actually procured. Has UNOS or OPTN made any
meaningful attempts to increase the number of organs that are
procured?
Dr. Lynch. No, Senator, UNOS did not make any comment on
the final rule that went into effect in November of 2020 until
April of this year.
Senator Young. We can remedy that.
Mr. Wadsworth, I was looking at you when I was discussing
these individuals who have done yeoman's work within the
parameters you are given, within this ecosystem, to try and
make improvements. You have done it at Life Connection of Ohio,
and in some of your previous work.
What were the most critical changes you implemented that
have led to improvements? Can these changes be replicated or
shared with other OPOs? And then, where I am leading with this
is, does anyone give you a venue to share those practices, and
shouldn't that perhaps be the role of the OPTN?
Mr. Wadsworth. We actually used a lot of Dr. Lynch's work
in our analysis of Life Connection when we first got there, and
what we did was, we built structures to capture what the data
said the potential was.
So yes, this absolutely can be replicated. We have done it
twice. We did it in 3 years in Nevada, and we did it in 2 in
Life Connection, with our amazing team there. So yes, it can be
replicated, for sure.
Senator Young. And what role should the OPTN be playing in
helping to facilitate some of this sharing of best practices?
Mr. Wadsworth. Yes. So to your second question, no, I do
not have a venue, and it is probably because I am looked at as
a little bit of pariah, given the House testimony in 2021, in
saying the things that probably should have been said a long
time ago. And I am sure I will get some backlash here for this.
But no, I do not have a venue. But one thing we talked
about internally is, our organization will share any practice,
anything we do, with any organization that asks, and we do not
need credit for it. Just save someone's life. But no one ever
asks. It is crazy to me.
Senator Young. Okay. I will have some more questions, Mr.
Chairman.
Senator Cardin. Senator Blackburn?
Senator Blackburn. Mr. Chairman, thank you so much, and I
want to thank each of you for being here. We had an insightful
roundtable last week as we started looking at this issue, and
to Tennesseans, this is an important issue, getting this right.
Mr. Wadsworth and Dr. Lynch, I so enjoyed my few moments of
conversation with you all.
Dr. Lynch, I think I want to come to you first. And when we
look at OPTN and look at the Securing Organ Procurement Act,
the bill would strip the nonprofit requirement for the manager
of the Organ Procurement and Transplantation Network, which
would open the door for profiting from organ procurement and
donation.
And to me, this is something that I think many people
really fear, especially people who are on a wait list. So, what
I would like for you to do is to address that, and address
those concerns, and why or why not you think the Act has it
right.
Dr. Lynch. Thank you, Senator. I think it is unfortunate
that people would be afraid of that, because it needs to be
changed. Many of the patients that you reference are wait-
listed at for-profit hospitals.
For-profit is a part of American health care, and I can
tell you that our not-for-profit entity, UNOS, does not work
and there are for-profit hospitals and for-profit transplant
centers that do work. So, patients do not need to be afraid of
that. They do need to be afraid of the status quo.
Senator Blackburn. Okay; thank you for that.
Mr. Wadsworth, we have talked about the OPOs and what they
could or could not do to follow HRSA's guidance on
modernization, and you have talked a little bit about that. So,
when it comes to leveraging some of the modernization efforts
and trying to enhance transparency, competition, and overall
efficiency in the system, what do you see as the most vital
steps that should be taken so that we are moving toward that
goal?
Mr. Wadsworth. For me, I think it is mostly around the data
analytics, the business development of the organizations, to be
structured in a way that they can capture the most potential
possible for the patients that they serve. And then also,
utilization of technology, the application of it.
Senator Blackburn. And then address the issue of patient
privacy, as you look at data and how some of that data is
captured and shared, and then how that moves into research.
What is the importance of anonymity and privacy for those
patients?
Mr. Wadsworth. It is always going to be important to
protect patient data, and it is personal. But there are ways to
look at the data that blinds that, and it is still going to
drive process improvement without having concerns of sharing
something that should not be shared.
Senator Blackburn. Okay.
Ms. McCarthy, did you want to weigh in on that?
Ms. McCarthy. I absolutely agree. Obviously, we need
protection of our personal data, but right now everybody hides
behind that, or UNOS hides behind that, as reason not to share
information with us. In the context of wait list accuracy, our
PAC several months ago made a request for data around how many
people are actually on the waiting list and whether it is
accurate, knowing that 40 percent are inactive.
We were told as recently as last week that we will not be
able to see any future movement on that for no less than 8
months, despite it being anonymized data. We were just
completely told that we could not do it, despite coming in with
the spirit and tooling to be able to find some opportunities to
improve.
Senator Blackburn. All right.
Dr. Lynch, anything to add on that topic?
Dr. Lynch. So, the responsible use of patient data is a key
part of health-care research, and it is something that happens
in other fields. This is something where we do take on the
public trust to do that, but it is a recognized way to move
forward. Saying that it is a stumbling block or an absolute
``no'' is simply false.
Senator Blackburn. And do you fault UNOS in that regard?
Dr. Lynch. I do.
Senator Blackburn. Okay. Thank you all.
Thank you, Mr. Chairman.
Senator Cardin. Thank you.
You know, the lack of transparency here in data makes it
difficult for us to understand all of the challenges that we
have. But I take a look at the waiting list and the numbers
that come off the waiting list with an organ, and the
percentages in the non-
Hispanic, minority racial communities versus the rest, it is a
much, much lower chance of getting an organ.
And I tried to find out why that is the case, whether it is
the ineptness of the OPOs that are in those regions, or whether
it is UNOS's issues. But I know that there is disparity here,
and we need to do something about it.
Ms. Goldring, you have experienced, and currently
experience, the frustrations of being on a wait list and not
being able to procure an organ transplant. Can you just share
with us some of the experiences that you have had in regards to
being on that wait list?
Ms. Goldring. Yes, Senator. In regards to being on a wait
list, I have gotten to a point where I sit by the phone and
wait and just wait basically. Every day you are waiting for
that chance to be able to get that one call, and it never
comes.
And so we are stuck battling the State when it comes to
insurance. As somebody waiting on one transplant list, you want
to be able to secure an organ in another State. Well, if I want
to go to another transplant site outside of the State of
Kentucky, I am stuck dealing with the medical side of trying to
figure out how can I qualify to go to the next team, in
response to not having the protections against insurance
discrimination.
On top of the failures of UNOS not calculating my GFR
correctly, it delayed my process of being listed a whole year
sooner for transplant. So, I am stuck on dialysis until I
actually get that transplant, and then in the process of going
to see various transplant teams and working with the OPO in my
State, I have managed to talk to them about discrimination
while still being discriminated against.
When I ask the same question, why are Black and Brown
people or just anybody who looks like me not being
transplanted, they have no answer other than, ``Well, we need
more Black donors.'' My response is, ``Why don't we see you in
the hospitals actually securing organs for us?''
When it comes down to it, organ donation is not about your
skin tone. Organ donation is about an individual looking for
another chance at life, and that is all I am asking for, a
chance at living.
Senator Cardin. Ms. Cryer, do you have any views as to why
it is a much lower-percentage chance for a racial minority to
be able to have a transplant?
Ms. Cryer. Yes, and it really does come down to UNOS not
doing its job of overseeing the Organ Procurement
Organizations. We know from many studies that Black and Brown
communities donate organs in the same percentage they are of
the population.
So it is not a problem of willingness to donate. It is a
problem, as Ms. Goldring was starting to discuss, about UNOS
and OPOs--not ensuring that OPOs go out into the communities
and develop relationships far before that horrible decision is
needed to be made to donate the organs of a family member.
Also, this underscores the importance of the transparency
of data. If we do not have granular data that shows those
specific disparities, whether it is racial and ethnic or rural
and urban, we really cannot solve the problem and continue to
improve.
Senator Cardin. Ms. McCarthy, do you have any view on this?
Ms. McCarthy. This is a topic that has been near and dear
to the heart of our PAC for quite some time. And more than a
year in advance of any movement on the eGFR calculation being
racially biased, we raised this time and again with the UNOS
leadership as something that was disadvantaging Black patients.
We were ignored. We were told to stop talking about it and
bringing it up, that it was a far too complicated topic for
them to address. Basically, we were dismissed, although now, as
a result of some of the movement forward, there is now a class-
action lawsuit by 27,000 Black Americans to actually,
hopefully, make right that which has been obviously a
disadvantage for them.
Senator Cardin. Do either of the two of you want to comment
on this? I would be glad to hear from you.
Dr. Lynch. So this is a multilayer problem for which we do
need interventions at every layer. What we know from within the
transplant community is that UNOS has failed to help us with
data, and this is why it is so important for CMS and HRSA to
require the recovery of data that is already being collected at
centers and OPOs on processes that go from before the wait list
decision, or from before somebody becomes an organ donor
patient.
So data will help us to address the parts of it that we can
address within transplant.
Senator Cardin. Absolutely.
Senator Cortez Masto?
Senator Cortez Masto. Thank you. And thank you to the
chairman and ranking member. Such an important issue. So, I
appreciate your work here and the panelists for being here.
And, Ms. Goldring, I want to thank you for being here today as
well and sharing your story with our subcommittee.
I think we all agree it is critical that we understand your
experience, the experience of many across this country, and
really try to fix or at least address what we are hearing are
some of the concerns.
Let me follow up on Senator Cardin's questions around
transparency. Unfortunately, as we all know, we have a
tremendous lack of transparency when it comes to the U.S.
transplant system, and even when information is made
available--and I hear this in my State--it is difficult to find
and hard to understand. This fosters mistrust and reinforces
the complexity of navigating the transplant network, a system
that should be, I believe and I think many of us believe, as
transparent as possible.
Dr. Lynch, what role does increased transparency play in
impacting the quality and outcomes of the transplant system?
How can transparency help make sure the United States
transplant system is really more equitable, as you were talking
about?
Dr. Lynch. I think we have a tremendous opportunity right
now, Senator. I think this legislation is going to be central
to that. Getting specialist organizations that will help us to
build trust within the community and for our patients is going
to be a part of it.
And then getting that, what we call ``process data'' to
understand how we are delivering care to various
sociodemographic groups, the various geographic areas, all that
is going to be central to how we help the patients with organ
failure, how we respect the decision to become an organ donor
patient for those people who have passed away, and how we make
the best and most efficient use of all the resources we have.
Senator Cortez Masto. Thank you.
And let me just ask the panel in general: in recent years,
some Organ Procurement Organizations have implemented new
practices really to the success of their region becoming high-
performing OPOs. However, I recognize that many are failing to
meet some of our most important measures of performance, and
quite frankly that is why we need to move forward with these
much-needed changes.
But--and this is open to the panelists. From your
perspective, is there a balance to consider here? Do you
believe we should be working on maintaining and promoting the
success of Tier 1 OPOs while moving forward with broader
reform? And, Ms. Cryer, you can start. Thank you.
Ms. Cryer. Nothing that we are contemplating today would
disrupt or disallow those who are performing well from
continuing to perform well. All it means is that we will have
more OPOs that are operating at that level. As Mr. Wadsworth is
a perfect example, leadership matters.
And it is so important to the point that you made about
equity as well, to ensure that every American, wherever they
are in the country, has the same chance at a lifesaving
transplant, and the same respect for their donation as well, no
matter where they live. And we cannot do that without the
legislation and the changes we are asking for today.
Senator Cortez Masto. Thank you.
And I noticed, Mr. Wadsworth, you had mentioned the
improvements of an OPO in Nevada as well, and I am curious
about your comments.
Mr. Wadsworth. Thank you. If you look at the data and you
watch, you can see who is treading and who is taking it
seriously. If you remove the pancreata for research loophole,
you can see whose improvement is genuine. Now, I do not think
giving anybody more time means their behavior is going to
change. They are who they are.
I think in other evidence--and I do not think it is a
coincidence that a lot of CEOs retired the moment this rule was
announced, because it got hard, right? That is just a lack of
leadership in our industry. When stuff gets hard, you lead your
organization through it and you help patients. You do not exit
stage left to leave someone else holding the bag.
So I do not think behaviors are going to change. The easy
way to make your procurement organization look better was to
take advantage of this pancreata for research loophole. And as
I said in my opening testimony, that is absolutely perverse,
that someone would actually do that and be in a position of
leadership and their board not act on that.
That is extremely troubling. We should not have given them
an opportunity to move tiers because they can do it, and then
exploit it even further on a larger population base.
Senator Cortez Masto. Thank you.
Ms. McCarthy, did you have anything to add?
Ms. McCarthy. As I said in my opening statement as well, as
a patient, I cannot fathom why we have any of these Tier 3 OPOs
that are being allowed to exist. For me, I would like to see
them closed down immediately, transfer the responsibility to
high-
performing OPOs that also happen to have high-performing
leadership, and make those changes now. I think that is the
only way we are going to start to see some material impact to
patients.
Senator Cortez Masto. Thank you. Thank you again for being
here. I so appreciate it.
Senator Cardin. Senator Young?
Senator Young. Thank you.
I just want to rejoin something you said earlier, Ms.
Goldring. I have to tell you, I am stunned to hear your
comments that you randomly discovered that you were listed as
inactive on an organ waiting list. It is horrifying. It ought
to send chills down the spine of anyone who is watching this
hearing. You were blocked by our U.S. Government contractee
from receiving lifesaving organs.
This, if anything, highlights to me the urgent need for
reform. In the wake of this horrible discovery, are you aware
if there was any attempt from UNOS to notify you that your
status had changed to inactive?
Ms. Goldring. Senator, to answer your question, no. UNOS
never particularly contacted me nor the hospital to say what
the actual problem was that happened, and I was never
apologized to. And so, I ended up having to talk to the actual
family who wanted to donate to me, to apologize----
Senator Young. They said it was a clerical error--I am
sorry for interrupting--a clerical error?
Ms. Goldring. Yes, sir.
Senator Young. Clerical errors happen. Was anyone held
accountable?
Ms. Goldring. No, sir. And all that I was told is, ``Well,
sometimes this may happen, but we will do what we can going
forward to make sure it does not happen to another patient,''
and that is all I was told about the situation. That was from
an executive director of an OPO.
Senator Young. This goes back to basic business principles.
When there are really important tasks to be done, there are
mechanisms that can be put in place administratively to highly
minimize the number of clerical errors that could occur, for
example.
Ms. McCarthy, is there any formal policy about when and how
to notify patients of this important status change, from active
to inactive?
Ms. McCarthy. To the best of my knowledge, there is a
policy that we are to be told of any changes in our status by
U.S. mail letter. Speaking as a patient who has been on the
list three times, and many patients that I have talked to as
well, none of us have any recollection whatsoever of actually
receiving any of those letters.
As recently as last August, our PAC spent 4 hours doing a
design thinking workshop around how we could solve this problem
using technology. I asked as recently as last week what the
outcome of that was. I was told by the UNOS leadership that
they are not allowed to tell me, but that I am going to really,
really like it. But as I have done more digging, there is
absolutely no movement forward in that.
Senator Young. I mean, this--so your PAC has come up with
all sorts of ways to avoid this, right?
Ms. McCarthy. Countless. We have proposed, yes----
Senator Young. And with the highest degree of respect, you
are not probably populated with NASA engineers and, well, maybe
you are. But nonetheless, I bet I could sit down and probably
come up with some guard rails here.
But it is not my job. Today, it is the job of UNOS. And if
we have our druthers, if this panel has its druthers, and
anyone watching this proceeding has their druthers, UNOS will
not be doing this for very long.
Ms. McCarthy. God willing.
Senator Young. I have about a minute left, and I want to
make use of our time together. So, Dr. Lynch, what does CMS
need to do to appropriately enforce the 2020 OPO rule?
Dr. Lynch. They need to move forward with this as quickly
as possible, not dilute it, not delay it, not risk-adjust it to
make it less effective.
Senator Young. What do OPOs need from CMS in order to
improve performance for Tier 2 and Tier 3 OPOs?
Dr. Lynch. So, they need honesty. They needed that 2 years
ago when UNOS had the ability to give that to them. It is
really important to reiterate--and this is an answer to Senator
Cortez Masto as well--there is no requirement under the CMS
regulation that any OPO go out of business, that it be
decertified.
The OPOs are being judged against what is being currently
performed by their peers, and so this is something that they
can achieve if they look and see what is happening to their
next-door neighbor.
Senator Young. Thank you. We've got some work to do up here
and within this body, and we owe that to all of you, to keep
pressing hard.
Mr. Chairman?
Senator Cardin. Well, just to follow up--Senator Cortez
Masto, do you have any additional questions?
[No response.]
Senator Cardin. Just to follow up on Senator Young's point,
you responded, Dr. Lynch, to enforce the rule, and we agree
with you. That means there should be considerations of
decertification if they are not performing at a level that is
acceptable.
But you also have to have the services available in a
community, so you need to have competition. You need to have
the ability to not just decertify, but to make sure there is
access to transplant services in the community. So, we do not
want CMS to hide behind that issue and say they are never going
to enforce this rule, and I think that is our major concern,
because we find a reluctance right now to pull the
decertification trigger, which may in fact be necessary.
Dr. Lynch. I think that is critical, and I think that
having this legislation go through and getting a responsible
contractor or set of contractors will take some of that burden
from you.
So, with all due respect, I do not want us to have to keep
coming back to the principal. This is something that we should
be figuring out in our own community, in our own transplant
system, and with the right oversight and regulatory
contractors, we can.
Senator Cardin. We agree completely with that. I am just
pointing out that I think the hurdle is, we have not yet
convinced CMS to be very firm about these dates, and to have
accountability if there are not the performance improvements
that are expected under the rule that was issued.
And the second point, Senator Young, your point to Ms.
Goldring, is that she found out, you found out that you were
inactive on the list, and you were able to get it corrected.
But I am equally certain that there have been other cases
similar to yours, where the individual did not know to correct
it, and that person may have ended up deceased.
The point that Dr. Lynch made in response to several of my
questions is, delay equals life and death. Mistakes are life
and death. So we are dealing with an urgent issue. Chairman
Wyden said that over and over again. This is urgent.
Every day we are losing people, and it is just extremely
upsetting and unacceptable to know that a clerical error that
should be able to be easily caught by technology that is
available today, would have prevented that from happening, or
that tracking of transportation--which technology is pretty
sophisticated today--why that is not being utilized.
As a result, it is very possible that lives--well, we know
lives could have been saved that have been lost as a result of
those types of mistakes. Well, you have heard Chairman Wyden
and Senator Grassley and Senator Young and myself, as well as
the other members of our committee, make it very clear that we
intend to treat this with urgency.
Your testimonies have been powerful, as I said before. We
sit through a lot of hearings. You have really motivated us in
your testimony. All five of you have been very effective.
We know it is not easy for you to be here. I know
professionally it is not easy for you to be here. We know that
it is uncomfortable to go through some of these stories. But as
I said earlier, when we look at numbers, yes, we are motivated
by numbers, but we really are motivated to action by seeing the
people who are directly impacted by the policies that we have
here.
So I just really want to underscore again our thanks for
your participation in this hearing. It is one that reinforces
what we want to get done, but now I think gives us an
additional impetus to move as quickly as we possibly can.
Chairman Wyden mentioned we are also working with Chairman
Sanders of the HELP Committee, because we recognize that we
have to work with two committees here in regards to these
issues, and Senator Sanders has expressed strong support for
the efforts that we are committed to doing.
I know there are a couple of other members who wanted to be
asking questions who are en route. I am not going to hold up--
do we have any updates?
[Pause.]
Senator Cardin. We are going to just be a little patient
for a few minutes, if you do not mind. We have a couple of
other members who really want to weigh in. This is an important
subject, and I want to make sure our members have the chance to
express their views. So, if everybody will be patient, we will
just stay in a quiet moment to reflect, and we will be back
very shortly.
[Pause.]
Senator Cardin. As I was saying, there is lot of interest
of members of our committee on this subject. Senator Lankford's
been very active in these discussions, and if Senator Lankford
is ready, I will call on Senator Lankford to inquire.
Senator Lankford. Thank you very much. I apologize. I was
literally running back and forth on the floor. We are dealing
with pharmacy benefit manager stuff. That is some of next week
as well, so I appreciate all your engagement and help on this.
I need help and clarification on this, and it deals with
the kidney side of the transplants. About 1 percent of our
Federal budget goes towards this issue. I mean, it is an
enormous amount of money. There seem to be challenges here in
multiple areas, both of getting kidneys to people and the
process of actually doing the transplant.
Other treatments for all the kidney diseases and a whole
multitude of those things out there, especially for diabetics
and others, there are a lot of challenges there. Help unpack
this for me, and what am I missing on this, and what can be
done?
Mr. Wadsworth. I think Dr. Lynch can weigh in a little bit
on the transplant center side, but a lot of the incentives just
do not line up. So, from the OPO side, it has a lot to do
with--I mean, what are you going after, what cases, how are you
pursuing these cases, and are you building your organizations
in a way that you can ask these families for the gift of
donation and then manage these patients in getting the kidneys,
getting the patient to surgery to remove kidneys for
transplantation?
I think the way things have changed in terms of financial
incentives and things like that--and then I think transplant
centers are incentivized differently, and I think they have
their own challenges. So, the OPO is trying to push for
increased kidney transplantation, but I think--and correct me--
transplant centers are more rewarded, a little bit, for being
more conservative.
We are lucky in Ohio that we have one of the best
transplant programs in terms of wait list and things in the
country. But maybe Dr. Lynch can weigh in on this a little bit.
Senator Lankford. Yes. I am trying to find the incentives
here and where they are. So, Dr. Lynch, go ahead.
Dr. Lynch. So, renal failure is a crisis in America as a
result of the epidemic of diabetes and organ failure. The
difference in the incentives is the OPO is incentivized, or
ideally will be incentivized, to recover as many donors as
possible.
The center is incentivized to do as many transplants as
possible, but it is also measured on both its pretransplant and
posttransplant mortality. We need to make sure that there is a
continuous chain of custody in these incentives, so that they
really do align, and so that we take the best care of the donor
patients, we get every potentially usable organ recovered, and
then get it to the recipient who can make the best use of
that--and we make sure that centers are incentivized to take
what, in some measures, would be considered a risk, both with a
riskier patient and a riskier organ, to give them that chance
at a longer, better life.
Senator Lankford. So, tell me what that would mean as far
as the incentive shift there. What would that look like? I
understand what you are saying; practically, what would that
look like?
Dr. Lynch. So ideally, with better contractors as a result
of this legislation, we would have a contractor that would
measure everything in transplant, looking at our pretransplant
listing policies, and looking at our predonor evaluation
policies of who the OPOs are seeing as donor patients.
What we would do is make sure that every organ that is
recovered is expedited to the best possible recipient for it,
and that centers are able to remain competitive so that they
are not routinely being pushed down the list or preempted in
order to retain access for their patients.
Senator Lankford. So at this point, you are assuming, maybe
rightfully so, that there are some individuals who could--that
there may be a kidney available for them, but because they are
considered a higher risk, they are kind of set aside?
Dr. Lynch. Yes, sir. So if, for example, we hypothetically
were to measure centers only on their pretransplant mortality
or their posttransplant mortality, it will make centers
conservative, and they will not list people who are at a higher
risk of not making it to transplant, so dying before, or of not
surviving as long after. But they deserve that chance if they
are medically able to get both those options.
Senator Lankford. Right, right.
Ms. McCarthy, you are nodding your head over here.
Ms. McCarthy. This is an area that PAC has really stepped
forward in as well, in terms of allowing patients an
opportunity to have a voice, to be included in those decisions.
There are some patients who are more willing to take a more at-
risk organ in exchange for not waiting so long. So definitely,
this is something patients would advocate for.
Senator Lankford. Okay. Thank you. Anyone else want to make
a comment? Yes, Ms. Cryer?
Ms. Cryer. I would just say that there are two ways to--I
think what you are really asking is to reduce the costs of the
ESRD program. And so, I think there are really two ways that
the work that we are doing here today can do that.
If you have fewer people who have run into renal failure,
you really have to focus on--and I know CBO has a hard time
scoring prevention. So, we have to find a way to be able to--I
know we have been discussing TROA and other things to reduce
obesity, to reduce diabetes.
Most patients are not controlled for their hypertension,
particularly Black and Brown patients. At the Global Liver
Institute, we have more advocates coming from Oklahoma telling
us of the issues in Native communities, of being able to deal
with these issues that drive the need for transplantation.
To the point of incentives, the incentives are to keep
people on dialysis, not to transplant. And so, the ESRD program
would be relieved if we had, on both ends, people being swiftly
moved to transplant instead of languishing on dialysis, and
preventing the drivers of renal failure in the first place.
Senator Lankford. Okay. That is extremely helpful to be
able to walk through, because we do have to fix the incentives
in the process that are pushing people towards dialysis long-
term, rather than trying to give them the opportunity to have a
higher quality of life.
Thank you.
Senator Cardin. Senator Warren?
Senator Warren. Thank you, Mr. Chairman.
The Organ Procurement and Transplantation Network, or OPTN,
was established by the Federal Government to manage the U.S.
organ donation program. Today, OPTN is run by the United
Network for Organ Sharing, or UNOS, which is the only entity
ever to have been awarded this Federal contract.
Last year, the Senate Finance Committee released the
findings of an investigation into UNOS that revealed that this
system is deeply broken. Organs are getting lost in transit,
infected organs are being transplanted into patients, and the
individuals responsible for running the system are riddled with
conflicts of interest.
So, let us talk about one of these conflicts. Federal law
requires OPTN to have a board of directors. Makes sense. Most
organizations are governed by a board of directors that, when
working properly, serves as a check on the organization's
performance and management.
Ms. McCarthy, you are a transplant patient yourself, and
you serve as vice chair of the OPTN's Patient Affairs
Committee. So you see up close the governance of the OPTN. So
tell me, Ms. McCarthy, is there any difference in membership
between the UNOS board of directors and the OPTN board of
directors?
Ms. McCarthy. Senator, there is not. They are absolutely
the same people.
Senator Warren. So, they are identical, right?
Ms. McCarthy. They are.
Senator Warren. And right now, that means the same people
are in charge of overseeing how well the contractor runs the
organ donation system, and those are the same people who are
actually running it. So, Ms. McCarthy, how does this governance
structure affect the integrity of the organ transplant system?
Ms. McCarthy. I would argue there is no integrity in the
system. There is no accountability; there is no transparency;
and sadly, the cost of that is that people are dying every day.
Senator Warren. So what you are telling me is, nobody holds
themselves accountable----
Ms. McCarthy. Absolutely not----
Senator Warren [continuing]. Because this is an identity of
interest. Okay.
My view on this is that OPTN changes are long overdue, and
I support the reforms to HRSA, the Federal agency that oversees
the OPTN. It was announced earlier this year that we are going
to move in this direction.
I also joined Chair Wyden in introducing legislation to
give HRSA additional statutory authority to strengthen
government oversight. Among the many reforms, the legislation
would support HRSA's proposal to break up the OPTN monopoly
contract into multiple smaller contracts, which would allow
some competition and allow the best vendors in the business to
manage different parts of the transplant network operation.
That means hiring IT experts to do the IT. It means hiring
logistics experts to do logistics, and so on. Now, UNOS does
not want to lose control, so they are pushing to have the
government limit eligibility only to nonprofit vendors that
have worked in the past on organ donation, meaning for
instance, that the IT company that is hired to run OPTN's
computer systems would have had to have worked on an organ
transplant network in the past, and be a nonprofit.
So, Ms. McCarthy, the requirement UNOS wants would seem to
make it so that only one organization could apply for the new
contract: UNOS. Would you have any concerns if HRSA awarded
part of the OPTN contract to an entity that does not fit that
narrow description?
Ms. McCarthy. Senator, absolutely not. Quite the contrary.
We need to have diversity so that we can have the best in class
serving patients.
Senator Warren. I am glad to hear this. You know, I think
what we are seeing here is nothing more than UNOS trying to
protect its monopoly. The reforms that we have proposed are a
common-sense step that everyone should be able to agree on.
Right now, Congress has an opportunity to root out
corruption in this system. But if we do not act before the
current contract expires, we do not have another shot for
years. Patients have waited long enough. Congress should pass
the Securing the U.S. Organ Procurement and Transplantation
Network Act, and do it without delay.
Thank you. Thank you all for being here and for your work.
Thank you, Mr. Chairman.
Senator Cardin. Thank you, Senator Warren. We completely
agree, and we have sensed the urgency here to act immediately.
As Dr. Lynch pointed out, delay means life and death here, so
thank you for very much for your comments.
Once again, I want to thank all five of our witnesses. It
has been an extremely important hearing, and reinforces, I
think, our desire to move quickly to open up competition, to
provide transparency, to have accountability--all of the above
that we have talked about before.
We need to have a much sounder basis for finding out
whether there is an equitable system here, not only a system
that is efficient at getting the maximum number of transplants
to save lives, but also to make sure it is done in an equitable
and fair way. All that requires us to act on transparency,
accountability, and competition, which we intend to do.
So, thank you all for your testimonies, and with that, the
subcommittee hearing will be adjourned.
[Whereupon, at 11:45 a.m., the hearing was concluded.]
A P P E N D I X
Additional Material Submitted for the Record
----------
Prepared Statement of Hon. Benjamin L. Cardin,
a U.S. Senator From Maryland
In the United States, the need for organs is far greater than those
available. There are about 104,000 adults and children on the national
transplant wait list, and every 10 minutes another person is added to
it. In 2020, the Senate Committee on Finance did an investigation into
the system and documented significant failures. Today, we discuss the
path forward to a better system.
My constituents in Maryland have access to two excellent transplant
centers in our State. Maryland also has a Tier 1 Organ Procurement
Organization (OPO) that is taking innovative actions in some of the
most underserved areas, like Baltimore City, to encourage organ
donation. This OPO has been among the top 10 performers nationwide.
Access to transplants in Maryland is far from perfect. Despite the
high-performing transplant ecosystem, due to major underlying issues
with the current transplant network, 148 people died while on the
transplant waiting list in Maryland last year. That's unacceptable.
Other States aren't so lucky. Marylanders and people across the Nation
deserve better.
Nationally, 17 people die each day waiting for an organ transplant.
OPOs are ranked between Tier 1, Tier 2, or Tier 3 depending on
performance level--Tier 3 being the lowest that have one or both
measures below the median. Further, according to the Centers for
Medicare and Medicaid Services' 2023 performance review, 24 OPOs, or 42
percent, have been classified in Tier 3.
Senators Wyden, Grassley, Young, and I have been leading the Senate
Finance Committee's investigation into the organ transplant system
network for over 3 years, and each new line of inquiry has exposed more
and more failures, which are often born by the sickest patients in the
Nation.
Specifically, our committee has uncovered transportation and
testing failures that have put patient lives at risk; outdated
information technology underlying the network; a lack of oversight by
the current Organ Procurement and Transplantation Network (OPTN)
contractor, the United Network for Organ Sharing (UNOS); and misuse of
Medicare funds.
These disparities impact people throughout the country, including
those who are low-income, the uninsured, members of racial and ethnic
minorities, people with disabilities, and rural populations.
Even more concerning, the U.S. Digital Service has found that UNOS
is incapable of modernizing the OPTN IT infrastructure. The stakes of
neglecting the needs of the underserved communities could not be
higher.
During the last administration, CMS put out an OPO final rule which
would establish a performance tiering system that triggers
decertification, competition, and potential DSA reassignment. HRSA has
taken critical steps to modernize the OPTN, but statutory changes are
necessary to ensure that HRSA is able to work with the better-equipped
organizations to ensure the OPTN is operating in an efficient and safe
manner. When lives are at stake, Congress cannot accept logistics or
poor administration as excuses.
Last week, we held a roundtable with senior officials from the
Centers for Medicare and Medicaid Services (CMS) and the Health
Resources Services Administration (HRSA). It was a productive
conversation where we discussed efforts to modernize the organ
transplant system and increase transparency and accountability.
Currently, we have a system that works well for some, as some of
our witnesses will discuss today, but that is insufficient. Where an
individual lives or their ability to afford to travel to get care
should not determine access to lifesaving organs.
Today, we have the opportunity to hear from patients and
professionals who are working on key reforms. Our committee will
continue to address the biggest challenges facing our Nation, including
the transplant system. We demand better, and we will not stop until we
make it so.
______
Prepared Statement of Donna R. Cryer, J.D., Founder and CEO,
Global Liver Institute
Thank you, Mr. Chairman, Mr. Ranking Member, and committee members,
for your bipartisan support and commitment to save the lives of the
more than 100,000 Americans waiting today for a solid-organ transplant
by passing legislation to break up the deadly Federal organ donation
monopoly and insisting that HHS steps fully up to its congressionally
authorized role to protect donors and patients relying on the
transplant system.
My name is Donna Cryer, and I am the president and CEO of Global
Liver Institute, the only patient-driven, nonpartisan liver health
nonprofit operating established in the United States and operating
through partnerships with more than 55 countries and 200 medical
societies, patient advocacy organizations, and other health promoting
organizations through our councils, campaigns, and events.
I have worked in the organ donation field for almost 3 decades,
since my own lifesaving liver transplant from a rare autoimmune disease
and have seen these issues from all angles: as a Harvard and Georgetown
educated lawyer; a nonprofit consultant, executive, and founder; a GAO
appointee to the HIT policy committee; an SGE representative to the
U.S. Food and Drug Administration; and the first call that thousands of
patients and families who find themselves in the overwhelming
circumstances of donating or waiting for the precious gift of life have
made.
As far back as 1993, when I navigated the circuitous route to be
diagnosed in liver failure, and evaluated for a transplant, the gaps,
inequities, and burdens on families posed by what is called our
transplant ``system'' were apparent. The decision to dedicate my gift
of life to helping other transplant patients by finding ways to improve
the system was clear. I started my career by serving in various roles
for the United Network for Organ Sharing, UNOS, the Federal organ
transplant monopoly contractor, which this very committee is
investigating.
I have waited decades to give this testimony. Only by the grace of
God am I alive to give it. The failures of the U.S. organ procurement
system are devastating, leaving in their wake needless death and
breathtaking inequity. The fault lies squarely with UNOS, as well as
many of the Nation's Organ Procurement Organizations, or OPOs, which
UNOS is supposed to oversee, under government contract.
At every turn, the organ industry is seen to prioritize executives
over patients. But perversely, because organ donation is such a
beautiful gift on behalf of generous donor families, and the science
enabling it is such a marvel, the public has been blind to the hard
truth that the industry behind it is corrupt.
I hope today that we are able to give you and everyday American
citizens a chance to see behind the curtain.
My first role with UNOS was as a Patient Affairs Specialist which
gave me views into policy, education, and communications. I sat in on
staff leadership meetings, negotiation strategy sessions for dealings
with HRSA, and it was even my job to draft the board minutes. Years
later I was elected as a member of UNOS's Membership and Professional
Standards Committee, or MPSC, which is charged with reviewing patient
safety lapses and generating remediation plans. I hoped that would
provide a different vantage point for me to make a difference.
The Senate Finance Committee's investigation findings revealed UNOS
executives joking that the MPSC is ``like putting your kids' artwork up
at home; you value it because of how it was created rather than whether
it's well done,'' and are consistent with my firsthand experiences.
The joke, I guess, is that UNOS knowingly leaves patients unsafe
and unprotected. I fail to see the humor in it.
What I experienced firsthand was that MPSC decisions were made by a
small cabal of industry insiders protecting each other, routinely
ignoring or excusing abhorrent and dangerous behaviors.
The patient in me was traumatized. The lawyer in me wondered at
what point the HHS staff in the room who were supposed to oversee the
overseers would step in and act. UNOS has been well aware, for decades,
of severe and often fatal risks to patients, and has worked far harder
to cover them up than to fix them.
There is no reason to believe that UNOS has changed since then.
Many of the same executives are not only still there, but have been
promoted, for example the current CEO, Maureen McBride, who has been
there since 1995.
UNOS executives know as well as I do that patients are dying
needlessly in every stage of the system, yet I am not aware of a single
meaningful action they have taken to address this. They post pretty
words and press releases on their website pledging to do things that
they have been empowered and requested to do for decades.
This time can be different. I have come before you to ask
specifically for the Senate passage S. 1668, Securing the U.S. Organ
Procurement and Transplantation Network Act, and to continue to keep
the spotlight on the Centers for Medicare and Medicaid Services' (CMS)
responsibilities in transplantation. CMS needs to, without further
delay, use data that they do have to enforce regulations to hold Organ
Procurement Organizations (OPOs), and the government contractors in
charge of reaching out to donor families and securing donor organs,
accountable for their performance, and to do so without caving to
industry lobbying pressure to weaken these standards in any way.
With rare exceptions--which only demonstrate how good leadership
and high performance are possible and in fact transformative to a
region--a majority of OPOs are not only failing across multiple
measures of performance, but have specifically been shown to
systemically deprioritize outreach to Black and Brown families and
communities, leading to fewer transplants to Black and Brown patients.
CMS taking the long-awaited actions requested by communities,
patient, and donor family advocates across the country would make organ
procurement safer, more equitable, and elevate the quality of organs
available. Transplantation is often painted as complex, but a few
simple steps would make a significant difference. Here are some
examples. Openly publish OPO process data. Require that all staff
interacting with patients have some baseline clinical training or
licensure. Require adverse patient events to be reported publicly.
Innovation and reform will never come from the same people who are
perpetuating the current dire status quo. Industry will push back, as
it always does, with protectionist arguments that any change is
disruptive, but I will assure you that nothing is more disruptive than
dying. At my sickest point, doctors stood outside the ICU and told my
mother that I only had 7 days left to live. Right now, under the
current regime, 210 people are estimated to die in the next 7 days.
They will not be saved by empty promises that reforms will come years
down the line. They need you, Senators, to act today.
Thank you.
______
Questions Submitted for the Record to Donna R. Cryer, J.D.
Question Submitted by Hon. Sheldon Whitehouse
Question. OPOs are only one of two major programs left in Medicare
that operate on what's called ``cost-reimbursement basis,'' meaning
they are reimbursed by taxpayers for whatever dollars they spend,
rather than for the value they deliver. This incentivizes them to spend
more money rather than to deliver high quality care for patients. The
Federal Government has moved away from cost- reimbursement almost
everywhere else in health care.
How do you suggest we move away from ``cost-reimbursement basis''
in organ transplantation?
Answer. Before considering changes to the reimbursement system for
organ transplants, steps must be taken to modernize the OPTN, as is
required by the Securing the U.S. Organ Procurement and Transplantation
Network Act, legislation passed by Congress and signed by the
President. A modern reimbursement system centered on value to the
patient can only work with the data to support appropriate quality
measures that drive accountability for high quality care. As I stated
in my opening testimony, I urge the OPTN to take steps toward
accountability by openly publishing OPO process data, requiring that
all staff interacting with patients have some baseline clinical
training or licensure, and requiring adverse patient events to be
reported publicly.
______
Questions Submitted by Hon. Ron Wyden
guaranteeing equity in the organ transplant system
Question. Disparities in the organ donation and transplant system
continue to persist. Black Americans are disproportionately represented
on waiting lists and experience longer wait times for organs than other
racial and ethnic groups. A few statistics that I find alarming are
that Black Americans are four times as likely to develop kidney failure
as White Americans, but are much less likely to receive a kidney
transplant; and that Black Americans experience the highest rates of
heart failure, yet receive heart transplants at lower rates than White
Americans. These types of disparities are unacceptable.
Can you summarize the root causes of these disparities and describe
how Congress can ensure that the U.S. transplant system better serves
patients from minority populations and addresses these disparities?
