Health Care Law and Policy Issues Surrounding the Allocation of Medical Resources and Organ Transplants for Individuals with Disabilities
Elyssa D. Durant, Ed.M. © Vanderbilt Law School 20017
Abstract
This paper will discuss the major historical efforts to legislate organ transplantation in the United States. In addition to discussing the problems found within the current system of voluntary donation, this paper will provide an overview of three alternative approaches: (1) changing the legal definition of death to include anencephalic infants as potential donors (2) commercialization, and (3) the presumed consent model of organ donation.
Introduction
Several years of lengthy and scholarly debate were taken into careful consideration before Congress drafted the first version of the Uniform Anatomical Gift Act in 1968 (UAGA). Despite this extraordinary undertaking, the new legislation failed to live up to its expectations.[1] "The UAGA (1968) made a variety of advances in the law of organ donation, standardizing the process and removing some uncertainties about the scope of permissible donations," (Jaffe, 1990).
The UAGA failed in its mission to develop and implement standardized procedures involved of organ procurement and donation.[2] Problems with ineffective implementation of the Uniform Anatomical Gift Act undermined the intended purpose of the legislation, and it has been difficult to regulate compliance with the procedures set forth by the UAGA. Ultimately, the legislation did not have any noticeable effect on the supply of transplantable organs, and policy makers continue to look for a solution to the severe shortage of organs in the United States.
The Problem Statement
The United States is in the midst of a severe shortage of transplantable organs. Over the last several years, medical technology has advanced rapidly enough to make organ transplants a "standard" procedure. The medical community has been unable to meet the demands of the growing list of individuals who would benefit from transplantation.
New immunosuppressive therapies, e.g., cyclosporine, vastly improved the survival rate for transplant patients, making organ transplantation a relatively safe medical procedure. Since transplant surgery has achieved such remarkable success, a growing number of patients and physicians feel transplant surgery would be the preferred medical treatment. As a result, the number of people waiting for a suitable organ to become available has grown exponentially. There are currently over 55,000 people registered with the United Network of Organ Sharing (UNOS) waiting for a human organ to become available.[3] The number of people on the waiting list is expected to increase steadily as the baby boom generation ages, but only a small percentage will be fortunate enough to benefit from the recent advances made in the field of organ and tissue transplantation.
The greatest challenge facing the transplant community is the lack of available organs. Until we find a way to increase the number of voluntary organ donors, 10 patients will die each day waiting for an organ to become available in the United States.
Scarcity of Medical Resources
It is difficult to justify and understand the cause of the American organ shortage. Enough healthy organs become available each day to meet the needs of the medical community, yet only a fraction of those will be donated for medical purposes. The number of organ and tissue donors has not kept pace with the number of patients who could benefit from their healthy organs. According to Carol Beasley, managing director of the Partnership for Organ Donation in Boston, the number of people waiting for organs jumped 300% between 1988 and 1995.[4] The number of donors increased by only 30% over the same time period.[5]
Under the current system of voluntary donation, the medical community only recovers a fraction of the human tissue and organs suitable for transplant. Legislative efforts to alleviate the shortage by removing the obstacles which hinder organ recovery have failed. In 1996, almost 4,000 people died waiting for an organ to become available for transplant.[6]
Because the demand for organs far exceeds the supply, policy makers, legal scholars, and the medical community have debated over the best way to increase the supply of scarce medical resources without jeopardizing the rights of potential donors and their families.
Allocating Scarce Medical Resources
Because of the severe shortage in transplantable organs, much of the public policy efforts in this area have focused on setting standard procedures to ensure equitable distribution. Concerns over the fair allocation of organs prompted the American Medical Association to publish a committee report outlining the medical criteria involved in the identification process for potential donors and recipients.
The issue of genetic compatibility has also raised questions regarding the proper distribution of organs among minority populations. These individuals are much more likely to receive organ transplants from their own community. This certainly seems fair in light of the violence and social conditions in which they live. Veatch (1989) discusses the distinction between social worth and social judgment that is often subjective.
Medical criteria used to allocate organs contain elements of social worth and moral judgment (Veatch, 1989). For example, should we consider AIDS patients as potential candidates for transplantation? How long must an alcoholic be sober before they are eligible for a new liver? This seems like a reasonable question, but it certainly raises questions about social worth. There is a fine line between social behavior and social worth.
The allocation of scarce medical resources is neither unique nor uncommon among medical and legal professionals. A few highly publicized transplant cases helped bring the issue of allocation to the forefront of American consciousness. The American public began to question the fairness of the methods used to match donors with recipients when Governor Casey was moved to the top of the waiting list for a transplant in 1994. One year later, Mickey Mantle was hospitalized, and the public began to speculate on the objectivity of the medical criteria used by transplant centers. Mickey Mantle received a liver transplant 48 hours after being placed on the waiting list.
Press coverage helped bring the issue to the front burner and there was a sudden surge in the number of organs donated by the public. But these highly publicized cases also raised questions about the methods used in the allocation of donor organs. Americans became skeptical of the current system and questioned the ethical basis of the criteria used by UNOS in the allocation of organs. Some felt that Mantle who had been an active alcoholic for most of his life did not deserve a new liver.
Unlike most medical conditions, individuals needing liver transplants are often viewed as responsible for their poor health. Some people believe that alcoholics should not be given equal consideration for medical treatment compared to other (non-alcoholic) patients needing liver transplants. Although UNOS maintains a position that drug and alcohol abuse are not taken into consideration in the allocation process, alcoholics are frequently ruled out because of additional health risks associated with alcoholism and the alcoholic lifestyle. "The patient's style of living might be taken into account, so that an active alcoholic in kidney failure might be excluded on the grounds he has a poor life expectancy even if his new kidneys do not fail."[7]
The medical community has adopted a set of standard criteria used to evaluate and identify potential recipients for available organs. The agreed upon medical standard is based strictly on medical criteria, and the transplant community has publicly denounced measures of social worth or utility in the identification of suitable candidates.
Since organs are considered such a rare and precious resource among the medical community, most transplant centers require patients to undergo a lengthy evaluation before being considered a potential transplant candidate. Preoperative evaluations are used to evaluate the patient's likelihood of survival. A closer look into this process reveals the subjective nature of the evaluation, which appears to contain a number of quality of life questions and measures. Candidates may be disqualified for transplant surgery based upon quality of life measures, which tend to be socially biased. Patients who have sufficient monetary resources and social support networks are preferred to patients who are socially isolated or unmarried.
"The subjectivity of the medical criterion becomes even more blatant when quality of life is taken into account. Sometimes quality of life has become a code word for nonmedical considerations. A wealthy intellectual might be said to have a better quality of life than a mechanic. Even if quality of life is limited to these more narrow medical considerations, inevitably subjective judgments must be made."[8]
The subjective nature of the criterion used to evaluate quality of life could potentially be used as a proxy for social worth.[9]
The Quality of Life Index evaluates the following:[10]
1. Health and functioning
2. Socioeconomics
3. Psychological well-being
4. Family life
Quality of life measures are considered valid indicators of surgical success, but they clearly contain some measure of social judgment. This provides a good illustration of the complex interaction between medical and social criteria used to evaluate potential transplant candidates. "Even assuming that benefits are limited to "the medical" and that these benefits that are taken as the criterion, the problem of subjectivity is not eliminated."[11]
The evaluation process is inherently subjective, and it is not always possible to distinguish medical criteria from social judgement. Even the act of assigning objective medical criterion contains subjective interpretations. "In principle, medical facts alone cannot determine which of these candidates medically benefits more by a transplant. 'Medical benefit' is inherently a subjective notion that will require value judgments by the one allocating the organ."[12]
Allocation disputes are not uncommon, and external agencies are sometimes asked to intervene. The medical community is in general agreement regarding the criteria used in the allocation of organs, but the actual methods used is unique to each transplant center.[13] Regional review committees were recently established in order to monitor consistency at the national level.[14]
The standard medical criteria used to identify the best recipient includes:[15]
1. Geographic weighting
2. Medical urgency
3. Organ Compatibility
4. Waiting time
Until we can significantly increase the supply of voluntary organ and tissue donors, we are doomed to debate the most equitable method of distribution, and the public will continue to look to the government to regulate the evolving organ industry. Despite the fact that the American public claims to support more active procurement procedures, there is an overwhelming apathy among the general population to take active steps in the event of death.[16]
The Uniform Anatomical Gift Act of 1968
Shortly after the first human heart transplant was performed in 1967, Congress began to think about the potential benefits of anatomical gifts. After much deliberation, Congress passed the first version of the Uniform Anatomical Gift Act in 1968 (Veatch, 1989). The UAGA was intended to increase public awareness of organ transplantation and to stress the need for people to sign organ donor cards. The UAGA also granted immunity to any physician acting in compliance with the UAGA.
The UAGA passed in 1968 represents the government's first, but not last attempt to increase the organ supply through federal legislation. By recognizing the medical utility of anatomical gifts and organs, the medical community successfully convinced Congress to assist them in the recovery of human organs and tissues for medical research and transplant procedures. Unfortunately, the 1968 legislation had virtually no impact on the supply of organs in the United States, so they took a different approach and passed the National Organ Transplant Act in 1984.
