Examining Disease Burden and Organ Transplant Waiting Lists

The system for coordinating organ donations and transplants in the United States is broken, according to experts who have testified over the course of many years to Congress. In this episode, hear their testimony about what is wrong with the current system and then we'll examine the bill that aims to fix the problems. Please Support Congressional Dish – Quick Links Contribute monthly or a lump sum via PayPal Support Congressional Dish via Patreon (donations per episode) Send Zelle payments to: Donation@congressionaldish.com Send Venmo payments to: @Jennifer-Briney Send Cash App payments to: $CongressionalDish or Donation@congressionaldish.com Use your bank's online bill pay function to mail contributions to: 5753 Hwy 85 North, Number 4576, Crestview, FL 32536. Please make checks payable to Congressional Dish Thank you for supporting truly independent media! View the show notes on our website at https://congressionaldish.com/cd281-private-policing-of-the-organ-transplant-network Background Sources "UNOS Hearing Confidential Memo [Jen Briney's Highlighted Version]." August 3, 2022. Senate Finance Committee. "70 deaths, many wasted organs are blamed on transplant system errors." Lenny Bernstein and Todd C. Frankel. August 3, 2022. The Washington Post. "Letter from Chuck Grassley et al. to Brian Shepard." February 10, 2020. Senate Finance Committee. The Bill H.R.2544: Securing the U.S. Organ Procurement and Transplantation Network Act Audio Sources The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System July 20, 2023 Senate Committee on Finance, Subcommittee on Health Care Watch on C-SPAN Witnesses: LaQuayia Goldring, Patient Molly J. McCarthy, Vice Chair & Region 6 Patient Affairs Committee Representative, Organ Procurement and Transplantation Network (OPTN) Matthew Wadsworth, President and CEO, Life Connection of Ohio Raymond J. Lynch, MD, MS, FACS, Professor of Surgery and Director of Transplantation Quality and Outcomes, Penn State Health Milton S. Hershey Medical Center Donna R. Cryer, JD, Founder and CEO, Global Liver Institute Clips 30:40 Sen. Ron Wyden (D-OR): HRSA, the Health Resources Agency, is on track to begin the contract process this fall and we're just going to be working here to complement their effort. 36:30 Sen. Chuck Grassley (R-IA): In 2005, I started the investigation of the deadly failures of UNOS, the monopoly tasked with managing the US organ donation system. Since then, more than 200,000 patients have needlessly died on the organ waiting list. There's a reason that I call UNOS the fox guarding the hen house. For nearly two decades, UNOS has concealed serious problems [at] the nation's organ procurement organizations, known as OPOs, instead of working to uncover and correct the corruption. This human tragedy is even more horrific because many of these deaths were preventable. They were the result of [a] corrupt, unaccountable monopoly that operates more like a cartel than a public servant. 44:45 LaQuayia Goldring: As a toddler, at the age of three, I was diagnosed with a rare kidney cancer that took the function of my left kidney. And when I was 17, I went back into complete renal failure and I received a first kidney transplant at that time. Unfortunately, in 2015, I went back into kidney failure. And at that time, I wasn't ready for another transplant, but I didn't have a choice but to go back on dialysis. I've been waiting nine agonizing years for a transplant, dependent upon a dialysis machine five days a week, just to be able to live. I was told that I would receive a kidney transplant within three to five years. But yet I am still waiting. I am undergoing monthly surgeries just to be able to get my dialysis access to work so that I can continue to live until I get a transplant. The UNOS waitlist is not like one to 100, where everybody thinks you get a number. I'm never notified on where I stand on the list or when I will get the call. I have to depend on an algorithm to make the decision of what my fate will be. 47:55 LaQuayia Goldring: Just a few weeks ago, a donor family reached out to me to be a directed kidney donor, meaning they chose me specifically for a kidney transplant. But unfortunately, due to the errors in the UNOS technology, I was listed as inactive and this was a clerical error. And all that they told me was this was a clerical error, and they could not figure out why I was inactive. But when it came down to it, I'm actually active on the transplant list. 51:45 Molly McCarthy: The Federal monopoly contractor managing the organ donation system, UNOS, is an unmitigated failure. And its leadership spends more time attacking critics than it does taking steps to fix the system. I've seen this firsthand in my five years as a patient volunteer with the OPTN and three years ago, I stepped into the role of Vice Chair of the Patient Affairs Committee, or PAC. 53:45 Molly McCarthy: Further, I have been called by a board member telling me to stop focusing on system outage and downtime of the UNOS tech system. He told me that having downtime wasn't a big deal at all, "the donors are dead anyway." That comment speaks volumes to me about the lack of empathy and respect UNOS has for donor families. 55:00 Molly McCarthy: Congress needs to break up the UNOS monopoly by passing 1668, ensuring that HHS uses its authority to replace UNOS as its contractor. 