[Senate Hearing 117-878]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 117-878

                      A SYSTEM IN NEED OF REPAIR:
                   ADDRESSING ORGANIZATIONAL FAILURES
                  OF THE U.S.'S ORGAN PROCUREMENT AND
                        TRANSPLANTATION NETWORK

=======================================================================

                                HEARING

                               BEFORE THE

                          COMMITTEE ON FINANCE
                          UNITED STATES SENATE

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             SECOND SESSION
                               __________

                             AUGUST 3, 2022
                               __________


                  [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                                     
                                     

            Printed for the use of the Committee on Finance
                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE
                    
56-327--PDF               WASHINGTON : 2024   

                          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         RICHARD BURR, North Carolina
SHERROD BROWN, Ohio                  ROB PORTMAN, Ohio
MICHAEL F. BENNET, Colorado          PATRICK J. TOOMEY, Pennsylvania
ROBERT P. CASEY, Jr., Pennsylvania   TIM SCOTT, South Carolina
MARK R. WARNER, Virginia             BILL CASSIDY, Louisiana
SHELDON WHITEHOUSE, Rhode Island     JAMES LANKFORD, Oklahoma
MAGGIE HASSAN, New Hampshire         STEVE DAINES, Montana
CATHERINE CORTEZ MASTO, Nevada       TODD YOUNG, Indiana
ELIZABETH WARREN, Massachusetts      BEN SASSE, Nebraska
                                     JOHN BARRASSO, Wyoming

                    Joshua Sheinkman, Staff Director

                Gregg Richard, Republican Staff Director

                                  (II)

                            C O N T E N T S

                              ----------                              

                           OPENING STATEMENTS

                                                                   Page
Wyden, Hon. Ron, a U.S. Senator from Oregon, chairman, Committee 
  on Finance.....................................................     1
Grassley, Hon. Chuck, a U.S. Senator from Iowa...................     3

                               WITNESSES

Shepard, Brian, chief executive officer, United Network for Organ 
  Sharing (UNOS), Richmond, VA...................................     5
Brockmeier, Diane, R.N., BSN, MHA, president and CEO, Mid-America 
  Transplant, St. Louis, MO......................................     7
Friedman, Barry S., R.N., BSN, executive director, AdventHealth 
  Transplant Institute, Orlando, FL..............................     9
Henry, Calvin, Region 3 Patient Affairs Committee (PAC) 
  representative, Organ Procurement and Transplantation Network 
  (OPTN), Dacula, GA.............................................    10
Locke, Jayme E., M.D., MPH, director, Division of Transplantation 
  Surgery, Heersink School of Medicine, University of Alabama, 
  Birmingham, AL.................................................    12

               ALPHABETICAL LISTING AND APPENDIX MATERIAL

Brockmeier, Diane, R.N., BSN, MHA:
    Testimony....................................................     7
    Prepared statement with attachments..........................    37
    Responses to questions from committee members................    48
Friedman, Barry S., R.N., BSN:
    Testimony....................................................     9
    Prepared statement...........................................    57
    Responses to questions from committee members................    60
Grassley, Hon. Chuck:
    Opening statement............................................     3
Henry, Calvin:
    Testimony....................................................    10
    Prepared statement with attachment...........................    63
    Responses to questions from committee members................    68
Locke, Jayme E., M.D., MPH:
    Testimony....................................................    12
    Prepared statement...........................................    71
    Responses to questions from committee members................    76
Shepard, Brian:
    Testimony....................................................     5
    Prepared statement with attachments..........................    79
    Responses to questions from committee members................   140
Wyden, Hon. Ron:
    Opening statement with attachments...........................     1
    Prepared statement...........................................   186

                             Communications

Abraham, Jaison M................................................   199
American Society of Nephrology...................................   199
Association of Organ Procurement Organizations...................   202
Center for Fiscal Equity.........................................   206
Guidehouse, Inc..................................................   209
Hughes, Suzanne..................................................   213
Hypertrophic Cardiomyopathy Association..........................   214
Ischemic Injured Organs and Limbs Foundation.....................   215
Ison, Michael G., M.D., MS et al.................................   223
Mississippi Organ Recovery Agency................................   225
National Down Syndrome Society...................................   226
National Kidney Foundation.......................................   227
Organ Donation Consortium........................................   233
Organ Procurement and Transplantation Network Patients Affairs 
  Committee......................................................   234
Paragonix Technologies, Inc......................................   236
Science in Donation and Transplant...............................   239
Silverstein, Amy.................................................   243
Starzl Network for Excellence in Pediatric Transplantation.......   245
Tennessee Donor Services.........................................   247
Transplant Families..............................................   248
Transplant Surgeon...............................................   254
University of Pittsburgh Medical Center..........................   254
Vanderbilt University Medical Center.............................   258

 
                      A SYSTEM IN NEED OF REPAIR:
                   ADDRESSING ORGANIZATIONAL FAILURES
                  OF THE U.S.'S ORGAN PROCUREMENT AND
                        TRANSPLANTATION NETWORK

                              ----------                              


                       WEDNESDAY, AUGUST 3, 2022

                                       U.S. Senate,
                                      Committee on Finance,
                                                    Washington, DC.
    The hearing was convened, pursuant to notice, at 2:30 p.m., 
in Room SD-215, Dirksen Senate Office Building, Hon. Ron Wyden 
(chairman of the committee) presiding.
    Present: Senators Cardin, Brown, Casey, Cortez Masto, 
Warren, Grassley, Thune, Portman, Cassidy, Young, and Barrasso.
    Also present: Democratic staff: Melissa Dickerson, 
Investigator; Daniel Goshorn, Chief Investigative Counsel; 
Joshua Sheinkman, Staff Director; and Ryder Tobin, 
Investigative Counsel. Republican staff: John O'Hara, 
Republican Trade Policy Director and Counsel; and Caitlin Soto, 
Senate Committee on the Judiciary Oversight Counsel for Senator 
Grassley.

   OPENING STATEMENT OF HON. RON WYDEN, A U.S. SENATOR FROM 
             OREGON, CHAIRMAN, COMMITTEE ON FINANCE

    The Chairman. The Finance Committee will come to order.
    The last place anybody wants to hear about gross 
mismanagement and incompetence is in the business of saving 
lives. That's precisely and unfortunately what the Finance 
Committee meets to discuss today. This morning's hearing is an 
update on an investigation Senator Grassley and I, along with 
Senator Cardin and Senator Young, have been conducting for more 
than 2\1/2\ years. It examines the network of dozens of 
organizations that manage organ transplants, and particularly 
the group that oversees and coordinates them, the United 
Network for Organ Sharing, or UNOS.
    We have reviewed 100,000 UNOS documents totaling more than 
a half-million pages. Before I get to specific findings, I want 
to frame what we have learned as simply as possible.
    Far too many Americans are dying needlessly because UNOS 
and many of the transplant organizations it oversees are 
failing and seem uninterested in improving. These issues 
involve an alphabet soup of acronyms and organizations, so I 
will start out with a bit of background. A 1984 law created the 
first computerized system to match sick patients with the 
organs they need. It was named the Organ Procurement and 
Transplantation Network. Someone needed to manage that system 
for the whole country, so the government sought to contract an 
organization to run it. UNOS was the only bidder for that first 
contract in 1986. The contract has come up for bid seven other 
times. UNOS has won all seven.
    Today, the network UNOS oversees is made up of nearly 400 
members, including 252 transplant centers and 57 regional 
organizations known as organ procurement organizations, or 
OPOs. Each OPO has a defined geographic service network. A 
family sitting in a hospital room thinking about donating a 
loved one's organ does not have a choice of OPOs.
    Those are the important terms to remember here. When a 
kidney donated in Corvallis needs to get to a patient in 
Portland, that is where an OPO comes in. UNOS oversees the 
OPOs. As our investigation shows, UNOS does this job quite 
poorly.
    Serious errors in the procurement and transplant system are 
shockingly common. Between 2010 and 2020, more than 1,100 
complaints were filed by patients and families, staff, 
transplant centers, and others. The nature of these complaints 
runs the gamut. For example, in a number of cases OPOs had 
failed to complete critical, mandatory tests for matters like 
blood types, diseases, and infection.
    Our investigation found one patient died after being 
transplanted with lungs that a South Carolina OPO marked with 
the wrong blood type. Similar blood-type errors happened 
elsewhere, and patients developed serious illness. Some had to 
have organs removed after transplant. Another patient was told 
he would likely die within 3 years after an OPO in Ohio 
supplied him with a heart from a donor who had died of a 
malignant brain tumor. UNOS did not pursue any disciplinary 
action. In a case from Florida, another patient contracted 
cancer from transplanted organs, and the OPO sat on the 
evidence for months.
    In total, our investigation found that between 2008 and 
2015, 249 transplant recipients developed a disease from 
transplanted organs. More than a quarter of them died.
    Delivering organs has been another source of life-
threatening errors. We found 53 such complaints between 2010 
and 2020, as well as evidence that this was just the tip of the 
iceberg. In some cases, couriers missed a flight. In others, 
the organs were abandoned at airports. Some organs were never 
picked up. Many of these failures resulted in organs being 
discarded.
    It is reasonable to assume that many more errors are going 
unreported. Why? Because filing official complaints with UNOS 
appears to accomplish zero productive oversight or reform. 
Organ transplant professionals repeatedly told the Finance 
Committee that the UNOS complaint process was--and I quote 
here--``a black hole.'' Complaints went in, UNOS went quiet.
    In interviews with the committee, UNOS leaders have dragged 
their feet, dodged tough questions, and shifted responsibility 
onto others. Investigations and disciplinary measures rarely 
amount to much more than a slap on the wrist. Only one time--
just once--has UNOS recommended that an OPO lose their 
certification.
    The bottom line is that the failures we uncovered cost 
lives. Thousands of organs donated each year wind up discarded, 
including one in four kidneys. Yet according to Federal data, 
roughly 6,000 Americans die every year while waiting for an 
organ transplant. This kind of mismanagement has a 
disproportionate impact on minority Americans. African 
Americans, for example, have a greater need for kidney 
transplants than other demographic groups.
    The Centers for Medicare and Medicaid Services recently 
issued new standards for OPO performance, and more than a third 
of OPOs are failing to meet them. Fixing what's broken could 
substantially increase the supply of lifesaving organs 
available for transplant.
    Finally, another area of the committee's investigation has 
examined the IT, the information technology, used by UNOS to 
run the transplant network. This system is outdated, 
mismanaged, and insecure. Using such decrepit technology to run 
the transplant network puts lives in danger and puts sensitive 
data at risk, and apparently there is no solution in sight.
    In a report issued last year titled ``Lives Are at Stake,'' 
the U.S. Digital Service flatly concluded that UNOS does not 
have the technical capability to modernize the system.
    I am going to close like this: if you looked at the staff 
at UNOS and many of the Nation's OPOs, I would wager the vast 
majority are hardworking, good people doing their best to save 
lives. The glaring issues uncovered in our investigation stem 
from failures at the top--leadership failures. Our 
investigation is ongoing. It's clear the system needs reform 
badly. We are going to keep digging into issues at UNOS and the 
OPOs, as well as the policies that need changing at the Federal 
level. This is not a partisan subject. Everybody wants the 
system to work with as few errors as possible.
    We have been conducting a bipartisan investigation on this 
for some time. I want to commend Senators Grassley, Cardin, and 
Young. The three of them have been working very closely with 
us. This is a thoroughly bipartisan inquiry. I want to thank 
Senator Cardin, who is here, Senator Grassley who is here. I 
also see Senator Thune here. So, we are going to have a lot of 
members interested in this. I see Senator Warren as well.
    And I want to thank our witness panel for joining the 
committee today.
    [The prepared statement of Chairman Wyden appears in the 
appendix.]
    The Chairman. Senator Grassley?

           OPENING STATEMENT OF HON. CHUCK GRASSLEY, 
                    A U.S. SENATOR FROM IOWA

    Senator Grassley. Yes, thank you, Mr. Chairman. Today we 
want to talk about the U.S. Organ Procurement and 
Transplantation Network and its government contractor 
overseeing this program, the United Network for Organ Sharing.
    In 1984, Congress passed the National Organ Transplant Act, 
a bill cosponsored by the late Senator Orrin Hatch, a friend of 
mine and former chairman of this committee. A few years later 
in 1998, the Federal Government contracted with the United 
Network for Organ Sharing to oversee the transplantation 
network.
    The network performs three critical functions on behalf of 
the Federal Government: policymaking, technology delivery, and 
oversight of member compliance with its policies and with its 
procedures. However, for more than a decade now, government 
watchdogs and the media have questioned the adequacy of the 
network's oversight. That is because of multiple reports of 
fraud, waste, and abuse; criminality; deadly patient safety; 
and failure to recover organs.
    Some have even observed that the network is 15 times more 
likely to lose, damage, or mishandle an organ in transit than a 
passenger airline is to lose its luggage. I have written about 
all these issues and more, going way back to 2005.
    Sadly, the Federal Government has only recently begun to 
take action. As a result, thousands of organs go to waste each 
year, resulting in lives lost and billions of dollars wasted. 
This system is even worse for people of color and rural 
residents, who are less likely to get on the wait list, and 
less likely to find a match. At least among themselves, the 
network's senior leadership admits these facts.
    One official's response to these concerns was to suggest 
rural Americans were dumb and should be just moved somewhere 
else to obtain lifesaving treatment. And of course, that 
attitude is totally unacceptable.
    Now a bit more about the investigation into the network. In 
February of 2020, this committee sent a letter to the network 
requesting information and data on its oversight of the 
transplantation organization. We found that there is a huge 
variability in how well organ procurement organizations, known 
as OPOs, are serving their communities. In fact, according to 
the Centers for Medicare and Medicaid Services, as many as 22 
of the 57 OPOs are failing outcome and performance metrics. 
This variability has negative consequences for the 
transplantation network and causes transplant hospitals to have 
fewer organs for patients on the wait list.
    We also found that the network has a broken governance 
system that fails to hold its members accountable for 
reoccurring patient safety issues. Now as I said, once again 
when I started looking into this way back in 2006, the network 
acts like, quote, ``the fox guarding the chicken house,'' end 
of quote, instead of a trustworthy and independent oversight 
body that holds its members accountable. As such, 
transportation failures, ABO blood type testing, and allocation 
errors are common occurrences at underperforming OPOs.
    So, Mr. Chairman, it is about time, and very timely that we 
hold this hearing. Congress has waited too long to fix a broken 
system. We must insist upon accountability moving forward. 
Patients' lives are at stake.
    Thank you.
    The Chairman. Thank you very much, Senator Grassley. As I 
noted in my opening statement, I am very glad that we have 
Senator Young here as well. Senator Young, Senator Grassley, 
Senator Cardin, and I have been at this for some time, and this 
has been thoroughly bipartisan.
    The committee has made a number of important findings 
during this bipartisan inquiry. We believe it is in the 
public's best interest to see these results.
    Therefore, I ask unanimous consent to enter the committee's 
hearing memo and all supporting documents related to that memo 
into the record.
    [The documents have been posted to the committee's 
website.]
    The Chairman. Let me now introduce our guests. We are 
pleased that they are here. Mr. Shepard is the chief executive 
officer of United Network for Organ Sharing. His organization 
currently holds the government contract for the Organ 
Procurement and Transplantation Network. He has been in this 
role since 2012. Prior to joining UNOS, he served for 15 years 
in various positions with the Virginia State Government.
    Diane Brockmeier is here. She is the president and CEO of 
Mid-America Transplant, an organ procurement organization 
located in St. Louis, MO. A nurse by training, Ms. Brockmeier 
started her career at Mid-America as the organ procurement 
coordinator in 1986. In 2016, she became the president and CEO, 
overseeing the organization's operations, including 
partnerships with more than 120 hospitals and transplant 
centers located throughout Missouri, northeast Arkansas, and 
southern Illinois.
    Mr. Barry Friedman is here. He is the executive director of 
the AdventHealth Transplant Institute in Orlando, FL. This is a 
position he has held since January of 2020. He began his 
civilian career in organ transplantation as an ICU staff nurse 
in St. Louis, MO in 1985 and has over 30 years of experience in 
the transplant community, including roles in leadership 
positions at transplant centers around the country. He has also 
had a distinguished military career.
    Calvin Henry is the Region 3 representative on the OPTN 
Patient Affairs Committee. In 2012 he received a double lung 
transplant at Houston Medical Hospital after being diagnosed 
with an untreatable lung disease considered to be a terminal 
illness. Now a successful lung transplant recipient, he runs 
marathons. Mr. Henry has a professional background in health 
information. He also volunteers as a patient mentor for his 
local transplant center in Georgia to connect those on the wait 
list with education on financial resources. Mr. Henry asked 
that a letter from the Patient Affairs Committee urging 
immediate reforms in the transplant system be entered into the 
record. Before he begins his statement, I ask unanimous consent 
to do so.
    And Dr. Jayme Locke is an abdominal transplant surgeon at 
the University of Alabama, Birmingham, where she is a professor 
and the chief of the Division of Transplantation, among other 
positions. A graduate of Duke University, she completed her 
medical degree at East Carolina University and her surgical 
residency at Johns Hopkins.
    We want to thank all our guests for their participation, 
and we will begin with Mr. Brian Shepard.

  STATEMENT OF BRIAN SHEPARD, CHIEF EXECUTIVE OFFICER, UNITED 
         NETWORK FOR ORGAN SHARING (UNOS), RICHMOND, VA

    Mr. Shepard. Thank you, Mr. Chairman, members of the 
committee. Thank you for inviting me to discuss our Nation's 
organ donation and transplant system, the role of the United 
Network for Organ Sharing, or UNOS, and our community's ongoing 
efforts to increase transplantation.
    My name is Brian Shepard. I am the CEO of UNOS, the 
mission-driven nonprofit which holds the Federal contract to 
serve as the U.S. organ donation and transplant network. In my 
role, I have seen up close the power of organ donation and 
transplants, lifting and sustaining the families of organ 
donors and restoring and inspiring transplant recipients.
    Through NOTA, Congress intentionally put organ allocation 
policy in the hands of the clinical, professional, and patient 
community. UNOS works with transplant hospitals, OPOs, and 
patients to address the most important issues in donation and 
transplant, and we leverage experts in the fields of technology 
research and science to continually improve the national 
system.
    We convene a community of diverse professionals and 
patients, sometimes with very strongly held opinions, and 
leverage that very diverse set of opinions into a system that 
provides the greatest possible benefit to patients awaiting 
transplants. In fact, all of the committed individuals on this 
panel with me have served on or even led at least one OPTN 
committee, and two of them have even served on the board of 
directors. And their opinions and insights have helped shape 
the system that we have today.
    Today I look forward to having a conversation about that 
system, a system that just marked its ninth consecutive record-
setting year of lifesaving transplants and surpassed 41,000 
transplants in the year 2021, a total never before achieved in 
a single year by the United States or any other country in the 
world.
    Transplantation on that scale would have been hard to 
imagine in 1984 when Congress passed the National Organ 
Transplant Act. The law established the OPTN to maintain a 
national registry for organ matching, and specified that that 
network would be a private, nonprofit entity. And it has been 
an honor to serve the Nation for over 3 decades. But we also 
realize that UNOS is not the final word in donation and 
transplant. We are part of a multifaceted system of improvement 
and oversight that includes multiple Federal agencies, 
including important roles for HRSA, CMS, CDC, FDA, and NIH.
    Consistent with the Institute of Medicine recommendations 
and best practices in health-care quality, the OPTN's 
authorizing regulation creates a role of peer monitoring and 
quality improvement that complements but is very different from 
the regulatory certification and oversight role granted to CMS 
to support their role.
    UNOS's work is bounded by NOTA, the OPTN final rule, and 
the OPTN contract, and focuses on three main areas: developing 
equitable allocation policies; maintaining the national wait 
list and offering matches to patients through safe, secure, and 
modern technology; and continuing to improve performance 
through peer review. All of our work is closely overseen by 
HRSA, who serve as members on all of our 19 committees and our 
national board of directors.
    That is the community that UNOS is so proud to be a part 
of, a community dedicated to the equitable distribution of 
organs, no matter who you are or where you live. We have made 
rapid and remarkable changes in the past few years alone, 
changes that have expanded equitable access to transplants for 
candidates on the list; increased priority for the sickest 
patients; and reduced disparities between races, ethnicities, 
and geographies. But there is always more to do.
    There are over 100,000 Americans waiting for an organ as we 
speak. Even as 115 patients are successfully transplanted every 
day, another 17 die waiting. We cannot rest until every patient 
who needs a transplant is able to get one.
    By building on the successes of our national system and our 
community's ongoing efforts, we can come together around that 
vision. And when we do, our work literally saves lives. UNOS 
stands ready to work with any Senator on potential legislation, 
to provide information, or to serve as a resource.
    Thank you again for inviting me to discuss the status of 
donation and transplant, and I look forward to taking your 
questions.
    [The prepared statement of Mr. Shepard appears in the 
appendix.]
    The Chairman. Thank you, Mr. Shepard.
    Ms. Brockmeier?

 STATEMENT OF DIANE BROCKMEIER, R.N., BSN, MHA, PRESIDENT AND 
           CEO, MID-AMERICA TRANSPLANT, ST. LOUIS, MO

    Ms. Brockmeier. Chairman Wyden and members of the 
committee, my name is Diane Brockmeier, and I am the president 
and CEO of Mid-America Transplant, the organ procurement 
organization serving eastern Missouri, southern Illinois, and 
northeastern Arkansas. Thank you for the opportunity to speak 
today.
    At our organization, we follow the ethos of ``every donor, 
every time.'' Our team is committed to giving donors and their 
families the care they deserve, while stewarding their gifts to 
patients desperately in need.
    Mid-America Transplant depends on the broader national 
transplant system administered by UNOS to accomplish this work. 
We need to urgently address patient safety. Each organ lost due 
to system or provider failure has a consequence to the 
thousands of patients waiting for a transplant. Furthermore, a 
discarded organ fails to honor the heroic gift from a selfless 
donor and compounds the family's sense of loss.
    UNOS lacks urgency and accountability around identifying 
and remediating this preventable loss of organs, and they are 
not required to publicly report adverse events when patients 
are harmed, organs are lost, or the quality of patient care is 
deemed unsafe.
    UNOS does not require clinical training, licensure, or 
certification standards for OPO staff delivering critical 
patient care. In this environment, who is looking out for the 
patient? Who is being held accountable for poor patient care? 
No OPO has ever actually been decertified, regardless of its 
performance or its safety record.
    UNOS has failed to align its efforts to ensure patient 
safety at the system level, and this decision has tragic and 
deadly consequences. We must update the archaic technology 
system at UNOS. As OPOs, we are required to work with UNOS's 
technology--DonorNet--every day. DonorNet is outdated, 
difficult to use, and often slow to function when every minute 
counts. Manual entry subjects it to error, and OPO and 
transplant center staff are not empowered with the right 
information when time is critical. I did serve in leadership 
roles on the OPO committee from 2017 to 2022. Committee members 
and industry leaders voiced repeated requests to improve 
DonorNet. The consistent response was: UNOS IT did not have the 
bandwidth to address this work.
    The limitations of the UNOS technology are delaying and 
denying transplants to patients who are dying on the wait list. 
Poor technology impacts the disturbingly high kidney discard 
rate in the United States, where one in four kidneys never make 
it to a patient for transplantation.
    Critical time is lost due to the inefficiency of DonorNet, 
wasting time on offers that will not be accepted. Of course, an 
available organ should be offered to the patient in list 
sequence. However, far too much of the matching, particularly 
on older donors and organs that are difficult to place, is left 
to the individual OPOs and transplant centers to find each 
other despite, rather than facilitated by, UNOS technology.
    Mid-America Transplant intentionally identifies surgeons 
who accept kidneys that have been repeatedly turned down many 
times. These are lifesaving options for those patients.
    In May of 2022, one of these patients was number 18,193 on 
the list. Relying on DonorNet alone, that kidney would never 
have been placed, and the chance to save a life would have been 
wasted. When an OPO goes out of sequence to place an organ that 
would otherwise be thrown away, UNOS requires an explanation. 
However, when organs are recovered and discarded, UNOS remains 
silent.
    We must remove conflicts to ensure effective governance. 
From 2018 to 2020, I served as a board member for the OPTN. 
Serving on the board of the OPTN automatically assigns 
membership to the UNOS board. My board experience revealed that 
at times UNOS's actions are not aligned with its fundamental 
vision of a lifesaving transplant for everyone in need.
    How can you fairly represent the country's interest and a 
contractor's interest at the same time? Board members are often 
kept in the dark about critical matters and are marginalized, 
particularly if they express views that differ from UNOS 
leadership.
    Preparatory small group calls are conducted prior to board 
meetings to explore voting intentions. And if the board member 
was not aligned with the opinion of UNOS leadership, follow-up 
calls were initiated. Fellow board members reported feeling 
pressured to vote in accordance with UNOS leadership.
    I implore the committee, along with CMS and HRSA, to ensure 
that those who speak out in support of system reform are not 
penalized. Patients deserve a transparent, accountable system 
that works on their behalf.
    To protect patients, I urge Congress and the administration 
to separate the OPTN functions into different contracts so that 
patients can be served by best-in-class vendors; to immediately 
separate the boards of the OPTN and OPTN contractors; and to 
ensure that patients are safeguarded through open data from 
both the OPTN and OPOs. Your immediate action on this matter 
will save lives.
    [The prepared statement of Ms. Brockmeier appears in the 
appendix.]
    The Chairman. Thank you very much, Ms. Brockmeier.
    Next will be Mr. Barry Friedman.

STATEMENT OF BARRY S. FRIEDMAN, R.N., BSN, EXECUTIVE DIRECTOR, 
         ADVENTHEALTH TRANSPLANT INSTITUTE, ORLANDO, FL

    Mr. Friedman. Chairman Wyden, Ranking Member Crapo, Senator 
Grassley, and members of the committee, on behalf of 
AdventHealth, I am honored to provide testimony on the current 
state of organ transplant policy in the United States. My 
testimony reflects 30 years of health-care and transplant 
experience and my direct leadership involvement in the United 
Network for Organ Sharing, and the Organ Procurement 
Transplantation Network.
    I currently serve as the executive director of the 
AdventHealth Transplant Institute, one of the busiest centers 
in the United States, having performed nearly 5,000 
transplants. I take very seriously our sacred duty to the 
families and patients who entrust us with the gift of life to 
provide for organ transplants.
    It is our duty to be good stewards of these organs, 
honoring the faith of these families and the health of our 
communities. Families in need of lifesaving organs have no 
other option but to trust the organ transplantation system that 
is in place. This system has failed many patients waiting for 
organ transplants, due to the lack of oversight and 
accountability. Approximately 23 percent of kidneys procured 
from deceased donors are not used and instead discarded, 
resulting in preventable deaths.
    It is our responsibility to address this issue. Organ 
transportation is a process left to federally designated organ 
procurement organizations, OPOs. Currently, they develop their 
own relationships with carriers, rely on airlines, charter 
flights, ground transportation, and Federal agencies to 
facilitate transportation. In many cases, organs must connect 
from one flight to another, leaving airline personnel 
responsible for transfers. While anyone can track their Amazon 
or FedEx package, there is currently no consistent way of 
tracking these lifesaving organs.
    The transplant community promoted the use of GPS tracking 
of organ shipments, and UNOS piloted an organ tracking system. 
This system was not dependable, therefore we opted out and now 
are working with a company that uses less-expensive, higher-
quality trackers and can monitor shipments in real time.
    Currently there is no requirement for OPOs to use tracking 
systems. Data availability and transparency are key to 
improving organ procurement, and UNOS has not proven capable of 
providing this function.
    OPTN technology has significant interoperability challenges 
and lags behind other technology platforms. This contributes to 
a fractured flow of information between OPOs, donor hospitals, 
and transplant programs. I also believe there is a conflict of 
interest related to the management of IT functions by UNOS, as 
the IT tools they offer transplant centers come with additional 
costs, despite them being essential for the safety and 
management of organs.
    UNOS is not effectively screening organ donors so that they 
can be quickly directed to transplant programs. UNOS asks 
centers to voluntarily opt out of certain organs via a 
filtering process. As a result, OPOs waste valuable time making 
organ offers to centers that will never accept them.
    Time wasted equates to prolonged cold ischemic time and 
organs not placed, resulting in lost organ transplant 
opportunities. This creates a vicious cycle that disadvantages 
patients on the wait list. Due to the limited expertise that 
UNOS has in the placement of organs, it would be best if they 
were no longer responsible for the development of organ 
placement practices.
    The UNOS policymaking process lacks transparency. Currently 
OPTN board members concurrently serve as the board members of 
UNOS, which creates a conflict of interest that contributes to 
this lack of transparency. UNOS committees are formed in a 
vacuum. There is no call for nominations, and no data shared 
with the transplant community to explain the rationale behind 
decisions that create policy change.
    A perfect example of this was seen recently during the 
kidney allocation change in policy where a geography committee 
was formed. This committee that was created, created an 
inequitable distribution of organs. The committee was 
instrumental in creating this policy, which resulted in a high 
kidney discard rate, which also caused increased cost and 
challenges with transportation.
    Most importantly in this equation, we are jeopardizing the 
trust of our most precious resource--organ donors and their 
families, and the recipients of those who receive these organs.
    The challenges that I have detailed to you are fixable, and 
we need to reempower the UNOS membership and increase patient 
advocacy representation within the policymaking process. We can 
implement interoperable technology, increase transparency, 
adopt real-time GPS tracking of organs, improve organ offers 
with the placement of friendly strategies, and reduce organ 
discard rates.
    We applaud the Senate Finance Committee for listening and 
learning today and thank you for providing the United States of 
America the opportunity to maintain the stellar clinical care 
for patients who require lifesaving organ transplants.
    [The prepared statement of Mr. Friedman appears in the 
appendix.]
    The Chairman. Thank you very much, Mr. Friedman.
    Next, we are going to have Mr. Calvin Henry, who I believe 
is going to be testifying virtually. Mr. Henry, are you out 
there in cyberspace?
    Mr. Henry. I am.
    The Chairman. Wonderful. We would like to hear from you.

 STATEMENT OF CALVIN HENRY, REGION 3 PATIENT AFFAIRS COMMITTEE 
  (PAC) REPRESENTATIVE, ORGAN PROCUREMENT AND TRANSPLANTATION 
                   NETWORK (OPTN), DACULA, GA

    Mr. Henry. Good afternoon, Chairman Wyden, Ranking Member 
Crapo, and members of the committee. My name is Calvin Henry, 
and I serve on the OPTN Patient Affairs Committee, the Region 3 
representative for the southeastern United States and the U.S. 
territories of the Virgin Islands and Puerto Rico.
    I am also a double-lung transplant recipient of 9\1/2\ 
years. I have spent much of that time as a dedicated patient 
advocate, in direct support of transplant candidates and 
recipients, organ donation, and as a strong proponent for 
system-wide improvements and transparency throughout the organ 
procurement and transplantation process.
    It is a privilege to be invited here today to share my 
thoughts regarding the current state of this system. Let me 
share my experience navigating the transplant system.
    Fifteen years ago, I was diagnosed with a terminal lung 
disease that was later identified as scleroderma and informed 
that my only option for survival was to receive a double-lung 
transplant. I was told, however, that I was unlikely to receive 
one, and that I should just begin making end-of-life 
preparations.
    The next several years after that diagnosis were perilous. 
On three separate occasions, I nearly lost my life due to the 
adverse effects of the disease. I was also diagnosed with 
achalasia, a serious and disqualifying disorder for transplant. 
The rejection I received from that program launched an arduous 
solo effort, without the assistance of any organization, to 
locate another program that would take me on as a patient.
    The specific circumstances of my own experiences may be 
unique, but the constant difficulties in accessing transplant 
services are all too common. I was fortunate because I had the 
means, including access to good insurance, that allowed me to 
travel to another State to receive care.
    That is not always the case. I want to highlight the 
disparities and inequitable access to transplant services that 
disproportionately harm Black people and people to color who do 
not have the resources to access transplants in these 
circumstances.
    This committee has previously highlighted that the organ 
donation system's failures are an urgent health equity issue. 
Across the board, the numbers for kidney failure for Hispanic 
Americans, Black Americans, and Native Americans are far worse 
than White Americans.
    We also know that Black people and people of color are less 
likely to receive transplants. Research has also documented 
that often Black families receive differential treatment from 
OPOs. As former Surgeon General Dr. Ken Moritsugu noted: 
``Often, misallocation of OPO resources found that OPOs do not 
respond to all donation cases, or do not properly train and 
support their front-line staff.''
    The impact of this, he said, unsurprisingly falls 
disproportionately on families of color. The donor study showed 
the U.S. may be recovering as few as 28,000 organs each year. 
According to the chief of transplant at Vanderbilt, who 
testified at the House Oversight hearing last year, if the 
system were fully functioning, there would be no waiting list 
for livers, hearts, or lungs within 3 years, and the kidney 
wait list would be dramatically reduced.
    The leaders, and several of my colleagues on the OPTN 
Patient Affairs Committee, asked me to submit a letter, 
included in my full written testimony. I have joined them. 
Among the messages to you: 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 wait 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.
    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, and we implore you to ensure that UNOS does not hold 
patients hostage in the process.
    Senators, I urge you all to act to ensure that we make 
better use of the organs that are donated, to ensure that 
health equity issues with Black people and people of color are 
addressed, and that the glaring technology issues causing 
patients harm are quickly remedied.
    I thank you for your time.
    [The prepared statement of Mr. Henry appears in the 
appendix.]
    The Chairman. Mr. Henry, thank you very much, sir, for your 
participating. And also, colleagues, I want to note that he has 
asked that a letter from the Patient Affairs Committee urging 
immediate reforms in the transplant system be entered into the 
record. Mr. Henry and colleagues, that has been done.
    [The letter appears in the appendix on p. 66.]
    The Chairman. Dr. Jayme Locke is next.

 STATEMENT OF JAYME E. LOCKE, M.D., MPH, DIRECTOR, DIVISION OF 
     TRANSPLANTATION SURGERY, HEERSINK SCHOOL OF MEDICINE, 
             UNIVERSITY OF ALABAMA, BIRMINGHAM, AL

    Dr. Locke. Chairman Wyden and members of the committee, my 
name is Dr. Jayme Locke, and I am the director of the Division 
of Transplantation Surgery at the University of Alabama at 
Birmingham.
    At UAB we currently have 1,022 patients wait-listed for 
kidneys. The majority self-identified as African Americans or 
Blacks. Transplantation was always supposed to be about the 
patient, but the system we operate now has almost a complete 
lack of ownership and responsibility, whether it is a failing 
OPO or UNOS failing at the most basic responsibilities of 
getting recovered organs matched and safely to their intended 
recipients.
    These are the government's own contractors. My patients, 
your constituents, need your help. We know that thousands of 
kidneys are recovered and discarded every year, and that 
thousands more are never recovered at all. Discards have 
increased since the most recent allocation change, as the new 
system increased complexity, and to date, UNOS has shown no 
ability to manage even simple logistics.
    The most powerful thing to know about this is that every 
organ represents a life. We can never forget that. Imagine 
having a medication you need to live being thrown away simply 
because someone took too long to get it to you--your life, 
quite literally, in a trash can.
    Organs are no different. They too have shelf lives, and 
they are measured in hours. Discarded organs and transportation 
errors may sound abstract, but let me make this negligence real 
for you.
    In 2014, I received a kidney that arrived frozen. It was 
hard as a rock, like an ice cube you could put in your drink. 
The intended recipient was sensitized, meaning difficult to 
match. The only thing we could do was tell the waiting patient 
that due to the lack of transportation safeguards, the kidney 
had to be thrown in the trash--the final generous act of a 
donor in Maryland.
    In 2017, I received a kidney that arrived in a box that 
appeared to have tire marks on it. The box was squished, and 
the container inside had been ruptured. We were lucky and were 
able to salvage the kidney for transplant. But why should luck 
even play a role?
    Since the frozen kidney and the box with tire marks, I have 
received other kidneys that had to be discarded, either due to 
handling issues or UNOS transportation errors. But one week 
this May was particularly difficult. In one week, I received 
four kidneys from four different OPOs, each with basic errors 
that led to the need to throw away those lifesaving organs; one 
due to a botched kidney biopsy into the kidney's collecting 
system, another because of a lower artery that had been cut 
during procurement that could have been fixed if someone 
involved had assessed the kidney for damage and flushed it 
before packing. But that did not happen. Two others arrived to 
me blue, meaning they had not been flushed either.
    Opacity at UNOS means that we have no idea how often basic 
mistakes happen across the country, nor can we have any 
confidence that anything is being done to redress such errors 
so they do not keep happening.
    All I know is that in one week I received four kidneys, two 
from Tennessee, one from Florida, and one from Georgia, that 
could not be used. What was particularly heart-breaking was 
that two of these kidneys were for sensitized African American 
or Black women. Women who have been pregnant, especially 
multiple times, are harder to match, contributing to both 
gender and racial disparities in access to transplant.
    This is a very real example of how a constrained pool of 
organs and high discards disproportionately hurt women and 
women of color, who are more likely to have multiple 
pregnancies.
    I know others have spoken up, and more still who want to 
speak up, but, Senators, please know that every person I have 
talked to who has spoken up about system failures has told me 
they have been punished in some way, through both micro- and 
macro-
aggression.
    The very highest level of leadership within UNOS is an 
insular club that has turned its back on patients by ignoring 
their own unconscious biases, and even impugning patients 
behind closed doors.
    We need reform now. I am asking for your urgent help on 
behalf of my patients and all the other patients waiting around 
the country.
    Number one, immediately separate the OPTN board from any of 
the boards of any contractors. Number two, bring in real 
experts to ensure our patients are served by the best of the 
best in each field, separating out key functions of the OPTN, 
including policy, technology, and logistics. And number three, 
ensure that patients are safer by holding all contractors 
accountable through event reporting and immediate redressing of 
problems.
    One final and critical point. I cannot tell you how 
disturbing it was to read of the way UNOS has allegedly held 
the UNOS transplant system hostage. According to The Washington 
Post, quote, ``UNOS also has at times even threatened to walk 
away and continue operating without a contract, despite the 
fact that it would be illegal,'' end quote.
    Doing anything to jeopardize patients, even threatening to 
walk away, violates a basic principle of health care. It is 
called ``patient abandonment.'' You simply cannot do that, or 
even threaten to do that. I would lose my medical license for 
walking away from a patient.
    If it is true that UNOS has suggested that it might walk 
away or not cooperate with a transition to new contractors, 
that would make it an organization that cannot be responsible 
for taking care of lives. There is very little in health care 
that has the immediate life-and-death stakes of organ 
transplantation.
    Please realize that every day that passes that these 
failing systems are in place, it means more of our neighbors 
will die. My patients need the Senate to act.
    Thank you.
    [The prepared statement of Dr. Locke appears in the 
appendix.]
    The Chairman. Thank you all. And these are terrible 
accounts that you have just given us, Dr. Locke: the idea that 
kidneys arrive with tire marks; the reprisals against those who 
speak the truth about the inefficiencies and gaps in quality 
with respect to these services. I mean, this is really a wake-
up call, and you have delivered it powerfully, and I thank you.
    I will start with this question that a number of you have 
referred to: the issue of the recovered organs being discarded. 
And obviously, the purpose of the transplant network is to 
match organs with patients who need them.
    Unfortunately, one in seven organs recovered by an organ 
procurement organization is not transplanted, at a rate, as far 
as I can tell, that is increasing and has been since 2018. For 
kidneys, the most needed organ, the situation is even worse. 
One in four recovered kidneys are discarded before transplant, 
a rate that is also increasing.
    Now obviously, there are instances where an organ cannot be 
transplanted for legitimate medical reasons, but in the course 
of this Finance investigation, we discovered an endless number 
of cases of organs being discarded because of errors at the 
OPOs. In several cases, organs were discarded because they were 
delayed or lost on their way to a transplant center. In another 
case, a heart was discarded because an OPO had a policy 
disagreement with a hospital. And yet in another case, an OPO 
literally threw two kidneys in the trash--in the trash--
immediately after recovering them.
    So, Mr. Henry, let me start with you. We have over 90,000 
people waiting for a kidney transplant in this country, yet one 
in four kidneys recovered are not being transplanted. So my 
question to you, Mr. Henry--you have been a patient advocate, 
and spoken eloquently today--how does this high discard rate, 
and the practices that are being documented and that you found, 
how does this affect the public's willingness to donate when 
they hear this?
    Mr. Henry. Well first, hearing about the, in my mind, 
inexcusable recovery rate, it is absolutely heartbreaking. And 
we talk about the fact that a little over 90,000 kidney 
candidates are on the waiting list, and 106,000 total organ 
recipients. As an advocate, I am asked to go out into the 
community, which I willingly do, because organ donors save 
lives.
    So I willingly and eagerly advocate for organ donation. But 
when you hear about this high non-use rate, people think, ``We 
are asked to donate, and the individuals, the OPOs and UNOS, 
who are in charge and are supposed to be stewards of ensuring 
efficient recovery, do not seem to be doing the job 
necessary.''
    So again, it is absolutely heartbreaking.
    The Chairman. So, Mr. Shepard, we have this tremendous 
sacrifice by donors and families. You heard what Mr. Henry 
said: all the time and money and effort, and recovered organs 
are not being translated into patients who need them.
    Is it acceptable that 25 percent of kidneys are being 
discarded? Is that okay with you?
    Mr. Shepard. No, Senator, absolutely not.
    The Chairman. So, it is not acceptable?
    Mr. Shepard. We find that number to be entirely too high 
and think that every missed opportunity for transplant is a 
tragedy.
    The Chairman. So why are they too high? And what are you 
doing about it?
    Mr. Shepard. There are any number of reasons that an organ 
would not be used. There are a few that are specific 
operational events at OPOs, and I think your research and your 
review of the MPSC files shows that. I think a much larger 
number are simply deemed not viable for transplant by the 
centers that they are being offered to.
    One of the things that UNOS is doing about it, we just 
adopted a new metric for our evaluation of transplant centers. 
This year we have adopted a metric to measure transplant 
centers on their organ acceptance rate. So, in the past we have 
measured them--and we still will--on their post-transplant 
success rate. How long did their patients last? How long did 
their grafts last? But now we will also be measuring transplant 
hospitals on whether or not they are accepting organs at an 
acceptable rate.
    The Chairman. Ms. Brockmeier, do you think that is the 
heart of the problem? I mean, Mr. Shepard says the big problem 
is you have a high discard rate because the transplant centers 
are refusing organs for medical reasons. That seems pretty far-
fetched to me, but I would like your thoughts.
    Ms. Brockmeier. Certainly, Senator, there are at times 
occurrences when we would discover that a potential donor might 
have cancer or something during the interoperative procedure. 
So those kidneys obviously could not be allocated for 
transplantation. So on occasion, yes, sir, that does happen.
    But the cumbersomeness of the technology by which we can 
identify the best homes for those kidneys certainly complicates 
and, I think, compounds the discard rate.
    The Chairman. That is, to me, the heart of the problem, 
that, yes, there are medical instances where it is warranted. 
You said that. I have said that. I think that is the consensus 
sentiment. But I think the heart of the problem is that the 
system does not work, and it is way too cumbersome and 
inefficient, and we have got to turn it around.
    Senator Grassley?
    Senator Grassley. I would like to have any one or two of 
you who could answer this question to do it. You heard me in my 
opening comments refer to the fact that the system does not 
seem to be fair to racial minorities or people living in rural 
communities.
    So what are your efforts underway to understand the root 
causes and help make the system fairer to patients on the 
waiting lists? Explain the factors that result in the disparity 
for minorities and rural populations in the process, and how 
can the Federal Government address the problem if we have to be 
involved in addressing it?
    Dr. Locke. One of the most important things that we do not 
currently do is, we do not actually account for disease burden 
in terms of examining our waiting list. So we have no way of 
knowing if we are actually serving the correct people, if the 
correct people are actually making it to the waiting list.
    Disease burden is super important because it not only 
identifies the individuals who are in need of transplantation, 
but it also speaks to supply. So areas of high rates of end-
stage kidney disease burden like the southeastern United States 
are going to have much lower supply. And they also are 
predominantly--those waiting lists predominantly consist of 
African American or Black individuals.
    So, if you want to make a truly equitable organ system, you 
have to essentially get more organs to those areas with higher 
disease burdens.
    I think the other thing is that we have to have more focus 
on how we approach donor families and make sure that we have 
cultural competence as a part of our OPOs in how they approach 
families to ensure that we are not marginalizing minority 
families with regard to the organ donation process.
    Senator Grassley. Mr. Shepard, UNOS has responsibility to 
conduct oversight of membership. There is little indication 
that your organization is capable of doing it. So if, in fact, 
this committee found that less than 40 percent of all patient 
safety cases are referred to the Membership and Professional 
Standards Committee--which is responsible for monitoring member 
compliance with the transplantation network's policies and 
procedures--how does UNOS staff determine what cases are 
referred to this committee?
    Mr. Shepard. Thank you, Senator. UNOS staff refers cases to 
the MPSC--that is the peer committee--and again, our statute 
and regulation require us to use peer review to do the quality 
improvement work that we do.
    Our staff is approved by the peer committee. The peer 
committee has given them a set of guidance rules to say, these 
are the types of cases that we would like to see, these are the 
types of cases that, when you evaluate them, do not need to be 
referred to the committee.
    Our staff do not make those judgments independently. All of 
those staff decisions as to whether a case meets the MPSC 
rubric for referral are referred in a group of the member 
quality staff, including the chief medical officer of UNOS.
    Senator Grassley. Well, with the committee's findings in 
mind, should your organization reevaluate its oversight efforts 
so that more cases are referred to the committee? And if you 
disagree with that, why not?
    Mr. Shepard. I would say one of the things that our 
conversation with your staff has led us to understand is that 
the current committee may not be as aware of some of the past 
decisions that past committees have made in establishing those 
rubrics. So we have created a new process where, at the seating 
of each new MPSC committee, we go over that rubric so that each 
committee can endorse, amend, or otherwise alter the 
description of what types of cases they would like to see, and 
not simply rely on what a past committee has decided.
    Senator Grassley. Mr. Friedman, in 2021 the U.S. Digital 
Service found that UNOS cannot properly modernize its IT system 
and its core systems are fragile. This is concerning, 
especially since the organization is the only government 
contractor responsible for making transplants possible.
    Can you give us an example of a time when UNOS's technology 
caused an adverse patient safety event? And generally, do you 
think AdventHealth is getting the best value with regard to the 
services offered by UNOS?
    Mr. Friedman. Senator Grassley, I agree with you that the 
IT system is fractured. There are situations where organs are 
not offered in a timely manner. The IT system that UNOS 
currently utilizes does not easily allow transplant centers 
opportunities to turn down organs or ensure that the right 
organ is going to the right patient.
    I also believe with IT technology, as I stated, monitoring 
organs and organ placement--when I was in the military, I did 
medical airlift. My crews out of Scott Air Force Base knew 
where I was, worldwide, with my patient.
    I could not even get a kidney that was 20 miles away from 
my transplant center with UNOS thinking that it was in Miami, 
when it was actually in Orlando, 20 miles away. Lack of IT 
systems, lack of technology, has caused harm potentially to 
patients, or delayed patient treatment, or increased the cost 
of care for patients.
    This is deplorable and needs to be fixed.
    The Chairman. Thank you, Senator Grassley.
    Senator Cardin?
    Senator Cardin. Thank you, Mr. Chairman. And I thank you 
for your leadership on this issue, and I want to thank our 
witnesses today.
    Our committee report verifies our fears that the system 
today is badly broken. And our witnesses today have reinforced 
that view. That is a tragedy that needs to be corrected.
    Unless you have transparency, unless you have 
accountability, there is no way that you can correct a system. 
And if those who want to report a problem are retaliated 
against, it makes the matter much, much worse.
    If we have to change the law to accomplish that, then we 
have to change the law to do that. I am hearing about numerous 
mistakes in harvesting and preparations and matching and 
transportation. But if you do not have timely knowledge of 
those errors, you cannot correct those errors. And from what I 
can tell, most of these errors are being hidden rather than 
acted upon and changed.
    So you know, all of us are involved in buying products that 
are tracked, and we are amazed at how we can see where they are 
at every step of the process. The technology is widely 
utilized.
    So, Mr. Shepard, let me just ask you about the technology 
that you are using. According to our reports, your system has 
crashed on several occasions. And when your system is down, you 
cannot do the match, so time is lost. We are seeing all these 
challenges.
    Is there a financial problem as to why you cannot update 
the technology? Is there a reason why we cannot get much better 
performance on vital organs being tracked or matched? What is 
the problem here?
    Mr. Shepard. Senator, the OPTN IT system that UNOS operates 
has 99.99 percent up-time. It is a highly reliable system. We 
are audited annually by HRSA.
    Senator Cardin. My information is you have had 17 days down 
since, I think, 1999. That is not correct?
    Mr. Shepard. In 23 years, yes, sir.
    Senator Cardin. Okay. Well, every day there is a loss of 
life, isn't it?
    Mr. Shepard. That is the total amount of time over the----
    Senator Cardin. I hope our national defense system is not 
down 17 days a year.
    Mr. Shepard. The system has never been down for a day, to 
my knowledge. And I have not been here since 1999, but to my 
knowledge there has been maybe one event that was longer than 
an hour, and that was 3 hours. But the total amount of time 
since 1999----
    Senator Cardin. So you are satisfied with your technology? 
You think you have the right technology? You are satisfied with 
your tracking systems now and you think everything is okay?
    Mr. Shepard. We constantly improve our technology. We are 
subject to 3 million attempts a day to hack into the patient 
database, and we successfully repel them all. So we are never 
satisfied with our technology, but we do maintain 99.99 percent 
up-time. We disagree with the USDS analysis of our systems.
    Senator Cardin. I understand you may feel that you have 
restrictions by law that you cannot do certain things, but then 
you should try to change those laws if the system is not 
working right.
    What I do not understand is, I have heard so many examples 
here of mistakes that need to be corrected, whether they are 
surgical mistakes, whether they are testing mistakes, whether 
they are shipping mistakes or matching mistakes, and they are 
not being corrected.
    Why are you not proactive in working with us if laws need 
to be changed so that we can get a higher efficiency on making 
these organs available?
    Mr. Shepard. We would be happy to work with the committee 
and anyone who is interested in legislation that would improve 
the safety of the system.
    We work directly in a peer review process with OPOs and 
transplant hospitals for any--either an incident, and many of 
our incidents, nearly half of our incidents that are reviewed 
by our peer committee, are self-reported.
    Senator Cardin. Self-reported is the way it should be. That 
is a good thing to have self-reporting.
    Mr. Shepard. Yes.
    Senator Cardin. Dr. Locke, who retaliates against people 
who are making--you mentioned the intimidation factor about 
making reports. Can you just shed a little more light on that 
as to what is happening out there?
    Dr. Locke. I personally have had people come up to me and 
make comments. We submitted--I signed a letter, along with the 
members of Region 3, related to some of the emails that were 
unsealed that disparaged our population in the southeastern 
United States. And I submitted that letter to UNOS, along with 
other colleagues from Region 3, and had two different board 
members approach me and suggest that I should not have done 
that, and that that was inappropriate. And so that makes it 
very challenging. That is just one example.
    I have had other colleagues who feel that they have been 
blocked from being on committees and other things. And we have 
all been silenced at our region meetings on more than one 
occasion when we have spoken up about what we think is not 
appropriate.
    We have been told ``that's something that you can't vote 
on,'' that you can't present data, that only they control the 
data that can be presented. And certainly, we are members of 
the OPTN, and the purpose of those meetings is to be able to 
have representation and have dialogue about what we think is 
going well and what is not going well. And it is incredibly 
proscribed, and we are routinely silenced.
    Senator Cardin. Well, thank you for coming forward. I 
appreciate it.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Cardin. And I also want to 
note this important question you asked, Senator Cardin, about 
all the mistakes that are taking place. As far as I can tell, 
there is a pretty serious operation for keeping them secret. 
The committee was forced to issue a subpoena to obtain 
information from UNOS on the number and nature of safety events 
that were reported to it.
    So this whole question that Senator Cardin is talking 
about, about additional transparency in dealing with mistakes, 
I think is very much on point, and I thank my colleague for 
raising it.
    Next in order of appearance will be Senator Portman.
    Senator Portman. Thank you, Mr. Chairman.
    And, Mr. Shepard, I am going to follow on some of the 
questions that Senator Cardin raised. Twenty-eight hundred 
Ohioans are on the transplant waiting list right now; you 
probably know that. And according to the information obtained 
by the committee, nationally in a 7-year period at least 249 
transplant recipients have developed diseases from infected 
organs, and at least 70 of these patients have died.
    One of those troubling cases was in Ohio. The recipient 
came for a routine follow-up and was informed that he had 
accidentally received a transplant from a donor with cancer. 
Tragically, it was not on the initial report, and the recipient 
had a 3-week period when he did not even know. But the donor 
had a brain tumor, and that was on the pathology report that 
was not available, for some reason. So this recipient has now 
been told he is likely to die within 3 years.
    There are four organ procurement organizations in Ohio, 
OPOs, and they all do lifesaving work, but we need to give them 
better tools to ensure that lives are not lost, and we do not 
have additional tragic situations like this one due to testing 
failures.
    Can you tell us, Mr. Shepard, what more UNOS can do to 
ensure that these 2,800 Ohioans we talked about awaiting 
transplants do not receive infected organs?
    Mr. Shepard. Yes, Senator; thank you. UNOS has created, in 
their operation of the OPTN, a Disease Transmission Advisory 
Committee, which also includes CDC. So, in addition to the peer 
review committee, which is studying the specific techniques, 
the specific operations that may need to be improved or changes 
that OPO or a transplant hospital might need to make in 
practice, the disease transmission committee actually reviews 
transmissions and ensures rapid communication between OPOs and 
all the recipient transplant hospitals. So, if one transplant 
hospital were to find that they had received an infected organ, 
there is a quick communication chain back through the rest of 
the organs that were recovered from that donor. And we 
continue--that committee routinely provides guidance, most 
recently offered on COVID. They offered quarterly guidance as 
new information came out about COVID.
    Senator Portman. You said earlier there is no regulation of 
these OPOs. Again, there are a lot of great ones that save 
lives every day, but others obviously fall short of the goal. 
So you are saying that there is a monitoring of this, and 
information provided, but there is no assurance that these best 
practices, as an example, would be followed, even on disease.
    Is that true?
    Mr. Shepard. If you are asking whether UNOS can prevent an 
OPO from operating, or from being an OPO, then the----
    Senator Portman. Not prevent them, but require them to do 
something. You do not have the ability to require them----
    Mr. Shepard. The peer review process has significant 
persuasive authority, but all the payment authority and all the 
certification and decertification authority lives at CMS.
    Senator Portman. So you do not have the ability to require 
that they do things. A lot of suggestions have come out in the 
context of this report. It has been recommended by the 
University of California that we should automate data entry. 
They indicate that 85 percent of data entry is automated in 
other health-care records, and these should be automated. Right 
now, an individual is required to enter the data manually, 
which costs time and allows for error, human error. Do you 
agree with that?
    Mr. Shepard. We absolutely agree that data entry should be 
automated. Sixty-five percent of UNOS's forms are available to 
be electronically filled out for APIs, and more than 200 
transplant hospitals and OPOs are using electronic APIs now to 
automatically deliver data to UNOS.
    Senator Portman. Does OPTN require that?
    Mr. Shepard. OPTN does not require them to use the API.
    Senator Portman. We also hear that upgrading technology at 
OPTN will protect it from cyber-attacks that could be the 
difference between life and death for people. Do you have a 
response to that?
    Mr. Shepard. I am sorry, Senator?
    Senator Portman. Do you believe you are protected from 
cyber-attacks?
    Mr. Shepard. We never are satisfied with our protection 
from cyber-attacks, but we do know that we are attempted to be 
hacked into more than 3 million times a day and have not yet 
been successfully hacked, but we continue to upgrade those 
protections on a regular basis.
    Senator Portman. Do you think there should be tracking of 
organs in transit?
    Mr. Shepard. I think that is a very beneficial thing. UNOS 
provides an optional service that a quarter of OPOs use. Many 
OPOs also use other commercially available trackers to do that. 
There is not a single requirement to use a particular system.
    Senator Portman. So the 21-percent discard rate, I 
understand, has a lot to do with the transporting of organs, 
and the lack of tracking is part of the problem. In one report, 
organs were 15 times more likely to be lost or damaged than 
your luggage when taken through an airport.
    Could that be possible?
    Mr. Shepard. I have not seen that number, and we will get 
you--I would certainly be surprised.
    Senator Portman. That is part of what came out of this 
report. You talked about the app that you are developing to 
offer transport options. Is this app fully operational?
    Mr. Shepard. It has been fully utilized by our organ center 
and is in a pilot phase with several OPOs.
    Senator Portman. Is that something you are going to have 
beyond pilot soon, so people can get best practices on transit?
    Mr. Shepard. Yes.
    Senator Portman. And how about manual entry? Do you have a 
plan to make the network safer for patients and protect from 
cyber-attacks by using more automation? Is there a plan to do 
that?
    Mr. Shepard. Yes. We continue to expand the number of APIs 
that are available. That also depends on the OPOs and hospitals 
making the changes to their IT systems on the other end to 
communicate across that bridge.
    Senator Portman. I did not mean to leave you out [motioning 
to the other witnesses]. We will have some questions for the 
record for you all.
    And again, I thank you for holding this hearing--more 
importantly, for this committee and its thorough report. Thank 
you, Mr. Chairman.
    The Chairman. Thank you, Senator Portman.
    Next is Senator Warren.
    Senator Warren. Thank you, Mr. Chairman.
    So, in the United States, when people need an organ 
transplant, their lives are in the hands of one Federal 
contractor that our government hires to run the entire national 
organ donation program. Today this system is run by UNOS, which 
first got its contract back in 1986. In fact, UNOS is the only 
entity that has ever been awarded, or even bid for this Federal 
contract.
    Now UNOS is responsible for overseeing local organ 
procurement organizations, or OPOs. Because UNOS's oversight is 
so bad, some OPOs are disasters: testing errors, lost organs, 
never collecting healthy organs that could have been donated. 
And without competition, the organ transplant system overall 
has become a dangerous mess. Right now, UNOS is 15 times more 
likely to lose or damage an organ in transit as an airline is 
to lose or damage our luggage. That is a pretty terrible 
record.
    Mr. Shepard, you are the CEO of UNOS, and we have 
documented these problems. And you have received more than 
1,000 complaints in the last decade alone.
    So tell me. In the 36 years that UNOS has had the contract 
to run our national organ system, how many times has UNOS 
declared its OPO members, any OPO members, not in good 
standing?
    Mr. Shepard. Two times, Senator.
    Senator Warren. Two times. So that's it. Two times. UNOS 
has run the program for 3 decades, and in the past 10 years it 
has received over 1,000 complaints. At least 249 recipients 
have developed diseases from infected organs after a 
transplant; at least 70 people have died from those diseases. 
And you looked the other way when one of your members was part 
of an illegal kickback scheme that eventually sent an OPO 
executive to Federal prison.
    So 36 years, a list of deadly problems, a kickback scheme, 
and yet UNOS has only twice declared one of its members, quote, 
``not in good standing,'' a designation that is so toothless 
that it does not even require the OPO to pause its operations.
    So let me get one other piece of data out here. Mr. 
Shepard, how many times has UNOS put an OPO on probation?
    Mr. Shepard. I do not know right off the top of my head, 
but it is not a large number.
    Senator Warren. It is not large. In fact, it is three. 
Three times in 36 years. Look, this is not oversight. This is 
sitting on your hands while people die. And UNOS has been 
allowed to look the other way because it has never faced any 
competition.
    Finally, HRSA, the Federal agency that awards your 
contract, is now heading into this contracting cycle that 
stakeholders have said must break up the monopoly for the first 
time ever. But faced with the prospect of accountability in the 
past, UNOS has demanded tens of millions of dollars to hand 
over the archaic technology system that it developed with 
taxpayer funding.
    UNOS has even threatened to walk away and illegally 
continue to operate the organ transplant system without a 
contract.
    So, Mr. Shepard, can you commit that UNOS will not in any 
way attempt to hijack the United States' transplant system 
during a transition to future contractors?
    Mr. Shepard. UNOS would never make an attempt to take any 
actions regarding a transplant system that would harm patients. 
And in fact, the discussion that has come to light in the USDS 
report was our attempt to assure HRSA that, despite coming very 
close to the negotiating deadline, we would not turn the system 
off and walk away from patients, even if bureaucratic paperwork 
pushed us beyond----
    Senator Warren. So you are not going to walk away and turn 
the system off? You are also not going to demand millions of 
dollars for a system that was developed at taxpayer expense?
    Mr. Shepard. The system has been paid for in part by 
taxpayers. Approximately 10 percent of the budget of this 
contract is 
taxpayer-funded. The rest of that is paid by hospitals when 
they list patients. The government has not, over the years, 
paid for the software.
    Senator Warren. So you are still planning to get millions 
of dollars for the system? That is what you want to do? Sell it 
back to the government, if you do not get this contract?
    Mr. Shepard. The contract allows the government to purchase 
the software from----
    Senator Warren. At what price? I mean, we have obviously a 
monopoly on both sides here.
    Tell you what: we will go into the pricing. I just want to 
be careful about my time.
    I will just be clear. You should lose this contract. You 
should not be allowed anywhere near the organ transplant system 
in this country, and if you try to interfere with the process 
of turning the contract over to someone who could actually do 
the job, you should be held accountable for that.
    There are a whole lot of reforms that are needed in the 
system, but this is a good place to start. Patients and 
families deserve better than they are getting right now from 
UNOS.
    Thank you, Mr. Chairman.
    The Chairman. That last sentence sums it up: patients and 
families deserve better.
    Senator Young?
    Senator Young. For many years, I have taken an active, 
personal interest in the organ donation system. I had a very 
good friend I served with in the U.S. Marine Corps. His name 
was David McFarland. I have gotten to know his wife, Jennifer. 
We called him ``Gunny McFarland.'' I reconnected with Gunny 
McFarland when I moved back to Indiana after service in the 
Marines, and he died waiting on a heart. And that was a really 
powerful experience for me.
    So, when I was elected to the U.S. House of 
Representatives, I resolved to do whatever I could to bring 
more organs into the system. I came to find out there was 
seemingly very little I could do. I scrutinized an existing 
system that was highly opaque, and that really frustrated me. I 
think it is frustrating to a lot of Americans.
    In recent years, as some of my colleagues have indicated, 
there have been a number of complaints submitted to UNOS--
1,118. Less than 40 percent of those were referred for 
additional review. Of that small number, only 1 case, 1 case 
out of 1,118 complaints, resulted in probation. It is either a 
very impressive record of success, or it is a very low record 
of probation.
    My strong suspicion is that more of these complaints are 
indeed valid and should result in probation. Two of these 
complaints have led to a designation of a member being ``not in 
good standing.''
    There have been multiple documented incidents of OPO poor 
performance, serious allegations ranging from illegal financial 
arrangements to testing failures resulting in patient deaths.
    I am going to ask for a really short explanation. Maybe, 
Mr. Shepard, you can provide it. Please explain why UNOS very 
rarely uses the probation and member ``not in good standing'' 
ratings?
    Mr. Shepard. Thanks, Senator. The reason would be that the 
primary tool for UNOS to promote improvement is the peer review 
process that is established in our regulation and in our 
contract. It calls for us to be the confidential coaching and 
best-practice arm, in contrast to the regulatory and financial 
oversight rules that CMS provides.
    Senator Young. Okay. And yet we still have a large gap 
between the need for organs and the number of organs that are 
brought forward. It does not seem like we are rewarding 
success. It does not seem like we are holding people 
accountable for falling short of success.
    Once an OPO is designated ``not in good standing''--Senator 
Warren referred to this; it is toothless. It does seem 
toothless to me. I will give you an opportunity, Mr. Shepard, 
to disabuse me of that notion, and indicate for me what 
penalties or sanctions are actually placed on an OPO when they 
are designated ``not in good standing.''
    Mr. Shepard. The statute does not give UNOS any authority 
to offer sanctions like that. The certification, 
decertification, payment authorities belong entirely to CMS. 
The UNOS statute does not give us the ability----
    Senator Young. So it is toothless, in that sense?
    Mr. Shepard. It is designed to be, by regulation and 
contract--it is designed to be a quality improvement process, 
in contrast to the oversight process operated by a Federal 
agency.
    Senator Young. Okay. What corrective actions must occur for 
the OPO to get back in good standing?
    Mr. Shepard. It depends on the situation. A member not in 
good standing is generally in an environment where multiple 
things have gone wrong, where there seems to be not simply an 
incident. An organization that has a strong culture can recover 
from an incident. An organization that has more systemic issues 
is likely to be a member not in good standing.
    Senator Young. Is there a formal audit or a review process 
in place to ensure OPOs and other OPTN members are complying 
with appropriate rules and policies?
    Mr. Shepard. Yes. A member not in good standing goes 
through monthly meetings with the MPSC peer committee for 
usually 2 or 3 years to come off of that standing. All OPOs and 
transplant centers are reviewed routinely.
    Senator Young. Okay.
    On the topic of failing to perform like the American people 
would expect the system to perform, I would like to turn to 
reports of donor organs that are lost or delayed in transport, 
and an apparent lack of ability to solve or even improve this 
issue.
    To what extent does UNOS currently track the status of all 
the organs in transit at any given time?
    Mr. Shepard. UNOS does not coordinate transportation or 
track organs in transit. We do provide a service that OPOs can 
use to use GPS trackers. Some OPOs use ours, and some use other 
commercially available products.
    Senator Young. So why is it that--and how does UNOS plan to 
optimize organ delivery if you do not have a 100-percent 
visibility into where they are at any given time?
    Mr. Shepard. I think that the GPS products that we offer, 
and that other people offer, are valuable. They do help in the 
delivery of kidneys--only kidneys travel unaccompanied. So this 
is a kidney issue. But I do think the GPS trackers are 
valuable, and I think that is why you have seen more OPOs using 
them.
    Senator Young. My son can order a pair of shoes, or a toy, 
and get a pretty good sense of where it is at a given period of 
time. This is lifesaving, of course, in so many instances. So 
it seems like that ought to be locked in.
    So okay; well, we will continue--I know that the chairman 
and ranking member have made this a real priority, and my 
colleagues, many of them have been dialed into the importance 
of this issue for some time, and others are beginning to get 
energized and animated about it. And I am encouraged by that.
    So we will keep fighting on behalf of our constituents.
    Thank you, Mr. Chairman.
    The Chairman. We will. And thank you for your 
participation.
    Before we go to Dr. Cassidy, just very quickly, colleagues, 
I want to make a point so that it is clear for the record.
    Mr. Shepard has said twice, with respect to this whole 
question of the power to decertify an OPO, that CMS has the 
power to do it. UNOS also has the power to refer an OPO for 
decertification under the OPTN final rule. That has been done 
exactly once.
    So I just wanted it understood with respect to making sure 
the committee knows what is really going on with respect to 
decertifying OPOs.
    Dr. Cassidy?
    Senator Cassidy. Mr. Shepard, before I go on to some of the 
other stuff, I just would like to ask procedurally: according 
to committee staff, they have on multiple occasions sought 
documents relevant to the committee's inquiry, and you were not 
cooperative; that records were not given; that after the 
committee issued a subpoena to UNOS on February the 3rd, UNOS 
continued to withhold relevant information from the committee 
without asserting a recognized constitutional, Federal 
statutory, or Federal common law privilege, et cetera.
    Finally, information was given with redactions. But these 
redactions were not of patients, it was not HIPAA-compliant. It 
was of senior OPO employees, time zones, addresses, and other 
contextual information.
    Now first, why was UNOS refusing to respond to subpoenas? 
And why were you stonewalling and, by all accounts, hiding 
information from the committee?
    Mr. Shepard. Thanks, Senator. We did not refuse the 
subpoena. In fact, we explained that because of the peer review 
protection of the evaluation process, the MPSC process, that it 
required a subpoena to open that box----
    Senator Cassidy. So the subpoena was given, and then you 
continue to withhold information from the committee without 
asserting a recognized right to do so. So what happened there?
    Mr. Shepard. We provided redacted documents----
    Senator Cassidy. So the redactions included senior OPO 
employees. That hardly seems on a doc--you know, the hospital 
administrator is not someone to be redacted if the patient is 
going to be redacted.
    So why were you redacting senior OPO employees?
    Mr. Shepard. Because the participation--the full and frank 
participation in our peer review process is what we believe 
leads to a full understanding of an adverse event. We asked the 
committee staff if redacted versions would allow them to 
understand how our oversight worked, and what had happened in 
these events. They said, ``no.'' And we submitted documents 
that were unredacted.
    Senator Cassidy. Now, next. You mentioned the transport 
system. I think a lot of what is going on here is--as you 
mentioned earlier, almost ironically it seems--continuous 
improvement, quality improvement. But it seems as if that has 
been lacking in UNOS. I am a doc. I am a liver specialist. I 
had a lot of patients who died from lacking transplants because 
of a lack of organs.
    I have worked among poor patients, and I had a lot of 
patients who died, just like Dr. Locke, who were Black, with 
renal failure who could not get transplanted. And so the 
remarks of your board member are particularly insulting to the 
patients for whom I cared for many years.
    And I had a sense of indignation, and Dr. Locke shares my 
indignation. I don't know if you allowed her to continue to 
serve on your board. It is amazing that she would have been, 
after revealing such prejudice.
    With that said, my Louisiana OPO tells me that they asked 
UNOS for a tracker; that they did not hear back; that they 
emailed more. ``We need more trackers.'' They did not hear 
back. Seven weeks later they get an organ, a kidney. They ship 
it. It gets lost in transit because they do not have a tracker, 
and eventually it expires.
    Now if this is a continuing quality, whatever, improvement 
process, and they are relying upon you--they say their emails 
were not being answered.
    Now what kind of breakdown do we have in a system where 
emails are not being answered, much less where the trackers are 
not being sent, which results in a kidney being lost and 
therefore a patient going without the transplant?
    Mr. Shepard. Senator, I am not aware of that situation. It 
is disturbing. It is certainly something I will look into. I 
know the leadership of the OPO, and I certainly wish, if they 
had had trouble getting an answer----
    Senator Cassidy. Well, they said they emailed the 
organization twice. And Dr. Locke has this specific incident in 
her testimony, so apparently it was known outside of Louisiana. 
So it just seems like a failure of the organization.
    What case would you make for UNOS continuing to have the 
contract that CMS would award? What would give us confidence 
that there will be a change in direction where there is a 
responsiveness to emails like ``I need a tracker,'' and then 
the obvious failure when the tracker does not come, and an 
organ is lost and the patient does not get her transplant? What 
case could you make?
    Mr. Shepard. I believe that by bringing together the 
transplant and donation community, UNOS has a unique 
understanding of how organ donation and transplant works. I do 
not understand the particular situation, and I certainly find 
that as troubling as you do. But I also think that UNOS has a 
long track record of promoting increases in transplantation, 
equitable transplantation. We have a public equity tracker that 
says that, once listed, rural patients and African American 
patients are transplanted at very similar rates to other 
patients. It is getting to the wait list that is the real 
equity challenge. UNOS has a long track record of success. And, 
while I think that we can improve, and we do every day, I do 
think that it is a strong organization that has served patients 
well.
    Senator Cassidy. We heard a lot of testimony today, and 
committee reports that suggest that that is not the case.
    With that, I yield.
    The Chairman. Thank you very much, Dr. Cassidy. And they 
are very important questions. And I am just going to walk 
everybody through what we have turned up with respect to 
transportation of organs, because this is a major focus of the 
committee's investigation.
    We asked about it. UNOS told us, and I quote, ``It does not 
collect transportation data on a national systematic basis.'' 
That strikes me as a showstopper kind of response. UNOS doesn't 
track its donated organs' arrival at transplant centers? How in 
the world can we give people confidence if the organization 
that runs this says that?
    It turns out UNOS only tracks the shipment handlers 
themselves. Four percent of organ shipments--even in this very 
small sample, dozens of organs are thrown away each year after 
transportation.
    UNOS does not know if the other 96 percent of shipments are 
just as bad because they do not ask. UNOS has not made any 
policies on safe organ transportation, and OPOs are not 
required to report these issues. And when complaints about 
transportation failures are made, UNOS does not even reply.
    So, Dr. Locke, you have been outspoken about this whole 
area with respect to the deficiencies in the operation. Tell us 
a little bit more about organ transplant problems, and what 
your response from them has been when you have reported 
problems with transportation?
    Dr. Locke. Thank you, Senator. Obviously, people have 
described that we have about a 25-percent kidney discard. So, 
one in four. If you look at numbers last year--these are rough 
numbers--it would be about 8,000 kidneys. And really, I think 
in some ways these were kind of a victim of entrenched and 
cumbersome allocation algorithms that are very ordinal. We have 
to go sort of in order, when data clearly have shown that 
introduction of multiple simultaneous expiring offers would 
result in more efficient placement of kidneys, and this would 
decrease our cold ischemia time.
    Also I think it reflects a failure of transportation 
logistics. So, if you take UNOS's organ center, they have a 
very rigid system, for example, for finding flights, and lack 
either an ability or interest in thinking outside the box.
    So, for example, if there are no direct flights from 
California to Birmingham, AL, instead of looking for a flight 
from San Francisco to Atlanta, understanding that a courier 
could then pick it up in Atlanta and drive it the 2 hours, they 
instead put it on a flight from SFO to Birmingham via Atlanta 
and allow it to go to a cargo hold over night where it 
literally is rotting, if you will, and so we are putting extra 
cold ischemia time on, waiting to catch the flight to 
Birmingham the next morning----
    The Chairman. Let's make sure everybody gets this. You are 
saying you have seen instances of something being put in cargo 
hold when it is very likely to rot?
    Dr. Locke. That is correct. So, if the kidney arrives after 
10 p.m. at the Atlanta Airport, it goes to cargo hold. We 
discovered that and made calls to the airlines ourselves, and 
after several calls, the airlines--of course they were 
mortified, not understanding that that was what was happening, 
and actually had their manager meet our courier, and we were 
able to get the kidney out of cargo hold. But this went on 
before we figured out what was happening. Because essentially, 
they fly it in. It sits in cargo hold. It comes out the next 
morning to catch the next flight.
    Instead of thinking outside the box--if we just get it to 
Atlanta, it is driveable to Birmingham. And those hours make a 
big difference.
    The Chairman. That sounds way too logical for what UNOS has 
been up to.
    So please go ahead.
    Dr. Locke. So I think, from our perspective, one of the 
things that we really want to understand is why have we not 
engaged experts in applied mathematics to really optimize our 
matching algorithms and organ placement? And why haven't we 
really engaged experts in logistics around transportation?
    I mean, I think of the FAA, for example; what a remarkable 
entity, the fact that every day thousands of flights across the 
U.S. are in the air at the same time and don't crash into each 
other. And they know exactly where a given plane is. And it 
happens almost seamlessly every day.
    We should be able to do the same thing for our transplant 
system, for our organs.
    The Chairman. As I said, too logical.
    Ms. Brockmeier, UNOS has developed this organ tracking 
system. Do you all use it? And I am curious what you think of 
it.
    Ms. Brockmeier. Senator, thank you for the question. 
Senator, we did use and participate in the beta pilot through 
UNOS and made the decision to not move forward using their 
product and have sought a commercial alternative.
    The Chairman. And why was that?
    Ms. Brockmeier. Part of the issues were some service-
related issues, the lack of the interconnectivity that we 
wanted, to be able to facilitate a more expedited visual 
tracking for the organ.
    The Chairman. Was the tracking technology low-quality?
    Ms. Brockmeier. Yes, sir.
    The Chairman. I will have some additional questions, but my 
time is up.
    Senator Grassley?
    Senator Grassley. We are done.
    The Chairman. Okay.
    Mr. Shepard, in your statement to the committee today, you 
highlighted how people who work on the organ transplant 
network's board and committees come from all corners of the 
transplant system. You noted that this diverse group of people 
is essential to making difficult policy decisions for the 
transplant network, and how effectively the system works to 
protect patients.
    Yet the way you describe these people and the peer review 
process in the documents you provided to the committee was very 
different. So I would like to enter into the record two emails 
that you wrote. Here is how you described the principal 
transplant oversight committee in one of your emails produced 
to the committee.
    You said, and I quote, ``Allowing the committee to fill 
these jobs increases the community's belief in the validity of 
the documents,'' end quote. You go on to say, and I quote, ``It 
is like putting your kid's artwork up at home. You value it 
because of how it was created rather than whether it is well 
done. Only in this case, we persuade ourselves that it is well 
done anyway.''
    One more. In this email you describe the organ transplant 
network that you are in charge of as nothing more than, and I 
quote, ``an overgrown homeowners association.''
    Now, when you compare the organ transplant network you 
oversee to an overgrown homeowners association, doesn't that 
call into question the effectiveness of the oversight and 
governance process used by the organ transplant system that you 
are saying works so well?
    [The emails appear in the appendix beginning on p. 188.]
    Mr. Shepard. Senator, I don't recall those particular 
emails, or the context----
    The Chairman. They are yours.
    Mr. Shepard. I assume that they are, sir.
    The Chairman. They are yours, Mr. Shepard, and they are 
central to your belief, as you try to tell us, that everything 
is hunky dory; that you have confidence in the people.
    You just wrote a bunch of emails that go 180 degrees in the 
other direction.
    Let me turn now to the issue with respect to information 
technology. So the principal function of UNOS is to manage the 
electronic database and to keep track of organ donations, and 
match them to people on the transplant waiting list.
    The technology that is used here is woefully out of date. 
The government report entitled ``Lives Are at Stake: The 
Government's Role in Modernizing the OPTN'' concluded that UNOS 
lacks sufficient technical capabilities to modernize their 
systems, which the current system requires. Instead of a 
modern, integrated cloud-based system, the UNOS system requires 
manual information updates at every stage. UNOS's transplant 
computers have crashed for a total of 17 days, with one 
February 2021 outage lasting 3 hours. When asked by our 
investigators, Mr. Shepard said improving the systems to meet 
industry standards was not a priority for UNOS, ``because it is 
not like air traffic control.''
    Mr. Henry, I think you are still with us, and we are glad 
that you are. These organs are very perishable. As somebody who 
received a lifesaving transplant, my guess is you believe every 
minute counts when you are on the transplant waiting list?
    Mr. Henry. Yes, absolutely. And like everyone else, we have 
read the USDS reports. We have read The Washington Post reports 
from earlier this week. And the IT services have been, in our 
opinion, inadequate for quite some time. The Patient Affairs 
Committee, our leadership, has voiced their concerns about the 
IT systems for quite some time, without much of a response.
    The Chairman. Mr. Henry, excuse me. How long have you been 
voicing your concerns about how outdated the IT systems are?
    Mr. Henry. I am speaking in this instance about Patient 
Affairs leadership. I have been recently appointed as a 
representative for the Patient Affairs Committee this year. So 
as far--I have read through a lot of the emails and background 
information, and spoken with leadership about these issues, 
including the IT services, and that is what I am referring to 
as far as our concerns about the IT systems being voiced but 
not addressed.
    The Chairman. Okay.
    Mr. Henry. So you are correct, Senator Wyden. Every minute 
counts; every second counts. When we hear about down time as a 
result of IT issues, those are lives that are potentially lost. 
Patients die while IT systems are down.
    So again, heartbreaking issues that we feel should be 
addressed.
    The Chairman. So, Ms. Brockmeier, again because you are on 
the front lines, tell us your experiences with UNOS systems. 
And let's talk, for example, about something like DonorNet. Why 
has that not been modernized?
    Ms. Brockmeier. The response, Senator Wyden, that we were 
provided when the committee that I was chairing asked 
repeatedly about improvements was that there wasn't bandwidth 
within the UNOS IT department to address those problems.
    The Chairman. So they just did not have current technology?
    Ms. Brockmeier. I cannot say what garnered their response, 
but that was their response.
    The Chairman. If you don't have bandwidth for something 
that is a priority, that says your technology is not up to 
date.
    All right, let's go next to OPO failure rates. Again, like 
everywhere in our society, there are performers that do well 
and some that do not. But the range of performance of organ 
procurement organizations is massive. The high-performing OPOs 
successfully recover and transplant four times as many organs 
as the poorly performing OPOs. After several years of debate on 
how to improve the performance of the subpar OPOs, the Centers 
for Medicare and Medicaid Services adopted a rule setting 
performance standards for the OPOs.
    When measured against these standards, more than one-third 
of the 57 OPOs are failing--not 1 or 2, but 22.
    Ms. Brockmeier, a lot of people in the OPO community oppose 
the CMS rule, including UNOS. When you see a large number of 
OPOs that are failing to meet the standard, I guess you can 
understand why.
    Your OPO is not one of them. Do you think the measure is a 
step in the right direction for holding OPOs more accountable?
    Ms. Brockmeier. Yes, Senator Wyden. Our organization went 
on the record very early on in strong support of the proposed 
metrics. While they may not be perfect, they are certainly an 
improvement over what we had had year-to-date.
    The metrics are designed in such a way that everyone can 
accomplish that. We can all be Tier 1 performers. It takes a 
dedicated effort, the right staff, the appropriate training, 
and resourcing to ensure that your OPO is able to respond every 
time the phone rings to ensure all the organs are recovered.
    The Chairman. All right.
    Let's talk for a moment about the boards that are supposed 
to be overseeing these, because it looks to me like there is a 
serious conflict of interest here. And I will send this to Ms. 
Brockmeier, and perhaps you would like to get to it as well, 
Mr. Friedman.
    The Organ Procurement and Transplantation Network--which is 
the formal title of the organ network that operates under 
Federal contract administered by HHS--and UNOS, which is the 
contractor that operates the network and controls information 
about the network, have the same boards of directors, despite 
efforts by the government to separate them.
    That means the people who look out for the best interests 
of UNOS's multimillion-dollar nonprofits are the same people 
who look out for the interests of the entire organ transplant 
network. It sure sounds like a conflict to me.
    Ms. Brockmeier, Mr. Friedman, UNOS claims the two boards 
must be the same. Okay, that is their claim. They have to be 
the same. And there is no need for the board of the OPTN to be 
independent from the board of the government contractor that 
runs it.
    Why shouldn't the network have an independent board--an 
independent board that can make its own judgments about whether 
the contractor is performing adequately?
    Your thoughts, Ms. Brockmeier and Mr. Friedman?
    Ms. Brockmeier. Yes, Senator Wyden, I think there should be 
an independent board. I think the division of the 
responsibilities of the board, and the inherent way that they 
are structured do pose conflicts. It would be like if you had 
an organization that was a supporting organization, you would 
want to hold it accountable for its performance. And the 
current structure really limits that opportunity.
    The Chairman. Mr. Friedman?
    Mr. Friedman. Chairman Wyden, actually HRSA and CMS, they 
actually changed board complexity for OPOs, requiring non-
transplant individuals. And the same thing can be employed here 
as well.
    As we make organ allocation changes, people win, people 
lose. And what we have done in this country, through the 
efforts of this board, is really allowed individuals to express 
their opinion at the board level, and the executive board 
level, that were based more towards their own individual needs. 
And this has to change. And that is why I, at our Region 3 
meetings, continuously recommend that we separate that out and 
allow the membership of UNOS--this is a membership-driven 
organization--to bring us up to speed so that we have 
transparencies, and so that we regain the trust of our 
providers, our hospitals, our OPOs, the patients, and the donor 
families. We cannot lose that trust, and I fully support you as 
the chairman of this, to enact that immediately. That can be 
part of the contract.
    The Chairman. We are just trying to determine if we have 
any Senators on the way. Let me ask our Republican colleagues. 
And we do. We do not? Thank you for your participation in this.
    We are very pleased a strong advocate of patients, Senator 
Casey, is here. And let's let him get settled, and then we will 
go to him for his questions. And then I have a couple of other 
areas that we need to look at briefly.
    Senator Casey, are you all set?
    Senator Casey. Mr. Chairman, thanks very much. I wanted to 
start by thanking you for the hearing and for the work that you 
and the ranking member have done in conducting this important 
investigation.
    This is a subject area that obviously does not get nearly 
enough attention in Washington. Not so in the context of this 
hearing and the work that was done by this committee and the 
staff. All of their good work should be held up for 
commendation.
    I also want to say I know I am late for the hearing, so I 
know I may have missed some of the engagement and some of the 
answers to questions. So if my questions are redundant, or 
duplicative, I apologize for that in advance.
    I come to this issue not just in the context of a public 
official and a member of a committee, but also in a very 
personal way. My father was the beneficiary of a double organ 
transplant in June of 1993, a heart and liver. Not many, at the 
time, 61-year-olds had been the beneficiary of that kind of 
transplantation. In fact, when he had it, I was told he was one 
of only--or I should say there had been, I think, only six in 
the Nation at that point, and four of those six were dead. So 
his chances were not great. But thankfully, he came through it 
and was able to live 7 more years, almost to the day. So we 
were blessed and fortunate.
    About a hundred separate things had to go right for him not 
to die before receiving that double organ transplantation. So 
we are grateful for that.
    But I guess I wanted to focus on the--I guess the last two 
recommendations that call for both transparency and 
accountability for the chain of custody and the transport of 
organs. We know that thousands of Americans are anxiously 
awaiting these lifesaving, life-changing operations, and 
waiting for that call to save the life of a family member.
    So I guess I wanted to start with Dr. Locke in terms of 
both transparency and accountability. How would a greater 
degree of both, a greater degree of transparency and a greater 
degree of accountability, improve the transplant system?
    Dr. Locke. I think, quite simply, it would result in more 
lives saved. If you think about the three sort of areas that 
UNOS is supposed to oversee, greater transparency and 
accountability around policy would have led us to address, for 
example, gender disparities in liver allocation much sooner.
    So in 2002, the model for end-stage liver disease was 
introduced, and we knew fairly quickly on that that created 
huge gender-based disparities in allocation because serum 
creatinine, one of the measures incorporated in MELD, does not 
reflect kidney function in women as well as it does in men. It 
is just this year that we finally updated the model to address 
that, some 20 years later. So that is a policy example that 
should have been addressed much sooner. And there were multiple 
cries from the community to do so.
    If you think about transportation--I gave an example a 
minute ago: having a UNOS organ center that is really more 
flexible in their ability to sort of figure out logistics, 
instead of thinking about trying to get a kidney from San 
Francisco to Birmingham, and only looking at flights that get 
you all the way to Birmingham, and having the kidney go from 
San Francisco, to Atlanta, getting there so late that it gets 
stuck in cargo hold overnight like lost luggage, where it has 
increased cold time and is literally rotting until it can get 
on a plane the next day.
    And then, as the surgeon getting the kidney, you have to 
make the decision, can I use this? Is it going to be okay? Is 
there too much time? Am I going to put the patient at risk for 
a primary nonfunction? Or should I go for it? Versus having the 
ability to get that kidney to Atlanta, have a courier pick it 
up and drive it to Birmingham, and save about 12 hours of cold 
time. Those things really matter.
    And if you think about IT, something as simple as having a 
system where we can more easily put in unacceptable antigens--
this was a debate for many years. So for context, we list 
unacceptable antigens in the system, and it allows us to better 
match kidneys so that, when someone comes up on the match run, 
we have a high probability that they will be a good tissue 
match.
    Well, that took forever. And we could not really get our 
unacceptable antigens in. So routinely, people get offered 
kidneys that are not going to be a match, and you have to get 
to all of those before you can get to the person that they 
really should go to.
    Those are simple examples. But if we could really have 
transparency and accountability around those kinds of things, 
we could save more lives.
    Senator Casey. Thanks very much. That is compelling. And I 
think for those of us who are concerned about the work of a 
committee like the Finance Committee being done, this kind of 
an investigation being done, of course a report and 
investigation study is only as good as the implementation of 
it.
    I'm sorry; I guess I would turn to you, Mr. Shepard, and, 
just having heard from Dr. Locke about the benefits of both 
increasing accountability and transparency, would you commit to 
implementing--and you may have already been asked this, so I 
may be redundant, and I'm sorry if I am--but would you commit 
to implementing the bipartisan recommendations with regard to 
both transparency and accountability when it comes to organ 
transplantation?
    Mr. Shepard. We are always looking, Senator, for ways to 
improve the process, and I look forward to receiving and 
reading the committee's recommendations on how to do that. I 
cannot commit to them because I have not seen them yet.
    Senator Casey. You have not seen the recommendations? Well, 
I hope that part of the follow-up of the work of the committee 
can be that kind of engagement with you and others, because we 
live in a world now where we can use technology and all the 
innovations that our economy presents to virtually have 
instantaneous retrieval of goods--everything from ordering food 
to ordering groceries or goods online. And the idea that we 
cannot have in place some of the practices and procedures and 
pathways to move organs faster, I hope would be something that 
would be the subject of history, as opposed to where we are 
headed in the future.
    But I look forward to talking to you more about it.
    But, Mr. Chairman, thanks very much for your time, and I 
know I am over, and I appreciate the work you have done.
    The Chairman. Thank you, Senator Casey, chairman of the 
Aging Committee, which has a great interest in these topics as 
well.
    I need to make another correction to something Mr. Shepard 
said, and we are going to get close to wrapping up, unless any 
other Senators on the committee are here.
    Mr. Shepard told Senator Warren that only 10 percent of 
UNOS funds come from taxpayer money and the rest comes from 
fees paid by transplant centers who add patients to the list. 
But the fact is, Medicare is the largest payer of the fees, for 
example for kidneys. So we are talking about inefficiency. 
Inefficiency that puts patients at risk, and certainly taxpayer 
dollars are used to cover some of these practices.
    So we have been at it for a couple of hours, and this has 
certainly been an ominous portrayal that you all have made. We 
have heard about organs with tire tracks. We have heard about 
organs left behind to spoil in airports. We have heard about 
reprisals against people who try to speak the truth about what 
is going on. We have heard about the culture of secrecy that 
dominates UNOS.
    We have emails that in effect have Mr. Shepard ridiculing 
employees he says that he counts on. And we have gone through 
some of the details with respect to the transportation system. 
And probably the best way I would describe it is, it is not 
even a system. It just sounds like it is confusing, at best, if 
not bedlam.
    So we heard testimony from witnesses today. And certainly, 
according to witnesses representing OPO transplant center 
patients, it is obvious that there are serious problems in the 
organ procurement and transplant system. And it is not keeping 
up with the demand for organs. Patients die every day while 
they wait.
    The committee is going to continue its investigation. We 
have already looked at over 1,100 safety complaints filed with 
UNOS. They provide example after example of patient deaths and 
near-misses after people have been selected from the list for 
transplant. One-third of the Nation's organ procurement 
organizations failed to meet even the minimum standards--the 
minimum standards--set out by the agency that certifies them to 
operate.
    One in four kidneys recovered for transplant is never 
transplanted. The Federal experts on information technology say 
that the network's IT systems are not up to the task and that 
UNOS, the contractor that operates them, simply does not have 
the technical capability to update them.
    Now, the testimony from UNOS, which is the organization 
that has run this for decades, is unrepentant. We have not 
heard anything resembling, ``You know, we learned this and this 
over the last decade. We should have done that, but we are 
going to get it fixed soon.'' According to Mr. Shepard, things 
have never been better.
    That is really what we have heard today. We have had the 
contract, claims Mr. Shepard, and we are doing fine, and people 
should be satisfied with us. The patients and the families, the 
physicians, basically are sending a very different message, 
that the situation is dire. The organization responsible for 
fixing it says there really is not anything to fix.
    So we have certainly found in our investigation thus far 
that there is a lot to fix. So we are going to continue the 
investigation. The committee will be looking more closely at 
the role of Federal agencies--the Centers for Medicare and 
Medicaid Services, HRSA--that are charged with overseeing the 
system, and we will be looking at that. And the Federal 
contract that UNOS has had for decades is up for renewal, and 
this is an opportunity to fix things.
    And on this committee, in a bipartisan way, we are 
determined not to miss this opportunity to get this fixed. 
Thanks to Senator Grassley, Senator Cardin, Senator Young, for 
their interest. They have been working with the committee for a 
long time. This is not a partisan issue. This is a national 
issue.
    And, as we have touched on repeatedly over the course of 
the afternoon, patients waiting for organs, and families of 
donors, deserve better. And we are going to stay at it until 
they get those fixes.
    And let me also note, procedurally, that members have 14 
days to submit any questions or statements for the record. I 
want to thank our witnesses--Mr. Henry, who has patiently been 
out there giving us good information from cyberspace--for their 
patience.
    The Finance Committee is adjourned.
    [Whereupon, at 4:28 p.m., the hearing was concluded.]

                            A P P E N D I X

              Additional Material Submitted for the Record

                              ----------                              


        Prepared Statement of Diane Brockmeier, R.N., BSN, MHA, 
               President and CEO, Mid-America Transplant
    Chairman Wyden, Ranking Member Crapo, and members of the committee, 
my name is Diane Brockmeier, and I am the president and CEO of Mid-
America Transplant, the organ procurement organization (OPO) serving 
eastern Missouri, southern Illinois, and northeastern Arkansas. Thank 
you for the opportunity to submit a written statement.

