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by
Amanda Walters Scarbrough
2008
The Dissertation Committee for Amanda Walters Scarbrough Certifies that this is
the approved version of the following dissertation:
Compassion and Conflict:
The Impact of the Medicare End-Stage Renal Disease Program
Committee:
William J. Winslade, PhD, JD
Supervisor
Cheryl Vaiani, PhD
Ronald Carson, PhD
Robert Beach, MD
Stella Smetanka, JD
__________________
Dean, Graduate School
Compassion and Conflict:
The Impact of the Medicare End-Stage Renal Disease Program
by
Amanda Walters Scarbrough, MHSA, BA
Dissertation
Presented to the Faculty of the Graduate School of
The University of Texas Medical Branch
in Partial Fulfillment
of the Requirements
for the Degree of
Doctor of Philosophy
The University of Texas Medical Branch
December 2008
Dedication
To my parents, Dr. Lynne Masel Walters and Dr. Timothy Walters, for their
unconditional love, support, and editing skills.
Acknowledgments
I would like to thank Dr. William J. Winslade for his endless encouragement. None of
this research would have been possible without his support and contributions to my thought
process. Further, I would like to thank Dr. Ronald Carson for pushing me to think outside of the
box. He challenged me to immerse myself in the material in order to grow as a scholar. Thanks
to Dr. Cheryl Vaiani for offering her expert advice. Her counsel helped me refine my work.
Thank you to Stella Smetanka and Dr. Robert Beach for serving on my committee and sharing
their knowledge and experience. Thank you to Meredith Masel, Ernie Aguilar, and Julie Kutac
for their collegiality. Also thank you to the entire UTMB community, including Donna Vickers,
Donna Ray, Dr. Anne Jones, Laura Teed, and Dr. Dorian Coppenhaver, who despite the
devastating effects of Hurricane Ike to both their personal and professional lives, stood behind
me and helped me achieve my goals. Lastly, thank you to Terry, Sydney, Carter, and Caroline
Scarbrough. You were my motivation to push myself to achieve this goal.
v
Compassion and Conflict:
The Impact of the Medicare End-Stage Renal Disease Program
Publication No._____________
Amanda Walters Scarbrough, PhD
The University of Texas Medical Branch, 2008
Supervisor: William J. Winslade
At its inception, the Medicare program was designed to insure that the elderly would not
be denied access to the health-care system because of a lack of financial resources. But, with
lobbying efforts, the original Medicare bill was amended to add coverage for those individuals
with end-stage renal disease (ESRD), permanent kidney failure requiring dialysis or kidney
transplant. To date, patients with ESRD are the only disease-specific population entitled to
federal coverage for services on virtually a universal basis.
Because of the unique nature of funding for the ESRD program, the question arises as to
whether it is ethically appropriate for the federal government to allocate monies on the basis of
disease status. To answer this question I examine the politics, morality, economics, and human
behavior that impact ESRD and the patients, the public, and the political response to it. I will
look at the variety of issues, both within and beyond the range of medical practice, that reveal
how ESRD is treated in the United States. To address these concerns, this research will explore
vi
the history, describe the current conditions, and then suggest possible futures for the ESRD
program.
Through this research, I will argue that the Medicare ESRD Amendments were a unique
phenomenon, the result of a perfect storm. The technology was available to save lives and it
worked. Further, not only did the technology save people, but also it had the capacity to restore
terminally ill individuals to normal and productive lives. This idea was irresistible. However,
while created with good intentions, the ESRD program was a strategic mistake. Caught up in the
rescue fantasy, politicians and providers gave inadequate forethought to the ethical, economic,
and regulatory demands the program would impose on the federal government.