1:00:15 Matt Wadsworth: Break up the OPTN contract and allow for competition. 1:00:40 Matt Wadsworth: I commend this committee for introducing legislation to finally break up this monopoly and I stand ready to work with you in any way possible to ensure that this bill passes. It's the only way this industry will be able to save more patients' lives. 1:02:10 Dr. Raymond Lynch: I want to differentiate between organ donation, which is the altruistic decision of the donor patient and their family, and organ procurement, which is the clinical care provided by OPO staff. This is what turns the gift of donation into the usable organs for transplant. Organ procurement is a clinical specialty. It's the last medical care that many patients will ever receive. It's reimbursed by the federal government and it's administered by OPOs that are each the only provider in the territory to which they hold federal contracts. Right now patient care delivered by OPOs is some of the least visible in American healthcare. I can't tell you how many patients were evaluated by OPO workers in the US in 2022. I can't tell you how many patients were examined, or how many families were given information about donation, or how many times an OPO worker even showed up to a hospital to do this clinical duty. This lack of information about what OPO providers actually do for patients is a root cause of the variability in rates of organ procurement around the country. My research has shown that what we call OPO performance is a measurable restriction on the supply of organs that results in the unnecessary deaths of patients with organ failure. For example, if the lowest performing OPOs from around the country had just reached the national median over a recent seven year period, there would have been 4957 more organ donors, yielding an estimated 11,707 additional organs for transplant. Because many OPOs operate in a low quality data environment and without appropriate oversight, almost 5,000 patients did not get adequate organ procurement care, and nearly 12,000 other patients did not receive life saving transplants. 1:03:55 Dr. Raymond Lynch: OPO clinical work is currently not visible, it's not benchmarkable, and it's not able to be adequately evaluated, analyzed, or compared. However, much of the hidden data about how OPOs provide care to patients is known to one entity and that entity is UNOS. 1:05:20 Dr. Raymond Lynch: We need a new network of highly skilled specialist organizations, each attending to areas of expertise in the management of the OPTN contract. 1:21:15 Sen. Marsha Blackburn (R-TN): When we look at OPTN, and look at the Securing Organ Procurement Act, the bill would strip the nonprofit requirement for the manager of the Organ Procurement and Transplantation Network, which would open the door for profiting from organ procurement and donation. And to me, this is something that I think many people really fear, especially people that are on a waitlist. And so what I would like for you to do is to address that and address those concerns. And why or why not you think the Act has it right. Dr. Raymond Lynch: Thank you, Senator. I think it's unfortunate that people would be afraid of that and it needs to be changed. Many of the patients that you referenced are waitlisted at for-profit hospitals. For-profit is a part of American healthcare. And I can tell you that our not-for-profit entity doesn't work. And there are for-profit hospitals and for-profit transplant centers that do work. So patients don't need to be afraid of that. They do need to be afraid of the status quo. 1:28:30 Sen. Ben Cardin (D-MD): Ms. Cryer, do you have any views as to why it's much lower percentage chances for a racial minority to be able to have a transplant? Donna Cryer: Yes. And it really does come down to UNOS not doing its job of overseeing the organ procurement organizations. We know from many studies that black and brown communities donate organs in the same percentage they are the population. So it is not a problem of willingness to donate. It is a problem, as Miss Goldring was starting to discuss, about UNOS not ensuring that OPOs go out into the communities, develop relationships far before that horrible decision is needed to [be] made to donate the organs of a family member. 1:56:45 Sen. Elizabeth Warren (D-MA): And among the many reforms the legislation would support HRSA's proposal to break up the OPTN monopoly contract into multiple smaller contracts, which would allow some competition and allow the best vendors in the business to manage different parts of the transplant network operation. That means hiring IT experts to do the IT. It means hiring logistics experts to do logistics, and so on. 1:57:15 Sen. Elizabeth Warren (D-MA): UNOS does not want to lose control, so they're pushing to have the government limit eligibility only to nonprofit vendors that have worked in the past on organ donation, meaning, for instance, that the IT company that is hired to run OPTNs computers systems would have had to have worked on an organ transplant network in the past and be a nonprofit. So Ms. McCarthy, the requirement UNOS wants would seem to make it so that only one organization could apply for the new contract: UNOS. 1:58:35 Sen. Elizabeth Warren (D-MA): Right now, Congress has an opportunity to root out corruption in this system, but if we don't act before the current contract