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 immunosuppresive 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 judgement 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 judgements 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 judgement. 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 judgements 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.
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[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
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[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
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[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
####
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
http://voices.yahoo.com/distributive-justice-health-care-2333826.html?cat=17
####
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.
Futile Care for Babies: Baby K and Anencephalic Infants
Baby K is frequently used as the classic example of an infant with a
hopeless medical condition. Born with a congenital defect known as
anencephaly, Baby K was born without a brain. Photographs of
anencephalic infants leave us with an unsettling image of the physical
reality ofthis particular birth defect. Dr. Boehm of Vanderbilt
University Medical Center gives a graphic description of "monster
children," making it easier on our psyches to withdraw medical care.
Anencephaly provides a good example of futile care for infants since it
represents the most extreme case of disfigurement and congenital
deformity. The case involving Baby K was a landmark ADA decision filed
in district court against Fairfax Hospital in Fairfax, Virginia.
Although Baby K was capable of maintaining the most basic life functions
at the early stages of her infancy, her mother soon began to bring her
to the emergency room to prolong her life when Baby K encountered
respiratory failure. The suit filed by Baby K's mother against Fairfax
Hospital raises several legal questions regarding the definition of
futile care and medical treatment for Americans with disabilities. The
case eventually became a landmark ADA (Americans with Disabilities Act)
case when the district court ruled that Baby K was being discriminated
against because of her anencephaly-clearly a disability under the
definition of the ADA.
The court found that Baby K was otherwise qualified for medical
treatment, however, they failed to address other critical issues
including an agreed upon clinical definition of futile care. Since Baby K
was privately insured, the court also did not address the allocation of
resources and public funding for medically futile care.
Although the court took an interesting approach to decide this case, I
am rather sympathetic to the plight ofthe physicians at Fairfax Hospital
since Baby K had little chance of survival beyond her early infancy.
Despite my agreement on the single issue of anencephaly, I would be
hesitant to make a generalization regarding futile care for all
medically "hopeless" cases-especially those involving degenerative
conditions such as Multiple Sclerosis (MS) and other forms of spinal
and/or brain trauma.
In the case of Baby K, it is the literal definition (or lack thereof)
which I find so troubling. Is medical research on myelin regeneration
futile? Are the expenditures for spinal rehabilitation inappropriate?
Who has the authority and expertise to make decisions about the quality
of life and who decides who shall live and who shall die? What makes one
life more valuable to society and worthy of medical expenditures?
Modern medical science is just starting to recognize the strength of the
mind-body relationship and traditional scientific models have vastly
underestimated the will to live and the ability to recover from
traumatic injuries.
These modern day "miracles" on the evening news- patients with no hope
who suddenly wake up from a twenty-year coma convey a message of hope
and cast doubt on the expertise of the American Medical
Association.
Published by Elyssa Durant
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yeah, I said it! Stop stealing my intellectual property... at the very
least, give me a cut of the profits you are making off my work. I CALL
FOUL!
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