This article is written by Raslin Saluja, from KIIT School of Law, Bhubaneswar. This article evaluates the various aspects of organ transplantation laws in the United States.
Introduction
The procedure of organ transplantation dates back to the 20th century when it began with the first-ever successful human organ transplant taking place in 1954. Since then, as many as 750,000 and more organ transplants have been performed by medical professionals in the United States. As per statistics, 39,718 people in the States received organ transplants in 2019 alone. Although there have been massive developments and improvements in the procedure with time, the ethical and legal implications of the practice still stick around and remain unsettled. Despite the growth in the rate of organ donations from deceased donors, the demand for organs has surpassed what could be supplied. This calls for making attempts to maximise the opportunities and possibility that the organs so available are able to sustain according to the recipient’s needs, thus we analyse the laws governing organ transplantation and donation in the United States.
What is organ transplantation
An organ is a mass of specialized cells working together to perform the functions of the body. Transplantation is a surgical operation where the deteriorating/damaged/failing organ of the body is removed and then replaced with a new healthy one. Typically, only solid organs such as the heart, lungs, kidney, liver, pancreas, and intestines are transplanted. The human organ in the transplantation process can even be replaced by an animal/artificial organ.
Process
The process usually involves assessing whether the person is medically eligible for a transplant or not. Their health and mental status are also evaluated along with the level of social support. If the patient is found eligible, then a donor organ needs to be found and arranged. There are usually two sources of donor organs.
First one being, removing organs from recently deceased people. These organs are called cadaveric organs. In these cases, the person while alive indicates that they want to donate their organs once deceased. The indication could be mentioned in the driver’s license or healthcare directive. In some states, when the person has not indicated so, their family members are asked if they are willing to donate the deceased’s organ. While in other states, irrespective of the indication, the hospitals seek the family’s consent. The second source of organ donation is a living person who is often related to the patient or could even be a stranger. There are a few non-profit organizations as well to keep a list of willing living donors like the Mayo Clinic, Alliance for paired kidney donation, American kidney fund, etc.
However, a living donor must not always be available or might even be ineligible for the patient as the predicted outcome is doubtful. Such patients are then kept in a list that is a waiting pool for an organ.
Medical and legal timeline for organ transplantation
Over the recent years, the medical practice of organ transplantation has grown immensely. While the medical advances will first start, the legal advances soon follow.
The 1950s
In 1954, the first successful kidney transplant had taken place from one identical brother to another.
The 1960s
The first successful cadaveric transplant took place from a deceased donor. It also expanded from kidneys to other different kinds of organs such as hearts, lungs, livers, and others. The first successful liver transplant took place in 1966, followed by the first successful heart transplant in 1967
The 1970s
1972 witnessed the legal practice taking off, the Uniform Organ Donor Card was established as a legal document in all 50 states due to the passage of the Anatomical Gift Act, 1968. The Act allowed anyone over 18 years to legally donate their organs. Insurance coverage for kidney transplants under Medicare was being provided under the End-Stage Renal Disease Act, 1972 Besides in the 1960s and 1970s, the development of anti-rejection drugs took place in order to increase the success of organ transplants
The 1980s
The first artificial heart transplant took place and was closely followed by the media. In 1986, the first xenotransplanted organ was performed which uses animal organs to replace human organs. Immunosuppressant drugs were approved. While on the legal side, in 1984, the National Organ Transplant Act (NOTA) was passed. It established the United Network for Organ Sharing (UNOS), allowing financing for organ procurement organizations and prohibited the sale of organs. In 1986, the Omnibus Reconciliation Act was passed which included “required request”. This required the hospitals treating Medicare/ Medicaid patients to legally ask the next of kin about donating their loved one’s organs.
The 1990s
First, a split liver transplant was performed in 1986, where one liver was split into small pieces to transplant in more than one person. While in 1998, the Department of Health and Human Services required organ procurement organizations to be notified of every hospital death.
