OrganWatch

HRSA review of 351 authorized-not-recovered organ-donation cases found concerning features in 29.3%, with at least 28 patients possibly not deceased when procurement was initiated

Health Resources and Services Administration (HRSA), HHS

A 2025 HRSA investigation reviewed 351 cases in which organ donation was authorized but not completed. It identified concerning features in 103 cases (29.3%), including 73 patients with neurological signs the agency deemed incompatible with proceeding, and concluded that at least 28 patients may not have been deceased at the time organ-procurement steps were initiated. The cases were concentrated in a donation service area covering parts of Kentucky, southwest Ohio, and West Virginia.

HHS.gov — HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System (HRSA to reform organ transplant system)

Bipartisan Senate Finance Committee report found OPO conflict-of-interest gaps and an 850% rise in pancreata recovered for research

U.S. Senate Committee on Finance

A June 10, 2025 bipartisan report by Senators Grassley and Wyden found that OPOs surveyed reported an 850% increase in pancreata recovered for research (a more than four-fold increase across OPOs since the 2020 CMS outcome rule) without a corresponding documented research benefit, and that CMS does not require uniform OPO conflict-of-interest policies, producing inconsistent definitions and coverage across organizations.

U.S. Senate Committee on Finance — Wyden-Grassley Report Exposes How Organ Procurement Organizations Game the System

Major published investigation reported rushed or premature procurement attempts in some donation-after-circulatory-death cases

Major published investigation (national newspaper)

A July 2025 investigation by a national newspaper reported that, in a number of donation-after-circulatory-death cases, organ-procurement steps were begun or attempted before death was clearly established, with some procedures halted after patients showed signs of life. The reporting prompted federal and congressional scrutiny and contributed to HHS-directed reforms.

AOPO Statement on The New York Times Coverage of Donation After Circulatory Death

HRSA review of 351 authorized-but-not-completed donation cases found concerning features in about 29%

Health Resources and Services Administration (HRSA), HHS

HRSA reviewed 351 cases in which organ donation was authorized but not completed and identified concerning features in 103 cases, about 29 percent. Reported issues included poor neurologic assessment, inadequate coordination with treating medical teams, and questionable consent practices, with a subset of cases in which patients may not have been deceased at the time organ procurement was initiated. HRSA reported that vulnerabilities were concentrated in smaller and rural hospitals.

HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System (HHS.gov, July 21, 2025)

CMS issued March 2026 guidance reinforcing full medical care regardless of donor status and coercion-free family decision time

Centers for Medicare & Medicaid Services (CMS)

On March 11, 2026, CMS issued Quality, Safety and Oversight guidance (QSO-26-05) clarifying that a patient's entitlement to appropriate medical care is not altered by potential donor status and that clinical teams must not let donation-related factors affect the scope or timing of treatment. The guidance directs that families be given time to decide on donation free from coercion and instructs surveyors to cite identified noncompliance regardless of subsequent self-correction.

CMS QSO-26-05: OPO and Donor Hospital Responsibilities in the Organ Donation Process (CMS, March 11, 2026)

Major published investigation documented rushed or premature procurement attempts in the DCD pathway

The New York Times (published investigation)

In July 2025 The New York Times published an investigation ('A Push for More Organ Transplants Is Putting Donors at Risk,' July 20, 2025) reporting that, in a set of cases, organ-recovery attempts in the donation-after-circulatory-death pathway proceeded while patients showed signs of life, and that federal pressure to increase transplant volume created risk for potential donors. The reporting was published one day before the HHS reform announcement and coincided with the HRSA case review.

A Push for More Organ Transplants Is Putting Donors at Risk (The New York Times, July 20, 2025)

CMS guidance memo QSO-26-05 directs surveyors to cite OPOs that begin organ recovery before the required waiting period after death is declared

Centers for Medicare & Medicaid Services (CMS)

In guidance memo QSO-26-05 (released March 11, 2026) and accompanying State Operations Manual interpretive guidance, CMS directs surveyors to cite an OPO for noncompliance if it fails to adhere to the protocol-defined waiting period between the hospital's pronouncement of death and the OPO/surgical team's procurement of organs. CMS also stated that a citation must be issued even where the OPO or hospital later implemented a corrective action.

CMS QSO-26-05: Organ Procurement Organizations (OPOs) and Donor Hospital Responsibilities (March 11, 2026)

HRSA case review found concerning features in roughly 29% of reviewed authorized-not-recovered cases, including cases where patients may not have been deceased when procurement began

Health Resources and Services Administration (HRSA) / U.S. Department of Health and Human Services (HHS)

HRSA reviewed 351 cases in which organ donation was authorized but not completed and reported that 103 of them (about 29%) showed concerning features, including instances of failure to recognize improving neurologic function, poor coordination with hospital teams, and inadequate family communication. HRSA described instances suggesting patients may not have been deceased at the time organ procurement was initiated. The review (announced in 2025) led to a corrective action plan and an OPTN directive.

HRSA: Strengthening Organ Donation and Procurement Safety

House Energy & Commerce Committee held bipartisan oversight on patient-safety failures in organ procurement and pressed HRSA for corrective action

U.S. House Committee on Energy and Commerce

On July 22, 2025, the Energy and Commerce Subcommittee on Oversight and Investigations held a bipartisan hearing, 'Ensuring Patient Safety: Oversight of the U.S. Organ Procurement and Transplant System,' examining HRSA's review (351 authorized-not-recovered cases, with about 30% showing concerning features) and the associated corrective action plan. Committee leaders subsequently sent a bipartisan letter to HRSA following the hearing.

E&C O&I Subcommittee Hearing: Ensuring the Nation's Organ Procurement and Transplant System Prioritizes Patient Safety (July 22, 2025)

HRSA special review of 351 authorized-but-not-completed donation cases found ~29% with concerning features; 28 patients may not have been deceased when organ recovery began

Health Resources and Services Administration (HRSA), U.S. Department of Health and Human Services

In July 2025 HHS/HRSA announced the results of a special review of 351 organ-donation cases that were authorized but did not proceed to transplant. The review identified 103 cases (about 29.3%) with concerning features, including 73 patients with neurological signs the agency deemed incompatible with proceeding, and concluded that at least 28 patients may not have been deceased at the time organ-recovery efforts were initiated. HRSA directed corrective action and system-wide safety changes. Reported at the aggregate finding level; no patient identities involved.

HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System (HHS.gov press release)

HRSA-directed review centered on the OPO serving Kentucky and adjacent areas (formerly Kentucky Organ Donor Affiliates, now Network for Hope)

Kentucky Organ Donor Affiliates / Network for Hope (organ procurement organization)

A federal review found that staff at the OPO serving Kentucky (formerly Kentucky Organ Donor Affiliates, now operating as Network for Hope) pursued donation procedures in cases where patients showed signs of life, improperly took over case management from physicians, and pressured families to proceed. The OPO was directed to conduct a root-cause analysis, including of noncompliance with the post-death observation period, and to develop enforceable donor-eligibility policies. Stated at the institution/finding level; no patient-identifying detail included.

Ky. nonprofit pushed for organ donation procedures despite signs of life, federal investigation finds (WKYT)

Major published investigation documented rushed/premature DCD attempts, including cases where patients reportedly showed signs of life

Major published investigation (The New York Times)

A New York Times investigation reported instances in the donation-after-circulatory-death process where recovery efforts were initiated or pursued despite reported signs of life, and described pressure on hospital staff and families to proceed. The reporting paralleled federal findings and preceded congressional and HRSA action. Cited at the report/finding level; victim-identifying detail is deliberately omitted.

New York Times: A Push for More Organ Transplants Is Putting Donors at Risk (reposted summary)

HRSA review found concerning features in ~29% of authorized-but-not-completed donation cases at one OPO

Health Resources and Services Administration (HRSA), HHS / Kentucky Organ Donor Affiliates (KODA)

A HRSA investigation reviewed 351 cases at one organ procurement organization in which donation after circulatory death (DCD) had been authorized but was not completed. The review identified 103 cases (29.3%) with concerning features, including 73 patients with neurological status reported as incompatible with donation. The review concluded that at least 28 patients may not have been deceased at the time the organ procurement process was initiated, and cited poor neurologic assessment, weak coordination with treating clinical teams, and questionable consent practices.

HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System (HHS.gov)

Structural conflict: federal pressure to raise donation/transplant counts is documented as a driver of DCD-safety and out-of-sequence problems

Health Resources and Services Administration (HRSA) / U.S. House oversight committees / OPTN

Federal review and congressional oversight records frame a structural tension in the procurement system: performance metrics and growth pressure to increase donation and transplant counts coincide with the documented DCD patient-safety concerns and the rise in out-of-sequence allocation. HRSA's corrective directive, House Energy and Commerce and Ways and Means oversight, and the CMS metric overhaul each respond to this incentive structure rather than to isolated incidents.

House Committee on Energy and Commerce is Continuing to Investigate Concerning Practices Within Our Nation's Organ Procurement and Transplant System (House E&C)

HRSA review of 351 authorized-not-recovered cases found ~29% had concerning features, including a subset that may not have been deceased when procurement was initiated

Health Resources and Services Administration (HRSA), HHS

A HRSA Division of Transplantation review examined 351 cases in which organ donation was authorized but not completed and found 103 cases (29.3 percent) with concerning features, including 73 cases showing neurological signs the agency deemed inconsistent or unfavorable for donation-after-circulatory-death recovery. HRSA reported patterns such as failure to recognize improving neurologic function, failure to coordinate with patients' primary medical teams, and concerns that procurement may have been initiated in some cases before death was appropriately confirmed.

HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System (HHS.gov, July 2025)

Four-year HRSA investigation of a Kentucky OPO (now Network for Hope, formerly Kentucky Organ Donor Affiliates) led to a federally directed corrective action plan

Network for Hope (formerly Kentucky Organ Donor Affiliates / KYDA)

HRSA's Division of Transplantation issued a March 24, 2025 report summarizing an investigation into the OPO then known as Kentucky Organ Donor Affiliates (now Network for Hope), which serves Kentucky and parts of neighboring states. On May 28, 2025, HRSA issued a Corrective Action Plan directing the OPTN to take specified actions, including a 12-month monitoring plan for the OPO. HRSA stated that after this review it had received reports of similar high-risk donation-after-circulatory-death procurement patterns at other OPOs.

Strengthening Organ Donation and Procurement Safety (HRSA)

House Ways & Means investigation and December 2025 hearing cited a reanimation-during-recovery allegation at a named OPO and Medicare overbilling

U.S. House Committee on Ways and Means

At a December 2025 Ways and Means Oversight Subcommittee hearing on tax-exempt OPOs, the committee described its investigation finding that the New Jersey Sharing Network proceeded with organ recovery in an instance where a patient who had been pronounced dead reanimated during the recovery process, and that OPOs more broadly overbilled Medicare for non-reimbursable costs such as executive compensation, lobbying, meals, and entertainment. The committee framed these as troubling clinical and financial practices warranting greater accountability.

Five Key Moments: Hearing on Holding Tax-Exempt Organ Procurement Organizations Accountable (House Ways and Means, Dec 2025)

House Energy & Commerce held a July 22, 2025 oversight hearing on procurement safety and pressed HRSA/CMS

U.S. House Committee on Energy and Commerce

On July 22, 2025, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on patient-safety concerns in the U.S. organ procurement and transplant system, focused on HRSA's investigative findings, and subsequently sent a bipartisan letter to HRSA. Committee leaders cited HRSA's findings of concerning features in reviewed cases and the possibility of similar high-risk procurement patterns at other OPOs, and later pressed CMS following the South Florida OPO decertification.

E&C Leaders Send Bipartisan Letter to HRSA Following Oversight Hearing (House Energy & Commerce, July 2025)

New York Times investigation documented rushed or premature procurement attempts amid expansion of donation after circulatory death

The New York Times (published investigation)

A 2025 New York Times investigation reported on rushed or premature attempts to recover organs in donation-after-circulatory-death cases, finding instances in which patients showed signs of life as the donation process advanced, and linking the pattern to a push to increase transplant volume. The reporting paralleled HRSA's findings and prompted congressional oversight; reporting on registry data indicated a subsequent increase in people removing themselves from organ-donor registries.

Mass Exodus From Organ Donor Registries Following New York Times Coverage (Newsweek, describing the NYT investigation)

The dead-donor rule: donors must be dead before vital-organ recovery and procurement must not be the cause of death

Bioethics / peer-reviewed literature (concept)

The dead-donor rule (DDR) is a foundational norm in transplant ethics, generally stated as: organ donors must be dead before procurement of vital organs begins, and the act of procurement must not itself cause the donor's death. The term is attributed to legal scholar John Robertson and has guided multi-organ procurement since the late 1960s.

American Journal of Transplantation — Execution by organ procurement: Breaching the dead donor rule (defining the DDR)

Central NRP controversy: restoring in-situ circulation after circulatory-death declaration is debated as conflicting with the basis for that declaration

Peer-reviewed transplantation literature (concept)

Normothermic regional perfusion (NRP) in controlled donation after circulatory death restores in-situ blood circulation after death has been declared on circulatory criteria. Critics argue this can conflict with the permanence basis on which circulatory death was declared and may implicate the dead-donor rule; proponents argue technical measures (e.g., excluding cerebral circulation) preserve compliance. The ethics remain actively contested in the transplantation literature.

OPTN Ethics Committee — Ethical Analysis of Normothermic Regional Perfusion (white paper)

American College of Physicians: NRP raises significant ethical concerns; ACP reaffirms the dead-donor rule and separation of death determination from transplantation

American College of Physicians (ACP)

The ACP has issued a statement of concern on NRP in controlled DCD, urging a pause on NRP implementation until ethical concerns are resolved, and reaffirming the dead-donor rule and the principle that determination of death must be separate from organ transplantation.

ACP — Individual Position Papers (ethics, determination of death, and organ transplantation in NRP)

ACP 2025 position paper: the physician's first obligation is to the patient, and the goal of increasing organ supply must not override that duty

American College of Physicians (ACP)

In a position paper published October 28, 2025 in Annals of Internal Medicine, the ACP stated that a physician's primary duty is to the individual patient under their care and that the goal of increasing the number of organs for transplant does not override that responsibility; it warned that the line between serving a prospective donor-patient and serving potential recipients and the public interest can be blurred in ethically problematic ways.

ACP — New ACP Paper Provides Ethical Guidance Amid Controversies and Changing Practices in Organ Transplantation

AMA Code of Medical Ethics requires independent determination of death and separation of the transplant team from end-of-life care

American Medical Association (AMA)

The AMA Code of Medical Ethics provides that death must be determined by a physician not associated with the transplant team, that decisions to withdraw life-sustaining treatment be made independently of and prior to any organ-donation decision, and that transplant-team members not be involved in determining death or in decisions to withdraw treatment.

AMA Code of Medical Ethics — Guidelines for Organ Transplantation from Deceased Donors

American Society of Transplantation supports NRP use while calling for continued ethical review and legal clarification

American Society of Transplantation (AST)

Based on current procedural, ethical, and legal assessments, the AST supports the use of NRP in DCD donation and its broader clinical implementation, while calling for legal clarification — through updates to the Uniform Determination of Death Act or other guidance — to remove perceived misalignment or legal barriers to NRP.

American Society of Transplantation — Normothermic Regional Perfusion (NRP) statement

AOPO states OPOs do not declare death, which remains a hospital function, while acknowledging DCD safety concerns

Association of Organ Procurement Organizations (AOPO)

Responding to national reporting on DCD, AOPO stated that it takes the patient-safety concerns seriously and clarified that OPOs do not declare death or make end-of-life or patient-care decisions — those remain the responsibility of hospital medical teams in collaboration with families.

AOPO — Statement on The New York Times Coverage of Donation After Circulatory Death

Uniform Law Commission paused indefinitely its effort to revise the Uniform Determination of Death Act amid unresolved death-criteria disputes

Uniform Law Commission (ULC)

After convening a drafting committee to revise the Uniform Determination of Death Act (UDDA), the ULC paused the effort indefinitely in September 2023, citing the political climate, the implications of changing the legal description of death, and the lack of stakeholder consensus that would allow a widely enactable revision.

Uniform Determination of Death Act — overview of the paused ULC revision effort

HRSA mandated corrective actions tied to the five-minute observation rule and staff authority to halt donation

Kentucky Organ Donor Affiliates / HRSA, HHS

As part of the July 2025 action, HRSA directed corrective actions for the organ procurement organization formerly operating as Kentucky Organ Donor Affiliates (since merged and operating as Network for Hope), including a root-cause analysis of noncompliance with the five-minute observation period following declaration of circulatory death and adoption of a formal procedure allowing any staff member to halt a donation process when patient-safety concerns arise.

HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System (HHS.gov, July 21, 2025)

Clinical ethics bodies dispute whether normothermic regional perfusion is compatible with the dead-donor rule

American College of Physicians (ACP) / OPTN Ethics Committee

A central dead-donor-rule debate concerns normothermic regional perfusion (NRP) in donation after circulatory death. The American College of Physicians issued a statement calling for a pause on NRP, citing concerns that the manner and declaration of death may be inconsistent with the dead-donor rule, while other clinicians and the OPTN Ethics Committee analysis argue NRP can be conducted consistent with the legal definition of death. The question remains unsettled in the professional literature.

ACP: Ethics, Determination of Death, and Organ Transplantation in NRP

CMS guidance requires procurement to stop immediately if signs of life are observed; a prior death declaration does not permit continuing

Centers for Medicare & Medicaid Services (CMS)

CMS guidance QSO-26-05 (March 11, 2026) provides that if signs of life appear during the recovery process, the OPO is expected to immediately stop the procurement process, with immediate reassessment and documentation, and the patient returned to continued hospital care. A prior declaration of death does not authorize continuing recovery once signs of life are observed.

Hall Render: CMS Issues Guidance Clarifying OPO and Donor Hospital Responsibilities (March 13, 2026)

CMS guidance separates clinical decision-making from donation and bars OPO involvement in withdrawal of life support or death declaration

Centers for Medicare & Medicaid Services (CMS)

CMS guidance QSO-26-05 (March 11, 2026) states that the decision to withdraw life-sustaining treatment and the subsequent declaration of death are solely the responsibility of the patient's attending physician or hospital physician designee, and that the OPO may not be involved in the decision or timing of withdrawal of life support or in declaring death in any way. Donor hospitals must continue to provide full, life-saving medical care regardless of potential donor status.

Crowell & Moring: New Federal Guidance for Organ Procurement (CMS QSO-26-05)

DCD protocol regulation (42 CFR 486.344(f)) requires written criteria for death declaration and the elapsed time before organ recovery

Centers for Medicare & Medicaid Services (CMS) / 42 CFR Part 486

Under 42 CFR 486.344(f), an OPO that has a donation-after-circulatory-death protocol must maintain written protocols addressing, among other things, criteria for the declaration of death and the time period that must elapse prior to organ recovery, withdrawal of support, and use of medications/interventions not related to withdrawal of support. (The explicit prohibition on OPO staff participating in the patient's care or death declaration is set out in CMS interpretive guidance such as QSO-26-05 and the State Operations Manual, rather than in the text of 486.344(f) itself.)

42 CFR 486.344 - Condition: Organ recovery and DCD protocols (Cornell LII / eCFR)

Peer-reviewed bioethics literature documents the long-standing 'dead donor rule' debate underlying DCD procurement

Peer-reviewed bioethics / medical literature (Hastings Center Report and related journals)

A substantial peer-reviewed literature documents an ongoing debate over whether donation-after-circulatory-death protocols are compatible with the 'dead donor rule' - specifically whether the cessation of circulatory and respiratory function is truly irreversible at the moment death is declared (commonly after a several-minute observation period). The debate appears across venues including the Hastings Center Report and other bioethics and medical journals, with scholars on multiple sides.

A Defense of the Dead Donor Rule - Hastings Center Report (2018)

AOPO professional-society statement responds to DCD coverage, asserting OPOs do not declare death and pledging to improve national DCD standards

Association of Organ Procurement Organizations (AOPO)

In a July 20, 2025 statement responding to New York Times coverage of donation after circulatory death, AOPO asserted that OPOs do not declare death and do not intrude on hospital duties such as patient care or end-of-life decision-making, that donation does not proceed until the hospital team declares death consistent with the Uniform Determination of Death Act and hospital policy, and pledged to work with members and stakeholders to improve national DCD standards for consistency, transparency, and ethical clarity.

AOPO Statement on The New York Times Coverage of Donation After Circulatory Death

HRSA directed OPTN to develop new DCD safety policies after identifying risk patterns across OPOs, including recovery efforts begun while patients showed signs of life

Health Resources and Services Administration (HRSA) / Organ Procurement and Transplantation Network (OPTN)

On May 28, 2025, HRSA issued a directive ordering the OPTN to develop policies strengthening donation-after-circulatory-death (DCD) safety. The directive followed a special review of alleged patient harm by an organ procurement organization and HRSA's identification of risk patterns across OPOs, including inconsistent neurologic assessment and poor care-team coordination. New requirements include allowing families, hospitals, or staff to pause the donation process, a standardized list of information OPOs must give families, and mandatory reporting of safety-related stoppages.

HRSA Directive for OPTN Donation after Circulatory Death Policy Development (HRSA.gov)

Senate Finance Committee found structural financial conflicts: OPOs have greater incentives to recover tissue than lifesaving organs, and no uniform conflict-of-interest policy

U.S. Senate Finance Committee / organ procurement system oversight

The Senate Finance Committee (Wyden-Grassley) documented that OPOs have greater financial incentives to recover tissue than lifesaving organs and that the system lacks uniform conflict-of-interest policies, with differing definitions of what constitutes a conflict and who is covered. The report also found that the OPTN and its former sole contractor failed to act on formal complaints about financial conflicts of interest.

Wyden-Grassley Report Exposes How Organ Procurement Organizations Game the System (Senate Finance Committee)

Normothermic regional perfusion (NRP) raises an unresolved dead-donor-rule question; the American College of Physicians urged a pause

American College of Physicians (ACP) / professional-society debate

Normothermic regional perfusion in controlled DCD (NRP-cDCD) restores circulation to organs after declaration of circulatory death, raising an unresolved question of consistency with the dead-donor rule. In a 2021 statement, the American College of Physicians said the method raises significant ethical concerns and recommended a pause in its use until those concerns are resolved. The position generated substantial professional debate, with other clinicians defending the practice.

The American College of Physicians says organ procurement method raises significant ethical concerns (ACP Online)

HRSA directed OPTN to develop DCD safeguards after review of procurement begun on patients showing signs of life

Health Resources and Services Administration (HRSA), HHS / Organ Procurement and Transplantation Network (OPTN)

On May 28, 2025, HRSA issued a directive instructing the OPTN to propose policies, within roughly 180 days, to strengthen safeguards for potential DCD patients and improve family communication. The directive requires a defined process to request and report an unplanned DCD pause (with OPTN notification within 24 hours), allows family members and other stakeholders to call a pause if there is concern for the patient, mandates a standard list of information OPOs must share with families, and addresses accuracy of neurological assessment and reassessment.

Strengthening Organ Donation and Procurement Safety (HRSA)

American College of Physicians issued a statement of ethical concern urging caution on normothermic regional perfusion in DCD

American College of Physicians (ACP)

In an April 2021 statement, the American College of Physicians raised ethical concerns about normothermic regional perfusion (NRP) in donation after circulatory death and urged caution pending resolution of those concerns. The concerns centered on whether cessation of circulatory and respiratory function is truly irreversible under the protocol, the adequacy of donor and recipient family consent and transparency, and the equity implications of expanding DCD, particularly for populations affected by the overdose crisis.

Response to American College of Physician's statement on the ethics of transplant after normothermic regional perfusion (PubMed)

OPO trade association acknowledged NYT patient-safety concerns while defending DCD and noting OPOs do not declare death or direct patient care

Association of Organ Procurement Organizations (AOPO)

In a July 20, 2025 statement responding to New York Times coverage, the Association of Organ Procurement Organizations said it was treating the patient-safety concerns seriously and pledged to improve national DCD standards for consistency, transparency, and ethical clarity, while defending DCD as a complex, multi-team clinical pathway. The statement specified that 'OPOs do not declare death for patients or intrude on other hospital duties such as patient care.'

AOPO Statement on The New York Times Coverage of Donation After Circulatory Death (AOPO)

American College of Physicians called for a pause on normothermic regional perfusion (NRP) over dead-donor-rule concerns

American College of Physicians (ACP)

In a 2021 position statement on ethics, determination of death, and organ transplantation, the American College of Physicians raised serious ethical concerns that normothermic regional perfusion in controlled donation after circulatory death may be inconsistent with the dead-donor rule and recommended a pause in its use pending further professional and public discussion. The position remains contested within transplant medicine, with other clinicians arguing NRP respects the dead-donor rule.

Ethics, Determination of Death, and Organ Transplantation in NRP (ACP, 2021)

HRSA directed OPTN to reopen a closed safety case and adopt system-wide procurement-safety reforms

Organ Procurement and Transplantation Network (OPTN) / HRSA

Following its 2025 review, HRSA directed the OPTN to reopen a previously closed safety case involving potential preventable harm to a neurologically injured patient, and to adopt system-wide reforms — including mandatory reporting of all safety-related donation stoppages and revised policies to improve communication with families and care teams.