However, for all the problems and unintended consequences, I will argue that the ESRD
Amendments are more than just a run-of-the-mill federally funded health-care program. The
Amendments created a legal right, a moral promise, and a special covenant, that cannot be
revoked, between the federal government and patients with a life-threatening illness.
vii
Table of Contents
Chapter 1 An Overview of Medical Treatment for End Stage Renal Disease ….19
The Early Days of the Treatment of Renal Disease ....................................22
The Early Days of the Artificial Kidney ......................................................23
The First Clinical Dialysis ...........................................................................24
The First Successful Artificial Kidney - Dr. Willem Kolff …… ...………..26
The Beginning of Chronic Dialysis - Dr. Belding Scribner and the
Teflon Shunt .................................................................................................31
Chapter 2 Rationing and the God Squad ...............................................................36
The Admissions and Policies Committee of the Seattle Artificial
Kidney Center at Swedish Hospital .............................................................39
Thoughts Regarding Their Role on the God Squad .....................................45
In Defense of the God Squad .......................................................................52
Were There Better Ways to Make These Rationing Decisions ...................54
Chapter 3 From Social Insurance to Medicare .....................................................57
The Depression and World War II ...............................................................58
Stumbling Blocks - Opposition to Federally Sponsored Health Insurance .65
Sluggish Progress - Federally Sponsored Health Care from FRD to JFK
to LBJ ..........................................................................................................70
The Ratification of Medicare .......................................................................75
Chapter 4 Federal Support for Kidney Disease: The Medicare Amendments ......86
ESRD as a Disability ...................................................................................87
How the ESRD Amendment Became Attached to Medicare ......................89
How to Medically Address ESRD: Current Treatment Modalities .............94
Hemodialysis .......................................................................................94
Peritoneal Dialysis (PD) .....................................................................99
The Realities of Being a Chronic Patient ...................................................102
Where to Treat ESRD: Location, Location, Location ...............................103
viii
Chapter 5 The Politics of the ESRD Amendment ..............................................107
Effects of the ESRD Amendment ..............................................................112
End of the God Squads .....................................................................112
Changes in the Renal Populations .....................................................116
Changes in the Age of Patients .........................................................120
Changes in Gender ................................................................122
Changes in Financial Status ..................................................123
Changes in Compliance ........................................................125
Implications of the Change in the Patient Population ................................127
Chapter 6 The ESRD Entitlement Program ........................................................135
What Does "Entitlement" Mean .................................................................135
Current Medicare Coverage .......................................................................138
Is Medicare Funding the Right Set of Services? ........................................140
The Changing Needs of ESRD Patients ...........................................140
The Changing Needs of ESRD Providers .........................................147
Chapter 7 The Future of the ESRD Program ......................................................156
Should We Fix It? - Is Government Support for ESRD Patients Ethical? .158
Other Life-Threatening Diseases ...............................................................158
Cancer ..............................................................................................158
HIV/AIDS ..........................................................................................159
Parkinson's Disease ..........................................................................160
Why Not Fund All Life-Threatening Diseases? ........................................161
The Future of the ESRD Program ..............................................................170
What Kind of Good is Health Care ............................................................170
Are There Social Obligations to Provide Health Care? .............................172
If Health Care is Not a Social Good Do We Still Have an Obligation to
ESRD Patients? ...........................................................................................174
Ideas for the Management of the Medicare ESRD Program ......................178
Bibliography ........................................................................................................180
Vita ....................................................................................................................190
ix
Introduction
What remains, as an afterglow, is the realization that I was present at the start of something
important and worthwhile. After all, what more can one ask of life?1
This statement was made by Dr. Eli A. Friedman, Chief of the Division of Renal Disease
for State University of New York, Health Science Center at Brooklyn, and chairman of the
American Association of Kidney Patient's Medical Advisory Board. Dr. Friedman was reflecting
on the role he played in the development of modern dialysis treatment, notably the suitcase
kidney, a portable mechanical kidney that allows people with End Stage Renal Disease (ESRD)
to live better, healthier, and longer lives.2
Because of their training, most health-care professionals, conceivably including Dr.