Current US laws for organ transplantation
The organ donation laws at the state and federal levels exist in the US for two major purposes. First, to ensure a safe, fair, and smooth collection of donations and practice of distribution. Second, to widen the pool of potential donors in an effort to increase the availability of the number of organs for transplant.
National Organ Transplant Act of 1984
Before the enactment of this Act in 1984, no other national system existed to oversee and monitor the recovery and allocation of organs from deceased donors for transplantation. Since it was not a widely accepted practice, the organs remained in short supply which led to competition for unfair and unequal access to donor organs. In response, Congress passed NOTA. The intent of NOTA is to ensure that equitable allocation of donor organs takes place and to increase the number of available organs for transplantation.
It defines organs as the heart, lungs, liver, kidney, pancreas, and other organs, such as the small intestine, as designated by the Secretary of the U.S. Department of Health and Human Services (HHS). The Act bans the sale of human organs and prohibits organ purchases for transplantation, with violations of the law punishable by imprisonment up to 5 years and a fine of $50,000.
Goal
The goal of the National Organ Transplant Act (NOTA) was to address the issues in the process of transplantation that arises due to organ shortage and improve the method of collection and distribution of organs to the needy all over the country.
- It introduced the United Network for Organ Sharing (UNOS) to maintain and update a countrywide network by forming a computer database by registering all the patients who are in need of organs.
- It established the Organ Procurement and Transplant Network (OPTN) which essentially finds matches of the organs and the patients based on their needs from the national registry.
- It established the Task Force on organ transplantation.
- It permanently prohibited any commercial transaction of buying and selling of organs or tissues.
NOTA has organ procurement organizations which include the Grant authority of the Secretary the establishment, initial operation, consolidation, and expansion of qualified organ procurement organizations. The Secretary may also make grants to, and enter into contracts with the qualified organizations as well as other non-profit private entities for carrying out special projects like increasing organ donors.
This organ procurement organization is supposed to perform the following functions:
- Make operative agreements to identify potential organ donors;
- Make systematically adequate efforts, including professional education, to collect all useable in good condition organs from potential donors;
- Make arrangements for the acquisition, storage, and preservation of donated organs conforming to the quality standards adopted by the Organ Procurement and Transplantation Network;
- Arrange for the appropriate tissue typing of donated organs;
- Follow the medical criteria for arranging systems to allocate donated organs fairly and equitably among transplant patients;
- Make arrangements for smooth mobility and transfer of donated organs to transplant centres and coordinate its activities with the centres in its service area;
- Participate in the Organ Procurement Transplantation Network;
- Make arrangements to cooperate and coordinate with tissue banks for the retrieval, processing, preservation, storage, and distribution of tissues as may be appropriate to assure that all useable tissues are obtained from potential donors;
- Evaluate the annual effectiveness of the organization in acquiring potentially available organs, and help hospitals in establishing and exercising protocols for making regular inquiries about organ donations by potential donors.
Analysis
The nationwide Organ Procurement and Transplantation Network (OPTN) is to be set by the Secretary of HHS authorized by NOTA to coordinate the donation and transplantation system and process. The Omnibus Budget Reconciliation Act of 1986 states that if medical centres performing organ transplantation do not participate in the OPTN, their eligibility for federal Medicare and Medicaid payments will be forfeited. Thus indirectly, in practical application, this legislation has made membership and compliance with OPTN policy mandatory for all U.S. transplant centres because all of them accept federal payments even though membership in the OPTN is voluntary.
