The Costly Effects of an Outdated Organ Donation System

COVID-19 Impact on Organs

COVID-19’s Impact on Organs & the Continued Need for Reform

Executive Summary

COVID-19 has highlighted the urgency of increasing the supply of transplantable organs. Evidence shows that COVID-19 can cause long-term damage to organs like kidneys, lungs, hearts, and livers. Experts warn that kidney disease is “surging” due to the pandemic, and they predict that the next epidemic in the U.S. will be chronic kidney disease from recovered COVID-19 patients. This suggests the demand for kidneys and other organs will greatly increase in the near future, which will only compound the current tragedy we’re facing with 33 Americans dying every day while waiting for an organ transplant.

Each year, federal contractors fail to recover thousands of organs from deceased patients – each of which contributes to the death of someone waiting for an organ. To mitigate those failures, the Centers for Medicare and Medicaid Services (CMS) released a Final Rule in November 2020, which will hold organ procurement organizations (OPOs) accountable to objective, patient-centric standards, and allow CMS – for the first time ever – to replace failing OPOs with higher performers. While some OPOs argued that these reforms should be halted due to the pandemic, research does not support that position. More than anything else, the COVID-19 pandemic exposed OPOs’ variable practices and lack of transparency – while simultaneously generating even more urgency for improved OPO performance, due to COVID-19’s expected effect on kidney demand.

Early data suggest that the COVID-19 pandemic was not a meaningful impediment to donation for OPOs. In fact, many OPOs had record years in 2020 in terms of the number of donors recovered. These record years were in part due to an increased potential donor pool – resulting largely from more “deaths of despair,” such as drug overdoses, as a second-order effect of the pandemic – as well as pressures from the Final Rule and oversight inquiries.

COVID-19 has only made implementing the Final Rule even more urgent – especially for Black, Hispanic, Native American, and Asian American communities who have been hit hardest by both the pandemic and failings in the organ donation system. Addressing such disparities through OPO reforms fits squarely with the Biden-Harris January 20, 2021 Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. This report explores the impact of COVID-19 on organs, and how OPOs and federal contractors have responded. We found:

  • While COVID-19 caused an initial dip in organ donation rates between March and April, overall the pandemic was not a limitation for OPOs with strong leadership; some ended the year with record recovery numbers. Despite the initial dip, 2020 saw an all-time record for deceased donor transplants. OPOs that showed decreases failed because of other underlying leadership factors and should be held accountable.
  • An unnecessarily high number of vulnerable people on dialysis face greater risk to COVID-19 exposure. Patients on dialysis – who are disproportionately people of color – are forced to sit in close proximity for prolonged periods of time. Evidence from patients recovering from COVID-19 suggests the number of people relying on dialysis will continue to increase.
  • Outcome measure changes in CMS’ Final Rule – which help better address the current gaps in data – are as important as ever because OPOs need to be held accountable.

Because of COVID-19’s effect on kidneys and lungs and hearts, organ donation reform is an essential part of COVID-19 action measures.

Introduction

Nearly 33 people die every day because they don’t have access to an organ transplant.1 COVID-19 has further increased the urgency to recover transplantable organs to save lives, as the virus is leaving behind long-term damage to organs, like kidneys, lungs, and hearts in recovered patients – suggesting a potential higher demand for transplantable organs in the near future.2 Given COVID-19’s immediate and lasting impact on organs, organ donation reform should be considered a key part of COVID-19 action measures.

Right now, estimates suggest the organ donation system is operating at “only one-fifth of the true potential,”3 leaving behind thousands of kidneys and other organs. Fortunately, urgently-needed measures to improve the performance of organ procurement organizations (OPOs) – those tasked with procuring, recovering, and matching organs from deceased donors – are underway. CMS released a Final Rule in November 2020,4 which, once implemented, will incentivize OPOs to pursue every potential donor, ensure that only transplanted organs are counted towards outcome measures, and rely on standardized metrics for performance rather than self-reported data.

While some OPOs have argued to halt these reforms due to the pandemic, the fact is that many OPOs had record years in 2020.5 This increase potentially shows the reforms may be already having a positive effect6 7 and that the pandemic, save for a few weeks in March and April, was not an obstruction for OPOs with motivation and strong leadership. Changes and consequences due to COVID-19 have simultaneously contributed to an increase in opioid deaths, which impact the donor potential for OPOs. While full 2020 death numbers are not yet published from the Centers for Disease Control (CDC),8 a JAMA study found that emergency department visits related to opioid overdoses and suicide attempts between March and October 2020 were significantly higher than the same time period in 2019.9 Emergency rooms saw up to a 45% weekly increase in visits related to opioid overdoses compared to the prior year.10 And in the 12 months leading up to June 2020, opioid deaths were the highest ever recorded – 38% higher than the 12 months prior.11 12 More recent data suggests those deaths continued to increase. “We lost 88,000 people in the 12-month period ending in August 2020,” Regina LaBelle, the acting head of the White House Office of National Drug Control Policy, told reporters. “Illicitly manufactured fentanyl and synthetic opioids are the primary drivers of this increase.”13 It logically follows that an increase in opioid deaths and other deaths of despair14 during the pandemic have led to a potential larger donor pool compared to previous years.15 In order to ensure the organ donation system is working to its full potential to recover these organs, we need the metrics within the Final Rule to be applied as soon as possible to accurately assess OPO performance and ensure OPOs are held accountable on behalf of patients.

This report explores the impact of COVID-19 on organs, how OPOs and federal contractors have responded, and why implementing the Final Rule is more critical now than ever.

