Organ Transplant Policy and NOTA

The National Organ Transplant Act (NOTA) of 1984 established the federal framework for organ donation and transplantation in the United States — creating the Organ Procurement and Transplantation Network (OPTN), funding organ procurement organizations, prohibiting the sale of human organs, and establishing the system through which approximately 46,000 organ transplants are performed annually. With over 100,000 people on the national waiting list at any time, organ allocation policy is literally a life-and-death government function. Hospitals receiving organs must also comply with EMTALA emergency treatment requirements.

Current Law (2026)

Legal Authority

• 42 U.S.C. § 273 — Organ procurement organizations (authorizes grants to establish and maintain OPOs that coordinate organ donation in their service areas)
• 42 U.S.C. § 274 — Organ Procurement and Transplantation Network (establishes the OPTN: a unified national network to match organ donors with recipients; operates a national waiting list; sets allocation policies; maintains a 24-hour coordination system)
• 42 U.S.C. § 274a — Scientific registry (requires a registry tracking the clinical outcomes of all organ transplant recipients)
• 42 U.S.C. § 274b — General provisions (the Secretary contracts with a private nonprofit to operate the OPTN; the contractor must have a board including transplant surgeons, physicians, patients, organ procurement professionals, and the general public)
• 42 U.S.C. § 274e — Prohibition of organ purchases (it is a federal crime to knowingly acquire, receive, or transfer any human organ for valuable consideration — i.e., buying or selling organs is illegal; exceptions for reasonable payments for removal, transportation, implantation, and processing)
• 42 U.S.C. § 274f — Reimbursement of living donor expenses (permits reimbursement of travel, subsistence, and lost wages for living organ donors to remove financial barriers to donation)

How It Works

The organ transplant system operates through a three-part structure: organ procurement organizations (OPOs) recover organs from deceased donors, the OPTN matches available organs with waiting recipients, and transplant centers perform the surgeries.

Organ Procurement Organizations are the ground-level coordinators. The 56 OPOs covering the entire United States are responsible for identifying potential donors in hospitals, obtaining consent from families, coordinating surgical recovery of organs, and ensuring proper preservation and transportation. OPOs work 24/7 — organ viability is time-critical, and coordination between donor hospitals, the OPTN matching system, and recipient transplant centers must happen within hours.

The Organ Procurement and Transplantation Network is the national system that maintains the waiting list and allocates organs. Since 1986, the OPTN has been operated under federal contract by the United Network for Organ Sharing (UNOS), a private nonprofit based in Richmond, Virginia. When an organ becomes available, the OPTN's computer matching system generates a ranked list of potential recipients based on medical criteria — blood type compatibility, tissue matching, time on the waiting list, geographic proximity, and medical urgency. The organ is offered to recipients in priority order until accepted.

The prohibition on organ sales is one of NOTA's most fundamental provisions. Buying or selling human organs for transplant is a federal crime punishable by up to 5 years in prison and $50,000 in fines. This prohibition ensures that organs are allocated based on medical need, not wealth. Reasonable payments for the costs of organ removal, transportation, and processing are explicitly excepted.

Living donor protections address the financial barriers that might prevent people from donating kidneys or liver segments to family members or others. Federal law permits reimbursement of living donors' travel, subsistence, and lost wages — removing a financial disincentive without violating the organ sale prohibition.

The Scientific Registry tracks outcomes for every organ transplant performed in the United States, providing the data that informs allocation policy, quality improvement, and research. Transplant center and OPO performance is publicly reported, creating accountability. Patient records are protected under HIPAA. Anti-rejection medications must be approved by the FDA.

How It Affects You

If you or a family member is on the transplant waiting list or being evaluated for listing: The OPTN maintains approximately 100,000 people on the national waiting list at any given time. Access begins at a transplant center: your physician must refer you, the center evaluates your medical eligibility, and the center then adds you to the OPTN list if you qualify. Transplant centers can list you at their own program and also at other programs if you're willing to travel — this "multi-listing" strategy is more common for kidney patients and can significantly reduce wait time by widening the geographic pool. The most important variables determining your wait: organ type (kidneys take the longest, often 3-7 years in high-demand regions; livers are faster for high-urgency patients; hearts typically months); blood type (O negative patients wait longer because their compatible donor pool is smaller than their actual number); and geography (wait times vary dramatically by region — a kidney recipient in Iowa may wait months while someone in California or New York waits years for the same organ). OPTN's system distributes organs first locally, then regionally, then nationally. Knowing your regional OPO's local practices and how listing at multiple centers affects your waitlist status is worth discussing with your transplant team. Patient advocacy organizations — the American Kidney Fund (kidneyfund.org), the National Kidney Foundation (kidney.org), the American Liver Foundation — can help navigate the listing process, insurance questions, and support programs.