HHS.gov — HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System

HHS announced an organ-transplant-system reform initiative in July 2025 following the HRSA review

U.S. Department of Health and Human Services (HHS)

On July 21, 2025, HHS announced a reform initiative for the organ transplant system after the HRSA review of authorized-but-not-completed donation cases. Announced measures included mandated corrective actions for the implicated organ procurement organization and directives that the OPTN strengthen procurement-safety policies and require reporting to regulators of safety-related stoppages of donation called for by families, hospitals, or OPO staff.

HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System (HHS.gov, July 21, 2025)

CMS Conditions of Participation require hospitals to refer every imminent death and death to an OPO in a timely manner

Centers for Medicare & Medicaid Services (CMS)

Under 42 CFR 482.45(a)(1), the hospital Conditions of Participation require a written protocol under which the hospital notifies the OPO (or a third party designated by the OPO) in a timely manner of individuals whose death is imminent or who have died in the hospital. The regulation requires referral of every imminent death and death but does not numerically define what counts as 'timely.'

42 CFR 482.45 - Condition of participation: Organ, tissue, and eye procurement (Cornell LII / eCFR)

OPO Conditions for Coverage require written hospital agreements covering 95% of qualifying donor hospitals and must define 'timely referral' and 'imminent death'

Centers for Medicare & Medicaid Services (CMS) / 42 CFR Part 486 Subpart G

Under 42 CFR 486.322, an OPO must have a written agreement with at least 95% of the Medicare- and Medicaid-participating hospitals and critical access hospitals in its service area that have both a ventilator and an operating room (and that have not been granted a CMS waiver to work with another OPO). The agreement must specify the meaning of the terms 'timely referral' and 'imminent death.'

42 CFR 486.322 - Condition for Coverage: Agreements (Cornell LII / eCFR)

CMS guidance treats pressuring families to consent to donation as a patient-rights concern citable to the hospital

Centers for Medicare & Medicaid Services (CMS)

CMS guidance QSO-26-05 (March 11, 2026) emphasizes that families must not be rushed, pressured, or forced into premature decision-making during periods of acute grief, and indicates that a hospital can be cited for noncompliance with patient-rights protections where such pressure is applied, including pressure originating from an OPO.

Crowell & Moring: New Federal Guidance for Organ Procurement (CMS QSO-26-05)

House Ways and Means Committee opened an investigation into the New Jersey OPO (NJ Sharing Network) over whistleblower allegations of premature procurement and consent/records failures

NJ Sharing Network (New Jersey Organ and Tissue Sharing Network) / U.S. House Committee on Ways and Means

In 2025 the House Ways and Means Committee (Chairman Smith and Oversight Subcommittee Chairman Schweikert) opened an investigation into NJ Sharing Network after nearly a dozen whistleblowers alleged misconduct, including an instance of organ recovery proceeding from a patient showing signs of life, disputed records of a mass discard of pancreata, use of motor-vehicle 'document of gift' records to assert first-person consent against families' wishes, and failure to fully comply with document requests. The committee sought records and interviews with more than 30 staff. Reported at the allegation/investigation level.

Smith Warns New Jersey Organ Procurement Organization: Compliance Is Not Optional After Alarming Whistleblower Claims (House Ways and Means)

Federal rules (1986 OBRA / 1998 CMS Conditions of Participation) require hospitals to refer all deaths to OPOs, with the OPO (not the care team) approaching families

Centers for Medicare & Medicaid Services / U.S. statute (Omnibus Budget Reconciliation Act of 1986)

Federal law and regulation require Medicare/Medicaid-participating hospitals to refer every death and imminent death to the designated OPO. The 1986 OBRA 'required request' provision and the 1998 CMS Hospital Conditions of Participation (codified at 42 CFR 482.45) establish routine notification of all deaths, and provide that the OPO, rather than the hospital care team, approaches families about donation. The decision to withdraw life support is to remain with the care team, not the OPO.

42 CFR 482.45 - Condition of participation: Organ, tissue, and eye procurement (Legal Information Institute)

House Ways and Means Committee investigating alleged DCD-case cover-up and out-of-sequence allocation at a New Jersey OPO

House Committee on Ways and Means / NJ Sharing Network (New Jersey Organ and Tissue Sharing Network)

On November 19, 2025, the House Ways and Means Committee (Chairman Smith) and its Oversight Subcommittee (Chairman Schweikert) sent a follow-up letter to a New Jersey organ procurement organization seeking documents and interviews after whistleblower allegations. The committee alleged, among other things, an attempted cover-up of a DCD case in which a patient showed signs of life after withdrawal of support, out-of-sequence allocation of more than a quarter of the OPO's organs, and manipulation of documents provided to federal investigators. These are committee allegations under investigation, not adjudicated findings.

Smith Warns New Jersey Organ Procurement Organization: Compliance Is Not Optional After Alarming Whistleblower Claims (Ways and Means)

AOPO publicly responded to DCD-safety coverage and federal findings, pledging improved national DCD standards while clarifying OPO roles

Association of Organ Procurement Organizations (AOPO)

In response to 2025 New York Times coverage of donation-after-circulatory-death cases, AOPO stated it was treating the concerns seriously and working with system partners to learn more, and pledged to improve national DCD standards for consistency, transparency, and ethical clarity. AOPO also emphasized that OPOs do not declare death or assume other hospital clinical duties. (Note: a prior draft claim that AOPO said media inquiries were needed to prompt HRSA action could not be verified in AOPO's published statements and has been removed.)

AOPO Statement on The New York Times Coverage of Donation After Circulatory Death (AOPO)

GAO: about 19% of organ allocations in 2024 occurred out of OPTN sequence, bypassing the intended match order

U.S. Government Accountability Office (GAO) / OPTN

GAO reported that in 2024 approximately 19 percent of organ allocations were made out of OPTN sequence, deviating from the intended match order that ranks candidates by medical and policy criteria.

U.S. GAO — Systemic Issues Plague Life-Saving Organ Transplant Program

HRSA directive: out-of-sequence allocation by OPOs is not authorized under the OPTN Final Rule wastage provision

HRSA / Organ Procurement and Transplantation Network (OPTN)

In a February 21, 2025 directive, HRSA advised the OPTN that the wastage provision at 42 CFR 121.7(f) of the OPTN Final Rule does not authorize out-of-sequence offers by OPOs, and directed the OPTN to remediate allocation-out-of-sequence practices and assess member compliance.

HRSA — Allocation Out of OPTN Sequence (AOOS)

Senators flagged out-of-sequence allocation in roughly 20% of deceased-donor transplants

U.S. Senate Judiciary Committee members (Grassley-Wyden)

Senators Grassley and Wyden raised concern about a sharp rise in organs allocated out of sequence (so-called line-skipping), citing reporting that officials bypassed patients on waiting lists in nearly 20 percent of deceased-donor transplants in the prior year, compared with roughly 2 percent in 2016. The senators urged HHS to strengthen oversight and transparency of out-of-sequence allocation.

Grassley, Wyden Sound the Alarm on Officials Bypassing Organ Donation List (U.S. Senate Judiciary Committee)

Senate Finance Committee bipartisan investigation found systemic OPTN/UNOS oversight failures and a complaint process described as a 'black hole'

U.S. Senate Committee on Finance

At an August 3, 2022 bipartisan Finance Committee hearing ('A System in Need of Repair: Addressing the Organizational Failures of the U.S.'s Organ Procurement and Transplantation Network'), the Committee released findings from a multi-year investigation. The Committee reported that transplant professionals repeatedly described the UNOS complaint process as a 'black hole,' that more than 1,100 complaints filed over roughly a decade produced little visible oversight or reform, and that UNOS had recommended an OPO lose certification only once.

Wyden Statement at Finance Committee Hearing on Failures in the Organ Transplant System (Aug. 3, 2022)

National Academies (2022): marked racial and socioeconomic inequities in transplantation; many donated organs go unused

National Academies of Sciences, Engineering, and Medicine (NASEM)

The 2022 National Academies report 'Realizing the Promise of Equity in the Organ Transplantation System,' requested by Congress and sponsored by NIH, found that a person's chance of referral, waitlisting, and transplant varies markedly by race and ethnicity, socioeconomic status, geography, disability, and immigration status, and that a substantial share of donated organs go unused. It recommended system-wide goals to reduce inequities and nonuse.

New Report Recommends Changes to U.S. Organ Transplant System to Improve Fairness and Equity, Reduce Nonuse of Donated Organs (National Academies)

NYT investigation: nearly 20% of 2024 deceased-donor transplants bypassed the waiting list; circumvention skewed toward white, Asian, and more-educated recipients

The New York Times (investigative reporting) / Organ Procurement and Transplantation Network (OPTN)

A 2024 New York Times investigation reported that nearly 20% of transplants from deceased donors in 2024 bypassed patients waiting at the top of the national list, a roughly sixfold increase over a few years, and identified more than a dozen transplant centers maintaining internal priority lists. The Times reported that out-of-sequence placements skewed toward recipients who were white, Asian, and more educated; corroborating peer-reviewed analyses likewise found out-of-sequence kidney placements more likely to go to white and privately insured recipients.

Organ groups, hospitals skirt transplant waiting lists: New York Times (Becker's Hospital Review)

OPTN eliminated race-based eGFR in kidney listing and granted retroactive wait time to affected Black candidates

Organ Procurement and Transplantation Network (OPTN) / UNOS

Effective January 5, 2023, the OPTN required all kidney transplant programs to identify Black candidates whose waitlist qualifying date had been based on a race-inclusive estimated glomerular filtration rate (eGFR) calculation, and to assign an earlier qualifying date (potentially predating registration) had a race-free calculation qualified them sooner. Programs were required to complete the adjustments and submit documentation by January 3, 2024. The policy followed the OPTN Board's elimination of the race-based listing calculation.

Waiting Time Modifications for Candidates Affected by Race-Inclusive eGFR Calculations (HRSA)

AAMC, drawing on transplant data, reports Black patients are about half as likely to be placed on a kidney transplant waitlist

Association of American Medical Colleges (AAMC), aggregating OPTN/SRTR and academic findings

An AAMC analysis states that Black patients are about half as likely to be placed on a kidney transplant waitlist as white patients, and that those who are waitlisted face an average wait roughly a year longer, despite Black Americans being about four times as likely to develop kidney failure. The article ties part of the disparity to the now-eliminated race-based eGFR calculation.

How our organ transplant system fails people of color (AAMC)

HRSA separated the OPTN board from its contractor to address a roughly four-decade structural conflict of interest

Organ Procurement and Transplantation Network (OPTN) / UNOS

HRSA documented that for roughly four decades the OPTN Board of Directors was effectively the same body as the corporate board of the network's sole contractor (UNOS), raising conflict-of-interest concerns. As part of the OPTN Modernization Initiative announced in March 2023, HRSA separated the OPTN Board from the contractor and seated an independent, newly elected board to mitigate the structural conflict.

Strengthening Oversight to Improve Patient Outcomes: Recent Advances in OPTN Governance and Transparency (HRSA)

Senate Finance investigation found organs recovered for research can inflate OPO performance metrics and obscure low organ utilization

U.S. Senate Committee on Finance

The June 2025 bipartisan Senate Finance investigation found that counting organs recovered for research can allow underperforming OPOs to inflate their measured performance under the 2020 CMS outcome metric, undermining HHS oversight, while OPOs often had little or no ability to verify that the recovered organs were actually used for appropriate research.

U.S. Senate Committee on Finance — Wyden-Grassley Report on Organ Procurement Organizations

GAO found HHS lacked detailed plans to act on its own OPTN-weakness assessments

U.S. Government Accountability Office (GAO)

In GAO-26-107434 (published January 22, 2026), GAO reported that while HHS had contracted assessments identifying OPTN weaknesses such as inequitable allocation and insufficient investigation of serious events, HHS had not developed detailed plans for the next phase of its OPTN Modernization Initiative, including how it would reform the OPTN to address those weaknesses. GAO made three recommendations to HHS.

Organ Transplantation: HHS Action Needed to Improve Lifesaving Program (GAO-26-107434, Jan. 22, 2026)

OPO trade association attributed organ non-use to a policy mismatch and defended out-of-sequence allocation

Association of Organ Procurement Organizations (AOPO)

Responding to investigative coverage, AOPO attributed rising organ non-use to a misalignment of system policies, specifically requirements that OPOs recover more organs while transplant centers adopt more conservative acceptance practices. AOPO defended rescue-pathway (out-of-sequence or expedited) allocation as a policy-addressed practice used in medically necessary circumstances to reduce non-use, and urged HRSA to reform policies so transplant centers accept organs more readily.

AOPO Statement on The New York Times Coverage of Organ Allocation (AOPO)

GAO found HHS oversight of the organ transplantation network needs strengthening and recommended modernization and contractor-risk steps

U.S. Government Accountability Office (GAO)

In GAO-26-107434 ('Organ Transplantation: HHS Action Needed to Improve Lifesaving Program'), GAO documented systemic concerns including unused organs, patient-safety oversight gaps, data reliability and IT-security issues, and inequities in access. GAO made three recommendations to HHS, including developing detailed plans for the next phase of the OPTN modernization initiative and assessing risks tied to its contractor's supplementary services and fees; HHS agreed with the recommendations.

GAO-26-107434, Organ Transplantation: HHS Action Needed to Improve Lifesaving Program

SRTR/OPTN data document a rising share of recovered deceased-donor kidneys that are procured but never transplanted

Scientific Registry of Transplant Recipients (SRTR) / Organ Procurement and Transplantation Network (OPTN)

The OPTN/SRTR Annual Data Report (Kidney) documents that the non-use (discard) rate for recovered deceased-donor kidneys has risen over time, reaching 27.9% in 2023 (up from 26.6% in 2022), with substantially higher non-use rates for biopsied kidneys, kidneys from older donors, and kidneys with a high kidney donor profile index.

OPTN/SRTR 2023 Annual Data Report: Kidney (PMC)

Wyden-Grassley report: pancreata recovered for research rose ~850% (169 in 2018 to 1,606 in 2022) after the 2020 CMS metric, with no corresponding research benefit

U.S. Senate Finance Committee (Wyden-Grassley) / Centers for Medicare & Medicaid Services (CMS)

A June 2025 Wyden-Grassley Senate Finance Committee report found that pancreata recovered for research by OPOs rose roughly 850% (from 169 in 2018 to 1,606 in 2022) without a clear corresponding research benefit, and that the share used for islet-cell research fell from 87.6% (2018) to 47.9% (2022). The report ties the spike to the 2020 CMS outcome-measure rule and concludes the metric can let OPOs inflate measured performance by counting research recoveries.

Wyden-Grassley Report Exposes How Organ Procurement Organizations Game the System (Senate Finance Committee)

Kidney nonuse (discard) rate reached a record ~29.3% in 2024, up from 18.2% in 2013

OPTN / Scientific Registry of Transplant Recipients (SRTR)

Per the OPTN/SRTR 2024 Annual Data Report, the proportion of deceased-donor kidneys recovered for transplant but not transplanted (nonuse) rose to a record 29.3% in 2024, up from 18.2% in 2013. Nonuse was substantially higher for certain subgroups, including biopsied kidneys (40.8%), kidneys from donors aged 65 or older (68.9%), and high-KDPI kidneys (69.5%).

OPTN/SRTR 2024 Annual Data Report: Kidney (American Journal of Transplantation)

In 2023 the kidney nonuse rate was 27.9%, against 16,335 deceased donors

OPTN / Scientific Registry of Transplant Recipients (SRTR)

The OPTN/SRTR 2023 Annual Data Report recorded 16,335 deceased donors in 2023 (a 9.6% increase over 14,904 in 2022) and a deceased-donor kidney nonuse rate of 27.9%. (The frequently cited absolute count of roughly 8,418 nonused kidneys could not be confirmed verbatim in the report text, which reports the 27.9% rate rather than that absolute figure; the rate and donor count are the verified figures.)

OPTN/SRTR 2023 Annual Data Report: Kidney (PMC)

More than a quarter of recovered deceased-donor kidneys are not transplanted; non-use rises sharply for older and higher-risk donors

OPTN/SRTR 2023 Annual Data Report (HRSA-sponsored)

The OPTN/SRTR 2023 Annual Data Report found the non-use (discard) rate for deceased-donor kidneys recovered for transplant rose to 27.9% in 2023, up from 26.6% in 2022. Non-use was substantially higher for higher-risk organs: 41.4% for biopsied kidneys, 72.2% for kidneys from donors aged 65 or older, and 72.5% for kidneys with a Kidney Donor Profile Index of 85% or higher.

OPTN/SRTR 2023 Annual Data Report: Kidney (PMC)

OPTN/SRTR data show kidney non-use (discard) reached roughly 28% in 2023

OPTN / Scientific Registry of Transplant Recipients (SRTR)

The OPTN/SRTR 2023 Annual Data Report for kidney documents that the rate of deceased-donor kidneys recovered for transplant but not transplanted (non-use) rose to 27.9 percent in 2023, up from 26.6 percent in 2022. Non-use was substantially higher for biopsied kidneys, kidneys from older donors, and kidneys with a high kidney donor profile index, and was somewhat higher for kidneys from Black and Asian donors than from White donors.

OPTN/SRTR 2023 Annual Data Report: Kidney

GAO documented an OPTN safety case serving Kentucky that was closed without corrective action and broader OPTN oversight gaps

U.S. Government Accountability Office (GAO)

GAO reported systemic issues in the organ-transplant program, noting that an HHS investigation found a concerning pattern of risk to certain patients due to staff practices at an organ procurement organization serving Kentucky, and that when the matter was first investigated the OPTN closed the case without taking corrective action. GAO also flagged that OPTN oversight is lacking, including insufficient investigation of serious patient-safety events.

U.S. GAO — Systemic Issues Plague Life-Saving Organ Transplant Program

CMS/HHS decertified a hospital-based South Florida OPO in September 2025, the first OPO decertification in U.S. history

Centers for Medicare & Medicaid Services (CMS) / HHS

In September 2025, HHS/CMS moved to decertify Life Alliance Organ Recovery Agency, a hospital-based OPO operated by the University of Miami Health System, citing years of documented noncompliance with OPO Conditions for Coverage including staffing, training, and quality-oversight deficiencies. HHS described it as the first decertification of an OPO in U.S. history.

CMS — CMS Announces New Provider of Organ Procurement Services in South Florida

Congressional oversight escalated in 2025 with House Energy & Commerce and Ways & Means hearings on procurement and OPO accountability

U.S. House Committees (Energy & Commerce; Ways & Means)

In 2025, House committees held oversight hearings on the organ procurement and transplant system: the Energy & Commerce Oversight and Investigations Subcommittee examined HRSA's findings on patient-safety practices (July 2025), and the Ways & Means Oversight Subcommittee held a hearing on holding tax-exempt OPOs accountable that also examined alleged Medicare overbilling for non-reimbursable costs (December 2025).

House Ways and Means — Five Key Moments: Hearing on Holding Tax-Exempt Organ Procurement Organizations Accountable

CMS proposed a January 2026 rule to strengthen federal oversight of OPOs and patient protections

Centers for Medicare & Medicaid Services (CMS)

On January 28, 2026, CMS issued a proposed rule (CMS-3409-P, Conditions for Coverage revisions for organ procurement organizations), published in the Federal Register January 30, 2026. The proposal would revise OPO designation and recertification requirements, add quality-assurance requirements for medically complex organs and donors, and reinforce that OPOs may not influence the timing of withdrawal of life support or declaration of death.

Medicare and Medicaid Programs; OPO Conditions for Coverage: Revisions (Federal Register, Jan. 30, 2026)

HHS moved to decertify a university-affiliated OPO mid-cycle for the first time, citing chronic underperformance

Life Alliance Organ Recovery Agency (University of Miami Health System) / CMS

On September 18, 2025, HHS announced the decertification of the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, after documented noncompliance with federal OPO Conditions for Coverage including deficiencies in staffing, training, and quality oversight. HHS described it as the first time an OPO was decertified mid-cycle, with CMS overseeing continuity of services and identifying a successor provider for the service area.

HHS to Close University of Miami's Failing Organ Agency (HHS.gov, Sept. 18, 2025)

Bipartisan Senate Finance report found OPOs game performance metrics and have unaddressed conflicts of interest

U.S. Senate Committee on Finance (Wyden-Grassley)

A June 10, 2025 bipartisan Senate Finance Committee staff report (Wyden-Grassley) concluded that organ procurement organizations used practices to boost performance ratings and that conflicts of interest were inadequately addressed. The report described a recertification loophole under which pancreata recovered for research counted toward metrics, noting a more than four-fold increase in such recoveries without matching research demand, and found CMS does not require uniform OPO conflict-of-interest policies.

Wyden-Grassley Report Exposes How OPOs Game the System (U.S. Senate Committee on Finance, June 10, 2025)

House Ways and Means expanded its OPO investigation after whistleblower reports of Medicare fraud

U.S. House Committee on Ways and Means

On August 1, 2025, the House Ways and Means Committee announced an expansion of its investigation into tax-exempt organ procurement organizations following whistleblower reports alleging Medicare fraud and financial conflicts of interest. The committee sought documents including financial records, flight logs, and Medicare reimbursement information from multiple OPOs and held a December 2025 oversight hearing on accountability of tax-exempt OPOs.

Chairmen Smith, Schweikert Expand Ways and Means Investigation into OPOs (House Ways and Means, Aug. 1, 2025)

CMS/HHS decertified an OPO (a University of Miami Health System division) and named a replacement provider for the South Florida service area

Centers for Medicare & Medicaid Services (CMS) / U.S. Department of Health and Human Services (HHS)

In 2025, CMS/HHS moved to decertify the Life Alliance Organ Recovery Agency, the OPO operated by the University of Miami, citing documented noncompliance with the OPO Conditions for Coverage, and announced a replacement provider of organ procurement services for the South Florida donation service area. HHS characterized the action as the first such decertification of an OPO.

CMS Announces New Provider of Organ Procurement Services in South Florida

Wyden-Grassley 'Operation Transplant' report found OPOs game performance metrics and that conflict-of-interest controls are inadequate

U.S. Senate Committee on Finance (Wyden-Grassley)

A June 10, 2025 bipartisan Senate Finance Committee staff report ('Operation Transplant') concluded that OPOs engage in practices that boost their performance ratings and that the system inadequately identifies and resolves conflicts of interest. It highlighted a 'pancreata loophole' under which pancreata recovered for research can be counted toward recertification without clear verification of research use, alongside a more-than-fourfold rise in research pancreata recovery, and found that CMS does not require uniform OPO conflict-of-interest policies.

Wyden-Grassley Report Exposes How Organ Procurement Organizations Game the System (June 10, 2025)

HHS decertified a South Florida OPO (Life Alliance Organ Recovery Agency, University of Miami) citing a record of deficiencies tied to patient harm

Life Alliance Organ Recovery Agency (University of Miami Health System) / U.S. Department of Health and Human Services

In 2025 HHS moved to decertify, and then decertified, Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, marking what HHS described as the first mid-cycle decertification of an OPO. CMS and HHS cited years of noncompliance with the OPO Conditions for Coverage, including problems with staffing, training, and quality oversight, and documented deficiencies tied to patient harm. CMS subsequently named a replacement provider for South Florida.

HHS to Close University of Miami's Failing Organ Agency (HHS.gov press release)

Senate Finance investigation (2022): more than 1,000 complaints documented; UNOS recommended OPO decertification only once; disease transmission to recipients

United Network for Organ Sharing (UNOS) / U.S. Senate Finance Committee

The Senate Finance Committee's multi-year investigation, presented at an August 3, 2022 hearing, documented more than 1,000 safety-related complaints to UNOS and found UNOS had recommended an OPO lose certification only once. The committee also cited that between 2008 and 2015, 249 transplant recipients developed a disease transmitted via a transplanted organ, with more than a quarter of those recipients dying. Reported at the system/finding level.

Wyden Statement at Finance Committee Hearing on the Urgent Need to Address Failures in the Organ Transplant System (Senate Finance Committee)

Senate Finance subpoenaed UNOS (February 2021) as part of the transplant-system probe; performance data historically self-reported

United Network for Organ Sharing (UNOS) / U.S. Senate Finance Committee

On February 4, 2021, Senators Grassley and Wyden subpoenaed UNOS as part of the Finance Committee's continuing investigation into the U.S. organ transplant system, after the committee determined a subpoena was necessary to obtain full document production. The committee ultimately reviewed hundreds of thousands of pages and raised concerns about oversight gaps and the largely self-reported nature of transplant-system performance data.

Grassley, Wyden Subpoena the United Network for Organ Sharing (Senate Finance Committee)

CMS 2020 Final Rule (CMS-3380-F) created two outcome measures and a three-tier system, with the lowest-performing OPOs to be decertified at the 2026 cycle end

Centers for Medicare & Medicaid Services (CMS)

CMS's November 2020 Final Rule (CMS-3380-F) replaced the prior self-reported OPO outcome measures with two objective measures (a donation rate and a transplantation rate) and a three-tier recertification system. OPOs whose performance falls below the median on one or both measures (Tier 3) are subject to decertification at the end of the recertification cycle ending July 31, 2026, when higher-performing OPOs may bid for their service areas.

Organ Procurement Organization (OPO) Conditions for Coverage Final Rule (CMS-3380-F) Fact Sheet (CMS.gov)

Congress passed the Securing the U.S. OPTN Act (signed September 2023) to end the single-contractor (UNOS) monopoly over the transplant network

U.S. Congress / Health Resources and Services Administration (HRSA)

The Securing the U.S. Organ Procurement and Transplantation Network Act (H.R. 2544, 118th Congress) was signed into law on September 22, 2023. It ends the long-standing single-contractor arrangement under which UNOS had administered the OPTN since the network's inception, authorizes HRSA to award multiple contracts/grants for network functions, and removes the prior statutory funding cap, enabling competitive bidding to modernize the system.

