Why was the National Organ Transplant Act passed

(Conference report filed in House, H. Rept. 98-1127)

National Organ Transplant Act - Title I: Task Force on Organ Procurement and Transplantation - Directs the Secretary of Health and Human Services to establish within 90 days a Task Force on Organ Transplantation.

Directs the Task Force to: (1) examine and advise the Secretary regarding medical, legal, ethical, economic, and social issues presented by human organ procurement and transplantation; and (2) assess immunosuppressive medications used to prevent organ rejections, including considerations of safety, cost, insurance coverage, grants, Federal program coverage, and other means of assuring public access to such medications.

Authorizes the Task Force to make interim reports to the Secretary and the appropriate congressional committees. Requires: (1) an immunosuppressive medication report within seven months; and (2) a final report within 12 months. Terminates the Task Force three months after it submits such final report.

Title II: Organ Procurement Activities - Amends the Public Health Service Act to authorize the Secretary to make grants for the planning of qualifed organ procurement organizations.

Authorizes the Secretary to make grants for the establishment, initial operation, and expansion of qualified organ procurement organizations. Directs the Secretary in making such grants to: (1) take into consideration any Task Force recommendations; and (2) give special consideration to applications from organ procurement organizations which cover geographic areas not adequately served by organ procurement organizations. Sets forth eligibility criteria, including the requirement of an agreement from the Secretary for kidney procurement reimbursement under title XIII of the Social Security Act. Authorizes FY 1985 through 1987 appropriations.

Directs the Secretary to: (1) establish an Organ Procurement and Transplantation Network to provide a central registry linking donors and potential recipients; (2) establish a scientific registry of organ recipients; (3) designate and maintain an identifiable unit in the Public Health service to coordinate Federal organ transplant programs and policies; and (4) publish an annual report on the scientific and clinical status of organ transplantation.

Title III: Prohibition of Organ Purchase - Prohibits the purchase or sale of human organs if such transfer affects interstate commerce. Establishes criminal penalties for such violations.

Title IV: Miscellaneous - Directs the Secretary to: (1) convene a conference to examine the feasibility of establishing a registry of voluntary bone marrow donors, and to determine whether such registry would be effective in matching donors and recipients; (2) establish such a registry for study and demonstration purposes if the conference reaches a positive feasiblility conclusion; and (3) report to the appropriate congressional committees within two years.

Requires the Secretary to assure that potential donors have given informed consent prior to being listed in the registry, that their names are kept confidential, and that registry access is restricted.

Passed by Congress in 1984, NOTA initiated the development of a national system of organ sharing and a scientific registry to collect and report transplant data. It also outlawed the sale of human organs in the United States. (Organdonor.gov April 2020)

The National Organ Transplant Act (1984 Public Law 98-507), approved October 19, 1984 and amended in 1988 and 1990, outlawed the sale of human organs and provided for the establishment of the Task Force on Organ Transplantation; authorized the Secretary of HHS to make grants for the planning, establishment, and initial operation of qualified OPOs; and established the formation of the Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). (OPTN Glossary May 2021)

42 U.S.C. Â§ 273 et seq. (OPTN Policy Definitions May 2021)

National Organ Transplant Act, passed by Congress in 1984, NOTA initiated the development of a national system of organ sharing and a scientific registry to collect and report transplant data. It also outlawed the sale of human organs in the United States (Alliance Terminology & Data Resources May 2021)

In 1984 the national Organ Transplantation Act (NOTA) as enacted. NOTA established the basic requirements for OPOs, the OPTN, and the Scientific Registry for Transplant Recipients (SRTR). NOTA also directed the Secretary of HHS to establish by contract the Organ Procurement and Transplantation Network (OPTN) that shall be a private, non-profit entity that has an expertise in organ procurement and transplantation. In addition, NOTA contains a criminal prohibition against the transfer of human organs for valuable consideration. (OPTN Bylaws Definitions, December 2020)

On October 19, 1984, the Congress of the United States approved the National Organ Transplant Act (NOTA). It not only established the framework for the U.S. organ transplant system but has served as a model for development of other transplant networks worldwide.

Through the establishment of a national Organ Procurement and Transplantation Network (OPTN), the law directed that organ allocation would be managed on a national basis and be developed through a unique public-private partnership. Since the initial network contract was finalized in 1986, United Network for Organ Sharing (UNOS) has served as the OPTN under contract with the U.S. Department of Health and Human Services.