The National Organ Transplant Act of 1984
The National Organ Transplant Act of 1984 (Pub. L. 98-507) provided federal funds to organ procurement agencies, created a national organ-sharing network, and explicitly prohibited the sale or purchase of human organs.[17]
The National organ Transplant Act (NOTA) included specific guidelines for the establishment of a national network to oversee organ procurement centers and provided them with federal funding. The legislation created the National Organ Procurement and Transplantation Network (OPTN), which was established to maintain a national database and waiting list for the 69 organ centers in the United States. The United Network for Organ Sharing (UNOS) is under contract with the federal government to carry out the duties as the designated OPTN.[18]
The purpose of OPTN was to monitor and assess the activity of three main components involved with organ donation and transplantation. In addition, OPTN collects and maintains statistical data for (1) transplant centers, (2) organ procurement organizations, and (3) hospital participation.[19] Federal law requires the OPTN to submit all allocation policies for review by the Secretary of the Department of Health and Human Services.
Second, the National Organ Transplant Act of 1984 created a federally funded Task Force to conduct a detailed investigation into the current system of donation. The Task Force was to identify the major problems encountered by organ procurement agencies, and recommend ways to improve the current system.
Findings of the Task Force on Organ Transplantation
Congress created a Task Force on Organ Transplantation to conduct a detailed investigation into the current problems associated with organ procurement and transplantation. In 1986, the Task Force reported their findings in "Organ Transplantation: Issues and Recommendations." The 1986 publication identified problems in the current system of voluntary donation. The Task Force reported on the medical, legal, social, ethical and economic components of organ procurement and transplantation.[20] They concluded that the problem lies within the lack of altruistic donors and suggested appealing to a public sense of community and social responsibility.[21]
Required Request Laws
Required Request laws mark the last serious attempt by the federal government to improve organ donation laws in this country. 1986 federal legislation mandating "Routine Inquiry" of potential organ donors was required in all hospitals receiving Medicare or Medicaid funds. Earlier legislation allowed for the removal of organs in persons over the age of 18 if they had signed an organ donor card. Medical professionals rarely remove organs without consent from a family member. Although federal law protects individuals acting in good faith, obtaining consent from the next of kin has proven to be a major obstacle in voluntary donation. Medical personnel are reluctant to discuss the need for organs upon an individual's death.[22]
It has been suggested that this is a reflection of their personal discomfort with the issue of death and dying[23]. Perhaps they fear being seen as callous or disrespectful of the recently deceased. Fentiman offers several possible explanations including, "a lack of education or cultural sensitivity on the part of health care workers, a concern about the appearance of overreaching a bereaved family, fear of legal liability, and the health care professional's own discomfort with death." The same logic has been used to explain why a number of willing donors had not signed a donor card or notified their next of kin. Fentiman (1993) attributes this to a psychological inability to confront ones own death, and this helps to explain the absence of signed donor cards among patients who claim to support voluntary donation.
The Hastings Center Report
A few years later after passing NOTA, the Hastings Center issued a report describing obstacles found within the system of voluntary organ donation. The Hastings Center Report (1986) concluded in order to develop a more effective donation system, each of the following problems must be addressed:
The key problems that hinder organ donation include:
1. Failure of persons to sign written directives.
2. Failure of police and emergency personnel to locate written directives at accident sites.
3. Uncertainty on part of the public about circumstances and timing of organ recovery.
4. Failure on the part of medical personnel to recover organs on the basis of organ recovery.
5. Failure to systematically approach family members concerning donation.
6. Inefficiency on the part of organ procurement agencies in obtaining referrals of donors.
7. High wastage rates on the part of some organ procurement agencies in failing to place donated organs.
8. Failure to communicate the pronouncement of death to the next of kin.
9. Failure to obtain adequate informed consent from family members.
More than a decade has passed since these issues were first identified, and a number of states, including Tennessee, have implemented their own versions of the Uniform Anatomical Gift Act.[24] Regardless of this repeated effort, legislation has not helped to increase the number of organs available to the medical community. The problems enumerated by the Task Force and again in the Hastings Center Report have not improved since they were first identified in 1986.
Although the medical, academic, and legal communities have fragmented opinions regarding the best approach to the scarcity problem, they are all in agreement regarding the fundamental issue of allocation: the problem of allocation and donation is inextricably intertwined. If more Americans became voluntary donors, the medical community could recover a greater percentage of available organs for transplant. In turn, we would no longer need to debate and inquire about the equitable distribution of organs since there would be enough organs to supply each of the 40,000 Americans who are currently on the waiting list.
Recently, there has been a strong national movement to create a national database without giving preferential treatment certain regions of the country. Should scarce resources be distributed to the victim's community before becoming available to the general population or distant transplant centers?
Despite numerous attempts to address these problems, they remain unresolved under current law. Neither version of the Uniform Anatomical Gift Act, (1968; 1987) nor the National Organ Transplant Act of 1984 (NOTA) had any substantial effect on the severe organ shortage in the United States. Thousands of individuals will die each year while waiting for an organ to become available unless we can agree upon an alternative solution to the crisis at hand.
Commercialization
A popular policy alternative to the current system of altruistic voluntary donation is a commercialized system of organ donation. It is believed that providing financial incentives for voluntary compliance would encourage people to take the initiative to become organ donors.
Under current law, it is illegal to buy or sell human organs, leaving altruistic donation as the only hope for people currently waiting for an organ to become available. The commercial sale of human tissues is a direct violation of the National Organ Transplant Act of 1984.[25] NOTA of 1984,[26] makes it "unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce."[27] This is punishable under criminal law and carries a prison term as well as a $50,000 fine.[28]
Arguments in favor of a commercialized system point out that everyone profits in the organ procurement industry except for the patient (Fentiman, 1990; Banks, 1995). Banks (1995) suggests that by allowing the commercial sale of transplantable organs, a significant number of people would opt into the system. A number of countries including Japan, currently allow the sale of human organs, but a report by the UNOS Ethics Committee expressed concern about the slippery slope problem which may result in the sale of human organs on the black market.[29] In addition, the committee was concerned that some people may actually be less inclined to donate if financial incentives were offered since it would minimize the benefits of altruistic donation.[30] Some individuals may object to the idea of commercialization simply because they believe anatomical gifts should be altruistically motivated. Alternative methods of compensation, such as provisions for a decent burial may be one option since it appears to maintain the integrity of anatomical gifts.
UNOS recommended a regional trial of commercialization since the ultimate effect on the number of donations is unknown.[31] If commercialization turns out to be an effective solution to the profound shortage of transplantable organs, Congress would have to amend current law and establish regulatory guidelines to prevent abuse in the system. Additional regulations would be needed to protect vulnerable populations from exploitation in a commercialized system of organ transplantation and donation.
One convincing argument is the obvious financial compensation provided for the surgeons and transplant centers. In some regards, it only seems fair that the donor receives some financial compensation for his or her participation, offering a system which benefits a third party, e.g., a charity or grandchild who might receive a voucher for college tuition, seems acceptable to most people.
If the United States were to switch to a commercialized system, more people may begin to doubt the fairness involved in allocating organs. Additional findings by the Gallup Organization revealed that only 12% of the survey respondents reported they would be more likely to donate their organs under a commercialized system.[32]
This may be due, in part, to a ceiling effect since such a large percentage of respondents indicate they are willing to donate their organs at the time of death. Survey respondents also reported being concerned with the effect the sale of organs might have on the length and/or quality of treatment they received in the event of a traumatic injury. They were fearful that medical professionals might discontinue medical treatment in order to begin harvesting organs.[33]
Those opposed to the market system feel that certain segments of the population are especially vulnerable to exploitation in a commercialized system.[34] Deutsh (1997) describes problems specific to Medicaid populations, and it seems probable that some segments of the population would feel threatened by such a system. Vulnerable populations already experience disparate treatment under the current system, and it is reasonable to expect poor or disabled individuals would suffer disproportionately in a commercialized system. A recent survey of attitudes regarding organ donation and transplantation revealed that respondents felt wealthy individuals are more likely to receive an organ transplant.[35]
Presumed Consent
The second proposal has considerable support from a large segment of the academic community. This is based upon the fundamental belief that human organs are a community resource, and should be treated as community property at the time of death. This basic assumption is critical to understanding and accepting a model of presumed consent.
Jesse Dukeminier, a lawyer, and David Sanders, a physician, first proposed a system of presumed consent in 1968 (Veatch, 1989). Dukeminier and Sanders adopted four basic principles as the foundation for their model of presumed consent:[36]
1. Making removal of useful cadaver organs routine.
2. Removing organs in a way that does not burden the bereaved.
3. Honoring objection by the "donor" made during his lifetime but also honoring his express wishes even if next of kin objects.
4. If donor neither objects nor expressly assents, honoring kin's objection to organ removal.
For this reason, many legal and medical scholars have proposed federal legislation based upon the notion of presumed consent (Dukeminier & Sanders, 1968; Fentiman, 1990). The presumed consent model views organs as community property and assumes that everyone is an organ donor unless they have opted out of the system.