H.R.2544 - Securing the U.S. Organ Procurement and Transplantation Network Act (Congress.gov)

OPO performance metrics long criticized as self-reported and gameable via the 'eligible deaths' denominator

Centers for Medicare & Medicaid Services (CMS) / Government Accountability Office / Senate Finance Committee oversight record

Before the 2020 CMS rule, OPO performance was measured against an OPO-defined 'eligible deaths' denominator that critics, including the Senate Finance Committee and federal oversight reviewers, said was self-reported and susceptible to manipulation, allowing underperforming OPOs to appear compliant. This critique motivated CMS's shift to objective, claims-based outcome measures in CMS-3380-F.

Organ Procurement Organization (OPO) Conditions for Coverage Final Rule (CMS-3380-F) Fact Sheet (CMS.gov)

HHS/CMS moved to decertify a Florida OPO after investigation found years of unsafe practices

U.S. Department of Health and Human Services / Centers for Medicare & Medicaid Services / Life Alliance Organ Recovery Agency (University of Miami Health System)

In September 2025, HHS/CMS announced the mid-cycle decertification of a Florida organ procurement organization, Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, after an investigation cited chronic underperformance, understaffing, inadequate training, and documentation errors. HHS described it as the first mid-cycle decertification of an OPO, and CMS subsequently announced a replacement provider of organ procurement services for South Florida.

HHS to Close University of Miami's Failing Organ Agency (HHS.gov)

Senate Finance Committee bipartisan investigation found systemic failures, disease transmissions, and a weak complaint process across the transplant network

U.S. Senate Committee on Finance (bipartisan Wyden-Grassley investigation)

A multi-year bipartisan Senate Finance Committee investigation, reviewing more than 100,000 UNOS documents, found that more than 1,100 complaints were filed about the procurement and transplant system between 2010 and 2020; that between 2008 and 2015, 249 transplant recipients developed a disease from transplanted organs, with more than a quarter of those recipients dying; and that the network's complaint process was widely described by professionals as opaque and unresponsive. Findings were presented at an August 2022 hearing, and a follow-on June 2025 report addressed OPO conflicts of interest.

Wyden Statement at Finance Committee Hearing on the Urgent Need to Address Failures in the Organ Transplant System (Senate Finance)

CMS shifted OPO performance metrics to objective measures, with roughly half of OPOs projected to face possible decertification

Centers for Medicare & Medicaid Services (CMS)

Under CMS's revised OPO Conditions for Coverage, performance is assessed using objective, verifiable data (a donation rate and a transplantation rate based on documented potential donors) rather than OPO self-reported figures, within a three-tier recertification system in which the lowest tier is decertified. CMS has estimated that roughly half of existing OPOs would not qualify for automatic recertification and would need to compete to retain their service areas. OPOs are held accountable to the measures for recertification beginning in 2026, with a further final rule anticipated.

Organ Procurement Organization (OPO) Conditions for Coverage Final Rule: Revisions to Outcome Measures for OPOs (CMS)

Bipartisan Senate Finance Committee report found OPOs game performance metrics and inadequately manage conflicts of interest

U.S. Senate Committee on Finance

A June 10, 2025 bipartisan staff report by Senators Wyden and Grassley concluded that organ procurement organizations engaged in practices to boost performance ratings and made inadequate efforts to identify and resolve conflicts of interest. The report found that a 2020 CMS metrics rule created a loophole allowing research-recovered pancreata to count toward recertification, after which such recoveries rose more than four-fold without a matching increase in research demand, and that OPTN/UNOS failed to act on formal conflict-of-interest complaints.

Wyden-Grassley Report Exposes How Organ Procurement Organizations Game the System (Senate Finance, June 10, 2025)

HHS/CMS moved to decertify a University of Miami OPO (Life Alliance Organ Recovery Agency) in the first mid-cycle OPO decertification

Life Alliance Organ Recovery Agency (University of Miami)

On September 18, 2025, HHS announced it was moving to decertify Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, after a review cited years of documented noncompliance with the federal OPO Conditions for Coverage, including chronic understaffing, training and quality-oversight deficiencies. HHS described it as the first mid-cycle decertification of an OPO; CMS subsequently approved another OPO to assume organ-procurement services for the South Florida donation service area.

HHS to Close University of Miami's Failing Organ Agency (HHS.gov, Sept 2025)

CMS tiered OPO performance framework places lowest performers (Tier 3) in decertification-eligible status

Centers for Medicare & Medicaid Services (CMS)

Under the CMS OPO Conditions for Coverage final rule (CMS-3380-F, effective via the 2020 rulemaking), OPOs are assigned to performance tiers each recertification cycle using outcome measures derived from objective data rather than OPO self-reported figures. Tier 1 (top performers) are automatically recertified; Tier 2 must compete to retain their service areas; and Tier 3 (lowest performers, below the median on one or both measures) are subject to decertification and barred from competing for open service areas.

OPO Conditions for Coverage Final Rule: Revisions to Outcome Measures (CMS-3380-F)

HHS-OIG audits found OPOs reported unallowable overhead costs to Medicare; nationwide audit work ongoing

HHS Office of Inspector General (HHS-OIG)

An HHS-OIG audit covering professional and public education overhead costs reported in 50 independent OPOs' Medicare cost reports (fiscal year-ends May 2015 through June 2019) estimated that about $664,295 of $50.9 million in Medicare payments for those costs was unallowable, attributing the errors to misunderstanding of Medicare requirements and administrative mistakes. OIG has placed nationwide audits of OPOs and certified transplant centers on its work plan as ongoing.

Medicare Paid Independent OPOs Over Half a Million Dollars for Overhead Costs That Did Not Meet Medicare Requirements (HHS-OIG, 2023)

Biomedical Tissue Services principal criminally convicted; FDA ordered cease-manufacturing and a nationwide tissue recall

Biomedical Tissue Services, Ltd.

In 2005 the FDA ordered Biomedical Tissue Services to cease manufacturing and recalled all human tissue the company had recovered, after authorities determined the firm obtained cadaveric tissue without proper donor consent or screening; the CDC reported roughly 25,000 tissue products had been distributed. The company's principal was later criminally convicted and sentenced to a lengthy prison term. The matter concerned non-transplant tissue recovered from decedents rather than solid-organ recovery from hospital patients, but it is a leading documented case of consent-and-screening failures in the U.S. human-tissue supply chain.

FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing (Infection Control Today)

RTI Surgical/RTI Biologics received FDA warning letters citing contamination and donor-screening deficiencies

RTI Surgical, Inc. (dba RTI Biologics)

The FDA issued warning letters to RTI Surgical/RTI Biologics, including a 2012 letter citing tissue contamination (bacteria, fungus, and yeast in products) and failures to process tissue and screen and test donors in a manner that prevents transmission of communicable diseases, and later letters in 2017 and 2019 citing adulteration/misbranding and process-control deficiencies. This concerns the human-tissue supply chain rather than solid-organ recovery from dying hospital patients.

FDA Warning Letter: RTI Surgical, Inc. dba RTI Biologics, Inc. (04/12/2019)

Detroit-area body broker (International Biological Inc.) criminally convicted of wire fraud for distributing infected human remains

International Biological Inc. (Detroit-area body-broker operation)

In January 2018 the operator of International Biological Inc. was convicted of multiple counts of wire fraud and an illegal-transportation-of-hazardous-material count for a scheme that distributed cadaveric body parts, including remains infected with HIV and hepatitis, to research buyers without disclosure, and was sentenced to a federal prison term. The case concerned the non-transplant 'willed-to-science' cadaver-parts market rather than solid-organ recovery from hospital patients.

Michigan Man Convicted in Fraud Scheme Involving Distribution of Infectious Human Remains (DOT-OIG)

Colorado funeral-home/body-broker operators convicted of fraud over non-transplant body parts transferred without consent

Sunset Mesa Funeral Home / Donor Services (Colorado)

The operators of a Colorado funeral home and affiliated donor-services business were federally charged and convicted in a scheme in which, over roughly 2010-2018, they transferred decedents' body parts to third parties without obtaining the required authorization, did not always perform promised cremations, and in some instances certified diseased remains as disease-free; the operators received multi-year federal prison sentences. The matter concerned the non-transplant body-parts market rather than solid-organ recovery from hospital patients.

Sunset Mesa Funeral Home Operators Sentenced to Federal Prison in Illegal Body Part Scheme (DOJ, USAO-CO)

UNT Health Science Center used unclaimed bodies and leased parts to outside groups without next-of-kin consent

University of North Texas Health Science Center (Fort Worth), Willed Body Program / BioSkills

An NBC News investigation ("Dealing the Dead") reported that the center obtained unclaimed bodies from Dallas and Tarrant counties, used them for dissection and training, and leased body parts to outside groups including medical-device companies, other universities, and the U.S. Army, after repeatedly failing to contact reachable relatives before declaring bodies unclaimed. NBC News reported the center earned roughly $2.5 million from the arrangement.

Cut up and leased out, the bodies of the poor (NBC News)

UNT Health Science Center suspended its body program and removed program leadership after the investigation

University of North Texas Health Science Center (Fort Worth)

Following NBC News' reporting, the center announced it was suspending its body donation program and terminating the officials who led it; subsequent reporting documented further leadership departures at the institution. The institution stated it stopped accepting unclaimed bodies.

Texas medical program stops using unclaimed bodies following NBC News investigation

Tarrant and Dallas county death-investigation systems ended their unclaimed-body arrangements with UNT after the reporting

Tarrant County (Texas) and Dallas County medical examiner / death-investigation systems

After NBC News documented failures to contact reachable family members before bodies were declared unclaimed, Tarrant County announced it would no longer send unclaimed bodies to the Fort Worth university, ending a multi-year arrangement under which the counties had sent thousands of unclaimed bodies since 2019 while saving on burial and cremation costs.

Tarrant County will no longer send unclaimed bodies to Fort Worth university after investigation (KERA News)

Texas medical-school acceptance of unclaimed bodies rose in recent years

Texas medical schools (statewide anatomical-donation practice)

Published reporting documents a sharp increase in the number of unclaimed bodies sent to Texas medical schools for dissection in recent years, with thousands of unclaimed bodies sent from Dallas and Tarrant counties to one institution alone since 2019.

More Unclaimed Bodies Sent to Texas Med Schools for Dissection (Texas Observer)

Texas law permitted medical use of unclaimed bodies without explicit consent, requiring only notification effort

State of Texas; Texas Health and Safety Code Chapter 691

Under Texas Health and Safety Code Chapter 691 as it stood before 2025, unclaimed bodies could be released to willed-body and anatomical-donation programs for the advancement of medical or forensic science without explicit informed consent from the decedent or next of kin, with the statutory scheme turning on whether a body was claimed for burial rather than on affirmative consent.

Texas Health and Safety Code Chapter 691 — Donation of Bodies and Anatomical Specimens

A Texas medical school used thousands of unclaimed bodies from two counties, leasing dissected remains for revenue

University of North Texas Health Science Center; Dallas County and Tarrant County (Texas)

An NBC News investigation reported that since 2019 the University of North Texas Health Science Center received roughly 2,350 unclaimed bodies under agreements with Dallas and Tarrant counties, dissected hundreds of them, and leased body parts to medical schools, the U.S. Army, and for-profit companies. The investigation documented repeated failures by county death investigators and the center to contact reachable family members before declaring bodies unclaimed.

Cut up and leased out, the bodies of the poor... | NBC News

Texas restructured oversight of body donation and enacted consent reforms following the unclaimed-bodies findings

Texas Legislature; Texas Funeral Service Commission (TFSC); former Anatomical Board of the State of Texas

Texas abolished the Anatomical Board of the State of Texas and transferred its body-donation regulatory functions under Chapter 691 to the Texas Funeral Service Commission, with the agency's substantive rules transferred in 2025 and a whole-body-donation advisory committee established. Subsequent 2025 legislation amended Chapter 691 to require clear, explicit informed consent before a body may be donated to a willed-body program or non-transplant anatomical donation organization.

Anatomical Board of the State of Texas Rule Transfer | Texas Secretary of State

No federal consent standard governs unclaimed bodies; many state laws require none

State anatomical-gift and unclaimed-body statutes; U.S. medical schools

In most U.S. jurisdictions, government officials may release unclaimed decedents' bodies to institutions of higher education for study with no legal requirement for prior consent from the deceased or their next of kin. Some states (for example New York, and exceptions noted in Hawaii, Vermont, and Minnesota) have restricted or banned the practice, but it remains legal in most states.

AMA Issue Brief: Unclaimed bodies in medical education

Texas health science center used unclaimed bodies without consent and leased parts for revenue

University of North Texas Health Science Center; Dallas County and Tarrant County death-investigation offices

A 2024 NBC News investigation documented that a Texas medical school used unclaimed bodies received from two county death-investigation offices for training and research without consent of the deceased or notice to reachable relatives, and leased dissected body parts to for-profit medical-device companies and others for fees. The center suspended the program and the counties ended their referrals in response.

Cut up and leased out, the bodies of the poor (NBC News)

Unclaimed bodies accepted by Texas medical schools rose roughly sevenfold in five years

Texas medical schools; the Uniform Anatomical Gift Act framework

A peer-reviewed study found that the number of unclaimed bodies accepted by Texas medical schools rose from 64 in 2017 (about 2.3% of donations) to 446 in 2021 (about 14.1%), a nearly sevenfold increase, and that a substantial share of sampled schools either directly used or received transferred unclaimed bodies.

Unclaimed Bodies and Medical Education in Texas (peer-reviewed study)

Texas medical school used unclaimed bodies for dissection and leased body parts to companies without family consent

University of North Texas Health Science Center (Willed Body Program; BioSkills of North Texas lab)

An NBC News investigation documented that the Fort Worth center accepted unclaimed bodies from Dallas and Tarrant county medical examiners and used them for dissection, research, and a fee-for-access lab (BioSkills) without consent of the decedents or their families. Reporting found repeated failures by county death investigators and the center to contact reachable next of kin before bodies were declared unclaimed. Following the reporting, the center suspended the Willed Body Program, closed the BioSkills lab, and Tarrant and Dallas counties ended their contracts.

NBC News, "The University of North Texas' body parts business: Cutting up and leasing out the poor" (2024)

State statutes still authorize dissection of unclaimed bodies without next-of-kin consent

Ohio Revised Code Section 1713.34; Oregon Revised Statutes Section 97.170

Ohio Revised Code 1713.34 directs that bodies that are not claimed or identified, or that must be buried at the expense of the state, county, or township, may be delivered to medical colleges or the embalming board for anatomical study or dissection without requiring next-of-kin consent (the related Section 1713.38 narrows this for non-residents). Oregon Revised Statutes 97.170 governs disposition and institutional use of bodies of unclaimed deceased indigent persons. Both statutes permit institutional use of unclaimed or indigent decedents absent affirmative family consent.

Ohio Revised Code Section 1713.34 (official Ohio Laws site); see also ORS 97.170

A minority of states banned use of unclaimed bodies without written consent; most have not

New York Public Health Law Section 4211 (amended 2016); Hawaii (2012); Vermont (2014)

New York amended its Public Health Law in 2016 to bar release of an unclaimed body to a university, college, school, or institute unless an anatomical gift or written consent has been made; Hawaii (2012) and Vermont (2014) enacted comparable restrictions. In most other states, officials may still transfer unclaimed bodies to institutions of higher education with no legal requirement for prior consent from the deceased or next of kin.

New York Public Health Law Section 4211 (2024), Justia; AMA issue brief on unclaimed bodies in medical education

Most US states permit donation of unclaimed/indigent bodies for medical education without next-of-kin consent

State anatomical-donation statutes and state anatomical boards (Uniform Anatomical Gift Act framework)

The AMA issue brief states that dissection of bodies without informed consent remains legal in most US states, and that in most jurisdictions government officials may donate unclaimed bodies to institutions of higher education with no legal requirement for prior consent from the deceased or next of kin. A 2019 survey of 89 US medical schools found about 12.4 percent reported use of unclaimed bodies.

AMA Issue Brief: Unclaimed Bodies in Medical Education

Some state anatomical statutes still use status-based language (tramps, indigent) to authorize dissection

Ohio Revised Code Section 1713.38 and Oregon Revised Statutes Section 97.170

The AMA issue brief quotes Ohio Section 1713.38 as currently allowing delivery for dissection of bodies of strangers or travelers "of that class commonly known as tramps," and states that Oregon Revised Statutes Section 97.170 similarly allows use of unclaimed bodies in medical dissection using the language of "indigent."

AMA Issue Brief: Unclaimed Bodies in Medical Education

Only a handful of states have banned use of unclaimed bodies without consent; consent is the exception

Hawaii (2012), Vermont (2014), New York (2016), and Minnesota and Rhode Island state legislatures

Published reporting and an academic review identify Hawaii, Minnesota, Vermont, Rhode Island, and New York as states that have prohibited the use of unclaimed bodies in medical education; Hawaii enacted its ban in 2012, Vermont in 2014, and New York in 2016 (requiring written consent). The AMA issue brief notes only that New York has banned the practice while it remains legal in most states.

Unclaimed dead bodies are often 'donated' to science — but it's not always consensual (Salon)

Texas legislature moved to ban research/training on unclaimed bodies without consent after the investigation

Texas Legislature (2025 session, Senate Bill 1406)

Following the NBC News investigation, legislation (Senate Bill 1406) was filed in the 2025 Texas legislative session to prohibit use of an unclaimed body for medical or forensic research or training without explicit consent and to add broader industry regulation, with penalties for serious violations.

Texas lawmaker moves to outlaw medical research on corpses without consent after NBC News investigation

The for-profit non-transplant body-broker market is legal and largely federally unregulated

Non-transplant anatomical donation organizations / body brokers (Uniform Anatomical Gift Act framework)

Reuters' "The Body Trade" investigation and subsequent reporting document that the for-profit market for non-transplant human remains operates largely without dedicated federal oversight, with the trade in bodies and parts for research and education governed mainly by state anatomical-gift law rather than a federal licensing or inspection regime.

Inside the largely unregulated market for bodies donated to science (CBS News)

The 2006 Revised Uniform Anatomical Gift Act deleted medical-examiner/coroner authority to make anatomical gifts; states largely followed

Revised Uniform Anatomical Gift Act (2006); Uniform Law Commission (National Conference of Commissioners on Uniform State Laws)

The official comments to the 2006 Revised Uniform Anatomical Gift Act state that, following a series of section 1983 actions in which coroners' and medical examiners' actions were held to violate surviving family members' property rights (citing Brotherton v. Cleveland), the drafters deleted the authority of the coroner and medical examiner to make anatomical gifts, substituting provisions on cooperation with procurement organizations. The Act has been enacted in most U.S. states.

Revised Uniform Anatomical Gift Act (2006), Uniform Law Commission (with official comments)

Cornea routine-removal statutes operated with little public awareness; several states later repealed or amended them

State coroner/medical-examiner cornea routine-removal statutes; National Academies (Institute of Medicine), Organ Donation: Opportunities for Action

A National Academies (Institute of Medicine) report on organ donation states that cornea-retrieval statutes do not presume consent but authorize routine removal subject to family objection, and that there appears to be little or no effort to educate the public about these laws and no evidence of widespread public understanding that they exist. Numerous states adopted such routine-removal statutes and several later repealed or amended them, notably as states adopted the 2006 Revised Uniform Anatomical Gift Act.

Organ Donation: Opportunities for Action, Chapter 7 'Presumed Consent' - National Academies

A Georgia routine-removal statute was associated with a roughly 40-fold rise in corneal transplants, illustrating the volume incentive

Georgia cornea routine-removal statute; documented in National Academies (Institute of Medicine), Organ Donation: Opportunities for Action

A National Academies (Institute of Medicine) report notes that corneal transplants attributed to a Georgia cornea-removal statute rose from 25 in 1978 to more than 1,000 in 1984 - roughly a 40-fold increase - which the report cites as evidence of the volume effect of routine, no-affirmative-consent removal authorized subject to family objection.

Organ Donation: Opportunities for Action, Chapter 7 'Presumed Consent' - National Academies

Federal circuit courts and a state supreme court reached opposite conclusions on whether next of kin have a constitutional property interest in a decedent's corneas

Constitutional split: Sixth Circuit (Brotherton; Whaley) and Ninth Circuit (Newman) versus Florida Supreme Court (Powell)

The Sixth Circuit (Brotherton v. Cleveland; Whaley v. County of Tuscola) and the Ninth Circuit (Newman v. Sathyavaglswaran) held that next of kin can have a constitutionally protected property interest in a decedent's corneas, grounded in state common-law and statutory rights to control disposition of remains. The Florida Supreme Court in State v. Powell reached the opposite conclusion, holding that next of kin have no protectable property or liberty interest in a decedent's remains, illustrating divergent legal treatment of the same question across jurisdictions.

Newman v. Sathyavaglswaran, 287 F.3d 786 (9th Cir. 2002) (discussing prior holdings) :: Justia

CMS now directs surveyors to cite organ-donation noncompliance even after it has been corrected

Centers for Medicare & Medicaid Services (CMS)

Under the March 11, 2026 CMS guidance (QSO-26-05 / QSO-26-06), surveyors are directed to cite noncompliance with the relevant requirements once identified, even if the deficiency has been corrected before the survey concludes.

CMS Issues Guidance Clarifying OPO and Donor Hospital Responsibilities During the Organ Donation Process | Hall Render

Non-transplant anatomical donation ('body brokers') operates largely outside federal regulation

Non-transplant anatomical donation organizations ('body brokers'); U.S. Food and Drug Administration (FDA)

Unlike organ transplantation, the donation of whole bodies and non-transplantable body parts for research and education is governed by no comprehensive federal statute and few state laws. The Uniform Anatomical Gift Act, adopted by most states, is among the few governing standards and requires informed consent, but there is no federal registration, inspection, or tracking system for these entities.

Inside the largely unregulated market for bodies donated to science | CBS News

Bipartisan federal legislation proposed to register and oversee non-transplant body brokers

U.S. Congress (bipartisan, bicameral sponsors); non-transplant anatomical donation industry

Members of Congress introduced bipartisan, bicameral legislation, the Consensual Donation and Research Integrity Act, that would give the Secretary of Health and Human Services oversight of entities handling whole bodies and non-transplantable body parts donated for research and education, creating standards for registration, inspection, chain of custody, labeling, and disposition, plus a tracking system. The measure was supported by the National Funeral Directors Association.

Bilirakis and Fletcher Introduce Bipartisan Bill to Stop Brokering of Body Parts | Rep. Gus Bilirakis

No single federal agency licenses or tracks non-transplant whole-body donation

Non-transplant anatomical donation organizations (body brokers); U.S. federal government

For-profit non-transplant body donation companies that supply cadavers and body parts for research, education, and medical-device training are not subject to a single federal licensing, registration, or tracking system, in contrast to the organ-transplant system. A 2017 Reuters investigation documented that no federal law governs the sale of donated cadavers or body parts for research or education and that few states impose oversight.

Reuters Special Report: The Body Trade

NOTA bans organ sale only for transplantation, leaving research and non-transplant uses uncovered

National Organ Transplant Act of 1984 (42 U.S.C. 274e)

NOTA makes it unlawful to knowingly acquire, receive, or transfer a human organ for valuable consideration only 'for use in human transplantation.' By its terms the prohibition does not reach organs or tissue transferred for research, education, or other non-transplant uses, and a paired-donation exception applies.

42 U.S. Code Section 274e - Prohibition of organ purchases (Cornell LII)

Federal law permits charging undefined 'reasonable' processing and storage fees for donated body parts

National Organ Transplant Act (42 U.S.C. 274e)

NOTA's definition of 'valuable consideration' expressly excludes 'reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage' of a human organ. Because the statute does not cap or define 'reasonable,' fees can be charged in connection with donated body parts without a statutory dollar limit.

42 U.S. Code Section 274e - Prohibition of organ purchases (Cornell LII)

Major investigation found no education or license required to operate a body donation business in much of the US

State licensing regimes for non-transplant anatomical donation; non-transplant tissue banks (body brokers)

Reuters' 2017 'The Body Trade' investigation reported that, in much of the United States, almost anyone regardless of expertise could legally dissect and sell human body parts, that most body brokers were not certified, and that loss of voluntary certification carried no real consequence. Reporters were able to legally purchase human remains with a credit card and a business address.

Reuters Special Report: The Body Trade

UAGA consent purposes for research and education are undefined, permitting broad downstream uses

Uniform Anatomical Gift Act (model state law); non-transplant donation organizations

The Revised Uniform Anatomical Gift Act (2006) permits anatomical gifts for transplantation, therapy, research, or education, but does not define those terms. Commentary notes that this leaves 'research' and 'education' broad, so a gift consented to for those purposes can be applied to uses a donor or family may not have anticipated.

The United States Revised Uniform Anatomical Gift Act (2006): New challenges (peer-reviewed)

No federal law governs the non-transplant body-broker industry, unlike FDA-registered transplant tissue

Non-transplant tissue banks / body brokers (regulatory gap relative to NOTA and FDA 21 CFR Part 1271)

Tissue used solely for nonclinical scientific or educational purposes is exempt from FDA's human-tissue rules under 21 CFR 1271.15(a), and the sale of organs for transplant is barred by the National Organ Transplant Act. Reuters' investigation documented that no comparable federal law governs the non-transplant cadaver-and-body-parts trade for research and education: there is no federal licensing system for body brokers and no federal tracking of where parts go, and reporters in 2016 legally purchased human remains from a broker without breaking any federal law.