In order to guide the structure and operation of OPTN, in 1998 HHS promulgated regulations known as the “Final Rule”. It was also to direct the OPTN to standardize transplant waitlist criteria and to group transplant candidates by medical urgency in order to allocate organs to the sickest patients first. NOTA requires the OPTN to have geographic regional centres with a national list of individuals in need of organs and a national system through computer services to match the requirements of that list. OPTN also performs other functions such as:
- Maintains a nationwide waitlist of the candidates in need of undergoing organ transplantation;
- Manage the allocation of organs received from a deceased donor to candidate on the waitlist as per requirement;
- Establish policies and guidelines pertaining to organ allocation;
- Set up good practices and quality standards for the acquisition and transplantation of organs;
- Assists in the nationwide distribution of organs;
- Coordinating the transfer and mobility of organs from OPOs to transplant hospitals;
- Make an analyzing brief on transplantation data for publishing;
- Provides information to concerned physicians and health professionals;
- Carry out studies, experiments, and demonstration projects for enhancing procedures; and
- Submit reports on comparative costs and outcomes from the nation’s transplant centres.
United Network for Organ Sharing (UNOS)
In order to operate OPTN, a private nonprofit entity known as the United Network for Organ Sharing (UNOS) is under contract with the Health Resources & Services Administration (HRSA). As mentioned previously, the regional OPOs, which are nonprofit entities responsible for coordinating the acquisition, preservation, and transportation of organs from donor hospitals to transplant centres are also established by NOTA.
Goal
OPTN divides the United States into 11 geographic regions, which are further divided into donation service areas (DSAs) which are served exclusively by one OPO. They vary widely in terms of the size of the population, the number of transplant centres and candidates, and the mortality rate of potential organ donors. The policies and standards for the working of the OPOs are promulgated by UNOS, and all OPOs are members of the OPTN. Members of the OPTN also include transplant centres, histocompatibility laboratories, medical scientific organizations, and public organizations.
The OPTN’s policies are mainly concerned with the allocation of individual organs among waitlisted candidates. It has many separate policies for each organ (heart, lungs, liver, kidneys, intestine, and pancreas). These allocation policies pertain to the location of the transplant candidates and the first criterion for the matching process, with the exception of livers, is the identification of a candidate within the OPO or donor hospital’s DSA. When a suitable candidate is not found in local areas, regional candidates can then be offered the organs by OPTN/UNOS, followed by national candidates.
Analysis
Their algorithms on allocation are based on compatibility to accept the organ without complications and other factors to identify suitable transplant candidates for the concerned organs. The algorithms generally also take into consideration a candidate’s present medical situation, the time spent waiting for an organ, and in some cases a candidate’s prognosis as determined by objective clinical tests. For effective outcomes, these allocation systems are often revised and updated.
The OPTN/UNOS database is updated with the medical information of each transplant candidate by the transplant coordinator who also designates the candidate as active or inactive depending upon receiving availability and medical unsuitability for transplantation at that time or that the candidate needs to complete eligibility requirements before being listed as active. Through this way, the database helps in matching the information about donor organs with the medical characteristics of active candidates on the waitlist.
Then a list that ranks active candidates according to the allocation rules is generated. The organ is offered by the OPTN to the transplant centre with the top-ranking matched candidate. The next highest-ranking matched candidate’s transplant centre is contacted if the organ is refused by either the transplant candidate or the candidate’s transplant hospital. This process goes on until the OPTN finds a suitable candidate (and transplant hospital) matching the characteristics and willing to accept the organ. For effectively coordinating and managing this process the OPOs receive a fee which as defined under NOTA is “reasonable payment associated with the removal, transportation, processing, preservation, quality control, and storage of a human organ.” NOTA allows transplant surgeons, hospitals, transporters, and organ procurement organizations (OPOs) to receive compensation for their services
To conduct ongoing evaluation of organ transplantation and track information and data about transplant candidates and recipients for transplant procedures, the Scientific Registry of Transplant Recipients (SRTR) in 1987 was established by NOTA. The SRTR databases contain both historical and up-to-date information about the transplantation process, including detailed information on waitlist candidates, transplant recipients, and survival statistics. This data helps in supporting the analysis of transplant programs and OPOs and encourages research on related issues by using “evidence-based policy”.