The proposed model of presumed consent recognizes the need to protect individuals who do not wish to donate their organs. These people would be given ample opportunity to opt out of the system. Everyone opting out of the system would be kept on file in a national database which must be checked prior to the removal of any organs from potential donors. Fentiman suggests the following as opportunities for people to opt out of the presumed consent system.[37]
1. When obtaining or renewing a driver's license.
2. On filing an income tax return.
3. When applying for welfare disability or other governmental benefits.
4. On every visit to a hospital or doctor's office.
5. When a health care provider explicitly requests a patient to consider donating her organs.
6. When executing a living will or health care proxy.
Legislation supporting the presumed consent model would reduce awkward discussion between medical professionals and the families of the deceased since next of kin would not be notified prior to organ procurement.[38]
Since the majority of Americans claim to support the concept of organ and tissue donation, the presumed consent model of organ donation could help bridge the gap between what Americans say and what Americans do. The lack of initiative taken by those who support voluntary organ donation appears to represent their apathy more than their indecision. It can be argued that presumed consent legislation would compensate for the difference between public opinion and public behavior.
The Uniform Determination of Death Act
In 1984, Baby Fae received the first xenograft (interspecies) heart transplant from a baboon, demonstrating the desperate need for neonatal organs for infants and children, (Veatch, 1989). This exemplifies the severe shortage of pediatric organs needed in the United States. Approximately 300 infants are born in this country each year with a severe congenital birth defect known as anencephaly. Anencephalic infants rarely live for more than a couple of days, and most will die within 24 hours after birth.[39]
Anencephaly is a congenital neural tube birth defect. An anencephalic infant is born without a fully functioning brain. Because their brain stem is intact, they are not considered to be clinically or legally brain dead. These infants have a very short life span, but due to biochemical medical degeneration, their organs decompose and become inadequate for medical transplantation. There is no cure or treatment for anencephaly.
Despite the absence of a normally developed and functioning brain, anencephalic infants are born with the rest of their vital organs intact. Due to the rapid deterioration of the child's condition, their organs and tissues are no longer viable for transplantation.[40] This is due to the inevitable onset of cardiopulmonary arrest in anencephalic infants.[41]
The severe shortage of pediatric organ donors has caused medical professionals to consider the use of anencephalic infants as potential donors. The severity of the crisis has led biomedical researchers to push the boundaries of ethical experimentation, as in the case of Baby Fae. Medical professionals have made several appeals to amend the Uniform Determination of Death Act and the National Organ Transplant Act so anencephalic infants can be considered potential organ donors for pediatric populations.
Many experts have suggested that we need to expand our current definition of brain death so anencephalic infants can become donors.[42] Anencephaly is clinically defined as, "markedly defective development of the brain, together with the absence of the bones of the cranial vault in the cerebral and cerebellar hemispheres, and with only a rudimentary brain stem and some traces of basal ganglia present."[43] In response to the unique problem of finding healthy organs for pediatric populations, medical researchers and policy makers have proposed legislation a change in the definition of brain death to include anencephalic infants.[44]
The clinical definition of brain death is, "in the presence of cardiac activity, the permanent loss of cerebral function, manifested clinically by the absence of purposive responsiveness to external stimuli, by absence of cephalic reflexes, by apnea when the patient is disconnected from a respirator, and by an isolectric electroencephalogram (EEG) for at least 30 minutes."[45]
The legal definition of death as defined by the Uniform Determination of Death Act is marked by (1) the irreversible cessation of circulatory and respiratory function or (2) the irreversible cessation of all brain functions.[46] Since anencephalic infants maintain limited brain stem activity during their short lives, they do not satisfy current legal or medical definitions of brain death. The National Organ Transplant Act prohibits the removal of any organs prior to the pronouncement of death. Since anencephalic infants can not be pronounced dead under the current definition, the act of removing organs would be the cause of death.
California courts have already been faced with the controversy surrounding the Constitutional rights of anencephalic infants and found that anencephalic infants do not meet the philosophical definition of a person.[47] As such, they are not entitled to equal protection under the law.[48]
Public Opinion v. Private Action
A 1985 Gallup Poll revealed that 75% of the American population approved of the concept of organ donation, yet, only 17% had completed organ donor cards. Less than half of willing donors had informed their next of kin of their intention to donate their organs and tissues at the time of their death.[49]
The severity of the organ shortage has commanded the attention of the general public on more than one occasion. Public health efforts intended to educate the public have not increased the number of voluntary donors.
Attempts to educate the public in order to increase the number of donors have failed miserably. Since public health efforts have been ineffective, special interest groups have requested government intervention to regulate the organ industry. Policy interventions have been aimed at both the general public and the medical community.
Conclusion
Future attempts to regulate public policy concerning organ donation and transplantation should reflect upon the failures of previous legislative efforts. Judging by the apparent failure of the Uniform Anatomical Gift Act of 1968, and the National Organ Transplant Act of 1984, future legislation should focus on alternatives rather than extending or modifying what we already have.
State courts have been left to preside over disputes related to equitable distribution and Medicaid payments. The Department of Health and Human Services (HHS) is responsible for enforcing federal guidelines and legislation, and Congress recently heard testimony regarding the regional imbalance in the allocation of organs. Recent debate has focused on the fairness of the regional system, which apparently gives preference to recipients living in highly populated locations.
We should be responsive to the unique problems facing pediatric populations, and public policy should be flexible for the benefit of the greater good. Applicable policies should be evaluated and regulated independent of adult populations. After thirty years of ineffective legislation and irresponsible public behavior, perhaps it is time to look for new solutions to the same old problems.
References
Banks, G. J. (1995). Legal and ethical safeguards: Protection of societies' most vulnerable participants in a commercialized organ transplant system. American Journal of Law and Medicine, 21 (45).
Botkin, J. R. (1988). Anencephalic infants as organ donors. Pediatrics, 82, 250-256.
Bureau of National Affairs Special Report (1997). Organ transplants: Policy issues of donation, allocation inextricably intertwined, experts say. BNA's Health Care Policy Report: Special Report, July 14, 1997.
Council on Ethical and Judicial Affairs, American Medical Association. Ethical considerations in the allocation of organs and other scarce medical resources among patients. [Special Article] Archives of Internal Medicine, 155 (1), 22-40.
Deutsch, L. B. (1997). Medicaid payment for organ transplants: The extent of mandated coverage. Columbia Journal of Law and Social Problems, 30, 185. Winter 1997.
Edward W.N.; Childress, J. E.; Perryman, J.; Robards, V.; Rowan, A.; Seely, M.S.; Sterioff, S.; Swanson, M. R. (June 30, 1993). Financial Incentives for Organ Donation: A Report of the UNOS Ethics Committee Payment Subcommittee.
Fentiman, L.C. (1993). Organ donation as a national service: A proposed federal organ donation law. Suffolk University Law Review, 1593, Winter 1997.
Ferrans, C.E., Powers, M.J. (1992). Psychometric assessment of the Quality of Life Index. Res Nurs Health, (15), 29-38.
Friedman, J. A. (1990). Taking the camel by the nose: The anencephalic as a source for pediatric organ transplants. Columbia University Law Review, May 1990.
The Gallup Organization, Inc., "The American Public's Attitudes Toward Organ Donation and Transplantation," conducted for The Partnership for Organ Donation, Boston, MA, February, 1993.
Jaffe, E. S. (1990). She's got Bette Davis['s] eyes: Assessing the nonconsensual removal of cadaver organs under the takings of the due process clause. Columbia Law Review, March 1990.
Historical Notes on the Uniform Anatomical Gift Act (1987): References and annotations. Uniform Laws Annotated.
Kolata, G. (1997). Controversy erupts over organ removals. The New York Times [Online]. Available: http://www.nytimes.com/yr/mo/day/news/national/organ-donor-dispute.html
Koop, C. E. (1983). Increasing the supply of solid organs for transplantation. Public Health Report 1983; 98: 566-572.
Randels, G. (1993). Finding the mean: Liver transplantation for alcoholics. Biolaw, 254-260.
Veatch, R. M. (1989). Death and dying and the biological revolution, 197-223.
[1] Dukeminier as cited in Jaffe, 1990.
[2] Jaffe, 1990.
[3] UNOS Fact Sheet; October 29, 1997.
[4] Carol Beasley, Partnership for Organ Donation, as cited in BNA's Health Care Policy Report, July 14, 1997.
[5]Id.
[6] James Burdick, as cited in BNA's Health Care Policy Report, July 14, 1997.
[7] Veatch, 1989, p.207.
[8]Id.
[9] Ferrans, C.E. & Powers, M.J. (1992). Psychometric assessment of the Quality of Life Index. Res Nurs Health, 1992; 15: 29-38.
[10]Id.
[11] Veatch, 1989, p.207.
[12]Id.
[13] Historical Notes on the Uniform Anatomical Gift Act, 1987: References and Annotations.
[14]Id.
[15]Id.