Friedman who is a prominent researcher as well as clinician, tend to see disease through a
scientific microscope.3 But, if we expand the range of our lens in the Medical Humanities field,
we will see that, in the case of ESRD, the response involves more than “Kiil dialyzers, twin coil
machines and external Teflon blood shunts.”4 Medical treatment has no value unless it gets to the
people who need it. In the United States today, dialysis therapy has transformed from a therapy
restricted to motivated, personally involved patients to a near universally available treatment for
everyone with ESRD. By the end of 2004, approximately 336,000 Americans were alive because
Eli A. Friedman and John Bower, “Physicians Share Experiences on the Medicare ESRD Program,”
Renallife 17 (May 2002) http://www.aakp.org/aakp-library/Physicians--on--Medicare-ESRD/ (accessed November
22, 2008).
2
“Kidney in a Suitcase,” Time, January 5, 1976. http://timeinc8sd11.websys.aol.com/time/magazine/article/0,9171,947623,00.html (accessed November 23, 2008).
3
Sherrie H. Kaplan, Sheldon Greenfield, and John E. Ware, Jr., “Assessing the Effects of Physician-Patient
Interactions on the Outcomes of Chronic Disease,” Medical Care 27, Suppl. 3 (March 1989): S110-S127.
4
Friedman and Bower.
1
1
of hemodialysis, and their number is growing by 8 percent each year.5 The reason that these
people have access to ESRD treatment is that the 1972 Amendments to the Medicare legislation
provided federal financing for kidney dialysis treatments.
This dissertation is an attempt to widen the lens beyond Dr. Friedman’s medical and
scientific microscope to discover the elements of politics, morality, economics, and human
behavior that impact ESRD and the patients, the public, and the political response to it. I will
look at a variety of issues, both within and beyond the range of medical practice, that reveal how
ESRD is treated in the United States. To address these concerns, this research will explore the
history, describe the current conditions, and then suggest possible futures for the ESRD program.
Through this research, I will argue that the Medicare ESRD Amendments were a unique
phenomenon of the moment, the result of a perfect storm. The technology was available to save
lives and it worked. Dying people could be released from the grim reaper’s grasp. Further, not
only did the technology save people, but it also had the capacity to restore terminally ill
individuals to new normal and productive lives. This idea was irresistible to politicians and
providers. However, while created with good intentions, the ESRD program was a strategic
mistake. Caught up in the rescue fantasy, politicians and providers gave inadequate forethought
to the ethical, economic, and regulatory demands the program would impose on the federal
government.
As it turned out, the program would be a victim of its own success. It did work. With
federal financing in place, dialysis was available to those who needed it and, therefore, countless
lives were saved. However, several unintended consequences of the success of the program
Ibid; also see, “Invasive Methicillin-Resistant Staphylococcus aureus Infections among Dialysis Patients United States, 2005,” http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5609a3.htm (accessed November 22,
2008).
5
2
would result in troubles. Once opened up to all, a large and diverse patient population flooded
into the system. Some patients were more ill than others; some patients were less compliant than
others; some patients were older than others. All these differences made the ESRD program an
enormous and unexpected expense to the federal government.
With the cost of renal care sky-rocketing, someone needed to be accountable for the
organization and coordination of the program. This need was filled with layers of governmental
bureaucracy. One department negotiated reimbursement rates with doctors, another department
negotiated rates with hospitals and clinics, and yet another coordinated benefits for those who
qualified. However, for all the problems and unintended consequences, I will argue that the
ESRD Amendments are more than just a run-of-the-mill federally funded health-care program.
The Amendments created a legal right, a moral promise, and a special covenant between the
federal government and patients with a life-threatening illness wherein the government promised
to care for vulnerable people.
I contend, and will argue in detail later, that, although the ESRD program bears
resemblance to a contractual agreement in which the federal government is merely legally bound
to fund ESRD services, the program has created a much more meaningful relationship. In effect,
the ESRD program is a secular covenant in which the government has not only established the
rights of the patients, the duties of the federal government, the conditions of the program, and the
qualifications that limit the agreement but also, through the government’s promise to care for a
vulnerable population, a covenantal relationship.6
In particular, and as explained in the latter chapters of this dissertation, the substantiation
of the covenantal relationship, rather than the classification as a legal contractual relationship, is
6
Stephen Lammers and Allen Verhey, eds,. On Moral Medicine: Theological Perspectives in Medical
Ethics (Grand Rapids, MI: William B. Eerdmans, 1998), 131.