COVID-19’s Effect on Organs and Communities of Color

While the full range of COVID-19’s impact on bodies are still being studied, doctors are finding evidence of long-term effects on various organs – specifically kidneys, lungs, livers, and hearts. According to a trauma surgeon, coronavirus survivors’ lungs look worse than smokers’ lungs.16 Other clinicians report evidence of heart inflammation, liver problems, and acute kidney disease.17 Many patients recover from the coronavirus, but the organ damage requires post-discharge care.18

Most notably for the organ donation system, experts warn that kidney disease is “surging” due to COVID-19.19 As CNBC reports, “Severe coronavirus patients are often as much in need of dialysis machines as they are ventilators. Many of the ones who recover from COVID-19 have some form of residual kidney damage that can last for months, years or even permanently.”20 Almost half the people hospitalized due to COVID-19 are showing signs of early damage to their kidneys, according to specialists,21 suggesting the U.S. is likely to face a greater need for kidney transplants in the future. As one nephrologist, Dr. Steven Coca, told CNBC, “Since the start of the coronavirus pandemic we have seen the highest rate of kidney failure in our lifetimes…The next epidemic will be chronic kidney disease in the U.S. among those who recovered from the coronavirus.”22 The American Society of Nephrology COVID-19 Response Team reports many patients who had no underlying kidney issues prior to getting severe COVID-19, were experiencing kidney failure that required dialysis.23 In February 2021, Reps. Katie Porter, Karen Bass, and Raja Krishnamoorthi wrote to the Biden-Harris Administration, “We must move urgently to implement OPO reforms today to serve COVID-19 surivors tomorrow,”24 which echoes similar sentiments from dozens of leading doctors and COVID-19 researchers in a December 2020 letter to then-HHS Secretary Nominee Xavier Becerra.25

Kidneys are the most in-demand organ – making up more than 80% of the waitlist.26 On average, an estimated 22 people die a day or become too sick to get a transplant while waiting for a kidney,27 a figure that does not even include the roughly 450,000 patients on dialysis nationally who may benefit from a transplant but never reach the waiting list.28 Without access to a transplant, most patients rely on painful and time-consuming dialysis treatments, which cost the U.S. about $36 billion annually to Medicare alone, not even including dialysis costs borne by Medicaid and Veteran Affairs.29 As Dr. Coca explains to CNBC, “[Kidney failure and dialysis] is a long-term health burden for patients, the medical community – and the U.S. economy.”30 Inefficiencies and severe underperformance in the organ donation system greatly contribute to this large cost.31 According to one study, the country could save as much as $40 billion over 10 years through reducing the need for dialysis – as well as tens of thousands of lives – through OPO reform.32

Congresswoman Karen Bass, then-Chair of the Congressional Black Caucus, has written about how COVID-19 increases the importance of implementing reforms to the organ donation system: “Now, in the age of COVID, given the imminent danger facing patients on dialysis, the health care workers who serve them, and the broader communities that house them, this [organ donation reform] work is even more urgent than when it first began.”33

COVID-19 exacerbates the burden of dialysis – and thus the failures of the organ donation system – since patients are forced to sit in enclosed places with other patients for multiple hours, often 3-4 times per week. As of January 20, 2021 there have been 84,757 dialysis patients who have gotten COVID.34 Of these COVID patients with end-stage renal disease (ESRD), 49% end up being hospitalized.35 “Going to dialysis centers is almost certainly an increased risk, no matter how careful you are,” said one transplant surgeon we spoke with. Patients with end-stage kidney disease often have co-morbidities like diabetes and chronic lung disease, which make them the most vulnerable to the effects of COVID-19. Yet, if patients are not able to get a kidney transplant and need dialysis to stay alive, self-quarantining at home is nearly impossible.

Communities of color are bombarded by disproportionate impacts of COVID-19, organ donation failures, and the burdens of dialysis. Black, Hispanic Americans, and Native Americans are approximately 3 times more likely to die from COVID-19 than white people, and approximately 4 times more likely to be hospitalized.36 Asian Americans are also slightly more likely to die and be hospitalized from COVID-19.37 A study in Michigan reported that Black people represent 15% of the state population, yet accounted for 42% of COVID-19-related deaths, while white people represent 75% of the state population and only 26% of COVID-19 deaths.38 As Dr. Pratima Sharma notes, “These results highlight the racial inequities that have overwhelmed the United States healthcare system during this pandemic.”39 Similarly, both the Senate Finance Committee and the House Committee on Oversight and Reform have highlighted the equity implications of the OPO Final Rule. The House Committee on Oversight and Reform wrote, “The burden of OPO failures is disproportionately borne by patients of color, making OPO reform an urgent health care equity issue.”40

Blacks and Hispanics are also much more likely to have end-stage renal disease and need a new kidney41 – and yet they are less likely than white patients to receive the life-saving organ they need.42 Black people make up 35% of all dialysis patients, even though they make up only 13% of the general population.43 They also “face disparities in nearly every step of transplant care,” according to the American Society of Nephrology.44 “Black Americans are less likely than White Americans to be identified as a transplant candidate, referred for evaluation, put on the kidney transplant waitlist, receive a kidney transplant, receive a higher-quality kidney from a living donor, while also being more likely to receive lower quality kidneys and have poorer transplant graft survival.”45 Only about 35% of all recovered organs come from non-white patients, even though people of color make up 60% of the waitlist.46 The smaller pool of available organs contributes to longer wait times for patients of color, since the most likely match for an organ recipient is from someone within the same ethnicity.47

As laid out in Bloom’s “Inequity in Organ Donation” report,48 these disparities are driven by a long history of discrimination, social inequities, and bias within institutions. In some cases, OPOs simply don’t show up for patients of color, due to a misconception that they won’t become donors. In a 1999 study, white families were nearly twice as likely as Black families to have been approached by an OPO and thus given the option to donate their loved ones’ organs.49 This not only blocks many Black families from the potentially healing opportunity of organ donation, but it also shrinks the pool of available organs for other Black patients.50 In another study, a surgeon identified several barriers that were preventing some Black patients from becoming donors: an unawareness of the need within their own community and a deep distrust of healthcare workers, stemming from incidents like the 1932 Tuskegee Syphilis Experiment.51 Once the surgeon addressed those barriers, however, all participants of color in the study signed on to become organ donors, suggesting that the historically-lower donation rates in communities of color are largely a function of OPO failures to properly address the needs of those populations.52 Similarly, studies show that donation rates are higher when the OPO staff discussing donation reflects the ethnicity and language of the people with whom they are speaking,53 54 and yet OPO staff remains overwhelmingly white and English-only speakers.