expires we won't have another shot for years. A System in Need of Repair: Addressing Organizational Failures of the U.S.'s Organ Procurement and Transplantation Network August 3, 2022 Senate Committee on Finance Watch on C-SPAN Witnesses: Brian Shepard, CEO, United Network for Organ Sharing (UNOS) Diane Brockmeier, RN, President and CEO, Mid-America Transplant Barry Friedman, RN, Executive Director, AdventHealth Transplant Institute Calvin Henry, Region 3 Patient Affairs Committee Representative, Organ Procurement and Transplantation Network (OPTN) Jayme Locke, M.D., MPH, Director, Division of Transplantation, Heersink School of Medicine, University of Alabama at Birmingham Clips 36:15 Sen. Ron Wyden (D-OR): 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 overseas is made up of nearly 400 members, including 252 transplant centers, and 57 regional organizations known as Organ Procurement Organizations, or OPOs. Each OPO is a defined geographic service network. Families sitting in a hospital room thinking about donating a loved one's organs does not have a choice of OPOs. 37:40 Sen. Ron Wyden (D-OR): 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 three 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, and 249 transplant recipients developed a disease from transplanted organs. More than a quarter of them died. 38:55 Sen. Ron Wyden (D-OR): 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. 39:20 Sen. Ron Wyden (D-OR): 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 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. 55:05 Diane Brockmeier: We must update the archaic technology system at UNOS. As OPOs, we are required to work with UNOS technology DonorNet every day. DonorNet is outdated, difficult to us,e 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 that are dying on the waitlist. 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 this sequence. However, far too much of the matching, particularly on older donors and organs that are difficult to place, are 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 life saving 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 had been placed and the chance to save a life would have been wasted. 55:20 Diane Brockmeier: 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's looking out for the patient? Who's being held accountable for poor patient care? No OPO has ever actually been decertified, regardless of its performance or its safety record. 57:55 Diane Brockmeier: 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, you must remain silent. 58:05 Diane Brockmeier: 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 actions are not aligned with its fundamental vision of a life saving transplant for everyone in need. How can you fairly represent the country's interest and a contractor's interest at the same time? 58:35 Diane Brockmeier: 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 are initiated. Fellow board members report feeling pressured to vote in accordance with UNOS leadership. 59:10 Diane Brockmeier: 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. 1:00:45 Barry Friedman: Approximately 23% of kidneys procured from deceased donors are not used and discarded, resulting in preventable deaths 1:00:55 Barry Friedman: Organ transportation is a process left to federally designated Organ Procurement Organizations, OPOs. Currently, they develop their own relationships with couriers, 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 life saving organs. 1:01:45 Barry Friedman: Currently there is no requirement for OPOs to use tracking systems. 1:02:20 Barry Friedman: I also believe there's 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 these being essential for the safety and management of organs. 1:02:35 Barry Friedman: 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. 1:03:10 Barry Friedman: 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 policy making [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. 1:11:35 Dr. Jayme Locke: 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 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 safeguard, 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? 1:12:45 Dr. Jayme Locke: In one week, I received four kidneys from four different OPOs, each with basic errors that led to the need to throw away those life saving organs. One due to a botched kidney biopsy into the kidneys collecting system, another because of a lower pole 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 didn't happen. Two others arrived to me blue, meaning they hadn't been flushed either. 1:13:15 Dr. Jayme Locke: 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 don't keep happening. 1:13:40 Dr. Jayme Locke: 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. 1:14:25 Dr. Jayme Locke: 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 public adverse event reporting and immediate redressing of problems. 1:22:00 Sen. Chuck Grassley (R-IA): The system doesn't 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 list to explain the factors that result in the disparity for minorities in rural populations in the process? And how can the federal government address a problem if we have to be involved in addressing it? Dr. Jayme Locke: One of the most important things that we don't currently do is we don't actually account for disease burden in terms of examining our waiting lists. So we have no way of knowing if we're 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 with high rates of end stage kidney disease burden, like the southeastern United States are going to have much lower supply. And 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 where there are 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, and how they approach families to ensure that we're not marginalizing minority families with regard to the organ donation process. 