OPTN policies are developed by a broad community that includes donation and transplant clinicians and professionals, as well as people personally touched by the donation and transplant experience. NOTA and subsequent federal regulation call on the OPTN to emphasize fair and equitable patient access to transplantation, as well as reliance on objective medical evidence and adaptability to rapid evolution in clinical treatment and scientific understanding.

Many of the OPTN’s responsibilities, priorities and policies have changed over the years. Yet the lifesaving gift organ donation, and the continuing need of candidates awaiting a transplant, remain the same today as they did 30 years ago. To fulfill the ultimate goals of NOTA, we must continue to ensure that the national transplant network allocates organs efficiently and fairly. We must also build public knowledge and trust in organ donation to help increase transplant opportunities for everyone in need.

Ochsner J. 1999 Jan; 1(1): 6–11.

PMCID: PMC3145429

Chief of the Division of Cardiothoracic Surgery and Transplantation, Ochsner Clinic and Alton Ochsner Medical Foundation; Chairman of the United Network for Organ Sharing, Thoracic Organs Committee; President of the Board of the Louisiana Organ Procurement Agency

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The Department of Health and Human Services (HHS) recently issued a final regulation governing the Organ Procurement and Transplantation Network (OPTN) that directs the allocation of organs to the sickest patients first without regard to a host of medical, geographic, and social factors that members of the transplant community view as an essential part of a sound organ allocation policy.

Current organ allocation mechanisms are based on policies that reflect a broad consensus of medical experts and provide equal consideration for both the needs of the sickest patients and the efficient use of organs. This system also reduces potential waste of organs by minimizing cold ischemic time, increases access to transplantation for patients in local communities, provides positive incentives for local citizens and medical professionals to support organ donation initiatives, and decreases the cost of organ transplantation.

Representatives of the American Society of Transplant Surgeons have testified before Congress that “giving priority to the sickest patients first over broad geographic areas would be wasteful and dangerous, resulting in fewer patients transplanted, increased death rates, increased retransplantation due to poor organ function, and increased overall cost of transplantation.” In response, Congress enacted a 1-year moratorium on the implementation of the HHS rule and provided for a study of the current organ allocation policy and HHS regulation by The Institute of Medicine.

Since the first successful development of kidney transplants in the mid-1950s, organ transplantation in the United States has undergone a legislative and regulatory metamorphosis (1). Until the late 1960s, organ transplantation existed without government involvement. Transplantation was predominantly a local endeavor consisting of a transplant surgeon, his or her team, and some form of organ procurement organization. Hospitals shared organs on an informal, voluntary basis (2). But as the number of organ transplants began to increase exponentially and as Medicare and Medicaid began paying for many of these procedures, the involvement of the federal government kept pace. Today we have a formal national infrastructure with governmental and quasi-governmental oversight.

On April 2, 1998, the Department of Health and Human Services (HHS) issued a final regulation governing the Organ Procurement and Transplantation Network (OPTN) and the United Network for Organ Sharing (UNOS) requiring the implementation of new organ allocation policies. The rule contains a controversial provision that directs the allocation of organs to the sickest patients without regard to geographic considerations and a host of medical and social factors that have long been viewed by members of the transplant community as an essential part of the development of sound organ allocation policy. A decade of progress toward increasing the supply of donated organs and expanding access for patients to organ transplantation is threatened by the policy. The ultimate disposition of these regulations could decide the future of organ transplantation in the United States.

The legislative and regulatory foundations of organ donation and transplantation began with the enactment of the Uniform Anatomical Gift Act of 1968 (Table 1). When Congress passed the National Organ Transplant Act in 1984, it recognized that a national organ allocation system would require the careful exercise of medical judgment coupled with the voluntary support and participation of the transplant community. Thus, Congress created the OPTN, an organization outside of government, self-governed by the transplant community, and charged with the responsibility for making difficult decisions concerning allocation of a scarce and precious resource—human organs for transplantation. The Secretary of HHS was directed to contract with a private, non-profit entity to establish and guide the OPTN. UNOS was awarded the original contract and has continued to operate the OPTN since 1986.