Given the disparities of COVID-19 and the lack of organs available – especially to people of color – these inequities will be perpetuated unless urgent organ donation reforms are made. As Dr. Marcella Nunez-Smith, the Chair of the White House COVID-19 Equity Task Force, said: “We know that these racial ethnic disparities in COVID-19 are the result of pre-pandemic realities. It’s a legacy of structural discrimination that has limited access to health and wealth for people of color.”55 Recent case studies suggest that individual OPOs have the power to rapidly improve performance – and thus be deemed passing within the outcome measures of the Final Rule – by simply better serving communities of color. For example, in 2019, the OPO that serves San Francisco hired a new CEO and increased donation rates by 29%. Most of those gains came from communities of color, which the CEO suggests were, largely, due to the OPO adopting a more inclusive approach.56 57

COVID-19’s Effect on Donation Rates and OPO Performance

OPOs reported that while there was an initial dip in donation rates in March and April of 2020, donations bounced back up between May and October – in many cases higher than in previous years.58 By June, national kidney donation rates had already recovered to 107% of pre-COVID-19 levels.59 Even with the dip in March and April, 2020 organ donation rates overall were up 6 percent compared to 2019.60

We found that the United Network for Organ Sharing (UNOS), the federal contractor for the Organ Procurement and Transplantation Network (OPTN) tasked with overseeing OPOs and optimizing the transplantation network, did little to facilitate national coordination61 or provide much-needed guidance or mandates.62 “UNOS in no way took any kind of leadership on [COVID-19 protocols],” said one OPO leader. Some leaders we spoke with resorted to text threads with other OPO executives. One hired an HR lawyer, while others relied on information from local health teams and the American Society of Transplant Surgeons (ASTS). “What we’ve received from the OPTN has been very limited…No great guidance from UNOS or OPTN. It was kind of each man for himself.”63

In many ways, the pandemic laid bare and exacerbated the variability of OPO performances. Left to figure things out on their own, OPOs that were stronger staffed fared better and adapted faster than other OPOs. Some OPOs adapted more quickly to social distancing recommendations and re-training staff on how to approach potential donor families on the phone, which OPOs already do for tissue donation cases. One OPO leader we spoke to had a data analyst on staff who collected prospective data on donor referral trends and foretold early on that the OPO would need to rely more heavily on phone approaches as COVID-19 increased.64 This OPO had their first phone approach training on March 20, 2020, just a week after closing their office due to COVID-19. Other OPOs moved more slowly, taking longer to reallocate resources to adapt to the changes. The challenge of responding to COVID exposure was exacerbated if the OPO was already understaffed – which Congressional oversight investigations suggest is a chronic problem65 – since clusters of staff would have to be quarantined at a time. “If you’re not staffing for what your potential is, you’re constantly chasing it,” explained one OPO leader.

Across the board, OPOs had varying levels of preparedness for dealing with emergencies and rapid changes.66 One OPO leader we spoke with described that one of the biggest challenges was keeping staff feeling safe in the first few weeks after the pandemic started: “It was more about psychological reassurance than technical changes.” OPOs with strong donor hospital and transplant center relationships pre-coronavirus had an easier experience getting their staff into hospitals to do donor management, had more access to COVID-19 testing for donors, and had quicker access to personal protective equipment (PPE) and vaccinations for staff.

While all OPOs had to adjust to new circumstances around the pandemic, COVID-19 was not much of an impediment for OPOs with strong leadership.67 In fact, 37 of the 58 OPOs had record years for organ recovery in 2020, and 41 OPOs did the same or better in 2020 compared to 2019.68 While organs from COVID-19 positive patients were ineligible for donation, a likely increase in the donor pool of other viable patients more than made up for the difference. OPOs we spoke with mentioned that while they saw a lower number of trauma cases, presumably due to more people staying home, they also saw donation increases from suicides and patients who went to the hospital “too late.”69 “[People] were afraid to go to hospitals, so when they showed up with stroke symptoms and heart attacks, they were in extremely bad shape,” shared one OPO executive. “They were eventually either pronounced brain dead, or were withdrawn from ventilators and became donors by the DCD [Donation after Cardiac Death] pathway…The gap that trauma left got filled by these deaths of despair, or deaths related to being afraid to come to the hospital.”

Tragically, COVID-19 contributed to the highest number of opioid deaths ever recorded in a year,70 which potentially increased the size of the donor pool and contributed to the OPO industry’s increase in terms of the absolute number of donors recovered. But it is far from the first time public health trends have influenced OPO outputs, often creating the false perception that OPOs improved year-over-year when, in reality, the donor pool grew for reasons outside of OPO influence. As two leading researchers told us, “when it comes to OPOs, policymakers need to understand that an increase in donors is not the same as an improvement in performance.” For example, drug deaths, scientific advances, and even simple population growth have been contributing to OPO gains over the last several years. As peer-reviewed research has found, “the increased number of donors is almost wholly attributable to the drug epidemic, and reflects the byproduct of a national tragedy, rather than an improved system to be celebrated.”71 Another researcher we spoke with noted that, “UNOS has falsely taken credit for donation increases in the last 8 years.”