    I joined Mid-America Transplant in 1986 as a registered nurse 
talking to families about organ donation on the worst days of their 
lives. These donor families, and the organ transplant recipients whose 
lives they save, remain at the forefront of my thoughts every day.

    At our organization, we follow the ethos of ``every donor, every 
time.'' Our clinical team is committed to giving donors and their 
families the care they deserve and stewarding their gifts to patients 
desperately in need. Mid-America Transplant depends on the broader 
national transplant system, administered by UNOS, to accomplish this 
work.

    From 2018 to 2020, I served as a board member for the Organ 
Procurement Transplantation Network (OPTN). As an OPTN Board Member, I 
concurrently served on the UNOS board. My board experience revealed 
that UNOS's actions are often not aligned with its fundamental vision--
a lifesaving transplant for everyone in need.

    But change is possible; these problems can be corrected. It is 
critical that we urgently address patient safety, update the archaic IT 
system, remove conflicts to ensure good governance, and return the 
focus of the OPTN to providing high-quality care and exceptional system 
performance to all patients, both donor patients and transplant wait-
list patients.

    We need to urgently address patient safety.

    Each organ lost due to system failure or provider failure has a 
consequence to the thousands of patients waiting for a transplant. 
Furthermore, a discarded organ fails to honor the heroic gift from a 
selfless donor and compounds the family's sense of loss.

    Errors and adverse events do happen in organ procurement and 
transplant, just like in any other field of health care. However, 
unlike the rest of health care, we have few, if any, mechanisms to 
protect patient safety and prevent adverse events. Specifically:

        There are no clinical training, licensure, or certification 
standards required for OPO staff, even those operating in matters that 
directly affect patient care.

        There is no public adverse event reporting required of or by 
UNOS when patients are harmed, organs are lost, or the quality of 
patient care is unsafe.

    UNOS lacks urgency and accountability around identifying and 
remediating the preventable loss of organs and addressing poor quality 
patient care. The process by which errors are reported and reviewed is 
woefully inadequate. Errors are not disclosed to the broader transplant 
community preventing practice improvement. In this environment, who is 
looking out for patients? Who is being held accountable for poor 
quality care? No OPO has ever been decertified, regardless of its 
performance or safety record.

    While decertification falls to the Centers for Medicare and 
Medicaid Services (CMS), the entire system relies on member compliance 
from the OPTN. UNOS has failed to align its efforts to ensure patient 
safety at the system level. It is a decision with tragic and deadly 
consequences.

    We must update an archaic technology system at UNOS.

    As OPOs, we are required to work with UNOS's technology--DonorNet--
every day. DonorNet is outdated, difficult to use, and often slow to 
function when every minute counts. Manual entry subjects it to error, 
and OPO and transplant center staff are not empowered with the right 
information when time is crucial.

    I served in leadership roles on the OPO Committee from 2017-2022. 
Committee members and industry leaders voiced repeated requests to 
address the need for DonorNet improvements. Year after year, these 
requests were consistently met with the response that UNOS IT did not 
have the bandwidth to address this work.

    The limitations of UNOS technology are delaying and denying 
transplants to patients dying on the wait list. Poor technology impacts 
the disturbingly high kidney discard rate in the United States; where 
one in four never makes it to a patient for transplantation.\1\
---------------------------------------------------------------------------
    \1\ Available at: https://optn.transplant.hrsa.gov/about/
committees/kidney-transplantation-committee/; OPTN Kidney 
Transplantation Committee Meeting Summary, June 24, 2022.

---------------------------------------------------------------------------
    Consider:

        UNOS policy requires use of their Organ Center for national 
kidney placement. The Organ Center is highly inefficient, although UNOS 
does not report data about the Center's effectiveness. At our OPO, we 
have consistently observed that the Organ Center is rarely successful 
at placing kidneys and often discards kidneys after failed placement 
attempts leaving many OPOs aware they are better off not using it at 
all.\2\,\3\
---------------------------------------------------------------------------
    \2\ Noreen, SM, Klassen, D, Brown, R, et al. Kidney accelerated 
placement project: Outcomes and lessons learned. Am J Transplant. 2022; 
22: 210-221, doi:10.1111/ajt.16859.
    \3\ Mohan, S and Scheid, JD (2022), Accelerating deceased donor 
kidney utilization requires more than accelerating placement. Am J 
Transplant. 2022; 22: 7-8. https://doi.org/10.1111/ajt.16866.

        Critical time is lost due to the inefficiency of DonorNet--
wasting time on offers that will not be accepted and delaying or 
denying a transplant. Of course, an available organ should be offered 
to patients on the list in sequence. However, far too much of 
matching--particularly on harder to place organs from older donors--is 
left to individual OPOs and transplant programs to find each other 
despite, rather than facilitated by, UNOS technology.\4\
---------------------------------------------------------------------------
    \4\ Doby, BL, Ross-Driscoll, K, Yu, S, Godwin, M, Lee, KJ, Lynch, 
RJ. Examining utilization of kidneys as a function of procurement 
performance. Am J Transplant. 2022; 22: 1614-1623, doi:10.1111/
ajt.16985.

        UNOS has millions of data points that could, and should, 
facilitate faster, more efficient organ placement, providing the 
centers and OPOs with real-time information to increase transplants. 
Leveraging this rich data source is a national imperative to improving 
---------------------------------------------------------------------------
patient outcomes.

        Mid-America Transplant intentionally identifies surgeons who 
accept kidneys that have been declined many times. These are lifesaving 
options for those patients. In May 2022, one of these patients was 
number 18,193 on the list. Relying on DonorNet alone, that kidney never 
would have been placed, and a chance to save a life would have been 
wasted.

        It is worth noting that when an OPO goes out of sequence to 
place an organ that would otherwise be thrown away, UNOS requires an 
explanation. However, when organs are never recovered or placed at all, 
UNOS remains silent. Organ Procurement Organizations are never 
penalized for discarding an organ. Conversely, they are penalized for 
placing organs out of sequence.

    We must remove conflicts to ensure good governance.

    Serving on the board of the OPTN automatically assigns membership 
on the UNOS board. How can you fairly represent the country's interests 
and a contractor's interests at the same time?

        Board members are kept in the dark about critical matters, and 
are marginalized, particularly if they have views that differ from UNOS 
leadership. As a board member, I do not recall the subject of the 
Senate Finance investigation being raised by UNOS leadership.

        Preparatory small group board member calls were conducted 
prior to the board meetings to explore voting intentions on upcoming 
issues. If the board member was not in agreement with the opinion of 
UNOS and board leadership, follow-up calls were initiated. Fellow board 
members reported feeling pressured to vote in accordance with UNOS and 
board leadership.

        Conflicts in the current structure, combined with the actions 
of UNOS leadership, have led to a deeply concerning perception that 
speaking out can lead to exclusion from critical decision-making, or 
worse--retaliation.

        After I left the board, I was disturbed to see UNOS leadership 
lobbying against Federal regulations for OPOs which would drive 
transparency, accountability, and improve performance.

    I implore the committee--along with CMS and HRSA--to ensure those 
who speak out in support of system reform are not penalized. Patients 
deserve a transparent, accountable system that works on their behalf.

    We must refocus on patients.

    To protect patients, I urge Congress and the administration to:

        Separate the OPTN functions into different contracts so 
patients can be served by best-in-class vendors,
        Immediately separate the boards of the OPTN and the OPTN 
contractors,
        Require public disclosure of all potential conflicts for the 
contractor and board members, and
        Ensure that patients are safeguarded through open data from 
both the OPTN and OPOs.

    Inaction by UNOS causes real harm to patients. This harm is 
measured in how many patients die waiting for a transplant. Your 
immediate action on this matter will save lives. Thank you.

                                 ______
                                 
         appendix a: morning consult opinion piece in support 
                   of the opo rule, october 13, 2020
Organ Donation Can Save More Lives Through Reform
    By Ginny McBride and Diane Brockmeier

    Last December, the Department of Health and Human Services proposed 
new regulations to reform the U.S. organ donation system. It would 
accomplish this by creating objective criteria by which to evaluate the 
government contractors, called organ procurement organizations, who are 
charged with recovering transplantable, lifesaving organs from deceased 
donors. These bipartisan reforms could save countless lives. It's 
important the Trump administration finalize them now.

    As CEOs of two OPOs, this is an issue we have followed closely, and 
we applaud these measures as long overdue.

    Our constituents are the more than 100,000 Americans currently 
waiting for a lifesaving transplant, with 33 dying every day for lack 
of an organ. Given that COVID-19 can cause organ failure, reform is 
even more urgent today than it was a year ago. HHS estimates that its 
proposal will mean an estimated 5,000 to 10,000 more lifesaving organ 
transplants every year.

    Central to the problem is that, historically, the government has 
not used objective criteria to evaluate OPO performance. OPOs are 
allowed to self-interpret and self-report our own performance data. As 
a result. no OPO has ever lost its government contract, even as wildly 
variable performance across OPOs has led to unnecessary deaths for 
patients in need of transplants.

    Compounding the problem is that 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.

    HHS's proposal, rightly, promises to implement much-needed 
accountability measures, with real consequence for our counterparts 
that fail to meet them--including replacing OPOs who simply do not get 
the job done. In response, many OPOs have responded with aggressive 
lobbying campaigns to block these proposed reforms by confusing the 
issue or proposing unworkable alternatives.

    But the more future-minded OPOs, like ours, are embracing change. 
HHS's new proposal signals something potentially game-changing for 
patients: allowing the highest performing OPOs to replace those who 
have proven themselves incapable of serving their communities. To the 
extent that 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, not on protecting specific 
OPOs.

    This, of course, is threatening for OPOs who have grown a bit too 
comfortable. Some of our colleagues have tried to paint any changes as 
destabilizing and unprecedented, positing that it will lead to 
situations in which areas of the country do not have OPOs at all. But 
this is simply not grounded in HHS's proposal, which explicitly states 
that ``our goal is to ensure continuous coverage of an OPO service area 
in the event an OPO is decertified.''

    There were originally 128 OPOs, and after decades of consolidations 
there are now 58 OPOs; never has this process been disruptive. Forcing 
OPOs to continually earn their contracts is a patient-centric 
accountability mechanism, ensuring that OPOs operate with the urgency 
befitting the life-and-death consequences of this work.

    Additionally, many OPOs have argued that the standard for OPO 
performance HHS has proposed is ``arbitrary.'' But the more important 
question is whether the improvements HHS seeks to drive are 
realistically achievable, and we believe unequivocally that they are; 
HHS data show the difference between the best and worst OPOs is almost 
500 percent. Put another way, some OPOs recover 4 or 5 times as many 
organs as their peers.

    So if we accept that higher performance is possible--and we 
understand that it would also be lifesaving--realizing these gains is 
not simply a policy question, but a social imperative. As patient 
advocates have argued, and with which we whole-heartedly agree, ``In a 
chronically underperforming system, patients should fear a perpetuation 
of the status quo, not a disruption of it.''

    It's time that HHS unleashed the best weapon it has against the 
life-threatening organ shortage: OPOs who have already proven 
themselves motivated and capable. HHS should finalize its proposal as 
urgently as possible, trusting the best among us to rise to that 
challenge. Any weakening of HHS's proposed standard will--
definitionally--result in lives lost, which is directly antithetical to 
our mission. Patients deserve nothing less.

    Ginny McBride is the CEO of OurLegacy, a Florida-based OPO. Diane 
Brockmeier is the CEO of Mid-America Transplant, which serves parts of 
Missouri, Illinois, and Arkansas; she also is the past president of the 
Association of Organ Procurement Organizations.

                                 ______
                                 
          appendix b: rfi response with other pro-reform ceos 
                   to cms re. opos, february 1, 2022
    To: Administrator Chiquita Brooks-Lasure, Centers for Medicare and 
Medicaid Services

    From: Diane Brockmeier, Mid America Transplant
          Virginia McBride, OurLegacy
          Patti Niles, Southwest Transplant Alliance
          Kelly Ranum, Louisiana Organ Procurement Agency
          Matt Wadsworth, Life Connection of Ohio
          Janice Whaley, Donor Network West
          Jennifer Erickson, Federation of American Scientists

    The FAS Organ Procurement Organization Innovation Cohort is 
committed to using data science and transparency to accelerate improved 
patient outcomes and to inform ongoing, data-driven policy development.

    The seven organ procurement organizations that are leading in 
opening up their data include: Donor Network West, Life Connection of 
Ohio, LiveOn New York, Louisiana Organ Procurement Agency, Mid-America 
Transplant, OurLegacy, and Southwest Transplant Alliance.

    During a transformative period in the organ procurement industry, 
the Innovation Cohort will help shape the future of organ recovery in 
America, improving OPO practice and informing OPO policy. Most 
importantly, the Innovation Cohort will strive toward new heights of 
operational excellence in order to increase organ transplants in an 
effort to best serve the public, organ donors, donor families and 
patients waiting for transplants.

    The FAS Organ Procurement Organization Innovation Cohort has 
publicly committed to:

        Transparency: public sharing of data/analysis in order to set 
a standard to which all OPOs can be held;
        Accountability: support for the OPO final rule, and any 
efforts to move up implementation date so all parts of the country can 
be served by high-
performing OPOs as soon as possible in 2024; and
        Equity: commitment to analyzing/publishing data to ensure all 
parts of community served.
Reducing disparities--p. 68599
    1. Are there revisions that can be made to OPO CfCs to reduce 
disparities in organ transplantation?

    Given bipartisan congressional leaders have called for 
accelerations of reforms of the donation and transplant ecosystem as an 
``urgent health equity issue'' exacerbated by the COVID pandemic, we 
call on CMS to make the public disclosure of all OPO process data a 
requirement of the OPO CfCs immediately.

    To reduce disparities in organ transplantation, it is critical to 
enforce the final rule as quickly as possible, and to update CfCs:
        The metrics contained in the final rule, are already best 
suited to measure OPO performance and hold OPOs accountable to the 
highest performance and to the idea of pursuing every donor and organ 
every time to save as many lives as possible.
        It is critical that the final rule be:
            Enforced as quickly as possible. moving up the 
implementation date so that all parts of the country can be served by 
high-performing OPOs;
            Not be revised in a way that dilutes or 
distorts its impact.
                CMS should maintain its earlier correct judgment 
disallowing both race-based adjustments (which could harm patient 
outcomes) and zero donors (which could allow for gaming of metrics).
        To have evidence of effective and equitable service, CMS 
should make all OPO process data publicly available.
            It is undeniable that a number of the questions 
raised in the RFI could be answered or resolved if all OPO process data 
were required to be made public, giving regulators the opportunity to 
understand and identify where performance gaps and inequitable service 
and outcomes exist.
            This data-driven transparency would ensure all 
OPOs are accountable to the highest levels of operational excellence, 
and would offer opportunities to design interventions to address 
particular gaps in service.
OPO metrics/performance--p. 68601, 68602, 68603
    1. Independent of CMS's specific outcome measures, what other 
metrics or attributes reflect a model or highest performing OPO?; 2. 
What are quantitative or qualitative indicators of excellent 
performance and how can CMS incorporate these with outcome measures 
when assessing OPOs for recertification purposes?; 3.  Should CMS 
consider additional metrics, such as those that measure equity in organ 
donation or an OPO's success in reducing disparities in donation and 
transplantation, and how should this be measured?; 4. Are there ways to 
scale, or rate, performance of other (new) factors that CMS may 
consider in assessing OPO performance? 5. Can the OPO CfCs address the 
issue of organs that are lost during transport to a transplant program?

    In answer to the above questions, CMS should look for evidence of 
effective and equitable service as seen in open and transparent OPO 
process data.

    The OPO Innovation Cohort is committed to transparency, 
accountability, and equity, and is already taking steps to make these 
commitments a reality through its collaboration with the Massachusetts 
Institute of Technology to make de-identified process data publicly 
available.

    This level of transparency should be required of all OPOs. This 
addresses the questions above as well as a range of questions related 
to OPO operational practices (e.g., organ tracking and lost organs; 
operational differences between high- and low-performing OPOs; 
standardization of definitions and practices; the potential impact of 
organ recovery centers; best practices regarding automated referrals, 
and so on).
Competition--68601
    1. Are there additional factors or criteria that CMS should 
consider when determining which OPO should be selected for an open 
service area?; 2. Should CMS consider other performance measures when 
selecting an OPO for an open DSA?; 3. What would be the anticipated 
impact from consolidation or expansion of the OPO community? Would 
consolidation or expansion of OPOs facilitate increased competition and 
improved performance or have a negative impact?; 4. Any other helpful 
information that could inform potential changes to the current 
recertification and competition processes.

    Appreciating the principles of the Biden Executive Order on 
Competition, the FAS OPO Innovation Cohort agrees with bipartisan 
congressional leaders that given COVID makes reform an ``urgent health 
equity issue,'' all parts of the country deserve to be served by high-
performing OPOs as soon as possible.

    As CMS considers elements for competition, transparency, 
accountability, and equity are critical. In addition to overall donor 
and recovery rates, through requiring all OPO process data to be 
publicly available, CMS will have evidence of an OPO's ability to 
equitably serve all donors in a designated service area (including by 
race/ethnicity), as well as improvements over potential, and 
transparency of key financial and organizational data to understand 
capacities to best serve OSAs (including transparency in any conflicts 
that may exist in an OPO's governance structure).

    The FAS OPO Innovation Cohort has already committed to these 
principles, and extending these practices to all OPOs via CfCs can 
allow CMS to best evaluate OPOs as they compete for serving an 
underserved community.

    For example, publicly available OPO process data via CfCs will 
allow CMS to consider evidence of effective and equitable treatment of 
donor patients/families (e.g., no disparities in response rates/times 
based on race/ethnicity).

    The anticipated outcome of both increased competition as well as 
replacing lower performing OPOs with higher performing OPOs would be 
more lives saved. See:

        The Bridgespan Group guidance on how CMS can oversee and 
implement the DSA competition process in a manner that is pro-patient 
and foregrounds racial equity;
        OPO CEOs in the news:
            Diane Brockmeier and Ginny McBride in Morning 
Consult: ``HHS's new proposal signals something potentially game-
changing for patients: allowing the highest performing OPOs to replace 
those who have proven themselves incapable of serving their 
communities. To the extent that 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, not on 
protecting specific OPOs . . . forcing OPOs to continually earn their 
contracts is a patient-centric accountability mechanism, ensuring that 
OPOs operate with the urgency befitting the life-and-death consequences 
of this work.''
            Patti Niles in The Dallas Morning News: ``The 
performance gaps seen in the OPO community would not be acceptable in 
any other sector of health care. There is no reason to accept them in 
the life-and-death context of organ donation. Many organ procurement 
organization leaders are on the record in favor of reform. We have 
worked together with patient groups, doctors, researchers, senior Obama 
and Trump administration officials, philanthropies and bipartisan 
members of Congress to get this right. . . . Lives are at stake. 
Patients deserve better. Our communities deserve better. We must do 
better.''
Oversight--p. 68601
    5.  Are the current CMS requirements for a governing body and 
advisory board adequate for OPO governance? Have OPOs included 
additional board positions or structures beyond what is required by CMS 
to improve operations? What structure best serves accountability, and 
efficient and effective organ procurement?

    The FAS OPO Innovation Cohort believes the principle of 
transparency should apply throughout the entire ecosystem, and that it 
is critical for CMS to:

        Release information related to OPO performance quickly and in 
an understandable way so that boards are aware and can exercise 
fiduciary responsibilities;
        Require transparency of potential conflicts of interest 
throughout the entire donation and transplantation ecosystem as a top 
priority, following the transparency commitment of FAS OPO Innovation 
Cohort.

          appendix c: rfi response with other pro-reform ceos 
                       to hrsa re. optn, may 2022
    To: HRSA Administrator

    From: Diane Brockmeier, Mid-America Transplant
          Ginny McBride, OurLegacy
          Kelly Ranum, Louisiana Organ Procurement Agency
          Matt Wadsworth, Life Connection of Ohio

    This letter Is in response to a Request for Information (RFI) 
regarding the contract to operate the national Organ Procurement and 
Transplantation Network (OPTN). Each of our organ procurement 
organizations (OPOs) supports HRSA's stated objectives of:

        Increasing accountability in OPTN operations, Including board 
governance, financial structures, data transparency, and policy 
development;
        Enhancing the usability and performance of the OPTN IT system 
and related tools; and
        Strengthening equity, access, and transparency in the organ 
donation, allocation, procurement, and transplantation process.

    With the above objectives in mind, key recommendations for HRSA to 
reform the OPTN in such a way that best serves patients, focusing on 
core competencies and removing conflicts, include:

        Ensure patient-centered governance of the OPTN, separating the 
OPTN board from any contractor(s) serving OPTN functions; and
        Revise the OPTN contract so that it subdivided into areas 
where the OPTN contractors can provide critical and expert functions:
            Policy: reforming OPTN governance (above) is 
critical to de-conflicting policy. Policymaking by an OPTN contractor 
should then be transparent, fueled by openly available data, aided by 
experts in government and the wider community, and with all potential 
conflicts publicly known and acted on accordingly.
            IT: the IT components of OPTN operations be 
outsourced by HHS in ways that are independent of, but complimentary 
to, the rest of the OPTN contract
                The Office of the National Coordinator (ONC) at 
HHS should work with the tech contractor on matters critical to 
national/health IT and organ donation/transplantation, including 
exploring better use and/or integration of hospital EMRs.
            Organ placement and shipping: these should be 
separate from existing OPTN contract, with best in class options 
available for OPOs to opt into as appropriate.
           Note: the Membership and Professional Standards Committee 
should cease its activities to evaluate OPO performance and conduct 
peer review, with OPO oversight being the purview of CMS, instead of 
fractured between CMS and OPTN.

        All of the above functions--both from HHS and OPTN 
contractors--should have strengthening equity, access, and transparency 
at their core, including ensuring all de-identified data are publicly 
available to best serve patients, and enable continuous innovation and 
improvement.
A. OPTN Technology--IT System: (A.1-4)
    We are acutely aware OPTN technology lags significantly behind 
other technology platforms because our OPOs use it every day. As 
citizens of the U.S. we enjoy the use of numerous corporate IT 
platforms to perform the most basic functions of life. These platforms 
have been developed by enterprising companies whose survival relies on 
capturing market share. Ease of use, convenience and continuous 
innovation are among the most prized factors. Companies compete against 
each other to satisfy and retain customers. Poor performers do not 
survive.

    Companies succeed because they prioritize continuous, rapid IT 
system improvement because IT is a core function. The current OPTN 
contractor has not positioned itself to provide state-of-the-art 
service and does not view evolving technology as a priority. The OPTN 
Board of Directors and committees and the current contractor's board 
and committees lack the needed expertise to make the necessary changes 
because the OPTN Bylaws restrict the involvement of individuals who 
could expand its capabilities. From an IT perspective, the current OPTN 
contractor is slow and reactive.

    It is our recommendation that the IT components of OPTN operations 
be separated from the monolithic OPTN contract by HHS In ways that are 
Independent of, but complimentary to, the rest of the OPTN contract. 
HRSA could require any other OPTN contractors to incorporate the 
services of the independent technology provider into its workflows. 
That independent contractor should be answerable to and benefit from 
digital service experts within the govemment--including HHS and the 
ONC--who can competently exercise oversight on behalf of patients and 
taxpayers.

    The flow of information among OPOs, donor hospitals, transplant 
programs and the OPTN in support of successful donation and 
transplantation, while constant, remains fractured. Donor hospitals and 
transplant hospitals utilize their own electronic health record 
systems. OPOs and transplant programs utilize customized, built-to-
purpose databases that interact with the OPTN only to transfer donor, 
candidate and recipient data that are, for the most part, not used for 
the critical functions of organ matching, offer and acceptance. The 
OPTN database operates in a one-way fashion in which members provide 
data but very little information is provided directly to them in 
return, and the entire process is hindered by the current OPTN 
contractor's inability to deploy APIs.

    The use of multiple databases to operate a network dependent on 
timely and accurate communication to achieve maximum performance is not 
efficient. The OPTN technology contractor should be working toward 
seamless integration from hospital EHR to OPTN database. The rules of 
engagement with the OPTN database should be changed so OPOs are no 
longer required to maintain an additional database to collect and store 
donor information. OPOs should be able to transfer donor clinical 
information directly from the hospital EHR to the OPTN database for the 
purpose of communicating donor evaluation information and organ 
allocation. OPOs should be able to enter and extract data from the 
national database utilizing their own internal capabilities, aided by 
APIs, rather than pay for an expensive database ``middleman.'' 
Additionally, there should be mutually agreed upon national OPO 
datasets that can be used for research and analysis purposes (see 
earlier response to CMS RFI on data transparency). Data availability 
and transparency are key to improving organ procurement. The database 
should be managed by the OPTN technology contractor in a way that 
prioritizes data transparency. The current OPTN contractor has not 
proven capable of this function.

    Historically, motivation for the OPTN to accelerate improvements to 
its technology platform have come from outside the OPTN. Pressure to 
create DonorNet came from HRSA. More recently, calls to implement a GPS 
system to track organ movements went unheeded by the OPTN until media 
accounts exposed the lack of a systematic method to protect vulnerable 
organs while in transit Incorporation of technology requirements into a 
single OPTN contract has not sufficiently served the needs of OPOs, and 
the noncompetitve monopoly structure has relieved all pressure from the 
current OPTN contractor to keep current with even basic technology 
standards, creating risks to patient safety and data security. HRSA 
must create opportunities to incorporate a wider array of contractors 
to serve technology needs, including by opening the pool to the widest 
range of innovative applicants. There are numerous U.S. companies with 
the ability to track and deliver packages. It would serve the interests 
of organ sharing better if one of those companies could establish a 
national organ shipping system that would monitor the progress of all 
shipments in real time on behalf of OPOs that opt in.

    B. Data Collection Activities: 1. Describe how you would/how 
vendors could develop performance metrics and benchmarks for the organ 
donation, procurement, allocation and transplant system, including 
through expert consultation, subcontracting, and engagement with 
transplant candidates, transplant recipients, organ donors and their 
families about the metrics they value. 2. Describe how you would/how 
vendors could structure data collection and reporting mechanisms for 
the system: a. To report OPTN performance metrics including process, 
outcome, and patient engagement measures. b. To establish OPTN member 
performance benchmarks. c. To capture patient and donor demographics, 
including race, ethnicity, language, and socioeconomic factors. d. To 
create public OPTN national, regional and local performance dashboards. 
e. To track long-term patient outcomes and health and non-health-
related factors that contribute to outcomes.

    CMS recently finalized new, objective OPO regulations which we 
supported along with patient groups, bipartisan congressional leaders, 
and equity advocates. The performance measures recently published by 
the CMS are already having substantial influence on OPO performance. 
One case in point is the Arkansas Organ Recovery Agency (ARORA), an OPO 
which had never recovered organs from more than 77 deceased donors in a 
single year. Because of leadership changes driven by years of 
underperformance, a new executive director achieved 108 deceased organ 
donors in 2021. It seems unlikely this leadership change would have 
occurred without external pressure from CMS to change course.

    HRSA, and other HHS entities, must establish national goals in 
collaboration with leading experts external to the OPTN but can use the 
donation and transplantation community as sources of data, information 
and insights. Additionally, all de-identified OPTN data should be 
publicly available to allow for oversight, innovative research, and 
donation/transplantation stakeholders to improve patient outcomes based 
on data.

    Additionally, we and the aforementioned groups have advocated for 
HHS to publish OPO process data (see CMS RFI response), which will not 
only inform best practices for OPO management, but help inform policy 
considerations at the intersection of multi-stakeholders, including in 
regards to best practices and thoughtful regulation related to donor 
hospital referrals and organ discards. Regardless of whether HHS takes 
on some of these responsibilities directly (including potentially 
through an Office of Organ Policy), or outsources them to an external 
vendor, all metrics and benchmarks should be informed by transparent 
process data, in line with international best practice standards.
C. (d) OPTN Finances
    The OPTN board and any OPTN operational contractor board must 
achieve complete separation. The OPTN board, populated mostly by 
transplantation professionals, does not have the expertise or 
background to oversee a financial, technological, human resources, 
customer service enterprise. UNOS's performance as the OPTN contractor 
bears this out. Its ability to keep pace with technological advances 
has been in question for many years, as evidenced by board and OPTN 
members who are frustrated at the time it takes to implement policy 
changes. The current board does not have the background enabling it to 
build wider corporate relationships enabling it to achieve strategic 
goals. The OPTN community has suffered as a result. UNOS's current 
strategy of using one board to serve two purposes must be abandoned. 
Any new contractor boards should commit to develop an independent 
operational plan that focuses on human resources needs, financial 
strategies, corporate IT objectives and other strategies to enable goal 
achievement that allows for HHS to meet its objectives for the 
transplant community. The OPTN board and staff should be financed by 
OPTN registration fees. Because both the OPTN board and the contractor 
operational board would be in accountability relationships with HRSA, 
they both would report on successes and barriers in meeting the 
strategic objectives of the OPTN. This reporting process could be 
extended to all elements within HHS with a stake in the operations of 
the OPTN to ensure alignment of goals and communication transparency. 
Ideally, NOTA should be updated, including to create a financing 
structure that aligns incentives for any OPTN contractors with the 
actual goals of HHS and patients in mind, which is to constantly 
increase transplant availability through improved stakeholder 
performance, something which is not accomplished in the current 
financing structure.

    Any donation and transplantation clinician who is a member of the 
OPTN board and employed by an OPO or transplant hospital is in a 
conflict of interest when voting on certain OPTN policies. And since at 
least 50 percent of the board meets this criterion (because of OPTN 
final rule requirements for board composition), a method of addressing 
the conflict must be identified. Currently, conflicts are self-
reported, narrowly defined, and not disclosed. One strategy specific to 
organ allocation could be that policies are voted on by non-OPO and 
transplant program members. This leaves patients, donor families, trade 
organizations (which would each get a single vote to represent each 
industry) and other non-allied members to vote. Board members would be 
prohibited from lobbying the patients and donor families to gain their 
votes. However, the best and most sustainable strategy would be to 
eliminate inherent conflicts entirely through subdivision of the OPTN 
contract. For example, organ allocation could be handled by a separate 
contractor with no financial or other business relationships to the 
stakeholders with a vested interest in the outcome of organ allocation 
policy.

    D. Increasing Organ Donation and Improving Procurement: 1. Describe 
how you would/how vendors could structure, finance and staff an OPTN 
board of directors independent of membership of the OPTN operational 
contractor's board of directors. 2. Describe the conflict of interest 
policies you would/vendors could implement to ensure independence of 
the OPTN board of directors. 3. Describe the reporting mechanisms you 
would/vendors could utilize to hold operational contractors' 
accountable tor system performance and outcomes. 4. Describe the 
additional factors and process steps you would/vendors could take to 
ensure effective operations of such an independent board of directors.

    The OPTN contractor should no longer be actively engaged in 
supporting OPO performance improvement activities. There should not be 
contract activities to support OPO performance and the Membership and 
Professional Standards Committee should cease its activities to 
evaluate OPO performance and conduct peer review. Neither of these 
activities has resulted in immediate and sustained donation increases 
and the OPTN has permitted some severely underperforming OPOs to 
continue practicing rather than make referrals to the HHS Secretary to 
decertify the underperformers. The MPSC began evaluating OPO 
performance many years ago at a time when CMS's OPO performance 
standards were vague and Incapable of identifying poor performers. At 
HRSA's request, the OPTN and SRTR stepped in to develop measures that 
would identify low performing OPOs. Despite having a set of standards, 
the OPTN has done little to positively impact the number of donors and 
organs transplanted. This inability came into stark relief in 2003 when 
HRSA launched the breakthrough collaboratives and, with almost no 
assistance from the OPTN except data analysis support, achieved 
unprecedented donation increases. Any funding to improve OPO 
performance could be better spent and allocated through a formal CMMI 
process of the best available data-driven options. The OPTN could then 
stay focused on evaluating OPOs for compliance with OPTN policies, such 
as following official OPTN allocation processes.

    CMS is already demonstrating with its new performance outcome 
standards that, despite the OPTN's 20-year history of OPO performance 
evaluation and improvement activities, more than a third of OPOs are 
failing. The Scientific Registry of Transplant Recipients (SRTR) data 
used by the OPTN MPSC to evaluate OPOs also seem ineffective in 
identifying poor performance. Therefore, it has been extremely ill-
structured for the OPTN, rather than CMS, to have unique visibility 
into the day-to-day issues necessary for CMS to exercise such oversight 
responsibility. Given this, HHS should reabsorb all OPO oversight 
functions from the OPTN.

    If, as alluded to earlier, HHS publishes full process data, this 
will help generate a multitude of solutions for remediating OPO 
performance failures during the course of a contracting cycle. For 
example, with specific deficiencies identified. including issues 
related to diversity, equity, and inclusion, OPOs will be able to 
engage external partners (including partners both traditionally within 
and outside of the OPO industry) to implement data-driven solutions. 
Such process data, in line with international best practice for data 
transparency, should include: whether OPOs are appropriately staffed to 
serve their communities; data about referral and request outcomes based 
on potential donor and family race; and other issues that could 
identify any deficiencies in any OPOs' service of communities of color. 
Using these data, HRSA could then also partner with multiple 
organizations to develop strategies to improve equity in organ donation 
at a systems-level.

    E. Organ Usage: 1. Describe how you would a vendor could support 
the OPO performance Improvement activities to decrease discarded organs 
and further increase the use of organs. 2. How can OPTN organ matching 
activities be modified to decrease non-usage (discards) of procured 
organs? 3. Describe the steps you would/vendors could take to improve 
transparency around the organ matching and acceptance process for 
transplant candidates, transplant recipients, other affected patients, 
organ donors and family members served by the OPTN.

    The most effective way to discourage OPOs from recovering organs is 
to ensure they don't get transplanted. This is the biggest problem 
facing the OPTN. From an OPO perspective, the OPTN is unintentionally 
enabling organ discards because organ allocation policies, particularly 
kidney allocation policies, prioritize how candidates are ranked on the 
waiting list rather than ensuring a transplantable kidney is implanted 
into a compatible recipient The balance between ensuring equity in 
candidate selection and ensuring viable organs are transplanted has 
been lost. This is partly because the people driving kidney allocation 
policy development (the OPTN Kidney Committee) are predominantly 
transplant professionals. There are no OPO voices advocating for better 
kidney utilization during the policy development phase. Discard rates 
are also influenced by an OPOs inability to get an offer to a program 
willing to use the kidney in a timely manner. High KDPI kidneys are 
``at risk'' from the moment of aortic crossclamp. But they aren't 
treated with sufficient priority. OPOs, or the Organ Center, must use 
precious time to wade through offers to transplant programs that 
rarely, if ever, use high KDPI kidneys. Kidney filters only do so much. 
Rather than rely on voluntary engagement of transplant programs to 
filter offers, high KDPI kidney allocation should prioritize the 
programs with a track record of using them.

    Much of the problem also results from the frictionful and otherwise 
insufficient UNOS technology system over which organ offers as made, 
leading to calls from the House Appropriation Committee for HHS to 
promote competition for the IT component of the OPTN contract for this 
explicit reason.

    Honoring donors and donor families by ensuring their kidneys are 
transplanted is our national obligation. Anything less is a disservice 
to those who have donated.

    Not every OPO agrees that handing kidneys to the Organ Center for 
the purpose of national placement is an effective means of getting 
kidneys transplanted. OPOs generally are not confident that placement 
will occur when relying on the Organ Center. The Organ Center's organ 
placement outcomes are not widely shared and OPOs deserve to be better 
informed about the likelihood of their organs being placed and should 
have a choice about whether to ask the Organ Center for assistance. 
OPOs are more invested than the Organ Center in placing organs because 
we know the families who have donated them and we will work to get them 
placed. Unfortunately, current OPTN policy makes this difficult.

    But there could be a different option to place difficult organs. 
Because transplant programs and OPOs are relying more frequently on 
staffing and operational support from third parties or call centers, it 
may be possible to create an organization whose sole purpose is to 
place kidneys. This organization could be operated under a separate 
section of the OPTN contract but receive financial support from OPOs 
that would be willing to utilize it (e.g., a fee-for-service, which 
would be optional for OPOs and applied on an opt-in, voluntary, case-
by-case basis). The objective would be to place high KDPI kidneys 
faster. Such an organization could quickly learn which centers are more 
inclined to transplant certain organs and collaborate with the host 
OPOs to develop a placement strategy. We must develop an increased 
level of national urgency to place the kidneys OPOs have successfully 
made available. It is our experience that transplant programs do not 
feel urgency when a kidney is at risk. But the OPOs feel that risk very 
acutely. Perhaps it is time to move away from the Organ Center concept 
and toward a more independent process.

    1. Describe how you would/vendors could incorporate, to the full 
extent permitted under applicable law, the NASEM report's 
recommendations on increasing racial, ethnic, professional, and gender 
diversity on the boards and committees responsible for developing OPTN 
policies. 2. Describe how you would/vendors could engage with experts 
in quality improvement and stakeholder collaboration in executing OPTN 
deliverables. Page 6 of 7. 3. Describe what you would/vendors could 
include in their code of business ethics and conduct for the entity 
that holds this contract to ensure the highest standards of conduct and 
integrity are observed. 4. What other improvements to OPTN operations 
and policy development processes can and/or should be incorporated into 
the OPTN contact?
F. OPTN Operations and Policy Development Improvements
    We support NASEM's recommendation that improvements to the OPTN's 
policymaking process to increase racial, ethnic, professional and 
gender diversity on the OPTN's board and committees are urgently 
needed. This can be accomplished by increasing or changing the number 
or type of medical/scientific members or public members and permitting 
them, via the OPTN bylaws, to serve on committees and the board. HRSA 
and the OPTN should actively recruit membership of organizations with 
expertise in health-care delivery to DEI communities. HHS should also 
clearly articulate its goals, as well as to foster a dynamic in which 
any OPTN contractor(s) understand that they will likely lose their 
contract should they fail to meet these goals.

    Many OPTN members are losing confidence in the OPTN policymaking 
process. It seems that significant time and resources are devoted to 
changes that make only small, incremental differences in the number of 
organs donated and transplanted. Many policies are also perceived to be 
tainted by the conflicts of interest inherent in the current OPTN 
structure, which again underscores the need for HHS to subdivide the 
OPTN. Although OPTN policies are developed by members, their impact is 
felt far beyond OPTN membership. Their ability to success is dependent 
on factors also beyond the membership of the OPTN. If the OPTN is to 
improve its success it is essential that we allow those societal 
factors that can affect our success be part of the policy development 
process. And to do that, we must re-examine that process, specifically 
our public comment process. Currently, the OPTN is reliant on 
commenters coming to regional meetings or depositing feedback on a 
website to obtain public feedback. To build trust in our system, we 
must consider how we can more actively engage influential communities 
to help us understand how we can do better. OPTN policies aren't just 
medical policies, they are public trust policies. The OPTN must build a 
community that is willing and capable to provide honest feedback. And 
we must have a public comment process that honestly and transparently 
incorporates that feedback so participants feel heard and valued. We 
strongly support the involvement of organizations such as the National 
Academy of Public Administration to assess the OPTN's current policy 
making process and advise on strategies to diversify how its 
development is influenced.

    Additionally, given how critical DEI is to all aspects of a high-
functioning organ donation and transplantation system. all OPTN 
contractors should include DEI expertise within its core leadership and 
DEI metrics as part of its transparent reporting.

    Creating strong foundations for the policy making process is what 
will drive how the OPTN ensures its code of ethics and integrity is 
maintained. Many perceive the OPTWs integrity has suffered and it is 
our belief that this is because the policymaking process lacks 
transparency and accountability.

                                 ______
                                 
 Questions Submitted for the Record to Diane Brockmeier, R.N., BSN, MHA
               Questions Submitted by Hon. John Barrasso
    Question. As a doctor for over 20 years, I've seen how complex and 
fragile the organ procurement and transplant system in the United 
States is. A single, seemingly minor mistake can cascade into the loss 
of the most important thing of all--a human life. That's why we need to 
make sure those involved in the procurement and transplant system are 
held accountable so patients--our constituents--are afforded the 
opportunity for a longer, healthier life.

    The committee's report highlighted multiple shortcomings in the 
U.S. Organ Procurement and Transplantation Network (OPTN). 
Specifically, it documented instances over the past years where OPOs' 
clear mistakes were not elevated within United Network of Organ Sharing 
(UNOS) to the appropriate staff, or the same mistakes were repeated 
with seemingly inadequate corrective action, investigation, oversight, 
or guidance from UNOS. This suggests a part of the problem could be 
systemic organizational failure.

    What regulatory or legislative actions could be taken to enhance 
accountability and performance within the OPTN, especially within UNOS 
or other potential OPTN contract recipients?

    Answer. I thank Senator Barrasso for this important question, and I 
appreciate how the Senator's experience as a physician brings attention 
to what is at stake: the lives of patients.

    As I testified, to protect patients, I urge Congress and the 
administration to separate the OPTN functions into different contracts 
so patients can be served by best-in-class vendors; immediately 
separate the boards of the OPTN and the OPTN contractor; require public 
disclosure of all potential conflicts for the contractor and board 
members; and ensure that patients are safeguarded through open data 
from both the OPTN and OPOs.

    Inaction by the current OPTN contractor, UNOS, has caused real harm 
to patients; the harm is measured in how long patients wait, and how 
many patients die waiting for a transplant.

    I agree with the bipartisan Senate Finance Committee 
recommendations (released on August 3, 2022) that the OPTN monopoly 
needs to be broken up. Having one entity--UNOS, or any singular OPTN 
monopoly contractor--is not serving patients.

    Question. The committee report briefly discussed how the legal 
requirement that the OPTN contract be awarded to only one entity may 
deter bidding and competition from other potential contract recipients. 
Similarly, the report suggests that the OPTN's responsibilities could 
be better carried out through multiple contracts with entities 
specialized in one function, like IT or compliance.

    What are the advantages and disadvantages of the current OPTN 
contract that allows only one entity to operate the Network?

    What potential trade-offs exist between having only one contract 
entity versus multiple specialized entities?

    Answer. Per my response above, it is critical to break up the OPTN 
contract and ensure transparency and accountability in the procurement, 
administration, and competition of the contract moving forward. In my 
opinion, the current OPTN contract structure does not permit 
competition, and through this lack of competition, innovation is 
stifled, suboptimal practice is calcified, and opportunities to improve 
are lost through the failures of UNOS leadership.

    Question. This committee has obviously been hard at work trying to 
identify shortcomings in the organ procurement and transplantation 
system over the past couple years. Also within the past couple years, 
the Trump administration proposed and the Biden administration 
finalized the OPO final rule. This rule established new performance 
metrics for OPOs as well as helped promote more frequent oversight and 
competition among OPOs.

    Are there other regulatory or legislative actions Congress or the 
administration should take to ensure the OPTN is performing to its 
maximum potential for patients and providers?

    Answer. I reiterate my support for the bipartisan recommendations 
released by the committee on August 3, 2022. As stated in my answers 
above, I believe that the most important steps Congress and HHS can 
take are to separate the OPTN functions into different contracts so 
patients can be served by best-in-class vendors; immediately separate 
the boards of the OPTN and the OPTN contractor; require public 
disclosure of all potential conflicts for the contractor and board 
members; and ensure that patients are safeguarded through open data 
from both the OPTN and OPOs.

                                 ______
                                 
                 Questions Submitted by Hon. Todd Young
    Question. Are there minimum standards and/or training at Organ 
Procurement Organizations (OPOs) set in Federal regulations or by the 
OPTN? If not, should there be? What is being done to make sure everyone 
is performing at their best at OPOs?


    Answer. I believe this is a critical issue facing our industry and 
our transplant system, and I am grateful for the opportunity to 
describe what can be done to support improvement and increased patient 
safety at OPOs.

    Under current regulations and OPTN policies, there are insufficient 
standards for OPO provider qualifications and inadequate safety 
monitoring and protections for patients. OPOs provide clinical care to 
critically ill patients, and those patients deserve highly qualified 
clinical providers. Right now, standards in Federal regulations, CMS 
audits, and OPTN policies do not require that all clinical care 
provided to donor patients is provided by licensed or certified health-
care workers. To ensure patient safety, to protect quality of patient 
care, and to increase OPO performance, regulations must be revised to 
include a minimum standard of licensure/certification and a minimum 
training requirement for any OPO staff who provide clinical care to 
donor patients.

    In my response, I will describe the current state of requirements, 
and also provide recommendations for actions legislators and regulators 
can take to address insufficiencies.

    First, as the Senator references, the Code of Federal Regulations 
does contain language that references qualifications of organ 
procurement organization (OPO) staff. The regulation reads in full:

        42 Sec. 486.326 Condition: Human resources.

        All OPOs must have a sufficient number of qualified staff, 
        including a director, a medical director, organ procurement 
        coordinators, and hospital development staff to obtain all 
        usable organs from potential donors, and to ensure that 
        required services are provided to families of potential donors, 
        hospitals, tissue banks, and individuals and facilities that 
        use organs for research.

        (a) Standard: Qualifications.

        (1) The OPO must ensure that all individuals who provide 
        services and/or supervise services, including services 
        furnished under contract or arrangement, are qualified to 
        provide or supervise the services.

        (2) The OPO must develop and implement a written policy that 
        addresses potential conflicts of interest for the OPO's 
        director, medical director, senior management, and procurement 
        coordinators.

        (3) The OPO must have credentialing records for physicians and 
        other practitioners who routinely recover organs in hospitals 
        under contract or arrangement with the OPO and ensure that all 
        physicians and other practitioners who recover organs in 
        hospitals with which the OPO has agreements are qualified and 
        trained.

        (b) Standard: Staffing.

        (1) The OPO must provide sufficient coverage, either by its own 
        staff or under contract or arrangement, to assure both that 
        hospital referral calls are screened for donor potential and 
        that potential donors are evaluated for medical suitability for 
        organ and/or tissue donation in a timely manner.

        (2) The OPO must have a sufficient number of qualified staff to 
        provide information and support to potential organ donor 
        families; request consent for donation; ensure optimal 
        maintenance of the donor, efficient placement of organs, and 
        adequate oversight of organ recovery; and conduct QAPI 
        activities, such as death record reviews and hospital 
        development.

        (3) The OPO must provide a sufficient number of recovery 
        personnel, either from its own staff or under contract or 
        arrangement, to ensure that all usable organs are recovered in 
        a manner that, to the extent possible, preserves them for 
        transplantation.

        (c) Standard: Education, training, and performance evaluation. 
        The OPO must provide its staff with the education, training, 
        and supervision necessary to furnish required services. 
        Training must include but is not limited to performance 
        expectations for staff, applicable organizational policies and 
        procedures, and QAPI activities. OPOs must evaluate the 
        performance of their staffs and provide training, as needed, to 
        improve individual and overall staff performance and 
        effectiveness.

        (d) Standard: Medical director. The OPO's medical director is a 
        physician licensed in at least one of the States or territories 
        within the OPO's service area or as required by State or 
        territory law or by the jurisdiction in which the OPO is 
        located. The medical director is responsible for implementation 
        of the OPO's protocols for donor evaluation and management and 
        organ recovery and placement. The medical director is 
        responsible for oversight of the clinical management of 
        potential donors, including providing assistance in managing a 
        donor case when the surgeon on call is unavailable.

    In the text of 42 Sec. 486.326, OPOs are only held to a standard of 
``sufficient number of qualified staff'' under the regulation. The 
definition of ``qualified'' is left to the interpretation of the OPO. 
Such ambiguity in the regulatory text allows for an unacceptable level 
of variability in training, credentialing/licensing, and verification 
of qualifications in OPO staffing.

    In my opinion as an OPO CEO and critical care nurse, I believe that 
CMS should define the term ``qualified'' for any OPO role that includes 
patient clinical care and interaction with patient health data. An 
unqualified or underqualified OPO staff person with a role in direct 
patient care and/or clinical evaluation of health information presents 
a safety risk to potential donor patients and transplant wait-list 
patients who rely on the safe, effective procurement of organs.

    Right now, some OPOs hire non-licensed health-care workers, or non-
health-care workers, in roles with direct patient care. This is 
permissible under the current regulatory environment. And, since 
neither CMS nor the OPTN contractor collect information about the 
number of OPO employees with clinical responsibilities or patient care 
interactions, our system does not have a way to quantify what lax 
standards for training and qualification may lead to in terms of 
adverse events, safety issues, or quality of patient care.

    For example, at Mid-America Transplant, we require that any staff 
member with patient interaction and/or clinical care responsibilities 
for in our Organ Recovery Center is a registered nurse with a minimum 
of 2 years of critical care experience. Our definition of ``qualified'' 
is based on 3 decades of organizational data and clinical care 
delivery. Our independently run Donor Care Unit has made this a more 
salient issue; when donor patients are moved to our facility, outside 
of a hospital, it is imperative that our team of care providers have a 
rich experience basis, clinical discernment, and the ability to address 
a wide range of clinical challenges.

    We know that potential donor patients (1) are critically ill with 
multi-system dysfunction; (2) are unable to personally advocate for 
their care, due to their condition; and (3) may provide lifesaving 
organs for transplant only if provided appropriate, safe, evidence-
based donor management and monitoring in the course of clinical care at 
our facility, or in our partner hospitals.

    The stakes for the care OPOs provide could not be higher. And, as 
more OPOs open organ recovery centers outside of hospitals, the 
qualifications, abilities, and experience level of OPO staff becomes 
more relevant to quality of care. When a donor patient is in an OPO 
recovery center, there is no way to rely upon other health-care 
providers and expertise that would be available in a hospital. A highly 
qualified OPO workforce is not just an issue of quality, but also 
safety, for the donors, OPO, transplant centers, and potential organ 
recipients.

    I also wish to direct the Senator to the section of the CMS audit 
that covers OPO personnel. The relevant text is below:

        State Operations Manual Appendix Y from CMS QSOG/CCSQ

        Part I--Survey Protocol for Organ Procurement Organizations

        E. Task Three--Personnel Record Review and Interview (Rev.)

        This task covers requirements of the CfC on Human Resources 
        (Sec. 486.326).

        The surveyor should use the organizational chart and/or staff 
        list of OPO staff to select a sample of full-time and contract 
        personnel. Request the personnel records for the selected 
        sample. The personnel interviews and personnel file reviews 
        should cover all staff positions. Review a minimum of five 
        employee files for the clinical and family support staff at the 
        OPO including contract employees in those positions. Expand the 
        sample as necessary based on other survey findings.

        1.  Personnel Review

        1. Review the personnel records of OPO employees and contract 
        employees to ensure that the OPO is meeting all requirements in 
        the OPO CfCs at Sec. 486.326.
            i.  Review current licensure records, orientation records, 
        position description, performance evaluations, conflict of 
        interest evaluations, and training records for the staff.
            ii.  Verify that the staff are licensed and/or registered 
        in their State.
            iii.  Verify that orientation and periodic in-service 
        training are provided to the staff.

        2. Confirm that the OPO verified prior to recovery that 
        recovery surgeons were currently credentialed.

        3. Review the file for the OPO medical director to verify that 
        he/she is currently licensed as a physician in one of the 
        States within the OPO DSA or as required by State or local law. 
        The position description for the medical director clearly 
        delineates his/her roles and responsibilities for 
        implementation of the OPO's protocols for donor evaluation and 
        management and organ recovery and placement.

    Under this language, a CMS audit checks for current licensure and 
certifications held by a sample of 5 staff members. The audit does not 
verify whether all staff members with patient care or patient health 
record evaluation responsibilities are licensed or certified. The audit 
also does not define which licenses or certifications are acceptable.

    CMS can remediate this problem by modifying the Task Three 
Personnel Review to include:

        The roles of staff members with direct patient care and/or 
clinical evaluation of patient health records.
        The number of staff that occupy these roles at the OPO.
        Require a threshold for licensed/certified health-care workers 
who occupy roles with direct patient care and/or clinical evaluation of 
patient health records.

    There are OPTN policies that reference the requirement that 
``licensed health-care workers'' complete certain tasks or hold certain 
responsibilities (see: OPTN policy 3.3, 5.8, 14.5). However, all but 
one of these OPTN policies reference transplant center activities. The 
only reference to OPO qualifications is in OPTN policy 2.14.B, which 
reads: ``Review the OPO's internal policies, procedures, and protocols 
to verify that it has a written protocol(s) that includes: Definition 
of qualified health-care professionals to perform the pre-recovery 
verification [of organs].''

    The current OPTN contractor does demonstrate understanding that 
having qualified health-care workers is important for the care provided 
by transplant centers. I cannot explain to the committee why the 
contractor has neglected to ensure that donor patients are cared for by 
qualified health-care workers, and that the only time at which a 
qualified health-care professional is necessary for an OPO role under 
OPTN policy is at the time of verifying the organ being allocated for 
transplant.

    An OPO can decide, as an organization, that a person without 
medical training, without a relevant license or certification (R.N., 
LPN, paramedic, respiratory therapist, APP, etc.) can occupy a role 
that requires the ability to evaluate patient health information, make 
clinical determinations, and even provide clinical care to patients. 
The OPO would remain in compliance with 42 Sec. 486.326, pass the 
associated CMS audit requirements, and adhere to current OPTN policy as 
long as their staffing remained ``sufficient'' and their own internal 
employee training declared the person as ``qualified.''

    I cannot speak for anyone else, but I can speak for myself and my 
family: I would not want a person who is not a licensed or certified 
health-care provider to perform a physical examination, or evaluate my 
medical records, or perform a medical procedure on me or someone I 
love. OPOs provide clinical care to patients. Patients, even those at 
the end of their lives, deserve high quality, safe, and dignified 
clinical care performed by highly trained, licensed or certified, 
health-care workers. Congress, and CMS, must act on this issue in order 
to ensure patient safety, and increase quality of care provided by 
OPOs.

                                 ______
                                 
                Question Submitted by Hon. Maggie Hassan
    Question. In 2019, the National Council on Disability (NCD) 
released a report finding that people with disabilities are often 
excluded as organ transplant candidates due to their disabilities. Does 
your organization have a policy that covers organ transplant access for 
individuals with disabilities?

    Answer. As an organ procurement organization (OPO), Mid-America 
Transplant does not have a direct role in evaluating and listing 
patients for transplantation. Instead, our work is with potential donor 
patients who are referred to our OPO by hospitals.

    Our OPO strongly supports equitable access to transplantation for 
people with disabilities. Although our own practice is with potential 
deceased donor patients, instead of potential transplant recipients, we 
have ensured in our clinical processes that no potential deceased donor 
patient may be excluded from consideration for organ, eye, and tissue 
donation due solely to disability.

    Our team has provided high-quality, compassionate care to deceased 
donor patients with documented disabilities and their families. We 
believe that equitable access to care for people with disabilities 
should be a goal for both organ procurement and transplant center 
providers. People with disabilities who are able to be organ donors 
should receive equitable, safe, high quality care from all organ 
procurement organizations. We believe that people with disabilities who 
have become deceased organ, eye, and tissue donors have provided a 
lifesaving gift, and should be honored and recognized for the legacy 
they create as donor heroes.

                                 ______
                                 
                Question Submitted by Hon. Bill Cassidy
    Question. Section 413.408 of CMS Proposed Rule 1752 sought to 
clarify that when a donor is transferred from a certified transplant 
center (CTC) to an Organ Procurement Organization Recovery Center, the 
CTC would be allowed to count the organs recovered at the OPO center in 
their cost report. This portion of the proposed rule has not been 
finalized by CMS. What is your view on this proposed change?

    Answer. I feel very strongly that the CTC should be allowed to 
count the organs on their cost report that are recovered at OPO 
Recovery Center. The recognition and incentive for CTCs, who are also 
donor hospitals, to identify, refer, and provide early clinical 
management for the potential donor patients remains imperative to 
increasing the volume of donors and transplantable organs. Currently, 
the financial barrier placed on the CTCs who transfer their cases to 
OPO ORCs handicaps growth and cost savings. The location where the 
organs are excised, which is the defining statement today for how this 
count is determined, is contained in an instruction line on the cost 
report at the CTC. This action in the donation process is not the 
driver of increased supply of organs, and as such, should not serve as 
the financial incentive for donation.

    Equally concerning is that this methodology for organ counting 
provides tremendous financial benefit for organ recovery centers based 
at CTCs, as some OPOs have adopted. The drain on the CMS trust fund has 
increased as donor patients are transferred from many outside hospitals 
to the CTC, where all the organs can be counted based on this 
instruction line. This serves as an additional revenue stream for the 
CTC and while this practice has certainly been deemed appropriate, 
leaving the financial barrier in place for independent ORC transfers 
from CTCs does not seem to be in the best interests of increasing lives 
saved through transplantation.

    These two distinct actions appear to be in conflict. I urge the 
committee, and CMS, to consider what can be done to address this 
financial conundrum while ensuring we are all good stewards of CMS 
dollars. Allowing the CTCs to define success as ``where the potential 
donor patient was identified and declared dead'' would equalize the 
incentive to aid in increasing the transplantable organ supply.

                                 ______
                                 
                Questions Submitted by Hon. Rob Portman
                           staff requirements
    Question. In your opening statement you mentioned that there are 
not any clinical training, licensure, or certification requirements for 
OPO staff. It is my understanding that CMS has standards from 2005 
relating to OPO practitioners and states that OPO staff must be 
qualified and trained. Clearly this ambiguity has been an issue.

    Could you elaborate on the requirements that you think should be 
mandatory for OPO staff?

    Answer. I believe this is a critical issue facing our industry and 
our transplant system, and I am grateful for the opportunity to 
describe what can be done to support improvement and increased patient 
safety at OPOs.

    Under current regulations and OPTN policies, there are insufficient 
standards for OPO provider qualifications and inadequate safety 
monitoring and protections for patients. OPOs provide clinical care to 
critically ill patients, and those patients deserve highly qualified 
clinical providers. Right now, standards in Federal regulations, CMS 
audits, and OPTN policies do not require that all clinical care 
provided to donor patients is provided by licensed or certified health-
care workers. To ensure patient safety, to protect quality of patient 
care, and to increase OPO performance, regulations must be revised to 
include a minimum standard of licensure/certification and a minimum 
training requirement for any OPO staff who provide clinical care to 
donor patients.

    In my response, I will describe the current state of requirements, 
and also provide recommendations for actions legislators and regulators 
can take to address insufficiencies. First, as the Senator references, 
the Code of Federal Regulations does contain language that references 
qualifications of organ procurement organization (OPO) staff. The 
regulation reads in full:

        42 Sec. 486.326 Condition: Human resources.

        All OPOs must have a sufficient number of qualified staff, 
        including a director, a medical director, organ procurement 
        coordinators, and hospital development staff to obtain all 
        usable organs from potential donors, and to ensure that 
        required services are provided to families of potential donors, 
        hospitals, tissue banks, and individuals and facilities that 
        use organs for research.

        (a) Standard: Qualifications.

        (1) The OPO must ensure that all individuals who provide 
        services and/or supervise services, including services 
        furnished under contract or arrangement, are qualified to 
        provide or supervise the services.

        (2) The OPO must develop and implement a written policy that 
        addresses potential conflicts of interest for the OPO's 
        director, medical director, senior management, and procurement 
        coordinators.

        (3) The OPO must have credentialing records for physicians and 
        other practitioners who routinely recover organs in hospitals 
        under contract or arrangement with the OPO and ensure that all 
        physicians and other practitioners who recover organs in 
        hospitals with which the OPO has agreements are qualified and 
        trained.

        (b) Standard: Staffing.

        (1) The OPO must provide sufficient coverage, either by its own 
        staff or under contract or arrangement, to assure both that 
        hospital referral calls are screened for donor potential and 
        that potential donors are evaluated for medical suitability for 
        organ and/or tissue donation in a timely manner.

        (2) The OPO must have a sufficient number of qualified staff to 
        provide information and support to potential organ donor 
        families; request consent for donation; ensure optimal 
        maintenance of the donor, efficient placement of organs, and 
        adequate oversight of organ recovery; and conduct QAPI 
        activities, such as death record reviews and hospital 
        development.

        (3) The OPO must provide a sufficient number of recovery 
        personnel, either from its own staff or under contract or 
        arrangement, to ensure that all usable organs are recovered in 
        a manner that, to the extent possible, preserves them for 
        transplantation.

        (c) Standard: Education, training, and performance evaluation. 
        The OPO must provide its staff with the education, training, 
        and supervision necessary to furnish required services. 
        Training must include but is not limited to performance 
        expectations for staff, applicable organizational policies and 
        procedures, and QAPI activities. OPOs must evaluate the 
        performance of their staffs and provide training, as needed, to 
        improve individual and overall staff performance and 
        effectiveness.

        (d) Standard: Medical director. The OPO's medical director is a 
        physician licensed in at least one of the States or territories 
        within the OPO's service area or as required by State or 
        territory law or by the jurisdiction in which the OPO is 
        located. The medical director is responsible for implementation 
        of the OPO's protocols for donor evaluation and management and 
        organ recovery and placement. The medical director is 
        responsible for oversight of the clinical management of 
        potential donors, including providing assistance in managing a 
        donor case when the surgeon on call is unavailable.

    In the text of 42 Sec. 486.326, OPOs are only held to a standard of 
``sufficient number of qualified staff'' under the regulation. The 
definition of ``qualified'' is left to the interpretation of the OPO. 
Such ambiguity in the regulatory text allows for an unacceptable level 
of variability in training, credentialing/licensing, and verification 
of qualifications in OPO staffing.

    In my opinion as an OPO CEO and critical care nurse, I believe that 
CMS should define the term ``qualified'' for any OPO role that includes 
patient clinical care and interaction with patient health data. An 
unqualified or underqualified OPO staff person with a role in direct 
patient care and/or clinical evaluation of health information presents 
a safety risk to potential donor patients and transplant wait-list 
patients who rely on the safe, effective procurement of organs.

    Right now, some OPOs hire non-licensed health-care workers, or non-
health-care workers, in roles with direct patient care. This is 
permissible under the current regulatory environment. And, since 
neither CMS nor the OPTN contractor collect information about the 
number of OPO employees with clinical responsibilities or patient care 
interactions, our system does not have a way to quantify what lax 
standards for training and qualification may lead to in terms of 
adverse events, safety issues, or quality of patient care.

    For example, at Mid-America Transplant, we require that any staff 
member with patient interaction and/or clinical care responsibilities 
for in our Organ Recovery Center is a registered nurse with a minimum 
of 2 years of critical care experience. Our definition of ``qualified'' 
is based on 3 decades of organizational data and clinical care 
delivery. Our independently run Donor Care Unit has made this a more 
salient issue; when donor patients are moved to our facility, outside 
of a hospital, it is imperative that our team of care providers have a 
rich experience basis, clinical discernment, and the ability to address 
a wide range of clinical challenges.

    We know that potential donor patients (4) are critically ill often 
with multi-system dysfunction; (5) are unable to personally advocate 
for their care, due to their condition; and (6) may provide lifesaving 
organs for transplant only if provided appropriate, safe, evidence-
based donor management and monitoring in the course of clinical care at 
our facility, or in our partner hospitals.

    The stakes for the care OPOs provide could not be higher. And, as 
more OPOs open organ recovery centers outside of hospitals, the 
qualifications, abilities, and experience level of OPO staff becomes 
more relevant to quality of care. When a donor patient is in an OPO 
recovery center, there is no way to rely upon other health-care 
providers and expertise that would be available in a hospital. A highly 
qualified OPO workforce is not just an issue of quality, but also 
safety, for the donors, OPO, transplant centers, and potential organ 
recipients.

    I also wish to direct the Senator to the section of the CMS audit 
that covers OPO personnel. The relevant text is below:

        State Operations Manual Appendix Y from CMS QSOG/CCSQ

        Part I--Survey Protocol for Organ Procurement Organizations

        E.  Task Three--Personnel Record Review and Interview (Rev.)

        This task covers requirements of the CfC on Human Resources 
        (Sec. 486.326).

        The surveyor should use the organizational chart and/or staff 
        list of OPO staff to select a sample of full-time and contract 
        personnel. Request the personnel records for the selected 
        sample. The personnel interviews and personnel file reviews 
        should cover all staff positions. Review a minimum of five 
        employee files for the clinical and family support staff at the 
        OPO including contract employees in those positions. Expand the 
        sample as necessary based on other survey findings.

        1. Personnel Review

        1. Review the personnel records of OPO employees and contract 
        employees to ensure that the OPO is meeting all requirements in 
        the OPO CfCs at Sec. 486.326.
            i.  Review current licensure records, orientation records, 
        position description, performance evaluations, conflict of 
        interest evaluations, and training records for the staff.
            ii.  Verify that the staff are licensed and/or registered 
        in their State.
            iii.  Verify that orientation and periodic in-service 
        training are provided to the staff.
        2. Confirm that the OPO verified prior to recovery that 
        recovery surgeons were currently credentialed.
        3. Review the file for the OPO medical director to verify that 
        he/she is currently licensed as a physician in one of the 
        States within the OPO DSA or as required by State or local law. 
        The position description for the medical director clearly 
        delineates his/her roles and responsibilities for 
        implementation of the OPO's protocols for donor evaluation and 
        management and organ recovery and placement.

    Under this language, a CMS audit checks for current licensure and 
certifications held by a sample of 5 staff members. The audit does not 
verify whether all staff members with patient care or patient health 
record evaluation responsibilities are licensed or certified. The audit 
also does not define which licenses or certifications are acceptable.

    CMS can remediate this problem by modifying the Task Three 
Personnel Review to include the roles of staff members with direct 
patient care and/or clinical evaluation of patient health records; the 
number of staff that occupy these roles at the OPO; and require a 
threshold for licensed/certified health-care workers who occupy roles 
with direct patient care and/or clinical evaluation of patient health 
records.

    There are OPTN policies that reference the requirement that 
``licensed health-care workers'' complete certain tasks or hold certain 
responsibilities (see: OPTN policy 3.3, 5.8, 14.5). However, all but 
one of these OPTN policies reference transplant center activities. The 
only reference to OPO qualifications is in OPTN policy 2.14.B, which 
reads: ``Review the OPO's internal policies, procedures, and protocols 
to verify that it has a written protocol(s) that includes: Definition 
of qualified health-care professionals to perform the pre-recovery 
verification [of organs].''

    The current OPTN contractor does demonstrate understanding that 
having qualified health-care workers is important for the care provided 
by transplant centers. I cannot explain to the committee why the 
contractor has neglected to ensure that donor patients are cared for by 
qualified health-care workers, and that the only time at which a 
qualified health-care professional is necessary for an OPO role under 
OPTN policy is at the time of verifying the organ being allocated for 
transplant.

    An OPO can decide, as an organization, that a person without 
medical training, without a relevant license or certification (RN, LPN, 
paramedic, respiratory therapist, APP, etc.) can occupy a role that 
requires the ability to evaluate patient health information, make 
clinical determinations, and even provide clinical care to patients. 
The OPO would remain in compliance with 42 Sec. 486.326, pass the 
associated CMS audit requirements, and adhere to current OPTN policy as 
long as their staffing remained ``sufficient'' and their own internal 
employee training declared the person as ``qualified.''

    I cannot speak for anyone else, but I can speak for myself and my 
family: I would not want a person who is not a licensed or certified 
health-care provider to perform a physical examination, or evaluate my 
medical records, or perform a medical procedure on me or someone I 
love. OPOs provide clinical care to patients. Patients, even those at 
the end of their lives, deserve high quality, safe, and dignified 
clinical care performed by highly trained, licensed or certified, 
health-care workers. Congress, and CMS, must act on this issue in order 
to ensure patient safety, and increase quality of care provided by 
OPOs.
                            declined organs
    Question. You noted in your opening statement that time is wasted 
by organs being declined and that your organization has been successful 
at identifying surgeons that accept kidneys that would otherwise be 
declined.

    Can you explain the differences in why some surgeons are more 
willing to accept organs for transplant that would otherwise be 
declined?

    Answer. Our system's transplant center metrics--those produced by 
the Scientific Registry of Transplant Recipients--monitor and grade 
even minute areas of transplant center practice, such that half of 
transplant centers are rated as ``aggressive'' or ``not aggressive'' in 
their organ acceptance practices in a given year.\1\ Emphasis on 
flagging transplant center practice means that much of our information 
about discarded or utilized organs is, as a system, related to 
transplant centers, not OPOs.
---------------------------------------------------------------------------
    \1\ Doby, B.L., Ross-Driscoll, K., Yu, S., Godwin, M., Lee, K.J., 
and Lynch, R.J. (2022). Examining utilization of kidneys as a function 
of procurement performance. American Journal of Transplantation: 
Official Journal of the American Society of Transplantation and the 
American Society of Transplant Surgeons, 22(6), 1614-1623, https://
doi.org/10.1111/ajt.16985.

    In contrast, only 1 in 5 OPOs received a similar, definitive 
message from SRTR on their organ procurement performance over the same 
period.\1\ We can, as a system, improve organ utilization, but we must 
understand all of the drivers of under-utilization of organs at both 
transplant centers and OPOs, and create standards for donor management, 
organ offers, and allocation practice across OPOs.\1\, 
\2\, \3\, \4\
---------------------------------------------------------------------------
    \2\ Lentine, K.L., Fleetwood, V.A., Caliskan, Y., Randall, H., 
Wellen, J.R., Lichtenberger, M., Dedert, C., Rothweiler, R., Marklin, 
G., Brockmeier, D., Schnitzler, M.A., Husain, S.A., Mohan, S., Kasiske, 
B.L., Cooper, M., Mannon, R.B., and Axelrod, D.A. (2022). Deceased 
Donor Procurement Biopsy Practices, Interpretation, and Histology-Based 
Decision-Making: A Survey of US Kidney Transplant Centers. Kidney 
International Reports, 7(6), 1268-1277, https://doi.org/10.1016/
j.ekir.2022.03.021.
    \3\ Giorgakis, E., Ivanics, T., Khorsandi, S.E., Wallace, D., 
Burdine, L., Jassem, W., Mathur, A.K., and Heaton, N. (2022). 
Disparities in the Use of Older Donation After Circulatory Death Liver 
Allografts in the United States Versus the United Kingdom. 
Transplantation, 106(8), e358-e367, https://doi.org/10.1097/
TP.0000000000004185.
    \4\ Cannon, R.M., Nassel, A.F., Walker, J.T., Sheikh, S.S., Orandi, 
B.J., Lynch, R.J., Shah, M.B., Goldberg, D.S., and Locke, J.E. (2022). 
Lost potential and missed opportunities for DCD liver transplantation 
in the United States. American Journal of Surgery, 224(3), 990-998, 
https://doi.org/10.1016/j.amjsurg.2022.05.001.

    Little data exists about why some OPOs appear to be more successful 
at allocating organs to transplant centers that accept them.\4\ What I 
can tell you is that our OPO has navigated our own way to increasing 
utilization of organs, and that efforts made by the current OPTN 
contractor to improve organ acceptance have not just been unhelpful, 
but have actually worsened the problem.\5\
---------------------------------------------------------------------------
    \5\ Schold, J.D., Mohan, S., Huml, A., Buccini, L.D., Sedor, J.R., 
Augustine, J.J., and Poggio, E.D. (2021). Failure to Advance Access to 
Kidney Transplantation over Two Decades in the United States. Journal 
of the American Society of Nephrology: JASN, 32(4), 913-926. Advance 
online publication, https://doi.org/10.1681/ASN.2020060888.

    Additionally, I can share that from Mid-America Transplant's own 
experience, not all OPOs allocate organs in the same way, with the same 
staffing model, or with the same emphasis on making every donor organ 
offer as amenable to acceptance or consideration by surgeons. There is 
significant variation between OPOs in how organs are described in organ 
offers, allocated, and even how they are procured and transported to 
transplant centers. Some of us have dedicated allocation staff who are 
trained to maximize utilization. Some of us have a dedicated process to 
establish relationships with transplant centers outside of our area 
that are less risk averse in their organ acceptances. Some of us see 
that this variation between how OPOs work leads to longer case times, 
longer times to organ acceptance, and what can be a very inefficient 
system of communication between surgeons and OPOs. All of these issues 
could, and should, be addressed by a functional OPTN contractor. To 
---------------------------------------------------------------------------
date, UNOS has not.

                                 ______
                                 
          Prepared Statement of Barry S. Friedman, R.N., BSN, 
         Executive Director, AdventHealth Transplant Institute
    Chairman Wyden, Ranking Member Crapo, Senator Grassley, and members 
of the committee, on behalf of AdventHealth, I am honored to be 
extended the opportunity to provide testimony on the current state of 
organ transplant policy in the United States. My testimony reflects 
more than 30 years of health care/transplant experience and my direct 
leadership involvement in the United Network for Organ Sharing (UNOS) 
and the Organ Procurement Transplantation Network (OPTN), including the 
UNOS board of directors and the Membership Professional Standards 
Committee. I also proudly served 30 years in the United States Air 
Force--including two tours of duty during Operation Iraqi Freedom.

    I currently serve as the executive director for the AdventHealth 
Transplant Institute, one of the busiest transplant centers in the 
Nation, having performed more than 4,000 transplants. Our survival 
rates are among the highest in the country, making us one of the most 
highly-sought adult and pediatric multi-organ transplant programs in 
the United States. We were the first hospital in central Florida to 
successfully perform a heart transplant. Today, we offer a wide range 
of transplant options, including, heart, kidney, lung, liver, pancreas, 
and blood and marrow. We are also home to a comprehensive living donor 
kidney program.

    As the executive director of the Institute, I take very seriously 
our sacred duty to the families and patients who entrust us with the 
gift of life to provide organs for transplant. It is our duty to be 
good stewards of these organs, honoring the faith of these families and 
the health of our communities. I offer testimony specifically on UNOS/
OPTN oversight of transplant policy, data and interoperability 
challenges, and opportunities to improve transplant equity across the 
Nation.
                 unos's oversight of transplant policy
    Families in need of a lifesaving organ have no option but to trust 
the organ transplantation system that is in place. Unfortunately, that 
system has failed many awaiting organ transplant due to lack of 
oversight and accountability. An organ is the greatest gift someone can 
give and yet, we have created a system that does not result in the good 
stewardship of that gift. Approximately 23 percent of kidneys procured 
from deceased donors are not used and discarded, resulting in 
preventable deaths.\1\ It is our responsibility to address this issue.
---------------------------------------------------------------------------
    \1\ How to Decrease the Discard Rate of Donated Organs, The 
American Society of Nephrology, https://www.sciencedaily.com/releases/
2017/10/171005190255.htm.
---------------------------------------------------------------------------
Avoidable Organ Loss
    Organ transportation is a process left to each federally designated 
organ procurement organization (OPO) to implement. OPOs currently 
develop their own relationships with transportation couriers, relying 
on them to engage with airlines, charter flights, ground transportation 
and Federal agencies to facilitate transportation. If an organ leaves 
the OPO's custody, OPOs and transplant centers are solely dependent on 
airline personnel to move organs on and off commercial flights in an 
expedited manner. In many cases, organs must connect from one flight to 
another, leaving airline personnel responsible for transfers. Neither 
OPOs nor couriers have control of an organ upon surrendering it to the 
airlines. While anyone can now track where their Amazon or FedEx 
package is, there is currently no consistent way of tracking organs.

    The OPTN recently broadened kidney-sharing policies with the goal 
of increasing the number of organs available. However, this policy is 
being instituted in an environment where the kidneys may be unescorted 
and unprotected during transit, making them more vulnerable to discard. 
This problem has been exacerbated due to industry staffing shortages 
caused by the pandemic and flight delays. There are occasions when we 
try to put the organs on charter flights, however, there are not enough 
charter flights available and the costs are significantly higher. When 
the transplant community raised these issues to UNOS at the regional 
meetings, UNOS staff stated that UNOS was not responsible for providing 
this service and that it was ``out of scope for discussion.''

    Many news articles have promoted the use of GPS tracking during 
organ shipments.\2\, \3\, \4\ UNOS developed an 
organ-tracking system to pilot with OPOs and transplant centers. 
However, staff from the UNOS Organ Center did not participate in organ 
tracking. There were no built-in warnings when an anticipated check 
point was not met. Further, the system depended on recycling the GPS 
trackers for repeated use, which was difficult if not impossible to do. 
Due to these challenges, we opted out of the UNOS tracking system and 
are now working with a different courier company that uses less 
expensive and higher quality trackers which can be discarded and 
monitor shipments in real time.
---------------------------------------------------------------------------
    \2\ For All Transplant Programs: The UNOS Organ Tracking Beta Test. 
UNOS, 2021, https://unos.org/news/labs-organ-tracking-beta-test/.
    \3\ How BrickHouse Security's GPS Tracking Helps the National 
Kidney Registry Save Lives. Fierce Healthcare, 2010, https://
www.fiercehealthcare.com/healthcare/transplants-transformed-how-
brickhouse-security-s-gps-tracking-helps-national-kidney.
    \4\ How Lifesaving Organs for Transplant Go Missing in Transit. 
Kaiser Health News, 2020, https://khn.org/news/how-lifesaving-organs-
for-transplant-go-missing-in-transit/.

    To address these organ transportation issues, this committee should 
---------------------------------------------------------------------------
recommend the following:

        1.  Promote increased transparency by requiring the reporting 
        of all organ loss and ``near misses'' due to transportation 
        issues. UNOS has a safety reporting system; however, our 
        program has reported these near misses with no feedback or 
        follow-up to the safety report submission.
        2.  Establish a national organ shipping system that would 
        monitor the progress of all shipments (e.g., aircrafts, ground 
        transport, train transportation) in real time on behalf of OPOs 
        and transplant centers that opt in. This could be done through 
        a partnership with a third-party organization that actually has 
        expertise in this.
        3.  Require all OPOs to utilize GPS technology to transport 
        unaccompanied organs. GPS tracking should be constantly 
        monitored by either OPO staff or a contracted service.
        4.  Require the development of safety standards for courier and 
        airline companies to follow when transporting human organs for 
        transplant.

Inferior Data Availability and Interoperability
    Data availability and transparency are key to improving organ 
procurement, UNOS has not proven capable of this function. OPTN 
technology lags significantly behind other technology platforms. In 
daily use by our transplant center, we have found the current OPTN IT 
contractor to be slow and reactive, one that does not provide state-of-
the-art service and does not prioritize being technologically current. 
This contributes to a fractured flow of health IT between OPOs, donor 
hospitals, transplant programs, and UNOS with significant data 
interoperability challenges. During regional meetings, this issue was 
raised and even though transplant centers voted for a resolution, UNOS 
called these concerns ``sentiments,'' and they were not given serious 
consideration.

    I also believe there is a conflict of interest related to the 
management of IT functionalities by UNOS, as the IT tools that they 
offer transplant centers come with an additional cost despite these 
being essential for the safely management of organs.

    To help improve the availability and useability of data, Congress 
should:

        1.  Separate the IT components of UNOS operations from the 
        broader OPTN contract with HHS.
        2.  Authorize and require OPOs and the OPTN to participate in 
        Health Information Exchanges.
        3.  No longer require OPOs to maintain additional, separate 
        databases with donor information, instead allowing them to 
        transfer donor information directly from hospital EHRs to the 
        OPTN database.
Ineffective Organ Screenings
    UNOS is not effectively screening organ offers so they can be 
quickly directed to transplant programs. Rather, UNOS asks transplant 
centers to voluntarily opt out of certain organ offers via an organ 
offer filtering process. History has repeatedly demonstrated that 
transplant programs desire to be informed of every organ available, 
even if they would never transplant it. Thus, they have a poor track 
record of voluntarily filtering offers. As a result, OPOs must waste 
valuable time making organ offers to centers that will never accept 
them. Time wasted equates to prolonged cold ischemic time, which 
equates to lost transplant opportunities. It is a vicious cycle that 
disadvantages patients on the waiting list. Thus far, UNOS refuses to 
adopt a more ``placement friendly'' philosophy. Additionally, while 
UNOS is proposing to increase their patient registration fees, they are 
not offering any increase in value or improvements in their processes.

    Due to the limited expertise that UNOS has in the placement of 
organs, it would be best if they were no longer responsible for 
developing organ placement practices. In the early years of UNOS, the 
placement of organs was stellar. If UNOS cannot perform this task, we 
recommend high-performing OPOs and transplant centers be partnered with 
technology and artificial intelligence experts using predictive models 
about organ utilization. Prioritizing organ offers to the centers most 
likely to use them will drive change in transplant center organ 
acceptance practices.

    The UNOS policymaking process lacks transparency. Currently, OPTN 
board members concurrently serve as the board members of UNOS, which 
creates a conflict of interest that contributes to the lack of 
transparency. The board then further delineates with an executive 
board, where closed-session decisions are made and sent out to the 
transplant community for implementation. UNOS has formed many 
committees throughout the years to develop policy changes. However, 
these committees are formed in a vacuum; there is no call for 
nominations and no data shared with the transplant community to explain 
the rationale behind a given policy change. A perfect example of this 
is the recent organ allocation change of policy where a geography 
committee was formed; this policy resulted in the inequitable 
distribution of organs and higher kidney discard rates.

    UNOS requires transplant centers to pay a registration fee for 
adding patients to the OPTN wait list to receive an organ transplant. 
Since 2021, these fees have increased from $926.00 to $990.00 in 2022; 
UNOS has proposed to increase the registration fees to $1,044.00 in 
2023. These are additional costs that go into the Medicare cost report, 
costing the Federal Government more money, with little transparency as 
to why. Transplant center leaders in the past have not been given a 
reason for these increases.

    There is no representation from patient advocacy groups or experts 
in quality measurement and improvement. The OPTN should be required to 
ensure that all populations, including ethnic minorities and persons 
with disabilities, are represented in the transplant policy development 
process. Finally, there should be representation of organizations, like 
the National Quality Forum, that have experience in quality 
measurement. Failure to make these changes will result in the continued 
development of inequitable policies and practices that do not result in 
measurable quality improvements.

    Overall and most importantly in this equation, we are jeopardizing 
the trust to our most precious resource--organ donors and their 
families and the recipients of those organs.

    We applaud the Senate Finance Committee for listening and learning 
today and thank you for providing the United States of America the 
opportunity to maintain the stellar clinical care for our patients who 
require lifesaving organ transplants.

                                 ______
                                 
   Questions Submitted for the Record to Barry S. Friedman, R.N., BSN
               Questions Submitted by Hon. John Barrasso
    Question. What regulatory or legislative actions could be taken to 
enhance accountability and performance within the OPTN, especially 
within UNOS or other potential OPTN contract recipients?

    Answer. First, I would like to endorse the bipartisan findings of 
the Senate Finance Committee's August 2022 investigation into the 
Nation's organ transplant system.\1\ My recommended actions to be taken 
align with that report's recommendations, particularly: removing 
barriers to competition; increasing the pool of potential bidders by 
clarifying that the OPTN functions described in NOTA and subsequent 
amendments may be operated by more than one contractor; and promoting 
innovation in all OPTN functions (e.g., policy development, compliance 
and patient safety mentoring, IT infrastructure, coordinating transport 
of organs, etc.) as the best qualified entities with distinct skill 
sets could compete for contracts for these functions.
---------------------------------------------------------------------------
    \1\ A System in Need of Repair Hearing Report. The United States 
Senate Committee on Finance (August 3, 2022), https://
www.finance.senate.gov/imo/media/doc/UNOS%20Hearing
%20Memo.pdf.

    In order to enhance accountability, Congress should require that 
---------------------------------------------------------------------------
any entities managing the OPTN:

          Establish a public comment process for stakeholders to 
        suggest innovations and new methods to improve the system. The 
        goal of this suggestion is to improve the level of trust 
        between any OPTN contractors and OPTN member institutions 
        during the policy development process. Currently, OPTN members 
        are encouraged to submit written comments regarding policies 
        under development. However, unlike the Federal public comment 
        process, the OPTN is not required to respond publicly and in 
        writing as to the OPTN committee's response to each comment and 
        whether/why the comment was adopted or rejected. If OPTN 
        committees were to engage in this process it would improve the 
        accountability relationship among the committees, any OPTN 
        contractors and the members. A similar process could be 
        implemented at OPTN member regional meetings in which comments 
        could be provided during discussion, catalogued by contractor 
        staff, and provided to committees for review and written 
        response. This process would help foster transparency and 
        create an environment for self-improvement within the OPTN. 
        These written summaries could also help establish a record of 
        issues brought to the OPTN and how they were addressed.

          Develop a feedback loop in the decision-making process, 
        allowing members to quickly share any opportunities for 
        improvement or refinement of a policy after a change. Currently 
        there is not a rapid response process available to OPTN members 
        when a policy change creates unintended consequences or is not 
        achieving the intended effect. The only rapid response 
        mechanism available to OPTN members is the patient safety 
        portal but this suggestion is not consistent with the portal's 
        current purpose. Members become frustrated when occurrences 
        happen and there is nowhere to catalogue events that provide 
        needed insights about the ``real-world'' implications of a 
        policy change. The absence of a feedback loop perpetuates 
        distrust between members and the OPTN/contractor and 
        discourages opportunities for rapid course corrections when 
        required.

          Promote increased transparency by requiring the public 
        reporting of all organ loss and ``near misses'' due to 
        transportation issues. There is currently no OPTN policy 
        requiring members to report the failure to transplant organs. 
        Organ loss can result from:

              Insufficient efforts to match an organ with a 
        candidate;
              Insufficient efforts to optimize organ 
        function prior to placement attempts;
              A turndown in the donor operating room 
        leading to a non-transplantable organ;
              Mishandling the organ acceptance/candidate 
        notification process; and
              Lateness/damage/loss during transportation.

    Current OPTN data vastly underreport the incidence of organ loss 
during transportation, which has resulted in a lack of urgency from the 
OPTN to address the issue. Although UNOS has a safety reporting system, 
which could be deployed for the purpose of documenting organ loss or 
near loss, there is no public reporting, feedback, or follow up to 
members when the system is used. Because problems submitted by OPOs and 
transplant centers go unaddressed, there is no incentive for members to 
report occurrences. This is a glaring omission in need of rapid 
correction.

    In order to enhance performance, Congress should:

          Require the establishment of a national organ shipping 
        system that monitors the progress of all shipments (e.g., 
        aircrafts, ground transport) in real time on behalf of OPOs and 
        Transplant Centers that opt in. This could be done through a 
        partnership with a third-party organization with demonstrated 
        logistics expertise. This logistics system could be awarded via 
        contract, with operational fees paid for by OPOs and transplant 
        programs that utilize it. Responsibility for tracking and 
        trending logistics problems would lie with the system; it would 
        also be accountable for developing relationships with national 
        commercial airline carriers to support better treatment of 
        organs while in transit.

          Require that all OPOs utilize GPS technology to transport 
        unaccompanied organs. GPS tracking should be constantly 
        monitored by either a contracted service, the OPO, or the 
        Transplant Centers.

          Require the development and adoption of safety standards, 
        with involvement of the Federal Aviation Administration, for 
        OPOs as well as courier and airline companies when transporting 
        human organs for transplant. The lack of safety standards for 
        the management of organs results in them being often handled as 
        any ordinary piece of merchandise.

          Separate the IT components of the OPTN contract so that a 
        third-party with expertise in this area can manage this 
        function.

          Require OPOs and the OPTN participate in Health Information 
        Exchanges.

          Encourage automated exchange of data between OPOs and 
        hospital electronic health records (EHRs) for the purpose of 
        potential organ donor referral and evaluation. This process 
        would allow hospitals to have an electronic notification option 
        so that clinicians don't have to cease their work to make 
        donation referrals. Further, all OPOs should have the 
        technological capability to receive these referrals 
        electronically.

          Ensure that any OPTN contractor(s) develop and maintain 
        Application Programming Interfaces (APIs) that automatically 
        provide required data to the OPTN and ease access of data for 
        researchers/other contractors, stakeholders, and outside 
        organizations. OPTN and transplant program databases should no 
        longer be the mechanism through which data are provided to the 
        OPTN. The This will allow for better access to OPTN data and 
        operations information (e.g., data generated during the process 
        of making and receiving organ offers) so efficiencies can be 
        created to decrease the number of discarded organs.

    Question. What are the advantages and disadvantages of the current 
OPTN contract that allows only one entity to operate the network?

    Answer. I strongly encourage Congress to ensure the OPTN contract 
can be opened to multiple contractor bids, particularly by separating 
out the IT function from the rest of the contract. Having a single 
entity manage the entire OPTN contract puts all the decision-making 
power into the hands of one organization, making it more difficult to 
hold it accountable to Federal oversight agencies, OPTN members or the 
patients it is intended to serve. In the current environment, 
policymaking becomes self-serving to the needs and capabilities of the 
contractor rather than what is in the best interest of recipient and 
donor patients. For example, when UNOS was tasked by the Federal 
Government to create an IT system, they built it but did not seek 
feedback on what capabilities members needed or what the price point of 
using the technology should be. Because the current OPTN contractor is 
not, per se, an IT company, the choice of technologies it adopts cannot 
be rapidly altered to keep up with industry advances. Consequently, the 
OPTN's current IT infrastructure is inefficient, outdated and 
inadequately serves patients and OPTN members. Implementing even small 
changes to the system takes months to years to accomplish, as 
illustrated by several sources.\2\
---------------------------------------------------------------------------
    \2\ National Library of Medicine. Restructuring the OPTN contract 
to achieve policy coherence and infrastructure excellence, https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC6494733/.

    UNOS also determines the transplant candidate registration fees 
with little input or transparency beyond a small subset of board 
members as to how those fees will be used or why they are necessary. 
Currently, members have no other choice but to pay whatever rate is set 
by UNOS with no explanation. Registration fees have increased from 
$926.00 in 2021 to $990.00 in 2022 and UNOS has already proposed to 
increase the registration fees to $1,044.00 in 2023. These price hikes 
are then reflected on the Medicare Cost Report, costing the Federal 
Government more money, with little transparency as to why they are 
necessary. Additionally, the Senate Finance Committee noted the issue 
of UNOS double charging transplant centers (and ultimately payers, 
including Medicare) for each wait-listed patient--charging a fee once 
as the OPTN and once as UNOS. UNOS fees are also not subject to 
contractual controls from HRSA, allowing UNOS to spend taxpayer dollars 
---------------------------------------------------------------------------
for self-benefit and entrenchment, rather than to benefit patients.

    When one organization is tasked with fulfilling so many different 
functions, it can essentially become an expert at nothing, contributing 
to inefficiencies. For example, UNOS currently requires information 
from our providers that they have already been provided but fail to 
retain in a way that allows ongoing use. When transplant programs hire 
a new physician that comes from another transplant center, the 
physician has to resubmit all their cases and certifications to UNOS 
despite having already provided the same information to UNOS from their 
previous transplant center. Even though these physicians have worked 
for other member transplant centers and have previously submitted all 
the same cases and certifications, they must resubmit that same 
information in its entirety when they move facilities. Because UNOS 
does not fear the loss of its OPTN contractor responsibilities, it does 
not have any sufficient incentive to build efficiencies into an 
outdated process.

    Question. What potential trade-offs exist between having only one 
contract entity versus multiple specialized entities?

    Answer. I believe that one organization operating in today's health 
care and technology environment cannot achieve the operational quality 
required to fulfill all aspects of the OPTN contract. If another 
singular organization were to replace UNOS, similar issues would 
eventually arise. There are many aspects to organ procurement and 
transplantation, including identifying organs, transporting organs, 
tracking organs and quality improvement, to rely on a single contractor 
to achieve high performance levels. It would be very difficult for one 
sole organization to deliver the best quality on every aspect or to be 
an expert in all these functions.

    To ensure the greatest quality, entities could submit bids to 
fulfill one or more responsibilities of the OPTN. The best organization 
equipped for that responsibility should be granted a contract. For 
example, a technology-focused organization would be better suited to 
develop a national system of automated, electronic notifications for 
organ donation than a company with limited IT capabilities.

    I believe that multiple organizations could achieve functionality 
together provided there is engaged and collaborative oversight by 
Federal entities. Involving multiple contractors in OPTN operations is 
not a new concept. In 2000, HRSA chose for the first time to award the 
Scientific Registry for Transplant Recipients (SRTR) to an entity other 
than UNOS and while it took time to adapt to the changes, UNOS did 
collaborate with the SRTR. This arrangement has benefitted the donation 
and transplantation community, particularly around data transparency. 
It is not unreasonable to expect that if the existing OPTN contractor 
(or any future OPTN contractors) were awarded only a portion of current 
OPTN contracted responsibilities, cooperation and collaboration with 
other entities would develop.

    Question. Are there other regulatory or legislative actions 
Congress or the administration should take to ensure the OPTN is 
performing to its maximum potential for patients and providers?

    Answer. Congress or the administration should ensure that there is 
more meaningful engagement from UNOS with patient advocacy groups, as 
well as experts in quality measurement and improvement. The OPTN should 
be required to ensure that all populations, including racial/ethnic 
minorities and persons with disabilities, are represented in the 
transplant policy-development process. Further, the OPTN should ensure 
that the voices of patients and donor families who volunteer on OPTN 
boards and committees are heard and their priorities for better 
service/resources for patients are acted upon.