3
established by both the philanthropic nature of the program, as well as the change of being
experienced by the ESRD patients.7 While a contract, “does not rely on the pose of philanthropy
. . . ,” a covenant establishes a donative relationship of benevolence.8 Clearly, the ESRD
program contains elements of compassion and charity. The federal government made a
humanitarian gift of federal sponsorship. That gift promised that the government would, without
expectation of reciprocation, assume responsibility for the heath care needs of individuals who
were suffering and dying from kidney failure.
Without a doubt, the support of the government forever changed the lives of the
recipients. While a contract is “an involvement with a partner in time . . . , ” a covenant entails
“the notion of a change of being, a covenanted people is changed utterly by the covenant.”9
Lacking federal intervention, many individuals who were in kidney failure would have died.
Without federal dollars, access to services to some individuals would have been completely
denied. The ESRD program transformed the lives of individuals in kidney failure; it was a
humanitarian federal gift that can be best viewed as a secular covenant.
As a covenantal arrangement between the government and ESRD patients, there is a
special obligation to ESRD patients and ESRD patients alone. Thus, the government is legally,
morally, and covenantally bound to support and continue to support, the health care of ESRD
patients, and, because of the gravity of the promise, it is one that should not and must not be
broken.
7
Ibid, 130-131; also see, William May, Ethics in Medicine: Historical Perspectives and Contemporary
Concerns, ed.,Stanley Reiser, et al. (Cambridge, MA: MIT Press, 1977), 88, Robert Veatch, The Physician Patient
Relation: The Patient as Partner Part 2 (Bloomington, IN: Indiana University Press: 1991), 30-32.
8
Lammers and Verhey, 131.
9
May, 88.
4
Nevertheless, I believe that there are better ways to manage the program. I contend that
investment in the prevention of diseases that lead to ESRD, such as diabetes and hypertension,
research and development into new drugs and technologies, and changes in the organ donor
pattern, may help the program be more efficient, which in turn could lead to a less expensive and
more functional program for providers and patients as well as the federal government.
To substantiate my thesis, the first chapter of this research gives an overview of the early
years of medical treatment for ESRD, from immersion in warm baths and blood letting with
leaches, to the administration of diaphoretic mixtures, with nitric acid in alcohol, and the use of
antimonial wine. It then offers a definition of kidney failure, and leads up to the invention of the
dialyzer by Dr. Willem Kolff and the shunt by Dr. Belding Scribner.
Chapter 2 covers “God Squads,” or “Life or Death Committees,” as they were less
humorously named, and their use in ESRD resource allocation decision making. The function of
these committees was to evaluate not only the patient’s medical condition, but also his/her worth
to the community.10 The God Squads, which were mostly made up of representatives of the
medical profession as it was then constituted, that is, well-educated white men, determined
which patients would receive the life-saving renal services and which would not.
At the height of the power of Life or Death Committees, including the infamous Seattle
Artificial Kidney Center (SAKC), social criteria were used to select the patients who would
receive services. Selection criteria included age, the patient’s ability to support himself or
herself, emotional stability and maturity, and potential for return to useful role in society.11
Davita Dialysis, “Political Advocacy and Chronic Kidney Disease,”
http://www.davita.com/dialysis/lifestyle/a/892 (accessed November 1, 2008).
11
Norman Levinsky, “The Organization of Medical Care–Lessons from the Medicare End-Stage Renal
Disease Program,” New England Journal of Medicine 329, no. 19 (November 4, 1993): 1395-1399.
