Health Care Law and Regulations 9

CHAPTER 25: Organ and Tissue Procurement and Transplantation

LEARNING OBJECTIVES

Upon completion of this chapter readers should be able to:

Explain why the demand for transplantable organs exceeds supply.

List the methods of allocating organs.

Discuss the system for allocation of organs using points.

Describe the means of obtaining permission for organ donation.

Distinguish the methods of declaring a person dead.

Discuss the potential for providing financial incentives for organ donations.

Distinguish organ transplantation from tissue transplantation regarding the economics involved.

Explain issues with xenotransplantation.

KEY TERMS

Acquired Immunodeficiency Syndrome

Allogenic grafts

Allotransplants

Alternate heart programs

American Association of Tissue Banks

Anencephalic neonates

Aplastic anemia

Assistive reproductive techniques

Autografts

Autotransplants

Biosynthetic tissues

Black market drugs

Brain death

Campaign for Responsible Transplantation

Cardiac death

Cofinity Institute of Excellence

Cognitively impaired

Cold ischemic times

Commoditized

Compelled living donations

Desecration of the body

Equity

Fairness

Fanconi anemia

Good faith immunity provision

HIV Organ Policy Equity Act of 2013

HIV-positive organs

Human Immunodeficiency Virus

Human tissue

Hurler syndrome

Immunologically incompatible

In vitro fertilization

Incompetency

Kidney-paired donation

Kidney swaps

Leukemia

LifeSharers

Living donors

Mandated choice

Maple syrup urine disease

National Organ Donor Registry

National Organ Transplantation of 1984

Net benefit

No-sale policies

Norwood Living Donation Act of 2007

Opt-out plan

Organ procurement agencies

Organ Procurement and Transplantation Network

Paired kidney transplants

Paired organ donation

Partially humanized organs

Pluripotent stem cells

Postmortem donations

Preimplantation genetic diagnosis

Presumed consent

Stem cells

Thalassemia

Tissue bank industry

Tissue processors

Tissue type

Uniform Anatomical Gift Act of 2006

Utility

Xenotransplants

Xenozoonosis

Zero antigen mismatch

Zoonoses

“Our bodies are our gardens to which our wills are gardeners.”

— William Shakespeare (1564–1616), English poet and playwright, from Othello

IN BRIEF

This chapter describes the process of organ and tissue procurement and transplantation as it relates to donors and recipients. Organs represent one of the most highly regulated and cumbersome of the fields involving human biological materials as well as one of the more publicly visible uses of body parts. Regulation of the tissues industry lacks this public visibility and consistent oversight. This chapter explains the principles and flaws of organ and tissue transplants. Proposals to increase the number of patients receiving organ transplants are also reviewed. The legal process itself and its accompanying ethical arguments for and against the sale of donated organs and tissue are discussed.

Presumed consent, directed donations, commoditization, and xenotransplants (the transplant of cells, tissues, and whole organs across species) offer future alternatives for enhancement of the supply of body parts. Xenotransplantation poses greater risks to human health and it is far too premature to guarantee success. None of these alternatives is without controversy.

FACT OR FICTION

Medicaid Insurance Coverage for a Liver Transplant

Must a state’s taxpayers pay for a liver transplant to cure a hereditary disease if the disease can be treated by dietary management?

Physicians at the Children’s Hospital of Pittsburgh determined an eight-year-old child with a severe genetic disorder known as maple syrup urine disease could only be cured with a liver transplant. The Missouri Medicaid insurance program declined to cover the liver transplant and maintained the child’s disease had been well managed by diet. Children with maple syrup urine disease are unable to metabolize essential amino acids used by the body to build proteins. As a result, children with the disease must restrict their intake of natural proteins, replacing them with daily intake of a special amino acid formula. When affected children become ill with a routine viral or bacterial illness or are unable to maintain their special diet, they are at risk for severe metabolic decomposition with neurological deterioration, brain swelling, coma, permanent brain injury, and death. Even with dietary management, metabolic decomposition can occur. The medical community was split over the medical necessity of a liver transplant when a child’s condition was otherwise managed by diet. Given the risks associated with a liver transplant, there was disagreement over the possible outcomes of the child’s treatment.

— See Law Fact at the end of this chapter for the answer.

Principles and ApplicationsLN1

The primary need for human body parts is for the transplantation of organs, tissues, and cells into humans. A secondary need for human body parts is for medical research in regenerative medicine, especially in stem cell and gene-based therapy (Terzic & Nelson, 2010). Human organ transplantation can be used to treat diseases of the heart, lungs, liver, kidneys, and pancreas, which are some of the most common causes of infirmity and death. Organ failure and tissue loss account for almost $400 billion in U.S. health care costs today, particularly among older adults. This cost covers approximately eight million surgical procedures to treat these disorders as well as recurring treatments for related chronic diseases and their subsequent complications (Terzic & Nelson, 2010). Treatment needs for organ failure and tissue loss are expected to increase as the average age of the population increases, including the need for:

Mechanical devices (mechanical kidneys as opposed to dialysis machines)

Surgical reconstructions

Transplants

While each of these treatments has its own limitations, of the three treatments, transplantation of organs and tissues has the greatest potential to treat:

Acquired conditions such as cancer (by replacing the removed cancerous tissue with externally grown healthy tissue)

Chronic conditions like diabetes (through regeneration of islets) and Parkinson’s disease

Congenital conditions such as hemophilia

Gross organ failure, such as renal failure

(Bluhm, 2016).

Organ transplantation is often the only treatment for end-stage organ failure, such as liver and heart failure.

Types of Transplants and Limitations

There are three types of transplants:

Autotransplants

Allotransplants

Xenotransplants

The first two are used extensively; the third is developing amidst rigid regulations.

Autotransplants

Autotransplants involve a process through which human material is harvested and subsequently transplanted from one part of a patient’s body to another. The limitations associated with autografts (the material used in autotransplants) include the availability of human material as well as donor site diseases. The most litigated issue in this type of transplant involved insurance coverage for bone marrow autotransplants (Lee, 2014). For more than a decade, the medical community generally thought bone marrow transplants produced remissions in advanced breast cancer patients unresponsive to conventional therapy. While some states mandated coverage, insurers often excluded coverage of the bone marrow transplant procedure as experimental treatment or as medically unnecessary. After a decade of controversy, medical studies concluded the procedure was in fact ineffective and even potentially harmful (Wiley, 2016).

Allotransplants

Allotransplants occur where human material is harvested from one individual and subsequently transplanted to another individual. The challenges associated with allogeneic grafts (cells, tissues, or organs involved in allotransplants) include:

Damage to donor organs and tissue during the transport process

Donor-recipient blood type compatibility

Donor-recipient physical compatibility (organ size, capacity, and lifespan)

Rejection of immunologically incompatible organs and tissues

Shortage of organs and tissue

Transmission of donor site diseases to recipients, such as Human Immunodeficiency Virus (HIV), as well as hepatitis B and C viruses

Use and long-term cost of immunosuppressive drugs to circumvent transplant immunorejection.

(Parent, 2015).

Xenotransplants

Xenotransplantation is the use of animal materials to replace human cells, tissues, or organs. A central limitation is the risk of transmission of novel viral and microbial pathogens from donor xenografts to human recipients, known as xenozoonosis. For instance, diseases that began in animals, but that now affect humans include:

Avian flu (from chickens, ducks, and geese)

Ebola (from baboons, bats, chimpanzees, duikers, monkeys, and gorillas)

Hantavirus pulmonary syndrome (from mice)

Hepatitis B and C (from horses)

Herpes (from chimpanzees)

HIV (from monkeys)

Influenza virus of 1918 (from birds)

Mad cow disease

Rabies (from bats, dogs, jackals, mongooses, raccoons, and wolves)

(Pippin, 2013; President’s Council on Bioethics, 2004).

Not surprisingly, rejection is a more significant issue with interspecies transplants. While litigation is just beginning to emerge for these transplants, the Campaign for Responsible Transplantation has been engaged in the federal courts since the late1990s for freedom-of-information demands for proprietary information about the FDA’s regulation of xenotransplants (Crepelle, 2016).

Organ Transplants

The law addressing organ transplants is vast, contradictory, and complex. How to treat organ transplants is far from obvious as case law and statutory regulations are to a large extent conflicted over the best approach to apply in allocating a scarce resource (Williams et al., 2014). Each potential framework for organ transplants offers appealing aspects, but each also has difficulty in meeting all of the concerns and interests surrounding the use of human biological material.

Organ transplants are not a new scientific concept, although several important medical advances have occurred recently, allowing for more successful transplants in terms of recipient survival and improved quality of life. Eighteenth-century experimentation with animal organ transplants led to the early human organ transplants. The first actual documented human organ transplants began to occur in the 1950s and 1960s. Other transplant developments are shown in Feature Box 25-1.

FEATURE BOX 25-1

Important Transplant Developments

1869—The first tissue transplant was performed.

1911—The first human-to-human organ transplant was conducted in the United States.

1954—The first successful human-to-human organ transplant was performed in the United States (a living donor donated his kidney to his identical twin).

1968—The first heart transplant took place.