If you want to register as an organ donor: Registering takes two minutes — go to RegisterMe.org (the national portal that links to your state's donor registry) or update your preference the next time you renew your driver's license. All 50 states have registries. Why registering matters: when someone dies in a hospital under circumstances that make donation possible, the OPO (Organ Procurement Organization) for that region contacts the family. If you're already registered, your documented intent carries significant weight — OPOs are trained to present registry enrollment as evidence of your own decision, not as asking the family's permission. In most states, first-person consent (registration) is legally binding, and OPOs may proceed even over family objection, though in practice they almost always seek family agreement. If you have specific donation preferences (certain organs only, research vs. transplant), document them in your registry entry and in an advance directive — the registry entry governs donation consent but your advance directive can add specificity. For families: when a hospital calls about a deceased family member and mentions organ donation, you have time to ask questions. OPO coordinators are trained counselors — you can ask what organs are medically viable, what the process involves, and how your family member will be treated. Saying yes or no is your family's decision when no registry consent exists.

If you're considering becoming a living kidney or liver donor: Living donation — typically one kidney (you can live with one) or a segment of a liver (which regenerates) — is the only way to address the organ shortage without a deceased donor. Approximately 6,500 living donor transplants occur annually in the U.S. Living donation is altruistic — federal law (42 U.S.C. § 274e) prohibits paying donors; however, it explicitly permits reimbursement of living donors' travel, housing, and lost wages through the National Living Donor Assistance Center (NLDAC) at livingdonorassistance.org — call 1-888-870-4747. NLDAC pays for travel to the transplant center, lodging, and can reimburse lost wages up to a maximum. Living donors also benefit from federal protections against insurance discrimination — the National Organ Transplant Act prohibits insurance companies from denying or limiting coverage solely because someone has been a living donor. The medical evaluation for living donation is thorough and free (paid by the recipient's insurance). Short-term surgical risks are real (1-2 days hospitalization for laparoscopic nephrectomy, longer for liver resection) and long-term kidney function is slightly reduced but generally within normal limits — studies show living donors have similar life expectancy to matched non-donors.

State Variations

NOTA creates a federal framework, but states play important roles:

• Donor registries: Each state maintains its own organ donor registry (linked to driver's licenses)
• First-person consent: Most states have enacted first-person consent laws (the donor's registration is legally sufficient)
• Required referral: Many states require hospitals to refer all deaths to their OPO for evaluation
• Living donor protections: Some states provide additional living donor protections (paid leave, insurance protections)
• Presumed consent: No U.S. state has adopted presumed consent (opt-out) organ donation, though it's used in several countries

Implementing Regulations

• 42 CFR Part 121 — Organ Procurement and Transplantation Network (OPTN): the HHS implementing regulation for the National Organ Transplant Act's OPTN mandate — establishing the governance, policy-making authority, transplant listing and allocation requirements, and federal oversight framework for the OPTN contractor (currently UNOS):