Technological and medical advancements also account for increases in organ recovery that is separate from OPO performance. Now that medical advancements allow hepatitis C (HCV, or hep C) to be cured with direct-acting antivirals, more transplant centers are accepting and transplanting HCV-positive organs in HCV-negative recipients.72 73 Additionally, the HOPE Act allows patients on the waitlist who have HIV to receive organs from HIV positive donors.74 Perfusion technologies, which increase the time that organs can remain viable outside of a body, and which, are owned and operated by transplant centers rather than OPOs in most cases75 – have also increased the pool of donors.76 77

Detailed map of organ donation increase over time

Download the “Organ Donation Increase Map” PDF

A closer look at the data suggests that OPOs are not even keeping pace with population growth after controlling for scientific advances, transplant center behavior, and opioid deaths.78 In some cases, OPOs are actually having worse performance in other types of donations, such as older donors, even while their overall donor numbers go up.79 “OPOs are the bottleneck in the process,” explained one researcher, while acknowledging that there needs to be a continuum of improvements along the process; “the OPO is the one absolute rate limit[ing] point.” As an OPO leader described, there are a finite number of organ procurement coordinators at each OPO, so if donor referrals dramatically increase because of drug-related deaths and the OPO has not staffed for the potential, coordinators cannot keep up and will only go after donation cases that are “easier” to place. “If an OPO is maximizing donor potential, they’re converting older and DCD donors at a higher rate, and not just relying on drug-related deaths to keep going,” said another researcher.

Historically, OPOs self-reporting data has led to the ability to obscure whether certain donors died from drug-related reasons or other clinical reasons. “There’s no national guidance [saying] ‘hey, OPOs, document all your deaths this way.’ There’s no flow map, so we’re all doing it differently,” said one OPO executive.80 When data related to drug-related deaths are fractured into multiple categories (like asphyxiation, cardiovascular collapse, natural causes, and others), it makes it harder to have a comprehensive view into its effect on donor potential, and thus accurately assess OPO performance.81 Such data inconsistencies, largely resulting from lack of standardization in OPO process and reporting, can make it difficult to map patterns related to public health crises, like COVID-19 and the opioid epidemic. Fortunately, the new OPO rule, finalized by CMS in November 2020 – which was recently supported in a bicameral, bipartisan letter from leaders of the Senate Finance Committee and the House Committee on Oversight and Reform82 – will standardize donor potential based on objective CDC data. This new rule that was recently finalized by the Biden-Harris Administration will replace the historical practice of OPOs self-reporting their data, although under the current implementation timeline, failing OPOs won’t be impacted until 2026.

Alarmingly, the government contractor tasked with providing statistical analysis related to organ donation and transplantation, the Scientific Registry of Transplant Recipients (SRTR), noted that because of COVID-19 it “will be modifying the evaluation metrics for transplant programs and OPOs” to “remove any patient and donor data from the performance metrics.” This means that, from March 12, 2020 onward, SRTR will not evaluate OPOs on key performance metrics such as how many referrals the OPO converts into donors or how many organs are recovered from potential donors.83 These performance metrics include waitlist survival, transplant rate, eligible death conversion rates, and deceased donor organ yield. As one transplant surgeon told us, “it opens the door to the worst kind of abuses of incomplete data…There’s going to be 18 to 24 months where we are going to allow OPOs to say how good they are and try to deflect from pressures to reform and be more transparent, while at the same time sharing even less data than they have in the past.”

Even more problematically, the current CMS metrics used to evaluate OPOs rely on these very calculations that SRTR has stopped making. As context, on March 17th, 2020, the Association of OPOs (AOPO) wrote to Vice President Pence requesting waivers from evaluation metrics during COVID, and, separately, wrote to HHS Secretary Azar Azar on June 6, 2020 reiterating the request. Neither time was such a request granted by HHS, CMS, or any other entity. Despite this, SRTR unilaterally decided to stop performing the calculations HHS relies on for enforcement of OPO metrics. Effectively, SRTR, without authority, overruled the Administration and granted waivers for OPOs stripping patients and taxpayers of any OPO accountability (see previous report on Oversight Gaps and Conflicts for further context on the problematic relationships with OPO and SRTR executives).

Given that CMS now will not have the data models available to enforce the current outcome measures in the 2022 cycle, HHS should explore how to use the metrics newly finalized in November 2020 as quickly as possible, which rely on objective, government-held data models outside of SRTR influence, and to decertify those OPOs whose glaring inefficiencies and mismanagement were laid bare by the pandemic.

SRTR is supposed to provide data-driven policy research regarding OPO performance to advise HHS. However, as we outline in our Oversight Gaps & Conflicts report,84 we have heard from stakeholders that SRTR leaders are allowed to work with individual OPOs as consultants, which creates a concerning conflict of interest if SRTR executives are viewing OPOs as potential clients. Additionally, abandoning metrics data measurements can have a very dangerous effect of halting deeper understanding and future improvements. As, one researcher shared: “The rejection of epidemiology to understand organ donation has tremendously negative effects…the willful ignorance about using bigger, more scientifically valid tools is perpetuated by SRTR. They [the organ donation community] see epidemiology as a threat. That’s really troubling.”

How the Final Rule and Oversight Efforts Affect OPO Performance

The Final Rule aims to address critical data gaps in the current organ donation system by switching from self-reported OPO data to using objective death certificate data – which HHS has characterized as “more reliable and verifiable” data source. This is a position supported in the Journal of the American Medical Association by the former U.S. Chief Data Scientist under President Obama.85 The Final Rule also implements quality measure thresholds that incentivize OPOs to pursue all eligible donors, even those who are older or only have one organ to donate.

More forward-looking OPOs have embraced the Final Rule. As two OPO CEOs, including a recent past president of the Association of OPOs, shared in an op-ed, “we applaud these measures as long overdue…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…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.”86 These high performing OPOs have successfully navigated the intermittent challenges that COVID-19 has brought, while also maximizing the increase in organ donors in 2020.

Early data suggest that organ recovery increases in 2020 could also reflect a response to pressures from CMS’ proposed reform metrics, released in December of 2019.87 88 89 OPOs we spoke with mentioned targeted efforts in 2020 to pursue organs from more older, single organ donors, and donors after cardiac death (DCD). One OPO noted a stronger focus on educating hospitals on how to transition patients who die via cardiac death in a way that keeps their organs viable until recovery is possible.