[16] Report of the Task Force on Organ Transplantation pursuant to the 1984 National Organ Transplant Act--P.L. 98-507-- "Organ Transplantation: Issues and Recommendations" (April 1986).
[17] Historical Notes on the Uniform Anatomical Gift Act, 1987: References and Annotations.
[18] UNOS Statement of Principles and Objectives of Equitable Organ Allocation, UNOS, 1997.
[19] Fact Sheet, prepared by Tennessee Donor Services, 1997.
[20] The National Attorney's Committee for Transplant Awareness, (1995). Organ tissue and transplantation: A legal perspective.
[21]Id.
[22] 42 U.S.C. § 1320b-8 (1988). "Routine Inquiry" requires all hospitals receiving federal funds through Medicare or Medicaid to establish protocols pursuant to which all families of dead or dying patients will be asked to consider donating the organs of their loved one.
[23] Fentiman, 1990.
[24] Uniform Anatomical Gift Act
[25] National Organ Transplant Act of 1984 (P.L. 98-507); 42 U.S.C.A. § 274 (e) (West 1995).
[26] National Organ Transplant Act § 274
[27]Id. The federal law as amended in 1988, subsec. (c)(1) of Pub.L. No. 100-607 defines "human organ" as the "human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other organ (or any subpart thereof, including that derived of a fetus) specified by the secretary of Health and Human Services by regulation." Id. at § 27274e.(c)(1). As cited in Banks (1995).
[28] 42 U.S.C.A. §274e (b).
[29]Nelson, et. al (1993). Financial Incentives for Organ Donation: A Report of the UNOS Ethics Committee Payment Subcommittee.
[30]Id.
[31]Id.
[32]The Gallup Organization, Inc., "The American Public's Attitudes Toward Organ Donation and Transplantation," conducted for The Partnership for Organ Donation, Boston, MA, February, 1993.
[33]Id.
[34] Banks, 1995; Deutsch, 1997; Jaffe, 1990.
[35] The Gallup Organization, Inc., "The American Public's Attitudes Toward Organ Donation and Transplantation," conducted for The Partnership for Organ Donation, Boston, MA, February, 1993.
[36] Dukeminier & Sanders, 1968, as cited in Veatch , 1989.
[37] Fentiman, L.C. (1993). Organ donation as a national service: A proposed federal organ donation law. Suffolk University Law Review, 1593. Winter 1997.
[38] Fentiman, 1990.
[39]Id.
[40] Botkin, 1988.
[41]Id.
[42] Anencephaly is a congenital neural tube birth defect. An anencephalic infant is born without a fully functioning brain. Because their brain stem is intact, they are not considered to be clinically and legally brain dead. These infants have a very short life span, but due to biochemical medical degeneration, their organs decompose and become inadequate for medical transplantation to healthier neonates and pediatric patients.
[43] Basal ganglia are the large masses of gray matter at the base of the cerebral hemisphere; currently, the corpus striatum (caudate and lentiform nuclei) and cell groups associated with corpus striatum (Steadman's Medical Dictionary, 1994).
[44] Koop, 1988; Fentiman, 1990; Friedman, 1990.
[45] EEG reading in the absence of hypothermia and poisoning by central nervous system depressants (Steadman's Medical Dictionary, 1994).
[46] Capron, A.M. (1987). Anencephalic donors: Separate the dead from the dying. Hastings Center Report 17:5-9.
[47] Friedman, 1990.
[48] Referring to due process protections under the Fourteenth Amendment of the United States Constitution.
[49] Historical Notes on the Uniform Anatomical Gift Act, 1987: References and Annotations.
Published by Elyssa Durant
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Underwriting the Social Contract: Distributive Justice & Health Care Reform
The Problem Statement
As health care costs climbed exponentially in the 1980's, so did the cost of health insurance plans. As a result, employers began to enroll their employees in managed care organizations, and many Americans were forced to leave their traditional indemnity type plans. With the advent of the health maintenance organization, there is a financial incentive for the underutilization of care. (Blumstein, 1996; Davis & Shoen, 1996).
In order to reduce financial risk, health insurance companies have restricted enrollment to individuals in poor health. By covering the minimal standards of treatment and excluding high risk groups altogether, major US insurance companies have realized that the health insurance market can a be an extremely profitable industry.
The public sector absorbs the cost of unreimbursed care for chronic care in America (Robert Wood Johnson Foundation, 1996). Based upon these findings, it seems clear that the money being removed from the health care marketplace is fattening the pockets of CEOs and majority stockholders.
Recent trend towards localized government leaves individuals without a financial safety net. This is the least efficient manner to handle health care costs, and evades the premise that medical care is a natural right in a civilized society. Few Americans feel secure within the current system. The rising costs of medical care contributed to the recent market changes in both the administration and delivery of health services. The financial incentive to cover only the healthiest individuals ignores the fact that medical care is a social good.
Health Insurance Portability Act of 1996
Two years after the Clinton Health Plan was defeated in Congress, Senator Ted Kennedy and Nancy
Kassebaum introduced the Kennedy-Kassebaum Bill in response to growing concerns about selective enrollment procedures used by health insurance companies in the private sector. In the final version of the Bill, insurance companies must limit preexisting condition clauses to twelve months. It has been estimated that this provision of the Bill will help an estimated 150,000 Americans obtain health insurance coverage.
There are many levels of the underinsured, including those without any coverage; effective policy must address the needs of the total population without shifting costs from one disadvantaged person to another. Kennedy-Kassebaum fails to address the cost issue-the primary concern for those at risk for losing their health insurance. It does nothing to help the uninsured acquire a decent health policy, and then provides no solution to the critical issue at hand- cost
Since Kennedy-Kassebaum does nothing to control the cost of health insurance and medical care in America, the Bill fails to respond to the issue of greatest concern to the citizens of this country: the cost of medical care. The Bill looks towards the states to develop consumer protections and weakens the regulatory role of the federal government. The majority of the American public is unaware of the fancy footwork involved with this legislation, and the demographics of the population it is intended to protect. In order to assess the utility of this Bill, it is critical to identify the populations at risk for loosing health insurance coverage and the underinsured.
Kassebaum-Kennedy focuses on a slim portion of the uninsured population, and those who would be eligible for COBRA continuation (Consolidated Omnibus Reconciliation Act of 1974). Of the 41 million uninsured Americans, only about 150,000 are expected to benefit from this legislation. The Health Insurance Portability and Accountability Act of 1996 is really nothing more than smoke and mirrors since it fails to address the true issue at hand-the simple fact that the cost of quality health care in America is becoming a privilege that only the wealthy can afford.
The Cost of Care for Pre-existing Conditions
An individual with high blood pressure may just require prescription medication. Cancer patients in remission may require chemotherapy, and a person suffering with a degenerative disease may be involved in treatment studies. Each condition requires individualized treatment that cannot be based upon the simple economic/cost-benefit analysis used in the utilization review process by large insurance companies. Clearly, the most effective treatment for one patient may not be the best for another. The time required for utilization review may present additional health risks and complications to a patient suffering from a chronic health condition.
Twelve months without insurance coverage may be financially devastating to some patients, and 63% of Americans have already forgone some type of medical treatment within the last year due to financial constraints. Publicity surrounding Kennedy-Kassebaum has hailed the bill as the "be all and end all in progressive legislation, however, in actuality it will only help about 150,000 people.
Recent studies have found that the majority of the uninsured population simply cannot afford to pay the premiums (Donelan et. al., 1996; Hoffman & Rice, 1996). According to their data, only 1% of the Uninsured population is due to current health status and exclusionary preexisting clauses, yet an overwhelming number of insured respondents reported an inability to receive medical care for chronic conditions. The majority of Americans with chronic illness are covered by some type of insurance, yet they are still subject to the utilization review process and access problems that deny or delay medically necessary treatment (Donelan, et. al., Hoffman & Rice, 1996).
Underwriting the Solidarity Principle
Traditional forms of insurance underwriting required that the contract explicitly state which illness or services are not covered by the policy, in advance. If the underwriter did not specifically state a certain condition in the contract, the insurer was held to the terms of the contract and required to pay for services utilized by the policyholder (Stone, 1994, as cited in Durant, 1996).
Increasing numbers of for-profit and non-profit insurance companies began to control costs by refusing to insure individuals who they felt would utilize more services. Insurers began to require health survey status questionnaires (refer to attachment A), and even began implementing AIDS and genetic testing to identify high-risk individuals (Brunetta, as cited in Gutmann & Thompson, 1996). In the 1980s, large insurance companies began including sexual orientation as a high-risk category, by using actuarial sound criteria. Such criteria concluded that gay men were a higher risk for contracting AIDS virus and refused to write policies for anyone believed to be homosexual, (Stone, 1994 as cited in Durant, 1996).
By limiting enrollment to the healthiest members of society, selective enrollment undermines the solidarity principle of health insurance (Davis & Shoen, 1996; Snow, 1996; Stone, 1994). By eliminating those who were suspect of using more services than their healthier counterparts use, insurance companies are able to offer rock bottom prices for young, healthy individuals. By excluding preexisting conditions and requiring certain individuals to purchase high-risk policies, the number of uninsured and underinsured Americans continues to grow exponentially (Durant, 1996).