1968—The Uniform Anatomical Gift Act of 2006 legalized donating tissues and organs (See 8A U.L.A. §§ 1-27) (every state has adopted its own version of this model legislation).

1983—The FDA granted approval of the first antirejection drug (cyclosporine) that helps stop transplant organ or tissue rejection from the recipient’s body and thus improves the recipient’s chance of survival.

1984—The National Organ Transplantation Act, which rendered it unlawful to “knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplants if the transfer affects interstate commerce” was passed (See 42 U.S.C.A. § 274e (2007)) (§ 274e is named for Charlie W. Norwood, the late congressman from Georgia (1941-2007), who underwent a lung transplant and who was an avid advocate of patients’ rights).

1986—Congress established the Organ Procurement and Transplantation Network, which sets standards and regulates organ transplant centers across the country; the Network establishes the process and policies for allocating organs (See 42 U.S.C.A. § 274 (2008)).

1988—The Joint Commission set donor standards and required hospital policies and procedures for organ and tissue procurement.

1996—Congress authorized the dissemination of organ donation information along with income tax refunds to approximately 70 million households to increase awareness and encourage organ donation; state tax agencies followed the federal example soon after.

1999—The Organ Procurement and Transplantation Network Final Rule was enacted (See 42 C.F.R. §§ 121.1-121.13) (13 years after the Network was established).

2000—The Children’s Health Act established the National Center on Birth Defects and Developmental Disabilities (42 U.S.C.A. § 247b-4).

2004—The Organ Donation and Recovery Improvement Act was enacted to provide funding for transplant centers and qualified organ procurement agencies to increase the rate of organ donations (See 42 U.S.C.A. §§ 273a, 274f-1-274f-4).

2006—The Uniform Anatomical Gift Act, a model law for adoption by the states that bars others from revoking the consent of a donor after death who legally registered as a donor during their lifetime, was passed (8A U.L.A. §10).

2007—The Norwood Living Organ Donation Act of 2007 codified a U.S. Justice Department ruling intended to increase the number of patients receiving paired kidney transplants by ensuring that criminal penalties do not apply (42 U.S.C.A. § 274e (2007)).

2013—The HIV Organ Policy Equity Act of 2013 directing the Organ Procurement and Transplantation Network to establish standards for transplant of HIV-positive organs was passed (127 Stat. 579 (2013))

2014—Skin, bone, muscles, blood vessels, nerves, and connective tissue are added to the definition of organs covered by the National Organ Transplant Act.

HHS, 2016; NKF, 2016.

Tissue typing dramatically improved the survival odds for transplant patients. Organs that can be transplanted from corpses include:

Bone marrow

Connective tissue

Corneas

Heart valves

Hearts

Intestines

Kidneys

Livers

Lungs

Pancreata

Skin

(Doty, 2015; Williams et al., 2014).

Living donors can donate:

Bone marrow

Kidney

Part of the liver

Part of the lung

(Meckler, 2007d).

Over three-quarters of transplants come from patients who indicate their desire to be organ donors after death by either signing a directive or directing their personal representative to allow for donation (Capron, 2014).

Current Context

The remarkable potential for saving lives with organ transplants is severely constrained by the failure of regulatory policy to keep pace with technological advances in medicine (Kessler & Roth, 2012; Wharton, 2011). Cadaveric organ procurement policies in the United States and other countries have failed to effectively respond to the growing demand for transplantable organs that has resulted from significant strides achieved in immunosuppressive therapy (Capron, 2014).

The result of this regulatory policy failure has been a chronic and growing shortage of human organs available for transplants (Kessler & Roth, 2012). At any one time there are over 120,000 patients awaiting organ donations (Mayo Clinic, 2016). Competing ideals surround the entire process of organ procurement and transplants. Current legislation regulating the process is unable to reconcile practical necessities with ethical considerations, resulting in a demand for transplantable organs that far exceeds the available supply.

Critical Shortage of Kidneys

Of all transplantable organs, the shortage of kidneys is most critical (Kessler & Roth, 2012). More than three-quarters of the wait list population on the National Organ Donor Registry comprises patients suffering from renal failure, also called end-stage renal disease. Over 84,000 patients are waiting for kidneys. Presumably a central financial authority could pay for these kidney transplants from tax revenues, such as Medicare’s end-stage renal disease program for dialysis and transplant services (Bluhm, 2016). Taxpayers could save money with this approach so long as the cost was less than $90,000 (Bluhm, 2016; Kessler & Roth, 2012).

Other Organ Shortages

Although more than 450,000 transplants have been performed in the United States, the number of patients who need transplants is growing at about five times faster than the rate of donations (OPTN & STRT, 2016b). Another 16,500 patients or so are waiting for livers. The rest are waiting for pancreata, intestine, heart, or lung transplants. Many patients are waiting for more than one kind of organ (See generally OPTN & STRT, 2016b).

Demand Exceeds Supply

About 7,700 Americans unnecessarily die waiting for transplant operations each year (Mayo Clinic, 2016). While only about 15,000 patients a year die under circumstances that would make them suitable donors for lifesaving transplants, these deaths could help more than 15,000 patients live because each person can donate multiple needed organs. Patients generally wait 5 years for donated organs, and on average, 22 of them die each day. Although most Americans claim to approve of organ donation and transplants, only about one in four expressly declare themselves organ donors (See generally OPTN & STRT, 2016b). Clearly the demand for organs far exceeds the supply, and much could be done to alleviate the shortage, such as:

Relaxing the restrictions on who can donate

Clarifying the misunderstandings surrounding organ donation

Compensating donors or their families

(Kessler & Roth, 2012).

Whatever approach is chosen, it is worth keeping in mind that the United States is among 11 countries listed by the World Health Organization as organ importers, meaning that a relatively high number of citizens get organs from another nation (Crepelle, 2016; Krawiec & Rees, 2014).

In Theory: How Organ Procurement and Transplants Occur

The federal government oversees the transplantation of human organs. To address the nation’s critical organ donation shortage and improve the organ matching and placement process, Congress passed the National Organ Transplantation Act. This law makes it illegal to sell human organs and tissues and imposes fines and imprisonment for doing so. Congress went on to institutionalize a complex system of not-for-profit organizations solely responsible for collecting and allocating all transplantable organs.

Organ Procurement and Transplantation Network

The National Organ Transplantation Act provided for the establishment of the Organ Procurement and Transplantation Network, which administers the retrieval, distribution, and transplantation of organs. All U.S. transplant centers and organ procurement agencies must be members of this network in order to receive any funds through Medicare insurance (OPTN & STRT, 2016b). Currently, there are about:

MANAGEMENT AND LAW ISSUES

Can we confine our arguments about health care efficiency to organ transplants, or can one argue that other types of medical treatments and health care services are also scarce?

Is the shortage of organs available for transplant one health care problem that could be solved by unlimited funding of the health care system?

100 transplant centers for liver transplants

150 for heart transplants

200 for kidney transplants

(NKF, 2016).

The network also standardizes the criteria for placement on distribution lists and maintains a National Organ Donor Registry for organ matching. A Web-based computer system stores the nation’s organ transplant waiting list and matches recipient and donated organ characteristics. The organ matching and placement process is facilitated by a fully staffed organ center that operates 24 hours a day (See generally NKF, 2016). Despite all this legislation and accompanying regulatory oversight, there are still many problems with organ procurement (O’Brien, 2015). Some of the criticisms are that the network fails to detect or fix problems at some transplant centers, and when there is a problem, the investigation is slow and its findings are kept secret. Transplant centers with problems are almost never sanctioned, or very weak sanctions are imposed (Capron, 2014).

Furthermore, the Organ Procurement and Transplantation Network is unable to police itself because it is essentially a membership association with no overarching supervision. Transplant centers are able to find ways around transplant rules, and patients are often not informed about a particular center’s transplant policies or outcomes. The federal government has previously sued the Network and has threatened to become more involved in its oversight.

Procurement Violations

Several studies have revealed that nearly every organ procurement agency is in violation of at least one government policy on the distribution of organs (Childress & Liverman, 2006; Truog, 2015). In response, more federal regulations were adopted allowing the government additional control and further limitations over how organs are allocated. The problem is that it often takes a decade or more for policy changes to become effective. The 1999 regulations that became effective 15 years after National Organ Transplantation Act was adopted by Congress sought to establish a standardized method of distributing donated organs to patients on transplant waiting lists and also made organ transplant data more available to the public (OPTN & STRT, 2016b).

Prior to 1999, organs were retained in the geographic area where they were obtained if a transplant patient was also waiting in that area. This meant the waiting time for organs varied wildly between geographic regions and patients with a more urgent need or with a better chance of survival often were denied organs. For instance, the waiting time for a liver in one region may be as low as 20 days, while in another region it may be as high as 443 days. The thinking behind this policy was that organs could be better preserved and patient costs could be kept to a minimum if transplants remained localized. The 1999 regulations allocated organs based on medical urgency and patient appropriateness, with the goal of making wait times more even across the country (See generally Capron, 2014).