Along these lines, we heard of OPOs making more effort in 2020 to show up on site for every referral – regardless of their donor potential – to help cultivate hospital relationships and incentivize hospitals to refer more patients from the outset. As Bloom noted in our Oversight Report,90 we’ve seen evidence that more scrutiny on OPOs can lead to quick turnarounds in performance improvements, which has already been documented in peer-reviewed data analysis. For example, when Senators Chuck Grassley (R-IA) and Todd Young (R-IN) questioned the financial practices of an OPO in Indiana, the OPO hired external consultants to improve performance. Within 6 months, the OPO increased donation rates by 44%, suggesting previous massive underperformance.91

Other OPO leaders, however, were seemingly more concerned with delaying and halting the proposed government reforms to the organ donation system. Various OPOs spent more than $450,000 in lobbying expenses in the first half of 2020 to deter CMS’ efforts to implement reform – a tactic that is now a subject of Congressional investigation from the House Committee on Oversight and Reform.92 In September 2020, when many OPOs were already seeing a higher rate of donors than previous years, some OPOs were discussing how to continue lobbying efforts to block the proposed changes.93 The Project on Government Oversight (POGO) obtained a recording of a roundtable conversation at a UNOS conference in which one OPO official says, “we were fortunate…If there is a silver lining to the COVID-19 cloud…[it’s that] HHS and CMS have certainly been distracted to [sic] a bigger issue [by the pandemic].”94

AOPO also worked to lobby against OPO regulation and ask for government funds due to COVID-19, even after kidney donation rates had bounced back up to 107% of their pre-COVID-19 levels.95 96 As one transplant surgeon mentioned, “OPOs have both begged for relief and taken PPP [Paycheck Protection Program] money, and at the same time, they’ve crowed on social media about their incredible successes. It’s unconscionable.” Additionally, AOPO recently changed its nonprofit status from 501(c)(3), where spending money on lobbying and electioneering are prohibited, to 501(c)(6), which enables freer spending.97 OPOs seem to show a pattern of exploiting public health crises for their own lobbying purposes: when the opioid epidemic emerged, OPOs used the increases in donation to deflect criticism of their performance. And now, many OPOs are using the pandemic as a means to derail much-needed oversight and reform.

By lobbying to halt or delay forms, OPOs are asking the government to sit back while thousands more people – disproportionately patients of color – die while waiting for an organ. As Ben Jealous, the former president and CEO of the NAACP wrote, “Congress and federal regulators cannot let up on reforms that are so close to helping patients, especially with so many dialysis patients living in mortal fear of COVID-19 transmission. We need OPOs to be held truly accountable — for all of us.”98

Implementing the Final Rule as soon as possible to help increase donations and reduce the organ waitlist is the best way to help mitigate the inequity in the current organ donation system. We applaud the work that has been done on this front from bipartisan Congressional leaders on the House Committee on Oversight and Reform (Representatives Carolyn Maloney, James Comer, Raja Krishnamoorthi, Michael Cloud, and Katie Porter), the Kidney Caucus (including Co-Chairs Representatives Suzan DelBene and Larry Buschon), the Diabetes Caucus (including Co-Chairs Representatives Diana DeGette and Tom Reed), the immediate past Chair of the Congressional Black Caucus (Representative Karen Bass), and the Senate Finance Committee (Senators Ron Wyden, Chuck Grassley, Todd Young, Ben Cardin, Michael Bennet, and Elizabeth Warren).

Congressional leaders wrote in support of urgently finalizing and implementing the Final Rule in March 2021 in a bipartisan, bicameral letter that highlighted the COVID-19 and equity implications of OPO reform.99 They also noted the Final Rule’s broad support: “this data-informed rule has the support of every major patient group engaged on this issue, all five former (bipartisan) HHS Chief Technology Officers, and advocacy groups ranging from Families USA to FreedomWorks, as well as leading economists, industry associations, doctors, and researchers, and data scientists including the former Chief Data Scientist of the United States.”

Organ donation reform has been a bipartisan effort that started under the Obama Administration and has continued through the Trump administration. Jeff Zients – the current COVID-19 Czar – opened the 2016 White House Summit on innovation in organ donation and transplant. And with support across the aisles, the Trump administration carried reform through the early wave of the pandemic, knowing how crucial these reforms are.100 101 The Final Rule is projected to result in more than 7,000 more lives saved every year, disproportionately people of color, while saving $1 billion annually to Medicare. With COVID-19 exacerbating the risks of people on dialysis and the failures of the organ donation system, it is imperative to implement the Final Rule as soon as possible. As OPO leaders stated in support of the proposed reforms, “Patients deserve nothing less.”102

Conclusion

As Congressman Cedric Richmond noted, COVID-19 “has made the health disparities that have long existed in America all the more apparent.”103 Poor and variable OPO performance, especially for patients of color, is clearly an urgent example of this broader problem. The organ donation system has failed to procure kidneys and other organs from people of color at the same rate as white donors, which drastically diminishes the chances of patients of color receiving the life-saving organ they need. This impact is exacerbated by evidence of higher rates of death and hospitalization for people of color due to COVID-19 – and in the higher rates of kidney failure and reliance on dialysis.

As part of its COVID-19 response, we encourage CMS and Congress to implement better oversight of OPTN and OPOs immediately. For patients and the public to be truly confident in the work of these federal contractors, we need better data and standardized performance metrics in the Final Rule to be implemented and published immediately. As the COVID-19 crisis continues, patients with kidney failure – disproportionately patients of color – are risking their lives every time they enter a dialysis building, multiple times a week. With evidence suggesting an increase of patients needing dialysis and more organ transplants in the future due to COVID-19, it’s more crucial than ever to fix the glaring failures in the current system.

Notes

  1. Many die waiting for organs. The Trump administration could help.Washington Post, 2020. 

  2. How coronavirus attacks organs: Doctors find damage in lungs, kidneys, hearts,” Washington Post, 2020. 

  3. OPTN Deceased Donor Potential Study (DDPS), 2015. 

  4. Final Rule, CMS, November 2020. 

  5. “A total of 12,587 people provided one or more organs to save and enhance the lives of others, representing an increase of six percent over 2019, according to preliminary data from United Network for Organ Sharing (UNOS),” Annual record trend continues for deceased organ donation, deceased donor transplants, PR Newswire, 2021. 