More individuals are choosing not to purchase insurance simply because they cannot afford it. Even among those with employer based health coverage, the policies frequently exclude coverage for long-term illness or care of chronic conditions (MSNBC News Forum, 1996). Without a standard definition of preexisting conditions, these clauses serve as "wildcards" since they allow insurers to deny coverage for any illness that "manifested itself before the issuing date of the policy (Stone, 1994 as cited in Durant, 1996).
This statement allows insurers to deny treatment for benefits and services for the policyholder for undiagnosed illnesses or conditions of which they were unaware. As a result, the insurers began to demand medical histories of applicants and their families in order to identify high risk individuals (please refer to attachment A).
Legitimacy of Distributive Justice
While there is a legitimate role of government to distribute scarce resources among the nation's neediest individuals, sadly this is not the cause for the mismanagement of medical dollars in the United States today.
There is a big distinction between an individual being denied prescription medication at their local pharmacy due to a cost-effective formulary developed by their Managed Care Organizations (MCOs), than an individual being denied a liver transplant because healthy livers are a scarce resource. While both may have equally devastating consequences, it is more difficult to rationalize a lost life based upon rigid cost benefit analysis and utilization decisions made according to formulas and cost-benefit analysis of treatment protocols.
"The political controversy over the distribution of health care in the United States is an instructive problem in distributive justice. Good health is care is necessary for pursuing most other things in life. Yet equal access to health care would require the government to not only redistribute resources from the rich, healthy to the poor, and infirm, but also restrict the freedom of doctors and other health care providers. Such redistributions may be warranted, but to what level, and to what extent?" Gutmann & Thompson (Page 178).
Blendon and his colleagues have reported similar findings in public opinion polls from 1992 and 1994 (Blendon et. al., 1992; Blendon et. al., 1994). A recent study by the American Medical Association found cost to be of paramount concern to an overwhelming number of Americans (Donelan et. aI., 1996). Of the 40 million uninsured Americans, only 1% attributes their failure to acquire health insurance coverage to their preexisting conditions. Among the uninsured, cost is cited as the primary obstacle in obtaining health insurance coverage. Only 1% of the uninsured attributes their lack of coverage to a preexisting condition.
Based upon these democratic principles of distributive justice, consistent opinion polls demonstrate the legitimate role and public desire for government regulation of the health care industry. It has become obvious that the federal government must intervene in order to protect natural law rights, the social contract, and the Constitution of the United States. Regulation is needed to protect the individual freedoms, liberty, and the pursuit of "health, happiness, and the American Dream."
If America is to be the "Land of Opportunity," then clearly individual health and wellness should be an ideal to reach for. Current models of distributive justice emphasize public consensus as a legitimate role for government intervention. According to a number of studies by Blendon and his colleagues, the public has reported an overwhelming general concern about health care in this country, (1992, 1993, 1994, 1995, 1996).
State civil courts are backed up with cases where HMOs have violated the First Amendment (gag orders), the Fourteenth Amendment (due process), and the rights of protected classes under the Americans with Disabilities Act. Countless examples of "anecdotal" evidence appear as headlines everyday across the country. (New York Times, 1996; The New York Daily News, 1996; Long Island Newsday, 1996; LA Times, 1996; Picayne Times, 1996; Columbia Spectator, 1996; Columbia University Record, 1996; US News & World Reports, 1996; Newsweek 1996; Healthline, 1996; The Tennessean, 1996; The Albany Times, 1996; The Nashville Scene, 1996). In their entirety, these case reports represent the human tragedy that lies beneath the web of the very worst of American capitalism: corporate greed.
Identifying Populations At-Risk
A study by The Lewison Group in 1996 reveals insight into the private individual health insurance market. Clearly, individuals choosing to purchase health insurance policies for several hundred dollars each month expect their health care needs and expenditures to exceed that amount Regardless of health status, a young healthy 25 year old who purchases an individual health insurance policy can expect to pay well over $300.00 monthly for a health insurance policy with Empire Blue Shield Blue Cross (based upon 1996 rates, current rates available from the New York State Insurance Department).
Since individual policies are not addressed in the Health Insurance Portability and Accountability Act of 1996 (HIPA), an individual policy with Blue Cross Blue Shield of Tennessee excludes preexisting conditions for 24 months (enrollment booklet available upon request). The critical markets in need of reform are the adversely selected individual insurance market, and the state's most vulnerable populations: children; the elderly; the chronically ill; the uninsured; and the underinsured.
For the millions of individuals who have lost their employer based coverage, the cost of private health insurance is prohibitively expensive. Many individuals opt out of the individual market and apply for public assistance when the need arises. Those who have retained their health insurance coverage through their employers are being moved into managed care despite their efforts to retain their indemnity style plans (Davis & Shoen, 1996; The Lewison Group, 1996).
Access to Medical Care
As routine practice, HMOs deny or delay care for all services that are not outright medically necessary. Growing numbers of individuals have suffered irreparable harm, and many have died awaiting approval from their HMO's (The New York Times, 1996; Long Island Newsday, 1996; The Tennessean, 1996; Healthline, 1996). It is hardly a secret that HMOs have fallen short of their promise to provide comprehensive health care for the "whole" individual by emphasizing preventative medicine, using medical management to coordinate care. There is substantial evidence that individuals with chronic conditions receive substandard care in HMOs.
A four-year longitudinal study of medical outcomes found that the elderly, the poor, and persons with chronic conditions were in better health when covered by fee-for-service plans compared with a control group covered in HMOs (Ware et. al., 1996). New statistics released in Washington, DC by the American Medical Association and the Robert Wood Johnson Foundation revealed the direct costs of individuals with chronic conditions account for 75% of direct medical expenditures in the United States (Hoffman & Rice, 1996; based upon the National Medical Expenditures Survey; raw data available on CD from the Department of Health and Human Services Washington, DC). 45% of the American population suffers from at least one chronic illness.
If managed healthcare has been found to deliver inadequate care to this population, then we are looking at 100 million individuals who are potentially facing personal and financial crisis as they are moved into managed care. The public already accounts for the largest payment of direct medical expenditures, which means the millions of dollars being made by for-profit insurance companies are not being circulated into the economy to assist in public health costs care. The industry made a 14.8% profit in the 3rd quarter of 1996, however these medical dollars were removed from health care and used to fatten the pockets of CEO's and majority stockholders (Healthline, 1996).
Based upon a new report from the Robert Wood Johnson Foundation, the direct costs for persons with chronic conditions represent 69.4% of national expenditures in personal health care (Robert Wood Johnson Foundation, 1996). Their direct medical costs are estimated at $4672.00 annually compared with $817.00 annually for individuals with acute illness (Hoffman & Rice, 1996; based upon National Medical Expenditures Survey 1987, not adjusted for inflation). This population is the most vulnerable to complications in their health and with their source of payment. Large insurance companies only provide adequate coverage for acute illness (Donelan et al., 1996; Hoffman et. al, 1996).
Medicaid Managed Care
Following Tennessee's lead, many states have enrolled their medically indigent populations in Medicaid Managed Care Organizations (MCOs). In Daniels v. Wadley, (926 F. Supp. 1305), the court held that TennCare violated the Due Process Clause of the Fourteenth Amendment since such procedures eliminate fair hearings and independent medical review of disputes. The court found the pattern of routine denials of care by MCOs participating in the states TennCare program to violate the Medicaid Act since it compounded the problem of institutionalized waiting periods for medical appeals pending independent review by the Medical Review Unit (MRU), (42 U.S.C. § 1396 (a)(8)).
Furthermore, the court ordered federal injunctive protection to participants and beneficiaries because no state law may preempt federal law by depriving individuals of their constitutional rights. The Department of Health and Human Services (HHS) was ordered to revise its utilization review procedures for TennCare recipients in keeping with the Medicaid Act (42 U.S.C. § 1396 (a) (8)) ensuring due process protections for all covered beneficiaries by requiring "services are provided with 'reasonable promptness,'" (926 F. Supp. 1305).
This case is one of 543 civil suits pending in the state courts for violations of the Medicaid Act (based upon a Lexis-Nexis search performed December 26, 1996). With the passing of H.R. 3507 into public law, (The Welfare Reform Bill) private citizens will find little reprieve in the federal courts, so any attempts to hold states accountable for violations of federal law will be feeble at best (Denkeret. al., 1996).
Managed care has shown itself to be a farce of "medical management" in light of all the condemning evidence to the contrary. Timothy Icenogle, a medical doctor in the state of Arizona commented in 1981, "We play sort of an advocacy role. I think the public demands something more from physicians than to just be a blob of bureaucrats, and I think we have to take a stand now and then. Our role essentially as patient advocate, is to tell them, well, just because the insurance company is not going to pay, that is not the end of all the resources," (Icenogle, as cited in Gutmann & Thompson, 1996).
Never has this statement been needed more than it is today. Unfortunately, as more insurance companies refuse to pay for medical treatment, fewer resources become available for patients in desperate need of financial assistance. As Judge Kessler eloquently stated as she handed down her decision in Salazar v. District of Columbia, No. 93-452, December 11, 1996, "behind every fact found herein is a human face and the reality of being poor in the richest nation on earth, (936 F. Supp. Slip op. At 3).