21 CFR 1271.15(a) (Cornell LII); Reuters "The Body Trade" series (2017)

FBI raided a major non-transplant body broker over how it distributed donated body parts

MedCure Inc. (non-transplant tissue bank, Oregon); Federal Bureau of Investigation

Reuters reported that FBI agents executed a sealed search warrant and seized records at the Oregon headquarters of MedCure Inc., one of the largest U.S. brokers of donated bodies and body parts, in an inquiry into how the company distributed body parts acquired from its donors. Reuters reported that from 2011 through 2015 the company received more than 11,000 donated bodies and distributed more than 51,000 body parts.

Reuters (via Investing.com), "Exclusive: FBI agents raid headquarters of major U.S. body broker"

Florida statute authorizes medical-examiner corneal removal without next-of-kin consent and grants immunity for not obtaining consent

Florida Statutes section 765.5185 (formerly section 732.9185); Florida district medical examiners

Florida Statutes section 765.5185 permits a district medical examiner or qualified designee to provide a decedent's cornea for transplant on request of an authorized eye bank when the decedent is under the medical examiner's jurisdiction, an autopsy is required, and no objection by next of kin is known to the medical examiner. The statute requires only that no objection be known rather than affirmative consent, and provides that neither the medical examiner, the designee, nor the eye bank may be held liable in any civil or criminal action for failure to obtain next-of-kin consent.

Chapter 765 - 2024 Florida Statutes - The Florida Senate (section 765.5185)

Florida Supreme Court held next of kin have no protectable property or liberty interest in a decedent's corneas, upholding the routine-removal statute

State v. Powell, 497 So.2d 1188 (Fla. 1986); Florida Supreme Court

In State v. Powell, the Florida Supreme Court upheld the constitutionality of the medical-examiner corneal-removal statute (then section 732.9185, Florida Statutes), holding that the right of next of kin to possess a decedent's body for burial is not a protectable liberty or property interest in the remains and does not amount to a property right. The court reversed a circuit-court ruling that had found the statute unconstitutional.

State v. Powell :: 1986 :: Florida Supreme Court Decisions :: Justia

Sixth Circuit held next of kin have a constitutionally protected property interest in a decedent's corneas (Ohio)

Brotherton v. Cleveland, 923 F.2d 477 (6th Cir. 1991); Hamilton County, Ohio coroner; Cincinnati Eye Bank for Sight Restoration

In Brotherton v. Cleveland, the U.S. Court of Appeals for the Sixth Circuit held that, under Ohio law including its Uniform Anatomical Gift Act, next of kin have a constitutionally protected property interest in a decedent's corneas amounting to a legitimate claim of entitlement. The case involved corneas removed after an autopsy and provided to an eye bank despite a documented refusal of anatomical gift recorded by the hospital; the court reversed dismissal of the section 1983 claim.

Brotherton v. Cleveland, 923 F.2d 477 (6th Cir. 1991) :: Justia

Sixth Circuit case described a financial arrangement in which an eye-bank operator paid county autopsy costs in connection with cornea removals (Michigan)

Whaley v. County of Tuscola, 58 F.3d 1111 (6th Cir. 1995); Saginaw and Tuscola Counties, Michigan; Central Michigan Eye Bank and Tissue Center

In Whaley v. County of Tuscola, the Sixth Circuit held that under Michigan law next of kin have a property interest in a deceased relative's body, including the eyes. The opinion describes a business arrangement in which an eye-bank operator (also a pathologist's assistant and certified enucleator) agreed to pay the counties' autopsy expenses when corneas were removed, and half those expenses when they were not, with corneas removed and sold in some instances where next of kin were never asked or had refused consent.

Whaley v. County of Tuscola, 58 F.3d 1111 (6th Cir. 1995) :: Justia

Ninth Circuit held parents had a property interest in deceased children's corneas removed by the Los Angeles County Coroner without notice or consent (California)

Newman v. Sathyavaglswaran, 287 F.3d 786 (9th Cir. 2002); Office of the Coroner, County of Los Angeles

In Newman v. Sathyavaglswaran, the U.S. Court of Appeals for the Ninth Circuit held that parents had exclusive and legitimate claims of entitlement to possess, control, dispose of, and prevent violation of their deceased children's corneas, recognizing a property interest protected by due process. The corneas had been removed by the Los Angeles County Coroner without notice to or consent of the parents; the court reversed dismissal of the section 1983 due-process claim.

Newman v. Sathyavaglswaran, 287 F.3d 786 (9th Cir. 2002) :: Justia

California amended its coroner cornea statute to require affirmative consent (SB 1403, 1998)

California Government Code section 27491.47; California Legislature (SB 1403, 1998)

California Government Code section 27491.47, as amended by SB 1403 (1998), requires the coroner to obtain written or telephonic consent of the next of kin (or other authorized person) before removing and releasing corneal tissue, replacing the prior implied/no-objection standard with an affirmative-consent requirement; the coroner must also have no knowledge of an objection by the decedent or other authorized person.

California Government Code section 27491.47 - FindLaw

Ohio repealed its coroner corneal-removal statute when it adopted the 2006 Revised Uniform Anatomical Gift Act

Ohio Revised Code 2108.60 (repealed); Ohio General Assembly (House Bill 529, 127th General Assembly)

Former Ohio Revised Code 2108.60 permitted a county coroner performing an autopsy to remove or authorize removal of a decedent's corneas. Ohio adopted the 2006 Revised Uniform Anatomical Gift Act through House Bill 529 of the 127th General Assembly (effective April 7, 2009), enacting Revised Code sections 2108.01 to 2108.29 and replacing the prior coroner corneal-removal framework with a consent-based anatomical-gift system.

Ohio Revised Code 2108.60 (2006) - Coroner who performs autopsy may remove or authorize removal of eyes :: Justia

Texas moved from a 1977 routine corneal-removal scheme to requiring eye-bank request and consent under Chapter 693

Texas Health and Safety Code Chapter 693 (Removal of Body Parts, Body Tissue, and Corneal Tissue)

Texas Health and Safety Code Chapter 693 now provides that, on request from an eye bank, the medical examiner or other authorized official may permit removal of corneal tissue from a decedent who died under circumstances requiring an inquest subject to the same provisions that apply to organ removal on a procurement organization's request, which require consent under Sections 692A.005-692A.010 or 693.003 (or, where consent is not required by those sections, that no objection by a listed person is known). This reflects a shift away from the prior routine no-affirmative-consent corneal-removal approach.

Texas Health and Safety Code Chapter 693 - Removal of Body Parts, Body Tissue, and Corneal Tissue :: Justia

Tennessee statute permits a county medical examiner to authorize corneal removal at any time on eye-bank request

Tennessee Code Annotated 38-7-106; Tennessee county medical examiners

Tennessee Code Annotated 38-7-106 provides that, on request from an authorized official of a not-for-profit corporation certified by the Eye Bank Association of America to obtain, store, and distribute donor eyes and eye tissues, the county medical examiner may permit, at any time, the removal of the cornea or corneal tissue from the body of a deceased person, in accordance with Title 68, Chapter 30, Part 1. The same section requires notice to next of kin of an impending autopsy where known or reasonably ascertainable.

Tennessee Code 38-7-106 (2024) - When autopsies authorized - Notice to next of kin - Donor eyes and eye tissues :: Justia

State cornea-removal statutes historically authorized coroners/medical examiners to remove corneas absent affirmative next-of-kin consent

State coroner/medical-examiner cornea-removal statutes (e.g., Ohio Rev. Code 2108.60; Georgia)

A number of states historically enacted statutes authorizing coroners or medical examiners to remove corneal tissue from bodies under their jurisdiction without affirmative next-of-kin consent, permitting routine removal so long as no objection was known. Some states, including Georgia, later amended these laws to require express written consent from next of kin.

Ga. Comp. R. & Regs. R. 111-8-28-.08 - Consent Requirements in Coroner or Medical Examiner Cases | LII

Federal appeals court held next of kin have a constitutionally protected interest in a decedent's corneas removed without consent

U.S. Court of Appeals for the Sixth Circuit; Ohio coroner cornea statute (Ohio Rev. Code 2108.60)

In Brotherton v. Cleveland, 923 F.2d 477 (6th Cir. 1991), the Sixth Circuit held that the rights granted by Ohio law gave a surviving next of kin a 'legitimate claim of entitlement' amounting to a constitutionally protected property interest in a decedent's corneas, so that removal under the coroner statute without consent and without predeprivation process implicated the Fourteenth Amendment Due Process Clause.

Brotherton v. Cleveland, 923 F.2d 477 (6th Cir. 1991) | Justia

Some state statutes let coroners or medical examiners remove corneal tissue without family notice

State cornea-retrieval statutes; coroner and medical examiner offices

Several state statutes have authorized coroners or medical examiners to permit removal of corneas in cases under their jurisdiction without an affirmative duty to locate or notify next of kin, subject only to a known objection by the decedent or family. Examples include statutes and rules in states such as Connecticut, Georgia, and Ohio.

Connecticut OLR Report: Harvesting Corneas in Connecticut

County coroner removed corneas from decedents without family consent under a presumed-consent statute; appeals court found a protected property interest

Los Angeles County Coroner's Office; California Government Code Section 27491.47 (presumed-consent corneal statute)

Under former California Government Code Section 27491.47 (enacted 1983), the Los Angeles County Coroner removed corneal tissue from decedents without seeking next-of-kin consent, so long as no objection was known. In Newman v. Sathyavaglswaran, 287 F.3d 786 (9th Cir. 2002), the U.S. Court of Appeals for the Ninth Circuit held that next of kin have a property interest in a decedent's body protected by the Fourteenth Amendment's Due Process Clause. The statute was subsequently amended to require consent.

Newman v. Sathyavaglswaran, 287 F.3d 786 (9th Cir. 2002), Justia

HRSA investigation found organ-procurement initiation on patients with concerning features in DCD cases

Health Resources and Services Administration (HRSA) / OPTN; Network for Hope (formerly Kentucky Organ Donor Affiliates, KYDA)

A HRSA Division of Transplantation report (March 24, 2025) on the OPO serving Kentucky and parts of nearby states reviewed 351 cases and found 103 (29.3 percent) showed concerning features in the donation-after-circulatory-death (DCD) process, including problems with neurological assessment and recognition of signs the agency described as raising safety concerns. HRSA issued a corrective action plan directing the OPTN to strengthen DCD safeguards.

Strengthening Organ Donation and Procurement Safety (HRSA)

Congressional oversight found the DCD safety pattern was not isolated and prompted system-wide action

U.S. House Committee on Energy and Commerce; HRSA; OPTN

At a July 22, 2025 House Energy and Commerce hearing, oversight focused on HRSA findings of patient-safety failures in organ procurement; committee leaders subsequently sent a bipartisan letter to HRSA, and HRSA and the OPTN announced corrective actions to address concerns about DCD practices across the system.

House Committee on Energy and Commerce continuing to investigate organ procurement and transplant system

HRSA review found nearly 30% of authorized-but-not-completed donation cases at one OPO had 'concerning features'

Health Resources and Services Administration (HRSA); U.S. Department of Health and Human Services (HHS)

A HRSA Division of Transplantation review of one organ procurement organization examined 351 cases in which donation was authorized but not completed and found that 103 cases (29.3%) had 'concerning features,' including problems with patient-family interactions, medical assessments, recognition of high neurologic function, and documentation of drugs. HHS announced reforms based on these findings in July 2025.

HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System | HHS.gov

HRSA found DCD procurement was sometimes rushed, with patients showing neurological signs and the waiting period not always observed

Health Resources and Services Administration (HRSA); Organ Procurement and Transplantation Network (OPTN)

In the same review, HRSA reported that the donation-after-circulatory-death process was sometimes rushed and that organ-procurement involvement could blur the line between clinical care and organ recovery. The review identified 73 cases with neurological signs reported as incompatible with the donation pathway and stated that at least 28 patients may not have been deceased at the time procurement was initiated, citing poor neurologic assessment, questionable consent practices, and noncompliance with the post-death observation period.

HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System | HHS.gov

CMS QSO-26-05 guidance: OPO may not influence the timing of withdrawal of life support or the declaration of death

Centers for Medicare & Medicaid Services (CMS)

On March 11, 2026, CMS issued survey-and-certification memo QSO-26-05 clarifying that the decision and timing of withdrawal of life-sustaining treatment and the declaration of death are solely the responsibility of the treating medical team and may not be directed or influenced by the organ procurement organization; the OPO's role is limited to confirming death has been pronounced before recovery begins.

QSO-26-05-OPO (CMS, March 11, 2026)

HRSA/OPTN DCD reform plan targets misclassified overdose deaths and inadequate neurological assessment

Health Resources and Services Administration (HRSA); Organ Procurement and Transplantation Network (OPTN)

In connection with the 2025 findings, HRSA directed a corrective-action plan and OPTN directive addressing donation-after-circulatory-death practices, including poor neurologic assessment and misclassification of causes of death, particularly in overdose cases, and requiring policies that let any staff member halt a donation process over safety concerns.

OPO Corrective Action Plan and OPTN Directive (HRSA, redacted)

HRSA found near-premature procurement risk in a donation-after-circulatory-death case and ordered new safeguards

Health Resources and Services Administration (HRSA); OPTN; a Kentucky-region organ procurement organization

HRSA's Division of Transplantation reported in 2025 on its investigation of an index donation-after-circulatory-death case involving a Kentucky-region OPO, and in May 2025 issued a corrective action plan directing the OPTN to develop a monitoring plan and propose policies to strengthen DCD safeguards, including a mechanism for stakeholders to pause the donation process.

Strengthening Organ Donation and Procurement Safety | HRSA

HRSA found nearly 30% of reviewed Kentucky-OPO circulatory-death cases had concerning features, with some patients possibly not deceased when organ recovery was initiated

Health Resources and Services Administration (HRSA); Organ Procurement and Transplantation Network (OPTN); Kentucky-area OPO (formerly Kentucky Organ Donor Affiliates, now Network for Hope)

HRSA's Division of Transplantation reviewed 351 authorized-but-not-recovered cases at the Kentucky-area OPO and found 103 (29.3%) had 'concerning features,' including poor neurologic assessments, weak coordination with hospital teams, and questionable consent. HRSA reported that at least 28 patients may not have been deceased at the time organ procurement was initiated. HHS issued a corrective-action plan (dated May 28, 2025) and an OPTN directive in response.

HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System (HHS.gov, 2025)

HRSA reported similar high-risk circulatory-death procurement patterns at other OPOs beyond Kentucky

Health Resources and Services Administration (HRSA); Organ Procurement and Transplantation Network (OPTN); multiple Organ Procurement Organizations

At a July 22, 2025 House Energy & Commerce oversight hearing, HRSA's Organ Transplant Branch Chief testified that the high-risk donation-after-circulatory-death procurement pattern identified in Kentucky 'is not limited to' that OPO, and HRSA stated it had received reports of similar patterns at other OPOs. HRSA framed the issue as a system-wide pattern of risk across OPOs, prompting an OPTN directive on DCD safeguards.

E&C Leaders Send Bipartisan Letter to HRSA Following Oversight Hearing on Concerning Practices in Organ Procurement and Transplant System (House Energy & Commerce, July 2025)

HHS/HRSA investigation found organ-recovery procedures initiated on patients who showed signs of life

Health Resources and Services Administration (HRSA); OPTN; Network for Hope (formerly Kentucky Organ Donor Affiliates)

HHS announced in July 2025 that an HRSA investigation of an organ procurement organization (Kentucky Organ Donor Affiliates, now Network for Hope) reviewed 351 authorized-but-not-completed donation cases and found 103 (about 29 percent) with concerning features, including 73 patients with neurological signs incompatible with donation and at least 28 patients who may not have been deceased when organ-procurement processes were initiated. HRSA mandated corrective actions and directed OPTN to strengthen national safeguards and reporting of safety-related stoppages.

HHS.gov, "HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System" (July 2025)

Senate Finance investigation found OPOs game performance metrics and that financial conflicts go unaddressed

Senate Finance Committee (Grassley–Wyden); Organ Procurement and Transplantation Network (OPTN) / United Network for Organ Sharing (UNOS)

A June 10, 2025 Senate Finance Committee report by Sens. Grassley (Iowa) and Wyden (Oregon) concluded that organ procurement organizations game performance measures and that CMS does not require uniform conflict-of-interest policies, producing inconsistent definitions and coverage and leaving financial conflicts inadequately addressed across the system.

Wyden-Grassley Report Exposes How Organ Procurement Organizations Game the System (Senate Finance Committee)

A decade of complaints to the OPTN/UNOS produced limited reform, per Senate Finance oversight

United Network for Organ Sharing (UNOS) / OPTN

Senate Finance Committee oversight reported that between 2010 and 2020 more than 1,100 complaints were filed regarding the organ transplant system, including instances in which OPOs failed to complete mandatory tests such as blood typing and disease/infection screening, and that the OPTN and its then-sole contractor UNOS failed to act on formal complaints, including those about financial conflicts of interest.

Wyden, Grassley, Finance Committee Members Continue Investigation into U.S. Organ Transplant System

HHS issued an unprecedented mid-cycle decertification of an OPO over chronic safety failures

U.S. Department of Health and Human Services / CMS; Life Alliance Organ Recovery Agency (University of Miami Health System)

On September 18, 2025, HHS/CMS announced the decertification of the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System serving South Florida, citing years of unsafe practices, chronic understaffing, poor training, and recordkeeping errors; HHS described the action as the first mid-cycle decertification of an organ procurement organization and announced a transition to a new provider.

CMS Announces New Provider of Organ Procurement Services in South Florida

Senate Finance bipartisan report: CMS does not require uniform OPO conflict-of-interest policies; OPTN does not collect financial-relationship data

U.S. Senate Committee on Finance; Centers for Medicare & Medicaid Services (CMS); Organ Procurement and Transplantation Network (OPTN)

A June 10, 2025 bipartisan Senate Finance Committee report found that CMS does not require uniform conflict-of-interest policies across organ procurement organizations, leading to differences in definitions and coverage, and that the OPTN is not required to collect details on financial relationships, board-member compensation, or affiliated businesses. The report examined COI documents from seventeen OPOs.

Wyden-Grassley Report Exposes How Organ Procurement Organizations Game the System, Fail to Adequately Address Conflicts of Interest | Senate Finance Committee

HHS moved to decertify a South Florida OPO and announced DCD safety guidelines after a procurement investigation

U.S. Department of Health and Human Services; Centers for Medicare & Medicaid Services; Life Alliance Organ Recovery Agency (University of Miami Health System)

In September 2025 HHS announced the first-ever decertification of an organ procurement organization, identifying the South Florida OPO operated within the University of Miami Health System, following an investigation citing unsafe practices, understaffing, and missed recoveries, and announced further organ-procurement and DCD safety guidelines.

HHS Announces Decertification of Florida OPO and Instates Further Safety Guidelines (House E&C)

OPOs operate as cost-reimbursed monopolies; decertification was historically never used until 2025

Organ procurement organizations; Centers for Medicare & Medicaid Services; UNOS/OPTN

Oversight analyses describe OPOs as government-granted regional monopolies reimbursed on a cost pass-through basis, with much performance and safety data self-reported, and note that despite performance failures no OPO had ever been decertified by CMS until HHS's first decertification in September 2025.

Oversight Gaps and Conflicts - The Costly Effects of an Outdated Organ Donation System

Senate Finance found a sharp rise in research-pancreata recovery with weak verification of use

Organ procurement organizations; Centers for Medicare & Medicaid Services; Senate Finance Committee

A bipartisan Senate Finance Committee inquiry reported that pancreata recovered for research by OPOs rose from 169 in 2018 to 1,606 in 2022, and raised concern that a 2020 CMS performance-metric rule created an incentive to count research pancreata toward recertification without clear verification that the organs were actually used in bona fide research.

Wyden, Grassley, Cardin, Young Raise Alarm Over Dramatic Increase in Pancreata Procurement (Senate Finance)

Fragmented governance and tissue-versus-organ financial incentives create structural conflicts

OPOs; FDA; CMS; HRSA; UNOS/OPTN; tissue processors

A 2025 Senate Finance Committee report and a Congressional Research Service overview describe diffuse oversight across HRSA, CMS, FDA, and the OPTN contractor, with the financials of tissue largely outside HRSA and CMS review, and note that OPOs can have greater financial incentives toward tissue recovery and limited ability to verify downstream research use.

Wyden-Grassley Report Exposes How OPOs Game the System (Senate Finance)

OPOs surveyed by the Senate Finance Committee reported an 850% rise in pancreata recovered for research after a 2020 CMS metric change, with weak verification

Organ Procurement Organizations (10 surveyed by the Senate Finance Committee); Centers for Medicare & Medicaid Services (CMS)

The Senate Finance Committee staff report 'Operation Transplant' (June 2025) found that among ten OPOs the senators surveyed, the total number of pancreata recovered for research rose from 169 in 2018 to 1,606 in 2022, an 850% increase, without a matching increase in researcher demand. The report attributes this to a 2020 CMS Final Rule that allowed pancreata procured for research to count toward OPO recertification performance metrics, and found many OPOs could not show the organs were used for bona fide islet-cell research.

Wyden-Grassley Report Exposes How Organ Procurement Organizations Game the System, Fail to Adequately Address Conflicts of Interest (U.S. Senate Committee on Finance, June 10, 2025)

Individual OPOs self-reported pancreata-for-research increases ranging from 10% to 6,400% in a single year (2021-2022)

Donor Alliance; Lifebanc; Indiana Donor Network; OneLegacy; Texas Organ Sharing Alliance; and other surveyed OPOs

In responses cited by the Senate Finance Committee 'Operation Transplant' report, OPOs reported widely varying single-year (2021-2022) increases in pancreata placed for research: Donor Alliance reported a 6,400% increase, Lifebanc 2,000%, Indiana Donor Network 747%, Lifeline of Ohio 392%, OneLegacy 390%, LifeQuest 267%, Texas Organ Sharing Alliance 216%, Mid-America Transplant 56%, NJ Sharing Network 89%, and Kentucky Organ Donor Affiliates 10%. The report flags these increases as evidence of possible gaming of CMS performance metrics.

Operation Transplant: Examining the Need for Oversight in the Organ Donation System (Senate Finance Committee staff report), footnote 30

CMS had never decertified an OPO in the history of the U.S. transplant system (as of the 2025 Senate report)

Centers for Medicare & Medicaid Services (CMS); Organ Procurement Organizations

The Senate Finance Committee 'Operation Transplant' report (June 2025) states that CMS has never decertified an OPO, allowing organizations to face little-to-no consequences for underperformance. Separately, HHS/HRSA announced in 2025 a corrective-action framework under which underperforming (Tier 3) OPOs are slated for decertification beginning with the 2026 performance assessment cycle, indicating this longstanding pattern is set to change.

Wyden-Grassley Report Exposes How OPOs Game the System (U.S. Senate Committee on Finance, June 10, 2025)

CMS does not require uniform OPO conflict-of-interest policies, and OPTN/UNOS failed to act on financial-conflict complaints

Centers for Medicare & Medicaid Services (CMS); Organ Procurement and Transplantation Network (OPTN); United Network for Organ Sharing (UNOS)

The Senate Finance Committee 'Operation Transplant' report found that, despite CMS's regulatory authority over OPOs, CMS has not required uniform conflict-of-interest policies, producing key differences across OPOs in scope, definitions, and handling of conflicts. The report further states that even when formal complaints about financial conflicts of interest were made, the OPTN and its contractor UNOS failed to act, and notes UNOS deemed at least one whistleblower complaint to fall outside OPTN policies.

Operation Transplant staff report (Senate Finance Committee), Conflicts of Interest section

Reported OPO conflicts of interest concentrated in outside employment and outside board memberships, 2015-2023

LifeCenter Organ Donor Network; LifeShare Network; Midwest Transplant Network; Donor Alliance; Gift of Life Donor Program (and other surveyed OPOs)

The Senate Finance Committee 'Operation Transplant' report tabulated conflicts OPOs reported for 2015-2023, dominated by outside-employment and outside-board-membership conflicts: e.g., LifeCenter reported 53 outside-employment conflicts plus 18 financial conflicts; Midwest Transplant Network 20 outside-employment and 2 board conflicts; LifeShare 22 outside-employment and 8 board conflicts; Donor Alliance 7 outside-employment and 8 board conflicts; Gift of Life Donor Program 8 outside-employment, 7 board-service, and 5 financial conflicts. The report criticized the disclosures as vague and inconsistently reviewed.

Operation Transplant staff report (Senate Finance Committee), 'Types and Numbers of Reported Conflicts'

HHS-OIG: OneLegacy claimed unallowable and unsupported overhead costs to Medicare in FY2006

OneLegacy (organ procurement organization); Centers for Medicare & Medicaid Services (CMS)

An HHS Office of Inspector General audit (A-09-08-00033, issued 2010) found that of $3.2 million of FY2006 organ-acquisition overhead and administrative costs reviewed, about $531,000 did not comply with Medicare requirements ($291,000 unallowable and $240,000 unsupported), and that OneLegacy overstated its Medicare reimbursement by an estimated $297,000. OIG recommended a revised cost report and improved cost-reporting procedures.