Uniform Anatomical Gift Act (UAGA)
Goal
This is an act which all the 50 states have in one way or the other passed in some measure. The Uniform Anatomical Gift Act, 1968 is a set of model regulations and laws concerning organ donation which operates in an “opt-in” model meaning that an individual while alive, or next of the kin or surrogate after his/her death must explicitly choose to donate organs. The legislation on organ donation and procurement was enacted in the 1960s by the U.S when such a medical procedure seemed viable. This led to the enactment of UAGA in 1968 by the National Conference of Commissioners on Uniform State Laws in order to promote a uniform application of it among states and making the process of obtaining organs from deceased persons simple and easy. Though often mistaken due to its universal application UAGA is not a federal law, and is to be used as a model/template which other states can refer to while enacting provisions of their own according to their suitability for governing anatomical gifts.
Analysis
The Act allows sound adults to make donations of all or any body part at their death with their consent expressed explicitly in writing and signed by the declarant and two witnesses. In case there does not exist the decedent’s authorization of donation before his or her death than in the absence of the decedent’s known objection, the Act empowers the decedent’s next of kin to donate the decedent’s organs.
The Act even grants rank to different family members by status in order to decide who among the next kin is officially authorized to make a donation of their deceased kin’s organs. Though the Act has placed focus on the deceased’s prior intention to donate, yet it has not mentioned whether the deceased’s decision will override the next of kin’s choice. However, comments to the 1968 UAGA recognizes and makes the right of individuals to choose the way they want to dispose of their body legally effectively.
Revisions
Various revisions were brought by the commissioners to the Act in 1987 and again in 2006. Among other several goals, they intended to expand the collection and supply of organs to meet rapidly growing demand. Since 1968 UAGA though brought clarity on the legal authorization of who can donate, could not address its implicit goal to increase the organ supply. In 1972, the Uniform Donor Card was passed as a legal document in all 50 states, allowing anyone over 18 to donate their organs. Then the 1987 Act was made to adopt NOTA and ban the commercial exchange of organs.
It also let go of the requirement of getting signatures of the two witnesses on the donation document. Furthermore, it gave more power to an individual’s choice for donating organs that cannot be revoked by others. It also empowered the medical professionals to remove body parts for transplantation in specific situations when there are no such known objections by the deceased. and when efforts had been made to contact the next of kin. However, due to many controversies in 2006 like the removal of body parts by the medical examiners where no prior objection was known, having presumed consent for removal, lack of uniformity as only 26 states had adopted the 1987 provisions, led this provision to be removed.
The most recent version (last amended in 2009 after 2006—provides that people of age 18 years or more have the choice of acceptance/refusal to make an anatomical gift. Among other things, it allowed recognition of donative intent by way of symbolic expressions/oral communication, permitted authorization by anyone applying for driver’s license, disallowed removal of an organ by medical examiner’s office without prior permission from the deceased or the surrogate’s authorization and lets individuals other than the decedent make an anatomical gift unless the decedent expressly refused donation during his or her lifetime.
The donor has to determine whether the gift will be of the entire body or parts of the body, and for what purpose will it be used for such as education, teaching, research, or transplantation. The Act treats donation as a property that can be transmitted to others by authorization of the decedent before death, by will, by next of kin or surrogate after death, or, in their absence, by the state.
As of today, most states have adopted the 2006 Act who have also made amendments to it, while a few are yet to adopt the updated versions of it. Thus, its application remains inconsistent and not uniform. Furthermore, each state has its own difference in form maintaining its own donor registry with many of these registries linked to drivers’ licenses and on what qualifies as authorization. However, despite these differences, all states have one common compliance to follow which is the ban for commercial exchange of organs for money since it’s a federal mandate.