    Next, Congress should require for the OPTN board and any contractor 
boards to be separated. This would help prevent any conflict of 
interest, enable the OPTN board to focus on service to patients, and 
allow members to provide feedback more openly to contractors.

    Congress or the administration should also ensure that all 
organizations that are managing the OPTN follow security guidelines to 
protect member data. UNOS requires significant information about our 
transplant centers and practices. Now, more than ever, it is critical 
that this information be protected. Managing organizations should be 
required to follow security requirements to ensure that patient data is 
protected.

                                 ______
                                 
                Question Submitted by Hon. Maggie Hassan
    Question. In 2019, the National Council on Disability (NCD) 
released a report finding that people with disabilities are often 
excluded as organ transplant candidates due to their disabilities. Does 
your organization have a policy that covers organ transplant access for 
individuals with disabilities?

    Answer. AdventHealth Transplant Institute adheres to guidelines set 
up by HHS and the U.S. Public Health Service (USPHS) to determine who 
is qualified to receive an organ. AdventHealth maintains policies 
addressing how we provide equitable care to patients with disabilities 
across our system. AdventHealth Transplant Institute evaluates every 
patient's intellectual and adaptive functioning in a clear, 
evidence-based and systematic manner. If a patient's disability hinders 
their ability to receive an organ, we do everything in our power to 
provide special accommodations for them. For example, having someone 
available to support the patient through the transplant process is a 
requirement in being a candidate for an organ. If someone does not have 
anyone or cannot support themselves, AdventHealth Transplant Institute 
would help find them a caretaker so they could meet the criteria to 
receive an organ transplant.

                                 ______
                                 
Prepared Statement of Calvin Henry, Region 3 Patient Affairs Committee 
  (PAC) Representative, Organ Procurement and Transplantation Network 
                                 (OPTN)
    Chairman Wyden, Ranking Member Crapo, and members of the committee, 
my name is Calvin Henry, and I serve on the OPTN Patient Affairs 
Committee as the Region 3 Representative for the southeastern U.S. and 
the U.S. territory of Puerto Rico. I am also a double lung transplant 
recipient of 9\1/2\ years and have spent much of that time as a 
dedicated patient advocate in direct support of organ transplant 
candidates and recipients, as a community advocate for organ donation, 
and as a strong proponent for system-wide improvements and transparency 
throughout the organ procurement and transplantation process. It is a 
privilege to be invited here today to share my thoughts regarding the 
current state of this system.

    I would like to share with the committee a bit of my experience 
navigating the transplant system in order to get wait-listed and then 
receive a transplant.

    Fifteen years ago, I was diagnosed with a terminal lung disease 
that was later identified as scleroderma and informed that my only 
option for survival was to receive a double lung transplant. I was 
told, however, that I was unlikely to receive one and that I should 
just begin making end of life preparations. I quickly moved on to 
another practitioner who subsequently made the referral for me.

    The several years after that initial diagnosis were perilous. On 
three separate occasions, I nearly lost my life due to the adverse 
effects of the disease. First, during the early progression of my 
disease, I traveled to a high elevation destination without the 
realization that my scarred lungs could not process oxygen at a 
sufficient rate in order for me to adequately breath. A local doctor 
who checked my symptoms found that I had a blood oxygen level of 53 
percent and noted I likely would have suffered from a stroke within 
that same day without immediate care. Secondly, during year 3 of my 5-
year journey to transplant, I went into respiratory arrest primarily 
due to the weakened lungs during a medical procedure and had to be 
resuscitated. Finally, just a few months before the transplant, I was 
hospitalized with a lung infection so widespread that it required 
hospitalization for a period of time that was 2 weeks longer than my 
post-transplant stay. The medical team later informed me that clearing 
the infection may not have been possible if I had sought treatment 8-12 
hours later than I did. I've also had more instances of a collapsed 
lung than I would care to remember.

    During this period, I was also diagnosed with achalasia. This is a 
disorder characterized by the inability of the esophagus to properly 
move food and liquids into the stomach. I was told after going through 
the evaluation process that this disorder disqualified me from 
receiving a transplant at my State's only lung transplant program since 
the risks of my surgery outweighed the benefits of receiving donor 
lungs. The rejection I received from that program launched a solo 
effort, without transplant program assistance, to locate another 
program that would take me on as a patient. Over the next several 
months I reached out to one program after another, slowly losing hope 
as each new month brought a new letter of rejection in the mail until I 
eventually found a program by happenstance while traveling out of State 
for work.

    Several things stood out to me during this experience: the absence 
of a basic standard of care from the specialty physician who did not 
give a referral to an appropriate transplant hospital so that I could 
receive follow up care, the void in guidance to an appropriate 
transplant hospital when my first-choice program disqualified me from 
theirs which left me ill-informed and on my own, and the lack of 
clarity as to which programs would automatically exclude me as a 
potential candidate based on my medical complications.

    When finally wait-listed, patients also do not have the visibility 
to know which organ offers are declined on their behalf. This lack of 
visibility disenfranchises the patient from the decision-making process 
and deprives us of opportunities to receive a life-saving transplant. 
These gaps in care and guidance are opportunities for improvement. We 
need a system that works for patients, is easily navigable, and is 
unambiguous.

    The specific circumstances of my own experience may be unique but 
the consistent difficulties in accessing transplant services are all 
too common. I was fortunate that I had the means, including access to 
good insurance, that allowed me to travel to another State to receive 
care. That is not always the case. Many studies highlight the 
disparities and inequitable access to transplant services that 
disproportionately harm Black people and people of color who do not 
have the resources to access transplant in these circumstances.

    This committee has previously highlighted that organ donation 
system failures are an ``urgent health equity issue.''\1\ Consider the 
numbers for kidney failure \2\--Hispanic Americans are 1.5 times more 
likely to experience kidney failure than White Americans; Black 
Americans are 3 times more likely; and Native Americans are 4 times 
more likely. Yet we also know Black people and people of color are less 
likely to receive transplants. One particularly troubling piece of 
data: organ procurement organizations (OPOs) have massive disparities 
amongst recovery rates of donors of color across the country. Axios 
highlighted a tenfold disparity \3\ of Black recovery rates between 
OPOs across the country. Since same ethnicity matches are more likely, 
Axios \4\ was clear about ``why [that] matters: Fewer Black donors 
correlates to fewer Black recipients, which has led to more Blacks 
dying on the organ transplant wait list.''
---------------------------------------------------------------------------
    \1\ https://www.finance.senate.gov/chairmans-news/bipartisan-
bicameral-members-of-congress-commend-federal-efforts-to-reform-organ-
donation-system-urge-acceleration-of-rules-impact-.
    \2\ https://opodata.org/equity/.
    \3\ https://www.axios.com/2021/11/09/organ-donation-recovery-worse-
people-of-color.
    \4\ https://www.axios.com/2021/11/09/organ-donation-recovery-worse-
people-of-color.

    As a transplant recipient, I am committed to taking the best care 
of my organ as possible. Not only is it a necessity for my health, 
safety, and best long-term outcome success, but I also consider it an 
almost sacred duty. It is the bare minimum for me to be the best 
steward possible to show the proper respect and honor for my donor. 
---------------------------------------------------------------------------
Patients resoundingly agree on this point.

    It is troubling to see, then, that we as Americans are asked to 
donate our organs but our OPOs do not appear to be the best stewards of 
the organs that we are donating. It is heartbreaking that thousands of 
recovered organs each year are not used while thousands more are not 
recovered at all. In addition, 23 percent of kidneys are wasted that 
could have made a significant dent in our transplant wait list and 
saved lives.

    Here is some additional data that is equally troubling:

    Thirty-three \5\ Americans die every day for lack of a transplant, 
while thousands of organs go unrecovered and not transplanted every 
year. That number includes both patients dying on the wait list and the 
removal from the wait list of those who have died from being too sick 
to transplant.
---------------------------------------------------------------------------
    \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.

    The federally funded deceased donor potential study showed the U.S. 
may be recovering as few as one in five \6\ potential organ donors.
---------------------------------------------------------------------------
    \6\ https://optn.transplant.hrsa.gov/media/1161/ddps_03-2015.pdf.

    To make this shocking status quo real: 28,000 \7\ organs go 
unrecovered each year, including: 17,000 kidneys; 8,000 livers; 1,500 
hearts; and 1,500 lungs.
---------------------------------------------------------------------------
    \7\ https://www.bridgespan.org/bridgespan/Images/articles/
reforming-organ-donation-in-america/reforming-organ-donation-in-
america-01-2019.pdf.

    For scale, according to the chief of transplant at Vanderbilt \8\ 
who testified at the House Oversight hearing last year, if the system 
were fully functioning, there would be no waiting list for livers, 
hearts, or lungs within 3 years, and the kidney wait list would be 
dramatically reduced.
---------------------------------------------------------------------------
    \8\ https://www.youtube.com/watch?v=TnKo8Q-Hemk&t=2748s.

    According to data released by the Centers for Medicare and Medicaid 
Services this April, the majority \9\ of organ procurement 
organizations are failing to miss performance standards; again, which 
translates into thousands of organs unrecovered each year.
---------------------------------------------------------------------------
    \9\ https://qcor.cms.gov/main.jsp.

    Research has documented that often Black families receive 
differential treatment from OPOs. As former Surgeon General Dr. Ken 
Moritsugu \10\ noted: ``Often, misallocation of OPO resources means 
OPOs do not respond to all donation cases, or do not properly train and 
support their front-line staff. The impact of this, unsurprisingly, 
falls disproportionately on families of color.'' When I have personally 
spoken at donor remembrance ceremonies or other events in my community 
these same anecdotes supporting Dr. Moritsugu's research have been 
shared with me. Similar anecdotes have been shared with me by mainly 
Spanish-speaking families who have had the hurdle of language barriers 
that are difficult to clear.
---------------------------------------------------------------------------
    \10\ https://opodata.org/equity/.

    Senators, the leaders and several of my colleagues on the OPTN 
Patient Affairs Committee asked me to submit a letter (Appendix A) for 
---------------------------------------------------------------------------
the record. I have joined them. Among their messages to you:

        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. . . .

        The alarming revelations in The Washington Post . . .\11\ 
        [including] 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.
---------------------------------------------------------------------------
    \11\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.

        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.''

    Senators, I urge you all to act to ensure that we make better use 
of the organs that are donated, to ensure that health equity issues 
with Black people and people of color are addressed, and that the 
glaring technology issues causing patients harm are quickly remedied.

    I thank you for your time.

                                 ______
                                 
          appendix a: unos hearing pac letter, 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.\12\
---------------------------------------------------------------------------
    \12\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.

    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 \13\ 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.''
---------------------------------------------------------------------------
    \13\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.

    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 \14\--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.
---------------------------------------------------------------------------
    \14\ https://khn.org/news/how-lifesaving-organs-for-transplant-go-
missing-in-transit/.

    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 \15\ reporting that UNOS's policy making processes 
have been so divisive that they have ``spark[ed] open conflict'' among 
OPTN members.
---------------------------------------------------------------------------
    \15\ https://www.washingtonpost.com/national/health-science/liver-
transplant-rules-spark-open-conflict-among-transplant-centers/2019/05/
16/91b37f84-781c-11e9-bd25-c989555e7766_story.html.

    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,\16\ and 
research in the Journal of the American Medical Association \17\ 
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.\18\
---------------------------------------------------------------------------
    \16\ https://www.medpagetoday.com/opinion/second-opinions/98363.
    \17\ https://jamanetwork.com/journals/jamasurgery/article-abstract/
2771051.
    \18\ https://bloomworks.digital/organdonationreform/assets/PDF/
donation-increase.pdf.

    The alarming revelations in The Washington Post \19\ (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.
---------------------------------------------------------------------------
    \19\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.

    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, Highland, IN

                                 ______
                                 
           Questions Submitted for the Record to Calvin Henry
               Questions Submitted by Hon. John Barrasso
    Question. This committee has obviously been hard at work trying to 
identify shortcomings in the organ procurement and transplantation 
system over the past couple years. Also within the past couple years, 
the Trump administration proposed and the Biden administration 
finalized the OPO final rule. This rule established new performance 
metrics for OPOs as well as helped promote more frequent oversight and 
competition among OPOs.

    Are there other regulatory or legislative actions Congress or the 
administration should take to ensure the OPTN is performing to its 
maximum potential for patients and providers?

    Answer. Opinions are mine only and do not reflect OPTN policy or 
views.

    1.  Pass the Living Donor Protection Act (S. 377/H.R. 1255).

    2.  Require UNOS, as the OPTN contractor, to work with Organ 
Procurement Organizations (OPO) and transplant centers to expand 
transplants performed under the HIV Organ Policy Equity (HOPE) Act 
(Pub. L. 113-51).

    3.  Require UNOS, as the OPTN contractor, to begin work to require 
transplant centers to implement informed, shared decision making with 
transplant candidates when considering organ offers.

    4.  Require UNOS, as the OPTN contractor, to collaborate with OPOs 
in evaluating OPO personnel makeup to ensure that they appropriately 
represent the demographics of the patients and communities that they 
serve.

    5.  Allow research pilot studies to determine if providing 
incentives can increase U.S. organ donor availability.

    Because of the depth of supporting material available, it is 
challenging to fully detail these proposed actions within this response 
from my viewpoint as a transplant recipient and patient advocate for 
the past decade, so I will briefly state what I think are the pertinent 
points. I welcome the opportunity to clarify or further discuss these 
in greater detail. These proposed actions address goals of reducing the 
donated organ non-use rate and increasing the number of transplants 
performed while improving access and equity in transplant.

    1.  Pass the Living Donor Protection Act (S.377/H.R.1255).

    The organ donation and transplant community has long advocated for 
Congress to enact law to provide protections for living organ donors. 
Bipartisan legislation has been introduced to Congress in successive 
sessions over the past 25 years in order to accomplish this goal. In 
the absence of Federal guidance, at least 28 States have enacted law to 
protect living organ donors and improve the number of transplants 
performed but these laws are not all consistent or comprehensive; my 
State of Georgia being the latest to pass such a law earlier this year. 
Only 8 more of your Senate colleagues are needed for cosponsor in order 
to push a standardized and comprehensive bill forward to a historic 
vote in the Senate. Passing this bill would not only be a lifesaving 
aid for many living donors, recipients, and their families in 
navigating the transplant process, I also believe it would help improve 
living donor rates by removing disincentives to the donation process. I 
ask that you urge your colleagues to action in cosponsoring and 
subsequently passing this bill.

    2.  Require UNOS, as the OPTN contractor, to work with the Organ 
Procurement Organizations (OPO) and transplant centers to expand 
transplants performed under the HIV Organ Policy Equity (HOPE) Act 
(Pub. L. 113-51).

    Approximately 240 HIV+ transplants have been performed under the 
HOPE Act, but currently less than 15 percent of the approximately 250 
U.S. transplant centers perform these organ transplants.\1\ Expansion 
of transplants performed under this act can save many more lives per 
year per the latest recommendations from the HHS Advisory Council on 
Organ Transplantation (ACOT) and also reduce the burden on organ donor 
availability.\2\ The council also unanimously agreed that there was 
cause to examine potential inefficiencies in organ procurement from 
HIV+ organ donors and to determine how many potential organs that could 
have been donated were not recovered.
---------------------------------------------------------------------------
    \1\ OPTN. Transplant centers approved for Hope Act. https://
optn.transplant.hrsa.gov/media/ex3bmasx/hope-act-hospitals.pdf 
(accessed October 3, 2022).
    \2\ U.S. Department of Health and Human Services Recommendations 66 
through 67. https://www.hrsa.gov/advisory-committees/organ-
transplantation/recommendations/66-67 (accessed September 19, 2022).

    3.  Require UNOS, as the OPTN contractor, to begin the work to 
require transplant centers to implement informed, shared decision 
---------------------------------------------------------------------------
making with transplant candidates when considering organ offers.

    As patients, we should have the ability to participate in the 
decision-making process when determining how transplantation will 
affect our lives. Our goals for quality of life post-transplant don't 
always coincide with expectations of transplant centers. Overwhelming 
patient sentiment supports our willingness to sometimes accept 
higher-risk organs that transplant centers traditionally would not 
consider. These transplant center practices contribute to the rate of 
organ non-use when organs that are considered higher-risk could have 
been used to satisfy unique patient needs, but are too often not used 
at all. Also, on average, people who die while waiting for a kidney 
transplant had 16 kidney offers that were ultimately transplanted into 
other patients.\3\ CMS rules may also need to be addressed in order to 
support transplant centers when accepting higher risk organs.
---------------------------------------------------------------------------
    \3\ Husain, S.A., K.L. King, S. Pastan, R.E. Patzer, D.J. Cohen, J. 
Radhakrishnan, and S. Mohan. 2019. Association between declined offers 
of deceased donor kidney allograft and outcomes in kidney transplant 
candidates. https://jamanetwork.com/journals/jamanetworkopen/
fullarticle/2749266 (accessed October 12, 2022).

    4.  Require UNOS, as the OPTN contractor, to collaborate with OPOs 
in evaluating OPO personnel makeup to ensure that they appropriately 
represent the demographics of the patients and communities that they 
---------------------------------------------------------------------------
serve.

    I shared in my August 3rd testimony that it has been my experience 
that OPOs do not consistently treat all organ donors in the same 
manner.\4\ Also, surveys of organ donor attitudes have shown that 
Black, Hispanic, Native American, and other historically disadvantaged 
populations are willing to become organ donors, yet OPOs often do not 
take steps necessary to recruit these donors. I believe UNOS should 
collaborate with OPOs and use best industry practices to ensure that 
OPO personnel makeup throughout the entire organization, and especially 
within executive leadership, is representative of the community 
demographics that it serves. Precedence exists to show that having such 
a structure in place can rapidly improve organ donation rates, 
especially in these historically disadvantaged populations.
---------------------------------------------------------------------------
    \4\ Hearing of the Senate Finance Committee: ``A System in Need of 
Repair: Addressing Organizational Failures of the U.S.'s Organ 
Procurement and Transplantation Network,'' 117th Cong. (2022) 
(testimony of Calvin Henry, OPTN Patient Affairs Committee). https://
www.
finance.senate.gov/imo/media/doc/
SenateFinanceCmte_832022_HenryCalvin_v2.pdf (accessed September 15, 
2022).

    5.  Allow research pilot studies to determine if incentivizing 
---------------------------------------------------------------------------
organ donation can increase U.S. organ donor availability.

    We discussed in this recent hearing that the demand for donated 
organs continues to increase and outpace the supply available to 
provide lifesaving transplantation, and I believe that newer approaches 
should be considered when determining methods to increase the organ 
supply since current and long-standing practices are not effective in 
reducing the size of the organ wait list. NOTA currently prohibits both 
the giving and receiving of incentives for organ donation as well as 
research to even determine if providing incentives would be effective. 
Public attitudes continue to show a positive view of incentives of some 
type for organ donation even though transplant professional concerns 
regarding the commodification of organs and the potential exploitation 
of vulnerable populations are well documented, but recent views suggest 
that Federal management of incentives is viable.\5\ Some States have 
already included forms of financial incentives in their respective 
living organ donor protection laws.\6\ I believe that providing 
incentives, other than direct compensation for organs, such as deceased 
donor funeral costs or reimbursement of living donor medical and life 
insurance premiums is not only a decent act, but could significantly 
increase organ donor rates and it is already demonstrated that 
reimbursements from the National Living Donor Assistance Center (NLDAC) 
are insufficient.\7\ Other countries that have enacted similar laws 
have realized a rapid increase in organ donor rates post-
implementation.\8\ An amendment to NOTA is required to allow HRSA 
funding for a research pilot program to allow for examination of 
viability.
---------------------------------------------------------------------------
    \5\ HRSA 2019 National Survey of Organ Donation Attitudes and 
Practices: Report of Findings. 4.13 Payments and Organ Donation, Q18. 
Payments Would Increase Likelihood of Organ Donation. https://
www.organdonor.gov/sites/default/files/organ-donor/professional/grants-
research
/nsodap-organ-donation-survey-2019.pdf (accessed September 14, 2022).
    \6\ S.B. 330, 2021 Biennium, 2022 Reg. Sess. (GA 2022). https://
www.legis.ga.gov/api/legislation/document/20212022/203236 (accessed 
September 27, 2022).
    \7\ Sarah Glazer, ``Organ Trafficking: Can the illicit trade be 
stopped?'', pgs. 31, 32. June 2022. https://library.cqpress.com/
cqresearcher/document.php?id=cqresrre2022062405 (accessed September 27, 
2022).
    \8\ J. Lavee, T. Ashkenazi, A. Stoler, J. Cohen, R. Beyar. 2012. 
Preliminary Marked Increase in the National Organ Donation Rate in 
Israel Following Implementation of a New Organ Transplantation Law. 
https://doi.org/10.1111/ajt.12001 (accessed September 27, 2022).

                                 ______
                                 
                Question Submitted by Hon. Maggie Hassan
    Question. The Organ Procurement and Transplantation Network's 2021-
2024 Strategic Plan includes priorities to help ensure broad access to 
transplants. That effort should include individuals with disabilities. 
How is the network ensuring that individuals with disabilities have 
equal access to organ transplants?

    Answer. The OPTN does not currently have a policy addressing 
disabilities nor does it explicitly offer a position on whether 
disabilities should be removed as exclusionary criteria for transplant. 
This absence of policy is a barrier that helps prevent equal access to 
organ transplants for individuals with disabilities. The OPTN, 
beginning in 2017, completed a significant amount of work in resolving 
this topic, but was notified by HRSA in early 2019 that the Health and 
Human Services (HHS) Office of Civil Rights (OCR) should be the agency 
first issuing guidance on this topic and that the OPTN would need to 
halt work on publishing any white papers or guidance representing the 
official position of the OPTN until the OCR completed their own 
guidance. My understanding is that the halting of this work was due, in 
part, to the then pending release of the Organ Transplant 
Discrimination Against People with Disabilities Report by the National 
Council on Disability (NCD) which was completed against the backdrop of 
increased widespread interest in this topic.\9\ The OPTN subsequently 
sent a memo to HRSA in August 2019 summarizing the progress to date as 
well as recommendations to aid the OCR as they began their work on a 
guidance document. The OPTN is not aware of any guidance document or 
further developments from the OCR subsequent to this memo, but a 
general public Request for Information from interested stakeholders was 
solicited by the office in January 2021.\10\
---------------------------------------------------------------------------
    \9\ Organ Transplant Discrimination Against People With 
Disabilities, September 2019. https://www.ncd.gov/sites/default/files/
NCD_Organ_Transplant_508.pdf (accessed September 21, 2022).
    \10\ OCR Seeks Information on Addressing Disability Discrimination 
in Health Care and Child Welfare Contexts, January 2021. https://
www.hhs.gov/about/news/2021/01/15/ocr-seeks-information-addressing-
disability-discrimination-health-care-child-welfare-contexts.html 
(accessed September 21, 2022).

    It is my strong belief that excluding patients for organ 
transplantation solely on the basis of disability is discriminatory and 
undercuts access to health care for an already vulnerable population. 
Removal of this barrier is critical to the success of ensuring 
equitable access to transplant services and restoring trust in the 
transplant system. In the absence of Federal or OPTN guidance, 34 
States have enacted laws prohibiting transplant programs from excluding 
individuals with disabilities solely on the basis of disability, 
recognizing the need to protect the rights afforded under the Americans 
with Disabilities Act, section 504 of the Rehabilitation Act, and 
section 1557 of the Affordable Care Act.\11\ I urge the HHS and the OCR 
to accelerate their process in issuing Federal guidance on this matter 
to help ensure that equal access to transplant is available for those 
with disabilities.
---------------------------------------------------------------------------
    \11\ National Down Syndrome Society (NDSS). Policy and Advocacy. 
Organ Transplant Discrimination State-Level Legislation. https://
ndss.org/advocacy#p_health (accessed September 30, 2022).

                                 ______
                                 
Prepared Statement of Jayme E. Locke, M.D., MPH, Director, Division of 
  Transplantation Surgery, Heersink School of Medicine, University of 
                                Alabama
    Chairman Wyden, Ranking Member Crapo, and members of the committee, 
my name is Dr. Jayme Locke, and I am the director of the Division of 
Transplantation Surgery at the University of Alabama at Birmingham 
(UAB), where I also serve as the Director of the Comprehensive 
Transplant Institute. I have dedicated my career to serving vulnerable 
populations with the goal of eliminating or at least mitigating health 
disparities. I believe that patients should be the focus of everything 
we do.

    At UAB, we currently have 1,022 patients wait-listed for kidneys, 
the majority self-identified as African American/Black. We have 
performed more than 10,000 kidney transplants and have performed the 
most living donor kidney transplants among African American/Black 
persons than any other program in the country. Our center is located in 
the southeastern United States, an area known to have one of the 
highest end-stage kidney disease burdens as well as communities with 
extreme social vulnerability--characteristics that drive demand for 
transplantation and reflect a limited supply.

    Transplantation was always supposed to be about the patient, but 
the system we operate now has almost a complete lack of ownership and 
responsibility--whether it is an OPO failing to show up at donor 
hospitals and engage families, or UNOS failing at the most basic 
responsibilities of getting recovered organs matched and safely to the 
recipients at the other side. These are the government's own 
contractors.

    My patients, your constituents, need your help.

    We know that thousands of kidneys are recovered and discarded every 
year, and that thousands more are never recovered at all. Discards have 
increased steadily and transportation errors are frequent particularly 
since the most recent allocation change, as the new system increased 
complexity, and to date UNOS has shown no ability to manage even simple 
logistics.

    The most powerful thing to know about this is that every organ 
represents a life. You could argue it represents more than one life; it 
has a profound impact on the patient, their family, and their 
community. We can never forget that. Imagine having a medication you 
need to live being thrown away simply because someone took too long to 
get it to you. Your life quite literally in a trash can. Organs are no 
different. They too have shelf lives, and they are measured in hours.

    Discarded kidneys and transportation errors may sound abstract. Let 
me make this negligence real for you--and please remember the 
disregarded donors whose families trusted us with the most sacred of 
gifts, and the sick and dying patients waiting for these transplants. 
Think of the young girl looking forward to not having to miss the prom 
for dialysis, the mom who wants to live long enough to see her children 
grow-up, the parent who needs to be able to hold down a job to provide 
for his/her family. The things we take for granted are the things that 
end-organ disease robs our patients of. Transplant is the cure--that is 
if the organ ever makes it to the patient.

    In 2014, I received a kidney that arrived frozen. It was hard as a 
rock, like an ice cube you could put in your drink. The intended 
recipient was highly sensitized--meaning difficult to match. The only 
thing we could do was tell the waiting patient that, due to the lack of 
safeguards regarding transportation of organs, the kidney had to be 
thrown in the trash--the final, generous act of a donor in Maryland.

    In 2017, I received a kidney that arrived in a box with tire marks 
on it. The box was squished, and the container inside had been ruptured 
(Image 1). We were ``lucky'' and were able to salvage the kidney for 
transplant. Why should luck even play a role?

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    This is the level of care too many kidneys receive. How does 
UNOS allow this?

    Once the kidney is packaged and leaves, no one really knows what 
happens, and that is as shocking as it is unacceptable.

    Consider this: for our patients in Birmingham, most of our kidneys 
fly through Atlanta. When they were arriving on flights after 10 p.m., 
they were being taken down to sit in cargo hold like lost luggage, only 
to be taken out in the morning when flights restarted.

    But Birmingham is only 2 hours away from Atlanta by car--and delays 
in transplanting organs literally mean life or death. Think of cold 
ischemia time this way: like shelf life. Each minute, each hour, that 
an organ is out of the donor's body, those cells are dying, which 
increases risk to the receiving patient. Increased cold ischemia time 
can mean delayed graft function--meaning the patient requires dialysis 
after transplant. Delayed graft function is a known risk factor for 
acute rejection and reduced long-term graft survival.

    When we realized what was happening with kidneys stuck in cargo 
hold at Atlanta airport, we called the airlines and dealt with it 
ourselves. I don't blame the airlines--their job is to move hundreds of 
thousands of people around the country each day. But where was UNOS? 
How did it ever let organs sit in cargo hold?

    Another even simpler example: instances of UNOS saying that no 
flights are available, when my team has hopped on Expedia and found 
available flights themselves.

    UNOS has failed at its responsibility for the efficient matching 
and distribution of organs. There are countless stories of inefficient 
algorithms and process that led to organs accruing unacceptably long 
cold ischemia times resulting in discard. In an era of same-day 
delivery of household goods from Amazon, the OPTN and its contractors 
have relied on outdated logistical systems akin to the Pony Express.

    Moreover, UNOS has abdicated its duty to hold under-performing OPOs 
responsible for failing to convert eligible donors and manage organs on 
their end, and as such, have not optimized the number of organs 
available for transplant.

    Since the frozen kidney, and the box with tire marks--I have 
received other kidneys that had to be discarded either due to surgical 
and OPO handling issues or UNOS transportation errors. But one week 
this May was particularly difficult.

    In 1 week, I received four kidneys from four different OPOs--each 
with basic errors that led to the need to throw away those lifesaving 
organs (Images 4 and 5). 

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


          One kidney had to be thrown away due to a botched biopsy 
        into the kidney's collecting system, which means urine would 
        have leaked from the kidney once transplanted;
          Another kidney had to be thrown away because the lower pole 
        artery had been cut during procurement. That would have been 
        fixable if someone involved in the procurement had assessed the 
        kidney for damage and flushed it before packing, but that 
        didn't happen; and
          Two other kidneys arrived to me blue--meaning they hadn't 
        been flushed.

    Errors happen. We all understand that. However, opacity at UNOS 
means that we have no idea how often basic mistakes happen across the 
country, nor can we have confidence that anything is being done to 
redress such errors so they don't keep happening.

    All I know is that in 1 week I received four kidneys--two from 
donors in Tennessee, one from a donor in Florida, and one from a donor 
in Georgia--that had to be thrown away.

    What was particularly heartbreaking was that two of these kidneys 
were for highly sensitized African American/Black women--meaning they 
were the proverbial needle-in-a-haystack kidneys for patients that are 
hard to match. Our patients become sensitized through prior exposure to 
foreign tissue--previous transplant, blood transfusion, and/or 
pregnancy.

    Women who have been pregnant--especially multiple times--are more 
sensitized/harder to match, and pregnancy related sensitization 
contributes to both gender and racial disparities in access to kidney 
transplantation. So when we talk about the system being inequitable, 
this is a very real example of how a constrained pool of organs for 
transplant, and high discards, are failures that disproportionately 
hurt women, and women of color who are more likely to have multiple 
pregnancies.

    Somewhere along the way we forgot why we're here--saving people's 
lives. We have to do better, and that includes transplant centers, too.

    I know others in my field have spoken up, and more still who want 
to speak up. But, Senators, please know that every person I have talked 
to who has spoken up about system failures has told me they have been 
punished in some way through both micro- and macroaggressions. The very 
highest levels of leadership within UNOS is an insular club that has 
turned its back on the very patients they purport to support by 
ignoring their own unconscious biases, and even impugning patients 
behind closed doors.

    For example, a UNOS board member in an email to the UNOS CEO, 
labeled patients from the southeastern United States as ``dumb f*$#''. 
This is not who we are as medical professionals. We are here to serve 
all people and in particular those who are the most vulnerable among 
us. We need reform now.

    The solutions are clear and I am asking for your urgent help on 
behalf of my patients and all the other patients waiting around the 
country:

          Immediately separate the OPTN board from any of the boards 
        of any contractors;
          Bring in the real experts to ensure our patients are served 
        by the best-of-the-best in each field, separating out key 
        functions of the OPTN: for example, policy, technology/
        matching, and logistics; and
          Ensure that patients are safer by holding all contractors 
        accountable, including through public adverse event reporting 
        and immediate redressing of problems.

    One final and critical point. I can't tell you how disturbing it 
was to read recent reporting of the way UNOS has allegedly held the 
U.S. transplant system hostage. According to The Washington Post: 
``UNOS also `has at times even threatened to walk away and continue 
operating the [transplant network] without a contract, despite the fact 
that it would be illegal.' ''

    Doing anything to jeopardize patients--including even threatening 
to walk away--violates a basic principle of health care. It's called 
patient abandonment. You simply can't do that--or even threaten to do 
that. I would lose my medical license for walking away from a patient.

    If it is true that in any way UNOS has suggested that it might walk 
away, or in any way not cooperate with a transition to new OPTN 
contractors, that would make it an organization that cannot be 
responsible for taking care of lives.

    There is very little in health care that has the immediate life and 
death stakes as organ transplantation. Please realize that every day 
that passes with these failing systems in place means more of our 
neighbors will die. My patients need the Senate to act.

                                 ______
                                 
          attachment: optn region 3 letter, february 23, 2022
    Dear Chairman Wyden, Senator Grassley, Senator Young, and Senator 
Cardin,

    We are writing to you as Region 3 members of the Organ Procurement 
Transplantation Network (OPTN) about grave concerns we have about the 
leadership of the OPTN (current contractor, UNOS) and to express our 
strongest possible objection to the content of recently published email 
communications among OPTN leaders.

    At the February 1, 2022 OPTN Region 3 meeting, several members 
sought to raise the issue of leadership, as a Federal judge recently 
unsealed deeply concerning emails from the UNOS CEO (Brian Shepard) and 
a then-OPTN/UNOS board member (Alexandra Glazier).

    In policymaking deliberations, we note the following exchanges:

    Glazier to Shepard: ``The fact that some States do better than 
others in preventing preventable deaths and providing health-care 
insurance coverage and access means you're a dumb fuck for living 
there.''

    Shepard to Glazier: ``Only people who have means can get a 
transplant. So this isn't a `give txs to poor people argument; its a 
`give txs to those of us who have to live near poor people' argument.''

    These exchanges are only a fraction of the concerning 
transgressions found in the unsealed emails, representing a serious 
failure of leadership and breach of trust. Irrespective of positions on 
any given policy, these comments are disqualifying for positions of 
public service. It does not represent who we are as leaders of the 
organ donation and transplantation community. It is equally concerning 
that the OPTN/UNOS Board of Directors has failed to apologize or 
publicly denounce these disparaging opinions voiced by Shepard and 
Glazier, suggesting that these views are truly those of the OPTN. UNOS 
speaks often of the importance of ``maintaining public trust'' in the 
organ donation system; it is unfortunate that its executives have so 
flagrantly flaunted it, and, as such, must be held accountable.

    At the most recent meeting, Region 3 member representatives wished 
to raise that (1) we believe Shepard should resign as the CEO of UNOS; 
and (2) that Glazier should no longer be permitted the privilege of 
OPTN/UNOS policymaking positions. However, we were told we could not 
raise this issue at the OPTN meeting as it was intended only for OPTN 
policy development purposes, not other matters pertaining to the OPTN 
or UNOS. Unfortunately, UNOS has offered no other public venues to 
discuss our concerns.

    Having been denied the opportunity to vote on our concerns for 
patient welfare, we and others in the community were further stifled in 
our discussion by repeated statements that we should discuss our 
opinions ``offline'' with OPTN/UNOS board president Dr. Matthew Cooper. 
During the public meeting, Mr. Shepard and Dr. Cooper misrepresented 
the OPTN/UNOS board's discussions of the emails and actions we have 
outlined above. The continued attempts to suppress conversations about 
vulnerable patients and avoid accountability for reprehensible views 
and actions has broken our faith in UNOS's ability to self-regulate its 
leaders, so, instead, we are writing to you.

    As you are aware, OPTN board members concurrently serve as the 
board members of UNOS. This creates a serious conflict of interest as, 
too often, the principal goal of UNOS is maintaining its status as the 
monopoly OPTN contractor, rather than focusing on issues that will 
actually help more patients and steward the use of precious donated 
organs. In fact, in 2018, the Government Accountability Office agreed 
with a directive from HRSA that the OPTN and the OPTN contractor 
(currently UNOS) must maintain separate boards, though, nearly 4 years 
later, UNOS still has not done so.

    It was more than 20 years ago that Forbes called UNOS the 
``cartel'' that's ``chilling the supply of transplantable organs and 
letting Americans who need them die needlessly,'' and--in the absence 
of structural reform to the OPTN--this dynamic remains today.

    The quashing of dissenting voices within the OPTN is both ongoing 
and deeply damaging to the patients we serve. If the OPTN/UNOS had 
proper governance, not only do we believe there would be clear 
leadership changes, we trust that there would be more attention--and 
action--on issues that cost patients their lives, rather than a primary 
focus on UNOS continually maintaining its monopoly hold on the U.S. 
organ donation system.

    Thirty-three Americans die every day for lack of an available organ 
transplant. Please ensure that proper governance is in place to help 
change this.

    Yours sincerely,

    Keith Wille, M.D.
    OPTN Board of Directors
    Region 3 Councilor 2020-2022
    Professor of Medicine
    Medical Director, Advanced Lung Diseases Program
    University of Alabama
    Birmingham, Alabama

    Christopher Anderson, M.D.
    OPTN Board of Directors
    Region 3 Councilor 2018-2020
    James D. Hardy Chair
    Professor and Chair, Department of Surgery
    Chief Perioperative Services Physician
    Medical Director, Transplant Service Line
    University of Mississippi Medical Center
    Jackson, Mississippi

    Virginia McBride, R.N., MPH
    OPTN Board of Directors
    Region 3 Councilor 2022-2024
    Executive Director
    OurLegacy Organ and Tissue Donation Services
    Maitland, Florida

    Kelly Ranum
    OPTN Board of Directors
    2019-2021
    Chief Executive Officer
    Louisiana Organ Procurement Agency
    Covington, Louisiana

    Raymond Lynch, M.D., MS, FACS
    Associate Professor of Surgery Executive Director
    Director of Public Policy and Community Relations
    Emory Transplant Center
    Atlanta, Georgia

    Barry Friedman
    AdventHealth Transplant Institute
    AdventHealth Orlando
    Orlando, Florida

    Jayme Locke, M.D., MPH, FACS, FAST
    Professor of Surgery
    Director
    UAB Comprehensive Transplant Institute Chief, Division of 
Transplantation
    Arnold G. Diethelm Endowed Chair in Transplantation Surgery
    Birmingham, Alabama

    Jonathan Hundley, M.D.
    Surgical Director
    Liver Transplantation
    Piedmont Transplant Institute
    Piedmont Healthcare
    Atlanta, Georgia

    M. Kevin Stump
    Chief Executive Officer
    Mississippi Organ Recovery Agency
    Jackson, Mississippi

                                 ______
                                 
    Questions Submitted for the Record to Jayme E. Locke, M.D., MPH
               Questions Submitted by Hon. John Barrasso
    Question. As we know, OPOs are overseen by UNOS, as well as the 
Centers for Medicare and Medicaid Services (CMS). One would think for 
organizations overseen by two different entities, serious mistakes 
would not frequently occur. Yet, as the committee report shows, grave 
mistakes, like testing errors and transportation failures, still plague 
OPTN members and cost numerous lives.

    Are there specific gaps in oversight between UNOS activities and 
those of CMS, and if so, can you shed some light on these?

    Answer. One of the biggest gaps in our transplant system is 
accountability with regard to organ transport. Once the kidney has been 
procured and packaged and begins its journey to the transplant center 
where it will be transplanted, the kidney, a lifesaving organ, is 
reliant on the goodwill of complete strangers (e.g., airport personnel, 
couriers, etc) who quite likely are unfamiliar with transplantation and 
the need for efficient and timely transport of the gift of life. No 
transplant-specific entity wants to ``own'' the kidney or be 
responsible for its care for the duration of the transport process. 
There is no system for holding a particular entity responsible or 
accountable for ensuring the kidney arrives in good condition and on 
time (e.g., ``on time'' being defined as a transportation route 
resulting in as little cold storage or cold ischemia time as possible; 
decreasing cold storage time has been associated with improved patient 
outcomes post-transplant).

    For all intents and purposes, kidneys in transit are on their own, 
with no metrics for delivery. This is a profound failure of the OPTN 
contractor.

    HRSA and CMS should reform this issue with urgency, as it relates 
to alarmingly high rates of kidney discards in the United States. 
According to the most recent data highlighted at the Senate Finance 
Committee hearing, one in four kidneys from generous donors in America 
are thrown in the trash. Much of this senseless waste is due to 
failures of clinical standards, processes, and technology from HHS's 
own contractors. Given patients of color are disproportionately 
impacted by kidney disease, these failures impact communities of color 
most, and further emphasize the fact that the organ shortage and kidney 
discards represent an urgent health equity issue.

    The government has a role to play in transparency and reform on 
this life-and-death issue. HHS (HRSA or CMS) should publish a lost 
organ reporting system--a dashboard of all kidneys recovered and not 
transplanted. These data are available to HHS agencies via the OPTN, 
and would allow for a near-real time reporting of: (1) total number of 
kidneys recovered and not transplanted; (2) where those kidneys 
originated (i.e., from which OPO); (3) where those kidneys were due to 
arrive (i.e., to which transplant center or State); and (4) why the 
kidney was discarded (e.g., clinical problems in recovery; 
transportation problems in delivery).

    It may also be worth reaching out to the FAA to understand how this 
agency has so successfully collaborated with stakeholders to ensure 
precise times in transit. In short, we have figured out complex systems 
with airplanes, understanding arrival and delay times . . . and imagine 
if we hadn't. . . . This should be possible with kidneys too.

    Question. This committee has obviously been hard at work trying to 
identify shortcomings in the organ procurement and transplantation 
system over the past couple years. Also within the past couple years, 
the Trump administration proposed and the Biden administration 
finalized the OPO final rule. This rule established new performance 
metrics for OPOs as well as helped promote more frequent oversight and 
competition among OPOs.

    Are there other regulatory or legislative actions Congress or the 
administration should take to ensure the OPTN is performing to its 
maximum potential for patients and providers?

    Answer. I support the bipartisan recommendations of the Senate 
Finance Committee \1\ to break up the OPTN monopoly, and open 
competition to the best-of-the-best in each field for the good of 
patients.
---------------------------------------------------------------------------
    \1\ https://www.finance.senate.gov/imo/media/doc/
UNOS%20Hearing%20Confidential%20Me
mo%20(FOR%20RELEASE).pdf.

    As I included in my testimony:\2\ ``The solutions are clear, and I 
am asking for your urgent help on behalf of my patients and all the 
other patients waiting around the country:
---------------------------------------------------------------------------
    \2\ https://www.finance.senate.gov/imo/media/doc/
SenateTestimony_8.2.22_Written%20Final
v2.pdf.

          Immediately separate the OPTN board from any of the boards 
        of any contractors;
          Bring in the real experts to ensure our patients are served 
        by the best-of-the-best in each field, separating out key 
        functions of the OPTN; for example, policy, technology/
        matching, and logistics; and
          Ensure that patients are safer by holding all contractors 
        accountable, including through public adverse event reporting 
        and immediate redressing of problems.''

    The OPTN should never again be allowed to be a monopoly. Having one 
organization/contractor performing a vast and disparate array of 
functions is a mistake, leading to a situation where a single 
organization acts as the proverbial ``jack of all trades'' while being 
the master of none.

    Separate contracts will allow for expertise, for example in 
allocation/mathematical modeling and transportation/logistics. What's 
more, for the good of patients, not only must the upcoming OPTN 
contracting cycle be transparent and competitive, every future cyclet 
should be transparent and competitive as well.

    As I said in my testimony, \3\ ``There is very little in health 
care that has the immediate life and death stakes as organ 
transplantation. Please realize that every day that passes with these 
failing systems in place means more of our neighbors will die. My 
patients need the Senate to act.''
---------------------------------------------------------------------------
    \3\ https://www.finance.senate.gov/imo/media/doc/
SenateTestimony_8.2.22_Written%20Final
v2.pdf.

                                 ______
                                 
                Question Submitted by Hon. Maggie Hassan
    Question. In 2019, the National Council on Disability (NCD) 
released a report finding that people with disabilities are often 
excluded as organ transplant candidates due to their disabilities. Does 
your organization have a policy that covers organ transplant access for 
individuals with disabilities?

    Answer. At the University of Alabama at Birmingham (UAB), I have 
transplanted patients with a range of disabilities, and similar, to 
their non-disabled counterparts they too have achieved a significant 
survival benefit from the lifesaving gift of transplantation. In short, 
people with disabilities should not be excluded from transplantation. A 
belief that my institution supports. The UAB Comprehensive Transplant 
Institute (CTI) does not discriminate against individuals with 
disabilities. Specifically, UAB CTI has a list of absolute and relative 
contraindications for each organ program, and neither category includes 
disabilities.

                                 ______
                                 
              Question Submitted by Hon. Benjamin L Cardin
    Question. Given the overrepresentation of Black Americans waiting 
on a kidney, do transportation problems that seem to disproportionately 
impact kidneys impact the disparity we observe?

    Answer. Transportation problems--along with all problems that 
unnecessarily constrain the supply of kidneys--exacerbate disparities 
in access to transplantation.

    As I testified before the Senate Finance Committee, highly 
sensitized patients are hard to match, and finding kidneys for these 
patients can be like finding the proverbial needle in a haystack. Our 
patients become sensitized through prior exposure to foreign tissue--
previous transplant, blood transfusion, and/or pregnancy. Women who 
have been pregnant--especially multiple times--are more sensitized/
harder to match, and pregnancy related sensitization contributes to 
both gender and racial disparities in access to kidney transplantation. 
So when we talk about the system being inequitable, this is a very real 
example of how a constrained pool of organs for transplant, and high 
discards, are failures that disproportionately hurt women, and women of 
color who are more likely to have multiple pregnancies.

    Therefore, it's critical that HHS (HRSA and CMS) immediately 
address the kidney discard problem, which is exacerbated by a lack of 
clinical standards and a lack of process standards in transportation.

    HHS (HRSA or CMS) should publish a lost organ reporting system--a 
dashboard of all kidneys recovered and not transplanted. These data are 
available to HHS agencies via the OPTN, and would allow for a near-real 
time reporting of: (1) total number of kidneys recovered and not 
transplanted; (2) where those kidneys originated (i.e., from which 
OPO); (3) where those kidneys were due to arrive (i.e., to which 
transplant center or State); and (4) why the kidney was discarded 
(e.g., clinical problems in recovery; transportation problems in 
delivery).

    Additionally, it is paramount that we evaluate whether the 
government's own contractors are using the most efficient/effective 
modes of transportation. For example, UAB is in the southeastern United 
States, an area with particularly high rates of end-stage kidney 
disease and health disparities. It is also a region where it is harder 
to get flights, and where missed flights can have calamitous 
consequences, yet too often simpler modes of transportation--such as 
driving--are not consistently explored and used.

                                 ______
                                 
                  Question Submitted by Hon. Tim Scott
    Question. During the hearing, our committee heard that organs in 
transport are 15 times more likely to go missing than customer luggage. 
You provided an example of an organ that was flown late at night and 
was placed in airport holding. Were it not for the quick actions of 
your team and cooperative airport staff, this organ likely would have 
been lost.

    Are there additional process improvements that were not discussed 
during this hearing that should be considered with regard to organ 
transportation to improve transplantation rates and care outcomes?

    Answer. HHS (HRSA or CMS) should publish a lost organ reporting 
system--a dashboard of all kidneys recovered and not transplanted. 
These data are available to HHS agencies via the OPTN, and would allow 
for a near-real time reporting of: (1) total number of kidneys 
recovered and not transplanted; (2) where those kidneys originated 
(i.e., from which OPO); (3) where those kidneys were due to arrive 
(i.e., to which transplant center or State); and (4) why the kidney was 
discarded (e.g., clinical problems in recovery; transportation problems 
in delivery).

    It may also be worth reaching out to the FAA to understand how this 
agency has so successfully collaborated with stakeholders to ensure 
precise times in transit. In short, we have figured out complex systems 
with airplanes, understanding arrival and delay times . . . and imagine 
if we hadn't. . . . This should be possible with kidneys.

    Simply put: we are not currently working with people/organizations 
who are experts in logistics and transportation. Whether that is the 
FAA or external organizations such as UPS and FedEx (as well as 
specialized logistics companies), transplant is too critical to be left 
to non-experts in logistics and supply chain issues.

                                 ______
                                 
     Prepared Statement of Brian Shepard, Chief Executive Officer, 
                United Network for Organ Sharing (UNOS)
    Chairman Wyden, Ranking Member Crapo, and members of the committee, 
thank you for inviting me to discuss our Nation's organ transplant 
system and the role of United Network for Organ Sharing, or UNOS. I am 
Brian Shepard, the CEO of UNOS, the nonprofit organization which holds 
the Federal contract to serve as the U.S. organ donation and 
transplantation network.

    I look forward to having a conversation with you about our Nation's 
diverse and thriving organ transplant system that just marked its 9th 
consecutive record-setting year of lifesaving transplants.

    In 1984, Congress passed the National Organ Transplant Act (NOTA) 
to address the Nation's critical organ donation shortage and improve 
organ matching and placement. The law called for an Organ Procurement 
and Transplantation Network (OPTN) to maintain a national registry for 
organ matching, and specified that the network would be a private, 
nonprofit entity.

    UNOS is proud to have been awarded the OPTN contract successively 
since 1986. Each contract rebid is based on a competitive process. We 
welcome this competitive process, and it has been our honor to serve 
the Nation for over 3 decades.

    From UNOS's inception as a mission-based non-profit and since we 
began serving as the Federal contractor, we have never once taken this 
privilege lightly; UNOS staff, volunteers--including transplant 
professionals, recipients, and donor families--and others dedicate 
their time and expertise every day to saving lives and improving the 
system. Our work focuses on three main areas: developing equitable 
allocation policies that ensure the fair distribution of organs; 
maintaining the national wait list with safe, secure and modern 
technology; and continuing to improve overall performance.

    But we do not exist in a vacuum; we convene a community of 40,000 
organ donation and transplant professionals and work in concert with 
our Federal partners.

    The OPTN contract is awarded and managed by the Health Resource 
Services Administration (HRSA). The Centers for Medicare and Medicaid 
Services (CMS), meanwhile, covers the cost for many of the Nation's 
lifesaving transplants and related services. Through its reimbursement 
programs, CMS regulates transplant hospitals, and is also charged with 
certifying and overseeing organ procurement organizations (OPOs).

    Together, UNOS, HRSA and CMS each play important roles in ensuring 
both the integrity and continuity of the complex national system on 
which so many rely. UNOS strives to align its efforts with those of 
HRSA and CMS so that we all work in concert as we fulfill our 
respective roles, while recognizing that there will always be room for 
improvement.
                            optn background
    The OPTN, as described in the statute, is a membership 
organization. We count amongst our members physicians, patients, 
transplant hospitals, organ procurement professionals, living donors, 
donor families, professional organizations, advocates, and volunteers, 
all of whom make the system what it is. And that is by design.

    When Congress developed the framework for the OPTN, it did so 
knowing that it was entrusting physicians and patients with the 
responsibility to make critical, medically complex policy decisions 
based on firsthand experience, shared values, and their ongoing 
participation in the organ donation and transplant process. We still 
agree with that prescient decision.

    That is the community UNOS is so proud to represent--a community 
dedicated to the equitable distribution of organs no matter who you are 
or where you live to save as many lives as possible through transplant.

    With this commitment to equity underpinning everything we do, we 
have seen rapid and remarkable changes in the past few years alone; 
changes that have expanded equitable access to transplants for 
candidates on the wait list, increased priority for the sickest 
patients on the wait list, addressed disparities by increasing 
transplants for historically marginalized communities, and so much 
more.

    However, while access to a transplant once a patient has been added 
to the wait list is largely equitable, there are systemic shortcomings 
within the larger U.S. health-care system that make getting added to 
the wait list inequitable. We must confront this issue as a Nation and 
we are committed to addressing it within our purview as the OPTN.

    Ours is a complex system; one that is dedicated to continuously 
improving, monitoring and adapting; one that involves thousands of 
people coming together every single day across the country in order to 
save lives.

    It is a system Congress set in motion nearly 40 years ago, and 
which, thanks to the decisions and expertise of those who laid the 
foundation, allows us to best serve patients in need of a transplant.
                           ongoing successes
    UNOS works to save lives every day, and the numbers bear out our 
successes in both improving the system and identifying new areas for 
enhancement.

    In 2021, for instance, the national system made global history: for 
the first time in a single year, the United States surpassed 41,000 
lifesaving transplants. That same year, the system also saw record 
numbers of liver, heart and lung transplants. These exciting milestones 
are the result of year-over-year increases in organ transplants for the 
past decade and occurred in the midst of worldwide pandemic.

    Additionally, post-implementation monitoring reports show the 
positive impact of recent modifications to kidney and liver allocation 
policies. According to the 1-year monitoring report analyzing changes 
to kidney allocation (the most transplanted organ), we saw an ongoing 
increase in kidney transplants nationally, especially for historically 
marginalized communities, patients on dialysis, and others. This 
includes increases of:

          23 percent for Black patients;
          29 percent for Hispanic patients;
          20 percent for Asian patients;
          36 percent for patients with long wait-times on dialysis; 
        and
          63 percent for pediatric patients.

    Meanwhile, the 2-year monitoring report for changes to liver 
allocation policy continued to show increases, with national rates 
increasing by 4.3 percent, including for the sickest patients, 
historically marginalized communities, and others.

    Again, these successes have taken place in the midst of the global 
pandemic that imperiled access to health care. Deceased donor 
transplant rates dipped in March of 2020, but quickly rebounded to pre-
pandemic levels by April 2020. This was the result of the collective 
effort of physicians, professionals and others on the front lines.

    It should also be noted that these successes are not stand-alone 
achievements, but instead the product of years of ongoing policy 
development, inclusive debate, rigorous discussion, monitoring, and a 
commitment to continuous improvement.

    While the votes to enact these policies were not unanimous, the 
changes were enthusiastically supported by a vast majority of Board 
members. Additionally, our policy development process has now been 
reviewed by HHS and the General Accounting Office, as well as multiple 
courts, and these policies are now in effect and benefitting patients 
across the country.

    Unfortunately, an ongoing misconception is that our Nation's 
success in donation and transplant is due to the ongoing and tragic 
opioid crisis and to the prevalence of gun violence.

    The national increase in transplants predates the beginning of the 
opioid crisis and the recent rise in violent crime. Additionally, both 
policy changes and technological advancements have played a role in 
increasing transplants. Yet there is another, more important point to 
be made here.

    Every death is tragic. However, regardless of the manner in which a 
potential donor dies, the Organ Procurement Organization (OPO) is still 
there to counsel the family, surgeons are still there to recover the 
selfless donor's organs, and the transplant hospital is still there to 
give the gift of life to a grateful recipient.

    As previously mentioned, we have seen dramatic increases in the 
number of transplants taking place over the past decade. We are also 
focused intently, not just on the number of transplants, but the 
equitable distribution of lifesaving organs.

    The OPTN Minority Affairs Committee (MAC) has been looking at these 
issues for years, resulting in the policies that have helped drive 
increases in transplants for patients of color.

    Just recently, following the efforts of a diverse workgroup made up 
of both patients and physicians, the OPTN Board passed a new rule 
requiring that all transplant hospitals must use race-neutral measures 
of kidney function.
                              role of unos
    With the creation of the OPTN, Congress designed a system to 
address the Nation's critical organ donation shortage and improve organ 
matching and placement. To accomplish this, Congress did not create a 
centralized, government-run process to determine policies impacting 
these life-saving actions. Instead, Congress believed that patients and 
physicians should lead the way. This was the correct decision then, and 
remains the best choice today.

    Thanks to congressional foresight, we now have an OPTN with a board 
and committees populated by patients, physicians, living donors, donor 
families and patient advocates who help make policy through rigorous 
debate and based on their unique experiences. There are currently 26 
OPTN Committees, including committees dedicated to specific organ 
transplant types, technology, minority affairs, patient affairs, policy 
oversight, safety, and others.

    These experiences are essential to making difficult, complex, and 
often emotional policy decisions that impact the lives of thousands 
across the country.

    So much of the ongoing discussion of our shared successes, 
collaborative efforts, and everything this diverse and thriving 
national community has accomplished is muddled by a basic 
misunderstanding of UNOS's role in our complex national system.

    Some think of UNOS as a regulator, with codified regulatory 
authority and congressionally mandated powers to oversee and penalize 
those not in compliance.

    However, based on the law Congress enacted, UNOS, in its role as 
the OPTN, is not a regulator.

    Regulatory authority of the Nation's organ donation and transplant 
system rests with CMS, and the delineation of our different roles is 
clear, established in both statute and policy, and essential to our 
ongoing collaboration and alignment.

    Our particular role is multifaceted, complex and essential:

          UNOS members work alongside each other as partners in 
        improvement;
          We operate a rigorous peer review process which includes 
        site visits, reviews, helping to develop plans of action, 
        offering educational opportunities, and other limited oversight 
        functions;
          We built, monitor and continuously improve the IT 
        infrastructure that makes it possible to match donor organs 
        with recipients in need of a transplant;
          We develop, implement, and monitor equitable organ 
        allocation policies; and
          We serve as both a convener of the transplant community and 
        as an advocate on behalf of the Nation's organ donation and 
        transplant system.
         membership and professional standards committee (mpsc)
    The Membership and Professional Standards Committee (MPSC) is an 
operational committee of the OPTN. In this role, the committee 
maintains OPTN membership criteria, monitors OPTN member compliance 
with this criteria, as well as compliance with OPTN bylaws, policies, 
and the OPTN final rule. As needed, the MPSC takes action or makes 
recommendations for further action to the OPTN board of directors.

    The MPSC also identifies opportunities for individual member 
improvement and opportunities for transplant community education, all 
in an ongoing effort to improve patient safety and safeguard the 
integrity of the transplant system.

    The MPSC is made up of volunteers who reflect the transplant 
community at large, including physicians with expertise in each organ 
transplant type and OPO volunteers. Health Resources Services 
Administration (HRSA) representatives also participate as ex officio 
members.

    Integral to UNOS's success in supporting continuous improvement 
among members and the community at large is the MPSC's confidential 
medical peer-review process--a vital process required by the OPTN final 
rule and the Federal contract that allows the OPTN to review member 
performance, conduct investigations, and fact-find within a 
confidential setting.

    Confidential peer review is a common practice across the U.S. 
health-care system. This was driven in large part by a landmark 
Institute of Medicine (IOM) report from 2000, which emphasized the 
importance of confidential peer-review to boost performance, ensure 
patient safety and encourage continuous improvement.

    This report led to a national sea change and spurred the adoption 
of confidential peer review across the health-care landscape. HHS 
incorporated this approach into the final rule in 2000 and this 
critical tool was included into the OPTN contract soon after.

    The ``peer review'' component is essential. Clinicians and 
professionals on the MPSC represent all the primary disciplines 
involved in transplantation. This expertise makes it possible to view 
member actions within the proper context, including what should have 
been known and what actions should have been taken under any given 
circumstance.

    Confidentiality is equally important, as it increases the 
possibility that OPTN members are more likely to come forward to report 
issues that occur at their organization. Without willing members able 
to provide critical information, the committee would not be able to 
fully assess a given event, and suggest needed improvements. Removing 
confidentially protections would imperil the process and may have a 
chilling effect on those who might otherwise report troubling behavior.

    The protection afforded by confidential medical peer-review also 
includes the opinions, statements and deliberations of MPSC committee 
volunteers themselves, ensuring their participation in the process 
without fear of professional reprisal or litigation.

    A range of actions are available if, after investigation and 
deliberation, the MPSC finds a member has not followed OPTN 
requirements. Some of those sanctions are not public, such as notices 
of noncompliance or letters of warning. However, if the MPSC recommends 
that the OPTN board of directors take an ``adverse action,'' which 
includes placing a member on probation or declaring a member not in 
good standing, and the Board acts on the recommendation, these 
designations are made public.

    The board may also decide a member's non-compliance with OPTN 
requirements risks patient health or public safety, or that the member 
consistently fail to improve while under an adverse action. In these 
cases, the Board must make an official referral to the U.S. Secretary 
of HHS.

    This complex but essential process helps ensure the Nation's organ 
donation and transplant system holds itself to the highest standards, 
drives member improvement and makes it possible to work with our 
community partners to address issues and arrive at workable, patient-
centered solutions, all with appropriate governmental oversight.

    The MPSC works collaboratively with every member in our community 
as a partner in improvement, and its rigorous process ensures prompt 
responses and swift action if necessary.
 national academies of sciences, engineering, and mathematics (nasem) 
                                 report
    UNOS has continued to pursue efforts to improve the Nation's organ 
donation and transplant system, increase equity, expand access, 
increase patient opportunities for involvement, and save even more 
lives.

    NASEM's February 2022 report addressed many of these issues. We 
were pleased that their in-depth analysis recognized many of our 
ongoing efforts, which aligned with their recommendations and reflect 
work already underway within and across our community, in many 
instances led by, in collaboration with or made possible by the support 
of UNOS.

    These include:

          Enhancing current educational offerings for patients;
          Emphasizing shared-decision making between patients and 
        physicians;
          Establishing new patient-centric transplant program 
        performance metrics that go into effect this year;
          Adjusting payment policies to incentivize the utilization of 
        harder to place organs; and
          Increasing transparency and accountability by launching a 
        new list of codes for transplant programs to use when they 
        refuse an order offer.

    And other efforts outlined in more detail below.
                                 equity
    The NASEM report emphasized the importance of increasing equity in 
access to the national wait list, regardless of where the patient lives 
or who they are. We agree, and have been dedicated to this proposition 
since our inception, both as a condition of our own organizational 
values and as a condition of the law which first established the OPTN.

    One recent example is the development of the ``Continuous 
Distribution'' framework, an approach the NASEM committee vigorously 
supported. The Continuous Distribution policy will erase hard 
boundaries, ensuring that no single attribute will determine if a 
patient gets a transplant. Importantly, this framework is also designed 
to be augmented over time, allowing for ongoing feedback from a wide 
range of stakeholders and giving patients an important seat at the 
table.

    As mentioned earlier in this statement, the OPTN board of directors 
voted in June on an equity-based proposal to prohibit the use of race-
based estimation of kidney health in OPTN policy.
                         systemic improvements
    The NASEM Committee also made several recommendations for the OPTN 
and the donation and transplant community overall to improve the 
system. One of these was the development and adoption of national 
performance metrics, which we fully support. Other tools we currently 
offer to the public and policymakers to monitor ongoing progress are 
the OPTN Metrics Dashboard and the OPTN Equity Dashboard. Both can be 
found on the OPTN website.

    NASEM also made recommendations for maximizing organ use. In its 
capacity as the OPTN, UNOS already has developed, tested and now offers 
the Kidney Offer Filters tool to transplant hospitals, which is in 
keeping with this NASEM recommendation. Our innovative tool, first 
available in January of 2022, allows kidney transplant programs to 
preemptively screen out offers they are unlikely to accept, reducing 
administrative burden, accelerating organ placement and making it 
easier for OPOs to find best-fit candidates quicker. We also must 
continue to reduce differences in practices from hospital to hospital 
and do our part to make sure everyone understands the organ offer 
review and acceptance process.

    As a part of overall system improvement, NASEM also recommended 
that the U.S. Department of Health and Human Services (HHS) conduct an 
evaluation of the OPTN IT system within 1 to 2 years. UNOS welcomes 
this evaluation; as of this writing, one has not been conducted.

    Beyond and before NASEM's recommendations, UNOS has always 
undertaken efforts to continuously improve the national system, bolster 
performance and support others within our community.

    While the above efforts, projects and tools are in no way a 
comprehensive list of ongoing work, they do represent an accurate 
picture of UNOS, as a Federal contractor, responding to the needs of 
patients, physicians, and the organ donation and transplant community 
at large.
                             transportation
    Transportation is essential to the success of the organ donation 
and transplant system. Unless a recovered organ happens to be accepted 
by a candidate in the same hospital where the organ was recovered, the 
organ must necessarily be transported from the donor hospital to the 
transplant hospital. The vast majority of organ shipment logistics are 
determined between the OPO and the transplant hospital on the ground, 
although the OPO may request OPTN assistance in rare cases. 
Additionally, the OPTN has multiple policies in place that address the 
safety of organs in transport, particularly regarding packaging, 
labeling, and ultimately verifying successful delivery to the patient 
who accepted the organ.

    Additionally, except for kidneys, most organs (hearts, lungs, 
livers, etc.) are transported in the company of the transplant 
physician who will be conducting the surgery. Disruptions are rare, but 
can still have a direct and serious impact on a patient in need of an 
organ.

    Like many things within this national system, transporting an organ 
is extremely complex. Something as simple as a courier taking a wrong 
turn can delay the delivery of an organ.

    That is why we have engaged in several collaborations with the 
community to improve the transport of organs through the development 
and adoption of innovative, evidence-based products to ensure patient 
safety.

    The UNOS organ tracking service, for example, is now in use by 15 
OPOs across the country and allows users to oversee organ shipments in 
real time. The tool provides OPOs with real-time location data, package 
updates and maps with easy-to-read visualizations. It also fully 
integrates with existing tools and systems, all in an effort to improve 
performance, speed, and patient outcomes.

    We have also conducted a successful pilot of a UNOS Travel App, 
which will allow OPOs to select the best options for transporting 
organs. Once fully operational, the app will allow OPOs to view and 
select the most efficient options for shipping lifesaving organs on 
commercial flights. While these are all important innovations, we 
continue to pursue efforts to further improve the transport of donor 
organs.
                           it infrastructure
    Our focus on continuous improvement also includes constantly 
enhancing our safe, secure and efficient IT infrastructure; a 
modernized system that we built, maintain, and enhance to ensure the 
highest performance on behalf of all those who have come to rely on it.

    Our system is audited by both Federal authorities and third-party 
cybersecurity firms. We regularly meet and exceed both their standards 
and our rigorous Federal contract obligations. Additionally, the OPTN's 
Network Operations Oversight Committee (NOOC) assists the OPTN Board in 
overseeing a variety of essential IT functions, including organ 
matching and data collection.

    We have spent years developing and improving our infrastructure, 
building and incorporating technological innovations, partnering with 
industry leaders, and leveraging Cybersecurity and Infrastructure 
Security Agency (CISA) resources to ensure robust performance and 
security on behalf of the communities we serve. This is why, despite 
more than 3 million hacking attempts each day, our system has remained 
safe and secure.

    Our modern infrastructure was designed to make the Nation's complex 
allocation policies possible; an effective, one-of-a-kind approach that 
weds robust technological capabilities with in-depth policy knowledge 
and has maintained, outside of periodic scheduled maintenance, a system 
uptime of 99.99 percent.

    While the votes to enact these policies were not unanimous, the 
changes were enthusiastically supported by a vast majority of board 
members. Additionally, our policy development process has now been 
reviewed by HHS and the General Accounting Office, as well as multiple 
courts, and these policies are now in effect and benefiting patients 
across the country.

    Our IT developers and business analysts are experts in both 
technology and transplant and donation; it requires this kind of unique 
background to successfully and thoughtfully integrate effective 
technology and lifesaving policy.
                     a shared vision for the future
    Our vision for the U.S. donation and transplant system is 
straightforward: being able to provide a lifesaving transplant for 
everyone who needs one. There is still much work to do, but in 
collaboration with our community partners, physicians, patients, OPOs, 
hospitals, policymakers, advocacy organizations, volunteers and others, 
we are making this vision a reality. From transportation to technology, 
from equity to system-wide improvements, by building on the successes 
of our national system and our community's ongoing efforts on all 
fronts, we can come together around these shared goals. It is 
challenging and sometimes controversial; we welcome constructive 
debates. But when we come together, our work can literally change 
someone's life.

    This collaborative, ambitious vision is transforming the system as 
we know it, building an even stronger national system we can be proud 
to call our own.

    I would like to thank Chairman Wyden, Ranking member Crapo, and the 
entire Senate Committee on Finance once again for inviting me to 
discuss the status of donation and transplant today and what we can 
accomplish when we work together to further improve this lifesaving 
system. I look forward to your questions.

                                 ______
                                 

                           Attachments Follow

                                        For Submission to the U.S. Senate Committee on Finance (October 12, 2022)
                                       Confidential treatment requested pursuant to Committee on Finance Rule XXVI
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Retired      Supporting
              Rule                     Type        Approved By    Approved Date     Date       Documentation         Active              Comments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Process for member waiving        Process         MPSC          7/23/2009                   Memo                Yes              Changes to Appendix L 6/
 interview. If a member waives                                                                                                    13/18 have made slight
 an interview, we will take the                                                                                                   changes to this, but
 issue back to the MPSC to                                                                                                        we would still go back
 determine what action they want                                                                                                  to the committee and
 to take.                                                                                                                         ask their opinions on
                                                                                                                                  it.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large and Small volume outcome    Outcomes        PAIS          Varying dates     7/1/2022  Guidance doc        Ending soon      Retiring with
 review principles: how the MPSC                                                                                                  introduction of new
 approaches outcomes reviews.                                                                                                     performance metrics--
                                                                                                                                  may reintroduce
                                                                                                                                  something for recently
                                                                                                                                  released programs as
                                                                                                                                  time goes on.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inactivity Review principles:     Outcomes        PAIS          Varying dates               Guidance doc        Yes
 how the MPSC approaches
 inactivity reviews.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of Compliance cases on     Process         PCSC          3/27/2012                   Slides              Yes              Documents refer to PCSC
 Committee Management.                                                                                                            but subcommittee does
                                                                                                                                  not exist anymore, all
                                                                                                                                  cases go to Committee
                                                                                                                                  Management.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Allocation--reportable            Policy          PCSC          4/1/2013                    Documents           Yes              Even if the allocation
 allocation events: provides a                                                                                                    meets these criteria,
 list of criteria for                                                                                                             allocations can be
 allocations that the MPSC does                                                                                                   referred if there are
 not need to review because                                                                                                       questions or something
 members are acting to prevent                                                                                                    seems unusual. Updated
 organ wastage.                                                                                                                   4/22/21.
--------------------------------------------------------------------------------------------------------------------------------------------------------
LDAE--not reporting outside 2     Process         MPSC Chair    10/27/2015                                      Yes
 years as FYI: previously all
 living donor events, even those
 that occurred longer than 2
 years after donation, were
 reported to the MPSC as an FYI.
 Changed process to only refer
 those cases to the MPSC if the
 event appears that it could be
 Pdonation-related.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vessel Storage--do not send       Policy          MPSC 1        0/27/2016                   Summary             Yes
 members to the MPSC the first
 time they store prohibited
 vessels (HCV, HBV).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Site survey--support for          Policy          Internal      10/27/2016                  Summary             Yes              Staff Summary
 changing sample sizes, creating
 a CAP template. NO OFFICIAL
 RULE CHANGE.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Two tiered review of SRTR 1-year  Outcomes        PAIS          10/27/2016        7/1/2022  Minutes             Ending soon      MPSC approved 37-0-0.
 post-transplant outcomes for                                                                                                     Eliminated with change
 kidney--if meets threshold for                                                                                                   to metrics and
 review with full cohort of                                                                                                       reduction in number of
 transplants, remove higher risk                                                                                                  programs identified.
 kidney transplants and only
 send inquiry if meet threshold
 for review.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Allocation--do not review         Policy          MPSC          7/13/2017                   Staff summary       Yes              Approved 30, 0, 0
 extrarenal organs turned down                                                                                                    Updated 4/22/21.
 in OR.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Elimination of identification of  Outcomes        PAIS          7/13/2017         7/1/2022  Minutes             Ending soon      MPSC approved 30-1-0
 programs for outcomes review                                                                                                     (Small volume no
 based on small volume criteria.                                                                                                  longer in bylaws after
                                                                                                                                  7/2022).
--------------------------------------------------------------------------------------------------------------------------------------------------------
NUV (now Notice of                Application     MPSC          7/15/2017                   Staff summary       Yes              Approved 30, 0, 0
 Noncompliance) for late key
 personnel reporting.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wait-list inactivity monitoring:  Process         MPSC          1/30/2018                   Staff Summary       Yes              MPSC approved 19-0-0
 the first instance of
 improperly notifying patients
 of wait-list inactivity will
 require a CAP, the second
 instance will be referred to
 the MPSC.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of non-institutional       Application     MPSC          3/1/2018                    Staff summary       Yes              MPSC approved 32-0-0
 member renewals: non-
 institutional renewal
 applications will be placed on
 a consent agenda if all
 requirements are met.
--------------------------------------------------------------------------------------------------------------------------------------------------------
KPC Application Review Process    Application     MPSC          7/18/2018                   Staff summary       Yes              MPSC approved 34-0-0
 Change: key personnel change
 applications will be placed on
 a consent agenda if the
 application clearly meets
 criteria.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Late Report to the OPTN of        Policy          MPSC          7/18/2018                   Staff summary       Yes              MPSC approved 34-0-0
 Potential Donor-Derived Disease                                                                                                  with two changes: all
 Transmissions: if a member                                                                                                       members start with a
 reports a potential disease                                                                                                      clean slate, and FTNC
 transmission appropriately to                                                                                                    time frame is 3 years,
 other members, but does not                                                                                                      to be consistent with
 report to the OPTN, the first                                                                                                    compliance history
 instance will not be sent to                                                                                                     time frame when
 the MPSC.                                                                                                                        reviewing cases.
--------------------------------------------------------------------------------------------------------------------------------------------------------
SET Tool introduction and         Policy          MPSC          7/18/2018                   Staff summary       Yes              MPSC approved 34-0-0
 implementation: approved use of
 Survey Evaluation Tool and for
 staff to close or review again
 without MPSC review.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revising Outcomes operational     Outcomes        MPSC          2/27/2019         7/1/2022  Staff summary       Ending soon      MPSC approved 35-0-0
 rule to no inquiry for 2 SRTR                                                                                                   Eliminated with change
 reporting cycles after release.                                                                                                  to metrics, will
                                                                                                                                  likely reintroduce as
                                                                                                                                  metric review matures.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Determining that the minimum two  Application     MPSC          2/27/2019                   Minutes             Yes              Made a decision on
 year (2-5 yr) time in the                                                                                                        interpretation, then
 Bylaws for physician/surgeon                                                                                                     approved an
 logs can be fulfilled by the                                                                                                     application with this
 person's employment at                                                                                                           issue to set
 designated transplant programs,                                                                                                  precedent.
 not just by the dates of the
 actual transplants.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Add application rejections to     Application     MPSC          2/26/2020                   Staff summary       Yes              Approved 37-0-0
 Membership consent agenda:
 after an application has been
 rejected unanimously by the ad
 hoc subcommittee, the rejection
 will be placed on a consent
 agenda.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Update older decision to close    Process         MPSC          4/22/2021                   Staff summary       Yes              Approved 26-0-0
 self- reported issues with no
 action to include placing self-
 reported issues directly on the
 consent agenda unless
 significant concerns with
 response or patient safety.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Update use of Survey Evaluation   Process         MPSC          4/22/2021                   Staff summary       Yes              Approved 27-0-0
 tool to use SET to evaluate
 both routine and first desk
 review, place first desk review
 directly on consent.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Made adjustments to allocation    Process         MPSC          4/22/2021                   Staff summary       Yes              Approved 26-0-0
 operational rules based on
 changes to policy.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of lung donor COVID-19     Process         MPSC          5/24/2021                   Staff summary       Yes              Approved 28-0-0
 testing.
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                 ______
                                 
                united network for organ sharing (unos)

                          700 North 4th Street

                           Richmond, VA 23219

                           tel: 804-782-4800

                           fax: 804-782-4816

                              www.unos.org

MEMORANDUM

To: OPTN/UNOS Membership and Professional Standards Committee

From: Suzanne Gellner, Assistant Director, Department of Evaluation and 
Quality

Date: July 23, 2009

Re: MPSC action following member waiver of rights to an interview

Historically, if a member waived its right to an interview for a 
proposed action, the department of evaluation and quality would, on 
behalf of the MPSC, issue the proposed sanction without further 
committee deliberation. It has come to our attention that this process 
has never been formally adopted by the Committee. Therefore, the 
department of evaluation and quality requests that the MPSC consider 
whether it would like to formally standardize this practice in all 
cases where a member waives its right to an interview.

According to OPTN Bylaws, Section 3.01A (3) (Interviews), except in the 
case of Category I potential violations, if the MPSC or MPSC/PCSC 
considers recommending an adverse action such as Probation or Member 
Not in Good Standing or is considering issuing a Letter of Reprimand, 
the applicant or member is entitled to an interview. OPTN Bylaws, 
Section 2.11 A (Procedural Rights) states that if a member waives its 
right to an interview, the MPSC may proceed to implement its proposed 
action. In order to exercise its rights to an interview before the MPSC 
or the MPSC/PCSC, the member must deliver a written request for an 
interview to UNOS within 14 days following its receipt of the notice of 
the MPSC's proposed action. In accordance with Section 2.11A of the 
OPTN Bylaws, if the member does not deliver a written request for an 
interview, the MPSC may proceed to implement its proposed action.

Since 2006, the MPSC has issued seven letters of reprimand to members 
who have waived the right to an interview. The MPSC issued letters of 
reprimand for site survey results that remained below thresholds, organ 
refusals after acceptance that led to an organ's discard, failure to 
comply with data submission requirements, and repeated violation of 
policy 5.3. No member recommended for Probation or Member Not in Good 
Standing has ever waived its rights to an interview. Historically, when 
a member waived the right to an interview, it did not submit additional 
materials for MPSC consideration; therefore, the MPSC did not review 
additional evidence or reconsider its original decision. Standardizing 
this process for future MPSC recommendations would be consistent with 
historical practice; however, proceeding directly with the MPSC's 
proposed action offers no opportunity for the committee to reevaluate 
its decision.

If the MPSC decides to formally standardize this practice, the 
resolution to consider recommending an adverse action or issuing a 
Letter of Reprimand, combined with the member's waiver of its right to 
an interview, will result in the MPSC imposing its proposed action.

Operational Principles

Outcomes--applies to Large and Small Volume outcomes

    Is the program active?--Membership database.

    Is the program already under review?--CMRS.

    If program released in last 2 meeting cycles, no action required--
CMRS.

    Has program had a death or graft failure since the date of most 
recent release from review?--Transplant Log Access Database.

Small Volume Outcomes--all of the above and then #2 below.

    1.  SRTR data provided includes all programs with 9 or fewer 
transplants that had at least one event in the 2.5 year cohort.
    2.  Review to determine if the program has had a subsequent event 
in the year since the end of cohort. If not, no action required--
Transplant log Access Database.
Additional Small Volume Guidance

To memorialize discussions regarding how to proceed with the several 
cases where programs that are currently under review have had a second 
component flagged (adult or pediatric) or are under review for 
inactivity.

      If a small volume program is flagged for outcomes that is 
already under review for inactivity, an outcomes case will be created, 
the inactivity case will be closed. No subsequent event is required.
      If a small volume component is flagged for outcomes when the 
program is already under review for the other component, the outcomes 
case will be combined into an all ages review without a subsequent 
event.
      In both situations, instead of automatically sending an initial 
outcomes survey, analyst should contact the reviewers for the existing 
case and determine if:
          An initial outcomes survey should be sent.
          If no initial outcomes survey, do the reviewers 
        want to request:
                  Only synopses and activity information for the newly 
                flagged component/program.
                  Request additional information on the new flagged 
                component/program.

                                 ______
                                 
Guidelines for Inactivity Review

Transplant inactivity.

Once receive Turndown Reports:

    1.  Is program currently active? If no, no action required--
Membership database.
    2.  Is program currently under review--check Active PAIS Case 
report--CMRS.
    3.  Has program been in active status for one year? If not, no 
action required.
    4.  Has program been released in last 2 meeting cycles? If yes, no 
action required--CMRS.
    5.  No offers received/no candidates on wait list--get a pass for 
one cycle--review turndown report/wait list.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
                                 

                      MPSC/PCSC Allocation Review

                         Exclusionary Criteria

The MPSC Allocation Analysis work group recommended that the UNOS staff 
not forward allocation cases involving the criteria listed below to the 
MPSC/PCSC for review.

    1. Hep C positive donors.
    2. Hep B Core positive donors.
    3. Donors with age > 70.
    4. DCD--for all organs EXCEPT kidney.
    5.  Local back up (Originally only in cases of actual vs. intended 
transplants associated with transplant center reviews. In October 2014 
the MPSC work group expanded the scope to include OPOs that grant 
centers local back up to avoid organ wastage after late declines or try 
to and place organs that would otherwise be wasted).

For kidney allocations ONLY:

    1.  ABO non-identical allocation not on a match run with 
appropriate documentation.
    2. Medical urgency with appropriate paperwork that local centers 
agreed.

                                 ______
                                 
The PCSC also discussed a number of possible improvements to PCSC/MPSC 
operational rules associated with site surveys and an educational 
referral to the OPTN Operations and Safety Committee. Specifically, the 
PCSC discussed potential changes to the process for requesting 
corrective action plans for each site survey violation, the timing and 
intent of follow-up focused desk reviews and the site survey sample 
size. The PCSC generally supported the following ideas, with the 
understanding that staff would continue to develop the ideas and bring 
them back to the PCSC for further discussion:

      The creation of a corrective action plan template for members.
      A tiered approach to which violations require a formal 
corrective action plan for MPSC review and which require another 
response such as self-audits, or potentially no response, if the 
member's policies and templates are updated at the time of the survey.
      A ``check in'' by UNOS staff after the routine survey to ensure 
the member has implemented its corrective actions and that the 
corrective actions are effective. This check in may delay the PCSC's 
review of the routine survey report, but would potentially provide 
enough information to allow the PCSC to close the review with no action 
instead of requesting a follow-up review.
      The creation of operational rules to identify which routine 
surveys automatically require follow-up reviews and which cases must go 
to the MPSC for the MPSC to determine whether a follow-up review, or 
more significant action is required.

The PCSC noted that smaller sample sizes, such as five records for 
small volume programs, would not provide statistically significant 
data. However, the PCSC supported the idea of considering other methods 
of identifying the appropriate sample size, such as a percentage of the 
program's total volume, and including the program's total volume as a 
reference point. The PCSC supported focusing reviews on the most recent 
and relevant data (by shortening the time frame of review) and focusing 
the review on identifying systematic issues.

The PCSC also reviewed the results of the UNOS staff analysis of 
prohibited vessel storage cases. Staff identified common root cause 
analyses and corrective action plans, and asked the PCSC to confirm 
whether their findings aligned with the PCSC members' review of these 
cases. The PCSC supported sharing the findings with the Patient Safety 
Advisory Group of the OPTN Operations and Safety Committee, to support 
the PSAG's development of educational resources for the transplant 
community. The PCSC generally supported the ongoing creation of such 
resources to share with the community.

In addition, based on its review of a number of prohibited vessel 
storage cases, the PCSC also approved a new operational rule to 
facilitate its review of these cases. Going forward, UNOS staff will 
automatically close with no action a member's first violation of the 
prohibited vessel storage policy. Staff will provide members with any 
educational materials available, will advise the member that the MPSC 
expects the member to implement a corrective action plan, and will 
advise the member that any additional instances of the member storing 
prohibited vessels will be forwarded to the MPSC for review. Staff will 
also inform the member that MPSC's review would include the initial 
violation.

                                 ______
                                 

                      UNOS Site Survey Discussion

                              PCSC Meeting

                            October 25, 2016

                             Staff Summary

Item for Consideration:

At the October 2016 PCSC/MPSC meeting, Member Quality staff would like 
the PCSC to provide feedback on:

      The need for corrective action plans/member responses to survey 
violations.
      A draft corrective action plan (CAP)/response template for 
members to use in response to their site surveys.
      The purpose and timing of follow-up desk reviews.
      Site survey sample sizes.

This feedback will help Member Quality staff as it continues to 
evaluate options and implement improved processes to promote value-
adding monitoring and increasing efficiencies to reduce the burden on 
members, the MPSC and staff.

Site Survey Corrective Action Plans:

Currently, Member Quality staff requires members to submit a CAP for 
each potential violation that will be forwarded to the MPSC for review. 
(Please note: we do not specify that the response must be a formal CAP 
with root cause analysis. Depending on the situation, a simple 
explanation may be sufficient, and we leave it up to the member to 
evaluate whether a RCA and CAP are appropriate. However, despite this 
guidance, we believe many members often feel obligated to provide a 
full RCA and CAP. In the rest of this document, we use the term CAP to 
mean any sort of formal response to the MPSC.)

During the site survey process, members receive an initial site survey 
report that details all potential policy violations identified during a 
site survey or focused desk review. Members are asked to either submit 
new documentation to verify compliance, or to submit a CAP to address 
the non-compliance. (We do not typically review or require a CAP for a 
policy that is no longer in effect at the time of the survey.) The 
final site survey report forwarded to the MPSC for review includes all 
potential violations and the member's corrective actions.

Staff are interested in the PCSC's feedback on what information it 
needs in order to decide on the appropriate action after a site survey? 
Does every identified violation need a CAP, or are there specific 
instances when the PCSC does need or want a formal response from 
members? Potential alternatives approaches include not requiring 
corrective actions for certain policies or issues such as data entry 
errors or not requiring corrective action plans for surveys that we 
know are going straight on the consent agenda.

Corrective Action Plan Template:

Member Quality staff are also evaluating whether to create a CAP 
template that members can fill out to address the violations. The idea 
is similar to the template plan for quality improvement that members 
receive in response to MPSC-directed peer visits. Member Quality staff 
want to make sure that this tool is useful for members as they create 
their CAP and also useful for PCSC members in your review of site 
survey reports.

Please review the enclosed template and be prepared to provide feedback 
during the PCSC meeting. Are any fields missing that you think should 
be added? Are there any fields that you think can be removed? Is the 
formatting easy to read?

Please note that the attached version assumes that all policy 
violations require a response of some kind according to the current 
process, but the form could be adapted as needed to fit a revised 
process for requesting CAPs. We can also consider whether the MPSC 
wants to specify which policy violations require a CAP and which do not 
and update the template accordingly.

Follow-Up Desk Reviews

Follow-up focused desk reviews are a key component of the site survey 
and MPSC monitoring process. Since July 2015, the MPSC has requested 
follow-up desk reviews in approximately 17.5% of transplant program and 
OPO site surveys and has requested follow-up desk reviews in 
approximately 38% of living donor surveys.

Historically, the MPSC has requested Member Quality staff conduct 
follow-up focused desk reviews when a member's site survey report shows 
non-compliance with one or more particular policies, and the MPSC 
continues to request follow up reviews until the member has 
demonstrated compliance and/or satisfactory improvement.

For example, if a member has errors in five of 10 records regarding 
informed consent, the MPSC will likely request a follow up focused desk 
review of compliance with the informed consent policy. If the follow up 
review finds errors in four or five records, the MPSC will likely 
request another follow-up desk review. This pattern would continue 
until the member shows improvement. On the other hand, if the follow up 
review finds no errors or just one error, it is likely that the MPSC 
would close the review. They key is that the member typically must have 
records available for review that show compliance before being 
released.

In another example, assume the member had errors in five records from 
2015, but no errors in the other five records from 2016. The program 
explained that they self-identified and corrected the error in late 
2015 by updating its informed consent template. Because the program has 
five records in their sample after they updated the template, the MPSC 
would consider the more recent records to be evidence of compliance and 
would typically not request a follow-up desk review. However, if the 10 
records in the sample were all from 2015, prior to the template update, 
the member would have no records in the sample to show that its 
corrective action was working, and the MPSC would likely request a 
follow up review. Similarly, if the member updated the template 
immediately before the site survey and provided it to surveyors during 
the visit, the MPSC would likely request a follow up focused desk 
review to ensure the template is properly implemented and used.

Items to consider:

      Does the MPSC wish for the standard to remain that members must 
actively demonstrate compliance, or is having an appropriate template 
or policy in place by the conclusion of the survey sufficient to close 
a review with no action? Should the standard be different for 
administrative policies or policies with patient safety or allocation 
implications?
      If the MPSC wants to ensure members are showing improvement and 
compliance, would the MPSC consider having a ``staff check in'' in lieu 
of a formal follow up focused desk review in some cases? Example: the 
member with errors in five of 10 records submits an updated template 
during the site survey visit. Site surveyors check in with the member a 
certain amount of time after the site survey and review additional 
records to confirm the new process is working, and includes that 
information in the site survey report to send to members. This may 
delay the site survey report making it to the MPSC for review, but may 
give the MPSC sufficient information to close the review with no action 
rather than requesting a formal follow-up desk review. The MPSC may 
need to identify which situations are appropriate for such ``check 
ins'' to avoid following up on every potential policy violation.
      Are there any other factors or data the MPSC would like to 
consider when deciding whether a follow up survey is appropriate? 
Examples include any other information surveyors may already obtain or 
start obtaining during site visits, the member's compliance history, 
and/or the member's outcomes.

Site Survey Sample Sizes (for Transplant Program Surveys)

In addition to considering potential changes to the follow-up desk 
review process, staff are also considering ways in which the emphasis 
of site surveys can change from an intensive chart review to an 
evaluation of a member's practices from evaluation through to 
transplant, death or removal. The living donor surveys currently review 
a selected sample of donors throughout the evaluation process.

Current process:

      Routine on-site surveys are conducted approximately once every 3 
years. The applicable timeframe from which records are identified for 
review is typically the two to three years prior to the survey.
      The number of records available for review varies by organ group 
and the type of policy being reviewed. Generally speaking, 
administrative policies such as notification of listing, removal, and 
the option to multiple list, as well as informed consent are limited to 
10 records in the sample. Clinical policies such as verification of 
candidate status include up to 30-45 records in the sample depending on 
the organ group. This may include anywhere from 60 to more than 100 
individual listings for review.

Proposed process:

In order to incorporate and focus on an overall process review rather 
than strict data review, to ensure surveyors are focusing on the most 
recent and relevant data, and to promote consistency across the number 
of records reviewed between organ groups and surveys, staff are 
evaluating whether to implement new and smaller sample sizes in their 
surveys.

      Centers will be categorized by size (based on the number of 
transplants performed the previous year and the nationwide percentile 
distribution of center volume per organ type).
      The program size category determines the number of records 
reviewed for all policies:
          Small centers--5 records.
          Medium programs--10 records.
          Large programs--15 records.
      Living donor kidney and liver programs would have 5 records for 
review.
      Surveys would still be scheduled approximately every three 
years. Rather than reviewing 2 to 3 years' of data, surveyors would 
limit the review period to the most recent 12 month timeframe. This 
would promote the review of the most recent and relevant practices and 
policy requirements. (Less but more relevant records.).
      Limiting the survey review period to the most recent year 
provides the most relevant data, but means we may never know if the 
program had significant issues in the other time between the surveys.
      A smaller sample may influence the effectiveness of current 
scorecards and thresholds. For example, intestine and pancreas programs 
do not currently have scorecards due to their low volumes, so we may 
need to discontinue using them in the smaller volume programs. We can 
of course revise the scorecards as needed, or develop an alternative 
method to identify surveys that can be placed on the consent agenda to 
close with no action.
      A smaller sample size may promote inconsistent review. If a 
survey shows errors in two of five records, will MPSC reviewers 
perceive that as only two errors, or as a 60 percent compliance rate? 
There is not a clear historical action in these cases.

Items to consider:

      Does the MPSC support the proposed sample sizes? If the site 
survey reports included fewer records, would the MPSC need any 
additional information to determine an appropriate action? If so, what 
information is needed? Examples include any other information surveyors 
may already obtain or start obtaining during site visits, the member's 
compliance history, and/or the member's outcomes.

                                 ______
                                 

 Scientific Registry of Transplant Recipients (SRTR) Proposed 
                    Evaluation Plan for Transplant Program Performance 
                    Measures (Outcome Measures) Proposal

The proposal focuses on improving the utilization of high-KDPI kidneys 
through reduced oversight of ``high-risk transplants,'' i.e., high-KDPI 
kidneys transplanted into high-EPTS candidates. The reduced oversight 
of high-risk transplants has raised concerns that unadjusted survival 
of high-risk transplants may worsen after the implementation of the 
proposal. It is therefore critical that the proposal has a detailed 
evaluation plan to ensure improved utilization of high-KDPI kidneys 
while maintaining adequate survival of high-risk transplants. The 
evaluation plan outlines the schedule and corresponding analysis to:

    1.  Estimate the impact of the proposal on the utilization of high-
KDPI kidneys.
    2.  Estimate the impact of the proposal on the survival rate of 
high-risk transplants.

The proposal should impact the utilization of high-KDPI kidneys 
relatively quickly after implementation. Therefore, one year after the 
implementation of the operational rule, the discard rate of high-KDPI 
kidneys one-year pre-and post-implementation will be compared. 
Specifically, data for recovered kidneys with KDPI = 85% along with 
donor characteristics will be pulled from the SRTR database. An initial 
descriptive analysis will compare the unadjusted discard rates pre- and 
post-
implementation. For the primary analysis, a generalized linear mixed 
model (GLMM) with a logit-link will estimate the effect of the proposal 
on the probability of discard with an indicator for recovery pre-or 
post-implementation. It is critical to account for differences in the 
donor pool as the proposal may lead to more aggressive OPO placement of 
high-KDRI kidneys. Thus, based in part on the June 2016 SRTR OPO yield 
model, the GLMM will account for potential differences in the donor 
pool pre-and post-implementation by including covariates for: age, 
KDRI, blood type, DCD donation, cause of death, cigarette use, 
circumstance of death, clinical infections (blood, lung, urine and 
other), cocaine use, gender, Hepatitis B serology, HCV serology, heavy 
alcohol use, CDC high infectious risk, history of cancer, history of 
diabetes, history of hypertension, insulin dependence, mechanism of 
death, organ recovery outside of contiguous 48 states and terminal 
serum creatinine. Penalized splines will estimate the effect of age, 
KDRI, and terminal serum creatinine. Finally, a random effect for donor 
will account for the potential correlation between kidneys from the 
same donor. The proposal will be determined to have a significant 
effect on discard rates of high-KDPI kidneys by having a one-sided p-
value less than 0.05 on the indicator for recovery pre- or post-
implementation. Missing data will be handled by indicators and 
continuous variables will additionally be set to the median of the non-
missing values.