Multidisciplinary Approach

There are many different health care professionals on a patient’s transplant team. Clinical transplant coordinators oversee patient evaluation, treatment, and follow-up care. Transplant physicians manage patient health care. Transplant surgeons perform the actual transplant surgery and follow-up. Financial coordinators organize and clarify the financial aspects of patient care before, during, and after the transplant. Finally, social workers help patients and their families cope with the issues associated with the transplant, including any illness or side effects (See generally OPTN & STRT, 2016b).

MANAGEMENT AND LAW ISSUES

What is the justification underlying laws restricting accepting or offering payment for transplant organs?

What legal distinction is there between selling human organs versus human tissues, blood plasma, ova, and sperm?

What practical considerations support or detract from legally regulating organ procurement and transplants?

Would it be permissible to remove the organs of healthy, deceased prisoners to save the lives of five to eight others who need organ transplants?

Under what circumstances might palliative sedation facilitate organ transplants?

United Network for Organ Sharing

The first step in the transplant process is that the physician and transplant center decide whether and when to place a patient on the National Organ Donor Registry’s wait list. Age is by far the biggest factor predicting how long someone will live after a transplant (DeVito, 2014). Organs are currently allocated based on a point system that considers how long the patient has been on the donor list and how urgent the patient’s medical status is.

Allocation of Donated Kidneys

For kidneys, it is proposed that time on the donor list be substituted with time on dialysis; time on the donor list would be a secondary factor, particularly for the best-quality kidneys. This regulatory change would favor healthier patients over those who may be too ill to benefit from a transplant. This change has already been adopted for livers, hearts, and lungs. Under the proposed scenario, the healthiest kidneys would be distributed through a formula relying largely on net benefit, while the formula for kidneys coming from older or sicker donors would give greater weight to time on dialysis. Already, kidneys from donors under age 35 are automatically offered first to children under 18 if any are on a waiting list (Meckler, 2007c).

Basis of Allocation Decisions

Many factors affect how long a patient may be on the National Organ Donor Registry’s wait list, such as the:

Number of organs available for donation

Patient’s blood type, tissue type, height, and weight

Size of available organs

Transplant center’s criteria for accepting donated organs

(Cook & Krawiec, 2014; DeVito, 2014; OPTN & STRT, 2016b).

Factors that do not affect the waiting time are gender, religion, financial status, and the willingness of recipients to someday donate their own organs. The patient’s physician has a considerable amount of discretion in deciding how to list the patient on the registry (Frank, 2014). The federal government has previously investigated listing practices at major hospitals, such as the University of Chicago and the University of Illinois, where physicians were accused of exaggerating their patients’ medical urgency status (See Cook & Krawiec, 2014). The hospitals denied the allegations and settled with the government.

There are no uniform criteria for deciding when to list patients for a transplant or for identifying patients’ medical urgency status. Moreover, medical criteria differ with each organ; certain organs require extensive prescreening to find a positive match for a patient while different organs remain viable before transplant for different periods of time (Capron, 2014). In addition, United Network for Organ Sharing encourages physicians to consider nonmedical factors such as whether patients have:

Caused their organ failure by their own behavior (diseases tied to smoking, drinking, or unhealthy diet and exercise patterns, among other lifestyle factors)

Complied with and adhered to their treatment regimen

Had or might have success with treatment other than a transplant (such as adults with maple syrup urine disease)

Received prior organ transplants

The United Network for Organ Sharing suggests nonmedical factors used to evaluate transplant candidates should be monitored and updated to reflect changes in technology and medicine, and to minimize subjectivity. For instance, African Americans are much more likely than Caucasians to have blood type B, but there are not as many type B organ donors, which is a major obstacle for African Americans waiting for kidney transplants (NKF, 2016). To resolve this disparity, it is proposed that certain blood type A kidneys, which work effectively in both A and B patients, be made available to patients with blood type B (See Saitta-Gill & Hodge, 2015).

Donor Reforms

While potential donors who die in a hospital have the best chance of donating viable organs (because organs have to be harvested almost immediately after death), alternatives are arising to address this issue. Most major cities, including New York City and Philadelphia, have special organ recovery ambulances that travel to the homes of patients who die suddenly. With improved medical technologies, cold ischemic times have been extended to allow for truly national allocations. Cold ischemic time is the time interval that begins when an organ is cooled with a solution after organ procurement surgery and ends when the organ is implanted (O’Brien, 2015).

Nongovernmental Networks

There is an ideological and practical divide between the United Network for Organ Sharing and the medical community concerning the procedures and criteria for allocating organs as well as the procedures for reviewing the organ allocation system. The root of this disagreement appears to be how to deal with scarcity. Regulatory policy decisions determining who receives the limited number of organs have crucial consequences for patients.

These are medical decisions that might better be made by the medical community as opposed to the government. It should be noted this does not imply that the United Network for Organ Sharing is ineffective, but it only suggests that commercial networks may better allocate scarce organs on a competitive basis (See Parish, 2015). For instance, Aetna developed the national Cofinity Institute of Excellence network comprising facilities that manage heart, lung, simultaneous heart/lung, kidney, liver, pancreas, simultaneous kidney/pancreas, small bowel/intestinal, bone marrow, and stem cell transplants. All of the transplant centers in the Aetna network have met quality, volume, and outcomes standards through Aetna’s credentialing process and external quality guidelines like those established by organizations such as Medicare and the United Network for Organ Sharing. Similar commercial developments may produce a change in how organ procurement and transplants occur, and will more closely parallel the rapid advances occurring with tissue transplants.

Donation Criteria

Nondirected donations, or donations by strangers, account for less than 1% of live kidney donations in the United States (NKF, 2016). Donors themselves must usually be 18 years of age or older unless a parent or guardian of a deceased minor consents to donation (OPTN, 2016a). Donors must also have written documentation of their wish to donate, such as a signed donor card or indication on their driver’s license (Capron, 2014). If a deceased person did not consent to donation prior to their death, a spouse, adult child, parent, adult sibling, grandparent, or legal guardian can consent to donation (Satel et al., 2014).

Even when patients did consent to donation prior to death, their relatives may still be asked for permission, and in some cases, the relatives may deny permission (Iltis, 2015). This is one example of the many factors resulting in a shortage of organs available for donation. Less than half the families give permission to donate a relative’s organs after death even when the decedent previously consented (Tenenbaum, 2016). One reason for this is because some cultures and religions forbid donating organs after death (Foos, 2012). Even if a culture or religion does not expressly forbid organ donation, some are under the false impression that their culture or religion does forbid it.

This falsehood seems to be particularly rampant among the Jewish community, many of whom believe organ donation is a desecration of the body; Jewish religious law is more nuanced than that. All four branches of Judaism (Orthodox, Conservative, Reform, and Reconstructionist) support and encourage donation. The Rabbinical Council of America (Orthodox) even approves organ donations from brain-dead patients (See generally Foos, 2012).

Zero Antigen Mismatch Rule

The question of how to distribute scarce organs presents a classic conflict between utility, which seeks to provide the greatest good for the greatest number, and equity, which seeks fairness for all individuals. The changes now under way are the most significant since a national allocation policy was first developed. A new allocation policy scraps rules automatically sending organs to anyone who is a perfect match on six antigens relevant to transplants (OPTN, 2016a).

One factor consistently overriding all other factors was whether there was a zero antigen mismatch between the transplant patient and the donated organ. A zero antigen mismatch meant the antigens all matched up, meaning the transplant patient’s body was much less likely to reject the organ; in short, it was akin to a perfect match between organ and patient. If there was a patient who had a zero antigen mismatch to an available organ, that patient automatically had top priority in receiving the available organ (Richards, 2013). If there were no patients with zero antigen mismatches to the available organ, the organ went to a patient with a partial antigen match. All these zero antigen mismatches have been eliminated (OPTN, 2016a).

This so-called zero antigen mismatch rule accounted for how almost one-fifth of the donated kidneys were distributed in the United States (NKF, 2016). Because more Caucasians donate organs than any other race, this resulted in more Caucasians receiving organs because there are more likely to be zero antigen mismatches when the donor and transplant patients are of the same race. Because of this disparity, the zero antigen mismatch rule has been relaxed, which allowed more minorities to receive donated organs. In reality, the rule did little to improve kidney transplant outcomes because of advanced antirejection drugs (NKF, 2016). This is a classic example of regulatory policy failing to rapidly adapt to technological advances in medicine.

COURT DECISION

Harvesting of Body Parts

Carey v. New England Organ Bank

(Parents of Tissue Donor v. Organ Bank)

843 N.E.2d 1070 (Supreme Court of Massachusetts 2006)

Facts: A 16-year-old boy was mortally injured in a vehicle accident. About two hours after his death, his parents consented to tissue donation; however, their son’s cornea and blood vessels were harvested and his tissues were unusable following saline infusions in the hospital emergency room before his death.

Issue: Were the boy’s organs improperly harvested when his parents only consented to donate the tissues of their deceased son for transplant?

Holding and Decision: No. Organ and tissue banks are not required to harvest and allocate body parts according to the donor’s wishes.

