Science in Organ Donation and Transplant Committee on Ways and Means Testimony
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Science in Organ Donation and Transplant Committee on Ways and Means Testimony
Dear Chairman Smith, Chairman Schweikert, and Members of the Oversight Subcommittee:
Science in Donation & Transplant (SID&T) appreciates the Committee’s interest in safeguarding the integrity of the U.S. organ donation and transplant system. Our mission is to ensure that federal policy in this field is grounded in peer-reviewed evidence-based science, accurate data, and practices that protect patients, donor families, and the American public. We welcome oversight when it is guided by evidence, not by advocacy narratives or flawed assumptions.
We submit this letter respectfully, in advance of the December 2 Oversight Subcommittee hearing, to provide scientific context that is missing from the Committee’s background memorandum and to highlight several concerning misdiagnoses in the Committee’s framing. The issues you have flagged are serious. But the causes and remedies are very different from what the memo suggests.
I. The United States Has the World’s Leading Donation and Transplantation System
A foundational fact that is absent from the Committee’s memo is that the United States leads the world in both organ donation and transplantation. Any discussion of reform must begin with the scientific reality that the U.S. donation and transplant system is not failing, it is performing at world-leading levels.
The U.S. performs more transplants per capita than any country in the world.
Deceased donor transplants have increased every year for the past 14 years, reaching 48,149 total transplants in 2024, with 16,988 deceased donors and 7,030 living donors.
Over the last four years, OPOs increased the number of kidneys offered to transplant centers by 58.4%—from 27.1 million offers in 2020 to 43 million in 2024.
U.S. deceased donation has increased by 59% since 2017, and total transplants have increased by 38%.
The U.S. has fifty-two deceased donors per 10,000 deaths, compared to Canada’s 26 and Germany’s 9.
The U.S. performed 160 transplants per million population, the highest rate in the world.
Our system is not perfect, but widespread claims of “systemic failure” or pervasive dysfunction are exaggerated and inconsistent with federal data. Oversight must begin with an accurate baseline.
II. Scientific Evidence Confirms the Fatal Flaws in the CMS Rule
The Committee memo focuses heavily on OPO “performance.” Still, it fails to acknowledge a critical, determinative fact: the Centers for Medicare & Medicaid Services (CMS) has never developed a scientifically valid method to evaluate OPO performance after more than 50 years of trying. The Repetitive History of CMS Failing Patients and Donors with Flawed Performance Metrics for Organ Procurement Organizations — Science in Donation and Transplant
SID&T has long raised alarms regarding CMS’s inconsistent, outdated, and scientifically unsound approach to OPO regulation. Multiple peer-reviewed studies have identified fatal flaws in the metrics CMS is now using to judge OPO performance.
CMS’s metric is not simply imperfect. It is mathematically incapable of producing accurate rankings. The Committee memo suggests that the 2020 Final Rule is widely accepted and functioning as intended. In fact, the Final Rule:
If uncorrected, it could decertify 40–70% of OPOs beginning in 2026.
Uses non-risk-adjusted, two-year-old data.
Systematically misclassifies and destabilizes OPOs that serve large, diverse, medically complex populations.
It is so inaccurate that more than half of OPOs change tiers simply due to statistical errors in the CMS methodology.
Advantage: small, less diverse, homogeneous regions.
Will decertify high-performing OPOs while leaving historically weak performers in place.
It has already produced such contradictions that experts predicted litigation. That litigation is now underway. (SID&T will provide the Committee with details pending court requirements.)
Will create chaos and potentially collapse the organ donor infrastructure.
CMS’s governance failures, not OPO structure, are a system-level threat. Unless Congress focuses on the scientific flaws in CMS oversight and the faulty Final Rule, the nation faces genuine disruption in 2026 when decertification begins, and patients will pay the price.
III. The NASEM Report Provides the Real Path to Reform—Yet Has Been Ignored
The bipartisan, Congressionally mandated 2022 study by the National Academies of Sciences, Engineering, and Medicine (NASEM) directly contradicts the advocacy narrative framing OPOs as the problem. Key conclusions in the report are:
The U.S. wastes too many usable organs primarily due to transplant center acceptance practices, not OPO performance.
The average kidney patient who dies waiting had been offered sixteen kidneys that were transplanted into other patients.
“It is too easy for transplant centers to decline usable organs.”
Equity gaps (especially for Black patients) must be addressed through system-wide, aligned metrics, not isolated punishment of OPOs.
CMS has not implemented these recommendations, and Congressional hearings rarely reference them. Instead, the Final Rule was built on special interests' white papers, not NASEM’s scientific roadmap.
IV. Using Tax-Exempt Status as a New Tool to Eliminate OPOs Endangers the Nonprofit Foundation Congress Created
Several Committee letters, including the recent correspondence to the New Jersey Sharing Network, begin by questioning whether an OPO should “retain” its nonprofit, tax-exempt status.