  • § 121.3 — OPTN organization: the OPTN must have a Board of Directors that is approximately 50% transplant surgeons and physicians and 50% non-healthcare representatives (patients, donor families, OPO professionals, public members); this 50/50 requirement ensures that allocation policies reflect patient and public perspectives, not just medical community consensus; the Board develops all allocation policies, which are reviewed by HHS before taking effect
  • § 121.4 — Policy review and appeals: all OPTN allocation policies are reviewed by the HHS Secretary before implementation; if the Secretary determines that a policy conflicts with federal law or is not equitable, it may be rejected; transplant programs, OPOs, and other OPTN members may appeal OPTN policy decisions to the HHS Secretary; this federal oversight of what is formally a private nonprofit organization (UNOS) is unique and reflects the life-or-death stakes of allocation policy
  • § 121.5 — Listing requirements: a transplant hospital may list a patient for transplant only at a hospital that is a designated transplant program under Part 121; a patient may be listed at multiple transplant programs (multi-listing); multi-listing is a controversial practice — it gives patients access to a wider geographic organ pool but also creates inequities in access based on ability to travel and health insurance coverage of multiple evaluations
  • § 121.7 — Organ allocation: when an organ becomes available, the procuring OPO must run the OPTN computer matching system within the time OPTN policies prescribe; the match run generates a ranked list of potential recipients based on OPTN allocation criteria (blood type, body size, time on waiting list, medical urgency, geographic location, and other factors that vary by organ type); the organ is offered to recipients in order; a recipient team has a limited time window to accept or decline before the offer moves to the next patient
  • § 121.8 — Allocation policy development: OPTN policies for equitable organ allocation must be based on sound medical judgment and achieve the best utilization of donated organs, provide equitable organ access for patients, and avoid discrimination on the basis of race, color, national origin, sex, age, or disability except when medically indicated; the requirement that allocation prioritize medical criteria over non-medical factors (including wealth or social status) is fundamental — buying organs is prohibited under 42 U.S.C. § 274e, and allocation criteria cannot create de facto preferences for wealthy or well-connected patients
  • § 121.9 — Designated transplant program requirements: to perform transplants and receive organs from the OPTN, a transplant program must be designated — meeting minimum volume requirements (typically a minimum number of transplants per year), having qualified personnel (transplant surgeons, coordinators, social workers, dietitians), 24/7 coverage capability, data reporting compliance, and performance outcomes within acceptable ranges; programs with poor outcomes are subject to monitoring, probation, and ultimately decertification
  • § 121.10 — Reviews and enforcement: HHS may conduct reviews and evaluations of member OPOs and transplant programs; if a member fails to comply with OPTN policies, the OPTN may take corrective action including probation, suspension, or membership termination; loss of OPTN membership means a transplant center cannot receive organs — effectively shutting down its transplant program; HHS retains authority to impose additional sanctions, including exclusion from Medicare participation
  • § 121.13 — Definition of human organ: the Part 121 definition of "human organ" — which determines what is covered by the prohibition on commercial transactions — includes kidneys, livers, hearts, lungs, pancreata, intestines, corneas, bone marrow, skin, and other tissues designated by the Secretary; the definition affects what exchanges and reimbursements are permissible; kidney paired donation programs (where incompatible donor-recipient pairs are matched in chains) are permitted under interpretive guidance issued by HRSA
  • § 121.14 — Living donor reimbursement: living organ donors may be reimbursed for incidental non-medical expenses including travel and lodging, lost wages, and dependent care costs incurred in making the donation; the reimbursement must come from a federally approved reimbursement program (the National Living Donor Assistance Center administers HRSA's living donor assistance program); reimbursement beyond incidental costs remains prohibited as "valuable consideration" under the organ sale prohibition

  Part 121 is the backbone of U.S. organ allocation — every transplant in the United States operates within its framework. OPTN policy development is one of the most consequential exercises of quasi-private regulatory authority in American health policy: when OPTN updated liver allocation from a geographically-based system to a continuous distribution system in 2022, the change affected waiting times for thousands of patients and triggered significant regional conflict between high- and low-volume transplant centers. The 2023 legislation (the Securing the U.S. Organ Procurement and Transplantation Act) created new competition for the OPTN contractor role previously held exclusively by UNOS since 1986, reflecting congressional concern that the prior monopoly arrangement was insufficiently accountable. Recent rulemakings: 88 FR 35960 (June 2023) — updates to OPTN Board governance following congressional legislation; 80 FR 78640 (December 2015) — major OPTN policy revision to increase geographic equity in liver allocation.

• 42 CFR Part 482 — Conditions of participation for hospitals (§§ covering organ transplant center requirements, including organ procurement responsibilities)

• 42 CFR Part 413 — CMS payment rules (organ acquisition costs reimbursement for transplant centers)

• 42 CFR Part 486 — Conditions for Coverage of Specialized Services Furnished by Suppliers (34 sections — the CMS performance and certification standards for organ procurement organizations (OPOs), portable X-ray services, and home infusion therapy suppliers; the OPO subpart (§§ 486.301–360) is the binding regulatory framework that determines whether an OPO may receive Medicare and Medicaid payment — and therefore whether it may continue to operate at all; authority: 42 U.S.C. § 273 (National Organ Transplant Act) and Social Security Act § 1138(b)):