Review of OneLegacy's Reported Fiscal Year 2006 Organ Acquisition Overhead Costs and Administrative and General Costs (HHS-OIG, A-09-08-00033)

HHS-OIG: Medicare could have saved an estimated $8.9 million had OPOs correctly reported double-lung procurements as two organs

Organ Procurement Organizations (54 reviewed, including 51 independent OPOs); Centers for Medicare & Medicaid Services (CMS)

An HHS Office of Inspector General audit (A-09-12-02085, issued 2013) found that of 54 OPOs reviewed, 44 reported lung statistics incorrectly in their FY2011 Medicare cost reports, with most reporting double lungs as a single organ rather than two. OIG estimated Medicare could have saved about $8.9 million had double lungs been correctly counted as two organs.

Medicare Could Have Saved Millions if OPOs Had Correctly Reported Procurement of Double Lungs as Two Organs (HHS-OIG, A-09-12-02085, 2013)

HHS-OIG: Medicare paid an estimated $664,295 in unallowable OPO professional/public-education overhead, including meals and entertainment tickets

Independent Organ Procurement Organizations (50 reviewed); Centers for Medicare & Medicaid Services (CMS)

An HHS Office of Inspector General audit (A-09-21-03020, issued 2023) estimated that Medicare paid about $664,295 in unallowable professional and public-education overhead costs across 50 independent OPOs. In the detailed sample, 36 of 300 reviewed costs ($15,852, with $6,423 in Medicare payments) did not meet Medicare requirements. OIG recommended CMS clarify that costs such as meals for non-OPO employees and tickets to entertainment events are unallowable.

Medicare Paid Independent OPOs Over Half a Million Dollars for Professional and Public Education Overhead Costs That Did Not Meet Medicare Requirements (HHS-OIG, A-09-21-03020, 2023)

Federal prosecution: former Alabama Organ Center officials took funeral-home kickbacks; $498,551 restitution ordered to the University of Alabama Health Services Foundation

Alabama Organ Center (now Legacy of Hope); University of Alabama Health Services Foundation

According to U.S. Department of Justice and FBI announcements (2012), two former Alabama Organ Center officials were convicted in a scheme in which they received more than $498,000 in kickbacks from a funeral home doing business with the organ center between roughly 2003 and 2011, without disclosing the financial conflict. The court ordered $498,551 in restitution to the University of Alabama Health Services Foundation; investigators stated the conduct did not endanger organ donors or recipients.

Former Alabama Organ Center Associate Director Sentenced for Fraud (U.S. Attorney's Office, N.D. Alabama / FBI, 2012)

OPO trade association converted from 501(c)(3) to 501(c)(6) to expand lobbying, and organ-procurement industry lobbying spending rose sharply around the 2020 reform rule

Association of Organ Procurement Organizations (AOPO); United Network for Organ Sharing (UNOS)

A Project On Government Oversight investigation reported that AOPO told industry supporters it would change its nonprofit status from 501(c)(3), where lobbying is sharply restricted, to 501(c)(6), which allows expanded lobbying advocacy. Per public filings cited by POGO, organ-procurement industry lobbying (OPOs, UNOS, and AOPO combined) rose from about $160,000 per year in 2017-2018 to $452,000 in 2019 and exceeded $450,000 in the first half of 2020 alone, coinciding with the December 2020 CMS OPO outcome-measure Final Rule. AOPO completed its 501(c)(6) conversion (reflected in its 2022 bylaws).

Heartless: Organ Donation Contractors Lobby Against a Popular Health Care Initiative While Pocketing Pandemic Relief Loans (Project On Government Oversight)

OPO funding flows through a self-reported, reasonable-cost Medicare reimbursement model with no fixed cap

Organ Procurement Organizations; Centers for Medicare & Medicaid Services (CMS); 42 CFR Part 413 Subpart L

Under 42 CFR Part 413 Subpart L (and related sections such as 42 CFR 413.200 and the reasonable-cost principles of 42 CFR 413.24), independent OPOs are reimbursed by Medicare on a reasonable-cost basis through self-reported cost reports, with organ-acquisition costs excluded from inpatient operating-cost ceilings rather than subject to a fixed prospective cap. Multiple HHS-OIG audits have found OPOs overstating allowable costs within this cost-based framework.

42 CFR Part 413 Subpart L -- Payment of Organ Acquisition Costs for Transplant Hospitals, Organ Procurement Organizations, and Histocompatibility Laboratories (eCFR)

Senate Finance Committee report found OPOs game recertification metrics and that conflict-of-interest oversight is inadequate

Organ Procurement and Transplantation Network (OPTN); United Network for Organ Sharing (UNOS); Organ Procurement Organizations

A 2025 bipartisan Senate Finance Committee report by Senators Wyden and Grassley found that OPOs used practices to boost performance ratings, including a CMS rule loophole that lets pancreata recovered for research count toward recertification without clear verification of research use (recovery of such pancreata rose more than four-fold without matching research demand). The report also found OPTN and its former sole contractor UNOS failed to act on formal conflict-of-interest complaints, and that OPTN does not require collection of OPO financial-relationship, board-compensation, or affiliated-business data.

U.S. Senate Committee on Finance, "Wyden-Grassley Report Exposes How Organ Procurement Organizations Game the System" (June 10, 2025)

HHS/CMS moved to decertify an Organ Procurement Organization mid-cycle for the first time

Life Alliance Organ Recovery Agency (division of University of Miami Health System); HHS / Centers for Medicare & Medicaid Services (CMS)

In September 2025, HHS announced it was moving to decertify the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, after an investigation cited years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors. HHS described it as the first time it had decertified an OPO mid-cycle. CMS subsequently named the Nevada Donor Network to provide organ-procurement services in southern Florida.

HHS.gov, "HHS to Close University of Miami's Failing Organ Agency" (Sept. 2025)

Non-transplant anatomical material used solely for education or research is excluded from FDA HCT/P regulation

U.S. Food and Drug Administration (21 CFR Part 1271)

Under 21 CFR 1271.15(a), an establishment that uses human cells, tissues, and cellular and tissue-based products (HCT/Ps) solely for nonclinical scientific or educational purposes is not required to comply with the requirements of Part 1271, leaving non-transplant anatomical material used for education or research outside that registration and current-good-tissue-practice framework.

21 CFR 1271.15 — Exemptions (Cornell Legal Information Institute / eCFR)

Federal and state cases against body brokers exposed consent fraud and disease-transmission risk

Biological Resource Center (Phoenix, AZ) and International Biological Inc. (Detroit, MI)

In the Biological Resource Center matter, the facility's owner pleaded guilty to a state enterprise charge for violating donor consent agreements, and a civil jury later awarded plaintiffs tens of millions of dollars over fraud and mishandling of remains. In a separate federal case, the operator of International Biological Inc. was convicted and sentenced in 2018 to nine years in prison for fraudulently selling remains, including remains infected with HIV or hepatitis, to buyers.

The Unregulated World of Body Brokers (Criminal Law Review)

Reuters 'The Body Trade' documented for-profit pricing and shipping of donated human remains with limited tracking

Non-transplant body-broker companies documented by Reuters

Reuters' 2017 investigative series 'The Body Trade' documented a largely unregulated supply chain in which donated human remains were priced, sold, and shipped by for-profit brokers, reporting that only a handful of states closely track such donations and that reporters legally purchased human body parts with no federal statute broken.

Special Report: The Body Trade (Reuters)

GAO found gaps in FDA regulation of human tissue banks and noted FDA lacked authority for some recommended safeguards

U.S. Government Accountability Office (GAO); U.S. Food and Drug Administration (FDA)

GAO report HEHS-98-25 (released December 1997), 'Human Tissue Banks: FDA Taking Steps to Improve Safety, but Some Concerns Remain,' evaluated FDA oversight of transplanted human tissue, identified gaps in the then-current regulation, and recorded multiple recommendations FDA could not implement on the basis that it lacked the statutory authority to do so.

Human Tissue Banks: FDA Taking Steps to Improve Safety, but Some Concerns Remain | U.S. GAO

FDA tissue rules exempt nonclinical, scientific, and educational uses of human tissue

U.S. Food and Drug Administration; 21 CFR 1271.15

FDA's tissue regulation at 21 CFR 1271.15 lists explicit exceptions from Part 1271, including an establishment that 'uses HCT/Ps solely for nonclinical scientific or educational purposes,' same-surgical-procedure autologous use, carriers, storage-only facilities, and certain reproductive-tissue transfers. Body-donation and research uses can therefore fall outside the full HCT/P framework.

21 CFR 1271.15 - Are there any exceptions from the requirements of this part? (Cornell LII)

FDA oversight of section 361 tissue establishments rests on self-registration, not premarket review

U.S. Food and Drug Administration; 21 CFR Part 1271

Under Part 1271, establishments manufacturing HCT/Ps regulated solely under section 361 of the PHS Act self-register with FDA and list their products, with annual updates, and are not subject to FDA premarket review or approval. FDA states that acceptance of a registration does not constitute a determination of compliance, and inspections operate under a risk-based surveillance program rather than systematic pre-clearance.

Tissue Establishment Registration | FDA

GAO found FDA had no universal tissue-bank registry and incomplete recipient tracing

U.S. Government Accountability Office (GAO/HEHS-98-25); U.S. Food and Drug Administration

A 1997/1998 GAO report found that the then-current FDA regulation did not require facilities to register, so FDA had 'no universal registry of tissue facilities currently operating in the United States,' and that FDA's tracking system for identifying recipients of potentially infected transplanted tissue was incomplete.

GAO HEHS-98-25, Human Tissue Banks: FDA Taking Steps to Improve Safety, but Some Concerns Remain

FDA shutdown of a New Jersey tissue recovery firm exposed donor-screening and recordkeeping failures

U.S. Food and Drug Administration; a New Jersey tissue recovery company; downstream tissue processors

In January 2006 FDA ordered a New Jersey tissue recovery company to cease manufacturing and retain inventories of HCT/Ps, citing failures in donor screening and recordkeeping and failure to follow standard operating procedures. The episode prompted a nationwide recall of tissue the firm had recovered, distributed through multiple downstream processors.

FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing

Arizona body-donation company found civilly liable over use of donated bodies; owner pleaded guilty to a state charge

Biological Resource Center of Arizona

A Maricopa County civil jury in 2019 awarded $58 million (including punitive damages) against the Biological Resource Center of Arizona and its owner over claims that the body-donation facility mishandled donated remains and deceived families about how the bodies would be used, including sale of remains for non-medical testing. The company's owner separately pleaded guilty in 2015 to a state charge of illegal control of an enterprise and was sentenced to probation.

Military Times / AP, "Jury awards $58M in lawsuit against body donation firm" (2019)

FDA shut down a tissue-recovery firm whose principals were convicted of forging consent and improperly recovering tissue

Biomedical Tissue Services (BTS), Fort Lee, New Jersey; U.S. Food and Drug Administration

The FDA ordered Biomedical Tissue Services, a New Jersey tissue-recovery firm, to cease operations in 2005 and to recover and quarantine tissue it had supplied, after investigations found tissue had been recovered from decedents without proper consent or adequate donor screening, with forged consent and screening documents. The firm's principal and associates were later criminally convicted in New York state court.

BMJ (via PMC), "FDA shuts down human tissue company" (2006)

FDA ordered recall and destruction of allografts from a tissue processor after contamination concerns and a fatal infection

CryoLife, Inc. (human tissue processor); U.S. Food and Drug Administration; CDC

In August 2002, after a CDC investigation linked a contaminated allograft to a fatal post-surgical infection, the FDA ordered CryoLife, Inc. to retain, recall, and destroy a large volume of its human-tissue allografts, finding the company could not ensure its tissue was free of contaminants and that its bacterial-detection systems were deficient and not reliable.

California Healthline, "FDA Orders Tissue Bank To Recall Most Human Tissue" (2002)

CDC documented hepatitis C transmission to multiple organ and tissue recipients from a single antibody-negative donor

U.S. tissue/organ donation system (CDC Morbidity and Mortality Weekly Report investigation)

A CDC investigation published in MMWR documented that a single organ-and-tissue donor who tested negative for hepatitis C antibody but was HCV-RNA positive was the probable source of HCV infection in at least eight organ and tissue recipients (United States, 2000-2002). The investigation noted this was the first reported tissue-transplant transmission from a donor found negative by a second- or third-generation antibody assay, and supported consideration of routine HCV nucleic-acid testing of donors.

CDC MMWR, "Hepatitis C Virus Transmission from an Antibody-Negative Organ and Tissue Donor --- United States, 2000-2002"

FDA warning letter cited a tissue establishment for donor-screening and communicable-disease testing deficiencies

Akan Biosciences, Inc. (HCT/P establishment); FDA Center for Biologics Evaluation and Research

In an FDA warning letter dated April 30, 2024 (ref. 654674), the FDA cited Akan Biosciences, Inc. for significant violations of HCT/P donor-eligibility and current good tissue practice requirements, including inadequate methods to screen and test donors for relevant communicable diseases and a donor-screening questionnaire that failed to address certain communicable-disease risk factors.

FDA Warning Letter, Akan Biosciences, Inc. (654674, 04/30/2024)

FDA warning letter documented a reproductive HCT/P establishment failing required donor-eligibility screening and testing

Washington Fertility Center; FDA (HCT/P donor-eligibility regime, 21 CFR Part 1271)

In an FDA warning letter dated April 30, 2024 (ref. 678931), the FDA cited Washington Fertility Center for incomplete donor-eligibility determinations, including donors not appropriately tested for relevant communicable-disease agents (HIV-1/HCV/HBV nucleic-acid testing) and screening questionnaires that did not capture all required communicable-disease risk factors.

FDA Warning Letter, Washington Fertility Center (678931, 04/30/2024)

Public officers must deliver bodies required to be buried at public expense to the State Anatomical Board for medical science unless a relative or connection affirmatively claims the body for burial; schools hold for 60 days for claims, then use follows. No affirmative next-of-kin consent is required.

Public Health Laws of Alabama (Title 22, Ch. 19, Art. 2 — Distribution of Unclaimed Bodies for Scientific Study), Alabama Dept. of Public Health

After a reasonable search for next of kin, unclaimed bodies are made available to the University of Arkansas for Medical Sciences Department of Anatomy; relatives, next of kin, friends, or fraternal/charitable representatives may claim the body within a 15-day holding period. No affirmative next-of-kin consent is required.

Arkansas Code Title 20, Subtitle 2, Chapter 17, Subchapter 7 (2024) — Unclaimed Bodies (Justia)

Officers must use due diligence to notify relatives, but in the absence of a known relative wishing to direct disposition the body is delivered for scientific or educational purposes; § 7202 allows a relative to claim the body within 30 days. Notification, not affirmative consent, is required.

California Health & Safety Code §§ 7200-7208 — Disposal of Unclaimed Dead (official California Legislative Information)

Officers must make reasonable effort to find a relative or friend; if none claims the body it is delivered to the anatomical board for the advancement of medical science. The body is not delivered if a relative, fraternal society, charity, or friend claims it; the board holds bodies 20 days for claims. Notification, not consent, is required.

C.R.S. § 15-19-302 — Duty of public officers as to unclaimed bodies (Colorado Revised Statutes)

A body not claimed by a surviving spouse or relative within a reasonable time (not less than 120 hours) that would require burial at public expense is reported to the Medical Council and delivered to an approved institution for anatomical study, including dissection. Relatives may claim within the window; no affirmative consent is required.

Delaware Code Title 16, Chapter 27, Subchapter I — Anatomical Studies, §§ 2701-2707 (Delaware Code Online)

Officers with control over a dead body required to be buried at public expense must deliver it to the Board for the Distribution of Cadavers for the advancement of medical science, unless a person of any degree of kin or connection claims the body for burial or other disposition. Relatives may claim to stop use; no affirmative consent is required.

2024 Code of Georgia § 31-21-21 — Delivery to board of certain unclaimed bodies (Justia)

Under the Cadaver Act, bodies of persons about to be buried at public expense in the custody of specified officials must be made available for anatomical, medical, biological or mortuary study. No affirmative decedent or next-of-kin consent is required; the default is delivery, subject to opt-out where the decedent left written instructions or a relative claims the body for burial.

Illinois Compiled Statutes, Cadaver Act (410 ILCS 510)

Indiana's Anatomical Education Program defines a 'cadaver' as a whole human body that has been donated OR is unclaimed by a relative or legal representative and would otherwise be buried at public expense. A coroner may direct an unclaimed body to the program rather than to burial or cremation (IC 36-2-14-16, except as provided in IC 21-44-2), so unclaimed bodies may be used without next-of-kin consent.

Indiana Code 21-44-2 (Anatomical Education Program)

Iowa Code 142.1 requires that the body of any person who dies in a public institution, is found dead, or is to be buried at public expense be delivered to a medical college for scientific purposes. No affirmative consent is required; delivery is the default, subject to opt-out where the decedent expressed a contrary desire, a relative so desires, or a friend objects and provides for burial.

Iowa Code Chapter 142 (Dead Bodies for Scientific Purposes)

Kansas requires coroners and other officials having charge of unclaimed dead bodies that would otherwise be buried at public expense or on pauper grounds to notify and release them to the University of Kansas department of anatomy for medical, surgical and anatomical study. No decedent or next-of-kin consent is required; protections are limited to a relative-claim window (72 hours after death) and a diligent search for relatives.

Kansas Statutes Annotated 65-902a

Kentucky permits a professor of a medical college to procure unclaimed dead bodies for anatomical study (KRS 311.300 to 311.350), and KRS 72.450 expressly allows a coroner to deliver an unclaimed body to a state medical school in lieu of burial at public expense. Relatives or friends must be notified and a holding period applies (KRS 311.330), but affirmative consent is not required for unclaimed bodies.

Kentucky Revised Statutes Chapter 311 (KRS 311.300 to 311.350)

Louisiana's Anatomical Board was created to receive the unclaimed bodies of deceased persons required to be buried at public expense (R.S. 17:2272) and distributes them to the LSU/Tulane departments of anatomy (R.S. 17:2275). No affirmative consent is required; protection is limited to a relative-claim opt-out, as receiving departments must hold each body at least 90 days during which a relative or friend may claim it for interment.

Louisiana Revised Statutes 17:2272 (Anatomical Board; purposes)

Maine requires public officers having charge of bodies required to be buried at public expense to deliver them to the board of distribution for the advancement of medical education (22 MRS 2883); the statute deems 'buried at public expense' to include the unclaimed dead bodies of all indigent persons. No affirmative consent is required, but no body is delivered if a family member or next of kin claims it for burial.

Maine Revised Statutes Title 22, Chapter 709 (Disposal of Dead Bodies)

When a public officer cannot find anyone to take control of a body, the officer must notify the State Anatomy Board; after 72 hours the body is under the Board's exclusive control (5-406) and is distributed to medical schools (5-407). No affirmative consent is required for unclaimed bodies; protection is limited to a relative-or-friend claim opt-out during the holding period.

Annotated Code of Maryland, Health-General Title 5, Subtitle 4 (Anatomy Board), 5-406 and 5-407

Unclaimed bodies and bodies of deceased patients in state-funded hospitals not claimed within a reasonable time by relatives or a fraternal order may be turned over to the state university, medical colleges, or mortuary-science programs for anatomical purposes without next-of-kin consent; travelers/strangers dying suddenly are excluded and remains must be decently interred or cremated afterward.

Mississippi Code Sec. 41-39-7 (2024) — Justia

Officials with custody of persons required to be buried at public expense must notify and deliver the body to the state anatomical board within 36 hours; no next-of-kin consent is required. A relative or friend may reclaim the body within a 30-day holding period for interment, but the default is delivery for anatomical use.

RSMo Section 194.150 — Missouri Revisor of Statutes

A medical school may procure unclaimed human bodies for teaching and demonstration of anatomy; the custodian may deliver an unclaimed body if the deceased did not request immediate burial. No next-of-kin consent is required, though the body must be kept at least three weeks after death before use.

50-21-101. Procurement of cadavers — Montana Code Annotated

RSA 291:1 directs public officials, upon request, to permit physicians and surgeons to use unclaimed bodies requiring public burial for the advancement of anatomical and medical science; RSA 291:3 bars surrender if claimed within 36 hours after death and excludes strangers/travelers and honorably discharged veterans. RSA 611-B:25 separately routes medical-examiner unclaimed bodies to burial/cremation with discretionary release to medical schools. Next-of-kin consent is not required.

New Hampshire RSA 291:1 (Request for Body) — Justia

After due-diligence notice to next of kin and a 14-day claim window, an unclaimed body may be retained by the office of the medical investigator for use only in medical education; the statute requires diligent notice but not affirmative next-of-kin consent before such use.

N.M. Stat. Ann. Sec. 24-12-2 - Disposition of unclaimed body (Justia, 2025)

Bodies not claimed for final disposition within 10 days of death may be received and delivered by the Commission of Anatomy after reasonable efforts to contact relatives; next-of-kin consent is not required, though bodies under medical-examiner jurisdiction and those subject to an anatomical gift are excluded.

N.C. Gen. Stat. Sec. 130A-415 (North Carolina General Assembly)

Medical schools and physicians may receive, on proper notice to relatives, the bodies of persons executed by law, persons dying in penitentiary or jail under sentence, and persons required to be buried at public expense; consent is not required, but the body must be released if a friend, relative, or guardian requests it within 36 hours of death or if the decedent had asked to be buried.

N.D. Cent. Code Ch. 23-06 (North Dakota Legislative Branch)

Unclaimed or unidentified bodies, and bodies that must be buried at public expense, may be delivered to a medical college after a 36-hour waiting period without next-of-kin consent; Sec. 1713.38 still bars delivery of strangers or travelers unless the decedent belonged to the class commonly known as tramps, retaining historical status-based language.

Ohio Rev. Code Sec. 1713.34 (Ohio Laws / codes.ohio.gov)

If reasonable effort does not locate a relative, friend, or representative willing to assume the body for burial within 24 hours after death, a government official may notify the State Anatomical Board; consent is not required, but no body is surrendered if a relative, fraternal society, charitable organization, or friend claims it for burial first.

Okla. Stat. tit. 63, Sec. 92 - Conditions for surrendering unclaimed bodies to Anatomical Board (Justia, 2025)

After a funeral establishment attempts for 10 days to locate relatives, the body of an indigent or unclaimed person may be transferred to a listed educational or research institution if no one claims it or the persons notified acquiesce; affirmative next-of-kin consent is not required, and the statute uses status language of the indigent person.

Or. Rev. Stat. Sec. 97.170 (Oregon Public Law)

Corrected: the cited 20 Pa.C.S. Sec. 8611 governs only voluntary, consent-based anatomical gifts. Pennsylvania's unclaimed-body authority is the still-in-force 1883 Anatomical Act, under which public officials must deliver bodies that would be buried at public expense to the Humanity Gifts Registry within 36 hours of death for distribution to medical and dental schools, without next-of-kin consent; relatives, friends, fraternal societies, or charities may instead claim the body for burial within 36 hours, and honorably discharged veterans are excluded.

Act of June 13, 1883, P.L. 119, No. 106 - Unclaimed Cadavers, Distribution and Disposition (PA General Assembly, unconsolidated statutes)

Officers of public institutions must notify and deliver, without charge, bodies that would otherwise be buried at public expense to the Anatomical Board for distribution to medical schools; next-of-kin consent is not required, but Sec. 44-43-540 provides that no notice is given and no body delivered if a person of kin or related by marriage claims the body for burial and pays the expenses.

S.C. Code of Laws Title 44, Chapter 43 (South Carolina Legislature)

A public official having an unclaimed body to be buried at public expense must notify the medical school, which may requisition it; the body is preserved at least 60 days during which a friend or relative may claim it, after which it may be used for anatomical study. No affirmative next-of-kin consent is required; the safeguard is the relative-claim window.

SDLRC - Codified Law 34-26, Custody and Disposition of Bodies and Body Parts (South Dakota Legislature)

Unclaimed bodies of persons dying in charitable/penal/publicly supported institutions or to be buried at public expense are subject to disposition directed by the chief medical examiner to promote medical and surgical science, after notice to any known relative and a holding period. Notification of relatives is required but affirmative consent is not; veterans are excepted.

Disposition of Unclaimed Dead Bodies (UT County Technical Assistance Service, summarizing T.C.A. 68-4-102 et seq.)

An official with charge of an unclaimed body to be buried at public expense must notify the dean of the University of Utah School of Medicine within 24 hours and forward the body on request; the body is preserved at least 60 days for a friend or relative to claim, after which it may be used to promote medical and surgical science. No affirmative next-of-kin consent is required.

Utah Code Title 53B, Chapter 17, Part 3 - Use of Dead Bodies for Medical Purposes (Justia, 2024)

A public agency responsible for disposition of human remains at public expense must surrender them to a physician or surgeon (preference to in-state medical schools) for the advancement of anatomical science, or to an accredited embalming program. The remains must instead be buried if the decedent requested burial or a relative or affiliated religious officer requires it. This is an objection-based model, not affirmative consent.

RCW 68.50.070, Human remains - Disposition (Washington State Legislature)

Unclaimed adult bodies may be released to the West Virginia Anatomical Board and delivered to medical schools for anatomical study after a required search for advance directives, next of kin, and authorized representatives. The next-of-kin inquiry is mandatory, but if no one is located or claims the body, it may be used without affirmative consent.