  6. Public discourse and policy change: Absence of harm from increased oversight and transparency in OPO performance, American Journal of Transplantation, 2021. 

  7. Results of a data‐driven performance improvement initiative in organ donation, American Journal of Transplantation, 2020. 

  8. While official data on 2020 deaths will likely not be released until late 2021 or early 2022, preliminary US death statistics show at least 12% more deaths in 2020 than in 2019. Preliminary US death statistics show over 3.1 million total deaths in 2020,” USA Facts, 2020. 

  9. Trends in US Emergency Department Visits for Mental Health, Overdose, and Violence Outcomes Before and During the COVID-19 Pandemic,” JAMA, 2021. 

  10. Ibid. 

  11. CDC reported that the 12 months ending in May 2020 caused a record 81,000 overdose deaths – 38.4% higher than the 12 months prior. CDC Director Robert Redfield, M.D. said, “The disruption to daily life due to the COVID-19 pandemic has hit those with substance use disorder hard.” “Overdose Deaths Accelerating During COVID-19,” CDC, 2020. 

  12. “According to findings from a CDC survey of US adults, 13% of respondents said in late June that they had started or increased substance use to cope with pandemic-related stress or emotions. Groups that were more likely to do so included young adults (nearly a quarter of those aged 18 to 24 years), Hispanic (21.9%) and Black (18.4%) respondents, essential workers (24.7%), and unpaid caregivers for adults (32.9%),” Drug Overdose Deaths Head Toward Record Number in 2020, CDC Warns, JAMA Health Forum, 2020. 

  13. Drug Overdose Deaths Spiked To 88,000 During The Pandemic, White House Says,” NPR, 2021. 

  14. “Mulligan, who was a White House economist in the Trump administration, argued in a recent working paper that increased isolation during the pandemic may have contributed to rising “deaths of despair” — that is, suicides, alcohol-related deaths and especially drug overdoses.” “They Lost Sons To Drug Overdoses: How The Pandemic May Be Fueling Deaths Of Despair,” NPR, 2020. “Widely reported studies modeling the effect of the covid-19 pandemic on suicide rates predicted increases ranging from 1% to 145%.” Trends in suicide during the covid-19 pandemic, BMJ, 2020. 

  15. “Prior to the crisis, a 2017 study estimated that a 1 percent increase in county-level unemployment resulted in a 3 percent increase in drug related deaths. While an employment shock of this magnitude makes it impossible to impose a similar projection, it is hard to imagine any uplifting scenario. Already in March there were reports of increased gun purchases (guns account for the majority of successful suicide attempts) and calls to suicide hot-lines.” Reopening America: How division and vulnerability hamper our response, Brookings, 2020. 

  16. “The scarring on some coronavirus survivors’ lungs is worse than in those who smoke, a trauma surgeon in Texas recently said when speaking to just one of the possible long-term effects this novel disease can have on its victims.” “Coronavirus survivors’ lungs worse than those of a smoker, surgeon says,” Fox News, 2020. 

  17. “Clinicians around the world are seeing evidence that suggests the virus also may be causing heart inflammation, acute kidney disease, neurological malfunction, blood clots, intestinal damage and liver problems.” “How coronavirus attacks organs: Doctors find damage in lungs, kidneys, hearts,” Washington Post, 2020. 

  18. “These results support that those with severe disease need post-discharge care,” the researchers concluded. “Longer follow-up studies in a larger population are necessary to understand the full spectrum of health consequences from COVID-19.” “Coronavirus survivors’ lungs worse than those of a smoker, surgeon says,” Fox News, 2020. 

  19. High odds severe Covid-19 can lead to kidney injury or failure, medical studies reveal,” CNBC, 2020. 

  20. Ibid 

  21. How coronavirus attacks organs: Doctors find damage in lungs, kidneys, hearts,” Washington Post, 2020. 

  22. High odds severe Covid-19 can lead to kidney injury or failure, medical studies reveal,” CNBC, 2020. 

  23. “What we have observed is that approximately 10% to 50% of patients with severe Covid-19 that go into intensive care have kidney failure that requires some form of dialysis.” Ibid 

  24. Katie Porter on Twitter: “Yesterday, @RepKarenBass, @CongressmanRaja, and I wrote to the new administration …Read our letter.”  

  25. Letter from Dara Kass, MD to Secretary-Nominee Xavier Becerra, Dec. 17, 2020. 

  26. Which organs and tissues are most needed?,” Gift of Hope, 2019. 

  27. National Data - OPTN 

  28. According to the U.S. Renal Data Service, as of February 2020 there were 541,932 patients with End Stage Renal Disease (ESRD) receiving dialysis in the United States. According to OPTN data, there are currently 91,343 candidates on the kidney waiting list. The difference between these numbers is 450,589 patients who are on dialysis but not on the wait list. USRDS: Home; National Data - OPTN 

  29. “A Cost-Benefit Analysis of Government Compensation of Kidney Donors,”_ NCBI,_ 2015. 

  30. High odds severe Covid-19 can lead to kidney injury or failure, medical studies reveal,” CNBC, 2020. 

  31. A HRSA estimate suggests organ procurement organizations (OPOs) are recovering “only one-fifth of the true potential.” OPTN Deceased Donor Potential Study (DDPS), 2015. 

  32. Transforming Organ Donation in America:,” The Bridgespan Group, 2020. 

  33. COVID-19 increases importance of implementing reforms to organ donation system,” The Hill, 2020. 

  34. Kidney Community Emergency Response (KCER) Data, https://www.kcercoalition.com/ 

  35. ESRD National Coordinating Committee (NCC), https://esrdncc.org/ 

  36. Hospitalization and Death by Race/Ethnicity, CDC, Nov. 2020. 

  37. Asian Americans are 1.1x more likely to die and 1.2x more likely to be hospitalized. Hospitalization and Death by Race/Ethnicity, CDC, Nov. 2020. 