  • § 486.301 — Basis and scope: Part 486 Subpart G implements Social Security Act § 1138(b), which requires OPOs to meet federal performance and operational standards as a condition of receiving Medicare payment for organ acquisition costs; the subpart applies to all OPOs seeking CMS certification and designation as the sole OPO in their service area
  • § 486.302 — Definitions: key defined terms include adverse event (an untoward, undesirable, and usually unanticipated event in a donor or recipient), potential donor (a brain-dead hospital patient from whom at least one organ could be recovered for transplant), and eligible death (an in-hospital death that is medically suitable for donation — the denominator used to calculate OPO performance rates); the definition of eligible death became central to the 2020 performance reform controversy
  • § 486.303 — Certification requirements: to be certified, an OPO must demonstrate compliance with all applicable conditions (§§ 486.318–360), operate as a nonprofit, maintain a defined service area, and have an agreement with each hospital in its service area for referral of potential donors; certification by CMS is the prerequisite for seeking designation as the responsible OPO in a service area
  • § 486.304 — Designation as condition for payment: CMS designates only one OPO per service area; designation — not just certification — is required for Medicare/Medicaid payment; payment for organ acquisition costs flows through transplant hospitals to the designated OPO; loss of designation ends Medicare revenue, effectively shutting down the OPO
  • § 486.306 — Service area size and documentation: OPOs must document their service area in a way that demonstrates all potential donors in the area can be covered; service area boundaries must be contiguous, not overlap with other OPO areas, and allow the OPO to provide 24/7 coverage; service area documentation requirements were tightened in the 2006 rulemaking to address inconsistent coverage gaps
  • § 486.308 — One OPO per service area: CMS designates only a single OPO per service area; when two OPOs overlap, CMS must resolve the conflict through designation proceedings; the one-OPO rule creates geographic monopolies that insulate OPOs from performance pressure — a design feature that the 2020 reforms targeted
  • § 486.316 — Re-certification and competition: OPOs are re-certified on a four-year cycle; if an OPO fails performance thresholds, CMS may open the service area to competition from other certified OPOs seeking designation; the 2020 rule (85 FR 77898) made the competition process more automatic by establishing bright-line outcome thresholds — OPOs falling below the 10th percentile on donation rate and organ yield rate become subject to open competition; this was the most significant structural change to OPO oversight since the program's founding
  • § 486.318 — Outcome measures: the central performance accountability provision; CMS measures each OPO against two primary outcomes: (1) donation rate — the percentage of eligible deaths that result in at least one organ being recovered; and (2) organ yield — the number of organs transplanted per eligible death; OPOs are ranked against each other; those in the top tier are considered high-performing; those in the bottom tier face re-certification competition; the 2020 reform changed the eligible death denominator from self-reported OPO data to independent CDC death certificate data, eliminating OPOs' ability to manipulate their own performance metrics by narrowing the denominator
  • § 486.320 — OPTN participation required: certified OPOs must participate in and comply with OPTN policies (42 CFR Part 121) as a condition of Medicare payment; this links the two parallel regulatory frameworks — OPTN membership governs organ allocation and matching; Part 486 certification governs OPO operational performance; an OPO expelled from OPTN for policy violations would simultaneously lose its Medicare certification
  • § 486.322 — Hospital relationships: OPOs must have written agreements with all hospitals in their service area for timely referral of potential donors; hospitals must notify OPOs of all deaths and imminent deaths that meet referral criteria; the CMS "required referral" standard means hospitals cannot cherry-pick which deaths to report; each agreement must establish the protocol for how OPO coordinators will be notified, how quickly they must respond, and how consent conversations will be handled
  • § 486.342 — Requesting consent: OPOs must develop protocols for consent conversations that emphasize discretion and sensitivity; the consent conversation must occur only after a physician has determined the patient will not survive; OPOs may not pressure families; the section codifies the practical counseling standards (timing, who speaks with the family, use of trained coordinators rather than hospital staff) developed from decades of consent research showing higher donation rates when properly trained OPO staff conduct consent conversations
  • § 486.344 — Donor evaluation and organ placement: OPOs must have written protocols covering the full donor management pathway: determining brain death criteria, managing the donor's physiological status during the evaluation period, assessing organ viability, running the OPTN matching system, placing organs with recipient transplant programs, and coordinating simultaneous multi-organ recovery; the logistics of managing a multi-organ donor (heart team arrives, kidney team departs, liver team waits) require real-time coordination that these protocols must govern
  • § 486.346 — Organ preparation and transport: recovered organs must be tested for infectious disease (HIV, hepatitis B and C, syphilis, HTLV) before transport; OPOs must arrange packaging and transportation that maintains organ viability; transportation chain of custody documentation must accompany each organ; the OPO bears liability for organ preservation failures from procurement through delivery to the transplant center
  • § 486.348 — QAPI (Quality Assessment and Performance Improvement): OPOs must maintain a written QAPI program that systematically collects data on performance, identifies improvement opportunities, and tracks whether interventions achieved their goals; adverse events (organ quality failures, transport delays, consent process complaints) must be analyzed for root cause; QAPI findings feed into CMS oversight and OPTN reporting