Answer. For people of color, the unrealized potential of organ
transplantation is devastating. We know people of color are
significantly less likely to be put on the wait list, and also less
likely than White patients to receive a lifesaving organ transplant
once on the wait list.\1\ While White people on the wait list have
about a 50-
percent chance of getting a transplant each year, the number is closer
to 25 percent for Black people.\2\ Studies also reveal the strong bias
against Black people when it comes to assessing the ``fit'' of getting
a transplant. In reality, people of color are more likely to be deemed
medically unfit based on a nonclinical assessment highly subject to
racial bias, or they may not be informed of the option at all.\3\ For
example, historically Black patients were less likely to be referred by
hospital staff to OPOs,\4\ including as the result of guidance by OPOs
to not call them in specific circumstances ``to avoid reporting on
cases when the OPO believes donation is unlikely.''\5\
---------------------------------------------------------------------------
\1\ https://bloomworks.digital/organdonationreform/Inequity/#fn:23.
\2\ ``Organ Donation and African Americans,'' Minority Health, HHS,
2020.
\3\ https://bloomworks.digital/organdonationreform/Inequity/.
\4\ https://pubmed.ncbi.nlm.nih.gov/12545008/.
\5\ https://bloomworks.digital/organdonationreform/Inequity.
Black families are also less likely to be approached for donation
in a manner that is compassionate and culturally competent. Among the
most common reasons they decline to donate are that the OPO did not
``give [them] enough time to discuss important issues . . . or respond
to [the family's] strong emotion with sensitivity and empathy.''\6\
Yet, we know families who have more contact with OPO staff are three
times as likely to donate.\7\
---------------------------------------------------------------------------
\6\ https://link.springer.com/article/10.1007/s40615-020-00806-7.
\7\ https://jamanetwork.com/journals/jama/fullarticle/193976.
When HHS announced the OPTN Modernization Initiative, the agency
committed to strengthen accountability, equity and performance in the
organ donation and transplantation system. The transplant community
strongly supports their focus on technology, data transparency,
governance, operations and quality improvement and innovation. I hope
this committee will continue to provide the oversight needed to ensure
increased transparency of the data needed to address its shortcomings
and hold OPO's accountable for improving their performance,
particularly for Black patients and their families.
organ procurement and transplantation network (optn) technology
Question. The Senate Committee on Finance's investigation into the
current OPTN contractor, the United Network for Organ Sharing (UNOS),
uncovered critical system outages and failures by UNOS, to adequately
manage lifesaving organ procurements and transplantations. In 2022, I,
along with Senator Grassley, called for updates to the OPTN's
information technology system in letters to the Federal Chief
Information Officer and UNOS. This year, Senator Grassley and I sent
another letter to UNOS, raising concerns about system outages of
DonorNet, the organ transplant wait list database, which went off line
on February 15th. The OPTN technology is a critically important
component of the OPTN system, which is why it is imperative that the
best in class are able to bid for a contract.
Given your experience as an Appointee to GAO's Health Information
Technology (HIT) Policy Committee, can you speak to the importance of
the OPTN technology?
Answer. As a member of the GAO's Health Information Technology
(HIT) Policy Committee, I recognized that transparency,
interoperability, and ease of engagement with data by clinicians and
patients should be the hallmarks of U.S. health technology. Those are
not present in this case. We know that the government has struggled to
promote innovation or engage best-in-class expert contractors to serve
patients due to OPTN policies that geared toward making the industry
look good, while hiding patient safety concerns. For example, the U.S.
Digital Service found that UNOS's technology is insecure and often
crashes, creating periods of downtime during which lifesaving organs
literally cannot be matched with recipients.\8\ Other investigators
found that UNOS maintains an archaic logistics infrastructure over
which organs are tracked with phone calls and paper manifests, as
opposed to using GPS or other electronic tracking. The result is
lifesaving organs, often shipped on commercial flights, being lost or
delayed and therefore unusable.\9\
---------------------------------------------------------------------------
\8\ https://58425eca-649a-42d4-b265-d1e1743b6c48.filesusr.com/ugd/
581bc3_11444ae6eeba4a65
a3894a01d9095bed.pdf.
\9\ https://kffhealthnews.org/news/how-lifesaving-organs-for-
transplant-go-missing-in-transit/amp/
?utm_source=STAT%20Newsletters&utm_campaign=06e49f9ea7-MR_COPY_01&utm_
medium=email&utm_term=0_8cab1d7961-06e49f9ea7-
149550985&twitter_impression=true.
Unfortunately, the protectionist culture of the industry was laid
bare when Federal regulations in 2020 called on Organ Procurement
Organizations to use objective--rather than self-reported--data to
evaluate their performance and to make performance metrics legally
enforceable. If you were approached or lobbied by anyone opposing an
unbiased data repository, then you have already seen these conflicts of
interest at work. The U.S. Digital Service reported that HRSA has tried
many things over the years to encourage more transparency and
accountability from UNOS through the OPTN contract, which were met with
hostility from UNOS and even threats to walk away and continue
operating the OPTN without a contract, which is illegal.\10\
---------------------------------------------------------------------------
\10\ https://58425eca-649a-42d4-b265-d1e1743b6c48.filesusr.com/ugd/
581bc3_11444ae6eeba4a
65a3894a01d9095bed.pdf.
Question. Additionally, why is it essential to have a contractor
---------------------------------------------------------------------------
that can deliver the best-in-class system for patients?
Answer. The importance of technology to improve outcomes in
transplantation cannot be understated. A less than efficient, modern
technology infrastructure and data analytics staff can mean life or
death to people on the waiting list. Patients erroneously made inactive
on the list, therefore losing crucial waiting time or the actual
opportunity to receive an organ is just the most glaring. Other areas
of American life have seen technological innovation that demonstrates
how much better it can be. A rapid delivery Amazon package of medical
equipment or home delivery of prescription drugs support better health
outcomes. There is no excuse for the secure and stable technology and
reliable logistics management we see in other sectors to be absent from
the organ donation system. Yet, the U.S. Digital Service ultimately
found that UNOS lacked the capability to modernize its technology. If
that is the case, isn't it time for OPTN to contract with a new entity
to bring this innovation to the transplant system?
HHS projected these policies supporting transparency and
accountability would save over 7,300 lives a year.\11\ These reforms
were supported by every major patient group \12\ and celebrated by
national health equity leaders.\13\ Expert data scientists and
epidemiologists, free of conflicts, now have the ability to conduct
research that informs policies aimed at increasing the number of
lifesaving organ transplants for patients every year.
---------------------------------------------------------------------------
\11\ https://www.healthaffairs.org/content/forefront/new-organ-
donation-rule-win-black-patients-and-health-equity.
\12\ https://blog.petrieflom.law.harvard.edu/2021/02/05/recent-
organ-procurement-organization-regulations-will-save-lives/.
\13\ https://www.healthaffairs.org/content/forefront/new-organ-
donation-rule-win-black-patients-and-health-equity.
The outcomes speak for themselves. More than 100,000 Americans are
waiting for lifesaving organ transplants and new data shows that 17
people die daily waiting for an organ. According to a study by HRSA, in
2015, organs for transplantation were recovered from about 8,000
deceased donors per year, potentially only one-fifth of the true
potential. These findings suggest that significant donation potential
exists that is not currently being realized. Ninety-five percent of
Americans support organ donation,\14\ yet donation rates have not kept
pace with simple population growth over the last 10 years, and clearly
demands more structural incentives for innovation.\15\
---------------------------------------------------------------------------
\14\ https://www.donornetworkwest.org/about-donation/organ-
donation-facts-statistics/#::text
=The%20majority%20of%20American_95,close%20and%20an%20important%20one.
\15\ https://organdonationreform.netlify.app/assets/PDF/donation-
increase.pdf.
______
Questions Submitted by Hon. Todd Young
Question. Is there any formal policy in place regarding when and
how to notify patients of any status change on the organ donation
waiting list?
Answer. Unfortunately, as you heard from Ms. LaQuayia Goldring in
her testimony, there is no requirement to notify a patient where they
stand on the wait list, and so-called clerical errors are common. While
there are patient notification policies in existence for transplant
hospitals to notify patients when the patient is registered on a
waiting list, when the patient's evaluation for transplant is complete,
if the patient is not registered on the waiting list, and when the
patient is removed from the waiting list for reasons other than
transplant or death, these policies are not consistently followed and
there is often no corrective or restorative action taken for failure to
adhere.\16\
---------------------------------------------------------------------------
\16\ https://optn.transplant.hrsa.gov/media/eavh5bf3/
optn_policies.pdf.
Question. What would be the most effective way to notify patients
---------------------------------------------------------------------------
of their waiting list status?
Answer. I would recommend that patients have an opportunity to
choose the method by which they prefer to be notified of their status
on the wait list, whether by patient portal, phone call, email, or by
regular mail (with address regularly updated) and that penalties be
assessed if the information is not shared in a timely manner.
Question. What, if any, additional information would be useful for
patients to have access to regarding their position on the waiting
list?
Answer. Patients should be able to easily access their position on
the wait list and whether they are active on the wait list, and if
inactive, an explanation as to why with steps to address and become
active again. It would also be useful to understand what factors would
affect their position or status on the wait list.
Question. How many patients are listed as inactive?
Answer. As of December 27, 2013, 26,407 registrations were waiting
with an inactive status for 1 year or longer without interruption, of
which 87 percent were kidney registrations.\17\ Reason codes do exist,
and patients are often not notified.
---------------------------------------------------------------------------
\17\ https://optn.transplant.hrsa.gov/media/1443/
pubcommentpropsub_344.pdf.
Question. Is there any regular review/oversight by UNOS or others
to ensure a patient listed as inactive is aware of their current
---------------------------------------------------------------------------
status?
Answer. While HRSA has proposed a policy to notify patients of
their inactive status, currently the rule only states, ``If the
candidate is temporarily unsuitable for transplant, then the
candidate's transplant program may classify the candidate as inactive
and the candidate will not receive any organ offers.''\18\
---------------------------------------------------------------------------
\18\ https://optn.transplant.hrsa.gov/media/eavh5bf3/
optn_policies.pdf.
Question. Is there any regular review/oversight by UNOS or others
to ensure patients listed as inactive are appropriately designated as
---------------------------------------------------------------------------
inactive, especially over an extended period of time?
Answer. I am not aware of such a requirement and would strongly
support one.
Question. Are patients provided appropriate information and
resources to determine any next steps needed to return to active
status?
Answer. Unfortunately, this level of communication with patients is
often lacking. We look forward to working with HRSA to update the
requirements for communication with patients to assure that patients
know and understand their status and concrete steps needed to return to
active status if deemed inactive.
______
Prepared Statement of LaQuayia Goldring, Kidney Transplant
Recipient and Kidney Transplant Candidate
Hello and good morning, Chairman Cardin, Ranking Member Young, and
members. Thank you for this opportunity to testify before you today.
My name is LaQuayia Goldring, and I am currently dependent on the
U.S. organ donation system to save my life while I await the lifesaving
blessing of receiving a 2nd kidney transplant--and the system is badly
failing me.
As a toddler, at the age of 3 I was diagnosed with a rare kidney
cancer called Wilms tumor (a golf-ball-size tumor) that took my left
kidney. Due to that, at the age of 17, when I was diagnosed with stage
five kidney failure, I was placed on the UNOS waiting list and received
my first kidney transplant.
At the age of 25 I went back into complete kidney failure. I've now
been waiting 9 long agonizing years for a transplant, dependent upon a
dialysis machine 5 days a week to live. I was told I should receive a
kidney transplant within 3-5 years, and still I wait as I continue to
undergo monthly surgeries on my dialysis access to get adequate
treatment. The UNOS wait list isn't like 1-100; I am never notified of
where I stand on the list because an algorithm is meant to determine my
fate. Every day that I'm waiting, I'm closer to becoming one of the 30
Americans who die each day waiting for an organ transplant.
I know this all too well, and that's why I've had to turn to social
media to try to find a living donor. I've lost multiple friends and
family to organ failure. I've seen more funerals than success stories.
I don't want to be next.
The reason it's so hard for me to get a transplant is because the
government contractors running the organ donation system are failing
and corrupt.
I grew up in rural Kentucky, where the Organ Procurement
Organization, or OPO--like more than half of OPOs across the country--
is failing. OPOs fail to recover as many as 28,000 lifesaving organs
every year. And even when they do recover organs, they waste them. More
than one in four kidneys are thrown in the trash after a generous
family has donated them.
It's even worse for minority-labeled patients. Our kidney function
was wrongly calculated by UNOS race-based calculations, delaying our
access to transplant. OPOs are less likely to respond to potential
donation cases if the donor patient is of Black/Brown descent, and they
treat those of us with less urgency, care, and compassion. I know this
firsthand, as my grandmother was a donor, and we had to reach out for
our OPO just to show up.
These failures lie at the feet of the monopoly contractor in charge
of managing the U.S. organ donation system--UNOS.
Patients like me are completely forgotten by the system. Just a few
weeks ago, a donor's family wanted to make a directed kidney donation
to me, meaning that they chose for me to receive their loved one's
kidney. This should have been my second chance at life, but my name was
unable to be found at first as active on the UNOS transplant wait list,
but I was told that this was a ``clerical error,'' and that I should
have been listed as ``active.''
This wasn't a one-off event. UNOS's technology is insecure and
unreliable. It crashes regularly for hours at a time, meaning patients
like me can't get organs, and kidneys are regularly lost at airports
and thrown in the trash. Every time this happens, patients like me die.
You can't even imagine how that feels.
In UNOS's system, Black patients are three times more likely to
need kidney transplants than White patients, but less likely to get
them. The inequity isn't an accident. It's by design.
An email from an OPO CEO, who at the time was a UNOS board member,
justified a policy proposal that would systematically hurt minorities
based on where we live by saying that we are ``dumb [expletives]'' for
living in the South and rural America in the first place.
What they think I'm too dumb to realize is that they've rigged the
game for themselves. OPOs waste taxpayer money on 7-figure salaries,
private planes, golf tournaments, and retreats to wine country. The
whole system is set up to make a few people rich. They get beach
houses; patients get coffins, especially patients who look like me.
But there is never any consequence for them because the government
has never held them accountable. The government has failed me. The only
solution is to replace failing OPOs and to get rid of UNOS.
This is urgent. We need to break up the UNOS monopoly now. Not in 2
to 4 years, but now. Not tomorrow, but today. I am grateful for this
committee for introducing legislation to do exactly that, and I hope
you will do everything you can to ensure that it passes. Lives are at
stake.
In 2021, I testified before the House Oversight Committee alongside
another patient, Tonya Ingram. She urged the government to hold OPOs
accountable, warning that she would die if they did not. Her calls were
ignored, and Tonya passed away last December. She deserved better, as
do patients across the country.
Please help give us a different fate.
Thank you.
______
Questions Submitted for the Record to LaQuayia Goldring
Question Submitted by Hon. Sheldon Whitehouse
Question. OPOs are only one of two major programs left in Medicare
that operate on what's called ``cost-reimbursement basis,'' meaning
they are reimbursed by taxpayers for whatever dollars they spend,
rather than for the value they deliver. This incentivizes them to spend
more money rather than to deliver high quality care for patients. The
Federal Government has moved away from cost-reimbursement almost
everywhere else in health care.
How do you suggest we move away from ``cost-reimbursement basis''
in organ transplantation?
Answer. The current cost-reimbursement structure is clearly not
sufficient to incentivize OPOs to allocate financial resources towards
effective and equitable care delivery and has particularly led to a
breathtaking divestment from hospitals which serve Black and Brown
patients. A transplant candidate cannot receive an organ that was
damaged before or after being harvested for organ donation, while an
OPO can still receive payment for delivering an organ that may not be
viable for transplantation. I suggest we come away from ``cost-
reimbursement basis'' to improve our U.S. organ transplant system so
more individuals can receive vital transplants.
In parallel, cost-reimbursement has done little if anything to
control wasteful spending, with government audits and investigative
journalists finding rampant fraud, waste, and abuse in the $3-billion-
per-year OPO industry. I believe there are urgent and important
opportunities to transition OPO reimbursement models away from cost-
reimbursement and toward value-based care models. For further
information, see this report from Organize and the Bridgespan Group
(https://www.bridge
span.org/getmedia/4905f7a5-41d7-4240-bd31-0017ec500029/Bridgespan-OPO-
Report-FINAL-Appendix-A.pdf).
______
Questions Submitted by Hon. Ron Wyden
urgent need for reform
Question. Currently, one out of four procured kidneys are
discarded, yet every day, 17 people die waiting for a lifesaving
transplant. The Finance Committee's investigation of the United Network
for Organ Sharing (UNOS), found several failures in the current organ
transplantation system. Whether its technology outages or damaged,
lost, discarded organs, each of these failures are vital to someone's
life.
On May 17, 2023, I introduced legislation that would improve the
National Organ Transplantation Act of 1984 (NOTA) and provide the U.S.
Department of Health and Human Services (HHS) with clear authority to
expand competition for contracts related to the operation of the Organ
Procurement and Transplantation Network (OPTN)--breaking up the
monopoly that UNOS has held since 1984. This legislation is a first
step in addressing the critical failures in the current transplantation
system.
Patients in need of a transplant are already fighting for their
lives. The system shouldn't make their fight harder. For example, one
Oregonian shared their story of how they donated their kidney into the
system so that her family member could receive one, yet months later,
their family member is still waiting for a kidney.
Would you agree that every donated organ is vital and there are no
minor errors?
Answer. Thank you for asking this vital question that sets a
precedent of why organ donation is so vital to every candidate waiting.
As a previous transplant recipient, and someone currently awaiting a
lifesaving kidney transplant, and the granddaughter to a nonliving
donor, I believe firsthand that all donated organs are vital to
increasing organ donation and there is no room for any minor errors. A
thorough health evaluation of the organs being used for procurement
should have set guidelines and policies that all Organ Procurement
Organizations and health personnel should be required legally to follow
so there is no room for human error. HRSA and CMS should set better
guidelines and policies that hold OPOS, transplant hospitals and
insurance companies accountable so that vital organ transplants can
occur at larger successful rates. One nonliving donor can save up to 75
lives with the donation of their eyes, organs, and tissues. A living
donor can save multiple lives as they choose through blood and plasma
donation, one kidney, a partial liver, and/or one lung lobe. Minor
errors that are occurring at UNOS and through OPOs are human errors
that can be addressed and fixed through quality control, hiring in new
individuals dedicated to the mission of organ donation, and introducing
new technologies and policies that address and fix the human errors
created by UNOS technology so those who choose to be organ donors can
donate vital organs, corneas, and tissues.
When it comes down to it, we need every OPO and transplant hospital
to work together to provide vital organs that can save the lives of
those individuals like me awaiting a lifesaving transplant. There is no
room in our society for any organ donated to be lost in transit,
discarded, or expired because of human or technological errors. As
mentioned by an advocate and friend of mine, Jennifer Erickson, 28,000
organs go unrecovered from generous donors. If the system works
correctly, we could use all the vital donated organs to eliminate the
long waiting lists. With over 103,000 individuals awaiting lifesaving
organs and 500,000 plus on dialysis, there is no room for minor errors
so therefore, every organ is vital to reduce wait times on the
transplant list and reduce the cost of alternative medications and
medical devices to temporary keep one alive while waiting for that
vital organ transplant.
Question. Can you tell me why reforms in this system are so
urgently needed for patients?
Answer. This question is the key basis of why every advocate across
the country stood up to vote to overhaul the current organ donation
system, ridding it of the taxpayer-funded monopoly, UNOS. We urgently
need organ donation reforms to aid in eliminating health disparities,
financial, racial, and geographical disparities to transplantation. By
enforcing new reforms, this would hold Organ Procurement Organizations
accountable for their lack of accountability, transparency, and failure
of basic performance measures. New organ donation reforms would save
Medicare and taxpayers millions of dollars because we could shorten
wait list times of those awaiting kidneys by promoting living organ
donation and giving incentives to all living donors by passing Federal
living donor protections; get more patients off dialysis; lower
hospitalizations from organ failure complications; and increase
survival rates of transplants.
Writing new reforms that include patient-focused initiatives would
allow for voices from the community that incorporate patient voices,
nonprofit organizations, clinicians, etc. who are focused on organ
donation reforms, and in turn, more patients will want to work towards
getting a transplant. Patients will be more compliant and more involved
with their care and trusting of providers and OPOs. These reforms could
eliminate the power health insurance and Medicaid has over transplants
by allowing patients like me who need transplants, to use their primary
and secondary health insurance to travel over State lines to be listed
for a transplant. Lastly, reforms are so urgently needed for patients
because we need a better, more dependable system for matching algorithm
and organ placement, and for transportation and tracking organs that
works closely with experts from STEM and the FAA to ensure a
collaborative, diverse, and patient-focused U.S. organ donation system
that will save more lives than ever before, going forth.
______
Prepared Statement of Raymond J. Lynch, M.D., M.S., FACS, Professor of
Surgery and Public Health Director, Transplantation Quality and
Outcomes, the Pennsylvania State College of Medicine
Chairman Wyden, Ranking Member Crapo, and members of the committee,
my name is Raymond Lynch. I am a liver and kidney transplant surgeon
and professor of surgery and public health at Penn State College of
Medicine in Hershey, PA. Thank you for the opportunity to speak today.
In my time as a surgeon, I have had the privilege of recovering
organs from more than 200 generous, compassionate organ donor patients.
I have performed hundreds of liver and kidney transplants. I have
published more than 50 peer-reviewed papers in academic medical
journals, and I am the principal investigator of an NIH-funded grant to
study and improve organ procurement clinical care in Veterans
Administration medical centers.\1\
---------------------------------------------------------------------------
\1\ Doby, B.L., Brockmeier, D., Lee, K.J., Jasien, C., Gallini, J.,
Cui, X., Zhang, R.H., Karp, S.J., Marklin, G., and Lynch, R.J. (2021).
Opportunity to increase deceased donation for United States veterans.
American Journal of Transplantation: Official Journal of the American
Society of Transplantation and the American Society of Transplant
Surgeons, 21(11), 3758-3764. https://doi.org/10.1111/ajt.16773.
I am here because Congress has the ability to take action to save
the lives of my transplant wait list patients. I am here to advocate
not only for their chance at a lifesaving transplant, but also to ask
for your help in improving a system that thousands of patients depend
on. I ask the committee to take concrete steps to make organ
procurement and transplant safer, more reliable, and more effective for
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all patients, by:
Supporting legislation that permits authentic competition
for the OPTN contract, allowing specialized, highly skilled
organizations the opportunity to move our transplant system
into the 21st century.
Ensuring that CMS and HRSA collect and report on how OPO
workers provide clinical care, in the same way that CMS
provides data on clinical care and health-care organizations in
all other parts of our health-care system.
Ensuring that CMS enforces the current OPO performance
threshold without delay or dilution.
I want to take a moment to differentiate between organ donation,
the altruistic decision that the donor patients and their families make
to help others, and organ procurement, the clinical care provided by
staff at Organ Procurement Organizations, that turns those gifts into
usable organs for transplant.
Organ procurement is a clinical specialty--the last medical care
that many patients will ever receive. It is fully reimbursed by the
Federal Government, and it is administered by providers--the OPOs--who
are the only provider option in their respective territories.
Fundamentally, when we talk about organ procurement, we are talking
about health care and health-care providers, such as hospitals or
nephrologists. Just like any other providers, OPO workers evaluate
patients, gather information from patient health records, make clinical
judgements, and intervene medically to get the best possible outcome.
Right now, patient care delivered by OPOs is some of the least
visible in American health care.\2\
---------------------------------------------------------------------------
\2\ Doby, B.L., Boyarsky, B.J., Gentry, S., and Segev, D.L. (2019).
Improving OPO performance through national data availability. American
Journal of Transplantation: Official Journal of the American Society of
Transplantation and the American Society of Transplant Surgeons,
19(10), 2675-2677. https://doi.org/10.1111/ajt.15508.
I can't tell you how many patients were evaluated by OPO workers in
2022. I can't tell you how many patients were examined, or how many
families were given appropriate information and care regarding the
option for donation, or even how many times an OPO worker showed up to
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a hospital for this critical duty.\2\
I don't know of any other contractors or providers in American
health care, especially ones that are reimbursed by CMS, that have so
little information reported about what patient care is actually
occurring.
This lack of information about what OPO providers actually do for
patients is a root cause of the variability of rates of organ
procurement around the country.\3\ My own research has shown that what
we euphemistically call ``OPO performance'' is a measurable restriction
on the supply of organs that results in the unnecessary deaths of
patients with organ failure.\3\, \4\ For example, if the
lowest performing or Tier 3 OPOs had simply reached the median level of
performance between 2013 and 2019, there would have been 4,957 more
organ donors, yielding an estimated 5,641 kidneys, 2,678 livers, 1,047
hearts, 1,895 lungs, and 446 pancreases for transplant.\4\
---------------------------------------------------------------------------
\3\ Johnson, W., Kraft, K., Chotai, P., Lynch, R., Dittus, R.S.,
Goldberg, D., Ye, F., Doby, B., Schaubel, D.E., Shah, M.B., and Karp,
S.J. (2023). Variability in Organ Procurement Organization Performance
by Individual Hospital in the United States. JAMA Surgery, 158(4), 404-
409. https://doi.org/10.1001/jamasurg.2022.7853.
\4\ Lynch, R.J., Doby, B.L., Goldberg, D.S., Lee, K.J., Cimeno, A.,
and Karp, S.J. (2022). Procurement characteristics of high- and low-
performing OPOs as seen in OPTN/SRTR data. American Journal of
Transplantation: Official Journal of the American Society of
Transplantation and the American Society of Transplant Surgeons, 22(2),
455-463. https://doi.org/10.1111/ajt.
16832.
These missing organs are equivalent to 9.4 percent of the total
number of kidney candidates who died or were delisted over the study
period, as well as 14.0 percent of the liver candidates, 22.5 percent
of heart candidates, 75.6 percent of lung candidates, and 23.0 percent
---------------------------------------------------------------------------
of pancreas candidates.\4\
Because I am a researcher, I just read you a list of calculated
values. But because I am a physician, I want you all to think of each
of the patients behind those numbers, with names like LaQuayia
Goldring, Donna Cryer, and Molly McCarthy.
Because many OPOs operate in a low-quality data environment and
without appropriate oversight, 4,957 patients did not get adequate
organ procurement care. Without procurement care, organs weren't made
available for transplant. Patients like Ms. Goldring, Ms. Cryer, and
Ms. McCarthy then carry the burden for the failures of our system.
OPO clinical work is not visible, not benchmarkable, and not able
to be evaluated, analyzed, or compared.\2\ This can and must be
remediated if we want to improve the organ supply. Much of the hidden
data about how OPOs provide care to patients is known to one entity in
the system: UNOS.\4\
The front-line OPO providers who administer procurement care are
some of the most dedicated and hardest-working individuals in medicine.
UNOS could report on how well and how equitably care is delivered by
OPO workers at every step. Yet, UNOS has actively refused to help OPOs
get better at providing care. Instead of offering assistance, UNOS has
advocated for a deadly status quo, where fearmongering and finger-
pointing take the place of concrete, achievable action to address
quality of patient care. Even worse, UNOS frequently claims recent
increases in organ donors as measures of their own success. I have
published peer-reviewed research that reveals a primary driver of a
large portion of those increases: the American opioid epidemic.\5\
Between 2009 and 2018, of the 2,700 additional organ donors procured,
94.6 percent died from a ``drug-related'' cause. Increasing, tragic
deaths driven by this epidemic in our communities should not function
as a commendation for UNOS.
---------------------------------------------------------------------------
\5\ Goldberg, D., and Lynch, R. (2020). Response to: Deceased
donors: Defining drug-related deaths. Clinical Transplantation, 34(5),
e13828. https://doi.org/10.1111/ctr.13828.
The current OPTN contractor, UNOS, is simply not capable of
managing a safe, effective, and innovative transplant system. I know
many of us have served to the best of our ability on UNOS committees,
and I want to emphasize that I entirely direct my critical comments to
UNOS leadership and their network of cronies. In spite of our best
efforts, UNOS's incompetent policymaking and ineffectual oversight
prevents patients from becoming organ donors or receiving transplants.
Instead of UNOS, which is a legacy contractor with a proven history of
obstructive and self-serving behavior, we need a new network of highly
skilled specialist organizations, each attending to areas of expertise
---------------------------------------------------------------------------
in the management of the OPTN contract.
I ask you to listen to patients, researchers, and front-line
health-care workers at OPOs, transplant centers, and hospitals. I ask
you to remove the burden from patients and put a new OPTN contractor to
work--my patients' lives depend on it.
______
Questions Submitted for the Record to Raymond J. Lynch, M.D., M.S.,
FACS
Question Submitted by Hon. Sheldon Whitehouse
Question. OPOs are only one of two major programs left in Medicare
that operate on what's called ``cost-reimbursement basis,'' meaning
they are reimbursed by taxpayers for whatever dollars they spend,
rather than for the value they deliver. This incentivizes them to spend
more money rather than to deliver high quality care for patients. The
Federal Government has moved away from cost-reimbursement almost
everywhere else in health care.
How do you suggest we move away from ``cost-reimbursement basis''
in organ transplantation?
Answer. My research work regarding Organ Procurement Organizations
has not yet examined the intersection of financial incentives and
procurement effectiveness, although I strongly agree with the Senator
that the unique reimbursement structure of OPOs is likely a material
consideration for improving quality and efficiency of OPO care.
I believe that with increased transparency into the frequency and
quality of patient care interactions, and objective reporting regarding
quality of that care, as provided to patients by OPOs, there will be
opportunities to describe how changes in reimbursement mechanism could
support the industry in improvement and innovation. As a component of
public health, with outcomes measurable at a population level, organ
procurement clinical care may be amenable to a capitated model of
payment. Capitation is just one way that OPO reimbursement could be
modernized, and there could well be other viable models that we cannot
yet describe, due to the lack of information about the practices of
these care providers. I hope that researchers, stakeholders, and
regulators may be able to examine modernized models of payment for OPOs
as soon as we can describe when, where, and how OPOs provide patient
care. In the meantime, I agree with the Senator that the cost
reimbursement basis used for OPOs is outdated, lacks transparency, and
leaves the system at risk for corruption, fraud, waste, and abuse.
______
Questions Submitted by Hon. Ron Wyden
guaranteeing equity in the organ transplant system
Question. Disparities in the organ donation and transplant system
continue to persist. Black Americans are disproportionately represented
on waiting lists and experience longer wait times for organs than other
racial and ethnic groups. A few statistics that I find alarming are
that Black Americans are four times as likely to develop kidney failure
as White Americans, but are much less likely to receive a kidney
transplant; and that Black Americans experience the highest rates of
heart failure, yet receive heart transplants at lower rates than White
Americans. These types of disparities are unacceptable.
Can you summarize the root causes of these disparities and describe
how Congress can ensure that the U.S. transplant system better serves
patients from minority populations and addresses these disparities?
Answer. In my career, I have been privileged to participate in the
care of patients across a range of racial, ethnic and geographic
settings. Transplant offers patients from all these backgrounds hope
for longer and better quality of life. The disparities to which you
allude are clearly unacceptable. Guaranteeing equitable access to care
may be beyond the scope of what providers and regulatory entities
within the procurement and transplantation system can address on our
own, but it is incumbent upon us to characterize the drivers of
observed differences. With this information, we can mitigate
disparities that are within our control and report to policymakers and
the public on issues that require broader efforts to correct.
Central to fully understanding disparities is to broaden our
collection and analysis of patient care beyond our current categories.
We have previously advocated that system entities report on all
patients referred to either procurement or transplant providers. With
this change, we will be able to characterize facilitators and barriers
to progression either as an organ donor or a transplant candidate.
These data will be critical to measuring differences in care and
outcomes for patient populations, and devising institutional and
system-wise measures to maximize equity access to care.
data and transparency
Question. In 2019, a Columbia University study found that kidney
candidates who died without a transplant received a median of 16 offers
for a kidney (over a period of 651 days) while wait-listed. This type
of wait list data is not accessible and available to patients and their
families. In 2021 CMS published the Organ Procurement Organization
(OPO) final rule, which was a major step towards improving
transparency. However, there is still more to be done. For example,
although current law requires that CMS collect OPO process data, the
regulations do not require that CMS use the collected process data to
inform their quality metrics. Additionally, CMS does not have a way to
collect other types of data such as, objective OPO referral data and
transplant center acceptance rates.
What type of data should HHS collect to incentivize better outcomes
and transparency for patients?
Answer. As the Senator notes, under 42 CFR Sec. 486.328, OPOs must
collect and report to: the OPTN contractor, the SRTR contractor, and
HHS, data about where, when, and how OPOs provide care and clinical
evaluation for patients, and access, review, and extract patient health
data.
Currently, the OPTN contractor collects at least some such data
from OPOs under a form called the ``Death Notification Registration''
or DNR. Although the current OPTN contractor has not collected nor
reported enough data from OPOs to fulfill the requirements of 42 CFR
Sec. 486.328, the good news is that every OPO already collects complete
patient and process data that would meet the regulatory requirements.
It is imperative that HHS step in to ensure compliance with OPO
data collection and reporting under 42 CFR Sec. 486.328, and the best
mechanism for such action is improving the DNR form to be compliant
with current regulations. Such OPO patient and process data would power
widespread quality improvement efforts that could be targeted to
remediate any OPO that is falling behind, and improve access to organs
for all patients on the transplant wait list.
Sometimes expressing this need in terms of regulations does not
adequately describe just what a disadvantage we force upon patients by
withholding quality data from them--data that is readily available for
hospitals, hospices, long-term care facilities, et cetera.
It is deeply critical for potential donor and potential recipient
patients to have access to complete data reporting for OPOs in order to
answer basic questions like:
Should I register as an organ donor?
Does my local OPO provide timely, high quality care to
patients?
Does my local OPO do a good job with procuring organs? If not,
does that negatively affect my ability to receive a transplant?
Will my family receive culturally competent care and education
from my local OPO, if I am a potential organ donor patient?
Does my local OPO fall short in serving communities of color,
and does that negatively impact my ability to receive a
transplant?
Patients deserve high-quality information about their OPO, and
there is no logical reason why OPOs should not participate in
Medicare.gov data reporting that empowers patients, whether potential
donors or recipients, to learn more about what contractors will provide
their care, or ensure that organs are procured to save their lives. In
fact, our research group recently published \1\ an early iteration of
an OPO care comparison tool that seeks to describe the relative
strengths and deficits of OPOs, available at https://opo-
dashboard.herokuapp.com/.
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\1\ Doby, B.L., Casey, K., Ross-Driscoll, K., Rahman Ovi, M.,
Hossain Bhuiyea, Md. S., Isty, I.A., and Lynch, R.J. (2023). What is
visible is fixable: Visual dashboards for multi-domain assessment of
OPO Performance. American Journal of Transplantation. https://doi.org/
10.1016/j.ajt.2023.08.020.
Regarding data for transplant wait list patients, I strongly
endorse the efforts of my colleagues who have described the need for
transparency into organ offers and acceptances for all patients.\2\ Our
patients deserve more opportunities for shared
decision-making and information that will allow them to be empowered in
their own care while waiting for their transplant.
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\2\ Husain, S.A., King, K.L., Pastan, S., Patzer, R.E., Cohen,
D.J., Radhakrishnan, J., and Mohan, S. (2019). Association Between
Declined Offers of Deceased Donor Kidney Allograft and Outcomes in
Kidney Transplant Candidates. JAMA Network Open, 2(8), e1910312.
https://doi.org/10.1001/jamanetworkopen.2019.10312.
______
Prepared Statement of Molly J. McCarthy, Vice Chair and Region 6
Patient Affairs Committee Representative, Organ Procurement and
Transplantation Network (OPTN), and 3-Time Kidney Transplant Recipient
Chairperson Cardin, Ranking Member Young, and members of the
committee, I'm grateful for the opportunity to testify today, and would
like to thank you for your work to drive lifesaving, patient-centric
reforms to the U.S. organ donation system through Senate bill 1668 to
break up the national organ transplant monopoly.
My name is Molly McCarthy. I am a 3-time kidney recipient, having
received my first 32 years ago. I'm one of the fortunate ones: I've
made it despite the broken and corrupt organ donation system we have
been saddled with, and I am all too aware that many patients aren't as
fortunate. I received two living donations, one from my mother and one
from my father--an option that I know many patients do not have.
Then 11 years ago, I received one from a generous deceased donor. I
am acutely aware that I may need a transplant again in the future. And
whether that happens is dependent on what Congress does now. I'm here
today to plead with you to pass Senate bill 1668.
The reason why is as simple as it is heartbreaking: the Federal
monopoly contractor managing the organ donation system--the United
Network for Organ Sharing, or UNOS--is an unmitigated failure, and its
leadership spends more time attacking critics than it does actually
taking steps to fix the system.
I have seen this firsthand. As a passionate advocate for patients,
I took on the volunteer role of vice chair of the Patient Affairs
Committee, or PAC, for the Organ Procurement and Transplantation
Network, the Federal contractor that UNOS holds. I thought this would
be a chance to ensure that the patient voice was included in national
policy. Sadly, I couldn't have been more wrong.
What I learned is that UNOS, at best, treats patients as props; at
worst, it outright lies to us, and then uses us as a shield against
much-needed oversight and reform. UNOS knows enough not to lie to
Congress, so it lies to patients instead, and then launders its lies
through us.
For the last year, much of my work on PAC has consisted of writing
to congressional offices to fact-check UNOS misinformation, which I
would like to take the opportunity to do here today.
For example, UNOS leadership has created a systematic effort to
misrepresent the facts, regularly celebrating recent increases in organ
donations as evidence of their success and a well-working system.
The reality, however, is that this growth is driven entirely by the
opioid epidemic and skyrocketing gun deaths, as well as other increases
in suicides and fatal car accidents. All UNOS is celebrating are
national tragedies, not a well-run organ donation system.
Similarly, UNOS dramatically downplays the deadly toll of its
failures by only publishing the number of deaths of patients who were
already on the transplant waiting list. But most patients who need
transplants are never even placed on the waiting list because of the
severe organ shortage in UNOS's system.
And this is also where most of the inequity occurs, as UNOS does
absolutely nothing to ensure that patients of color are added to the
waiting list at the same rate as White patients.
For years, Black patients were even subject to a racist metric of
kidney function; in fact, there is currently a class action lawsuit
from 27,500 Black Americans alleging systematic racial discrimination
against them in waiting list practices.
This is an issue that PAC had been raising for more than a year
before UNOS took any action, and even then, the action wasn't enough to
help many patients.
Worse than being ignored, however, is that people who speak out
have been bullied, threatened, and retaliated against. This is well
documented, including in recent investigative journalism from the
Richmond Times-Dispatch, UNOS's hometown paper.
I personally have been warned that the UNOS board is unhappy with
my advocacy, and that there will be consequences if I continue to speak
out. Imagine saying that to a patient. Further, I've been called by a
board member telling me to stop focusing on system outages of the UNOS
system; he told me that having the system down for a few hours wasn't a
big deal, that the donors are dead anyway.
UNOS has also failed to oversee Organ Procurement Organizations
(OPOs). As a patient, I don't understand why any Tier 3 OPO is still
allowed to operate. This is a life and death business, and the Centers
for Medicare and Medicaid Services (CMS) must immediately replace
failing OPOs with successful OPOS that are getting the job done. Now.
It's costing taxpayer dollars and thousands of lives.
There is no shortage of evidence that the system is broken. But
what I hope I can communicate to you is that the problems are far worse
than what is publicly known, and the rot is far deeper.
UNOS behaves like mob bosses, and for every whistleblower who
speaks out, there are another hundred who remain silent. It is no
exaggeration that Forbes once called UNOS a ``cartel.''
