National Organ Transplant Act (NOTA): Provisions and 2023 Reforms

The National Organ Transplant Act is the 1984 federal law that created the United States’ organ donation and transplantation system. Signed on October 19, 1984, it set up a national network to match donors with recipients, made it a federal crime to buy or sell human organs for transplant, and convened a task force whose recommendations shaped transplant policy for decades. Four decades later, the framework it built is still in place, though the federal government is now restructuring how the network is run.

What NOTA Established

NOTA responded to rising demand for transplants and the absence of any coordinated national system for recovering and distributing donated organs. The law did three things at once: it built a national infrastructure, drew an ethical line against commerce in organs, and directed experts to recommend what should come next.

The Organ Procurement and Transplantation Network

The law authorized the Secretary of Health and Human Services to contract with a private, nonprofit entity to establish and operate the Organ Procurement and Transplantation Network, known as the OPTN. The network was charged with maintaining a national registry of people awaiting transplants, running a computer-based organ matching system, operating a 24-hour telephone service, helping distribute organs that could not be placed locally, and adopting quality standards for organ acquisition and transportation.¹ Its board must include representatives from transplant centers, organ procurement organizations, and the general public.²

In 1986, the United Network for Organ Sharing (UNOS) won the initial federal contract to operate the OPTN and the Scientific Registry of Transplant Recipients.³ UNOS held that contract, through renewals and extensions, for nearly four decades.

The Task Force on Organ Transplantation

NOTA also required the Secretary of HHS to convene a 25-member Task Force on Organ Transplantation within 90 days of enactment. The task force was directed to examine the medical, legal, ethical, economic, and social issues surrounding transplantation, assess immunosuppressive medications, and recommend policies for organ procurement, equitable allocation, and public education.¹

Its 1986 report declared donated organs a “national resource” and firmly opposed any commercialization of transplants, stating that “society’s moral values militate against regarding the body as a commodity.” The panel recommended a single national sharing system, called for transplants to be available regardless of race, sex, or ability to pay, and urged that heart and liver transplants be covered by Medicare, Medicaid, and other public and private health plans.⁴

The Ban on Buying and Selling Organs

Section 301 of NOTA, codified at 42 U.S.C. § 274e, makes it illegal to “knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation” when the transfer affects interstate commerce. Violations carry penalties of up to five years in prison and a $50,000 fine.⁵ The statute carves out exceptions for reasonable payments tied to organ removal, transportation, processing, preservation, and storage, and for donor expenses like travel, housing, and lost wages.⁶

“Valuable consideration” is not explicitly defined in the law. A 2007 memorandum from the Department of Justice’s Office of Legal Counsel concluded that the phrase refers to monetary gain or commercial transactions, and that under the rule of lenity, altruistic exchanges like paired kidney donations do not violate NOTA.⁷

Federal prosecution under the ban has been exceedingly rare. The only known conviction is Levy Izhak Rosenbaum, a Brooklyn man who brokered illegal kidney transplants between 2006 and 2009, recruiting donors in Israel for as little as $10,000 per kidney and charging American recipients between $120,000 and $160,000. In July 2012, he was sentenced to 30 months in prison, three years of supervised release, a $5,000 fine, and forfeiture of $420,000 in illegal proceeds.⁸

How Congress Has Amended NOTA

Congress has revised NOTA several times since 1984 to keep pace with medical advances and shifting ethical questions:

1988 — the Organ Transplant Amendments, part of the Health Omnibus Programs Extension of 1988, amended existing procurement and transplantation authorities.⁹
1990 — the Transplant Amendments Act established and funded a National Bone Marrow Donor Registry.
2000 — the Children’s Health Act required the OPTN to consider the special needs of pediatric patients in organ allocation.
2004 — the Organ Donation and Recovery Improvement Act created a grant program to reimburse travel and subsistence expenses for living donors.
2007 — the Charlie W. Norwood Living Organ Donation Act clarified that paired kidney donation does not constitute “valuable consideration” under NOTA and mandated annual reports on the long-term health effects of living donation.⁹
2014 — the definition of organs covered under NOTA was expanded to include vascularized composite allografts, such as hand and face transplants.³

Paired Kidney Donation

Paired donation emerged as a solution for patients with a willing living donor who was biologically incompatible. In a typical exchange, two incompatible pairs effectively trade donors, and more complex chains involve three or more pairs, sometimes initiated by an altruistic donor. Before the Norwood Act, hospitals worried that these swaps could be read as exchanging organs for valuable consideration. The 2007 amendment settled the question and cleared the way for UNOS to launch a national kidney paired donation pilot program in 2010.¹⁰