The National Organ Transplant Act (NOTA) established the basic requirements for OPOs and determined that they must be nonprofit entities to operate. Removing tax-exempt status is not a compliance correction, it is equivalent to eliminating the OPO in favor of capitalistic-driven private entities (not altruistic organizations).
SID&T does not comment on ongoing investigations, nor on the respective jurisdictions of the IRS and Congress. Any misuse of funds should be investigated and corrected.
However, it is essential to recognize that targeting nonprofit status as a primary lever is a new advocacy tactic distinct from evidence-based oversight. Earlier advocacy campaigns targeting OPOs, founded on non-peer-reviewed white papers and self-referential data, have not held up against federal statistics or scientific scrutiny. As those narratives have eroded, the strategy to undermine nonprofit OPOs has shifted.
We fear that the Committee is targeting nonprofit status as a back-door decertification. These risks will:
Destabilize high-performing OPOs that serve diverse populations.
Erode public trust in local, nonprofit procurement, the trust upon which donation depends.
Open the door to for-profit entities in an area Congress deliberately structured as a nonprofit public-utility function.
We urge the Committee to separate legitimate cost-report questions from broader efforts to dismantle the nonprofit foundation of American organ donation.
V. The Committee’s Memo Overstates Evidence of “Systemic Fraud” and Relies on Outdated Findings
The memo highlights OIG audits of OPO cost reports. SID&T supports OIG oversight. But context matters:
Several of the cited audits are 15–20 years old.
The amounts at issue are tiny fractions of annual OPO expenditures.
OIG issues similar findings for hospitals, nursing homes, dialysis programs, and home health agencies.
No data supports the claim that the OPO field engages in “systemic fraud.”
OPOs file annual Form 990s and Medicare cost reports, creating more transparency than many healthcare entities.
Oversight should target actual wrongdoing, not rely on isolated, dated findings to justify broad structural conclusions.
VI. The Committee Should Exercise Caution Regarding Witness Testimony That Does Not Reflect Scientific Consensus
We respect every witness who shares their perspective. But the hearing’s current panel does not include a single transplant surgeon, transplant physician, epidemiologist, statistician, donor-family representative, or OPO clinical expert.
Jennifer Erickson
SID&T urges the Committee to view Ms. Erickson’s testimony as a special interest advocacy perspective rather than that of a subject-matter expert. Her public statements, including on NPR, have repeatedly contradicted federal data and mischaracterized the structure and incentives of the U.S. organ donation system. She is closely aligned with an interconnected special-interest network funded by Arnold Ventures, including Organize, Bridgespan, and Bloom Works, which has repeatedly produced vendor-funded, non-peer-reviewed materials used to advance a particular policy agenda.
Her claims that the system is “an abject failure,” that uncredentialed individuals may recover organs, and that OPOs lose organs “15 times more often than airlines lose luggage” are not supported by data. The U.S. loses approximately 0.09% of organs in transport—compared to 0.6% of airline luggage.
Ms. Erickson is entitled to her views, but the Committee deserves scientific balance.
SID&T respectfully recommends that the Committee invite or consult transplant surgeons, statisticians, donor family leaders, and independent researchers—voices whose conclusions are grounded in evidence-based peer-reviewed science.
VII. A Collaborative, Science-Based Path Forward
SID&T strongly supports improvements to the U.S. donation and transplant system. We urge the Committee to:
Implement the recommendations of the NASEM report, which Congress funded, but CMS has not acted on.
Require CMS to replace the Final Rule metrics with risk-adjusted, scientifically valid measures.
Address transplant center organ acceptance practices, which account for more than 20% of unused kidneys.
Modernize data collection and death reporting.
Strengthen donor hospital accountability and EMR interoperability.
Expand the collaborative, evidence-based model that produced the Organ Donation Breakthrough Collaborative, which increased donation by 30%.
These steps would increase donations, improve equity, and strengthen public trust.
VIII. What Congress Should Ask on December 2
In light of the scientific concerns outlined in this letter, SID&T respectfully urges the Committee to focus its December 2 oversight on several fundamental questions that have direct implications for system performance, public trust, and the lawful implementation of federal policy.
1. Why is CMS ignoring peer-reviewed evidence showing its metrics are fatally flawed?
2. Why were SRTR researchers censored?
3. Why has CMS not implemented the NASEM recommendations mandated by Congress?
4. How will CMS prevent nationwide chaos in 2026 when mass decertifications begin?
5. What guardrails exist to prevent a for-profit takeover of organ recovery?
Conclusion
SID&T supports rigorous, fair, and science-based oversight. We respectfully caution the Committee against narratives shaped by special interest networks rather than evidence, and against emerging strategies that could destabilize high-performing nonprofit OPOs while distracting from the urgent need to correct CMS’s regulatory failures.
The United States has the world’s leading transplant system. With science-guided policy and balanced expert input, we can make it better still.
SID&T stands ready to assist the Committee by providing scientific analysis, clinical expertise, and connections to transplant professionals, donor families, and researchers across the nation.
Respectfully submitted,
Science in Donation & Transplant (SID&T)
www.sidandt.org