While we may never know the true toll of the gross negligence and
abuse of the government's own organ contractors, we do at least know
the solutions.
CMS needs to move urgently to open data for Organ
Procurement Organizations; replace failing OPOs without caving
to industry pressure to weaken standards; and close the
dangerous pancreas loophole that allows OPOs to pad their
numbers and jeopardize patients' lives; and
Congress needs to break up UNOS's monopoly by passing S.
1668, ensuring that the Department of Health and Human Services
uses its authorities to replace UNOS as its contractor.
Before my last transplant, I waited 6 agonizing years. Watching the
Senate Finance hearing last August, I realized that potentially years
of that wait were unnecessary. Patients deserve an effective, safe,
transparent, and equitable organ donation system. Speaking as a patient
of this system, I have no zero confidence that we will ever have it if
UNOS has any role in the transplant system.
Thank you.
Appendices Below
Appendix A: ``Fact Check of AOPO Misinformation,'' Posted on
Medium,\1\ February 2023.
---------------------------------------------------------------------------
\1\ https://medium.com/@mollymccarthy_12951/correcting-aopo-
misinformation-f7f8e58a7892.
---------------------------------------------------------------------------
Appendix B: Fact Check of then-UNOS President Dr. Jerry
McCauley sent to various congressional offices,\2\ October
2022.
---------------------------------------------------------------------------
\2\ https://58425eca-649a-42d4-b265-d1e1743b6c48.filesusr.com/ugd/
581bc3_e282c96a63c44f
41812f5e6ecbe1e7dd.pdf.
---------------------------------------------------------------------------
Appendix C: OPTN Patient Affairs Committee Statement for the
Record \3\ for Senate Finance Committee August 2022 Hearing.
---------------------------------------------------------------------------
\3\ https://58425eca-649a-42d4-b265-d1e1743b6c48.filesusr.com/ugd/
581bc3_f693990492544
88b93a4ca57fbbd716d.pdf.
---------------------------------------------------------------------------
Appendix A: ``Fact Check of AOPO Misinformation,'' Posted on
Medium,\4\ February 2023
---------------------------------------------------------------------------
\4\ https://medium.com/@mollymccarthy_12951/correcting-aopo-
misinformation-f7f8e58a7892.
---------------------------------------------------------------------------
On January 28th, The New York Times \5\ ran a heartbreaking guest
essay about Tonya Ingram,\6\ a 31-year-old woman who died in need of a
kidney transplant. Tonya had tirelessly advocated for reforms to the
organ donation system, including the government's monopoly contractors
charged with organ recovery, called Organ Procurement Organizations
(OPOs).
---------------------------------------------------------------------------
\5\ https://www.nytimes.com/2023/01/28/opinion/organ-donation-
reform-delays.html.
\6\ https://www.latimes.com/entertainment-arts/books/story/2023-01-
23/tony-ingram-an-inspiring-l-a-poet-and-lupus-warrior-died-waiting-
for-a-kidney.
Tonya even testified before the House Oversight Committee \7\ in
May 2021 that absent such reforms, she would die. No reforms came, and
she was ultimately proven right: she died on December 30, 2022. Tonya
was full of joy,\8\ and her life was cut way too short.
---------------------------------------------------------------------------
\7\ https://www.youtube.com/watch?v=TnKo8Q-Hemk&t=127s.
\8\ https://www.instagram.com/p/Bd3GSnpDBwk/?igshid=Zjc2ZTc4Nzk%3D.
In response, the Association of Organ Procurement Organizations
(AOPO), which is currently the subject of a congressional investigation
\9\ for various abuses, including misinformation and anti-patient
lobbying, issued an absolutely wild statement in which they spread
falsehoods and deflected blame, and, implicitly, disparaged Tonya's
work and dishonored her legacy.
---------------------------------------------------------------------------
\9\ https://oversightdemocrats.house.gov/news/press-releases/
oversight-subcommittee-launches-investigation-into-poor-performance-
waste-and.
Below is a fact-check of AOPO's statement, which I post with the
hope that facts will prevail, and the reforms that Tonya fought so
vigorously for may ultimately be finalized, saving the lives of tens of
---------------------------------------------------------------------------
thousands of other future patients.
Molly McCarthy
3-time Kidney Transplant Recipient
Vice Chair of the Organ Procurement Transplantation Network Patient
Affairs Committee
AOPO wrote: Sadly, 17 people die each day waiting for a lifesaving
transplant. There is no question that Americans, especially those
suffering from acute kidney disease, deserve greater access to organs
for transplant.
Fact-check: The number of people who die every day is much higher
than 17. Inclusive of patients who die every day after having been
removed from the waiting list for becoming ``too sick to transplant,''
the current number is 32. (The OPTN database \10\ is quite difficult to
use, however, if you run a report for ``waiting list removals by
reasons by year'' and then add the columns for ``died'' and ``Too Sick
to Transplant'' for 2022 and then divide by 365, the number is 31
deaths per day. In 2021, when Tonya Ingram testified before House
Oversight, it was 33--see Washington Post.\11\)
---------------------------------------------------------------------------
\10\ https://optn.transplant.hrsa.gov/data/view-data-reports/
national-data/.
\11\ https://www.washingtonpost.com/health/organ-collection-
agencies-told-to-improve-performance-or-face-tighter-rules/2021/05/04/
68847bce-ad06-11eb-acd3-24b44a57093a_story.html.
Of course, inclusive of patients who never even reach the waiting
list--disproportionately patients of color because of racial bias in
waiting list practices--the number is much, much higher than that.
Using the number 17 erases their deaths and suffering from the story
and is simply a function of UNOS's ``accounting practices'' in wait
---------------------------------------------------------------------------
list management to downplay the scale of the system's failures.
AOPO wrote: Recent data released by the Organ Procurement and
Transplantation Network (OPTN) shows how these efforts have resulted in
an increase in the number of deceased organ donors year over year for
the last 12 consecutive years. Since 2010, the data represents an 87-
percent increase overall in deceased organ donors. Notably, in 2022,
OPOs recovered a record number of kidneys from deceased donors
resulting in over 25,000 kidney transplants.
Fact-check: These statistics are wildly devoid of context, as has
been pointed out repeatedly in response to misleading UNOS lobbying. As
former United States Chief Data Scientist DJ Patil \12\ has published,
``To deflect criticism, OPOs and UNOS have lobbied aggressively \13\ to
confuse the recent increases \14\ in organ donors from opioid and other
external causes (i.e., non-medical deaths like trauma, substance use,
and suicide) with improved performance overall. If donation numbers are
increasing, their argument goes, then the system must be performing
well, and so the push for reform must be misguided. This is a cynical
attempt to politically profit from the opioid scourge and other second-
order effects of the deadly pandemic, mischaracterizing the data to
evade accountability.''
---------------------------------------------------------------------------
\12\ https://www.medpagetoday.com/opinion/second-opinions/98363.
\13\ https://www.pogo.org/investigation/2021/04/americas-
transformative-new-organ-donation-rule-goes-into-effect-over-
objections-from-monopolistic-contractors/.
\14\ https://unos.org/news/deceased-organ-donation-and-transplant-
annual-trend-continues-2020/.
In fact, peer-reviewed data published in JAMA \15\ has found that,
after controlling for increases in donation outside of OPO control
(e.g., public health trends), donation rates in recent years have not
even kept pace with simple population growth (see data visualization--
here).\16\ If a baseball player had 5 hits in 10 at-bats his rookie
year, and then 10 hits in 100 at-bats during his second season, we
would all find it risible if his agent argued that he deserved a huge
new contract because he doubled his number of hits. Only in this case,
what AOPO is shamefully claiming credit for are terrible American
public health tragedies, including spikes in opioids overdoses, gun
deaths, suicides, and fatal car accidents, including as second-order
effects of the COVID pandemic.
---------------------------------------------------------------------------
\15\ https://pubmed.ncbi.nlm.nih.gov/33026442/.
\16\ https://bloomworks.digital/organdonationreform/assets/PDF/
donation-increase.pdf.
The fact that AOPO does not seem to understand the drivers of
donation, or even how to describe procurement practice in the U.S.,
calls into question its ability to identify and rectify system
failures. In case anyone has not seen it, here is a video of AOPO CEO
Steve Miller testifying before Congress \17\ that he does not have a
deep understanding of the OPO regulatory system. Based on his comments,
I believe him.
---------------------------------------------------------------------------
\17\ https://www.youtube.com/watch?v=TnKo8Q-Hemk&t=6351s.
AOPO wrote: These numbers show improvement and support that the
U.S. is the world's most successful organ donation and transplantation
---------------------------------------------------------------------------
system, yet there is more to do.
Fact-check: As alluded to above, these numbers do not actually show
system improvement. In fact, as a relative matter, the system has
gotten worse over this period. Likewise, these numbers absolutely do
not show that the U.S. has the ``world's most successful organ donation
and transplantation system.'' As DJ Patil \18\ wrote in the editorial I
referenced above:
---------------------------------------------------------------------------
\18\ https://www.medpagetoday.com/opinion/second-opinions/98363.
Similarly, a common OPO and UNOS refrain is that the U.S. now
has the highest number of organ donors per capita \19\ of any
country, which they use to characterize the American organ
donation system as the ``best in the world.''\20\ But context
is critical. The higher organ donation rates in the U.S.
actually reflect higher levels of societal ills, rather than
superiority of the organ procurement system.
---------------------------------------------------------------------------
\19\ https://oversight.house.gov/sites/
democrats.oversight.house.gov/files/AOPO%20Joint%20
Testimony.pdf.
\20\ https://unos.org/transplant/opos-increasing-organ-donation/.
More plainly: We have more organ donors in America not because
we have a strong--or even remotely adequate--organ procurement
system, but because on a per capita basis among wealthy
nations, we have many times more deaths in those subsets of
deaths that allow for organ donation to occur. This includes 20
to 30 times \21\ more opioid deaths, 25 times as many gun
deaths, the highest suicides rates,\22\ and more than twice as
many fatal car accidents \23\--a number that spiked again \24\
precipitously last year.
---------------------------------------------------------------------------
\21\ https://www.washingtonpost.com/health/2021/11/17/overdose-
deaths-pandemic-fentanyl/.
\22\ https://www.commonwealthfund.org/press-release/2020/new-
international-report-health-care-us-suicide-rate-highest-among-wealthy.
\23\ https://www.cbsnews.com/news/us-car-crash-death-rate-worse-
than-other-affluent-countries/.
\24\ https://abcnews.go.com/Politics/wireStory/us-road-deaths-rise-
record-pace-risky-driving-82600871.
To give an even more plain-speak analogy, imagine that 100
Americans were in one room, and in another room, there were 100
Canadians. In the American room, let's say 15 of them die in organ
donation-eligible ways, and our system successfully converts 2 of them
into organ donors. In the Canadian room, 2 people die in such ways, and
their system converts 1 of them into an organ donor. It is simply not
statistically reasonable--or intellectually honest--to suggest that
this means the U.S. system is twice as good as the Canadian system
---------------------------------------------------------------------------
simply because it had 2 donors per capita instead of 1.
Obviously, the numbers used in the example above are for
simplicity, but it is to make the point that using a per capita
comparison across different countries is nonsensical. That the U.S. has
more organ donation eligible deaths than other countries (e.g., from
opioids, gun deaths, suicides, and car accidents) is one tragedy; when
we fail to recover potential organ donors, that's another, and the two
compound.
AOPO wrote: A key area of improvement is in the number of organs
recovered by OPOs but refused by transplant centers and instead go to
waste. That number is rising dramatically. In fact, 7,540 kidneys,
amounting to 26 percent of all kidneys recovered and offered by OPOs
for transplantation in the U.S., were turned down by transplant centers
last year.
Fact-check: Discards in the U.S. are too high and are rising. There
is broad agreement on this. AOPO's framing of the problem as entirely a
transplant center issue, however, is incorrect and overly reductive.
There are many contributing factors, certainly including transplant
center ``weekend effect''\25\ and transplant center risk aversion,
though also including:
---------------------------------------------------------------------------
\25\ https://www.medscape.com/viewarticle/866260.
Differential effort and ability from OPOs in clinical
management of donors and wait list navigating, as evidenced by
wildly different organ placement rates across OPOs for
clinically similar organs;
DonorNet inefficiencies and frictions, as identified by the
United States Digital Service \26\ and reported on by The
Washington Post,\27\ and testified before the Senate Finance
Committee by Mid-America's Diane Brockmeier;\28\
---------------------------------------------------------------------------
\26\ https://58425eca-649a-42d4-b265-d1e1743b6c48.filesusr.com/ugd/
581bc3_11444ae6eeba4a
65a3894a01d9095bed.pdf.
\27\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.
\28\ https://www.finance.senate.gov/imo/media/doc/
Diane%Brockmeier%20Written%20
Testimony-Senate%20Finance%20Committee.pdf.
---------------------------------------------------------------------------
Failures of organ logistics and transportation, including
deeply unprofessional OPO practices of selecting and managing
transportation vendors, as well as gross failures of the UNOS
Organ Center, as reported on by Kaiser Health News \29\ and
covered in the Senate Finance Committee hearing;\30\ and
---------------------------------------------------------------------------
\29\ https://khn.org/news/how-lifesaving-organs-for-transplant-go-
missing-in-transit/amp/?utm
_source=STAT%2BNewsletters&utm_campaign=06e49f9ea7-
MR_COPY_01&utm_medium=email
&utm_term=0_8cab1d7961-06e49f9ea7-149550985&__twitter_impression=true.
\30\ https://www.finance.senate.gov/hearings/a-system-in-need-of-
repair-addressing-organizational-failures-of-the-uss-organ-procurement-
and-transplantation-network.
---------------------------------------------------------------------------
OPOs often recover kidneys they have no intention of placing
for transplant, but, because of an arcane reimbursement system,
OPOs are able to overbill Medicare through cost-shifting
enabled by explanting more kidneys \31\ even if they are not
transplanted. There is, honestly, likely an issue of systemic
Medicare fraud here.
---------------------------------------------------------------------------
\31\ https://www.bridgespan.org/bridgespan/Images/articles/
transforming-organ-donation-in-america/Bridgespan-OPO-Report-FINAL-
Appendix-A.pdf.
The best way to inform solutions on this is to have more
transparency into the system. Ironically, this is one of the solutions
explicitly called for in the NYT piece--as well as Tonya's advocacy: to
follow the Senate Finance Committee's recommendations for CMS to
publish OPO process data.\32\ This is standard in every other mature
transplant system in the world, including, of course, all systems with
lower discard rates than ours.
---------------------------------------------------------------------------
\32\ https://www.finance.senate.gov/imo/media/doc/
040722%20Wyden%20Grassley%20Young
%20Transplant%20System%20RFI%20letter.pdf.
AOPO wrote: In Los Angeles, where Tonya Ingram lived, organ
donation was up 10 percent last year--a 2-decade upward trend. The
local OPO recovered a record 2,143 organs in 2022 but also saw 520
organs rejected by transplant centers, up from 376 the year before.
Moreover, 397 of the 520 rejected organs were kidneys, up from 273 the
year before. One of these kidneys may have saved Tonya's life. This
rise in rejection rates is disheartening to the OPOs that work each day
to increase the number of organs they are recovering. But it is
devastating to patients living--and often dying--on dialysis, waiting
for an organ. OPOs have no control over whether organs are actually
transplanted into patients. Our Nation's transplant centers make this
critical decision, determining whether to accept an organ offered from
---------------------------------------------------------------------------
an OPO.
Fact-check: The ``2-decade upward trend'' framing is addressed
above, as well as the organ discard issue. I will note here, though,
that OneLegacy's OPO is Tier 3,\33\ failing according to CMS, as it has
been for every year that CMS has published tier ranking data. (In the
most recently available data from 2020 released by CMS last year,
OneLegacy's failure to reach Tier 1 standards by 328 transplants, or--
in plain speak--328 preventable deaths.) I would also note that
OneLegacy is under investigation by the House Oversight Committee \34\
for ``shocking mismanagement.''
---------------------------------------------------------------------------
\33\ https://opodata.org/opo/CAOP.
\34\ https://oversightdemocrats.house.gov/news/press-releases/
oversight-subcommittee-launches-investigation-into-poor-performance-
waste-and.
AOPO wrote: The exclusion from this discussion of our Nation's
transplant centers and their regulators as important stakeholders
involved in improving the system's ability to save more lives is a
serious oversight. For the entire system to save more lives, we need to
ensure that transplant centers have declared clear organ acceptance
criteria, have the appropriate resources to process the influx of
available organs, and utilize organs from more medically complex
---------------------------------------------------------------------------
donors.
Fact-check: While transplant centers (and UNOS) certainly have some
responsibility related to discards, as further expounded on above, the
NYT piece itself highlights that the Indiana OPO, in response to
oversight pressures, increased organ donation rates by 44 percent in 1
year \35\ by simply approaching 57 percent more donors. Restated: the
increase did not necessitate behavior changes at transplant centers,
new OPTN technology, or any other changes; the major increase resulted
through the single intervention of applying oversight pressure to the
OPO to follow the existing legal mandate of approaching every donation
referral it receives.
---------------------------------------------------------------------------
\35\ https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.16442.
AOPO wrote: The National Academy of Science, Engineering, and
Medicine's (NASEM) report--``Realizing the Promise of Equity in the
Organ Transplantation System''--which was developed in 2021 at the
request of Congress and sponsored by the National Institutes of Health
(NIH) is the only peer-reviewed, data-driven assessment of the entire
organ donation and transplantation system, and it focuses specifically
on kidneys. The report categorically states that the whole system--the
Center for Medicare and Medicaid Services (CMS), the United Network for
Organ Sharing (UNOS), transplant centers, OPOs, and donor hospitals--
bears responsibility for increasing the number of transplants in the
U.S. NASEM found that ``on average, patients who die waiting for a
kidney had offers for 16 kidneys that were ultimately transplanted into
other patients, indicating that many transplant centers refuse viable
kidney offers on behalf of those on the waiting list (Husain et al.,
---------------------------------------------------------------------------
2019).''
Fact-check: The NASEM report is currently being investigated by two
separate congressional committees--House Oversight Committee \36\ (see
Kaiser Health News \37\) and Senate Finance Committee \38\--for
apparent financial conflicts of interest among its members, with the
Senate Finance Committee writing upon the publication of the NASEM
report: ``We are concerned that the NASEM report seems to align with
the lobbying positions of UNOS and the Association of Organ Procurement
Organizations (AOPO), and that these recommendations will not address
the concerns raised during our investigation.''
---------------------------------------------------------------------------
\36\ https://oversightdemocrats.house.gov/news/press-releases/
chair-krishnamoorthi-and-rep-porter-request-documents-regarding-
potential.
\37\ https://khn.org/news/article/national-academies-conflict-of-
interest-congress-cites-khn-investigation-drug-waste/.
\38\ https://www.finance.senate.gov/chairmans-news/wyden-grassley-
cardin-young-raise-conflict-of-interest-concerns-related-to-national-
academies-report-on-organ-donation-system.
AOPO can help shed light on this by sharing any contracts it--or
its member OPOs--have signed with any of the consultants who were
members of the NASEM study, including Dennis Wagner of Yes And
Leadership.\39\ (See Senate Finance letter.\40\) If AOPO is looking for
support of the NASEM study as an unbiased, unconflicted resource, there
is no reason AOPO shouldn't be willing to share the financial
relationships that would inform whether or not such conflicts exist.
---------------------------------------------------------------------------
\39\ https://www.bing.com/ck/
a?%21&p=156965a9111613cdJmltdHM9MTY3NTI5NjAwMCZpZ
3VpZD0yOTI3ZTg4Zi1hNmEzLTZjZTctMGY0OC1mOTEzYTc4ZTZkMzMmaW5zaWQ9NTE3M
w&ptn=3&hsh=3&fclid=2927e88f-a6a3-6ce7-0f48-
f913a78e6d33&psq=YEsandleadership&u=a1a
HR0cHM6Ly95ZXNhbmRsZWFkZXJzaGlwLmNvbS8&ntb=1.
\40\ https://www.finance.senate.gov/imo/media/doc/
111722%20Wyden%20Grassley%20Cardin
%20Young%20Letter%20to%20NASEM%20-
%20conflicts%20of%20interest%20organ%20procure
ment.pdf.
Put another way, if there were no conflicts, AOPO would presumably
---------------------------------------------------------------------------
be very eager to clarify that.
AOPO wrote: Rather than referencing NASEM, however, The New York
Times editorial relies on the privately funded Bridgespan study from
2019, which claims that OPOs fail to recover an additional 28,000
organs a year is unrealistic. This estimate would only be possible if
all potential organ donors said yes to donation, all their organs were
medically suitable for transplant, and transplant centers accepted and
successfully transplanted all their organs. The report notes that the
figures represent the ``full potential'' of the system, assuming 100
percent donation rates and 100 percent organ utilization, an unfeasible
measure in the medical field. OPOs nationwide are unwavering in their
commitment to saving patients' lives and reducing the numbers on the
waiting list.
Fact-check: This one is, candidly, quite bizarre, as investigative
reporting \41\ has already highlighted that the AOPO/OPO talking points
about Bridgespan are objectively, factually false. Similarly, a letter
to the House Oversight Committee from a then-AOPO board member \42\
clarified the same. For the abundance of clarity, I will repeat the
fact-check below: AOPO is simply factually incorrect in its assertion
that Bridgespan's study--which was based on peer-reviewed research \43\
from leading researchers at the University of Pennsylvania, a former
U.S. Surgeon General, and two OPO executives--assumes that ``all [of
every donor's] organs were medically suitable for transplant.''
---------------------------------------------------------------------------
\41\ https://www.postbulletin.com/newsmd/organ-failure-the-
gatekeeper-of-minnesotas-organ-transplant-system-is-underperforming-it-
may-be-costing-lives.
\42\ https://www.documentcloud.org/documents/20529240-
wadsworthletter.
\43\ https://pubmed.ncbi.nlm.nih.gov/28726327/.
The study estimates a donor potential of 24,007 annually for the
years 2009-2012, and an organ potential of just over 50,000 annually
(see figure on page 5 \44\). As a matter of simple math, this assumes
an average of just over 2 organs transplanted per donor, representing
an estimate far more conservative than the 3.45 medically suitable
organs recovered per donor which AOPO states is industry average. The
methodology for this study is clearly laid out in the peer-review
publication. It is unclear why AOPO believes that the study assumes 8
organs per donor, or why they continue to assert it despite numerous
fact-checks to the contrary.
---------------------------------------------------------------------------
\44\ https://www.bridgespan.org/bridgespan/Images/articles/
reforming-organ-donation-in-america/reforming-organ-donation-in-
america-01-2019.pdf.
Additionally, if AOPO does not like Bridgespan's research, it can
also rely on a publicly funded study which HRSA funded and the OPTN
performed, which found an even larger donor potential than Bridgespan
did. Specifically, the deceased donor potential study,\45\ published in
2015, found (see page 8): ``Currently, organs for transplantation are
recovered from about 8,000 deceased donors per year, potentially only
one-fifth of the true potential. These findings suggest that
significant donation potential exists that is not currently being
realized.'' (Note: the donor potential today is now certainly even much
higher, given the above-referenced spikes in donor potential driven by
the opioid epidemic and other public health trends.)
---------------------------------------------------------------------------
\45\ https://optn.transplant.hrsa.gov/media/1161/ddps_03-2015.pdf.
Finally, I will also note the incredible irony (or gall?) of AOPO
breathlessly asserting that Bridgespan's peer-reviewed 51,000 organ
potential conclusion is ``unfeasible,'' while in the very same
statement self-celebrating their imagined future success of 50,000
---------------------------------------------------------------------------
transplants.
AOPO wrote: Too many patients have put their faith in our system
for anyone to waste another minute avoiding responsibility or spreading
falsehoods.
Fact-check: Yes, agreed. Extensive investigative reporting \46\ has
found that AOPO, many individual OPOs, and UNOS have been responsible
for the active spreading of misinformation and outright falsehoods.\47\
As far as ``avoiding responsibility,'' not a single sentence in AOPO's
comment accepted any responsibility for anything. I wish they had.
---------------------------------------------------------------------------
\46\ https://www.postbulletin.com/newsmd/organ-failure-the-
gatekeeper-of-minnesotas-organ-transplant-system-is-underperforming-it-
may-be-costing-lives.
\47\ https://www.pogo.org/investigation/2021/04/americas-
transformative-new-organ-donation-rule-goes-into-effect-over-
objections-from-monopolistic-contractors.
---------------------------------------------------------------------------
Appendix B: October 2022 Fact Check of UNOS Misinformation
Dear Dr. McCauley,
As a 3-time kidney transplant recipient and patient advocate who
has previously corrected misinformation from UNOS, I write this letter
to:
Clarify misinformation from your letter dated 28 October
2022, which a UNOS lobbyist is disseminating;
Alert HRSA Administrator Johnson, the Senate Finance
Committee, and the House Oversight Committee as well as Senator
Booker and Congressman Jones, to ongoing UNOS efforts to
disseminate such misinformation; and
Most importantly, to express my disappointment at your
condescending implication that Ben Jealous, a known civil
rights icon and distinguished scholar who has published on
organ donation reform issues (see here and here), was unable to
understand the pro-patient, pro-equity congressional letter
which he endorsed, in line with his previous advocacy.
On the last point, I note the irony that it was your letter to Mr.
Jealous which demonstrated a shocking grasp of basic facts and context,
which I will address below. People are dying while UNOS is spending its
time protecting its reputation and contract, and I fear that should the
day come that I need another kidney, I, too, will die if the status quo
is allowed to continue.
Urgently submitted,
Molly McCarthy
3x Kidney Transplant Recipient
Vice Chair, OPTN Patient Affairs Committee
Redmond, WA
You stated: ``The number of deceased donor transplants has
increased every year for the last nine consecutive years to a record
high of 41,356 transplants in 2021. The number of deceased donors has
increased every year for the past eleven consecutive years, for a
record high of 13,863 in 2021. Deceased organ donor recoveries have
increased 58 percent since 2007.''
Fact-check: These statistics are wildly devoid of context, as has
been pointed out repeatedly in response to misleading UNOS lobbying. As
former United States Chief Data Scientist DJ Patil has published, ``To
deflect criticism, OPOs and UNOS have lobbied aggressively to confuse
the recent increases in organ donors from opioid and other external
causes (i.e., non-medical deaths like trauma, substance use, and
suicide) with improved performance overall. If donation numbers are
increasing, their argument goes, then the system must be performing
well, and so the push for reform must be misguided. This is a cynical
attempt to politically profit from the opioid scourge and other second-
order effects of the deadly pandemic, mischaracterizing the data to
evade accountability.''
In fact, peer-reviewed data published in JAMA has found that, after
controlling for increases in donation outside of OPO control (e.g.,
public health trends), donation rates in recent years have not even
kept pace with simple population growth.
The fact that UNOS does not seem to understand the drivers of
donation, or even how to describe procurement practice in the U.S.,
calls into question its ability to identify and rectify system
failures, and further underscores the need for additional data
transparency and competition for the OPTN contract, the two very
suggestions proposed by Senator Booker and Congressman Jones.
You stated: ``A single study from 2003 as cited in the `Dear
Colleague' letter cannot responsibly be applied to the state of the
organ donation and transplant system of 2022, much less serve as the
basis for a system overhaul. A great deal has changed in nearly 20
years, and the study from 2003 does not reflect those reforms, new
polices [sic], improvements and new data.''
Fact-check: By no means is a single study from 2003 the ``basis''
for a system overhaul; it is rather one data point in a litany of
evidence, and in the estimation of countless experts who have noted
deadly system deficiencies. For example, the Senate Finance Committee,
now more than 2 years into a bipartisan investigation into UNOS,
recently published a report concluding that ``From the top down, the
U.S. transplant network is not working, putting Americans' lives at
risk.''
Similarly, the United States Digital Service (USDS) published a
scathing report about the state of UNOS's technology entitled ``Lives
Are at Stake,'' and determined that ``it has become apparent that the
organ transplantation system in this country is not set up to enable
the best outcomes for patients waiting for lifesaving transplants. In
order to properly and equitably support the critical needs of these
patients, the ecosystem needs to be vastly restructured.''
The reforms called for in the congressional sign-on letter are
broadly supported by propatient groups including the National Kidney
Foundation, American Society of Nephrology, Global Liver Institute and
Organize; equity leaders including the ACLU, Just Equity for Health,
Health Justice, Empower Her Health, and the Institute for Antiracism in
Medicine; and editorial boards including The New York Times; as well as
the House Appropriations Committee and leaders from the House Oversight
Committee and Congressional Black Caucus.
In fact, perhaps most interestingly, the reason that there have not
been more peer-reviewed studies on inequitable care provision for
patients of color since 2003 is that the United States is unique among
mature international transplant systems in its failure to make
transparent the data necessary to evaluate such OPO performance.
Additionally, based on other proxy points, there is every reason to
believe this inequitable care persists. For example, based on the most
recent data available from CMS, there is a 10x variability in OPO
recovery rates among Black donors. If UNOS is objecting to opening OPO
data, as called for in the congressional letter you object to, that
seems designed to prevent this very analysis, thereby continuing to
mask such inequities. Any position against opening OPO data is
antithetical to patient needs.
You stated: ``The results of new organ allocation policies have
shown large gains in access to transplant for wait-listed patients of
color. One report shows significant increases in the number of kidney
transplants for key populations, including a 23-percent gain for Black
patients, 31 percent for Hispanic patients, and 21 percent for Asian
patients.''
Fact-check: Per above, this is reflects a complete misunderstanding
of the role public health trends--including increases in opioid deaths,
gun deaths, fatal car accidents, and suicides as second-order effects
of the COVID pandemic--which have increased the absolute number of
organ donation eligible deaths.
Additionally, some of the increase also appears to have resulted
from increased public scrutiny of the organ donation system, as well as
CMS's recent regulatory interventions to hold OPOs accountable, both of
which UNOS has vehemently opposed, including through untoward tactics
such as the dissemination of misinformation.
You stated: ``The assertion that an additional 28,000 transplants
are possible reflects a poor understanding of how donation works and
reveals a faulty assumption that every person who has died in a
hospital is a `potential donor,' even if they were not medically
cleared to be an organ donor. Less than 1 percent of all deaths in the
U.S. occur in ways clinically compatible with organ donation; people
who die of cancer, sepsis, certain infectious diseases, or organ
failure cannot be cleared for donation by the OPO based on medical
criteria established by transplant physicians for the safety of their
patients.''
Fact-check: This is objectively false. The 28,000 number in no way
assumes that every person who dies in a hospital is a ``potential
donor.'' The research itself, which was peer-review published by
leading researchers, a former United States Surgeon General, and two
OPO executives, explains that ``these estimates were compared to
patient-level data from chart review from two large OPOs'' and found
that ``among 2,907,658 inpatient deaths from 2009-2012, 96,028 (3.3
percent) were a ``possible
deceased-organ donor.'' The methodology, which your letter entirely
misrepresents, is clearly laid out in Figure 1 of the peer-review
analysis.
The 28,000 number is significantly more conservative than UNOS's
own analysis, funded by HHS, which found in 2015 (see page 8) that:
``Currently, organs for transplantation are recovered from about 8,000
deceased donors per year, potentially only one-fifth of the true
potential. These findings suggest that significant donation potential
exists that is not currently being realized.''
The mischaracterization of this research seems to parrot lobbying
points from an OPO special interest misinformation campaign, including
which the Project on Government Oversight characterized as ``replete
with personal attacks, and political maneuvering''--as well as a
particularly odious Astroturf campaign run by a lobbyist for the New
Jersey OPO--and which is currently animating a House Oversight
Committee investigation into OPO antipatient lobbying.
Lastly, the research identifying 28,000 additional potential
transplants--which you seem to, albeit based on a complete
misunderstanding of the underlying, reject as impossible--calculated
those numbers based on a total organ of just over 50,000 annually (see
Figure 2). I note the irony that UNOS has never once publicly rebuked
AOPO's 50,000 organs campaign.
As a matter of basic math and logic, I do not understand how you
can simultaneously believe that 50,000 organs can be wholly impossible
as a denominator in peer-reviewed research, and yet laudable when
promoted in industry lobbying materials as a numerator. I also
highlight previous fact-checks of these same industry talking points
which have been sent to other congressional offices.
You stated: ``Our national, forty-two member board of directors is
comprised of [sic] a broad, diverse cross-section of the community, and
includes [sic] one quarter patient and donor affairs representatives,
one quarter donation and transplant professionals, and half physicians
and surgeons. Together with HRSA, the OPTN board serves as the voice of
the community.''
Fact-check: I note emails from UNOS's previous CEO Brian Shepard,
which were unsealed by a Federal judge, revealing his belief that UNOS
``do[es]n't have a real board.'' I also note that, far from being the
``voice of the community,'' that UNOS has lobbied against
accountability reforms championed by ``every major patient group''
engaged in transplant advocacy--including leadership and members of the
OPTN's own Patient Affairs Committee--and that Senate Finance Committee
testimony from UNOS board members has detailed a culture of retaliation
and retribution.
You stated: ``In February 2022, the OPTN welcomed a report from the
National Academies of Science, Engineering, and Medicine (NASEM), a
congressionally mandated 2-year study including a diversity of
stakeholders, donation and transplant experts, and patient and donor
perspectives.''
Fact-check: The NASEM organ donation study is under investigation
from the House Oversight Committee for conflicts of interest among its
committee members, which included two past UNOS presidents. This
appears to be just another example in a long history of UNOS attempts
at regulatory capture, dating back to at least 1999, when Forbes
characterized UNOS as a ``cartel'' and ``the Federal monopoly that's
chilling the supply of transplantable organs and letting Americans who
need them die needlessly.''
You stated: ``In contrast to this approach, the development of the
U.S. Digital Service's unreleased report referenced in this letter was
conducted without our engagement, and was developed without review of
the OPTN, UNOS or any of its technology infrastructure.''
Fact-check: The reason that the USDS report was conducted ``without
[UNOS's] engagement'' is because, as The Washington Post reported,
``UNOS has not allowed anyone in government to analyze its code base,
instead providing only the English-language description of it, known as
pseudocode, officials said. That surprised Digital Service analysts; it
was the only time that its engineers' request to inspect code used by
government agencies and contractors has been refused on nearly 100
occasions, according to the former White House adviser who was involved
but not authorized to speak.''
This seems to be part of a larger pattern of UNOS obstructionism,
including, as the Senate Finance Committee report detailed,
``Resistance to Requests for Information and a Valid Subpoena.''
You stated: ``The challenges that face the system are complex and
multifaceted, and no one entity can address them all.''
Fact-check: This is actually correct, and presumably is precisely
why, in part, the congressional letter from Senator Booker and
Congressman Jones urges HHS to demonopolize the OPTN contract, in line
with so many leaders in Congress as well as external stakeholders.
Dr. McCauley, in closing and as discussed at our virtual meeting on
October 13, 2022, I continue to be extremely concerned at what appears
to me to be an utter lack of accountability on the part of UNOS to face
its failings. It's hard for me not to read your letter and see it as
anything more than a purposeful effort to mislead investigators,
patients and the general public. As a recipient and on behalf of
patients across this country, I implore you and the UNOS leadership to
stop investing your time in these evasive letters, tactics and
misleading PR, and instead to invest the time in addressing the issues
for which UNOS is being investigated
Appendix C: OPTN Patient Affairs Committee Statement for the Record
for Senate Finance Committee August 2022 Hearing
August 2, 2022
Dear Members of the Senate Finance Committee,
As the leaders of the OPTN Patients Affairs Committee (PAC), we are
reaching out to share our experiences on the committee that we believe
indicate a systemic failure of UNOS to serve patients as the OPTN. This
is all the more urgent in light of investigative reporting from the
Washington Post.
Antiquated technology and an apathetic culture cause patients to
languish with incomplete and often incorrect information, and leave
people to die every day on the list. OPTN PAC members have raised these
points often with UNOS leadership, and have seen our calls for reform
ignored. We have been aghast at the absolute failure of UNOS to operate
the practice and business of transplant, and to acknowledge--much less
effectively serve--patients who are waiting and dying on the organ wait
list.
On July 28th, in preparation for the upcoming August 3rd Senate
Finance Committee hearing into UNOS, PAC leaders received an email from
UNOS CEO, Brain Shepard, referring to your investigation, in which he
makes four assertions that UNOS has shared with the committee.
We wish to correct the record for your urgent consideration.
Shepard: ``Our IT system remains safe, secure, and routinely
meets and surpasses Federal standards.''
The Washington Post reported: ``The system for getting donated
kidneys, livers and hearts to desperately ill patients relies on out-
of-date technology that has crashed for hours at a time and has never
been audited by Federal officials for security weaknesses or other
serious flaws.''
We hope the committee asks UNOS how many patients have died due to
the inability to match organs during downtime, as well as other
technological inefficiencies such as data error due to manual entry, as
well as how many patient life-years have been lost due to delays in
organ transportation. That said, given the lack of transparency in the
UNOS tech system, it is difficult to imagine anyone at UNOS could
answer this question with any confidence.
Shepard: ``We have worked together as a community to improve
the transport of organs with innovative, evidence-based
products.''
The UNOS transportation record on organs is woefully--and fatally--
inadequate, as outlined by investigative reporting from Kaiser Health
News--as well as cases brought before the Senate Finance Committee. Put
simply, UNOS operates as an antiquated, closed system that keeps out
external innovators that could help patients with better tools and
services.
Shepard: ``Our committees and staff are proud to work
collaboratively with all members to serve as partners in
improvement.''
PAC members have often sought--and not received--clarity on how
patient input is used. When PAC takes clear positions (such as the need
to fast-track proposed changes to using eGFR results to list people of
color), UNOS has refused to act. Compare this to a recent UNOS fast
track process that addressed a hardware defect in a mechanical heart
that went through in less than a month. Black patients deserved this
kind of speedy remedy when eGFR was proven to have racial bias. We also
note Washington Post reporting that UNOS's policymaking processes have
been so divisive that they have ``spark[ed] open conflict'' among OPTN
members.
Shepard: ``The system we are all so honored to be a part of
just surpassed 41,000 transplants in 2021, while continuing to
expand equitable access to transplant.''
UNOS obscures its underperforming record behind recent increases in
organ donation rates that have resulted from tragic spikes in opioid
overdoses, gun deaths, and car accidents, including as second-order
effects of the COVID pandemic, not from UNOS's own performance. See the
former U.S. Chief Data Scientist making this point in MedPage, and
research in the Journal of the American Medical Association finding
that, after controlling for public health trends and scientific
advancements which have increased the size of the donor pool, organ
donation rates have not even kept pace with population growth.
The alarming revelations in The Washington Post (antiquated
technology; covering for failures of Organ Procurement Organizations;
and lack of cooperation with the government, even devolving to UNOS
having ``threatened to walk away'') lead us to believe that UNOS has
proven itself incapable of functioning as the OPTN.
We ask that you ensure that the Federal Government makes the fast-
approaching contracting OPTN cycle competitive for the first time since
the original OPTN contract was awarded in 1986, opening critical
functions up to best-in-class innovators across the country; and we
implore you to ensure that UNOS does not hold patients hostage in the
process.
We urge you to continue with your oversight and institute urgent
reforms that will literally result in lives saved.