1:30:00 Brian Shepard: The OPTN IT system that UNOS operates has 99.99% uptime. It is a highly reliable system. We are audited annually by HRSA.... Sen. Ben Cardin (D-MD): My information shows it's had 17 days down since I think 1999. That's not correct? Brian Shepard: In 23 years, yes, sir. Sen. Ben Cardin (D-MD): Okay, well, every day there's a loss of life, isn't it? Brian Shepard: That's the total amount of time over the couse of -- Sen. Ben Cardin (D-MD): I hope our national event system isn't down 17 days a year. Brian Shepard: The system has never been down for a day. And to my knowledge, and I have not been at UNOS since 1999, there's been maybe one event that was longer than an hour, and that was three hours. But the total amount of time since 1999 -- Sen. Ben Cardin (D-MD): So you're satisfied with your technology? You think you have the right technology? You're satisfied with your tracking systems now? You think everything is okay? Brian Shepard: We constantly improve our technology. We're subjected to 3 million attempts a day to hack into the patient database and we successfully repelled them all. So we are never satisfied with our technology, but we do maintain 99.99% uptime. We disagree with the USDS analysis of our systems. 1:37:25 Brian Shepard: If you're asking whether UNOS can prevent an OPO from operating or for being an OPO -- Sen. Rob Portman (R-OH: Well not prevent them, but require them to do something .You don't have the ability to require them...? Brian Shepard: The peer review process has significant persuasive authority, but all the payment authority and all the certification and decertification authority live at CMS. 1:39:00 Sen. Rob Portman (R-OH: Do you think there should be tracking of organs in transit? Brian Shepard: I think that's 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. 1:41:55 Sen. Elizabeth Warren (D-MA): Mr. Shepherd, you are the CEO of UNOS. We have documented these problems and you've received more than 1000 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. Brian Shepard: Two times, Senator. 1:43:20 Sen. Elizabeth Warren (D-MA): How many times has UNOS put an OPO on probation? Brian Shepard: I don't know that number off the top of my head, but it's not a large number. Sen. Elizabeth Warren (D-MA): It's not large, in fact it's three. 1:45:20 Brian Shepard: Approximately 10% of the budget of this contract is taxpayer funded. The rest of that is paid by hospitals when they list patients. 1:49:30 Sen. Todd Young (R-IN): Once an OPO is designated not in good standing, Senator Warren referred to this as toothless. It does seem toothless to me. I'll give you an opportunity, Mr. Shepherd, 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. Brian Shepard: The statute does not give UNOS any authority to offer sanctions like that. The certification, decertification, payment authorities belong entirely to CMS. UNOS's statute doesn't give us the ability -- Sen. Todd Young (R-IN): So it is toothless in that sense. Brian Shepard: It is designed to be, by regulation and contract, a quality improvement process, in contrast to the oversight process operated by a federal agency. 1:51:15 Sen. Todd Young (R-IN): To what extent is UNOS currently tracking the status of all the organs in transit at any given time? Brian 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 of the OPOs use ours and some use other commercially available products. Sen. Todd Young (R-IN): So why is it, and how does UNOS plan to optimize organ delivery if you don't have 100% visibility into where they are at any given time? Brian 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 that GPS trackers are valuable and I think that's why you've seen more and more OPOs use them. 1:52:50 Sen. Ron Wyden (D-OR): Mr. Shepherd 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 has got what's really going on with respect to decertifying OPOs. 2:00:15 Dr. Jayme Locke: Obviously people have described that we have about a 25% kidney discard, so one in four. So if you look at numbers last year, these are rough numbers, but that'd be about 8000 kidneys. And really, I think, in some ways, these are kind of a victim of an entrenched and cumbersome allocation algorithms that are very ordinal, you 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. 