10
5
Based on the information gathered, committee members would then vote, “for patient A to live
on dialysis, while rejected patient B was left to die with convulsions eased by morphine.”12
Chapter 3 transitions from the “God Squads” to trace the roots of political and public
recognition for the need for federal intervention in personal health care. Although federal support
for ESRD may have seemed to be an instant miracle to patients suffering from kidney failure, the
inclusion of ESRD under the Medicare umbrella was not a straightforward occurrence. The roots
of the addition of ESRD to Medicare can be traced to the endorsement of social insurance. Only
then would there be a political culture that would allow for the ratification of Medicare. With the
acceptance of a need for a Medicare system, Congress could pass the ESRD program, portrayed
as a gap in the health care system that should be filled by federal monies.
Chapter 4 addresses the movement from social insurance to the ratification of the
Medicare ESRD amendment in 1972, with an historical examination of how the ESRD program
came to be a part of the Medicare system, discussing the political environment that created the
perfect storm for endorsement of the ESRD amendments. With the ESRD amendments in place,
renal patients became the only disease-specific population entitled to federal coverage for
services, and their coverage under Medicare is unconditional. However, the remarkable feature
of the program was that it created heroes out of ordinary people: politicians. With technology,
providers were able to “save” people who would without medical intervention surely die.
Politicians became superheroes who swept in and rescued people through humanitarian
financing.
The research continues in chapter 5 by delineating the assumptions made by legislators
when they ratified the ESRD amendments and reveals how these assumptions had serious, as
12
Friedman and Bower.
6
well as dangerous, effects on the continuation of the program. Chapter 5 continues with the
consequences of the ESRD amendment in the management of chronic kidney disease. In
particular, the chapter addresses the transformation of the population eligible for the ESRD
program at its inception to the current population receiving services paid for by the Medicare
ESRD program. This includes an investigation of the changes in the ethnic, gender, age, financial
status of the ESRD population, as well as treatment compliance in this patient population.
A careful examination of the transformation in the patient population is essential to the
understanding of the ESRD program. Demographics have truly had a profound and marked
effect on the program. Not only have changes in the make-up of the patient population altered
the financial demands that ESRD puts on the Medicare program, but the change in the patient
population has also had a drastic effect on the delivery of renal services.
Chapter 6 investigates the parameters of an entitlement program and includes a summary
of the ESRD services covered by Medicare. I question whether the services provided by the
program are meeting the needs of the patient population. In addition, I ask whether what the
government is paying for is the best (and most cost effective) way to address and manage the
disease for patients and providers. In order to answer these questions, it is essential to consider
how the provision of patient services and provide reimbursement affects the delivery of care.
Chapter 7 concludes with a reflection on the future of the program, considering an issue
central to the ethics of ESRD entitlement. If ESRD patients have the right to treatment, why not
federally sponsor all care for all patients who are in need of life saving procedures? Renal
disease is not the only potentially fatal illness for which treatments are available. With a
significant infusion of federal funding, medical professionals could “save” individuals afflicted
with the other disease entities, such as cancer, HIV/AIDS, and Parkinson’s, at the very least.
7
To include ESRD in the Medicare program was a voluntary decision made by the federal
government. Even though pressured by special interest groups, the government did not have to
amend the Medicare bill to include individuals with ESRD, but, in 1972, they did. When the
Medicare bill was amended, it established a legally enforceable right of ESRD patients to federal
sponsorship for their health care needs. Further, by guaranteeing federal coverage, the
government created for itself a moral obligation to ESRD patients. However, because of the
gravity of the promise to the life ESRD patient, the program evolved from just a legal right and a
moral responsibility into a secular version of a live-saving covenant between ESRD patients and
the federal government.
Renal disease is the only life-threatening disease for which the federal government made
such a special promise. Thus, the government is only required to support treatment for ESRD.
Unfortunately, this means some other individuals may be altogether shut out from the health care
system. Chapter 7 addresses the question: is it just to allocate federal monies on the basis of
disease status, thereby entitling some individuals to federal health care while others go without?