West Virginia DHHR/BSS Unclaimed Deceased Adult Body Policy (citing W. Va. Code ch. 18B art. 4)

Under Wis. Stat. 157.02, an unclaimed corpse may be delivered to a university or school for anatomical study; relatives may claim it any time before delivery (or after cremation but before burial), and 157.03 bars delivery where the decedent requested burial or cremation in last sickness. This is the unclaimed-body provision; 157.06 is the separate consent-based anatomical-gift statute.

Wis. Stat. 157.02 - Disposition of unclaimed corpses (Wisconsin Legislature)

W.S. 35-4-601 requires boards and officials, on request, to surrender bodies of persons to be buried at public expense to physicians, dentists, or medical colleges for the advancement of anatomical science, with a penalty for refusing to deliver (35-4-604). Section 35-4-602 exempts decedents who requested not to be dissected, those claimed by kindred or a friend within 48 hours, strangers or travelers, and honorably discharged veterans. Opt-out, not affirmative consent.

Wyoming Statutes Title 35, Chapter 4 - Health Regulations Generally (Justia)

Unclaimed remains are reported to the Anatomical Board for medical education or research, but § 406.50 exempts a body when a legally authorized person objects to such use, requires reasonable effort to identify and contact relatives, and § 406.52 sets a 48-hour minimum hold. Family objection blocks use, making consent conditional.

The 2024 Florida Statutes, Chapter 406 §§ 406.50-406.53 (The Florida Senate)

A body becomes available to the department only after officials use due diligence to notify the persons with authority to control disposition (next of kin under EPIC Sec. 3206) and no such person directs another disposition. This is a notice-and-opportunity-to-claim regime, not pure consent and not unrestricted use.

MCL Section 333.2653 — Michigan Legislature

Section 4211 uses a deemed-assent/claim-window model rather than requiring affirmative consent statewide, but in cities of one million or more it requires anatomical-gift or written consent, and statewide it bars delivery where the decedent expressed opposition (or carried an objection card) and where the religious-objection limits of Sec. 4210-c apply, making the regime conditional/restrictive.

N.Y. Pub. Health Law Sec. 4211 (NY State Senate, current)

The cited unclaimed-body statute (ch. 113, Secs. 1-5), which formerly let medical schools take publicly-buried bodies without next-of-kin consent (subject to a 14-day identification/claim window under Sec. 3), was repealed effective about November 25, 2025 by Acts of 2025, c. 73, Sec. 31. With that permissive statute gone and anatomical donation now governed by the consent-based UAGA (ch. 113A), a current without-consent pathway cannot be confirmed.

Acts of 2025, Chapter 73, Sec. 31 (repealing G.L. c. 113, Secs. 1-5) — Massachusetts Legislature

The originally cited sections (26:6-9 and the Medical Examiner Act, ch. 26:6B) address death notification and medicolegal investigation, not without-consent educational use; anatomical donation is governed by the consent-based Revised Uniform Anatomical Gift Act (26:6-77 et seq.). No current New Jersey statute permitting use of unclaimed bodies for medical education without next-of-kin consent could be confirmed, so the status is treated as unclear.

N.J. Rev. Stat. Sec. 26:6-77 (Short title; Revised Uniform Anatomical Gift Act) — Justia

AS 12.65.100 directs unclaimed bodies to be buried or cremated by court order; it contains no pathway to use an unclaimed body for education or research. Anatomical/educational use must proceed through the consent-based anatomical gift provisions of AS ch. 13.52, which require authorization by the decedent or a priority class of relatives.

2024 Alaska Statutes Sec. 12.65.100 — Unclaimed bodies (Justia)

Section 36-831 makes the county responsible for burial or crypt placement of unclaimed remains and does not authorize delivery to medical schools. Anatomical/educational use must proceed under the Revised Uniform Anatomical Gift Act, which requires authorization by the decedent or a listed priority class and bars a gift over a known refusal or objection.

Ariz. Rev. Stat. § 36-848 — Who may make anatomical gift of decedent's body or part (Arizona Legislature)

Section 19a-282 expressly provides that the body of any person known to have relatives by blood or marriage may not be delivered for anatomical study without their consent, and § 19a-270 allows relatives to claim the body within a 48-hour period. Next-of-kin consent is required.

Connecticut General Statutes Chapter 368i — Anatomical Donations, §§ 19a-270, 19a-282 (Connecticut General Assembly)

The District governs anatomical use through its Revised Uniform Anatomical Gift Act, under which a body or part may be used for research or education only pursuant to an anatomical gift made by the donor or by an authorized person. The RUAGA contains no provision permitting use of unclaimed or indigent bodies without consent.

D.C. Code 7-1531.10, Persons that may receive anatomical gift; purpose of anatomical gift (D.C. Law Library)

Hawaii routes body donation through the Revised Uniform Anatomical Gift Act, which requires authorization (consent) by the decedent or a person in the statutory priority class; commentators on unclaimed-body practice classify Hawaii among the states that bar dissection of unclaimed bodies absent written consent. Unclaimed remains are otherwise directed to disposition (cremation), not to medical schools without consent.

Hawaii Revised Statutes 327-9 (Who may make an anatomical gift of decedent's body or body part)

Idaho has no statutory unclaimed-body dissection program. Use of a decedent's body for education runs through the Revised Uniform Anatomical Gift Act, which requires authorization by the decedent or a statutory-priority person (39-3409). The coroner statute directs unclaimed bodies to burial or cremation after 14 days (31-2802), not to medical schools, so use generally requires consent.

Idaho Code 39-3409 (Who may make an anatomical gift of a decedent's body or part)

For unidentified or unclaimed bodies, Sec. 390.21 directs the medical examiner to provide dignified burial or storage and expressly states that dignified burial shall not include donation for anatomic dissection. Anatomical use therefore requires a gift made with consent under ch. 525A. (The cited 149A.81, subd. 2 governs disposition after a gift, not consent for unclaimed bodies.)

Sec. 390.21 MN Statutes — Minnesota Revisor's Office

The former mandatory-delivery provisions for unclaimed bodies (Secs. 71-1002, 71-1004, 71-1005) were repealed by Laws 2019, LB559, Sec. 6. The State Anatomical Board now takes and distributes only bodies received as provided in Sec. 71-4834, which is part of the consent-based Revised Uniform Anatomical Gift Act, so a current without-consent unclaimed-body pathway is no longer evident.

Neb. Rev. Stat. Sec. 71-1003 (Board; dead human bodies; distribution) — Nebraska Legislature

Nevada's Anatomical Dissection Committee scheme, which required notification and delivery of unclaimed or public-expense bodies for dissection (e.g., NRS 451.350, 451.400, 451.420, 451.430), was repealed by chapter 60, Statutes of Nevada 2023. The current statutory framework is the consent-based Revised Uniform Anatomical Gift Act (NRS 451.500-451.598).

NRS Chapter 451 - Dead Bodies — Nevada Legislature

Confirmed: Rhode Island has no statute authorizing use of unclaimed bodies for medical education without consent. Under Sec. 23-4-10 an unclaimed body must be buried, and any anatomical use must proceed through the consent-based Revised Uniform Anatomical Gift Act; the AMA issue brief lists Rhode Island among states that restrict the practice.

R.I. Gen. Laws Ch. 23-18.6.1 - Revised Uniform Anatomical Gift Act (Justia, 2024)

S.B. 1406 (2025) removed automatic authority of state and institutional officials to donate unclaimed bodies and now requires that a body be donated either by the decedent in writing or with the informed consent of a person authorized to claim the body for burial before it may go to a willed-body program, non-transplant anatomical donation organization, or other donee.

Bill Analysis, S.B. 1406, 89th Texas Legislature (2025) - Texas Legislature Online

Vermont governs anatomical use of bodies through its Revised Uniform Anatomical Gift Act, which requires an anatomical gift made by the donor or by an authorized person in a defined priority order. The chapter contains no provision permitting use of unclaimed or indigent bodies for education or research without consent.

18 V.S.A. Chapter 110 - Revised Uniform Anatomical Gift Act (Vermont Statutes Online)

After the 2014 reform (SB 304), Va. Code 32.1-298 limits delivery to the Commissioner to bodies that have been lawfully donated for scientific study, and unclaimed bodies are routed to burial or cremation under Chapter 8.1 rather than automatically to anatomical study. Scientific use thus turns on donation/consent. Classification reflects the post-2014 statutory text; some procedural nuance remains.

Code of Virginia 32.1-298, Notification of Commissioner; delivery of bodies (Virginia Law Library)

OneLegacy (largest US OPO): $142.8M revenue, $217.3M assets, CEO paid ~$1.01M (FY2024 Form 990)

OneLegacy (Los Angeles OPO; EIN 95-3138799) · $142.8M revenue; $217.3M assets; CEO $1,011,953 (FY2024)

Per its fiscal-year-2024 IRS Form 990 (extracted on ProPublica Nonprofit Explorer), OneLegacy, the federally designated organ procurement organization for greater Los Angeles, reported total revenue of $142,795,454 and total assets of $217,331,658. The organization's Chief Executive Officer role received total reportable compensation of $1,011,953 for the year. Revenue grew from $105.5M (FY2022) to $124.6M (FY2023) to $142.8M (FY2024).

OneLegacy - Nonprofit Explorer, ProPublica (IRS Form 990, FY2024)

Gift of Life Donor Program (Philadelphia): $152.9M revenue, $152.2M assets, President/CEO paid $833,139 (FY2024 Form 990)

Gift of Life Donor Program / Greater Delaware Valley Society of Transplant Surgeons (Philadelphia OPO; EIN 23-7388767) · $152.9M revenue; $152.2M assets; President/CEO $833,139 (FY2024)

Per its fiscal-year-2024 IRS Form 990 (extracted on ProPublica Nonprofit Explorer), the Philadelphia-area OPO operating as Gift of Life Donor Program (legal entity: Greater Delaware Valley Society of Transplant Surgeons) reported total revenue of $152,878,717 and total assets of $152,212,630. The President/CEO role received total reportable compensation of $833,139 for the year (corrected; an earlier draft figure of ~$1.01M was inaccurate). It is the highest-revenue OPO in the sample.

Greater Delaware Valley Society of Transplant Surgeons (Gift of Life Donor Program) - Nonprofit Explorer, ProPublica (IRS Form 990, FY2024)

Mid-America Transplant: $108.1M revenue, $133.5M assets (FY2024 Form 990)

Mid-America Transplant Services (St. Louis OPO; EIN 23-7426306) · $108.1M revenue; $133.5M assets (FY2024)

Per its fiscal-year-2024 IRS Form 990 (extracted on ProPublica Nonprofit Explorer), Mid-America Transplant Services, the OPO serving parts of Missouri, Illinois and Arkansas, reported total revenue of $108,143,652 and total assets of $133,538,293. Revenue rose from $82.5M (FY2022) to $95.6M (FY2023) to $108.1M (FY2024).

Mid America Transplant Services - Nonprofit Explorer, ProPublica (IRS Form 990, FY2024)

LiveOnNY: $93.3M revenue; President/CEO total compensation ~$1.55M (FY2024 Form 990)

LiveOnNY / Liveonny Inc (New York City OPO; EIN 13-2945229) · $93.3M revenue; President/CEO $1,553,591 (FY2024)

Per its fiscal-year-2024 IRS Form 990 (extracted on ProPublica Nonprofit Explorer), LiveOnNY (legal entity Liveonny Inc), the OPO for the greater New York City area, reported total revenue of $93,277,152 and total assets of $76,925,749. The President/CEO role was the highest-paid officer, with total reportable compensation of $1,553,591 for the year.

Liveonny Inc - Nonprofit Explorer, ProPublica (IRS Form 990, FY2024)

OneLegacy: >$500K of cost-reported spending flagged as unallowable/unsupported (incl. parade, football tickets, lobbying); ~31% organ-recovery rate cited by reform advocates

OneLegacy (Los Angeles OPO) · >$500K unallowable/unsupported (FY2006 audit); ~31% recovery (2012-2014 UPenn analysis)

Published oversight/reform documentation states OneLegacy 'misspent more than half a million taxpayer dollars on unallowable or poorly documented items - including football tickets, parade expenses, and lobbying costs - according to a government audit,' tracing to the HHS-OIG FY2006 cost-report audit (~$531K of unallowable/unsupported costs, including Rose Parade, lobbying, meals and entertainment). The same documentation cites a University of Pennsylvania analysis (2012-2014) reporting OneLegacy recovered organs from roughly 31% of potential donors. The two figures derive from different periods and sources and are presented together by advocates; the underlying audit and analysis are public record.

Oversight Gaps and Conflicts - The Costly Effects of an Outdated Organ Donation System (citing HHS-OIG audit and UPenn OPO analysis)

OneLegacy executive-compensation pool: ~$5.18M total officer/key-employee compensation in a single year (FY2024 Form 990)

OneLegacy (Los Angeles OPO; EIN 95-3138799) · $5,176,629 total officer/key-employee compensation (FY2024)

Beyond the single CEO figure, OneLegacy's fiscal-year-2024 IRS Form 990 reports aggregate 'Executive Compensation' (officers, directors, trustees and key employees) of $5,176,629 - about 4.0% of total expenses for the year - per the extracted data on ProPublica Nonprofit Explorer. Individual reported figures by role include the CEO (~$1.01M), the Chief Information Officer role, and two medical-director roles, among others.

OneLegacy - Nonprofit Explorer, ProPublica (IRS Form 990, FY2024, extracted executive compensation)

~$600M-revenue nonprofit organ/tissue organization paid its CEO over $3.5M in one year

LifeNet Health, 501(c)(3) organ-procurement/tissue organization, Virginia, EIN 52-1273592 · $598.6M revenue; $3.55M CEO total comp (FY2024)

LifeNet Health, a 501(c)(3) categorized by the IRS as an organ-and-tissue bank, reported total revenue of $598,564,898 in FY2024 (and $535,478,299 in FY2023). Its Form 990 lists the CEO role as the highest-compensated officer, with total compensation of $3,545,517 in FY2024.

Lifenet Health — Nonprofit Explorer, ProPublica (IRS Form 990)

OPOs hold board seats and reported financial stakes in tissue processors (per reform-group analysis of OPO 990s)

AlloSource board (executives from Donor Alliance, Iowa Donor Network, Mid-America Transplant, ConnectLife, Gift of Hope); MTF Biologics board (Midwest Transplant Network, LifeShare of Oklahoma, New Jersey Sharing Network) · stakes reported $8M-$26.4M (per analysis of OPO 990s)

A published analysis by Organ Donation Reform (costlyeffects.organdonationreform.org), citing the OPOs' own IRS Form 990 filings on ProPublica, states that executives from five named OPOs sit on AlloSource's board and that these OPOs hold ownership stakes in AlloSource ranging from $8 million to $26.4 million, and that executives from three additional named OPOs sit on the MTF Biologics board. This is an advocacy-group compilation derived from public 990 data, not a government finding; the underlying per-OPO 990 figures should be independently confirmed.

Tissue Donation & Processing — The Costly Effects of an Outdated Organ Donation System (Organ Donation Reform), citing OPO IRS Form 990s

OPOs are Medicare cost-reimbursed for organ acquisition, while donated tissue is a separate revenue stream

CMS organ-acquisition cost reimbursement framework (42 CFR Part 413, Subpart L); federally designated OPOs (~56-57) · ~56-57 federally designated OPOs

Under 42 CFR Part 413 Subpart L, organ acquisition costs are reimbursed on a reasonable-cost basis (the OPO is reimbursed via the transplant center, subject to Medicare adjustment). This federal cost-reimbursement framework applies to organ acquisition; revenue from processing and distributing donated human tissue falls outside that organ-acquisition cost-reimbursement system. Source counts of federally designated OPOs cluster around 56-57.

42 CFR Part 413 Subpart L — Payment of Organ Acquisition Costs (eCFR)

Surveyed OPOs reported dozens of outside-employment, board, and financial conflicts (2015-2023)

MTN, LifeShare, Donor Alliance, TN/NM Donor Services, LifeCenter, Gift of Life Donor Program, Versiti (OPOs) · LifeCenter: 18 financial conflicts; Gift of Life: 5 financial conflicts

The June 2025 Senate Finance staff report tabulated conflicts each OPO reported for 2015-2023, including: MTN (20 outside-employment, 2 board, 1 shareholder/investment); LifeShare (22 outside-employment, 8 board, 3 family); Donor Alliance (7 outside-employment, 8 board); TN/NM Donor Services (2 outside-employment, 2 board); LifeCenter (53 outside-employment plus 18 financial conflicts); Gift of Life Donor Program (8 outside-employment, 7 board, 5 financial); Versiti asserted it had no conflicts. The report notes it is unclear whether these were actual or potential conflicts or how they were reviewed.

Operation Transplant Staff Report (Senate Committee on Finance, June 2025), p.16

Harvard working paper: OPO solid-organ procurement coverage totaled $9.25B over 2015-2021

Independent Organ Procurement Organizations (CMS Form 216-94 cost reports); Harvard/UMD researchers · $9.25B total (2015-2021); $1.8B in 2021

A Harvard Law (Project on the Foundations of Private Law) working paper using FOIA-obtained OPO cost reports states that total payer coverage for procuring the four solid organs (kidney, liver, heart, lung) between 2015 and 2021 was $9.25 billion, with the 2021 cost approximated at $1.8 billion. Kidneys accounted for 51% of the industry, followed by liver (26%), heart (12%), and lung.

Cost-Shifting in Healthcare: Insights from OPO Cost Reports (Ozbay & Rava, Harvard working paper)

Average Standard Acquisition Charge per kidney was $31,381; total kidney SAC $4.7B (2015-2021)

Independent OPOs / CMS cost-reimbursement system · $31,381 avg kidney SAC; $4.7B total kidney SAC

Per the same Harvard cost-report analysis, total kidney Standard Acquisition Charge (SAC) between 2015 and 2021 was $4.7 billion and the average SAC of a single kidney was $31,381. CMS guarantees OPOs 100% coverage of the SAC for both viable and non-viable kidneys, with OPOs required to repay Medicare any excess.

Cost-Shifting in Healthcare: Insights from OPO Cost Reports (Ozbay & Rava, Harvard working paper), Tables 2-3

Largest OPO (OneLegacy) reported ~$143M revenue (2024); CEO compensation over $1M

OneLegacy (Southern California OPO), EIN 95-3138799 · $142.8M revenue (2024); CEO $1,011,953 (2024)

Per IRS Form 990 data on ProPublica Nonprofit Explorer, OneLegacy reported total revenue of $142,795,454 in fiscal 2024 (up from $97.8M in 2021), and the Chief Executive Officer role received $1,011,953 in compensation in 2024.

OneLegacy, IRS Form 990 via ProPublica Nonprofit Explorer (EIN 95-3138799)

LifeSource (Upper Midwest OPO) reported ~$82-101M revenue in recent years; CEO comp up to ~$735K

Upper Midwest Organ Procurement Organization / LifeSource, EIN 36-3584029 · $82.5M-$100.8M revenue (2023-2024); CEO up to $734,946

Per IRS Form 990 data on ProPublica, the Upper Midwest Organ Procurement Organization (LifeSource) reported total revenue rising from $41.4M (2015) to a peak of $100.8M (2023), with $82.5M in 2024. The Chief Executive Officer role's compensation reached $734,946 (2024).

Upper Midwest Organ Procurement Organization (LifeSource), IRS Form 990 via ProPublica (EIN 36-3584029)

Medicare guarantees 100% kidney cost reimbursement on OPO self-reported costs (42 CFR Part 413 Subpart L)

CMS / OPO cost-reimbursement model (42 CFR Part 413 Subpart L) · 100% kidney SAC coverage; 42 CFR Part 413 Subpart L

Under 42 CFR Part 413, Subpart L, covered kidney-acquisition services furnished by independent OPOs are reimbursed under reasonable-cost principles: OPOs submit cost reports, a contractor reviews them and sets an interim kidney Standard Acquisition Charge, and the rate is reconciled to actual costs. The Harvard cost-report paper characterizes CMS's guarantee of 100% coverage of the kidney SAC (viable and non-viable) as the financial engine of the system.

42 CFR Part 413 Subpart L (eCFR); Harvard OPO cost-report paper

UNOS, the longtime sole OPTN contractor, runs a roughly $69-93M/yr operation funded mainly by patient registration fees

United Network for Organ Sharing (UNOS), EIN 54-1327878 · ~$69M (FY2019) to ~$92.9M (FY2023) gross receipts; $1,036/candidate registration fee (FY2026)

UNOS, which for decades held the federal Organ Procurement and Transplantation Network (OPTN) contract as sole contractor, is a 501(c)(3) headquartered in Richmond, VA. Per its IRS Forms 990, gross receipts rose from about $69.0M (FY2019) to about $92.9M (FY2023). Most of its operating budget is funded by OPTN patient registration fees that transplant programs pay per candidate added to the waiting list (the FY2026 fee is $1,036 per candidate); registration fees have been reported to comprise roughly 85% of UNOS's budget.

United Network for Organ Sharing - Nonprofit Explorer, ProPublica (IRS Form 990)

The self-described largest OPO is a $140M+ nonprofit with $200M+ in assets and seven-figure CEO pay

OneLegacy (Los Angeles OPO), EIN 95-3138799 · $142.8M revenue, $217.3M assets, ~$1.15M CEO total comp (FY2024)

OneLegacy, which describes itself as the nation's largest organ procurement organization (serving the Los Angeles region), reported total revenue of about $142.8M and total assets of about $217.3M in FY2024 per its IRS Form 990, up from about $124.6M revenue / $141.1M assets in FY2023. Its highest-paid executive, the chief executive officer, received roughly $1.15M in total compensation in FY2024.

OneLegacy - Nonprofit Explorer, ProPublica (IRS Form 990)

OneLegacy (Los Angeles), the nation's largest OPO, reported $142.8M revenue and ~$1.01M CEO pay (FY2024)

OneLegacy (EIN 95-3138799) · $142.8M revenue; ~$1.01M CEO base comp (FY2024)

OneLegacy, the federally designated organ procurement organization for greater Los Angeles, reported total revenue of $142,795,454 for the fiscal year ending Dec. 31, 2024 on its IRS Form 990. Its Chief Executive Officer reported base/reportable compensation of $1,011,953 plus $139,130 in other compensation for that year. The prior year (FY2023) revenue was $124,586,536.

OneLegacy — IRS Form 990, ProPublica Nonprofit Explorer (EIN 95-3138799)

Gift of Life Donor Program (Philadelphia) reported $152.9M revenue and ~$833K CEO pay (FY2024)

Gift of Life Donor Program / Greater Delaware Valley Society of Transplant Surgeons (EIN 23-7388767) · $152.9M revenue; ~$833K CEO total comp (FY2024)

The Gift of Life Donor Program (the OPO serving eastern Pennsylvania, southern New Jersey and Delaware, organized as the Greater Delaware Valley Society of Transplant Surgeons) reported total revenue of $152,878,717 for the fiscal year ending Dec. 31, 2024 on its IRS Form 990. Its President and CEO reported total compensation of $833,139 for that year.

Greater Delaware Valley Society of Transplant Surgeons (Gift of Life) — IRS Form 990, ProPublica Nonprofit Explorer (EIN 23-7388767)

Medicare reimburses OPOs for kidney acquisition on a reasonable-cost basis via the Standard Acquisition Charge

CMS / OPOs (42 CFR Part 413 Subpart L) · Cost-based SAC per usable kidney (42 CFR 413.404 / 413.420)

Under 42 CFR Part 413 Subpart L (notably 413.404 and 413.420), an independent OPO sets a per-kidney Standard Acquisition Charge derived from its own prior-period kidney-acquisition costs divided by usable deceased-donor kidneys, and is reimbursed for covered kidney-acquisition services on a Medicare reasonable-cost basis. This cost-based structure pays OPOs against self-reported costs, which OIG audits have repeatedly found included unallowable or unsupported items.

42 CFR 413.404 — Standard acquisition charge (eCFR)

Nonprofit tissue foundation runs a half-billion-dollar allograft operation

Musculoskeletal Transplant Foundation (MTF Biologics), 501(c)(3), EIN 22-2803458 · $509.5M total revenue (FY2024)

MTF Biologics is a tax-exempt 501(c)(3) organization whose IRS Form 990 reports total revenue of $509,478,090 for FY2024 (and $493,471,813 for FY2023), the overwhelming majority from program services tied to recovering, processing and distributing donated human tissue. Its 2024 program-service investments included roughly $204M in tissue recovery/processing and $229M in tissue distribution.

Musculoskeletal Transplant Foundation Inc — Nonprofit Explorer, ProPublica (IRS Form 990)

Large nonprofit organ/tissue organization files alongside multiple related LifeNet entities

LifeNet Health and related/affiliated LifeNet entities (IRS Form 990 filers)

ProPublica's Nonprofit Explorer shows LifeNet Health (EIN 52-1273592) alongside separately-filing related LifeNet entities, including LifeNet Services Inc (EIN 45-4996122), and LifeNet Health publicly describes multiple divisions (Bio-Implants, Tissue Services, Transplant Services, an Institute of Regenerative Medicine, and a foundation). The precise Schedule R parent/subsidiary and for-profit-affiliate structure should be confirmed against the filed Schedule R before characterizing it as a commercialization vehicle.