Analysis: The court reviewed the Uniform Anatomical Gift Act and acknowledged time is always very limited for obtaining consent and procuring body parts. Once consent for a postmortem gift is received, organ and tissue banks are not required to disclose that the donation may be unusable for specified purposes. While a cause of action may arise when organs are harvested beyond the scope of consent, the law’s good faith immunity provision often protects organ banks. Moreover, improper harvesting claims address the right to prevent the harvesting of corpses without consent; there is no requirement that banks harvest and allocate body parts according to the donor’s wishes.

Rule of Law: The Uniform Anatomical Gift Act may provide grounds for a donor’s family to sue when donated body parts are used for a purpose other than their specified purpose of transplant, although organ and tissue banks may be excused from liability by good faith protections.

References discussing this court decision: Bonnie et al., 2008.

Limited Property Interest in Human Biological Material

Regardless of all these regulatory changes, and even as scientific advances lead to increased use of and demand for human organs, the body continues to take on the functional characteristics of property in the law. Most courts refuse to overturn traditional notions of a limited property interest in the human body as demonstrated by the landmark Colavito case.

COURT DECISION

Property Right in Donated, Cadaveric Organs

Colavito v. New York Organ Donor Network, Inc.

(Recipient of a Designated Kidney v. State Network for Organ Sharing)

486 F.3d 78 (U.S. Court of Appeals for the 2nd Circuit 2007)

Facts: A widow made a directed donation of her husband’s kidney to Colavito. While awaiting implantation of the first kidney, the attending surgeon discovered the kidney had been damaged by aneurysms. Therefore, a staff member called to request the second kidney be airlifted for transplant. However, the New York Organ Donor Network informed the party that the second kidney had already been implanted in another recipient; as it turned out, the kidney was not transplanted until three days later. Instead of Colavito receiving both kidneys, one kidney was successfully transplanted in another donee. Colavito brought suit, alleging fraud and conversion in the kidney donation, and alleging the New York Organ Donor Network violated organ donor laws. As it turned out, the donated kidneys were incompatible with Colavito’s immune system, although Colavito refused to concede that he could not have derived a medical benefit from the transplant.

Issue: Does either the donor or next of kin have a property right in regards to a cadaveric organ donated for transplant?

Holding and Decision: No. Neither the donor nor next-of-kin has any property rights to a donated incompatible organ.

Analysis: The court found that corpses are not recognized as property in common law. Property interests only extend to preserving and burying the corpse. Therefore, it would be against regulatory policy to recognize broad property rights in the body of a corpse.

The court reasoned there was no consensus that body parts are excluded from conversion actions, noting that the existence of property rights in body parts is a new question with very little authority and commentary. The court concluded Colavito may have been able to maintain a cause of action had the organ been compatible because, as a human organ recipient, the suit was not brought for control of the corpse and its parts but rather for the deprivation of a working organ.

In short, the court argued Colavito may have had a legal claim based on the loss of a functioning organ if the organ would have otherwise medically benefited him. The court adhered to the common law rule and refused to identify or forecast the circumstances in which someone might have actionable rights in the corpse or organ of a deceased person.

Rule of Law: No one can have a property right in a corpse; next of kin only have a common law right to possess the corpse for the purposes of burying it and a corresponding duty to do so.

References discussing this court decision: E.g., Hain, 2015; Terrell, 2014.

In Reality: How Organ Procurement and Transplants Occur

Historically, organs were recovered from patients who suffered cardiac death (meaning the victim was no longer breathing, had no pulse, and the heart could not be revived). This often meant that by the time their organs could be transplanted, they could no longer be used because they had been without a blood and oxygen supply for so long that they would be unlikely to function in the recipients (Saitta-Gill & Hodge, 2015). In 1968, the medical community redefined death to include brain death which occurs when the brain is no longer functioning, despite the body being sustained by drugs and machines (Williams et al., 2014). This means organs can be transplanted earlier, or before they suffer blood and oxygen deprivation, making them much more likely to be viable.

The concept of brain death has been described as at once well settled and persistently unresolved (E.g., Dolgin, 2016). Use of brain death has, however, led to the rampant misunderstanding that patients who might otherwise survive might be killed for their organs, something unconditionally prohibited. Although organs transplanted from a brain-dead patient are more likely to be useful, only 1 to 2% of patients who die in hospital are declared brain dead (Capron, 2014).

Deaths occurring outside of a hospital setting generally do not result in usable transplant organs because organs need a continuous supply of blood and oxygen in order to be transplantable. Some transplant centers still do not consider transplanting organs from patients who are older than 65 or who have high blood pressure, even though studies have shown organs from these “less than perfect” patients can be successfully transplanted. This factor further contributes to the short supply of usable transplant organs.

This is also why the transplant community wants to do more for living donors such as providing health insurance and reimbursing them for their time. At the same time, there is significant disagreement about how far medicine should go in encouraging patients to donate organs. Disagreements extend to living and postmortem donations.

Access to Organs

As illustrated in Table 25-1, organ transplants are expensive procedures, available only to those who have health insurance and private funds. Many health insurance policies do not cover the full cost of a transplant, which then must be paid out of pocket.

Table 25-1 Estimated Average First-Year Billed Charges per Transplant

Transplant Procurement Hospital Physician Evaluation Follow-Up Immunosuppressants Total

Double lung only $133,100 $419,500 $85,700 $51,500 $169,600 $48,600 $907,900

Heart only $146,400 $624,400 $65,500 $37,300 $151,500 $47,900 $1,073,000

Heart-lung $249,100 $819,200 $92,500 $43,000 $171,700 $50,000 $1,425,000

Intestine only $122,900 $981,300 $141,900 $67,900 $128,000 $38,100 $1,480,000

Kidney only $95,000 $121,400 $35,000 $23,800 $78,200 $48,100 $401,400

Kidney-heart $241,400 $682,800 $65,500 $37,300 $151,500 $57,200 $1,235,800

Kidney-pancreas $202,800 $196,000 $40,100 $24,000 $78,700 $59,900 $600,400

Liver only $96,000 $404,100 $109,900 $42,200 $144,200 $50,700 $846,400

Liver-intestine $219,200 $1,098,800 $141,900 $67,900 $144,200 $57,500 $1,723,500

Liver-kidney $278,700 $523,000 $109,900 $42,200 $144,200 $60,600 $1,070,200

Liver-pancreas-intestine $327,000 $957,400 $141,900 $67,900 $144,200 $57,200 $1,695,500

Pancreas only $107,800 $175,400 $40,100 $23,900 $78,700 $59,300 $484,300

Pancreas-intestine $230,700 $955,800 $141,900 $67,900 $128,000 $57,700 $1,581,800

Single lung only $65,800 $341,000 $54,100 $32,600 $106,900 $49,700 $651,700

Note: Where the itemized charges were inconsistent from the data sources, the billed charges were averaged. The total billed charges were generally consistent across the data sources. All charges were calculated to future values for 2016.

Data from Analogous Blood and Marrow Treatment Registry, International Bone Marrow Transplant Registry, National Marrow Donor Program, Organ Procurement and Transplantation Network, Scientific Registry of Transplant Recipients, United Network for Organ Sharing, U.S. Renal Data System.

Kidney Transplants

Kidney transplants are the most frequently performed organ transplant and the least expensive transplant procedures (OPTN & STRT, 2016b). This can be expected since the diseases with a high predisposition to end-stage renal disease are diabetes and hypertension, which are tied to the nation’s obesity epidemic (Tenenbaum, 2016). It is debatable whether the comparatively high number of kidney-only transplants is a factor in driving down the charges per transplant. A typical 25-year-old diabetic will gain an extra 8.7 years of life from a transplant, while a typical 55-year-old diabetic will gain 3.6 extra years (NKF, 2016).

Regardless of age, most individuals with end-stage renal disease are covered under Medicare’s end-stage renal disease program. The cost of lifetime dialysis or, for individuals who receive kidney transplants, the costs of the transplants and three years of follow-up care including immunosuppressive drugs needed to sustain the transplants are covered by Medicare insurance. Although end-stage renal disease can be treated through other renal replacement therapies, kidney transplants are generally accepted as the best treatment both for quality of life and cost-effectiveness (NKF, 2016).

Medicare insurance has been paying in excess of $32 billion in end-stage renal disease-related costs each year, or about $65,000 per person (NKF, 2016). A debatable issue is whether Medicare insurance should continue paying for most adult kidney transplants in the United States when the underlying diseases leading to the need for transplants are usually caused by lifestyle choices. This question is directly related to the high incidence in transplant failures from one year to three years due to treatment noncompliance and continued unhealthy habits (Tenenbaum, 2016). As discussed, the new United Network for Organ Sharing policy relies significantly, though not exclusively, on net benefit, which seeks to give kidneys first to those who will benefit most from them (Beard & Leitzel, 2014). This would favor recipients who have more years to gain from a new organ, meaning individuals with healthier lifestyles and who have demonstrated compliance with their treatments plans (Fleck, 2014).

Heart Transplants

Every year about 500 patients on the National Organ Donor Registry’s wait list die before a heart is made available. Thousands more die because they are considered too old or sick to get on the list. Many of these patients could be saved if transplant centers were less particular about the quality of donor hearts. In response to this need, more hospitals are starting alternate heart programs that provide lower quality hearts to older and sicker patients. While about 2,000 hearts are transplanted each year, an additional 3,000 are offered by families of the deceased and are rejected (OPTN & STRT, 2016b). These 3,000 hearts are often rejected because they are not top quality, and the hearts were consequently buried or cremated with their original owners. Estimates are that half the rejected hearts are suitable for transplanting (O’Brien, 2015).