Due to the follow-up required for assessing post-transplant survival, 
the evaluation of the proposed operational rule on the survival rate of 
high-risk transplants will be completed two years after implementation. 
Specifically, data on high-risk transplants completed one-year pre-and 
post-implementation will be pulled from the SRTR database. Similar to 
the evaluation of post-transplant outcomes, recipients will be 
administratively censored after one year of survival. An initial 
descriptive analysis will compare the unadjusted one-year survival 
rates. For the primary analysis, a Cox proportional hazards model will 
estimate the effect of the proposal on post-transplant graft survival 
with an indicator for pre-or post-implementation transplant. Due to 
potential differences in recipient and donor characteristics, the Cox 
proportional hazards model will adjust for KDRI, EPTS, CDC high 
infectious risk and DCD donation. Penalized splines will estimate the 
effect of KDRI and EPTS. Every covariate in the SRTR post-transplant 
graft survival model cannot be used due to the relatively low number of 
expected events over two years within the subset of high-risk 
transplants. Missing data will be handled through multiple imputation 
as implemented in the most recent PSR cohort.

A non-inferiority test will determine whether post-implementation graft 
survival is appropriately maintained with the non-inferiority margin 
set to a hazard ratio of 1.75. That is, the proposal will be determined 
to have maintained appropriate graft survival if the indicator for pre-
or post-implementation transplant has a one-sided p-value less than 
0.05 for the null hypothesis that the hazard ratio is greater than 
1.75. The non-inferiority margin was selected because the one-year 
graft survival rate for kidneys with KDPI = 85% was approximately 85% 
in the 2014 OPTN/SRTR Annual Data Report, and a hazard ratio of 1.75 
would ensure that the one-year graft survival rate for kidneys with 
KDPI = 85% remains above 75%.

Sensitivity analyses will be completed for both objectives of the 
proposal. To assess the sensitivity to the assumptions made within 
GLMMs, the utilization of high-KDPI kidneys will include an analysis 
based on generalized estimating equations (GEE) with an exchangeable 
working correlation structure for donors. Post-
transplant survival will include an analysis based on a frailty model 
accounting for potential correlation between kidneys from the same 
donor. Additional sensitivity analyses will be completed that consider 
covariates or interactions that were not included in the primary 
analyses, especially for covariates included in the SRTR post-
transplant graft survival model. Finally, a sensitivity analysis will 
investigate the potential presence and impact of temporal trends on 
organ utilization and post-transplant survival.

The significant advantage of the evaluation plan is the primary 
analysis for both objectives is a priori specified including covariates 
for adjustment and their functional form. This improves the scientific 
validity by ensuring the false-positive rate of 5% is not adversely 
impacted by stepwise variable selection methods (e.g., backwards 
selection). Additionally, the analysis is not biased by post-hoc 
selection of statistical methods (e.g., the selection of GLMM versus 
generalized estimating equations) or the post-hoc selection of clinical 
outcomes (e.g., graft versus patient survival). A potential 
disadvantage is the omission of potentially important covariates or 
interactions in the primary analysis although appropriate sensitivity 
analyses should alleviate these concerns. Additionally, important risk 
factors may not be collected (e.g., cardiovascular risk factors) and 
could confound the analysis if the prevalence of the risk-factors in 
high-risk transplants increases post-implementation. Finally, the 
analysis may also be confounded by temporal trends in the organ 
utilization of high-KDPI kidneys or graft survival of high-risk 
transplants.

                                 ______
                                 

                           MPSC STAFF SUMMARY

                  Allocation Operational Rule Updates

                             July 11, 2017

Item for Consideration:

At the July 2017 MPSC meeting, the MPSC will be asked to consider an 
update to its existing allocation operational rule. The proposed rule 
would automatically close cases with no action when an OPO expedites 
placement of an extra-renal organ if a transplant program declines the 
organ in the donor OR.

Background:

Member Quality staff review the match run for all deceased donor organ 
allocations that result in a transplant. Each month, the Quality 
Assurance Analysts identify approximately 250-300 transplants with 
deviations from the match run. The analysts inquire with members and 
forward potential policy violations to the MPSC. Possible violations 
include instances when an OPO skips or bypasses patients on the wait 
list (``allocation out of sequence''), a transplant program accepts an 
organ offer for one patient but transplants another patient on the 
match run (``actual versus intended''), or a transplant program 
transplants a patient not on a match run (``not on the match run''). 
Analysts send the MPSC one summary per year for each member. The 
summary allows the MPSC to review any potentially concerning patterns 
of behavior over time.

The MPSC has closed almost all allocation deviations with no action; 
most members attempt to follow the match run as much as possible but 
deviate from the match run to avoid organ wastage. To streamline the 
review process, the MPSC developed operational rules to automatically 
close cases with no action when it is likely that allocation deviation 
was necessary to avoid organ wastage. The MPSC developed the current 
operational rules through 2012 and 2013, and the committee approved 
them in April 2013.

The MPSC does not review allocations when:

      An OPO expedites placement of any organ from a Hepatitis C 
positive donor.
      An OPO expedites placement of any organ from a Hepatitis B core 
positive donor.
      An OPO expedites placement of any organ from a donor more than 
70 years old.
      A program transplants any organ into a patient other than the 
original intended recipient and the Host OPO granted the transplant 
program local back up.
      A program transplants a kidney patient out of sequence due to 
medical urgency as permitted by Policy 8.2.A.
      A program transplants a kidney recipient who does not appear on 
the match run as described in Policy 5.4.E.
      An OPO expedites placement of any organ except kidneys from a 
DCD donor.

Proposed Operational Rule:

MPSC leadership asked Member Quality staff to review relevant data and 
suggest possible updates to the existing operational rules.

2016 MPSC Allocation Reviews:

      270 total allocation reviews.
      162 extra-renal organ allocations.
      28 heart allocations, 3 declined in the donor OR.
      36 lung allocations, 7 declined in the donor OR.
      98 liver allocations, 66 declined in the donor OR.

The MPSC closed all 76 extra-renal allocations where a transplant 
program declined the organ in the donor OR with no action. While 
reviewing these cases, MPSC members often commented that the OPOs 
appropriately expedited placement to avoid organ wastage.

Does the MPSC wish to add instances where an OPO expedites placement of 
an extra-renal organ after a transplant program declines the organ in 
the donor OR to its list of exclusionary criteria? This could eliminate 
approximately 25 percent of the allocation cases the MPSC currently 
reviews. Staff can make details of any case automatically closed with 
no action available at any time. In addition, staff can provide data on 
organs declined in the OR as needed for any allocation review projects.

The Subcommittee also considered whether the current criteria for 
identification of small volume programs for lower than expected graft 
or patient survival be removed from the Transplant Program Performance 
bylaw. New criteria for identification of programs for review was 
implemented in January 2015. The bylaw included new Bayes criteria for 
identification of large volume programs and retained the previous 
criteria for small volume programs of one death or graft failure in a 
two and half year cohort. Programs that perform 9 or less transplants 
in two and a half years are considered small volume under the 
Transplant Program Performance bylaw. The MPSC uses operational rules 
to decrease the number of small volume programs that receive an initial 
inquiry.

The MPSC retained the small volume criteria in the proposal because of 
some concerns that the Bayes methodology may not adequately identify 
small volume programs that need improvement. However, the MPSC 
committed to evaluate whether this small volume criteria could be 
eliminated post-implementation. The Subcommittee reviewed data 
regarding small volume program reviews since implementation of the new 
bylaw. Based on this review, the Subcommittee recommended that the MPSC 
approve elimination of the small volume criteria from OPTN Bylaws, 
Appendix D.11.A.Transplant Program Performance. The Subcommittee 
further recommended that the MPSC approve implementation of an 
operational rule that would operationalize this change until the Bylaws 
can be revised. The operational rule would provide that only those 
small volume programs that are identified using the large volume Bayes 
criteria be sent an initial outcomes inquiry.

    The Committee approved the following resolution by a vote of 30 
For; 1 Against; 0 Abstentions:

        RESOLVED, the MPSC approves the elimination of the separate 
        small volume program criteria from OPTN/UNOS Bylaws, Appendix 
        D.11.A. Transplant Program Performance; using the current Bayes 
        criteria for identification of programs regardless of volume; 
        and implementation of an operational effective immediately to 
        operationalize this change until the OPTN/UNOS bylaws can be 
        revised.

                                 ______
                                 

                           MPSC Staff Summary

              Late Notification of Key Personnel Departure

                       Proposed Operational Rule

Item for Consideration:

At the July meeting, the MPSC will be asked to consider an operational 
rule to automatically place late notifications of key personnel 
departures on a MPSC consent agenda with a recommendation to issue a 
Notice of Uncontested Violation.

Summary:

Transplant programs and histocompatibility laboratories must notify 
UNOS within 7 days of learning of a key personnel departure. These 
members must also submit a key personnel change application 30 days 
prior to the current key personnel's departure. (If the member receives 
less than 60 days notice of the key personnel's planned departure, the 
program must submit the key personnel change application within 30 days 
of the departure). These requirements are in place to allow the member 
to submit and the MPSC to review any key personnel change applications 
prior to the current key personnel's departure and to avoid periods 
where a program is without approved key personnel.

The following is a description of the current MPSC process for late 
notifications of key personnel changes:

      Staff identify a late notification and prepare a staff summary.
      Staff present each late notification as a discussion item at the 
in-person MPSC meeting.
      The MPSC issues an action, generally a Notice of Uncontested 
Violation.

The MPSC will discuss six late notification cases at the July 2017 
meeting.

In an effort to reduce the MPSC's workload and to promote consistent 
MPSC actions, staff are constantly evaluating potential operational 
rules to place items on the MPSC's consent agenda. This minimizes the 
number of cases posted for MPSC reviewers and the meeting time spent 
discussing cases.

Based on the number of late notifications, the consistent MPSC action 
and limited discussion or debate typically associated with these cases 
at MPSC meetings, staff have developed the following operational rule 
for the MPSC's consideration:

      Staff identify a late notification.

      If the member notified UNOS more than 7 days after hospital 
learned of key personnel departure and submits a key personnel change 
application at least 30 days before the current key personnel departs, 
staff will document and close the late notification with no further 
action needed. Staff will educate the member on the late notification 
requirements.

      If the:

          Member fails to notify UNOS within 7 days after 
        the hospital learned of a key personnel departure; and
          The failure to timely notify results in an 
        inability to submit a key personnel change application at least 
        30 days before the current key personnel departs; and
          This is the member's first late notification.

     Staff will place the item on the Applications Consent agenda with 
a recommendation to issue a Notice of Uncontested Violation.

      If the:

          Member fails to notify UNOS within 7 days after 
        the hospital learned of a key personnel departure; and
          The failure to timely notify results in an 
        inability to submit a key personnel change application at least 
        30 days before the current key personnel departs; and
          The member has at least one previous late 
        notification in its compliance history or if there are any 
        extenuating or unusual circumstances.

     Staff will post a staff summary and case packet for reviewers.

          If reviewers agree on a recommendation, staff 
        will add the recommendation to the Applications Consent Agenda.
          If reviewers disagree on a recommendation, the 
        MPSC will discuss the issue at its next meeting.

      The MPSC will receive a copy of the consent agenda in advance of 
the meeting. An MPSC member may request to see the corresponding 
documentation and/or move any consent agenda item to the discussion 
agenda.

Examples:

      Notice of Uncontested Violation: Program notifies UNOS 2 days 
after primary surgeon departed. Upon inquiry, the member states that 
the surgeon notified the hospital of the departure date 6 months 
earlier.
      Notice of Uncontested Violation: Program notifies UNOS 15 days 
prior to primary surgeon departure and states that the surgeon had 
given notice of his departure to the hospital 6 months earlier. 
Application cannot be completed, processed and approved by MPSC prior 
to departure resulting in a period where the program is without an 
approved primary surgeon.
      Document and close with no action: Program notifies UNOS 2 
months prior to primary surgeon departure and states that the surgeon 
had given notice of his departure to the hospital 6 months earlier. 
Application sent to member and received 30 days prior to departure 
date.
      No Bylaw Violation: Primary surgeon notifies hospital that he is 
departing effective that day. Hospital notifies UNOS and submits 
application within 30 days.

Relevant OPTN Bylaw or Policy:

Appendix C.5 Changes in Key Laboratory Personnel

A.  Change in Laboratory Director, Technical Supervisor, or Clinical 
                    Consultant

When the histocompatibility laboratory is informed that the laboratory 
director, technical supervisor, or clinical consultant plans to leave 
or otherwise ends active participation in the laboratory, the 
laboratory must:

1.  Notify the OPTN contractor in writing within 7 business days of 
when the laboratory becomes aware of the change in key personnel.
2.  Submit a completed Personnel Change Application to the OPTN 
contractor no less than 30 days before the end of the individual's 
active employment or change in status. The Personnel Change Application 
must document that the new or acting laboratory director, technical 
supervisor, and clinical consultant meet the requirements of these 
Bylaws.
3.  Submit an updated Laboratory Coverage Plan no less than 30 days 
before the date of departure that specifies how continuous coverage 
will be provided at the laboratory by all key personnel during and 
after the transition period to a new or acting laboratory director, 
technical supervisor, or clinical consultant.
4.  If the histocompatibility laboratory receives less than 60 days 
notice of the key personnel change, then the laboratory must submit a 
completed Personnel Change Application and updated Laboratory Coverage 
Plan to the OPTN contractor within 30 days of the date of departure.

Appendix D.7 Changes in Key Transplant Program Personnel

Designated transplant programs must have key personnel, specifically a 
primary surgeon and a primary physician, who meet the required minimum 
levels of commitment to and knowledge of organ procurement and 
transplantation as specified in these Bylaws. All transplant programs 
should develop a succession plan that addresses changes in these key 
personnel.

When a designated transplant program is informed of a change in key 
personnel, it must notify the OPTN contractor within 7 business days in 
writing and follow the procedures that are described below. A change in 
key personnel can be any of the following:

      Departure of the primary surgeon or primary physician.
      Change in position from primary surgeon or primary physician to 
an additional surgeon or physician.
      Temporary leave.
      Reinstatement of the previously designated primary surgeon or 
physician.

Transplant programs are also responsible for maintaining Program 
Coverage Plans as described in Section D.6.B. Surgeon and Physician 
Coverage (Program Coverage Plan) above during changes in key personnel. 
The Program Coverage Plan must address instances when key personnel are 
unavailable to perform their transplant duties for short periods of 
time.

A. Primary Surgeon or Primary Physician Departure

When the transplant hospital is informed that either the primary 
surgeon or primary physician plans to leave the hospital or otherwise 
end their active participation in the transplant program, the 
transplant hospital must:

1.  Notify the OPTN contractor in writing within 7 business days.
2.  Submit a completed Personnel Change Application to the OPTN 
contractor no less than 30 days before the end of the individual's 
active employment. The Personnel Change Application must document that 
the new primary surgeon or primary physician meets the requirements of 
these Bylaws.

If the transplant hospital receives less than 60 days advance notice of 
the key personnel change, then the transplant hospital must submit a 
completed Personnel Change Application to the OPTN contractor within 30 
days from the date the OPTN contractor was notified.

If a program is unable to demonstrate through a completed Personnel 
Change Application that it has on site both a transplant surgeon and a 
transplant physician who meet the requirements for primary surgeon and 
primary physician, the transplant hospital must either:

      Inactivate the designated transplant program.
      Withdraw its designated transplant program status as described 
in Section K.4: Withdrawal or Termination of Designated Transplant 
Program Status of these Bylaws.

B. Primary Surgeon or Primary Physician Change in Role

When the transplant hospital plans to propose a new primary surgeon or 
primary physician and the currently designated primary surgeon or 
physician will remain on staff as an additional surgeon or physician, 
the transplant hospital must:

1.  Notify the OPTN contractor in writing within 7 business days.
2.  Submit a completed Personnel Change Application to the OPTN 
contractor no less than 30 days before the change will take effect. The 
Personnel Change Application must document that the new primary surgeon 
or physician meets the requirements of these Bylaws.

The transition to the new primary surgeon or primary physician is 
effective after the application has been reviewed and approved by the 
MPSC or an Ad hoc Subcommittee of the MPSC, as described in Appendix A: 
Membership Application and Review of these Bylaws.

C. Primary Surgeon or Primary Physician Temporary Leave

If the primary surgeon or physician must take a temporary leave of 
absence or otherwise temporarily cease their active participation with 
the transplant program, the transplant hospital must:

1.  Notify the OPTN contractor in writing within 7 business days.
2.  Submit a completed Personnel Change Application to the OPTN 
contractor no less than 30 days before the individual's leave begins. 
The Personnel Change Application must document that the replacement 
primary surgeon or physician meets the requirements of these Bylaws.

Temporary leave is defined in these Bylaws as greater than 30 days but 
less than one year. If the transplant hospital receives less than 60 
days advance notice of the leave, then the transplant hospital must 
submit a complete Personnel Change Application to the OPTN contractor 
within 30 days from the date the OPTN contractor was notified.

If a program is unable to demonstrate through a completed Personnel 
Change Application that it has on site both a transplant surgeon and a 
transplant physician who meet the requirements for primary surgeon and 
physician, the transplant hospital must either:

      Inactivate the designated transplant program.
      Withdraw its designated transplant program status as described 
in Appendix K of these Bylaws.

D. Reinstatement of Previously Designated Primary Surgeon or Primary 
                    Physician

If the previously designated primary surgeon or primary physician 
returns to the same transplant program within one year of departure the 
individual can be considered for reinstatement as the primary surgeon 
or primary physician. The transplant hospital must submit a written 
reinstatement request to the OPTN contractor.

The written reinstatement request must include all of the following:

1.  A letter from the Transplant program director, department chair, or 
chief of the division, verifying the individual's current working 
knowledge and experience.
2.  A letter from the individual confirming the individual's on-site 
availability and commitment to the program.
3.  A current letter from the hospital credentialing committee 
verifying that the individual meets the requirements and is qualified 
and able to resume as primary surgeon or primary physician.

The MPSC or an Ad hoc Subcommittee of the MPSC will review requests for 
reinstatement, as described below. In cases where reinstatement of a 
surgeon or physician affects the transplant program's current status, 
the MPSC will recommend the appropriate new program status, along with 
any resulting special conditions.

E. Failure to Notify the OPTN Contractor of Key Personnel Changes

Any member who fails to inform the OPTN contractor of a change in the 
primary surgeon or primary physician or to submit the required 
Personnel Change Application within the periods specified above will be 
reviewed by the MPSC. The MPSC may impose a sanction, including any of 
the following:

      A Notice of Uncontested Violation.
      Letter of Warning.
      Letter of Reprimand.

Each of these sanctions and other adverse actions that may be taken by 
the MPSC are further described in Appendix L: Reviews, Actions, and Due 
Process of these Bylaws.

Failure to inform the OPTN contractor of changes in primary surgeon or 
primary physician or to submit the required Personnel Change 
Application will result in a recommendation that the Board of Directors 
take appropriate adverse actions. Additionally, the Board of Directors 
may notify the Secretary of Health and Human Services (HHS) of the 
violation.

                                 ______
                                 

                           MPSC STAFF SUMMARY

                 Wait-List Inactivity Operational Rule

                       Proposed Operational Rule

                            January 30, 2018

Item for Consideration:

During the January 30, 2018 teleconference meeting, staff will present 
a proposed operational rule regarding member compliance with the 
requirements for patient notification in OPTN Bylaws Appendix D.11.B 
which require a member to notify all candidates on its wait list when a 
threshold of 15 consecutive days of inactivity and/or 28 cumulative 
days of inactivity is met. The MPSC will be asked to vote to approve 
the rule.

Summary:

Historically, compliance with this bylaw was reviewed at each PAIS 
meeting. Notification letters submitted to staff were posted to 
committee management for review, and the committee would often issue a 
Notice of Uncontested Violation for any instance of noncompliance 
identified.

The site survey team has assumed responsibility for reviewing member 
compliance with this bylaw and will perform member reviews on an annual 
basis. Site Survey would like to propose an operational rule, similar 
to the rules that Safety Analysts and Allocation Analysts use; a first 
event of noncompliance would be ``closed'' and not forwarded to the 
committee, and language would be communicated to the member that any 
subsequent instance would then be forwarded on for committee review (as 
well as the first event).

Proposed rule: ``Site survey staff will request members to implement 
corrective actions for first event of identified noncompliance with the 
wait-list inactivity notifications bylaw and will not forward the 
matter to the MPSC for review. If staff identifies a second event of 
noncompliance in a subsequent annual review, staff will gather 
documentation from the member and provide all events' documentation to 
the MPSC for review.''

If approved, the rule will be effective immediately.

Examples:

Member ABCD's kidney transplant program met the 28 cumulative day 
inactivity threshold in 2016. UNOS's Research department provides to 
the site survey team a random sample of 10 candidates on member ABCD's 
kidney wait list. Site Survey mails an inquiry letter with the patient 
sample to Member ABCD and requests that the member submit all required 
patient notifications. Member ABCD responds that they failed to notify 
their candidates when they met the cumulative day inactivity threshold, 
although they had notified their candidates of their plan to inactivate 
their list per other bylaw requirements. Site Survey requests a 
Corrective Action Plan and provides education to Member ABCD about the 
requirements in Bylaws Appendix D.11.B. Site Survey mails a Closing 
Letter to Member ABCD notifying them that the review is closed, that 
the event will not be forwarded to the MPSC, and that if another event 
of noncompliance is identified on a future annual review, all events 
will be forwarded to the MPSC at that time.

Relevant OPTN Bylaw or Policy:

OPTN Bylaws Appendix D.11.B Patient Notification Requirements for 
Waiting List Inactivation.

A transplant program must provide written notice to candidates if it 
does either or both of the following:

    1.  Inactivates its waiting list for 15 or more consecutive days.
    2.  Inactivates its waiting list for 28 or more cumulative days 
during any calendar year.

A transplant program must provide written notice each time it reaches 
either of the inactive waiting list thresholds listed above. Written 
notice must include all of the following:

    1.  The reason for the inactivity.
    2.  The expected length of time that the waiting list will be 
inactive.
    3.  The explanation that during the period of inactivity, organs 
cannot be accepted on the candidate's behalf at this transplant 
program.
    4.  The options available to the candidate during this period, 
including multiple listing or transferring of accrued waiting time to 
another Transplant Hospital.
    5.  How the candidates will be notified when the waiting list is 
reactivated or if the expected length of inactivation is extended.
    6.  A copy of the OPTN contractor's Patient Information Letter.

Note:  If written notice is required because a transplant program 
exceeded the inactive waiting list threshold due to cumulative periods 
of inactivation, then the written notice must also include the dates of 
each instance of waiting list inactivation.

Written notice must be provided within the periods defined in the table 
below:


------------------------------------------------------------------------
                                               Written Notice Must Be
                 For . . .                         Provided . . .
------------------------------------------------------------------------
Periods of waiting list inactivation        30 days before inactivity
 scheduled at least 30 days in advance.      begins.
------------------------------------------------------------------------
Periods of waiting list inactivation        No more than 7 days
 scheduled less than 30 days in advance.     following the initial date
                                             of waiting list
                                             inactivation.
------------------------------------------------------------------------
Any periods of waiting list inactivation    No more than 7 days
 related to a cumulative period of           following the last date of
 inactivation.                               the inactive period that
                                             caused the transplant
                                             program to exceed the
                                             inactive waiting list
                                             threshold.
------------------------------------------------------------------------


                                 ______
                                 

                           MPSC Staff Summary

            MPSC Review of Non-institutional Member Renewals

                       Proposed Operational Rule

                             March 1, 2018

Item for Consideration:

During the Applications agenda review at the MPSC meeting on March 1, 
2018, staff will present a proposed operational regarding MPSC review 
of non-institutional member renewals under OPTN Bylaws Article 1. Non-
institutional members are required to renew their OPTN membership every 
2 years. Staff are proposing that the MPSC adopt an operational rule 
that would place these renewal applications directly on an MPSC Consent 
Agenda if all requirements are met. The MPSC will be asked to vote to 
approve the operational rule.

Summary

Non-institutional members of the OPTN include:

      Medical/Scientific.
      Public Organization.
      Business.
      Individuals.

Non-institutional members must meet the fairly minimal requirements for 
membership contained in OPTN Bylaws, Article 1. For example, a medical/
scientific member needs to be a non-profit organization whose members 
include medical or scientific professionals with an interest in organ 
donation or transplantation and that has either of the following:

      Been in operation for at least one year.
      Letters of recommendation from at least three OPTN transplant 
hospital, OPO, histocompatibility laboratory, public organization or 
medical/scientific Members.

The non-institutional members have two year terms and need to apply for 
renewal of their membership at the end of each term.

Currently, all of the applications, new members and renewals, are 
posted for review by an ad hoc subcommittee and then placed on the 
applications consent agenda for the full MPSC.

UNOS staff is proposing that renewals for non-institutional members be 
placed directly on the MPSC consent agenda to approve if all 
requirements under OPTN Bylaws, Article 1 are met.

Below are the non-institutional member application numbers for 2016 and 
2017:


------------------------------------------------------------------------
                                      2017                  2016
         Member type         -------------------------------------------
                                 New      Renewals     New      Renewals
------------------------------------------------------------------------
Medical/Scientific                    0          2          0         11
------------------------------------------------------------------------
Public Organization                   1          3          0          2
------------------------------------------------------------------------
Business                              1          2          0          1
------------------------------------------------------------------------
Individual                            0          6          0          2
------------------------------------------------------------------------
Totals                                2         13          0         18
------------------------------------------------------------------------

Relevant OPTN Bylaw or Policy:

OPTN Bylaws, Article 1:

1.5 Medical/Scientific Members

A medical/scientific member is a non-profit organization whose members 
include medical or scientific professionals with an interest in organ 
donation or transplantation and that has either of the following:

1.  Been in operation for at least one year.
2.  Letters of recommendation from at least three OPTN transplant 
hospital, OPO, histocompatibility laboratory, public organization, or 
medical/scientific Members.

1.6 Public Organization Members

A public organization member is an organization with an interest in 
organ donation or transplantation and must have been in operation for 
at least one year. A public organization member must also be one of the 
following:

1.  A hospital that refers at least one potential organ or tissue donor 
per year.
2.  A non-profit organization that engages in organ donation 
activities, or represents or directly provides support and services to 
transplant candidates, recipients or their families.
3.  A non-profit organization that has letters of recommendation from 
at least three OPTN transplant hospital, OPO, histocompatibility 
laboratory, public organization, or medical/scientific members.

1.7 Business Members

A business member must be an organization in operation for at least one 
year that engages in commercial activities with two or more active OPTN 
transplant hospital, OPO, or histocompatibility laboratory members.

1.8 Individual Members

An individual member must be a person who meets any of the following 
criteria:

1.  Has served or is presently serving on the OPTN Board of Directors 
or an OPTN committee.
2.  Is a transplant candidate, recipient, or organ or tissue donor.
3.  Is the family member of a transplant candidate, recipient, or organ 
or tissue donor.
4.  Is presently employed by or is an independent contractor to OPO, 
transplant hospital, or histocompatibility laboratory members.
5.  Is formerly employed by or is formerly an independent contractor 
for OPO, transplant hospital, or histocompatibility laboratory members.
6.  Is formerly employed by a Federal or State government agency 
involved in organ donation or transplantation, and who demonstrates 
continued interest and involvement in organ donation or 
transplantation.
7.  Has an active interest and involvement in organ donation or 
transplantation demonstrated by at least three letters of 
recommendation for membership from three other OPTN individual members.

                                 ______
                                 

                           MPSC STAFF SUMMARY

                        Proposed Process Change

                          Key Personnel Change

                              Applications

                             July 18, 2018

Item for Consideration:

During the July 18, 2018 meeting, staff will present a proposed process 
change regarding moving Transplant program Key Personnel Change 
applications directly to an MPSC consent agenda if staff review reveals 
the application clearly meets the OPTN bylaws membership criteria. The 
MPSC will be asked to vote to approve the rule at this meeting.

Summary:

Ad hoc subcommittees of the MPSC review every key personnel change 
application for compliance with the membership requirements in the OPTN 
bylaws. In 2017, these subcommittees reviewed 175 transplant program 
key personnel change applications. The OPTN bylaw membership 
requirements are detailed and the membership applications request 
specific information designed to demonstrate whether a proposed primary 
surgeon or primary physician meet the requirements. Most proposed 
transplant program key personnel clearly meet the requirements of the 
OPTN bylaws. Therefore, MPSC ad hoc subcommittee review does not appear 
to be a value added activity and is not a productive use of MPSC 
members review time.

Proposed rule: Transplant program key personnel change applications 
that clearly meet the OPTN bylaw membership requirements will be placed 
directly on the MPSC consent agenda for the next scheduled meeting 
(conference call or in person). UNOS staff will post for MPSC ad hoc 
subcommittee review any application where expert judgment is needed to 
determine if the application should be approved.

If approved, the rule will be effective immediately.

Example(s):

UNOS staff have identified the following examples that would require 
posting of an application for MPSC ad hoc subcommittee review:

      The program is requesting conditional approval for key personnel 
or extensions of conditional approval.
      Coverage plans that require approval of exceptions provided for 
in the OPTN bylaws.
      Letters of recommendation that do not clearly contain all 
requirements.
      Situations where a letter of attestation must be used such as 
for procurements from a long time ago.

Relevant OPTN Bylaw or Policy:

OPTN Bylaws, Appendix D, D.7 Changes in Key Transplant Program 
Personnel

Designated transplant programs must have key personnel, specifically a 
primary surgeon and a primary physician, who meet the required minimum 
levels of commitment to and knowledge of organ procurement and 
transplantation as specified in these Bylaws. . . .

A. Primary Surgeon or Primary Physician Departure

When the transplant hospital is informed that either the primary 
surgeon or primary physician plans to leave the hospital or otherwise 
end their active participation in the transplant program, the 
transplant hospital must:

     1.  Notify the OPTN contractor in writing within 7 business days.
     2.  Submit a completed Personnel Change Application to the OPTN 
contractor no less than 30 days before the end of the individual's 
active employment. The Personnel Change Application must document that 
the new primary surgeon or primary physician meets the requirements of 
these Bylaws.

         If the transplant hospital receives less than 60 days advance 
notice of the key personnel change, then the transplant hospital must 
submit a completed Personnel Change Application to the OPTN contractor 
within 30 days from the date the OPTN contractor was notified.

         If a program is unable to demonstrate through a completed 
Personnel Change Application that it has on site both a transplant 
surgeon and a transplant physician who meet the requirements for 
primary surgeon and primary physician, the transplant hospital must 
either:

          Inactivate the designated transplant program.
          Withdraw its designated transplant program status as 
described in Section K.4: Withdrawal or Termination of Designated 
Transplant Program Status of these Bylaws.

B. Primary Surgeon or Primary Physician Change in Role

         When the transplant hospital plans to propose a new primary 
surgeon or primary physician and the currently designated primary 
surgeon or physician will remain on staff as an additional surgeon or 
physician, the transplant hospital must:

        1.  Notify the OPTN contractor in writing within 7 business 
days.
        2.  Submit a completed Personnel Change Application to the OPTN 
contractor no less than 30 days before the change will take effect. The 
Personnel Change Application must document that the new primary surgeon 
or physician meets the requirements of these Bylaws.

         The transition to the new primary surgeon or primary physician 
is effective after the application has been reviewed and approved by 
the MPSC or an Ad hoc Subcommittee of the MPSC, as described in 
Appendix A: Membership Application and Review of these Bylaws.

C. Primary Surgeon or Primary Physician Temporary Leave

         If the primary surgeon or physician must take a temporary 
leave of absence or otherwise temporarily cease their active 
participation with the transplant program, the transplant hospital 
must:

        1.  Notify the OPTN contractor in writing within 7 business 
days.
        2.  Submit a completed Personnel Change Application to the OPTN 
contractor no less than 30 days before the individual's leave begins. 
The Personnel Change Application must document that the replacement 
primary surgeon or physician meets the requirements of these Bylaws.

         Temporary leave is defined in these Bylaws as greater than 30 
days but less than one year.

         If the transplant hospital receives less than 60 days advance 
notice of the leave, then the transplant hospital must submit a 
complete Personnel Change Application to the OPTN contractor within 30 
days from the date the OPTN contractor was notified.

         If a program is unable to demonstrate through a completed 
Personnel Change Application that it has on site both a transplant 
surgeon and a transplant physician who meet the requirements for 
primary surgeon and physician, the transplant hospital must either:

          Inactivate the designated transplant program.
          Withdraw its designated transplant program status as 
described in Appendix K of these Bylaws.

D.  Reinstatement of Previously Designated Primary Surgeon or Primary 
                    Physician

         If the previously designated primary surgeon or primary 
physician returns to the same transplant program within one year of 
departure the individual can be considered for reinstatement as the 
primary surgeon or primary physician. The transplant hospital must 
submit a written reinstatement request to the OPTN contractor.

         The written reinstatement request must include all of the 
following:
        1.  A letter from the Transplant program director, department 
chair, or chief of the division, verifying the individual's current 
working knowledge and experience.
        2.  A letter from the individual confirming the individual's 
on-site availability and commitment to the program.
        3.  A current letter from the hospital credentialing committee 
verifying that the individual meets the requirements and is qualified 
and able to resume as primary surgeon or primary physician.

           The MPSC or an Ad hoc Subcommittee of the MPSC will review 
requests for reinstatement, as described below. In cases where 
reinstatement of a surgeon or physician affects the transplant 
program's current status, the MPSC will recommend the appropriate new 
program status, along with any resulting special conditions.

Applicable membership requirements for organ specific primary 
transplant surgeons and physicians can be found in:

  Appendix E: Membership and Personnel Requirements for Kidney 
Transplant Programs.
  Appendix F: Membership and Personnel Requirements for Liver 
Transplant Programs.
  Appendix G: Membership and Personnel Requirements for Pancreas 
and Pancreatic Islet Transplant Programs.
  Appendix H: Membership and Personnel Requirements for Heart 
Transplant Programs.
  Appendix I: Membership and Personnel Requirements for Lung 
Transplant Programs.

                                 ______
                                 

                           MPSC STAFF SUMMARY

                        Proposed Process Change

                       Late Reports of Potential

                   Disease Transmissions to the OPTN

                             July 18, 2018

Item for Consideration:

During the July 18, 2018 meeting, staff will present a proposed process 
change regarding late reports of potential disease transmission to the 
OPTN required in Policies 15.4, 15.5, and 15.6. The MPSC will be asked 
to vote to approve the rule.

Summary:

Policies 15.4.A and 15.4.B require host OPOs to submit certain 
potential donor-
derived disease transmissions to the OPTN Improving Patient Safety 
Portal as well as to the receiving transplant centers within 24 hours. 
Policy 15.5.B requires transplant centers to notify both the host OPO 
and the OPTN Improving Patient Safety Portal within 24 hours after 
learning of a potential donor-derived disease transmission. Policy 
15.6.A requires recovery hospitals to notify the receiving transplant 
program and the OPTN Improving Patient Safety Portal within 7 days when 
new information is learned about a living donor that indicates a risk 
of potential disease transmission or malignancy within two years post-
donation.

Currently, events that are appropriately reported to the applicable 
members within required time frames but submitted late to the OPTN are 
referred to the MPSC for review, even though the patient safety risk 
was appropriately mitigated.

In an effort to reduce MPSC and UNOS staff workload and promote process 
improvement, staff are proposing a First-Time Non-Compliance (FTNC) 
process change in certain late reports of potential disease 
transmission to the OPTN. If a case meets FTNC criteria, Safety 
Analysts would investigate the cause of the delayed report, request the 
results of any root cause analyses (RCA) performed, and request 
documentation of any corrective action plans (CAP) per the normal 
investigative process. Assuming the RCA and CAP appropriately address 
the gap that led to the late report, the new process change would allow 
Safety Analysts close the case instead of sending it to the MPSC for 
review. This allows the member to develop corrective actions without a 
MPSC referral and reduces the workload of MPSC members and UNOS staff.
FTNC Conditions:

Member has no late report non-compliances since August 1, 2016, and 
meets one of the following three circumstances as appropriate:

    1.  A host OPO who did not report a Pathogen of Special Interest, 
malignancy or other finding highly suggestive of malignancy recognized 
after procurement, or discovery of recipient disease to the Improving 
Patient Safety Portal within 24 hours, but did make the required 
notifications to all recipient centers per OPTN Policy 15;
    2.  A transplant center who did not report to the Improving Patient 
Safety Portal within 24 hours when an organ recipient has, is suspected 
to have, or has died from a potentially donor-derived transmissible 
disease, infection or malignancy, but did notify the host OPO within 24 
hours per OPTN Policy 15;
    3.  A living donor recovery hospital who notified the receiving 
transplant program of new information indicating a risk of potential 
disease or malignancy transmission during the first two years post-
donation, but did not report it to the Improving Patient Safety Portal 
within 7 days per OPTN Policy 15.

The FTNC process change can only be applied to a member one time. Thus, 
if a member has a subsequent case of a late report to the OPTN, that 
case would be referred to the MPSC even if the other members were 
notified within time frames required. If a second case is identified 
and referred to the MPSC for review, the first case will also be 
included for MSPC review.

Since August 2014, Member Quality has investigated 26 cases of 
potential donor-derived disease transmissions and malignancies reported 
late to the OPTN and/or to the required members. Of these 26 cases, 14 
(54%) were reported to the necessary members as required by policy and 
were reported late only to the OPTN. To date, none of those centers 
have reported a potential donor-derived disease transmission late a 
second time, which suggests the member implemented appropriate 
corrective actions in response to those events.

Proposed rule: Cases that meet FTNC conditions would be investigated, 
with RCAs and CAPs obtained and reviewed by Safety Analysts, but would 
be closed and would not be referred to the MPSC for review. Should 
subsequent non-compliances be identified, those cases would be sent to 
the MPSC for review and the first case initially closed would be 
included.

If approved, the rule will be effective August 1, 2018.

Example(s):

OPO ABCD received donor test results that resulted positive for Chagas 
in the left kidney recipient of a donor who also donated a right 
kidney, heart, and liver. OPO ABCD notified all other recipient centers 
immediately upon receiving the notification, but did not submit the 
information to the OPTN Improving Patient Safety Portal for five days. 
Investigation into the late reporting revealed that internal policy did 
not specify the need to report Pathogens of Special Interest to the 
OPTN Improving Patient Safety Portal within 24 hours so staff believed 
the timely reporting to the receiving centers was all that was 
required. Internal policy was updated and staff were re-educated on 
Policy 15.4. Because the appropriate notifications were made to protect 
patient safety and the OPO had no prior non-compliances with regard to 
reporting potential disease transmissions, this case would not be 
referred to the MPSC for review.

Hospital EFGH identified adenocarcinoma in the heart recipient and upon 
review of donor and recipient records, had substantial concern that the 
malignancy could be donor-derived. The Hospital immediately notified 
the OPO but did not submit a report to the OPTN Improving Patient 
Safety Portal. During the investigation, the hospital reported that 
they believed hospitals were only responsible for notifying the OPO and 
that the OPO was responsible for all notifications and reports 
thereafter. The Hospital updated all process checklists, internal 
policy, added a note in their EMR to remind staff to notify the OPO and 
the OPTN, and re-educated staff. The hospital notified the OPO within 
24 hours and had not had a prior late report to the OPTN, so this case 
would not be referred to the MPSC for review.

A living kidney donor is diagnosed with breast cancer one year post-
donation. The hospital documented the information in the donor's chart, 
but did not notify the receiving center until two months later when a 
new coordinator identified the error during chart review. The hospital 
had no prior non-compliances related to potential disease 
transmissions, but had not made the required notification to the 
receiving transplant program so this case would be referred to the MPSC 
for review.

Relevant OPTN Bylaw or Policy:

15.4.A Host OPO Requirements for Reporting Post-Procurement Donor 
Results and Discovery of Potential Disease Transmissions

The host OPO must report all positive test results and other relevant 
information received post-procurement for each donor as soon as 
possible but no later than 24 hours after receipt as follows:

1. All results indicating Pathogens of Special Interest must be 
reported to the receiving transplant program's patient safety contact 
and the OPTN Improving Patient Safety Portal. The OPTN contractor 
provides a list of Pathogens of Special Interest, including any results 
that can be excluded from reporting. The OPTN contractor reviews and 
updates this list at least annually.

2. All other positive test results and relevant information must be 
reported according to Table 15-1 below.

     Table 15-1: Host OPO Reporting Requirements for Positive Post-
      Procurement Donor Results and Discovery of Potential Disease
                              Transmissions
------------------------------------------------------------------------
The host OPO must report all of the
    following positive results:                      To:
------------------------------------------------------------------------
Samples relevant to all recipients
------------------------------------------------------------------------
Serologic, NAT, or antigen results   The receiving transplant program's
 indicating presence of parasites,    patient safety contact
 virus, or fungi
------------------------------------------------------------------------
Cultures from the following           The receiving transplant program's
 specimens:                           patient safety contact
 Ascites
 Blood
 Cerebrospinal fluid (CSF)
 Deep wound
 Genital
 Pericardial
 Pleural fluid
------------------------------------------------------------------------
Mycobacterial smears and cultures    The receiving transplant program's
                                      patient safety contact
------------------------------------------------------------------------
Fungal smears and cultures with the  The receiving transplant program's
 exception of Candida species         patient safety contact
------------------------------------------------------------------------
Relevant information
------------------------------------------------------------------------
Respiratory samples (bacterial or    The receiving transplant program's
 Candida species) only to             patient safety contact
 transplant programs receiving
 lungs or head and neck VCAs
------------------------------------------------------------------------
Urine cultures (bacterial or         The receiving transplant program's
 Candida species) only to             patient safety contact
 transplant programs receiving
 kidneys or genitourinary VCAs
------------------------------------------------------------------------
Malignancy or other findings highly  1. The receiving transplant
 suggestive of malignancy             program's patient safety contact
 recognized after procurement
                                     2. The OPTN Improving Patient
                                      Safety Portal
------------------------------------------------------------------------
Histopathology results reported      The receiving transplant program's
 post-procurement                     patient safety contact
------------------------------------------------------------------------
Relevant information
------------------------------------------------------------------------
All final culture information for    The receiving transplant program's
 any culture results that were        patient safety contact
 reported according to these
 requirements
------------------------------------------------------------------------
Other psycho-social history,         The receiving transplant program's
 medical history, autopsy, testing,   patient safety contact
 and laboratory findings
 identifying infectious conditions
 that may adversely affect a
 potential transplant recipient
------------------------------------------------------------------------


15.4.B Host OPO Requirements for Reporting Post-Procurement Discovery 
of Recipient Disease or Malignancy

If the host OPO is notified that an organ recipient is suspected to 
have, is confirmed positive for, or dies from a potential transmissible 
disease, infection, or malignancy and there is substantial concern that 
it could be from the transplanted organ, then the host OPO must do all 
the following:

1. Communicate the suspected donor's and affected organ recipient's 
test results and diagnosis that may be relevant to acute patient care, 
as soon as possible but no more than 24 hours after receipt, to any 
transplant program patient safety contacts and tissue banks that 
received organs, vessels, or tissue from the donor. This includes any 
test results that were not available at the time of procurement or that 
were performed after procurement. The host OPO must document that this 
information is shared with all receiving transplant programs and tissue 
banks.

2. Report the event to the OPTN Improving Patient Safety Portal as soon 
as possible but no more than 24 hours after notification or receipt of 
recipient test results or diagnosis.

15.5.B Transplant Program Requirements for Reporting Post-Transplant 
Discovery of Recipient Disease or Malignancy

When an organ recipient is suspected to have, is confirmed positive 
for, or has died from a potential transmissible disease, infection, or 
malignancy and there is substantial concern that it could be from the 
transplanted organ, then the transplant program must do all of the 
following:

1. Notify host OPO or living donor recovery hospital that procured the 
organ without waiting for all medical documentation that may eventually 
become available. The transplant program must notify the host OPO or 
living donor recovery hospital by phone and provide documentation as 
soon as possible but no more than 24 hours after learning of the event.

2. Report the event through the OPTN Improving Patient Safety Portal as 
soon as possible but no more than 24 hours after learning of the event.

3. Provide additional related information or specimens if requested.

15.6.A Living Donor Recovery Hospital Requirements for Reporting Post-
Donation Discovery of Living Donor Disease or Malignancy

If a living donor recovery hospital learns new information about a 
living donor during the first two years post donation that indicates 
risk of potential transmission of disease or malignancy, then the 
living donor recovery hospital must do all of the following:

1. Disclose to the living donor that the potential disease transmission 
or malignancy will be reported to the receiving transplant program and 
the OPTN Improving Patient Safety Portal.

2. Notify the receiving transplant program.

3. Report the potential transmission through the OPTN Improving Patient 
Safety Portal as soon as possible but no more than 7 days after receipt 
of the new information.

MPSC Determination:

At its meeting on July 18, 2018, the MPSC accepted the proposal with 
two changes:

1. All members will begin with a ``clean slate,'' i.e., any instances 
of late reports that have occurred prior to implementation of this 
process change are not counted towards the member's FTNC conditions 
considerations.

2. The FTNC condition will be maintained for three years. Because the 
MPSC reviews a member's compliance history going back three years, 
members thought a similar time frame should be applied here.

No other changes were recommended. With the above two changes added 
into the proposal, the MPSC voted 33-0-0 to accept and implement this 
change.

                                 ______
                                 

                       Member Quality Site Survey

                            Process Proposal

                              MPSC Meeting

                             July 18, 2018

                             Staff Summary

Item for Consideration:

At the July 2018 MPSC meeting, the MPSC will consider changes to the 
process by which the MPSC reviews member site survey reports. The 
proposed process revisions will decrease the MPSC's case review 
workload and will better identify for the MPSC review members that have 
ongoing compliance issues. The process change will also reduce the 
amount of time members must wait to learn the outcome of their survey 
and the amount of time between the initial survey to and follow-up 
surveys.

Background:

The site survey ``scorecard'' is a tool used to determine which site 
surveys can be placed straight on a MPSC consent agenda to close with 
no action and which site surveys must be posted for MPSC reviewers to 
determine an appropriate action. The chart below summarizes the current 
``scorecard'' thresholds for different survey types:

_______________________________________________________________________

HR KI LI LU Transplant        95% Clinical Score Threshold
 Programs                     90% Administrative Score Threshold
                              Posted for reviewers if member's score is
                               below either threshold
------------------------------------------------------------------------
IN PA Programs                No scorecard, posted for reviewers if
                               survey has any errors
------------------------------------------------------------------------
Living Donor Component of KI  No scorecard, posted for reviewers if
 and LI Program                survey has any errors
------------------------------------------------------------------------
OPOs                          Clinical scorecard only; posted for
                               reviewers if survey has any errors.
------------------------------------------------------------------------


Problems with the current scorecard and MPSC site survey review process 
include the following:

      Members rely on their ``score'' as a determination of their 
overall effectiveness. For example, members under outcomes review may 
cite their ``100% clinical compliance score.''
      Changes to the scorecard are difficult to make. Because each 
policy is weighted within the scorecard, adding or changing a policy to 
the survey process requires re-evaluating the weight assigned to every 
other policy.
      Surveys without an established scorecard and threshold must be 
posted for MPSC review. This results in the MPSC reviewing surveys with 
a small number of errors that the member has already corrected.
      The MPSC reviewers typically must decide whether to close the 
review with no action or request a follow-up desk review of certain 
policies. Feedback received from MPSC reviewers in the past has 
suggested that they are often happy to defer to staff recommendations 
on whether to close the review or conduct a follow-up survey.

Proposed Process Change:

The proposed process would completely eliminate the current scorecard 
approach for determining which cases are posted for MPSC review. 
Instead, Member Quality staff will use a Survey Evaluation Tool (SET) 
to determine whether a survey can be closed with no follow-up, whether 
a follow-up focused desk review of certain policies is needed, or 
whether the survey should be sent to MPSC reviewers to determine the 
appropriate action.

Survey Evaluation Tool:

All policies reviewed will be placed into a category based on the 
potential risk to patient safety. OPOs will have four categories while 
transplant programs, including living donor, will have three categories 
based on assigned risk. Each category will have a threshold for 
compliance as described in the charts below.


                       Survey Evaluation Tool--OPO
------------------------------------------------------------------------
                     Examples of Policies in this    Required Compliance
                               Category                      Rate
------------------------------------------------------------------------
Tier I             Policy 2.6.B--A2 and A2B          100%
                    Requirements
------------------------------------------------------------------------
Tier II            Policy 2.4 requires               90%
                    documentation of communicating
                    factors associated with an
                    increased risk for disease
                    transmission
------------------------------------------------------------------------
Tier III           Policy 2.8 requires OPOs to have  80%
                    a urinalysis within 24 hours of
                    cross clamp
------------------------------------------------------------------------
Tier IV            Policy 18.1 requires accuracy of  No follow-up
                    data submitted on DDRs
------------------------------------------------------------------------


               Survey Evaluation Tool--Transplant Programs
                        (including Living Donor)
------------------------------------------------------------------------
                     Examples of Policies in this    Required Compliance
                               Category                      Rate
------------------------------------------------------------------------
Tier I             Policy 5.8.B--Pre-Transplant      90%
                    Verification Upon Organ Receipt
                   Policy 14.4.A--Living Donor
                    Medical Evaluation Requirements
------------------------------------------------------------------------
Tier II            Policy 3.9--Removing Candidates   80%
                    from the Waiting List
                   Policy 14.3--LD Informed Consent
                    Requirements
------------------------------------------------------------------------
Tier III           Policy 3.2--Notifying Patients    No follow-up
                    of Their Options
                   Policy 18.1--Data Submission
                    Requirements Accuracy
------------------------------------------------------------------------


Members continue to be asked to submit a corrective action plan for 
noncompliance with any policy in any tier.

If an OPO member does not meet the required compliance threshold for a 
policy in Tiers I, II and III, UNOS staff will automatically conduct a 
follow-up desk review of that policy. Transplant programs that do not 
meet the required compliance threshold for a policy in Tiers I and II 
will automatically have a follow-up desk review of that policy within 
six or twelve months, depending on the program's transplant volume. If 
a member meets all the required compliance thresholds, UNOS staff will 
automatically close the review with no action, without posting the case 
for MPSC review.

UNOS staff will post for MPSC review the results of any follow-up 
focused desk review where the member continued to not meet the required 
compliance threshold.

Benefits of the proposed process include:
      A reduction in cases posted for MPSC review. For example, staff 
anticipate the MPSC will review approximately 18 fewer heart program 
surveys and 20 fewer liver program surveys each year under this rule, 
which will free up time the MPSC can use for other purposes.
      Continued ability to post any unusual or concerning cases for 
MPSC review. Currently, staff will send a case for MPSC review based on 
concerns regarding patient safety or any unusual findings, regardless 
of whether the case meets the established scorecard threshold. Staff 
will continue to prioritize posting for MPSC review any such survey 
report, regardless of the program's compliance rate with given 
policies.
      Ability to easily adapt the survey evaluation tool to policies. 
For example, if site survey adds a newly implemented policy to the list 
of policies reviewed during a survey, site survey will only need to 
determine which tier to assign the policy; adding or removing a policy 
from the site survey process will not impact the assigned tier or 
compliance rate for any other policy.
      Emphasis on member's improvement rather than strict adherence to 
compliance. Members who have errors on their initial survey but 
demonstrate improvement in their follow-up survey will automatically be 
released from monitoring.

Data Modeling:

Data modeling comparing review via the SET with prior MPSC review show 
the outcome is the same or slightly more conservative than the outcomes 
determined by MPSC reviewers, as shown in the chart below.


------------------------------------------------------------------------
                     Same outcome in
                       current and     More follow-up    Fewer follow-up
    Survey Type         proposed       desk reviews in   desk reviews in
                        processes     proposed process  proposed process
------------------------------------------------------------------------
HR KI LI LU IN PA   305 reviews       45 reviews        5 reviews
------------------------------------------------------------------------
Living Donor KI     33 reviews        17 reviews        3 reviews
 and LI
------------------------------------------------------------------------
OPO                 19 reviews        9 reviews         3 reviews
------------------------------------------------------------------------


Data modeling also indicates there will be a significant reduction in 
MPSC workload, as described in the table below.


------------------------------------------------------------------------
                                                  Number       Number
                                               Reviewed by    Requiring
 Survey Type      Date Range        Surveys     MPSC Under   MPSC Review
                                   Performed     Current      Under New
                                                 Process       Process
------------------------------------------------------------------------
Heart         March 2017-March   74            22           4
               2018
------------------------------------------------------------------------
Liver         March 2017--March  53            22           2
               2018
------------------------------------------------------------------------

Recommendation

The Policy Compliance Subcommittee (PCSC) of the MPSC heard a report 
from site survey staff on this proposed process change during the 
PCSC's June 25 conference call and unanimously recommended that the 
MPSC vote to support the proposed concept. The MPSC will be asked to 
vote on this concept as a part of the PCSC consent agenda during the 
MPSC meeting on July 18, 2018.

                           MPSC STAFF SUMMARY

                 Possible Revision to Operational Rule

       No inquiry 2 meeting cycles from release in outcomes cases

                           February 26, 2018

Item for Consideration: During the February 26, 2018 PAIS meeting, 
staff presented possible options for revision of the operational rule 
regarding postponement of new MPSC outcomes inquiry. The PAIS 
recommended that the operational rule be revised to make a program 
ineligible to receive a new inquiry for 2 SRTR reporting cycles which 
results in a time period of ineligibility which is more consistent 
regardless of when the program is released. The PAIS approved this 
recommendation by a vote of 15 for, 0 against and 1 abstention.

Summary: Under the current operational rule, the MPSC will not send an 
inquiry to a program for 2 meeting cycles following release from review 
for lower than expected post-transplant outcomes. In July 2017, the 
PAIS/MPSC endorsed the elimination of the data request for updated 
Spring SRTR reports for use at the October Subcommittee/MPSC meeting. 
UNOS staff have noticed that the elimination of this October report has 
resulted in an inconsistent result when applying the 2 meeting cycle 
operational rule:


------------------------------------------------------------------------
                            Inquiry if
  Release      2 meeting       still                 Results
    date         cycles       flagged
------------------------------------------------------------------------
March 2018   July 2018,     March 2019  Skip if flagged in July 2018
              October 2018               SRTR report and send inquiry if
                                         flagged in January 2019 SRTR
                                         report--1 year from release
------------------------------------------------------------------------
July 2018    October 2018,  July 2019   Skip if flagged in January 2019
              March 2019                 SRTR report and send inquiry if
                                         flagged in July 2019 SRTR
                                         report--1 year from release
------------------------------------------------------------------------
October      March 2019,    March 2020  Do not receive SRTR reports in
 2018         July 2019      (3          October 2019 so skip January
                             meeting     2019 and July 2019 SRTR reports
                             cycles)     and receive inquiry if flagged
                                         in January 2020 SRTR reports--1
                                         year and 5 months from release
------------------------------------------------------------------------


The MPSC adopted this operational rule to accommodate the fact that 
there is a 1 year lag in the SRTR reporting of one-year post-transplant 
outcomes but the MPSC reviews current data and events when a program is 
under review. For example, the MPSC will have reviewed synopsis of 
events and improvement efforts through April 30, 2018 for a program 
that is released in July 2018. In addition to the 2 meeting cycle 
operational rule, the MPSC does not send an inquiry if there have been 
no new events at the program since the program's release from review.

If the MPSC was to change the operational rule to use the SRTR 
reporting periods as the deciding factor for when a new inquiry would 
be sent, the following would be the effect for skipping 1 reporting 
cycle or 2 reporting cycles: Two SRTR reporting cycles:


------------------------------------------------------------------------
                 2 SRTR     Inquiry if
  Release      reporting       still
    date         cycles       flagged
------------------------------------------------------------------------
March 2018   July 2018,     July 2019   Eligible for new inquiry 1 year,
              January 2019               4 months after release
------------------------------------------------------------------------
July 2018    January 2019,  March 2020  Eligible for new inquiry 1 year,
              July 2019                  8 months after release
------------------------------------------------------------------------
October      January 2019,  March 2020  Eligible for new inquiry 1 year,
 2018         July 2019                  5 months after release
------------------------------------------------------------------------


One SRTR reporting cycle:


------------------------------------------------------------------------
                 1 SRTR     Inquiry if
  Release      reporting       still
    date         cycle        flagged
------------------------------------------------------------------------
March 2018   July 2018      March 2019  Eligible for new inquiry 1 year
                                         after release
------------------------------------------------------------------------
July 2018    January 2019   July 2019   Eligible for new inquiry 1 year
                                         after release
------------------------------------------------------------------------
October      January 2019   July 2019   Eligible for new inquiry 9
 2018                                    months after release
------------------------------------------------------------------------

Questions for PAIS/MPSC:

1.  Should the current operational rule postponing new inquiry for 2 
meeting cycles be revised to be based on SRTR reporting cycles?

2.  If answer to question 1 is yes, should the new inquiry be postponed 
for 1 SRTR reporting cycle or 2 SRTR reporting cycles?

If revisions to the rule are approved, the new rule will be effective 
immediately.

3.   Following the decision on the operational rule, the PAIS/MPSC will 
need to vote on whether to send inquiries to the following programs 
that were released in March 2018, are flagged in the SRTR reports from 
January 2019 and have had additional events since release:

      03953N LU pediatric component; identified for lower than 
expected graft and patient survival

      21440N KI adult component, identified for lower than expected 
graft survival

      41540N KI pediatric component, identified for lower than 
expected patient survival



Relevant OPTN Bylaw or Policy:

OPTN Bylaws, Appendix D

Section D.11 Additional Transplant Program Requirements

    A. Transplant Program Performance

    Appendix D.12.A does not apply to VCA transplants.

The MPSC will conduct reviews of transplant program performance to 
identify underperforming transplant programs and require the 
implementation of quality assessment and performance improvement 
measures. One measure of transplant program performance is triggered 
through a review of the one-year graft and patient survival rates. The 
MPSC utilizes performance metrics produced by the Scientific Registry 
of Transplant Recipients (SRTR) as the principal tool to identify 
transplant programs that have lower than expected outcomes.

For programs performing 10 or more transplants in a 2.5 year period, 
the MPSC will review a transplant program if it has a higher hazard 
ratio of mortality or graft failure than would be expected for that 
transplant program. The criteria used to identify programs with a 
hazard ratio that is higher than expected will include either of the 
following:

1. The probability is greater than 75% that the hazard ratio is greater 
than 1.2.
2. The probability is greater than 10% that the hazard ratio is greater 
than 2.5.

For programs performing 9 or fewer transplants in a 2.5-year period, 
the MPSC will review a transplant program if the program has one or 
more events in a 2.5-year cohort.

The MPSC review will be to determine if the higher hazard ratio or 
events can be explained by patient mix or some other unique clinical 
aspect of the transplant program. If a program's performance cannot be 
explained by patient mix or some other unique clinical aspect of the 
transplant program, the program, in cooperation with the MPSC, will 
adopt and promptly implement a plan for quality improvement. The 
member's failure to adopt and promptly implement a plan for quality 
improvement will be considered a noncompliance with OPTN Obligations 
and may result in an OPTN action according to Appendix L: Reviews and 
Actions.

As part of this process, the MPSC may conduct a peer visit to the 
program at the member's expense. The MPSC may also require, at its 
discretion, that the member participate in an informal discussion. The 
informal discussion will be conducted according to Appendix L: Reviews 
and Actions.

The MPSC may recommend that a member inactivate a program, or a 
component of a program, or withdraw its designated transplant program 
status based on patient safety concerns arising from review of the 
program's graft and patient survival. The MPSC must offer the member an 
informal discussion before recommending that the program inactivate or 
withdraw its designated transplant program status. A program's failure 
to inactivate or withdraw its designated transplant program status when 
the MPSC recommends it do so will be considered a noncompliance with 
OPTN Obligations and may result in an OPTN action according to Appendix 
L: Reviews and Actions.

        Excerpt from 2/27/2019 MPSC Confidential Meeting Minutes

1. Clinical Experience Pathway--2- to 5-year requirement

Prior to review of the above described key personnel change application 
discussion, UNOS staff presented information about the requirement in 
the clinical experience pathways for all organs that the primary 
transplant surgeon perform a certain number of transplants or the 
primary transplant physician care for a certain number of transplant 
patients over a 2- to 5-year period. The language contained in the 
bylaws is vague and could lead to an inconsistent application or 
unintended application of the requirement. It is unclear whether the 
requisite number of surgeries or patient care must take place 
throughout the entire period. The Committee discussed various scenarios 
and two interpretation options under the bylaws. The Committee 
expressed support for an interpretation that would require a proposed 
transplant surgeon or transplant physician demonstrate that they did 
the requisite number of transplants or cared for the requisite number 
of transplant patients over a 2-year period in which the surgeon or 
physician was employed and on-site at a designated transplant 
program(s). The transplants/patients used to satisfy the volume 
requirement do not have to span the entire two year period as long as 
the individual was employed and on-site at designated transplant 
programs for a consecutive 2-year period.

                                 ______
                                 

                           MPSC STAFF SUMMARY

                       Proposed Operational Rule

          Adding Application Rejections to the Consent Agenda

                           February 26, 2020

Item for Consideration:

During the February 2020 meeting, staff will present a proposed 
operational rule regarding adding application rejections to the consent 
agenda. The MPSC will be asked to vote to approve the rule.

Summary:

Currently, only applications where all subcommittee voters agree to 
approve are included on the Membership consent agenda. When the 
subcommittee votes to reject an application, the application is brought 
for discussion with the full committee. This has led to the MPSC having 
discussions to reject applications that do not meet the OPTN Bylaws, 
which the MPSC has no option to approve. To eliminate this discussion, 
which takes the MPSC's time but does not allow for the MPSC to take a 
different action than the subcommittee recommendation, staff propose 
that, when a subcommittee unanimously agrees on a rejection, that 
decision be placed on the Membership consent agenda. This change would 
be consistent with the way that Performance and Compliance create their 
agendas. For those cases, if the subcommittee agrees on an action, it 
goes on the consent agenda.

Staff will continue to review the application and prepare a staff 
summary. The summary will indicate whether the completed application 
meets the OPTN Bylaw requirements. The cases will still be posted for a 
subcommittee of reviewers so that they can confirm the staff assessment 
of the application.

Proposed rule:

If all reviewers agree to reject an application, the rejection will be 
placed on the consent agenda for the full MPSC to approve.

If approved, the rule will be effective immediately and used in 
creating the next consent agenda.

Example:

A member submits an application for a Primary Surgeon who does not have 
logs for the appropriate number of procurements. The member provides a 
letter that states that he performed the procurements, but does not 
have the record information. Staff review the documentation and post it 
for reviewers, noting that the documentation submitted does not meet 
the OPTN Bylaw requirements. The subcommittee votes in Committee 
Management to reject the application, so staff puts the rejection on 
the consent agenda for the next full committee meeting.

                                 ______
                                 

                           MPSC STAFF SUMMARY

                        Proposed Process Change

            Adding Self-Reported Cases to the Consent Agenda

                             April 22, 2021

Item for Consideration:

During the April 2021 meeting, staff will propose a change to the 
existing operational rule regarding closing issues that members self-
report with no action. The change would allow self-reports to be added 
to the consent agenda for closure, rather than being posted for 
reviewers. The MPSC will be asked to vote to approve the rule.

Summary:

During its December 2019 meeting, the MPSC approved an operational rule 
regarding closing issues that members self-report with no action. The 
MPSC changed the recommended action for self-reported compliance cases 
where there seems to be an appropriate response through a root cause 
analysis (RCA) and corrective action plan (CAP), no likelihood of 
recurrence, and no ongoing patient safety issues from a Notice of 
Noncompliance to closing the issue with no action. The MPSC intended 
this change to help support a plan to encourage self-reports and shift 
community perception of the committee from solely focused on compliance 
toward a focus on process improvement. Originally, reviewers still 
examined all of these cases to confirm that the proposed action was 
appropriate.

During the COVID-19 pandemic, staff and the MPSC agreed to a process 
change that allowed self-reports with an appropriate RCA and CAP, no 
concerns about recurrence, and no associated compliance history to be 
placed on the consent agenda.

Cases reviewed:

------------------------------------------------------------------------
                             Straight to   Posted for
     Issue         Total       Consent     Reviewers        Outcomes
------------------------------------------------------------------------
Hemodilution              4            4            0  All closed
------------------------------------------------------------------------
HLA errors                3            2            1  All closed
------------------------------------------------------------------------
Packaging and            16            7            9  13 closed, 3
 Labeling,                                              Notice of
 Laterality                                             Noncompliance
 Errors
------------------------------------------------------------------------
Wait-list                 4            3            1  All closed
 errors
------------------------------------------------------------------------
Data entry                2            1            1  Both closed
 errors
------------------------------------------------------------------------
Vessel errors             1            1            0  Closed
------------------------------------------------------------------------
OPO                       3            1            2  2 closed, 1
 Responsibilit                                          Notice of
 ies                                                    Noncompliance
------------------------------------------------------------------------
Total              33 self-           19           14  29 closed, 3
                   reported                             Notice of
                      cases                             Noncompliance
------------------------------------------------------------------------


Reasons posted for reviewers:

------------------------------------------------------------------------
      Issue            July 2020        October 2020      February 2021
------------------------------------------------------------------------
Weak RCA/CAP       1 HLA error case   1 case--2 KI
                                       were
                                       accidentally
                                       discarded, went
                                       to discussion
------------------------------------------------------------------------
Patient safety     1 KI program                         1 case--HR
 issue/member       failed to place                      surgeon left OR
 under review       35 KI candidates                     without
                    on wait list on                      allowing
                    time, 1 data                         packaging
                    entry error
------------------------------------------------------------------------
Recent Hx of       3 packaging and    1 KI laterality   1 hemodilution
 similar event      labeling cases     error case and    case, 4
                                       1 packaging and   packaging and
                                       labeling case     labeling cases,
                                                         one went to
                                                         discussion
                                                         because of
                                                         history
------------------------------------------------------------------------

As you can see, staff have posted 14 case for MPSC review. Of those 14, 
10 were also closed with no action, and four received a Notice of 
Noncompliance. Based on this information, the MPSC is asked to 
officially approve that self-reported compliance cases where there 
seems to be an appropriate response through an RCA and CAP, no 
likelihood of recurrence, and no ongoing patient safety issues be added 
to the consent agenda with a recommendation to close the issue with no 
action.

All cases will still be reviewed for whether the RCA and CAP are 
appropriate, the member has a pattern of noncompliance, or the 
circumstances of the issue call for a stronger action. Any cases with 
concerns about these items will be posted for reviewers. As always, any 
cases with strong patient safety concerns will be posted for MPSC 
reviewers.

Proposed Rule:

The MPSC will close self-reported policy issues with no action on a 
consent agenda, unless patient safety concerns, member history, 
inadequate response, or other circumstances indicate another action.

If approved, the rule will be effective immediately.

                                 ______
                                 

                           MPSC STAFF SUMMARY

                       Proposed Operational Rule

             Use of Survey Evaluation Tool on Desk Reviews

                             April 22, 2021

Item for Consideration:

During the April 2021 meeting, staff will present a proposed 
operational rule regarding continuing to evaluate desk reviews with the 
Survey Evaluation Tool (SET) and adding them to the consent agenda. The 
MPSC will be asked to vote to approve the rule.

Summary:

Since July 2018 Member Quality staff use a Survey Evaluation Tool (SET) 
to determine whether a survey can be closed with no follow-up, whether 
a focused desk review of certain policies is needed, or whether the 
survey should be sent to MPSC reviewers to determine the appropriate 
action. The tool separates policies reviewed into categories based on 
the potential risk to patient safety.

If a member does not meet the required compliance thresholds staff 
automatically conduct a desk review of that policy after six months. If 
a member meets all the required compliance thresholds, staff 
automatically close the review with no action, without posting the case 
for MPSC review. Prior to the COVID-19 pandemic, staff posted the 
results of any focused desk review where the member continued to not 
meet the required compliance threshold for MPSC review, as well as any 
surveys with concerns that the MPSC needs to address.

During the pandemic, staff began assessing both routine surveys and the 
resulting desk reviews with the SET, and adding the recommendation from 
the desk review to the MPSC consent agenda. The table below shows that 
site survey cases for the MPSC have decreased dramatically since the 
implementation of the SET (February 2019). It also shows that the 
number of surveys recommended for closing versus having a desk review 
has not changed drastically using the SET for 2020. For July 2019--
February 2020, 80 surveys closed and 44 had a desk review. After the 
process change May 2020--February 2021, 57 surveys closed and 34 had a 
desk review.


------------------------------------------------------------------------
                                  Closed                Desk Review
------------------------------------------------------------------------
February 2019            150                      53
------------------------------------------------------------------------
July 2019                24                       31
------------------------------------------------------------------------
November 2019            28                       4
------------------------------------------------------------------------
February 2020            28                       9
------------------------------------------------------------------------
May 2020                 14                       4
------------------------------------------------------------------------
July 2020                19                       6
------------------------------------------------------------------------
October 2020             6                        4
------------------------------------------------------------------------
February 2021            18                       20
------------------------------------------------------------------------


If the operational rules is approved, going forward the MPSC will 
review only a member's second desk review. In all cases, any surveys 
with serious concerns about patient safety, compliance, or corrective 
action plans can be sent to the MPSC for review despite the SET 
recommendation.

Proposed rule:

Staff will continue to evaluate routine site surveys with the SET and 
close or conduct a desk review as recommended by the tool. Staff will 
also evaluate the first desk review with the SET and add that 
recommendation to the MPSC consent agenda. The MPSC will review any 
second desk review results.

If approved, the rule will be effective immediately.

                                 ______
                                 

                           MPSC STAFF SUMMARY

                        Proposed Process Change

                Updates to Allocation Operational Rules

                             April 22, 2021

Item for Consideration:

During the April 2021 meeting, staff will propose several changes to 
the existing operational rules for MPSC review of allocation 
deviations. The MPSC will be asked to vote to approve the changes to 
the rules.

Summary:

Member Quality staff review the match runs for all deceased donor organ 
allocations that result in a transplant. Each month, the Allocation 
Analysts identify approximately 450-500 transplants with deviations 
from the match run. The analysts inquire with members and forward 
potential policy violations to the MPSC. Possible violations include 
instances when an OPO skips or bypasses patients on the wait list 
(``allocation out of sequence''), a transplant program accepts an organ 
offer for one patient but transplants another patient on the match run 
(``actual versus intended''), or a transplant program transplants a 
patient not on a match run. During the COVID pandemic, analysts have 
concentrated on making sure that they have adequate information about 
each allocation and have only referred the most egregious or clear 
policy violations to the Committee for review. As the analysts begin to 
return to a more normal review process, policy changes have led to the 
MPSC needing to review several of its current operational rules. After 
the MPSC moves back into normal monitoring of allocations, staff will 
continue to evaluate data for additional changes to these operational 
rules.

Analysts send the MPSC one summary per year for each member. The 
summary allows the MPSC to review any potentially concerning patterns 
of behavior over time. The MPSC has closed almost all allocation 
deviations with no action; most members attempt to follow the match run 
as much as possible but deviate from the match run to avoid organ 
wastage. To streamline the review process, the MPSC developed 
operational rules to automatically close cases with no action when it 
is likely that allocation deviation was necessary to avoid organ 
wastage.

Currently, the MPSC does not review allocations when:

      An OPO expedites placement of any organ from a Hepatitis C 
positive donor.
      An OPO expedites placement of any organ from a Hepatitis B core 
positive donor.
      An OPO expedites placement of any organ from a donor more than 
70 years old.
      A program transplants any organ into a patient other than the 
original intended recipient and the Host OPO granted the transplant 
program local back up.
      A program transplants a kidney patient out of sequence due to 
medical urgency as permitted by Policy 8.
      A program transplants a kidney recipient who does not appear on 
the match run as described in Policy 5.4.E.
      An OPO expedites placement of any organ except kidneys from a 
DCD donor.
      An OPO expedites placement of an extra-renal organ turned down 
in the Operating Room.

Kidney and Pancreas Allocation Changes

    1.  March 15, 2021 changes to kidney and pancreas allocation 
included a change to Policy 5.9 (Released Organs) which now states 
``The transplant program must transplant all accepted, deceased donor 
organs into the original intended recipient or release the deceased 
donor organs back to and immediately notify the host OPO or the OPTN 
for further distribution. If a transplant program released an organ, it 
must explain to the OPTN the reason for refusing the organ for that 
candidate. The host OPO or OPTN must then allocate the organ to other 
candidates according to the organ-specific policies. The host OPO may 
contact the OPTN for assistance allocating the organs. The host OPO may 
delegate the responsibility to the OPO serving the candidate transplant 
program's DSA, except in the cases of released kidneys, pancreata, and 
islets.'' (emphasis added)

       Therefore, the idea of local backup involving the importing OPO 
running a match and reallocating organs is no longer permitted for 
kidneys and pancreata. While there may still be instances where the 
host OPO chooses to offer the organ to the same hospital for a 
different patient, it seems appropriate that the MPSC review these 
instances, especially while the policy is new. Therefore, the MPSC is 
asked to remove kidney and pancreas from the operational rule stating 
``a program transplants any organ into a patient other than the 
original intended recipient and the Host OPO granted the transplant 
program local back up.''

    2.  Changes to Policy 8.5.A.i (Medically Urgent Status for Adult 
and Pediatric Candidates) have added medically urgent candidates as an 
allocation classification, and the offers for medical urgency are no 
longer dependent on each individual DSA approval. Therefore, the MPSC 
is asked to remove the operational rule ``a program transplants a 
kidney patient out of sequence due to medical urgency as permitted by 
Policy 8.5.A.i (formerly 8.2.A).''

Liver Expedited Placement Policy Change

Policy 9.10 (Expedited Placement of Livers) recently went into effect, 
which provides OPOs with conditions under which they are permitted to 
make expedited liver offers and a process for those allocations. These 
conditions include the turndown of a liver offer after the donor has 
entered the operating room. Staff will confirm that the OPO allocates 
the liver appropriately using the new policy. Therefore, the MPSC is 
asked to remove liver from the operational rule ``an OPO expedites 
placement of an extra-renal organ turned down in the Operating Room.''

Conclusion

For any and all of these rules, staff can make details of any case 
automatically closed with no action available at any time. In addition, 
staff can provide aggregate data on reasons for closing cases for any 
allocation review projects. During their reviews, even with these 
rules, MPSC members often find that the OPOs appropriately expedited 
placement to avoid organ wastage.

Based on this analysis, the MPSC is asked to officially approve the 
rules as amended below.

Proposed Rules Summary:

------------------------------------------------------------------------
                Rule                          Applicable Organs
------------------------------------------------------------------------
Hep C positive                       All
------------------------------------------------------------------------
Hep B Core positive                  All
------------------------------------------------------------------------
Over 70 years old                    All
------------------------------------------------------------------------
Transplanted a different recipient   Heart, Intestine, Liver, Lung
 with local backup
------------------------------------------------------------------------
Kidney recipient not on match but    Kidney
 follows 5.4.E
------------------------------------------------------------------------
DCD Donor                            Heart, Intestine, Liver, Lung,
                                      Pancreas
------------------------------------------------------------------------
Turndown in OR                       Heart, Intestine, Lung, Pancreas
------------------------------------------------------------------------


The MPSC will adjust the review of kidney, pancreas, and liver 
allocations based on the recent policy changes.

If approved, the rule changes will be effective immediately.

                                 ______
                                 

                           MPSC STAFF SUMMARY

                       Proposed Operational Rule

          Lower Respiratory SARS-CoV-2 Testing for Lung Donors

                       May 25, 2021 MPSC Meeting

Item for Consideration:

During the May full MPSC meeting, staff will present a proposed 
operational rule regarding real-time monitoring of the emergency policy 
approved 4/26/21 that requires lower respiratory SARS-CoV-2 testing on 
all lung donors. The MPSC will be asked to vote to approve the rule.

Summary:

This is a new policy that was proposed by the DTAC and it was taken to 
the Executive Committee for emergency approval, to be implemented 
within 30 days of approval. It will go through the summer Public 
Comment cycle, while in effect, and then ultimately to the BOD in 
December, pending with changes or as is. Site Survey will monitor OPOs' 
compliance with this policy in real-time, by use of a weekly report 
provided from the UNOS Research department. If it is found that an OPO 
has not reported the test results in DonorNet and/or not uploaded the 
results to the Attachments tab of DonorNet, then Site Survey will send 
an inquiry email to the OPO to investigate. If it is found that the 
member did not perform the test, Site Survey will ask the OPO to 
provide an explanation and a plan for future potential lung donors. 
Site Survey proposes to ``close'' the first identified event for each 
OPO (same process as the operational rule for Wait-list Inactivity 
notification letters), without forwarding to the MPSC for review, and 
will communicate language to the member that any subsequent event would 
then be forwarded on for committee review (as well as the first event).

Proposed rule: ``Site Survey staff will request members to provide an 
explanation and develop a plan for future potential lung donors after 
the first event of identified noncompliance with the Lower Respiratory 
SARS-CoV-2 Testing requirement in Policy 2.9 and will not forward the 
matter to the MPSC for review. If staff identifies a second event of 
noncompliance in a subsequent weekly review, staff will ask the member 
to provide an explanation as well as a corrective action plan and then 
staff will provide all events' documentation to the MPSC for review.''

If approved, the rule will be effective immediately upon implementation 
of the policy on May 27, 2021.

Of note: The weekly report from the Research department will provide a 
list of donors where lower respiratory specimen results were not 
reported in DonorNet prior to the lung recipient's removal from Wait 
list.

Example:

OPO ABCD recovers lungs from donor A on 5/31/21. As of the run time of 
the weekly report from Research on Friday 6/4/21, OPO ABCD has not 
entered lower respiratory specimen test results in DonorNet. Site 
Survey views the Attachments tab of DonorNet on 6/4/21 and confirms 
that OPO ABCD has not uploaded a source document of the test. On the 
afternoon of 6/4/21, Site Survey sends an Inquiry email to OPO ABCD to 
ask if the test was completed and if so, for the OPO to provide the 
test results to Site Survey and upload the source document to DonorNet. 
Site Survey requests an answer by COB 6/7/21. OPO ABCD responds that 
the test was not completed. Site Survey then requests an explanation 
and a plan for future potential lung donors by COB Thursday 6/10/21. 
Site Survey sends by email a Closure Letter to OPO ABCD noting the 
noncompliance. Site Survey logs this first event of noncompliance into 
an Excel tracker. OPO ABCD recovers lungs from donor B on 6/30/21. As 
of the run time of the weekly report from Research on Friday 7/2/21, 
OPO ABCD did enter lower respiratory specimen test results in DonorNet, 
in compliance with Policy. OPO ABCD recovers lungs from donor C on 7/
31/21. As of the run time of the weekly report from Research on Friday 
8/6/21, OPO ABCD had not entered lower respiratory specimen test 
results in DonorNet. Site Survey views the Attachments tab of DonorNet 
on 8/6/21 and confirms that OPO ABCD has not uploaded a source document 
of the test. On the afternoon of 8/6/21, Site Survey sends an Inquiry 
email to OPO ABCD to ask if the test was completed and if so, for the 
OPO to provide the test results to Site Survey and upload the source 
document to DonorNet. Site Survey requests an answer by COB 8/9/21. OPO 
ABCD responds that the test was not completed. Site Survey then 
requests an explanation and corrective action plan by COB Thursday 8/
12/21. Site Survey sends by email a formal Closure Letter to OPO ABCD 
noting the noncompliance and informing the member that the events of 
donors A and C will be forwarded to the MPSC. Site Survey logs this 
second event of noncompliance into an Excel tracker. Site Survey 
provides a case packet to the COAs prior to the next MPSC meeting, for 
presentation and review by the MPSC. The MPSC will provide a final 
resolution.

Relevant OPTN Bylaw or Policy:

New requirement: OPTN Policy 2.9, ``3. Infectious disease testing for 
all potential deceased lung donors using an FDA licensed, approved, 
cleared, or emergency use authorized lower respiratory specimen test 
for SARS-CoV-2 (COVID-19) by nucleic acid test (NAT)

Lower respiratory specimen test results for SARS-CoV-2 by nucleic acid 
test (NAT) must be available prior to transplant.''

Also relevant (current policy, no change)--OPTN Policy 2.2 #14 
``Ensuring that documentation for all of the following deceased donor 
information is submitted to the OPTN upon receipt: . . . c. Infectious 
disease results source documentation. . . .''

Supporting Documents:

See proposal and policy notice on OPTN site.

                                 ______
                                 

                           MPSC STAFF SUMMARY

                       Proposed Operational Rule

       Sending Performance Inquiries to Newly Identified Members

Item for Consideration:

The Performance Monitoring Enhancement Subcommittee is asked to 
consider a proposed operational rule regarding the timing of sending 
inquiries to members newly identified for performance review. The 
Subcommittee will be asked to recommend that the MPSC approve the rule.

Summary:

Currently, staff receive the SRTR performance data twice a year, prior 
to the MPSC's February and July meetings. When the data arrives, staff 
determine which members are newly identified for review. Staff 
automatically then add a row to the upcoming meeting's consent agenda 
with a proposed action of ``Send Initial Inquiry.'' Members do not 
receive their initial inquiry letter until after the MPSC approves the 
consent agenda.

Proposed operational rule: The MPSC approves sending an initial inquiry 
for members newly identified for outcomes review when the data is 
available automatically, without a committee vote.

Benefits of this proposal are:

      Newly identified members will receive their inquiry earlier, 
which may allow both more time for their response and more time for 
MPSC review before the next meeting.
      The rule is consistent with the process used for inquiries in 
other MPSC case types.
      Shorter performance consent agendas and reduction of potential 
errors.

If questions arise about whether to send an inquiry to a particular 
program, staff will have the option to place the item on discussion for 
MPSC consideration and decision.

If approved, the rule will be effective with the release of the Spring 
2022 PSR in July.

                                 ______
                                 
                United Network for Organ Sharing (UNOS)

                          700 North 4th Street

                           Richmond, VA 23219

                           tel: 804-782-4800

                           fax: 804-782-4816

                           https://unos.org/

August 17, 2022

The Honorable Ron Wyden, Chairman
The Honorable Charles Grassley
U.S. Senate Finance Committee
Washington, DC 20150

Dear Chairman Wyden and Senator Grassley,

United Network for Organ Sharing (UNOS) offers the following additional 
information to the Senate Finance Committee following the testimony of 
Mr. Brian Shepard, CEO, on August 3, 2022, concerning the U.S. organ 
donation and transplantation system. UNOS shares the Committee's desire 
to see a successful transplant for every patient in need. We ask that 
the Committee please include this letter and the attached documents in 
the record.

As Mr. Shepard testified, UNOS is and has always been committed to 
improving the U.S. organ donation and transplantation system. We heard 
the concerns shared by members of the Committee and will work in 
collaboration with Congress, our federal partners, and community 
members, to further improve the national system and save more lives. We 
have a demonstrated record of continuous improvement, and in 
partnership with Health Resources and Services Administration (HRSA) 
and the broader transplant community, we have played a key role in nine 
consecutive years of increases in the number of deceased donor 
transplants. In 2021, we saw record breaking numbers of kidney, liver, 
and heart transplants.

This sustained record of growth, which continued throughout a global 
pandemic, shows that the system is dedicated to serving patients 
through unprecedented challenges. The best course for our nation's 
transplant system is to continue building on this momentum and to 
identify and execute on new opportunities for continued improvement.

We would like to take this opportunity to reiterate our commitment to 
continuous improvement in four key areas in particular:

      State of the art technology: UNOS has always provided reliable, 
effective, secure technology services to support the organ donation and 
transplant community. The system UNOS built and operates to support the 
OPTN has 99.99% up time, is regularly audited by HRSA, and exceeds 
performance and security standards established by the federal 
government. Just within the last two weeks, UNOS has achieved high 
scores on two separate government reviews, and HRSA is currently 
preparing for a full audit that will begin in a few weeks.

     As with all developing technology, we are never satisfied with the 
performance of the system, however, and we bring the leading technology 
providers in the country together to make the system stronger. UNOS 
partners with Nutanix to host the OPTN systems in the cloud. UNOS has 
engaged Accenture to help apply human-centered design principles to 
modernize the user experience of the OPTN system. UNOS uses Apigee to 
support Application Program Interfaces (APIs) for electronic data 
sharing, and more than 200 hospitals and OPOs provide data to UNOS 
through APIs.

     Attached to this submission are a copy of the IT presentation made 
to committee staff earlier this year and a letter to the HRSA 
administrator reiterating our commitment to government review of OPTN 
IT systems.

      Organ transportation: UNOS agrees with the consensus at the 
hearing that any organ lost in transit, damaged or arriving otherwise 
unable to be transplanted is a tragedy--both for the generous donor and 
the patient waiting.

     UNOS heard a desire from the community to improve the visibility 
of tracking unaccompanied organs as an opportunity to improve 
efficiency. UNOS has and offers a tracking solution, one of several on 
the market. Just last week, the 5,000th organ carrying a UNOS-provided 
tracker was shipped and transplanted. As mentioned during the hearing, 
we are also currently piloting an organ travel mobile app that will 
enable OPOs to more quickly determine the very best travel plan for an 
organ in transit, based on a variety of factors.

     UNOS is engaged with major commercial airline providers to design 
improved organ handling processes that comply with TSA regulations 
while safely and reliably delivering the organ. UNOS would be pleased 
to work with the Committee in making improvements to federal 
restrictions on organ handling, such as returning organs to the 
passenger cabin or cockpit, where they once were allowed to travel.

      Organ Discards: The hearing included discussions of the decade-
long rise in the number of kidney discards. UNOS agrees that there are 
organs recovered by OPOs that could be acceptable for transplant yet go 
unutilized. The OPTN has undertaken a number of initiatives designed to 
empower transplant programs with relevant and timely information, 
providing data, tools and analytics to help centers get to ``yes'' 
faster, as noted by the NASEM study.

     UNOS recently deployed data-driven predictive analytics to help 
clinicians decide whether to accept organ offers. A new offer filters 
tool built by UNOS helps target organ offers to the candidates most 
likely to accept them, improving system efficiency and ultimately 
increasing the number of transplants. Similarly, the Center Acceptance 
and Refusal Evaluation (CARE) tool allows centers to see all of the 
outcomes for offers they accept, as well as those they refuse. The OPTN 
Image Sharing project offers surgeons access to high resolution images 
of a donor organ, enabling teams to make more informed acceptance 
decisions up front, and reduce the likelihood of having to reallocate 
an organ last minute. Further, the OPTN's Membership and Professional 
Standards Committee (MPSC) has recently implemented additional 
transplant center metrics to include Organ Offer Acceptance Rate 
Ratios, a risk-adjusted calculation with an intent to both ensure 
organs suitable and safe for transplantation are allocated to the 
appropriate recipients on the waiting list based upon established 
policy and to improve transparency of the offer system to patients and 
providers.

      OPTN member performance improvement and peer review: At times, 
it seemed that questioners at the hearing conflated the two 
complementary but distinct roles that the OPTN and CMS play in 
oversight of the national transplant system. By statute, regulation, 
and contract the OPTN, through its Membership and Professional 
Standards Committee (MPSC), is designed to provide a collaborative 
quality improvement process. In contrast, CMS has authority to impose 
sanctions, including payment and decertification.

     As Mr. Shepard testified, full and frank participation in our peer 
review process is what we believe leads to understanding and 
improvement following adverse events. Confidential peer review is a 
quality improvement practice implemented across healthcare disciplines 
following the Institute of Medicine's seminal report, To Err Is Human 
(2000). The IOM recommended a two-pronged system, one that included 
both confidential peer review for near misses and lesser events, and 
stricter sanctions for serious events. We are committed to working with 
the Committee and with HRSA and CMS at ensuring that the two-pronged 
system is working correctly and cooperatively, and that the types of 
events to be reviewed by each part of the system are properly defined. 
However, we strongly believe that abandoning confidential peer review 
entirely would have a detrimental effect on honest disclosure, and 
ultimately on patient safety.

UNOS has a long and successful record of facilitating transplants in 
the United States, and we are proud to be a part of the most successful 
organ donation and transplant community in the world. It is our daily 
mission to continue to improve the donation and transplant system.

We welcome the support of the Senate Finance Committee in implementing 
improvements to the system, and continuing to pursue our shared goal of 
saving lives through organ donation.

Sincerely

Jerry McCauley, M.D., MPH
President, UNOS Board of Directors
Chief, Division of Nephrology
Medical Director, Transplantation Services
Vice Chairman, Health Equity, Diversity and Inclusion
Thomas Jefferson University Hospitals
Philadelphia, PA

                                 ______
                                 
                United Network for Organ Sharing (UNOS)

                          700 North 4th Street

                           Richmond, VA 23219

                           tel: 804-782-4800

                           fax: 804-782-4816

                           https://unos.org/

August 2, 2022

The Hon. Carole Johnson, Administrator
Health Resources and Services Administration
U.S. Department of Health and Human Services
Rockville, MD 20857

Dear Administrator Johnson,

United Network for Organ Sharing (UNOS) is proud to have served as the 
Organ Procurement and Transplantation Network (OPTN) since 1984. In 
partnership with HRSA, we are nearing a decade of continued growth in 
the number of organ transplants and we are proud that our partnership 
with HRSA has yielded the highly equitable and efficient system we know 
today. We continue to make improvements every day for the benefit of 
the patients we serve.

UNOS has recently been provided with a document that has since been 
leaked to the media purporting to be a ``draft'' United States Digital 
Service (USDS) report on the OPTN IT system. We have never received an 
official copy of this draft report, despite a FOIA request to the U.S. 
Office of Management and Budget (OMB). Unfortunately, the report 
contains significant factual errors and demonstrably false 
misstatements about the OPTN IT infrastructure. We understand HRSA may 
have seen a copy of this report, and so we wanted to extend this 
invitation to you to discuss these claims to clarify and correct its 
numerous inaccuracies.

By way of background, the draft USDS report appears to be based 
entirely on a ninety-minute presentation by UNOS on December 10, 2020, 
pursuant to a request from HRSA during its 2019 Market Research for the 
Modernization National Resource Allocation System, as well as UNOS's 
responses to a set of follow-up questions submitted by HRSA. The USDS 
neither engaged with nor sought further information from UNOS during 
the development of this report, nor were we provided a chance to 
comment on the report or identify and correct any inaccurate 
information.

In contrast, the HRSA team has consistently reviewed the performance 
and security of the OPTN IT system in great detail throughout our 
performance of the OPTN contracts. HRSA reviews all OPTN contractual 
requirements for compliance annually, as well as on a periodic basis 
throughout each year, and UNOS consistently meets or exceeds its 
contractual obligations. Specifically, UNOS submits to HRSA results of 
the cybersecurity penetration testing conducted by a 3rd party on a 
semi-annual basis. Further, HRSA security audits are conducted annually 
to ensure the quality and security of the OPTN system. Just today, UNOS 
received another 100% score on the HRSA Office of Information 
Technology's Capital Planning and Investment Control (CPIC) dashboard.

With that background, UNOS offers the following selected clarifications 
to the certain statements contained in the draft USDS report:

      UNOS utilizes an industry best practice, cloud-based approach 
incorporating both private and public cloud service providers. There 
are no components hosted on-premises.

      UNOS has maintained an IT system up time of 99.99% (outside of 
scheduled maintenance) for more than 10 years.

      More than 200 transplant hospitals and OPOs are leveraging UNet 
system APIs for reporting or querying data, and in the past year alone, 
the system processed nearly one million API transactions for members, 
with no additional manual data entry required.

      UNOS shares segments of real code with HRSA as part of both our 
ongoing application security program and the government's annual audit.

      UNOS has documented version control and the ability to replicate 
historical matches based on the policies in effect at the time.

We note that this represents only a selection of the statements in the 
draft report about which we have factual concerns.

Further, we are also concerned that the draft report mischaracterizes 
what we view as UNOS' productive, cooperative relationship with HRSA 
and ignores HRSA's above-referenced robust audit and oversight 
functions. As you know, the relationship described in the USDS report 
bears no resemblance to the working partnership we have with the HRSA 
team, a partnership that has produced positive results for patients 
since its inception.

You already have access to your team's routine annual audit information 
about the reliable, safe IT system that UNOS operates, but we stand 
ready to provide any additional briefings or information you request or 
to host you and/or your team for additional onsite meetings so that you 
can further understand our systems and processes.

