Science in Donation & Transplant, a non-profit advocating for true science based-reform, today lauded the release of the study by NASEM mandated by Congress entitled “Realizing the Promise of Equity in the Organ Transplantation System.” * https://doi.org/10.17226/26364
SID&T Chairman Anthony Pizzutillo stated “For eighteen months SID&T has advocated for true reform in the donation and transplant system based on peer-reviewed science, not politics, as the path to better patient results. NASEM’s study confirms point after point of our advocacy by separating fact from fiction, calling for better alignment and accountability among organ procurement organizations, transplant centers and hospitals, and adopting logical and proven metrics to evaluate the performance of the various components of the donation and transplant system.”
“We encourage the Centers for Medicare and Medicaid in the Department of Health and Human Services to adopt these approaches as SID&T presented in our response to their recent Request for Information for improving the Rule.”
The NASEM study support a number of the reforms advocated by SID&T.
NASEM notes that good kidneys are often not used.
Transplant Centers reject organs at a much higher rate than Europe. Again, de-certifying OPO’s based on transplant rate which they do not control is an illogical answer to improving patient result. Better alignment, coordination and metrics among OPO’s transplant centers and hospital is the right approach.
Donate Life analysis shared with CMS through our RFI response shows that under the Rule the numbers of future donations will lag behind the curve expected under the previous Rule.
NASEM recommends increasing the utilization rate of donated organs. We again strongly agree that results show (in their words) “It is too easy for transplant centers to decline usable organs, and accountability for transplant center decision making is lacking.”
SID&T advocates for better alignment among the donation and transplant entities. We strongly support NASEM identifying their “Statement of Task”:
“Better align the performance metrics of various stakeholders within the Organ Procurement and Transplantation Network (OPTN) - donor service areas, organ procurement organizations, and transplant centers - to maximize donor referrals, evaluations, procurement and organ placement/allocation while minimizing organ discard rates.”
CMS needs to improve the performance metrics in the Rule. We have advocated for this NASEM study conclusion.
“Creating standardized, consensus-based metrics to compare performance of donor hospitals, OPOs, and transplant centers needs to be a priority for HHS and the OPTN.”
The critical area of health equity is addressed by NASEM. SID&T recognizes and advocates for reform of CMS’ current Rule which does nothing to address racial reality. In fact, their decertification metrics may exacerbate this NASEM conclusion:
“Black patients have a 37 percent lower chance of being referred for a kidney transplant prior to beginning maintenance dialysis (preemptive kidney transplantation).
Patients who are white, have greater health literacy, and have private health insurance have greater access to preemptive kidney transplantation.”
SID&T concurs that CMS needs to focus on the entire system, that indeed transplant center performance varies widely and directly impacts the donation rate that just OPO’s are judged upon. SID&T supports this health equity recommendation of the NASEM study as cited in their announcement webinar.
“Within 1 to 2 years, HHS should publish a strategy with specific proposed requirements, regulations, payment structures, and other changes that will lead to the elimination of disparities.”
SEE THE TIMELINE AS LANDMARK NASEM STUDY IS IGNORED:
SID&T FACTS AND REFORM SETS THE RECORD STRAIGHT
Science in Donation and Transplant: Facts and Reform
2023 www.sidandt.org
Effective reform and improvement of the world’s leading organ donation and transplant system requires a comprehensive solution based on peer-reviewed science and proper alignment of its component elements. Every element of the world’s leading donation and transplant system can improve from OPOs, to hospitals and transplant centers and to HHS/CMS themselves.
The current special interest political movement to accelerate the full force of the Rule governing donation and transplant is not a plan. It is a roadmap to chaos which will inordinately impact patients of color and lower economic standing.
We, and many peers in the field, advocate peer-reviewed science-based reforms, an approach Congress recognized when it mandated and funded a groundbreaking study by The National Academies of Sciences, Engineering, and Medicine (NASEM).
NASEM completed a congressionally authorized and funded1 report entitled Realizing the Promise of Equity in the Organ Transplantation System2 that provides key recommendations to instill accountability, increase equity, and improve outcomes throughout America’s organ donation ecosystem. We believe this critical research deserves your full attention as it provides clear, actionable recommendations for federal policymakers and represents the evidence-based, peer-reviewed, consensus position of the National Academies.
Unfortunately, HHS/CMS adopted the Rule governing organ donation and transplant in November of 2020 without awaiting this landmark study. Since 2020 an organized political effort, supported by outdated or simply wrong so-called data, has promoted the fast tracking of this flawed Rule.
For example, some parties are distributing what can only be termed “sponsored content” data that purports that tens of thousands of more transplants would occur if OPOs were held accountable. First, less than one percent of donors pass with organs suitable for transplant. Second, sixteen kidneys for example on average are rejected for transplant by surgeons before an operation actually takes place.
In fact, one Congressional committee had to withdraw its media release/report that was based on that faulty science.