Perhaps most distressing is the lack of accountability for mismanaged healthcare and improper denials of medically necessary treatment. HMOs claim immunity under ERISA, and leaving individuals without recourse in a sea contractual language and lengthy court calendars. It is evident that individuals protected under the Medicaid Act are not fundamentally different from other populations entrapped in the maze of managed care. They are simply those who have "had their day in court."
Due Process Protections
Since all Americans are theoretically entitled to due process protections under the constitution of the United States, it seems the federal courts are long overdue for making such a public statement. We are wasting precious time and losing millions in valuable human resources as we await decisions to be handed down from state courts. The Supreme Court of the United States has agreed to hear New York's request for an ERISA (Employee Retirement Income Security Act of 1985) waiver, making health maintenance organizations liable for medical malpractice in the state of New York.
When HMOs deny care from patients, it is ludicrous to hold individual physicians liable for the utilization decisions made by decentralized corporate review boards. It is time to take a serious look at tort reform, and demand action by the Supreme Court as they approach the date of New York's ERISA hearing. A blanket court ruling upholding Daniels v. Wadley, and Salazar v. District of Columbia is desperately needed to avoid an avalanche of liability suits filed in state courts. The court must uphold Daniels v. Wadley, and Salazar v. District of Columbia if further lives are to be saved in medicine rather than wasted away in the utilization review procedures. While we wait patiently for District of Columbia circuit court to order injunctive relief, the number of individuals suffering irreparable harm due to the systematic denial of medical care grows larger each day.
The history of Medicaid Managed Care does not provide a very optimistic look into the future of TennCare recipients and Medicaid beneficiaries in states around the country. Dating back to the implementation of the Arizona Health Care Cost Containment System (AHCCCS) in 1981, there are documented cases where "people reportedly died for lack of medical treatment before their eligibility was determined," (Varley, as cited in Gutman & Thompson, I 996). This leaves me to wonder why the states continue to enroll their most vulnerable populations into a system of managed care that has proven to be a disaster.
Perhaps worthy of comment is that Arizona is the only state to have voted Republican in every election since 1948-certainly provides insight into the conservative morale of the state. Although Arizona was the last state to accept the Medicaid cost sharing incentive proposed by the federal government in 1966, it was the first state to force its medically indigent population into managed care in 1981.
Violating Federal Law
Rigid pre-certification requirements and nonspecific utilization review procedures place strategic barriers to access medical treatment and services in Health Maintenance Organizations (HMOs). Pre-certification requirements are strategic barriers incorporated into the "black box" of utilization review that institutionalizes exclusionary waiting periods and routine denials of medically necessary treatment. According to federal law, "care and services are to be provided in a manner consistent with the simplicity of administration and the best interests of recipients," (42 U.S.C. § I 396a (a) (19)). Clearly, such rigid pre-certification requirements that complicate administrative processing and paperwork on the part of the enrolled beneficiaries is a violation of United States Code.
Furthermore, using primary care providers as a mechanism to limit access to specialists not only complicates administrative processing, but limits enrolled beneficiaries choice of health professionals beyond what is available to the general public in the geographic area (42 U.S.C. § 1 396a (a)(30)(A)). Certainly referral procedures do not "assure that recipients will have their choice of health professionals within the plan to the extent possible and appropriate," (42 U.S.C. § 434.29). Under this provision, it seems that any individual, especially those with chronic health conditions or disabilities should be allowed to choose a primary care provider with more expertise than a nurse practitioner. I will argue that a neurologist is more familiar with the unique needs of a patient with Multiple Sclerosis than a nurse practitioner is with little to no knowledge specific to the medical management of degenerative
Under the Medicaid Act of 1966, covered beneficiaries may appeal any utilization review decision which denies care or limits services. The Medicaid Act gives individuals the right to a fair hearing in front of an impartial independent Medical Review Unit (MRU). Furthermore, the Medicaid Act clearly states that medical services for a Medicaid beneficiary may not be terminated until the said beneficiary receives such a hearing
Conclusion
The country as a whole must realize what Judge Kessler told her courtroom. Her words are certainly words I will not forget-certainly worth being quoted at length:
"This case is about people-children and adults who are sick, poor, and vulnerable-for whom life, in the memorable words of poet Langston Hughes, "ain't been no crystal stair". It is written in the dry and bloodless language of "the Iaw"-statistics, acronyms of agencies and bureaucratic entities, Supreme Court case names and quotes, official governmental reports, periodicity tables, etc. But let there be no forgetting the real people to whom this bloodless language gives voice: anxious working parents who are too poor to obtain medications or heart catheter procedures or lead poisoning screening for their children, AIDS patients unable to get treatment, elderly persons suffering from chronic conditions like diabetes and heart disease who require constant monitoring arid medical attention. Behind every fact found herein is a human face and the reality of being poor in the richest nation on earth. (Slip op. At 3). -Judge Gladys Kessler, December 11, 1996.
Patients are routinely being denied medical care-- and being forced into a system that incorporates long waiting periods into their physician contracts and handbooks (Green, 1996). The private for-profit insurance industry has single-handedly undermined the solidarity principle of health insurance by using strict underwriting techniques, ridiculous treatment protocols; inconsistent definitions of chronic illness and rigid utilization review procedures unavailable to the consumer; and inconsistent definitions of "chronic illness" and "emergency" (Dallek, 1996). It is an industry which justified using sexual orientation to avoid covering AIDS patients, calling such methods "actuarially sound." The privatization of a public good has removed millions of dollars from the healthcare marketplace with "medical loss ratios" of 57% compared to 85% in the traditional health insurance market
Although a slim portion of the general public is unable to obtain health insurance coverage due to a preexisting condition, the more critical issue remains the cost of coverage. The cost of medical care will remain an issue since recent legislative efforts evade the issue. Recent changes in the delivery of health services is of grave concern and different options must be considered in order to find more effective ways to provide public and private assistance-
MANAGED CARE IS NOT THE ANSWER!!! FOR-PROFIT HEALTH CARE IS NOT THE ANSWER! PRIVATIZATION IS NOT THE ANSWER!
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Underwriting the Social Contract: Distributive Justice & Health Care Reform
The Problem Statement
As health care costs climbed exponentially in the 1980's, so did the cost of health insurance plans. As a result, employers began to enroll their employees in managed care organizations, and many Americans were forced to leave their traditional indemnity type plans. With the advent of the health maintenance organization, there is a financial incentive for the underutilization of care. (Blumstein, 1996; Davis & Shoen, 1996).
In order to reduce financial risk, health insurance companies have restricted enrollment to individuals in poor health. By covering the minimal standards of treatment and excluding high risk groups altogether, major US insurance companies have realized that the health insurance market can a be an extremely profitable industry.
The public sector absorbs the cost of unreimbursed care for chronic care in America (Robert Wood Johnson Foundation, 1996). Based upon these findings, it seems clear that the money being removed from the health care marketplace is fattening the pockets of CEOs and majority stockholders.
Recent trend towards localized government leaves individuals without a financial safety net. This is the least efficient manner to handle health care costs, and evades the premise that medical care is a natural right in a civilized society. Few Americans feel secure within the current system. The rising costs of medical care contributed to the recent market changes in both the administration and delivery of health services. The financial incentive to cover only the healthiest individuals ignores the fact that medical care is a social good.
Health Insurance Portability Act of 1996
Two years after the Clinton Health Plan was defeated in Congress, Senator Ted Kennedy and Nancy Kassebaum introduced the Kennedy-Kassebaum Bill in response to growing concerns about selective enrollment procedures used by health insurance companies in the private sector. In the final version of the Bill, insurance companies must limit preexisting condition clauses to twelve months. It has been estimated that this provision of the Bill will help an estimated 150,000 Americans obtain health insurance coverage.
There are many levels of the underinsured, including those without any coverage; effective policy must address the needs of the total population without shifting costs from one disadvantaged person to another. Kennedy-Kassebaum fails to address the cost issue-the primary concern for those at risk for losing their health insurance. It does nothing to help the uninsured acquire a decent health policy, and then provides no solution to the critical issue at hand- cost
Since Kennedy-Kassebaum does nothing to control the cost of health insurance and medical care in America, the Bill fails to respond to the issue of greatest concern to the citizens of this country: the cost of medical care. The Bill looks towards the states to develop consumer protections and weakens the regulatory role of the federal government. The majority of the American public is unaware of the fancy footwork involved with this legislation, and the demographics of the population it is intended to protect. In order to assess the utility of this Bill, it is critical to identify the populations at risk for loosing health insurance coverage and the underinsured.
Kassebaum-Kennedy focuses on a slim portion of the uninsured population, and those who would be eligible for COBRA continuation (Consolidated Omnibus Reconciliation Act of 1974). Of the 41 million uninsured Americans, only about 150,000 are expected to benefit from this legislation. The Health Insurance Portability and Accountability Act of 1996 is really nothing more than smoke and mirrors since it fails to address the true issue at hand-the simple fact that the cost of quality health care in America is becoming a privilege that only the wealthy can afford.