We appreciate your consideration of our concerns about the inaccuracies 
in the leaked draft report. It is our sincere hope that these 
assurances, in combination with HRSA's own records, addresses any 
concerns the draft report may have raised for you. We look forward to 
continuing our work together on the critical mission of our Nation's 
transplant system.

Sincerely,

Jerry McCauley, M.D., MPH
President, UNOS Board of Directors

CC: Cheryl Dammons, Associate Administrator, HRSA
    Adriane Burton, Chief Information Officer, HRSA

                                 ______
                                 
                United Network for Organ Sharing (UNOS)

                          700 North 4th Street

                           Richmond, VA 23219

                           tel: 804-782-4800

                           fax: 804-782-4816

                           https://unos.org/

March 2, 2022

The Hon. Ron Wyden, Chairman
The Hon. Charles Grassley
U.S. Senate
Committee on Finance
Washington, DC 20510

Dear Chairman Wyden and Senator Grassley,

We appreciated the opportunity to brief your staff regarding the issues 
raised in your January 31, 2022, letter concerning UNOS' IT security 
and technology infrastructure and practices. We are pleased to provide 
the following additional information and actions taken since our 
February 17, 2022 meeting, in addition to the presentation materials 
and requested root cause analysis submitted to HRSA on February 26, 
2021.
Penetration Testing
Senate staff inquired about the role of external entities in conducting 
penetration testing. Below are clarifications about our most recent 
tests.

      A third-party commercial company conducted the 2021 tests. 
Penetration test was a web application test with and without 
credentials. Testing was conducted in our ``production equivalent'' 
environment.

          The HHS Office of Inspector General (OIG) and 
        HRSA accepted this test in lieu of performing their own 
        penetration test for the 2021 Audit

          No vulnerabilities were identified allowing 
        escalation of privilege or ability for lateral movement

          As promised, we are providing the results and 
        remediations from the 2021 penetration test:

                  0 Critical
                  3 High: All closed immediately
                  6 Medium: 5 Closed, 1 pending software update 
                available in June 2022
                  3 Low: 1 Closed, 2 pending closure with code 
                roll-out May 2022

      A HRSA-selected vendor, Synack, will conduct the 2022 test. It 
will be a crowd-sourced penetration test. The test will be in non-
credentialed and credentialed format.
 UNOS Relationship with Cybersecurity and Infrastructure Security 
        Agency (CISA)
Senate staff recommended UNOS seek out free cybersecurity resources and 
services, such as the EINSTEIN sensor, offered by CISA to private 
sector organizations operating ``critical infrastructure'' for the 
nation. At this time, the OPTN system is categorized by HHS as a 
``high-value asset'' and is ineligible for all services provided to 
infrastructures with this more elevated designation.

We appreciate, however, the suggestion to secure cybersecurity hygiene 
scans from CISA and have taken steps to request this important service.

UNOS established a relationship with CISA in 2015 and at that time 
registered for and participated in the Government Telecommunications 
Service (GETS), Wireless Priority Service (WPS), and Telecommunications 
Service Priority (TSP) programs. We have since sponsored numerous OPOs 
in support of their participation in the program.
Security Clearances and Classified Warnings
      In response to a staff suggestion for gaining Top Secret 
clearance for pertinent UNOS staff so that UNOS may receive classified 
briefings from the U.S. government on security threats, a formal 
request to HRSA has been made to determine the requirements for Secret 
or Top-Secret clearances and sponsorship and is under review within 
HHS. To date, Secret and Top-Secret designations have not been required 
nor sponsored by HHS for the OPTN. UNOS currently receives unclassified 
email alerts from the FBI, HRSA, and CISA.

      UNOS meets the contractual obligation as stated in the Position 
Sensitivity Designations requirements within the current OPTN contract, 
which states: ``All contractor (and/or any subcontractor) employees 
must obtain a background investigation commensurate with their position 
sensitivity designation that complies with Parts 1400 and 731 of Title 
5, Code of Federal Regulations (CFR).''
Code Scanning and Review
      UNOS scans code throughout the software development lifecycle 
using Veracode technology.

      Snippets of code have been and will continue to be made 
available to HRSA for verification and closure of findings as needed.

      Over the past several months, HRSA and UNOS have been working to 
establish a process for reviewing code. We estimate that HRSA will 
begin code reviews in Q2 of 2022.
Vulnerability Management
      Infrastructure vulnerability scanning is performed weekly using 
Tenable, and all results are provided to HRSA.

      HRSA is provided access upon request and on a regular schedule 
to perform web applications scanning, using NetSparker, against a 
production equivalent environment.
Offsite Backup Storage
      Offsite backup storage practices have been in place since the 
OPTN system's inception in 1999 and continue in the present.
2010 Modernization Project
      As a follow-up to your question regarding the 2010 system 
modernization project:

          A project called Chrysalis was terminated in 2012 
        after concluding that it would not go far enough to modernize 
        and evolve the OPTN technology.

          Following that decision, UNOS determined that the 
        path forward needs to be centered on digital transformation of 
        the OPTN System, embracing and practicing the Agile 
        methodology, test automation, open-source frameworks, 
        Application Programming Interfaces (APIs), mobile capabilities, 
        elevated security practices, and cloud computing. As a result 
        of this direction and culture, we have been able to --

                  React faster to the needs of the transplant 
                community.

                  Establish and maintain a consistent feedback 
                loop with the users of OPTN system.

                  Integrate cloud-based data analytics and machine 
                learning capabilities.

                  Implement a variety of open-source frameworks to 
                deliver value.

                  Enable members to benefit from our seamless 
                integration with EHRs and EMRs.

                  Empower members with secure mobile capabilities 
                to perform work whenever and wherever.

                  Reduce the threat landscape by implementing zero 
                trust principles in conjunction with a defense-in-depth 
                strategy.

                  Maintain high quality of software, leveraging 
                24x7 automated testing.

                  Deliver on the OPTN Board of Directors 
                commitments.

                  Retain and attract engineering talent.
February 2021 Service Outage
      To clarify our response in our meeting, the February 2021 one-
hour service outage occurred as the result of a failure within a high-
availability redundant pair of internal firewalls, not a manual human 
error. The human error occurred during the service restoration effort. 
As requested during the meeting, the root cause analysis previously 
provided to HRSA is included as part of this response. Since this 
incident, further automation has been added to service restoration 
procedures to eliminate the need for human intervention.

      Please note the graphic depicted in the provided RCA reflects 
the OPTN system architecture as of February 2021, while we were in 
transition to the current state architecture. The OPTN system 
architecture today reflects what was presented to the staff during our 
call. It has additional built-in redundancies and security components, 
advanced use of public and private cloud, and automation.

Please do not hesitate to contact me if you have additional questions 
or require further clarifications.

Sincerely,

Brian Shepard, CEO

Attachments (2): UNOS IT Security Presentation for Senate Finance (17 
February 2022); UNet Root Cause Analysis (6 February 2021)

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


Areas of Focus

      System modernization and reliability

      Sufficient backup systems

      Cloud utilization

      Security of the system from cyberattacks

      Basic features and security systems

      Ensuring that security flaws do not lead to preventable deaths

      Prevention of service interruptions due to ransomware attack, 
technical failure or inefficiency causing delays

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                              Appendix

UNOS Information Security Team

      More than 112 years of combined IT and Information Security 
Experience
      Holds 27 industry recognized certifications including:
          Certified Ethical Hacker (CEH)
          Certified Cloud Security Professional (CCSP)
          Certified Detection Analyst (CDA)
          Certified Incident Handler (CIH)
          Certified Information Systems Security Professional (CISSP)
          Certified Penetration Tester (GPEN)

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
        

Incident: Periodic UNetSM Access Impact.

Date and Duration of Incident: 2021-02-06 8:10PM EST-11:00 PM EST.

Incident Summary

Starting around 2021-02-06 8:15PM EST, users began to experience 
periodic latency and errors in UNet functions.

Root Cause

East Region 1 (ER1) Computing Environment experienced a Network 
Equipment failure.

Detailed Description

UNet users experienced periodic latency or errors as a result of ER1 
Networking Equipment failure.

Between 08:10pm and 08:15PM EST, one node of a clustered pair of 
internal Cisco firewalls experienced an interface failure which 
cascaded to the other firewall node, resulting in a total failure of 
the internal firewall cluster.

This failure, in turn, caused interruption to internal network traffic 
in ER1. Cisco technical support confirmed that the issue was caused by 
a defect in the Cisco firewall's firmware.

Issue resolution actions consisted of transitioning impacted workloads 
from ER1 to ER2 computing environment, as well as taking the ER1 
internal firewall cluster offline and bypassing internal network 
traffic. Confirmed no impact to matching function or patients.

Additional Information

Throughout the incident some workloads running in ER1 remained there. 
Periodically, between 08:25 and 09:25PM EST, ER1 was not accessible to 
UNet users. Procedural errors made in the process of transitioning some 
workloads from ER1 to ER2 contributed to this incident. All other steps 
taken (manual and automated) during this incident were accomplished 
without any errors.

The equipment in question has not been put back in service.

Since the incident, ER1 has been and continues to be fully operational. 
All normal workloads/ activities have been and are functioning there.

Action steps taken during incident:

_______________________________________________________________________

08:12PM EST       Initial ThousandEyes.com alerts received
------------------------------------------------------------------------
08:25PM           Organ Center (OC) receiving Members Calls
------------------------------------------------------------------------
                  IT On-call responding engineer informs On-call manager
                   and begins to evaluate the issue
------------------------------------------------------------------------
08:33PM           Conference Bridge initiated
------------------------------------------------------------------------
08:56PM           ER1 Networking Equipment failure identified as
                   triggering event
------------------------------------------------------------------------
                  Systems Engineer enroute to ER1
------------------------------------------------------------------------
09:10PM           Decision is made to move some UNet functions to ER2.
                   Leverage external Transition Plan (TP) in
                   Attainium.net
------------------------------------------------------------------------
                  Additional Systems Engineers are brought into the
                   Conference Bridge to assist
------------------------------------------------------------------------
09:23PM           TP procedures to ER2 are initiated
------------------------------------------------------------------------
09:40PM           TP procedures to ER2 are completed
                  Reviewing periodic ThousandEyes.com alerts reported in
                   operational logs
------------------------------------------------------------------------
09:45PM           UNet functions to add candidate or register donor are
                   functional
------------------------------------------------------------------------
10:01PM           Some functions transitioned from ER1 to ER2 generating
                   periodic alerts
------------------------------------------------------------------------
10:22PM           Issues in executing TP procedures to ER2 identified on
                   the Conference Bridge: (1) External Plan not up to
                   date; (2) Human data entry errors
------------------------------------------------------------------------
10:30PM           Corrective Actions identified to address issues in TP
                   procedures
------------------------------------------------------------------------
10:58PM           UNet functions accessible both internally and
                   externally
------------------------------------------------------------------------

Corrective Action:

We have completed our detailed investigation and compiled our 
corrective actions to prevent future incidents of this kind:

      All procedural documentation will be updated in Attainium.net 
first then synchronized with on premises copy. Attainium.net has no 
dependency to internal infrastructure. (Completed 2/8/21).

      Transition Plan (TP) procedures training will be updated to 
accommodate all scenarios. Staff retraining has commenced, and will be 
required for all new team members. Training will be ongoing as 
procedures are updated, and a quarterly review of all procedure 
documentation will be conducted.

      Continue with additional automation (scripting) to further 
reduce manual TP tasks, avoiding potential for human error and 
resulting in faster transitions. 
(2/28/21)

      Continue with West Region turn-on project (see below). Ensure 
Transition Plan is updated accordingly to incorporate Nutanix advanced 
management capabilities and staff are trained. (April 2021)

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      Provide continuous updates to HRSA (2/9 and 2/11/21) and 
NOOC (2/19/21) on UNet availability to maintain confidence in the 
system

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


                                 __
                                 
          Questions Submitted for the Record to Brian Shepard
                 Questions Submitted by Hon. Ron Wyden
    Question. Black Americans are disproportionately impacted by the 
organ shortage. According to the 2022 OPTN kidney update, 28.5 percent 
of kidney registrations on the wait list are Black. This is essentially 
double their percentage in the population (2020 U.S. census data shows 
that 14.2 percent of the U.S. population is Black or identifies as 
Black). Additionally, minorities have much higher kidney disease burden 
than their Caucasian counterparts. The 1-year monitoring report for the 
new OPTN kidney allocation policy notes that transplant rates for 
minorities are approaching/similar to Caucasians. However, to be 
equitable, Black Americans would need to be transplanted at much higher 
rates than their Caucasian counterparts given this disproportionality 
of Black wait-list registrants.

    Given the disproportionately large percentage of Black Americans on 
the waiting list, what kidney transplant rate for this community would 
the system need to achieve to reach equity for Black Americans? How has 
UNOS calculated this? How has this community's transplant rate changed 
over time?

    Has UNOS calculated the equitable rates for other minorities? If 
so, please provide these rates, how each was calculated, and how they 
changed over time.

    Answer. We agree that increasing equity in donation and transplant, 
especially among historically marginalized communities, is of paramount 
importance. Organ Procurement and Transplantation Network (OPTN) 
policies play a key role in addressing these inequities, and the data 
show that important gains in access for Black and other racial and 
ethnic minority wait-listed patients have accelerated since December 
2014, when the OPTN Kidney Allocation System (KAS) was implemented. 
Following that policy change, we saw a dramatic expansion in the number 
of Black patients with long wait times on dialysis who were able to 
receive transplants. Six years later, despite the pandemic, 2020 
deceased donor kidney transplant rates were similar for White and Black 
patients.

    As the question notes, a new kidney policy was implemented in March 
2021, and the 1-year monitoring report showed sharp increases in kidney 
transplant rates: 16-percent increase overall; 23-percent increase for 
Black patients; and 36-percent increase for patients with 3 or more 
years of dialysis time at listing.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Since 2015, as shown in table 1, the discrepancy between the 
percentage of kidney transplants going to ethnic minorities in relation 
to the percentage of the kidney waiting list comprising ethnic 
minorities has been shrinking. This is seen most dramatically in the 
Black candidate population. As of December. 31, 2015, 34 percent of 
kidney waiting list registrations were Black, and 28 percent of 2015 
deceased donor kidney transplants went to Black recipients. By 
December. 31, 2021, 32 percent of registrations on the kidney waiting 
list were Black, and 29 percent of 2021 deceased donor kidney 
transplants went to Black recipients.

    The Hispanic candidate population has seen similar increases in 
equity; the percentage of candidates waiting for a transplant who are 
Hispanic and the percentage of transplants going to Hispanic candidates 
are now nearly on par, as of 2021. These improvements follow changes to 
OPTN policies relating to human leukocyte antigen (HLA) matching and 
typing as well as increased priority for highly sensitized patients. 
The percent of transplants going to Asian recipients has declined 
slightly relative to their waiting list presence, while the discrepancy 
between percent transplanted and percent waiting has remained stable 
over time for all other ethnic minorities.

    While these gains are important, we agree that they are but one 
component of the effort to eliminate inequities in access to the 
transplant wait list. The community has long called for enhanced data 
collection to better understand the socioeconomic factors that restrict 
access to the transplant wait list as well as to the care that is often 
required pre-listing, enabling the community to answer important 
questions like 1a above and many others. Further, while understanding 
the national disease burden is a key step toward addressing inequities 
in access to transplant, it is also crucially important to understand 
how many patients with end-stage organ failure are unable to seek 
transplant due to comorbidities or other clinical factors. Both factors 
are unknown.

    While OPTN regulatory authority is limited to organ donors and 
wait-listed patients, the OPTN has still sought to contribute to 
understanding the barriers that exist to accessing the wait list. For 
example, in 2021, the OPTN Data Advisory Committee (DAC) proposed a 
project, currently under review with the Health Resources and Services 
Administration (HRSA), to collect pre-wait-list patient referral and 
evaluation data and to work with partners to study and improve 
equitable access to the wait list. The OPTN also requested and received 
additional funding from HRSA to study the feasibility and utility of 
linking existing external social determinants of health (SDOH) datasets 
with the OPTN dataset. That study led to the creation of two research 
studies that helped the OPTN understand the role of SDOH in determining 
wait-list outcomes among transplant candidates. As a result of these 
studies, the OPTN is currently working with committees to find ways to 
incorporate SDOH data into policy monitoring and evaluation. Finally, 
the OPTN recently supported an amendment by HRSA to the OPTN Systems of 
Records Notice, which added a new routine use to allow HRSA or its 
contractors to disclose OPTN records ``to physicians or other health-
care professionals providing clinical treatment to such individuals, 
for clinical purposes.''\1\ This will allow the OPTN to share candidate 
information with physicians, such as nephrologists, and health-care 
professionals, such as dialysis providers, to assist in the evaluation 
and wait-listing process for their current patients who may be 
potential candidates for kidney transplant.
---------------------------------------------------------------------------
    \1\ OPTN Systems of Record Notice, 87 Fed. Reg. 46967 (August 1, 
2022). https://www.federalregister.gov/documents/2022/08/01/2022-16344/
privacy-act-of-1974-system-of-records.

    Question. According to UNOS 990s, in the year ending September 30, 
2020, the organization brought in $4 million more in OPTN revenue than 
it spent on expenses. In the year ending September 30, 2019, the 
organization had $5.6 million more in OPTN revenue than expenses. Since 
at least FY 2019, UNOS has had a financial management policy that it 
could use revenues from OPTN contract fees that exceed reimbursable 
costs for its general expenditures, and as of the year ending September 
30, 2021, UNOS total assets are reported to be $97.7 million not 
including property and equipment. What role did UNOS have in approving 
---------------------------------------------------------------------------
this policy and for how long has it been in place?

    Please describe how the UNOS policy of using excess revenues from 
fees for general expenditures came about and how long it has been in 
place.

    Who ultimately determined that UNOS could utilize OPTN fee revenues 
in this manner? UNOS management? The UNOS Board? HRSA?

    Answer. UNOS has no such policy in place. While UNOS as a private 
corporation may have revenues exceeding its expenses, any excess OPTN 
Registration Fee revenue may not be used by UNOS for any purpose other 
than for allowable costs under the OPTN contract and only when such 
allowable costs are approved by the HRSA Contracting Officer. In order 
to support the committee's understanding of our financial processes and 
policies, however, we offer the below clarifying information.

    The Form 990s referenced above are for UNOS, a private nonprofit 
Virginia membership corporation. The OPTN is not yet a distinct private 
nonprofit entity and accordingly, its financial position is presented 
in consolidated financial statements with UNOS. In audited financial 
statements, OPTN assets are listed as ``restricted cash'' and 
``restricted investments'' within those consolidated financial 
statements. As detailed in financial records provided to the Senate 
Finance Committee and available online, OPTN Registration Fees may only 
be used for allowable OPTN contract expenses, and only when a monthly 
voucher is approved by the OPTN Contracting Officer's Representative at 
HRSA. At the end of each fiscal year, OPTN Registration Fee revenue in 
excess of allowable contract costs remains in the OPTN operating 
account, and the amount may be carried forward to the next OPTN fiscal 
year budget and included in the OPTN budget calculations. The annual 
OPTN budget is developed by the OPTN Finance Committee and approved by 
the OPTN Board of Directors with oversight by U.S. Department of Health 
and Human Services (HHS) staff and ultimate approval by the HHS 
Secretary. From time to time, OPTN operating account funds are invested 
in a separate restricted OPTN reserve fund account.

    To illustrate the funds transfer process, for the month of June, 
UNOS would pay all of its expenses during the month from UNOS' 
operating account. On behalf of the OPTN, UNOS continuously invoices, 
collects, and holds in a separate OPTN operating account all OPTN 
registration fee revenue received from OPTN member transplant hospitals 
who add a candidate to the OPTN candidate waiting list. At the end of 
June, UNOS prepares a voucher and submits it to the HRSA Contracting 
Officer, accounting for all allowable OPTN contract expenses that UNOS 
incurred during the month of June. HRSA reviews the voucher, and once 
approved, UNOS transfers funds from the OPTN operating account to the 
UNOS operating account to reimburse UNOS for expenses that UNOS has 
already incurred and paid. This process occurs every month.

    In pre-hearing interviews, Finance Committee staff specifically 
asked about Note 4 in UNOS's most recent financial audit, which is 
readily available online.\2\ The American Association of International 
Certified Professional Accountants' (AICPA) Financial Accounting 
Standards Board established a requirement that nonprofit organizations 
must disclose publicly the amount of liquid resources available to 
cover 12 months of expenses, in order for readers of the financial 
statements to more accurately assess the organization's financial 
stability.\3\ Note 4 of the UNOS financial audit details the amount of 
assets that are available to pay organizational expenses in the next 
12-month period.
---------------------------------------------------------------------------
    \2\ 2021 UNOS Audited Financial Statement. https://unos.org/wp-
content/uploads/2021-Audited-Financial-Statement.pdf.
    \3\ Accounting Standards Update (ASU) 2016-14, Not-for-Profit 
Entities (Topic 958): Presentation of Financial Statements of Not-for-
Profit Entities, available at https://www.fasb.org/page/
PageContent?pageId=/projects/recentlycompleted/statements-
notforprofit.html&isstaticpage=true (accessed October 11, 2022).

    An auditor completing the type of information contained in Note 4 
evaluates whether there are limitations or restrictions on a nonprofit 
organization's cash or cash equivalents that would make those assets 
unavailable for general expenditures that will arise in the next 12 
months. General expenditures are not defined but are understood to mean 
those costs associated with the ordinary course of business. Cash or 
cash equivalents are restricted if, for example, a donor places 
limitations on the purpose for which a cash donation can be used, or 
---------------------------------------------------------------------------
the time period during which it must be used.

    It is also important to read Note 4 in conjunction with the 
preceding Notes in the report. In particular, Note 1 describes that 
UNOS ``functions as the sole national network whose mission is to 
improve the effectiveness of the United States organ procurement and 
transplantation system and to provide for the fair and equitable 
distribution of all donated organs. To carry out this mission, the 
Organization maintains a computerized database to identify potential 
transplant recipients and to provide for the systematic matching of 
donated organs with such recipients.''

    Thus, in Note 4, ``when collection of OPTN registration fees exceed 
the reimbursable costs incurred at a given point in time by the 
Organization,'' the Organization ``has determined that the use of the 
restricted cash and investments amounts will be for mission-related 
activities within 1 year and, accordingly, these amounts are included 
in financial assets available to meet general expenditures within 1 
year.'' The mission being those OPTN activities described in Note 1.

    To reiterate, excess OPTN registration fee revenues are used only 
for allowable OPTN contract purposes and will remain in the OPTN 
operating account until authorized to pay allowable contract costs, or 
transferred to the OPTN reserve fund, as appropriate.

    Question. One of the baseline requirements for Federal contracting, 
Medicare, and Medicaid costs is that they must be reasonable and 
necessary.

    How does OPTN/UNOS define both ``reasonable'' and ``necessary'' for 
itself and other parties in the OPTN?

    Answer. The OPTN and UNOS Board of Directors Finance Committees are 
composed of members of the donation and transplant community, along 
with non-voting advisors and, on the OPTN Finance Committee, 
representatives from HRSA. These Committees develop the annual OPTN and 
UNOS budgets and related fees before seeking approval from the Board of 
Directors.

    The OPTN final rule requires the OPTN, annually, to establish the 
OPTN registration fee for patients registered on the wait list, and 
requires that the fee shall be determined by the OPTN and calculated to 
cover the ``reasonable costs'' of operating the OPTN, with approval 
from the Secretary:

        An OPTN member shall pay a registration fee to the OPTN for 
        each transplant candidate it places on the waiting list. The 
        amount of such fee shall be calculated to cover (together with 
        contract funds awarded by the Secretary) the reasonable costs 
        of operating the OPTN and shall be determined by the OPTN with 
        the approval of the Secretary. No less often than annually, and 
        whether or not a change is proposed, the OPTN shall submit to 
        the Secretary a statement of its proposed registration fee, 
        together with such supporting information as the Secretary 
        finds necessary to determine the reasonableness or adequacy of 
        the fee schedule and projected revenues. This submission is due 
        at least 3 months before the beginning of the OPTN's fiscal 
        year. The Secretary will approve, modify, or disapprove the 
        amount of the fee.\4\
---------------------------------------------------------------------------
    \4\ 42 CFR Sec. Sec. 121.5(c).

    The budget development process applies these ``reasonable cost'' 
principles as is inherent in the budgeting process for public and 
private institutions. The OPTN Finance Committee considers multiple 
factors when determining what the ``reasonable costs'' of operating the 
OPTN will be for the upcoming fiscal year. With respect to the OPTN 
contract, revenue will consist of the estimated number of candidates 
added to the waiting list multiplied by the approved OPTN Registration 
Fee, and the contracted amount for the Federal appropriation. The 
expense portion of the budget includes a detailed analysis of several 
factors including but not limited to: the strategic and operational 
goals of the OPTN; the estimated personnel costs to deliver the 
requirements of the OPTN contract; the technology roadmap; and the 
estimated number of policy projects the OPTN is anticipating and 
---------------------------------------------------------------------------
developing.

    The OPTN Finance Committee propose a budget to address these goals, 
and the board of directors approves the proposed budget. Ultimately, 
the Secretary of HHS must approve the OPTN budget and associated OPTN 
Registration Fee.

    Neither UNOS nor the OPTN bill Medicare, Medicaid, or any Federal 
or State public health insurance program for services.

    Question. In the August 3rd hearing, you stated that UNOS lacks 
strong enforcement levers to hold OPOs accountable. Specifically, you 
stated that, ``The statute does not give UNOS any authority to offer 
sanctions . . . the certification, decertification and payment 
authorities belong to entirely to CMS.'' However, the OPTN final rule 
gives UNOS the ability to refer an OPO to the Secretary of HHS for 
decertification. In the 40 plus years of holding the OPTN contract, 
UNOS has only referred an OPO to the Secretary once.

    Why has UNOS only used this enforcement authority one time? Does 
UNOS feel this appropriate reflects the overall performance of OPOs 
during its tenure as the OPTN?

    Answer. Oversight, rigorous performance measures, and continuous 
improvement are essential parts of the Nation's organ donation and 
transplantation system. The OPTN maintains a robust system for 
monitoring member compliance with ``OPTN Obligations.'' OPTN 
Obligations are defined in the OPTN Bylaws as ``. . . all the 
applicable provisions of the National Organ Transplant Act (NOTA), OPTN 
Final Rule, OPTN Charter, OPTN Bylaws, and OPTN Policies.'' Pursuant to 
42 CFR Sec. 121.10(b), the OPTN conducts ongoing and periodic reviews 
of each member OPO for compliance with these obligations.\5\
---------------------------------------------------------------------------
    \5\ OPTN Compliance and Evaluation. https://
optn.transplant.hrsa.gov/policies-bylaws/compliance-and-evaluation/.

    The final rule defines the scope of the OPTN's role in monitoring 
members, and that role was specifically designed by HHS to focus on 
---------------------------------------------------------------------------
member support and quality improvement.

    The OPTN board-approved charge for the Membership and Professional 
Standards Committee (MPSC) requires that the MPSC monitor OPTN member 
compliance with OPTN membership criteria, OPTN bylaws and policies, and 
the OPTN final rule. Through a robust peer and effective peer review 
process, the MPSC analyzes events that are identified as presenting a 
risk to patient safety, public health or the integrity of the OPTN. The 
MPSC also evaluates and supports OPTN members by providing feedback on 
and making recommendations to improve members' performance, compliance 
and quality systems. The MPSC also identifies opportunities to educate 
the community about improving patient safety through effective 
practices.

    When the MPSC considers members under review, the committee's 
discussion centers primarily on how the member can improve its 
performance, if corrective action planning or quality improvement 
planning is necessary, and what benchmarks the member can provide the 
MPSC to ensure they are correcting and improving. The MPSC is made up 
of experienced donation and transplant professionals who are in the 
best position to identify programs who can benefit from coaching and 
help them improve. The MPSC takes action or makes recommendations for 
further action to the OPTN board of directors as needed.

    Based on law, precedent, policy, and longstanding effective 
practices for quality improvement in health care, the OPTN's role is to 
support its members in driving their improvement. Both the final rule 
and the OPTN contract require the OPTN to employ a peer review process 
and provide and facilitate confidential coaching of effective 
practices, in contrast to the regulatory and financial oversight rules 
that CMS provides. Sanctions are indeed a tool, but actions such as 
decertification reside outside of the OPTN's mandated purview. Only the 
Secretary of HHS is empowered to remove a member from the OPTN, and the 
Secretary is not bound by the OPTN's recommendation, even in those 
instances in which a member is referred to them. If a referred member 
is not decertified, they remain a member of the OPTN. In all cases, the 
OPTN's focus remains on member improvement. As noted in our response to 
Senator Wyden, the MPSC will discuss specific potential improvements to 
the process at its October 2022 meeting.

    UNOS supports enhanced communications with CMS in particular, as 
well as a more formal communication process between CMS and the OPTN. 
In that process, UNOS believes communication must flow both ways. UNOS 
would also be pleased to discuss with Congress, CMS, HRSA and HHS any 
ongoing concerns about this process, to provide additional information 
about how the review and member improvement approach works. We 
understand the committee's interest in promoting the sharing of 
valuable incident data within the OPTN and with Federal regulators. We 
believe it is critical that any mechanisms for increased sharing 
continue to protect patient privacy and to promote candid self-
disclosure when incidents do occur.

    Question. During the August 3rd hearing you stated that the OPTN 
``peer review process has significant persuasive authority, but all the 
payment authority and all the certification/decertification authority 
[for OPOs] live at CMS.''

    Does UNOS routinely provide CMS with critical information on each 
OPO's history of performance, policy compliance, and safe practice or 
lack thereof, so that CMS may adequately enforce these payment and 
decertification authorities?

    If yes, please describe the mechanisms in place for UNOS to share 
this information on a routine basis.

    At the hearing, you alluded to HRSA's role in communicating this 
type of information to CMS. Does UNOS routinely provide HRSA with 
critical information on each OPO's history of performance, policy 
compliance, and safe practice or lack thereof, so that HRSA may report 
this information to CMS?

    We understand from your testimony that HRSA participates in MPSC 
discussions, but how does UNOS ensure HRSA is fully informed when less 
than half of the OPO patient safety cases reported to UNOS in recent 
years were referred to the MPSC?

    Are OPOs and transplant centers required to report safety events to 
UNOS? If so, please describe the requirements.

    Is UNOS aware of failures to report safety events by any OPOs or 
transplant centers? If so, what were the consequences of these 
failures?

    Answer. As the OPTN contractor, we have always welcomed a 
substantive conversation about how best to share information with the 
Federal Government in this process to ensure that all parties remain 
informed. While we routinely provide HRSA information on member 
performance, we do not routinely provide CMS with the same information. 
Whether HRSA shares information with CMS is beyond our knowledge, as we 
have traditionally been required to limit sharing of information only 
to HRSA. However, we will be pleased to provide CMS with information if 
directed and permitted by the OPTN Contracting Officer's Representative 
(COR).

    Engagement with HRSA and CMS: The OPTN board and committee 
structure as required by NOTA, the final rule, and the OPTN contract is 
designed to ensure HRSA is engaged and included at all levels of 
governance. HRSA representatives serve as non-voting members of all 
OPTN committees, as well as on the OPTN board of directors. 
Additionally, HRSA representatives are present for all closed sessions 
of the MPSC. If HRSA requests information from the OPTN, even 
information protected by confidential medical peer review, the OPTN is 
obligated to provide that information. The OPTN does not have 
discretion over what HRSA does with any of this information after it is 
provided and does not have insight over what HRSA provides to CMS.

    We believe it is important that both HRSA and CMS fully understand 
the issues the MPSC addresses in its peer review and monitoring 
processes. Expanding communication to include direct engagement between 
CMS and the OPTN is likely important to have more coordinated oversight 
of the system and of OPOs in particular.

    As mentioned above, HRSA is intimately involved in the OPTN's 
compliance processes, and is informed of all cases sent to the MPSC. In 
addition to being a part of the MPSC and the OPTN board of directors, 
HRSA attends weekly MPSC leadership calls, during which HRSA and MPSC 
leadership are apprised of any ongoing issues. HRSA has access to all 
MPSC meeting agendas and materials, consistent with contract 
requirements. If staff are not clear about whether a case should be 
referred to the MPSC, staff will brief the MPSC leadership, including 
HRSA, so that MPSC leadership can make an informed determination. Staff 
also provide the MPSC with a retrospective report of the issues 
reported in the previous year and provide a similar report to HRSA as 
required in the OPTN contract. Even if a case is not reported to the 
MPSC, it may nevertheless be reported to HRSA if it meets certain 
agreed upon criteria, or other criteria agreed upon in the OPTN 
contract.

    Additionally, pursuant to the OPTN contract, UNOS staff annually 
provide HRSA a monitoring report, which includes aggregate information 
about the monitoring activities of both the MPSC and UNOS Member 
Quality. The report provides data on efforts to monitor members and 
improve member performance and compliance.

    Reporting Patient Safety Events: Promoting patient safety is 
central to the integrity of the donation and transplant system. OPTN 
members are both required and encouraged to report safety events, and a 
dedicated Patient Safety Portal is available for members to report 
issues. However, the OPTN has been intentional about not explicitly 
defining a ``patient safety event'' in OPTN policy in order to avoid 
the risk of members potentially not reporting concerning events that 
might fall outside a strict definition.

    The OPTN contract requires UNOS to ``encourage OPTN member self-
reporting of potential patient safety issues'' but does not provide an 
explicit definition for patient safety, save for a reference to types 
of patient safety events described in the August 5, 2011 letter from 
former HRSA Administrator Mary Wakefield (``the Wakefield letter'') to 
then-OPTN board president Dr. John Lake.

    As an example of the emphasis on patient safety, regardless of 
definition, UNOS exceeds what is required in terms of providing 
expedited notice to HRSA should any event meet the criteria outlined in 
the Wakefield letter list of events; UNOS routinely provides notice 
about other events that appear to be patient safety events despite not 
being included on this list. This ensures that the broadest possible 
scope of events reaches the MPSC for expert review and reasoned 
deliberation to determine if an incident poses a risk to patient health 
or public safety.

    There are a number of OPTN policies that require submission 
regarding specific kinds of patient safety events. Those policies 
include, but are not limited to:\6\
---------------------------------------------------------------------------
    \6\ OPTN Policies. https://optn.transplant.hrsa.gov/policies-
bylaws/policies/.

          15.5 Transplant Program Requirements for Communicating Post 
        Transplant Discovery of Disease or Malignancy.
          15.6 Living Donor Recovery Hospital Requirements for 
        Reporting Post-
        Donation Discovery of Disease or Malignancy.
          16.2 Packaging and Labeling Responsibilities.
          18.5 Reporting of Living Donor Events.

    Additionally, when OPTN members use the Patient Safety Portal to 
file a report, the portal itself outlines the types of events that OPTN 
members should report, including: ``situations or activities that could 
have affected patient safety. These situations may be related to 
patient safety, organ placement/availability, communications, clinical 
information accuracy, or risk of disease transmission that was 
prevented. Situations that may not directly impact safety, 
availability, or utilization but cause concern from a transplantation, 
donation and/or quality perspective may also be reported.''

    The OPTN becomes aware of patient safety events when events are 
reported directly or otherwise discovered by the OPTN. If a member does 
not report a patient safety event to the OPTN as outlined in OPTN 
policies, that would qualify as a separate OPTN policy violation and 
would be addressed on a case-by-case basis by the MPSC. Any 
noncompliance is serious, and we are committed to engaging in 
substantive conversations to address additional concerns the committee 
may have about the MPSC's processes, and welcome opportunities to work 
collaboratively to strengthen the rigorous, widely-used, and regulation 
and contract-mandated confidential peer review process.

    Question. Is UNOS able to calculate how many organs are matched 
with a wait-list patient but ultimately not transplanted? If so, please 
provide this number for each organ type in each of the last 5 years. To 
the extent possible, please provide the reason the organ was not 
ultimately transplanted.

    Answer. Increasing the number of transplants by improving organ 
utilization is a key strategic goal of the OPTN. The OPTN classifies 
organ ``discards,'' or organs recovered for transplant but not 
transplanted, as an organ that is recovered for the purpose of 
transplant and ultimately not transplanted. The reasons for an organ 
not being transplanted are provided to the OPTN by the recovering OPO, 
and are categorized below:

    1.  Each transplant team who received the organ offer declined the 
offer until there were no remaining wait-listed patients who matched 
with the available organ.
    2.  There were biopsy findings that would make transplant unsafe.
    3.  There were poor organ function or organ disease that would make 
transplant unsafe.
    4.  There were anatomic abnormalities that would make transplant 
unsafe.
    5.  There were other unspecified medical reasons.

    In most cases it is only kidneys, pancreata, and organs which will 
be used for research purposes that travel without an accompanying team 
of physicians. Livers, hearts, and lungs are generally not recovered 
until the offer has been accepted by the candidate's transplant team; 
the organ is then recovered by the candidate's transplant team who 
maintain physical possession of the organ until the transplant surgery.

    The following 2 tables provide the rate of ``discarded'' organs by 
year/organ and the reasons for ``discard.''

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Question. For over 40 years, UNOS has remained the only 
organization to manage the OPTN. As the sole operator, UNOS is 
accountable for the outcomes that have occurred during their 
management.

    How does UNOS plan to address concerns raised by members during the 
committee's August 3rd hearing, as well as concerns raised in the 
committee's report?

    What is UNOS doing, or planning to do, to improve its performance 
in its role as the OPTN? Please provide these plans for improvement, as 
well as when and how UNOS plans to accomplish them.

    Answer. The strength of the U.S. donation and transplant system 
lies in the hundreds of volunteer committee members who are integral to 
the policy development process. This governance system includes two 
patient and donor affairs representatives on all policy development 
committees, and one quarter of the national board of directors is 
composed of such representatives. As a whole, OPTN committees are made 
up of experienced medical professionals, recipients, donors and donor 
family members, and all are focused on honoring the gift of life by 
increasing transplant. These stakeholders come together to create 
policies after extensive collaboration, which also involves 
incorporating input received during a rigorous public comment process. 
The OPTN contractor is tasked with facilitating this process.

    We agree that the OPTN contractor and all parties involved in the 
organ donation and transplant system should be held to extremely high 
standards and be held accountable for their performance. UNOS is proud 
to be part of a system celebrating 9 consecutive years of growth in the 
number of deceased donor transplants, 11 consecutive years of growth in 
deceased donation, and record numbers of kidney, heart, and liver 
transplants in 2021--a year in which the U.S. exceeded 40,000 
transplants for the first time.\7\ In this system, tireless and 
dedicated donation and transplant professionals continued to go above 
and beyond to serve patients, despite a global pandemic. Of course, 
though these are remarkable achievements, they are only made possible 
thanks to the generosity of organ donors and their families nationwide.
---------------------------------------------------------------------------
    \7\ All-time records again set in 2021 for organ transplants, organ 
donation from deceased donors. Organ Procurement and Transplantation 
Network. https://optn.transplant.hrsa.gov/news/all-time-records-again-
set-in-2021-for-organ-transplants-organ-donation-from-deceased-donors/. 
January 11, 2022.

    It is incumbent upon us as the OPTN contractor to honor these gifts 
of life not only by fulfilling the obligations of NOTA and the OPTN 
contract to develop policies that ensure organs are allocated safely, 
equitably and efficiently to the Nation's sickest patients, but also to 
contribute to the growth and development of the system by proactively 
offering system-wide, evidence-based and patient-focused policy 
solutions at all levels of governance. Accordingly, the OPTN board of 
directors adopts a new strategic plan every 3 years to guide the work 
of the OPTN and its committees.\8\ The strategic plan maintains a 
balance between setting high level community goals and allowing 
committees the flexibility to design specific policy projects. The plan 
for 2021-2024 is built around four primary goals. The most important is 
Goal 1: Increasing the Number of Transplants, to which one third of the 
OPTN's committee project resources are allocated. The other three goals 
are Provide Equity in Access to Transplants, Promote Living Donor and 
Transplant Recipient Safety, and Improve Wait-listed Candidate, Living 
Donor, and Transplant Recipient Outcomes. Each goal is accompanied by a 
suite of performance metrics, which is presented as an annual report to 
the Board by the OPTN Executive Director. HRSA also receives this 
report as a deliverable in the OPTN contract.
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    \8\ 2021-2024 OPTN Strategic Plan. https://
optn.transplant.hrsa.gov/about/strategic-plan/.

    In addition, the OPTN maintains a publicly accessible OPTN metrics 
dashboard online, which displays key system performance indicators 
related to donation, transplantation, wait-list details, patient and 
graft survival, and transplant and mortality rates.\9\ The OPTN also 
publishes the Equity in Access Dashboard, which shows how the OPTN 
monitors trends related to equitable access to deceased donor 
transplants among active waiting list candidates in the U.S. through an 
Access to Transplant (ATS) score. The ATS follows the National 
Institute on Minority Health and Health Disparities' Minority Health 
and Health Disparities Framework, which lays out potential conditions 
that can influence a person's health outcomes.\10\
---------------------------------------------------------------------------
    \9\ OPTN Metrics Dashboard. https://insights.unos.org/OPTN-
metrics/.
    \10\ OPTN Equity in Access Dashboard. https://insights.unos.org/
equity-in-access/.

    As indicated in her inaugural message to the entire organ donation 
and transplant community, interim CEO Maureen McBride, Ph.D., said UNOS 
will remain responsive to feedback received from the public, the 
Federal Government, Congress, and other stakeholders.\11\ Dr. McBride 
will seek engagement and support from the board of directors and 
community as a whole in developing responsive improvements that 
continue to accelerate system growth, increase patient and public 
engagement, and seek to address challenges that face the system within 
and outside the scope of the OPTN contract. Dr. McBride has identified 
key areas of focus, including:
---------------------------------------------------------------------------
    \11\ UNOS names interim CEO. https://unos.org/news/unos-names-new-
interim-ceo/. October 1, 2022.

    1.  Engage patients, donors and their families to reimagine public 
engagement, information and resources: In partnership with an external 
vendor, Accenture Federal Services, a consulting firm and expert in 
human-centered design, UNOS launched a research project to better 
understand what specific information, tools and resources patients need 
the most to support them in their journey. To date, UNOS and Accenture 
have conducted more than 50 interviews with a broad spectrum of 
patients, caregivers, living donors and transplant coordinators to 
better understand their perspectives. The results of these interviews, 
which will include members of the OPTN Patient Affairs Committee, will 
serve as a foundation for operational, policymaking, and strategic 
changes to UNOS and the OPTN in service of a more patient-focused 
---------------------------------------------------------------------------
organization.

    2.  Organ tracking and transportation: We share your concern about 
organ transportation and agree that one organ lost is one too many. 
Both UNOS and the OPTN have supported system-wide improvements in this 
area, from the launch of UNOS's own organ tracking service to the 
recently board-approved enhancements to OPTN data collection related to 
organ logistics and allocation.\12\ Pending OMB approval, the data 
collection is expected to begin in May 2023. OPTN committees are 
currently building upon this work, exploring the development of common, 
community-wide guidance outlining the importance of organ tracking data 
and effective practices, as well as possible pathways within the 
authority of the OPTN for enhancing organ tracking system-wide. UNOS is 
also developing a technology product to help OPOs identify the most 
expeditious transportation options for organs given the dynamic 
challenges in the allocation system.
---------------------------------------------------------------------------
    \12\ ``Notice of OPTN data collection changes: Data collection to 
evaluate organ logistics and allocation.'' https://
optn.transplant.hrsa.gov/media/5accb1s3/policy-notice_osc_data-
collection.
pdf.

    3.  Enhancements to the MPSC peer review process: At its October 
2022 meeting, the MPSC plans to review and reaffirm its operational 
rules and discuss the current construct of peer review as a mechanism 
for its reviews. The committee also plans to assess potential 
improvements to the way it shares information with the broader 
community, as well as other OPTN committees, for the benefit of the 
system and, ultimately, patients. Several recent system enhancements 
focused on increasing patient safety were a direct result of the MPSC 
peer review process. The MPSC is also driven to connect community 
members with peer mentors in order to improve the system and 
disseminate effective practices. Continuing to broadly disseminate MPSC 
learnings and improvement structures may inform future OPTN 
policymaking, lead to additional technology enhancements and spur 
future collaborative improvement initiatives. The OPTN Board will 
review and discuss the MPSC's recommendations at its December 2022 
---------------------------------------------------------------------------
meeting.

    4.  Seek support from HHS to expand data collection throughout the 
transplant journey: Referral to a transplant program for a medical 
eligibility evaluation is the initial step to receiving a transplant, 
but patient referral information is siloed and not available in a 
systematic fashion. The barriers in these initial steps in the 
transplant process may be exacerbated by a number of social 
determinants of health. The OPTN will seek support from the Secretary 
to expand data collection of patient referral information as a next 
step to evaluating and enhancing equity in access to the transplant 
wait list.

    5.  Changes to UNOS senior leadership: On October 1st, Dr. McBride 
announced a restructured senior leadership team. Her new team includes 
key positions that renew a focus on streamlining operations to ensure 
UNOS is providing an equitable and inclusive environment for the 
volunteer workforce, the donation and transplant community, and the 
patients it serves; ensuring UNOS is the best possible steward of the 
resources it manages, promoting excellence and efficiency; and taking a 
holistic, data-based approach to how it drives strategy across the 
organization.

    6.  Separating the OPTN and UNOS boards: UNOS board leadership 
finalized a work plan to formally separate the OPTN and UNOS boards in 
September 2022, developed after ongoing discussions that began in 2021. 
UNOS will work with HRSA to take the necessary legal, contractual and 
operational steps to implement the plan.

    7.  Serve as a ``convener'' for system-wide initiatives and 
improvements: UNOS will continue to partner with other key stakeholder 
groups and leaders in the fields of medicine, technology and data on 
strategic initiatives that contribute to the advancement of the field 
of organ donation and transplant. For example, UNOS hosts an annual 
conference for transplant administrators annually, sponsors a 
professional education forum, and hosts meetings with key stakeholders 
in the community. To this end, UNOS also will seek to expand 
relationships with patient advocacy groups and other public health 
organizations. Together, UNOS and its partners will identify and 
advocate for evidence-based, patient-centered, systems improvement 
policy solutions.

                                 ______
                                 
               Questions Submitted by Hon. Chuck Grassley
    Question. The U.S. Digital Service (USDS) found UNOS's information 
technology (IT) systems outdated and voiced concerns that it operates 
on local data centers, rather than the cloud, and relies on manual data 
entry, resulting in user error and unacceptable downtime. USDS 
recommended that the Federal government take action to create a better 
organ transplant system including that the Organ Procurement and 
Transplantation Network (OPTN) IT contract be bid separately because 
UNOS has ``denied nearly 100 Federal requests to audit source code.''

    Why has UNOS denied Federal requests to audit its source code?

    How can Congress--or patients--trust UNOS to oversee its IT systems 
when reports show that it is fragile and antiquated?

    Has UNOS provided a demonstration of its IT system for the Health 
Resources and Services Administration (HRSA) or discussed its IT 
modernization efforts with them? If not, why not?

    Will you commit that UNOS will have this discussion with HRSA or 
other Federal agencies?

    If the technology component of the OPTN contract is awarded to a 
different vendor, will UNOS commit to working with the Federal 
government to ensure a smooth transition for transplant patients?

    Answer. UNOS appreciates the opportunity to address this concern 
and clarify any lingering misconceptions. The entirety of the report, 
as provided by a member of the media earlier this year, appears to be 
based on a 90-minute presentation by UNOS on December 10, 2020, 
pursuant to a request from HRSA during its 2019 Market Research for the 
Modernization National Resource Allocation System, as well as UNOS's 
responses to a set of follow-up questions submitted by HRSA.

    The USDS has never conducted a review of our systems, and to date, 
they have not reached out to UNOS directly regarding the results of 
their report. UNOS continues to welcome the opportunity to review our 
systems with the USDS and discuss our architecture, code base and 
infrastructure. In an August 2, 2022, letter to the HRSA Administrator, 
UNOS reiterated our willingness to undergo any additional review deemed 
necessary. UNOS was and continues to be eager to engage directly with 
USDS in the interest of continually improving our technology systems 
and infrastructure.\13\
---------------------------------------------------------------------------
    \13\ Letter to HRSA Administrator. https://unos.org/wp-content/
uploads/20220802_UNOS-McCauley-Letter-to-HRSA-Administrator.pdf.

    HRSA conducts an annual audit of our entire IT infrastructure, and 
consistently reviews the performance and security of the OPTN system in 
detail, as required by the OPTN contract. Their 2022 audit of our 
systems is currently underway. HRSA also reviews all OPTN contractual 
requirements for compliance annually, as well as on a periodic basis 
throughout each year. UNOS consistently meets or exceeds all 
contractual obligations. Semiannual tests are also conducted on OPTN IT 
systems by a verified third party. UNOS has also just shared with HRSA 
the results of the most recent cybersecurity penetration testing 
---------------------------------------------------------------------------
conducted by a third party in August.

    The topics discussed have included the IT 3-year strategic plans, 
API strategy and updates, new concepts requested by the transplant 
community, information security, business continuity and disaster 
recovery, cloud transformation, test automation, establishment, and 
updates on the organ allocation assurance program, collaboration/
innovation events at various transplant conferences and numerous 
others. Multiple times every year, and outside of annual audits, UNOS 
has discussed a modernization strategy and updates on efforts for the 
IT system with HRSA and the OPTN board of directors. Since 2016, this 
has been a standing agenda item at every technology committee meeting 
and annually at the OPTN board meeting. These discussions are 
memorialized in OPTN Network Operations and Oversight Committee (NOOC) 
meeting summaries published on the OPTN website.\14\
---------------------------------------------------------------------------
    \14\ OPTN Network Operations and Oversight Committee (NOOC) meeting 
summaries. https://optn.transplant.hrsa.gov/about/committees/network-
operations-oversight-committee-board-of-directors/.

    On February 9, 2017, HRSA staff (including the program office, 
information technology and procurement) conducted an onsite, all-day 
visit where various UNet functions were demonstrated, and where an IT 
modernization strategy and progress were presented. More recently, our 
IT system was demonstrated to HRSA at the December 2020 HRSA Market Day 
presentation and again in September 2022, during the kickoff of the 
---------------------------------------------------------------------------
annual HRSA audit.

    Since April 2019, the start of the current OPTN contract, and at 
every subsequent contract year kickoff meeting with HRSA, UNOS IT has 
presented technology modernization accomplishments for the prior year, 
as well as plans for the current contract year. These meetings are with 
the HRSA OPTN Contracting Officer's Representative (COR) and other HRSA 
staff.

    UNOS's technology systems are uniquely designed to support complex 
allocation policies; they are flexible, modular and integrated within 
the policy development framework, so as policies and clinical 
requirements evolve, our systems can quickly evolve and change with 
them. Additionally, our technology experts have deep experience and 
understanding of transplant allocation algorithms, business rules and 
logic, making for a seamless transition from policy to technology. A 
dedicated IT liaison is assigned to each policy-making committee and 
regularly attends committee and leadership meetings to ensure the 
committee understands how the system works, and how intended changes to 
policies might impact data collection and workflows. As part of the 
interdepartmental team supporting committees, the IT liaison 
participates in policy development from the idea stage, through public 
comment, and board approval, refining business requirements and 
ensuring that the policies can be supported with scalable technology 
solutions that meet policy intent. IT's engagement with the solution 
development allows a variety of technology options to be shared with 
the committee as new policies are developed. Weekly meetings among 
support staff and with committee leadership ensure alignment between 
policy and system implementation at each stage.

    However, UNOS is never satisfied with the status quo. That is why 
we remain committed to constantly improving our IT systems and 
responding to shifts in the technology and cybersecurity landscape to 
make our systems as safe, secure, efficient, and responsive to our 
members' needs as possible.

    Since 2019, UNOS has maintained a cross-departmental team that is 
focused on creating public cloud patterns that can scale our ideas and 
core infrastructure for the capabilities found in the public cloud. 
While building this expertise, we have partnered with the Microsoft 
Tech for Social Impact team to align our vision with a reality we can 
bring to the transplant community.

    In 2021, UNOS completed a transformation to a multi-regional hybrid 
cloud environment built using Nutanix cloud infrastructure and 
Microsoft Azure public cloud. In line with a cloud-first approach for 
all new functionality, UNOS has implemented new cloud-native real-time 
capabilities in Predictive Analytics decision support for organ offer 
acceptance, while actively executing a roadmap to move existing core 
infrastructure to the public cloud. Building microservices is critical 
to driving a seamless experience for a scalable solution that is built 
both by UNOS teams and vendors in the community. As of January 2022, 
UNOS has built hundreds of microservices as well as APIs with key 
integrations with vendors through our developer portal that is 
supported by Google Cloud's API management platform, Apigee.

    One of the greatest challenges remains community adoption. Building 
and providing members with APIs does not guarantee that transplant 
hospitals, organ procurement organizations and histocompatibility 
laboratories will use them. Decisions to adopt APIs are at times driven 
by cost considerations between OPTN members and their Electronic Health 
Records (EHRs, such as Epic, CareDX, TransplantConnect, etc.) who 
integrate with our APIs. There are also cases when the OPTN members 
decide not to leverage APIs because of previously implemented 
automation, where the information they submit to OPTN is created 
automatically within their EHR versus being entered manually. This 
automation was built years ago in collaboration between UNOS and the 
EHRs servicing OPTN members.

    UNOS believes that APIs are still the path forward for seamless 
data exchange between systems and have staff who work directly with 
OPTN members and their software vendors (EHRs) to promote awareness and 
adoption of our APIs. To build on that investment, UNOS is partnering 
with Accenture Federal, a consulting firm and tech leader, to expand 
and extend our API strategy to increase API adoption. This strategy is 
focused on working with OPTN Member organizations to help them 
understand what APIs they have access to but are not yet leveraging, 
assisting them with implementation and testing, and driving process 
improvements to further streamline future adoption.

    There are opportunities to continue to improve the usability of 
UNet applications to save users time and streamline customer 
experience. To accomplish this, we also are working with our strategic 
partner Accenture Federal, given their expertise in digital 
transformation for Federal agencies using human-centered design, to 
redesign the user interface and workflows within UNet applications. Our 
goal is to make it more convenient, easier and faster for transplant 
coordinators to manage patients in the national transplant system.

    UNOS welcomes the opportunity to have focused and open discussions 
about how we can continue to improve the information technology systems 
that support the national transplant system. It bears repeating that we 
invite the USDS and HRSA to participate in meaningful conversations 
about our systems and improvements, and UNOS welcomes any additional 
feedback they can provide.

    Based on the data, annual HRSA audits, demonstrations, third-party 
reviews and the fact that the system has remained safe for 36 years 
despite over 3 million hacking attempts each day, Congress and patients 
can trust the technology that powers the Nation's transplant system, 
which remains safe, secure and efficient.

    Question. During the committee's August 3, 2020 hearing, you 
testified that UNOS's IT system was ``paid for in part by taxpayers.''

    How much of UNOS's IT system was paid for by taxpayers?

    How much of UNOS's IT system was paid for by OPTN members?

    Answer. The National Organ Transplant Act (NOTA), 42 U.S.C. 273 et. 
seq. requires that the OPTN operate a national system to allocate 
organs using computer systems, and thus the costs of operating the OPTN 
include the costs of operating a national system using computer 
technology to allocate organs, including updates to reflect changes in 
organ allocation policies, data collection, security, privacy, 
reliability, improvements and architecture. The OPTN contract requires 
the OPTN contractor to provide computer systems and software to meet 
the statutory obligations of the OPTN, as well as meet extensive 
Federal requirements for security, operability, privacy, and 
reliability.

    Within the UNOS budget, which is separate and distinct from the 
OPTN budget, approximately 8-10 percent of UNOS revenues come from 
Federal appropriations. Because UNOS does not directly bill Medicare, 
Medicaid, or any other public insurance program or system, UNOS cannot 
provide insight into the reimbursements hospitals and transplant 
centers receive from public or private insurance. UNOS bills the 
hospital directly and in turn is reimbursed by the hospital directly.

    Approximately 85-90 percent of the OPTN budget is from a one-time 
fee transplant hospitals pay per patient registered on the wait list.

    Question. During the committee's August 3, 2022 hearing, you 
acknowledged that over 3,000,000 attempts are made each day to hack 
into UNOS's IT system. Does UNOS report these hacking attempts to the 
Cybersecurity and Infrastructure Security Agency (CISA)? If so, what 
types of information does UNOS share with CISA, and how often?

    Answer. CISA conducts cyber hygiene scans of our external-facing 
network weekly for vulnerabilities. Our scanning efforts with CISA 
began this year, resulting in one ``low'' priority finding to date. We 
subscribe to their alert program and are provided alerts for active 
attacks and vulnerabilities. We also receive Indicators of Compromise 
(IOCs) from them. We would report any impactful cybersecurity incidents 
to CISA.

    Question. On April 27, 2022, UNOS acknowledged that it failed to 
report 35,000 deaths among patients on the waiting list. According to 
UNOS, ``process improvement and automation'' allowed it to verify this 
figure. This is deeply concerning and illustrates how the quality of 
information provided by UNOS complicates policymakers' understanding of 
how to improve outcomes for patients.

    Please explain what new ``process improvement and automation'' have 
allowed UNOS to report 35,000 additional deaths on the waiting list.

    What caused the failure to identify to and report the additional 
deaths? Is the failure attributed to UNOS technology, and/or other 
factors?

    Can UNOS provide a breakdown of the 35,000 additional deaths based 
on patient attributes such as race, religion, age, sex, veteran status, 
rural status, or physical or mental disability? If not, why not?

    How many new or amended OPTN policies have relied on UNOS's faulty 
data?

    How many times did UNOS cite incorrect patient death data in 
communications with policymakers and administrators in the executive or 
legislative branches?

    Answer. We appreciate the opportunity to clarify this issue for the 
committee.

    Prior to 2013, UNOS, as the OPTN contractor, had routine access to 
the full and publicly available Social Security Death Master File. That 
information supplemented the deaths reported to the OPTN by member 
institutions. As of 2013, however, that file has not been publicly 
available.

    A new agreement between HRSA and CMS was established that allowed 
the OPTN to continue having access to death data, on the condition that 
the OPTN must verify each of the deaths with an external source prior 
to release in the publicly available OPTN dataset. As part of this 
workflow between 2013 and 2022, a multi-tiered process was used for 
this verification, which included a manual review of obituaries online. 
This process consumed significant resources each month, and the OPTN, 
in collaboration with HRSA, limited the process to verifying those 
deaths most likely to impact data analyses used for policy development 
and monitoring of member performance.

    As part of our continuous improvement efforts, UNOS evaluated 
several technology and software solutions to automate the manual 
searching of obituaries. UNOS partnered with a vendor in 2021 whose 
technology was able to scan vastly more obituaries and match those 
deaths to become part of the publicly available OPTN dataset.

    The first complete scan with this new software verified 35,087 
deaths that had been previously unreported to the OPTN, and that dated 
back several decades. Following the data use agreement between HRSA and 
CMS, those data were then incorporated into the publicly available OPTN 
data set in the spring of 2022.

    It is important to note that of these 35,087 deaths, roughly 23,000 
were of transplanted patients who died at some point after their 
transplant (which in many instances could be years later). Fewer than 
100 were of patients who were active on the waiting list at the time of 
their death, and roughly 12,000 were patients who died at some point 
after they had been removed from the wait list. Transplant programs 
remove patients from the wait list for a variety of reasons including 
the patient being too sick to transplant, their condition improves, 
they refuse a transplant, transplant programs are unable to contact 
them, or other reasons. In this verification process used by the OPTN, 
the reasons for death are unknown or unreported and could be for 
reasons unrelated to transplantation.

    Religion and/or physical or mental disability are not part of OPTN 
policies and are not collected by the OPTN. Data regarding veteran 
status is not specifically collected; however, the primary source of 
payment is reported by transplant programs, and the Department of 
Veterans Affairs is one of the possible selections.

    Below is a breakdown of the recently verified 35,087 patient deaths 
by race/
ethnicity, age (at listing or transplant), education status at time of 
listing, primary source of payment (at listing or transplant).


------------------------------------------------------------------------
                                          Number of        Percent of
                                       Patient Deaths    Patient Deaths
------------------------------------------------------------------------
Total Individuals                               35,087            100.0%
------------------------------------------------------------------------
Race/Ethnicity
------------------------------------------------------------------------
White, Non-Hispanic                             20,282             57.8%
------------------------------------------------------------------------
Black, Non-Hispanic                              8,425             24.0%
------------------------------------------------------------------------
Hispanic/Latino                                  4,590             13.1%
------------------------------------------------------------------------
Asian, Non-Hispanic                              1,209              3.4%
------------------------------------------------------------------------
American Indian/Alaska Native, Non-                349              1.0%
 Hispanic
------------------------------------------------------------------------
Native Hawaiian/other Pacific                      131              0.4%
 Islander, Non-PHispanic
------------------------------------------------------------------------
Multiracial, Non-Hispanic                           96              0.3%
------------------------------------------------------------------------
Unknown                                              5              0.0%
------------------------------------------------------------------------
Age at Transplant/Listing *
------------------------------------------------------------------------
< 1                                                  1              0.0%
------------------------------------------------------------------------
1-5                                                 35              0.1%
------------------------------------------------------------------------
6-10                                                74              0.2%
------------------------------------------------------------------------
11-17                                              249              0.7%
------------------------------------------------------------------------
18-34                                            3,097              8.8%
------------------------------------------------------------------------
35-49                                            9,424            26.89%
------------------------------------------------------------------------
50-64                                           15,860             45.2%
------------------------------------------------------------------------
65+                                              6,347             18.1%
------------------------------------------------------------------------
Education Level at Listing **
------------------------------------------------------------------------
Not Reported                                     2,948              8.4%
------------------------------------------------------------------------
None                                               138              0.4%
------------------------------------------------------------------------
Grade School (0-8)                               1,821              5.2%
------------------------------------------------------------------------
High School (9-12) or GED                       13,284             37.9%
------------------------------------------------------------------------
Attended College/Technical School                6,804             19.4%
------------------------------------------------------------------------
Associate/Bachelor Degree                        3,984             11.4%
------------------------------------------------------------------------
Post-College Graduate Degree                     1,700              4.8%
------------------------------------------------------------------------
N/A (< 5 years old)                                 32              0.1%
------------------------------------------------------------------------
Unknown                                          4,376             12.5%
------------------------------------------------------------------------
Primary Source of Payment at
 Transplant/ Listing *, **
------------------------------------------------------------------------
Not Reported                                     2,418              6.9%
------------------------------------------------------------------------
Private Insurance                               13,704             39.1%
------------------------------------------------------------------------
Public Insurance--Medicaid                       1,780              5.1%
------------------------------------------------------------------------
Public Insurance--Medicare FFS (Fee              8,236             23.5%
 for Service)
------------------------------------------------------------------------
Public Insurance--Medicare & Choice              3,925             11.2%
------------------------------------------------------------------------
Public Insurance--CHIP (Children's                   3              0.0%
 Health Insurance Program)
------------------------------------------------------------------------
Public Insurance--Department of VA                 334              1.0%
------------------------------------------------------------------------
Public Insurance--Other government                 145              0.4%
------------------------------------------------------------------------
Self                                                62              0.2%
------------------------------------------------------------------------
Donation                                             3              0.0%
------------------------------------------------------------------------
Free Care                                           35              0.1%
------------------------------------------------------------------------
Pending                                             57              0.2%
------------------------------------------------------------------------
Foreign Government                                   2              0.0%
------------------------------------------------------------------------
Public Insurance--Medicare (further              4,169             11.9%
 detail not collected)
------------------------------------------------------------------------
U.S./State Government Agency                       214             0.6%
------------------------------------------------------------------------
* For recipients with a transplant, age at transplant and source of
  payment at transplant were used. Age at listing and source of payment
  reported at listing were used for all other patients.
** Education at listing and primary source of payment were not collected
  throughout the entire period of OPTN data collection and therefore are
  not available for all patients.


    Question. In 2018, UNOS made significant changes to heart 
transplant selection criteria in order to reduce wait-list times, among 
other reasons. I understand that some in the heart transplant community 
are beginning to raise questions about the impact these changes have 
had on physician practice patterns.

    Is UNOS monitoring long-term changes in both clinical outcomes and 
quality of life for these post-transplant? If not, does UNOS intend to 
study the impact on these patients? If not, why not?

    Is UNOS open to making any appropriate adjustments to the system to 
help improve patient outcomes and quality of life while maintaining 
shorter wait times? If not, why not?

    Answer. Policy development does not end with implementation. A key 
aspect of the community-driven OPTN policy process is how it monitors 
both the short- and long-term outcomes and impacts of policy changes on 
patients and the system. Following the implementation of any policy, 
the OPTN begins monitoring the impact, looking for opportunities to 
potentially improve the policy, for any unintended consequences, and 
results that may require additional actions by OPTN committees and the 
board. The review process for any policy is agreed upon beforehand by 
committee leadership and is documented in the proposal that is 
ultimately reviewed and approved by the OPTN board of directors. Staff, 
committees and the board continue to analyze whether the policy is 
meeting stated goals. Additionally, UNOS researchers present their 
ongoing analysis to the sponsoring committee and interested external 
stakeholders. The committees' reviews of this analysis may result in 
new ideas to improve the policy and by extension, the overall 
transplant system. In this way, the policy development process comes 
full circle, resulting in continued innovations and improvements.

    As it specifically relates to the 2018 heart policy change, the 
OPTN Heart Committee has reviewed monitoring reports gauging the 
ongoing impact of this policy at 1 year, 18 months, 2 years and 3 years 
post-implementation of the heart allocation policy changes. As noted in 
each report, a number of key metrics are monitored, including patients 
added to the heart wait list by medical urgency, patients waiting for a 
heart transplant by medical urgency, deaths on the wait list, post-
transplant survival, the total number of transplants, the time it takes 
for a transplant hospital to accept offers, distance the heart travels 
between the donor and the recipient, utilization rates, and many other 
metrics.\15\ Where relevant, these metrics are then stratified by age, 
region, and urgency status to arrive at a fuller, more accurate picture 
of the policy's ongoing impact.
---------------------------------------------------------------------------
    \15\ OPTN Heart and Lung Resources: Heart Monitoring Reports. 
https://optn.transplant.hrsa.
gov/professionals/by-organ/heart-lung/.

    The 3-year report reviewed by the committee on October 10, 2022 is 
responsive to specific questions raised by the Heart Committee based on 
its review of past data, as well as the collective clinical experiences 
of its members who have been practicing under the new policy.\16\ For 
example, based on previous findings and recent scholarly analyses, the 
Heart Committee has since emphasized the need to better understand 
wait-list mortalities associated with the individual criteria found in 
the adult heart medical urgency statuses 2, 3 and 4. The Heart 
Committee believes these data will provide a better idea of the medical 
urgency of patients who are being transplanted at each status and help 
to identify additional opportunities to assist any populations in need 
of improved access under the revised policy.
---------------------------------------------------------------------------
    \16\  Schellinger, E.; Bradbrook, K.; Lindblad, K. ``Three-Year 
Monitoring of the Heart Allocation Proposal to Modify the Heart 
Allocation System Prepared for the OPTN Heart Committee.'' October 11, 
2022. https://optn.transplant.hrsa.gov/professionals/by-organ/heart-
lung/.

    Consistent, rigorous, data-driven monitoring and responsive policy 
changes are essential to continuously improving the national system and 
---------------------------------------------------------------------------
ensuring the best outcomes for patients.

    Question. In 2018, HRSA issued a request for proposal (RFP) for the 
operation of the OPTN. The RFP included conditions that required the 
contractor to submit a plan to ensure that the OPTN board of directors 
be separate from the contractor's board of directors. UNOS filed a 
protest with the Government Accountability Office, arguing that HRSA 
``does not have the authority under NOTA to direct the OPTN to have a 
board of directors that is separate from the entity that is awarded a 
contract to operate the OPTN.'' GAO rejected UNOS's argument and found 
``nothing in [the National Organ Transplant Act] prohibits the agency 
from issuing a solicitation that treats the UNOS and the OPTN as 
separate entities.''

    Has UNOS taken steps to separate the UNOS and OPTN board of 
directors? If not, why not?

    How does the current board structure prevent conflicts of interest?

    Answer. Yes, UNOS has taken these steps, and began the effort to 
separate the UNOS board and OPTN board in earnest in Spring 2021.

    More recently, the UNOS board of directors leadership affirmed this 
plan, passing a resolution in August 2022 charging staff ``to explore 
the separation of the boards to develop a viable framework for separate 
boards that provides clarity on roles and responsibilities, fiscal 
matters, and operational interactions between the OPTN board, HRSA, and 
UNOS. Staff are authorized to retain such experts as appropriate and 
will provide a report to the committee for its review within 30 days.''

    Currently, the existing OPTN contract with HRSA requires that the 
UNOS board of directors also serve as the OPTN board of directors. 
Thus, separation of the boards will require approval by HRSA, as it 
would require a significant modification to the OPTN contract.

    Regarding conflicts of interest, the OPTN bylaws include specific 
provisions to address and avoid conflicts of interest for both board 
and committee membership. Additionally, the OPTN board has approved a 
plan to augment its current policies regarding potential conflicts of 
interest. Activities of the OPTN are clearly described and separate 
from UNOS's. The OPTN board of directors receives an annual orientation 
regarding its obligations to the OPTN, which includes a presentation 
from HRSA staff. In addition, members of the OPTN board sign an 
attestation document acknowledging their obligation to the OPTN 
separate from any obligations to any other organization, including to 
UNOS.

    As previously stated, efforts are currently underway to officially 
establish two separate boards, a process UNOS began over a year ago and 
which we believe will help address concerns about conflicts of interest 
and will provide another layer of transparency and accountability.

    Question. Please identify the OPTN policy that prohibits organ 
procurement organizations (OPO) from discriminating against donor 
patients or their families based on attributes such as race, religion, 
age, sex, veteran status, rural status, or physical or mental 
disability?

    Answer. OPTN policies do not allow for the segregation of patients 
or donors by distinguishing characteristics such as disability, race, 
religion, sex, age, veteran status or rural location.

    OPTN Policy 2.2: OPO Responsibilities, includes the following 
provision:

          ``The host OPO is responsible for all of the following . . . 
        6. Establishing and then implementing a plan to address organ 
        donation for diverse cultures and ethnic populations.''

    OPTN Policy 5.4.A: Nondiscrimination in Organ Allocation, states 
the following:

          ``A candidate's citizenship or residency status in the 
        United States must not be considered when allocating deceased 
        donor organs to candidates for transplantation. Allocation of 
        deceased donor organs must not be influenced positively or 
        negatively by political influence, national origin, ethnicity, 
        sex, religion, or financial status.''

    Question. In May 2012, the former director of the Alabama Organ 
Center was sentenced to 13 months in prison in his role in a scheme to 
take kickbacks from a funeral home that did business with the organ 
center. Has UNOS ever addressed Medicare fraud and misuse of Medicare 
dollars among OPOs by implementing OPTN policies and procedures? If so, 
please identify the OPTN policy that addresses Medicare fraud among 
OPOs. How does UNOS monitor and enforce compliance?

    Answer. Because Federal law does not provide the OPTN with the 
authority to investigate Medicare fraud or misuse of public monies, 
this issue is not within the scope of the OPTN's authority. CMS has 
direct access to OPO cost reporting and information relating to the 
OPO's business practices. Under the current regulatory and oversight 
construct, the OPTN would not have this information. Federal law and 
regulation for the OPTN primarily directs the OPTN to assist OPOs in 
organ placement and develop organ allocation and clinical data 
collection policies.

    In this particular case from Alabama, we understand that the scheme 
related to tissue recovery from deceased donors, which is regulated by 
the Food and Drug Administration (FDA), and not the OPTN or HRSA. 
Because of this separation of oversight responsibilities, the OPTN does 
not collect data on payment or tissue recovery/allocation.

    Question. Studies show that, on average, kidney transplant 
candidates receive 16 organ offers while on the transplant wait list. 
However, studies also show that a large number of these offers are 
declined on their behalf by transplant hospitals, contributing to the 
shortage of available organs in the United States. It's critical that 
the OPTN be transparent with patients and their families when these 
decisions are made so that we improve trust in the OPTN.

    Does UNOS have a system to alert patients when organ offers are 
rejected by transplant centers on their behalf? If not, why not?

    Members of UNOS's Patient Affairs Committee (PAC) told committee 
staff that they discussed this issue with UNOS, but that UNOS did not 
listen to their concerns. If UNOS's PAC raised this issue, why hasn't 
it been addressed?

    How will you alleviate concerns raised by PAC members that UNOS 
does not listen to their advice or counsel?

    Answer. UNOS agrees that the continued rise in the number of organs 
recovered for transplant that are ultimately not transplanted requires 
a multi-pronged, systemic approach to address this issue, as noted in a 
February 2022 report from the National Academies of Science, 
Engineering, and Medicine (NASEM).\17\ In this report recommendation, 
``Key Area for Improvement for Transplant Centers: Organ Offer 
Acceptance,'' the authors review in detail many of the factors that may 
contribute to this trend. The NASEM report also notes two OPTN tools, 
enhanced ``refusal codes'' and ``offer filters'' as having the 
potential to increase system efficiency and contribute to a hospital's 
understanding of its own acceptance practices with improved data. UNOS 
agrees that patients, not just hospitals, need more information in key 
areas.
---------------------------------------------------------------------------
    \17\ National Academies of Sciences, Engineering, and Medicine. 
2022. ``Realizing the promise of equity in the organ transplantation 
system.'' Washington, DC: The National Academies Press. https://
doi.org/10.17226/26364.
---------------------------------------------------------------------------
                         shared decision-making
    UNOS does not currently have a mechanism to alert patients when 
organ offers are declined on their behalf by their transplant teams. 
UNOS, however, supports and encourages clear communication between 
transplant teams and the patients they serve, and is in the discovery 
phase of developing a tool that members could use to help patients 
understand why they have refused organ offers.

    UNOS is also currently conducting a research study with Accenture 
Federal Services, a consulting firm and expert in human centered 
design, to understand patient information needs throughout the 
transplant journey. More than 50 patients, caregivers, living donors 
and transplant professionals representing pre- and post-transplant, 
representing all organ types and geographic areas, along with members 
of the PAC, are being interviewed as part of the study. Findings will 
inform actions the OPTN can take to better meet patient's information 
needs and ensure equity in access to transplant.

    UNOS agrees with recommendations in the NASEM report that 
empowering patients with information about their care leads to more 
positive transplant outcomes and is committed to pursuing tools and 
technology that will facilitate greater shared decision-making.
                           patient engagement
    As of October 1st, UNOS has an interim CEO who is prioritizing 
listening to and determining how to better engage with patients. The 
patient, donor and family perspective are an essential component of 
both OPTN and UNOS governance and the interim CEO attended the in-
person Public Affairs Committee (PAC) meeting in September. In the 
coming months, UNOS will seek new ways to ensure the patient voice is 
heard and acted upon. The UNOS leadership team will engage the board of 
directors, the PAC and members of the donation and transplant community 
in identifying concrete solutions for addressing this concern.

    UNOS has evolved support of the PAC over the past several years and 
made multiple operational changes to improve patient engagement both 
within our volunteer network and beyond, including:

          During the development of the current strategic plan, the 
        PAC provided numerous and specific comments intended to improve 
        patient engagement. Almost all of those comments were adopted 
        and included in the plan. Following adoption of the strategic 
        plan, several changes have occurred to follow up on that 
        commitment:

                  An increase in the number of patient and 
                donor affairs representatives to ensure a minimum of 
                two on all policy development committees (the OPTN 
                final rule at 42 CFR Sec. 121.3(a)(4)(i) requires at 
                least one transplant candidate, transplant recipient, 
                organ donor or family member), with staggered terms so 
                that new patient representatives will have the support 
                of another representative that has experience on the 
                committee moving forward.
                  Creation of a standard to include a 
                patient representative on each of the regional 
                nominating committees that nominate regional 
                representatives to serve on the OPTN board of 
                directors.

          Strengthened the patient voice by recruiting experienced PAC 
        alumni to serve on other committees and the board of directors.
          Developed a two-step process for soliciting patient feedback 
        on OPTN policy proposals, so that PAC members receive education 
        and background on a topic first, and are asked for more 
        detailed feedback on subsequent meeting, building on previous 
        efforts to ensure and empower patients to provide informed, 
        actionable feedback.
          Created focused, plain language prompts and a glossary of 
        terms for proposals out for public comment, so patients and the 
        general public are more empowered to influence policy 
        development.
          Released new, patient-specific on-demand education modules 
        on UNOSConnect, UNOS's learning management system, designed to 
        inform patient volunteers on the donation and transplantation 
        system.\18\
---------------------------------------------------------------------------
    \18\ UNOSConnect. https://unos.org/resources/education/.
---------------------------------------------------------------------------
          Promoted attendance and participation by patient 
        representatives at OPTN Regional Meetings:

                  Highlighted and welcomed PAC regional 
                representative at the beginning of each meeting (Winter 
                cycle 2022).
                  Held prep sessions for PAC 
                representatives prior to Summer 2022 regional meetings 
                and provided opportunity for them to introduce 
                themselves and their connection to transplant at the 
                meetings.
                  Offered and committed to maintaining 
                virtual attendance options for regional meetings to 
                allow for increased patient accessibility.
                  Created and distributed a customized 
                ``what to expect'' meeting guide to all registered 
                patient and donor family attendees in advance of the 
                meeting with contact information for questions/
                suggestions.
                  Noted an increase in almost all regions 
                with patients providing their feedback during the 
                regional meeting, providing valuable perspectives to 
                the transplant community in attendance.

    Building on these accomplishments will require taking a holistic 
look at what information UNOS and the OPTN can provide to support 
patient empowerment. From their time on the wait list to their life 
post-transplant, treating patients as informed partners in their own 
care is a critical, system-wide goal.

    Question. Section 5.4.A of OPTN policy mandates that ``[a]llocation 
of deceased donor organs must not be influenced positively or 
negatively by political influence, national origin, ethnicity, sex, 
religion, or financial status.'' However, recent research demonstrates 
that some transplant centers factor in financial resources in wait-list 
determinations, causing otherwise eligible transplant candidates to be 
determined ineligible for transplantation based on socioeconomic 
status.

    Is this behavior a violation of section 5.4.A of OPTN policy?

    How does UNOS ensure that its members do not consider political 
influence, national origin, ethnicity, religion or financial status 
when making the initial wait-list decision?

    Answer. It is important to distinguish between the allocation of 
deceased donors to transplant candidates who are on the waiting list, 
and access of potential transplant candidates to be placed on the 
waiting list. OPTN policies, including organ allocation algorithms, are 
programmed into the computer systems that allocate organs. The OPTN 
monitors every organ transplant to ensure that the organ allocation 
``match run'' is followed, or that deviations from the ``match run'' 
are adequately explained by objective criteria. The question cites 
research that some transplant hospitals may deny patients access to the 
waiting list based on the financial resources of the patient, which is 
not addressed by OPTN Policy 5.4.A. Decisions on whether to add a 
patient to the OPTN waiting list are complex medical and social 
decisions made by a team of health-care providers at each transplant 
hospital.

    To ensure that every transplant has the best chance for success and 
to prevent futile transplants, NOTA requires that patients demonstrate 
critical success factors for transplant, including availability of a 
full-time caregiver, transportation to the transplant center during the 
recovery period, and financially related matters among other things. 
Transplant teams conduct full psycho-social evaluations of every 
potential transplant patient as part of their decision to add them to 
the waiting list.

    Question. UNOS's new organ allocation policy appears to have added 
significant chaos to the transplantation system. What is the OPTN doing 
to alleviate this chaos that is adversely impacting patients before 
making additional changes that require even greater travel distances--
and more cold ischemic time--for organs? How can Congress--or 
patients--trust UNOS to effectively quarterback this system when 
investigative reports show it fails at even the basics of organ 
transportation, regularly losing track of organs in transit?

    Answer. The data does not support the above assertions. In fact, 
similar arguments have been raised by certain plaintiffs in litigation 
in an attempt to block implementation of the national liver and kidney 
allocation policies. However, the GAO found no fault in their 
development, and the courts have upheld the OPTN's adoption of these 
policies.\19\
---------------------------------------------------------------------------
    \19\ ``Organ Transplants: Changes in Allocation Policies for 
Donated Livers and Lungs.'' U.S. Government Accountability Office. 
October 16, 2020. https://www.gao.gov/products/gao-21-70.

    Since the implementation of new allocation policies in recent 
years, we have seen national increases in transplants for all major 
organs. In fact, the three organ types most commonly transplanted 
(kidneys, livers and hearts) all set records in 2021, despite a global 
pandemic. Liver transplant totals have set annual records for the past 
9 years, and heart transplants have set a new record each of the past 
---------------------------------------------------------------------------
10 years.

    Specifically for kidney and liver, OPTN monitoring reports for 
recent changes to allocation policies for both organs have shown that 
these policies are fulfilling the obligations of NOTA by ensuring 
donated organs are shared as broadly as possible to reach the sickest 
patients first, regardless of where a patient is listed. These 
community- and data-driven allocation policies and ongoing efforts to 
further improve the system have resulted in more transplants and more 
lives saved; policies that have increased equity, expanded access and 
met the dual goals of ensuring that changes to cold ischemic time have 
no impact on the health of the organ (minimal increases were shown to 
be clinically insignificant) while also prioritizing the sickest 
patients first. Looking at this data and the policies that helped drive 
these outcomes, Congress as well as patients and their families can 
trust the Nation's organ donation and transplant system.

    All organ allocation policy monitoring reports are available on the 
OPTN website for the public's review at https://
optn.transplant.hrsa.gov/professionals/by-organ/.

                                 ______
                                 
               Questions Submitted by Hon. John Barrasso
    Question. This committee has obviously been hard at work trying to 
identify shortcomings in the organ procurement and transplantation 
system over the past couple years. Also within the past couple years, 
the Trump administration proposed and the Biden administration 
finalized the OPO final rule. This rule established new performance 
metrics for OPOs as well as helped promote more frequent oversight and 
competition among OPOs.

    Are there other regulatory or legislative actions Congress or the 
administration should take to ensure the OPTN is performing to its 
maximum potential for patients and providers?

    Answer. UNOS is pleased to offer the following items for your 
consideration:

    1.  Invest in innovations that may offer improved OPO regulatory 
oversight and increase organ donation: In order to improve regulatory 
oversight and identify underperforming OPOs, UNOS recommends automating 
donor referrals to collect data that will accurately measure true donor 
potential.\20\ At least six OPOs with service areas across 15 States 
have partnered with donor hospitals to replace current manual data 
entry with automated donor referral, leveraging existing technology on 
the market to automatically alert an OPO of a potential donor in a 
hospital ICU.\21\, \22\, \23\ One study's 
analysis on three pilot hospitals in Texas found that electronic 
referral was associated with a 45-percent increase in referrals, an 83-
percent increase in approaches for donor family authorization, a 73-
percent increase in donor family authorizations, and a 92-percent 
increase in organ donors.\24\ A national investment into this 
innovation could not only save more lives by increasing the number of 
donor referrals, but also provide a more granular, independently 
reported and clinically accurate data set that would enable the OPTN 
and CMS to best assess performance.
---------------------------------------------------------------------------
    \20\ ``5 ways to improve the U.S. organ donation and transplant 
system: Automate real-time donor referral.'' Accessed October 10, 2022. 
https://unos.org/news/media-resources/5-ways/automate-real-time-donor-
referral/.
    \21\ Niles, Patricia; Hewlett, Jonathan; Piano, John; Liu, Wade. 
``Automated Electronic Referrals Are Changing Donation.'' 
Transplantation: September 2020--Volume 104--Issue S3--p. S259 doi: 
10.1097/01.tp.0000699788.52410.58.
    \22\ Glazier, A.; Moss, M.; Martin, L. (2021). ``Electronic Health 
Records Can Improve the Organ Donation Process.'' Retrieved January 20, 
2022, from https://hbr.org/2021/12/electronic-health-records-can-
improve-the-organ-donation-process.
    \23\ ``Cleveland Clinic, Lifebanc and Transplant Connect Develop 
Automated Donor Referral Process.'' April 30, 2021. https://
newsroom.clevelandclinic.org/2021/04/30/cleveland-clinic-lifebanc-and-
transplant-connect-develop-automated-donor-referral-process/. Accessed 
January 20, 2021.
    \24\ Levan, Macey L.; Trahan, Chad; Klitenic, Samantha B.; Hewlett, 
Jonathan; Strout, Tyler; Levan, Michael A.; Vanterpool, Karen B., 
Ph.D., MPH; Segev, Dorry L., M.D., Ph.D.; Adams, Bradley L.; Massie, 
Allan B., Ph.D.; Niles, Patricia, BS, RN. ``Short Report: Evaluating 
the Effects of Automated Donor Referral Technology on Deceased Donor 
Referrals.'' Transplantation Direct: August 2022--Volume 8--Issue 8.

    2.  Encourage HHS to enable the OPTN to collect data on inequities 
in access to pre-wait-list care and referral: Substantial research has 
documented inequities in access to the national wait list, and 
substantial variation across transplant programs with respect to 
transplant access.\25\, \26\ However, what is unknown is the 
extent to which these inequities in access to transplantation are due 
to patient characteristics or to transplant program characteristics. 
OPTN data collection begins at the time a patient is wait-listed for 
transplantation. The transplant community, including clinicians,\27\ 
community members,\28\ and researchers,\29\ has repeatedly called for 
pre-wait-list data collection to address this important problem, but no 
national data exist to identify patients who have end-stage organ 
failure and are appropriate candidates for transplantation. Authorizing 
the OPTN to collect this data would allow for better system evaluation 
and performance improvements. The OPTN Data Advisory Committee (DAC)'s 
request to HRSA to collect and study these elements is currently 
pending.
---------------------------------------------------------------------------
    \25\ Ashby, V.B., J.D.; Kalbfleisch, R.A.; Wolfe, M.J. Lin; F.K. 
Port; A.B. Leichtman. ``Geographic Variability in Access to Primary 
Kidney Transplantation in the United States, 1996-2005.'' American 
Journal of Transplantation 7, no. s1 (2007): 1412-23. https://doi.org/
10.1111/j.1600-6143.2007.01785.x.
    \26\ King, Kristen L.; Syed Ali Husain; Zhezhen Jin; Corey Brennan; 
Sumit Mohan. ``Trends in Disparities in Preemptive Kidney 
Transplantation in the United States.'' Clinical Journal of the 
American Society of Nephrology 14, no. 10 (2019): 1500-1511. https://
doi.org/10.2215/cjn.03140319.
    \27\ Sehgal, Ashwini R. ``Should Transplant Referral Be a Clinical 
Performance Measure?'' Journal of the American Society of Nephrology 
28, no. 3 (2016): 721-23. https://doi.org/10.1681/asn.2016111169.
    \28\ Fowler, Kevin John. ``Accountability of Dialysis Facilities in 
Transplant Referral.'' Clinical Journal of the American Society of 
Nephrology 13, no. 2 (2018): 193-94. https://doi.org/10.2215/
cjn.13741217. 2018;13(2):193-194.
    \29\ Patzer, Rachel E.; Laura McPherson. ``Variation in Kidney 
Transplant Referral: How Much More Evidence Do We Need To Justify Data 
Collection on Early Transplant Steps?'' Journal of the American Society 
of Nephrology 30, no. 9 (2019): 1554-56. https://doi.org/10.1681/
asn.2019070674.

    3.  Support information sharing between the OPTN and CMS: As 
previously mentioned, CMS and the OPTN can mutually benefit from 
increased information sharing to aid in their respective roles in the 
system. UNOS continues to support the development of such a process in 
a way that enhances and improves holistic oversight and improvement for 
---------------------------------------------------------------------------
the system.

                                 ______
                                 
             Questions Submitted by Hon. Benjamin L. Cardin
                          organ transportation
    Question. Since 2010, what penalties have OPOs or transportation 
companies received when an organ has been lost or damaged in transit 
such that it has to be subsequently discarded?

    What is the exact number of organs lost, delayed, and/or damaged? 
Of those, what is the exact number of the resulting loss of prospective 
transplants, and how many patients died waiting for a new organ? Please 
provide a methodology to support your answer in a manner that is 
reproducible.

    Does UNOS collect or have access to data regarding the number and 
percentage of organs that are transported with real time tracking 
(i.e., GPS) and organs transported with temperature tracking? If so, 
please provide that information you have from the last 5 years.

    Given the overrepresentation of Black Americans waiting on a 
kidney, do transportation problems that seem to disproportionately 
impact kidneys impact the disparity we observe?

    Answer. Any transplant opportunity lost due to transportation 
errors is one too many. As the committee is aware, organs are currently 
tracked by the OPTN's TransNetSM system, made mandatory by OPTN Board 
action in 2017, requiring the use of color-coded external, internal and 
vessel labels when shipping or transporting organs outside the donor 
hospital.\30\
---------------------------------------------------------------------------
    \30\ OPTN organ transport. https://optn.transplant.hrsa.gov/
professionals/by-topic/organ-transport/.

    Nonetheless, UNOS agrees that improving data collection and 
transportation tracking would benefit the system and supports an 
increase in data collection in this area to identify any appropriate, 
---------------------------------------------------------------------------
data-driven interventions that would support any improvements needed.

    Should Congress wish to establish a central authority to track all 
organs unaccompanied by a transplant team (primarily kidneys) in 
transit across all transportation and logistics vendors, we submit the 
following for your consideration to support the development of 
potential policy solutions.

          At present, the only authority the OPTN has under both 
        Federal law and regulation relates to its member institutions. 
        The OPTN cannot make requirements or lodge penalties of 
        transportation companies because they are not OPTN members and 
        would not qualify as one per the OPTN final rule (42 CFR Sec. 
        121.3(b)(1)).

          Additional Federal appropriation may be required to develop 
        and implement the technology required to track organs in 
        transit across multiple commercial, non-clinical vendors and 
        airlines, depending on the level of granularity of data and 
        whether ``real time'' tracking is desired.

          Any policy solutions should clearly define a ``reportable'' 
        transportation-
        related delay or damage, including how to determine if a 
        specific incident played a role in the non-use of an organ or a 
        transplant failure, or what individuals, organizations, private 
        entities, businesses, etc. to hold ultimately accountable and 
        under what authority.

    We strongly believe the donation and transplant community, and 
especially patient and donor affairs representatives, should be engaged 
to develop requirements for such a solution, in addition to all other 
key stakeholders, to ensure all necessary considerations are 
identified. The OPTN would be pleased to provide a review of the 
previous Operations and Safety Committee, OPO Committee and MPSC's 
discussions on this topic to date should the committee desire.

    As mentioned during the hearing, UNOS is taking action to address 
some of these challenges. In 2019, UNOS began developing an organ 
tracking solution to offer to OPOs. Since the product launched in June 
2021, and as of September 22, 2022, 5,628 shipments have been tracked, 
accounting for roughly 8 percent of all packaged organs during that 
time period. Clients on average track 30 percent of all their packaged 
organs. Some OPOs don't track organs such as hearts, lungs and livers 
because they are traditionally accompanied by the procuring surgeon. 
Other OPOs only track kidneys and/or livers that use commercial air 
and/or are exported from their service area.

    Based on currently available data, it is difficult to assess the 
impact that transportation might have on transplant disparities.

    Please see additional transportation information in the responses 
to Senator Wyden's seventh question and Senator Young's first question.
                               technology
    Question. You testified that UNOS's IT system has a 99.99-percent 
uptime, and according to a report from the USDS entitled ``Lives Are At 
Stake,'' UNOS told the Federal Government that it had ``experienced 
99.79 percent uptime since 1999.'' Since January 1, 2022, UNOS began 
reporting uptime excluding scheduled maintenance.

    Please provide documentation of UNOS uptime including scheduled 
maintenance time.

    Why is UNOS now excluding planned maintenance from its uptime 
calculation?

    Are there any contract requirements for downtime related to planned 
maintenance?

    Is there a definition of planned maintenance in the service-level 
agreement?

    Answer. Both during the oral testimony and in the written 
testimony, we have affirmed the fact that UNOS has consistently met or 
exceeded OPTN contract requirements across the board, including for 
system uptime.

    The new uptime requirement, as referenced in your question, was 
adopted following a study requested by HRSA and conducted by the OPTN's 
Network Operations Oversight Committee (NOOC) to determine a 
``clinically acceptable'' level of availability of the OPTN matching 
function. As detailed in a June 2022 report to the board, based on the 
committee's findings and supported by Gartner research into health-care 
applications on a national scale, the NOOC recommended that the OPTN 
maintain a 99.9-percent matching function uptime, not including planned 
maintenance.\31\ The committee noted that any potential delay in organ 
matching as a result of downtime is managed at the donor level so that 
patient safety is protected, and organ offers are not missed.
---------------------------------------------------------------------------
    \31\  ''Clinically acceptable availability of the OPTN matching 
function.'' OPTN Network Operations Oversight Committee report to the 
board. June 26, 2022.