Chronology of Legislation and Regulation

The members of UNOS include patients; transplant recipients; donor family members; representatives of voluntary health, medical, and scientific organizations (such as the American Heart Association, National Kidney Foundation, American Medical Association, etc.); and every transplant center, organ procurement agency, and tissue typing laboratory in the United States. UNOS is governed by representatives of the transplant community, including surgeons, physicians, and professionals from organ procurement agencies, who are elected by their peers from transplant regions around the country to committees charged with developing and codifying organ allocation policy. Among their responsibilities are setting and maintaining professional standards for participation in all transplant organizations, standardizing medical criteria for listing, measuring the medical status of patients awaiting organ transplantation, and adjusting organ allocation policies to optimize benefits to potential recipients.

The dissemination of medical capability and expansion of public and professional education concerning organ donation have increased the availability of multi-organ transplant services for all Americans. Recent years have seen not only the development of techniques and technologies to foster transplant capabilities, such as lung and pancreas transplantation, split-liver transplantation, and mechanical bridges to cardiac transplantation, but also the expansion of UNOS-approved transplant centers serving patients in all regions of the country.

Unfortunately, the disparity between the number of patients who require organ transplantation and the number of donor organs continues to grow (Figure 1). “Since 1988, the organ transplant waiting list has quadrupled with nearly 61,000 men, women, and children waiting for a transplant today” (3). The number of organ donors, however, has grown at a much less rapid pace, providing roughly 20,000 organs for transplantation in 1997 (4). As a result, the American Society of Transplant Surgeons has stated that the primary goals of public policy should be to expand and enhance organ donation, and ensure “that the precious organs presently available provide the maximum benefit to the maximum number of Americans in an equitable fashion.” (5)

For UNOS members, the challenges associated with the development of organ allocation policy are often described as a struggle to provide balance and equal consideration of factors related to utility and justice. The principle of utility “suggests that when the demand for transplantable organs exceeds supply, the organs should be allocated to patients who have the best chance of benefiting from a transplant. The principle of justice, which insists that the benefits and burdens of the [organ allocation] system be shared among all patients equitably, would favor the patient who had the most urgent need or has waited the longest” for a transplant (4).

Organ allocation policies must also be crafted to reflect specific medical factors, such as the limited viability of donor organs in the absence of oxygenated blood. Maximum cold ischemic times vary by the type of organ. Hearts must be transplanted within approximately 4 hours and livers retain viability for approximately 12 hours, with maximum cold ischemic time influenced by the condition of the donor organ.

Increases in cold ischemic time raise the probability that an organ will not function after transplantation. In addition, allocation policies should weigh the fact that the most severely ill patients awaiting transplantation have lower survival rates and an increased need for a second organ transplant when compared with the entire population of transplant patients. Finally, certain patient groups require special medical consideration, including children and patients with highly sensitized immune systems.

UNOS has addressed this situation through development of an organ allocation policy based on a broad consensus of experts in the transplant community, striking a balance between the many competing objectives surrounding the concepts of justice and utility. Organs are first allocated to patients within the boundaries of the local organ procurement organization (OPO) (which in Louisiana encompasses the entire state), then to patients in the contiguous region, then to patients nationally. Organs are offered first to the sickest patients in a local OPO area, then to patients in the same area with less medically urgent conditions if a patient with an urgent medical need is not available. If there are no suitable patients in a local OPO community, this same allocation process is replicated at the regional and then national level. (Note: There is a different allocation system for kidneys that addresses special problems involving the medical compatibility of patients and donor organs.) Within each status group, patient priority is determined on the basis of numerous factors, including blood type and time on the waiting list.

This system provides equal consideration for both the needs of the sickest patients (Justice) and the efficient use of organs (Utility) “by permitting transplantation of some less urgent patients who have a higher probability of surviving the longest and not needing a second transplant (further depleting the already scarce resource).” (6) A balanced approach to organ allocation results in high overall survival rates, and also distributes “the benefits and burdens of organ transplantation among patients throughout the country with the most urgent” and severe medical conditions (4). This allocation mechanism also reduces potential waste of donated organs by minimizing cold ischemic time; increases access to transplantation for patients in local communities, many of whom are from minority and economically disadvantaged populations; provides positive incentives for local citizens and medical professionals to support organ donation initiatives; and decreases the costs of organ transplantation attributable to medical complications, the need for hospital care, and transportation and procurement costs.

The HHS regulation contains a sweeping organ allocation policy that overrides the established OPTN system and replaces it with a mechanism that allocates organs to the sickest patients first without regard to geographic location. More specifically, the HHS rule creates a policy “to allocate organs among transplant candidates in order of decreasing medical urgency status, with waiting time in status used to break ties within status groups. Neither place of residence nor place of listing shall be a major determinant of access to a transplant” (7). Patients who need liver transplants will be the first individuals affected by the new policy.