  Part 486's OPO certification and outcome standards are the enforcement backbone for the U.S. organ procurement system. The 2020 overhaul replacing self-reported performance data with independently-verified CDC death records was the most contested regulatory change in organ donation history — OPOs challenged it as methodologically flawed, while reformers argued the self-reporting system had allowed chronic underperformance to go undetected for decades. Donation rates increased measurably after the 2020 rule took effect. The portable X-ray services subpart (§§ 486.100–110) sets separate Medicare conditions for suppliers providing portable X-ray services to homebound patients (physician supervision, qualified technicians, equipment inspection); the home infusion therapy subpart (§§ 486.500–525) establishes conditions for home infusion therapy suppliers providing intravenous drugs and related services to homebound patients under 7-days-a-week coverage requirements. Recent rulemakings: 85 FR 77898 (December 2020) — major OPO performance metric overhaul replacing self-reported eligible death denominator with CDC death certificate data; 71 FR 31046 (June 2006) — previous OPO conditions of coverage update adding outcome measure framework

Pending Legislation

• S 4109 — Reauthorize federal stem cell transplant programs, extend cord blood inventory through 2031. Status: Introduced.
• S 4009 — Targeted sanctions for forced organ harvesting in China, public report on PRC transplant practices. Status: Introduced.
• HR 7581 — Medicare demo to train living-kidney-donor facilitators, track outcomes. Status: Introduced.
• S 3105 — Treat human cadaveric islets as organs for transplantation. Status: Introduced.
• HR 5259 (Rep. Matsui, D-CA) — Let HHS charge OPTN fees, require transplant dashboard. Status: Introduced.
• S 2751 (Sen. Wyden, D-OR) — HHS per-candidate OPTN fees, public dashboard, GAO review. Status: Introduced.

Recent Developments

• HRSA shifted from single-vendor to multi-vendor OPTN operations (2024–2026): Implementing the bipartisan Securing the U.S. Organ Procurement and Transplantation Network Act (signed September 2023), HRSA in September 2024 awarded multiple modernization contracts — including Arbor Research Collaborative for Health (patient safety), General Dynamics Information Technology (IT modernization), and Maximus Federal Services (transparency and public engagement) — ending UNOS's roughly four-decade monopoly on OPTN operations. UNOS's prior contract expired December 29, 2025, after which HRSA exercised continuity options keeping UNOS on a short-term extension (up to 12 months, through December 29, 2026, in three-month increments) while transitioning specific OPTN functions to the new vendors. The transition raised questions about continuity of the matching algorithm, donor/recipient data systems, and the Scientific Registry of Transplant Recipients. As of early 2026, the multi-vendor transition was underway with heightened congressional oversight.
• OPO performance reforms produced measurable results and controversy: HHS's 2020 overhaul of OPO performance metrics — replacing survey-based thresholds with outcome-based measures comparing each OPO's donation rates to the potential donor population — led to several OPO decertification proceedings and forced mergers. Supporters said the reforms finally held underperforming OPOs accountable for leaving usable organs unretrieved; critics argued the new metrics were methodologically flawed. Donation rates did increase meaningfully in the 2022–2025 period, with some attributing the improvement to OPO competitive pressure and others to expanded use of HCV-positive and older-donor organs.
• House investigation into foreign national organ access (February 2026): House Ways and Means Committee leadership opened an investigation in February 2026 into allegations that foreign nationals — particularly affluent individuals from China and other countries — have been accessing U.S. transplant waiting lists in ways that disadvantage U.S. citizens. The investigation requested data from transplant centers about the citizenship and residency status of organ recipients. Transplant centers allocate organs based on medical criteria, not citizenship; the investigation reflected broader political tensions about foreign access to U.S. medical resources.
• Hepatitis C-positive organ expansion increased supply significantly: The development of highly effective HCV curative treatments (direct-acting antivirals) enabled transplant centers to use HCV-positive organs — previously discarded — for HCV-negative recipients who are then treated for HCV after transplantation. This practice, now widespread, has meaningfully expanded the donor pool and reduced wait times for some organ types. The FDA-approved HCV treatments used in this context (sofosbuvir/velpatasvir and others) are expensive ($20,000–$30,000 per treatment course), and insurance coverage for post-transplant HCV treatment is a persistent access issue for some recipients.