    As shown in the UNet Availability Summary below, the early years 
(2000-2005) of our systems' existence were challenging as new features 
and functions were being added. During 2005, core stability and 
scalability improvements were made and since 2006, the system has been 
consistently reliable and available. Additional high-availability 
improvements have been implemented between 2016 and 2022, including 
---------------------------------------------------------------------------
migration to multi-regional hybrid cloud.

    Nonetheless, as shown below, UNOS has consistently exceeded 99.9 
percent availability.


                        UNet Availability Summary
------------------------------------------------------------------------
                                                               Total
                              Uptime/         Planned      Availability
          Year            Availability %   (Maintenance)    (Planned +
                                          Availability %   Unplanned) %
------------------------------------------------------------------------
2000                              99.09%          98.90%          97.99%
------------------------------------------------------------------------
2001                              99.68%          99.51%          99.19%
------------------------------------------------------------------------
2002                              99.89%          99.90%          99.79%
------------------------------------------------------------------------
2003                              99.96%          99.95%          99.90%
------------------------------------------------------------------------
2004                              99.98%          99.89%          99.87%
------------------------------------------------------------------------
2005                              99.93%          99.95%          99.88%
------------------------------------------------------------------------
TOTAL 2000-2005                   99.76%          99.68%          99.44%
------------------------------------------------------------------------
 Significant scalability improvements made after 2005
------------------------------------------------------------------------
2006                             100.00%          99.93%          99.92%
------------------------------------------------------------------------
2007                              99.98%          99.94%          99.92%
------------------------------------------------------------------------
2008                              99.99%          99.98%          99.97%
------------------------------------------------------------------------
2009                              99.98%          99.95%          99.94%
------------------------------------------------------------------------
2010                              99.97%          99.95%          99.92%
------------------------------------------------------------------------
2011                              99.99%          99.97%          99.96%
------------------------------------------------------------------------
2012                              99.92%          99.98%          99.90%
------------------------------------------------------------------------
2013                             100.00%          99.93%          99.93%
------------------------------------------------------------------------
2014                             100.00%          99.91%          99.91%
------------------------------------------------------------------------
2015                             100.00%          99.95%          99.95%
------------------------------------------------------------------------
2016                              99.99%          99.97%          99.96%
------------------------------------------------------------------------
2017                             100.00%          99.95%          99.95%
------------------------------------------------------------------------
2018                              99.98%          99.96%          99.94%
------------------------------------------------------------------------
2019                             100.00%          99.94%          99.94%
------------------------------------------------------------------------
2020                              99.99%          99.92%          99.91%
------------------------------------------------------------------------
2021                              99.99%          99.93%          99.92%
------------------------------------------------------------------------
2022 (thru August)                99.99%          99.90%          99.89%
------------------------------------------------------------------------
TOTAL since 2006                  99.99%          99.95%          99.93%
------------------------------------------------------------------------


    Planned maintenance is defined in the SLA as time when UNet is 
purposefully taken offline to perform regular system maintenance or to 
deploy organ allocation policy changes. To minimize impact to users, 
UNOS performs planned maintenance at low-usage times and with advance 
communication to users.

    In January 2022, after the recommendation by the NOOC, HRSA agreed 
to increase the Matching Function Service Level Agreement (SLA) from 
99.5 percent uptime to 99.9 percent, excluding planned maintenance. 
This new SLA provides a more accurate picture of system stability by 
removing planned events from the measure, while also decreasing the 
contractually permitted amount of unplanned downtime from 0.5 percent 
to 0.1 percent. Further, it was determined that where practical, 
planned maintenance periods should not exceed 30 minutes per event.

    Question. You testified that UNOS is ``subject to 3 million 
attempts a day to hack the patient database.''

    How many hack attempts is UNOS receiving if you exclude attacks 
that are just routinely defended against using standard, commodity 
anti-virus, firewall software?

    How many of those are targeted specifically and uniquely at UNOS, 
rather than just being the result of broad vulnerability scans of the 
Internet by attackers?

    Answer. UNOS takes the position that all attacks have the potential 
to be targeted and we have implemented automation capabilities to block 
or respond to the wide threat landscape. Based on extensive and 
continuous system monitoring and alerting, there are attacks that are 
raised to levels of greater concern and are investigated by UNOS's 
Information Security team. Over the last year, almost 300 events were 
elevated for additional investigation, with zero impactful incidents.

    The sources of these attacks are as follows:


------------------------------------------------------------------------
           Threat or vulnerability (CY 2021)                Quantity
------------------------------------------------------------------------
Websites blocked for malicious or inappropriate                3,813,576
 content
------------------------------------------------------------------------
Inbound email blocks for inappropriate content or spam           444,600
------------------------------------------------------------------------
Emails quarantined based on confirmed security                    33,806
 concerns
------------------------------------------------------------------------
Crowdstrike--End-Point Detection                                     592
------------------------------------------------------------------------
Refused connections                                        1,204,258,768
------------------------------------------------------------------------
Events requiring follow-up by Information Security                   286
------------------------------------------------------------------------
Impactful incidents                                                    0
------------------------------------------------------------------------

                                  data
    Question. Given testimony during the hearing that UNOS has 
retaliated by withholding data access from researchers it disfavors, 
will UNOS commit to transparently sharing with all qualified 
researchers a full and complete reporting of the number of patients 
referred by hospitals to each OPO by month since 2010?

    Answer. NOTA, the OPTN final rule, and the OPTN contract outline 
the criteria that members of the general public and researchers must 
meet to receive different types of data (i.e., identifiable data, 
limited datasets, etc.). The more identifiable the data, the more 
rigorous are the criteria for receiving access to such data.

    UNOS, as the OPTN contractor, has always fulfilled all requests in 
compliance with these requirements. Further, Task 3.7 in the OPTN 
contract, quoted below, requires the OPTN contractor to report to HRSA 
when certain requests cannot be fulfilled.

        Task 3.7: The contractor agrees to meet the following data 
        disclosure standards (except sub-task 3.7.2, when it concerns 
        requests from the Secretary of HHS): some data requests involve 
        data that may be withheld under the terms of the Privacy Act of 
        1974 (5 U.S.C. 552a), the Trade Secrets Act (18 U.S.C. 1905), 
        the Freedom of Information Act (FOIA) (5 U.S.C. 552), or other 
        applicable laws. For example, any 
        personally-identified or personally identifiable data will be 
        maintained according to the OPTN/SRTR/HRSA Data System of 
        Records, HHS/HRSA/HSB/DoT, No. 09-15-0055, including data 
        maintained electronically, must be disclosed consistent with 
        the Privacy Act and the Systems Routine Uses, outlined in the 
        applicable System of Records Notice (73 Fed. Reg. 19519, as 
        amended). The contractor will provide a log of these requests 
        and releases with level of effort for each request to the COR 
        in the quarterly report.

        The contractor shall notify the COR in the quarterly report if, 
        in its view: (1) the data are not collected and/or verified; 
        (2) release of the data violates the Privacy Act or applicable 
        laws; or (3) the data and information are otherwise exempted 
        from disclosure under the FOIA, when applicable.

    The OPTN collects aggregate-level data on the number of referrals 
by hospital to each OPO by month. That data is submitted by the OPOs 
and is part of the OPTN dataset that we would provide to any researcher 
requesting it. UNOS, as the OPTN contractor, does not withhold data 
access from researchers for OPTN data. We don't know the specifics 
around the context that generated this question, but UNOS would be 
happy to talk with any researchers to get them the OPTN data they seek.

    Question. In April 2022, UNOS acknowledged that it failed to report 
35,000 deaths among patients on the waiting list. In 2019 alone, nearly 
one in four pre-transplant patient deaths were missed or mislabeled in 
UNOS data. Low-quality data provided by UNOS impedes researchers and 
Congress from understanding how to improve patient care.

    How many new or amended OPTN policies have relied on UNOS's faulty 
data?

    How many times did UNOS cite incorrect patient death data in 
communications with the Senate Finance Committee or its members?

    Answer. Please see response to Senator Grassley's fourth question.

    Question. Given one of your emails, which was included in the 
record at the Senate Finance Committee hearing, described UNOS's peer-
review process as ``Like putting your kids' artwork up at home. You 
value it because of how it was created rather than whether it's well 
done.''

    When and in how many instances has UNOS communicated to the Federal 
governing that UNOS's peer-review process was deficient?

    If UNOS made such communications, please provide any supporting 
written communications from UNOS to the Federal Government.

    Answer. The segment of the email as cited was a personal ad hoc 
reaction to a discussion taking place in the moment. It does not 
reflect an evidence-based conclusion that the OPTN peer review process 
is substantially flawed, nor was it intended as a specific, action-
oriented recommendation for a change to the process.

    Confidential medical peer review is critical to achieve 
improvements to the entire transplantation network and even more 
broadly, foundational to quality assessment throughout the health-care 
system and beyond.

    Question. In 2022, UNOS approved the implementation of ``bypass 
filters,'' allowing transplant centers to preemptively indicate donor 
characteristics that they are unwilling to consider for patients on 
their wait list. Currently, these filters are not shared with patients, 
who may be unaware if they are listed at a transplant center where they 
will not meet criteria to receive an organ. Bypassed organ offers are 
not currently included in the denominator of SRTR reported organ offer 
acceptance rates, further obfuscating choices for patients.

    Did UNOS consult with the data advisory committee or SRTR review 
committee before implementing these bypass filters?

    How is information regarding the use of bypass filters being shared 
with patients?

    Is UNOS monitoring how the use of these filters will adversely 
impact the probability of transplantation for patients at a given 
transplant center?

    Has UNOS done any analysis to determine how bypass filters may 
impact organ discards, organ offer acceptance rates, or disparities by 
age, race/ethnicity, and geography in patients receiving a transplant?

    Will UNOS commit to providing transparency to the public, 
especially to patients, regarding which bypass filters are being used 
by which transplant programs, and how these filters may impact the 
ability of wait-listed patients to obtain a transplant?

    Answer. The OPTN implemented the Offer Filters tool as a system 
enhancement based on the organ donation and transplant community's 
feedback and collaboration. The goal of Offer Filters is to increase 
kidney utilization by helping transplant hospitals automate ``refusal'' 
of organ offers that they know they will not accept in accordance with 
their existing acceptance criteria, allowing the OPO to find an 
accepting center more quickly, especially for hard to place organs. In 
other words, Offer Filters screens offers that centers were already 
manually declining for their patients. Offer Filters significantly 
reduces the delays that could occur as a result of the former manual 
process.

    By analyzing hospitals' kidney acceptance trends, Offer Filters 
reduces the time between offer and acceptance, bringing kidneys to 
patients faster and reducing non-utilization of organs (``discards'').

    The Transplant Coordinators Committee formed a work group to give 
feedback on the development of the Offer Filters project. In 2019, 29 
kidney programs participated in the Offer Filters pilot. In 2020, UNOS 
conducted a second pilot with 34 more kidney programs. The results of 
these two pilots were used to refine the requirements for the national 
rollout of Offer Filters in 2022.

    UNOS is committed to providing transparency to the public and to 
patients about all facets of its operations. UNOS recognizes the 
potential benefit to patients of using the Offer Filters tool for 
shared decision-making and will explore options for doing so.

    Increasing the use of Offer Filters by transplant hospitals is 
currently under consideration by the OPTN Operations and Safety 
Committee (OSC). This summer, the committee released a concept paper to 
seek community and public feedback. The committee is considering 
proposing a policy change in this area, which could come with additions 
to the monitoring plan.\32\ The current monitoring plan tracks 15 
metrics at a national and program level. Changes in transplant volume 
are among these metrics tracked, as well as national and program-level 
rates of non-utilized organs.
---------------------------------------------------------------------------
    \32\ ``Optimizing Usage of Kidney Offer Filters.'' OPTN Operations 
and Safety Committee. December 20, 2021. https://
optn.transplant.hrsa.gov/policies-bylaws/public-comment/optimizing-
usage-of-kidney-offer-filters/.

                                 ______
                                 
            Question Submitted by Hon. Robert P. Casey, Jr.
    Question. The Finance Committee's investigation and witness 
testimony documented repeated instances of transportation errors 
leading to organs being damaged beyond use. However, the investigation 
found that transportation errors are rarely referred to the MPSC--of 53 
transportation-related complaints, just 6 percent went to the MPSC for 
review. Accordingly, the Finance Committee recommended (1) increasing 
transparency and accountability for chain of custody and transportation 
of organs procured for transplant by providing for public reporting, as 
appropriate, on the status of organs in transport; and (2) increasing 
accountability for organs lost, damaged, or delayed in transport by 
requiring oversight and corrective action for such incidents.

    What actions will UNOS take to implement these recommendations?

    Answer. As shared in answer to question 7 of Senator Wyden, the 
OPTN agrees with the committee that increasing transparency and 
accountability for the transportation of organs would be an important 
system-wide improvement. The majority of organs that travel 
unaccompanied by surgical teams are kidneys, which are the most 
transplanted organ and thus impact the greatest number of patients on 
the waiting list.

    The actions UNOS is taking to implement the committee's 
recommendations include discussions underway among the members of the 
OSC about ways to increase our understanding of the breadth and depth 
of transportation errors in the system. Discussion within both the OPO 
and OSC committees has acknowledged the complexity of implementing 
nationwide organ tracking and begun to review possible pathways to 
address the issue within the scope of the OPTN's authority.

    UNOS provided data to the committee in a July 11, 2022, letter that 
offers some insight into the scale of transportation issues reported to 
the MPSC. The letter provided a more detailed accounting of data 
discussed in a UNOS Member Quality staff interview.

    Over a 5-year period, there were 37 transportation-related cases 
out of 1,479 total OPO-related cases, or 2.5 percent of cases. Of those 
37 unique cases over the same 5-year period, 14 were classified as 
involving commercial air transportation, 7 were classified as involving 
private or chartered air transportation, and 16 were classified as 
involving ground transportation. Of these 37 cases, 13 organs (or 0.88 
percent of cases) over 5 years were ultimately unable to be 
transplanted for reasons that may or may not be related to the 
transportation error. During this same time period, 151,531 organs were 
transplanted.

    While the OPTN is required to admit designated OPOs as members of 
the OPTN, not all organizations involved in the chain of custody for 
transporting organs are members of the OPTN. For example, commercial 
airlines, other common carriers, commercial shippers, and courier 
companies are not members of the OPTN, yet OPOs rely on these 
organizations to ship organs thousands of times a year. Please see 
question 20 of Senator Cardin for more detail on this issue.

                                 ______
                                 
                  Question Submitted by Hon. Tim Scott
                            care disparities
    Question. Your unsealed emails reveal your belief that, in the 
transplant system which you have managed for a decade, ``Only people 
who have means can get transplants.''

    Why, despite this awful care disparity which you yourself 
acknowledge, has UNOS spent its considerable resources lobbying against 
reforms, like the previous administration's Executive Order on 
Advancing American Kidney Health, that have been universally championed 
by patient groups?

    Answer. This quote from a personal email of former UNOS CEO Brian 
Shepard has been routinely mischaracterized by plaintiffs in an ongoing 
lawsuit seeking to prevent more equitable distribution of livers. In 
the email, Mr. Shepard acknowledges the challenges of achieving equity 
in the U.S. health-care system, where access to insurance coverage or 
personal resources are so critical to accessing treatment. The 
transplant system is impacted by the flaws and challenges of the 
greater health-care system. UNOS would be pleased to work with the 
committee or individual Senators on initiatives that would expand 
access to health care, including organ transplantation.

    UNOS routinely offered its support for important reforms, like the 
Executive Order on Advancing American Kidney Health, which issued 
ambitious and laudable goals for all actors in the system. In addition, 
while UNOS also strongly and routinely agreed with the need for 
improvements to OPO regulation, we were joined by many members of the 
community in cautioning against some of the technical aspects of the 
now-implemented rule that will harm patients if not addressed, such as 
mass decertification of OPOs without a transition plan in place.\33\ 
UNOS and its partners also offered evidence-based, collaborative 
alternative solutions to achieve these goals.
---------------------------------------------------------------------------
    \33\ AST, ASTS and UNOS letter to CMS Acting Administrator Richter. 
https://unos.org/wp-content/uploads/UNOSGR-202210304-AST-ASTS-UNOS-
Joint-Comment-CMS-3380-F2-OPO-Medicare-Conditions-for-Coverage-
March2021.pdf. March 4, 2021.

                                 ______
                                 
              Questions Submitted by Hon. Elizabeth Warren
    Question. You testified that ``the system has been paid for in part 
by taxpayers; approximately 10 percent of the budget of this contract 
is taxpayer funded, the rest of that is paid by hospitals when they 
list patients.'' Your answer spoke only to contract funding from HRSA, 
and entirely ignored Medicare dollars that have funded the system, as 
well as taxpayer dollars from Medicaid, Children's Health Insurance 
Program (CHIP), and the Department of Veterans Affairs (VA).

    What percentage of the OPTN patient registration fees are 
ultimately reimbursed by all taxpayer funded sources? Please breakdown 
by source including Medicare, Medicaid, CHIP, and the VA.

    What percentage of UNOS fees are ultimately reimbursed by all 
public sources, despite the fact that the UNOS fees are voluntary and 
not required to add a patient to the waiting list? Please breakdown by 
source including Medicare, Medicaid, CHIP, and the VA.

    Answer. The OPTN final rule, 42 CFR 121.5(c) requires OPTN members 
to pay a registration fee to the OPTN for each transplant candidate it 
places on the waiting list. UNOS bills hospitals directly whenever a 
transplant center places a patient on the national transplant waiting 
list and requires the OPTN registration fee established by the OPTN 
board of directors, and approved by the Secretary, to cover the 
reasonable costs of operating the OPTN. Reimbursement is received from 
hospitals directly. Therefore, UNOS has no visibility to how public or 
private insurance programs are billed by the hospital. UNOS does not 
have information concerning hospitals' financial models, costs of care, 
or payor reimbursements.

    Question. In October 2020, the Senate Finance Committee wrote to 
the Secretary of HHS with a concern about ``double billing'' from OPTN/
UNOS.

    Currently, to list the exact same patient on the organ waiting 
list, how much in fees does OPTN/UNOS charge to Medicare?

    Answer. Federal regulation requires transplant hospitals to pay a 
fee to the OPTN to add a candidate to the organ transplant waiting 
list.\34\ Neither the OPTN nor UNOS bill Medicare, Medicaid, or any 
other insurance provider for costs it incurs.
---------------------------------------------------------------------------
    \34\ 42 CFR Sec. 121.5(c). ``An OPTN member shall pay a 
registration fee to the OPTN for each transplant candidate it places on 
the waiting list. The amount of such fee shall be calculated to cover 
(together with contract funds awarded by the Secretary) the reasonable 
costs of operating the OPTN and shall be determined by the OPTN with 
the approval of the Secretary.''

    Authorized by Federal regulation and approved annually by the OPTN 
board of directors and the Secretary of HHS, the OPTN assesses a one-
time registration fee (currently $868), billable to a transplant 
hospital at the time it registers a candidate for a transplant. 
Pursuant to section 121.5(c) of the final rule, the OPTN establishes 
the fee based on the reasonable costs of operating the OPTN, and HRSA 
approves that fee. The OPTN does not know the source of funding that 
OPTN members use to pay the OPTN registration fee. UNOS is a Virginia 
nonprofit membership corporation founded by the transplant community in 
1984. UNOS members also pay a fee to UNOS, $100 per patient added to 
the waiting list in FY23, to fund UNOS operations and for the services 
that UNOS provides to the donation and transplant community and to its 
members. It is important to note that these are separate fees for 
different services to transplant hospitals; payment of the UNOS fee is 
not required for a transplant hospital to add a patient to the OPTN 
---------------------------------------------------------------------------
waiting list.

    UNOS has no visibility to how public or private insurance programs 
are billed by the hospital. UNOS does not have information concerning 
hospitals' financial models, costs of care, or payor reimbursements. To 
supplement this response, please see our response to your first 
question.

    Question. How much in fees does OPTN/UNOS charge to other public 
sources including Medicaid, CHIP, and the VA, including via hospital 
fees for which government payers reimburse?

    Answer. See above answer.

    Question. For each of the last 10 years (2012 to present):

    What have been (a) per patient and (b) total OPTN fees received by 
UNOS as the OPTN?

    What percentage of that total has been paid by Medicare?

    What percentage of that total has been paid by other public sources 
including Medicaid, CHIP, and the VA, including via hospital fees for 
which government payers reimburse?


                                OPTN Fees
------------------------------------------------------------------------
 Fiscal    OPTN Fees Per
  Year       Candidate                     Fees Collected
------------------------------------------------------------------------
2012                $603                                     $41,259,959
------------------------------------------------------------------------
2013                $651                                     $43,682,960
------------------------------------------------------------------------
2014                $810                                     $55,946,345
------------------------------------------------------------------------
2015                $793                                     $57,081,282
------------------------------------------------------------------------
2016                $812                                     $57,125,866
------------------------------------------------------------------------
2017                $834                                     $59,310,720
------------------------------------------------------------------------
2018                $834                                     $61,812,887
------------------------------------------------------------------------
2019                $794                                     $65,479,021
------------------------------------------------------------------------
2020                $748                                     $59,082,927
------------------------------------------------------------------------
2021                $748                                     $60,461,138
------------------------------------------------------------------------
2022                $868                                     $66,270,399
 (August
 YTD)
------------------------------------------------------------------------


    The OPTN final rule, 42 CFR 121.5(c) requires OPTN members to pay a 
registration fee to the OPTN for each transplant candidate it places on 
the waiting list. UNOS, serving as the OPTN contractor, bills hospitals 
whenever a transplant center places a patient on the national 
transplant waiting list. As such, UNOS does not have visibility into 
hospitals' financial models, costs of care, or payor reimbursements, 
and does not know the source of funding that OPTN members use to pay 
the OPTN Registration fee.

    Question. For each of the last 10 years (2012 to present):

    What have been (a) per patient and (b) total UNOS fees received by 
UNOS as the OPTN?

    What percentage of that total has been paid by Medicare?

    What percentage of that total has been paid by other public sources 
including Medicaid, CHIP, and the VA, including via hospital fees for 
which government payers reimburse?

    Answer. The OPTN Registration Fee and the UNOS fee are for distinct 
and separate services. The OPTN Registration Fees, as outlined above, 
are required to be paid by OPTN members for the reasonable costs of 
operating the OPTN, outlined in the OPTN contract and below. The UNOS 
fee is collected from UNOS members and pays for services outlined 
below.


                                UNOS Fees
------------------------------------------------------------------------
 Fiscal
  Year       UNOS Fees                     Fees Collected
------------------------------------------------------------------------
2012                $122                                      $4,788,048
------------------------------------------------------------------------
2013                $125                                      $5,131,425
------------------------------------------------------------------------
2014                $147                                      $5,454,592
------------------------------------------------------------------------
2015                $164                                      $6,410,040
------------------------------------------------------------------------
2016                $145                                      $6,763,625
------------------------------------------------------------------------
2017                $145                                      $7,980,220
------------------------------------------------------------------------
2018                $145                                      $8,414,851
------------------------------------------------------------------------
2019                $158                                      $9,657,618
------------------------------------------------------------------------
2020                $178                                      $8,909,304
------------------------------------------------------------------------
2021                $178                                     $10,845,896
------------------------------------------------------------------------
2022                $122                                      $7,063,800
 (YTD
 August)
------------------------------------------------------------------------


    UNOS does not have visibility into hospitals' financial models, 
costs of care, or payor reimbursements, and does not know the source of 
funding that UNOS members use to pay the UNOS Fee.

    Question. On what activities are OPTN fees spent?

    Answer. The OPTN registration fees and budget must be calculated to 
meet the ``reasonable costs of operating the OPTN'' and are approved 
annually by the HHS Secretary pursuant to 42 CFR Sec. 121.5(c). Those 
costs will include sufficient resources to perform the following OPTN 
contract tasks:

     (1)  Administering the OPTN contract through a project management 
plan; providing daily, weekly, quarterly, and annual updates to HRSA 
and other external audience; proposing the annual OPTN registration fee 
schedule and associated annual budget; providing HRSA monthly reports 
tracking revenue and expenditures associated with the OPTN contract; 
and maintaining various secure web-based platforms, including a 
platform for submitting contract deliverables to HRSA, and a document 
management platform to allow OPTN governance group members to share 
documents.
     (2)  Supporting the OPTN board of directors (BOD) and executive 
committee, and OPTN BOD operating committees by: supporting an annual 
OPTN BOD composition review and recruiting plan; reviewing the OPTN 
charter; supporting the appointment of the OPTN executive director; 
supporting the operating committees and policy development committees; 
strategic planning to guide OPTN activity; providing ongoing education 
on OPTN legal and regulatory requirements; providing opportunities for 
public access to OPTN governance activities; and other administrative 
and logistical support and subject matter expertise.
     (3)  Supporting the OPTN policy process and policy development 
committees and expert groups to address critical OPTN policy issues by: 
developing, revising, and maintaining OPTN bylaws, policies, standards, 
and guidelines for the operation of the OPTN; recruiting volunteers to 
serve on the OPTN policy development committees; documenting the OPTN 
policy development process; tracking policy development process 
metrics; reviewing the OPTN regional process; and hosting consensus 
conferences to solicit input from the transplant community and public 
on matters related to OPTN bylaws, policies, or operations.
     (4)  Providing an OPTN electronic matching of donor organs to 
transplant candidates 24 hours per day, every day; ensuring real-time 
access to the electronic matching function for allocating deceased 
donor organs; developing innovative applications to enhance the 
matching functions; operating the OPTN Kidney Paired Donation Pilot 
Project (KPDPP); electronically managing all OPTN patient review board 
processes; and maintaining allocation decision rules.
     (5)  Operating the Organ Center to facilitate organ placement by 
providing technical assistance to OPTN members 24 hours/day, 7 days/
week.
     (6)  Monitoring OPTN member compliance and performance, quality 
improvement, and sanctioning, by: maintaining documentation describing 
the OPTN monitoring, performance improvement, and enforcement 
requirements; measuring the effectiveness of the processes used to 
identify compliance, encourage improvement, and determine sanctions; 
providing HRSA with an annual OPTN monitoring activity report on all 
OPTN members; reviewing and periodically reassessing OPTN membership 
applications, including submitting OPTN membership application forms 
for OMB clearance; developing new models for monitoring and improving 
OPTN membership performance through collaborative performance 
improvement structures; reporting to HRSA information about member 
performance that poses significant risk to patient health or public 
safety; and conducting special reviews of OPTN members as requested by 
the Secretary.
     (7)  Collecting official OPTN data to support the operations of 
the OPTN and maintaining a data repository of all official OPTN data, 
which according to contract must be collected after submitting 
clearance packages for Office of Management and Budget (OMB) approval, 
collecting all official OPTN data through direct electronic transfer; 
integrating standard clinical data ontologies into OPTN data collection 
and operation of the OPTN, identifying and supplementing official OPTN 
data with information from external data sources, and collecting 
official OPTN data through survey methods.
     (8)  Providing access to official OPTN data by: making standard 
analysis data sets and other data sets available to the scientific 
community and the public for research and analysis purposes; responding 
to data requests from HRSA and other components within the Federal 
Government; responding to data requests from OPTN members and providing 
online access to OPTN-branded online data reports to members to improve 
system performance; and responding to data requests from the general 
public.
     (9)  Coordinating OPTN policy development and analytic needs with 
the Scientific Registry for Transplant Recipients (SRTR) contractor 
through a formal written agreement for data transfer, and by 
coordinating activities and meetings with the SRTR contractor to 
discuss OPTN data issues, planning and participating in joint meetings 
with the SRTR contractor, and collaborating with the SRTR contractor on 
the development of the OPTN/SRTR Annual Data Report.
    (10)  Maintaining and improving the OPTN website to be a 
comprehensive source of OPTN-related information for the public and the 
transplant community, which also must be securely configured.
    (11)  Communicating about all activities of the OPTN with OPTN 
members, transplant professionals, transplant patients, living organ 
donors, donor families, media, and the general public by: developing a 
communications plan and a branding plan; developing OPTN educational 
materials for patients, the public, and transplant professionals; and 
informing HRSA and the SRTR of media inquiries.
    (12)  Providing an OPTN patient services line to provide 24-hour 
toll-free information with English and Spanish capabilities.
    (13)  Providing written updates and summaries on OPTN activity to 
HRSA as required for reports to Congress or other official reports.
    (14)  Managing and maintaining OPTN records to retain functionality 
and integrity throughout the full records lifecycle, subject to the 
Privacy Act of 1974, including maintaining records identified in the 
OPTN System of Records Notice.
    (15)  Executing special studies on topics identified by HRSA.
    (16)  Meeting security and privacy requirements and safeguarding 
information and information systems by meeting Federal standards for 
protection, confidentiality, and nondisclosure of sensitive 
information; encryption of computing devices and information; complying 
with Federal Rules of Behavior, notifying HRSA of, and responding to, 
security incidents and privacy breaches; continuous monitoring of 
information security; permitting government access for security 
assessments; and adhering to security requirements for cloud services.

    Federal appropriations constitute approximately 8-10 percent of the 
resources used to meet the obligations of the OPTN contract.

    Question. On what activities are UNOS fees spent?

    Answer. UNOS is a nonprofit nonstock membership corporation founded 
by the transplant community in 1984 to serve as the national 
transplantation network. With the tremendous growth in transplantation 
and to meet the broad responsibilities of the OPTN contract, UNOS has 
since grown to 450 diverse professional staff. The UNOS fee is one of 
the revenue sources for UNOS and those revenues are maintained in UNOS 
operating accounts where the fees are commingled with revenues from 
other sources including charitable donations, unrelated business 
income, and most significantly, costs reimbursed to the contractor 
under the OPTN contract. The UNOS fee makes it possible to provide 
enhanced services not required by Federal contract that respond to the 
community's needs and continuously improve the national transplant 
system. Examples of these UNOS enhancements include, but are not 
limited to:

          Data tools and analysis to help member institutions analyze 
        and improve performance and patient outcomes.
          Innovative technology and research to improve the efficiency 
        of organ offers, placement and transportation.
          Educational offerings and collaborative events to help 
        transplant professionals grow their knowledge and skills.

    General and administrative expenses are also covered by the UNOS 
fee, which include maintaining the infrastructure essential to serve as 
the OPTN contractor and which costs are not directly reimbursable under 
the OPTN contract.

    The structure of a separate UNOS fee to provide enhanced services 
to the transplant community not covered by the OPTN fee represents an 
ongoing effective 
public-private solution to a public health challenge. Managed in the 
private sphere but overseen in the public, the U.S. organ donation and 
transplant system has demonstrated growth year over year that has led 
to nearly a million lives saved through transplant, more than any other 
country in the world.

    Question. Are UNOS fees used to pay for activities disallowed under 
the Federal Acquisitions Regulations (e.g., lobbying expenses)?

    Answer. UNOS's private funds are used for UNOS efforts, including 
our government relations work. Lobbying expenses are not an allowable 
cost for reimbursement under the Federal Acquisition Regulations and 
are never billed to the OPTN contract in compliance with HHSAR 352.203-
70: Anti-Lobbying, which is incorporated into the OPTN contract.

    Question. Are any OPTN fees used to support OPTN/UNOS technology?

    Answer. The National Organ Transplant Act (NOTA), 42 U.S.C. 273 et. 
seq. requires that the OPTN operate a national system to allocate 
organs using computer systems. Thus, the costs of operating the OPTN 
include the costs of operating a national system using computer 
technology to allocate organs, including updates to reflect changes in 
organ allocation policies, data collection, security, privacy, 
reliability, improvements and architecture. The OPTN contract requires 
the OPTN contractor to provide computer systems and software to meet 
the statutory obligations of the OPTN, as well as meet extensive 
Federal requirements for security, operability, privacy, and 
reliability. UNOS utilizes registration fees paid to the OPTN by 
transplant hospitals and appropriated funds paid to the contractor by 
HRSA to meet its technology obligations under the OPTN contract.

    Question. Are any UNOS fees used to support OPTN/UNOS technology?

    Answer. The OPTN contract requires the contractor to provide a 
computer system to meet all of the obligations of the OPTN organ 
matching and data collections functions for all organ types, while also 
meeting the extensive security and privacy requirements of the OPTN 
contract. The contractor's computer system must be in operation 
exceeding 99.9-percent availability, while being continuously updated 
by changes to organ allocation policies/algorithms approved by the OPTN 
board of directors. The government has never provided software or 
hardware to the OPTN contractor to meet these contract requirements.

    UNOS pays its operating expenses and makes investments in 
technology from its operating account. The UNOS operating account 
receives funds from different sources but primarily from reimbursement 
of allowable costs under the OPTN contract, revenues from UNOS members 
paying the UNOS fee, charitable contributions, and unrelated business 
income. UNOS expenses are paid from its operating account, which 
include salaries and benefits for all staff; general and administrative 
costs; and property, plant and equipment. Since UNOS was formed in 1984 
by the transplant community, UNOS Information Technology staff 
developed, maintain and enhance UNOS software that it uses to power the 
OPTN and meet the obligations of the OPTN contract.

    See Senator Cardin's first question.

    Question. Please distinguish what aspects of the OPTN/UNOS IT 
system (e.g., hardware, platforms such as UNet, DonorNet, and TransNet, 
and code used to facilitate matching) were paid for using UNOS fees; 
which were paid for using OPTN fees; and which were paid for using 
appropriated funds awarded through the contract.

    Answer. See question above.

    Question. Please provide the amount spent on OPTN/UNOS IT from each 
of these three sources of funding for each year under the current 
contract for the operation of the OPTN.

    Answer. Please see the below report of expenditures on the IT-
related tasks under the current OPTN contract, which commenced with a 
partial year on April 1, 2019:


----------------------------------------------------------------------------------------------------------------
                                                     Task 5--                        Task 20--
                                   Task 4--OPTN       Collect      Task 9--OPTN    Security and
                                    Electronic     Official OPTN      Website         Privacy          Total
                                     Matching          Data                        Requirements
----------------------------------------------------------------------------------------------------------------
Year 1           FY 2019 (Apr-       $12,114,912      $1,727,410        $106,806        $953,039     $14,902,167
                  Sep)
----------------------------------------------------------------------------------------------------------------
Year 2           FY 2020             $26,567,255      $4,896,707        $264,113      $2,693,269     $34,421,345
----------------------------------------------------------------------------------------------------------------
Year 3           FY 2021             $26,216,727      $4,977,437        $323,871      $2,378,211     $33,896,246
----------------------------------------------------------------------------------------------------------------
Year 4           FY 2022 (Aug.       $26,210,887      $4,828,467        $231,152      $2,972,366     $34,242,872
                  YTD)
----------------------------------------------------------------------------------------------------------------
                 Total               $91,109,780     $16,430,022        $925,942      $8,996,885    $117,462,629
----------------------------------------------------------------------------------------------------------------


    Question. In light of your misleading answer about taxpayer funding 
of the OPTN system and technology (since both HRSA funding and Medicare 
funding are from the taxpayer, as are funds from the other government 
sources such as the VA), how do you justify that the taxpayer should 
have to pay to buy back OPTN/UNOS technology in the event of HRSA 
electing different OPTN contractors?

    Answer. With the passage of NOTA in 1984, Congress determined that 
the organ transplant network should reside in the private sector with 
appropriate oversight by the Federal Government. The OPTN contract 
requires the contractor to provide a computer system to meet the 
obligations of the OPTN organ matching and data collections functions 
for all organ types, while also meeting the extensive security and 
privacy requirements of the OPTN contract. The contractor's computer 
system must be in operation exceeding 99.9-percent availability, while 
being continuously updated by changes to organ allocation policies/
algorithms approved by the OPTN board of directors. The government has 
never provided software or hardware to the OPTN contractor to meet 
these contract requirements. Through a cost-sharing contract, the 
government has exercised its discretion to utilize a contractor-owned, 
contractor-operated (COCO) system to meet the requirements of NOTA and 
the OPTN contract.

    Question. Given that taxpayers have paid for this technology, how 
do you justify that UNOS refused to allow the USDS to inspect its code, 
making UNOS the first and only of nearly 100 agencies/contractors to 
rebuke such a request from USDS?

    Answer. We appreciate the opportunity to address these concerns and 
believe it is important to establish the factual foundation for our 
response. As discussed above in more detail, since 1984, UNOS has 
developed and maintained its software that it uses to provide the 
services required by the OPTN contract and power the OPTN's statutory 
functions. The government has not provided software or hardware to the 
OPTN contractor and instead opted for a model where the OPTN contractor 
utilizes contractor-owned systems to meet the OPTN requirements 
specified by the government. UNOS has used a variety of funding sources 
to develop its software and it is inaccurate to state that taxpayers 
have paid for the UNOS-owned software and systems. For more 
information, please see our response immediately above.

    We appreciate the opportunity to clarify that UNOS never received a 
request from the USDS to review our code. UNOS would have welcomed 
then--and still welcomes now--a meeting with USDS to have a focused 
review of our code, coding practices, code repositories, and other 
relevant information that could facilitate a more accurate 
understanding of our systems.

    UNOS reiterated its willingness to undergo any additional review 
deemed necessary in an August 2, 2022, letter to the HRSA 
Administrator, so that we can discuss the significant factual errors 
about the OPTN IT infrastructure contained within the USDS report.\35\ 
We would be pleased to have the opportunity to further clarify the 
facts for Congress, HHS and the USDS alike.
---------------------------------------------------------------------------
    \35\ McCauley, Jerry, M.D., MPH. Letter to HRSA Administrator 
Carole Johnson. August 2, 2022. https://unos.org/wp-content/uploads/
20220802_UNOS-McCauley-Letter-to-HRSA-Administrator.pdf.

    The HRSA team has consistently reviewed the performance and 
security of the OPTN IT system in great detail throughout our 
performance of the OPTN contracts, and their annual audit of our 
systems is currently underway. HRSA reviews all OPTN contractual 
requirements for compliance annually, as well as on a periodic basis 
throughout each year, and UNOS consistently meets or exceeds its 
---------------------------------------------------------------------------
contractual obligations.

    Question. In response to The Washington Post article on UNOS's 
``refusal to turn over the full code,'' you stated that this was to 
``safeguard patient data''; as there should not be any patient data in 
the code itself, it is concerning that UNOS does not understand basic 
terminology. Can you clarify?

    Answer. There is no patient data in our code. That being said, 
allowing broad access to any part of the system, regardless of whether 
it contains patient data, would introduce significant risk to system 
security. That's why UNOS works closely with HRSA to ensure access is 
given only to those with appropriate clearance. UNOS does, however, 
offer the opportunity for an on-site and fully secured review of the 
code.

    We are pleased to share the full statement provided by UNOS to The 
Washington Post below as clarification.

        USDS has never made a formal request to come onsite to review 
        the code. As we've mentioned before, we would welcome USDS to 
        visit UNOS, where we will provide an overview of our software, 
        review matching function code, our coding practices, and how 
        the code is managed and tested.

        HRSA conducts annual audits of our system. We provide excerpts 
        of code at their request if they identify areas of improvement 
        during an audit. We also provide HRSA both before and after 
        sections of code to show that the audit-identified improvements 
        have been made.

        Additionally, the OPTN contract requires that we regularly 
        provide HRSA with extensive documentation, which includes 
        decision logic used to implement the organ allocation policies. 
        This documentation is updated any time organ allocation 
        policies change and is used by our software engineers when 
        making any updates.

        While the source code remains UNOS's intellectual property, we 
        have still offered HRSA the opportunity to do an on-site review 
        of our code repositories, but as of this writing, they have not 
        taken us up on this offer.

        We have struck an important balance: providing HRSA and other 
        auditors the access they need to ensure the system's security 
        while limiting wider access in order to safeguard patient data 
        and protect UNOS' intellectual property.

    Question. In light of concerns expressed by the Senate Finance 
Committee about the state of OPTN/UNOS technology, including but not 
limited to concerns identified by the USDS's report ``Lives Are at 
Stake,'' please provide your total compensation for 2021 and 2022; the 
total expenditures for lobbying, marketing, and public relations for 
2021 and 2022; and the expenditures for hardware and software 
maintenance in 2021 and 2022.

    Answer. As reported on IRS form 990, total chief executive officer 
compensation for fiscal year 2021 was $734,490. The 2022 990 has not 
been prepared, but the chief executive officer compensation as of the 
September 30th pay stub was $627,634.


------------------------------------------------------------------------
                                          FY 2021      FY 2022--Aug. YTD
------------------------------------------------------------------------
Lobbying, Marketing, PR (UNOS               $296,129            $476,796
 expenses)
------------------------------------------------------------------------
Hardware and software maintenance        $25,584,244         $25,498,223
 (OPTN and UNOS)
------------------------------------------------------------------------


                                 ______
                                 
                 Questions Submitted by Hon. Todd Young
    Question. Once an Organ Procurement Organization (OPO) is 
designated as on probation or not in good standing, how does UNOS 
evaluate when and how an OPO should be removed from probation or 
restored to good standing?

    What corrective actions must occur for the OPO to get back in 
``good'' standing?

    Answer. The overall process is described in Appendix L to the OPTN 
bylaws. In general, the MPSC actively monitors the member's activity 
and documents progress toward process improvement. After the member has 
addressed the area(s) of concern and communicated to the MPSC's 
satisfaction the actions they have taken to meet performance standards, 
it will recommend to the OPTN board of directors that the designation 
be removed.

    In the case of Member Not in Good Standing (MNIGS), the institution 
must remain in that status for a minimum of 9 months. It is also an 
option that the board may move the institution from MNIGS to probation 
for an additional period of time. Similarly, a member institution 
placed on probation must remain in that status for a minimum of 9 
months before there is any consideration that it may regain full 
standing.

    The corrective actions required for a member to demonstrate 
improvement and regain full member standing are specific to the 
issue(s) under review. The MPSC provides the member with notice of the 
areas where the member must document improvement, often with a specific 
set of milestones or metrics by which improvement will be assessed.

    Question. In November 2020, CMS issued a final rule changing the 
methodology used to evaluate OPO performance. Based on 2018 data, CMS 
estimated that 22 of the 57 OPOs would fail the new outcome measures 
and be decertified. As the entity overseeing policy compliance, what 
steps is UNOS taking to improve OPO performance given the new 
performance measures?

    Answer. The OPTN continues to believe that the best way to hold 
OPOs accountable for their performance is to develop an accurate, clear 
metric with a rationale that has been adequately justified. It is 
important to note CMS's metric is a comparative one, and each review 
period will always identify OPOs not in the top 25 percent as 
``failing'' regardless of how many OPOs are in operation. Further, a 
comparative metric alone does not provide sufficient information on how 
well an OPO performs.

    UNOS is committed to improving performance for OPOs and for the 
system as a whole. In addition to the OPTN MPSC's routine peer-review-
based performance improvement work, already described in detail for the 
committee throughout the investigation as well as described on the OPTN 
website, the OPTN also provides other pathways for all member 
improvement. They include:

          Collaborative improvement (CI) projects designed to spread 
        change in a targeted area of focus, involving transparent peer-
        to-peer sharing of successes and challenges in a collaborative 
        environment. In an OPTN collaborative, members are part of a 
        network with a common aim. With CI, effective donation and 
        transplant practices can be gathered, shared and implemented by 
        others for broad, collective impact.

          Individual member-focused improvement (IMFI) that involves 
        working closely with an OPTN performance improvement support 
        team and tailoring a project plan to meet specific quality 
        improvement goals. IMFI also supports donation and transplant 
        members by facilitating peer mentorship sessions with 
        experienced leaders in relevant fields and delivering other 
        services that can vary according to need.

         More detail about these programs is available at https://
optn.transplant.
hrsa.gov/professionals/improvement/.

    The continued, accelerated growth in organ donation and transplant 
sustained over many years indicates that the U.S. system overall is 
strong. Notably, the volume of deceased organ donors has been steadily 
rising after a plateau of approximately 8,000 donors annually from 
2006-2013. In 2021, nearly 14,000 deceased donors were recovered, the 
11th straight year of growth.

    While it is a commonly held misconception that the national opioid 
epidemic is the sole source of this growth, the data do not support 
this assertion. The number of donors from other natural causes, other 
injuries, and cardiovascular events has also continued to rise. The 
percentages of total deceased donors dying of drug intoxication, which 
includes but is not limited to opioid intoxication, was approximately 
13 percent from 2016-2019, and then increased to 16 percent in 2020; 
this remained stable in 2021.

    Regardless of the manner of death of an organ donor, OPOs and 
transplant hospitals have continued to increase performance for the 
last nine consecutive years in the number of deceased donor organs 
transplanted. Our community is grateful for the lifesaving gifts we've 
received from so many generous donors.

    Question. What attention has UNOS given to the significant annual 
increase in organ discards? What plan does UNOS have to address and 
improve the organ discard rate?

    Answer. While the decision whether to accept an organ for 
transplant belongs in the hands of transplant clinicians and their 
patients, UNOS and the OPTN have consistently provided system-wide 
tools, data and strategies to increase organ utilization across 
multiple modalities. A select few are below.
                           policy monitoring
    All OPTN committees closely monitor the non-utilization 
(``discard'') rate in organ allocation policy evaluation reports and 
have adjusted policies where possible to reduce their incidence. A 
recent example of this includes the 2018 implementation of allocation 
policies for dual and en bloc kidney offers, when data showed that 
these more complex organ offers were recovered but accepted at lower 
rates.
                               data tools
    The kidney Offer Filters tool, discussed in detail in the NASEM 
report as an effective tool to decrease the time between offer and 
transplant, has shown a preliminary positive impact on the rate of 
kidneys recovered but not transplanted. Preliminary data following the 
national rollout of Offer Filters on January 27, 2022, show an 
approximate 5 percent decrease in the number of organs recovered for 
transplant but not transplanted. The OPTN Operations and Safety 
Committee sought public comment on ways to optimize the use of offer 
filters this fall.\36\
---------------------------------------------------------------------------
    \36\ ``Optimizing usage of kidney offer filters concept paper.'' 
OPTN Operations and Safety Committee. Fall 2022 public comment. https:/
/optn.transplant.hrsa.gov/policies-bylaws/public-comment/optimizing-
usage-of-kidney-offer-filters/. Accessed October 11, 2022.

    Transplant programs may utilize the Center Acceptance and Refusal 
Evaluation (CARE) report tool. The tool allows programs to see all of 
the outcomes for organ offers they accept as well as all of those they 
refuse. The CARE report is designed to help transplant centers adopt 
best practices and reduce the non-utilization rate by understanding 
their organ acceptance behavior and enhancing their ability to analyze 
acceptance patterns. The tool provides a visualization of organ 
rejection organ acceptance for specific types of donors as well as 
transplant-specific and aggregate outcomes so centers can learn what 
happened to the organs they turned down.
                          performance metrics
    The MPSC Performance Metrics proposal, which was recently approved 
by the OPTN board of directors and which has begun to be implemented 
this summer, focuses on both pre-transplant as well as post-transplant 
patient data. With less emphasis placed just on post-transplant 
outcomes, acceptance behaviors are expected to change, which also may 
encourage more programs to transplant more complex organs that are 
otherwise refused.
                             refusal codes
    In June 2021, the OPTN board approved a project to update OPTN 
``reasons for refusal'' of organ offers made to patients. These revised 
codes were implemented in December 2021. Revising the list of refusal 
codes supports increased efficiency of the OPTN through better 
understanding of refusal behaviors, providing more robust data to 
develop improved allocation strategies to reduce cold ischemic time, 
reduce the number of non-utilized organs, and increase the number of 
transplants.\37\
---------------------------------------------------------------------------
    \37\ OPTN project to update refusal codes. https://
optn.transplant.hrsa.gov/policies-bylaws/a-closer-look/project-to-
update-refusal-codes/. Accessed October 11, 2022.
---------------------------------------------------------------------------
                           allocation policy
    In advance of the transition to the Continuous Distribution organ 
allocation framework beginning with lung in early 2023, the Utilization 
Considerations of Kidney and Pancreas Continuous Distribution Workgroup 
is studying the operational aspects of kidney and pancreas allocation 
that encourage optimization of kidney and pancreas utilization. The 
workgroup has a practical focus on utility and efficiency, and is 
composed of representatives from the OPO, Operations and Safety, 
Transplant Coordinator, Data Advisory, Kidney, and Pancreas committees, 
who provide experienced clinical and practical allocation perspectives. 
This workgroup is charged with developing recommendations for 
transitioning current utilization and efficiency optimization tools and 
ensuring that these tools function effectively in a Continuous 
Distribution framework.

    Question. Please share the number of organs lost and/or delayed and 
the resulting loss of prospective transplants that occurred over the 
past year.

    The data provided in response to this question is necessarily 
limited to only the small subset of organ transportation arrangements 
that were facilitated by the UNOS Organ Center, because the OPTN does 
not collect transportation data on a national, systematic basis.

    It is important to note that transportation arrangements 
facilitated by the UNOS Organ Center are based on the transportation 
vendors and methods (driving, commercial aircraft, etc.) selected by 
the OPOs and transplant hospitals involved in the shipment. UNOS staff 
serve as a communication hub to connect those vendors with the senders 
and receivers of the shipments throughout the process. The vast 
majority of organ transportation arrangements are facilitated directly 
by the recovering organ procurement organization, and not by UNOS. As 
noted in a Kaiser Health News article, ``Matters involving the 
transportation methods used by organ procurement organizations (OPOs) 
are arranged directly between OPOs and transplant centers.''\38\
---------------------------------------------------------------------------
    \38\ JoNel Aleccia, ``How Lifesaving Organs for Transplant Go 
Missing in Transit,'' Kaiser Health News (February 10, 2020), available 
at https://khn.org/news/how-lifesaving-organs-for-transplant-go-
missing-in-transit/ (accessed on February 26, 2020).

    Between October 1, 2021. and September 30, 2022, the Organ Center 
assisted with providing deceased donor organ transportation 
arrangements for 1,727 of 35,319 deceased donor transplants (4.9 
percent) performed in this same time period. Out of the 1,727 organ 
shipments, 70 had a 2-hour or more delay from the original estimated 
time of arrival, and 13 were transplanted at an alternate transplant 
hospital. Thirty-five organ shipments were not ultimately transplanted, 
but it is important to note that it is not possible to draw any 
absolute conclusions about the association between an incident that may 
have occurred in transit and the ultimate outcome of the transplant. 
There are many reasons why a transplant hospital may not ultimately 
---------------------------------------------------------------------------
transplant an organ it accepted for a recipient, including:

          Too much cold ischemic time (which may or may not be due to 
        a transportation issue).
          The anatomy or appearance of the organ upon arrival (which 
        may or may not be due to a transportation issue).
          A change in the health of the recipient that may make them 
        unsuitable for the scheduled transplant.

    The same reasons can also be true for organs without any 
``transportation issues.'' For all the same reasons (cold ischemic 
time, anatomy of the organ, health of the recipient) and many others 
not listed, the transplant surgery may still not occur.

    Please see additional information about transportation in responses 
to Senator Wyden's seventh question and Senator Cardin's first 
question.

    Question. Are there penalties or repercussions for OPOs or 
transportation companies if an organ is lost and subsequently 
discarded?

    Answer. As provided by Federal law and regulation and the terms of 
the OPTN contract, the OPTN will review OPTN member institutions for 
compliance with OPTN obligations. ``Transportation companies'' 
including commercial airlines and couriers, are not members of the OPTN 
and therefore, the OPTN has no oversight or ability to impose penalties 
on those companies.

    For OPOs, the OPTN has authority to investigate issues of potential 
OPTN policy noncompliance or issues involving patient safety. Of the 
OPTN adverse member actions resulting in either Probation or Member Not 
in Good Standing (MNIGS), none to date has specifically involved a 
sentinel event related to organ transportation. Such an issue, however, 
might be subject to OPTN review if the event or issue directly relates 
to OPTN Obligations or, in the opinion of peer reviewers, is a threat 
to patient safety.

    Question. What process improvements has UNOS put in place to 
minimize lost organs?

    Answer. UNOS developed its own organ tracking solution, in addition 
to the variety of organ tracking tools already available on the market. 
Because of this, UNOS has access to data for the OPO clients who use 
our tracking service, but not for all organs being transported. Since 
the product launched in June 2021, and as of September 2022, 5,628 
shipments have been tracked, recently accounting for an average of 8 
percent of all packaged organs. Clients on average track 30 percent of 
all their packaged organs. OPOs don't typically track organs such as 
hearts, lungs and livers because they are traditionally accompanied by 
the transplanting surgeon (accounting for 40 percent of all packaged 
organs). Other OPOs only track kidneys and/or livers that use 
commercial air and/or are exported from their service area. Currently, 
OPOs can choose the tracking system that best suits their needs.

    Please see additional information about transportation in responses 
to Senator Wyden's seventh question and Senator Cardin's first 
question.

    Question. In 2017, I asked UNOS for information about an OPO which 
it had recently placed as a ``member not in good standing'' as a result 
of patient safety endangerment issues. UNOS's response to me at the 
time, which was personally signed by Mr. Shepard, was that UNOS could 
not share any of the documents I requested, but that UNOS ``provides 
appropriate and highly effective oversight.'' Then, when Senators 
Grassley, Wyden, Cardin and I launched an investigation into these 
patient safety failures, UNOS changed its messaging to state that it 
actually does not consider itself responsible for OPO oversight at all.

    How can Congress be assured there is ``appropriate and highly 
effective oversight'' when UNOS is unwilling to provide any 
documentation showing oversight is actually taking place--and when 
pushed, changes tactics to point fingers or deny UNOS's role in the 
oversight process?

    Answer. Oversight of OPOs is shared between the Centers for 
Medicare and Medicaid Services (CMS) and the OPTN. The OPTN is charged 
with monitoring OPTN members, including OPOs, for compliance with OPTN 
Obligations as defined in the OPTN bylaws. These obligations include 
NOTA, the OPTN final rule, and OPTN policies and bylaws. Federal 
regulation,\39\ the OPTN contract, and OPTN bylaws also require the 
OPTN to maintain a peer review process to promote quality assurance and 
performance improvement for all OPTN members, and this is the 
appropriate and intended role for the OPTN particularly with respect to 
OPOs where the OPTN's enforcement options are particularly limited. For 
example, the OPTN has no discretion whether to admit an OPO as a member 
of the OPTN nor does it have the authority to expel an OPO from OPTN 
membership.\40\ The OPTN has requirements that OPOs must meet, and 
reviews OPOs for compliance with those obligations. When an OPO is 
found to be noncompliant with an OPTN obligation, the MPSC works 
collaboratively with the OPO to correct deficiencies, implement 
corrective actions, and improve the quality of services it provides.
---------------------------------------------------------------------------
    \39\ 42 CFR Sec. 121.10(b)(1)(i).
    \40\ ``The OPTN shall admit and retain as members the following: 
(i) All organ procurement organizations;'' 42 CFR Sec. 121.3(b)(1)(i) 
(emphasis added).

    The Centers for Medicare and Medicaid Services (CMS) has the most 
complete and extensive Federal regulatory oversight over OPOs. This 
includes granting licensure to operate and designation to serve as an 
OPO, and approving financial reimbursement. To the extent that the OPTN 
has oversight authority, as provided by Federal law and regulation and 
the OPTN contract, the OPTN addresses member compliance with OPTN 
obligations and, in the opinion of peer reviewers, issues which may 
affect patient safety and the quality of services it provides. This is 
by necessity a more limited scope, and with different enforcement 
mechanisms. OPTN ``oversight'' is not duplicative but rather, 
---------------------------------------------------------------------------
complements CMS's oversight authority.

    Question. Will UNOS commit to sharing needed documents with 
appropriate oversight agencies to ensure thorough review and evaluation 
of adverse events in order to save lives and improve the organ donation 
and transplant system?

    Answer. Yes. In an effort to support the committee's investigation, 
UNOS suggested several pathways for the committee to obtain the data it 
needs to conduct its work. These included offers to meet with 
investigative staff in person to review documentation, providing 
detailed but deidentified case information, and a suggestion that 
Congress request the Secretary for the information, because we are 
required to provide the Secretary with any information the Secretary 
requests. We would suggest these mechanisms for future requests as 
well.

    UNOS is an organization that brings together all components of the 
nationwide organ transplantation community and has a compelling 
interest in preserving the sanctity of its highly effective peer review 
process. The medical peer review privilege between the OPTN and OPTN 
members is a reciprocal privilege; that is, both parties to the peer 
review process have an obligation to the other party to maintain the 
confidentiality of the communications and materials shared throughout 
the process. These mutual assurances of confidentiality ensure the 
candor and openness that is essential to an effective peer review 
process as envisioned in the Institute of Medicine Report, ``To Err is 
Human: Building a Safer Health System.''\41\ Statements made and 
information provided by an OPTN member to the OPTN contractor and vice 
versa during any interview, hearing, investigation, or inquiry with the 
MPSC, as a peer review body, are made during the course of its 
confidential peer review process and with the understanding that these 
statements and information would also be protected from discovery under 
the medical peer review privilege. The OPTN bylaws provide assurances 
to OPTN members that information provided during compliance activities 
will remain confidential pursuant to medical peer review \42\ and 
further exposes the OPTN contractor and its staff to personal liability 
for violating this peer review privilege.\43\ In light of the OPTN's 
obligation to provide a peer review system and the widely recognized 
benefits of confidential medical peer review, UNOS provides aggregate 
data on system-wide compliance activities that demonstrate the OPTN 
provides appropriate and highly effective oversight when OPTN members 
are found to be non-compliant with OPTN obligations.
---------------------------------------------------------------------------
    \41\ Washington (DC): National Academies Press (US); 2000. 
Available at: https://pubmed.ncbi.nlm.nih.gov/25077248/ accessed 
October 11, 2022.
    \42\ OPTN Bylaws Article A.1 (A)(5)(B). ``Any act, communication, 
report, recommendation or disclosure, with respect to any applicant or 
member made in good faith and at the request of the OPTN contractor and 
its representatives, anywhere and at any time, for the purposes 
described in (a) above are privileged to the fullest extent permitted 
by law as part of the OPTN medical peer review. The medical peer review 
privilege extends to any third parties who either supply or are 
supplied information and are authorized to receive, release or act upon 
the same.''
    \43\ Id. at (c). ``The immunity and release from liability provided 
in this section shall not apply to acts of willful misconduct by the 
OPTN contractor and its representatives.''

    HRSA presently provides oversight of the OPTN on behalf of the HHS 
Secretary. The OPTN is required by regulation to provide the Secretary 
any information that may be requested by the Secretary (42 CFR 
121.11(b)(iii)). The OPTN has always met this requirement and will 
continue to provide the Secretary any information that the Secretary 
---------------------------------------------------------------------------
prescribes.

    Question. Organ Procurement Organizations (OPOs) are constrained 
from placing their own kidneys with national transplant centers and 
instead forced to wait for the Organ Procurement Transplantation 
Network system to place them. According to the Report of National 
Kidney Foundation Consensus Conference to Decrease Kidney Discards 
published in Clinical Transplantation, October 2018, the overall 
placement rate for high Kidney Donor Profile Index (KDPI) kidneys 
allocated through the Organ Center is 28 percent, which those with KDPI 
of 80+ have a placement rate of less than 15 percent. OPOs who work to 
place kidneys themselves, have much higher placement rates. Why are 
OPOs penalized for placing the kidneys themselves?

    Answer. The ``Report of National Kidney Foundation Consensus 
Conference to Decrease Kidney Discards'' published in Clinical 
Transplantation, October 2018, does not cite an overall placement rate 
for high KDPI kidneys or those with a KDPI of 80+ allocated through the 
Organ Center.

    It's important to note that when this report was written, kidneys 
allocation was different than it is currently. Kidneys at that time 
were offered first within the OPO's Donation Service Area (DSA), then 
regionally, and finally to the Nation. Once all potential candidates at 
transplant programs within the OPO's DSA and region had received and 
refused kidney offers, OPTN policy required the OPO to contact the 
Organ Center for assistance allocating the kidney. An OPO's placement 
rate of high KDPI kidneys at the local DSA and regional classifications 
is not comparable to the Organ Center's placement rate at the national 
classifications. The higher quality organs will be accepted and 
transplanted prior to offers at the national level. Kidneys that have 
been declined by the local DSA and region often have more extended cold 
ischemic times, abnormal biopsy/laboratory findings, and/or anatomical 
issues, making Organ Center nation placement attempts significantly 
more challenging.

    Kidney allocation changed in 2021, and kidneys are now offered to 
transplant hospitals located within 250 nautical miles (NM) of the 
donor hospital and then to centers located over 250NM away from the 
donor hospital. OPTN policy requires the OPO to contact the Organ 
Center for assistance allocating a kidney once all centers within the 
250NM classifications have declined. The same issues apply to these 
placements; higher quality kidneys are more likely to be placed within 
the higher ranked 250NM classifications, leaving the allocation of the 
harder to place kidneys to the Organ Center. Therefore, just as in the 
prior policy, placement rates between the OPO and the Organ Center are 
not comparable.

    OPOs and the Organ Center use the same kidney match for placement. 
Successful kidney placement has three major components: (1) quality of 
the donor and organ, (2) distance/logistical constraints, and (3) 
transplant program and transplant candidate requirements. If the OPO is 
following the rank order of the match, then holding all else equal, 
placement rates should be the same at the national classifications 
regardless of the entity that is making the offers. UNOS staff do not 
prohibit nor penalize OPOs that make national kidney offers. However, 
if made aware of a case, staff will educate them on the OPTN policy and 
the potential deviation.

    The OPTN has pursued many projects from the 2018 NKF Consensus 
Conference recommendations. Below are just a few.

    Recommendation: ``Create expedited placement pathway to directly 
offer organs at risk of discard to small subset of centers that opt in 
to accepting these organs.'' ``Center must sustain high rates of 
acceptance to receive offers.''

    In 2019, the Organ Center implemented a data-driven yearlong Kidney 
Accelerated Placement (KAP) project, which was very similar to the 
recommendation from the NKF Consensus Conference. During the KAP 
project, hard-to-place kidneys were offered to transplant programs that 
had a history of accepting them. The acceptance to transplant rate was 
slightly higher under KAP (72.7 percent versus 71.2 percent), although 
not significant. More information about the project can be found at:

          https://onlinelibrary.wiley.com/doi/epdf/10.1111/
        ajt.16859.

    Recommendation: ``Understanding the role of kidney biopsies in the 
evaluation of organ quality and impact on allocation/acceptance.''

    In June 2022 two policies related to biopsies were passed by the 
OPTN board of directors. The policies establish minimum kidney donor 
criteria requiring a biopsy and standardize the reporting and data 
collection of kidney biopsies. In addition to improving allocation 
efficiencies, these two policies will allow for further research around 
the impact kidney biopsies have on acceptance and transplantation 
rates. More information about those policies can be found at:

 https://optn.transplant.hrsa.gov/policies-bylaws/public-
    comment/standardize-kidney-biopsy-reporting-and-data-collection/.
 https://optn.transplant.hrsa.gov/policies-bylaws/public-
    comment/establish-minimum-kidney-donor-criteria-to-require-biopsy/.

    Recommendation: ``Strengthen local OPO-transplant center 
cooperative QAPI efforts to reduce discard.''

    The OPTN created a collaborative improvement framework where 
members could share best practices and ideas for improvement. The 
primary aim of the Collaborative Innovation and Improvement Network 
(COIIN) was increasing transplantation with a particular focus on 
moderate to high Kidney Donor Profile Index (KDPI) kidneys. Favorable 
results were seen in both cohorts, and findings show that an increase 
in transplant rate and greater utilization of moderate to high KDPI 
organs were realized in many participating centers.\44\
---------------------------------------------------------------------------
    \44\ Wey, A., Foutz, J., Gustafson, S.K., Carrico, R.J., 
Sisaithong, K., Tosoc-Haskell, H., McBride, M., Klassen, D., Salkowski, 
N., Kasiske, B.L., Israni, A.K., Snyder, J.J. ``The Collaborative 
Innovation and Improvement Network (COIIN): Effect on donor yield, 
wait-list mortality, transplant rates, and offer acceptance.'' Am J 
Transplant. 2020 Apr;20(4):1076-1086. https://pubmed.ncbi.nlm.nih.gov/
31612617/.

    Recommendation: ``Develop and test measures of transplant center 
---------------------------------------------------------------------------
organ acceptance to help inform organ allocation.''

    In 2021, the reason for refusal of an organ list was updated.\45\ 
Revising the list of refusal codes supports increased efficiency of the 
OPTN through better understanding of refusal behaviors. Offering 
members more options for reporting why an offered organ is refused 
provides more robust data to develop improved allocation strategies to 
reduce cold ischemic time and number of non-utilized organs well as 
increase the number of transplants.
---------------------------------------------------------------------------
    \45\ Project to update refusal codes. OPTN Data Advisory Committee. 
Nd. https://optn.transplant.hrsa.gov/policies-bylaws/a-closer-look/
project-to-update-refusal-codes/.

    Question. Why is UNOS so far behind in creating Application 
Programming Interface (API) software that electronically transmit data 
between hospitals/OPOs/transplant centers to UNOS without having to 
manually enter data into other databases first? What APIs currently 
exist? What is the process for their use? How many are entities in the 
---------------------------------------------------------------------------
system are using APIs?

    UNOS launched the UNet application in 1999 with tools for users to 
transmit data electronically to avoid manual entry. As part of ongoing 
modernization, UNOS started a formal API program in 2016. Since that 
time, UNOS development and implementation of APIs has advanced and is 
increasing.

    As of September 2022, 243 hospitals and OPOs use APIs to transmit 
or receive data. Our external APIs empower OPTN members to 
electronically:

          Manage donor data
                  Demographics
                  Vitals
                  Medical and social history
                  Clinical lab values
                  Infectious disease testing results
                  Diagnostic test results
                  Urinalysis
                  Blood gases
                  Culture results
                  Medications and fluids
                  Human Leukocyte Antigens (HLA)
                  Kidney preservation data
                  File attachments (for images and source 
                documentation)
          Manage candidate data
                  Demographics
                  Unacceptable antigens
                  Liver labs
                  Lung labs and functional status
                  Offer acceptances
          Report organ-specific data on patients and donors at key 
        transplant milestones
                  Transplant Candidate Registration (TCR)
                  Transplant Recipient Registration (TRR)
                      Transplant Immunosuppression Data (IMR)
                  Transplant Recipient Follow-Up (TRF)
                      Transplant Immunosuppression Data during 
                Follow-Up (IMF)
                  Deceased Donor Registration (DDR)
                  Living Donor Registration (LDR)
                  Living Donor Follow-Up (LDF)
          Calculate key transplantation scores
                  Calculated Panel Reactive Antibody Score 
                (CPRA)
                  Model for End-Stage Liver Disease Score 
                (MELD)
                  Pediatric End-Stage Liver Disease Score 
                (PELD)
                  Lung Allocation Score (LAS)
          Report deceased donor referrals
          Retrieve donor hospital data
          Retrieve public reporting data

    UNOS coordinates with OPTN members and EHR vendors prior, during, 
and after our own API development. This includes conducting community 
research to identify API development targets that OPTN members and 
their EHR vendors want to integrate with, maintaining regular 
communication and hosting town hall events with the community to 
describe upcoming offerings and changes to existing APIs, and 
collaborating with vendors and members throughout their 
implementations.

    In addition to providing direct user assistance, we maintain a 
developer portal with detailed API documentation through our Google 
Cloud API Management platform, Apigee. We inform stakeholders of 
upcoming changes months in advance, provide them with specification 
details prior to implementation, and offer direct support throughout 
their own work.

    Furthermore, we maintain our Beta Portal, an external facing, non-
production OPTN System (UNet) environment that enables vendors and 
members to build and test their own systems against upcoming changes. 
Changes to existing APIs are deployed to Beta Portal 6-8 weeks prior to 
moving to production. UNOS regularly monitors Beta Portal activity to 
identify challenges developers are encountering. We also adapt our API 
roadmap to minimize the frequency an API experiences significant 
changes. These measures appropriately throttle our own development to 
provide stability for our customers (OPTN members end users) while 
still improving our technology.

    The U.S. health-care system's unique complexity and fragmentation 
presents both a greater need for integration and a higher barrier to 
it, and that is reflected in current API adoption. UNOS recognizes that 
building APIs does not guarantee that transplant hospitals, organ 
procurement organizations and histocompatibility laboratories will use 
them. Decisions to adopt APIs go through software vendors as well as 
OPTN members' leadership, IT teams, and clinicians. These parties act 
in alignment with their own interests and constraints, and may choose 
to rely on historical solutions. Transplantation remains a small sector 
of health care, and in this respect, lagging API adoption and continued 
reliance on historical solutions are to be expected.

    Nevertheless, UNOS is not a passive observer in this space. While 
OPTN members have not been mandated to use APIs, UNOS has taken 
measures to lead the community forward through the deprecation of 
previously developed solutions and standards. This includes the recent 
sunset of a tool to import candidates' unacceptable antigen data, which 
increased use of the corresponding API from 16 centers in January 2022 
to 91 centers in September 2022. Similarly, UNOS is enforcing updates 
to API authentication protocols in 2022, ensuring that OPTN members 
consistently adhere to the most current cybersecurity standards for 
integration. In these cases, UNOS balances community readiness and 
value to the OPTN to set appropriate deadlines, similar to Congress and 
HHS's journey to retire ICD-9 from 2008 to 2015.

    To further drive adoption, the UNOS API program has begun ramping 
up proactive engagement efforts with OPTN members. Staff are conducting 
direct outreach to OPTN members and EHR Vendors for API implementation 
based on their needs and their EHR vendors' capabilities, to assist 
with implementation and testing, and to drive continuous improvement 
for future API development, rollout, and updates. UNOS is also 
partnering with Accenture Federal, a consulting firm and tech leader, 
to expand and extend our API strategy to increase API adoption with 
plans to assist OPTN members with any implementation or testing needs, 
and driving process improvements to further streamline future adoption.

    Question. What have you committed to investing in OPTN systems to 
bring them into the 21st century? What is your action plan, timeline 
and allocation of resources to do so?

    Answer. Some of the key technology trends in the 21st century are 
Microservices, APIs, Cloud, Mobile, Big Data/Machine Learning and 
leveraging Agile methodology to build software.

    In addition to implementing OPTN policy projects, since 2014, UNOS 
has leveraged these industry themes and never lost sight that the most 
important factor of successfully using technology is to focus on the 
customer.

    With that in mind, to date we have invested in iterative modular 
development and automated testing while building an API platform, using 
Google Cloud's Apigee, that we can use to share data securely using RFC 
standards. We focused on modularizing our software through 
microservices. These web-based microservices are a foundation for all 
development as we build new solutions, seamlessly share data with 
external systems, and transform our production systems used by OPTN 
members to save lives. The illustration and summaries below depict some 
of the modernization efforts accomplished since 2016. In addition, the 
projects listed below the timeline are other OPTN Board of Directors or 
Member requested projects implemented during that time.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


                  technology highlights since 2016
    In 2016, in addition to launching our APIs and Microservices 
efforts, UNOS developed and released reporting and analytics 
capabilities to help improve the quality, scope, and timeliness of 
organ offers for transplant centers and OPOs. Leveraging Big Data 
concepts, Hortonworks Connected Data Platforms, 100-percent open-source 
ApacheTM Hadoop and Tableau, transplant centers were given 
automated, detailed, and visually rich reports on all organ offers they 
received and the outcome if it was transplanted.

    In 2017, UNOS developed a matching function test automation suite 
to conduct ongoing software testing to reduce project implementation 
time. This suite continues to be updated with every OPTN policy change 
or customer requested functionality enhancement. This was built on the 
open-source framework Selenium and gives us the robust capabilities to 
leverage coding to test all critical features.

    In 2018, UNOS implemented and integrated with Salesforce.com 
leveraging their industry leading Software as a Service (SaaS) Customer 
Relationship Membership (CRM) platform to manage the OPTN Membership.

    Also in 2018, a new reimagined and modernized version of the OPO 
mobile experience was released. This product was developed with 
critical input and prioritization by the OPO community and incorporated 
numerous existing and newly developed microservices.

    We continued this journey in 2019, when we created a cross-
departmental team that is focused on creating public cloud patterns 
that can scale our ideas and core infrastructure for the capabilities 
found in the public cloud. In parallel, we developed a new Security 
Administration application. The new application increased capabilities 
for OPTN site security administrators, leveraged microservices and 
features an immersive, modern user experience.

    In 2020, UNOS implemented an integrated Clinical Image Sharing 
solution via integration with an industry leader, Ambra Health. This 
intuitive, feature rich DICOM viewer enables OPOs to upload organ donor 
clinical studies and allows transplant professionals to make more 
informed decisions.

    Also in 2020, UNOS launched a new mobile, web-responsive experience 
for transplant hospitals to interact with DonorNet utilizing 
microservices. We collaborated closely with many transplant 
coordinators, administrators, and surgeons throughout the country using 
human-centered design techniques to create and test designs. This new 
design and experience enabled them to evaluate and respond to offers 
regardless of where they are at any time of day.

    In 2021, we completed a transformation to a multi-regional hybrid 
cloud environment built using Nutanix cloud infrastructure and 
Microsoft Azure public cloud. Aligned with our cloud-first approach for 
all new functionality, we have implemented new cloud-native real-time 
capabilities in Predictive Analytics decision support for organ offer 
acceptance, while actively executing a roadmap to move existing core 
infrastructure to the public cloud.

    To protect the organ matching system and patient data to which we 
are entrusted, over the last several years we made significant 
investments in security capabilities aligned with defense-in-depth and 
zero trust principles. Among these are robust authentication 
capabilities, application code vulnerability scanning, security log 
aggregation, correlation and visualization, industry leading endpoint 
detection and response, and distributed denial of service (DDoS) 
protection.
                          resources allocated
    Since 2016, UNOS has invested more than 200,000 hours of resources 
into ongoing technology modernization efforts; we understand the 
importance of enhancing and securing the technology the OPTN members 
use to save lives.

    UNOS routinely documents and updates the OPTN Network Operations 
Oversight Committee (NOOC) and HRSA on improvement plans. Please see 
roadmap below, shared with the NOOC and HRSA, for planned improvements 
to the system.

    The illustration below depicts continued improvements and 
innovation areas we envision and aim to implement over the next several 
years.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    UNOS leverages microservices (internal-facing APIs) as part of 
its continued technology transformation into a modern microservices 
architecture. A number of internal system components already make heavy 
use of internal APIs, free of external dependencies, allowing UNOS to 
rapidly expand its footprint in this area. Through these efforts, we 
continue to mature our technology systems and practices.
            partnering with leaders in technology innovation
    A significant component of our strategy is leveraging or 
integrating leading technologies in areas beneficial to the transplant 
ecosystem. That is the reason UNOS has advanced the OPTN system with 
solutions utilizing open-source frameworks that include: Angular; 
Swift; Kotlin; and NodeJS.

    This is extended with integrations offered by key Cloud SaaS 
providers: Twilio; Salesforce; Ambra; and Azure.

    UNOS understands and has prioritized the use of open-source 
frameworks and created partnerships with dozens of recognized 
technology leaders to advance the capabilities of the OPTN system.

    During the transformation of our technology, we have partnered with 
the Microsoft Tech for Social Impact team to align our vision with a 
reality we can bring to the transplant community. This partnership has 
also helped us make connections with other countries, share our 
learnings and assist them in using the public cloud for solving their 
problems.

    Question. Why does it take 2-plus years to process a policy change 
at the OPTN, even when it is non-controversial and there is agreement 
on the needed change?

    Answer. The OPTN must balance its requirements under the law, which 
includes involving multiple stakeholders during the policy development 
process and during public comment. Public comment, a critical aspect of 
the policy development process is required by NOTA (42 U.S.C. 
Sec. 274(b)(2)(B)) and the OPTN final rule (42 CFR Sec. 121.4(b)(1)).

    The time to process large allocation proposals has fallen over the 
last decade. For example, the revised kidney allocation system took 
over 9 years and liver distribution over 6 years. In contrast, the 
development of lung continuous distribution, which included an overhaul 
of the entire framework of the allocation system and member tools, took 
less than 3 years to develop.

    Continuous advances in the science and practice of organ 
transplantation require ongoing refinement of policy that involves 
experts in the field as well as the public and the larger donation and 
transplant community. To ensure the best possible solutions for 
patients awaiting transplantation and for the donors whose precious 
gifts make that possible, the policy development process is:\46\
---------------------------------------------------------------------------
    \46\ OPTN Policy Development Process. https://
optn.transplant.hrsa.gov/policies-bylaws/policy-development/
#policyProcess.

          Inclusive--encouraging participation by interested persons, 
        organizations and the general public.
          Responsive--assessing and modifying policies to remain 
        current with the field.
          Equitable--helping to ensure that all patients have an equal 
        chance of receiving a suitable organ.
          Evidence based--making decisions based on extensive and 
        valid scientific data and analysis.

    The hundreds of volunteers who serve on OPTN committees that 
develop policy comprise highly experienced medical professionals, 
patients, and donor families. UNOS values the feedback of the whole 
community and strives to achieve consensus, which contributes to the 
time it takes to develop a policy.

    Question. During the hearing, you referenced a rubric for matters 
referred to the Membership and Professional Standards Committee (MPSC)? 
Please provide the rubric.

    Answer. The rubric, part of the MPSC's operational rules, is 
provided as part of this submission.

    Question. What are you doing to ensure OPOs and donor hospital and 
transplant centers are aligned in their work? And what accountability 
measures do you have in place for transplant centers to align their 
efforts with those of OPOs?

    Answer. UNOS brings together all stakeholders in the community to 
drive continuous improvement and increase transplant.

    Our field is uniquely interdependent. Making the system more 
equitable and efficient requires regulatory agencies, OPOs, transplant 
centers and the approximately 6,000 donor hospitals in the U.S. to 
efficiently and effectively align their work toward our common goal of 
saving and enhancing lives. Many people, often in different parts of 
the country, collaborate at all hours of the day or night. This occurs 
nowhere else in medicine, and it requires our constant vigilance and 
care to assure that it is done well and that all facets of the system 
are accountable for its success.


    Recent efforts by UNOS to better align work across the organ 
donation and transplant system and ensure the highest level of 
accountability include:

          A new performance monitoring system for transplant 
        hospitals.
          Collaborative Improvement (CI) and Individual Member Focused 
        Improvement (IMFI) projects that bring together transplant 
        programs, OPOs and HRSA on quality improvement initiatives.\47\
---------------------------------------------------------------------------
    \47\ OPTN Collaborative Improvement. https://
optn.transplant.hrsa.gov/professionals/improvement/collaborative-
improvement/.
---------------------------------------------------------------------------
          The incorporation of predictive analytics into the organ 
        offer experience for adult deceased donor kidneys that is 
        intended to impact acceptance behavior and increase organ 
        utilization.

    Every day, our community's collective efforts to provide 
exceptional clinical care, assure equitable organ allocation policies, 
and innovate to continuously improve move the system forward and save 
even more lives.

                                 ______
                                 
                 Prepared Statement of Hon. Ron Wyden, 
                       a U.S. Senator From Oregon
    The last place anybody wants to hear about gross mismanagement and 
incompetence is in the business of saving lives. That's precisely and 
unfortunately what the Finance Committee meets to discuss today.

    This morning's hearing is an update on an investigation Senator 
Grassley and I, along with Senator Cardin and Senator Young, have been 
conducting for more than 2\1/2\ years. It examines the network of 
dozens of organizations that manage organ transplants, and particularly 
the group that oversees and coordinates them, the United Network for 
Organ Sharing, or UNOS. We have reviewed 100,000 UNOS documents 
totaling more than a half-million pages.

    Before I get to specific findings, I want to frame what we've 
learned as simply as possible. Far too many Americans are dying 
needlessly because UNOS and many of the transplant organizations it 
oversees are failing and seem uninterested in improving.

    These issues involve an alphabet soup of acronyms and 
organizations, so I'll start out with a bit of background. A 1984 law 
created the first computerized system to match sick patients with the 
organs they needed. It was named the Organ Procurement and 
Transplantation Network. Somebody needed to manage that system for the 
entire country, so the government sought to contract an organization to 
run it. UNOS was the only bidder for that first contract in 1986. The 
contract has come up for bid seven other times. UNOS has won all seven.

    Today the network UNOS oversees is made up of nearly 400 members, 
including 252 transplant centers and 57 regional organizations known as 
organ procurement organizations, or OPOs. Each OPO has a defined 
geographic service area. A family sitting in a hospital room thinking 
about donating a loved-one's organ doesn't have a choice of OPOs.

    Those are the important terms to remember. When a kidney donated in 
Corvallis needs to get to a patient in Portland, that's where an OPO 
comes in. UNOS oversees the OPOs. As our investigation shows, UNOS does 
it very poorly.

    Serious errors in the procurement and transplant system are 
shockingly common. Between 2010 and 2020, more than 1,100 complaints 
were filed by patients and families, staff, transplant centers, and 
others. The nature of those complaints runs the gamut. For example, in 
a number of cases OPOs had failed to complete critical, mandatory tests 
for things like blood types, disease, and infection.

    Our investigation found one patient died after being transplanted 
with lungs that a South Carolina OPO marked with the wrong blood type. 
Similar blood-type errors happened elsewhere, and patients developed 
serious illness. Some had to have organs removed after transplant.

    Another patient was told he would likely die within 3 years after 
an OPO in Ohio supplied him with a heart from a donor who had died of a 
malignant brain tumor. UNOS did not pursue any disciplinary action.

    In a case from Florida, another patient contracted cancer from 
transplanted organs, and the OPO sat on the evidence for months.

    In total, our investigation found that between 2008 and 2015, 249 
transplant recipients developed a disease from transplanted organs. 
More than a quarter of them died.

    Delivering organs has been another source of life-threatening 
errors. We found 53 such complaints between 2010 and 2020, as well as 
evidence that those were just the tip of the iceberg. In some cases, 
couriers missed a flight. In others, the organs were abandoned at 
airports. Some organs were never picked up. Many of these failures 
resulted in organs being discarded.

    It's reasonable to assume that many more errors are going 
unreported. Why? Because filing official complaints with UNOS appears 
to accomplish zero productive oversight or reform. Organ transplant 
professionals repeatedly told the Finance Committee that the UNOS 
complaint process was a ``black hole.'' Complaints went in, UNOS went 
quiet.

    In interviews with the committee, UNOS leaders have dragged their 
feet, dodged tough questions, and shifted responsibility onto others. 
Investigations and disciplinary measures rarely amount to more than a 
slap on the wrist. Only one time--just once--has UNOS recommended that 
an OPO lose certification.

    The bottom line is that the failures we've uncovered cost lives. 
Thousands of organs donated each year wind up discarded, including one 
in four kidneys. Yet according to Federal data, roughly 6,000 Americans 
die every year while waiting for an organ transplant.

    This kind of mismanagement has a disproportionate impact on 
minority Americans. African Americans, for example, have a greater need 
for kidney transplants than those from other demographic groups.

    The Centers for Medicare and Medicaid Services recently issued new 
standards for OPO performance, and more than a third of OPOs are 
failing to meet them. Fixing what's broken could substantially increase 
the supply of lifesaving organs available for transplant.

    Finally, another area of the committee's investigation has examined 
the IT used by UNOS to run the transplant network. This system is 
outdated, mismanaged, and insecure. Using such decrepit tech to run the 
transplant network puts lives in danger and puts sensitive data at 
risk, and there is no apparent solution in sight. In a report issued 
last year titled ``Lives Are at Stake,'' the U.S. Digital Service 
flatly concluded that UNOS did not have the technical capability to 
modernize the system.

    I'll close on this. If you looked at the staff at UNOS and many of 
the Nation's OPOs, I'd wager the vast majority are hardworking people 
doing their best to save lives. The glaring issues uncovered in our 
investigation stem from leadership failures.

    Our investigation is ongoing. It's clear this system needs reform 
badly. We're going to continue digging into issues at UNOS and the 
OPOs, as well as the policies that need changing at the Federal level. 
This is not a partisan subject. Everybody wants this system to work 
with as few errors as possible. Senators Grassley, Cardin, Young, and I 
are going to keep at it.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


                                 __
                                 

                             Communications

                              ----------                              


                 Letter Submitted by Jaison M. Abraham
Hello, Honorable Senator(s),

For the record, I believe it is extremely unfair to blame United 
Network for Organ Sharing (UNOS) and OPOs for bad performance and poor 
outcomes. The allocation system may not be perfect but has evolved over 
the years. It will always be a continuous process to decrease 
disparities and better serve patients. Transplant Centers should also 
be held accountable. Programs that failed to evolve their practices are 
struggling more. The Senate committee selected AdventHealth, a non-
academic center with one of the lowest organ offer acceptance rates and 
lowest 1M, and lowest 1Y outcomes in its Kidney and Liver Transplant 
programs, to provide witness testimony in its investigation. Though I 
do not believe the Senate intended to select a low-performing center to 
represent the transplant community--it did. I urge the Senate committee 
to look at a broader cross-section of the transplant community for 
better representation at future hearings.

The U.S. Transplant system is the most developed and successful in the 
world. Transparency is one of its strengths. As transplant 
administrators, we appreciate the efforts of the senate to improve the 
transplant system and are hopeful that the inquiry will elevate 
processes and improve care for the patients cared for by all of the 
centers.

Respectfully,

Jaison Abraham, MBA, LSSBB
Director of Transplant Programs
UF Health Shands
Office: 352-594-5288
Web: https://ufhealth.org/transplant-center/

                                 ______
                                 
                     American Society of Nephrology

                      1401 H Street, NW, Suite 900

                          Washington, DC 20005

On behalf of the 37 million Americans living with kidney diseases, 
thank you for your efforts to improve the United States transplant 
system. ASN seeks to transform transplant care and applauds the Senate 
Finance Committee for investigating shortcomings of the Organ 
Procurement Transplantation Network (OPTN).

``ASN believes a strong and equitable transplant system is essential to 
meet the needs of the more than 800,000 Americans living with kidney 
failure. While a kidney transplant is the optimal therapy for most 
people living with kidney failure, transplantation remains out of reach 
for too many people. ASN is deeply concerned with reports of technology 
failures from the OPTN contractor that are contributing to the immense 
organ discard rate and shortage of kidneys for transplantation. ASN 
reaffirms our call for the OPTN contract to be modernized. The more 
than 21,000 kidney health professionals who comprise ASN are committed 
to creating a world without kidney diseases, including by transforming 
transplant care. ASN commends the Senate Finance Committee for 
continuing to drive improvements in transplantation and stands in 
partnership to ensure all Americans who could benefit have access to 
this critical therapy,'' said ASN President Elect Michelle A. 
Josephson, M.D., FASN in a press statement.

Of the more than 100,000 people currently on the transplant waiting 
list, there are nearly 90,000 people currently waiting to receive a 
kidney, the largest subset of any organ. Devastatingly, a national 
organ shortage means that 13 people die every day while on the kidney 
transplant wait list.

ASN believes that transformations are needed across the transplant 
system in order to meet the growing need for kidney transplantation, 
including at the level of the OPTN. This statement focuses on 4 policy 
recommendations that address challenges related to the OPTN, including:

      Modernize the OPTN contract by separating the IT infrastructure 
into a distinct contract.

      Address barriers to transplant access that promote or exacerbate 
inequities, including the use of race in the organ quality metric that 
guides allocation Kidney Donor Profile Index (KPDI).

      Streamline oversight of the U.S. transplant system by 
establishing an office of organ transplantation.

      Elevate transplant patients as partners in care, including by 
improving transparency regarding organ offers.

 Modernize the OPTN Contract by Separating the IT Infrastructure Into a 
                    Distinct Contract

The OPTN is a quasi-governmental government agency responsible for 
establishing organ transplant and allocation policy, conducting 
oversight and enforcement of transplant programs and Organ Procurement 
Organizations (OPOs), and maintaining an IT infrastructure to support 
transplantation. The OPTN contract has been held by a single not-for-
profit organization, the United Network for Organ Sharing (UNOS) since 
the contract was created in 1986.

UNOS maintains an IT infrastructure, which UNOS claims to be 
proprietary despite being developed under a federal contract with tax 
dollars and user fees, to support wait-listing, organ allocation, 
sharing of donor information and data capture for regulatory oversight. 
As revealed by The Washington Post, stakeholders in government have 
expressed repeated concerns over UNOS continued use of antiquated 
systems for data capture and collection with no validation tools or 
interoperability features. The stakeholders, including the White House 
U.S. Digital Service, noted deep issues with transparency when reviewed 
by the service as well as major security vulnerabilities. Efforts to 
modernize these systems have been slow and ineffective, with changes in 
policy such as new organ allocation schemes taking as long as a year or 
more to implement.

Further, data are collected from different parts of the transplant 
system at the expense and labor of transplant centers and OPO staff, 
and then returned back to transplant centers and OPOs in the form of 
well curated dashboards (for a fee for national datasets), while some 
free reporting tools exist, they are often clunky and lack the depth of 
information provided in paid reporting tools. Despite being established 
through taxpayer- and user-fee-supported funding, The Washington Post 
reports that UNOS claims ownership of the system and would charge the 
American taxpayer $55 million to purchase the current IT system should 
it ever lose the contract.

This arrangement is unique as other important responsibilities in 
transplantation, such as the statistical and analytical support 
provided by the Scientific Registry of Transplant Recipients (SRTR), 
are structured as an independent contract. It is no surprise that 
stakeholders ranging from the White House U.S. Digital Service to a 
bipartisan group of HHS technology officers to the National Academies 
of Science and Medicine have all called for the IT infrastructure 
responsibilities of OPTN to be separated into an independent and 
competitive contract. Separating the IT infrastructure portion of the 
OPTN contract would align with other federal contracting protocols, 
increase competition, and drive innovation.

 Address Barriers to Transplant Access That Promote or Exacerbate 
                    Inequity, Including the Use of Race in the Organ 
                    Quality Metric That Guides Allocation, Kidney Donor 
                    Profile Index (KPDI)

Kidney transplantation is the optimal therapy for most people living 
with kidney failure, yet kidney transplantation is not equally 
accessible for all Americans. For example, Black patients are less 
likely to be identified as transplant candidates, referred for 
evaluation to receive a pre-emptive transplant, and to complete the 
transplant evaluation. Black patients are also less likely to have the 
preferred living donor and less likely to be placed on the waiting 
list, while also being more likely to receive lower quality kidneys 
regardless of the age of the patient and length on the kidney wait 
list, and have poorer transplant graft survival for a multitude of 
reasons that may include difficulties in access to care--a cyclical and 
compounding struggle that is nearly impossible to defeat without real 
identification and solution to racism.

Many of the policies needed to establish equity in transplant require 
cooperation between multiple stakeholders in the private sector and 
across different government agencies. However, one improvement is 
squarely in the purview of the OPTN contractor: removing the use of 
race in metrics related to organ allocation.

Race does not have any physiological relationship with the function of 
a patient's kidney, yet clinical decision support tools such as the 
estimated Glomerular Filtration Rate equation (eGFR) have included race 
adjustor variables, systemically overestimating the kidney function of 
Black patients and leading to reduced access to transplantation. On 
June 27, 2022, OPTN finalized a policy to remove race as a variable 
from eGFR, following the recommendation of the American Society of 
Nephrology and National Kidney Foundation and citing concerns that the 
variable was leading to a 16% overestimation of kidney function among 
Black patients.

Despite this welcome decision, OPTN is still allowing a race adjustment 
in the Kidney Donor Profile Index (KDPI), with no public plans to cease 
their use. The KDPI estimates the relative risk of post-transplant 
kidney graft failure of organs obtained from a deceased donor. The KDPI 
includes a race variable, automatically assigning lower quality to 
kidneys obtained from Black donors independent of biological factors, 
arbitrarily reducing the supply of donated kidneys and effectively 
turning away the gift of life from Black donors. Analyses from SRTR 
have demonstrated that removing a race variable does not alter the 
equation's predictability of graft failure or patient survival. Race 
variables should be removed from tools assessing biological factors, 
including the organ quality metric that guides kidney allocation, the 
Kidney Donor Profile Index.

 Streamline Oversight of the U.S. Transplant System by Establishing an 
                    Office of Organ Transplantation

Oversight of the U.S. transplant system is currently divided between 
the Centers for Medicare and Medicaid Services (CMS), who oversee 
transplant programs, and the Health Resources and Services 
Administration (HRSA), who oversee OPTN and OPO contractors. This split 
responsibility leads to gaps in oversight, confusion in navigating the 
transplant system, and a regulatory framework that does not elevate 
patients to be true partners in care.

One glaring example of this confusion is the use of financial means 
testing to evaluate a transplant recipient's eligibility to receive a 
transplant. In 2020, Congress passed the Comprehensive 
Immunosuppressive Drug Coverage Act, effectively ending the need for 
kidney transplant recipients to pay for immunosuppressive drugs out of 
pocket and a commonly used justification for financial screening.

Both transplant programs, regulated by CMS under the Conditions for 
Coverage, and the OPTN contractor, regulated by HRSA under the OPTN 
final rule mandate that patient selection (CMS) and organ allocation 
(HRSA) must ensure fair and non-discriminatory distribution of organs, 
yet financial criteria are still used to screen low-SES people from 
access to transplantation, even if the patient is otherwise healthy and 
a good transplant candidate.