Signed,
Garrett Erdle
Chair, OPTN PAC Living Kidney Donor
Alexandria, VA
Molly J. McCarthy
Vice Chair, OPTN PAC
3-time Kidney Transplant Recipient
Redmond, WA
Chris Yanakos
Former Member of OPTN PAC
Living Liver Donor, Caregiver and Donor Family Member
Pittsburgh, PA
Steve Weitzen
Region 2 Representative, OPTN PAC Heart Recipient
Randolph, NJ
Calvin Henry
Region 3 Representative, OPTN PAC Lung Recipient
Dacula, GA
Lorrinda Gray-Davis
Region 4 Representative, OPTN PAC Liver Recipient
Yukon, OK
Julie Spear
Region 8 Representative, OPTN PAC Donor Family Member
Boulder, CO
Eric Tanis
Region 10 Representative, OPTN PAC Liver Recipient
Gary, IN
______
Questions Submitted for the Record to Molly J. McCarthy
Question Submitted by Hon. John Thune
impact of decertification on rural areas with an opo monopoly
Question. I understand your concerns outlined in your opening
statement regarding the performance of OPOs that have received a Tier 3
grade.
Could you expand on what you think the impact would be of
decertifying Tier 3 OPOs in areas where they are the only ones serving
transplant centers? How could the lack of an OPO nearby affect
transplant centers' ability to do their important work, particularly in
rural areas? And how could we mitigate this risk?
Answer. Any Tier 3 OPO is already failing patients and its
surrounding area, so decertifying them and offering that coverage area
to a high-performing, Tier 1 OPO would be an improvement in service to
both donor families and patients waiting on the list, AND would save
lives. The counterfactual is also true: any delays in decertifying
failing OPOs, or any weakening of standards, results in lives being
lost.
Additionally, if a Tier 3 OPO is replaced by another, higher-
performing OPO, that OPO would assume the relationships with all
transplant centers in that area, meaning that there would never be a
situation of any transplant center ever running with a ``lack of an
OPO.'' CMS has stated this explicitly in the 2020 final rule.
______
Question Submitted by Hon. Sheldon Whitehouse
Question. OPOs are only one of two major programs left in Medicare
that operate on what's called ``cost-reimbursement basis,'' meaning
they are reimbursed by taxpayers for whatever dollars they spend,
rather than for the value they deliver. This incentivizes them to spend
more money rather than to deliver high quality care for patients. The
Federal Government has moved away from cost-reimbursement almost
everywhere else in health care.
How do you suggest we move away from ``cost-reimbursement basis''
in organ transplantation?
Answer. OPOs are one of only two major Medicare programs which
still run on a cost-reimbursement basis, an archaic mechanism which is
inherently susceptible to abuse, and does not lead to good health
outcomes for patients. This is precisely why HHS has moved away from
cost-reimbursement in almost all other areas of health care, and why it
should do so for OPOs as well. Your leadership on value-based care
provides an excellent roadmap for how HHS can consider paradigmatic
reforms in OPO reimbursement.
______
Questions Submitted by Hon. Todd Young
Question. Is there any formal policy in place regarding when and
how to notify patients of any status change on the organ donation
waiting list?
Answer. No, there is no policy in place to notify patients of a
change in status, nor is there any system-wide operational policy to
ensure patients on inactive are moved back to active. This results in
patients unknowingly not being considered for organ offers, with no
assurance that they'll be moved back to active state.
Question. What would be the most effective way to notify patients
of their waiting list status?
Answer. Most effective would be a simple phone app or web portal
where patients could view their real-time status. However, to create
such innovations, HHS must replace UNOS as its contractor, given its
complete technological ineptitude, as experienced by patients and
identified by the United States Digital Service.
Question. What, if any, additional information would be useful for
patients to have access to regarding their position on the waiting
list?
Answer. Most useful would be their status in terms of active versus
inactive, where they sit on the waiting list, whether they've received
any offers and why those offers were rejected, and projected wait time
for a successful match. It would be even more helpful to be told of
other centers that may be able to get them transplanted more quickly.
Most important, however, is shortening the waiting time for each
patient, which would require increasing the number of transplanted
organs every year. To do so, HHS needs to strongly enforce the OPO
rule, without any weakening or delay, as well as move swiftly to
replace UNOS with more competent contractors.
Question. How many patients are listed as inactive?
Answer. The OPTN Patient Affairs Committee (PAC), of which I serve
as the vice chair, has been told that 40 percent of the patients on the
wait list are inactive.
Question. Is there a clear reason recorded for why a patient has
been listed as inactive?
Answer. PAC has not been provided with any documentation, but we
know patients may be listed as inactive in cases of planned travel
(e.g., where their destination would make it impossible for them to
return to their transplant center in time to receive an organ), active
infection, or other health complexities that may make it impossible for
them to receive. Sadly, we also know that some patients are listed as
inactive due to clerical error, as Ms. Goldring testified in her own
particular case. This is why patients are rightly demanding to have a
method to look at their own status, so they can take ownership of
correcting errors.
Question. Is that reason communicated to the patient?
Answer. Not systematically, no. A patient may be told if they're
currently being treated as a hospital inpatient, but there is no policy
or system-wide practice to notify patients of any change in their
status.
Question. Is there any regular review/oversight by UNOS or others
to ensure a patient listed as inactive is aware of their current
status?
Answer. No, there is not. Another important piece to consider on
this topic is that when patients are moved to inactive, not only are
they not able to receive organ offers, but they also stop accruing time
on the wait list, which affects their rank on the list. The longer a
person waits while they are considered ``active,'' they get ``credit''
for that waiting time, which increases their chance of receiving an
offer. When patients are put into inactive status, that accumulation of
``credit'' pauses, which means they likely wait longer and get sicker,
ultimately reducing their chances of a successful transplant. This is
an added tragedy of patients being incorrectly listed as ``inactive,''
as was the case for Ms. Goldring.
Question. Is there any regular review/oversight by UNOS or others
to ensure patients listed as inactive are appropriately designated as
inactive, especially over an extended period of time?
Answer. No, this is left entirely to the transplant hospitals with
no required or documented practice to be followed to ensure accuracy,
fairness and equity.
Question. Are patients provided appropriate information and
resources to determine any next steps needed to return to active
status?
Answer. Not at all. UNOS has completely failed them.
______
Prepared Statement of Matthew D. Wadsworth,
President and CEO, Life Connection of Ohio
Chairman Cardin, Ranking Member Daines, and members of the
committee. My name is Matthew Wadsworth, and I serve as the president
and CEO of Life Connection of Ohio, the Organ Procurement Organization
responsible for facilitating organ donation in northwest and west-
central Ohio.
My job is to help as many patients as possible receive lifesaving
transplants. Most days, I try to do that through continually improving
practice at our OPO. But to affect meaningful change at scale, we need
Federal policy reforms.
The current system is broken. OPOs have geographic monopolies,
which has made too many sluggish and complacent, at the expense of
patients' lives. There are absolutely no guard rails in place to ensure
that OPOs are adequately serving patients, and many of them aren't. And
yet the Centers for Medicare and Medicaid Services (CMS) has never once
decertified an OPO for performance failures.
In recent years, it appeared as if things may finally be starting
to change. CMS finalized new regulations in 2020 to hold OPOs
accountable for the first time in 40 years. Three years later CMS has
still not taken the steps to provide OPOs with any guidance on how the
rule will be enforced, or any indication that it will support
meaningful competition to ensure that patients are only served by the
best OPOs. Furthermore, CMS has remained silent on waivers filed by
hospitals who want to work with higher performing OPOs immediately
instead of waiting until 2026.
Additionally, CMS has not yet taken any apparent steps to close a
dangerous loophole in the rule which gives OPOs credit for recovery of
pancreata that are never transplanted, pancreata labeled for research,
and which many OPOs have begun to flagrantly exploit, evidenced by over
a 400 percent increase in the number placed for research since this new
rule.
This means that OPOs that are failing at their central task--
recovering organs for transplant--can avoid accountability simply by
recovering one organ and labeling it research. The fact that executives
in our industry lack the moral compass not to exploit this loophole is
incredibly perverse; I am deeply appreciative of this committee for
investigating this abuse.
This should be proof positive of a perhaps self-evident notion:
OPOs respond to their incentive structure. Unfortunately, those
incentives are currently entirely misaligned with what patients need.
This is not only regulatory, but financial; the OPO industry,
including OPO boards, are often rife with financial conflicts of
interest, which means OPOs all-too-often spend taxpayer resources on
special interest projects rather than on investing in organ recovery.
Another issue that deserves urgent attention is the lack of safety
guard rails. There isn't even a standardized process for declaring
brain death across the country. The reality is that the quality of care
that donor patients and donor families receive depends on where in the
country someone dies.
The fact that the organ procurement system has been so broken for
40 years speaks directly to the complete abandonment of patients by the
organization at the top of the system--UNOS.
Even now, more than 3 years into this committee's investigation
into UNOS's failures, UNOS has transitioned from an organization that
is inept and possibly incompetent to one that takes an active role in
preventing patients from being transplanted.
Take, for example, recent reporting in The Washington Post that
UNOS is proposing changes to its terms of service which disallow
external organizations from conducting data-driven research into the
most effective ways to place organs for transplantation, even as organ
discard rates skyrocket.
UNOS only appears to be doing this to interfere with the business
of a potential competitor for its contract, showing that once again the
system has been held hostage by a terrible actor--one which values its
own contract far above the lives of the patients we are meant to serve.
This is a perfect microcosm of the problem: at every turn UNOS stifles
innovation and hides deadly failures, all to keep its monopoly
contract.
There are three things the Department of Health and Human Services
needs to do immediately to ensure patients receive safe and high-
quality organ procurement care:
(1) Prepare to enforce the OPO rule, without weakening or
delaying it, including closing the pancreas for research
loophole, publishing guidance on how the rule will be enforced,
and requiring the publication of OPO process data.
(2) Break up the OPTN contract and allow for competition so
that patients are served by the best in areas such as
technology, logistics, data analytics, business development,
and process improvement.
(3) Eliminate board and financial conflicts that exist in our
industry that prevent OPOs and any OPTN contractors from
investing their dollars in areas that grow organ donation and
transplantation.
I commend this committee for introducing legislation to finally
break up this monopoly, and I stand ready to work with you in any way
possible to ensure that this bill passes. It is the only way this
industry will be able to save more patients' lives.
Appendices Below
Appendix A: ``Temporal Changes in Procurement of Pancreata
for Research,'' American Journal of Transplantation, May 2023.
Appendix B: Fact-Check of AOPO Misinformation Sent to House
Oversight Committee, Spring 2021, as Published by the Project
on Government Oversight.
Appendix A: ``Temporal Changes in Procurement of Pancreata for
Research,'' American Journal of Transplantation,
May 2023
Title Page
Manuscript title: Temporal Changes in Procurement of Pancreata for
Research
Author names: David Goldberg, M.D., MSCE1; Darius Chyou, M.D.2; Rachael
Wulf, MSBS, CPTC3; Matthew Wadsworth, MBA3.
Author affiliations: 1--Division of Digestive Health and Liver
Diseases, University of Miami Miller School of Medicine, Miami, FL; 2--
University of Miami/Jackson Memorial Hospital, Department of Medicine,
Miami, FL; 3--Life Connection of Ohio, Toledo, OH.
Corresponding author:
David Goldberg, M.D., MSCE
Don Soffer Clinical Research Building
1120 NW 14th Street, Room 807
Miami, FL 33136
Phone: 305-243-7956
E-mail: [email protected]
Keywords: donation, metrics, policy
Disclosures: None of the authors have any relevant financial conflicts
of interest as defined by the American Journal of Transplantation
Abbreviations:
Organ procurement organizations (OPOs)
Centers for Medicare and Medicaid Services (CMS)
Organ Procurement and Transplantation Network (OPTN)
United Network for Organ Sharing (UNOS)
To the Editor:
Organ procurement organizations (OPOs) are the Federal contractors who
manage all aspects of deceased organ donation, including procurement of
organs from deceased donors for research purposes. In 11/20/2020 the
Centers for Medicare and Medicaid Services (CMS) updated the ``Final
Rule'' for OPO Conditions for Coverage, which included redefining an
organ donor for regulatory purposes as an individual with: (a) 1 organ
transplanted; or (b) pancreas procured for research or islet cell
transplantation (only performed under research
protocol).\1\-\3\ We sought to evaluate for temporal changes
in procurement of pancreata for research purposes, and whether there
were changes that coincided with the CMS rule change.
---------------------------------------------------------------------------
\1\ Centers for Medicare and Medicaid Services. Organ Procurement
Organization (OPO) Conditions for Coverage Final Rule: Revisions to
Outcome Measures for OPOs CMS-3380-F. Accessed January 19, 2023,
https://www.cms.gov/newsroom/fact-sheets/organ-procurement-
organization-opo-conditions-coverage-final-rule-revisions-outcome-
measures-opos.
\2\ Heinze G, Wallisch C, Dunkler D. Variable selection--A review
and recommendations for the practicing statistician. Biom J. May
2018;60(3):431-449. doi:10.1002/bimj.201700067
\3\ U.S. Department of Health and Human Services. Advancing
American Kidney Health. Accessed January 19, 2023, https://
aspe.hhs.gov/sites/default/files/private/pdf/262046/
AdvancingAmericanKidneyHealth.pdf.
We conducted a retrospective cohort study using data from the Organ
Procurement and Transplantation Network (OPTN)/United Network for Organ
Sharing (UNOS). We evaluated data over a 10-year period from 1/1/2013-
12/31/2022. Pancreata donated for research were identified based on
OPTN/UNOS codes, and pancreas-only donors were those for whom a
pancreas was procured for research, and no other organs were donated.
OPTN/UNOS data does not include data on the disposition of the organ,
the specifics of the research study, and whether the research was
---------------------------------------------------------------------------
related to all aspects of the pancreas, or solely islet sell isolation.
Based on the new CMS definition of a deceased donor, there was a steady
increase in the number of donor with 1 organ transplanted, increasing
from 11,578 in 2020 to 12,753 in 2022 (Figure 1a), with a more than
tenfold from 2020 (n=25) to 2022 (n=353) in the number of individuals
classified as a donor solely because their pancreas was procured for
research (Figure 1a). This phenomenon of increased organ procurement
for research purposes was limited to pancreata, despite stable numbers
of other organs procured for research (data not shown).
The increase in the number of pancreata procured for research varied
across OPOs (Figure 1b). Of the 57 OPOs, 8 (14.0 percent) procured >100
pancreata for research in 2022, accounting for 1,548 (58.2 percent of
the national total) pancreata research procurements. These 8 OPOs were
geographically dispersed. The procurement of pancreata research-only
donors was also geographically dispersed and concentrated in a small
number of OPOs, with nine OPOs procuring 20 pancreas research-only
donors in 2022, accounting for 242 (68.6 percent of the national total)
pancreas
research-only donors (Figure 1c). One OPO (OneLegacy, CAOP) had 74
pancreas
research-only donors in 2022, accounting for 21 percent of the national
total.
Over the last 2 years, there has been a striking increase in the number
of pancreata procured for research. As transplant professionals, we are
supportive of advancements in the field that may ultimately increase
the number and/or longevity of organ transplants. However the temporal
relationship to the CMS rule changes merits further study (e.g.,
specifics of research studies, disposition of research pancreata) This
would include potential re-evaluation of the CMS OPO final rule to
determine whether an unintended consequence of the Federal rule change
is increased procurement of research pancreata to improve an OPOs
metric without increasing the number of lifesaving transplants.
Acknowledgments
This work was supported in part by Health Resources and Services
Administration contract HHSH250--2019-00001C. The content is the
responsibility of the authors alone and does not necessarily reflect
the views or policies of the Department of Health and Human Services,
nor does mention of trade names, commercial products, or organizations
imply endorsement by the U.S. Government.
Figures and Figure Legends
1. Figure 1 (three panels):
a. Figure 1a: Annual number of deceased donors based on CMS
criteria of 1 organ transplant or a pancreas procured for
research or islet cells from 2013-2022.
b. Figure 1b: OPO-level changes change in total pancreata
procured for research in 2022 vs 2020.
c. Figure 1c: OPO-level changes in the number of individuals
classified as an organ donor solely due to having their
pancreas procured for research in 2022 vs 2020.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Appendix B: Fact-Check of AOPO Misinformation Sent to House
Oversight Committee
Dear Chairman Krishnamoorthi and Representative Porter,
I write today to thank you for your much-needed oversight of the U.S.
organ procurement system in effort to ensure it is working effectively
and transparently on behalf of patients. Given COVID-19 leaves patients
with organ failure particularly at risk, and the disease itself is also
damaging patients' organs, and given your point that OPO is an urgent
health care equity issue, your investigation is particularly important
to some of our country's most vulnerable patients.
I am an Organ Procurement Organization (OPO) CEO and currently a member
of the Association of Organ Procurement Organizations (AOPO), which
also makes me an AOPO board member. As such, I understand that AOPO
recently responded to the committee's oversight letter, and I wanted to
clarify that I had not seen AOPO's response before it was sent; I do
not feel it represents my views, nor do I feel it is grounded in
science.
Given this, I felt a duty to clarify misstatements and
misrepresentations contained within AOPO's letter. The irony is not
lost on me that, in response to the committee's inquiry about bad-faith
lobbying, AOPO's 8-page letter necessitated a 10-page fact-check.
I hope to serve as a resource in your ongoing inquiry. Patients deserve
transparency and accountability.
Signed,
Matt Wadsworth
AOPO wrote: In 2020, OPOs increased organ donation by 6 percent, which
makes 10 consecutive years of growth over which time organ donation has
increased by 58 percent. As a result of these improvements since 2010,
there are now, on average, 110 lifesaving, deceased donor organ
transplants per million population, and 128 living and deceased
transplants per million.
Fact check/relevant context: As has been well-documented, and has
certainly been pointed out to AOPO repeatedly (see fact-check letter
\1\ from the former Chief Technology Officer of the U.S. Department of
Health and Human Services (HHS)), the increase in donation in absolute
terms over the last 10 years does not owe to OPO improvements, but
rather an expanding donor pool. In fact, peer-reviewed research \2\
finds: ``it is indisputable that nationally the increased number of
donors is almost wholly attributable to the drug epidemic, and reflects
the byproduct of a national tragedy, rather than an improved system to
be celebrated.''
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\1\ https://58425eca-649a-42d4-b265-d1e1743b6c48.filesusr.com/ugd/
581bc3_b7d0e7fec4754ae0
a8ec9d0bb65b4417.pdf.
\2\ https://onlinelibrary.wiley.com/doi/full/10.1111/ctr.13755.
Peer-reviewed research in the Journal of the American Medical
Association \3\ from authors including DJ Patil, the former Chief Data
Scientist of the United States under President Obama, finds that
advancements in transplant science have also contributed to an
expanding donor pool. In fact, after controlling for increases owing to
the opioid epidemic, as well as transplant center advancements which
have increased the absolute size of the donor pool, over the last 9
years it turns out the OPO industry has not even kept pace \4\ with
simple population growth.
---------------------------------------------------------------------------
\3\ https://jamanetwork.com/journals/jamasurgery/article-abstract/
2771051.
\4\ https://jamanetwork.com/journals/jamasurgery/article-abstract/
2771051.
This should not be surprising given the lack of structural incentives
for OPO improvement and innovation. As The Washington Post editorial
board \5\ noted: ``in a system in which [OPOs] have an effective
monopoly on organ recovery within their zones, there are few incentives
for them to improve unless decertification is a serious possibility.''
---------------------------------------------------------------------------
\5\ https://www.washingtonpost.com/opinions/many-die-waiting-for-
organs-the-trump-administration-could-help/2020/07/31/77e3a102-dfd6-
11e9-b199-f638bf2c340f_story.html.
While the OPO industry, on net, actually seems to have backslid over
the last 10 years relative to donor potential, there have certainly
been individual OPOs that exhibited improvement. As research finds,
this has largely resulted from replacing underperforming OPO
leadership,\6\ as well as, tellingly, a response to the very oversight
pressure that AOPO is fighting.
---------------------------------------------------------------------------
\6\ https://jamanetwork.com/journals/jamasurgery/article-abstract/
2765994?appId=scweb.
According to research \7\ supported by Schmidt Futures and Arnold
Ventures, ``Since the [2019] executive order announcing the proposed
new metrics and increased oversight, data show that OPO performance has
already begun to improve, perhaps early evidence of the `Hawthorne
effect' (i.e., increased scrutiny and observation by itself drives
behavior change that leads to improved outcomes). That such gains were
possible, and yet unmade prior to the executive order, underscores the
importance for HHS to institutionalize such regulatory pressure for
OPOs to improve performance.''
---------------------------------------------------------------------------
\7\ https://www.bridgespan.org/bridgespan/Images/articles/
transforming-organ-donation-in-america/transforming-organ-donation-in-
america-dec2020-update.pdf.
I applaud the committee's active interest in oversight and reforms on
behalf of patients, and would be happy to serve as a resource to
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support any current or future lines of inquiry.
Lastly, AOPO also includes living donor transplants per million
population ``as a result of [OPO] improvements.'' This is curious, as
OPOs are in no way involved with living donation. In fact, there is
anecdotal evidence to suggest that increases in living donation occur,
at least in part, as a reaction to OPO failures.\8\
---------------------------------------------------------------------------
\8\ https://nypost.com/2020/01/08/americas-deadly-failure-on-organ-
donations/.
AOPO wrote: Your December 23 letter references a figure of 28,000
available organs from deceased donors that could be procured for
transplantation, but ultimately are not transplanted. However, the non-
peer reviewed consultant's report on which this number is based shows
---------------------------------------------------------------------------
that it presumes many conditions which are unrealistic.
Fact check/relevant context: As has been pointed out to AOPO before in
previous fact-checks to misleading AOPO claims,\9\ the 28,000 available
organs number does, in fact, come from peer-reviewed research \10\
coauthored by researchers from the University of Pennsylvania, a former
Surgeon General of the United States, and two OPO executives, validated
against administrative data voluntarily provided by two OPOs. Notably,
in AOPO's public comment \11\ to HHS regarding the then-proposed OPO
rule, AOPO cited this very peer-reviewed research as the most accurate
published estimate of donor potential (see page 497 \12\):
---------------------------------------------------------------------------
\9\ https://static1.squarespace.com/static/
53bafd3ce4b0ae714af7153f/t/5dc9a78c0665e33d5425
75c4/1573496733189/GLI_Azar+Verma+_OPO+103019-2.pdf.
\10\ https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.14391.
\11\ https://www.dropbox.com/s/ppnjkdhxav64gkm/Comments%20-
%20CMS%20Proposed%20O
PO%20Outcome%20Measurements.pdf?dl=0.
\12\ https://www.dropbox.com/s/ppnjkdhxav64gkm/Comments%20-
%20CMS%20Proposed%20O
PO%20Outcome%20Measurements.pdf?dl=0.
``An important starting point is to define the donor pool. Published
estimates range from 10,500 to 24,000 to 37,000 to a staggering
272,000; however, literature and published studies based on review of
---------------------------------------------------------------------------
hospital records suggest a figure closer to 20,000 to 24,000.''
As noted in AOPO's citation, the latter figure, which AOPO notes is
based on review of hospital records, refers to the research from which
the 28,000 figure was derived.
Additionally, as has also been previously pointed out to AOPO, the
write-up \13\ of this study also specifically States that the donor
potential research is meant to inform the scale of what is possible:
``It is important to note that the above figures represent the `full
potential' of the system, assuming 100-percent donation rates and 100-
percent organ utilization. Achieving even 20-percent of this potential
improvement would result in approximately 6,000 lives saved per year
and $2.6 billion in taxpayer savings over 5 years.''
---------------------------------------------------------------------------
\13\ https://www.bridgespan.org/bridgespan/Images/articles/
reforming-organ-donation-in-america/reforming-organ-donation-in-
america-01-2019.pdf.
These projections are in line with HHS's projections for expected
increase in donations resulting from the increased accountability
brought by the new metrics. If the 58 percent increase in donations
over the last 10 years were truly the result of OPO improvements
(rather than an ever-growing donor pool), it is unclear why AOPO
seemingly believes a relatively modest prospective increase would be
---------------------------------------------------------------------------
unattainable.
AOPO wrote: To achieve this [28,000] number of organs, all of the
following conditions would be necessary:
100 percent of donor hospitals would have to notify their local
OPO in a timely manner of 100 percent of all potential organ donors.
100 percent of the potential donors would need to be registered
as an organ donor or alternatively 100 percent of families of potential
donors must approve the donation. Currently, CMS requires a conversion
rate of 75 percent.
100 percent of all eight organs must meet medical suitability
for transplant.
100 percent of organs must be accepted by the transplant centers
to which they are offered. Currently, on average 3.45 organs recovered
from a donor are considered medically suitable and accepted for
transplantation.
While we recognize there is room for improvement in the number
of available organs, basing a regulation on the assumption of
100 percent success rates in each of these categories is simply
unrealistic for OPOs, donor hospitals, and transplant centers
to achieve.
Fact check/relevant context: As noted above, neither the study AOPO
references, nor HHS's final rule--which was based on HHS's independent
analysis--presume that OPOs can or should recover 100 percent of
potential. As such, it is not necessary to respond to every point
above.
It is important to note, however, that AOPO is simply factually
incorrect in its assertion that the donor potential study in question
assumes that ``100 percent of all eight organs must meet medical
suitability for transplant.'' The study estimates a donor potential of
24,007 annually for the years 2009-2012 (see Figure 1 \14\) (note: this
number has since increased for reasons explained above), and an organ
potential of just over 50,000 annually (see Figure 2 \15\).
---------------------------------------------------------------------------
\14\ https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.14391.
\15\ https://www.med.upenn.edu/goldberglab/data.html.
As a matter of simple math, this assumes an average of just over 2
organs transplanted per donor, representing an estimate far more
conservative than the 3.45 medically suitable organs recovered per
donor which AOPO states is industry average. The methodology for this
study is clearly laid out in the peer-review publication. It is unclear
---------------------------------------------------------------------------
why AOPO believes that the study assumes 8 organs per donor.
In response to AOPO's assertion that ``100 percent of donor hospitals
would have to notify their local OPO in a timely manner of 100 percent
of all potential organ donors'', I note a quote from Tom Mone, CEO of
the OPO based in Los Angeles, in The New York Times:\16\ ``If I can't
engage the hospitals and inspire them and motivate them to actively
participate in donation, and we are not performing at the expected
levels, the buck has to stop with our leadership.'' I agree with Mr.
Mone on this point.
---------------------------------------------------------------------------
\16\ https://www.nytimes.com/2018/07/11/nyregion/organ-donation-is-
desperate-in-new-york.html.
Regarding the AOPO position that many organs that OPOs recover are not
ultimately utilized by transplant centers, please see a report \17\
from alumni of the United States Digital Service regarding the myriad
reasons organs, even once recovered, are not transplanted. While some
percentage of these discards do owe to transplant center behavior, much
also owes to differential ability and effort from OPOs in placing
organs, a dynamic which CMS noted in the Final Rule,\18\ and which AOPO
continually minimizes or outright ignores.
---------------------------------------------------------------------------
\17\ https://bloomworks.digital/organdonationreform/OPO-Best-
Practices/#drop-off-point-5-when-an-opo-does-not-place-an-organ-while-
it-is-still-viable.
\18\ https://www.cms.gov/files/document/112020-opo-final-rule-cms-
3380-f.pdf.
Additionally, much of the problem also results from the deeply outdated
UNOS technology system \19\ on which organ offers are made, and I note
the House Appropriations Committee's 2020 Report \20\ calling for
increased competition for the Organ Procurement and Transplantation
Network (OPTN): ``The committee supports HHS's Request for Information
for the technology system over which these organ offers are facilitated
and encourages HHS to promote competition for this contract.''
---------------------------------------------------------------------------
\19\ https://bloomworks.digital/organdonationreform/Technology/.
\20\ https://appropriations.house.gov/sites/
democrats.appropriations.house.gov/files/LHHS%
20Report%20-%20GPO%20-%207.8.20.pdf.
Finally, AOPO's assertion that the regulation is ``bas[ed] on . . . the
assumption of 100-percent success rates in each of these categories is
simply unrealistic for OPOs, donor hospitals, and transplant centers to
achieve'' is nonsensical. As AOPO presumably--although perhaps not
necessarily--understands, the new regulation simply evaluates OPOs
compared against each other. This is in effort to address the
unexplainable performance variability of 470 percent \21\ across OPOs.
---------------------------------------------------------------------------
\21\ https://bloomworks.digital/organdonationreform/Summary/.
In no way is the regulation based on the assumption that any OPO will
achieve 100-percent success rates. In actuality, it is this very
recognition that informs the rationale for comparing OPOs relative to
---------------------------------------------------------------------------
each other rather than on an absolute basis.
AOPO wrote: The prevalence of organs being lost or delayed on
commercial flights or other transportation is extremely rare.
Fact check/relevant context: Investigative reporting from Kaiser Health
News reviewed 8,800 organ and tissue shipments handled by the UNOS
Organ Center and found, ``between 2014 and 2019 nearly 170 organs could
not be transplanted and almost 370 endured `near misses,' with delays
of 2 hours or more, after transportation problems.''
These data indicate that multiple organs are lost or damaged in transit
every month, and have been for years. In total, about 7 percent of all
organs shipped by the UNOS Organ Center experience transportation
problems, which means, as noted by the American Society of Nephrology:
``UNOS is approximately 15 times \22\ as likely to lose, damage or
mishandle an organ as the airline industry is your luggage.''
---------------------------------------------------------------------------
\22\ https://www.kidneynews.org/policy-advocacy/leading-edge/
kidney-donation-transportation-issues.
Organs handled by the UNOS Organ Center represent only a small subset
of all organs shipped, with the balance of cases handled by the OPO,
either directly or via a courier engaged by the OPO. Research \23\
indicates that this process is highly variable and often inefficient.
---------------------------------------------------------------------------
\23\ https://bloomworks.digital/organdonationreform/OPO-Best-
Practices/#drop-off-point-7-when-an-opo-fails-to-transport-an-organ-to-
its-destination-in-a-timely-manner-or-if-on-arrival-the-organ-is-
unsuitable-for-the-intended-recipient.
AOPO wrote: In addition, through the adoption and deployment of
perfusion technologies, OPOs are using innovative techniques to help
drive substantial increases in donation and transplantation of organs.
We now have normothermic perfusion devices for hearts, lungs and
livers. These technologies, which preserve organs for longer periods of
time, are especially important during Donation After Circulatory Death
(``DCD'')--which refers to recovery of organs for the purpose of
transplantation from patients whose death was confirmed using cardio-
respiratory criteria. In 2020, DCD donations increased by 18.6 percent
over 2019 and this trend will continue with advancements in perfusion
---------------------------------------------------------------------------
technologies.
Fact check/relevant context: This seems to validate that the increases
in donations AOPO cites are, at least in part, driven by scientific
advancements \24\ driven by transplant centers, rather than by OPO
performance improvements. In most cases, the perfusion machines AOPO
references are owned and operated by transplant centers, rather than
OPOs.
---------------------------------------------------------------------------
\24\ https://www.modernhealthcare.com/safety-quality/hepatitis-c-
treatments-could-expand-organ-donor-pool-study-suggests.
AOPO wrote: OPOs are highly regulated organizations held to accountable
---------------------------------------------------------------------------
standards.
Fact check/relevant context: As has been highlighted in previous fact-
checks \25\ of misleading AOPO claims, while OPOs are titularly
regulated by various bodies, none of that oversight is functionally
effective. As The New York Times editorial board \26\ wrote, ``an
astounding lack of accountability and oversight in the Nation's
creaking, monopolistic organ transplant system is allowing hundreds of
thousands of potential organ donations to fall through the cracks.''
---------------------------------------------------------------------------
\25\ https://58425eca-649a-42d4-b265-d1e1743b6c48.filesusr.com/ugd/
581bc3_b7d0e7fec4754ae
0a8ec9d0bb65b4417.pdf.
\26\ https://www.nytimes.com/2019/08/20/opinion/erika-zak-organ-
donor.html.
For example, and as your oversight letter to AOPO correctly noted,
while OPOs report performance data to CMS, AOPO itself \27\ has argued
that such data should not be legally enforced because it is ``unaudited
and self-reported [and] there is no provision for even random audits,''
and the former Chief Data Scientist of the United States has gone as
far as to characterize OPO data reporting as ``functionally
useless.''\28\
---------------------------------------------------------------------------
\27\ https://obamawhitehouse.archives.gov/sites/default/files/omb/
assets/oira_0938/0938_10
292013b-1.pdf.
\28\ https://twitter.com/dpatil/status/1148867331180785664.
It is unclear what AOPO means by ``held to accountable standards,'' but
no OPO has ever lost a contract for underperformance, despite what even
---------------------------------------------------------------------------
AOPO implicitly concedes has been massive historical underperformance.
Consider AOPO's position that OPOs have improved performance by 58
percent in 10 years, which AOPO implies is not related to an expanding
donor pool. If this were true--and, again, peer-reviewed data clearly
finds it is not--then AOPO's position would simultaneously suggest that
the OPO industry was underperforming by at least 58 percent 10 years
ago; and that, despite no OPO losing its contract for that
underperformance, OPOs are held to ``accountable standards.''
For further analysis of the systemic failures of OPO oversight, see a
new report \29\ from alumni of the United States Digital Service, which
finds ``Failures within the U.S. organ donation and transplantation
system--which disproportionately harm patients of color--are left
unaddressed by oversight bodies.''
---------------------------------------------------------------------------
\29\ https://bloomworks.digital/organdonationreform/oversight/.
AOPO wrote: Indeed, this model is replicated worldwide; none of the
countries with high-performing deceased donation utilize or permit
entities to compete in a free-
market system for the recovery of deceased organ donation. The reality
is that having OPOs, or other potentially for-profit entities,
competing for organs would be antithetical to the very purpose of
donation as a precious resource requiring public trust and not a
---------------------------------------------------------------------------
commercial enterprise.
Fact check/relevant context: It is unclear why AOPO makes this
assertion--which mirrors similar, uninformed statements from some OPOs
and/or their surrogates--as no one is proposing a free market for
organs. By statute, OPOs must be nonprofit entities, and in no way does
HHS's regulation introduce a free market (though, to the extent that
AOPO is concerned that for-profit, commercial activities would
undermine public trust in organ donation, I would encourage them to
support the committee's oversight requests seeking to understand the
extent to which OPOs are already engaged in such activities).
The actual issue at hand is simply how to increase transparency and
accountability for OPOs using objective data, specifically because OPOs
operate as nonprofit, geographic monopolies in the public trust. As a
past president of AOPO wrote:\30\ ``All OPOs operate as geographic
monopolies, which means we have neither regulatory nor competitive
pressure to provide high service to patients. And while there may be
legitimate reasons for at least some monopolism (e.g., potential donor
families should not have two OPOs competing for their attention), the
trade-off must be increased transparency and oversight.''
---------------------------------------------------------------------------
\30\ https://morningconsult.com/opinions/organ-donation-can-save-
more-lives-through-reform/.
Regarding AOPO's invoking of the need for public trust, I highlight
CMS's comment in the final rule \31\ that ``The current OPO outcome
measures are not sufficiently objective and transparent to ensure
public trust.'' Thank you for your support of HHS's final rule.
---------------------------------------------------------------------------
\31\ https://www.cms.gov/files/document/112020-opo-final-rule-cms-
3380-f.pdf.
AOPO wrote: Additionally, every OPO is also required to submit an
annual cost report for audit to ensure compliance with CMS allowable
---------------------------------------------------------------------------
expenses.
Fact check/relevant context: As the committee's oversight itself
indicated, previous audits from the Office of the Inspector General
(OIG) have detailed fraud, waste, and abuse at certain OPOs, though,
inexplicably, and as your colleagues on the Senate Finance Committee
\32\ have noted, the OIG has not conducted further audits since these
findings.
---------------------------------------------------------------------------
\32\ https://www.finance.senate.gov/imo/media/doc/
CEG.Young%20to%20HHSOIG%20(OPO%
20Oversight)%20Dec.18.2019.pdf.
Additionally, as a recent report from the Bridgespan Group \33\
highlights, there is much reason to question whether CMS's current
definition of ``allowable expenses'' for OPOs does, in fact, serve
patients: ``OPOs are reimbursed based on self-reported costs--passing
these costs along to the Centers for Medicare and Medicaid Services
(CMS) and transplant centers--regardless of performance. The current
OPO payment model does not give OPOs an incentive to reallocate
resources in order to increase the number of organs available for
transplant, and it reimburses OPOs for costs that may not, in fact,
help produce the desired outcomes.''
---------------------------------------------------------------------------
\33\ https://www.bridgespan.org/bridgespan/Images/articles/
transforming-organ-donation-in-america/transforming-organ-donation-in-
america-dec2020-update.pdf.
AOPO wrote: Equally important, the Health Resources and Services
---------------------------------------------------------------------------
Administration (``HRSA'') oversees the OPTN contract.
Fact check/relevant context: I refer you to research from alumni of the
United States Digital regarding deficiencies in HRSA's management \34\
of the OPTN contract, including a roadmap for how HHS can more
effectively manage \35\ this contract going forward.
---------------------------------------------------------------------------
\34\ https://bloomworks.digital/organdonationreform/Buying-OPTN-
Tech/.
\35\ https://bloomworks.digital/organdonationreform/Buying-OPTN-
Tech/#procurement-strategy.
As a factual matter, as of January 15, 2021, HHS has moved the Division
of Transplantation from HRSA to the Office of the Assistant Secretary
for Health (OASH), in line with calls from patient advocates \36\ to
bring more active oversight of the OPTN going forward.
---------------------------------------------------------------------------
\36\ https://www.dayoneproject.org/post/addressingorgandonorcrisis.
AOPO wrote: The OPTN performs ongoing reviews of OPO performance and
compliance with OPTN policy. The OPTN also surveys all OPOs every 3
years to ensure they are in compliance with operating and productivity
requirements. Finally, the Food and Drug Administration regulates all
---------------------------------------------------------------------------
tissue recovery within an OPO.
Fact check/relevant context: As covered comprehensively in the
aforementioned report by alumni of the United States Digital Service,
UNOS, which currently operates as the OPTN, is deeply conflicted. As
The Los Angeles Times \37\ has noted in investigative reporting, UNOS
is a ``reluctant enforcer'' with ``collegiality built into [its] very
structure.'' Senators Grassley and Young have characterized UNOS's
oversight over its members as ``the fox guarding the hen house.''
---------------------------------------------------------------------------
\37\ https://www.latimes.com/news/la-me-transplant22oct22-
story.html.
The FDA's regulation of tissue recovery is confined only to clinical
regulation; there is no oversight over OPO business practices related
---------------------------------------------------------------------------
to tissue donation.
AOPO wrote: If any OPO fails to meet the regulatory standards put forth
by these Federal organizations, they must commit to a performance
improvement plan to continue organ recovery operations in their DSA.
Fact check/relevant context: As detailed in a new report \38\ from the
Bridgespan Group: ``Further strengthening the case for [OPO]
decertifications: there is no evidence to suggest that HHS's
alternatives have ever been successful.'' Specifically, in 2012, HHS
placed an underperforming OPO on a ``performance improvement plan'' in
lieu of decertification, in hopes that such a governmental plan would
lead the OPO to turn around. As noted in The Washington Post, since
2012, CMS has required the OPO to submit at least three ``corrective
action plans.'' Despite such plans, for at least the past 8 years, the
OPO ``has consistently registered one of the poorest performances in
the Nation,'' and ``ranked as the country's second-worst OPO [in
2017].''
---------------------------------------------------------------------------
\38\ https://www.bridgespan.org/bridgespan/Images/articles/
transforming-organ-donation-in-america/transforming-organ-donation-in-
america-dec2020-update.pdf.
Representatives Porter and Bass have highlighted the ineffectiveness of
OPO performance improvement plans in a previous oversight letter.\39\
And as the past president of AOPO \40\ has written, if ``an OPO is not
able to rise to the challenge of a high standard, the focus of our
attention and energy must be on better serving patients on the national
wait list [by replacing them with a higher-performing OPO, as HHS's
final rule will enable], not on protecting specific OPOs.''