One limitation to establishing alternate heart programs is that insurers scrutinize success rates at each transplant center to decide whether they will cover transplant operations performed there. If a transplant center accepts too many sick recipients or individuals over the age of 65, its success rate will go down and health insurers may refuse to pay for its treatment procedures. Heart transplants, which cost patients upwards of $600,000, are a profit generator at many hospitals (OPTN & STRT, 2016b). This is one reason alternate heart programs are usually only found at major teaching hospitals like the UCLA Medical Center, which can afford to accept donor hearts that either require bypass surgery prior to transplant or originate from older donors.

While UCLA was the nation’s first alternate heart program to offer transplants to seniors with end-stage heart failure, other teaching hospitals have developed similar programs (Satel & Hippen, 2007). Alternate heart recipients do somewhat worse than top-quality heart recipients, but still do fairly well in comparison to how they would have done with no heart transplant at all. The United Network for Organ Sharing will often find no takers for alternate hearts, and that is where UCLA and other transplant centers with alternate donor lists come in. After everyone else says no, the United Network will call an alternate heart program and look for a patient to accept the lower quality heart (Noah, 2013). Patients on the alternate list must agree they will not ordinarily be eligible for a heart from the regular list. This leaves another dilemma for the medical community: how far should transplant centers go in using lower quality organs ?

Anencephalic Neonates

One of the earliest controversies surrounding organ donation involved anencephalic neonates.LN2 Anencephalic neonates are babies who are born nearly brain dead, with the exception of minor electrical activity. They have no possibility of living a life beyond the vegetative state within which they are born and are permanently unconscious. They do not feel pain due to the lack of cerebral function. Most, in fact, die within days of birth (See generally CDC, 2015; Gilman, 2012).

In order to donate organs, there must be either total brain death or cardiac death (Shuster, 2014). An anencephalic neonate cannot be declared dead either way (Gilman, 2012). If their life support machines are turned off and death occurs naturally, their organs are no longer usable because of the time it takes death to occur and the damage to their fragile organs in the meantime (CDC, 2015). The American Medical Association was originally of the opinion that it was ethically acceptable to transplant the organs of such infants even before they were technically dead as long as there was parental consent and certain other safeguards were followed, but they withdrew that opinion due to controversy (Gilman, 2012).

HIV-Positive Transplant Candidates

There is public controversy over whether HIV-positive transplant candidates should receive organs, even if they have no symptoms and are not in the end stage of the disease. While positive HIV status was once thought to be a relative or even absolute contraindication to receiving a transplant, the United Network for Organ Sharing does not bar HIV-positive patients from receiving organs. HIV-positive patients argue their status is at least equal to other transplant patients who previously received transplants but whose bodies rejected the organs, or to transplant patients with other diseases such as hepatitis or diabetes, or to elderly transplant patients (White, 2016). With the advent of antiretroviral drugs, those infected with HIV are now living longer and dying from illnesses other than Acquired Immunodeficiency Syndrome (AIDS).

Recent transplant studies have demonstrated results comparable to those of recipients without HIV infection (See Saitta-Gill & Hodge, 2015). Still, a number of issues persist regarding ethics, patient selection, postoperative management, and drug interactions between antiretroviral and immunosuppressant agents. Some transplant centers often refuse to list HIV-positive patients in the National Organ Donor Registry’s wait list; this is so even though some HIV-positive patients have the disease through no fault of their own, such as those who were born with the disease or who contracted it through violence or medical error. Since 2013, when the federal HIV Organ Policy Equity Act was enacted, only HIV-positive patients are eligible to receive HIV-positive organs (See 42 U.S.C.A. § 274(b)(3)(A)).

These and other controversies over the way organs are allocated have led to the suggestion that potential survivability should be the only criteria for selecting transplant recipients. Some states have gone as far as to reject the federal regulations. These states have enacted their own state legislation in an attempt to maintain local geographic preferences for organ transplants by restricting organ donors from donating their organs out of state (See generally White, 2016).

Alternative Procurement of Organs

Several alternatives to xenotransplants are immediately available to enhance organ procurement and increase organ supply. Federal and state governments are considering alternatives such as mandated choice, which would force everyone to choose whether or not they want to be a donor, or presumed consent, which would assume everyone wants to be a donor unless they indicate otherwise.

While stem cell therapies and xenotransplants offer future alternatives for organ enhancement or supply, neither is without controversy (Crepelle, 2016). Both alternatives pose greater risk to human health since they are both emerging medical procedures without guaranteed success. Further controversy surrounds how organs for transplant are sometimes obtained. Many states have laws allowing any organ to be removed from a cadaver without consent as long as an attempt was made to contact the family. California and Idaho are two such states. Other states allow for the removal of specified items as long as no objection is actually known, whether or not an attempt to notify the family was made. Missouri, Arkansas, and Colorado are three such states. The Uniform Anatomical Gift Act allows a donor to specify a recipient, a regulatory policy adopted to encourage more donations (OPTN, 2016a).

Presumed Consent or Opt-Out

Presumed consent systems, common in Europe and Eastern Asia, provide that organs will be automatically donated at death, unless stated otherwise (Kessler & Roth, 2012). This method is often called an opt-out plan because persons who do not wish to donate their organs upon death must opt out during life. The advantage of this system is an increase in the available supply of organs (Wharton, 2011). However, there is some opposition to the practice of silence as consent.

Mandated Choice

Mandated choice is very similar to presumed consent except that under mandated choice individuals must either opt in or opt out; there is no presumption of opting in (Orenstein & Bettini, 2014). The advantage of this system is greater personal autonomy, the lack of which is the main criticism of presumed consent. Similar to the presumed consent method, it places the burden on individuals to think about organ donations. The largest criticism of mandated choice is the cost of coordinating a national system, since everyone’s organ donation preference would have to be recorded and followed (Beard & Leitzel, 2014).

Internet Solicitation

Another approach to organ procurement involves communication between potential donors and recipients through Internet-based chat rooms and websites (Saitta-Gill & Hodge, 2015). The website MatchingDonors.com and a free message board at livingdonorsonline.org have allowed individuals in need of organs to meet and chat with others who are willing to be living organ donors. The idea remains controversial because it raises questions about potential commercialism and donor compensation.

MatchingDonors.com, created in 2004, is a for-profit Internet business with over 5,100 organ recipients registered. Several hundred recipients are from the United States. Potential donors determine who the most deserving person is for their organ based on information provided by potential recipients.

Live Organ Swaps and Paired Living Donations

There are also organizations, such as LifeSharers, designed to improve transplant candidates’ chances of receiving an organ by requiring members to agree to donate organs to other members before the general public. LifeSharers has over 9,000 members. These organizations argue it is not fair to give organs to patients who have not also agreed to donate their own organs should the opportunity arise. LifeSharers points out organ donors themselves receive only about 30% of donated organs, whereas the remaining 70% go to non-donors.

Kidney swaps are one newly popular but complex method for doing so. Also known as kidney-paired donation, the process connects an incompatible donor-recipient pair such as a husband and wife or a parent and child with another incompatible donor-recipient pair. The healthy member of each pair donates a kidney to the person who is the medical match in the other pair, and the surgeries are performed simultaneously so one healthy donor cannot back out after their loved one receives a kidney. Sometimes the swaps involve as many as five pairs. The first swap of this kind actually occurred in 2000 and several hundred have occurred since then. At least three paired kidney organizations foster this method of allocating kidneys:

Alliance for Paired Donation

New England Organ Bank

North American Paired Donation Network

(Meckler, 2007b).

Regulatory Changes

The slow initial growth of paired organ donations reflected concerns that trades might violate a federal ban on selling organs. However, Congress passed Norwood in 2007 clarifying that such arrangements are legal. It is estimated there are as many as 4,000 kidney exchanges per year (NKF, 2016), a big addition to the kidney transplants performed every year involving living donors. Still, this is not nearly enough organs to satisfy the need for kidney transplants. As interest in kidney swaps grows, logistical, medical, ethical, and legal questions are emerging.

One of the fundamental issues is who should get priority on a match (Tenenbaum, 2016). A donor with blood type O, for instance, can give to patients of any blood type and might match with hundreds of pairs. In the early days of kidney swaps, transplant surgeons matched pairs using a pen and paper or by moving magnetic pieces around on a board. Today, computer experts, working with economists and clinical researchers, are optimizing matches to enable the greatest number of organ transplants (Wharton, 2011). Mathematical techniques from major league baseball schedules, airline departures, and online driving directions are being used. The days when federal regulations allocated scarce organs based on a list of evolving technical criteria are over. The goal of many is to develop a national paired kidney network (White, 2016).