Establishing a unified office of organ transplantation at HHS would 
enable transplant policy to be built around people in need of a 
transplant as opposed to being built around regulatory silos. Broadly, 
transplant policy should be aligned with the primary goal of increasing 
access to kidney transplantation to the maximum number of patients with 
kidney failure while improving longer term post-transplant outcomes 
(particularly among our younger recipients) and quality of life 
(particularly among older recipients where long-term survival may not 
be the paramount goal).

Currently, regulations across kidney care, including for dialysis 
facilities, transplant centers, and OPTN are not aligned and do not 
recognize the role of all in facilitating a smooth transition of care 
for patients. As a result, there are silos of care that occur in the 
nephrology clinic, dialysis unit, and the transplant center that 
increase challenges faced by patients in achieving optimal patient 
care. Establishing a single office of organ and transplant policy would 
better encourage patient-centered regulation instead of the current 
framework which focuses almost exclusively on short-term patient 
outcomes. This shift would improve communications across silos of care 
(dialysis units, referring nephrologists, and transplant centers), 
encourage transplant centers to provide increased and timely access to 
evaluation and related testing, and encourage greater communication 
about wait-listed candidates among transplant centers and current care 
teams. Unifying oversight of the transplant system under a single 
office would ensure that patients' interests do not become lost in gaps 
of oversight.

 Elevate Transplant Patients as Partners in Care, Including by 
                    Improving Transparency Regarding Organ Offers

ASN believes that patients should be informed partners in their care, 
and most patients want more rather than less information about their 
care. Unfortunately, the current transplant system does not emphasize 
this principle: most patients are currently unaware of organ offers 
that are declined on their behalf by their care team. This is 
particularly concerning given research has shown that 85% of all 
kidneys are declined at least once, and that the 10,000 people who die 
per year on the transplant wait list receive a median of 16 organ 
offers while waiting for an organ.

While real-time notifications of organ offers are likely not feasible, 
practical, or desirable, asynchronous communication of these offers are 
a potential option for improving patient engagement and elevating 
patients as partners in their care. IT systems could be developed to 
facilitate local EHR communications and increase transparency and 
communication between people waiting for a transplant and the 
transplant care team. and

For example, informing patients at regular intervals (every three or 
six months) could help by improving communication between patients, 
transplant center and dialysis providers about patient preferences and 
priorities, and by helping patients appreciate the tradeoff between 
increased selectivity for organs and wait times for those organs.

Finally, it would be of considerable benefit for transplant centers to 
have effective tools to assess the implications of turning down an 
offer, just as much as patients need tools to assess the implications 
of accepting a higher-risk kidney compared to remaining on the 
transplant wait list. Above all, patients should be provided the 
opportunity to be true partners in their care, and transparency should 
be fostered in the transplant system to elevate patients to be informed 
decision makers wherever possible.

Conclusion

Again, thank you for addressing this high area of need in the 
transplant system. ASN stands ready to help address these challenges 
and transform transplant care into an accessible therapy for all 
Americans. Should you have any questions about this statement, please 
do not hesitate to contact Zach Kribs, ASN Manager of Congressional 
Affairs at [email protected] or 202-618-6991.

Sincerely,

Michelle A. Josephson, M.D., FASN
President-Elect

Roslyn B. Mannon, M.D., FASN
Chair, Policy and Advocacy Committee

                                 ______
                                 
             Association of Organ Procurement Organizations

                     8300 Greensboro Drive, #L1-620

                            McLean, VA 22102

                             (703) 556-4242

                           https://aopo.org/

On August 3, 2022, the Senate Finance Committee held a hearing and 
released a report \1\ entitled: ``A System in Need of Repair: 
Addressing Organizational Failures in the U.S. Organ Procurement and 
Transplantation Network.'' The Association of Organ Procurement 
Organizations (AOPO) shares the Committee's goal of creating and 
maintaining a more equitable and efficient system.
---------------------------------------------------------------------------
    \1\ https://www.finance.senate.gov/imo/media/doc/
UNOS%20Hearing%20Memo.pdf.

The year 2021 marked the eleventh record year in a row for deceased 
organ donors and the ninth consecutive year of increases in the number 
of organ transplants nationwide.\2\ We are actively working to ensure 
this upward trend continues. As part of that effort, we are committed 
to improvement and seek feedback from impacted individuals, 
communities, and other stakeholders.
---------------------------------------------------------------------------
    \2\ OPTN Press: ``All-time records again set in 2021 for organ 
transplants, organ donation from deceased donors,'' https://
optn.transplant.hrsa.gov/news/all-time-records-again-set-in-2021-for-
organ-transplants-organ-donation-from-deceased-donors/.

AOPO agrees that by investing in new, promising technologies, aligning 
policies and metrics towards shared, system-wide goals, and 
establishing mutual accountability for participants in the organ 
donation and transplantation process, we can improve the efficiency and 
equality of our system and ultimately save more lives. To move forward, 
the Committee should endorse the findings from the National Academies 
of Sciences, Engineering, and Medicine (NASEM)\3\ report which assesses 
where the system currently stands, delineates the role each stakeholder 
plays, and charts a path to a more equitable donation and 
transplantation system. We agree that continued improvements are 
necessary to advance care for patients.
---------------------------------------------------------------------------
    \3\ NASEM Publication: ``Realizing the Promise of Equity in the 
Organ Transplantation System,'' https://www.nationalacademies.org/our-
work/a-fairer-and-more-equitable-cost-effective-and-transparent-system-
of-donor-organ-procurement-allocation-and-distribution.
---------------------------------------------------------------------------

Organ Acceptance Rates and Non-Utilization

The under-use of viable organs, leading to an increase in organ waste, 
is an urgent issue that all donation and transplant stakeholders must 
solve as it is a major contributing factor to the nationwide wait list 
exceeding 100,000 patients. According to research cited in the NASEM 
report, a person who dies on the wait list has, on average, been 
offered 16 organs. Unfortunately, transplant center acceptance rates 
are low, and one fundamental way to advance equity is by increasing 
acceptance rates for organs from older and more medically complex 
donors.

OPOs are currently engaging in groundbreaking technologies, pushing the 
boundaries of what is possible. For example, lung perfusion technology 
can potentially rehabilitate and transplant up to two-thirds of lungs 
that would otherwise be unusable.\4\ However, transplant programs are 
directly responsible for the patients in their care, and they decide 
whether to utilize organs that OPOs make available. In addition, 
transplant programs are evaluated based on survival rates that 
discourage them from taking on ``riskier'' patients or transplants.
---------------------------------------------------------------------------
    \4\ UNOS Press: ``Companies at the Forefront of Organ Perfusion 
Technology,'' https://unos.org/news/insights/game-changers-at-the-
forefront-of-organ-perfusion-technology/.

At the hearing, specific cases of kidneys were discussed where the 
witness described declining an organ based on an assessment of its 
condition upon arrival. However, it should be noted that not all of 
these organs were discarded. In fact, one of the kidneys the witness 
rejected was re-allocated and successfully transplanted into a patient 
---------------------------------------------------------------------------
at another transplant program.

This example highlights the significant role that the variability in 
clinical practice by transplant center plays in organ acceptance 
practices. In fact, UNOS will now evaluate transplant centers by their 
acceptance rates and make that information available to the public. The 
acceptance rates are also affected not just by the donor's clinical 
factors but also by when the donor organ was recovered. The NASEM 
report cites research supporting the ``weekend effect'' as a reason for 
non-utilization, stating:

        There has been compelling research on the ``weekend effect'' 
        for kidneys and livers. In SRTR data from 2000 to 2013, and 
        compared with weekday kidneys, organs procured on weekends are 
        significantly more likely not to be used . . . even after 
        adjusting for organ quality. Program structure and staffing, 
        particularly during weekends and in smaller programs, affects 
        kidney use and ultimately affects a patient's chances of 
        receiving a transplant. This is unacceptable for a lifesaving 
        surgical procedure such as transplantation.\5\
---------------------------------------------------------------------------
    \5\ NASEM Report: ``Realizing the Promise of Equity in the Organ 
Transplantation System'' (pages 6-24), https://
www.nationalacademies.org/our-work/a-fairer-and-more-equitable-cost-
effective-and-transparent-system-of-donor-organ-procurement-allocation-
and-distribution.

High and increasing non-utilization of available organs is a 
significant problem involving all components of the donation and 
transplantation system. Between 2018 and 2020, the number of donor 
kidneys not transplanted increased by 34%,\6\ partly due to low 
acceptance rates and high variability in acceptance practices across 
transplant programs. AOPO supports implementing a robust system to 
document the cause of every organ which is not utilized and the 
implementation of strategies to increase organ acceptance and minimize 
organ waste. For example, advancements in and the usage of screening 
tools could reduce the number of patients offered an organ with a known 
deferral, expediting the matching process and lowering the number of 
discards.
---------------------------------------------------------------------------
    \6\ AOPO Report: ``50,000 Annual Organ Transplants in 2026 Goal,'' 
based on OPTN data as of February 17, 2021, https://aopo.org/wp-
content/uploads/2022/03/AOPO50K-Campaign-Overview-03-29-2022.pdf.
---------------------------------------------------------------------------

System Efficiency and Performance

The United States has the most effective system in the world for 
maximizing donation and transplantation. In the last 5 years, OPOs have 
increased the number of deceased organ donors by 35% and increased the 
number of recovered organs by 27%.\7\ Although we are proud of the 
increase in the number of available organs for transplantation, there 
is more work to be done. AOPO concurs that improvements are necessary 
to advance care and equity for patients.
---------------------------------------------------------------------------
    \7\ AOPO Infographic: ``U.S. Organ Donation and Transplantation 
Highlights,'' based on OPTN data as of January 30, 2022, https://
aopo.org/wp-content/uploads/2022-US-Donation-Highlights-Infographic-
1.pdf.

AOPO does note that the Senate Finance Committee report references the 
non-peer-reviewed Bridgespan report, which claims that more than 28,000 
additional organs could be transplanted each year. AOPO submits that 
this is not validated and is conditioned upon certain circumstances 
which will not occur, including a 100% donation rate and 100% 
utilization of donated organs. Some organs are simply not safe for 
---------------------------------------------------------------------------
transplant.

The Senate Finance Committee report also attributes increased donation 
and transplantation rates in recent years to increased suicides and 
opioid-related deaths. The study cited to support this claim is based 
on a dataset that includes all donors who had at any time in their life 
used an illegal drug or were reported as a one-time drug user by a 
family member. While the opioid epidemic impacted donation, it is far 
from the only factor. Much more significant are advancements such as 
donation after circulatory determination of death (DCDD), which has 
increased an unprecedented 123% over the last five years, and organ 
preservation technologies extending the time between organ recovery and 
transplantation.

AOPO supports meaningful performance measurement that holds all system 
stakeholders accountable for reaching our shared mission of saving as 
many lives as possible. We are working with our member OPOs to meet the 
new performance metrics established by the Center for Medicare and 
Medicaid Services (CMS). In fact, several OPOs identified as having 
issues within the Senate Finance report have become top performing OPOs 
with a ``Tier 1'' status according to CMS's latest release of data.\8\
---------------------------------------------------------------------------
    \8\ CMS Quality, Certification, and Oversight Reports (QCOR): ``OPO 
Public Performance Report,'' https://view.officeapps.live.com/op/
view.aspx?src=https%3A%2F%2Fqcor.cms.gov%2Fdocu
ments%2F2021%2520OPO%2520Aggregate%2520Performance%2520Report.xlsx&wdOri
gin=
BROWSELINK.

The report states that 22 out of 57 OPOs would fail the new outcome 
measures and be decertified. It is critical to understand that the new 
methodology used in evaluating OPO performance is a comparative measure 
defining the bar to ``pass'' as the top 25th percentile. Therefore, by 
design, the metrics can result in OPOs assigned to ``Tier 2'' and 
``Tier 3'' categories being subject to possible decertification or 
competition, regardless of continued improved performance over the 
certification cycle.

Organ Evaluation

The Senate Finance Committee report shares that 249 recipients 
experienced disease transmission following an organ transplant or an 
error in blood typing, and 70 recipients died due to failures in the 
donation and transplantation system. Any death resulting from an error 
is tragic, and the system must ensure that when errors occur, they are 
reviewed and understood, and steps are taken to prevent them in the 
future.

Despite systems in place to prevent mistakes and best practices in 
place to identify the risk of transmission, the risk of disease 
transmission following an organ transplant is extremely low but will 
never be zero. The numbers reported by the Committee represent .03% of 
the 231,180 organs transplanted over the indicated seven-year 
period.\9\ The numbers show that nearly 99.9% of transplants resulted 
in successful outcomes and did not result in illness or death due to 
infected organs. The minimal risk must be understood in the context of 
the extremely high risk of death from organ failure for patients not 
being transplanted.
---------------------------------------------------------------------------
    \9\ Based on OPTN data as of August 8, 2022, https://
optn.transplant.hrsa.gov/data/.

Overall, organ transplantation is safe and the best treatment for organ 
failure. Patient safety is always of utmost importance to the OPO 
professionals working every day to save lives. All medical procedures 
have associated risks and complications, and OPOs work to prevent such 
adverse outcomes. OPOs conduct multiple tests for every organ donor to 
identify the potential for disease transmission and other safety 
issues. Many of these tests are guided by transplant centers when 
considering an organ for their patient to assess organ viability and 
---------------------------------------------------------------------------
donor match suitability.

The Organ Procurement and Transplantation Network (OPTN)/United Network 
of Organ Sharing (UNOS) requires a medical record review and donor risk 
assessment interview with the potential donor's next of kin to obtain a 
five-year history of illness and other social determinants of health. 
OPTN/UNOS also requires physicians to perform a visual examination and, 
if warranted, a biopsy of potential donor organs to identify risks. As 
an extra step to rule out undiagnosed cancers and other diseases, OPOs 
are actively working to routinely administer CT scans on patients that 
pose a known possible risk.

As part of organ evaluation, OPOs and hospital partners are also 
required to identify the potential donors' blood type to prevent organ 
rejection in the recipient. Some potential donors have experienced 
severe trauma requiring blood transfusions which can, in rare 
instances, impact the blood typing results. Therefore, OPOs and 
hospitals tasked with donor management and assessment must take extra 
precautions if the blood type test is unclear or has shown varying 
results. Following blood typing errors in recent years, new policies 
were implemented to prevent such incidences.

Organ Transportation

With mere hours to transplant life-saving organs after recovery, proper 
transportation is essential to the organ donation and transplantation 
process. OPOs are tasked with determining the safest and quickest way 
to transport donor organs. While even one organ lost or damaged in 
transport is too many, the transit incidents covered in this report are 
extremely rare,\10\ and something OPOs have actively implemented 
mechanisms to avoid.
---------------------------------------------------------------------------
    \10\ During the hearing, it was stated that OPOs are 15 times more 
likely to lose, damage, or delay an organ in transport than a 
commercial airline does with passenger luggage. This appears to be 
based on a misunderstanding of a February 2020 Kaiser Health News 
article that examined shipments handled by UNOS. As the article 
correctly points out, UNOS only manages transportation for a small 
fraction of annual transplants. Regardless of the validity of the 
analysis concerning UNOS, our OPO members have not experienced adverse 
transportation incidents of the magnitude claimed.

Post-9/11-rules prohibit OPO staff from taking organs through airport 
security and directly to an awaiting aircraft, which created a barrier 
to efficient commercial transport. In response, many individual OPOs 
use private aircraft, when possible, to avoid delays from restrictive 
commercial air travel schedules. OPOs also partner with charter, 
courier, and delivery companies to expedite the ground transportation 
of organs. Undoubtedly, additional tools from the OPTN to support 
transportation and track organs in transit will facilitate overall 
system efficiency and effectiveness. Federal Aviation Agency (FAA) 
regulations standardizing how airlines handle organ shipments would 
---------------------------------------------------------------------------
also improve efficiency and reduce travel-related delays.

It is noteworthy that in the interim, and as referenced during the 
hearing, OPOs are collaborating with companies offering organ tracking 
technology, which has helped improve transportation logistics and 
efficiencies between the donor hospital and transplant center. OPOs are 
also using TransNet, a barcode system, to automate the organ packaging 
and labeling process, ensuring that organs are transported to the 
correct recipient. When OPOs experience transportation issues, details 
are promptly documented and reported to OPTN/UNOS.

In Conclusion

As the Committee is aware, the recent NASEM report includes several 
detailed recommendations focused on establishing a more effective and 
equitable system.\11\ The recommendations align with AOPO's goal to 
achieve 50,000 annual organ transplants in 2026 by expanding 
collaboration with stakeholders, reducing health inequities, increasing 
organ utilization, and driving innovation and research. We welcome the 
opportunity to meet with Committee members and staff to discuss the 
report's recommendations and collaborate to identify changes to 
policies, practices, and programs that will help ensure the nation's 
organ procurement and transplantation system meets the needs of all 
patients.
---------------------------------------------------------------------------
    \11\ NASEM Report: ``Realizing the Promise of Equity in the Organ 
Transplantation System,'' https://www.nationalacademies.org/our-work/a-
fairer-and-more-equitable-cost-effective-and-transparent-system-of-
donor-organ-procurement-allocation-and-distribution.

We stand ready to work with our fellow stakeholders, Congress, and the 
Biden Administration to pursue the day when every donation opportunity 
---------------------------------------------------------------------------
results in lives saved.

                                 ______
                                 
                        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.

At first blush, the consideration of this issue by the Committee is 
puzzling until one draws the connection between Medicare and organ 
transplants, including establishing universal healthcare and funding 
it. Please see the following attachments, as well as the second part of 
this submission, for discussion of these topics.

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 health-care 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--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.

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--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

3.  Employers distribute the child tax credit with wages as an offset 
to their quarterly tax filing (ending annual filings).

4.  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.

5.  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.

6.  Employer paid taxes could as easily be called a subtraction VAT, 
abolishing corporate income taxes. These should not be zero rated at 
the border.

7.  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.

                                 ______
                                 
                            Guidehouse, Inc.

                  1676 International Drive, Suite 800

                            McLean, VA 22102

                             guidehouse.com

Guidehouse appreciates the opportunity to submit a statement for the 
record to the Senate Finance Committee (the ``Committee'') on this 
critical public health issue. Guidehouse is a leading global provider 
of healthcare consulting services to the public sector, including the 
U.S. federal government, 40 U.S. state governments, and commercial 
markets providing broad capabilities in management, technology, and 
risk consulting. As a result of the services we provide across the 
entire health ecosystem, we are in a unique position to provide 
perspective across the various policies, governance, stakeholders, and 
technology influencing the OPTN. Our statement for the record includes 
two sections. The first section details our view on challenges and 
recommendations facing the OPTN with a focus on ``Rebuilding Trust 
Through Policy and Governance Reform, Stakeholder Engagement, and 
Communications to Improve Quality'' and ``IT Modernization: Digital 
Twin Study and Impact with Performance Metrics.'' In the second section 
we detail our background, experience and previous related engagements 
to establish our qualifications in the tasks necessary to modernize the 
OPTN. We applaud the bipartisan support and ongoing examination by this 
Committee in its efforts to reform the OPTN to provide equity, 
transparency, and quality of care to save lives in an efficient and 
timely manner.

OPTN Challenges and Recommendations:

Health Resources and Services Administration's (HRSA) released two 
Requests for Information, issued April 8, 2020, and April 8, 2022, but 
later modified and re-
released on May 5, 2022, identifying required services to modernize and 
maintain the OPTN. Recommendations from the NASEM 2022 Report 
``Realizing the Promise of Equity in the Organ Donation Process,'' 
provided additional detail and prescriptive feedback for the OPTN. 
Based on this awareness of OPTN programming, Guidehouse provides the 
following lessons learned from implementing programs similar in scale 
and complexity for OPTN reform and modernization:

 OPTN Operational Transformation: Rebuilding Trust Through Policy and 
                    Governance Reform, Stakeholder Engagement, and 
                    Communications to Improve Quality

Modernizing the OPTN requires rebuilding stakeholder trust through 
outcome focused policy and governance reform. We recommend HRSA and the 
OPTN to access a similar network of multi-discipline thinking and 
established partnerships for the OPTN to support national reform. We, 
along with additional partners, manage coalitions of the nation's 
existing medical research institutions and professional networks, 
including representation from Historically Black Colleges and 
Universities and other Minority Serving Institutions, can guide OPTN's 
health equity policy agendas and priorities. Part of this effort may 
include restructuring the OPTN Board, reassessing organ distribution 
criteria, and integrating quality control and evidence-based best 
practices with oversight management policies. The OPTN and government 
programs can leverage this expertise across health and medicine, gain 
access to unique and existing data resources, and realize valuable 
opportunities to collaborate with communities, including those 
underserved by current organ donation and transplant systems. Patient 
and provider engagement strategies must consider early on how cultural 
nuances influence communications outcomes, participation, 
implementation, and evaluation methods. Our Guidehouse and partnership 
programs engage racially and ethnically diverse stakeholders and keep 
them involved throughout the process. This is critical for the future 
of the OPTN network and helps to quickly identify and eliminate 
cultural biases. It is also an approach that helps minimize or avoid 
conflict of interest and rebuild trust with underserved communities.

Challenges: 20% discarded or unused; limited availability especially 
with underserved and minority communities, rural areas and Midwest 
states; status on the waiting list is a mystery.

Solutions: Increase targeted education with cultural appropriateness 
and community champions; create transparency with data and access to 
waiting list status; onboard patient advocates with hospital care 
transplant teams; maintain a Patient Advocacy Coalition and network of 
donors, recipients, and families; create additional opportunities to 
register as a donor besides the DMV (driver's license) including 
options with paired donations/living donors for kidneys through primary 
care providers.

In our experience assisting executive leadership teams launch system-
wide, patient focused modernization initiatives in large health systems 
we have collected several lessons learned that are relevant to the 
OPTN. Accountability and transparency regarding tough decisions is 
necessary for optimizing change, building skills and redesigning 
processes that sustain success while focusing on measurable results and 
outcomes to address issues in real time. For the OPTN, we can apply 
these lessons learned from commercial industry best practices to align 
a redesign process with performance incentive models that drive 
accountability with the organ procurement organizations (OPOs). We also 
recommend partnerships, as recommended by the NASEM report, with the 
National Quality Forum and the National Academy of Public 
Administration to integrate oversight and monitoring standards with 
certified and contracted OPOs.

Increasing culturally appropriate and audience-segmented communication 
and education about organ donation and transplants is critical. The 
transplant process is less familiar and can be stressful to even the 
most informed patients. Having a better understanding through all 
phases of the process, especially from the patient journey perspective 
or the living donor perspective may encourage more donor registrations 
and accessibility to organs. Communication strategies need to be 
patient-centric and relevant to cultures and communities, especially 
with underserved communities and subpopulations. Using a ``human-
centered design'' approach will engage patients who have already been 
through the process of donating or receiving an organ to inform new 
patients and families what they need to know prior to their journey. 
This approach can also highlight where challenges or bottlenecks in the 
process typically occur and where additional support may be needed.

Stakeholder engagement is also imperative when reforming the nation's 
OPTN. It is particularly important to maximize this engagement by 
diversifying partnerships and enlisting nontraditional organizations 
that can inspire community organizations among underserved populations 
to help recruit new organ donors. We have experienced success enlisting 
organizations to support clinical trial recruitment while building 
future workforces. Our vision for OPTN is to fully immerse the 
stakeholder voice into the OPTN Board through the formation and 
management of a virtual ``roundtable'' with ongoing feedback for the 
transplantation community through patient feedback and monitoring to 
provide quality improvement, influence and increase organ procurement, 
and represent diversity and inclusion across all OPOs.

 IT Modernization: Digital Twin Study and Impact with Performance 
                    Metrics

Modernization of complex data collection systems in the 21st century 
requires the ability to model, represent, and evaluate inputs and 
outcomes of interdependent systems while interacting with the system's 
variables, dependencies, and connections. Led by Guidehouse's Chief 
Innovation Officer, Dr. Rod Fontecilla, Guidehouse understands that a 
real-time understanding of a complex network of people, places, 
policies, processes, and data is the first and most critical step 
towards achieving true data transparency and insight into the 
performance and quality metrics of that network and its individual 
components.

A unique concept Guidehouse proposes for HRSA and the OPTN is the 
``digital twin'' virtual representation of physical entities such as 
devices, people, processes, or systems that use computer simulation, 
machine learning, reasoning, and real-time data to help organizations 
make model-driven decisions related to detection, prevention, 
prediction, and optimization.

Digital twins are more easily adaptable than their physical 
counterparts, as organizations can modify digital assets and assess the 
results without incurring the time or monetary costs needed to adjust 
physical assets. Digital twin architectures use data from the assets 
being modeled and from related systems, to provide a method of storing 
and providing access to that data, and track and organize that data so 
that it stays in sync with real-world data about the asset and other 
digital twins. Industries use digital twins to track assets, such as 
products, throughout their lifecycles. For example, a hospital might 
use a digital twin based on its emergency room attributes to simulate 
and evaluate their readiness (e.g., resources, infrastructure, 
processes) under different scenarios (e.g., infectious disease pandemic 
response, emergency due to civil unrest, or natural disasters etc.), to 
explore changes and predict outcome (i.e., improved readiness) prior to 
making changes.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


The digital twin concept was first introduced in 2002 for use in 
large manufacturing applications such as defense and aerospace 
engineering. Today's digital twins are accessible to any enterprise due 
to the scalable, cost-effective computing capabilities of the cloud. 
The level of maturity has driven commercial toolkits with cloud 
providers now offered at a price point that allows a broader set of use 
cases to use digital twins for enterprise applications. A digital 
twin's performance is driven by the effective use of cloud-based 
technologies for compute and storage, as well as the ability to ensure 
that the data is representative of live data in the field, so that data 
scientists and SMEs can more rapidly derive algorithms that ensure the 
simulations are operationally relevant.

Challenges: Conflict of Interest with the current OPTN Board and UNOS 
participation; lack of Quality Improvement monitoring.

Solutions: OPTN Board to be comprised of elected and credentialed 
members with backgrounds in medical research, bioinformatics, 
epidemiology, patient safety, transplant expertise; no engagement from 
the awarded contractor; equal representation from minority serving 
institutions and geographic diverse OPOs; use of evidence-based 
research and OPO performance metrics for decision-making; transparency 
of all OPTN Board communications and decisions.

Guidehouse proposes creating a digital twin of the OPTN to unite 
elements of the operational network environment (e.g., organ donor-
specific, organ recipient-specific, processes related to procurement/
logistics etc.) to inform HRSA performance metrics and impact of 
potential policy or process changes without changing the physical 
configuration of OPTN itself. Digital twins can incorporate relevant 
data, such as logistics, supply chain, physical and human resources, 
donor registration policy, recipient registration/wait-list practices, 
data collection and sharing, and social determinants of health. We 
propose a phased approach to simulate the behavior and future 
performance, as well as deliver real-time synchronization for data 
access, visualization, and dynamic decision making.

Background on Guidehouse

Guidehouse \1\ is comprised of public and commercial health executives, 
strategists, actuaries, Ph.D.s, regulators, physicians, nurses, 
technologists, programmers, and consultants with direct experience 
modernizing IT systems and managing business operations for large scale 
health systems, including several of the U.S.'s largest transplant 
centers and the largest health system, Veteran's Affairs. We also 
provide expertise with finance and payer/insurance models, business 
process improvement, clinical transformation, and strategy for health 
equity and governance infrastructure that integrates transparency and 
performance metrics reporting. Examples of our related work to the OPTN 
include:
---------------------------------------------------------------------------
    \1\ https://guidehouse.com/capabilities/industries/healthcare.

      Subject Matter Expertise: Edward Abraham, M.D., is a partner and 
executive physician leading and transforming academic medical centers, 
including healthcare delivery, finances, research, and educational 
programs. Most recently, he served as Executive Vice President for 
Health Affairs of the University of Miami and CEO of the University of 
Miami Health System, an academic medical center with more than $2.5 
billion/year in revenues, 1,300 physicians, and 10,000 employees. He 
led the oversight of the Miami Transplant Institute, which has 
performed more organ transplants than any other center in the country. 
He served as Dean of two medical schools (University of Miami and Wake 
Forest School of Medicine), leading strategic planning initiatives 
including those around organ transplantation.
      Public Sector Transplantation and Veterans: Guidehouse manages 
the VA's Office of Integrated Veteran Care, a national program that 
integrates healthcare services from the private sector for veterans for 
acute and chronic diseases where transplantation may be an option. 
Guidehouse supports VA in assisting with implementing the new Live 
Donor benefit and the Chimeric Antigen Receptor (CAR) T-cell therapy, 
coordinating with VA Medical Centers, VA Transplant Centers, community 
specialists, and the OPTN.
      Commercial Sector Transplantation and Business Process 
Improvement: St. Louis University Hospital engaged Guidehouse to 
evaluate and prepare responses to transplant contracts associated with 
payers. We developed a price transparency tool based on the provider 
files to create a comparative database of reimbursement by payer, plan, 
facility, geography, and service code. By integrating social 
determinants of health indicators, market share information, and 
hospital statistics, we detected trends in reimbursement for 
transplants.
      Medicare Claims with End-Stage Renal Disease (ESRD): We support 
contract work with the Centers for Medicare and Medicaid Innovation 
Center Business Services Group to identify, test, and evaluate new ways 
to improve care for Medicare beneficiaries with the Comprehensive ESRD 
Care model. This includes managing participant compliance and 
assessment of data collection and analysis of payment and service 
delivery.
      IT Infrastructure Modernization and Support: Guidehouse provides 
a full suite of enterprise IT services for a large, national defense 
contract including project management; application administration; 
application operations and maintenance support; cloud services planning 
and implementation; infrastructure management; ITSM implementation; and 
security operations, with 99.99+% availability. With 150+ full-time 
employees, including engineering, operations, and support personnel, 
the team securely designs, develops, and deploys all technical services 
for over 60 applications used by 150,000+ international users via 
5,000+ hardware devices and serviced by 2000+ servers. Key 
modernization efforts have included server technology refresh, network 
upgrades, security compliant private cloud implementation, and 
converting the existing operating environment from traditional server-
based infrastructure to a virtualized server environment with real-time 
back-ups and redundancy. These efforts, and other supported program 
initiatives, have led to multi-million-dollar savings on an annual 
basis.
      Modernizing IT for a Federal Health Research Agency: This agency 
required collations, analysis, and storage of large-scale datasets 
while using a wide range of digital tools for complex research 
processes. Guidehouse assessed the existing operating model and 
collaborated with the federal IT staff to develop a strategic roadmap 
to support the adoption of cloud technology, proactively mitigated 
risks, and defined critical processes to optimize IT operations and 
provide higher quality IT services for the agency. Our team also 
provided a change management strategy and training to support the 
maintenance of the new solutions.

Conclusion

We believe HRSA can reform and modernize the OPTN through a combined 
clinical and operational program transformation. This effort should 
focus on two major areas. First, rebuilding trust in the OPTN system by 
implementing a human centered approach to modernizing policy, 
governance, stakeholder engagement, and communications; and, second, 
accelerating technology implementations by using digital twins and 
performance metrics. Modernizing OPTN is essential for enhancing 
quality, optimizing distribution channels, and ensuring access for all 
patients involved with the OPTN. Thank you again for this opportunity 
to submit a statement for the record to the Committee on this critical 
public health issue.

For any further discussion or to answer any questions, please contact 
Steve Reynolds, Partner, Guidehouse Health, at (703) 258-2083 or 
[email protected].

                                 ______
                                 
                   Letter Submitted by Suzanne Hughes
My kidney transplant date: June 15, 2022.

Summary: Received organ with inactive TB and active syphilis discovered 
post-transplant

I had been on the kidney transplant list since August 2020, and I 
received the call at 10:30 p.m. on June 14, 2022 that a kidney had 
become available, and I would need to take a flight the next morning 
for the transplant if I accepted this kidney. Per the call with the 
transplant nurse Cathy who is out of VA Portland (I am a U.S. Army vet, 
served 7 years in regular army and 2 years in reserves), the kidney was 
rated a 45 on the KDPI scale, which is a fairly good score. I was 
notified that the donor was positive for Hep C, but I knew the VA 
Portland had a good record of preventing transmission of Hep C post-
transplant, and that I would be monitored. Since there were no other 
issues with the kidney and I am a difficult person to match with (I was 
told my body would reject 99 out of 100 kidneys), I accepted, and 
received the transplant on June 15, 2022 out of the Portland VA 
Hospital.

About 2 days post-transplant, I was visited by an infectious disease 
doctor, who told me that although most tests are completed prior to 
transplant, not all tests are back in time for the surgery. I was then 
told that in addition to Hep C, the transplanted kidney also was 
positive for TB, meaning the patient at one time had TB but it was not 
active TB at the time of the owner's passing. But in addition, the 
kidney also had active syphilis. My dismay and shock of learning about 
this was immense, even though every doctor assured me that it really 
wasn't a big deal, take the meds and move on. Obviously, I have not yet 
moved on.

Part of my career involves project management and research, and I 
approached my transplant the same way. I researched and read a lot of 
info prior to my transplant, and I had learned that nationwide the 
chance of me receiving an organ with an STD was 0.05%. So after 
receiving an organ with Hep C (known) and then also learning it had TB 
and syphilis, I was disillusioned with the organ transplant process. I 
still feel like I am waiting for another shoe to drop, even though the 
doctors assure me that all is well, and I should be grateful. One 
question a doctor did ask me is if I would have accepted the organ had 
I known about all of the issues with the organ, and I said I would not. 
I wish I had been provided a choice with all facts up front.

Currently I am being monitored and treated with meds to prevent Hep C, 
monitored for TB, and I have been tested and remain negative for 
syphilis. The treatment I received for syphilis is 3 LARGE intra-
muscular injections in the rear end, and the shots are spread over 3 
weeks. I cannot express how painful these shots are, and they result in 
a welt the size of a dollar coin that lasts 7 to 10 days. Now imagine 
you have a 12 inch incision on your belly from the transplant, and 
welts on both sides of your rear end, which means sleep was close to 
impossible due to the inability to find a comfortable position and 
pain.

I write to you in the hope that this does not happen to anyone else in 
the future. I was shocked to read some of the details on your 
investigation, and I think complications are either not being reported 
or are able to be cloaked under the privacy of organ donation. I 
certainly don't recall in my research seeing some of the stories that 
you uncovered. In addition to the above, I also had two other 
complications although not related to the donated kidney. One was leg 
numbness resulting in needing a walker to walk for one month, and I 
also developed bilateral DVTs most likely due to my limited mobility. 
Although this is not related to UNOS, I am hoping the hospital does 
list this as a complications so patients in the future have this info.

I thank you for allowing me to add my experience with the committee, 
and I hope for higher standards and oversight.

Best Regards,

Suzanne Hughes

                                 ______
                                 
                Hypertrophic Cardiomyopathy Association

                        66 Ford Rd., Suite 213B

                           Denville, NJ 07834

                            P: 973-983-7429

                            F: 973-983-7870

                           https://4hcm.org/

August 16, 2022

U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200

Dear Chairman Wyden, Ranking Member Crapo, and Members of the 
Committee,

The Hypertrophic Cardiomyopathy Association (HCMA) respectfully submits 
this Statement for the Record in response to the Senate Finance 
Committee hearing on Wednesday, August 3, 2022, ``A System in Need of 
Repair: Addressing Organizational Failures of the U.S.'s Organ 
Procurement and Transplantation Network.'' We commend the Committee for 
escalating the importance of the nation's organ donor and transplant 
system and its desire to improve upon the existing system to maximize 
the rate of organ donation in the country and maximize the rate of 
successful procurement and transplant of vital human organs.

HCMA was established in 1996 to serve the hypertrophic cardiomyopathy 
(HCM) spectrum disorder community. HCM is a genetic heart muscle 
disorder affecting one in 200 worldwide and presents with highly 
variable symptoms such as shortness of breath, chronic fatigue, life-
threatening dysrhythmias, and the mental health challenges of living 
with a chronic illness. Approximately 5% require heart transplant. In a 
study published in 2010 in the United Network for Organ Sharing (UNOS) 
database, 1% of all heart transplants were given to HCM patients1. 
Today that number has grown to nearly 5% of all heart transplants, 
thanks partly to better disease management and timely listing for 
transplants. The age of transplant ranges from infants to those in 
their 70s. Kidney, lung, or liver transplants may also be necessary for 
these individuals.

On a personal note, I received a heart transplant at the age of 47 on 
February 2, 2017 due to complications associated with HCM and my 
sister, also afflicted with HCM, died of sudden cardiac death in 1995 
and was a kidney and liver donor.

The current subject of this committee's investigation is of paramount 
importance to the HCM community and all stakeholders. In January 2016, 
I participated in a meeting held by UNOS on changes to the organ 
procurement process for donors and listing status for patients awaiting 
transplants. During this meeting, I inquired about UNOS' experience 
with what appeared to be inconsistencies among UNOS regions in the 
listing of an HCM patient in need of a heart transplant. HCMA provided 
guidance for listing HCM patients for heart transplant that were 
incorporated in 2018 to minimize inconsistencies in listing HCM 
patients for heart transplant.

HCMA wishes to alert the committee of a grave consequence of the lack 
of screening for HCM among potential heart donors. We know of at least 
two occasions when heart transplant recipients received hearts with 
hypertrophic cardiomyopathy. I am aware of another case in which a 
woman died from what was classified as tonsillitis complications. 
Later, her sister was found to have a diagnosis of hypertrophic 
cardiomyopathy. Upon communication with the OPO, it was confirmed that 
the individual had anatomy consistent with hypertrophic cardiomyopathy 
at her death. Yet, her heart valves were donated, and her family was 
never informed of the underlying disease process.

As a transplant recipient, a donor family, and an advocate on behalf of 
a community whose very lives rely on the safe, timely, and appropriate 
use of transplant medicine, I call on the committee to take appropriate 
action to ensure the highest standards are met when lives are on the 
line.

HCMA recommends the Organ Procurement and Transplantation Network 
(OPTN) be competitively awarded and the contractor be required to have 
in place an adverse reporting system that will capture these potential 
problems and others arising from the unknown consequences of donation. 
These reports must be transparent and timely.

HCMA recommends that governance of the OPTN, through government 
oversight and contractor performance, be conducted with utmost 
transparency and representation from all stakeholders in the organ 
donation and transplantation field. This includes donor families and 
recipients, both actual and those waiting. Government oversight of 
these actions is critical to the success of a robust, safe, fair, and 
sustainable system. Technology and systems used in the organ 
procurement process must be consistent, efficient, and not overly 
redundant.

Finally, HCMA encourages the committee to consider legislation that 
would adopt ``opt-out'' organ donor policies in the National Organ 
Transplant Act as in place in European nations.

Thank you for your time and attention and please contact me at 
[email protected] should you have additional questions or I can be of 
assistance.

Sincerely,

Lisa Salberg
CEO and Founder

                                 ______
                                 
              Ischemic Injured Organs and Limbs Foundation

                      2000 Kraft Drive, Suite 1208

                          Blacksburg, VA 24060

August 3, 2022

Hon. Ronald Wyden
Chairman
Hon. Michael Crapo
 Ranking Member
U.S. Senate
Committee on Finance

Ladies and Gentlemen,

I requested to appear before the Senate Finance Committee to present a 
different perspective of what needs to be done to eliminate the organ 
shortage and the security that is demanded to protect the personal 
identities of the organ donors, the donor families, and the transplant 
recipients. However, I became aware of this meeting on Monday, August 
1, 2022. I will agree with this committee that UNOS has not been clear 
and open about the security of the current computerized system. UNOS, 
along with the OPOs, has also been very arrogant to the general public 
with an attitude that we know more than the general public about 
improving the organ donation rates in the United States. However, CMS 
is just as guilty when they have been contacted multiple times with 
ideas addressing how to increasing the number of viable organs for 
transplant. CMS's return comment to me was we control this monopoly and 
will not allow alternative OPOs to recover organs that go to the grave 
with trauma victims. HHS, along with the Division of Transplantation, 
are also just as guilty for refusing to listen to proposals that would 
exceed the new requirements for an OPO to be recertified. The Senate 
and the House of Representatives are also accountable because they 
control the budgets of these federal agencies. Jim Casey, the founder 
of UPS, stated, ``you expect what you inspect.'' Have either the Senate 
or the House committees responsible for overseeing UNOS and the OPOs 
inspected what they have done since the Transplant Act of 1984 was 
approved? Since July 2020, I have been contacting the staff members of 
Senators Cardin, Van Hollen, Warner, Kaine, and Peters; as well as the 
House of Representatives' Raskin, Kildee, and Griffith. Their staff 
members have been kind and polite looking at our research numbers and 
were supposed to pass on the data to our elected officials but not one 
elected official has requested an appointment to see my data. Only 
Congressman Griffith has shown interest in our research data, and has 
met with my colleagues and myself at our Blacksburg, Virginia lab and 
his office twice in DC.

While attending the Ohio State University, majoring in perfusion, I was 
a work-study student in the dialysis and transplant programs performing 
preventative maintenance on the equipment. When I graduated in 1983, I 
worked full-time for the transplant program in the transplant research 
lab and the University based OPO. As I became more experienced in 
transplants, I learned to preserve kidneys on perfusion equipment, 
obtained organ consent, and assisted in organ recoveries. When there 
were no donor activities, I honed my skills in the transplant research 
lab; working on various projects from self-sealing dialysis grafts, 
xenotransplants, liver preservation systems, kidney preservation 
systems, and algorithms predicting kidney viability. 1993 moving to 
Washington DC to develop a Non-Heart-Beating trauma donor program, and 
in 1996 presented our data that led to a Federal law to preserve organs 
inside the cardiac dead trauma victim while the next-of-kin was located 
and gave permission for organ donation. 2000 established the Baltimore 
regional organ preservation lab for Johns Hopkins and the University of 
Maryland transplant programs and developed a new kidney preservation 
system. 2005 I went to the Army-Navy Transplant program to establish a 
limb preservation system for amputated arms and legs. To test the limb 
preservation hypothesis, I received Congressionally Directed grant 
W81XWH1120212, ``Development of Room Temperature Human Organ & Tissue 
Preservation Technology.'' This grant set up the Army-Navy Transplant 
research lab in Bangkok, Thailand. 2016 I started collaborating with 
Dr. John Robertson to develop a more efficient cardio-emulating organ 
preservation systems for hearts, lungs, livers, kidneys, pancreas, 
small bowel, and amputated arms and legs. The system produces a cardiac 
QRS complex and the pressure Dicrotic notch waveforms. Raman 
Spectroscopy to monitor the preservation solution's chemistries, 
Infrared Imaging to provide a clear picture of the organ's vascular 
structure, and a filtration system that removes bacteria preventing 
infections, and reduces the need for antibiotics. In May 2022, the 
final prototype of the Robertson Cardio-
Emulating heart, kidney, pancreas, small bowel, arm and leg systems are 
ready for the final system build-out. The room temperature preservation 
has been redeveloped to address the long ischemia time without oxygen, 
reduce the organ's metabolism, scavenger the cytokines and chemokines 
that are released due to the lack of oxygen, and vasodilate the 
vascular structure of the organs and preserve the organs for at least 
24 hours.

In May 2021, the Ischemic Injured Organ and Limb (IIOL) Foundation was 
invited to participate in the first long-range FAA-authorized drone 
organ transportation project. We used a large kidney preservation 
system with 3D printed kidneys at the Ohio State Medical Center. Using 
a small Drone, we transported a box that contained blood and tissues 
specimens for cross-matching the organ donor and the transplant 
recipient from the OSU Medical Center to OSU airport. I drove the 
kidneys from the hospital to Don Scott airfield, where the kidney 
preservation system and the tissue typing material had arrived. They 
both were placed onto a remote-controlled helicopter to transport 30 
miles northwest to a satellite hospital in Marysville, Ohio. Once at 
the Marysville airport, the kidneys and the tissue typing material were 
transferred to the Ohio State self-driving van for the 2 miles trip to 
the hospital. While drones were transporting the organs and tissue 
typing material, we were tracking them on our phone app, keeping track 
of the perfusion parameters and the location of the drones o an 
encrypted secure computerized program.

Background:

Dr. Robertson and I were part of a collaborative team UNOS put together 
to submit a research project to the Chan Zuckerberg Initiative, which 
was not funded. However, we have been working with UNOS and the other 
collaborative universities to fund a more advanced transplant project. 
That will increase the number of transplants in the United States and 
address the past discriminatory practices of minorities and 
socioeconomically deprived individuals who are not eligible for the 
current transplant waiting list. Organs are in short supply, and the 
need for organ transplants will only increase over the next few years, 
primarily due to projected increases in the number of individuals with 
organ failure and chronic disease. Today more than 100,000 individuals 
are waiting for an organ transplant. Still, the number of patients on 
the National Organ Transplant Wait List does not encompass the entirety 
of organ failure prevalence across the United States. Approximately 
800,000 Americans have an end-stage renal disease (ESRD), 6.2 million 
have heart failure, 5.5 million have end-stage liver disease (ESLD), 
and 16.4 million have Chronic Obstructive Pulmonary Disease (COPD). CDC 
estimates that over 3.1 million Americans are ineligible to be placed 
on the National Organ Transplant Waiting list. It is projected by 2030, 
over five million people in the US will require renal replacement 
therapy. We envision a future where there is no waiting list, and there 
is a lifesaving transplant for everyone in need. What science and 
technologies can be leveraged to address this anticipated surge in 
demand for kidneys and other transplantable organs? The organ 
transplant ecosystem must integrate living, brain dead, and cardiac 
dead human donors with the emergence of xenotransplantation and new 
technologies to manufacture organs and repair tissues in donated 
organs.

A more significant emphasis must be placed on the recovery, 
resuscitation, and validation of cardiac dead human organ donors. There 
are five different cardiac dead classifications: dead on arrival, those 
who succumb shortly after arrival at the hospital, those who are not 
brain dead but have no chance of survival and the family removes them 
from life support, brain dead patients who progress to cardiac death, 
and the patient that has either a cardiac arrest or respiratory arrest 
in a hospital with unsuccessful resuscitation attempt and pronounced 
cardiac dead. Since 2012 the Healthcare Cost and Utilization Project 
reported 661,000 annual hospital cardiac deaths. The American College 
of Surgeons trauma data has shown since 2010, and there have been an 
average of 200,000 cardiac deaths annually in the United States. The 
U.S. House of Representatives in the health and welfare subcommittee 
reported (February 2022), that since the beginning of the COVID 
pandemic, an average of 100,000 yearly opioid cardiac deaths along with 
an untold increased number of suicides.

The DMV Region consists of the states of Maryland, Virginia, and the 
District of Columbia. There are eleven adult and five pediatric Level I 
Trauma Centers, eleven adult Level II Trauma Centers, and nine adult 
Level III Trauma Centers in the DMV region. Because of the need to 
properly train staff at each Rapid Organ Recovery (ROR) unit, it was 
determined to establish ROR units at the six most active trauma centers 
in the DMV region. As more personnel are trained, ROR units will be 
expanded to the remaining trauma centers in the study region. Personnel 
may be assigned to two or more trauma centers in the rural areas of the 
DMV region.

ROR unit consists of Family Advocates (FA), Physician Assistants (PA), 
and Organ Recovery Technicians (ORT). FAs will be responsible for 
locating the next of kin, preserving forensic evidence, and obtaining 
organ donation consent. PAs will place the cannulas in the trauma 
victims and resuscitate the organs while waiting for authorization from 
the next of kin, assist with recovering the organs, and oversee the 
medical practices under the medical director's supervision. ORTs will 
operate the Rapid Organ Resuscitation system, correct and initiate 
resuscitation of abdominal and thoracic organs during consent, preserve 
the organs during recovery, and place the organs on individual organ 
resuscitation systems.

Training of the various ROR staff functions will consist of didactic 
and hands-on training. FAs will receive a minimum of six to eight weeks 
of training in forensic evidence identification, handling forensic 
evidence, identifying and locating the next of kin, obtaining organ 
donation consent, and identifying cardiac and brain dead organ donors. 
PAs will receive about four weeks of training in identifying and 
cannulating femoral arteries and veins in cadavers. PAs will also 
receive training in the chemical composition of the organ resuscitation 
solution and how to operate the various organ resuscitation systems, 
along with assisting in the recovery of the donated organs. ORTs will 
receive the most in-depth training for two to three years, receiving a 
Bachelor of Science degree before being eligible for certification. 
ORTs will learn transplant history, abdominal and thoracic organs 
anatomy and physiology, donor chemistry, monitoring the organs on the 
different organ resuscitation systems, transporting organs, Homeland 
Security and Transportation Security Administration rules and 
regulations for transporting organs on commercial airlines, and 
microbiology. We intend to initially train as many ORTs and get them 
hands-on experience in the animal lab as the Cardio-Emulating equipment 
is being prepared for FDA animal and human clinical trials.

Pilot Study Preliminary Data:

The following tables show the potential number of cardiac dead deaths 
in the DMV Region. Table 1 shows the potential number of brain dead 
organ donors and the potential number of cardiac deceased organ donors. 
Table 1 shows the number of deaths reported by each hospital to the 
state's vital statistics department. Data from the Healthcare Cost and 
Utilization Project states that brain deaths were approximately 2% of 
the total cardiac deaths recorded annually in the United States.


            Table 1 Mean Death Rates DMV Region Past 5 Years
------------------------------------------------------------------------
       Hospital            City      State    Brain Dead   Cardiac Dead
------------------------------------------------------------------------
Level I
------------------------------------------------------------------------
Shock Trauma UMMS      Baltimore         MD           30           1,200
------------------------------------------------------------------------
Johns Hopkins Adult/   Baltimore         MD           15             500
 Pediatric
------------------------------------------------------------------------
Washington Hospital    Washington        DC           15             575
 Center/Children's
------------------------------------------------------------------------
George Washington      Washington        DC           15             525
------------------------------------------------------------------------
Howard University      Washington        DC           10             375
 Hospital
------------------------------------------------------------------------
Chipenham              Richmond          VA           12             400
------------------------------------------------------------------------
INOVA Fairfax          Fairfax           VA           20             600
------------------------------------------------------------------------
Children's Hospital    Norfolk           VA            8             100
 Kings Daughter
------------------------------------------------------------------------
Sentara Norfolk        Norfolk           VA           15             525
------------------------------------------------------------------------
Carillion Roanoke      Roanoke           VA           10             375
 Adult/Pediatric
------------------------------------------------------------------------
VCU MC Adult/          Richmond          VA           17             550
 Pediatric
------------------------------------------------------------------------
UVA MC                 Charlottesv       VA           16             400
                        ille
------------------------------------------------------------------------
Level I Total                                        183           6,125
------------------------------------------------------------------------
Level II
------------------------------------------------------------------------
Hopkins Bayview        Baltimore         MD           12             400
------------------------------------------------------------------------
UMMS Capital Regional  Largo             MD           20             500
------------------------------------------------------------------------
Sinai Hospital         Baltimore         MD            9             200
------------------------------------------------------------------------
Hopkins Suburban       Bethesda          MD           10             275
 Hospital
------------------------------------------------------------------------
Henrico Doctors        Richmond          VA            8             175
------------------------------------------------------------------------
Lynchburg General      Lynchburg         VA            6             100
------------------------------------------------------------------------
Mary Washington        Fredericksb       VA            6             125
                        urg
------------------------------------------------------------------------
Reston Hospital        Reston            VA            4             225
 Center
------------------------------------------------------------------------
Riverside Medical      Newport           VA            5             175
 Center                 News
------------------------------------------------------------------------
Virginia Hospital      Arlington         VA            7             225
 Center
------------------------------------------------------------------------
Winchester Medical     Winchester        VA            4             100
 Center
------------------------------------------------------------------------
Level II Total                                        91           2,500
------------------------------------------------------------------------
Level III
------------------------------------------------------------------------
Merritus Medical       Hagerstown        MD            4             125
 Center
------------------------------------------------------------------------
UPMC Western Maryland  Cumberland        MD            4             100
------------------------------------------------------------------------
Tidal Health           Salisbury         MD            7             150
 Peninsula Hospital
------------------------------------------------------------------------
New River Valley       Christiansb       VA            6             125
 Medical Center         urg
------------------------------------------------------------------------
Lewis Gale-Montgomery  Blacksburg        VA            4             100
 Hospital
------------------------------------------------------------------------
Loudoun Hospital       Leesburg          VA            4             125
------------------------------------------------------------------------
Southside Regional     Petersburg        VA            3              75
 Medical Center
------------------------------------------------------------------------
Virginia Beach         Virginia          VA            3              75
 General                Beach
------------------------------------------------------------------------
Sentara Northern       Woodbridge        VA            3              80
 Virginia MC
------------------------------------------------------------------------
Level III Total                                       38             955
------------------------------------------------------------------------
Grand Total                                                        9,580
------------------------------------------------------------------------


Table 2 compares the Standard Acquisition Fee for the Brain Dead OPO 
versus the projected Cardiac Dead Standard Acquisition Cost. The 
Standard Acquisition Fee consists of evaluating the potential organ 
donor, recovering the organs, preserving the organs, transporting the 
organs to the transplanting hospital, personnel, office rent and 
utilities, various insurances, and other ancillary office costs. The 
Brain Dead OPO Standard Acquisition was taken from the ``Milliman 
Research Report 2020 U.S. Organ and Tissue Transplants: Cost Estimates, 
Discussion, and Emerging Issues.'' The Cardiac Dead Standard 
Acquisition Fees are from the projected cost of the preservation 
systems, preservation solution, transportation, hospital recovery, 
personnel, office rent and utilities, various insurances, and other 
ancillary office costs.


                  Table 2 Comparison of the Standard Acquisition Cost for  BD OPO Versus CD OPO
----------------------------------------------------------------------------------------------------------------
                                                                                               Difference  (BD
                     Organ                             BD SAC             CD Pilot SAC            Savings)
----------------------------------------------------------------------------------------------------------------
Heart                                                    $131,500.00            $59,500.00            $72,000.00
----------------------------------------------------------------------------------------------------------------
Single Lung                                              $110,100.00            $65,000.00            $45,100.00
----------------------------------------------------------------------------------------------------------------
Double Lung                                              $127,700.00            $68,000.00            $59,700.00
----------------------------------------------------------------------------------------------------------------
Liver                                                    $104,200.00            $65,000.00            $39,200.00
----------------------------------------------------------------------------------------------------------------
Kidney                                                   $113,900.00            $58,500.00            $55,400.00
----------------------------------------------------------------------------------------------------------------
Pancreas                                                 $113,900.00            $61,000.00            $50,800.00
----------------------------------------------------------------------------------------------------------------
Total                                                    $699,200.00           $377,000.00           $322,200.00
----------------------------------------------------------------------------------------------------------------

Collaborative Team Approach:

A solution to the organ shortage is at hand, but only if we work 
together. This collaborative, diverse team of regional university 
partners will work for the creation of a Bio Hub focused on enhancing 
and expanding the existing organ transplant ecosystem. This endeavor 
will bring together powerhouses across the transplant community with a 
regional focus centered within the region. The collaborative team 
consists of the United Network for Organ Sharing (UNOS), Virginia Tech, 
University of Virginia, Virginia Commonwealth University, Old Dominion 
University, and Wake Forest University. This collaborative group 
presents unique scientific and scholarly strengths across every facet 
of organ and composite tissue transplants.

UNOS: is a private, non-profit organization that serves as the United 
States organ transplant system (Organ Procurement and Transplantation 
Network [OPTN]). UNOS collaborates internationally with transplant 
organizations in Canada, the United Kingdom, Europe, France, and 
Australia.

Virginia Tech (VT): brings decades of experience designing and 
fabricating organ preservation systems for abdominal, thoracic, and 
amputated limbs. VT's focus has been on resuscitation of ischemic 
injured organs and limbs utilizing predictive analytics, sensing 
technologies, and algorithms to predict organ viability. VT's expertise 
in multimodal machine learning, medical imaging, data quality, 
visualization, and data fusion, augmented reality and geospatial 
systems make them a strong partner in the group's efforts to enhance 
and expand the existing organ transplant ecosystem, especially in 
cardiac dead organ donors, with a seamless transition to new 
technologies maximizing equitable patient access and outcomes. The VT 
team combines the expertise of organ preservation and transplantation 
engineers with specialists in multimodal predictive data analytics, 
augmented and virtual reality-based visualization systems, and 
transplantation ``hardware'' prototyping.

University of Virginia (UVA): is one of the oldest transplant programs 
in the United States, focusing on transplantation research, ischemic-
reperfusion injury, engineering, and applied science, translational 
medicine, social and decisional analytics, system science and advanced 
computing, mathematical and biocomplexity, visual and decision 
informatics, and engineering in medicine. UVA's transplant research lab 
offers cutting technology and innovative methods to explore novel 
opportunities to eliminate end-stage organ diseases, optimize donor 
organ health, and dramatically improve transplant patients' outcomes.

Virginia Commonwealth University (VCU): Is one of the country's most 
extensive liver and kidney transplant programs, with expertise in 
reducing minorities and socioeconomic disparity, and unique protocols 
to utilize Hepatitis C, HIV, and COVID donor organs in successful 
transplants. VCU's transplant laboratory uses molecular biology and 
cell culture models in standard and extended criteria donors and 
cardiac dead donors for therapeutic interventions.

The Virginia Modeling, Analysis, and Simulation Center (VMASC) is an 
enterprise center of Old Dominion University (ODU): the advanced 
analytics, geospatial analytics, machine learning, and artificial 
intelligence methods analyze data collections from the community and 
stakeholder-led efforts, environmental assessments, and curating of 
social, environmental and medical information to determine various 
outcomes from the collected and analyzed data.

Wake Forest Institute of Regenerative Medicine (WFIRM): is pioneering 
regenerative medicine technologies to improve human health. These 
technologies aim to enhance the human body's intrinsic regenerative 
ability to repair after damage, rendering marginal organs 
transplantable and enabling the manufacturing of body parts that will 
replace functionally impaired organs and tissues. WFIRM scientists are 
currently working to create organs and tissues, developing therapeutic 
cell treatments for over 30 areas of the body. WFIRM is the 
coordinating site for the Armed Forces Institute of Regenerative 
Medicine II, with 35 participating institutions throughout the United 
States. WFIRM recently received a significant award from the Defense 
Threat Reduction Agency for their ``Body on a Chip'' project to develop 
a miniaturized system for human organs that mimics the body's responses 
to harmful agents and develop potential therapies.

Air Space Link: Northern Virginia company building small drones and 
contracts with the FAA for routing drone flights in the United States. 
Has developed small drone technology to transport blood and specimens 
for transplant histocompatibility and serology testing. Air Space 
Link's expertise will allow for developing and implementing drone 
transport of organs and tissues and obtaining FAA certification.

MOOG Aerospace, a Division of MOOG Incorporated: is located on the 
Virginia Tech campus. Large drones up to helicopter-size remote-
controlled aircraft to transport the deceased body to an organ recovery 
center or transport multiple organs from a donor hospital to a regional 
organ preservation lab.

Revivicor: is a biotechnology company that has developed a unique line 
of pigs that are compatible with humans to increase the supply of 
organs for human transplants Revivicor provided the pig heart for the 
first Xenograft, pig to human, transplant in January 2022. Revivicor 
brings expertise in developing xeno-transplantable organs for humans 
that cannot be matched with a deceased organ donor.

Space Link: is a secure communication network located in Northern 
Virginia utilizing Medium Earth Orbit (MEO) satellites. Collaborating 
with Space Link will allow for more rapid communication between 
regional organ preservation labs, UNOS, the organ center, organ 
recovery teams, and the transplanting teams. This system will ensure 
that personal data will be transmitted with clear and concise 
information about the recovered organs to the transplanting team. Space 
Link solves the security problem, and the data is encrypted, so there 
will be no Personal Information, Privacy Issues, or HIPPA violations 
when sharing data between multiple locations, thus allowing for more 
placement and delivery of organs around the United States.

From Bench to Bedside:

In the first two years of funding, this collaborative research between 
the university programs will develop algorithms to evaluate the organs 
before transplantation. Share secure computerized organ perfusion data 
so multiple transplant centers can simultaneously evaluate organs. 
Expeditiously distribute the organs to the appropriate transplant 
recipient. Collect and analyze pre and post-transplant data and predict 
the survival length of the transplanted organs. In order to implement 
the findings, a central location, either the VT campus in Crystal City 
or Falls Church, is the most central location for the trauma centers 
and the transplanting hospitals involved in the DMV pilot study. The 
Cardiac Dead Pilot program in the DMV Region will use the 1996 Federal 
to recover and resuscitate organs from all Maastricht cardiac dead 
classification. If the hypothesis proves true at the end of the DMV 
cardiac dead pilot program, we will expand the cardiac dead trauma 
victims program nationwide. By having a nationwide Cardiac Dead OPO 
complementing the Brain Dead OPOs, we anticipate in five years a 
minimum of 50,000 Cardiac Dead organ donors and 12,000 to 15,000 yearly 
Brain Dead organ donors, providing a potential of 300,000 to 400,000 
yearly organ transplants. As the programs become more acceptable, we 
believe there will be over 200,000 Cardiac Dead organ donors and close 
to 35,000 to 40,000 Brain Dead organ donors annually. Thus, allowing 
Revivicor to continue its research and obtain FDA clearance to 
transplant xenoallographs into individuals who cannot receive a human 
organ transplant because of rare antibodies that do not match an organ 
donor.


 Table 3 Potential of Cardiac Dead Organ Donors Pin the DMV Pilots Study
------------------------------------------------------------------------
            Hospital               Yr. 1   Yr. 2   Yr. 3   Yr. 4   Yr. 5
------------------------------------------------------------------------
Level I
------------------------------------------------------------------------
Shock Trauma                         120     180     180     180     180
------------------------------------------------------------------------
Johns Hopkins Adult/Pediatric          0      60      60      60      60
------------------------------------------------------------------------
George Washington                      0      60      60      60      60
------------------------------------------------------------------------
Washington Hospital Center/           60      60      60      60      60
 Children's
------------------------------------------------------------------------
Howard University                      0      36      60      60      60
------------------------------------------------------------------------
Chipenham                              0       0      36      48      60
------------------------------------------------------------------------
INOVA Fairfax                         60     120     120     156     156
------------------------------------------------------------------------
Children's Hospital Kings              0      36      36      60      60
 Daughter
------------------------------------------------------------------------
Sentara Norfolk General                0      60      84      84     120
------------------------------------------------------------------------
Carillion Roanoke                      0      36      60      60      60
------------------------------------------------------------------------
Virginia Commonwealth Adults/         60      60      84      84      84
 Pediatrics
------------------------------------------------------------------------
University of Virginia Adult/         60      60      84      84      84
 Pediatric
------------------------------------------------------------------------
Total                                360     768     924     996   1,044
------------------------------------------------------------------------
Level II
------------------------------------------------------------------------
Bay View                               0      48      48      60      72
------------------------------------------------------------------------
UMMS Capital Regional Medical         60      60      72      72      84
 Center
------------------------------------------------------------------------
Sinai Hospital Baltimore               0      36      48      48      60
------------------------------------------------------------------------
Suburban                               0      60      60      72      84
------------------------------------------------------------------------
Henrico Doctors Hospital               0       0      36      48      60
------------------------------------------------------------------------
Lynchburg General                      0      36      48      60      72
------------------------------------------------------------------------
Mary Washington Hospital               0       0      36      48      60
------------------------------------------------------------------------
Reston Hospital Center                 0       0      36      48      60
------------------------------------------------------------------------
Riverside Medical Center               0       0      36      48      60
------------------------------------------------------------------------
Virginia Hospital Center               0       0      36      48      48
------------------------------------------------------------------------
Winchester Medical Center              0       0      36      48      48
------------------------------------------------------------------------
Total                                 60     240     492     600     720
------------------------------------------------------------------------
Level III
------------------------------------------------------------------------
Merritus Medical Center                0       0      36      48      60
------------------------------------------------------------------------
UPMC Western Maryland                  0       0      36      48      48
------------------------------------------------------------------------
Tidal Health Peninsula Hospital        0       0       0      36      36
------------------------------------------------------------------------
New River Valley Medical Center        0      36      36      48      48
------------------------------------------------------------------------
Lewis Gale-Montgomery Hospital         0      36      36      48      48
------------------------------------------------------------------------
Loudon Hospital                        0       0      36      48      48
------------------------------------------------------------------------
Southside Regional Medical             0       0      36      36      48
 Center
------------------------------------------------------------------------
Virginia Beach General Hospital        0       0      36      36      48
------------------------------------------------------------------------
Sentara Northern Virginia              0       0      36      48      48
 Medical Center
------------------------------------------------------------------------
Total                                  0      72     288     396     432
------------------------------------------------------------------------
Grand Total                          420   1,080   1,704   1,992   2,196
------------------------------------------------------------------------

Development and Utilization of Drone Technology:

The DMV region is one of the worst areas for traffic delays in the 
United States. A small drone is needed to transport blood and organs 
from the donor hospital to regional histology and serology labs. 
Transporting the specimens to the proper laboratories more 
expeditiously will allow the lab results to be obtained sooner, thus 
decreasing the time to start the organ placement. Once the donor and 
the recipients are identified for each organ, especially if recipients 
are determined before the organ recovery procedure is initiated, the 
organs need to be resuscitated and prepared for transportation to the 
regional preservation lab. Because of the potential of eight organs 
being recovered from one donor and transported to the regional 
preservation lab, larger drones will be required to transport the 
organs. As more Cardiac Dead Organ Donors become standard practice, the 
need to have a regional recovery center added to the regional organ 
preservation lab will expedite organ recoveries and placement. Having 
both the recovery center and the preservation lab located up to 250 
radial miles from the trauma centers would require larger drones for 
the more extended transportation of donors and organs.

Secure Communications for all Transplant Parties:

One of the biggest complaints from transplant surgeons concerning the 
recovery teams is the lack of clear communication. The Bio Hub proposal 
will address this significant problem that leads to many discarded 
organs because of long preservations time and unclear documentation of 
recovered organs outside the transplant team's home region between the 
organ recovery team and the organ transplanting teams. Utilizing the 
Bio Hub collaborators, computer science engineers, and scientists to 
develop a secure communication link to share real-time data. There 
needs to be a partner organization to transmit and share real-time data 
securely. The addition of Space Link (an MEO satellite provider) allows 
for UNOS, the regional organ preservation labs, and the transplanting 
hospitals to share real-time data about the recovered organs with each 
team member. Another major problem with the current organ center's 
sharing policy is the wasted time placing the cadaveric organs because 
transplant programs do not trust the existing data transmitted to the 
potential recipient hospitals. By simultaneously utilizing real-time 
encrypted donor information to all potential recipient hospitals so the 
transplant programs can decide whether to accept the organs. Then 
creating a cue for which recipients will receive the organs can be done 
more expeditiously than in the current system. This same system will 
have pre-signed consents for all potential recipients accepting Cardiac 
Dead organs for a transplant. The potential transplant recipients will 
have all their blood work, health exams, and vaccines maintained at a 
current status or be placed in an inactive status until the transplant 
centers have the potential recipient missing data brought current. 
Using secured, rapidly transmitted data at Terabyte speed will make the 
data system more user-friendly and efficient. Allowing for the 
transportation of organs around the United States to the closest match 
donors and recipients is an exciting benefit of this proposal.

As Dr. Robertson and myself work with UNOS to set up the collaboration 
between the multiple universities to address the concerns of this 
Senatorial Committee, we have seen the UNOS staff members' awareness of 
past mistakes and an interest in becoming more accountable for their 
past actions. I believe submitting this Statement for the Records will 
hold UNOS responsible to the Senate and the House of Representatives 
during this five-year proposal. I look forward to presenting a more in-
depth presentation of our data for this proposal to the Senate Finance 
Committee and addressing your questions. I also ask for your support in 
funding this proposal through the American CARES Act 2.0 and hold us 
accountable for the annual milestones for this funded project.

Respectfully,

Frederick A. Gage
Director

                                 ______
                                 
          Letter Submitted by Michael G. Ison, M.D., MS et al.

U.S. Senate
Committee on Finance
219 Dirksen Senate Office Bldg.
Washington, DC 20510-6200

Organ transplantation provides the opportunity for improved life for 
patients with end-stage organ disease. Recently, there has been 
attention to adverse outcomes of the organ procurement and 
transplantation processes in the United States. While these reports may 
be viewed as alarming, it is critical to place them within the context 
of the overall risk of end-organ disease and transplantation. As prior 
chairs of the Disease Transmission Advisory Committee (DTAC) of the 
Organ Procurement and Transplantation Network (OPTN), a volunteer 
position, we have a unique understanding of many of the relevant 
issues. We write as practicing physicians, engaged in the care of 
transplant recipients and involved in the transplant community.

Recent media attention and Senate hearings have highlighted 
transmission of disease from the organ donor in 249 people of whom 70 
have died. While these numbers may seem high and the details of 
specific cases may seem shocking, they must be placed within the 
context of the absolute number of transplants performed annually. End-
stage organ disease has significant risk of death and illness; more 
than 50% of people with advanced liver disease die within 3 months of 
diagnosis. From 2008 through mid-2015, the period that the Senate 
reported on, 174,338 individuals underwent transplantation, placing the 
rate of unexpected disease transmissions at 0.14%. During this same 
time, the deaths attributed to disease transmission only account for 
0.09% of the 74,253 total deaths that occurred in patients transplanted 
during this period. Importantly, the types of diseases transmitted as 
well as the rates of disease transmission and death are nearly 
identical to those reported by other countries that track donor deaths 
such as France where transplantation oversight is managed by a 
government agency, Agence de la Biomedecine. The fact that results 
under the UNOS oversight of organ vigilance and donor screening are 
similar to those under the French system suggests that these outcomes 
are part of the known risks associated with transplantation.

The OPTN DTAC was established to develop an organ vigilance system in 
the United States. The group represents a unique collaboration between 
the various transplant communities, including transplant center and 
organ procurement professionals, and key government agencies, including 
HRSA and the Centers for Disease Control and Prevention (CDC). Since 
its inception, the DTAC has strived to be transparent, sharing key 
findings through regular presentations and publication of current data. 
The program's success has made it the model emulated as other countries 
sought to establish similar programs.

This organ vigilance work has helped keep transplant patients safe, 
maintaining a low rate of disease transmission whilst fostering an 
increase in transplant volume amidst the challenges of a pandemic. UNOS 
has encouraged DTAC to be nimble, updating testing parameters for organ 
donors based on continuous assessments of patient experience. We have 
seen similar updating in other committees of the OPTN, where the need 
to be proactive remains a high priority. The pandemic is an especially 
good example of how this constant process of reassessment allows for 
the maximal safe use of donors. Data on testing and disease 
transmission risk have been reviewed and guidelines updated throughout 
the pandemic. As a result, transplantation in the US not only returned 
to pre-pandemic rates but grew to record numbers despite the ongoing 
impact of SARS-CoV-2.

Organ transplantation is incredibly complex and limitations exist as to 
what can be known about any donor within the time available between a 
donor becoming eligible to donate and organs being placed into their 
grateful recipients. Optimal donor assessments must always balance 
risks with benefits to ensure maximal use of potential donated organs. 
The landmark Institute of Medicine article ``To Err is human'' 
recognized that rather than assigning blame, processes need to be 
developed to prevent errors or minimize harm. Similarly, through 
lessons learned as part of organ vigilance programs, we continue to 
strive to improve our systems and processes. Unexpected disease 
transmissions and other adverse events will always occur no matter what 
system is in place, but putting these into context is critical. 
Thankfully they occur rarely and when recognized, systems implemented 
by UNOS, refine the processes further in a non-blaming fashion to 
improve survival of all transplant recipients. While every system 
requires continuous quality improvement, the implication that the 
current system has failed to promote patient safety as relates to 
disease transmission--or that an alternative administrative structure 
or contractor would result in a safer system--is not supported by our 
experience.

Michael G. Ison, M.D., MS
Northwestern University Feinberg School of Medicine, Chicago, Illinois
340 E North Water St., Unit 2210, Chicago, IL 60611

Emily Blumberg, M.D.
Perelman School of Medicine at University of Pennsylvania, 
Philadelphia, Pennsylvania
3400 Spruce St., 3 Silverstein Suite E, Philadelphia, PA 19104

Michael Green, M.D.
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
3705 5th Avenue, Pittsburgh, PA 15213

Dan Kaul, M.D.
University of Michigan Medical School, Ann Arbor, Michigan
3116 Taubman Center, Ann Arbor, MI 48109
Marian Michaels, M.D.
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
3705 5th Avenue, Pittsburgh, PA 15213

Cameron Wolfe, M.D.
Duke University School of Medicine, Durham, North Carolina
Hanes House, Room 150, Trent Drive, Durham, NC 27710

                                 ______
                                 
                   Mississippi Organ Recovery Agency

                          4400 Lakeland Drive

                           Flowood, MS 39232

                            PH 601-933-1000

                            FAX 601-933-1006

                           https://msora.org/

August 17, 2022

U.S. Senate
Committee on Finance
Dirksen Senate Office Bldg.
Washington, DC 20510-6200

        Re: Mississippi Organ Recovery Agency's Statement for the 
        Record on Senate Finance Committee Hearing of August 3, 2022, 
        entitled ``A System in Need of Repair: Addressing 
        Organizational Failures of the U.S.'s Organ Procurement and 
        Transplantation Network''

Dear Members of the Senate Committee on Finance,

    On behalf of the Mississippi Organ Recovery Agency (MSOP), I thank 
the Committee for its dedication to improving the organ procurement and 
transplantation system. During the above-referenced hearing (Hearing) 
on August 3, 2022, the Committee represented that the goal of the 
hearing was to create a more equitable and efficient organ donation and 
transplant system. We greatly appreciate the Committee's willingness to 
work to engage with the stakeholders to improve the system to ensure as 
humanly as possible that every organ is given the best chance to save a 
life.

    In conjunction with the Hearing, the Committee released a memo 
entitled ``Staff Memo on Organizational Failures of The United States 
Organ Procurement'' (Memo) along with exhibits. Page 11 of the Memo 
references a ``Courier Case'' involving Mississippi Organ Recovery 
Agency (MSOP), and states that ``[o]n February 25, 2017, two incidents 
were reported to UNOS where the courier service requested by the OPO 
did not arrive in time to get the organs to their flight.'' Appendix F 
to the Memo provides additional documentation related to the events. I 
write to provide information to clarify the situation identified.

    With regard to the incidents on February 25, 2017, it is important 
to clarify that MSOP facilitated the donation of the right, but not the 
left kidney. The right kidney was offered by MSOP and accepted by AZMC. 
According to the courier, when the courier arrived at our local 
airport, the commercial airline company agent refused to accept the 
kidney for the flight to Phoenix via Dallas. Also, according to 
courier, even though the right kidney arrived within the parameters of 
acceptance for acceptance for the flight, the airline agent refused to 
put it on the flight. The courier immediately notified the UNOS Organ 
Center. UNOS, in collaboration with the courier company, then 
identified another commercial airline company to fly the kidney to 
AZMC, AZMC declined the kidney due to the later arrival time on the new 
flight, even though the new flight departed only fifteen (15) minutes 
later than the original flight. The right kidney was then quickly 
accepted by the transplant center that had also accepted the left 
kidney. Both the right and left kidneys were then placed on the same 
flight to the new transplant center on a different commercial airline 
company flight. Both kidneys arrived in a safe and timely manner to the 
transplant center that accepted both kidneys. However, according to the 
accepting transplant center, on arrival and after further evaluation, 
unfortunately the effects of the donor's history of hypertension and 
diabetes had damaged the kidneys to the point they were not 
transplantable.

    In spite of the transportation challenges in this case, MSOP worked 
diligently with the courier and UNOS to ensure that the organ was 
quickly placed with another transplant center and transported 
expeditiously. In spite of these efforts, ultimately, the discard in 
this case was within the discretion of the transplant center.

    MSOP recognizes the urgent need to address organ discards and 
supports the statement made by AOPO on August 4:

        AOPO encourages a robust system to trace the cause of every 
        organ discard to better determine the reasons for organ 
        declines by transplant centers and develop strategies to 
        minimize organ waste and increase organ acceptance. With the 
        discard rate trending upward this year, this is an urgent issue 
        that all donation and transplant stakeholders must solve for 
        all the patients on the waiting list.

    More broadly, MSOP also agrees with and strongly supports Senator 
Wyden's statement that the system should work with as few errors as 
possible. However, in order to effectively reduce or eliminate those 
errors and meaningfully transform the system, the policies and 
practices of all donation and transplant partners should be considered. 
As Senator Wyden acknowledged in his opening statement, UNOS oversees 
nearly 400 members, including 252 transplant centers and 57 OPOs. The 
focus of the Hearing was on the ``failures'' of the government Organ 
Procurement Transplant Network (OPTN) contractor, UNOS, and Organ 
Procurement Organizations. Notably absent from this discussion is any 
reference to transplant centers or their policies. OPOs and transplant 
programs are equally integral to the system. If the system is to be 
comprehensively reformed, all partners' policies must be considered.

    In addition to OPOs and transplant centers, the above-referenced 
incident highlights the numerous partners, whether members of UNOS or 
otherwise, whose practices affect the ultimate outcome of a successful 
organ recovery and transplantation. In addition to this event, others 
of the ``Transportation Failures'' referenced in the Memo appear to 
have been completely outside of the control of UNOS, the organ 
procurement organization, or the transplant program. MSOP suggests that 
policies should be developed to ensure that all partners, including 
transportation partners, maximize protection of these precious life-
saving gifts.

    The Mississippi Organ Recovery Agency has been and always will be 
striving to be the best possible organ procurement organization in the 
United States of America. We welcome any meaningful and comprehensive 
improvements to the system to ensure that ALL stakeholders are held 
accountable.

Sincerely,

M. Kevin Stump
President/CEO

                                 ______
                                 
                     National Down Syndrome Society

                    1155 15th Street, NW, Suite 540

                          Washington, DC 20005

                              800-221-4602

                              www.ndss.org



U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510 6200

Dear Chairman Wyden and Ranking Member Crapo:

On behalf of the Down syndrome community, we wish to thank you for 
holding a hearing on addressing the organizational failures of the 
United States' organ procurement and transplantation network. We look 
forward to working together to address this critical issue, 
particularly as it affects individuals with intellectual and 
developmental disabilities. As you consider improvements to the system, 
we urge you to recognize that the lives of individuals with 
disabilities have equal value to the lives of people without 
disabilities, so they deserve equal access to organ transplants. We ask 
that you advance meaningful solutions to address systemic 
discrimination against individuals with disabilities found at all 
levels of the organ procurement and transplantation network.

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) 
recently 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. 
Last year, NDSS learned of Zion Sarmiento, a baby born in June 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 34 states,\3\ this patchwork does not adequately 
ensure individuals with disabilities are protected because the organ 
transplant ecosystem, as a whole, is firmly interstate. We therefore 
strongly urge the Committee to support consideration and passage of the 
Charlotte Woodward Organ Transplant Discrimination Prevention Act (S. 
3301), 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, Sec. 504 of the Rehabilitation Act of 1973, and Sec. 1557 of 
the Affordable Care Act. This commonsense legislation is bipartisan in 
both chambers (with H.R. 1235) 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 is eager to partner with you as the Committee explores and 
develops meaningful policies to improve the nation's organ transplant 
ecosystem, including protecting the civil rights of individuals with 
disabilities. For more information, please contact Bartholomew N. 
---------------------------------------------------------------------------
Devon, senior director of public policy, at [email protected].

Sincerely,

Kandi Pickard
President and CEO

The National Down Syndrome Society (NDSS) is the leading human rights 
organization for all individuals with Down syndrome. NDSS envisions a 
world in which all people with Down syndrome have the opportunity to 
enhance their quality of life, realize their life aspirations, and 
become valued members of welcoming communities.

                                 ______
                                 
                       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 24,669 
people received a kidney transplant in 2021, far too many are still 
waiting. Many never access the transplant wait list or learn that a 
transplant is an option. There are over 100,000 individuals on the 
transplant wait list, and more than 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.

NKF is fiercely committed to holding the transplant system accountable 
for the ethical stewardship of organs as a precious, life-saving 
resource. NKF's transplant policy agenda seeks to implement policy 
changes, payment reforms, legislative solutions, quality measurement, 
---------------------------------------------------------------------------
and oversight activities that:

  Maximize the number of kidneys procured and transplanted;
  Minimize the number of kidneys discarded;
  Enhance the transplant process to become more transparent and 
patient-centric; and
  Drive continuous performance improvement across the transplant 
system.

The United Network for Organ Sharing (UNOS) has been the sole 
contractor of the Organ Procurement and Transplantation Network (OPTN) 
contract--without competition--since 1986. In its nearly 40 years of 
providing oversight of the organ donation and transplant system, UNOS 
has witnessed the continuous growth of the wait list, which comprises 
almost 106,000 organ failure patients currently waiting for a kidney 
transplant.\3\ UNOS is acutely aware that supply is not meeting demand. 
The OPTN goals should include transparency, equity, and efficacy of 
organ donation and transplantation practices.
---------------------------------------------------------------------------
    \3\ National data--OPTN (hrsa.gov).

A vital responsibility of UNOS is to provide oversight to the nation's 
organ procurement organizations (OPO). As revealed in recent 
congressional investigations, life-threatening inefficiencies and 
inequities in the transplant system are directly related to OPO 
underperformance. OPOs are the only transplant stakeholders with the 
privilege and responsibility of recovering organs from deceased donors 
for transplant. The lack of oversight is a catastrophic disservice to 
patients. Transplant centers and OPOs are left to their own devices and 
tools to sort out logistics of organ and patient transportation leading 
to inefficiency, wasted expense and directly leading to increased 
---------------------------------------------------------------------------
discards.

We have made many recommendations to the Centers for Medicare and 
Medicaid Services (CMS), Health Resources and Services Administration 
(HRSA), Organ Procurement and Transplantation Network (OPTN), and 
Scientific Registry for Transplant Recipients (SRTR) on strategies to 
improve the organ donation and transplant system, which are summarized 
below.

1. Improving Organ Procurement and Increasing Organ Donation

Immediate data transparency: OPOs collect organ donation data that is 
currently inaccessible to the public. As an entity whose sole purpose 
is to serve the public, it is a disservice to patients needing 
transplantation, organ donors, and donor families who make the selfless 
decision to donate their loved one's organs. The following metrics (at 
a minimum), currently captured by all OPOs, should be made publicly 
available for quality assurance, performance improvement, and 
stratified by gender, race, ethnicity, age, zip code for health equity 
purposes:

  Number of organ referrals.
  Number of braindead donors.
  Number of donation after cardiac (DCD) donors.
  Missed organ referrals.
  Conversion rate.
  Approach rate.
  Consent rate.
  Percentage of first-person consent.

Regulatory consequences for OPOs failing to respond timely to donor 
hospitals to evaluate potential organ donors: When donor hospitals make 
a referral for a patient who is not automatically clinically ruled out 
as an organ donor, the OPTN contractor should require OPOs to make 
every effort to elicit a timely onsite response for an evaluation.

Regulatory consequences for missed organ referrals: Donor hospitals 
should face repercussions for missed referrals of potential organ 
donors. When a hospital fails to notify an OPO of a potential organ 
donor, critically ill patients continue to wait for a life-saving organ 
transplant. Further, families lose the opportunity to continue the 
legacy of their loved ones through the selfless gift of organ donation, 
and the wishes of the person who has designated their desire to donate 
their organs are unfairly forfeited.

Staffing to reflect the DSA (Donor Service Area) community: The OPTN 
contractor must call for OPOs to recruit, hire, and train staff 
representing the diverse racial, ethnic, and cultural communities they 
serve. Diversity, equity, and inclusion should be reflected across all 
departments within the OPO, including executive leadership, OPO 
professional staff, the clinical teams that interface with donor 
hospitals, and the teams that work with potential donor families.

Transportation: Organ transportation delays and inefficiencies have 
life-threatening consequences for waiting patients. It is unacceptable 
that donated organs are discarded due to transportation pitfalls after 
donors and donor families have made the selfless decision to donate 
organs. Examining challenges in the transportation system and 
identifying policies, best practices, and strategies to mitigate cold 
ischemia time that results in organ discards is imperative.\4\
---------------------------------------------------------------------------
    \4\ Cooper M., Formica R., Friedewald J., et al. Report of National 
Kidney Foundation Consensus Conference to Decrease Kidney Discards. 
Clin Transplant. 2019;33(1):e13419. doi:10.1111/ctr.13419.

Consent training: Reducing disparities and ensuring that each donor and 
their families are respectfully considered and supported during the 
donation process must be a standard upheld by all OPOs.\5\ OPO staff 
must be adequately trained and equipped to approach families of all 
races, ethnicities, socioeconomic backgrounds, and religious beliefs 
for organ donation. OPOs should be held accountable for instituting 
donor family communication best practices, especially around 
recognizing and eliminating implicit bias, ensuring racial equity, and 
delivering trauma-informed care.
---------------------------------------------------------------------------
    \5\ Guadagnoli E., McNamara P., Evanisko M.J., Beasley C., 
Callender C.O., Poretsky A. (1999). The influence of race on 
approaching families for organ donation and their decision to donate. 
American Journal of Public Health, 89(2), 244-247. https://doi.org/
10.2105/ajph.
89.2.244.

Donor management and patient safety: The OPTN contractor must assess 
and improve the clinical knowledge of OPO staff to maximize organ 
recruitment and transplantation. This includes perfusing organs and 
donation outcomes after cardiac death (DCD) and braindead (BD) donors 
and organs. Patient safety during organ recovery and transplantation 
must never be compromised, and documentation of adverse events should 
undoubtedly be documented, reported, and reviewed to determine the 
---------------------------------------------------------------------------
cause and need for remedy.

2. Reducing Deceased Donor Kidney Discards

In partnership with CMS, HRSA, and other stakeholders, the OPTN 
contractor should implement regulatory changes, payment policy 
adjustments, and quality improvement initiatives to incentivize OPO and 
transplant center practices that could reduce discards as recommended 
by NKF's 2017 Discard Consensus Conference:\6\ Such recommendations 
include:
---------------------------------------------------------------------------
    \6\ Cooper M., Formica R., Friedewald J., et al. Report of National 
Kidney Foundation Consensus Conference to Decrease Kidney Discards. 
Clin Transplant. 2019;33(1):e13419. doi:10.
1111/ctr.13419

  Begin the organ allocation process earlier in the donor evaluation 
phase.
  Improve communication between OPO and transplant surgeons--The 
Kidney Allocation System relies on an electronic communication 
platform, DonorNet, that limits verbal communication between the OPO 
and transplant center. The exclusive use of DonorNet without 
collaborative conversations between the OPO and transplant center 
contributes to decreased organ utilization.
  Accelerate virtual crossmatching and send early prospective 
crossmatch samples.
  Require frequent QAPI meetings with OPOs and transplant centers to 
review and analyze data and investigate root causes for low organ 
transplant rates.
  Secure ``local backups'' to mitigate the possibility of a kidney 
discard.
  Increased patient-centricity around organ offers may reduce kidney 
discards.
  The OPTN contractor should consider creating an algorithm that 
recommends which patient group receives specific organ offers (ex., 
determine which patient group would benefit most from a particular 
organ offer to mitigate ``list diving'' and reduce organ discards).

Risk aversion in the transplant system is a significant contributor to 
kidney discard and devastating for patients depending on a life-saving 
kidney transplant. NKF has urged CMS to develop new reimbursement 
mechanisms that incentivize transplant centers to list high-risk 
patients, accept less-than-perfect organs for transplant, and adopt 
innovative therapies and technologies. New transplant center 
performance measures should be designed to reduce risk-aversion.

Patients have an essential role in improving risk aversion and reducing 
discards by making their wishes clear to their care teams. Patients are 
often less risk-averse than their surgeons and centers. As they spend 
more time on the wait list, they may accept an imperfect organ that 
still confers clinical value compared to dialysis. Transplant centers, 
nephrologists, and dialysis facilities must regularly consult patients 
to assess and refine their transplant goals. Increasing utilization is 
closely linked to reimbursement, transparency, and improved organ 
acceptance practices. However, it begins with a patient-centered 
approach to understanding the wait-
listed patient's goals and preferences. Transplant programs should also 
promote shared decision-making with inactive wait-list patients.

Place urgent attention on the role of organ transportation in organ 
discards: Changes in the allocation system have resulted in more organs 
being transported across the nation than ever before. Dependence on 
commercial flights presents several challenges for transplantation that 
contribute to avoidable discards. Organ recovery usually occurs in the 
late hours when donor hospital operating rooms are less busy and when 
there are fewer commercial flights. Every hour a recovered organ waits 
to be transplanted, cold ischemia time (CIT) increases, decreasing the 
likelihood of transplantation. Federal regulations no longer allow 
organs to fly in the cockpit with the pilot, only as cargo, which 
exacerbates CIT. Kidneys with too much CIT are discarded and represent 
a potential life lost on the wait list. Deceased kidneys are a scarce 
resource; inefficiencies in air travel should never be a reason for 
organ discard.

3. Making the Transplant Process and Experience More Transparent and 
Patient-Centered

Patients on the wait list receive many organ offers; however, the 
transplant center often declines organ offers on behalf of their 
patients without their knowledge or consent. Increasing organ 
utilization is closely linked to reimbursement, transparency, and 
improved organ acceptance practices. However, it begins with a 
patient-centered approach to understanding the wait-listed patient's 
goals and preferences. Transplant programs should never lose sight of 
promoting shared decision-making with patients. Patient-centricity 
should be a priority for every regulatory agency that oversees the 
organ donation and transplant system, as patients should always have 
the option to be active participants in shared decision-making with 
their healthcare team.

There is a need for organ donation and transplant stakeholders to 
implement additional 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 rejecting 
imperfect organs. In addition, if, through this process of shared 
decision-making, transplant programs and candidates discover either 
donor or recipient characteristics that would result in universal organ 
decline, we encourage transplant programs to utilize the organ filters 
now better optimized to minimize allocation of unacceptable offers 
resulting in increased cold ischemia time and slowing identification of 
the appropriate recipient and potential organ discard.

4. Improving System Performace

Harmonizing regulatory agency oversight: NKF supports policies that 
remove silos, improve operations, drive system-level performance, and 
increase equity. CMS, UNOS, HRSA, SRTR, and the Joint Commission share 
oversight of the organ donation and transplantation system. This 
fragmented oversight contributes to communication, process, and 
alignment gaps. NKF advocates for one HHS-level office that would 
provide overall management of the transplant ecosystem to mitigate 
deficiencies that result from a lack of cohesion and accountability. It 
is of the utmost importance that performance standards among the 
regulatory agencies that oversee organ donation and transplantation are 
aligned in both process and implementation. Misaligned measures only 
muddle behavior rather than direct it towards shared goals.

Modernizing the technology infrastructure: NKF supports two separate 
contracts for the Information Technology (IT) Infrastructure and one 
for other OPTN priorities. The current IT architecture is outdated and 
fraught with inefficiencies that impair organ donation and 
transplantation, such as OPO and transplant center communication, wait-
list management, and organ allocation. Patients face life-threatening 
consequences because the UNOS technology is not sophisticated enough 
for efficient organ distribution. For example, nearly one in five 
kidneys is offered to a deceased person still on the wait list because 
the transplant center is unaware that the patient has died, and 
deceased candidates receive a median of 4 organ offers before being 
removed from the wait list.\7\
---------------------------------------------------------------------------
    \7\ Husain S.A., Winterhalter F.S., Mohan S. Kidney transplant 
offers to deceased candidates. Am J Transplant. 2018 Nov;18(11):2836-
2837.

The OPTN contractor should not own any technology associated with the 
organ donation and transplantation process. Separating the two 
contracts allows OPTN to leverage significant improvements in 
information technology and mitigate the risk of disruption to the 
---------------------------------------------------------------------------
donation and transplant process.

Mandating transparency: Data transparency of organ donor hospitals, 
OPOs, and transplant centers must be prioritized to improve organ 
allocation processes. The lack of data transparency creates significant 
barriers to care and inequities for the entire population that could 
benefit from transplantation. Data collected from OPOs and transplant 
centers are outdated, inadequately audited, incomplete, and self-
reported, making it impossible to develop modern quality measures, 
specifically for steps in the pre-transplant process. Patients need 
real-time data, or as close to real-time as possible, to make informed 
decisions about transplantation. The current delay in data does not 
accurately portray the current state of organ donation and 
transplantation.

NKF was deeply troubled by OPTN's announcement about adding 35,000 
verified deaths to the standard analytical files. This adjustment 
illustrates the failure of the current system to capture data from a 
range of sources and cross-reference it to ensure maximum efficiency. 
Further, OPTN's announcement lacked urgency or even recognition of the 
gravity of data inconsistencies and their implications for 
transplantation-related research. This incident reinforces the critical 
need for transparency and the need to separate the IT contract from 
other OPTN requirements to ensure that patients and the system benefit 
from the cutting-edge technologies that can eliminate these 
inconsistencies and inefficiencies. HRSA must also determine how death 
data is collected and verified with the OPTN contractor and CMS to 
mitigate an error of this magnitude in the future.