The main justification for the policy is an inaccurate assertion that the sickest patients are treated unfairly by the current allocation system and suffer from wide disparities in waiting times (8). HHS officials claim that the rule will equalize waiting times, thus creating a fairer allocation system. The final rule also acknowledges, however, that “current measures of waiting time disparities are weak because the lack of listing standards does not create uniform, status-related measures …” (9). Further, the regulation concedes that these policies will lead to lower survival rates, fewer patients transplanted, and longer time on the waiting list for most patients (10). The final rule also states that “the Secretary has final authority over OPTN policies and procedures” (11) and that, “If the Secretary objects to a policy, the OPTN may be directed to revise the policy consistent with the Secretary's direction.” (12)

The new regulation has been met with widespread dismay and opposition by members of the transplant community. One major point of contention involves whether the regulation creates a new organ allocation system. Officials of HHS describe the regulation as establishing broad “performance goals” to be achieved through policies developed by the OPTN. Representatives of UNOS have stated that the “policies, as expressed in this regulation include specific elements of what we interpreted as a required new organ allocation policy-including the exact criteria by which organs are to be allocated. Relieved of the allocation policy-making duties, the OPTN's remaining task … is that of developing detailed procedures for implementing the Secretary's policy.” (13)

The specific directives of the regulation have also generated enormous concern because the policy is medically unbalanced. “When asked during a national conference call … whether the new policy would yield the greatest benefit for the greatest number of patients,” HHS officials “admitted that the new rule favors equity over utility” (14). In response, Dr. Ronald Busuttil, President-elect of the American Society of Transplant Surgeons and Chief of the Division of Liver and Pancreas Transplantation at the University of California at Los Angeles School of Medicine, testified before Congress that “giving priority to sickest first over broad geographic areas would be wasteful and dangerous, resulting in fewer patients transplanted, increased death rates, increased retransplantation due to poor organ function, and increased overall cost of transplantation.” He also stated that “the rationale for rushing this rule into effect may largely have disappeared.” Since the implementation by UNOS of standardized medical criteria for listing an [Text is not Clear] the medical status of patients, “data for 1998 through the month of August” indicate “that for status-one patients, the most critically ill, the mean waiting time for a [liver]transplant-across the country – now is running 4 days, with not a great deal of regional variation” (15).

In addition, UNOS and many observers have expressed great concern that implementation of the HHS rule would result in the allocation of organs to a small group of large transplant centers, reducing access to transplantation for patients in local communities, particularly for Medicaid and economically disadvantaged recipients who cannot afford to seek their care at medical centers in distant locations. This policy would also undermine local communities that have been particularly successful in their efforts to stimulate organ donation, failing to account for the linkage between increased organ donation and decreased patient waiting times within OPO service areas. On a broader level, the rule does not assess the wide disparities in OPO performance and how these variations influence patient waiting times in specific regions of the country.

Transplant surgeons fear that new surgical techniques, such as the split liver procedure, where 1 organ is divided and used to serve 2 patients, would be impaired by the regulation because the success of the procedure is dependent upon minimizing cold ischemic time. “Full utilization of this split-liver procedure would potentially increase available donor livers by close to 1,000 per year in the U.S.” (15).

From a quantitative perspective, “data generated by a national panel of experts” (16), led by Alan Pritsker, PhD and UNOS staff scientists, “predict the following: … over a seven-year period, 1,508 fewer patients [will] be transplanted” (4, 16) (Figure 2), the survival rate for the entire patient population will fall by 9.3% (Figure 3) (4), and patients will have to wait much longer for a transplant (Figure 4) (4), with many individuals throughout the country experiencing a substantial increase in waiting time for a liver transplant of between 51 and 86 days (Figure 5) (17). “Further, the model did not assume any increased organ wastage despite the fact that” (13) the median distance for transportation of donor organs to recipients will increase from 71 miles to 930 miles (Figure 6) (4). The regulation also suggests that the percentage of organs donated and provided to patients in local OPO areas may drop from approximately 80% to 20% (18), “a fact that could be tremendously damaging to local organ donation efforts” (16).