Federal and State Innovations

The federal government established a program to reimburse living donors for expenses including travel, lodging, and meals (OPTN & STRT, 2016b). States are also experimenting with how to increase cadaveric and live donor rates with more than a dozen states offering tax deductions to help defray expenses (Underhill, 2016). Wisconsin gives state tax breaks of up to $10,000 to benefit organ donors for expenses such as travel, hotel bills, and lost wages. Pennsylvania has a fund from voluntary donations when state residents apply for driver’s licenses or vehicle registration; the fund provides up to $3,000 per cadaveric donor to help with hospital, medical, and funeral expenses. In both instances, the expenses are paid directly to providers to avoid conflicting with the ban on payment for organs.

Some states propose mandates requiring all organ donors to have lifetime insurance coverage; others propose that Medicare insurance cover all organ donors. Both proposals could serve as an inducement (Capron, 2014). Most recently, South Carolina introduced legislation that would shorten the term of prisoners’ sentences if they chose to donate an organ. Other ideas include tax credits, tuition vouchers, deposits in retirement accounts, and recognition of tax deductions for charitable contributions. All these could be offered in a regulated environment overseen by tax authorities. The savings from dialysis could be used to underwrite the various types of compensation. According to the Congressional Budget Office, Norwood alone will save almost $500 million in Medicare insurance costs over 10 years (Williams, 2014).

Compelled Donations

Advances in immunology and the growing ability to circumvent rejection of transplanted organs are slowly replacing the need for compelled donations (AMA, 2011). The focus has turned to anonymous donations, which again brings to the fore the place where strangers go to transact business: the market. Still, every year, organs are harvested from minors and mentally incompetent adults who neither voluntarily donate their organs nor consent to the surgical procedure (Longo, 2011). Compelled living donations from children and incompetent persons are the least desired forms of organ donation (Coleman, 2014). Since living donations generally involve kidneys, part of a liver, or bone marrow, donation does not involve serious physical harm to donors. However, the physical pain or risks to the donor should not be minimized, especially in the case of kidney or liver donations, which are major surgeries involving general anesthesia. Also, in the case of kidney donation, donors are left with only one kidney, which puts them at a greater risk for kidney complications in the future. Siblings are usually the best donors for reasons including matching blood types and relative ages of the donor and recipient. Sometimes the best possible match, and maybe the only possible match, will be the recipient’s incompetent sibling (Ouellette, 2010).

Incompetency is defined as a lack of legal ability in some respect. Looking to a variety of factors, courts determine whether a person is legally incompetent. Generally, organ donations from living minors are only permitted if the donor is above the age of 12 or 13 (Coleman, 2014). Children under the age of 18 are generally considered legally incompetent and cannot independently provide consent to donate their organs or tissues.

Cognitively impaired children are considered legally incompetent if born severely cognitively impaired or if born healthy but become severely cognitively impaired before age 18. Legal competency is disputable if a child is close to 18 before becoming severely cognitively impaired. Incompetence can vary among persons from severe and profoundly impaired, to mild and less impaired. When incompetence is severe, individuals will have limited awareness of their surroundings and will often have serious medical conditions. The severity of incompetence can therefore vary significantly and should be considered (Coleman, 2014).

Generally courts use substituted judgment reasoning to determine whether the best interests of potential donors are being met (Sabatello, 2014). Most family requests are resolved at the lower court level in favor of donation with few decisions appealed, thus there is a paucity of reported cases. In an attempt to address donor coercion, organ transplant teams have long allowed potential donors to opt out of donation by providing faux medical excuses that are intended to shield donors from external pressures, real or perceived, to donate (Coleman, 2014).

Creation of Child Donors Through Assisted Reproductive Technologies

Parents sometimes conceive another child for the purpose of donating bone marrow to an older sibling in need of a human leukocyte antigen match. Whether this is a legally or ethically sound practice remains unclear. It is clear that there is no legal obligation for siblings to donate. The practice of procuring tissue and organs from children drastically changed when it became possible to use assistive reproductive techniques primarily for the purpose of a child becoming an organ donor. Preimplantation genetic diagnosis and in vitro fertilization (IVF) can be used to conceive a child who is a perfect antigen match for an older sibling. Stem cells from the child’s umbilical cord blood can be harvested from the newborn at birth and transplanted into the older sibling. This controversial technique has been used in only about 2,000 children because:

Cord blood is in short supply.

The process is time consuming.

The procedure is expensive.

There are only about 50 reproductive centers worldwide offering the technique.

(McClean, 2016).

Despite the limited use of this procedure, it is likely to be used extensively in the near future to conceive child donors as the costs decrease, as technological advances in assistive reproductive techniques are made, and as the number of reproductive centers offering the procedure increases. Just as the history of organ donation has rapidly evolved, so likely will the use of assistive reproductive techniques to create child donors. Healthy cord blood donors hold great promise to treat those with Fanconi anemia, leukemia, thalassemia, Hurler syndrome, and other diseases causing the immune system and bone marrow to fail.LN3

What is perhaps more worrisome than using assistive reproductive techniques more extensively in the future to create perfectly human leukocyte antigen-matched child donors is the fact that younger siblings might be asked to donate their bone marrow if the stem cell transplants are unsuccessful. If a bone marrow transplant fails for any reason, they may be asked to donate other tissues and organs. In fact, children conceived via assistive reproductive techniques combined with in vitro fertilization and preimplantation genetic diagnosis for human leukocyte antigen-matching could be asked to serve as donors for their ailing siblings throughout their entire lives.

Procurement Protections for Compelled Donors

The current legal framework under which compelled donations occur may not adequately protect children and the cognitively impaired unless several standards are followed. Most important, a guardian ad litem should always be appointed to look out for the interests of compelled donors. Many courts require family and independent counseling to ensure parents understand the dynamics and depth of their actions and the potential long-term consequences. Often, independent physicians are appointed for the prospective compelled donors to avoid conflicts of interest. Ideally, a statement should be issued to the court from the donor as to why they desire to participate as an organ or tissue donor. Restricting compelled donations may reduce the pool of viable organs, and other solutions may have to be sought. However, limiting the pool of incompetent donors will necessitate and hopefully force a reconsideration of the altruistically based procurement regimen (Goodwin, 2007).

Lengthening Post-Transplant Organ Survival

A variety of techniques prevent injury that results from temporary arterial blockage and restoration of blood flow to transplanted organs. Rejection of the donor organ or tissue is also preventable through the use of a variety of tissue and molecular manipulations before the transplant occurs. Medicare provides insurance coverage for most organ transplants; however, coverage of immunosuppressant drugs ends 36 to 44 months after transplant surgery or when the patient reaches adulthood (OPTN & STRT, 2016b). Many patients, especially young adults, cannot afford to pay for these maintenance drugs without health insurance (Tenenbaum, 2016). Transplant patients who lose their insurance coverage are more likely to stop taking necessary antirejection drugs, and not taking the drugs increases the risk of losing the transplanted organs due to organ failure or other complications (Frank, 2014).

Immunosuppressive drugs that prevent organ rejection can be as high as $60,000 for the first year following a transplant. This represents a significant financial burden for families, even if insured, because of co-payment obligations. If families cannot afford the drugs, it can mean losing the transplanted organ or even death. Outcomes for children whose families are uninsured are very poor (Strong, 2014). The cost of failed organ transplants is also high. Functioning transplants are 10 times less expensive to maintain than the costs involved in the years following a failure; the cost of returning to dialysis after a transplant failure averages $89,000 annually (USRDS, 2015). This is one reason proposals are emerging to provide lifetime medical coverage for organ transplant recipients; it would be cost-effective and would prolong patients’ longevity and their productivity.

There are black market drugs available through an underground network run by transplant patients with the cooperation of sympathetic health care workers and overlooked by law enforcement. They simply give drugs away to patients who cannot afford immunosuppressant drugs. Their sources include patients who have changed drug regimens and contribute their old medicines, some drug manufacturers, and drugs scavenged and unused from the dead and passed on to the underground. There is probably an illicit underground in every major metropolitan area (Weinstock, 2014).

Tissue Transplantation

Human tissue is anything donated from the human body that is not a vital organ. Blood vessels, bone, bone marrow, connective tissues such as tendons and cartilage, corneas, heart valves, and skin are common types of tissues used for transplants to help patients in many different types of surgeries (OPTN & STRT, 2016b). Transplantation of musculoskeletal tissues is the most common medical procedure, including skin tissue replacements to treat burns, bone to facilitate spinal fusions, and tendons to reconstruct knee ligaments and repair joint and limb injuries (Saitta-Gill & Hodge, 2015). It also includes implantation of brain matter, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes, and semen (McClean, 2016).

U.S. Navy Tissue Bank

The first tissue bank was established by the U.S. Navy in 1949 to deal with war injuries and remained the primary tissue bank in the United States for almost 30 years. Scientists at the Navy Tissue Bank pioneered many of the commercial standards followed today:

Cryopreservation, freeze drying, and irradiation sterilization of tissue

Documentation and clinical evaluation of tissues

Establishment of a graph register

Identification of appropriate donor criteria for tissue donation

Immunological principles of tissue transplants, including cadaveric bone marrow recovery and immunosuppressive protocols

Procurement and processing methods

The Navy was also instrumental in establishing the National Marrow Donor Program and the American Association of Tissue Banks. Although the Navy Tissue Bank ceased operations after 50 years, it pioneered the establishment of regional tissue banks. Similar to blood banks, they provided the human tissue necessary to meet the demands of their local communities.