Although the study of the ESRD program is an examination of the past, it provides a
unique parallel to the present environment. Undeniably, the health-care delivery system today is
a mess. Nobody, not patients, not providers, not politicians, is satisfied with how things are
operating. Politicians up for election, providers ensconced in health care delivery, and patients
snubbed by the system tout the need for an overhaul. We sit on the verge of potential collapse or
major change. Some clamor for a federally sponsored universal health-care program. Physicians,
perhaps for the first time, are joining in that call. However, before we make the leap into another
near universal entitlement program, we must examine what happened with ESRD, when a
8
heartfelt, well-intended attempt was made to protect a vulnerable population. Then, we must
consider how we can manage our ambitions in order to make sure that our intentions are realized.
9
Chapter 1: An Overview of Medical Treatment for End Stage Renal Disease
The kidneys are a pair of bean-shaped organs, each about the size of a fist, located behind
the stomach. Their purpose is to filter bacteria, extra salt and water from the human body. The
filtering happens in small units inside the kidneys called nephrons.13 Healthy nephrons remove
extra water, which becomes urine, and waste products. The wastes in the blood come from the
normal breakdown of active tissues and from the food an individual eats. After the body has
taken what it needs from the food, waste is then sent to the blood. If the kidneys fail to remove
wastes, and the medical condition goes untreated, the wastes will build up in the blood.14
When waste builds up substantial and irreversible harm can occur to the body. Damage in
individuals with kidney failure is most often the result of a condition called uremia. Uremia, or a
build up of urea in the blood, causes the hands and/or feet to swell and leaves the individual
feeling tired and weak because the body lacks clean blood to function properly. 15 If a build up in
waste goes untreated, it can lead to seizures or coma and will ultimately result in death.16
The kidneys can stop filtering wastes when damage occurs to the nephrons. Often, illness
or injury is what keeps the kidneys from working correctly. Damage to the kidneys can occur
suddenly, such as an accident that directly injures the kidneys. For example, the rapid loss of a
significant amount of blood can cause sudden kidney failure. Further, some drugs or poisons can
One healthy kidney has approximately a million nephrons. Christine Chmielewski, “Renal Anatomy and
Overview of Nephron Function,” Nephrology Nursing Journal 30, no. 2 (April 2003): 185-193.
14
American Family Physician, “Kidney Failure,” http://www.aafp.org/afp/20030615/2539ph.html
(accessed November 22, 2008); also see, National Kidney Disease Education Program, “Kidney Disease
Information,” http://www.nkdep.nih.gov/patients/kidney_disease_information.htm#1 (accessed November 22,
2008).
15
Ibid.
16
Ibid.
13
10
cause the kidneys to stop working. Rapid decline in kidney function is called acute renal failure
(ARF). ARF may lead to permanent loss of kidney function. However, if the kidneys are not
seriously damaged, acute renal failure may be reversible.17
Although ARF is a cause of kidney failure, most kidney problems occur slowly over a
long period of time. The gradual loss of kidney function is called chronic kidney disease (CKD)
or chronic renal insufficiency.18 People with CKD may progress to permanent kidney failure. In
untreated kidney failure, bacteria and salts will build up, resulting in devastating effects on the
body. The heart may be damaged and congestive heart failure can result. Impaired memory,
confusion, disorientation or poor thinking processes, hallucinations, delirium, convulsions and
coma or even strokes may also occur.19
Because kidney failure can be a slow progressing disease, symptoms often go unnoticed
and individuals may not be aware that damage is happening.20 Early indicators of kidney
problems may include a need to urinate more often or less often. Other symptoms are fatigue,
itchy skin, loss of appetite, or nausea and vomiting. Swelling or numbness of the hands or feet,
drowsiness, trouble concentrating, darkening of the skin or have muscle cramps are frequent
signs.21
In an attempt to encourage the early diagnosis and prevent the devastating affects of
kidney failure the National Kidney Foundation has published Practice Guidelines for Chronic
Kidney Disease. The NKF recommends early screening, particularly for those who are at greater
National Kidney and Urologic Diseases Information Clearinghouse, “Your Kidneys and How They
Work,” http://kidney.niddk.nih.gov/kudiseases/pubs/yourkidneys/ (accessed November 22, 2008).