2:00:50 Dr. Jayme Locke: 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, Alabama, 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 two hours, they'll instead put on a flight from SFO to Atlanta and allow it to go to cargo hold overnight, where it literally is rotting, if you will, and we're putting extra time on it. Sen. Ron Wyden (D-OR): Just to make sure everybody gets this. You're saying you've seen instances of something being put in cargo hold when it is very likely to rot? Dr. Jayme Locke: That is correct. So if the kidney arrives after 10pm at the Atlanta airport, it goes to cargo hold. We discovered that and made calls to the airlines ourselves and after several calls to 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's drivable to Birmingham. And those hours make a difference. Sen. Ron Wyden (D-OR): That sounds way too logical for what UNOS has been up to. 2:03:05 Sen. Ron Wyden (D-OR): Miss Brockmeier, UNOS has developed this organ tracking system. Do you all use it? I'm curious what you think of it. Diane Brockmeier: 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. Sen. Ron Wyden (D-OR): And why was that? Diane 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 of where the organ was. Sen. Ron Wyden (D-OR): Was the tracking technology low quality? Diane Brockmeier: Yes, sir. 2:11:25 Sen. Ron Wyden (D-OR): 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's a serious conflict of interest here and I'll send this to Ms. Brockmeier, and perhaps you'd 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, the multimillion dollar nonprofit, are the same people who look out for the interests of the entire organ transplant network. Sure sounds like a conflict to me. 2:12:55 Diane Brockmeier: I think there should be an independent board. I think the division of the responsibilities of the board and by the inherent way that they're structured, do pose conflicts. It would be like if you had an organization that was a supporting organization, you'd want to hold it accountable for its performance. And the current structure really limits that opportunity. 2:19:50 Dr. Jayme Locke: 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 that allows us to better match kidneys so that when someone comes up on the match run, we have a high probability that there'll be a good tissue match. Well, that took forever and we couldn't really get our unacceptable antigens in, so routinely people get offered kidneys that aren't going to be a match, and you have to get through 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. 2:23:10 Sen. Ron Wyden (D-OR): Mr. Shepherd told Senator Warren that only 10% 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're talking about inefficiency, inefficiency that puts patients at risk. And certainly, taxpayer dollars are used to cover some of these practices. The Urgent Need to Reform the Organ Transplantation System to Secure More Organs for Waiting, Ailing, and Dying Patients May 4, 2021 House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy Watch on YouTube Witnesses: Tonya Ingram, Patient Waiting for a Transplant Dr. Dara Kass, Living Donor and Mother of Transplant Recipient LaQuayia Goldring, Patient Waiting for a Transplant Steve Miller, CEO, Association for Organ Procurement Organizations Joe Ferreira, President, Association for Organ Procurement Organizations Matt Wadsworth, President and CEO, Life Connection of Ohio Dr. Seth Karp, Director, Vanderbilt Transplant Center Donna Cryer, President and CEO, Global Liver Institute Watch on C-SPAN Clips 5:15 Tonya Ingram: The Organ Procurement Organization that serves Los Angeles, where I live, is failing according to the federal government. In fact, it's one of the worst in the country. One analysis showed it only recovered 31% of potential organ donors. Audits in previous years found that LA's OPO has misspent taxpayer dollars on retreats to five star hotels and Rose Bowl tickets. The CEO makes more than $900,000. Even still, the LA OPO has not lost its government contract and it has five more years to go. 30:00 Rep. Raja Krishnamoorthi (D-IL): Unusual among Medicare programs, their costs are 100% reimbursed, even costs unrelated to care. So, extravagant executive compensation and luxury perks may be passed off onto the taxpayer. 46:55 Dr. Seth Karp: We have 10 hours to get a liver from the donor to the recipient, and about one hour to sew it in. For heart, we have about six hours. Time matters. 47:55 Dr. Seth Karp: Last year, I had the opportunity to co-write a viewpoint in one of the journals of the American Medical Association with TJ Patel, former Chief Data Scientist of the United States. In that article, we provided evidence that the metrics used to judge the performance of organ procurement organizations are basically useless. Until the recent OPO Final Rule, performance was self-reported, and OPO employees admitted to having gamed the system. When threatened with decertification, one of the OPOs themselves successfully argued that because the performance data were self reported and unaudited, they failed to meet a reasonable standard and the OPO should not be held accountable. In other words for decades, the metrics supposed to measure performance didn't measure performance, and the results have been disastrous, as you have heard. 49:45 Dr. Seth Karp: Whenever I, and quite frankly most everyone else in the field, gives a talk on transplantation, we usually make two points. The first is that organ transplantation is a miracle of modern medicine. The second is the tragedy that there are not enough organs for everyone who needs one. I no longer use the second point, because I don't believe it. Based on my work, I believe that there are enough organs for patients who require hearts, lungs, and probably livers, and we can make a huge improvement in the number of kidneys available. In addition to improving OPO performance, new technologies already exist to dramatically increase the organ supply. We need a structure to drive rapid improvement in our system. 