Current Context

The practice of tissue transplantation has grown quickly; its visibility and ability to escape government overregulation has allowed it to separate itself from organ transplants. This new visibility has come with the rise of for-profit tissue banks that process, transform, package, and store tissue for years before distribution for transplants, unlike organs that are transported quickly and rarely change form before getting to a recipient (Williams, 2015). With the growth of tissue transplants, it has been easy for human tissue to be commoditized and turned into valuable medical products. As the market expanded, the regional tissue banks began to distribute outside of their local communities. The 1990s saw an expansion and consolidation in the tissue industry as the large for-profit tissue banks moved to control more than half of the tissue bank business (Townsley, 2015). Today, the typical tissue donation chain is as follows:

Organ procurement agencies meet with the donor’s family in order to get consent for tissue removal and then procure the tissue at a hospital (most of the recoveries occur in hospital operating rooms) or morgue; recoveries are often made at multiple sites.

Organ procurement agencies then give the recovered tissue to a processor and collect recovery fees.

Tissue processors process the transplantable tissue into marketable tissue products and then distribute the processed tissue products to marketing agencies and collect processing fees.

Marketing agencies sell the processed tissue products to hospitals and physicians for transplantation and collect distribution fees.

Hospitals and physicians then transplant the processed tissue products into patients and collect medical fees.

(See Townsley, 2015; Williams, 2015).

Some of the most important technological advances in the tissue industry have occurred because of for-profit tissue processors. Over the course of two decades, the tissue industry has evolved from a $20 million industry to a multibillion-dollar industry with double-digit growth.

Regulatory Oversight of Human Tissue

When the tissue bank industry emerged, federal regulations were nonexistent. Even though tissue transplantations are similar to organ transplantations, the two entities are treated completely differently. Traditionally, organs have been thoroughly regulated by the federal government and individual state governments. The same cannot be said for human tissue (Williams et al., 2014). Until 1993, the idea of regulating the tissue industry was foreign. The government did not have regulations for tissue banks until the 1990s, when it was discovered there was a need to protect the public from the possibility of transmitting disease through tissue transplants. Even with this pressing need, it still took years to enact regulations.

Today, human tissue is regulated by the Center for Biologics Evaluation and Research (See 21 C.F.R. §§ 1270-1271). The federal regulations act as a base for the state regulations to stand on. The regulations created by the states require that tissue banks comply with federal regulations, but often the state regulations appear more specific and better enforced. The states appear to give additional protection and instructions to tissue banks than the federal regulations do. Florida, New York, Maryland, and California have enacted their own state regulations and standards for tissue banks that operate in their states. In addition, the American Association of Tissue Banks has its own voluntary regulations and accreditation guidelines for all tissue banks. In order to legally comply with federal regulations, tissue banks must register with the U.S. Food and Drug Administration. Many do not register, and thus exist under the radar of government supervision (Williams et al., 2014).

American Association of Tissue Banks

The American Association of Tissue Banks accredits tissue banks with higher standards than the FDA or state laws require. Created in 1976, the Association works through regional and local tissue banks to ensure the availability of a safe, adequate, and economical supply of tissues and cells for medical procedures and research, as it seeks to:

Create a forum for scientific exchange

Encourage human tissue donation

Ensure quality standards

Promote ethical standards throughout the tissue industry

Secure an adequate supply of transplantable human tissue

American Association of Tissue Banks, 2012; Neal, 2012).

While most of the major U.S. tissue banks are accredited, fewer than 100 of the 2,000 tissue banks registered with the FDA are actually accredited (Williams, 2015). When a tissue bank is in the process of accreditation, inspectors visit the bank and review its on-site operations and procedures. Tissue banks that do not meet the Association standards are denied accreditation. Tissue banks are accredited for three years.

The Association also develops technical standards for recovery and preservation of human tissues. Specific areas cover screening for communicable diseases, tissue labeling, qualification of tissue bank personnel, safety practices, equipment testing, and facilities for tissue storage. The FDA and the Association work together to address tissue bank donor selection criteria, quality processing, and record-keeping in an attempt to keep infectious tissue out of circulation (FDA, 2014). Neither the FDA nor the Association concerns itself with distribution issues in the tissue industry; allocations are market driven.

Biosynthetic Tissues

Biosynthetic tissues, including synthetic skin and bone substitutes, are viable alternatives to traditional human transplant materials. Numerous restrictions, however, such as the technical limitations associated with engineering complex tissues so as to duplicate their innate function in vivo, currently limit their use outside major teaching hospitals (Weinstock, 2014). As a result, the leading potential solution to this shortage for the foreseeable future is xenotransplantation (See generally Hagen & Gittens, 2008).

Xenotransplants

Fewer than 5% of the human organs needed are actually made accessible for transplant. This disparity between need and availability has led medical researchers to consider the possibility of animal-to-human transplants, or xenotransplants. Strictly regulated by the FDA, xenotransplantation involves any procedure that transplants, implants, or infuses into a human one of the following:

Live cells, tissues, or organs from a nonhuman animal source

Human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs

A medical practice endorsed by the President’s Council on Bioethics, xenotransplants are used to treat certain diseases such as neurodegenerative disorders, liver failure, and diabetes where human body parts are not usually available (President’s Council, 2004). While the transplant, implantation, or infusion into a human recipient of cells, tissues, or organs from an animal source has been occurring in some fashion for over 100 years, it often results in rejection by the body’s immune system (Crepelle, 2016).

In order to minimize the rejection of xenotransplants, the possibility of using part-human organs, tissues, and cells, such as pig hearts containing human DNA, for transplantation is actively being explored. Xenotransplants, developed in the late 20th century simultaneously with the use of artificial organs, calls into question the once clear distinction between human and animal life (Westphal, 2006). As human genes are introduced into mammals such as pigs to make the animals’ organs more acceptable to the human body for the purposes of organ transplants, this scientific development blurs distinctions. These technologies are expensive and have lower success rates than human organ donation, so they are unlikely to comprise many organ transplants in the near future.

Oversight of Safety and Effectiveness

For over 20 years, the National Institutes of Health publicly disclosed summary safety and effectiveness data for studies related to xenotransplants (Crepelle, 2016). In 2001, proposed rules were made to extend this same level of disclosure to the FDA’s regulation of xenotransplants, given the concerns about protecting animals and humans from cross-species diseases, known as zoonoses. However, the rules were never finalized. The concern is that communicable diseases, or the infectious agents that cause them, might move from animals to humans through xenotransplants (Spillman & Sade, 2007). An edifice of exemptions has protected confidential commercial information about xenotransplants from disclosure to the public. At the same time, the larger question of whether commercial interests should automatically take priority over public health concerns is strongly debated (Lurie & Zieve, 2006).

Most current xenotransplant research focuses on the pig as an organ donor because of its size and commonalities with humans in some physiological pathways. New strategies are being examined for their ability to prevent rejection of organ allograft. The goal of preventing rejection of donor tissue is to selectively suppress the immune response to the organ while retaining normal immune response to pathogens.

Techniques to accomplish this selective immune suppression are expected to improve in the future as medical researchers gain and apply new knowledge about immune function from the results of the Human Genome Project (Pippin, 2013). A number of potential methods are under consideration and are being pursued. These include:

Modification of the donor to increase its compatibility with the recipient

Organ and clonal T-cell deletion

Transplant of bone marrow (as a source of precursor donor T cells)

(See Brody, 2015; Pippin, 2013).

The latter is considered the most successful medical treatment, with transgenic techniques used to introduce genes for recipient surface antigens. Efforts to produce transgenic animals such as pigs altered with human DNA are under way in the hopes of tricking the human body into accepting the animal organ (Brody, 2015). The goal is to create partially humanized organs to use as spare parts for humans. A number of additional issues must be overcome before xenotransplantation becomes widespread. For instance, organs and tissues from animal sources may carry endogenous retroviruses, which must be identified and removed (Macintosh, 2015). Additionally, the ethics surrounding the use of animals for human benefit must be explored and resolved. Nevertheless, xenotransplants of nerve tissue are currently used to treat patients with Parkinson’s disease.

Xenotransplant Tourism

One resulting problem is xenotransplants occurring in countries with no regulatory oversight. Patients seeking xenotransplant procedures visit countries like Mexico, Cambodia, Laos, and Myanmar for controversial treatments that can be exceedingly dangerous (Cortez, 2008). Moreover, xenotransplant tourism by patients willing to pay for unproven interventions in countries without adequate controls risks global dissemination of new pathogens and may undermine this fledgling field just as it is emerging (Delmonico, 2011).

Alternative Strategies for Developing Organ and Tissue Replacements

Current research efforts can be divided into four areas:

Development of new organs, taking advantage of advances in stem cell biology, genetic engineering, and tissue engineering

Improvement in medical devices to replace organ functions

Methods for improving organ and tissue preservation during transport from donor to recipient

Procedures for lengthening postimplantation survival of the organ and the recipient

While engineering of replacement tissues now uses large-scale tissue cultures, research is extending relatively crude current cell and tissue culture techniques to better determine the conditions required to create organ systems in vitro. Matrices and factors controlling tissue architecture outside the human body are continuously enhanced. Research laboratories and the medical products industry are actively trying to create skin, blood vessels, cartilage, bone, and corneas through similar tissue engineering techniques (Strong, 2014). Other efforts in less-advanced stages include windpipe, kidney, pancreas, liver, and heart tissue (Weinstock, 2014). Tissue engineering has seen a number of ups and downs in the 20 years since its inception.