---------------------------------------------------------------------------
\39\ https://porter.house.gov/uploadedfiles/
cms_hhs_opo_oversight_final_7.9.20.pdf.
\40\ https://morningconsult.com/opinions/organ-donation-can-save-
more-lives-through-reform/.
AOPO wrote: OPOs have not, as you assert in your letters,
misrepresented their efficiency at identifying donors and recovering
transplantable organs. In support of this allegation, you cite an
opinion piece and a non-peer reviewed report that is based on faulty
data and funded by committed critics of OPOs. OPOs report data on
identifying donors and recovering transplantable organs consistent with
---------------------------------------------------------------------------
government requirements.
Fact check/relevant context: The data cited by The New York Times
\41\--in which a whistleblower said ``I used to work at an OPO and we
reported false numbers to make it appear we were doing better than we
were''--is based on peer-reviewed research \42\ which AOPO cited in its
HHS public comment as the single most accurate estimate of donor
potential. Criticism of OPOs from disinterested third parties, informed
by objective, peer-reviewed data, is a logical response, and only
further validates the need for HHS's OPO reforms.
---------------------------------------------------------------------------
\41\ https://www.nytimes.com/2019/06/11/opinion/organ-transplant-
deaths.html.
\42\ https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.14391.
More importantly, OPOs have written \43\ to the White House Office of
Management and Budget (OMB) that, currently, ``the data that OPOs
submit to CMS in connection with the outcome measures is self-reported
and unaudited . . . errors have been found in the data on which CMS has
relied as the basis for judging OPO performance. . . [and that]
clearly, this type of `evidence' fails to meet any reasonable
definition of empirical.''
---------------------------------------------------------------------------
\43\ https://obamawhitehouse.archives.gov/sites/default/files/omb/
assets/oira_0938/0938_10
292013b-1.pdf.
To the extent that OPO reporting has, in fact, been ``consistent with
government requirements'' and yet OPO-reported data still is not
legally enforceable,\44\ this only underscores the importance of HHS's
final rule, which AOPO has vigorously opposed and continues to oppose.
Thank you for your support of HHS's propatient, proaccountability
reforms.
---------------------------------------------------------------------------
\44\ https://www.washingtonpost.com/national/despite-low-
performance-organ-collection-group-gets-new-federal-contract/2019/02/
04/9b9ba2aa-2895-11e9-b2fc-721718903bfc_story.html.
AOPO wrote: Far from lobbying against such reforms, as your letter
alleges . . . AOPO has advocated on behalf of its member OPOs as part
---------------------------------------------------------------------------
of a committed effort to work collaboratively with policymakers.
Fact check/relevant context: Whether AOPO has ``worked collaboratively
with policymakers'' is a matter of judgment, and, in this case, I will
defer to yours, though will note that the emails and other
communications you have requested from AOPO would certainly inform such
a judgment, and also note from investigative reporting from the Project
on Government Oversight:\45\ ``UNOS did not deny that industry players
are lobbying to undermine the President's reform initiative.''
---------------------------------------------------------------------------
\45\ https://www.pogo.org/investigation/2020/10/heartless-organ-
donation-contractors-lobby-against-a-popular-health-care-initiative-
while-pocketing-pandemic-relief-loans/.
AOPO wrote: It is worth noting that AOPO's 501(c)(3) entity will
continue to exist, and that the 501(c)(6) organization will act as a
---------------------------------------------------------------------------
complimentary [sic] organization.
Fact check/relevant context: It is my understanding as an AOPO board
member that, counter to AOPO's representation to the committee, the
501(c)(6) will serve as the primary program.
I call your attention to the following email sent from Steve Miller to
all OPO CEOs and executive directors, dated June 2, 2020 at 8:19 p.m.
EST, and subsequently covered in investigative reporting from the
Project on Government Oversight:\46\
---------------------------------------------------------------------------
\46\ https://www.pogo.org/investigation/2020/10/heartless-organ-
donation-contractors-lobby-against-a-popular-health-care-initiative-
while-pocketing-pandemic-relief-loans/.
As noted above, we are recommending spending down the funds in
the 501(c)(3) to the level determined by the executive
committee while transitioning operations to the new 501(c)(6).
To accomplish this, all new dues and revenue streams will be
directed into the 501(c)(6), while all spending not related to
advocacy will be paid out of the 501(c)(3). Any spending
related to advocacy will be paid out of the 501(c)(6). This
will allow reserves to be built up in the 501(c)(6) while
spending down the funds in the 501(c)(3) to the level
determined by the executive committee. The full transition in
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operations will take approximately 12 to 24 months to finalize.
AOPO wrote: AOPO's recent advocacy efforts are aimed at ensuring those
reforms are thoughtful and driven by science. The OPO community
supports independently verifiable metrics based on sound data. AOPO
believed the proposed metrics included in the 2020 OPO Rule failed to
meet this standard on several fronts.
Fact check/relevant context: As highlighted above, AOPO's claims that
its policy positions are ``driven by science'' is spurious. HHS's final
rule has been supported by the former Chief Data Scientist of the
United States \47\ as well as the Day One Project at the Federation of
American Scientists,\48\ among other expert researchers.\49\
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\47\ https://jamanetwork.com/journals/jamasurgery/article-abstract/
2765994?appId=scweb.
\48\ https://www.dayoneproject.org/cms-policy-change.
\49\ https://58425eca-649a-42d4-b265-d1e1743b6c48.filesusr.com/ugd/
581bc3_e7064016057049
1b9855d21980e87092.pdf.
AOPO wrote: AOPO's recent efforts to add a 501(c)(6) entity to the
overall organization is part of an effort to engage more effectively in
---------------------------------------------------------------------------
First Amendment-protected advocacy.
Fact check/relevant context: No one is questioning AOPO's protections
under the First Amendment. The problem is that AOPO is using these
protections to promote spurious claims in order to push anti-
accountability, antipatient policies.
AOPO wrote: The Chief of Mortality Statistics Branch at the CDC's
National Center for Health Certificates recently stated, ``1 in 3 death
certificates were already wrong before COVID-19.'' While he later
revised this estimate down to 25 percent, still an unacceptable high
error rate when determining donor potential for OPOs.
Fact check/relevant context: As has been pointed out in previous fact-
checks of misleading AOPO claims,\50\ ``Almost all errors in death
certificate data pertain to the chain of events leading to death, not
the final cause, so do not impact the ultimate determination as to
whether the donor was viable for transplant. In fact, 92 percent of all
causes of donor death are asphyxiation, blunt injury, drug
intoxication, gunshot wounds, drowning, stroke, or cardiovascular
causes, which is obvious to diagnose. AOPO's invoking of ``death
certificate errors'' is a red herring.''
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\50\ https://www.globalliver.org/news/2020/8/bipartisan-reform-of-
organ-procurement-organizations-opos-will-save-lives.
More simply, organ donation-eligible deaths represent a subset of all
deaths which are uniquely insulated from the issues AOPO cites. For
further information, I also refer to the committee to peer-reviewed
research in the Journal of the American Medical Association.\51\
---------------------------------------------------------------------------
\51\ https://jamanetwork.com/journals/jamasurgery/article-abstract/
2765994?appId=scweb.
AOPO wrote: The concern that death certificates are a poor data source
for accurately calculating the denominator for donation rate was echoed
in the public comments to the 2020 OPO rule's performance measure
regulation made by a wide range of expert stakeholders in the field
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including medical examiners.
Fact check/relevant context: I refer the committee to extensive
reporting in The Los Angeles Times detailing how OPOs have been able to
co-opt medical examiners for lobbying purposes through gifts,
sponsorships, and other forms of payment.
AOPO wrote: AOPO also had strong reservations regarding the 2020 OPO
rule's proposed threshold to pass CMS certification of OPOs at the top
25 percent.
Fact check/relevant context: Much of OPO and AOPO messaging \52\ has
centered on a misleading message that the new rule would necessarily
result in 75 percent of OPOs being decertified, even despite various
fact-check responses.\53\ Presumably, the emails and other
communications that the committee is seeking would inform whether such
statements reflect AOPO's complete misunderstanding of the mechanics of
the rule versus a more willful misrepresentation.
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\52\ https://www.abqjournal.com/1518295/attacks-on-organ-
procurement-are-unfair.html.
\53\ https://thehill.com/opinion/healthcare/516882-patients-are-
dying-unnecessarily-from-organ-donation-policy-failures.
AOPO wrote: Despite all the challenges brought about by the pandemic,
OPOs recovered almost 1,000 more organs that were transplanted in 2020
than during 2019, a 6 percent increase, which led to a 3 percent
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increase in transplants from deceased donors.
Fact check/relevant context: Recent reporting in The New York Times
\54\ finds that, as a second-order effect of the pandemic, drug
overdose deaths represented a record high in 2020. While AOPO
represents that the increase in donation in 2020 was ``despite'' the
pandemic, the data suggest that the increase actually resulted from the
pandemic.
---------------------------------------------------------------------------
\54\ https://www.nytimes.com/interactive/2020/07/15/upshot/drug-
overdose-deaths.html.
On a personal level, I find AOPO's use of the pandemic to deflect
criticism to be exploitative, and also call the committee's attention
to a comment from an OPO executive at a UNOS conference that: ``OPOs
are fortunate for COVID,''\55\ which afforded AOPO more time to
``organize and lobby harder against proposed rules to implement
reform.''
---------------------------------------------------------------------------
\55\ https://www.pogo.org/investigation/2020/10/heartless-organ-
donation-contractors-lobby-against-a-popular-health-care-initiative-
while-pocketing-pandemic-relief-loans/.
______
Questions Submitted for the Record to Matthew D. Wadsworth
Questions Submitted by Hon. John Thune
Question. In your testimony, you noted the geographic monopolies of
OPOs in some areas.
Could you expand on what you think the impact would be of
decertifying Tier 3 OPOs in areas where they are the only ones serving
transplant centers? How could the lack of an OPO nearby affect
transplant centers' ability to do their important work, particularly in
rural areas? And how could we mitigate this risk?
Answer. Decertifying Tier 3 OPOs and assigning their donation
service areas (DSAs) to higher-performing OPOs will improve system
performance and organ recovery, meaning more organs will be available
for transplant centers to serve their patients. Related: if higher-
performing OPOs are expanding their DSAs, they will definitionally be
near transplant centers in their DSA. As part of the competitive
process to decide which OPOs should serve DSAs from decertified OPOs,
any bidding OPO should present a plan to CMS on how it will provide
adequate support for all their transplant programs the same way they
would need to show how they support the entire geography they are
bidding on.
organ distribution
Question. As I'm sure you may know, in 2018, UNOS adopted
principles of geographic organ distribution that some have suggested
discourage donations in smaller or rural areas.
What is your response to this, and how could this be addressed? And
how has the algorithm for assigning donations affected your
organization?
Answer. The changes in organ distribution, in my opinion, were put
into place to support transplant programs whose OPO wasn't providing
adequate service to their DSA. It is my opinion that the root of the
problem is OPO performance; we must make the pie bigger (in this case,
better serve donor families, in turn recovering more organs for
transplant) instead of just cutting the same pie differently
(reallocating the existing organ supply and assuming it is fixed). My
OPO, Life Connection of Ohio, has always been a massive organ exporter
so it hasn't been as impactful for us. What has changed though is the
number of kidneys that we are exporting versus allocating to our local
transplant center. When I first arrived at Life Connection of Ohio, we
grew so rapidly that the transplant program couldn't list patients fast
enough to keep up. It is unquestionably true that if all OPOs performed
at a Tier 1 level there would be literally thousands more organs
available for transplant every year. Focusing on allocation fights
misses the real point, which is that there should be a much larger pool
of organs available, and literally every geography in the country would
be better served by increased OPO accountability rather than focusing
on organ allocation.
______
Questions Submitted by Hon. Sheldon Whitehouse
Question. In your testimony, you mentioned that Organ Procurement
Organization (OPOs) ``are often rife with financial conflicts of
interest, which means OPOs all too often spend taxpayer resources on
special interest projects rather than on investing in organ recovery.''
Can you explain the conflicting financial incentives of OPOs and
solutions to address these incentives to improve patient outcomes?
Answer. To identify the conflicting financial incentives for OPOs,
you don't need to look any further than their board structures and
composition. It is my belief that the potential for innovation and
appropriate resource allocation at some OPOs is essentially being
``snuffed out'' by their boards. For example, transplant surgeons,
tissue processors, and other interests groups very often have positions
on OPO boards, and the institutions and interests they represent may
have financial or operational interests in conflict with those of the
OPO. Further, hospital-based OPOs arguably have the highest level of
financial conflicts. It is rumored that hospital-based OPOs essentially
must pay a ``deans' tax,'' and their resources are gobbled up by their
parent institution instead of being invested into the mission of organ
donation and transplantation.
Question. Would you agree that the mismatched incentives of OPOs is
part of the reason so many of them are failing to recover enough organs
to help patients?
Answer. OPOs are only one of two major programs left in Medicare
that operate on what's called ``cost-reimbursement basis,'' meaning
they are reimbursed by taxpayers for whatever dollars they spend,
rather than for the value they deliver. This incentivizes them to spend
more money rather than to deliver high quality care for patients. The
Federal Government has moved away from cost- reimbursement almost
everywhere else in health care. I believe that the cost reimbursement
structure has created a system that was meant to support OPOs and their
mission, but HHS has not provided the needed oversight, and
unfortunately many OPO leaders have taken advantage of that.
Question. How do you suggest we move away from ``cost-reimbursement
basis'' in organ transplantation?
Answer. I think strict enforcement of the OPO rule will drive
regulatory pressures on OPOs to better allocate financial resources,
increase transparency around OPO costs, and will serve to stop wasteful
or abusive spending.
______
Questions Submitted by Hon. Ron Wyden
opo accountability (pancreata loophole and cms rule)
Question. As part of President Trump's Executive Order on Advancing
American Kidney Health, CMS published the final rule, titled,
``Medicare and Medicaid Programs: Organ Procurement Organizations
Conditions for Coverage: Revisions to the Outcome Measure Requirements
for Organ Procurement Organizations; Final Rule,'' (the ``OPO Final
Rule'') which creates stronger new quality and transparency
requirements for OPOs. According to CMS, the intent of the OPO Final
Rule is to ensure that OPO performance and outcome measures are more
transparent, reliable, and enforceable. The new OPO final rule became
effective on March 30, 2021 and HHS has made meaningful first steps at
reform, but more remains to be done.
However, this new rule also introduced a new loophole that allows
OPOs to falsely inflate their performance by procuring pancreases for
research. In the 2 years since the rule was finalized, the number of
pancreases recovered by OPOs for ``research'' has skyrocketed,
increasing by more than 400 percent. The Finance Committee has been
investigating this potential loophole with the OPO Final Rule. So far,
the committee's investigation has found that some OPOs have increased
their pancreas research more than 700 percent since the rule went into
effect.
Why is it imperative that CMS addresses the Pancreata loophole
created by the 2021 OPO Final Rule?
Answer. The number of pancreata for research has increased
dramatically since the passing of this rule. Should CMS choose not to
address this, they may lose their ability to decertify some of the
worst-performing OPOs. The pancreas for research loophole allows for
OPOs to falsely inflate their donation and transplant rates which puts
them in a position to not only avoid decertification but to actually
acquire other territories. Through this acquisition process, these same
OPOs would serve a larger population that they could further exploit.
Anecdotally, I have heard that OPOs have adopted the practice of
creating, ``research banks,'' where they recover all pancreata and
place them in freezers for possible future research. This is not only a
gross exploitation that warps the intentions of the OPO rule, it is
also a gross disservice to generous donor families. The other issue
here is if an OPO were to go to surgery for blatantly nontransplantable
kidneys, and simultaneously choose to recover the pancreas for
research, all that expense is allocated to the Medicare cost report.
You could potentially have OPOs committing Medicare fraud in hopes of
not being decertified, which in turn could allow them to commit
Medicare fraud on an even larger scale.
Question. Additionally, what else should CMS be doing to make sure
the 2021 OPO Final Rule is enforced as intended?
Answer. CMS needs to be ready to enforce the rule immediately--
without weakening the tier standards, including through risk-
adjustments, or otherwise delaying or weakening implementation--running
transparent, data-driven competitive cycles for DSAs that will best
serve donor families and transplant patients. I believe that CMS will
see proactive mergers, and then some OPOs may ask for more time to
improve, because they have merged. My fear is that a group of Tier 3
OPOs or even a couple lower Tier OPOs proactively merge into a Tier 1
OPO and then claim they shouldn't be decertified, because they need
time to turn the organization around. Any additional time for OPO rule
enforcement will translate to additional patient deaths on the waiting
list. History has shown us that this industry will exploit every
opportunity they have to avoid accountability, and we need to be
absolute in our enforcement of the rule.
Additionally, CMS should be much more active in promoting and
approving waivers to allow hospitals to choose to work with higher
performing OPOs. Firstly, it is definitionally better for patients to
have more hospitals work with Tier 1 OPOs rather than Tier 2 or Tier 3.
Additionally, a more ubiquitously used waiver system would create a
constant pressure on OPOs to better serve hospitals, standing in for
the regulatory incentives which are currently on a very protracted 4-
year cycle.
Lastly, to the extent that CMS ultimately does have to decertify an
OPO, presumably many of its hospitals would have chosen to exercise the
waiver process during that OPO's 4-year contract, meaning that the
number of decertifications for CMS to oversee would necessarily be
smaller in nature.
______
Questions Submitted by Hon. Todd Young
Question. There's been little guidance from the Centers for
Medicare and Medicaid Services (CMS) to indicate that they are fully
prepared to enforce the 2020 Organ Procurement Organization (OPO) rule.
What does CMS need to do to appropriately enforce this rule?
Answer. They must stay vigilant. CMS needs to close the pancreas
for research loophole so we have a clear picture of who is actually
transplanting organs. CMS also needs to close the pancreas for research
loophole to protect donor patients. For example, there appears to be
violation of section 2927.01 of Ohio Revised Code, Abuse of a Corpse,
within my own State. This law states that:
(A) No person, except as authorized by law, shall treat a
human corpse in a way that the person knows would outrage
reasonable family sensibilities.
(B) No person, except as authorized by law, shall treat a
human corpse in a way that would outrage reasonable community
sensibilities.
(C) Whoever violates division (A) of this section is guilty of
abuse of a corpse, a misdemeanor of the second degree. Whoever
violates division (B) of this section is guilty of gross abuse
of a corpse, a felony of the fifth degree.
If what I hear from staff level employees at OPOs is true, not only
are some OPOs committing a felony, taxpayers are paying the bill. This
must stop.
Question. Has CMS released any guidance or additional information
on how competition for Tier 2 and Tier 3 OPO donation service areas
(DSA) will occur?
Answer. We have received zero guidance on how competition will
occur, what we can compete for, or what we obtain if we are awarded
additional territory. This is a massive disservice to donor families
and patients on the organ waiting list, as every part of the country
deserves to be served by a Tier 1, high-performing OPO.
Question. What specific guidance is needed for OPOs to fully
prepare and participate in this competition process?
Answer. We need the guidance on the following:
What are the criteria for awarding a territory?
What are we acquiring? Only the contract?
Is there financial support to do this, such as a zero/low
interest loan? While most OPOs likely don't need financial
support, an organization like mine will need to have support
with resources to start.
What is the timeline for turning around a failing DSA?
Can we keep the acquired DSA separate in our org. structure
to avoid decertification of the entire entity if we are
unsuccessful turning the new territory around?
What are the repercussions for board members that behave
badly by allowing the OPO to shift money away from the parent
organization, or otherwise interfere with the acquiring OPO
operating within their facility?
What type of data will we have access to in order to
determine if we want to acquire a territory, or develop our
strategic plan to turn that organization around?
Question. Given the timeline for decertification, when would CMS's
release of this information be most beneficial to OPOs for their
planning?
Answer. We must know no later than May 2024, which is the timing by
which OPOs considering acquiring additional territory will need to
start thinking through strategic planning to build our organizations up
in 2025 in a way that we can acquire in 2026. The May 2024 deadline
gives us time to evaluate the information, make determinations of what
we want to bid on, seek board approval, and begin the process of
growing our organization to be what it needs to be by 2026. Some
organizations, Life Connection of Ohio included, don't currently have
the bylaws or other organizational structures needed to allow
acquisition. As the CEO, I need time to work with my board, and get
everyone to the point that they feel confident in our structure to
serve donor families and transplant patients.
______
Communications
----------
American Society of Nephrology
1401 H Street NW, Suite 900
Washington, DC 20005
Statement of Michelle A. Josephson, M.D., FASN
On behalf of the 37 million Americans living with kidney diseases,
particularly the nearly 90,000 Americans including more than 1,000
children on the kidney transplant wait list, thank you for your efforts
to transform transplant care. American transplantation has grown
immensely over the past 40 years and must continue to evolve to meet
the needs of people with kidney diseases.
The American Society of Nephrology (ASN) believes the North star of the
entire transplant system should be to maximize access to kidney
transplants, which are the optimal therapy for kidney failure and which
improve patients' quality of life. As detailed below and published in
the Clinical Journal of the American Society of Nephrology, there are
five key changes that advocates and policymakers can take to achieve
this goal.
Thank you for your leadership and dedication to the millions of
Americans living with kidney diseases, especially to those who would
benefit from a kidney transplant. ASN's leaders, staff, and members
stand ready to assist in the implementation of these vital changes.
Sincerely,
Michelle A. Josephson, M.D., FASN
President
Transforming Transplant in the United States
Michelle A. Josephson, M.D., FASN and Rachel N. Meyer
Published ahead of print in the Clinical Journal of the American
Society of Nephrology: doi: https://doi.org/
10.2215/CJN.0000000000000271.
A recent Biden administration announcement, the Health Resources and
Services Administration (HRSA) Organ Procurement and Transplantation
Network (OPTN) Modernization Initiative--and bipartisan, bicameral
proposed legislation supporting it, the Securing the U.S. OPTN (SUS
OPTN) Act--aims to implement crucial reforms to help more patients
receive a transplant. It is imperative that nephrologists, transplant
professionals, patient advocates, and others collaborate to ensure
these efforts fulfill their potential and pursue other opportunities to
achieve the ultimate goal: maximizing patient access to kidney
transplantation. Too often, that access is treated as a scarce
resource, available to only a subset of the many people who could
benefit.
By focusing on five key changes, described below, advocates and
policymakers have a clear path to achieving that ultimate goal. The
initiative and the legislation are foundational steps implementing
needed reforms today--and enabling significant future advancements.
For most people with kidney failure, transplant is the optimal therapy.
It is also the most cost-effective therapy, less than half the cost of
dialysis. While 2022 saw a record number of kidney transplants, an
unacceptable 12 people die waiting for a kidney every day. People who
die on the wait list receive a median 16 kidney offers that are
declined, often without their knowledge.\1\ Twenty-six percent of
kidneys procured from deceased donors go unused, even though data show
patients would have benefitted from transplantation with many of those
non-used organs.\2\
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\1\ Husain, S.A., et al. ``Association Between Declined Offers of
Deceased Donor Kidney Allograft and Outcomes in Kidney Transplant
Candidates.'' JAMA Netw Open. 2019;2(8):e1910312.
doi:10.1001/jamanetworkopen.2019.10312.
\2\ Mohan, S., et al. ``Increasing Discards as an Unintended
Consequence of Recent Changes in United States Kidney Allocation
Policy.'' Kidney International Reports. February 2023. Vol. 8 Issue 5.
Stark and unacceptable disparities also persist in kidney
transplantation. As we work towards increasing transplantation, we must
ensure equitable access regardless of patients' race/ethnicity, sex/
gender, geography, and socioeconomic status. For example, Black
patients are less likely to receive a pre-emptive transplant referral
or complete the transplant evaluation. They are less likely to have a
living donor and more likely to receive lower quality kidneys.\3\
Americans who reside in rural areas are less likely to be wait-listed
or transplanted, while socioeconomically disadvantaged people face
similarly worse odds.\4\, \5\ Women are less likely to be
referred for transplant than men.\6\
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\3\ Purnell, T.S., et al. ``Association of Race and Ethnicity With
Live Donor Kidney Transplantation in the United States From 1995 to
2014.'' JAMA 319:1 Jan 2018.
\4\ Axelrod, D.A., et al. ``Rates of Solid-Organ Wait-listing,
Transplantation, and Survival Among Residents of Rural and Urban
Areas.'' JAMA. 2008;299(2):202-207. doi:10.1001/jama.
2007.50.
\5\ Axelrod, D.A., et al. ``The Interplay of Socioeconomic Status,
Distance to Center, and Interdonor Service Area Travel on Kidney
Transplant Access and Outcomes.'' CJASN 5(12):p 2276-2288, December
2010. DOI: 10.2215/CJN.04940610.
\6\ Smothers, L., et al. ``Gender Disparities in Kidney
Transplantation Referral Vary by Age and Race: A Multiregional Cohort
Study in the Southeast United States.'' Kidney International Reports
2022 Jun; 7(6): 1248-1257 doi: 10.1016/j.ekir.2022.03.027.
The initiative and legislation will contribute to changing these grim
realities, yet additional safety net efforts supporting underserved
populations--including transportation, post-transplant medication
access, and financial assistance--are also needed. Transplant
reimbursement often does not support best practices in, for example,
community education, patient recruitment, living donor support, and
post-transplant care--particularly for socioeconomically disadvantaged
populations. We must align incentives, financial and otherwise, in a
manner that allows all health professionals to make decisions that
maximize access for all patients regardless of insurance or income.\7\
---------------------------------------------------------------------------
\7\ Moe, S.M., Brennan, D.C., Doshi, M.D., Gaston, R.S., Gurley,
S.B., Mujtaba, M.A., Schmidt, R.J., Segal, M.S., Tucker, J.K., Wiseman,
A.C., Josephson, M.A. The Importance of Transplant Nephrology to a
Successful Kidney Transplant Program. Clin J Am Soc Nephrol. 17: 1403-
1406, 2022. CJN.02000222. doi: 10.2215/CJN.02000222.
Because the kidney transplant community has a rich history of leading
and embracing bold advancements, especially during the past decade, the
American Society of Nephrology (ASN) is optimistic about the future of
transplant policy. Stemming from recognition that the current system is
not optimally serving patients, the HRSA initiative and related
legislation build on work across the Obama, Trump, and Biden
Administrations and on a bipartisan, bicameral basis across many
Congresses. Informed by this history and bolstered by the HRSA
Modernization Initiative and the SUS OPTN Act, we can maximize access
to transplant and advance equity by focusing on at least five
---------------------------------------------------------------------------
objectives.
1. Expedite the clear government reforms necessary to maximize
access to transplant. Patients deserve a coordinated, system-wide
approach that allows all stakeholders to work towards maximizing
patients' access to transplant. By requiring OPTN and any OPTN
contractor(s) to have separate governing boards, the legislation
institutes good governance and increases accountability. Conflicting
government incentives must be aligned--such as ending OPTN's use of a
1-year outcome metric for transplant centers, even though the Centers
for Medicare and Medicaid Services (CMS) eliminated the metric because
it impeded patients' access to transplant.\8\ Ensuring patient safety
and graft survival is paramount but can be achieved while also making
transplant more accessible than current metrics allow. As with all
regulatory changes, the effects should continuously be monitored and
assessed, and updated as new evidence suggests future opportunities for
improvement. Policies that conflict with current science must also be
reformed--such as ending the use of race, a social construct, in the
algorithm that ranks and allocates kidneys, a step we commend OPTN for
now undertaking.\9\
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\8\ Chandraker, A., et al. ``Time for reform in transplant program-
specific reporting: AST/ASTS transplant metrics taskforce.'' AJT Vol.
19 Issue 7. https://doi.org/10.1111/ajt.15394.
\9\ Gill, J.S., Kelly, B., Tonelli, M. ``Time to Abolish Metrics
That Sustain Systemic Racism in Kidney Allocation.'' JAMA.
2023;329(11):879-880. doi:10.1001/jama.2023.1076.
2. Establish transparency to improve access to transplant and
reduce barriers in the kidney health ecosystem. Lack of transparency at
every step in the transplant process makes navigating it difficult,
exacerbating inequities and barriers. It is opaque to many patients and
their nephrologists which transplant centers might be willing to accept
them, and many cannot even ascertain whether they are wait-listed after
clearing the many hurdles to be evaluated. A nationwide, centralized
clearinghouse is needed to help patients match with a program with the
expertise to accept and actually transplant them. HRSA's commitment to
increased transparency and data-sharing should address these
---------------------------------------------------------------------------
challenges.
Transplantation generally confers a better, longer life
versus dialysis, but many who would benefit aren't wait-listed.
Nephrologists must embrace greater responsibility in
championing transplant as the optimal therapy for most of their
patients, supporting them during the early referral and
evaluation stages and beyond. CMS and HRSA need to collect and
share data about patients who are referred but never make it to
the wait list so researchers can better understand--and
advocates and policymakers can address--their barriers.\10\
This transparency is particularly crucial for groups with
disproportionate challenges to wait-listing, such as Black,
rural, and socioeconomically disadvantaged Americans.
Waitlisted patients also deserve transparency about decisions
made on their behalf: most are never notified when surgeons
decline kidneys for them, eliminating their voice in these
life-or-death decisions. Would 1 in 4 donated kidneys still go
unused if potential recipients were aware?
---------------------------------------------------------------------------
\10\ Patzer, R.E., et al. ``A Population Health Approach to
Transplant Access: Challenging the Status Quo.'' AJKD Feb. 2022. Vol 80
Issue 3. https://doi.org/10.1053/j.ajkd.2022.01.422.
3. Enable the use of more organs. More patients could receive
transplants if barriers to using deceased donor organs were removed,
and the myriad challenges people must overcome to become living donors
were mitigated. For example, regulations like the 1-year outcome metric
have pushed transplant centers to become risk-averse, aiming for
optimal results for a smaller pool of candidates with only the highest-
quality donor kidneys instead of maximizing patient access and
accepting more offered kidneys. Data show it is a mistake not to use
many of the kidneys that go unutilized.\11\ It is time for CMS and HRSA
to change policy to encourage transplant centers to say ``yes'' to more
offered kidneys, becoming accountable to patients' preferences over
short-sighted metrics. While using 100% of deceased donor kidneys is
not a realistic goal, we know we can better serve patients by using
more than just 74%.
---------------------------------------------------------------------------
\11\ Husain, S.A., et al. ``Characteristics and Performance of
Unilateral Kidney Transplants from Deceased Donors.'' Clin J Am Soc
Nephrol. 2018 Jan 6;13(1):118-127. doi: 10.2215/CJN.
06550617.
Congress should increase appropriations to support living
donors and base eligibility for those funds on donor--not
recipient--income. No living donor should have to pay to donate
their kidney, and the federal program that exists to support
this goal, the National Living Donor Assistance Center (NLDAC),
needs more support. HRSA, which oversees the program, should
ensure it covers all donation-related costs and allow more
donors to qualify. Recently, NLDAC eligibility increased from
---------------------------------------------------------------------------
300% to 350% of poverty level, a trend HRSA should continue.
4. Expand investment in transplant-related research and
innovation. While transplantation has saved thousands of lives,
transplant professionals and their patients largely rely on 40-year-old
therapies. Establishing a National Institutes of Health (NIH) National
Center for Kidney Health and Transplantation would centralize
transplant research in one focused place instead of spread across NIH,
creating efficiencies and ensuring a balanced portfolio across the
research continuum.
ASN is calling for the Centers for Medicare and Medicaid
Innovation to launch a transplant model, particularly aimed at
meeting patients' long-term needs instead of focusing on
shorter-term outcomes. Living donors also deserve more long-
term focus and support. By expanding the Living Donor
Collective, a national longitudinal living donor data
collection effort, we can narrow the gap between the number of
actual and potentially interested living donors and better meet
their needs.
5. Embrace modern technology to increase access to transplant.
Implementing a modern infrastructure for our transplant system is a
foundational step to improving transparency and efficiency and is a
focus of HRSA's Modernization Initiative. The legislation will enable
competition and new ways of thinking about improving the nation's
transplant system--particularly its IT system. For example, a
successful information technology (IT) system would make widespread use
of application programming interfaces to transfer of information across
electronic health records, healthcare systems, and the OPTN registry,
instead of relying on fax, phone, and email.
As with every element of these technology and other reforms,
the voices of patients and transplant and kidney health
professionals should lead the way shaping these initiatives and
ensuring they optimally serve patients.
At least 10 components within the Department of Health and Human
Services (HHS) have a role in kidney health. Today's redundant and
often contradictory agency rules impede a synergistic focus on meeting
patients' needs. A new Office of Kidney Health and Transplantation,
situated in the HHS Secretary's Office, could ensure all components
work in coordination towards maximizing access to transplantation.
Emphasizing the importance of patients' voices in policymaking, the
office would focus on collaborating with patients to ensure their
perspectives are central to any changes relating to the 37 million
Americans with kidney diseases.
As the world's largest organization of health professionals dedicated
to improving care for people living with kidney diseases, ASN's leaders
and members stand ready to collaborate with patients, other
nephrologists and transplant professionals, and Congress and the Biden
Administration--especially HHS, CMS, and HRSA--to transform transplant
in the United States, maximizing patients' access to the optimal
therapy and ensuring that access is equitable.
The authors would like to thank Scott Bieber, D.O.; Zachary Kribs;
Roslyn B. Mannon, M.D., FASN; and David L. White for their critical
thought partnership and work on this effort.
______
Association of Organ Procurement Organizations
8300 Greensboro Drive, #L1-620
McLean, VA 22102
AOPO Urges Congressional Action to Address Key Concerns in U.S. Organ
Transplant System Reform
On Thursday, July 20, 2023, the Senate Finance Committee (SFC)
Subcommittee on Health Care held a hearing,\1\ ``The Cost of Inaction
and the Urgent Need to Reform the U.S. Transplant System,'' which
addressed the organ donation and transplantation system. As the
national non-profit representing 48 Organ Procurement Organizations
(OPOs) across the U.S., the Association of Organ Procurement
Organizations (AOPO) stands firmly behind comprehensive reform
initiatives to enhance data accuracy, transparency, equity, and
alignment of stakeholder goals to save more lives. For the official
record, our objective is to offer valuable insights and clarity on the
current state of the U.S. organ donation and transplantation system and
recommend opportunities for growth.
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\1\ https://www.finance.senate.gov/hearings/the-cost-of-inaction-
and-the-urgent-need-to-reform-the-us-transplant-system.
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NASEM Report
In February 2022, the National Academies of Science, Engineering, and
Medicine (NASEM) released a report titled ``Realizing the Promise of
Equity in the Organ Transplantation System.''\2\ This report provides
data-driven recommendations for donor hospitals, OPOs, transplant
centers, federal policymakers, and the Organ Procurement and
Transplantation Network (OPTN) to advance the ``fairness, equity,
transparency, and cost-effectiveness in the system of procuring,
allocating, and distributed deceased donor organs.'' The NASEM report,
requested by Congress and sponsored by the National Institutes of
Health (NIH), serves as a valuable blueprint for driving productive
system reform. The SFC should leverage these insights to guide its
actions in promoting productive reform efforts.
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\2\ National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Health Care Services; Board on
Health Sciences Policy; Committee on A Fairer and More Equitable, Cost-
Effective, and Transparent System of Donor Organ Procurement,
Allocation, and Distribution; Hackmann, M., English, R.A., Kizer, K.W.,
editors. Realizing the Promise of Equity in the Organ Transplantation
System. Washington (DC): National Academies Press (US); 2022 Feb 25.
Summary. Available from: https://www.ncbi.nlm.nih.gov/books/NBK58
0019/.
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Organ Non-Utilization
As determined in the NASEM research, the non-utilization of organs
recovered by OPOs and declined by transplant centers poses a critical
challenge to the donation and transplantation system. In 2022, the non-
utilization rate reached a record high of 19%,\3\ resulting in
thousands of viable organs not transplanted.\4\ In comparison, the
organ non-utilization rate was 11% in 2002. This issue has increased
exponentially each year, resulting in missed opportunities to save
lives.
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\3\ https://aopo.org/50k-transplants/organ-utilization/.
\4\ Based on OPTN data as of February 28, 2023.
During the hearing, it was claimed that ``poor performance by OPOs and
UNOS'' are responsible for 1 in 4 kidneys not being transplanted. This
is false. Neither OPOs nor UNOS determines whether a recovered kidney
is used for transplantation. The responsibility of accepting an organ
offer and carrying out the kidney transplant lies with the transplant
center. Tragically, last year, 4,318 kidney patients on the national
wait list lost their lives while simultaneously, OPOs authorized,
recovered, and offered 7,548 kidneys to transplant centers that were
not accepted for use, many due to the outcome measure restrictions
placed on transplant centers.\5\ OPOs are recovering more organs than
transplant centers are accepting for transplantation.
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\5\ Based on OPTN data as of July 20, 2023.
Research reveals the U.S. non-utilization rate for procured organs is
nearly double the rate of other developed countries, such as France,
where 62% \6\ of kidneys declined in the U.S. would have been
successfully transplanted.\7\ Additionally, ``on average, patients who
die waiting for a kidney had offers for 16 \8\ kidneys that were
ultimately transplanted into other patients, indicating that many
transplant centers refuse viable kidney offers on behalf of those on
the waiting list.''\9\ These statistics highlight the severity of the
problem and demonstrate a huge oversight in the United States organ
donation and transplantation system.
---------------------------------------------------------------------------
\6\ https://pubmed.ncbi.nlm.nih.gov/31449299/.
\7\ Aubert, O., Reese, P.P., Audry, B., Bouatou, Y., Raynaud, M.,
Viglietti, D., Legendre, C., Glotz, D., Empana, J.P., Jouven, X.,
Lefaucheur, C., Jacquelinet, C., Loupy, A. Disparities in Acceptance of
Deceased Donor Kidneys Between the United States and France and
Estimated Effects of Increased US Acceptance. JAMA Intern Med. 2019 Oct
1;179(10):1365-1374. doi: 10.1001/jamainternmed.2019.2322. PMID:
31449299; PMCID: PMC6714020.
\8\ https://jamanetwork.com/journals/jamanetworkopen/fullarticle/
2749266.
\9\ Husain, S.A., King, K.L., Pastan, S., et al. Association
Between Declined Offers of Deceased Donor Kidney Allograft and Outcomes
in Kidney Transplant Candidates. JAMA Netw Open. 2019;2(8):e1910312.
doi:10.1001/jamanetworkopen.2019.10312.
Organ non-utilization leads to unnecessary deaths on the transplant
waiting list. It also impacts OPOs, which are evaluated based on
transplantation rates influenced by a multitude of factors outside of
the OPO's control, including proper use of organ acceptance filters,
unintended consequences of the allocation system, and organ acceptance
practices. AOPO urges the SFC to align performance metrics and
incentives for OPOs and transplant centers in order to promote the
increased use of organs, especially from older and medically complex
donors. This issue warrants urgent attention and examination to ensure
every available organ is successfully transplanted.
HRSA Modernization Initiative
AOPO supports the goals of the Health Resources and Services
Administration (HRSA) Modernization Initiative to strengthen
accountability and transparency in the OPTN with the goal of increasing
organ transplantation to serve patients. As Congress coordinates with
HRSA to advance its goals, AOPO suggests several recommendations.
As noted in our June 5, 2023, letter \10\ to the sponsors of the
Securing the U.S. Organ Procurement and Transplantation Network Act (S.