Lifenet Health / Lifenet Services Inc — Nonprofit Explorer, ProPublica

A university tissue bank spun out a for-profit processor that became a public company

RTI Surgical (originally Regeneration Technologies, Inc.), from University of Florida Tissue Bank · IPO Aug 2000 (NASDAQ: RTIX)

In February 1998 the University of Florida Tissue Bank transferred its allograft processing operations, equipment, technologies and distribution arrangements to Regeneration Technologies, Inc. The company completed an initial public offering in August 2000 and traded on NASDAQ under the symbol RTIX, later becoming RTI Biologics and then RTI Surgical through mergers and acquisitions — a documented path from nonprofit/university tissue bank to publicly traded for-profit processor.

RTI Surgical — Wikipedia (company history; corroborated by company history page rtix.com)

AlloSource: a 501(c)(3) tissue processor with ~$180M revenue

AlloSource, 501(c)(3) tissue processor, Colorado, EIN 84-1327507 · $180.05M total revenue (FY2024)

AlloSource is a 501(c)(3) classified by the IRS as an organ-and-tissue bank, reporting total revenue of $180,054,973 in FY2024 ($172,749,079 in FY2023; $157,659,866 in FY2022), with roughly 98.8% from program services. It processes and distributes donated human tissue.

Allosource — Nonprofit Explorer, ProPublica (IRS Form 990)

Publicly traded processor runs a hundreds-of-millions human-tissue preservation business

Artivion (formerly CryoLife), NYSE: AORT · ~$441M TTM revenue (2025)

Artivion (formerly CryoLife) is a publicly traded company reporting trailing-12-month revenue of about $441 million (as of Dec. 31, 2025) and operates a 'Preservation Services' segment that derives revenue from preserving implantable human cardiac and vascular tissues — illustrating a for-profit, hundreds-of-millions-of-dollars business downstream of human tissue donation.

Artivion 2024 Annual Report to Stockholders (NYSE: AORT)

Reuters investigation: tens of thousands of donated bodies, 180,000+ parts in the non-transplant 'body broker' market

US non-transplant 'body broker' / willed-body industry · 50,000+ bodies; 180,000+ parts (2011-2015)

A 2017 Reuters investigation ('The Body Trade') documented that between 2011 and 2015 private brokers in the US received at least 50,000 donated bodies and shipped more than 180,000 body parts, tracing roughly 50,000 bodies through 34 brokers, with destinations (device companies, dental schools, defense contractors) often not clearly disclosed on the consent forms families signed. This non-transplant market operated with minimal federal regulation.

Reuters 'The Body Trade' investigation (2017)

Tissue (cornea, bone, skin) is sold at market prices CMS does not govern; OPO tissue revenue over $9B (2015-2021)

Independent OPOs / human-tissue market · over $9B OPO tissue revenue (2015-2021); median ~$4.5M/OPO

The Harvard cost-report paper states that, separate from CMS-governed solid-organ reimbursement, OPOs recover and sell human tissues (cornea, bone, skin) to both non-profit and for-profit organizations at market prices that are not governed or overseen by CMS, and that tissue procurement is a significant revenue source with revenues of over $9 billion between 2015 and 2021. The paper's per-OPO summary statistics show median OPO tissue revenue of about $4.5M and a maximum of $425.6M.

Cost-Shifting in Healthcare: Insights from OPO Cost Reports (Ozbay & Rava, Harvard working paper)

Tissue revenue per donor body estimated at $80,000+ in a ~$1B industry (NPR/ICIJ investigation)

US human-tissue banking industry · ~$80,000+ per body; ~$1B industry (2012 estimate)

A 2012 NPR investigation, co-reported with the International Consortium of Investigative Journalists, reported that human-tissue donation fuels an estimated $1 billion industry and that the tissue recovered from a single body can generate revenues of $80,000 or more. The series also reported that donors were told tissue might go to a for-profit company only about 18% of the time.

NPR, "Tissue Donation A Growing Billion Dollar Business" (2012)

Processed human tissue priced up to ~$500/gram (researcher estimate)

Human-tissue product market (processors / distributors) · ~$500/gram (estimate)

A reform-advocacy review compiling the tissue-donation literature cites an estimate that processed human tissue can be valued at roughly $500 per gram, attributing the figure to a 2015 EMBO Reports article on access to human tissue for research and development. The figure is a published estimate rather than a regulated or audited price.

Organ Donation Reform, "Tissue Donation & Processing" (citing EMBO Reports, 2015)

Several OPOs hold multimillion-dollar equity stakes in a nonprofit tissue processor (AlloSource), per 990s

Donor Alliance, Iowa Donor Network, Mid-America Transplant, ConnectLife, Gift of Hope (re: AlloSource, EIN 84-1327507) · $8M-$26.4M equity stakes (5 OPOs)

A reform-advocacy review citing the organizations' IRS Form 990 filings on ProPublica reports that five OPOs (Donor Alliance, Iowa Donor Network, Mid-America Transplant, ConnectLife, and Gift of Hope) hold equity stakes in AlloSource ranging from $8 million to $26.4 million, with OPO executives sitting on AlloSource's board. AlloSource is itself a 501(c)(3) nonprofit tissue bank, not a for-profit company.

Organ Donation Reform, "Tissue Donation & Processing" (citing OPO IRS Form 990 filings via ProPublica)

LifeNet Health reported ~$599M total revenue (2024); a major nonprofit OPO/tissue processor

LifeNet Health (Virginia), EIN 52-1273592 · $598.6M total revenue (2024)

Per IRS Form 990 data on ProPublica, LifeNet Health, a Virginia-based 501(c)(3) organ-and-tissue bank, reported total revenue of $598,564,898 in 2024 (up from $260.2M in 2015). A reform-advocacy review separately cited a ~$411.9M tissue-procurement revenue figure attributed to LifeNet's 2019 Form 990; LifeNet's total reported revenue for 2019 was $441.1M.

LifeNet Health, IRS Form 990 via ProPublica Nonprofit Explorer (EIN 52-1273592)

Publicly traded firms in the allograft/medical-device chain report hundreds of millions to over $20B in annual revenue

Stryker; Becton Dickinson (BD); Artivion (formerly CryoLife) · Stryker $17.1B (FY21); BD $20.2B (FY21); Artivion $298.8M (2022)

Per the companies' SEC disclosures: Stryker reported full-year 2021 net sales of $17.1 billion; Becton Dickinson reported fiscal-2021 revenue of $20.2 billion; and Artivion (which rebranded from CryoLife in January 2022) reported 2022 revenue of $298.8 million. These for-profit firms operate in segments of the allograft, surgical-device, and tissue-processing supply chain.

Becton Dickinson Form 8-K (FY2021) via SEC EDGAR; Stryker FY2021 results; Artivion Form 8-K (FY2022)

A nonprofit OPO/tissue processor reported ~$598M revenue and ~$3.5M CEO compensation

LifeNet Health (Virginia), EIN 52-1273592 · $598.6M revenue, $650.8M assets, ~$3.55M CEO total comp (FY2024)

LifeNet Health, a tax-exempt nonprofit classified as an 'Organ and Tissue Banks' organization that functions as both a federally designated OPO and a tissue processor, reported total revenue of about $598.6M and total assets of about $650.8M in FY2024 per its IRS Form 990, up from about $156.9M in FY2011. Its highest-paid executive, the chief executive officer, received about $3.55M in total compensation in the most recent year reported.

LifeNet Health - Nonprofit Explorer, ProPublica (IRS Form 990)

Donated human tissue feeds a multibillion-dollar processed-product market with steep service-fee markups

Tissue-processing industry (e.g., MTF Biologics, AlloSource; OPO/tissue-bank referral chain) · ~$80,000-$200,000 cash flow per donated body; ~$5B+ global soft-tissue allograft market

While buying or selling human tissue is illegal, federal law permits 'service fees' covering recovery, storage and processing, which has built a multibillion-dollar industry (the global soft-tissue allograft market is estimated at roughly $5B+). Investigative reporting (NBC News; Reuters' 'The Body Trade') has documented that a single donated body can generate cash flows of roughly $80,000 to $200,000 across the nonprofit and for-profit entities that recover tissue and manufacture medical and dental products from it.

Body wranglers at work: Inside the global trade in human corpses, NBC News

NOTA bans paying for organs but exempts 'reasonable payments' for processing/preservation/storage

National Organ Transplant Act of 1984 (42 U.S.C. 274e) · Up to $50,000 fine / 5 years; 'reasonable payments' carve-out (42 U.S.C. 274e)

NOTA makes it unlawful to knowingly acquire, receive or transfer a human organ for valuable consideration for transplantation if interstate commerce is affected, punishable by a fine up to $50,000 and/or up to 5 years imprisonment. The statute defines 'valuable consideration' to exclude reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control and storage of an organ — the legal opening through which fee-based procurement and tissue-processing revenue flows.

42 U.S.C. 274e — Prohibition of organ purchases (Cornell LII)

Musculoskeletal Transplant Foundation (MTF Biologics), the largest tissue bank, reported ~$509.5M revenue (FY2024)

Musculoskeletal Transplant Foundation Inc. / MTF Biologics (EIN 22-2803458) · ~$509.5M revenue (FY2024); ~$228.7M tissue distribution

MTF Biologics, a nonprofit tissue bank, reported total revenue of $509,478,090 for the fiscal year ending Dec. 31, 2024 on its IRS Form 990 (up from $493,471,813 in FY2023). Its largest program expenses for 2024 included roughly $228.7M in tissue distribution, $203.7M in tissue recovery and processing, and $15.3M in research and development — illustrating the scale of revenue generated from processing donated human tissue.

Musculoskeletal Transplant Foundation Inc. — IRS Form 990, ProPublica Nonprofit Explorer (EIN 22-2803458)

Donated tissue flows into multibillion-dollar device/biologics firms; tissue valued up to ~$500/gram in published analyses

Tissue industry (nonprofit tissue banks and for-profit processors, e.g. Stryker, Becton Dickinson) · Tissue valued up to ~$500/gram; downstream firms >$17B annual revenue

Published analyses of the U.S. tissue system describe a model in which nonprofit OPOs/tissue banks recover donated tissue that is then processed and distributed into a multibillion-dollar for-profit device/biologics market, with human tissue valued at up to roughly $500 per gram. The Organ Donation Reform compilation notes large tissue-using device firms (e.g. Stryker and Becton Dickinson) each reported well over $17 billion in annual revenue, with one cited former CMS staffer characterizing tissue procurement as a multibillion-dollar for-profit business with volume incentives, in contrast to nonprofit organ procurement.

The Costly Effects of an Outdated Organ Donation System — Tissue Donation & Processing

Tissue foundation's top executive role drew ~$900K base pay at a tax-exempt charity

Musculoskeletal Transplant Foundation (MTF Biologics), 501(c)(3), EIN 22-2803458 · $901,884 CEO base comp (FY2024)

Per MTF's IRS Form 990, the President/CEO role received $901,884 in reportable (base) compensation in FY2024 (up from $863,875 in FY2023) at an organization classified as a tax-exempt public charity.

Musculoskeletal Transplant Foundation Inc — Nonprofit Explorer, ProPublica (IRS Form 990)

The OPO trade group's affiliated foundation is a modest nonprofit relative to its members' scale

AOPO Foundation, EIN 58-1652896 · ~$1.57M total assets; ~$61K revenue (FY2024)

The Association of Organ Procurement Organizations Foundation (EIN 58-1652896) is a small 501(c)(3): per its IRS Form 990 it reported total assets of about $1.57M and total revenue of about $61,000 in FY2024 (about $16,700 revenue / $1.27M assets in FY2023), a fraction of the budgets of the OPOs whose interests the broader association represents.

Association of Organ Procurement Organizations Foundation - Nonprofit Explorer, ProPublica (IRS Form 990)

AOPO Foundation (the trade group's charitable arm) is a small 501(c)(3); AOPO itself operates as a 501(c)(6) trade group

Association of Organ Procurement Organizations Foundation (EIN 58-1652896) · AOPO Foundation revenue $61,319 (FY2024); 501(c)(3) vs AOPO 501(c)(6)

The AOPO Foundation is a 501(c)(3) charitable organization (EIN 58-1652896) with modest revenue ($61,319 in FY2024; $16,702 in FY2023; about $2.1M in FY2022 per its IRS Form 990), distinct from its parent trade association, the Association of Organ Procurement Organizations, which (per POGO's reporting) operates as a 501(c)(6) trade group permitting freer lobbying.

Association of Organ Procurement Organizations Foundation — IRS Form 990, ProPublica Nonprofit Explorer (EIN 58-1652896)

Senate Finance: OPTN not required to collect OPO financial-relationship, board-compensation or affiliated-business data

U.S. Senate Committee on Finance / OPTN / UNOS

The Wyden-Grassley investigation (June 10, 2025 report) found significant transparency gaps: CMS does not require uniform conflict-of-interest policies across OPOs, and OPTN is not required to collect details on OPOs' financial relationships, board/director compensation, or affiliated businesses. The senators concluded additional transparency is needed to strengthen integrity and address conflicts of interest in the organ procurement network.

Wyden-Grassley Report Exposes How OPOs Game the System (U.S. Senate Committee on Finance, June 10, 2025)

UNOS was the sole OPTN contractor for decades; the OPTN contract is now ~$64M/year

United Network for Organ Sharing (UNOS) / OPTN · ~$64M/year OPTN contract; ~92% from member fees

UNOS was awarded the OPTN contract following the 1986 solicitation and remained the federal government's sole OPTN contractor for decades (the 2023 Securing the U.S. OPTN Act ended the single-contractor model). The OPTN contract is now worth roughly $64 million a year, with about 10% from the federal government and the majority funded by registration fees collected from transplant programs (the registration fee comprises roughly 92% of OPTN operating budget).

UNOS and the OPTN — UNOS (corroborated by Senate Finance/WRIC reporting on the ~$64M figure)

OPTN contract opened to competition; UNOS was sole contractor since 1986; modernization award (Leidos) up to $235M

United Network for Organ Sharing (UNOS); Leidos; HRSA/OPTN · Leidos award up to $235M; UNOS cloud contract ~$12.25M

UNOS was the sole contractor administering the OPTN since the program began in 1986. After President Biden signed the Securing the U.S. Organ Procurement and Transplantation Network Act in September 2023, HRSA began competing OPTN functions among multiple vendors. An OPTN operations modernization contract was awarded to Leidos with a total potential value of about $235 million (one-year base plus four option years), and UNOS separately won a roughly $12.25 million sole-source OPTN cloud-migration and hardware contract.

HRSA, "Historic Steps to Overhaul the Nation's Organ Transplant System"; UNOS/Leidos contract releases

UNOS held the OPTN contract continuously from 1986; 2018 renewal estimated at ~$250M

United Network for Organ Sharing (UNOS) / HRSA OPTN contract · ~$250M total est. value (2018 contract, through Sept 2023)

UNOS operated the federal Organ Procurement and Transplantation Network (OPTN) continuously as the contractor from 1986 until the system began transitioning to multiple vendors in 2024 (the OPTN is roughly 40 years old). The 2018 OPTN contract renewal, running through September 2023 including option years, was estimated at close to $250 million in total funding. The 2018 procurement was technically opened to competitive bidding, but the contract had been held only by UNOS since the network's inception; the prior competitive offering was in 2005.

United Network for Organ Sharing retains contract for managing national transplant network (Healio, Nov 2018)

OPTN operating costs ~$64M/year, with the large majority funded by patient registration fees rather than federal appropriations

OPTN budget (operated by UNOS under HRSA contract) · ~$63.9M FY2022 budget; ~$6.5M federal appropriations; ~85-90% from registration fees

The OPTN budget was approximately $63.9 million for FY2022, of which direct federal appropriations were budgeted at about $6.5 million and the remainder came from the OPTN patient registration fee (a one-time fee assessed to member institutions when listing a transplant candidate). The registration-fee share has been reported at 84.7% of the budget for FY2017 and roughly 90% for FY2022; the exact percentage varies by year, but the OPTN states most operating costs are paid by patient registration fees, not federal appropriations.

OPTN budget and OPTN registration fee set for new fiscal year (OPTN/HRSA)

OPTN registration-fee collection authority moved from the contractor to HHS (2025 appropriations, Section 1904)

HHS / HRSA (OPTN fee collection), formerly UNOS · FY2026 fee $1,036 per candidate; fee collection shifted to HHS

Section 1904 of the Full-Year Continuing Appropriations and Extensions Act, 2025 (H.R.1968, enacted March 2025) granted HHS explicit legal authority to directly collect and distribute OPTN patient registration fees from member institutions, a function the OPTN contractor (UNOS) had performed for decades. HRSA began invoicing transplant hospitals via Pay.gov in October 2025; HRSA approved a FY2026 registration fee of $1,036 per transplant candidate.

H.R.1968 - Full-Year Continuing Appropriations and Extensions Act, 2025 (Congress.gov)

OPTN modernization: first multi-vendor IDIQ break-up of the single-contractor model (~$440M combined ceiling)

HRSA OPTN Operations Transition IDIQ (solicitation 75R60224R0008) · ~$440M combined ceiling (Domains: $30M/$145M/$235M/$40M)

In September 2024 HRSA made multi-vendor awards under the OPTN Operations Transition IDIQ (solicitation 75R60224R0008), ending roughly four decades of the OPTN being run by a single contractor. The IDIQ is structured across four domains with ceilings of approximately $30M (Domain 1), $145M (Domain 2), $235M (Domain 3), and $40M (Domain 4), for a combined ceiling of about $440 million.

HRSA Makes First-Ever Multi-Vendor Awards to Modernize the Nation's Organ Transplant System (HHS, Sept 19, 2024)

Fourteen prime contractors won OPTN modernization domains, including large for-profit federal integrators

OPTN modernization prime awardees (Operations Transition IDIQ) · 14 prime awardees; GDIT across domains totaling ~$380M ceiling

Fourteen prime awardees were named across the four IDIQ domains: ABT Global, Arbor Research Collaborative for Health, RAND Corporation, Guidehouse Digital, Maximus Federal Services, KPMG, United Network for Organ Sharing, Customer Value Partners, General Dynamics Information Technology (GDIT), Accenture Federal Services, Leidos, Sapient Government Services, Deloitte Consulting, and Highlight Technologies. Several large for-profit federal IT integrators (GDIT, Accenture Federal, Leidos, Deloitte, KPMG, Maximus, Guidehouse) are among the awardees, with GDIT spanning domains carrying ceilings totaling roughly $380M.

14 Prime awardees named for $440M in HHS HRSA OPTN Operations Transition IDIQs (OrangeSlices AI)

HRSA's September 2024 announcement named five contractors for the initial transition efforts

HRSA OPTN modernization awards (Arbor Research, GDIT, Maximus, Deloitte, Guidehouse) · 5 named initial-effort contractors; "first time in 40 years" of multi-vendor awards

HRSA's September 2024 announcement of multi-vendor OPTN awards highlighted five initial efforts: Arbor Research Collaborative for Health (patient safety and policy-compliance oversight), General Dynamics Information Technology (organ-matching IT system improvements), Maximus Federal Services (public visibility and policy-making transparency), Deloitte Consulting (communications), and Guidehouse Digital (OPTN budget development and management). HRSA described this as the first time in 40 years that multiple contractors were awarded to improve the national organ transplant system.

HRSA Makes Multi-Vendor Modernization Awards to Support the Nation's Organ Transplant System (HRSA, Sept 2024)

Under a short-term extension, UNOS retained the matching software (UNet), the Organ Center, data, review boards and education, while losing membership, fee collection and public-facing roles

United Network for Organ Sharing (UNOS) — post-modernization role · Extension effective Dec 30, 2025; up to one year through Dec 29, 2026

Under a contract extension effective December 30, 2025 (with up to four optional three-month periods through December 29, 2026), UNOS continues to maintain UNet (its proprietary organ-matching software), information security, the Organ Center, management of OPTN records and data, management of review boards/support of policy committees, and education for transplant professionals. UNOS no longer manages OPTN membership and patient-safety/compliance oversight, the OPTN website and public communications, research support for committees, or collection of OPTN registration fees and Finance Committee support; further functions are slated for competition.

How UNOS' role in the OPTN has changed under the additional contract extension (UNOS)

Separate $12.25M HRSA OPTN cloud-migration contract awarded to UNOS (sole bidder)

United Network for Organ Sharing (UNOS) — OPTN Cloud Migration & Hardware Support contract 75R60226C00001 · $12,250,000 total value / $12,000,000 obligated; 1 bidder

Distinct from the Operations Transition IDIQ awards, HRSA awarded UNOS a separate contract (award ID 75R60226C00001) for OPTN cloud migration and hardware support, with a total contract value of $12,250,000 and an action obligation of $12,000,000. The award received one bidder. The contract covers personnel, management, and services to migrate OPTN IT systems to cloud infrastructure over roughly a 16-month period.

USAspending keyword search — award 75R60226C00001 (HHS/HRSA, UNOS)

Senate Finance and House Energy & Commerce oversight framed the OPTN contract as a decades-long no-competition arrangement

U.S. Senate Committee on Finance / House Energy & Commerce — OPTN oversight · UNOS contractor without competition since 1986; Aug 3, 2022 Finance hearing

The Senate Finance Committee conducted a bipartisan investigation of the U.S. organ transplant system beginning in 2020, subpoenaed UNOS in February 2021, and held a hearing on August 3, 2022 accompanied by a staff memo detailing findings, noting UNOS had served as the OPTN contractor without competition since 1986. The committee's leadership later introduced and supported the Securing the U.S. Organ Procurement and Transplantation Network Act (enacted 2023) to enable multiple contractors, and the House Energy & Commerce Committee also launched its own investigation into the network.

Grassley, Wyden Subpoena the United Network for Organ Sharing (Senate Finance Committee, Feb 2021)

Congress lifted the OPTN funding cap and HRSA moved to break up the single-contractor structure

OPTN / HRSA / statute P.L. 118-14 (Securing the U.S. OPTN Act) · $7M statutory funding cap removed (P.L. 118-14, Sept. 22, 2023)

From the program's 1984 origin, statute had capped OPTN-related appropriations at $7 million. The Securing the U.S. Organ Procurement and Transplantation Network Act (P.L. 118-14), signed Sept. 22, 2023, removed that funding limit and authorized HRSA to award multiple grants, contracts, or cooperative agreements for network operations, ending the long-standing single-contractor (UNOS) arrangement and enabling competitive bidding for OPTN functions.

Public Law 118-14 (137 Stat. 69), Sept. 22, 2023, Congress.gov

After the OPTN was opened to competition, federal OPTN work began flowing to commercial contractors

General Dynamics Information Technology (GDIT) / HRSA OPTN modernization awards · ~$440M IDIQ ceiling (multi-vendor); ~$8.6M GDIT patient-safety task order

As HRSA restructured the OPTN under P.L. 118-14, it made multi-vendor modernization awards in September 2024, ending roughly four decades of single-vendor management. HRSA named multiple prime awardees under OPTN operations-transition IDIQ vehicles (reported at roughly $440M in aggregate ceiling). Among the awardees, GDIT received an indefinite-delivery contract (IDV 75R60224D00032, awarded 9/24/2024) and subsequently an OPTN Patient Safety and Compliance task order valued at about $8.6M.

HRSA Makes Multi-Vendor Modernization Awards to Support the Nation's Organ Transplant System (Sept. 2024)

UNOS, the sole OPTN contractor since the late 1980s, reported $76.6M revenue and ~$779K CEO pay (FY2025)

United Network for Organ Sharing (UNOS) (EIN 54-1327878) · $76.6M revenue; ~$779K CEO comp (FY ending Sept 2025)

The United Network for Organ Sharing, the private nonprofit that held the national Organ Procurement and Transplantation Network (OPTN) contract from the 1980s until the 2023 reform, reported total revenue of $76,646,659 for the fiscal year ending September 2025 on its IRS Form 990, with CEO compensation of $779,131. Revenue was $95,976,220 (FY ending Sept 2024) and $90,392,700 (FY ending Sept 2023).

United Network for Organ Sharing — IRS Form 990, ProPublica Nonprofit Explorer (EIN 54-1327878)

Congress and HRSA acted to end UNOS's decades-long OPTN monopoly contract (2023)

OPTN contract / HRSA / Securing the U.S. OPTN Act (P.L. 118-140) · Removed ~$7M OPTN contract funding cap; P.L. 118-140 (Sept 22, 2023)

The National Organ Transplant Act historically required the OPTN to be run by a single private nonprofit contractor, a role UNOS held from the late 1980s. The Securing the U.S. Organ Procurement and Transplantation Network Act was signed into law Sept. 22, 2023; it removed the prior ~$7 million contract funding cap and let HRSA award multiple OPTN contracts to different entities, ending UNOS's sole-source position. HRSA separately announced steps to make the OPTN Board independent from the contractor's board.

HRSA — Historic Steps to Overhaul the Nation's Organ Transplant System

Senate Finance Committee's ~2.5-year investigation found systemic OPTN/OPO oversight failures (Aug 2022)

Senate Finance Committee / OPTN / UNOS · >100,000 documents / >500,000 pages reviewed; hearing Aug 3, 2022

After a roughly 2.5-year bipartisan investigation reviewing more than 100,000 documents totaling over half a million pages, the Senate Finance Committee held a hearing on Aug. 3, 2022 titled 'A System in Need of Repair' documenting operational failures in the U.S. organ transplant network, including transplant-transmitted diseases, transportation failures, and that the OPTN contractor had recommended an OPO lose certification only once.