  38. COVID-19 Outcomes Among Solid Organ Transplant Recipients: A Case-control Study,” Transplantation, 2021. 

  39. Are Organ Transplant Recipients at Greater Risk of Death from COVID-19?,” Michigan Health Lab, 2020. 

  40. Oversight Subcommittee Launches Investigation into Poor Performance, Waste, and Mismanagement in Organ Transplant Industry, House Committee on Oversight and Reform, 2020. 

  41. Chronic Kidney Disease in the United States,” CDC, 2019. 

  42. Inequity in Organ Donation · The Costly Effects of an Outdated Organ Donation System,” Bloom Works, 2020. 

  43. “African Americans and Kidney Disease,” Kidney.org. 

  44. September 25, 2020 The Honorable Richard Neal Chair Committee on Ways and Means US House of Representatives 1102 Longworth House 

  45. Ibid. 

  46. “Organ Donation and African Americans,” Minority Health, HHS, 2020. 

  47. Does My Race & Ethnicity Matter in Organ Donation?,” Life-Source.org 

  48. Inequity in Organ Donation · The Costly Effects of an Outdated Organ Donation System 

  49. The influence of race on approaching families for organ donation and their decision to donate., Am J Public Health, 1999. 

  50. Does My Race & Ethnicity Matter in Organ Donation?,” Life-Source.org 

  51. “How a surgeon helped solve the problem of far too few black organ donors,” Center for Health Journalism, 2018. 

  52. At the beginning of the study, only 2 out of the 40 participants said they would be willing to sign an organ donation card. “How a surgeon helped solve the problem of far too few black organ donors,” Center for Health Journalism, 2018. 

  53. The impact of race on organ donation authorization discussed in the context of liver transplantation,” Transactions of the American Clinical and Climatological Association, 2012. 

  54. “Variables such as race and sex of OPO representative and time of day should be considered before approaching a family for organ donation. Avoiding translators during the approach process may improve donation rates.” From “Improving organ donation rates by modifying the family approach process,” The Journal of Trauma and Acute Care Surgery, 2014. 

  55. Dr. Marcella Nunez-Smith: Racial discrimination could be the key reason for high mortality rates of COVID-19 among African Americans,Yahoo! News, 2020. 

  56. Inequity in Organ Donation · The Costly Effects of an Outdated Organ Donation System,” Bloom Works, 2020. 

  57. Data available via OPTN

  58. “Organ transplants from deceased donors, totaling 33,309 in 2020, also set another annual record for the eighth consecutive year. This occurred despite significant effects from the COVID-19 pandemic, where deceased-donor transplantation briefly fell by approximately 50 percent in early April before returning to a more consistent baseline in late May.” “Annual record trend continues for deceased organ donation, deceased donor transplants,” Cision PR Newswire, 2021. 

  59. COVID-19 Assessment, KidneyRegistry.org, 2020. 

  60. National Data - OPTN 

  61. UNOS did add some fields in their software programs for transplant centers to track whether organs came from patients who tested positive for COVID, and recommended that “donor history and rapid COVID‐19 testing be a routine part of the donor and recipient evaluation.” However, beyond those basic measures, OPOs were left to determine best practices on their own. 

  62. UNOS refused to instate a mandate for local recovery and a moratorium on out-of-state travel for organ recovery, as one transplant surgeon directly advised. The refusal to stop travel led anecdotally to COVID infections in hospital staff doing recovery, and a subsequent burden from that staff needing to quarantine. UNOS also did nothing to help coordinate OPOs that had private travel with those that didn’t. “Air travel essentially stopped for a while. There was a tremendous amount of disruption related to not being able to get organs, particularly kidneys flown,” explained one transplant surgeon. “UNOS did not have a national transportation strategy to say if your airport is closed or limited, here are the OPOs or transplant centers that have their own planes. Those conversations weren’t happening.” 

  63. One OPO CEO shared that the OPTN also did not share donation data as COVID-19 progressed. “Sometimes you just want to have something to benchmark against to see if what you’re experiencing is isolated right or if there’s other folks in your company. I think some stronger guidelines early on would have been helpful coming up from the OPTN and especially when we really didn’t know what we were tackling.” 

  64. Another OPO leader shared, “It’s one of my biggest regrets that I haven’t been able to have some full time analytic capabilities…I feel like I’m working with one hand tied behind my back.” 

  65. Oversight Subcommittee Launches Investigation into Poor Performance, Waste, and Mismanagement in Organ Transplant Industry, House Committee on Oversight and Reform, 2020. 

  66. Some OPOs learned that they should have more established relationships with departments of health and be more connected to public health networks. One OPO leader explained, “OPOs are disconnected from the public health network. Departments of Health didn’t know who we were or what we did. We had to explain in real time about why it was important that we be considered a part of their network. That’s been under appreciated until now.” 

  67. Many OPOs we spoke with reported a greater challenge placing lungs – starting in March and April and persisting throughout the pandemic. 

  68. National Data - OPTN 

  69. COVID-19 excluding some from organ donation; Lifebanc’s COO explains the effects,” WKBN, 2020. 

  70. CDC reported that the 12 months ending in May 2020 caused a record 81,000 overdose deaths – 38.4% higher than the 12 months prior. CDC Director Robert Redfield, M.D. said, “The disruption to daily life due to the COVID-19 pandemic has hit those with substance use disorder hard.” “Overdose Deaths Accelerating During COVID-19,” CDC, 2020. 