54:00 Joe Ferreira: One common misconception is that OPOs are solely responsible for the entire donation and transplantation system, when, in fact, OPOs are the intermediary entity and their success is highly dependent on collaborations with hospitals and transplant programs. At the start of the donation process, hospitals are responsible for notifying any OPO in a timely manner when a patient is on a ventilator and meets medical criteria to be an organ donor. Additionally, transplant centers must make the decision whether to accept or decline the organs offered by OPOs. 57:55 Matt Wadsworth: As geographic monopolies, OPOs are not subject to any competitive pressure to provide high service. As the only major program in all of health care 100% reimbursed for all costs, we do not face financial pressures to allocate resources intelligently. 1:02:10 Rep. Raja Krishnamoorthi (D-IL): Mr. Ferreira, I'd like to turn to you. You run the OPO called the Nevada Donor Network. I have your OPO's 2019 financial statement filed with the CMS. It appears that your OPO spent roughly $6 million in 2019 on administrative and general expenses. Interestingly, in 2019, I see your OPO spent approximately $146,000 on travel meetings and seminars alone. And your itemization of Administrative and General has an interesting line item for $576,000 for "ANG". It took me a minute but that means you have an "Administrative and General" subcategory in your "Administrative and General" category. Very vague. Now Mr. Ferreira, I was informed by Mr. Wadsworth, a former executive of yours at the Nevada Donor Network, that your OPO has season tickets to the NHL's Las Vegas Golden Knights, isn't that correct? Joe Ferreira: That is correct, Mr. Chairman. Rep. Raja Krishnamoorthi (D-IL): And you also have season tickets to the Las Vegas Raiders too, right? Joe Ferreira: That is correct. Rep. Raja Krishnamoorthi (D-IL): And according to Mr. Wadsworth and others, your OPO took a board retreat to Napa Valley in 2018. Joe Ferreira: That is correct. Rep. Raja Krishnamoorthi (D-IL): And Sonoma in 2019, right? Joe Ferreira: That is correct. Rep. Raja Krishnamoorthi (D-IL): Mr. Ferreira, what you're spending on the Raiders, the Golden Knights, Napa Valley and Sonoma have one thing in common: they have nothing to do with recovering organs. 1:10:30 Dr. Seth Karp: In 2019, there were six heart transplants that were performed using donors after circulatory determination of death. And I don't want to get into the technical aspects of that. But in 2019, that number was six. In 2020, that number was 126. This is a new technology. This is a way that we can increase the number of heart transplants done in United States dramatically. And if we think that there were 500 patients in the United States waiting for a heart in 2020, 500 patients that either died or were delisted because they were too sick, and you think in one year, using a technology, we got another 100 transplants, if we could get another 500 transplants out of that technology, we could almost eliminate deaths on the on the heart transplant waiting list. That technology exists. It exists today. But we don't have a mechanism for getting it out to everybody that could use it and it's going to run itself through the system, it's going to take too much time. 1:24:05 Rep. Andrew Clyde (R-GA): You know, I'm a little disappointed that we're discussing race as a factor in organ transplant. We're all one race in my opinion; color makes no difference to me. We're the human race. And to me, the interjection of race into this discussion is very concerning. Discrimination based on race was outlawed almost 60 years ago through the Civil Rights Act of 1964. Now, I'm not a medical doctor, and I have very little knowledge of medicine. But last year, there was an article that came out in LifeSource and it says, "Does my race and ethnicity matter in organ donation?" And so my question here is for Dr. Karp. In your experience, would you agree that a donor's organs are more likely to be a clinical match for a recipient of the same ethnicity? Could you comment on that? Is that actually a factor, or not? I mean, we're all human beings, we all, you know, have similar bodies. Dr. Seth Karp: Yes. So there definitely are certain HLA types that are more common. That is race-based. So the answer to that question is yes. Rep. Andrew Clyde (R-GA): Okay. All right. And so if you have more of one particular race, more donations of one particular race, then naturally you would have more actual matches of that particular race. Is that correct? Dr. Seth Karp: That would tend to be the case. Rep. Andrew Clyde (R-GA): Okay. All right. All right. Okay, that's just a question that I wanted to clear up here. 1:34:20 Donna Cryer: We'd like to see investments in languages that are spoken by the community. Educational resources should be, as required by law, for those with limited English proficiency. They should be in the languages spoken by the community. They should be hiring diverse staff to have those most crucial conversations with families. The data shows, and certainly experience and common sense shows as well, that having people of color approaching families of color results in more donations. Executive Producer Recommended Sources Music Tired of Being Lied To by David Ippolito Editing Pro Podcast Solutions Production Assistance Clare Kuntz Balcer