18
Ibid.
19
Alan Kilger, “How CKD Affects Your Body,” Kidney Beginnings: The Magazine 3 (June/July 2004),
http://www.aakp.org/aakp-library/how-ckd-affects-your-body/ (accessed November 7, 2008).
20
American Family Physician; also see, National Kidney Disease Education Program.
21
National Kidney and Urologic Diseases Information Clearinghouse, “Your Kidneys and How They
Work.”
17
11
risk; persons with hypertension, diabetes, a history of kidney problems in their family or those
falling into ethnic groups that are at particular risk such as African Americans or Hispanics.22
The National Kidney Foundation recommends three tests to screen for kidney disease: a blood
pressure measurement, a spot check for protein or albumin in the urine (proteinuria), and a
calculation of glomerular filtration rate (GFR) based on a serum creatinine measurement.23
To categorize the progression of chronic kidney disease the GFR, which provides an
indication of how well the kidneys are working, is most often used. A base line GFR level of 90
or above is considered normal. Stage 1 chronic kidney disease involves some level of kidney
damage with a normal GFR (90 or above). In the first stage of kidney disease, the goals of
treatment are to slow the progression of CKD to reduce the risk of heart and blood vessel
disease. Stage 2 chronic kidney disease involves kidney damage with mild decrease in GFR;
levels are from 60 to 89. As kidney function begins to decline, providers will approximate the
progression of the CKD and continue to recommend treatments to reduce the risk of health
problems. Stage 3 chronic kidney disease involves a moderate decrease in GFR; levels from 30
to 59. When CKD has advanced to stage 3, anemia and bone problems become more common.
Stage 4 chronic kidney disease involves a severe reduction in GFR -15 to 29. At stage 4, it is
recommended that the patient continue following the treatment for complications of CKD but
prepare by learning about the treatments that are available to manage kidney failure such as
hemodialysis, peritoneal dialysis, and transplantation. The last stage of chronic kidney disease,
22
Andrew S. Levey, Josef Coresh, Ethan Balk, Annamaria T. Kausz, Adeera Levin, Michael W. Steffes,
Ronald J. Hogg, Ronald D. Perrone, Joseph Lau, and Garabed Eknoyan, “National Kidney Foundation Practice
Guidelines for Chronic Kidney Disease: Evaluation, Classification, and Stratification,” Annals of Internal Medicine
139, no. 2 (July 15, 2003):137-147.
23
National Kidney and Urologic Diseases Information Clearinghouse, Your Kidneys and How They
Work.”
12
stage 5, with a GFR less than 15), is when the kidneys do not work well enough to maintain life.
At this point, in order to continue to live, the patient will require dialysis or a kidney transplant.24
The Early Days of the Treatment of Renal Disease
From 1600 until 1800, treatment for renal insufficiency was relatively crude and
elementary. The traditional methods of medical treatment involved the application of heat,
immersion in warm baths, and blood letting with leaches. In addition, the administration of
diaphoretic mixtures with nitric acid in alcohol and antimonial wine was a commonly used
procedure by medical practitioners. Moreover, it was generally accepted by physicians, who
were at the time either university educated or apprenticeship trained, that such treatments had the
ability to cure renal insufficiency within twenty-four hours.25
It was not until 1854 that significant progress was made towards the treatment for kidney
disease. An invention by a Scottish chemist would prove to be the first step toward effective
medical treatment for renal insufficiency. Thomas Graham’s research on osmotic force is the
first reference to the process of separating substances using a semipermeable membrane. In his
studies, Graham described a process by which colloids and crystalloids could be separated using
a membrane fashioned from an ox bladder.26 In addition, Graham’s investigation of osmotic
force made a critical discovery. He was able to determine that urea diffuses as fast as sodium
chloride.
24
National Kidney and Urologic Diseases Information Clearinghouse, “Your Kidneys and How They
Work.”