  71. Improvements in organ donation: Riding the coattails of a national tragedy,” Clinical Transplantation, 2019. 

  72. “This guideline brings us one step closer to shortening the national transplant waiting list and saving more lives,” said Admiral Brett P. Giroir, M.D., assistant secretary for health. “It reflects the impressive advances in testing and treatment over the last seven years and provides actionable steps that will protect transplant patients from HIV and hepatitis B and C viruses.” HHS Announces New Organ Transplant Guidance 

  73. For example, “Vanderbilt’s donor pool has increased significantly since it started accepting hepatitis C-positive donors in September 2016, she said. They now account for 37% of all adult heart transplants at the health system. Vanderbilt performs twice as many heart transplants since the change, jumping from 130 between 2013 and 2015 to 260 between 2016 and 2018.” Hepatitis C treatments could expand organ donor pool, study suggests, Modern Healthcare, 2019. 

  74. “Researchers who championed the law, including Segev, argued that it was unethical to waste the opportunity for transplants between HIV-positive individuals and that allowing such transplants would help HIV-negative individuals in need move up the wait list faster as well.” New HIV, Hepatitis B and C Guidelines Will Make More Organs Available for Transplant, Experts Say 

  75. Letter from OPO CEO to Representatives Krishnamoorthi and Porter, 2021. 

  76. “Organ preservation and re‐conditioning using machine perfusion technologies continue to generate promising results in terms of viability assessment, organ utilization and improved initial graft function.” The future of organ perfusion and re‐conditioning, Transplant International, 2019. 

  77. “Recent advancement in organ perfusion technology has led to increase clinical transplantation of marginal donor organs and allow for distant procurement of cardiac allograft beyond the time limitation of cold static storage.” The donor heart and organ perfusion technology, Journal of Thoracic Disease, 2019. 

  78. “Whereas deceased donors increased by 3848 between 2009 and 2019 (4% per year), roughly 3400 were owing to advances in transplant science, center behavior, or public health trends… Considering these numbers and eliminating multiple counting leaves 450 additional donors related to factors with OPO control, a 5% increase that does not keep pace with the 7% US population growth over that time.” “Using Data to Achieve Organ Procurement Organization Accountability—Reply,” JAMA, 2020. 

  79. Improvements in organ donation: Riding the coattails of a national tragedy, Clinical Transplantation, 2020. 

  80. For example, an OPO coordinator may code a donor death as “anoxia,” instead of “drug related,” which is technically true, but it also obscures the fact that it was a drug-related death. 

  81. Improvements in organ donation: Riding the coattails of a national tragedy,” Clinical Transplant, 2020. 

  82. Letter from Senators Wyden, Grassley, Cardin, and Young and Representatives Maloney, Comer, Krishnamoorthi, Cloud, Porter, and Reed to then-Acting HHS Secretary Norris Cochran, March 16, 2021. 

  83. COVID-19 Changes: Upcoming Adjustments to Transplant Program and OPO Evaluation Metrics, SRTR, 2020. 

  84. Oversight Gaps and Conflicts · The Costly Effects of an Outdated Organ Donation System,Bloom Works, 2020. 

  85. CMS Finalizes Policy that will Increase the Number of Available Lifesaving Organs by Holding Organ Procurement Organizations Accountable through Transparency and CompetitionCMS, 2020. 

  86. Organ Donation Can Save More Lives Through ReformMorning Consult, 2020. 

  87. “Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization,CMS NPRM, 2019. 

  88. Recent Organ Procurement Organization Regulations Will Save Lives, Bill of Health, Harvard Law Review, 2021. 

  89. Public discourse and policy change: Absence of harm from increased oversight and transparency in OPO performance, American Journal of Transplantation, 2021 

  90. Oversight Gaps and Conflicts · The Costly Effects of an Outdated Organ Donation System,Bloom Works, 2020. 

  91. Results of a data‐driven performance improvement initiative in organ donation, American Journal of Transplantation, 2020. 

  92. Heartless: Organ Donation Contractors Lobby Against a Popular Health Care Initiative While Pocketing Pandemic Relief Loans,” POGO, 2020. 

  93. In September, UNOS hosted a roundtable with various OPO representatives, who discussed CMS’ proposed oversight measures. “Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization,CMS NPRM, 2019. 

  94. Heartless: Organ Donation Contractors Lobby Against a Popular Health Care Initiative While Pocketing Pandemic Relief Loans,” POGO, 2020. 

  95. In a letter to the former United States Secretary of Health and Human Services, AOPO asks that the, “Administration delay finalizing the proposed OPO metrics until after the public health emergency has ended to ensure information obtained as a result of the pandemic, such as errors in the use of death certificates as a data source, can be addressed.” As the Final Rule explains, “Every state submits death certificate data to the CDC and the elements collected in the death certificates are standardized to the greatest degree possible. Errors in reporting on the death certificates are primarily from user error, where the individual completing the form makes a mistake. The same user errors likely plague other potential data sources, such as hospital records, and those data sources would come with significant added reporting burdens with limited to no additional benefit. We are not aware of differences in the error rates that would disadvantage one DSA over another DSA.” The Final Rule defines donor potential “as total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that is not an absolute contraindication to organ donation,” using data submitted to the CDC. 

  96. COVID-19 Assessment, KidneyRegistry.org, 2020. 

  97. Heartless: Organ Donation Contractors Lobby Against a Popular Health Care Initiative While Pocketing Pandemic Relief Loans,” POGO, 2020. 

  98. Don’t let the COVID-19 crisis delay reforms to our organ transplant system,” Roll Call, 2020. 

  99. Letter from Senators Wyden, Grassley, Cardin, and Young and Representatives Maloney, Comer, Krishnamoorthi, Cloud, Porter, and Reed to then-Acting HHS Secretary Norris Cochran, March 16, 2021. 

  100. Saving Lives and Improving Health Care through Innovation in Organ Donations and Transplants 

  101. Congressional letter from Rep. Katie Porter and Rep. Karen Bass to the former Secretary of HHS, Alex Azar and Administrator of CMS, 2020. 

  102. Organ Donation Can Save More Lives Through ReformMorning Consult, 2020. 

  103. Rep Cedric Richmond on Twitter,” Twitter, 2020. 

Research supported by Arnold Ventures and Schmidt Futures in partnership with Organize and the Federation of American Scientists.

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