1668/H.R. 2544), AOPO supports enhancing the OPTN to better serve
patients, donors, and donor families. AOPO believes this legislation
allows HRSA ``to engage in a competitive process to award discreet OPTN
functions to multiple contractors and would also allow HRSA to award
contracts to for-profit entities for the first time.'' However,
``nothing in the bill text prevents a for-profit entity from taking on
the policymaking role, as the statute does not explicitly list
policymaking as the sole duty of the OPTN board.'' While Senator Wyden
stated during the hearing that the OPTN policymaking role would be
awarded to a nonprofit, AOPO emphasizes that such a decision is not
codified in the legislation and, as a result, cannot be assured.
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\10\ https://aopo.org/wp-content/uploads/AOPO-Letter-to-Senate-
Finance-Committee-on-OPTN-Bill-6-5-2023.pdf.
Stakeholder engagement and input are critical to improving organ
donation and transplantation and should not be driven by profit.
Donation relies on public trust, and introducing for-profit entities
could damage the public's perception, negatively impacting individuals'
decisions to authorize donation for themselves or family members. AOPO
strongly recommends Congress ensure the policymaking component of the
OPTN is overseen by a non-profit entity with proven experience in
complex operations, as it's critical to ensure improvements in the
organ donation and transplantation process are driven by fairness,
equity, and sound medical principles without regard for making a
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profit.
Furthermore, AOPO recommends the OPTN Board's policy committees reflect
diversity in race, ethnicity, ability, profession, and gender. As
stated in our July 19, 2023, letter to HRSA, ``changes to the Board of
Directors and policy bodies of OPTN should better reflect the entire
organ donation and transplantation system to further a patient-centric
approach.'' The NASEM report supports this recommendation, advocating
for an intensive, consensus-based, multi-stakeholder policy development
process that would increase collaboration. AOPO agrees that developing
a more expedient and responsive policymaking process with greater
representation on the OPTN Boards and Committees would significantly
improve the OPTN contract.
Lastly, the implementation of changes should be conducted in a stepwise
manner, through collaboration with key stakeholders to address process
changes and establish clear timelines. The organ donation and
transplantation system is presently undergoing numerous reforms, and it
is essential that HRSA's advancements of the OPTN align with the
Centers for Medicare & Medicaid Services (CMS) changes. AOPO urges the
SFC to advocate for an integrated approach that mitigates the risk of
destabilizing the system and compromising quality patient care.
CMS OPO Performance Metrics
AOPO has voiced concerns regarding the CMS metrics and their ability to
accurately evaluate OPO performance. Despite having one of the world's
leading donation and transplantation systems, with notable advancements
in deceased organ donation rates, organs recovered and made available
for transplant, as well as successful transplantations, it is
concerning that a record number of OPOs (42%) are disproportionately
ranked in the lowest performance category, according to the latest
released data.\11\
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\11\ https://www.cms.gov/files/document/opo-annual-public-
performance-report-2023.pdf.
This raises alarm, as these OPOs are at risk of automatic
decertification with no opportunity for remediation under the new CMS
regulations effective in 2026. The data reveals highly fluctuating OPO
Tiers, with some OPOs experiencing significant shifts within a single
year. For example, the OPO serving Hawaii transitioned from Tier 3 in
2019 to one of the highest-performing OPOs in Tier 1 in 2020, only to
fall back to Tier 3 in 2021. The Maryland OPO, Infinite Legacy, which
Senator Cardin referenced in his opening statement, has been ranked in
each of the three tiers over the same 3-year period. Such inconsistent
performance findings have left the community concerned about potential
implications for the system's integrity and the quality of support
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provided to donor families and transplant patients in the future.
Furthermore, CMS has not provided any guidance regarding the transition
of OPO donation service areas after Tier 3 OPO decertification occurs,
leaving OPOs without the necessary details to prepare for future
operations and to mitigate disruptions to the system. Additionally, the
majority of Tier 1 OPOs come from smaller geographical areas,
emphasizing the need for meticulous planning to ensure a successful
transition with minimal interference in larger service areas. Despite
consistent efforts to seek clarification on these issues and more from
CMS, including raising our concerns in a letter \12\ to the SFC, AOPO
has received no response to the following pending questions:
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\12\ https://aopo.org/wp-content/uploads/AOPO-Letter-to-Senate-
Finance-Committee-4-18-2023.pdf.
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I. Selecting OPOs
Will CMS consider risk corridors for OPOs in which a small
number of organs (i.e., less than five or ten) would have made a
material difference in their tier?
What criteria will CMS consider when selecting an OPO to take
over a Tier 2 or 3 DSA?
Will CMS use the same or different criteria when deciding
whether a Tier 2 OPO can retain its own DSA?
How, if at all, will recent improvement be taken into account
when determining whether a Tier 2 OPO is allowed to retain its DSA?
How will the letter ranking system be used in the decision-
making process? For example, will a Tier 2 A OPO have a higher
likelihood of retaining their DSA over a Tier 2 C OPO?
In considering whether to allow a Tier 2 OPO to retain its DSA,
will CMS consider whether the potential for long-term gains would
outweigh inevitable disruptions in continuity of care, long-standing
relationships with local hospitals, as well as the current OPO's
potential and plans for future improvement?
Will there be an opportunity to appeal Tier 2 decisions?
What factors will CMS consider when selecting a new OPO? Having
a DSA of similar population demographics, urban versus rural
environment, and payer mix?
What will CMS do if there is a situation in which no OPO is
interested in taking over a particular decertified OPO's DSA?
How long will the bidding process last?
II. Merging DSAs
In the past, CMS has required that OPOs merge completely or
retain separate staffing and operational structures. However, CMS
states in the rule that the regulations ``do not require that DSAs
merge when a new OPO takes over . . . OPOs could merge, or service
areas could be merged . . . since DSAs are not required to merge, one
OPO could run several DSAs.'' Will CMS generally approve DSA mergers if
requested by an OPO? Or will the agency establish certain criteria or
consider specific variables?
If the latter, what types of variables will be considered when
deciding to allow OPOs to merge DSAs? Will it be the size of the DSA?
Whether the two regions are contiguous? The number of hospitals within
a DSA?
Will CMS evaluate OPO mergers proposed before the 2026
recertification cycle differently than those after?
When a new OPO wins a bid to take over a DSA, what types of
ownership structures would CMS approve?
Note: There are various potential structures, including (but
not limited to) separate governing bodies and staffing with
separate DSAs under a parent organization, merging into a
single OPO with single governance and staffing but multiple
DSAs, or combining OPOs and DSAs. We would appreciate more
guidance on what type of structures CMS would allow (or prefer)
and how documentation requirements may vary depending on the
proposed organizational structure of the merger. Due to a range
of factors that make each DSA unique, we encourage CMS to allow
a sufficient degree of flexibility so OPOs can make a decision
that is best suited for the circumstances of the DSA and donors
and patients served. We also note that it is important to
leverage the benefits of possible mergers, including
efficiencies of scale and scaling successful cultural and
operational strategies of the high-performing OPO to promote
greater efficiency while ensuring a seamless transition that
maintains important relationships with transplant and donor
hospital partners and avoids potential workflow disruptions
that could jeopardize lives.
Will there be a certain timeframe within the decertification
cycle when mergers must occur?
After a winning OPO candidate is selected, how long will the
OPOs have to take over the operations and DSA of the decertified OPO?
Will there be a defined transition period, or will it depend on the
circumstances of each merger (which AOPO recommends)?
Note: We appreciate that CMS notes in the rule that: ``careful
planning and implementation of OPO de-certifications and OPO
DSA competitions could ease such transitions'' and urge the
Agency to both allow sufficient time and work with both OPOs to
agree on a mutually agreeable, reasonable transition timeline
that considers the unique circumstances of that particular DSA
and OPO and prioritizes minimizing service disruptions.
Selecting an appropriate transitional period will depend on
when the applicant assumes control of the DSA and the
operational and demographic considerations of each OPO and DSA.
For instance, merging two DSAs under a single OPO
organizational structure will conceivably take longer than if
an OPO seeks to run a new DSA as a separate and distinct
division maintaining the existing infrastructure of the OPO.
Successful consolidation of this magnitude requires significant
planning and implementation of management, cultural, staffing,
and workflow changes, as well as likely could require approval
by the state's Attorney General or other state agencies
considering the charitable nonprofit corporate status of OPOs.
Altogether, this typically entails a multi-year process. A
thorough and well-planned integration is critical to long-term
success.
III. Implications for Future Certification Cycles
Given certification currently occurs at the OPO level, will CMS
evaluate recertification differently moving forward to accommodate
scenarios where a single OPO is responsible for multiple separate DSAs?
Will performance metrics used for recertification be calculated at the
OPO or the DSA level?
If a merger occurred during or after the reporting year, will
the OPOs and/or the DSAs be evaluated separately or jointly for
purposes of recertification?
If a single OPO manages multiple DSAs and one falls into Tier 2
or 3 for one of the DSAs, will this negatively impact the OPO's ability
to maintain its other existing DSAs, or to take on new DSAs in the
future? Will CMS consider offering certain time-limited protections to
encourage successful OPOs to compete for DSAs of OPOs that have not
performed as well?
If an OPO is recertified for one DSA and decertified for
another, could the OPO compete for tier 2 or tier 3 OPOs?
CMS states in the rule that ``if an OPO takes over another OPO's
DSA on a date later than January 1 of the first year of the agreement
cycle so that 12 months of data are not available to evaluate the OPO's
performance in its new DSA, we will hold the OPO accountable for its
performance on the outcome measures in the new area once 12 months of
data are available.'' Does this mean that OPO would be evaluated on a
different 12 months of data than all other OPOs? Could these 12 months
span multiple calendar years?
CMS notes in the rule that ``it would be our preference not to
merge DSAs so that we can properly assess whether the new OPO is
improving performance in each DSA.'' Is there a certain minimum number
of DSAs that CMS wants to preserve in order to ensure an ``adequately
diversified'' market?
Has CMS considered how the number of DSAs may impact median and
upper quartile calculations for purposes of delineating tiers?
CMS states in the rule that for purposes of distinguishing
between tiers, ``the percentiles are calculated based on the number of
OPOs in the year prior to the reporting year.'' How will the number of
mergers in the year between assessment calculation and the
decertification year affect tier assignment?
IV. Data Collection and Transparency
Will the Scientific Registry of Transplant Recipients (SRTR) be
validating CMS' calculations? AOPO believes this would be an important
way to help ensure transparency in the process and get buy-in from
OPOs.
Will CMS share the donor potential of all OPOs broken down by
DSA or county level? This would greatly streamline the process of
having to make individual requests to the Centers for Disease Control
(CDC) for raw data.
Urgent action from policymakers and federal regulators is imperative to
address these concerns promptly and provide an implementation plan to
safeguard the highly successful U.S. organ donation and transplantation
system, ensuring patient lives are not compromised.
Pancreas for Research
The inclusion of pancreata allocated to research in an OPO's donation
rate and performance evaluation has raised concerns. AOPO previously
expressed apprehension to CMS during the initial rulemaking process,
highlighting the potential for skewed comparisons and inaccurate
conclusions resulting from this inclusion. Despite the ongoing
uncertainty surrounding this issue, OPOs have diligently complied with
the adopted rule. OPOs actively recover pancreas for transplantation
purposes and explore research options when an organ cannot be placed
with a recipient, ensuring the gift is honored, and supporting research
and innovation in the field to increase organs for transplant.
Meeting the research demand for pancreata is essential for studying
human islet cells, which play a vital role in expanding scientific
knowledge and developing effective treatments for patients with
diabetes. Progress in this field has the potential to reduce the number
of patients requiring pancreas transplants. AOPO urges policymakers to
closely monitor this matter to ensure a fair assessment of OPOs'
lifesaving capabilities in organ donation and transplantation.
Opioid Epidemic
The research frequently referenced in discussions about the impact of
the opioid epidemic on donation rates, as cited by witnesses and
legislators at the SFC hearing, is flawed. The study design states,
``we hierarchically created four categories: (a) donor's mechanism of
death coded as ``drug intoxication'' by the OPO; or donor coded as
another mechanism of death but his/her history noted (b) intravenous
drug use, (c) non-intravenous drug use (e.g., snorting), or (d) no drug
use. The first three categories were grouped as ``drug-related.''\13\
Consequently, the estimates within the study include individuals who
died of causes unrelated to drug use but may, at some point in their
lives, have used drugs, leading to an overestimation of drug-related
deaths that resulted in organ donation.
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\13\ Goldberg, D., Lynch, R. Improvements in organ donation: Riding
the coattails of a national tragedy. Clin Transplant. 2020 Jan;34
(1):e13755. doi: 10.1111/ctr.13755. Epub 2019 Dec 2. PMID: 31742783.
Furthermore, while the opioid epidemic is often credited as the primary
reason for the increase in organ donation and transplantation in the
U.S., it is essential to recognize that drug-related deaths contribute
to only a small fraction of total organ donors. Over the last five
years, deceased organ donation has seen a remarkable 39% \14\
increase.\15\ While drug intoxication deaths account for 6% of this
rise, a substantial 33% can be attributed to other advancements in the
system, including OPO process improvements and procurement techniques
such as the implementation and expansion of donation after circulatory
determination of death (DCDD).
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\14\ https://aopo.org/wp-content/uploads/2023-AOPO-US-Donation-
Highlights-Infographic.pdf.
\15\ Based on OPTN data as of January 18, 2023.
It is also important to highlight that the causes of death can vary
from year to year. Nevertheless, it remains the responsibility of the
OPO to respond to all potential organ referrals, regardless of the
cause of death, and diligently work to recover organs for lifesaving
transplantation. Deceased organ donation is always the result of a
traumatic event in which an individual dies in a hospital while on a
ventilator. Potential organ donors must also meet medical criteria and
be authorized, either as registered donors or through family
authorization, for the organ donation to move forward. OPOs are
involved in every step of this process and pursue all opportunities for
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donation to occur.
AOPO is concerned about the dissemination of misinformation surrounding
the true impact of the opioid epidemic on the success of the organ
donation and transplantation system. While opioid-related donations
play a role, the significant increase in organ donors can be attributed
to various factors and improvements, emphasizing the critical efforts
of OPOs in saving lives through transplantation. AOPO strongly urges
the SFC to consult with experts in the field, including the Scientific
Registry of Transplant Recipients (SRTR), to validate and confirm
research findings, ensuring the highest standards of accuracy in the
information presented in congressional hearings and used as evidence
for legislative and regulatory decisions on system reform.
Conclusion
AOPO appreciates the opportunity to provide our comments for the
hearing record. However, we are frustrated that despite repeatedly
sharing our concerns with Congress and CMS, AOPO and its members have
not been solicited for input, which is based on extensive knowledge of
the nation's OPO system and of OPO professionals with decades of
experience in the field. We urge the SFC to broaden its examination of
the system by actively engaging all stakeholders in advancing reform
efforts. This collaborative approach will serve donors, donor families,
and potential recipients who rely on the collective dedication of all
entities involved in the organ donation and transplantation process.
______
Center for Fiscal Equity
14448 Parkvale Road, Suite 6
Rockville, MD 20853
[email protected]
Statement of Michael Bindner
Chairman Wyden and Ranking Member Crapo, thank you for the opportunity
to address this issue. I made comments on A System in Need of Repair:
Addressing Organizational Failures of the U.S.'s Organ Procurement and
Transplantation Network in August of 2022, which I am resubmitting to
keep on the record. While the need is urgent, the solution will take
time. As we used to say on the Air Staff, if you want it bad, you get
it bad.
Other than its impact on Medicare and affordable care, we are leery of
any congressional involvement in this issue. Ideally, it is based on
science and best regulated by medical professionals. Even without
intervention, putting pressure on the system is ill-advised. With
political pressure often comes pressure from donors. The beauty of the
current process is that the ability to pay is not part of it. Of
course, if there are abuses on this front in the current system, they
should be looked into and dealt with by the Congress and this
Committee.
Even with the best of motives, adjusting the process (even if flawed)
does not resolve the issues facing organ transplantation. There are
simply not enough organ donors and the system, which relies on
voluntary donation for its legitimacy, would not be helped with
economic incentives--especially as these would be more attractive to
the poor. This borders on abuse. Not only do we exploit them in life,
incentives would continue this exploitation in death.
Ultimately, the solution is better science. This is where government
involvement can help and where issues of fiscal equity come in. Any
treatment must be provided to all, regardless of the ability to pay.
While the private sector may be helpful in developing treatments,
government funded research would help the process and assure equity.
A promising solution is the use of retargeted stem cells, either grown
on cartilage or injected into the sick organ. Both would render
donation and its possibility of rejection to the realm of temporary
solutions, as would artificial organs.
Research in this process can always be sped up with more government
money for NIH. To make sure everyone can benefit from advancements,
such as using 3D printing to create cartilage on which to grow stem
cells both outside and inside the body, research and actual organ
generation can be publicly funded. Public organ manufacture, because of
its expense in every case, is likely better than relying on for profit
medicine.
As we have stated before, most recently in March of this year, but also
in 2019 and 2020, orphan drug research and manufacture should be owned
and managed by the federal government. The same path can be taken for
the development of cloned organs. If the government owned the process,
profiteering would be minimized. To facilitate cooperation and speed
the process, creation of a quasi-governmental enterprise would be
useful. It would combine NIH, NSF, FDA. To repeat our previous comments
on drug pricing:
``A main problem with high cost drugs, especially orphan drugs, is the
high development costs and the cost of small batch manufacturing. This
could drive the need to raise drug prices for mature drugs in order to
subsidize the orphans, although some hikes are undertaken because no
one can stop them. The solution for this is for NIH and the FDA to own
the rights to orphan drugs and to contract out research and development
costs as it does basic research, as well as testing and production.
``Hospitals and doctors would still make reasonable profit, but the
government would eat the risk and sometimes reap the rewards. NIH/FDA
might even break even in the long term, especially if large volume
drugs which were developed with government grants must pay back a share
of basic research costs and the attached profits, as well as regulatory
cost.''
Another way to assure equity in the growth and distribution of cloned
organs, health care reform is essential. Again, to repeat our comments
from March:
``Universal coverage, starting with a public option under the
Affordable Care Act, with eventual evolution to some type of single-
payer system is inevitable. Unless we start building negotiation into
the system now, we will give the drug companies a reason to oppose
reform later.
``A public option will only pass if pre-existing condition reforms are
abolished with public option enrollment being automatic upon rejection.
The public option must be subsidized, replacing Medicaid for the
disabled and those not requiring long-term nursing care. Long-term care
should be removed from states and replaced with a new federal Medicare
Part E.
``The profit motive, with the need to constantly increase profits to
attract Wall Street investment or keep stock prices growing, will lead
to an ever increasing number of people who will be considered
uninsurable, thus relying on the public option.
``Most healthcare systems will provide services to both comprehensive
insurance beneficiaries, the retired, the disabled and those with the
public option. In other words, Medicare for All is our future, with the
only exception being firms abandoning the system and providing their
own doctors while making arrangements with local hospitals and
specialists--essentially creating local HMOs.
``The major issue here is funding, although more efficiency will reduce
prices. Costs are already minimized by the for-profit and by
governmental medical care (which often uses for profit networks). To
repeat, with a shout THE ISSUE IS PRICE, NOT COST!''
Thank you again for the opportunity to add our comments to the debate.
Please contact us if we can be of any assistance or contribute direct
testimony.
Attachment One--Hearing on Pathways to Universal Health Coverage, June
12, 2019
There are three methods to get to single-payer: a public option,
Medicare for All and single-payer with an option for cooperative
employers.
The first to set up a public option and end protections for pre-
existing conditions and mandates. The public option would then cover
all families who are rejected for either pre-existing conditions or the
inability to pay. In essence, this is an expansion of Medicaid to
everyone with a pre-existing condition. As such, it would be funded
through increased taxation, which will be addressed below. A variation
is the expansion of the Uniformed Public Health Service to treat such
individuals and their families.
The public option is inherently unstable over the long term. The profit
motive will ultimately make the exclusion pool grow until private
insurance would no longer be justified, leading-again to Single Payer
if the race to cut customers leads to no one left in private insurance
who is actually sick. This eventually becomes Medicare for All, but
with easier passage and sudden adoption as private health plans are
either banned or become bankrupt. Single-payer would then be what
occurs when
The second option is Medicare for All, which I described in an
attachment to June 18th and 19th's comments and previously in hearings
held May 8, 2019 (Finance) and May 8, 2018 (Ways and Means). Medicare
for All is essentially Medicaid for All without the smell of welfare
and with providers reimbursed at Medicare levels, with the difference
funded by tax revenue.
Medicare for All is a really good slogan, at least to mobilize the
base. One would think it would attract the support of even the Tea
Partiers who held up signs saying, ``don't let the government touch my
Medicare!'' Alas, it has not. This has been a conversation on the left
and it has not gotten beyond shouting slogans either. We need to decide
what we want and whether it really is Medicare for All. If we want to
go to any doctor we wish, pay nothing and have no premiums, then that
is not Medicare.
There are essentially two Medicares, a high option and a low one. One
option has Part A at no cost (funded by the Hospital Insurance Payroll
Tax and part of Obamacare's high unearned income tax as well as the
general fund), Medicare Part B, with a 20% copay and a $135 per month
premium and Medicare Part D, which has both premiums and copays and is
run through private providers. Parts A and B also are contracted out to
insurance companies for case management. Much of this is now managed
care, as is Medicare Advantage (Part C).
Medicaid lingers in the background and the foreground. It covers the
disabled in their first two years (and probably while they are seeking
disability and unable to work). It covers non-workers and the working
poor (who are too poor for Obamacare) and it covers seniors and the
disabled who are confined to a long-term care facility and who have run
out their assets. It also has the long-term portion which should be
federalized, but for the poor, it takes the form of an HMO, but with no
premiums and zero copays.
Obamacare has premiums with income-based supports (one of those facts
the Republicans hate) and copays. It may have a high option, like the
Federal Employee Health Benefits Program (which also covers Congress)
on which it is modeled, a standard option that puts you into an HMO.
The HMO drug copays for Obamacare are higher than for Medicare Part C,
but the office visit prices are exactly the same.
What does it mean, then, to want Medicare for All? If it means we want
everyone who can afford it to get Medicare Advantage Coverage, we
already have that. It is Obamacare. The reality is that Senator Sanders
wants to reduce Medicare copays and premiums to Medicaid levels and
then slowly reduce eligibility levels until everyone is covered. Of
course, this will still likely give us HMO coverage for everyone except
the very rich, unless he adds a high-option PPO or reimbursable plan.
Either Medicare for All or a real single payer would require a very
large payroll tax (and would eliminate the HI tax) or an employer paid
subtraction value-added tax (so it would not appear on receipts nor
would it be zero rated at the border, since there would be no evading
it), which we discuss below, because the Health Care Reform debate is
ultimately a tax reform debate. Too much money is at stake for it to be
otherwise, although we may do just as well to call Obamacare Medicare
for All and leave it alone.
The third option is an exclusion for employers, especially employee-
owned and cooperative firms, who provide medical care directly to their
employees without third-party insurance, with the employer making HMO-
like arrangements with local hospitals and medical practices for
inpatient and specialist care.
Employer-based taxes, such as a subtraction VAT or payroll tax, will
provide an incentive to avoid these taxes by providing such care.
Employers who fund catastrophic care or operate nursing care facilities
would get an even higher benefit, with the proviso that any care so
provided be superior to the care available through Medicaid or Medicare
for All. Making employers responsible for most costs and for all cost
savings allows them to use some market power to get lower rates.
This proposal is probably the most promising way to arrest health care
costs from their current upward spiral--as employers who would be
financially responsible for this care through taxes would have a real
incentive to limit spending in a way that individual taxpayers simply
do not have the means or incentive to exercise. The employee ownership
must ultimately expand to most of the economy as an alternative to
capitalism, which is also unstable as income concentration becomes
obvious to all.
Attachment Two--Tax Reform, Center for Fiscal Equity, December 7, 2021
Subtraction Value-Added Tax (S-VAT). These are employer paid Net
Business Receipts Taxes. S-VAT is a vehicle for tax benefits, including
Health insurance or direct care, including veterans' health care
for non-
battlefield injuries and long-term care.
Employer-paid educational costs in lieu of taxes are provided as
either
employee-directed contributions to the public or private unionized
school of their choice or direct tuition payments for employee children
or for workers (including ESL and remedial skills). Wages will be paid
to students to meet opportunity costs.
Most importantly, a refundable child tax credit at median income
levels (with inflation adjustments) distributed with pay.
Subsistence-level benefits force the poor into servile labor. Wages and
benefits must be high enough to provide justice and human dignity. This
allows the ending of state administered subsidy programs and
discourages abortions, and as such enactment must be scored as a must
pass in voting rankings by pro-life organizations (and feminist
organizations as well). To assure child subsidies are distributed, S-
VAT will not be border adjustable.
The S-VAT is also used for personal accounts in Social Security,
provided that these accounts are insured through an insurance fund for
all such accounts, that accounts go toward employee ownership rather
than for a subsidy for the investment industry. Both employers and
employees must consent to a shift to these accounts, which will occur
if corporate democracy in existing ESOPs is given a thorough test. So
far it has not. S-VAT funded retirement accounts will be equal-dollar
credited for every worker. They also have the advantage of drawing on
both payroll and profit, making it less regressive.
A multi-tier S-VAT could replace income surtaxes in the same range.
Some will use corporations to avoid these taxes, but that corporation
would then pay all invoice and subtraction VAT payments (which would
distribute tax benefits. Distributions from such corporations will be
considered salary, not dividends.
Tax Reform Summary
1. Employers distribute the child tax credit with wages as an offset
to their quarterly tax filing (ending annual filings).
2. Employers collect and pay lower-tier income taxes, starting at
$100,000 at 7.2%, with an increase to 14.4% for all salary payments
over $150,000 going up 7.2% for every $50,000--up to $250,000.
3. Shift payment of HI, DI, SM (ACA) payroll taxes to employers,
remove caps on employer payroll taxes and credit them to workers on an
equal dollar basis.
4. Employer paid taxes could as easily be called a subtraction VAT,
abolishing corporate income taxes. These should not be zero rated at
the border.
5. Expand current state/federal intergovernmental subtraction VAT to a
full GST with limited exclusions (food would be taxed) and add a
federal portion, which would also be collected by the states. Make
these taxes zero rated at the border. Rate should be 19.5% and replace
employer OASI contributions. Credit workers on an equal dollar basis.
______
Letter Submitted by Adam Frank, M.D.
To whom it may concern:
I think all professionals in the transplant space will obviously concur
that whatever can be done to reasonably improve transplant access and
outcomes should be done. However, the characterization of UNOS and the
OPTN as a ``monopoly,'' a ``cartel,'' or ``the fox guarding the hen
house'' is completely inaccurate and is a starting premise which will
likely cause great harm to patients desperately awaiting transplant.
Although the current system has major problems, including an increase
in wastage of transplantable organs, the infrastructure it has provided
has saved nearly a million American lives. I have worked in the
transplant space for 23 years and have served on the OPTN board of
directors recently. In all of that time, I have never encountered a
single UNOS employee who is not a dedicated professional who
prioritizes what is best for the patients served by United States
transplant system. The current increase in wasted transplantable organs
is a complex problem that does not have one simple quick fix. The
senators running the July 20th, 2023, quickly made it clear that they
are not truly looking for solutions, but rather are looking to blame.
They will not find the answers through this type of inquiry. They
should be wise enough to realize this. Their slanderous
characterization of UNOS and professionals employed in that
organization does the country a disservice. The senators should realize
that not ever urgent problem has an obvious ``villain.'' This is one of
those cases.
Sincerely,
Adam Frank, M.D.
Letter Submitted by the Family of Mary Ann Hollis
U.S. Senate
Committee on Finance
Subcommittee on Health Care
Honorable Chairman Benjamin L. Cardin
221 Dirksen Senate Office Building
Washington, DC 20510
RE: Failure of the US Transplant System regarding Mary Ann Hollis of
Imperial, Missouri
Dear Chairman Cardin and Subcommittee Members,
On October 30, 2022, wife, mother, and mother-in-law Mary Ann Hollis
received a liver and kidney transplant at Barnes Hospital (BJC) in St.
Louis, Missouri. On Page 1021 of the over 10,500 pages of BJC notes, it
is admitted that the donor liver given to Mary contained cancer cells.
The family was told the same donor, from which Mary also received her
new kidney, also had prostate, bile duct, and gall bladder cancer. We
strongly believe the donated kidney was also compromised prior to
transplantation. The compromised kidney later required surgical
procedures, including a nephrostomy bag. We still have not been told by
BJC from which U.S. Organ Procurement Organization (OPO) these organs
were harvested for transfer to Barnes. BJC discovered the cancer cells
via pathology two days post-transplant. She was again placed on a liver
transplant list and, on November 8, 2022, received a second liver
transplant. This second liver transplant, which should not have been
necessary, took a drastic toll on Mary's quality-of-life. For three
weeks post-
transplant, she suffered delirium and hallucinations due to her body
receiving a second transplant within a 10-day time span. Therefore,
Mary had three livers in her body within 10 days. By the time of the
second liver transplant, we believe the cancer had rapidly began
metastasizing in her immunosuppressed body via antirejection
medications. Another question is why Mary wasn't also given a second
new kidney given the fact that it was known that the donor's liver
contained cancer cells.
Following numerous exploratory procedures on her weakened body, for
which she was frequently placed NPO, and the contraction of biological
and fungal infections, the donor kidney began to fail. BJC Nephrology
attempted to place a stent in her donated kidney twice but incurred an
undefined blockage/masses about which we were never told the nature.
Soon after, they inserted a nephrostomy tube. We lost Mary on January
13, 2023--approximately 2.5 months post-transplant--NOT from the
rejection of the donated organs but from the negligence of the
harvesting OPO, the lack of OPO oversight by the United Network for
Organ Sharing (UNOS), and by BJC for not discovering the cancer cells
pre-transplant. Mary passed all pre-transplant testing during September
and October 2022, during which time she was both cancer and infection
free. One, or all entities involved are negligent by not providing
cancer-free organ(s) for Mary.
Ironically, the causes of death listed on her death certificate do not
list cancer as a cause of death; however, cancer cells were found via
thoracentesis three days before her death. We strongly believe the
donated kidney also contained cancer cells OR the introduced liver
cancer spread rapidly to her other organs. That cause of death is
listed as ``Acute Renal Failure.'' We also believe the uncontrolled
cancer had spread into her GI tract. Mary developed a gastrointestinal
blockage in her lower right abdominal quadrant of which nature we were
never informed. As a result, Mary couldn't process her tube feeding
properly and was also subjected to an NG vacuum pump to remove excess
gastric juices. That eventually began removing her tube nourishment.
Mary then began receiving IV nourishment for 10 days prior to her
admission to the ICU. Through the many procedures, transfusions, and
unsterilized conditions surrounding her central line access, Mary
contracted and also passed from ``Necrotizing Soft Tissue Infection''
from the biological and fungal infections in her bloodstream. None of
this would have occurred had the original organs been disease-free.
Our family is seeking legal counsel to find justice for Mary's untimely
and certainly unfortunate, unnecessary death; however, we're having
difficulty finding any firm willing to accept Mary's case. This, in and
of itself, is a travesty for justice for Mary. She was never able to
meet her new step-grandchildren and step-great grandchildren, and had
also suffered the recent loss of her youngest daughter. Mary had been
purchasing gardening materials for use this year once she became strong
enough post-transplant. Mary looked forward to eating healthily again.
She had been purchasing new clothes, looking forward to the day she
could come home and be with her family and pets. Sadly, these things
will now never occur. Her husband and high school sweetheart for over
50 years prayed by her bedside daily that she would return home healthy
and happy. He now sits alone wondering what could and should have been.
It's very sad that so much obvious negligence occurred surrounding
Mary's case. Please ensure the U.S. Transplant System in place is
completely overhauled. We simply want justice on Mary's behalf and to
ensure that this extremely unfortunate situation doesn't occur ever
again to any other family. Our question is who else received this
donor's other organs? We pray the recipients and their families aren't
suffering the same consequences as Mary's.
Each of us in Mary's family would cherish the opportunity to tell her
story to each committee member, either via phone, Zoom, or in-person.
Thank you for your time and dedicated commitment to the rapid
improvement of our Nation's organ transplant system.
Sincerely,
The Family of Mary Ann Hollis
Keith Hollis, Husband
Heather Hollis Knuckles, Daughter
Steven Knuckles, Son-in-Law
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
January 13, 2023--Three hours prior to Mary Hollis' death soon
after life support was removed via her Living Will wishes. This is
Mary's daughter, Heather, placing her mother's hand over her heart.
This is the last time she would see her mother alive. Heather misses
her greatly and continues receiving weekly grief counseling.
______
Letter Submitted by Patrick McGlone
U.S. Senate
Committee on Finance
Subcommittee on Health Care
July 20, 2023
Dear Subcommittee Chair Cardin, Ranking Member Daines and all other
members of the Finance Committee's Subcommittee on Health Care,
Thank you for your efforts to improve organ donation and
transplantation.
My name is Patrick McGlone. I am a kidney and pancreas transplant
recipient and I write to you on behalf of over 5,000 individuals across
the nation who have come together in a petition to oppose the potential
introduction of for-profit companies to the U.S. organ donation and
transplant system. Our petition grows with every minute and can be
viewed at https://sign.moveon.org/p/dont-profit-off-organs.
As a representative of our petition, I sent a letter to you as well as
other members of Congress, explaining our concerns regarding bills S.
1668 and H.R. 2544, which would modify the Public Health Service Act in
ways that would allow for-profit companies to receive contracts to
operate the Organ Procurement and Transplantation Network (OPTN). That
letter is enclosed further below, and I urge you to please read it.
Regular changes and reforms are essential to maintaining the
effectiveness of the OPTN. However, any such reform must be carefully
examined for any intended or unintended consequences it would have on
our nation's transplant patients, organ donors and their families. We
fear that allowing for-profit companies to influence or guide OPTN
responsibilities such as organ matching or policymaking would be a
disaster for these people. For-profit companies are designed to make
decisions based on what will maximize their revenue and market share,
which is a mindset that has no place in a system designed to save
patients in need no matter their wealth or backgrounds. Simply put:
those two goals cannot coexist.
Thank you again for your time and attention to this urgent matter. As
you work to reform the OPTN, we ask that you consider the voices of the
thousands of petitioners who have spoken out in concern and prioritize
human lives above all else.
Sincerely,
Patrick McGlone
Kidney and pancreas recipient (June 2021)
Petition to Stop For-Profit Takeover of Organ Donation
______
July 19, 2023
Senator Bernie Sanders
332 Dirksen Senate Office Building
Washington, DC 20510
Representative Cathy McMorris Rodgers
2188 Rayburn House Office Building
Washington, DC 20515
Senator Ron Wyden
221 Dirksen Senate Office Building
Washington, DC 20510
Subject: Please Protect America's Patients by Keeping Profits Out of
Organ Donation and Transplant
Dear members of Congress,
I write to you as one of the thousands of individuals who have come
together to express our deep apprehension towards legislation that
threatens our nation's organ donors and transplant patients.
As patients, donor families, volunteers and concerned citizens, we ask
you to carefully consider the consequences that would occur should S.
1668 \1\/H.R. 2544 \2\ be passed by Congress.
---------------------------------------------------------------------------
\1\ https://www.congress.gov/bill/118th-congress/senate-bill/1668/
text.
\2\ https://www.congress.gov/bill/118th-congress/house-bill/2544/
text.
First and foremost, I must acknowledge the resounding support received
for our petition on MoveOn.org: Stop For-Profit Takeover of Organ
Donation. With over 5,000 signatures and growing, it is evident that
the public recognizes the importance of protecting our country's
transplant patients and honoring the priceless gifts that organ donors
give to save lives. I have attached a list of our signers to-date to
the digital version of this letter. You can also track the petition's
growth in real time by visiting https://sign.moveon.org/p/dont-profit-
---------------------------------------------------------------------------
off-organs.
The U.S. organ donation and transplant system is structured around a
unique public-private partnership known as the Organ Procurement and
Transplantation Network (OPTN). Created nearly 40 years ago through the
passing of S. 2048, the National Organ Transplant Act,\3\ the OPTN
today is run much like a congress of its own. It combines the efforts
and perspectives of our country's hospitals, laboratories, volunteers,
agencies within the U.S. Department of Health and Human Services, and
specialty non-profit contractors to keep the system moving.
---------------------------------------------------------------------------
\3\ https://www.congress.gov/bill/98th-congress/senate-bill/2048.
To this day, U.S. law has mandated that the OPTN must be operated as a
``nonprofit entity that has an expertise in organ procurement and
transplantation.'' This language is present in the Public Health
Service Act, which S. 1668/H.R. 2544 would revise if passed.
Specifically, those bills would delete the requirements that the OPTN
has to be run as a non-profit, as well as the requirement that the OPTN
---------------------------------------------------------------------------
must have expertise in organ procurement and transplantation.
In removing these legal requirements, S. 1668/H.R. 2544 would allow
for-profit companies to bid on and receive contracts from the
government to operate the OPTN. This would include the OPTN's most
important work, such as setting the algorithms that match donated
organs to patients and even the development and revision of policies
controlling how organs are allocated nationwide.
Our petition does not represent any particular organizations,
associations or other groups within or outside of the organ donation
and transplant system, nor are we doing this in the interest of any
such groups. We are patients and donor families, parents and friends,
and everyday men and women who in one way or another have been touched
by the noble gift of organ donation and the lifesaving surgeries it
enables. We also do not oppose any true efforts to improve the organ
donation and transplant system. However, we refuse to see those efforts
subverted to the benefit of for-profit companies, which would
jeopardize human lives.
Our primary concerns are that a for-profit takeover of the OPTN would
inevitably prioritize financial gain over the well-being and survival
of patients in need, undermine the trust of potential organ donors and
recipients, and perpetuate existing disparities in transplant access
based on wealth. The inherent strength of an OPTN run by non-profits is
that they have no other goals than to save as many lives as possible.
In contrast, for-profits are inherently conflicted between that mission
and their existence as companies designed to maximize revenue for
themselves and their shareholders.
There are plenty of for-profit hospitals and other organizations, such
as software companies and couriers, who already play valuable roles in
the OPTN. However, that is not the same as having for-profits control
organ matching and organ policymaking for our entire country. It is
troubling enough that S. 1668/H.R. 2544 do not include any
``guardrails'' against possible misuse of the OPTN by for-profits. We
believe that even allowing them to take on leadership roles will bring
us one step closer to a system that values the wealthy and privileged
over the sickest and most underserved patients, who already struggle to
receive medical treatment.
We implore you, as our elected representatives, to publicly provide
assurance that lives will be prioritized over profits by revising S.
1668/H.R. 2544 to keep the OPTN a non-profit enterprise run by medical
experts.
We trust that you will carefully consider our concerns and act in the
best interest of the countless people who depend on the organ donation
and transplant system. Please stand with us in preserving the
generosity, compassion, and unwavering commitment to human life that
organ donation represents.
Sincerely,
Patrick McGlone
Kidney and pancreas recipient (June 2021)
https://sign.moveon.org/petitions/stop-congress-from-monetizing-organ-
donation-reject-for-profit-healthcare.
Mid-America Transplant
1110 Highlands Plaza Dr. E, Suite 100
St. Louis, MO 63110
T 314-735-8200
https://www.midamericatransplant.org/
July 18, 2023
U.S. Senate
Committee on Finance
Washington, DC 20510
Re: Thursday, July 20, 2023 Subcommittee Hearing ``The Cost of
Inaction and the Urgent Need to Reform the U.S. Transplant System''
Dear Senate Finance Committee Members:
Mid-America Transplant appreciates the opportunity to provide a written
comment in advance of the upcoming hearing, ``The Cost of Inaction and
the Urgent Need to Reform the U.S. Transplant System,'' on July 20,
2023. We support Congressional efforts to improve the organ donation
system.