Senate Finance Committee — hearing statement on failures in the organ transplant system (Aug. 3, 2022)

Senate Finance (Wyden-Grassley): OPOs have stronger financial incentives for tissue than for life-saving organs; pancreata 'research' recovery up 850%

U.S. Senate Committee on Finance / Organ Procurement Organizations · 850% rise in research-pancreata (169 in 2018 -> 1,606 in 2022)

The bipartisan Wyden-Grassley investigation (staff report released June 10, 2025) and prior correspondence found structural financial-incentive concerns in the OPO system. A 2020 letter to HHS stated 'OPOs have greater financial incentives to focus more on tissue recovery compared to their incentives to recover lifesaving organs.' The investigation also documented an 850% increase in pancreata recovered for research among surveyed OPOs - from 169 in 2018 to 1,606 in 2022 - without a clear corresponding research benefit, and noted the share used for islet-cell-transplant research fell from 87.6% (2018) to 47.9% (2022).

Wyden-Grassley Report Exposes How OPOs Game the System (U.S. Senate Committee on Finance, June 10, 2025)

UNOS lobbying spending rose around the time of federal reform efforts

United Network for Organ Sharing (UNOS) · ~$120K/yr 2015-2019; Madison Associates ~$30K/quarter

Public filings indicate UNOS spent roughly $120,000 per year on federal lobbying from 2015-2019 and then increased its lobbying effort (roughly doubling the number of lobbyists) in 2020 amid federal reform efforts. UNOS's outside firm Madison Associates, LLC billed about $30,000 per quarter in 2019-2020 (around $1.05M reported over its engagement, which it terminated April 19, 2021).

Lobbying for UNOS by Madison Associates, LLC — ProPublica Represent (corroborated by POGO reporting)

Organ-procurement industry, UNOS, and the AOPO trade association lobbied against federal reform

Association of Organ Procurement Organizations (AOPO) and OPO industry / UNOS · >$450K OPO lobbying H1-2020; ~500% increase since 2017

POGO reported that, per public filings, OPOs, UNOS, and the AOPO trade association together spent about $160,000/year on lobbying in 2017-2018, then ramped up sharply after a 2019 executive order pushing OPO reform — OPOs alone spent more than $450,000 in the first half of 2020 to deter CMS reform, with industry lobbying up nearly 500% since 2017. AOPO is a registered federal lobbying client (OpenSecrets ID D000047417); a previously asserted '$600,000 AOPO lobbying in 2024' figure could not be verified against OpenSecrets and has been dropped.

Heartless: Organ Donation Contractors Lobby Against Reform — Project On Government Oversight

OPO trade association (AOPO) converted to 501(c)(6) and lobbied against the 2020 OPO reform rule

Association of Organ Procurement Organizations (AOPO) · ~$160K/yr (2017-18) to ~$452K (2019)

Per a Project On Government Oversight investigation, AOPO transitioned from a 501(c)(3) (where lobbying is sharply restricted) to a 501(c)(6) trade association that permits greater lobbying, following a June 2020 internal memo stating AOPO needed to become "substantially more involved in advocacy." OPO-industry lobbying rose from roughly $160,000 per year in 2017-2018 to about $452,000 in 2019, coinciding with CMS's 2020 OPO Conditions for Coverage reform rule.

Project On Government Oversight, "Heartless: Organ Donation Contractors Lobby Against..."

AOPO federal lobbying is disclosed under the Lobbying Disclosure Act

Association of Organ Procurement Organizations (AOPO) · $290,000 (Q1-Q3 2025, partial year)

AOPO files federal lobbying disclosures under the Lobbying Disclosure Act, aggregated by OpenSecrets (client ID D000047417). The OpenSecrets profile shows AOPO reported $290,000 in lobbying for the first three quarters of 2025, consistent with documented increases in OPO-industry lobbying since 2019.

OpenSecrets, AOPO federal lobbying profile (Senate LDA filings)

The tissue trade group functions as the industry's standards-setter and was rebranded in 2025

American Association of Tissue Banks (AATB), EIN 52-1114697 · ~$5.5M annual revenue; ~1,100 members

AATB, a 501(c)(3) founded in 1976 and headquartered in McLean, VA, serves as the tissue-banking industry's voluntary accreditation and standards body with roughly 1,100 members. It reported about $5.5M in revenue in its most recent fiscal year per public filings. In 2025 it rebranded as the Association for Advancing Tissue and Biologics, retaining the same EIN.

American Association of Tissue Banks - Nonprofit Explorer, ProPublica (IRS Form 990)

OPO/UNOS/AOPO federal lobbying roughly tripled as CMS/OPTN reform advanced

Association of Organ Procurement Organizations (AOPO) and OPO sector - Senate LDA filings / POGO · ~$160K/yr (2017-18) rising to ~$452K (2019); >$450K (H1 2020)

Per a Project On Government Oversight (POGO) review of Senate Lobbying Disclosure Act filings, OPOs, UNOS and AOPO together spent only about $160,000 per year on federal lobbying in 2017 and 2018, then increased sharply to about $452,000 in 2019, exceeding $450,000 in just the first half of 2020. POGO reported an internal AOPO memo (June 2020) stating the group needed to become 'substantially more involved in advocacy,' coinciding with proposed organ-procurement performance reforms.

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

UNOS increased its federal lobbying amid OPTN modernization and Senate scrutiny

United Network for Organ Sharing (UNOS) - Senate LDA filings · ~$120,000 reported lobbying (2019); rising thereafter

Per Senate LDA disclosures aggregated by OpenSecrets, UNOS reported federal lobbying of about $120,000 in 2019 and substantially increased its spending in subsequent years as Congress and HRSA moved to open the OPTN contract to competition; in 2025 it reported retaining a lobbying firm and disclosed lobbying on 'federal budget issues and organ donation, procurement and transplant matters.' The precise year-by-year multiplier could not be fully confirmed from free public sources.

United Network for Organ Sharing Lobbying Profile, OpenSecrets (Senate LDA data)

OPOs lobbied against the CMS performance rule while industry entities received large PPP loans despite sizable reserves

OPO sector / AOPO - POGO investigation (Senate LDA + SBA PPP data) · >$100M potential PPP across industry; one OPO reserves >$112M

A POGO investigation reported that organ-donation-industry entities lobbied against CMS's proposed OPO performance reforms while being approved for what POGO estimated could total more than $100 million in federal Paycheck Protection Program (PPP) loans. POGO noted at least one OPO sat on reserves valued at more than $112 million, and that one Los Angeles OPO with roughly $85 million in cash reserves (as of 2018) was approved for a PPP loan in the $150,000-$350,000 range.

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

Industry lobbying against organ-donation reform rose ~500% since 2017; AOPO converted to a 501(c)(6) trade group

AOPO (Association of Organ Procurement Organizations) / OPOs / UNOS · Lobbying up ~500% since 2017; AOPO 501(c)(3) to 501(c)(6)

A Project On Government Oversight investigation ('Heartless,' 2020) reported that lobbying expenditures by organ-procurement contractors rose nearly 500% since 2017 amid federal reform efforts, and that the Association of Organ Procurement Organizations changed its tax status from 501(c)(3) — where lobbying is sharply limited — to 501(c)(6), a trade-association status permitting freer lobbying. A 2020 internal AOPO memo (attributed by POGO to the association's president) stated AOPO needed to become substantially more involved in advocacy.

POGO — 'Heartless: Organ Donation Contractors Lobby Against a Popular Health Care Initiative While Pocketing Pandemic Relief Loans'

UNOS roughly doubled its federal lobbying amid the reform push (from ~$120K in 2019)

United Network for Organ Sharing (UNOS) · ~$120K federal lobbying (2019); reportedly more than doubled by ~2020

Per federal lobbying disclosures summarized by OpenSecrets, UNOS reported about $120,000 in federal lobbying in 2019, and reporting (POGO, cited in subsequent coverage) indicates UNOS more than doubled its lobbying as the federal push to reform organ procurement intensified around 2019-2020. A specific 2020 total in the ~$280,000 range was cited in some secondary accounts but could not be independently confirmed against the primary OpenSecrets/LDA filing.

United Network for Organ Sharing — Lobbying Profile, OpenSecrets (2019 cycle)

Organ-procurement contractors were approved for what POGO estimated at over $100M in PPP loans while lobbying against reform

Organ procurement industry (multiple OPOs) / SBA Paycheck Protection Program · >$100M in PPP loans (POGO estimate)

POGO's 2020 'Heartless' investigation reported that organ-procurement contractors were approved for what it estimated could total more than $100 million in federal Paycheck Protection Program (PPP) loans intended to help small businesses during the COVID-19 pandemic, during the same period the industry was lobbying against the Trump-era executive order and CMS rulemaking to reform OPO performance.

POGO — 'Heartless' investigation (2020)

HHS-OIG: OneLegacy charged ~$531K in unallowable/unsupported costs to its Medicare organ-acquisition cost center (FY2006 cost report)

HHS Office of Inspector General / OneLegacy · ~$531K unallowable+unsupported; ~$297K Medicare overstatement (FY2006)

An HHS-OIG audit (report A-09-08-00033, issued January 28, 2010) reviewed OneLegacy's FY2006 Medicare organ-acquisition overhead and administrative/general costs. Of $3.2M reviewed, OIG found $290,968 of unallowable costs and $240,492 of unsupported costs (~$531K combined), and estimated OneLegacy overstated its Medicare reimbursement by ~$297,000. OIG recommended a revised cost report and improved cost-reporting procedures.

Review of OneLegacy's Reported FY2006 Organ Acquisition Overhead and A&G Costs (HHS-OIG A-09-08-00033)

HHS-OIG: ~$664K of Medicare-reimbursed OPO 'education' overhead was unallowable (nationwide audit, 2023)

HHS Office of Inspector General / independent OPOs (industry-wide) · ~$664,295 estimated unallowable of $50.9M Medicare education overhead

A 2023 HHS-OIG nationwide audit reviewed $101.6M of professional and public education overhead costs (Medicare share $50.9M) reported across the 50 independent OPOs for cost reports with fiscal-year ends from May 2015 through June 2019. Sampling found that an estimated $664,295 of the Medicare-paid education overhead did not meet Medicare requirements. OIG recommended CMS recover $72,208 in sampled unallowable payments and clarify which education overhead costs are unallowable.

Medicare Paid Independent OPOs Over Half a Million Dollars for Education Overhead Costs That Did Not Meet Medicare Requirements (HHS-OIG, 2023)

Senate Finance bipartisan report: OPOs lack uniform conflict-of-interest controls

Senate Finance Committee Wyden-Grassley 'Operation Transplant' staff report (released June 10, 2025); 17 OPOs reviewed · 17 OPOs reviewed

The bipartisan Wyden-Grassley Senate Finance Committee staff report (released June 10, 2025) reviewed 17 OPOs and found that CMS does not require uniform conflict-of-interest policies, producing inconsistent definitions of who is covered, and that the OPTN and its former contractor UNOS failed to act on formal complaints about financial conflicts of interest. Most OPOs reviewed allow their board of directors to approve potentially conflicted transactions.

Operation Transplant Staff Report — U.S. Senate Committee on Finance (Wyden/Grassley), 2025

An OPO described using for-profit organizations to place 'research' organs to satisfy CMS metrics

Kentucky Organ Donor Affiliates (KYDA) (primary-source letter reproduced in Senate Finance report) · 850% reported increase in research pancreata

A KYDA response letter reproduced verbatim in the Senate Finance 'Operation Transplant' report states that, following a 2012 CMS recertification corrective-action plan, KYDA increased the number of national research organs recovered 'by utilizing for-profit organizations to place organs for research (which requires approval by KYDA's Board of Directors).' The report separately documents that surveyed OPOs reported an 850% increase in pancreata recovered for research without a clearly corresponding research benefit.

Operation Transplant Staff Report — Senate Finance Committee (KYDA letter reproduced therein)

Senate Finance "Operation Transplant" staff report (June 2025): OPO conflicts of interest go uncollected by OPTN/UNOS

Senate Committee on Finance (Wyden-Grassley); OPOs; OPTN/UNOS · 17 OPOs reviewed; report dated 6/10/2025

A June 10, 2025 bipartisan Senate Finance staff report ("Operation Transplant") found that CMS does not require uniform OPO conflict-of-interest policies, and that the OPTN is not required to collect details on OPOs' financial relationships, board-member compensation, or affiliated businesses. Investigative staff reviewed conflict and research-protocol documents from all seventeen OPOs contacted, and found OPTN and its former sole contractor UNOS failed to act on formal complaints about financial conflicts.

Operation Transplant Staff Report (Senate Committee on Finance, June 2025)

HHS-OIG audit: ~$47M of ~$80M reviewed in organ-acquisition cost claims was unallowable/unsupported

11 certified transplant centers; CMS (HHS-OIG report A-09-05-00034) · ~$47M unallowable/unsupported of ~$80M; ~$28M Medicare share

A 2006 HHS-OIG consolidated audit (A-09-05-00034) of 11 certified transplant centers found that, of almost $80 million of organ-acquisition costs audited, about $33 million complied with Medicare requirements while almost $47 million did not comply with Medicare's definition of organ-acquisition costs, exceeded limits on physician salaries, or was not properly allocated or documented. Medicare's estimated share of the $47 million was approximately $28 million.

HHS-OIG, Review of Organ Acquisition Costs Claimed by Certified Transplant Centers (A-09-05-00034)

Former OPO director and associate director were federally prosecuted in a funeral-home kickback scheme

Alabama Organ Center (AOC) — director and associate-director roles · >$498,000 in kickbacks (2003-2011)

Per U.S. Department of Justice and FBI releases, the former director and former associate director of the Alabama Organ Center were charged and, in 2012, sentenced for fraud after receiving more than $498,000 in kickbacks (2003-2011) from a funeral home that did business with the organ center in exchange for steering the center's business to it. The director was sentenced to 13 months and the associate director to a year and a day in prison.

U.S. Attorney (N.D. Ala.) / FBI Birmingham press releases (2011-2012)

Pancreata-for-research "loophole" let OPOs count research organs toward certification; 850% reported increase

OPOs (re: CMS performance certification); biobanks/research facilities · 850% increase (169 in 2018 to 1,606 in 2022)

The June 2025 Senate Finance staff report found that the 2020 CMS OPO final rule allows organs recovered for research to count toward recertification without clear verification the organs advanced research. Among ten OPOs the senators contacted, pancreata recovered for research rose from 169 in 2018 to 1,606 in 2022, an 850% increase, without a clear corresponding research benefit.

Operation Transplant Staff Report (Senate Committee on Finance, June 2025)

HHS-OIG audit found a major OPO charged Medicare for lobbying, Rose Parade and entertainment costs

OneLegacy (Los Angeles OPO) - HHS-OIG audit A-09-08-00033 · ~$291K unallowable + ~$240K unsupported of ~$3.2M reviewed (FY2006)

An HHS Office of Inspector General audit (report A-09-08-00033, issued Jan. 28, 2010) of OneLegacy's reported FY2006 organ-acquisition overhead and administrative/general costs found that of about $3.2M reviewed, roughly $291,000 were unallowable costs and about $240,000 were unsupported. The unallowable costs included items reported as incurred for the Rose Parade, deferred compensation, donations and gifts, lobbying, meals and entertainment, resulting in an estimated Medicare overstatement of about $297,000.

HHS-OIG, Review of OneLegacy's Reported FY2006 Organ Acquisition Overhead Costs (A-09-08-00033, Jan. 2010)

Government-wide HHS-OIG review found independent OPOs billed Medicare ~$664K in non-compliant education overhead

Independent OPOs (50 nationally) - HHS-OIG 2023 audit · ~$664,295 unallowable (est.); ~$72,208 recommended recovery

A 2023 HHS-OIG audit reviewed professional and public education overhead costs reported by the 50 independent OPOs. Sampling 300 costs (30 each) from 10 randomly selected OPOs, OIG estimated that about $664,295 of the roughly $50.9M Medicare paid for such overhead was unallowable, attributing the errors to misunderstanding of Medicare requirements and administrative mistakes. OIG recommended CMS recover about $72,208 in identified overpayments and clarify the rules.

HHS-OIG, Medicare Paid Independent OPOs Over Half a Million Dollars for Education Overhead Costs That Did Not Meet Medicare Requirements (2023)

CMS adopted the first objective, enforceable OPO performance rule with possible 2026 decertifications

CMS OPO Conditions for Coverage Final Rule (CMS-3380-F) · 85 FR 77898 (Dec. 2, 2020); 2026 recertification with decertification risk

CMS issued a final rule (announced Nov. 20, 2020; published 85 FR 77898 on Dec. 2, 2020) replacing self-reported OPO quality measures with two objective, data-based outcome measures (donation rate and organ-transplantation rate). OPOs are assessed for recertification in 2026; the lowest-performing tier faces decertification, and CMS estimated the rule could affect roughly half of OPOs at recertification.

Federal Register: OPO Conditions for Coverage; Revisions to the Outcome Measure Requirements (CMS-3380-F)

Senate Finance found OPOs game a 'research pancreata' loophole and have weak conflict-of-interest controls

OPO sector / OPTN - Senate Finance Committee 'Operation Transplant' staff report (2025) · 850% reported increase in pancreata recovered 'for research' post-2020

The bipartisan Wyden-Grassley Senate Finance Committee staff report 'Operation Transplant' (released June 10, 2025) found that pancreata recovered for 'research' increased more than four-fold (an 850% increase reported by some OPOs) after the 2020 CMS rule, without a corresponding documented research benefit, and that OPOs often had little ability to verify whether transferred organs were actually used for research, a practice the report characterized as gaming performance metrics.

Wyden-Grassley Report Exposes How OPOs Game the System (Senate Finance, June 10, 2025)

Senate report catalogs OPO conflicts of interest with no required uniform review process

OPO sector (8 OPOs surveyed for COI policies; 17 reviewed overall) - Senate Finance 'Operation Transplant' report · 8 OPOs (COI policies) / 17 OPOs (overall review)

Reviewing conflict-of-interest documents from OPOs (8 asked to disclose COI policies, 17 reviewed for research protocols and COI documents overall), the Senate Finance Committee report found CMS does not require uniform COI policies, producing inconsistent definitions and coverage, and that OPTN is not required to collect financial-relationship, board-compensation, or affiliated-business data. It also found OPTN and its former sole contractor failed to act on formal complaints about financial conflicts.

Wyden-Grassley 'Operation Transplant' Report (Senate Finance, June 10, 2025)

House Oversight opened a probe into OPO performance, waste and conflicts; trade group lost members

AOPO / OPO sector - House Oversight Subcommittee on Economic and Consumer Policy investigation · 11 of 57 OPOs queried; 6 OPOs left AOPO (May 2021)

The House Oversight Subcommittee on Economic and Consumer Policy launched an investigation (letters sent December 2020 to AOPO and 11 of the then-57 OPOs; hearing held May 4, 2021) into OPO performance, finances, operations and potential conflicts of interest. At the hearing, six OPOs announced they were leaving AOPO, and testimony surfaced documented examples of OPO spending on items such as professional-sports season tickets and out-of-state board retreats.

Oversight Subcommittee Launches Investigation into Poor Performance, Waste, and Mismanagement in Organ Transplant Industry (House Oversight)

HHS-OIG audit (2023): Medicare paid 50 OPOs an estimated $664,295 in unallowable education overhead

50 independent OPOs (audited population) / CMS · $664,295 estimated unallowable across 50 OPOs

HHS-OIG report A-09-21-03020 (issued Aug. 9, 2023) reviewed professional and public education overhead costs at 50 independent OPOs (one fiscal year each, with fiscal-year ends from May 31, 2015 through June 30, 2019) and estimated Medicare paid $664,295 in costs that did not meet Medicare requirements (an estimated $598,510 from the statistical sample plus $65,785 in reconciliation findings).

HHS-OIG report A-09-21-03020 (Aug. 9, 2023)

HHS-OIG (2010): OneLegacy overstated Medicare reimbursement by ~$297K on its FY2006 cost report

OneLegacy / CMS (Medicare) · ~$297K Medicare overstatement (FY2006 cost report)

HHS-OIG report A-09-08-00033 (issued Jan. 28, 2010) found OneLegacy did not fully comply with Medicare requirements for reporting selected organ-acquisition overhead and administrative/general costs on its FY2006 Medicare cost report. Of $3.2 million reviewed, the OIG identified roughly $291,000 in unallowable and $240,000 in unsupported costs, and concluded OneLegacy overstated its Medicare reimbursement by an estimated $297,000.

HHS-OIG report A-09-08-00033 (Jan. 28, 2010)

HHS-OIG (2012): LifeCenter Northwest did not fully comply with Medicare cost-report requirements

LifeCenter Northwest (Washington-area OPO) / CMS · ~$88,205 Medicare overstatement (FY2009 cost report)

HHS-OIG report A-09-11-02039 (issued Nov. 15, 2012) found LifeCenter Northwest, the OPO serving Washington, Alaska, Montana and north Idaho, reported incorrect organ statistics on its FY2009 Medicare cost report. The OIG found Medicare's share of organ-procurement costs was overstated by an estimated $88,205 (with a separate $9,132 understatement on another item).

HHS-OIG report A-09-11-02039 (Nov. 15, 2012)

CMS 2020 final rule (CMS-3380-F) ties OPO recertification to outcome measures, with lowest-tier OPOs facing decertification

CMS / Organ Procurement Organizations (42 CFR Part 486 Subpart G) · Tier-3 (below median) OPOs face decertification; recertification 2026

CMS's final rule CMS-3380-F (issued Nov. 20, 2020; Federal Register Dec. 2, 2020) revised the OPO Conditions for Coverage to rank OPOs into tiers based on objective donation and transplantation outcome measures. The lowest-performing tier (Tier 3, below the median on one or both measures) is subject to decertification and barred from competing for open donation service areas, with accountability for recertification applying in the 2026 cycle.

CMS — OPO Conditions for Coverage Final Rule (CMS-3380-F) fact sheet

HHS moved to decertify University of Miami's OPO (Life Alliance Organ Recovery Agency), Sept 2025

Life Alliance Organ Recovery Agency / University of Miami Health System · First mid-cycle OPO decertification move (Sept 18, 2025)

On Sept. 18, 2025, HHS announced it was moving to decertify the Life Alliance Organ Recovery Agency, the OPO operated by the University of Miami Health System, after an investigation cited unsafe practices, inadequate training, chronic understaffing and underperformance. HHS described it as the first time it had moved to decertify an OPO mid-recertification-cycle; CMS subsequently announced a replacement provider of organ-procurement services for South Florida.

HHS — 'HHS to Close University of Miami's Failing Organ Agency'

Network for Hope (formerly Kentucky Organ Donor Affiliates) drew federal investigation and corrective action (2024-2025)

Network for Hope / Kentucky Organ Donor Affiliates (KODA) · >350 cases reviewed; ~70 unfit, 28 possibly not deceased

A federal HRSA investigation reviewed more than 350 organ-procurement cases handled by Kentucky Organ Donor Affiliates (since merged into Network for Hope) and found about 70 patients had neurological conditions making them unfit for donation, of whom 28 may not have been deceased when the donation process began. The findings prompted congressional scrutiny and a broader HHS-announced organ-donor safety overhaul in July 2025.

CNN — HHS to begin reforms of organ donation system after federal investigation

Former Alabama Organ Center director and associate director imprisoned for a funeral-home kickback scheme (2012)

Alabama Organ Center / University of Alabama Health Services Foundation · Kickbacks ~$242K and ~$256K; $498,551 restitution

Per DOJ/FBI announcements, the former director and former associate director of the Alabama Organ Center (an OPO operated under the University of Alabama Health Services Foundation) were sentenced in 2012 to 13 months and to 12 months and a day in prison, respectively, for taking kickbacks (approximately $242,344 and $256,207) from a funeral home in exchange for steering organ-center business to it. The associate director was ordered to pay $498,551 in restitution to the University of Alabama Health Services Foundation and forfeit $256,207.

U.S. Attorney (N.D. Ala.) / FBI — Former Alabama Organ Center Associate Director Sentenced for Fraud (2012)

Wyden-Grassley Senate Finance report: OPOs game recertification via a research-pancreata loophole (June 2025)

Senate Finance Committee (Wyden-Grassley) / OPOs / CMS · 850% rise in research-pancreata recoveries among surveyed OPOs

A June 10, 2025 bipartisan Senate Finance Committee staff report by Senators Wyden and Grassley found OPOs game performance metrics, citing an 850% increase among surveyed OPOs in pancreata recovered 'for research' without a clear corresponding research benefit — a practice that can inflate recertification metrics. The report also found CMS does not require uniform conflict-of-interest policies and that the OPTN does not collect data on board compensation or affiliated businesses. (The report is the Wyden-Grassley OPO staff report; it is not formally titled 'Operation Transplant.')

Senate Finance Committee — Wyden-Grassley report on OPOs gaming the system (June 10, 2025)

Congressional/OIG records cite wasteful spending by OPOs (LA OPO; California Transplant Donor Network) that triggered no decertification

OneLegacy (Los Angeles OPO) and California Transplant Donor Network / HHS-OIG / Senate Finance Committee · Questioned costs incl. sports tickets, gala expenses; no decertification

Per HHS-OIG cost-report reviews and Senate Finance Committee oversight (2020-2021), OPOs including OneLegacy and the California Transplant Donor Network charged questionable costs to Medicare, with examples cited including professional sports season tickets and gala-event expenses; the OIG audits identified unallowable/unsupported costs but, under the rules then in effect, such financial findings did not by themselves trigger decertification.

Senate Finance Committee (Grassley-Wyden) letter to HHS on OPO oversight (Oct. 23, 2020)