In response to the HHS rule, Congress intervened in the regulatory process by enacting legislation to extend the effective date of the regulation from July 1, 1998 to October 1, 1998, and conducted hearings to review the impact of the HHS policy. Both the American Society of Transplant Surgeons and UNOS called on members of Congress to block the implementation of the HHS rule in hearings held on September 10, 1998. The President-elect of the American Society of Transplant Surgeons testified that, “the Department in subsequent discussions with our society has told us that in fact, giving priority to sickest patients first-in effect, creating a national waiting list-is not the intent of the rule. Nevertheless, they [HHS] have not changed the rule to make it clear that it would not require transporting organs across broad geographic regions.” The regulation “as it now stands, would harm a system which we have tried to make as fair as humanly possible” and “permit substitution of the Secretary's judgment on organ allocation for the judgment of medical professionals. We do not believe this is what was intended by Congress when it enacted the National Organ Transplant Act” (15).

In late September, the State of Louisiana, led by Attorney General Richard Ieyoub, the Louisiana Organ Procurement Agency, and Louisiana transplant centers, filed a lawsuit in a Baton Rouge Federal Court challenging the new HHS organ allocation scheme. Judge Ralph Tyson issued a stay order enjoining HHS from enforcing the final rule until the legal challenge is resolved.

Finally, as part of the broad agreement on the federal budget crafted in October of 1998, members of Congress, lead by Representative Bob Livingston, and officials of the Clinton Administration agreed to a 1-year moratorium on the implementation of the HHS rule. The legislation also provides for a study of the current organ allocation policies and the HHS regulation, to be conducted by The Institute of Medicine, and mechanisms for future discussions between UNOS and HHS officials (19).

The organ allocation controversy will be addressed in the coming year by the Institute of Medicine, representatives of HHS and the transplant community, members of Congress, and, perhaps, the Federal Courts. In the end, we must hope for three positive developments: first, that the public never be concerned or led to believe that organ allocation policy is anything less than the best that can be achieved; second, that organ allocation policy remains in the hands of the transplant medical community under the appropriate oversight of federal agencies; finally, that the full focus and effort of all parties be redirected toward the goal of enhanced public and professional education leading to increased organ donation.

1. Murray JE, Merrill JP, Harrison JH. Kidney transplantation between seven pairs of identical twins. Ann Surg. 1958;148 [PMC free article] [PubMed] [Google Scholar]

2. Prottas J. The Most Useful Gift: Altruism and the Public Policy of Organ Transplants, San Francisco: Jossey, Bass,; 1994. [Google Scholar]

3. Testimony of Dr. William W. Pfaff before the Senate Appropriations Committee, Labor, Health and Human Service, Education Subcommittee, September 10, 1998. p. 1.

4. United Network for Organ Sharing, Congressional Staff Briefing: Impact of HHS OPTN Regulations. May 1, 1998.

5. American Society of Transplant Surgeons: Position paper on the Department of Health and Human Services Rule on the Organ Procurement and Transplantation Network, June 1, 1998. p. 1.

6. United Network for Organ Sharing. The UNOS Statement of Principles and Objectives of Equitable Organ Allocation. June 29, 1994. p. 165.

7. Federal Register. Rules and Regulations. 1998;63(63):16335. [Google Scholar]

8. Federal Register. Rules and Regulations. 1998;63(63):16298. [Google Scholar]

9. Federal Register. Rules and Regulations. 1998;63(63):16327. [Google Scholar]

10. Federal Register. Rules and Regulations. 1998;63(63):16325. [Google Scholar]

11. Federal Register. Rules and Regulations. 1998;63(63):16299. [Google Scholar]

12. Federal Register. Rules and Regulations. 1998;63(63):16334. [Google Scholar]

13. Response to HHS Concerns about UNOS Statements Regarding the Regulations. May. 1998. www.unos.org.

14. The Patient Access Coalition. Comments on the Department of Health and Human Services' April 2, 1998 Final Rule Regarding the Organ Procurement and Transplantation Network, August 28, 1998.

15. Statement of Ronald W. Busuttil, MD, Ph.D., FACS, before the hearing of the Subcommittee on Labor, Health and Human Services and Education of the Senate Appropriations Committee, September 10, 1998.

16. Sollinger H, MD. Transplants: Who should get them first; how to raise donation rates. June 18, 1998. p. 1.

17. Federal Register. Rules and Regulations. 1998;63(63):16327. [Google Scholar]

18. Federal Register. Rules and Regulations. 1998;63(63):16324. [Google Scholar]

19. Conference Report 105-825 to accompany H.R. 4328. “Making Omnibus Consolidated and Emergency Supplemental Appropriations for Fiscal Year 1999”