Enhanced wait-list management: The transplant wait list is poorly 
maintained because of inconsistent communication between transplant 
centers, dialysis facilities, and patients or caregivers due to the 
current antiquated IT architecture. Patients on the wait list are 
frequently unaware of their wait-list status--active or inactive--and 
receive little or no information from the transplant centers. This 
absence of communication among patients, their dialysis facilities, and 
transplant centers represents a failure of the OPTN to improve 
communication between various stakeholders in transplantation, 
resulting in inefficient allocation and the perpetuation of silos of 
care.

Health equity: Prejudice and implicit bias are common elements of OPO 
practice. Beliefs that people of color will not donate perpetuate 
patterns where hospitals are less likely to refer prospective donors to 
the OPO. In studies, Black/African American families have declined 
donation because of insufficient time to process and discuss important 
issues and a lack of sensitivity and empathy during the approach 
process.\8\ Research has also found that OPOs are more likely to 
approach White families over Black/African American families.\9\ NKF 
strongly opposes race-based adjustments to the OPO metrics and suggests 
that OPOs adopt best practices to overcome bias and prejudice on the 
ability of families to donate their loved one's organs. For example, 
hiring staff that represents the communities they serve and 
implementing frequent training on cultural sensitivity, diversity, and 
inclusion to improve conversations with non-White populations about 
donation.
---------------------------------------------------------------------------
    \8\ Siminoff L.A., Alolod G.P., Gardiner H.M., Hasz R.D., Mulvania 
P.A., Wilson-Genderson M. A Comparison of the Content and Quality of 
Organ Donation Discussions with African American Families Who Authorize 
and Refuse Donation. J Racial Ethn Health Disparities. 2021;8(2):485-
493. doi:10.1007/s40615-020-00806-7.
    \9\ Guadagnoli E., McNamara P., Evanisko M.J., Beasley C., 
Callender C.O., Poretsky A. The influence of race on approaching 
families for organ donation and their decision to donate. Am J Public 
Health. 1999;89(2):244-247. doi:10.2105/AJPH.89.2.244.

A kidney transplant is the optimal treatment for end-stage renal 
disease. Still, Black/African American people are disadvantaged at 
every step of the transplant process and have poorer graft 
outcomes.\10\ Organ failure patients desperately need an equitable 
transplant ecosystem. Justice, fairness, equity, and transparency are 
values our organ donation and transplant system need, and patients 
deserve. Federal agencies that oversee the organ donation and 
transplant system must uphold these values to influence public 
confidence in our organ donation and transplant system. Regardless of 
demographic characteristics or socioeconomic status, every person 
should have the right to access the national transplant wait list.
---------------------------------------------------------------------------
    \10\ Norton JM, Moxey-Mims MM, Eggers PW, et al. Social 
Determinants of Racial Disparities in CKD. J Am Soc Nephrol. 
2016;27(9):2576-2595. doi:10.1681/ASN.2016010027.

---------------------------------------------------------------------------
5. Amplifying the Patient Voice

As a patient advocacy organization, NKF is proud to uplift the voices 
of the patients we have the honor to represent. Improvement of the 
organ donation and transplantation system should not occur without 
patients learning what they need and want for the success of their 
transplant journey. When presented with the opportunity to comment on 
how to improve the current transplant system, we received the following 
responses from patients:

Improve communication--``Ensure that transplant centers have adequate 
resources and staff to support their patients with consistent and 
effective communication. Patients deserve to know when they are listed 
for transplant and the actions they can take to maintain optimal health 
on the wait list. Centers must alert patients of their wait-list status 
when they become listed and made inactive or delisted. Physicians, 
Advanced Practice Providers, Nurses, Transplant Coordinators, Social 
Workers, and other transplant center staff that interface with patients 
should adequately and compassionately share the reasons for an inactive 
status with patients and why they have been delisted.''

Include the patient as part of the care team--``Clear and timely 
communication between the transplant team and patients can promote 
shared decision-making should be afforded to each patient. Transplant 
centers have complained about patient compliance; if transplant centers 
want improved cooperation from patients, they should prioritize shared 
decision-making.''

Promote cultural sensitivity--``Clinical and non-clinical transplant 
center staff must practice cultural sensitivity and inclusivity to 
decrease patients' risk of falling through the cracks due to language 
barriers and cultural misunderstandings. Transplant centers need 
appropriate communication strategies and mechanisms to relay messages 
with non-English speaking patients to prevent patient isolation and 
poor outcomes.''

Address patients' mental and emotional well-being--``Organ failure is 
scary. Dialysis creates added stress and anxiety. Dialysis patients 
face various challenges--healthcare complications, lethargy (too tired 
to participate in common daily activities), lack of social support, and 
depression, to name a few. Patients experience a general fear when 
faced with organ failure and the prospect of their mortality. Organ 
donation and transplant surgery are overwhelming to think about. 
Transplant centers could assuage these feelings by communicating with 
their patients in as close to real-time as possible about what to 
expect during the process (not just once, but reminders throughout 
would be helpful).''

Conclusion

The National Kidney Foundation has been fighting kidney disease for 
over 55 years and works tirelessly to improve outcomes for kidney 
patients and patients at risk by emphasizing prevention, early 
detection, and CKD management to slow or stop the progression of kidney 
disease. We are also committed to increasing access to kidney 
transplantation and improving patient choice of high-quality, patient-
centered options to treat kidney failure. Kidney care is fraught with 
disparities. We will continue to advocate for policies that prevent 
barriers, biases, and prejudices that prevent all patients from 
receiving the care they rightly deserve.

We welcome any questions about our recommendations and to improve the 
American organ donation and transplant system. 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, DC 20004

                             [email protected]

                             August 5, 2022

U.S. Senate
Committee on Finance
219 Dirksen Senate Office Bldg.
Washington, DC 20510-6200

Chairman Wyden, Ranking Member Crapo, and Members of the Committee:

The Organ Donation Consortium (the ``ODC''), comprised of five of the 
nation's leading organ procurement organizations (``OPOs'') and 
collectively representing almost 38 million Americans, applauds the 
work of the U.S. Senate Committee on Finance (the ``Committee'') 
addressing organizational failures of the U.S. Organ Procurement and 
Transplantation Network (``OPTN''), including severely lacking 
technology and its impact on our ability to save lives through organ 
donation and transplantation. We formed the ODC in part to address such 
failures and gaps left by many in the donation and transplantation 
ecosystem. Our strategic focus is fully aligned with the Committee's 
work as well as with many of the key recommendations, particularly 
those concerning health equity, organ utilization and the modernization 
and integration of state-of-the-art heath information systems, found in 
the report of the NASEM Committee on a Fairer and More Equitable, Cost-
Effective, and Transparent System of Donor Organ Procurement, 
Allocation, and Distribution.

The ODC's strategic focus is on technological innovations and 
integrations, cross-sector stakeholder collaboration, and transparent 
accountability. With the open integration of systems among all 
stakeholders--donor hospitals, OPOs, and transplant centers, as well as 
the OPTN--we have set out to save more lives through donation and 
transplantation while:

      Eliminating health disparities in donation and transplantation;
      Increasing the number of organs made available for transplant;
      Eliminating the unnecessary discard of transplantable organs;
      Reducing inefficiencies and errors in the donation process;
      Improving quality through the donation process;
      Reducing the time it takes to shepherd a life-saving organ from 
donor to recipient;
      Reducing costs in the donation system; and
      Providing a framework for the consistent and reliable collection 
of data for performance measurement of all stakeholders that make organ 
donation and transplantation possible.

No one is above scrutiny in these matters, including OPOs, hospital 
systems, transplant centers, and those overseeing this work, including 
the OPTN, and the ODC stands ready to assist in the development of 
further reforms and technological innovations to achieve significant 
improvements in organ donation and transplantation for all Americans.

Sincerely,

Janice F. Whaley                    Diane Brockmeier
President and CEO                   President and CEO
Donor Network West                  Mid-America Transplant
San Ramon, California               St. Louis, Missouri
Kelly Ranum                         Ginny McBride
President and CEO                   Executive Director
Louisiana Organ Procurement Agency  Our Legacy
Covington, Louisiana                Orlando, Florida

Bradley L. Adams
President
Southwest Transplant Alliance
Dallas, Texas

                                 ______
                                 
             Organ Procurement and Transplantation Network 
                       Patients Affairs Committee
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.\1\
---------------------------------------------------------------------------
    \1\ https://www.washingtonpost.com/health/2022/07/31/unos-
transplants-kindeys-hearts-technology/.

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 \2\--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.
---------------------------------------------------------------------------
    \2\ https://khn.org/news/how-lifesaving-organs-for-transplant-go-
missing-in-transit/.

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 \3\ reporting that UNOS's policy making processes 
have been so divisive that they have ``spark[ed] open conflict'' among 
OPTN members.
---------------------------------------------------------------------------
    \3\ https://www.washingtonpost.com/national/health-science/liver-
transplant-rules-spark-open-conflict-among-transplant-centers/2019/05/
16/91b37f84-781c-11e9-bd25-c989555e7766_story.
html.

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,\4\ and 
research in the Journal of the American Medical Association \5\ 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.\6\
---------------------------------------------------------------------------
    \4\ https://www.medpagetoday.com/opinion/second-opinions/98363.
    \5\ https://jamanetwork.com/journals/jamasurgery/article-abstract/
2771051.
    \6\ https://bloomworks.digital/organdonationreform/assets/PDF/
donation-increase.pdf.

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

                                 ______
                                 
                      Paragonix Technologies, Inc.

                            222 Third Street

                          Cambridge, MA 02142

                   https://paragonixtechnologies.com/

August 16, 2022

U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200

Dear Chairman Wyden, Ranking Member Crapo, and Members of the 
Committee,

Paragonix Technologies, Inc. (``Paragonix'') respectfully submits this 
Statement for the Record in response to the Senate Finance Committee 
hearing on Wednesday, August 3, 2022, A System in Need of Repair: 
Addressing Organizational Failures of the U.S.'s Organ Procurement and 
Transplantation Network. We commend the Committee for escalating the 
importance of the nation's organ donor and transplant system, and its 
desire to improve upon the existing system to maximize the rate of 
organ donation in the country and maximize the rate of successful 
procurement and transplant of vital human organs.

Paragonix Technologies, Inc. is a medical device company headquartered 
in Cambridge, MA, that designs, produces, and markets organ 
transportation devices that preserve human organs intended for 
transplant during the journey between the donor procurement facility 
and the transplant recipient center. Paragonix is a leader in providing 
FDA-cleared devices for the transportation and preservation of all 
solid organs: heart, liver, lung, kidney, and pancreas. Since its 
commercial launch in 2020, Paragonix devices have preserved over 2,200 
donor organs.

We also recognize the benefits of the Recommendations provided by the 
Senate Finance Committee following the Hearing on August 3, 2022. In 
particular, we would like to offer support and solutions towards 
improvements in the methods, tracking and data reporting of organ 
transportation systems, highlighted as one of the most pressing 
concerns voiced at the Hearing. We refer to the following specific 
recommendation:

VIII.

Recommendations:

Increase transparency and accountability for chain of custody and 
transportation of organs procured for transplant by providing for 
public reporting, as appropriate, on the status of organs in 
transport.''

(https://www.finance.senate.gov/imo/media/doc/UNOS%20Hearing%20Confiden
tial%20Memo%20(FOR%20RELEASE).pdf)

 Improvements in the Method, Tracking, and Data Reporting of Organ 
                    Transportation Systems

For nearly 5 decades, the most common form of organ preservation (i.e., 
storage during transport between donor and recipient) has been ice-cold 
storage in simple non-medical grade, non-regulated containers (e.g., 
plastic coolers, cardboard boxes, food storage tubs, etc). This method 
is fraught with complications and potential hazards and lacks any 
regulatory oversight consistent with updated methods and needs.

This is an extremely outdated approach to the storage of organs during 
transport, yet remains embedded in current OPTN Policy (sections 
16.3.E.i. and 16.3.E.iii):

        An outer container of corrugated plastic or corrugated 
        cardboard, with at least 200 pounds burst strength, that is 
        coated with a water-resistant substance.'' (OPTN Policy, 
        Section 16.3.E.i) . . . ``If a member of the organ recovery 
        team is accompanying the organ to the potential transplant 
        recipient's transplant hospital, the organs and tissue typing 
        material may be transported in a cooler. A cooler may be reused 
        only if it is properly cleaned and sanitized and all labels 
        from previous donor organs are removed.'' (OPTN Policy, section 
        16.3.E.iii)

These policies describe a method of cold storage using coolers or 
disposable cardboard boxes filled with ice to cool the organ and 
thereby reduce the metabolic demand of the organ. This ice-based method 
has been ensconced in the transplant field to the point it thwarts 
innovation and progress. It also is not reflective of the technological 
advancements and clinical advantages of mechanical preservation 
systems.

Admittedly, this ice-based method provides an inexpensive approach to 
organ preservation; however, it poses serious risks to the patient and 
is difficult, nearly impossible, to standardize. In short, the ice-
based method of transporting organs is outdated, potentially harmful, 
and does not reflect current methods of storage recognized and cleared 
by the FDA.

A multitude of potential harms have been noted, including: (a) freezing 
injury of organs as a result of organs becoming frozen due to an ice-
based method of preservation, (b) uneven cooling of the organ tissue 
and violations of FDA-regulated temperature requirements of 
preservation solutions, (c) lack of standardization due to a 
variability in composite, type, and strength of packaging materials; 
(d) the inability to know the biocompatibility of the material that 
touches the organ; (e) potential tissue injury due to erratic movements 
or vibrations during manual handling; and (f) the lack of knowledge of 
the real-time changes in temperature during transport, one of the most 
important parameters in organ preservation that directly impacts organ 
function post-transplant.

With these limitations in mind, Paragonix makes the following 
recommendations regarding transporting organs for transplantation:

(A) OPTN Policies should require, and organ procurement and transplant 
        programs should adopt, the use of FDA-cleared and regulated 
        preservation systems.

In contrast to non-regulated containers used during organ transport 
(e.g., plastic food containers), FDA-regulated devices require rigorous 
review and validation prior to gaining market clearance for use in a 
healthcare setting. This includes design verification, electronic 
safety review, thermal qualifications, ship testing (for clinical use 
conditions), sterile validations, sterile barrier qualifications, 
biocompatibility testing, etc. None of these requirements are made of 
retail, commercially purchased storage containers, posing unknown risks 
to patients. For example, retail coolers used for transporting organs 
are not required to demonstrate they are safe for physical contact with 
human organs, nor are they validated to maintain a consistent, 
documented temperature.

The 2020 Consensus Statement of the International Society of Heart and 
Lung Transplantation states, ``[T]here are some new technologies for 
packaging . . . that prevent direct contact of the ice with the 
``myocardium [which] may cause freezing . . . and is undesirable 
because freezing and thawing cause irreversible cellular damage.'' In 
short, transplant professionals recognize the advantages possible in 
newer technologies, such as mechanical preservation systems that offer 
temperature control.

Using our own technology, Paragonix has shown the clinical and economic 
value of mechanical and controlled preservation of organs over 
uncontrolled cold storage on ice through studies conducted with data 
from the GUARDIAN registries (NCT04141605, NCT04930289 for lung, 
NCT05082077 for liver). In particular, the GUARDIAN Heart registry 
collects and evaluates various clinical effectiveness parameters in 
patients with transplanted donor organs that were preserved and 
transported within the Paragonix SherpaPak' Transport 
Systems and those that were transported using simple ice storage. Data 
collected by 17 transplant centers for approximately 800 patients was 
presented at the International Society for Heart and Lung 
Transplantation in April of 2022 (Leacche et al.). In a propensity-
score analysis, the authors showed improvements in the function of 
donor hearts post-transplant using controlled mechanical preservation 
when compared to simple ice storage in several important areas, 
including statistically significant:

      I.  fewer complications within 24 hours post-op of the 
transplant, as evidenced by a 72% reduction in severe primary graft 
dysfunction,
     II.  improved post operative care as evidenced by a 39% reduction 
in post-
transplant mechanical circulatory support, 66% reduction of the use of 
intra-aortic balloon pumps, and a 60% reduction in ECMO or temporary 
VAD requirement, and
    III.  improved long-term benefits, as evidenced by a 68% mortality 
reduction at 1 year.

These clinical findings were noted even at extended total ischemic 
times (i.e., long transport times).

GUARDIAN registry data has also been analyzed to evaluate post-
operative cost differences from improvements in clinical outcomes and 
their associated reductions in clinical interventions, with a total 
average savings of tens of thousands of dollars per patient when a 
Paragonix system was used to transport a donor heart.

In summary, the requirement to use an FDA-regulated preservation system 
will ensure that the most current approaches using technology that is 
validated specifically for safe use in organ transplantation is 
consistently utilized across all organ procurement and transplant 
programs. Paragonix recommends that those organ procurement 
organizations (OPOs) and transplant programs that currently do not 
utilize an FDA-regulated mechanical preservation system develop a plan 
to adopt this method of organ transport by 2024.

(B) OPTN Policies should require, and organ procurement and transplant 
        programs should adopt, the use of FDA-cleared and regulated 
        preservation systems that continuously collect data on the 
        temperature of the preservation solutions used during transport 
        of the organ and have such data incorporated into the donor 
        record.

The lowering of an organ's metabolic demand during transport using 
hypothermic storage is another critically important concept in organ 
preservation. Again, however, current OPTN policies do not require 
temperature data to be collected or reported.

The lack of temperature data makes it difficult to ascertain organ 
viability. Rapid temperature decreases to below freezing temperatures 
have been observed in multi-center clinical studies as well as 
preclinical studies that show average organ temperatures during ice 
cooler transportation below 2 +C and below 0 +C (Horch et al., 
Transplant Proceed 2002; Hendry et al., J Thorac and Cardiovasc Surg 
1989; Michel et al. Ann Transplant 2014; Michel et al. Ann Transplant 
2015; Ingemansson et al., Ann Thorac Surg 1996; Mankad et al., J Thorac 
and Cardiovasc Surg 1992; Keon et al., Ann Thorac Surg 1988). Organs 
such as the liver, lung, and kidney frequently are exposed to prolonged 
(several hours) temperatures at freezing, below, or just above 
freezing. The consequences of frozen preservation solutions, and of 
exposing a donor organ to temperatures at or below freezing, poses 
undue harm and injury to the organ and potentially leads poor patient 
outcomes.

Even in Dr. Locke's insightful testimony in the August 3 hearing, she 
highlighted the issue of receiving frozen kidneys. In her written 
testimony, she writes of receiving a kidney ``as hard as a rock, like 
an ice cube you could put in your drink,'' where she was forced to 
discard the selfless gift of a donor and inform the potential recipient 
they would have to remain on the wait list.

Although this data is currently not collected on a routine basis, the 
FDA recognizes the importance of temperature regulation in its review 
and approval of all preservation solutions used during transport. For 
example, the Belzer UW' Cold Storage Solution, used to 
``flush'' the organ's vasculature and provide cold storage of kidney, 
liver, and pancreas organs, has an Indication for Use (IFU) that reads: 
Belzer UW' Cold Storage Solution must be cooled to 2+ to 6 
+C (36+ to 43 +F) prior to use . . . Administration of Belzer 
UW' Cold Storage Solution, at the recommended temperature, 
will effectively cool the organ and lower its metabolic requirements. 
Similar IFUs for other solutions state: ``do not freeze'' and ``do not 
use if frozen.'' Thus, it is well recognized that temperature control 
is a key necessity in organ transportation systems, and should be 
continuously monitored and recorded.

(C) OPTN Policies should require OPTN members to develop written 
        protocols for recording temperatures during transport, 
        including corrective actions for deviations from recommended 
        temperature ranges.

Paragonix recommends that OPOs and transplant centers develop written 
protocols and/or regulations to collect data regarding the temperature 
of preservation solutions. Additionally, Paragonix recommends the 
placement of corrective actions should the monitored temperature be 
observed lower or higher than required by the labeling of the FDA-
cleared preservation solution. Transport temperature data would be easy 
to obtain, does not require any laboratory testing or interpretation of 
findings, and is consistent with the growing use of innovative 
mechanical technologies used in organ transport. There would be no 
inherent additional burden on the OPO or transplant program to collect 
this data. This data can be analyzed to review the likelihood of 
temperature control during the transportation of organs and its impact 
on post-transplant organ function.

(D) OPTN policies should be developed to require the tracking of organs 
        during transport.

Of considerable concern, the inability to track an organ with any 
confidence during its transport between donor and recipient was voiced 
repeatedly at the Senate Finance Committee Hearing on August 3, 2022. 
Sadly, many noted the comparison to a consumer's use of DoorDash, ``who 
knows where my food is,'' and the lack of similar tracking abilities in 
something as critical as organ transportation.

Paragonix wishes to call attention to the newer technologies that can 
easily and aptly track organs during transport with confidence and 
accuracy. In developing its own tracking system, the Paragonix App 
allows users of the Paragonix organ preservation systems to (1) utilize 
Bluetooth technology for pairing with Paragonix organ preservation 
systems for real-time monitoring and data collection; (2) monitor GPS 
tracking so organs are not misplaced or lost; (3) log key clinical 
events in real-time to minimize communication between coordinator and 
transplant hospital; and (4) rely on HIPAA compliant communications 
platforms to keep all parties informed in real-time. This type of 
technology simplifies an enormous amount of work, time, and resources 
traditionally expended by personnel. It eliminates outdated, subpar 
methods of tracking organs, streamlines the process more efficiently 
across the country, ensures a consistent and readily available 
``picture'' of the organ during transport, and minimizes the risk of an 
organ being lost.

Tracking systems that provide similar advantages should be routinely 
used by OPOs and transplant centers and, if not standardized, at a 
minimum include a baseline number of capabilities that eliminates the 
chance that organs will be lost or misplaced during transport.

(E) OPTN Policies should require, and organ procurement and transplant 
        programs should adopt, the collection of ``ischemic time'' data 
        during organ transport.

The transplant community has historically placed considerable emphasis 
on the donor organ's ``ischemic time''--the time between the cross-
clamp of blood flow to the donor organ and the in situ reperfusion in 
the recipient. Organ allocation policies have been based, in part, on 
unique ischemic times for each organ type; however, the actual time the 
organ spends within an organ preservation device is not documented. 
OPTN policies should require data collection and reporting of 
``ischemic time'' during organ preservation and transport. This data 
should be part of the donor record.

In closing, Paragonix appreciates the opportunity to provide this 
Statement for the Record to be officially entered into the Senate 
Finance Committee's record. It is deeply concerning that challenges 
exist in the transportation of human organs for transplant that can be 
readily eliminated by improvements in transportation protocols that are 
reviewed and regulated by the FDA and accessible to all within the 
field.

Please contact me at [email protected] with any additional 
questions regarding our concerns and recommendations.

Respectfully,

Lisa Anderson, Ph.D.
President and CEO

                                 ______
                                 
                   Science in Donation and Transplant

                           791 Alexander Rd.

                          Princeton, NJ 08540

August 16, 2022

U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200


Chairman Wyden and Ranking Member Crapo,

    Thank you for this opportunity to respond to the issues raised 
during the August 3, 2022 presentation concerning the United States' 
Organ Procurement and Transplantation Network before the Senate Finance 
Committee. Our organization, Science in Donation and Transplant 
(SID&T), shares the commitment of the physicians, patient advocates and 
donation professionals who labor daily to make the miracle of 
transplant work. This commitment includes the study of ways to improve 
the nation's system of altruistic organ donation and transplant, a 
system which is, already and without question, the best opt-in system 
in the world. SID&T understands that the foundation of a system based 
on altruism is public trust. We are concerned that certain actions of 
the Senate Finance Committee, and the process of one-sided vituperative 
attack, risks damaging this trust, and that this attack is not designed 
to further the goals of system improvement, but rather engenders 
mistrust and threatens the peer-reviewed scientific evidence based 
quality-enhancing processes.

    Congress recently charged the National Academies of Sciences, 
Engineering, and Medicine (NASEM) to examine and recommend improvements 
to research, policies, and activities related to deceased donor organ 
procurement, allocation, and distribution.\1\ The congressional 
language requested that the report include recommendations to update 
the Organ Procurement and Transplantation Network's (OPTN's) policies 
and processes. NASEM took up this challenge and issued its report 
earlier this year, making targeted recommendations for further study, 
not only of the OPTN, but of the OPOs and transplant centers and 
physicians that make the miracle of transplant a reality. The Senate 
Finance Committee hearing, the report for which was drafted before the 
hearing was even held, added nothing to the worthwhile and serious 
project of NASEM to save more lives, more equitably. Instead, it 
damaged efforts to ascertain quality in an irresponsible effort to 
diminish the public's trust in a system, which while imperfect, is in 
need of support, not constant, privately orchestrated attack. If there 
was an interest served by this hearing, it was not the public's 
interest, or the interest of even a single patient on the waiting list.
---------------------------------------------------------------------------
    \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.

    The purpose of the ``hearing'' (which to be fair was more of a 
public flogging), was for Chairman Wyden and Senator Grassley to voice 
their concerns about the government contractor serving as the nations' 
Organ Procurement and Transplantation Network (OPTN). United Network 
for Organ Sharing (``UNOS'') is the private nonprofit entity that has 
been designated to serve as the Network for the last thirty-eight 
years. Federal oversight of UNOS' organ transplant policies is 
conducted by the Health Resources and Services Administration 
(``HRSA''), an agency within HHS (see 42 U.S.C. Sec. 274c). The 
``hearing'', apparently intended as an expose of gross failures, 
instead demonstrated the wisdom of Congress in 1984 when it put the 
complex issues of organ donation and transplantation policy in the 
hands of a non-profit representative member organization, made up of 
---------------------------------------------------------------------------
experts, and not into the political sphere.

    Experts in healthcare, such as peer-selected UNOS leadership know 
how to review, evaluate, and assess factual claims. They also know how 
to utilize data on frequency, severity and trends. Most importantly, 
they know how to conduct reviews of facts in a manner best calculated 
to obtain those facts, design better outcomes, and protect the 
confidentiality of the patients involved. The Senate Finance 
Committee's process and report flouted all of these standards and 
practices, decimating its own statutory construct for a peer review 
system in order to spew a few out-of-context sound bites designed not 
to improve quality, but presumably to score media headline points. 
Having already gnawed one leg of the table, by flogging the network of 
non-profit OPOs, the second leg has now been chewed to a nub. According 
to the Committee, the next leg will be the Executive Branch. We will 
see if transplant centers and hospitals, as the fourth leg, will also 
be cut off, leaving no institution left for the public to rely on to 
ethically obtain organs from the altruistic deceased and their 
families, and equitably share them nationally. The only solution 
proposed to correct the ``failures'' of the world's most successful 
system seems to be closure and de facto replacement by new, preferably 
technology-based entities, and the entry of large for-profits into 
Americans' most intimate moments.

    While there are real problems to be addressed, by serious and 
knowledgeable policy makers, the Senate Finance Committee seems to 
prefer overlooking the remarkably few errors over several years, the 
significant gains in organ donation and transplant, and ways for 
improving the existing donor transplant infrastructure. The report on 
which the hearing was based was released to the press, the non-UNOS 
participants and others prior to the hearing, but was withheld from 
UNOS, its membership, and the public until after the spectacle, 
eliminating any opportunity to correct errors, provide context or 
correct misleading contents. This process underscored the nature of the 
hearing as an effort to sling mud, rather than to gather or examine 
facts.

    Rather than discuss the recommendations of the Congressionally 
mandated and financed NASEM report, including the need for a lengthy 
and fact-based examination of the OPTN's IT capability, the Senate 
Finance Committee instead shared stories concerning medical errors 
investigated by UNOS, without context, comparison or recommendation 
about how another, different process would have changed any of the 
incidents. While SID&T believes that any error is too many, we support 
the process of peer review and corrective action that is the bedrock of 
all healthcare quality efforts. UNOS' role is not to ``close poor 
performers'', but rather to investigate and remediate the causes of 
errors, in order to prevent them. While UNOS can recommend to HRSA that 
action be taken against an OPO or transplant center, its statutory role 
is not primarily punitive, but rather policy-making and prophylactic. 
Public stoning, like the Senate Finance Committee meeting, has never 
fixed a process error. By punitively revealing materials that were 
openly shared in a peer review process, and sharing more than the 
minimum necessary facts about these materials, Congress undermines the 
peer review process created by the National Organ Transplant Act 
created; a process that has saved more lives than any other nation's 
donation and transplant system.

    The OPTN is a membership organization that was established to be 
``operated by the transplant community [. . .] with oversight by HHS.'' 
It is governed by a Board of Directors that is made up of 
representatives from transplant centers, physicians, organ candidates, 
donors, and recipients, along with organ procurement organizations 
(``OPOs''), voluntary health associations, and members of the general 
public. Members include OPOs, transplant hospitals, and other 
institutions or individuals with an interest in organ donation. Each of 
the witnesses paraded before the Finance Committee admitted to being 
UNOS members, and each of them was unquestionably granted an equal 
voice in policy decisions and processes. What the Committee failed to 
share with the public is that most of the individuals testifying are 
also engaged in litigation against UNOS, due to policy disagreements 
between their private hospitals, and UNOS' representative members.\2\
---------------------------------------------------------------------------
    \2\ See e.g., Adventist Health Sys./Sunbelt, Inc. v. United States 
Dep't of Health and Hum. Servs., No. 320CV00101SMRSBJ, 2021 WL 973455, 
at *20 (S.D. Iowa Mar. 12, 2021), aff'd, 17 F.4th 793 (8th Cir. 2021) 
in which both Mr. Friedman's employer (Adventist) and Dr. Locke's 
hospital (University of Alabama) sought to enjoin national organ 
allocation policy, and where the Court ruled ``This case demonstrates 
exactly why judicial review of agency action--particularly that based 
on scientific expertise, complex data modeling, and detailed 
statistical analysis--should be made in a slow, deliberate, and 
cautious manner. Plaintiffs raise genuine policy disagreements [but] 
they do not reach the high threshold required to block the enactment of 
a federal regulation. [. . .] The short time frame under which the 
Court is asked to rule on Plaintiffs' claims weigh strongly against [. 
. .] second-guessing the technical expertise of a scientific body.'' 
Where the courts were leery of second-guessing technical expertise, the 
Senate Finance Committee had no apparent problem with allowing one side 
of a policy dispute to rail against the other without the burden of 
evidentiary rules or the ability to cross-examine. See also, Callahan 
v. United States Dep't of Health and Hum. Servs. Through Azar, 434 F. 
Supp. 3d 1319, 1327 (N.D. Ga. 2020) in which a hospital affiliated with 
Ms. Brockmeir's OPO sought unsuccessfully to enjoin the nationwide 
implementation of UNOS and DHHS' policy for allocating donated livers.

    SID&T does not have a comment on the wisdom or equity of the policy 
position that UNOS' membership and HRSA approved, a policy 
determination that has thus far been sanctioned by the courts, but we 
note that presenting members engaged in active litigation against the 
nation's plan to equitably allocate organs as being representative of 
the transplant community as a whole was at least disingenuous, and 
could be seen as disqualifying in any real ``hearing''. These witnesses 
---------------------------------------------------------------------------
had conflicts of interest that, at least, needed to be disclosed.

    The risks of political actors engaging themselves in issues of 
complex policy and healthcare systems without objective guidance were 
on full display during the hearing. For example:

    1.  Although UNOS, a private non-profit entity, is currently the 
contract holder for the nation's OPTN system, they will presumably be 
in a competitive bidding posture against other private entities in the 
near future. This hearing taints the process of public contracting by 
injecting political pressure into what should be a fair bidding process 
based on legal processes and measurable deliverables.
    2.  The Committee spouted facts and figures without context or 
analysis, as though numbers have an independent magical meaning. When 
discussing healthcare outcomes, stating that 70 deaths occurred is 
profoundly misleading without the context of the number of successful 
transplants over those seven years, which in this case is over 230,000. 
It is also meaningless without the context of medical error rates in 
general.\3\ Any health care outcomes reviewer would acknowledge that 
the numbers compare extremely favorably to overall death rates due to 
medical error (0.03% for deaths due to donation and transplant system 
errors, compared to 9.5% for medical error rates overall). If the point 
of the hearing was fact-finding, or general concern, as opposed to 
lobbying for a new private contractor, this point would have been 
shared.
---------------------------------------------------------------------------
    \3\ According to a study by Martin Makary of Johns Hopkins, 9.5 
percent of all deaths each year in the U.S. stem from a medical error. 
Thus, as unacceptable as a single death due to error in transplant 
system processes is, the rate of deaths due to transplant error is 
indicative of high quality, not failure. See Medical error--the third 
leading cause of death in the U.S., BMJ 2016;353:i2139, https://
doi.org/10.1136/bmj.i2139 (Published May 3, 2016).
---------------------------------------------------------------------------
    3.  The Senators, both in the report and in Committee, devoted much 
time to stating that of the complaints submitted, too few were 
forwarded to HRSA for decertification. Again, this presumes that 
referral for decertification is the best or most appropriate response 
to a complaint, rather than review, investigation, peer review, root 
cause analysis and monitored effective corrective action. It also 
assumes that all complaints are within UNOS' scope of action, and 
meritorious. Again, without context, such facts are meaningless, worth 
less than anecdotes. Health care quality does not arise from the 
recounting of stories, it arises from close analysis of the cause of 
mishaps, and full-throated participation from the professionals 
involved, including doctors, nurses, OPO professionals and others. UNOS 
promises that those who participate in fact-sharing will be protected, 
because this is how quality is done in America.

    Perhaps the worst thing accomplished by the Senate Finance 
Committee in its presentation was the assault on health care quality by 
its unnecessary violation of basic tenets of peer review and quality. 
The Senate requested, and eventually obtained, the peer review 
privileged material entrusted to UNOS under federal law. In managing 
the OPTN, UNOS has established a Membership and Professional Standards 
Committee (MPSC) that, among other things, conducts quality assurance 
and peer review of OPTN members, and reviews events that are identified 
as a risk to patient safety, public health, or the integrity of the 
OPTN. Participation in the quality assurance and peer review process is 
mandatory for continued membership in the OPTN. In reporting the 
results of its ``investigation'', the Senate Finance Committee bared 
these sensitive materials to the public eye in a manner and scope that 
served no public purpose; there was not a single point made or scored 
that could not have been made without revealing sensitive data.

    The purpose of peer review protection is to ensure the very 
transparency that the Committee states that it is trying to achieve, 
and that Congress mandated as it passed such laws as the UNOS enabling 
statute and the Healthcare Quality Act. With a single publication, the 
Finance Committee broke the trust of the hundreds of witnesses and 
evaluators who have participated in UNOS' standards' committees over 
the years, and damaged the ability of this organization or any other 
quality review organization in the future to do its job. As any health 
care provider can tell you, revealing such information as patient age, 
gender, diagnosis and date of death, all identifying factors which 
could easily lead to public identification of donors or recipients 
violates both law and basic privacy. This breach served no public 
purpose except to cast aspersions on some but not all of the 
participants in the chain of events leading to possible medical errors. 
Again, without the full story, expert involvement and explanation, the 
citation of these ten incidents serves no purpose but to re-state cases 
which have already undergone complete review and disposition. Every 
medical professional would agree that medical errors happen, and that 
improvements in process are always possible. Reiterating this 
conclusion in this hearing and report does nothing to further quality, 
transparency or trust. It is merely sensationalizing the very real 
tragedies of the patients who were injured, while adding nothing to the 
journey toward quality.

    Furthermore, the line of questioning related to access and equity 
was simply hypocritical because a number of the Senators doing the 
questioning had long since written letters to the Department of Health 
and Human Services asking to expedite Trump Administration regulations 
that will decertify OPOs and leave system vacuums in the organ donation 
and transplant ecosystem, particularly among high risk populations.

    We all have a shared desire to improve organ donation outcomes 
through a more accountable, more equitable, and more productive organ 
transplantation system. The NASEM report has provided us with the tools 
to achieve these goals for all the patients and families who need the 
system to work to its full potential. We owe it to them to heed the 
consensus advice of our scientific community. We look forward to 
working with you to follow the science and build the stronger, fairer 
transplantation system that America deserves.

Sincerely,

Anthony Pizzutillo
Chair

                                 ______
                                 
                  Letter Submitted by Amy Silverstein
Living with a transplanted heart for 34 years has allowed me to 
experience firsthand the history of the organ transplant system in all 
its aspects, almost since the inception of the UNOS contract.

Over these decades, I've dug deep into the workings of transplant from 
the inside out, giving back to the community by serving as an elected 
patient representative on the UNOS board (and executive committee) for 
six years, as well as an appointed patient rep on committees of 
professional transplant organizations--the American Society of 
Transplantation (AST), the American Society of Histocompatibility and 
Immunogenetics (ASHI), and the Scientific Registry of Transplant 
Recipients (SRTR). I have also written articles for transplant medical 
journals, as well as two transplant-centered books that have been 
published by major publishers. Given my substantial and uniquely 
lengthy experience in transplantation, I feel a responsibility to share 
my insights with the Committee in the wake of yesterday's 
groundbreaking hearing.
What it's Like on the Waiting List
My transplant peer and friend Cal Henry did a wonderful job answering 
your questions on this issue. I'd like to offer some additional food 
for thought.Here's what it's like on the heart wait list.

I was a 24-year-old, second-year law student at NYU School of Law when, 
from out of nowhere, I developed heart failure. The doctors said it was 
a virus and all would resolve in about 6 months. But 6 months later, I 
was rushed by ambulance to Columbia Presbyterian Hospital in New York 
City, having had an episode of ventricular fibrillation that nearly 
ended my life. I spent the next 2.5 months at Columbia, waiting for a 
donor heart. I was told that in order to get to the top of the heart 
waiting list (where it's most possible to get a donor heart), patients 
generally need to have a 2-week life expectancy. I was in that 
precarious zone. I was that sick. And yet, I waited 2.5 months for a 
donor heart, hospitalized and dying.

The defibrillator cart careened into my room with gruesome regularity. 
A swarm of physicians had the terrible task of trying to prevent my 
heart from giving out. One morning, I flatlined--lost breath and pulse 
for a good long time. I woke to the sound of crying nurses, one of whom 
kept calling my name through tears, ``Amy! Amy!''

Being on the heart transplant waiting list is an experience no one 
should ever have--watching and feeling one's own death. I experienced 
my heart dying increasingly by the day. I lost my ability to get out of 
bed (even to go to the bathroom) because it would set off another 
deadly arrhythmia attack. I lost my breath: my lungs became like two 
balloons poked with holes. At 24, I came to know death as much as any 
living person can.

And most affectingly, to this day, I carried and carry the trauma that 
comes with waiting desperately at the top of the heart transplant 
waiting list.

To think that there was inefficiency, ill management, greed, mumbo 
jumbo transportation glitches, and other slipups in the organ donation/
procurement system that might have elongated the intense illness and 
trauma I experienced on the waiting list--is horrifying. To think that 
I might have had my chest burned by defibrillator paddles for 
additional days or weeks due to systematic failures--I shudder. And I 
know many heart recipients who have been or are currently in as 
desperate a position as I was: they shudder, too.

Please keep wait-listed heart patients in mind when getting tough on 
UNOS and OPOs.
The Gratitude Problem
But of course, there is a happy ending to my wait-list story: I 
received a heart. And this part of the transplantation is, I believe, a 
major factor in why and how UNOS, OPO's (and other system aspects of 
transplantation) have been able to perpetuate their failures so well 
and for so long. I think of it as ``the gratitude problem''. It is a 
phenomenon in transplant that did not come up at the hearing, but was a 
constant underpinning, nonetheless.

Every transplant saves a life. Every transplant moves a patient from 
organ failure to organ function. Every transplant delivers a patient 
from death's door to life's promise. It's wonderful.

I can tell you--you lie down on the operating table, and you cannot 
catch your breath, and you wake up hours later with pink cheeks and 
toes (both had been gray from oxygen deprivation), an appetite (which 
had disappeared), and an incredible sense of being full of air and 
light. The death is gone. You are full of life. And enormous gratitude 
and awe for the donor whose pulse has now become your own. A pulse that 
saved you. Two weeks later, you're hiking. Six weeks later, I was 
jogging.

And you're told by everyone you know: It's a miracle! And you find 
yourself saying all the time: I'm so grateful!

Miracle and grateful become your transplant mantras.

There's a problem with this.

Transplant is not a miracle. It is the result of science and medicine. 
And there is nothing miraculous about the life expectancy post heart 
transplant: after my transplant in 1988, I was told if I was luckiest 
lucky, I might eke out 10 years with my transplanted heart (the 
statistics are still pretty much the same, 34 years later). And I soon 
found out that the transplant medicines have serious side effects that 
impair everyday life--and they also cause secondary diseases like 
diabetes, high blood pressure and cancer. Worst of all, it became clear 
that these immunosuppressive medicines, for all their side effects and 
drawbacks, do not work to protect transplanted organs long term.

I bet you didn't know this, senators.

Transplant is a wonderful medical intervention. But it is no miracle. 
Everyone I know who received a transplant around the time I had mine in 
1988 is long gone. And I know donor families who are bereft because the 
donated organs of their loved ones lasted only a few years. Patients 
and donors alike are aware that transplant is no miracle. And yet 
society expects us to speak the miracle mantra at every turn.

This makes for a silent, non-complaining transplant community of 
patients. How dare we criticize UNOS or OPO's when we are living 
miracles? How dare we voice our frustrations about antiquated 
transplant medications and the gross underfunding of transplant 
research by the NIH and FDA when it's a miracle that we are alive?

If there is anything miraculous about transplantation, it's this: organ 
donation. That families or others can rise above their incredible grief 
to donate an organ or organs at the most terrible moment of their lives 
is, I believe, a miracle in humanism.

And this, too, acts as a silencer of patients' complaints: it would be 
ungrateful to say something is wrong with the way transplant works--
administratively, clinically, medically.

Have you ever heard a transplant patient say transplant life is 
incredibly hard? Debilitating? Frustrating? Heartbreaking? Cancerous? 
Deadly? Or that complacency in transplant research/science has 
maintained the status quo with the same antiquated, dangerous 
transplant medicines just where they've been for the last 34 years, and 
the lack of FDA and NIH funding has stymied progress?

Before yesterday's hearing, had you ever heard a transplant recipient 
say the transplant system is a mess or that they deserve better than 
the current system?

I rest my case.
Transparency
The hearing raised issues about UNOS' Membership and Professional 
Standards Committee (MPSC) with regard to citing and censuring troubled 
or failing OPOs. I'd like to point out another issue with the MPSC.

MPSC is tasked with managing low performing or failing transplant 
centers as well. Last year, the head of the MPSC rallied my committee 
at the AST in hopes that we might post a comment in the public record 
in support of some changes to MPSC rules. My committee was not 
satisfied with the changes. Namely, it was apparent that patients still 
would have no way of knowing if their transplant center was in serious 
or even dangerous violation of transplant center safety rules. It 
seemed to me notable that when we go to restaurants, we see the safety 
grade posted in the window (which allows us to gauge whether to, say, 
have the seafood salad), but we know nothing about our transplant 
centers. In many areas, there are several transplant centers to choose 
from; patients, thus, need information to transparency to make an 
informed decision about where to entrust their survival.

The MPSC chairman responded to my comment by saying ``Some things have 
to stay behind the curtain.'' When I pushed and asked why, he said 
something like, ``Patients don't need to know how the sausage is 
made.''

I told him that I am alive for 34 years post-transplant precisely 
because I have made it my business to know exactly how the sausage is 
made--and to make my sausage choices very carefully. To which he 
replied that the information found on the SRTR should suffice. But see, 
it doesn't.

There is no way for patients to know if the transplant center they're 
choosing for their care is failing or in serious violation of 
transplant regulations.

Transparency is crucial to transplant health and well-being. But, 
again, patients don't dare ask for it. They're miracles, after all. And 
they are expected to be nothing but grateful. They have the seafood 
salad they're served and hope for the best.
Thank You, Senate Finance Committee
I watched yesterday's hearing while texting with a transplant friend--a 
kidney recipient who has had 3 kidney transplants over the last 31 
years (again transplant does not last long). We shoveled popcorn into 
our mouths and drank root beer, and we shared with each other our 
feelings: aghast, excited, sad, thankful.

We have been waiting a long time for what we call ``truth in 
transplant.'' The ``miracle and gratitude'' mantras attached to 
transplantation have put a veil over the whole system. It takes courage 
and grit to stand up to it (as the speakers yesterday attested to). My 
transplant friend and I have had to shore up ours to speak up about the 
various issues I've mentioned in this long comment. We've been rebuffed 
and rebuked at times. We've also made some inroads.

As we see it, UNOS/OPOs is a crucial start of the process of seeking, 
revealing, and attending to ``truth in transplant.''

We hope to live long lives with good quality. We hope to help all 
patients do the same. To honor our donors, we must help these donor 
organs live on and on. Thank you for your part in addressing the 
systemic aspects of our quest.

Amy Silverstein

                                 ______
                                 
       Starzl Network for Excellence in Pediatric Transplantation

                            4401 Penn Avenue

                      Faculty Pavilion, 6th Floor

                          Pittsburgh, PA 15224

                       https://starzlnetwork.org/

August 16, 2022

Chairman Ron Wyden
Ranking Member Mike Crapo
U.S. Senate Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200

RE: Statement of University of Pittsburgh Medical Center (UPMC) in 
response to August 3, 2022, Full Committee Hearing, ``A System in Need 
of Repair: Addressing Organizational Failures of the U.S.'s Organ 
Procurement and Transplantation Network''

Dear Chairman Wyden and Ranking Member Crapo:

We are writing on behalf of the families and pediatric transplant 
providers of the Starzl Network for Excellence in Pediatric 
Transplantation www.starzlnetwork.org.

The Starzl Network is a consortium of leading pediatric liver 
transplant centers across the United States--including centers in 
California, Colorado, Florida, Georgia, Illinois, New York, Ohio, 
Pennsylvania, Texas, Virginia, and Washington State. The Network 
closely integrates the patient and family voice along with transplant 
professionals and other collaborators to increase transparency, develop 
and share best practice, and improve outcomes for children undergoing 
transplantation.\1\ The Network recognizes that delivering the best 
care possible is an urgent task and adopting policies which align with 
and enable such practice will benefit the whole of the transplant 
community. Thus, we applaud the Committee for highlighting the voices 
of transplant patients and their families in their recent hearing. 
Incorporating the priorities and experiences of patients and families 
who entrust their lives to this system is critical to understanding--
and improving it.
---------------------------------------------------------------------------
    \1\ Perito E.R., Squires J.E., Bray D., et al. A Learning Health 
System for Pediatric Liver Transplant: The Starzl Network for 
Excellence in Pediatric Transplantation. J Pediatr Gastroenterol Nutr. 
March 1, 2021;72(3):417-424. doi:10.1097/MPG.0000000000002974.

Network members have reviewed the testimony and wish to add several 
---------------------------------------------------------------------------
areas of additional focus:

We appreciate the committee's focus on inequalities faced by 
marginalized populations and those mentioned in the hearing--African 
Americans and persons living in rural communities--were rightly 
emphasized. However, disparity in care delivery is an unfortunate 
reality for many other vulnerable populations and we welcome the 
opportunity to specifically discuss why children deserve special 
protection and priority in any efforts to improve the national system 
of organ allocation.

Among pediatric patients listed for liver transplant in the U.S. today, 
1 in 10 infants and 1 in 20 children die while awaiting a suitable 
organ. This is an unacceptable reality. Particularly since in those 
children that do receive a liver transplant--either a deceased donor 
allocated through UNOS or a living donor--the vast majority survive and 
thrive well into adulthood.

And while improvements can surely be applied to the current system, we 
do strongly support the management of organ allocation by a single, 
nationally organized, non-profit institution. Should the U.S. organ 
allocation system be overseen by a for-profit entity, we are extremely 
concerned that disadvantaged populations such as children, which 
represent only 2% of the transplant wait list, would be further 
deprioritized and undervalued.

Saving the lives of children awaiting liver transplant requires that 
they have reliable access to offers of the rare organs that are right 
for them. Here, the Committees focus on decreasing organ discard rates 
presents another opportunity. To ensure that every child awaiting 
transplant has access to the best possible care, we believe it is 
critical that offers to vulnerable, under-represented populations--like 
children--are not bypassed in favor of expedited placement from organ 
procurement organizations (OPO) to adult transplant centers.

Having a well-coordinated, technologically efficient, and up-to-date 
national transplant system is critical for getting children to life-
saving liver transplants. If OPTN functions are divided amongst 
multiple contractors, it is imperative that there is an oversight body 
to ensure that the work of all contractors is carefully aligned and 
collaborative. For the pediatric liver transplant community, having 
centralized data collection on ALL children awaiting transplant has 
been critical to identifying those at highest risk of waiting list 
death--and to designing policies that will prioritize and protect those 
at-risk children.

Among other technological initiatives, we urge the prioritization of an 
application programing interface (API) serving the integration, 
coordination, and centralization of streaming data among the community 
of stakeholders around the OPTN, including verified 3rd party IT 
support systems, custom interfaces, and electronic health record 
systems. Deeper, two-way integration of the OPTN data with verified 
stakeholder systems create a fertile environment for innovation that is 
both ancillary and complementary to the primary functions of the OPTN 
technology ecosystem.

Notably, modification of the current system is possible and recent 
policy changes have enabled modest improvements in access to care. With 
contemporary adaptations, more than 60% of children now receive livers 
that are ``shared nationally;'' meaning that the organ travels to the 
child who needs it most. Since this change, more timely transplants 
have occurred, and fewer children have died awaiting an acceptable 
organ offer.

Unfortunately, other policy initiatives, such as prioritizing the 
splitting of donor allografts so that a child and an adult can benefit 
from one liver, have not been implemented. A ``split-first'' liver 
allocation policy has proven efficacious in Europe resulting in 
increased access to transplant for kids while maintaining access for 
adults. Evidence suggests that outcomes are equivalent for both adult 
and pediatric split-liver recipients. The Network would welcome the 
opportunity to provide additional data and documentation on this topic 
and firmly believe legislation that would mandate improved organ 
utilization using split liver transplantation is a move that could 
efficiently improve wait-list outcomes for both adults and children.

We also recommend optimization of the policy review and implementation 
process. Currently, most policy changes from proposal to Board approval 
may take 18-24 months and then still await programming or 
implementation challenges. Efforts for improvement should focus on 
ensuring stakeholder engagement, public review, and expert input while 
still allowing for more rapid implementation of life saving policies.

Finally, to help children access the liver donors they need, OPOs must 
have the training and resources to work with families of pediatric 
donors, to appropriately manage pediatric donors, and to help deliver 
the ``gift of life'' from those children and families to transplant 
centers that can use them for children.

In the Starzl Network, our mission is to unite big data, technology, 
patient advocacy, and transplant thought leaders to deliver the best 
possible care and develop new, scalable solutions to pediatric 
transplantation's most challenging problems. We believe the OPTN, and 
the U.S. transplant system, can and should provide this same support to 
all organ transplant candidates.

Respectfully submitted on behalf of the Starzl Network,

George Mazariegos, Chair

James E Squires, Co-Chair

                                 ______
                                 
                        Tennessee Donor Services

                          566 Mainstream Drive

                          Nashville, TN 37203

                            (O) 615-564-3642

                            (F) 615-564-3911

                         Website: tds.dcids.org

I am writing to CORRECT THE RECORD as it pertains to Dr. Jayme Locke's 
testimony on August 3, 2022. She described 4 kidneys that, for various 
reasons, she declined to transplant. The subject of my response is the 
one noted to have had a ``botched biopsy'' pictured in image 4 of her 
written testimony (https://www.
finance.senate.gov/imo/media/doc/
SenateTestimony_8.2.22_Written%20Finalv2.
pdf). She was seemingly unaware the kidney was successfully 
transplanted elsewhere. When we got word it was being declined for the 
specific reason, we were essentially 100% confident it was 
transplantable. Given the importance of every hour of being outside the 
body with no blood flow that Dr. Locke accurately described, we 
retrieved it from her hospital over a 3-hour drive away, while 
simultaneously attempting to reallocate it. Fortunately, another 
transplant center approximately 4 hours away accepted and successfully 
transplanted this kidney. As of August 5, 2022, the recipient was doing 
``great'' according to that center and had a creatinine = 1.16, which 
signifies excellent kidney function, 3 months post-transplant. Since 
her testimony was based on specific anecdotes and not aggregate data, I 
felt it necessary to correct the one anecdote I knew to be wrong.

Dr. Locke and her colleagues at UAB need to be recognized for their 
superior kidney offer acceptance ratios (OARs). UAB has been a leader 
in kidney transplantation in that regard for decades. If every kidney 
transplant program in the U.S. emulated their offer acceptance 
behavior, morbidity and mortality from end-stage renal disease would be 
far less in this country. They are within 250 nautical miles of much of 
our donation service area, which means their patients are likely to 
heavily populate the match runs on many of our donors. As such, their 
OAR undoubtedly benefits our organ transplantation rate, which is a 
very important metric for us as an organ procurement organization. 
Again, their acceptance practice is laudable.

In addition to the kidney described in her testimony, which was clearly 
transplantable, we had another kidney declined earlier this year by 
them for the same reason. Unfortunately, it was declined too many hours 
after removal from the donor for us to reallocate it, and it was 
discarded. We retrieved it for surgical review and unequivocally 
concluded it was transplantable. This was a 37 year-old kidney donor 
with normal kidney function and a normal biopsy, so it would have 
likely gotten someone off dialysis for many years. So, despite being an 
exemplary program in most respects, even model programs like hers 
contribute to our tragically high kidney discard rate, which now is 
approximately 30%. We respectfully reached out to her asking her to re-
examine their practice of assessing transplantability of biopsied 
kidneys and to clarify how we can do a biopsy that they don't deem a 
kidney non-transplantable. We want to help her help her waitlisted 
patients. They deserve for us to be on the same page.

While it is not appropriate to make system changes based on anecdotes, 
each of these anecdotes have many similar sister-anecdotes, which means 
we have a worsening problem. The ones detailed here and ones Dr. Locke 
eloquently testified to each equate to a life saved or lost, depending 
on whether the system functions optimally. They also illustrate the 
fact that all persons and steps in the process must function optimally; 
failure by any person/step can derail the entire endeavor and 
contributes to the problems of organ discard and wait-list mortality. 
Moreover, each failure robs the donor and their family of an important 
component of their legacy and/or emotional healing; the importance of 
this cannot be overstated.

I have been in the organ donation/transplantation profession for over 
25 years and have seen first-hand the amazing work that has resulted 
from it. I have also witnessed the amazing progress made. Wait-list 
mortality, however, remains unacceptably and unnecessarily high. It is 
not overdramatic to say that each death represents a failure of our 
current system, processes, and society.

All in the system--CMS, UNOS/OPTN, OPOs, donor hospitals, transplant 
centers--are responsible for addressing failures, and all must be held 
accountable to serve our mission to candidates on the wait list and to 
donors and donor families. Meaningful accountability is lacking. We 
all, including and especially you, are in a position to improve it; so, 
thank you for your attention to this life-and-death matter.

If you have any questions regarding my thoughts or desire further 
information from me, please reach out anytime.

Sincerely,

Marty T. Sellers, M.D., MPH
Organ recovery surgeon
        Tennessee Donor Services
Former transplant surgeon
        University of Alabama at Birmingham
        University of Pennsylvania
        University of Pittsburgh
        Piedmont Atlanta Hospital
        Emory University
Medical Advisor
        Association of Organ Procurement Organizations

                                 ______
                                 
                          Transplant Families

                  24654 N. Lake Pleasant Pkwy #103-187

                            Peoria, AZ 85383

August 12, 2022

The Honorable Ron Wyden
Chairman
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510

The Honorable Mike Crapo
Ranking Member
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510
Dear Chairman Wyden and Ranking Member Crapo:

We are writing to you today as a coalition of community-based 
organizations with a vested interest in pediatric transplantation. Each 
of us has either watched our child slowly succumb to organ failure, not 
knowing if they would live or die, or we have supported someone who has 
been through this process. We, caregivers, have watched our childrens' 
transplant teams work extremely hard to list our children on the 
national organ waiting list, and, thereafter, they have provided 
around-the-clock care and a shoulder to cry on in our most helpless of 
hours. We have celebrated with our transplant teams when algorithm 
matching is successful, and our child is offered a second chance at 
life. We are especially thankful when a donor family makes a 
heartbreaking and selfless choice to allow that second chance at life 
for our loved ones. Many of these things were discussed in your hearing 
on August 3rd, 2022. We commend the Committee on their commitment to 
continuous improvement for a system that saves the lives of so many.

However, we couldn't help but notice that the most vulnerable 
recipients were left out of consideration. We are writing to you to 
consider pediatric patients in future proceedings regarding the Organ 
Procurement and Transplantation System (OPTN) and its contractor, 
United Network for Organ Sharing (UNOS).

We believe the current system needs improvement, as it is not 
representative of people who live with organ failure: patients and 
caregivers. Often the voices of one of the most marginalized groups of 
organ failure are underrepresented throughout the system: children. 
Time and time again, past policies created around organ procurement, 
such as multi-organ transplants, have harmed pediatric patients. In 
this example, multi-organ transplants take priority over those children 
waiting for kidney transplant.\1\ Children need fair access to the 
national system, and all involved need specialized training to work 
with donor families who are losing a child and recipient families who 
receive the gift of life. We all agree the list is too long, and organ 
discard rates need to decrease, but not at the expense of children who 
may be passed over in favor of adult transplant centers.
---------------------------------------------------------------------------
    \1\ Organ Procurement and Transplant Network. [Ethical implications 
of multi-organ transplants]. [https://optn.transplant.hrsa.gov/
policies-bylaws/public-comment/ethical-implications-of-multi-organ-
transplants/]. Accessed [August 2022].

---------------------------------------------------------------------------
A few items to consider are:

    1.  Incorporating the patient and family's voice in the OPTN's work 
is critical! There should be appropriate representation on Committees, 
in the discussion of policy priorities, and in considering patient-
centered outcomes and metrics--these advocates need to have adequate 
training and support from the organization. They should not have to be 
employed by a hospital, OPO, or the like to be considered. Sometimes 
the best advocates that will give an objective point of view do not 
work within the transplant system.
    2.  There was important attention in the Committee's Report and in 
the hearing to that of minority groups, like African-Americans, which 
are at risk for limited access to transplant and poorer outcomes. We 
applaud the Committee for bringing attention to this and would like to 
add that races other than white often make up over half of all 
pediatric transplants, according to the SRTR donation and transplant 
analytics page.\2\ Many of these are Hispanic families with no access 
to Spanish patient education.
---------------------------------------------------------------------------
    \2\ Scientific Registry of Transplant Recipients. [Donation and 
Transplantation Analytics]. [https://www.srtr.org/tools/donation-and-
transplantation-analytics/]. Accessed [August 2022].
---------------------------------------------------------------------------
    3.  Currently, there are just 2,100 children on the U.S. wait list 
for solid organ transplant--this is less than 2% of the total wait list 
(1 in 100 on the kidney wait list, 1 in 20 for liver, 1 in 10 for 
heart, 1 in 50 for lung). But every one of those children is on the 
organ transplant wait list because they have a risk of dying without 
transplant--and every one of them is likely to survive and thrive into 
adulthood IF they get a transplant.
                a.  There was NO mention in the report, accompanying 
                documents, or the hearing itself about children on the 
                transplant wait list--another vulnerable population 
                that is critical to prioritize and protect.
                b.  In terms of the amount of patient years they have 
                lived, children are underrepresented in policy-making 
                but almost always see the full impact of policies, good 
                or bad.
    4.  A well-coordinated national transplant system is imperative for 
these children. Because children are small, they have fewer options for 
suitable donors. Well-organized, efficient, regional, and national 
sharing of organs is thus critical for children and pediatric 
transplant centers to obtain the right organ for every child.
    5.  Ensuring that OPOs have the training and resources needed to 
approach families of pediatric donors--and to manage pediatric donors 
and connect them to transplant centers that can utilize them 
effectively for children--is an important need. There is little known 
about OPO performance specifically as relates to pediatric donors.
    6.  In considering OPO strategies for decreasing organ discard 
rates, it is imperative to ensure that potential offers to marginalized 
populations--like children--are not skipped over in favor of expedited 
placement along well-trodden paths from OPOs to adult transplant 
centers. To save the lives of children on the transplant wait list, 
they need to have broad, trustworthy access to offers of organs that 
are right for them. This is specified in the ``Maximin'' principle as 
spelled out in the Ethical principles of pediatric organ updated 
November 2014 on the OPTN website.\3\
---------------------------------------------------------------------------
    \3\ Organ Procurement and Transplant Network. [Ethical implications 
of multi-organ transplants]. [https://optn.transplant.hrsa.gov/
policies-bylaws/public-comment/ethical-implications-of-multi-organ-
transplants/]. Accessed [August 2022].

Finally, we would like to address a few line items based on the 
recommendations outlined in the Staff Memo on Organizational Failures 
of the United States Organ Procurement.\4\
---------------------------------------------------------------------------
    \4\ United States Senate Committee on Finance (August 3, 2022) 
Staff Memo on Organizational Failures of the United States Organ 
Procurement [https://www.finance.senate.gov/imo/media/doc/
UNOS%20Hearing%20Confidential%20Memo%20(FOR%20RELEASE).pdf].

      While we encourage competition to improve any system, 
specifically opening the contract to for-profit entities as the first 
line item concerns patients and families as this will most certainly 
drive costs up for organ transplant, pre- and post-care. As we have 
seen in other for-profit areas, these costs are always shifted to the 
consumer (or patient in this case), who already shoulders significant 
costs when it comes to life-saving transplants. We hope that the 
Committee will please take this into consideration.
      The second line item stating that policy can be enacted by 
several contractors is also concerning. Having centralized organ 
allocation (i.e., a ``clearinghouse function'') is almost necessary in 
order to keep seamless exchange to and from OPOs and transplant 
hospitals. In other countries that have separate organ allocation 
systems (that would mimic the several contractor's scenario), there 
aren't easy or automated ways to share life-saving resources. Our 
current data allocation system works well. It is the discards and 
transport that is one of the most concerning items, along with access 
to the wait list. We hope the solution that you are alluding to in item 
4 is actually a centralized data store and allocation with potential 
contractors involved at another point besides decisioning and would 
like clarification between points 2 and 4.
      All of the other suggestions we strongly support and are willing 
to give specifics as to why.

Thank you for your compassion, time, and effort during these hearings. 
It is clear that the Committee shares a desire for positive change 
within our organ allocation system. We write to you in hopes that these 
changes will always include and consider those it affects the most: the 
donor and recipient patients and their families.

Sincerely,

Melissa McQueen
Parent to heart transplant recipient Dylan (14, transplanted 8 months 
old)
Executive Director/Founder Transplant Families
Member, OPTN/UNOS Board of Directors
Member, OPTN/UNOS IT Advisory Committee/Network Ops and Oversight 
Committee
Former Member, OPTN Data Advisory Committee
Former Member, OPTN Pediatric Committee
Families in Action Council Co-Chair, Advanced Cardiac Therapies 
Improving Outcomes Network (ACTION)
PARTNER Project Lead--PCORI project facilitated by Starzl Network and 
Transplant Families

Jennifer Lau
Parent to liver transplant recipient Nathan (10, transplanted 9 months 
old)
Board Vice President, Transplant Families
Member, OPTN Pediatric Committee
Co-Founder/President BARE Inc.
Chair, Patient and Family Engaged Partners of SPLIT (Society of 
Pediatric Liver Transplantation)
PARTNER Project Lead--PCORI project facilitated by Starzl Network and 
Transplant Families
PFV Member, Starzl Network

Stacy Hillenburg
Parent to pediatric heart transplant recipient (10 years old, 2 months 
old at transplant)
Board Secretary, Transplant Families

Jill L. Brown, MPA
Parent and Living Donor to kidney transplant recipient Kylee (12, 
transplanted at 3 years old)
Executive Director of NW Kidney Kids
Board Treasurer, Transplant Families

Riki Graves, MHA
Parent to heart transplant recipient, Juliana (8, transplanted at 17 
days old)
Board Member, Transplant Families
Quality Initiatives Committee Member, Pediatric Heart Transplant 
Society
Families in Action Council Member, Advanced Cardiac Therapies Improving 
Outcomes Network (ACTION)

Joseph Hillenburg
Parent to pediatric heart transplant recipient (10 years old, 2 months 
old at transplant)
Strategy Advisor, Transplant Families
Member, Scientific Committee, Pediatric Heart Transplant Society
Member, Families in Action (FACT), Advanced Cardiac Therapies Improving 
Outcomes Network (ACTION)
Member, American Society of Transplantation Transplant Community 
Advisory Committee
Member, Donate Life America Volunteer Committee
Former Member, OPTN/UNOS Board of Directors
Former Member, OPTN/UNOS IT Advisory Committee/Network Ops and 
Oversight Committee
Former Member, OPTN Patient Affairs Committee
Former Member, OPTN Pediatric Committee

Ansara Piebenga
Parent to kidney/liver transplant recipient, Lauren (16, transplanted 
at 16 months old)
Board Member, Transplant Families
Member, Improving Renal Outcomes Collaborative (IROC)'s Community 
Engagement Workgroup
Ambassador and Volunteer, National Kidney Foundation

Sarah Vargas
Parent to pediatric two-time liver transplant recipient, Rosie (8, 9 
months and 4 years of age)
Board Member, Transplant Families
PFV and Executive Steering Committee, Starzl Network

Erin Babin, LCSW
Parent to liver transplant recipient Elise (10, transplanted at 17 
months)
Member, Patient and Family Engaged Partners of SPLIT (Society of 
Pediatric Liver Transplantation)

Anna Beeman
Parent to liver transplant recipient, Will (4, 6 months old at 
transplant)
CEO of Liver Mommas and Families, Inc.

Christopher Beeman
Parent to liver transplant recipient, Will (4, 6 months old at 
transplant)
Board Member, BARE, Inc.
Bonnie Bolin, RN, BSN
Mother to heart transplant recipient Raylan (2, transplanted at 3 
months old)
Advanced Cardiac Therapies Improving Outcomes Network (ACTION) 
Committee Member
Hospital Services Coordinator for Southwest Transplant Alliance

Jessica Callear
Parent to liver transplant recipient Hazel (6, transplanted 10 months 
old)
Member, Patient and Family Engaged Partners of SPLIT (Society of 
Pediatric Liver Transplantation)

Hilary Camille
Parent to heart transplant recipient Shiloh (11, heart transplant at 2 
years old)
Certified Grief and Trauma Coach
Advocate and Co-Administrator of Pediatric Heart Transplant Caregiver 
Group, representing nearly 2,000 caregivers nationwide

Amanda Morcheles Goldstein
Parent to pediatric kidney transplant recipient (Lily, transplanted in 
2016, 11 years old)
Co-Chair of the Improving Renal Outcome Collaborative's (IROC) 
Community Engagement Workgroup

Serina Guerrero
Parent to heart transplant recipient Amaya (9, transplanted at 8 months 
old)
Advocate and Co-Administrator of Pediatric Heart Transplant Caregiver 
Group, representing nearly 2,000 caregivers nationwide

Jasmine Hollingsworth
Parent to liver transplant recipient, Kai (14, 4 months old at 
transplant)
Founder/Executive Director of Liver Mommas and Families, Inc.

Amanda Kammes
Parent to current liver wait-list child, William (12)
Board Member BARE, Inc.

Sherrie Logan, BSc, BA
Parent to liver transplant recipient, Ashley (15, 2 years old at 
transplant)
Co-Founder of Ashley's Angels (Third party fundraising initiative in 
support of The Hospital for Sick Children)
Executive Committee Member Starzl Network
Member, Patient and Family Engaged Partners of SPLIT (Society of 
Pediatric Liver Transplantation)

Kimberly Matthews
Parent to liver transplant recipient, Isaac (18, transplanted at 5 
months)
Member, Patient and Family Engaged Partners of SPLIT ( Society of 
Pediatric Liver Transplantation)

Stephanie Mullett
Parent to pediatric liver transplant recipient (4, 10 months old at 
transplant)
Program Administrator, Alagille Syndrome Alliance
CHOC Representative for PFV, Starzl Network

Brittany Munn
Parent to liver transplant recipient Caleb (8, transplanted at 6 months 
old)
Board Member, BARE Inc.
Member, Patient and Family Engaged Partners of SPLIT (Society of 
Pediatric Liver Transplantation)

Jennifer Rodriguez
Parent of pediatric kidney transplant recipient Emily (3.5 years post-
transplant)
IROC Community Engagement Workgroup Member

Jordan Sarbaugh
Parent to liver transplant recipient Hudson (5, transplanted 9 months 
old)
Co-Founder, VP BARE Inc.
Member, Patient and Family Engaged Partners of SPLIT (Society of 
Pediatric Liver Transplantation)

Krupa Shah
Parent of liver transplant recipient Jaisal (11, transplanted 15 months 
old)
Member Parent and Family Voice, Starzl Network
Stephanie Skrede
Parent to liver transplant recipient Sophia (9, transplanted at 9\1/2\ 
months old)
Board Member, BARE Inc.

Vanessa Smith
Living Liver Donor
Parent to liver transplant recipient Rylie (15, transplanted at 10 
months)
Member, Patient and Family Engaged Partners of SPLIT (Society of 
Pediatric Liver Transplantation)

Jennifer White
Parent to liver transplant recipient Joshua (24, transplanted 14 years 
old)
Co-Chair, Patient and Family Engaged Partners of SPLIT (Society of 
Pediatric Liver Transplantation)

Tawanna Williams, CPC
Parent to heart transplant recipient Avery Grace (6, 2 years old at 
transplant)
Diversity, Equity, and Inclusion Consultant
Certified Professional Coach
National Board Member/Medical Advisory Council
The Children's Heart Foundation
Parent and Advisory Board Member
Additional Ventures

Cheryl Witty
Parent to pediatric kidney transplant recipient Kimberly (transplanted 
at 12 years old)
Co-Founder, Children's Transplant Initiative

Ross Witty
Parent and living kidney donor to daughter Kimberly (transplanted at 12 
years old)
President/CEO, Co-Founder, Children's Transplant Initiative

Leslie Wyers
Parent to TWO pediatric kidney transplant recipients (Logan, 
transplanted 10 years ago, and Kylie, transplanted 8 years ago)
Living Donor
Co-Chair of Improving Renal Outcome Collaborative's (IROC) Community 
Engagement Workgroup
President NephHope Foundation
Past UNOS Patient Affairs Committee member

Kathleen Yago
Parent to heart transplant recipient Hana (7, transplanted at 21 months 
old)
Member, Families in Action (FACT), Advanced Cardiac Therapies Improving 
Outcomes Network (ACTION)
Family Advisory Council Member, Stanford Medicine Children's Health at 
Lucile Packard Children's Hospital

Susan Zohner
Parent to pediatric heart transplant recipient (10 years old, 4 months 
old at transplant)

Deborah Morrissey Pham
Parent to pediatric heart transplant recipient Madelyn (18, 
transplanted at 7 weeks old)

Madelyn Pham (18)
Pediatric heart transplant recipient at 7 weeks of age

Diana D. Kendall
Executive Director
Transplants for Children

Rick Lofgren
President and CEO of the Children's Organ Transplant Association (COTA)
Representing more than 2,000 pediatric transplant families across the 
country since 1986

Carolyn Salvador
Chief Executive Officer, Enduring Hearts

Diann Begley R.N., BSN
Program Administrator, Enduring Hearts

Lisa Yue
President and Founder
Children's Cardiomyopathy Foundation

                                 ______
                                 
                Letter Submitted by a Transplant Surgeon
August 10, 2022

To whom it may concern;

I am a transplant surgeon at Thomas Jefferson University Hospital. I 
have worked in transplantation for slightly more than 22 years. I am a 
current OPTN/UNOS board member. My comments are based on my viewing of 
the entire hearing. I have not had the time to review the accompanying 
documents. I have gotten to know Brian Shepard during the time I have 
served on the UNOS board and have found him to be an effective leader 
who is unflappable and professional. Of course, he is not perfect and I 
am sure that in the 10 years that he has been the CEO of UNOS, there 
have been a few things that he wished he had done differently. All in 
all, his leadership has been highly effective and 41K transplants while 
the country is still struggling with a pandemic is testament to his 
focused leadership. I found the hearing to be disheartening as someone 
who has worked tirelessly in my profession. There was a gross over 
simplification of the problems faced and a is characterization of who 
are the heroes and who are the ``villains.'' Seeing an individual, 
Brian Shepard who I know to be a force of good being vilified by 
several U.S. Senators, was mockery of good governance and the fact that 
it was bipartisan did nothing to lessen the blow. Fortunately, my State 
Senator, Senator Casey, stood out as being reserved in judgement. There 
were no real solutions proposed during this hearing. Dividing UNOS and 
OPTN leadership perhaps might improve things, but I humbly submit it 
would do little and on the whole the mission of UNOS and the OPTN are 
largely quite aligned.

I would hope the Senators consider the following: (1) There has been a 
profound push within the OPTN/UNOS leadership to encourage 
diversification of the committee membership to ensure that all voices 
are heard in making policy. Having a greater voice for patient and 
donor representatives, has been a significant part of this push. These 
moves have championed by UNOS leaders like Brian Shepard and Dr. Mathew 
Cooper. (2) Geographic disparity with regards to deceased donor kidney 
transplant access has been a great inequity within the U.S. and is in 
violation of the final rule from 2000. OPTN policies have been placed 
into effect to deal with this inequity which have caused strains on the 
transplant system. Dealing with this inequity does require greater 
deceased donor kidney travel and with travel comes risk. (3) 
Sensational stories of deceased donor kidneys being incorrectly 
surgically procured; incorrectly package leading to the organ being 
frozen; mishandled during transport; or even run over by likely a poor 
chain of custody for the organ are not the real story of the problems 
that plague the system. That does not mean that they do not need to be 
addressed, but these are not the real numbers behind kidney discards. 
(4) Deceased donor kidney discards are a real problem and I know the 
Senators recognize this. Many deceased donor kidneys do come with 
sizeable risks including donor derived disease which was discussed 
during the hearing.

I humbly submit my comments as a transplant surgeon and as citizen of 
this country. I found the approach of several Senators to be overly 
opinionated and devoid of balance that I expect of our country's 
leaders.

                                 ______
                                 
                University of Pittsburgh Medical Center

                            U.S. Steel Tower

                               Suite 6200

                            600 Grant Street

                          Pittsburgh, PA 15219

August 16, 2022

Hon. Ron Wyden
Chairman
Hon. Mike Crapo
Ranking Member
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200

Dear Chairman Wyden and Ranking Member Crapo:

    UPMC appreciates the Committee's diligence in reviewing and 
spotlighting shortcomings in the nation's organ procurement, allocation 
and transplantation systems.

    Since 1981, UPMC Transplant Services has performed more than 20,000 
organ transplant surgery procedures, including liver, kidney, pancreas, 
small bowel, liver/small bowel, heart/lung, double lung, single lung 
and multiple-organ transplants. UPMC is home to some of the world's 
foremost transplant experts and has a long history of developing new 
anit-rejection therapies, allowing organ recipients to enjoy better 
health. Our program is also distinguished by its commitment to 
discussing living donation with each patient who will benefit. Our 
living-donor liver and kidney transplant programs have helped many 
patients receive the gift of life through living donation.

                           Executive Summary

    As a leader in transplantation, we share many of the concerns 
raised by the Committee, and write today to include our perspectives 
with respect to additional opportunities not addressed during the 
hearing that United Network for Organ Sharing (UNOS) can implement to 
drive system innovation and improvement and that can ultimately reduce 
or eliminate wait-list mortality. First, UNOS' policies unnecessarily 
deny children the most optimal care by failing to fully endorse and 
support deceased donor liver transplant (DDLT) splitting, a practice 
common in other countries that has effectively reduced wait-list 
mortality elsewhere.\1\ Second, UNOS' policies do nothing to improve 
adult and pediatric wait-list mortality by failing to promote and 
implement living donor liver transplant (LDLT) options. Third, UNOS has 
for years displayed a lack of sincere effort, and in some instances a 
total breakdown in communication, in responding to UPMC and other 
living donor allied groups in seeking to better educate the public 
about the benefits of living donor transplants.\2\
---------------------------------------------------------------------------
    \1\ For example, the United Kingdom's intent-to-split study policy 
resulted in [a] dramatic reduction of wait-list mortality and was 
accomplished with deceased donor liver transplant (DDLT) variant split 
grafts. Sixty-five percent of pediatric liver transplants were 
performed as split deceased donor grafts with excellent outcomes . . . 
[and] most significantly, pediatric wait-list mortality was eliminated 
during the last 4 years of the study period. Battula N.R., Platto, M., 
Anbarasab R., Perera M.T.P.R., Ong E., Roll G.R., et al. Intention to 
split policy: A successful strategy in a combined pediatric and adult 
liver transplant center. Ann Surg. 2017;265:1009-15.
    \2\ See Addendum I, Index of Communications with UNOS on 
Educational Initiatives Since 2018.

    UNOS is slow to embrace these and other innovations in 
transplantation. In UPMC's experience, it is very difficult to raise 
pediatric voices within UNOS' committee structure, in particular, and 
even more challenging to implement policy change in general. UNOS' 
policy review process is lengthy and all too often years elapse between 
peer-reviewed recommendations and policy implementation, increasing 
mortality risk for adults and tragically, to even greater degrees, for 
children.\3\ With respect to pending liver transplants alone, 
approximately 20 percent of adults die while waiting, and in some 
centers, up to 10 percent of children perish or get to sick for 
transplant while waiting for transplant therapies.
---------------------------------------------------------------------------
    \3\ The U.S. transplant community does regularly assess the impact 
of policy change, although these assessments may take too much time and 
often do not distinguish between pediatric and adult outcomes, limiting 
their ability to drive efficient cycles of continuous improvement. 
Mazariegos G.V., Soltys K.A., Perito E.R.; Editorial, Waitlist 
mortality in pediatric liver transplantation: The Goal is Zero. Liver 
Transpl 2022;00:1-2.

    This mortality trend is unacceptable and could be substantially 
improved or eliminated with robust support for DDLT splitting, with 
substantial LDLT program implementation, and for other novel 
transplantation innovations. Currently at UPMC, LDLTs comprise 65 
percent of our total number of liver transplants (contrasted with the 
national average of 6 percent), resulting in substantial increases in 
transplant rates and reductions in wait-list mortality.

               Innovations in Pediatric Liver Allocation

    Deceased donor livers remain a limited resource, in the U.S. and 
elsewhere. In the U.S., mortality of pediatric patients on liver 
transplant waiting lists persists despite improved care for patients 
and directed efforts to increase pediatric priority in liver 
allocation. Organ allocation systems, like those managed by UNOS in the 
U.S., play a primary role in determining wait time and likelihood of 
transplantation on the pediatric waiting list. As long as wait-list 
mortality persists, a need exists to use all available methods, 
especially technical variant grafts that should drive increased 
utilization of split-liver transplantation, which U.S. and 
international data now suggest equivalent outcomes for both adult and 
pediatric split recipients.\4\ However, under UNOS oversight, voluntary 
splitting of livers to 2 recipients is rare in the U.S. and essentially 
only occurs when the organ is first allocated to a pediatric 
recipient.\5\
---------------------------------------------------------------------------
    \4\ Hsu E.K., Mazariegos G.V., Global Lessons in Graft Type and 
Pediatric Liver Allocation: A Path Toward Improving Outcomes and 
Eliminating Wait-List Mortality, Liver Transpl 23:86-95 2017.
    \5\ Id. at 89.

    More generally, UNOS, in implementing the Institute of Medicine's 
recommendations on Congress' Final Rule \6\ with respect to liver 
allocation in 2002, adopted the Model for End-Stage Liver Disease 
(MELD) and Pediatric End-Stage Liver Disease (PELD) scoring system, 
which UNOS recognized did not accurately reflect the true mortality 
risk of every pediatric patient on the waiting list. And so UNOS 
created standardized exceptions that were designed to elevate the 
priority score in those children who met certain criteria, and 
additional nonstandard case-by-case exceptions reviewed by UNOS 
Regional Review Boards.
---------------------------------------------------------------------------
    \6\ The Final Rule mandated that an objective wait list of patients 
be established. 63 Fed. Reg. 16296-16338 (1998).

    By 2005, UPMC and others in the pediatric liver transplant 
community observed an increasing dependence on standard PELD exception 
requests for allocation.\7\ Further examination of the nonstandard 
(case-by-case) exception requests found a five-fold increase,\8\ with 
variation in approval rates from 65 percent (Region 5) to 100 percent 
(Region 6).\9\ The case-by-case exceptions were associated with better 
outcomes and lower mortality in children, but UPMC was then and remains 
today concerned that such significant regional and racial variation in 
case-by-case or nonstandard exception rates, with those of caucasian 
identity and private insurance being more likely to benefit,\10\ 
creates an unfair imbalance in the system that UNOS should address in a 
more consistent manner, ideally in a uniform fashion rather than a 
provider-directed, case-by-case one, which would reduce both regional 
and racial disparity.
---------------------------------------------------------------------------
    \7\ Shneider B.L., Suchy F.J., Emre S., National and regional 
analysis of exceptions to the Pediatric End-Stage Liver Disease scoring 
system (2003-2004), Liver Transpl 2006;12:40-45.
    \8\ Braun H.J., Perito, E.R., Dodge J.L., Rhee S., Roberts J.P., 
Nonstandard exception requests impact outcomes for pediatric liver 
transplant candidates, Am. J Transplant 2016;16:3181-3191.
    \9\ Id.
    \10\ Hsu E.K., Shaffer M., Bradford M., Mayer-Hamblett N., Horslen 
S., Heterogeneity and disparities in the use of exception scores in 
pediatric liver allocation. Am. J Transplant 2015;15:436-444.

    More broadly, UNOS' attempt at redistricting to resolve regional 
disparity concerns like those discussed supra have shown little 
significant impact upon pediatric allocation and transplantation 
rates.\11\
---------------------------------------------------------------------------
    \11\ Gentry S.E., Massie A.B., Cheek S.W., Lentine K.L., Chow E.H,. 
Wickliffe C.E., et al. Addressing Geographic Disparities in liver 
transplantation through redistricting. Am. J Transplant 2013;13:2052-
2058.

    With the exception of the U.S., many other countries have 
prioritized liver allocation in a definitive manner without detriment 
to adult liver access. Revisiting splitting criteria is critical. UNOS 
policy 9.8.A allows for regional splitting when the adult is the index 
patient, but the policy has not resulted in a significant increase in 
split grafts benefitting children. This lack of change in split 
utilization in the U.S. suggests that pediatric prioritization will be 
essential to improve split application.\12\ UNOS can and should 
repurpose resources and policies to prioritize pediatric access to life 
saving therapy, primarily by emphasizing the importance of split-graft 
utilization.
---------------------------------------------------------------------------
    \12\ See supra FN 3 and 1, respectively.
---------------------------------------------------------------------------

            Innovations in Adult Liver and Kidney Allocation

    UPMC believes that the Committee's investigation and hearing offer 
a critical opportunity to raise awareness to what we strongly believe 
is a key part of the solution to organ shortages, and, by extension, 
long patient wait lists: living donation. We hope this letter augments 
the Committee's work in acknowledging that certain diseases, like 
diabetes, chronic kidney disease and end-stage liver and renal diseases 
are on the rise and will drive an even greater need for kidney and 
liver transplantation in the coming years.

    It is our hope that UNOS establishes a substantial commitment to 
broader education and public awareness about living donation for kidney 
and liver transplantation, in addition to split-graft liver transplant 
procedures like those discussed supra.

    So far, UNOS has not shown this level of interest or commitment. In 
fact, as UPMC has pressed UNOS for greater promotion of living donor 
options, including the publication and dissemination of materials and 
data to the public that make the case for living donation, UNOS has, 
for the most part, stood down.

    Either because of ambivalence or because of bureaucratic red tape, 
UNOS' failure to move in the direction of advancing living donor 
transplantation forced UPMC to act on its own.\13\ Understanding the 
great need for public awareness and acceptance of living donor liver 
transplantation, UPMC invested in and launched its own national 
awareness campaign in 2018 to educate the public about the option.\14\ 
Our own results with LDLT clearly demonstrate the successes of 
educational campaigns to promote living donation and beneficial effects 
on patient outcomes. UPMC has partnered with other non-profit and 
transplant-related organizations to help continue to promote awareness 
and education of this life-saving procedure, and of the benefits of 
living donation overall. We believe UNOS can, and should, join us.
---------------------------------------------------------------------------
    \13\ A description of UPMC's efforts to coordinate with and 
convince UNOS of the benefits of novel transplant options since 2018, 
like living donation, is attached as Addendum I.
    \14\ See generally https://www.upmc.com/services/transplant/liver/
living-donor.
---------------------------------------------------------------------------

                               Conclusion

    As the Committee continues to examine possible structural 
alternatives to the current UNOS-governed organ procurement and 
allocation system, we strongly advocate that greater attention be given 
to LDLT, split liver and novel transplant procedures that can increase 
organ availability and reduce wait-list mortality. We are pleased to 
submit this response to the Committee's hearing and stand ready to 
further expand on our points and references described herein at your 
convenience. Thank you for your ongoing attention to this matter.

Sincerely,

Abhinav Humar, M.D.
Clinical Director of the Thomas E. Starzl Transplantation Institute
Chief, Division of Transplantation in the Department of Surgery at UPMC

George Mazariegos, M.D.
Chief Pediatric Transplantation, UPMC Children's Hospital of Pittsburgh
Professor of Surgery and Critical Care, University of Pittsburgh School 
of Medicine

                               ADDENDUM I

                   INDEX OF COMMUNICATIONS WITH UNOS 
                 ON EDUCATIONAL INITIATIVES SINCE 2018

Fall 2018. UPMC submitted topics for a co-branded consumer webinar to 
UNOS communications officials. UPMC met with UNOS designees and UPMC 
was advised to provide content for review before UNOS would commit to 
the webinar. UPMC developed content and submitted it but never received 
return acknowledgement from UNOS on topics including (1) current status 
of living donor liver transplantation in the U.S.; (2) shifting the 
paradigm toward living donor liver transplant; and (3) novel 
indications for living donor liver transplant.

Winter 2019. UPMC submitted copy to UNOS for a co-branded consumer-
directed brochure on living donor liver options. UPMC met with UNOS 
officials and were advised that the project would be held pending a 
rebuild of the UNOS website. UPMC did not receive any further contact.

Summer 2019. UPMC, Donate Life America, American Liver Foundation and 
WedMD participated in an educational summit in Washington, DC to 
educate the public about the shortage of deceased-donor livers 
available for transplantation and living donation as an option to 
reduce wait-list deaths. Brian Shepherd represented UNOS on a panel of 
experts.

Summer 2020. UPMC submitted three patient stories and photographs for 
the newly rebuilt UNOS website. The patient stories were only 
temporarily posted publicly.

    March 2022. UPMC convened a phone call with Brian Shepherd to 
introduce a new idea for updating the multi-listing brochure that all 
transplant centers are required to give waitlisted patients to include 
information about living donation. UNOS agreed this could be part of 
the brochure update but advised that it would be assigned to a work 
group of the UNOS Patient Committee and could take up to a year to 
complete because of the levels of review involved. UPMC followed up in 
late May and received no response from UNOS. As an alternative, UPMC 
has been working with contacts at Donate Life America to reach members 
of the UNOS Patient Committee directly to facilitate approval and 
publication of the new information about living donation. Success of 
those efforts is to be determined.

                                 ______
                                 
                  Vanderbilt University Medical Center

                         1161 21st Avenue South

                      D-4316 Medical Center North

                        Nashville, TN 37232-2730

                            tel 615-322-2363

                            fax 615-343-5365

                           [email protected]

August 16, 2022

U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510

Dear Chairman Wyden, Ranking Member Crapo, Senator Grassley, and 
Members of the Senate Finance Committee:

As the largest heart transplant center, largest donor hospital and one 
of the largest overall transplant centers in the United States, 
Vanderbilt University Medical Center (VUMC) would like to express its 
gratitude to the Senate Finance Committee for holding an important and 
compelling oversight hearing on the Organ Procurement and 
Transplantation Network (OPTN). The hearing and related Committee 
investigation highlighted numerous failings of the current OPTN 
contractor, the United Network for Organ Sharing (UNOS), running this 
central component of the nation's transplant system.

Members of the Vanderbilt Transplant Center have served on the Board of 
Directors of OPTN/UNOS, have testified before Congress on related 
subject matter,\1\ and held numerous national leadership positions in 
transplantation over a period of more than 30 years. Based on this 
experience, we strongly endorse the conclusions reached by the 
Committee in its investigative findings, namely that there is 
widespread and consequential failure by UNOS in managing the OPTN 
contract. These failings most certainly have led to patient harm and 
death, demanding prompt action by the Department of Health and Human 
Services (HHS) to ensure stewards of the U.S. transplant donation and 
allocation system immediately address deficiencies and improve service 
for prospective transplant patients.
---------------------------------------------------------------------------
    \1\ Testimony of Seth Karp, M.D. before the U.S. House Committee on 
Oversight and Reform, ``The Urgent Need to Reform the Organ 
Transplantation System to Secure More Organs for Waiting, Ailing, and 
Dying Patients'', May 4, 2021. Online at https://oversight.house.gov/
legislation/hearings/the-urgent-need-to-reform-the-organ-
transplantation-system-to-secure-more.

Although the problems are widespread, we believe significant 
improvement can be made by addressing the following issues identified 
---------------------------------------------------------------------------
by the Committee:

    (1)  Lack of effective oversight of Organ Procurement Organizations 
(OPOs):

         Assessment: Many in the governance and leadership of UNOS are 
also leaders of OPOs. Although the Final Rule Sec. 121.10 instructs the 
OPTN to design appropriate plans and procedures to review the 
performance of each member OPO, this is simply not occurring. In fact, 
multiple Board Members are actively involved in blocking oversight of 
OPO performance. Twenty years of high-quality research suggests the 
number of donors in the U.S. should be 2-3 times the number of actual 
donors, and that poor OPO performance is a principal cause of this gap 
between what is, and what could be, the number of organs available for 
transplant.

         Recommendation: OPO performance oversight must be immediately 
removed from the purview of UNOS. We applaud the new CMS guidelines 
(CALC metric) for assessing OPO performance but stress the need for 
active enforcement by HHS to ensure the intended goal of improving OPO 
performance is being achieved. All stakeholders, including OPOs, 
transplant centers and the OPTN must be held to account when we fail 
patients.

    (2) Obsolete technology:

         Assessment: As the hearing elucidated in great detail, UNOS 
technology is failing with respect to logistics, safety, usability, 
reliability and efficiency. As Members of the Committee described, UNOS 
lacks the core competency to improve the system.

         Recommendation: A new contract should be issued after an open 
bidding process for the OPTN commences. HHS should take necessary steps 
to assure that HHS or another appropriate Federal oversight agency has 
permanent rights of use and further development in the current 
technology and software platforms used by UNOS, as well as those that 
may be developed in the future by any new organization retained to 
serve as the OPTN contractor.

    (3) UNOS is a bad faith actor:

         Assessment: Although the majority of members of UNOS are 
motivated by a desire to serve the transplant community, the leadership 
of UNOS subverts this energy to serve the interests and objectives of 
UNOS, whether or not those interests ultimately will serve transplant 
candidates well. When UNOS senior leadership reports to Congress that 
only 10% of the UNOS budget is taxpayer funded and ignores the 
significant contributions by the Medicare program (and in some cases 
Medicaid) through payment of organ acquisition fees, it undermines the 
transplant community's trust of the OPTN. When UNOS lobbies HRSA to 
require anyone competing for the OPTN contract to have extensive 
experience in running the OPTN, it eliminates competition and 
perpetuates the same poor performance. When UNOS refuses to separate 
the Boards of UNOS and the OPTN, it ensures that the OPTN cannot 
separately hold UNOS to account for deficits in its operating 
performance, and thus prevents HHS from regulating the OPTN contractor 
effectively. When multiple members of the community are subject to 
reprisals for speaking out against UNOS policy, as detailed by Dr. 
Jayme Locke, an environment of fear and intimidation is created.

         Recommendation: HHS and HRSA should immediately bid out the 
OPTN contract and prevent any current or recent board member of UNOS 
from taking on a leadership position in whatever organization may be 
awarded the contract. In addition, HHS and HRSA should assure that the 
boards of the OPTN and any new contractor retained to operate the OPTN 
are separate and distinct, and that a majority of members of the OPTN 
Board are independent from, and do not serve in the leadership or 
governance of, any organization selected to serve as the OPTN 
contractor.

In our view, these aims can only fully be achieved by HHS awarding a 
new contractor that is fully committed to improving upon the status 
quo. VUMC and the Vanderbilt Transplant Center stand ready to be a 
resource to policymakers as you seek additional oversight and 
accountability, and as you push for meaningful reforms of the OPTN.

Thank you for your commitment to this critical issue.

            Sincerely,

            Seth J. Karp, M.D.
            Professor and Chair, Section of Surgical Sciences
            Surgeon-in-Chief, Vanderbilt University Medical Center
            Director, Vanderbilt Transplant Center

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