Pancreata for Research
Mid-America Transplant (MT) recognizes the need to improve the organ
donation and transplantation system in the United States. MT fully
supports the Centers for Medicare and Medicaid Services (CMS) in its
efforts to improve the organ transplant process to maximize donation
opportunities that will lead to more lives saved.
As stated in our April 3, 2023, letter to the Senate Finance Committee,
we support changes to CMS' performance metrics that remove research
pancreata from the calculation.
At Mid-America Transplant, placing organs for transplant to shorten the
wait list and save more lives is always our priority. We move forward
with an authorized donor only when we believe there is an opportunity
for transplantation. There are instances in which transplant centers
decline a previously accepted organ based on discoveries that take
place during or after surgical recovery of that organ. For example:
In 2021, MT took an authorized donor to the operating room on 13
occasions where, ultimately, no organs were transplanted.
At the time of surgery, transplant centers had provided a
provisional acceptance for at least one kidney for 12 out of these 13
donors.
At the time of surgery, transplant centers had provided a
provisional acceptance for the liver with 8 of these 13 donors.
Ultimately, the transplant centers rescinded their acceptance of
the kidneys and livers for transplant.
In all 13 cases, MT placed the pancreas for research with one of
the two academic medical centers located in St. Louis, Missouri.
Since 2017, Mid-America Transplant has partnered with researchers at
Saint Louis University and Washington University in St. Louis to
support pancreas research. These studies, two of which are NIH-funded,
are IRB-approved and supported through a formal evaluation process.
Mid-America Transplant recognizes that medical advancements through
research such as this may better help treat diseases like diabetes and
ultimately reduce the number of people who one day need an organ
transplant. The prevalence of diabetes is a national health issue,
impacting minority communities at even greater rates and contributing
to overall health inequities. Forty-three percent (43%) of the
individuals waiting for a lifesaving transplant in MT's designated
service area have diabetes. We believe these pancreata research
programs have the potential to provide valuable clinical insights and
will continue to partner in this manner.
Mid-America Transplant's research partnerships are not limited to
pancreata; we currently have 35 active research agreements with
researchers at the above-
mentioned institutions for organs and tissues that cannot be
transplanted. All organs, including pancreata, are provided to the
researchers at no charge.
Mid-America Transplant is committed to maximizing donation through
innovative practices that are supported by research. Over the past ten
years, MT's Chief Medical Officer has led or participated in multi-OPO
and academic medical center research projects that have resulted in 25
peer-reviewed publications to date. This research has led to an
increase in the number of organs recovered and transplanted across the
nation, resulting in more lives saved.
Thank you for the opportunity to submit this comment. We are happy to
provide additional data supporting our top priority of placing organs
for transplant, and additional details surrounding our research
initiatives at the Committee's request.
Mid-America Transplant is eager to continue the dialogue about ways to
improve the system to ensure every community is served by a high
performing Organ Procurement Organization.
Sincerely,
Kevin Lee
President and CEO
______
National Down Syndrome Society
1155 15th Street, NW, Suite 540
Washington, DC 20005
800-221-4602
https://ndss.org/
U.S. Senate
Committee on Finance
The Honorable Ron Wyden The Honorable Mike Crapo
221 Dirksen Senate Office Building 239 Dirksen Senate Office Building
Washington, DC 20510 Washington, DC 20510
RE: NDSS statement for the record, Senate Finance hearing on organ
transplant reform
Dear Chairman Wyden and Ranking Member Crapo:
The National Down Syndrome Society (NDSS) empowers individuals with
Down syndrome and their families by driving policy change, providing
resources, engaging with local communities, and shifting public
perceptions. We write today in response to the Senate Finance
Committee's hearing on ``The Cost of Inaction and the Urgent Need to
Reform the U.S. Transplant System.'' More specifically, we wish to
highlight the prevalent discrimination against individuals with
disabilities that persists in the organ transplant system today.
Organ transplants are a key part of our nation's health care system.
They save lives every day. Unfortunately, people with disabilities have
consistently been denied organ transplants in the United States based
on unfounded assumptions on their quality of life and ability to comply
with post-operative care. This is in direct violation of the Americans
with Disabilities Act, Section 504 of the Rehabilitation Act of 1973,
and Section 1557 of the Affordable Care Act, which prohibit
discrimination on the basis of disability.
Despite these existing overarching protections, real-world
discrimination persists. The National Council on Disability (NCD)
reviewed applicable federal and state laws, the disability-related
policies of various organ transplant centers, and policies of the Organ
Procurement and Transplantation Network and issued a report in
September 2019.\1\ The report found that people with disabilities are
frequently denied access to organ transplants based on written and
unwritten policies excluding people with disabilities as organ
transplant candidates, even in the nine states that, at the time, had
state laws in place prohibiting such practice. Furthermore, some
medical professionals even refused to evaluate a patient's medical
suitability for organ transplant because of their disability.
---------------------------------------------------------------------------
\1\ National Council on Disability. (2019). Organ transplant
discrimination against people with disabilities. Retrieved from https:/
/ncd.gov/sites/default/files/NCD_Organ_Transplant_508.
pdf.
In our community, the threat of discrimination in organ transplantation
presents a real-world danger. About 50% of all people born with Down
syndrome have congenital heart disease, which often requires heart
surgery and, if unsuccessful, can lead to the need for transplantation.
In October of 2021, NDSS learned of Zion Sarmiento, a baby born with
Down syndrome in Florida. Zion had a congenital heart defect and
underwent multiple surgeries, but ultimately, he needed a transplant to
survive. Despite Florida having passed a state-law prohibition of
disability discrimination in organ transplantation, effective July 1,
2020,\2\ Zion was unable to access a transplant and tragically passed
away in October. He was less than four months old.
---------------------------------------------------------------------------
\2\ Florida CS/HB 1179 (2020) https://www.myfloridahouse.gov/
Sections/Bills/billsdetail.aspx
?BillId=69420.
While progress has been made since NCD issued their report, including
the passage of laws in 39 states,\3\ this patchwork system does not
adequately ensure individuals with disabilities are protected because
the organ transplant ecosystem, as a whole, is firmly interstate. We
therefore strongly urge members of the Committee to support the
Charlotte Woodward Organ Transplant Discrimination Prevention Act (S.
2706), which would prohibit discrimination against people with
disabilities who need organ transplants, upholding, clarifying, and
building upon rights established in the Americans with Disabilities Act
of 1990, Section 504 of the Rehabilitation Act of 1973, and Section
1557 of the Affordable Care Act. This commonsense legislation is
bipartisan in both chambers (with H.R. 1183) and has no fiscal impact.
---------------------------------------------------------------------------
\3\ National Down Syndrome Society. (2022). Organ transplant
discrimination state laws. Retrieved from https://www.ndss.org/
advocacy#p_health.
NDSS strives to ensure all individuals with Down syndrome are assured
their human rights and valued by a more inclusive society. We applaud
the Committee for examining these important issues and look forward to
working with Congress to advance bipartisan policies that improve the
nation's organ transplant ecosystem, including protecting the civil
---------------------------------------------------------------------------
rights of individuals with disabilities.
Sincerely,
Kandi Pickard
President and CEO
______
National Kidney Foundation
30 East 33rd Street
New York, NY 10016
Statement of Sharon Pearce, Senior Vice President, Government Relations
The National Kidney Foundation (NKF) respectfully submits our statement
for the record on behalf of the 37 million individuals in the United
States, 1 in 7 adults, estimated to have chronic kidney disease
(CKD).\1\ The prevalence of kidney failure is expected to increase
dramatically, possibly exceeding one million people who may need access
to the transplant wait list by 2030.\2\ There are not enough deceased
or living donor organs to meet current or future needs creating a
public health emergency that needs immediate attention. Although more
than 25,000 people received a kidney transplant in 2022, far too many
are still waiting. Many never access the transplant wait list or learn
that a transplant is an option. More than 100,000 individuals are on
the transplant wait list, and nearly 90,000 are waiting for a kidney.
---------------------------------------------------------------------------
\1\ Centers for Disease Control and Prevention. Chronic Kidney
Disease in the United States, 2021. Centers for Disease Control and
Prevention; 2021.
\2\ McCullough, K.P., Morgenstern, H., Saran, R., Herman, W.H.,
Robinson, B.M. Projecting ESRD Incidence and Prevalence in the United
States through 2030. J Am Soc Nephrol. 2019 Jan;30(1):127-135. DOI:
10.1681/ASN.2018050531. Epub 2018 Dec 17. PMID: 30559143; PMCID:
PMC6317596.
The current transplant system infrastructure has numerous opportunities
for improvement to better serve individuals who can benefit from a
kidney transplant. NKF has worked to transform the transplant system so
that it is more patient-
centric, transparent, and equitable. We appreciate the Senate Finance
Committee's continued efforts to amplify the critical need for a high-
performing transplant system. The lack of appropriate oversight,
accountability, and support from regulatory agencies has had life-
threatening consequences for the people who rely on the American
transplant system for another chance at a healthy life through
transplantation. Patients are in dire need of a reformed transplant
system that optimizes every single opportunity for organ donation and
---------------------------------------------------------------------------
transplantation.
Approximately 14 people on the national transplant list die each day
awaiting their lifesaving kidney.\3\ Yet, more than 7,000 recovered
deceased donor kidneys went untransplanted in 2022, according to data
from the Organ Procurement and Transplantation Network (OPTN). Access
to transplantation remains disparate for rural populations, communities
of color, and people of lower socioeconomic status. Patients highly
regard transparency and shared decision-making and desire the same from
the stakeholders within the transplant ecosystem. The Senate Finance
Committee's 2022 hearing on transplantation uncovered a disturbing
array of shortcomings in our national transplant system and identified
numerous opportunities for improvement that warrant its reformation and
modernization to be best-in-class.
---------------------------------------------------------------------------
\3\ OPTN/SRTR 2021 Annual data report: Preface. (2023). American
Journal of Transplantation, 23(2). https://doi.org/10.1016/
j.ajt.2023.02.002.
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Why Patient-Centricity and Transparency Matter
There does not seem to be any truth in disclosure. I have been
on dialysis for three years, and it took two years to meet my
transplant team due to the weight I was supposed to be. For two
years, I had to struggle on my own with no guidance. They left
me out to dry, more like drown, without any safety device.
E.F., NKF Kidney Patient Advocate
Patients are deeply invested in their health and wish to be active
participants in decision-making processes along the transplant journey,
from initial transplant referral, through the transplant consultation
and evaluation phases, through wait-
listing, transplantation, and post-transplant recovery. However,
inadequate patient education and opacity in transplant program
processes make it difficult for patients to make informed decisions.
Because transplant hospitals are not transparent about their patient
selection criteria, patients do not have the information they need to
determine which transplant program will be best able to serve someone
with their clinical history or healthcare values.
Even when a patient is able to be listed for transplant, they are often
left in the dark about their status on the wait list. On average,
transplant candidates receive 17 organ offers that are declined on
their behalf without their knowledge or consent. While those organs are
sometimes accepted by and transplanted into other patients with lower
allocation priority, in many cases, those declined organs are not
utilized at all.4 Increasing organ utilization is closely linked to
reimbursement, transparency, and improved organ acceptance
practices.\4\ However, it begins with a
patient-centered approach to understanding the wait-listed patient's
goals and preferences (including preferences that might evolve as time
is spent on the wait list). Transplant programs must always maintain
sight of promoting shared decision-making with patients. Patient-
centricity must always be a priority, and transplant programs should
report on evidence of the inclusion of patients in the decision-
making process.
---------------------------------------------------------------------------
\4\ Husain, S.A., King, K.L., Pastan, S., et al. Association
Between Declined Offers of Deceased Donor Kidney Allograft and Outcomes
in Kidney Transplant Candidates. JAMA Netw Open. 2019;2(8):e1910312.
doi:10.1001/jamanetworkopen.2019.10312.
NKF supports patient-centric process measures, including bi-annual
reports to patients on organs offered and declined on their behalf and
annual conversations between patients and their care team regarding
patient preferences and tolerances for accepting or declining certain
organs.
The Importance of Equity in Access to Kidney Transplantation
As a Black patient who has collectively waited more than 14
years on the transplant list, the journey is daunting, and hope
is diminished. Time is life when waiting for a lifesaving
transplant.
M.B., NKF Kidney Patient Advocate
All kidney failure patients must have a fair chance of receiving a
lifesaving kidney transplant, regardless of their race or ethnicity.
Unfortunately, people in underserved communities who want to pursue
transplantation as a treatment for kidney failure often face racial,
geographic, and socioeconomic barriers. Other hurdles include a lack of
patient education and low health literacy which links to the
substandard access to transplantation endured by people of lower
socioeconomic status, which leaves them reliant upon dialysis instead
of receiving the optimal treatment for kidney failure: transplantation.
NKF strongly supports efforts to improve data collection and
transparency in the transplantation referral, evaluation, and wait-
listing process. The absence of data on the pre-wait list experience
makes it challenging to determine where problems exist. Better data
collection would shed light on individual transplant center
performance, identify gaps in the system, and would inform policy
development to assure that all candidates have equitable access to
transplantation. Congress and the OPTN could advance this objective by
advancing policy that develops a standard definition of a transplant
referral and promoting a nationwide system for tracking racial and
ethnic disparities in transplant referral, evaluation, and wait-
listing.
Saving More Lives by Reforming the U.S. Transplant System
[Receiving a] Transplant means everything to me. Living on
dialysis is very hard. Dialysis is surviving. Transplant is
living.
A.H., NKF Kidney Patient Advocate
NKF supports reforming and modernizing the U.S. Transplant System to
increase and enhance kidney transplantation by upholding patient-
centricity, transparency, and equity. We believe that the Health
Resources and Services Administration (HRSA) has a responsibility to
the American people to create, maintain, and support a high-quality,
high-performing transplant system. We look forward to its Organ
Procurement and Transplantation Network (OPTN) Modernization
Initiative. With increased kidney non-utilization rates, lack of
innovation in a world that now has cutting-edge technology, and wide
disparity gaps in access to kidney transplantation, we are eager for
HRSA to take action to revitalize the transplant system to mitigate the
life-threatening consequences of antiquated practices and poor
regulatory oversight and accountability.
Conclusion
The National Kidney Foundation applauds the Senate Finance Committee
for endeavoring to improve transplantation in the United States. We
firmly believe in the achievement of a transplant system that
prioritizes patients; it is long overdue. We welcome any questions or
comments and stand ready to support Congress in its effort to reform
transplantation. Please contact Morgan Reid, Director of Transplant
Policy and Strategy ([email protected]), or Lauren Drew, Director
of Congressional Relations ([email protected]).
Thank you for your consideration.
______
Organ Donation Consortium
975 F Street, NW, Suite 400-A
Washington, D.C. 20004
[email protected]
July 28, 2023
Honorable Benjamin Cardin, Chair
Honorable Steve Daines, Ranking Member
U.S. Senate
Committee on Finance
Subcommittee on Health Care
219 Dirksen Senate Office Building
Washington, DC 20515
Re: Hearing of the Subcommittee on Health Care ``The Cost of
Inaction and
the Urgent Need to Reform the U.S. Transplant System,''
Thursday,
July 20, 2023 at 10:00 a.m.
Dear Chair Cardin and Ranking Member Daines,
We, the members of the Organ Donation Consortium, offer this statement
for the record for the Health Subcommittee Hearing--``The Cost of
Inaction and the Urgent Need to Reform the U.S. Transplant System.'' As
Senator Grassley noted at the hearing, failures in the transplant
system result in deadly costs not only to those who await a transplant
but also to the generous donor families who make the gift of life
possible. As organ donation professionals, and on behalf of those donor
families we have the privilege of serving every day, we thank you for
making reforms to the entire system a priority.
Who We Are. The Organ Donation Consortium, or ODC, is comprised of five
of the nation's leading Organ Procurement Organizations (OPOs) and
collectively represents almost 38 million Americans--over 10% of the
U.S. population stretching from California to Florida. The ODC was
formed in part to promote collaboration, transparency, and
accountability among all stakeholders, to decrease disparities in the
transplantation ecosystem, and to modernize technology and systems
among all institutions engaged in this work.
Support of S. 1668. We fully support S. 1668--the Securing the U.S.
Organ Procurement and Transplantation Network Act, which would allow
the Health Resources and Services Administration (HRSA) to run a
competitive process to choose from the best contractors for different
functions of the national Organ Procurement and Transplantation Network
(OPTN). This bill would bring important, needed improvements to the
organ donation and transplantation ecosystem and would make for a more
equitable and accountable system.
OPTN Governance. We support a governance structure for the OPTN that is
wholly independent from the organizations it engages to conduct its
work. This will lead to greater oversight and accountability of the
entire transplant ecosystem for years to come and should be a top
priority of HRSA and its Modernization Initiative.
For-Profit Contractors. While the OPTN itself should continue to
function as a board operated solely as a non-profit organization, we
believe for-profit contractors should be allowed to bid for the
operational portions of the OPTN contract. The organ donation and
transplantation system should be allowed to benefit from best-in-class
services regardless of the exempt status of the organization at hand.
The current OPTN contractor as well as every OPO in the country already
relies on for-profit entities to provide services in this work, and
some transplant centers themselves are for-profit hospitals. There is
simply no reason why the donation and transplant system should be
prohibited from working with entities deemed best able to provide a
given service.
That said, we firmly believe that only non-profit organizations should
be allowed to serve as OPOs, just as the OPTN board itself must be non-
profit. OPOs are frontline organizations working directly with donor
families in the most tragic of circumstances as they make the selfless
decision to donate their loved one's organs. The public's trust in the
donation and transplant system is sacrosanct, and no one should fear
that the system itself is an attempt to profit from the gift of life.
Need for Data Collection, Performance Metrics, and Transparency. We
support the adoption of performance metrics for all stakeholders
throughout the system--donor hospitals, OPOs, and certified transplant
centers--with common definitions and guidelines at their core. With the
collection of uniform process data, each stakeholder can be compared,
benchmarked, and evaluated as a participant in the donation and
transplantation system. We also support the public disclosure of
systemwide performance data to drive accountability and improvements.
Doing so could be accomplished without jeopardizing patient privacy,
which today is routinely realized through medical research leading to
evidence-based best practices.
The OPO Final Rule. We support the enforcement of the OPO Final Rule to
ensure every community is served by a high-performing OPO, although we
recommend the rule be implemented in a way that does not disrupt the
system irresponsibly. We support the immediate publication of
interpretive guidelines to provide clear direction on the impending
recertification process. We also support a revision to the OPO Final
Rule that would remove the inclusion of research pancreas in the OPO
performance metrics.
We look forward to working with you to improve the efficiency and
effectiveness of the organ transplantation process. Thank you again for
your leadership on this issue.
Sincerely,
Janice F. Whaley Kevin Lee
President and CEO President and CEO
Donor Network West Mid-America Transplant
San Ramon, California St. Louis, Missouri
Ginny McBride Kelly Ranum
Executive Director President and CEO
Our Legacy Louisiana Organ Procurement Agency
Orlando, Florida Covington, Louisiana
Bradley L. Adams
President and CEO
Southwest Transplant Alliance
Dallas, Texas
cc: Senator Ben Cardin, Senator Todd Young, Senator Bill Cassidy,
Senator
Elizabeth Warren, Senator Cory Booker
______
Science in Donation and Transplant
791 Alexander Road
Princeton NJ 08540
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Bldg.
Washington, DC 20510-6200
August 1, 2023
Re: Subcommittee Hearing ``The Cost of Inaction and the Urgent Need to
Reform the U.S. Transplant System,'' Subcommittee on Health Care, Date:
Thursday, July 20, 2023
Thank you for this opportunity to respond to the issues raised during
July 20, 2023, Senate Finance Committee Health Subcommittee Hearing on
Organ Transplantation Reform and the United States's Organ Procurement
and Transplantation Network. Our non-profit organization, Science in
Donation and Transplant (SID&T), supports evidence-based donation and
transplant policy-making. Donors and transplant recipients alike
deserve a well-aligned, science-based system. We advocate reform with
leading medical practitioners for enhanced coordination and alignment
among Organ Procurement Organizations and transplant centers. We aim to
ensure that the metrics and measures used to credential and designate
donation and transplant organizations are grounded in science and
protected from political whim and private financial influence. SID&T
understands that public trust is the foundation of a system based on
altruism. We are concerned that statements of the Senate Finance
Committee threaten the world's leading donation and transplant system.
Mass Closure of OPOs does not lead to system improvement, but instead
destabilizes the donation and transplant system: System improvement
requires that there be evidence-based quality-enhancing processes. The
hearing rehashed outdated data and doubled down on the extremely poorly
conceived metrics governing organ donation. Committee members advocated
that the Centers for Medicare and Medicaid Services (CMS) demand that
Tier 1 Organ Procurement Organizations immediately take over Tier 3
OPOs. This demand is both unachievable and downright dangerous. Was the
Committee aware, leaving aside for a moment the medically flawed
metrics that established Tiers in the first place, that the data used
for current standing is two years old at the time that of? The real-
life impact, therefore, of the ``immediate closure'' could well be that
an OPO currently performing as a Tier 3 might be required to take over
an OPO presently functioning as a Tier 1. Additionally, since adopting
the Rule over 31 months ago , CMS has yet to establish any mechanism
for avoidance of the inevitable chaos that would follow mass
unwarranted decertifications.
The focus on system closure rather than data-based system improvements,
underscores the source of the current rule: i.e., special interests
intent on shutting and privatizing OPOs and monetizing what's left of
the world's leading procurement system without the donor or recipient
in mind. No other health entity or hospital is regulated in this
manner; accountability is measured by adherence to standards, and data
which reflects current performance, rates of improvement, and adherence
to best practices. No other health care entity participating in the
federal system of reimbursement is required to compete in a ``hunger
games'' race, pitted against one another. HHS does not arbitrarily shut
42% of the nation's so-called underperforming hospitals by pitting the
performance of urban and poor rural facilities against those located in
wealthy and homogenous suburban locations; no data would assume that
health care access is the same in every community. Achieving high
quality is a goal, one that is achieved through researching and
understanding best practices and processes. Quality and community
service is not a win/lose, live/die proposition.
The Committee ignored Congress' own analysis of the donation and
transplant system: The Senate Finance and Senate Budget Committees
would be better served by investigating why Health and Human Services
and CMS ignored the will of Congress. Congress charged the National
Academies of Sciences, Engineering, and Medicine (the National
Academies) to examine and recommend improvements to research, policies,
and activities related to deceased donor organ procurement, allocation,
and distribution. The congressional language requested that the report
include recommendations to update the Organ Procurement and
Transplantation Network's (OPTN's) policies and processes. Shortly
before the problematic OPO performance rule was promulgated Congress
mandated an in-depth peer-reviewed scientific study of organ donation
and transplant by the National Academies of Sciences, Engineering, and
Medicine (NASEM). The rule was promulgated without reference to the
report, and to date, has not incorporated its findings.
Beginning in 2020, NASEM held 17 discussions, meetings, listening
sessions, and webinars ending in February 2022, with the release of
their report: A Fairer and More Equitable, Cost-Effective, and
Transparent System of Donor Organ Procurement, Allocation, and
Distribution. Nevertheless, in November 20, 2020, amid data gathering
for a scientific study still underway, powerful lobbyists convinced
federal regulators at CMS to finalize rules governing Organ Procurement
Organizations (OPOs) despite warnings from healthcare and science
professionals on its potentially devastating impact. While, in late
2021 Health and Human Secretary Becerra called for subject matter
experts, science professionals, and others to respond to a CMS Request
for Information on opportunities to improve and grow the organ donation
and transplant system, even this effort ignored the pending release of
the Congressionally-sponsored NASEM study. Prior to receipt of either
Congress' report, or digestion of its own data, some Federal officials
proposed allowing federal bureaucrats to delegate for-profit organ
management companies to replace current community-based, nonprofit
Organ Procurement Organizations. This effort was fortunately never
acted upon, allowing for the February 2022 release of the landmark
NASEM study authorized by Congress, which highlighted significant flaws
in regulations recently enacted by federal regulators.
We, and many peers in the field, know from fact-based experience that
improving accessibility and outcome for patients and the overall
efficiency and effectiveness of the donation and transplant system
requires specific CMS-encouraged goals:
Encouraging the proper alignment and cooperation among Organ
Procurement Organizations, Transplant Centers, Hospitals, and community
partners.
Recognizing that the certification and decertification metrics
for OPOs need revision. Measuring OPOs based on transplant rates fails
public policy and basic logic tests. Transplant decisions are made by
transplant centers, not OPOs.
The many questions raised by the Rule's failure to address all
of the critical criteria and timeframe questions of potential
decertification of up to two-thirds of existing OPOs, and the potential
negative impact this poses to the most at-risk populations demand the
establishment of a National Task Force of science-based experts and
community stakeholders to study the issues and make recommendations.
The compassionate nature of organ donation and procurement begs
for CMS to protect, nurture and improve the community-based nonprofit
system and not be the instrument of the system's destruction.
Proposed Decertification has inequitable impact: We are concerned that
most entities headed for decertification under the latest data
publication from CMS are OPOs whose service area demographics are
disproportionately underserved communities. First, the research has yet
to be done to determine if these OPOs are being fairly evaluated, given
the impact of their certification on factors they cannot control, such
as transplant rates. As stated in the NASEM report: From the NASEM
report:
While waiting lists remain long and many listed individuals die
while awaiting an organ every day, too many donated organs
procured and offered to patients at transplant centers are not
accepted--leaving thousands of potentially lifesaving donated
organs unused yearly. Evidence indicates that many, if not a
large majority, of unused organs could be successfully
transplanted and benefit patients. This problem is much more
prominent in the United States than in many other countries.
For example, the overall nonuse rate in the United States is
twice that in France. In the United States, on average,
patients who die waiting for a kidney had offers for 16 kidneys
that were ultimately transplanted into other patients. This
indicates that many transplant centers refuse viable kidney
offers on behalf of those on the waiting list.
This clearly must improve through better alignment.
Second, given the unknown impact, and tremendous complexity of closing,
merging or reorganizing OPOs, frightening questions about how those
populations will be served are raised. Given CMS' one-year timeframe
for improvement, what high-
performing OPO will take over a lower-performing service area? There is
a tremendous cost associated with decertification. Who will be
responsible for the fiscal issues related to physical facilities,
buildings, labor, affiliates, and contractors? The uncertainty around
these issues, and the process of this rule making and decertification
itself opens the door to an avalanche of lawsuits? Federal judges, not
experts in quality improvement or the delivery of scarce services, will
determine the future of organ procurement.
In closing, the current special interest political movement to
accelerate the full force of the Rule governing donation and transplant
is not a plan. It is a roadmap to chaos which will inordinately impact
patients of color and lower economic standing. The sensitive nature of
organ donation and procurement begs Congress and HHS/CMS to protect,
nurture and improve the community-based nonprofit system based on
evidence-based science, not special interest politics. In support of
the efforts of policy-makers, Science in Donation and Transplant
commissioned a literature review by Healthcare Management Associates,
providing important resources for those who are concerned with quality
improvement. The result of this research, much of which belies the
arguments made by the hand-chosen witnesses placed before the Committee
is attached for your edification.
Thank you for the opportunity to respond.
(1) Realizing the Promise of Equity in the Organ Transplantation System
(The National Academies of Sciences, Engineering, and Medicine
Consensus Study Report, 2022), https://nap.nationalacademies.org/
catalog/26364/realizing-the-promise-of-equity-in-the-organ-
transplantation-system.
(2) https://unos.org/about/fast-facts/.
(3) Prior rule projections calculated by Donate Life America. CMS rule
projections based on CMS new rule goal.
The following is the full report of Health Management Associates
(https://sidandt.org/the-science/hma-executive-summary-and-report).
Health Management Associates was engaged to review the November 2020
RULE based on sound science and research.
Health Management Associates (HMA)
Founded in 1985, HMA is a leading independent, national research and
consulting firm that provides technical assistance and training,
facilitation and strategic planning, research and evaluation, policy
development and recommendations, technical report writing, and
analytical services with a focus on improving the administration and
delivery of public health, healthcare, and social services programs.
Introduction
The United States has one of the highest-performing donation and
transplant systems in the world and is continually improving to
increase organ donation and transplant.\1\ Based on data from the
International Registry in Organ Donation and Transplantation, the U.S.
has the highest number of organ donors per million population and the
highest number of kidney, liver, and heart transplants per million
population. In 2022, 42,887 organ transplants were performed in the
country, which reflected a 3.7% increase over the previous year. to
further reduce the wait list for organs, CMS issued the final rule,
``Medicare and Medicaid Programs: Organ Procurement Organizations
Conditions for Coverage: Revisions to the Outcome Measures Requirements
for Organ Procurement Organizations: Final Rule.'' The new rule
includes the following provisions: (1) donation rate measure, (2)
transplantation rate measure, (3) performance benchmark, (4) 12-month
review periods, (5) performance tiers, (6) increased competition, (7)
transparent OPO performance, and (7) implementation timeline.
---------------------------------------------------------------------------
\1\ International Registry in Organ Donation and Transplantation
(IRODaT). (2023, May 15). Database. International Registry in Organ
Donation and Transplantation (IRODaT). https://www.irodat.org/.
---------------------------------------------------------------------------
Reliable and Timely Data for Evaluation
Both the donation rate and transplant rate measures utilize ``donor
potential'' in measuring the OPO performance. Under the new rule,
``donor potential'' is defined as ``the number of inpatient deaths
within the DSA among patients 75 and younger with a primary cause of
death consistent with organ donation.'' Donor potential will be
calculated utilizing state death certificate data which is an
unreliable source of data. According to the CDC, approximately 20-30%
of death certificates have issues with completeness.\2\ A recent study
sought to compare the accuracy of using death certificate data in
calculating the potential donor as defined under the new rule versus
the true potential as determined by an OPO in the real-time disposition
of donor referrals. Utilizing death certificate data, approximately 55%
of the 140 deaths reviewed were deemed ``potential donors.'' Whereas an
analysis applied OPO evaluation of clinical exclusion characteristics
to determine donor potential determined that only 10% were truly
eligible donors.\3\ It is vital to utilize a data source to evaluate
OPOs; however, utilizing death certificate data does not provide the
level of clinical detail needed to accurately reflect the number of
viable organs that can be transplanted. In accordance with the National
Academies of Science, Engineering, and Medicine (NASEM), SID&T urges
that patient-level data be collected and used as the measure
denominator. The patient-level data should be granular enough to
contain essential information about referrals of ventilated deaths,
medical suitability of donors, and other key information.
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\2\ Department of Health and Human Services, Understanding Death
Data Quality: Cause of Death from Death Certificates. Centers for
Disease Control and Prevention. Retrieved May 15, 2023, from https://
www.cdc.gov/nchs/data/nvss/coronavirus/cause-of-death-data-quality.pdf.
\3\ Gunderson, S., Kemink, J., Topp, C., Payne, W., Brown, T.,
Welsch B. Can Organ Donor Potential Be Determined from Death
Certificates? A Case Report [abstract]. Am J Transplant. 2020; 20
(suppl 3). https://atcmeetingabstracts.com/abstract/can-organ-donor-
potential-be-determined-from-death-certificates-a-case-report/.
Accessed January 6, 2023.
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Metrics for Evaluation
CMS proposed to revise the definition of ``donation rate'' from
``eligible donors as a percentage of the eligible deaths'' to ``the
number of donors as a percentage of the donor potential.'' The
inclusion criteria for donor potential are ICD-10-CM codes I20-I25
(ischemic heart disease); I60-I69 (cerebrovascular disease); V-1-Y-89
(external causes of death): Blunt trauma, gunshot wounds, drug
overdose, suicide, drowning, and asphyxiation. Donor potential will be
adjusted using the proportion of Medicare beneficiary inpatient deaths
in the hospital compared with the total Medicare beneficiary inpatient
deaths in the county for OPOs servicing a hospital within a waiver
under Sec. 486.308. Currently, the donation rate measure fails to take
into account various factors, such as gender, race/ethnicity, and BMI.
These factors have been found to significantly affect donation metrics
(i.e., donors per death,\4\ donors per eligible death,\5\ and eligible
donors per eligible death).\6\ According to an assessment of national
organ donation rates, male donor subgroups, compared with female
donors, had higher donors per death, donors per eligible death, and
eligible donors per eligible death.
---------------------------------------------------------------------------
\4\ Donors per death measures the percentage of the population who
become donors of 1 or more organs when deceased.
\5\ Donors per eligible death is an adjusted metric that accounts
for the number of deaths meeting the predefined eligibility criteria.
\6\ Eligible donors per eligible death represents the eligible
deaths that are converted into donors.
In comparison to other racial/ethnic groups, it was found that White
individuals had the highest likelihood of donation across these three
donation metrics. The study also found that body mass index greater
than 30, compared with BMI less than 30, was significantly inversely
associated with all donation metrics. It is vital to take into
consideration BMI since the prevalence rate of obesity among adults
aged 20 is over nearly 42 percent. Additionally, obesity is an
important risk factor for ischemic heart disease.\7\, \8\
SID&T recognizes the value of the donation rate; however, we agree with
NASEM that a consensus-based process be utilized to develop the
donation rate measure and that it be one of many measures in a
dashboard of metrics to assess OPO performance. We urge that the
dashboard include elements to address disparities, referrals responded
to, and others. SID&T also recommends that the dashboard be available
to patients.
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\7\ Bryan, S., Afful, J., Carroll, M., Te-Ching, C., Orlando, D.,
Fink, S., and Fryar, C. (2021). National Health and Nutrition
Examination Survey 2017--March 2020 Prepandemic Data Files Development
of Files and Prevalence Estimates for Selected Health Outcomes.
National Health Statistics Reports. https://doi.org/10.15620/
cdc:106273.
\8\ McPherson, R. (2015). Obesity and ischemic heart disease.
Circulation Research, 116(4), 570-571. https://doi.org/10.1161/
circresaha.115.305826.
Under the new final rule, CMS is also changing the transplantation rate
measure to the number of transplanted organs from an OPO's DSA as a
percentage of inpatient deaths among patients 75 years old or younger
with a primary cause of death that is consistent with organ donation.
The transplant rate does not take into consideration regional
differences. According to a study published in the Journal of the
American Medical Association (JAMA), heart, liver, and kidney
transplantation rates in rural/small towns are lower than those in
urban areas despite their waiting list registration rates being
lower.\9\
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\9\ Axelrod, D.A., Guidinger, M.K., Finlayson, S., et al. Rates of
Solid-Organ Wait-listing, Transplantation, and Survival Among Residents
of Rural and Urban Areas. JAMA. 2008;299(2):202-207. doi:10.1001/
jama.2007.50.
It is also important to highlight the organ procurement and transplant
system relies both on OPOs and transplant centers to work
collaboratively to ensure the recovery and transplantation of organs to
individuals in need. OPOs are responsible for coordinating the
procurement, preservation, and transportation of organs, as well as
maintaining a system for locating prospective beneficiaries for
available organs. However, this measure will hold OPOs accountable for
transplant centers which are responsible for determining whether a
patient is added to the national waiting list that UNOs manages and
whether to accept or decline organ offers for their patients. This
measure puts the OPOs and transplant centers at odds while compromising
patient care. It is essential that CMS develop and design measures that
align and appropriately hold OPOs and transplant centers for their
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performance.
This was seen in 2007 when CMS established that if the total number of
patient deaths or graft failures that occur within one year of
transplant exceeds 150% of the risk-adjusted expected number (i.e., 1.5
times the expected number) for a 2.5-year period, and the result is
both statistically significant (p<0.05) and numerical meaningful (O-E
3), then the program is not in compliance.\10\ A study by Dr. Adel
Bozorgzadeh, a transplant surgeon at UMass Memorial Medical Center,
found transplant centers dropped a large number of patients from organ
transplant waiting lists following the implementation of this policy.
Since surgeries involving imperfect organs and extremely ill patients
were riskier, transplant centers would perform less high-risk
procedures that could affect their federal hospital ratings and
Medicare funding. Additionally, the research referenced in the rule
analyzed the untapped potential of organs during a time period in which
organ transplant rates were lower given transplant surgeon's hesitancy
to undertake high risk transplant procedures. For example, in calendar
year 2015, a total of 3,159 adult kidneys were recovered from deceased
donors but not used (out of a total of 16,410 deceased donor adult
kidneys recovered for transplant). This represented an increase from
2,889 such adult kidneys that were donated and recovered but not used
for transplant in CY2014, and 2,632 in 2007 and 2,084 in 2004.
---------------------------------------------------------------------------
\10\ Center for Clinical Standards and Quality/Survey and
Certification Group. (2016). (rep.). Solid Transplant Programs--Outcome
Thresholds--Revised Guidelines. Department of Health and Human
Services--Centers for Medicare and Medicaid Services. Retrieved May 15,
2023, from https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertification
GenInfo/Downloads/Survey-and-Cert-Letter-16-24.pdf.
With the addition of the transplant measure, SID&T recommends that HHS
update the OPTN contract to require increased transparency around organ
offer declines and require transplant center accountability for patient
engagement and partnership between transplant center professionals and
patients in deciding whether to accept or reject an offered organ. It
is also vital that HHS make it easier for transplant centers to accept
organ offers and work with OPTN to enhance organ allocation and
distribution policies and processes to reduce nonuse of deceased donor
organs.
Decertification
There are concerns regarding the unintended consequences of the
decertification process of OPOs. CMS may not voluntarily renew its
agreement with an OPO if it fails to meet the requirements for
certification which includes criteria based on both the donation rate
and transplant rate. As previously mentioned, these metrics do not take
into consideration the myriad of factors that are out of the control of
the OPOs which may put them at risk for decertification. An analysis of
the 2023 OPO Interim Annual Public Aggregated Report revealed that
42.0% of 52 OPOs were in Tier 3 in 2021. Based on the new rule, these
OPOs would be at-risk for decertification.
The rule does not provide a plan for a seamless transition should an
OPO become decertified. Additionally, should CMS choose to renew its
agreement with an OPO, it leaves the DSA open for competition to only
OPOs that fall within Tier 1 and Tier 2. Given the limited number of
OPOs, there are legitimate concerns regarding whether another OPO will
even apply to complete for the open DSA or an existing OPOs ability to
provide adequate services which may create a massive disruption in the
DSA and population being served similarly to what occurred to
transplant centers.
In the example above, CMS inevitably issued a memo in 2016 revising its
policy to relax the transplant standards. Unfortunately, in the eight
years the policy was in place, 145 transplant centers were cited for
deficiencies and 17 programs lost their Medicare funding. Unlike the
example above, there are far fewer OPOs and they have limited control
in the number of organs actually transplanted as the transplant
surgeons determine on patients' behalf whether to accept an organ. It
is also important to highlight that transplant centers that have lost
their Medicare approval may seek to re-enter the program; whereas, OPOs
that become de-certified cannot compete for any open DSA.\11\
---------------------------------------------------------------------------
\11\ 42 CFR part 486 subpart G.
SID&T stresses the importance NASAM's recommendation that HHS take
actions to reduce variations in the performance of donor hospitals,
OPOs, and transplant centers and increase the reliability,
predictability, and trustworthiness through implementing and sustaining
continuous quality improvement efforts across the system. Additionally,
HHS should hold the appropriate entities of the organ transplantation
system accountable for achieving demonstrable performance improvement.
The government should facilitate quality improvement efforts that
fosters greater systemness and accountability for the highest possible
performance among all donor hospitals, OPOs, and transplant centers.