The Cost of Care for Pre-existing Conditions
An individual with high blood pressure may just require prescription medication. Cancer patients in remission may require chemotherapy, and a person suffering with a degenerative disease may be involved in treatment studies. Each condition requires individualized treatment that cannot be based upon the simple economic/cost-benefit analysis used in the utilization review process by large insurance companies. Clearly, the most effective treatment for one patient may not be the best for another. The time required for utilization review may present additional health risks and complications to a patient suffering from a chronic health condition.
Twelve months without insurance coverage may be financially devastating to some patients, and 63% of Americans have already forgone some type of medical treatment within the last year due to financial constraints. Publicity surrounding Kennedy-Kassebaum has hailed the bill as the "be all and end all in progressive legislation, however, in actuality it will only help about 150,000 people.
Recent studies have found that the majority of the uninsured population simply cannot afford to pay the premiums (Donelan et. al., 1996; Hoffman & Rice, 1996). According to their data, only 1% of the Uninsured population is due to current health status and exclusionary preexisting clauses, yet an overwhelming number of insured respondents reported an inability to receive medical care for chronic conditions. The majority of Americans with chronic illness are covered by some type of insurance, yet they are still subject to the utilization review process and access problems that deny or delay medically necessary treatment (Donelan, et. al., Hoffman & Rice, 1996).
Underwriting the Solidarity Principle
Traditional forms of insurance underwriting required that the contract explicitly state which illness or services are not covered by the policy, in advance. If the underwriter did not specifically state a certain condition in the contract, the insurer was held to the terms of the contract and required to pay for services utilized by the policyholder (Stone, 1994, as cited in Durant, 1996).
Increasing numbers of for-profit and non-profit insurance companies began to control costs by refusing to insure individuals who they felt would utilize more services. Insurers began to require health survey status questionnaires (refer to attachment A), and even began implementing AIDS and genetic testing to identify high-risk individuals (Brunetta, as cited in Gutmann & Thompson, 1996). In the 1980s, large insurance companies began including sexual orientation as a high-risk category, by using actuarial sound criteria. Such criteria concluded that gay men were a higher risk for contracting AIDS virus and refused to write policies for anyone believed to be homosexual, (Stone, 1994 as cited in Durant, 1996).
By limiting enrollment to the healthiest members of society, selective enrollment undermines the solidarity principle of health insurance (Davis & Shoen, 1996; Snow, 1996; Stone, 1994). By eliminating those who were suspect of using more services than their healthier counterparts use, insurance companies are able to offer rock bottom prices for young, healthy individuals. By excluding preexisting conditions and requiring certain individuals to purchase high-risk policies, the number of uninsured and underinsured Americans continues to grow exponentially (Durant, 1996).
More individuals are choosing not to purchase insurance simply because they cannot afford it. Even among those with employer based health coverage, the policies frequently exclude coverage for long-term illness or care of chronic conditions (MSNBC News Forum, 1996). Without a standard definition of preexisting conditions, these clauses serve as "wildcards" since they allow insurers to deny coverage for any illness that "manifested itself before the issuing date of the policy (Stone, 1994 as cited in Durant, 1996).
This statement allows insurers to deny treatment for benefits and services for the policyholder for undiagnosed illnesses or conditions of which they were unaware. As a result, the insurers began to demand medical histories of applicants and their families in order to identify high risk individuals (please refer to attachment A).
Legitimacy of Distributive Justice
While there is a legitimate role of government to distribute scarce resources among the nation's neediest individuals, sadly this is not the cause for the mismanagement of medical dollars in the United States today. There is a big distinction between an individual being denied prescription medication at their local pharmacy due to a cost-effective formulary developed by their Managed Care Organizations (MCOs), than an individual being denied a liver transplant because healthy livers are a scarce resource. While both may have equally devastating consequences, it is more difficult to rationalize a lost life based upon rigid cost benefit analysis and utilization decisions made according to formulas and cost-benefit analysis of treatment protocols.
"The political controversy over the distribution of health care in the United States is an instructive problem in distributive justice. Good health is care is necessary for pursuing most other things in life. Yet equal access to health care would require the government to not only redistribute resources from the rich, healthy to the poor, and infirm, but also restrict the freedom of doctors and other health care providers. Such redistributions may be warranted, but to what level, and to what extent?" Gutmann & Thompson (Page 178).
Blendon and his colleagues have reported similar findings in public opinion polls from 1992 and 1994 (Blendon et. al., 1992; Blendon et. al., 1994). A recent study by the American Medical Association found cost to be of paramount concern to an overwhelming number of Americans (Donelan et. aI., 1996). Of the 40 million uninsured Americans, only 1% attributes their failure to acquire health insurance coverage to their preexisting conditions. Among the uninsured, cost is cited as the primary obstacle in obtaining health insurance coverage. Only 1% of the uninsured attributes their lack of coverage to a preexisting condition.
Based upon these democratic principles of distributive justice, consistent opinion polls demonstrate the legitimate role and public desire for government regulation of the health care industry. It has become obvious that the federal government must intervene in order to protect natural law rights, the social contract, and the Constitution of the United States. Regulation is needed to protect the individual freedoms, liberty, and the pursuit of "health, happiness, and the American Dream."
If America is to be the "Land of Opportunity," then clearly individual health and wellness should be an ideal to reach for. Current models of distributive justice emphasize public consensus as a legitimate role for government intervention. According to a number of studies by Blendon and his colleagues, the public has reported an overwhelming general concern about health care in this country, (1992, 1993, 1994, 1995, 1996).
State civil courts are backed up with cases where HMOs have violated the First Amendment (gag orders), the Fourteenth Amendment (due process), and the rights of protected classes under the Americans with Disabilities Act. Countless examples of "anecdotal" evidence appear as headlines everyday across the country. (New York Times, 1996; The New York Daily News, 1996; Long Island Newsday, 1996; LA Times, 1996; Picayne Times, 1996; Columbia Spectator, 1996; Columbia University Record, 1996; US News & World Reports, 1996; Newsweek 1996; Healthline, 1996; The Tennessean, 1996; The Albany Times, 1996; The Nashville Scene, 1996). In their entirety, these case reports represent the human tragedy that lies beneath the web of the very worst of American capitalism: corporate greed.
Identifying Populations At-Risk
A study by The Lewison Group in 1996 reveals insight into the private individual health insurance market. Clearly, individuals choosing to purchase health insurance policies for several hundred dollars each month expect their health care needs and expenditures to exceed that amount Regardless of health status, a young healthy 25 year old who purchases an individual health insurance policy can expect to pay well over $300.00 monthly for a health insurance policy with Empire Blue Shield Blue Cross (based upon 1996 rates, current rates available from the New York State Insurance Department).
Since individual policies are not addressed in the Health Insurance Portability and Accountability Act of 1996 (HIPA), an individual policy with Blue Cross Blue Shield of Tennessee excludes preexisting conditions for 24 months (enrollment booklet available upon request). The critical markets in need of reform are the adversely selected individual insurance market, and the state's most vulnerable populations: children; the elderly; the chronically ill; the uninsured; and the underinsured.
For the millions of individuals who have lost their employer based coverage, the cost of private health insurance is prohibitively expensive. Many individuals opt out of the individual market and apply for public assistance when the need arises. Those who have retained their health insurance coverage through their employers are being moved into managed care despite their efforts to retain their indemnity style plans (Davis & Shoen, 1996; The Lewison Group, 1996).
Access to Medical Care
As routine practice, HMOs deny or delay care for all services that are not outright medically necessary. Growing numbers of individuals have suffered irreparable harm, and many have died awaiting approval from their HMO's (The New York Times, 1996; Long Island Newsday, 1996; The Tennessean, 1996; Healthline, 1996). It is hardly a secret that HMOs have fallen short of their promise to provide comprehensive health care for the "whole" individual by emphasizing preventative medicine, using medical management to coordinate care. There is substantial evidence that individuals with chronic conditions receive substandard care in HMOs.
A four-year longitudinal study of medical outcomes found that the elderly, the poor, and persons with chronic conditions were in better health when covered by fee-for-service plans compared with a control group covered in HMOs (Ware et. al., 1996). New statistics released in Washington, DC by the American Medical Association and the Robert Wood Johnson Foundation revealed the direct costs of individuals with chronic conditions account for 75% of direct medical expenditures in the United States (Hoffman & Rice, 1996; based upon the National Medical Expenditures Survey; raw data available on CD from the Department of Health and Human Services Washington, DC). 45% of the American population suffers from at least one chronic illness.
If managed healthcare has been found to deliver inadequate care to this population, then we are looking at 100 million individuals who are potentially facing personal and financial crisis as they are moved into managed care. The public already accounts for the largest payment of direct medical expenditures, which means the millions of dollars being made by for-profit insurance companies are not being circulated into the economy to assist in public health costs care. The industry made a 14.8% profit in the 3rd quarter of 1996, however these medical dollars were removed from health care and used to fatten the pockets of CEO's and majority stockholders (Healthline, 1996).