Initial success at growing tissues in labs and in small animals led researchers to declare success too early. As soon as the same tissues were tested in larger animal models, it became clear that size is one of the significant limiting factors in tissue engineering; the thicker the tissue one aims to grow, the harder it is to create. Use of undifferentiated pluripotent stem cells and other undifferentiated cells is extending the possibilities for tissue culture. Further research is occurring on stem cell isolation and culture, while identification of cell surface markers allows for easier isolation of stem cells. In addition, the conditions required for stem cell differentiation are being identified, including signaling pathways, transcription factors, and gene activation sequences (See generally Morad, 2012).

Moving Altruism Forward

Competing legal and social interests surround the transplant of human organs in the United States. As medical advances have made organ transplants easier and more successful, questions arise:

Are living donations ethical?

Should organ donors be compensated similarly to those who donate plasma or reproductive material?

Which patient should be the priority when an organ becomes available: the sickest and the one suffering the most, or the healthiest and the most likely to survive, or the one who has been waiting the longest?

Who should receive the limited supply of transplantable organs?

Equal and fair access to the few other goods or services (if any) there are is as highly controversial as access to health care, particularly access to transplantable organs. Health care is perhaps the only service Americans view as something beyond a commodity. Rather, health care is viewed as something everyone should have access to. The question becomes, then, if basic economic concepts are not an appropriate way to distribute scarce transplantable organs, what is the best way to do so?

Now that Congress has clarified the National Organ Transplantation Act through Norwood, the next move might be to change the prohibition against rewarding those who decide to donate their organs or families who donate the deceased member’s organs. The current procurement system demands altruism as the sole legitimate motivation for donation of human biological material. However, altruism is not producing the number of organ donors necessary to keep pace with the ever-increasing number of wait-listed patients, many of whom die while waiting. The current altruistic system of organ procurement, which relies primarily on cadaveric donors, does not take into account today’s technological advances.

Organ procurement policies based on a transplant system relying exclusively on living related donors has evolved into a system that now relies heavily on cadaveric organs and living unrelated donors. No-sale policies are now one of the principal causes of the ongoing organ shortage (Meckler, 2007a). Transplant policies have not kept pace with medical technology or the realities of the marketplace. While altruistic procurement of organs is not meeting the growing demand for transplantable organs, there is not sufficient moral certainty to warrant allowing marketplace approaches to organ transplants (Wharton, 2011).LN4 The idea of combining organ donation with material gain can make some patients uneasy, yet the mix of financial and altruistic motives is common. Few object to tax credits for charitable contributions. An increase in the supply of organs could prevent needless suffering and death. It could be argued this is more important than whether an organ has been given freely or for material gain.

LAW FACT

Medicaid Insurance Coverage for a Liver Transplant

Must a state’s taxpayers pay for a liver transplant to cure a hereditary disease if the disease can be treated by dietary management?

Yes. The harm to an individual life and health clearly outweighs any fiscal harm a state may suffer. Notwithstanding the fact that lifelong dietary management is an option for maple syrup urine disease sufferers, the United Network for Organ Sharing ranks children with classical symptoms as high-priority liver transplant candidates because of the neurological burden and risks of the disease.

— J. D. v. Sherman, 2006 U.S. Dist.LEXIS 78446 (U.S. District Court for the Western District of Missouri, Central Division 2006).

CHAPTER SUMMARY

Organ transplants date back to the late 1800s, although more recent scientific advances have made the process much more likely to be successful and have expanded the kinds of transplantations that can be accomplished, leading to a higher demand for transplantable organs across the board.

The demand for transplantable organs far exceeds the supply. Of the nearly 120,000 patients awaiting organ donations, approximately 70% are awaiting kidneys. This is leading the federal and state governments to consider incentivizing donations.

Patients wait an average of 5 years for a transplant, and every day 21 patients die waiting. Despite the fact that most Americans approve of organ donation, only about 25% expressly declare themselves donors.

The National Organ Transplantation Act makes it illegal to sell human organs and established the Organ Procurement and Transplantation Network, which administers the organ transplant process. However, other methods of allocating organs have appeared such as LifeSharers, paired-kidney swaps, and making use of lower quality donor organs.

Although the Organ Procurement and Transplantation Network makes the recipient patient selection process more fair and equitable through the establishment of standardized criteria, it has been criticized for not regulating transplant centers more closely in order to ensure they adhere to the regulations.

Organs are allocated based upon a point system that considers how long the patient has been on the list and the urgency of the patient’s medical status, as well as criteria matching an available organ to a patient on the list, such as blood types.

Organ donations come from those with written documentation prior to death of their wish to donate, or those whose family members consent to donation after death. Even when there is written documentation of a desire to donate, in some states family members may withdraw permission after death and prevent donation. In other states, donation will proceed as long as there is no known objection. New methods of procurement are under consideration, including presumed consent, opting out, and mandated choice.

Before organs can be removed from a body, the person must be declared dead—whether the death is cardiopulmonary death or brain death. This regulation excludes some potential donors such as anencephalic infants.

There are many ethical controversies over how organs are allocated, such as whether HIV-positive patients should receive organs, or whether patients who have not declared themselves donors should receive organs.

The Uniform Anatomical Gift Act prohibits the sale of human organs, but there are loopholes allowing practically everyone involved in the trade of human organs, except for the donors and their families, to profit. This has led to support for financial incentives for donation, as has the argument that financial incentives would increase the number of donors.

Those against financial incentives argue it demeans the human body and may exploit the poor to the advantage of the rich.

Demand for organs is so high that Americans have resorted to visiting other countries in order to receive transplanted organs, and sometimes organs transplanted from animals, because the wait time is too long in the United States.

Tissue transplants appear much less controversial than organ transplants and are treated entirely differently. The tissue industry is composed of for-profit tissue banks and is run according to basic market principles of supply and demand. Further, it appears to be more highly regulated by states and other organizations, as opposed to the federal government.

Xenotransplants are emerging as one possible solution to the shortage of human organs. However, much research must be done in order to ensure safety and effectiveness before it can become widely accepted or supported by the health insurance industry.

LAW NOTES

1. The data reported in this chapter were prepared by the Scientific Registry of Transplant Recipients, a national database of transplant statistics at the University of Michigan, unless otherwise stated. Data in the National Organ Donor Registry are collected by the Organ Procurement Transplantation Network from hospitals and organ procurement agencies across the country. The National Organ Donor Registry contains current and past information about the full continuum of transplant activity, from organ donation and waiting list candidates, to transplant recipients and survival statistics.

2. In a high-profile case, parents of an anencephalic newborn sought a Florida Supreme Court declaration stating their child was legally dead so they could donate its organs (See In re: T.A.C.P., 609 So.2d 588 (Supreme Court of Florida 1992)). The newborn had a fatal birth defect in which the child was born with only a brain stem but otherwise lacked a brain. In this case, the back of the skull was entirely missing. Anencephalic newborns can sometimes survive several days after birth because their brain stem has a limited capacity to maintain autonomic bodily functions such as breathing and heartbeat; this ability soon ceases, however, in the absence of regulation from the missing brain. The parents found out about the child’s condition during the mother’s eighth month of pregnancy, but on the advice of physicians expressly continued the pregnancy in the hopes they could donate the child’s organs and save the lives of other children. After the child’s birth, however, health care providers refused to declare the child dead for donation purposes out of fear they would incur civil or even criminal liability. The child died while court proceedings were ongoing, thereby preventing the donation of any organs, as child organs are too fragile to be sustained after cardiopulmonary death. The court denied the parents’ request to declare their newborn legally dead for several reasons:

It was uncertain whether anencephalic newborns could provide viable organs to be successfully transplanted to other children in need.

The medical community’s opinions on the ethical considerations were in flux.

The court was reluctant to possibly create further legal or constitutional issues without any consensus on the merits of using anencephalic newborns as organ donors.

3. Cord blood transplants are being used as an alternative to transplants of bone marrow to treat diseases such as:

Aplastic anemia, a serious blood disorder where the bone marrow does not make enough new blood cells and that leads to heart failure (E.g., Hosokawa et al., 2016)

Hurler syndrome, in which the body is missing an enzyme that builds bones and tissues and leads to organ and tissue damage with death by 5-10 years of age

Leukemia, which is cancer of the white blood cells

Thalassemia, in which the body makes an abnormal form of hemoglobin that leads to anemia and body shrinking (E.g., Amid et al., 2015; Goss et al., 2014)

4. Until recently, outright sales of human organs have remained a largely unpopular subject. However, the American Society of Transplant Surgeons is now in favor of studying incentives for living donors and the fastest growing source of transplantable organs is now living donors. The American Medical Association is also calling for pilot studies of incentives for organs (AMA, 2011).

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