Lastly, it is essential that special attention be given to spreading
best practices in organ procurement and transplantation that reduce and
eliminate inequities and disparities.
Conclusion
Recognizing the inherent challenges within the organ procurement and
transplant system, SID&T encourages CMS to re-evaluate and revise the
rule to both increase access to lifesaving organs, while ensuring the
success of the entities within the organ procurement and transplant
system. It is essential that a reliable and timely data infrastructure
be created to adequately evaluate the performance of OPOs in a way that
fosters quality improvement. Additionally, a consensus-based approach
is needed to develop standardized performance metrics based on peer
reviewed, evidence-based research to foster the improvement throughout
the organ procurement and transplant process. These metrics should
properly hold both OPOs and transplant centers for their roles within
the transplant process while driving collaboration and the development
of best practices to improve their performance.
Given the CMS rule does not provide guidance around the decertification
of OPOs, SID&T urges that HHS provide guidance and for Congress to take
action to ensure there is no disruption with the organ donor transplant
ecosystem by legislating NASEM's recommendations implementing
continuous improvement efforts across the entire system.
______
Society of Pediatric Liver Transplantation
7916 Birmingham Drive, 2nd floor, Gastro
San Diego, CA 92123
Statement of Amber Hildreth, D.O., FAAP, Vice Chair,
SPLIT Advocacy Committee
The Society of Pediatric Liver Transplantation has written the
following statement as an initial community response to the Health
Resources and Services Administration's OPTN Modernization Initiative.
We look forward to engaging with HRSA, the OPTN, and the transplant
community on initiatives to modernize and improve transplant in the
U.S.--particularly for children awaiting and after lifesaving liver
transplant.
The Society of Pediatric Liver Transplantation (SPLIT), as the largest
consortium of pediatric liver transplant centers in the United States
and in close collaboration with our Patient, Family, and Engaged
Partners (PFEP), supports meaningful innovation initiatives that
tangibly improve equitable access to pediatric liver transplant,
ongoing research to improve wait list and post-transplant outcomes,
provisions for living donation, diversity of the workforce, and
sustainable health for organ donation and transplant institutions.
To ensure that our transplant system successfully serves children, a
persistently vulnerable transplant population, we need the following:
A modernization effort that recognizes and considers pediatric-
specific concerns at every stage, in parallel to concerns that
primarily impact adult candidates.
Pediatric provider and patient representation in every step of
the planning process.
A well-organized national system that ensures nationwide sharing
of pediatric organs prioritized for pediatric recipients, acknowledging
that these children are vulnerable with more limited donor options.
It is imperative that our society and government take all available
action to urgently prioritize optimal health care delivery to children,
especially in focused initiatives that explore improvements to the
organ donation and transplant system. SPLIT, as a society of
multidisciplinary experts on pediatric transplant, is poised and
compelled to serve as a resource for the proposed modernization agenda.
We recognize there are significant improvements needed in our organ
transplant system. In 2019, the pediatric wait list mortality rate for
liver candidates less than 1 year of age exceeded that of adults of all
ages, with a peak rate of 12.1 deaths per 100 wait list years (SRTR
Annual Report, Liver 2018, SRTR Annual Report, Liver 2019). However, we
also need to acknowledge the significant advances and improvements that
have been made. In 2020, after implementation of the new acuity circle
allocation policy, deaths on the pediatric liver wait list reached its
lowest since 2011, at 4.9 deaths per 100 wait list years. For pediatric
liver recipients, we have achieved greater than 90% patient survival
rate at 5 years post-transplant (SRTR Annual Report 2020)--but this
means that transplant was available too late, or that complications
were too overwhelming, to save 1 in 10 of these children. UNOS allows
for data- driven tracking of every U.S. transplant, which is more
comprehensive than tracking for any other medical condition. Access to
this data has allowed for research aimed at improving outcomes in
pediatric transplant patients.
While much recent press has focused on UNOS, improvements are also
needed in individual transplant programs to optimize outcomes for
children. All patients, regardless of geographical location or
resources, need to have equal access to transplant. This includes
access to all graft types--with the surgical expertise and team
willingness to include split and living donor transplant.
A nationally organized system is critical to ensuring equitable access
to organs for children and other difficult to match candidates. It is
important to ensure that this system provides oversight for all
transplant centers and Organ Procurement Organizations to optimize
organ distribution and lives saved. This is not about creating a
monopoly or having one entity run every aspect of organ transplant but
creating shared accountability with adequate oversight.
We implore new entities interested in managing the OPTN to engage with
pediatric groups such as SPLIT. The United Network for Organ Sharing
(UNOS) has made substantial efforts to engage and involve the pediatric
community since its inception, and particularly in the last half-
decade. There is significant risk of losing ground towards the goal of
eliminating pediatric wait list mortality in this modernization effort.
The Health Resources and Services Administration (HRSA) does not
address pediatric patients at all in the modernization announcement nor
in the aims of the initiative.
We strongly encourage including pediatric-focused advocates in any
modernization initiatives proposed by the HRSA, and SPLIT welcomes the
opportunity to participate in all phases of this proposal.
______
TransMedics, Inc.
200 Minuteman Road, Suite 302
Andover, MA 01810
+1 978-552-0900
https://www.transmedics.com/
EXECUTIVE SUMMARY: TransMedics, Inc. applauds the bipartisan leadership
of the Senate Finance Committee for convening this hearing today and
continuing the Committee's longstanding focus on improving
implementation of our national Organ Procurement and Transplantation
Network (OPTN) for the benefit of patients and their families. We
appreciate the Committee's persistent focus on solid organ
transplantation and the impending Health Resources and Services
Administration (HRSA) reforms of the OPTN, and we submit testimony to
kindly urge the Committee to ensure that HRSA preserves flexibility in
the OPTN system to allow innovation, such as the TransMedics' National
Organ Care System Program (``NOP''), to continue to increase the number
of organ transplants in the U.S. working within the OPTN structure.
TransMedics is a medical device company founded by a surgeon two
decades ago to address the unmet need for more and better organs for
transplantation, with a current focus on heart, lung, and liver
transplants. For decades, cold storage (literally ice storage in a
suspended animation state) has been the only option for organ
preservation, dictating strict limits on transportation, timing, and
viability of organs for transplant. However, beginning in September
2021 with its first FDA approval, TransMedics' Organ Care System (OCS)
introduced an entirely new approach to organ transplantation, utilizing
oxygenated blood perfusion technology to keep human organs alive and
functioning (hearts beating, lungs breathing, livers producing bile)
outside of the human body. This technology was validated in large FDA
clinical trials to increase the rate of donor organ utilization for
transplants.
Remarkably, perfusion technology has eliminated the historical time and
distance limitations imposed by cold storage, enabling previously
unutilized organs to reach record numbers of patients in geographic
areas previously unreachable, in better condition, and with better
outcomes. Equipped with FDA approvals for heart, lung, and liver
perfusion devices to facilitate transplants, TransMedics developed the
first national organ surgical recovery and organ clinical management
model using dedicated surgical and clinical expertise to remove
logistical barriers to maximize organ utilization and has dramatically
increased recovery and transplant of lung, heart, and liver donations--
organs that are massively underutilized today in the US. As a result of
these innovations, TransMedics has facilitated more than 2,000
transplants of hearts, lungs and livers that might not have otherwise
been used over the past year and a half.
TransMedics appreciates that transplantation has always been a
collaborative effort, requiring coordination and contribution from
multiple parties, including donors, their families, skilled surgeons
and transplant programs, technology systems, Organ Procurement
Organizations (OPOs), the OPTN, and many other healthcare providers.
TransMedics' innovative approach to organ recovery and transplantation
is already delivering meaningful improvements in heart, lung, and liver
transplants alongside the current OPO/OPTN system and offers tremendous
potential as Congress and HRSA modernize this system.
We share the goal of this Committee and the OPTN, to dramatically
increase organ transplants and facilitate broader utilization and
equitable distribution of these precious lifesaving donor organs. We
support HRSA's OPTN Modernization Initiative as well as the pending
OPTN Modernization legislation. We commend the Senate Finance Committee
and the individual Senators that have worked for years, even decades,
to improve our system to benefit patients and their families, and urge
the Committee to ensure that any reforms implemented in the coming
weeks and months retain the necessary flexibility to permit innovative
technology and programs like the NOP program to continue to thrive and
succeed in increasing transplants across the United States.
BACKGROUND: TRANSMEDICS AND THE OCS SYSTEM
TransMedics has developed the FDA-approved OCS to replace the decades-
old static cold storage standard of care that is significantly limiting
access to lifesaving transplant therapy for hundreds of thousands of
patients worldwide. Since receiving FDA approval in 2021, we have
initiated a national program to provide an end-to-end clinical service
and technology solution for donor organ surgical retrieval, OCS
perfusion, and clinical assessment in collaboration with leading
transplant programs and select OPOs across the U.S. with the primary
goal of increasing utilization of donor organs for transplant.
The OCS technology is the first, and currently the only, portable,
multi-organ platform for extracorporeal, oxygenated blood perfusion of
solid donor organs in a living and functioning state (heart beating,
lungs breathing, and liver producing bile), outside of the human body
for eventual transplantation into recipients who suffer from end-stage
heart, lung, and liver failure. Unlike historic and traditional cold
static-storage methods for solid organ preservation for transplants
(ice coolers and ice to preserve precious vital human organs), the OCS
technology replicates many aspects of the organ's natural living and
functioning environment outside of the human body, which significantly
reduces damage that occurs using cold-storage, enables optimization and
clinical assessment of the donor organ viability for transplantation to
maximize clinical confidence to transplant organs to recipients in
need. The results of clinical trials demonstrate a significant increase
in capacity to preserve transplantable organs and ensure that they
could be used over greater time and distance than had been the case
historically:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Given these results, the OCS held the potential to create a
fundamental paradigm shift in organ preservation by allowing more
organs to remain usable for longer and reach patients in better
condition. In fact, that is precisely what has happened--the OCS was
able to transform the standard of care in transplantation by increasing
donor organ utilization, improving patient outcomes, and reducing
transplant costs. To date, and as discussed in more detail below, use
of the OCS has resulted in more than 2,000 organs transplanted.
The OCS system was particularly timely given that there was a massive
underutilization of hearts, lungs, and livers across the transplant
program. As demonstrated below, in 2022 there were nearly 15,000
deceased donors who were able to contribute a solid organ for
transplant. Yet, while nearly 20,000 kidneys were recovered for
transplant, only 2,700 lungs, 4,100 hearts, and 8,900 livers were
recovered from these same donors. While TransMedics acknowledges that
not every deceased donor was eligible to donate a heart, lung, or
liver, many of these organs that could have been recovered were not,
exacerbating the wait list and impacting both patient care and cost to
the Medicare program.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Securing FDA approval for the OCS system, however, was not enough.
TransMedics quickly recognized that it would need to innovate in
several ways to ensure that its OCS solution would have a material
impact on increasing heart, lung, and liver transplantation nationally.
First, TransMedics built a team of clinical experts who had the
training and experience to recover hearts, lungs and livers from
deceased donors, utilize the OCS system to expand the quality and
duration of the organs itself, and ensure that these revered organs
could reach those on the waiting list for transplantation. TransMedics
worked closely with both UNOS and the OPOs all across the country to
ensure that the benefits of the OCS system could work for transplant
patients. As a result, in 2022 TransMedics was able to facilitate
nearly 1,000 additional heart, lung, and liver transplants above 2021
levels--all at no separate charge to the Medicare program. As
importantly, because of the OCS system, these additional organs were
able to travel farther and last longer on the OCS system than had ever
been the case before, eliminating the historic limitations in
transplanting these fragile organs. The chart below speaks for itself--
and could never have occurred without the OCS perfusion technology.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
TransMedics also learned through its work that the significant
limitations of chartered flights transport of solid organs, with which
this Committee is well familiar, simply were not sufficient to support
the increase in hearts, lungs and livers that needed to be shared
across the country due to UNOS matching. As a result, TransMedics is
building its own network of dedicated aircraft to be available upon
demand and with the capacity to fly the necessary distances needed to
transport needed organs for transplant. The aircraft network is still
growing, and is currently configured as follows:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
We highlight these features to bring to light the innovation that
can, and has, occurred within the transplant system today. Three years
ago, hearts, lungs, and livers were barely being recovered, and were
unable to be used due to highly restricted time and distance
limitations. Due to the innovation described above, in the first
quarter of 2023 alone an additional 430 transplants were performed
though the NOP program, using the specialized organ recovery clinical
team, the OCS perfusion system, and the dedicated transportation
network. And this system was built in partnership with the existing
UNOS infrastructure that helped make the national donor-recipient
``matches'' to ensure that recovered organs got to those in greatest
need notwithstanding the distance, and with the OPOs who partnered with
TransMedics to facilitate the organ recoveries.
RECOMMENDATIONS FOR THE COMMITTEE'S CONSIDERATION
TransMedics appreciates that transplantation has always been a
collaborative effort. Successful organ transplantation requires
significant coordination and contribution from multiple parties
including donors, their families, skilled surgeons and transplant
programs, technology systems, OPOs, the OPTN, and many other healthcare
providers. As reflected in our comments above, TransMedics is committed
to working with all current U.S. transplant stakeholders to develop and
provide the best possible outcomes to those in need of organ
transplantation.
As the February 2022 National Academies of Science, Engineering, and
Medicine (``NASEM'') report titled, ``Realizing the Promise of Equity
in the Organ Transplantation System,'' recognized--components of the
transplantation system suffer from significant variations in
performance, which leads to a system containing inefficiencies and
inequalities. While many of the NASEM conclusions relate to kidney
transplant access (an issue that TransMedics is working on), the
Committee's work also included an examination of heart, lung, and liver
transplants. Historically, the program for heart, lung, and liver
transplants has been limited in its ability to improve the number of
transplants for patients with end-stage organ failure. For the past
decade or longer, donor lungs and hearts have been limited to 20%-30%
of the available deceased donors annually. This significant waste of
valuable and precious resources is now being reversed, thanks to
innovation at multiple levels--the FDA approval of the OCS systems; the
development of specialty teams able to recover hearts, lungs, and
livers, and connect them to the OCS devices; the transportation network
dedicated to ensuring that organs get where they need to be on time and
healthy; and the logistical infrastructure to work with the OPTN and
the OPOs to make it all happen. This innovation has been difficult to
build, and we urge the Committee to ensure that it is preserved and
given the opportunity to thrive.
For these reasons, TransMedics has three recommendations that we ask
the Committee to urge HRSA to adopt:
HRSA's OPTN Modernization Initiative presents an ideal
opportunity to dramatically increase heart, lung, and liver transplants
using latest FDA approved perfusion technologies and a first-of-its
kind national surgical procurement service model to facilitate broader
utilization of precious donor organs for transplants.
Congress should ensure that HRSA considers the option of
contracting or allowing the establishment of a national independent
clinical procurement and medical technology entities focused
exclusively on procurement, clinical management and transportation of
donor heart, lung, and liver for transplants. The current model enables
these national entities to charge transplant programs for the service
directly, rather than charge HRSA for serving as contractor.
At a minimum, the Committee should ensure that HRSA's upcoming
reorganization of the OPTN accommodates this type of creative NOP model
that is demonstrating significant promise in the field today.
We appreciate the Committee's time and attention to this crucial issue,
and we look forward to continuing to partner with the Committee on this
important work.
United Network for Organ Sharing
700 North 4th Street
Richmond, Virginia 23219
The United Network for Organ Sharing (UNOS) appreciates the opportunity
to submit a statement for the record on the Senate Finance Committee's
Health Subcommittee hearing titled ``The Cost of Inaction and the
Urgent Need to Reform the U.S. Transplant System,'' held on July 20,
2023.
UNOS is the mission-driven, non-profit organization that serves as the
nation's organ donation and transplant system--the Organ Procurement
and Transplantation Network (OPTN)--under contract with and oversight
by the Health Resources and Services Administration (HRSA) of the U.S.
Department of Health and Human Services (HHS). We are committed to
working with policymakers to help ensure that the United States
continues to be the leader in successful organ donation and transplant.
UNOS has heard calls from policymakers and stakeholders urging reforms
to the organ donation and transplant system and is embracing change. In
support of a more competitive bidding process, UNOS welcomes HRSA's
modernization initiative \1\ and does not oppose the Securing the U.S.
Organ Procurement and Transplantation Network Act.\2\ As the current
OPTN contractor, UNOS is committed to being an invaluable partner to
HRSA as reforms are implemented.
---------------------------------------------------------------------------
\1\ UNOS Statement Supporting Improvements to the National System,
March 22, 2023, https://unos.org/news/unos-welcomes-competitive-
bidding-process-for-next-optn-contract/.
\2\ UNOS Position on the Securing the U.S. Organ Procurement and
Transplantation Network Act, June 30, 2023, https://unos.org/wp-
content/uploads/UNOS-letter-securing-US-Organ-Transplantation-Network-
Act-063023.pdf.
In keeping with UNOS' goal of seeking to improve the system, under the
new leadership of Maureen McBride, Ph.D., UNOS released an Action
Agenda \3\ in January 2023, which is a set of collaborative reforms
that will strengthen the system and address concerns shared by Members
of Congress and other stakeholders. The Action Agenda also aligns with
the reforms that HRSA announced in March, including a focus on quality
improvement, data transparency, governance and technology. Every aspect
of the agenda is focused on serving patients, and these reforms will
help to bolster and streamline the nation's system.
---------------------------------------------------------------------------
\3\ UNOS Actions to Strengthen the U.S. Organ Donation and
Transplant System, January 30, 2023, https://unos.org/wp-content/
uploads/Actions-to-strengthen-the-US-organ-donation-and-transplant-
system-30-Jan-2023.pdf.
UNOS is actively identifying areas for improvement so that we can adopt
changes that strengthen the system to better serve the patients who
rely on us every day. Being transparent about systemic challenges is
critical because addressing these areas will require action and
collaboration from the entire organ donation and transplant community
---------------------------------------------------------------------------
as well as policymakers.
Consistent with its Action Agenda, UNOS is working to drive change in
key areas including: (1) increasing direct services, tools and
resources to patients, donors, caregivers and their families to more
easily navigate the transplant journey, which could provide information
to candidates about their status on the wait list; (2) reducing the
organ non-use rate (non-use refers to organs recovered for transplant
but ultimately not transplanted); (3) improving equity in access to the
transplant healthcare system; (4) ensuring access to OPTN data; (5)
maintaining safe, modern, and reliable information technology (IT)
systems and infrastructure; (6) reforming the OPTN Membership and
Professional Standards Committee (MPSC) processes; and (7) restoring
trust in the organ donation and transplant system by establishing an
independent OPTN board of directors.
I. Increasing Patient Resources to Navigate the Transplant Journey
A key component of the Action Agenda is patient empowerment through
additional services, tools and resources for patients, donors,
caregivers and their families. Our aim is to help patients and their
families navigate their transplant journey, which can be complex and
burdensome, especially to those already struggling with a difficult
diagnosis, ongoing illness and other sources of stress. HRSA has the
opportunity, as it undertakes OPTN modernization, to ensure patients
have the information they need, including about their status on the
wait list, in an accessible format.
Given the importance of ensuring a patient-centered organ donation and
transplant system, UNOS is advocating that HRSA require the OPTN to
offer more expansive consumer empowerment tools to enable patients to
make choices regarding their care, as well as education and resources
for patients, donors, caregivers, parents, and their families. The next
contract should require, in collaboration with the patient community,
the development of consumer choice tools that include information to
assist patients in finding appropriate care for their needs, timely
updates about new patient benefits or care programs, emerging medical
innovations, and a candidate's status on the wait list to help patients
navigate through the donation and transplant process. Including these
enhanced offerings as part of the OPTN Contract would ensure that the
OPTN serves as a centralized resource to patients and their loved ones
during their journey.
Patients have shared concerns about the lack of clear and readily
accessible information regarding their status on the wait list.
Transplant hospitals, which know their patients best, make the decision
about whether to temporarily inactivate a transplant candidate, meaning
that the candidate will not receive organ offers while in that status.
Neither UNOS nor the OPTN are involved in any decision to inactivate or
reactivate an individual candidate. UNOS does not communicate with
patients about their placement or status on the wait list. The
transplant hospital is responsible for all phases of the patient's
treatment and serves as the first and most authoritative source of
information for patients and their caregivers.
At the direction of a transplant program or by individual choice, a
candidate may have an inactive status on the wait list for a variety of
reasons. In many cases, a transplant team changes a candidate's status
to inactive due to medical factors that would decrease the likelihood
of a successful transplant. For example, a patient may develop a
medical condition, such as cancer, that requires treatment before that
person is healthy enough to receive a transplant. Other reasons that a
transplant hospital may make a candidate inactive include lack of
health insurance, non-
compliance with required transplant medical evaluations, or that the
candidate is waiting for a living donor. Transplant hospitals have the
ability to modify a candidate's waiting list status from active to
inactive, and they must also report to the OPTN a reason for
inactivation. Data regarding the number of candidates who are active or
inactive are publicly available on the OPTN website.
II. Reducing the Organ Non-Use Rate
Any organ not ultimately transplanted represents a profound loss, both
for the selfless donor's family and the patient waiting. Between 2011
and 2020, the annual non-use rate for kidneys was between 18 and 20
percent. Liver non-use since 2011 has been between 8 and 10 percent.
The non-use rate for kidneys increased following a change in kidney
allocation policy and was approximately 25 percent as of March 2022.
The number of deceased-donor organs recovered has increased annually
over the past decade. As the medical criteria for deceased organ
donation continue to broaden, increasing numbers of organs come from
older donors and people who died of circulatory death. The increase in
the number of medically complex donor organs that are recovered and
offered to transplant hospitals corresponds to an increase in the non-
use of organs but also the number of transplants performed and lives
saved.
Livers and kidneys are viable outside of the body longer than hearts
and lungs, so an organ may be recovered before a recipient is
identified or biopsy results of the donor are known, both in the
interest of the patients in need and to best honor deceased donors. The
primary issue for non-use reported to the OPTN is that the wait list
has been exhausted, meaning that all transplant hospitals declined the
organ for their patients. Sometimes, post-recovery biopsy findings may
determine that an organ is not suitable for transplant. As a result,
livers and kidneys that were initially recovered for transplant but
were ultimately determined to not be medically suitable are likely to
have a higher rate of non-use.
UNOS, working in collaboration with members of the organ donation and
transplant community, is pursuing a variety of innovative strategies to
improve organ acceptance rates at hospitals, make it easier to say
``yes'' to organ offers, and save more lives. The OPTN and UNOS are
working to improve acceptance through kidney offer filters, predictive
analytics, an offer acceptance collaborative, transplant hospital
performance metrics, and improvements in the efficiency of
transportation of organs by commercial air. Additionally, the OPTN
Board is establishing a task force to identify additional ways the
community can work together to reduce the non-use rate.
Kidney Offer Filters
The kidney offer filters tool creates a more efficient offer process
and reduces the risk of non-use. The tool enables transplant hospitals
to avoid receiving offers that they would not accept. For example, a
hospital may have a filter that would prevent it from receiving offers
for any donor over a specified age or other medical criteria. The OPTN
recommends filters to hospitals based on offers that they have
historically received but never accepted, and hospitals may design
their own filters as well. With these filters enabled, offers can then
reach programs more willing to accept them sooner.
The tool also shows hospitals data on offers that were filtered from
their program but transplanted at other programs, allowing them to
review and adjust their own acceptance practices and filters. More than
half of kidney transplant programs have elected to use the tool. The
OPTN Board adopted a policy in June 2023 that would automatically turn
on offer filters in all adult kidney transplant programs with the
ability for them to modify or opt out of the offer filters.
Predictive Analytics
In 2023, the OPTN launched the predictive analytics tool, which is
available to all adult kidney programs, with the aim of increasing
organ use rates by providing information about the impact that
accepting or declining an offer could have on a patient. At the time of
an organ offer, the tool uses statistical models to display: (1) the
time-to-next offer, which predicts the length of time the candidate
could wait for another high-quality organ offer; and (2) a mortality
prediction, which offers a visualization of the candidate's likelihood
of survival over the next three years without a transplant. During a
pilot test, participating programs showed a 2.9 percentage point
increase in offer acceptance compared to the previous period, while
programs in the control group did not show an increase.
Offer Acceptance Collaborative
Earlier this year, UNOS brought together 83 transplant hospitals to
participate in the OPTN Offer Acceptance Collaborative. The 6-month
project, launched on January 31, 2023, supports OPTN members as they
work together to improve offer acceptance practices and processes at
their respective transplant programs. The transplant community and
other stakeholders have access to recorded sessions from the kickoff
conference as well as webinars hosted throughout the collaborative.
Transplant Hospital Performance Metrics
In December 2021, the OPTN Board of Directors approved new metrics for
monitoring the performance of transplant programs. The OPTN began to
evaluate transplant programs' offer acceptance rates in July 2023. The
collection of these data will help inform future initiatives to reduce
non-use.
Efficient Transportation of Organs
The current OPTN Contract does not include a task for facilitating,
tracking, or collecting data on the transportation of organs. However,
our Action Agenda includes recommendations to improve the efficiency of
the transportation of organs. UNOS supports provisions in the Federal
Aviation Administration (FAA) reauthorization legislation that would
enable the transportation of donated organs, primarily kidneys and
livers, in the passenger cabin instead of in the cargo hold of an
airplane. Transporting organs through cargo involves more logistical
challenges including restricted schedules, gaps in handling, and less
flexibility. Cargo does not lend itself to the nature of organ
transplant, where organs are viable outside of the body for a limited
amount of time and must be transported at all hours of the day and
night.
Additionally, UNOS developed a travel application to make it easier for
Organ Procurement Organizations (OPOs) to select the most efficient
option to transport organs on commercial flights. It aggregates real-
time flight schedules, driving directions, and critical logistics data
like cargo hours to give users a comprehensive understanding of an
organ's projected travel time and path. The tool is being pilot tested
by a limited number of OPOs. It is expected to be available to all OPOs
later this year.
III. Improving Equity in Access to the Transplant Healthcare System
UNOS is striving for increased equity in access to transplant through
the continuous distribution allocation framework and changes to the
estimated glomerular filtration rate (eGFR) equation and soon to the
kidney donor profile index (KDPI) score. Previously, transplant
hospitals sometimes used a race-inclusive calculation of eGFR to
estimate a candidate's level of kidney function. The KDPI is used to
evaluate every kidney offered for transplant from a deceased donor. It
estimates how long a kidney from that donor may function after a
transplant. UNOS is also seeking authorization for the OPTN to collect
pre-wait list data to understand the burden of end-stage organ failure,
including the prevalence, incidence, and mortality, and barriers that
patients face to being included on the wait list.
Continuous Distribution Allocation Framework
As established by federal law, explicated in what is known as the OPTN
Final Rule,\4\ the OPTN has an obligation to design policies to achieve
equitable organ allocation by distributing organs over as broad a
geographic area as possible and with the sickest patients being served
first regardless of location. In 2010, the Secretary's Advisory
Committee on Organ Transplantation (ACOT) explicitly recommended that
the OPTN develop evidence-based allocation policies not determined by
arbitrary administrative boundaries such as donation service areas
(DSAs), OPTN regions or state borders. Where people live and receive
treatment does not determine the severity of their illness nor priority
for a lifesaving organ.
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\4\ 42 CFR 121.
Continuous distribution is a new organ allocation framework aimed at
making the national system even more equitable and the organ allocation
policymaking process more accessible. This new approach will ensure
more meaningful engagement with patients and the public about the
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values that should guide organ allocation in the United States.
As a result of HRSA's July 2018 directive that the OPTN remove the use
of DSAs in organ allocation policies, the OPTN approved allocation
policies that consider distance between donor and recipient for liver
and kidney transplants as a bridge to the continuous distribution
allocation framework. The liver acuity circles allocation policy
ensures that the sickest patients and children are getting transplants
more quickly than ever before. The kidney allocation policy has
resulted in a 29 percent increase in overall transplant rates and
improved equity in access to transplants for key populations including
Black candidates, Hispanic candidates, Asian candidates, highly-
sensitized candidates, and pediatric candidates.\5\
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\5\ OPTN Kidney Transplantation, Eliminate Use of DSA and Region
from Kidney Allocation Two Year Post-Implementation Monitoring Report,
June 22, 2023, https://optn.transplant.
hrsa.gov/media/4mhfm3oq/
eliminate_use_of_dsa_and_region_from_kidney_allocation_two_year_
post_implementation_monitoring_report_2yr.pdf.
In December 2018, the OPTN Board of Directors approved the continuous
distribution framework for future policy development. Continuous
distribution will consider all patient factors together to determine
the order of an organ offer, and no single factor will decide an organ
match. The score will consider factors like patient medical urgency,
outcomes and biology, in balance with the efficient management of organ
placement, providing the sickest patients with even better access to
lifesaving organs. The goal is to increase fairness by removing all the
hard boundaries that are part of the classification-based system. All
organ systems are transitioning to the continuous distribution model.
The framework was first implemented on March 9, 2023, for lung. In
July, the OPTN published its three-month lung allocation policy
monitoring report \6\ presenting data describing the U.S. transplant
system before and after the allocation policy change. The report showed
an overall decrease in wait list removals due to death or too sick to
transplant.
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\6\ OPTN Lung Transplantation Committee, Lung Continuous
Distribution Three Month Monitoring Report, July 13, 2023, https://
optn.transplant.hrsa.gov/media/fzhh1e5r/data_report_
lung_committee_cd_07_13_2023.pdf.
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Elimination of Inclusion of Race in eGFR Equation
In December 2022, the OPTN Board approved a process to improve
transplant equity by backdating the waiting times of Black kidney
transplant candidates who were disadvantaged by previous use of a race-
inclusive calculation to estimate their level of kidney function. The
Board action requires all kidney transplant programs, starting January
5, 2023, and within one year, to identify those Black kidney candidates
whose current qualifying date was based on the program's use of a race-
inclusive eGFR calculation, and to determine whether a race-neutral
eGFR calculation shows the candidate should have qualified sooner to
start gaining waiting time for a transplant. Programs must then apply
to the OPTN for a waiting time modification for such candidates.
As of July 31, 2023, UNOS, as the OPTN contractor, has completed 7,733
waiting time modifications for kidney transplant candidates who
qualify, submitted by 116 of the 230 kidney transplant programs.
Elimination of Race in KDPI Score
During its June 2023 meeting, the OPTN Executive Committee approved a
new project sponsored by the Minority Affairs Committee to revise the
KDPI score to eliminate the consideration of race and exposure to the
hepatitis C virus (HCV). The KDPI is used to evaluate every kidney
offered for transplant from a deceased donor and estimate how long a
kidney from that donor may function after a transplant. An OPTN working
group that includes key stakeholders from the kidney community has been
established to identify how to revise the KDPI calculation without race
and HCV. UNOS has been working with the Scientific Registry of
Transplant Recipients (SRTR) to develop a simulated allocation model to
evaluate the effects of potential changes to the KDPI score formula.
The OPTN will issue a proposed revision to the KDPI score for public
feedback during the OPTN Winter 2024 comment period.
Collection of Pre-Waitlist Data
The OPTN is currently charged with developing and maintaining equitable
organ allocation policies that apply to wait-listed patients. The OPTN
has been able to continually monitor and adjust organ allocation
policies to improve equity in access to transplants among wait-listed
patients. The OPTN maintains an Equity in Access dashboard \7\ to
enable public research and review of these ongoing efforts and
publishes organ allocation policy monitoring reports for the public.
These resources include data on key equity indicators such as race and
ethnicity, rural vs. urban, insurance type, and education level.
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\7\ Equity in Access to Transplant Dashboard, https://
insights.unos.org/equity-in-access/.
True access to transplant, however, not just the wait list, cannot be
measured without understanding the national disease burden. UNOS calls
for government action to seek broader equity in access to transplant
health care. UNOS seeks authorization for the OPTN to collect data to
identify barriers to equitable access to the wait list and quantify the
national disease burden. More data collection on patients before they
are added to the wait list is necessary to eliminate inequities in
access to the transplant wait list. Such data are important to
understanding patient, population, and transplant program-level factors
that may contribute to inequities in wait list and transplant access,
which could drive research, quality improvement, and other initiatives
for OPTN members to address these inequities.
IV. Ensuring Access to OPTN Data
UNOS is committed to data transparency and accessibility. As the OPTN
contractor, UNOS is required by the OPTN Final Rule to provide data for
research and analysis of the performance of the OPTN or individual
transplant programs. UNOS and the OPTN are similarly required by the
OPTN Final Rule and the OPTN Contract to provide to the Secretary of
HHS or their designees any OPTN data or information that the Secretary
requests.
UNOS responds to formal requests for OPTN data from the public and OPTN
members. Like OPTN members and the public, UNOS must similarly submit
formal requests to obtain OPTN data for the work it performs outside of
its support for the OPTN. In 2022, UNOS received more than 1,400 formal
requests for OPTN data. Anyone can submit a data request through the
OPTN website \8\ and OPTN members can request data through UNetSM,
UNOS' IT system. OPTN members may request data they have previously
submitted to the OPTN at any time, and the OPTN will provide that data
to the OPTN member without charge. Information can be provided in
datasets, so that requesters can perform their own analysis, or in
static reports.
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\8\ Organ Procurement and Transplant Network, Request Data, https:/
/optn.transplant.hrsa.
gov/data/request-data/.
Pursuant to the OPTN Final Rule and the OPTN Contract, patient-
identified data requests require that the requester submit a signed
data use agreement (DUA), a plan to secure the data, a research plan,
and documented approval by an Institutional Review Board (IRB).
Requests for patient-identified data must be approved by HRSA before
UNOS can release the information to the requester. UNOS also has an
obligation as the steward of OPTN data under the OPTN Contract to
secure all OPTN data, and therefore all OPTN data requests are subject
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to restriction on how OPTN data can be stored and used.
Our goal is for the organ donation and transplant community to leverage
data for performance improvement. To that end, UNOS has expanded our
online self-service tools, enhanced and built new public-facing
dashboards, and has a data analytics department to assist with
inquiries.
V. Maintaining Safe, Modern, and Reliable IT Systems and Infrastructure
UNet has been the focus of significant discussion, especially in the
wake of reports from the National Academies of Sciences, Engineering,
and Medicine (NASEM) and the United States Digital Service (USDS) last
year. UNet is the system that helps match donor organs to candidates on
the transplant wait list. In January, UNOS engaged an independent
consulting firm to assess our technology and modernization efforts
against industry best practices and the USDS Digital Services Playbook.
This assessment is in progress. Security, reliability, and
modernization have deservedly received much attention. UNOS has also
focused many of our improvement efforts on the IT system and security.
UNet Improvements
UNOS is making improvements to UNet, including steadily moving the
platform into the cloud, as recommended by our own experts as well as
by NASEM and USDS. The OPTN's predictive analytics tool, which enables
all adult kidney transplant programs to evaluate organ offers through
predictive analytics data, was born in the cloud. Other functions of
UNet are being transitioned to Microsoft Azure and should be in the
cloud next spring. This work will not complete our modernization, but
it is an important step in what is and should be continuous momentum
for improvement. And it will make our system even more secure. As we
work, UNOS is building to the highest industry and federal government
security standards.
Cybersecurity Defenses
HHS Office of Inspector General (OIG) contractors recently conducted
rigorous penetration tests of UNOS' IT security and have told us we
already have established strong defenses against cyberattacks that
exceed what most similar organizations have in place. Nonetheless, we
continue to press for ongoing improvement in this quickly evolving
environment.
Network Reliability
In February, the IT system experienced a 51-minute outage. However,
during the last 15 years, the network has been up and running 99.9
percent of the time, consistent with the target service level agreement
(SLA). By that measure, reliability is good, and getting better, but we
believe we can make additional improvements.
UNOS shares policymakers' concern about patient safety, and UNOS can
confirm that during the February service outage, there were no reported
negative effects on any donor or recipient activity taking place within
the entire organ donation and transplant network. UNOS staff conducted
prompt outreach to all OPTN members who contacted us during the outage
and confirmed that all donor and recipient functions being performed
within UNet before the interruption were completed successfully once
service was restored. We understand that no transplants were put in
jeopardy despite the outage.
As we have shared with HRSA and staff for Chair Ron Wyden (D-OR) and
Sen. Chuck Grassley (R-IA), UNOS has taken and will continue to take
actions to safeguard against future system disruptions. Most
significantly, UNOS implemented additional monitoring and alerts to
ensure visibility of all database conditions that could lead to a
system failure and has accelerated plans to transition the UNet
database into one of the Azure public cloud database platforms.
VI. Reforming MPSC Member Compliance Investigations Processes
In response to concerns that investigations examining compliance with
OPTN membership requirements were not forwarded to the OPTN MPSC for
review, the MPSC implemented improvements in October 2022 to increase
transparency.
Specifically, the MPSC established a new process to review all
investigative activity assessing member compliance with OPTN
requirements and policies. Previously, the MPSC reviewed reports when
investigations revealed potential noncompliance with OPTN obligations.
Staff would consult with MPSC members during the investigation,
particularly for guidance on clinical matters pertaining to medical
judgement and patient safety; however, the full Committee did not
receive information about investigative activity that was not
identified as a potential noncompliance or safety issue.
This process has been reformed to provide the MPSC with greater
information and to aid in its decision making and compliance function.
Now, the MPSC will regularly receive information including but not
limited to:
The number of reports submitted;
The method of receipt, such as the Improving Patient Safety
Portal, Member Reporting Line, and referrals from Patient Services;
Whether the reporter was an OPO, transplant program,
histocompatibility laboratory, patient or donor family member, or
anonymous;
Whether the report was a self-report or about another
organization;
The number of reports that are still pending review, referred to
the MPSC for action, or are not forwarded for an MPSC action; and
For cases not referred to the MPSC for formal action, the MPSC
will receive a brief summary of the nature of the reports and
investigative findings that led to staff's determination not to forward
for MPSC review.
Staff have implemented revised processes and documentation so that
cases are not formally closed until the MPSC has received the
information described above about a case. When the MPSC learns of
issues that are outside of OPTN purview, it informs our HRSA
colleagues.
VII. Restoring Trust in the System by Establishing an Independent OPTN
Board of Directors
Governance of the OPTN has been an area of ongoing attention. UNOS has
requested HRSA engagement since May 2021 to create an independent OPTN
board of directors distinct from the OPTN contractor's board of
directors.
On July 14, 2023, in response to a contract task added by HRSA on May
12, 2023, UNOS submitted an in-depth plan to HRSA for creating an
independent OPTN board. This would clearly establish an OPTN board with
distinct priorities, providing greater role clarity and ensuring trust
in the national system. UNOS recommended to HRSA that this separation
will require the formation of an OPTN corporate entity as required by
the National Organ Transplant Act (NOTA), affirming its establishment
as a private, non-profit entity among other steps.
To ensure seamless continuity, according to this plan, the separation
will occur prior to or coinciding with the end of the current OPTN
Contract. UNOS is committed to working with HRSA to ensure the
successful and timely implementation of any OPTN governance
restructuring plan under the current OPTN Contract to ensure the OPTN
board is independent from the governance of any OPTN contractor.
UNOS appreciates the engagement of Congress, HRSA, and the Centers for
Medicare and Medicaid Services (CMS) on these complex issues. All
stakeholders, including UNOS, share a common mission: Identify,
allocate and transplant as many suitable organs as safely, equitably
and efficiently as possible. We must hold all parts of the system
accountable for making sure that this happens. UNOS extends our
gratitude to Chair Wyden and the other Senators on the Senate Finance
Committee who have worked with UNOS. We look forward to your ongoing
collaboration to improve the system for the benefit of patients,
donors, and their families.
[all]