How the OPTN Is Regulated

The detailed rules for how the OPTN actually operates live in 42 CFR Part 121, sometimes called the OPTN Final Rule. First issued in 1998, these regulations require the OPTN Board to develop organ-specific allocation policies based on sound medical judgment that seek the best use of donated organs, promote patient access, and avoid waste. Allocation policies cannot favor candidates based on where they live or where they are listed, except to the extent required by medical urgency or logistical efficiency.¹¹

The regulations give the Secretary of HHS significant oversight power. The OPTN must submit proposed policies to the Secretary at least 60 days before they take effect, and those policies are not enforceable until approved. The Secretary can also direct the OPTN to revise policies found inconsistent with NOTA.²

The 2023 Reform Law and OPTN Modernization

Criticism of the single-contractor model built up for years. In September 2023, Congress passed the Securing the U.S. Organ Procurement and Transplantation Network Act (Public Law 118-14), introduced by Representatives Robin Kelly and Larry Bucshon. The law authorized HRSA to award multiple, distinct contracts for OPTN functions rather than relying on a single vendor, and required that the OPTN board of directors be supported independently from the operational contractors.¹²¹³ It also required the Government Accountability Office to review the historical financing of the OPTN, including its use of registration fees.

HRSA implemented the new structure quickly. By late 2025, it had divided OPTN operations among specialized contractors. American Institutes for Research was selected to support the independent OPTN Board. Guidehouse took over meeting logistics and the patient call center. Sapient was hired to build transplant data infrastructure. MITRE was tasked with developing new safety and quality standards. IQ Solutions was assigned the OPTN website, and GDIT built the collaboration platform.¹⁴

UNOS kept a limited role. A contract extension awarded in December 2025 kept it running the national matching system, but patient safety monitoring, committee support, and tracking of potential donor-derived transmission events were removed from its scope and opened to competitive bidding.¹⁵ As of early 2026, contracts for policy and membership committee support and patient safety processes were still being awarded.¹⁴

HRSA also centralized direct federal control over several critical functions. It took over collection of OPTN patient registration fees, which the contractor had previously managed, after Congress extended that authority through HR 5371 in November 2025.¹⁶ The agency moved OPTN data and the matching system to a government-managed cloud environment, established an anonymous reporting system for misconduct, and required every organ procurement organization to appoint a Patient Safety Officer.¹⁵

The Scale of Demand Behind the Law

The pressure on the system NOTA built has not eased. As of mid-2025, more than 103,000 people were on the national transplant waiting list. In 2024, more than 48,000 transplants were performed, a record, yet 13 people still die each day waiting for an organ, and a new person is added to the waiting list roughly every eight to ten minutes. Roughly 170 million people in the United States had registered as organ donors as of 2022, though only about 3 in 1,000 people die in circumstances that permit deceased organ donation.¹⁷

What NOTA Does Not Cover

NOTA addressed the deceased donation system in detail, but protections for living donors have been slower to develop. There is no federal law guaranteeing living donors job-protected leave or shielding them from insurance discrimination. As of 2026, 37 states have enacted some form of anti-discrimination protection for living donors in life, disability, or long-term care insurance, and 39 states provide job-protected leave for public employees who donate organs. Only 13 states extend that leave to private-sector employees.¹⁸

The Living Donor Protection Act of 2025 was introduced in both chambers as S. 1552 and H.R. 4583, the latter sponsored by Representative Don Bacon and referred to the House Committees on Energy and Commerce and Financial Services in July 2025.¹⁹ The bill would codify Family and Medical Leave Act rights and anti-discrimination protections for living donors at the federal level.

1
U.S. Government Publishing Office. National Organ Transplant Act, Public Law 98-507
2
eCFR. 42 CFR Part 121 — Organ Procurement and Transplantation Network
3
UNOS. UNOS History
4
Los Angeles Times. Task Force on Organ Transplantation Report
5
Office of the Law Revision Counsel. 42 USC 274e — Prohibition of Organ Purchases
6
Legal Information Institute. 42 U.S. Code § 274e
7
U.S. Department of Justice. Office of Legal Counsel Memorandum on Organ Transplantation
8
U.S. Department of Justice. Rosenbaum Sentencing News Release
9
OrganDonor.gov. History of Legislation and Policy
10
National Kidney Registry. A Systematic Review of Kidney Paired Donation
11
eCFR. 42 CFR 121.8 — Allocation of Organs
12
U.S. Government Publishing Office. Securing the U.S. Organ Procurement and Transplantation Network Act
13
Rep. Robin Kelly. Reps. Kelly, Bucshon Applaud Bipartisan Passage
14
HRSA. Learn More About OPTN Modernization
15
HRSA. OPTN Modernization Update, January 2026
16
HRSA. OPTN Modernization Update, November 2025
17
OrganDonor.gov. Organ Donation Statistics
18
American Kidney Fund. Living Donor Protection Report
19
U.S. Congress. H.R. 4583 — Living Donor Protection Act of 2025