Based upon a new report from the Robert Wood Johnson Foundation, the direct costs for persons with chronic conditions represent 69.4% of national expenditures in personal health care (Robert Wood Johnson Foundation, 1996). Their direct medical costs are estimated at $4672.00 annually compared with $817.00 annually for individuals with acute illness (Hoffman & Rice, 1996; based upon National Medical Expenditures Survey 1987, not adjusted for inflation). This population is the most vulnerable to complications in their health and with their source of payment. Large insurance companies only provide adequate coverage for acute illness (Donelan et al., 1996; Hoffman et. al, 1996).
Medicaid Managed Care
Following Tennessee's lead, many states have enrolled their medically indigent populations in Medicaid Managed Care Organizations (MCOs). In Daniels v. Wadley, (926 F. Supp. 1305), the court held that TennCare violated the Due Process Clause of the Fourteenth Amendment since such procedures eliminate fair hearings and independent medical review of disputes. The court found the pattern of routine denials of care by MCOs participating in the states TennCare program to violate the Medicaid Act since it compounded the problem of institutionalized waiting periods for medical appeals pending independent review by the Medical Review Unit (MRU), (42 U.S.C. § 1396 (a)(8)).
Furthermore, the court ordered federal injunctive protection to participants and beneficiaries because no state law may preempt federal law by depriving individuals of their constitutional rights. The Department of Health and Human Services (HHS) was ordered to revise its utilization review procedures for TennCare recipients in keeping with the Medicaid Act (42 U.S.C. § 1396 (a) (8)) ensuring due process protections for all covered beneficiaries by requiring "services are provided with 'reasonable promptness,'" (926 F. Supp. 1305).
This case is one of 543 civil suits pending in the state courts for violations of the Medicaid Act (based upon a Lexis-Nexis search performed December 26, 1996). With the passing of H.R. 3507 into public law, (The Welfare Reform Bill) private citizens will find little reprieve in the federal courts, so any attempts to hold states accountable for violations of federal law will be feeble at best (Denkeret. al., 1996).
Managed care has shown itself to be a farce of "medical management" in light of all the condemning evidence to the contrary. Timothy Icenogle, a medical doctor in the state of Arizona commented in 1981, "We play sort of an advocacy role. I think the public demands something more from physicians than to just be a blob of bureaucrats, and I think we have to take a stand now and then. Our role essentially as patient advocate, is to tell them, well, just because the insurance company is not going to pay, that is not the end of all the resources," (Icenogle, as cited in Gutmann & Thompson, 1996). Never has this statement been needed more than it is today. Unfortunately, as more insurance companies refuse to pay for medical treatment, fewer resources become available for patients in desperate need of financial assistance. As Judge Kessler eloquently stated as she handed down her decision in Salazar v. District of Columbia, No. 93-452, December 11, 1996, "behind every fact found herein is a human face and the reality of being poor in the richest nation on earth, (936 F. Supp. Slip op. At 3).
Perhaps most distressing is the lack of accountability for mismanaged healthcare and improper denials of medically necessary treatment. HMOs claim immunity under ERISA, and leaving individuals without recourse in a sea contractual language and lengthy court calendars. It is evident that individuals protected under the Medicaid Act are not fundamentally different from other populations entrapped in the maze of managed care. They are simply those who have "had their day in court."
Due Process Protections
Since all Americans are theoretically entitled to due process protections under the constitution of the United States, it seems the federal courts are long overdue for making such a public statement. We are wasting precious time and losing millions in valuable human resources as we await decisions to be handed down from state courts. The Supreme Court of the United States has agreed to hear New York's request for an ERISA (Employee Retirement Income Security Act of 1985) waiver, making health maintenance organizations liable for medical malpractice in the state of New York.
When HMOs deny care from patients, it is ludicrous to hold individual physicians liable for the utilization decisions made by decentralized corporate review boards. It is time to take a serious look at tort reform, and demand action by the Supreme Court as they approach the date of New York's ERISA hearing. A blanket court ruling upholding Daniels v. Wadley, and Salazar v. District of Columbia is desperately needed to avoid an avalanche of liability suits filed in state courts. The court must uphold Daniels v. Wadley, and Salazar v. District of Columbia if further lives are to be saved in medicine rather than wasted away in the utilization review procedures. While we wait patiently for District of Columbia circuit court to order injunctive relief, the number of individuals suffering irreparable harm due to the systematic denial of medical care grows larger each day.
The history of Medicaid Managed Care does not provide a very optimistic look into the future of TennCare recipients and Medicaid beneficiaries in states around the country. Dating back to the implementation of the Arizona Health Care Cost Containment System (AHCCCS) in 1981, there are documented cases where "people reportedly died for lack of medical treatment before their eligibility was determined," (Varley, as cited in Gutman & Thompson, I 996). This leaves me to wonder why the states continue to enroll their most vulnerable populations into a system of managed care that has proven to be a disaster.
Perhaps worthy of comment is that Arizona is the only state to have voted Republican in every election since 1948-certainly provides insight into the conservative morale of the state. Although Arizona was the last state to accept the Medicaid cost sharing incentive proposed by the federal government in 1966, it was the first state to force its medically indigent population into managed care in 1981.
Violating Federal Law
Rigid pre-certification requirements and nonspecific utilization review procedures place strategic barriers to access medical treatment and services in Health Maintenance Organizations (HMOs). Pre-certification requirements are strategic barriers incorporated into the "black box" of utilization review that institutionalizes exclusionary waiting periods and routine denials of medically necessary treatment. According to federal law, "care and services are to be provided in a manner consistent with the simplicity of administration and the best interests of recipients," (42 U.S.C. § I 396a (a) (19)). Clearly, such rigid pre-certification requirements that complicate administrative processing and paperwork on the part of the enrolled beneficiaries is a violation of
United States Code.
Furthermore, using primary care providers as a mechanism to limit access to specialists not only complicates administrative processing, but limits enrolled beneficiaries choice of health professionals beyond what is available to the general public in the geographic area (42 U.S.C. § 1 396a (a)(30)(A)). Certainly referral procedures do not "assure that recipients will have their choice of health professionals within the plan to the extent possible and appropriate," (42 U.S.C. § 434.29). Under this provision, it seems that any individual, especially those with chronic health conditions or disabilities should be allowed to choose a primary care provider with more expertise than a nurse practitioner. I will argue that a neurologist is more familiar with the unique needs of a patient with Multiple Sclerosis than a nurse practitioner is with little to no knowledge specific to the medical management of degenerative
Under the Medicaid Act of 1966, covered beneficiaries may appeal any utilization review decision which denies care or limits services. The Medicaid Act gives individuals the right to a fair hearing in front of an impartial independent Medical Review Unit (MRU). Furthermore, the Medicaid Act clearly states that medical services for a Medicaid beneficiary may not be terminated until the said beneficiary receives such a hearing
Conclusion
The country as a whole must realize what Judge Kessler told her courtroom. Her words are certainly words I will not forget-certainly worth being quoted at length:
"This case is about people-children and adults who are sick, poor, and vulnerable-for whom life, in the memorable words of poet Langston Hughes, "ain't been no crystal stair". It is written in the dry and bloodless language of "the Iaw"-statistics, acronyms of agencies and bureaucratic entities, Supreme Court case names and quotes, official governmental reports, periodicity tables, etc. But let there be no forgetting the real people to whom this bloodless language gives voice: anxious working parents who are too poor to obtain medications or heart catheter procedures or lead poisoning screening for their children, AIDS patients unable to get treatment, elderly persons suffering from chronic conditions like diabetes and heart disease who require constant monitoring arid medical attention. Behind every fact found herein is a human face and the reality of being poor in the richest nation on earth. (Slip op. At 3). -Judge Gladys Kessler, December 11, 1996.
Patients are routinely being denied medical care-- and being forced into a system that incorporates long waiting periods into their physician contracts and handbooks (Green, 1996). The private for-profit insurance industry has single-handedly undermined the solidarity principle of health insurance by using strict underwriting techniques, ridiculous treatment protocols; inconsistent definitions of chronic illness and rigid utilization review procedures unavailable to the consumer; and inconsistent definitions of "chronic illness" and "emergency" (Dallek, 1996). It is an industry which justified using sexual orientation to avoid covering AIDS patients, calling such methods "actuarially sound." The privatization of a public good has removed millions of dollars from the healthcare marketplace with "medical loss ratios" of 57% compared to 85% in the traditional health insurance market
Although a slim portion of the general public is unable to obtain health insurance coverage due to a preexisting condition, the more critical issue remains the cost of coverage. The cost of medical care will remain an issue since recent legislative efforts evade the issue. Recent changes in the delivery of health services is of grave concern and different options must be considered in order to find more effective ways to provide public and private assistance-MANAGED CARE IS NOT THE ANSWER!!! FOR-PROFIT HEALTH CARE IS NOT THE ANSWER! PRIVATIZATION IS NOT THE ANSWER!
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Published by Elyssa Durant
Medical Treatment for Individuals with Disabilities by Elyssa Durant, Ed.M.
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