Consolidated Omnibus Reconciliation Act of 1986
The Consolidated Omnibus Reconciliation Act (COBRA) was passed by the United States Congress in 1986. It primarily brought amends to the Employee Retirement Income Security Act, 1974 (ERISA), the Internal Revenue Code, 1986, and the Public Health Service Act, 1944, and addressed health benefits and health insurance coverage. The landmark federal law mandates the employers to provide continuing group health insurance coverage for certain eligible employees and their family members in the event of job loss or other qualifying events like work reduction, transition periods, etc. Other qualifying events include employee death, business filing for bankruptcy, medicare eligibility, divorce/legal separation, covered dependent reaching adulthood. Thus even after losing a job for some period of time, the employee can access such benefits.
Eligibility
Essentially the private sector employers with more than 20 employees have to provide that option as well as the state and local governments excluding the federal government and church employees. These employees can be both full-time and part-time who are in the group of participants right before losing a job/qualifying event. It includes covered spouses, dependents, legal partners, retirees only when they are not eligible for Medicare. Those employees who are excluded from the COBRA coverage who cannot be covered under the group health plan due to length of employment/ other reasons, employees who have themselves declined to participate in a health plan, and who are receiving medicare coverage.
Reforms on organ transplantation
Ever since its enactment, it has been expanded quite a few times, and eventually, regulation relating to organ transplantation and allocation made its way into the COBRA reforms. It requires the hospitals and the federally mandated Organ Procurement Organization to cooperate and build a relationship for effective working and coordination for carrying out transplants at the local level. It also compelled all the hospitals funded by Medicare and Medicaid to enact a required request policy that will ensure that families of all potential donors are made aware of organ donation and their right to decline.
Medicare conditions of participation
In 1988, Medicare developed five incentive policies for its participating hospitals to promote organ donation and organ procurement. The website of the International Association for Organ Donation enumerated five such policies :
- Every death occurring in the facility must be notified by the hospital to the organ procurement agency.
- The organ procurement agency will train each and every hospital personnel who will be presenting the option of making donations to the families.
- There has to be an explicit written agreement by the hospital to work with organ, tissue, and eye banks.
- The appropriate recovery agency shall conduct the screening for potential donors that have been acknowledged by the hospital.
- The recovery agency and the hospital will work in collaboration with each other to conduct record reviews to determine the donation potential of individual facilities.
Organ transplantation is a unique process that needs to keep in the loop the patient’s requirements and donor’s needs, which might lead to conflict especially in the case of living donors. Thus professional guidelines and U.S. law attempt to strike a balance between protecting donors and saving the lives of as many recipients as possible.
First Person Consent Laws
First-Person Consent Laws were passed in the 1990s in order to acknowledge the wishes of the person donating organs. The hospitals and organ procurement organizations would have to follow the patient’s organ donation desires as indicated on their driver’s license or in a health care directive required by the law.
For places with enacted laws, the hospital and the organ procurement organization are legally entitled to just follow the written wishes of the deceased person who made the donation and without approaching the deceased person’s family for organ removal permission. Though it has been suggested by some advocacy organizations that as many as 2/3 of people who sign organ donation consent forms do not have their wishes honoured when they die. The reason behind this is that they do not get the family’s approval to conduct such removal. Thus these laws try to settle the complexities between the deceased organ donator’s wishes and their families’ consent by honouring the patient’s wishes. The acknowledgement of autonomy is vastly supported in America and considers self-determination as a fundamental right that comes from exercising autonomy.
Besides these laws, the U.S. Food and Drug Administration (FDA) also supports and regulates research on deceased organ donors that are similar to but not identical with those in the Common Rule.
Conclusion
It is an undisputed fact that to be able to receive a replacement for organs is a life-changing event. It impacts several people and stories from people who have been subject to such miraculous events vividly describe the effect and impact it creates in people’s lives. However, it also raises various ethical issues that mainly arise from its acute shortage. Not everyone in need of an organ is able to get one. In furtherance of the shortage, the concept of distributive justice arises as to how we decide who deserves the organ. The dilemma heightens when patients with similar needs and complexities require the same organ. Then the criteria of equal justice based on first come first serve and age would not suffice. In those cases, how does one justify the choice made?
References
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