NASEM recognizes that OPOs are judged both on donations, which they control, and transplant rates over which they have no control. That is why NASEM calls, and Congress should enact, reforms to better align procurement and transplant that hold all elements of the system properly accountable.
Let’s set some facts straight about the misinformation circulated to Congress and the media.
The number of deceased donor transplants has increased every year for the last nine consecutive years to a record high of 41,356 transplants in 2021.1
The number of deceased donors has increased every year for the past eleven consecutive years, for a record high of 13,863 in 2021.2 Deceased organ donor recoveries have increased 58% since 2007.3
The U.S. organ donation and transplant system recently surpassed one million transplants since 1954. Notably, more than half of these transplants have occurred since 2007.
A single study from 2003 as cited in the “Dear Colleague” letter cannot responsibly be applied to the state of the organ donation and transplant system of 2022, much less serve as the basis for a system overhaul. A great deal has changed in nearly 20 years, and the study from 2003 does not reflect those reforms, new policies, improvements and new data.
Even more so, the assertion in Congressional testimony and the Dear Colleague letter that an additional 28,000 transplants are possible reflects a poor understanding of how donation works and reveals a faulty assumption that every person who has died in a hospital is a “potential donor,” even if they were not medically cleared to be an organ donor. Less than 1% of all deaths in the U.S. occur in ways clinically compatible with organ donation; people who die of cancer, sepsis, certain infectious diseases, or organ failure cannot be cleared for donation by the OPO based on medical criteria established by transplant physicians for the safety of their patients. The effect of suggesting that OPOs should seek donation authorization for every in-hospital death (as the “Dear Colleague” letter does) would force staff to approach grieving families about donating their loved one’s organs even after a physician had already determined that they are not clinically safe for transplant.
From the NASEM report:
While waiting lists remain long and many listed individuals die while awaiting an organ every day, too many donated organs that are procured and offered to patients at transplant centers are not accepted—leaving thousands of potentially lifesaving donated organs unused every year. [...] Evidence indicates that many, if not a large majority, of unused organs could be successfully transplanted and benefit patients. This problem is much more prominent in the United States than in many other countries. For example, the overall nonuse rate in the United States is twice that in France. In the United States, on average, patients who die waiting for a kidney had offers for 16 kidneys that were ultimately transplanted into other patients, indicating that many transplant centers refuse viable kidney offers on behalf of those on the waiting list.
This clearly must improve through better alignment.
Additionally, HHS does not arbitrarily shut 42% of the nation’s so-called underperforming hospitals by judging the performance of urban and poor rural facilities against suburban ones. It demands remedial action based on best practices.
NASEM and peer reviewed science call for the proper metrics and alignment to insure improvement.
Adopting the full impact of the Rule, now, or 2026 for that matter, will result in chaos. There are no criteria in the Rule for what happens after so-called decertification. In other words, the Bronx or rural poor eastern Kentucky would be left without an Organ Procurement Organization with the vague assurance someone would take it over.
Simply put, the implementation of the Rule now would cause chaos in the system particularly in many poorer areas of the country.
We are concerned that most of the entities headed for de-certification under the latest data publication from CMS are OPOs whose service area demographics are disproportionately minority. First, the research has not been done to determine if these OPOs are being fairly evaluated given the impact on their certification on factors they cannot control such as transplant rates.
Second, given the multi-year time frame for the successful integration of “friendly” OPO mergers, frightening questions are raised about how those populations will be served.
OPOs may have higher net numbers, but lower numbers of minorities donating and being transplanted. We feel this lack of measurement might hide, at best, useful truths about performance, and, at worst, patterns of bias in otherwise high performing OPOs. There is also a grave concern that by pitting OPOs against each other, which the Rule seems to encourage, collaboration between and among these lifesaving organizations will actually become a liability.
In fact, Donate Life America estimates that the Rule will result in some five thousand fewer donations than under the previous Rule over the next five years.
The truly sensitive nature of organ donation and procurement begs for Congress and HHS/CMS to protect, nurture and improve the community-based non-profit system, based on science not politics.
Let’s work towards adoption of the NASEM principles and recommendation while not rushing to judgment based on poor science.
1) Further Consolidated Appropriations Act of 2020 (adopted December 19, 2019), https://www. nationalacademies.org/ocga/public-laws/ further-consolidated-appropriations-act-2020.
2) Realizing the Promise of Equity in the Organ Transplantation System (The National Academies of Sciences, Engineering, and Medicine Consensus Study Report, 2022), https://nap.nationalacademies.org/catalog/26364/ realizing-the-promise-of-equity-in-the-organ- transplantation-system.
3) ibid
Science in Donation and Transplant is a non-profit devoted to the support and education of members and stakeholders in the donation and transplant communities. Donors and transplant recipients alike deserve a well-aligned, science-based system. We advocate in concert with leading medical practitioners for enhanced coordination and alignment among organ procurement organizations and transplant centers. Our goal is ensuring that the metrics and measures used to credential, license, designate and certify donation and transplant organizations are grounded in science and protected from political whim and private financial influence.