25
Allen Nissenson and Richard Fine, Clinical Dialysis (New York, NY: McGraw-Hill, 2005), 2.
Allen Weisse, Medical Odysseys: The Different and Sometimes Unexpected Pathways to TwentiethCentury Medical Discoveries (Piscataway, NJ: Rutgers University Press, 1991), 89.
26
13
Graham’s definition and experimental proofs of the laws of diffusion and osmosis are
classics on which the very essence of which dialysis is based.27 Graham, “described in very
specific terms the relationship of solute diffusion rates to molecular size, showing that the larger
the molecule the slower the diffusion rate. These principles are used by every dialysis
practitioner today.”28 Further, Graham termed the passage of solutes at a high concentration in a
solution on one side of the semipemiable membrane across to a solution with a lesser
concentration of the same molecules dialysis.29
The Early Days of the Artificial Kidney
The first attempt to construct a device that would filter the blood and thus serve as an
artificial kidney was made by Abel, Rowntree, and Turner and published in 1913. Their
apparatus consisted of a branch network of colloidion tubes that were semipermeable. The
apparatus was able to conduct blood through a small rinsing solution and remove salicylate from
the blood in order to treat salicylate intoxication. Abel, Rowntree, and Turner tested their
creation on dogs in an attempt to produce an apparatus for the treatment of salicylate intoxication
in man.30 While their devise was ingenious, in that it was able to filter blood, the tubes had to be
constructed by hand, which was extremely time-consuming.31
Following on the work of Abel, Rowntree, and Turner, other scientists made several
attempts to construct an artificial kidney. None of the other inventions, however, proved safe for
27
Nissenson and Fine, 2-3.
Ibid., 3.
29
Weisse, 89.
30
J. P. Merrill, “Early Days of the Artificial Kidney and Transplantation,” Transplant Proceedings 13, no.
1, suppl 1 (March 1981): 4.
31
Ibid.
28
14
use on humans. It was not until World War II that a Dutch physician constructed a machine that
transformed the artificial kidney from a scientific aspiration to a medical reality.32
The First Clinical Dialysis
Scientist George Haas began his studies of hemodialysis in 1914 at the University of
Geissen in Germany. Haas’s early research involved animals and was relatively unsuccessful
because he was unable to satisfactorily achieve diffusion. Before Haas could make any further
attempts at refining his investigation, his work was postponed by a call to duty to serve in World
War I. After the war, in 1919, Haas returned to the University of Geissen to continue his work.
Hass was unable to satisfactorily perform hemodialysis since he could not achieve diffusion
without an adequate anticoagulant.33 “Haas worked with various membrane materials such as
reed tubings, sheep peritoneum, and paper membrane. However, none of these was satisfactory
and they brought him complete disappointment.”34
Even though Haas’s research was flawed, he was able to perform the first clinical dialysis
on a uremic human in October of 1924. His first attempt was performed for fifteen minutes on a
patient with terminal uremia.35 His second human dialysis, which was longer than the first lasting
thirty minutes, was via the radial and carotid artery and the portal vein. In this second dialysis,
the blood passed through three dialysis cells.36 His patient, except for a mild febrile reaction,
tolerated and survived the treatment.37
32
Ibid.
Nissenson and Fine, 5.
34
Ibid.
35
Weisse, 91.
36
Nissenson and Fine, 5.
37
Weisse, 91.
33
15
For his dialysis, Haas used the anticoagulant medication hirudin. Hirudin is an
anticoagulant found in the salivary secretions of leaches. While hirudin would allow him to
successfully perform dialysis, it had its limitations. Hirudin was not an appropriate drug for longterm dialysis because possible allergic reactions as well as its potential to be toxic.38
Still searching for an appropriate anticoagulant, Haas turned to research being done in the
United States by W. H. Howell and L. E. Holt from Johns Hopkins. Howell and Holt were
working with a drug called heparin. Haas believed that heparin could be the answer to his
problem. After several trials with animals, in 1927, he administered heparin for the first time to a
human receiving hemodialysis. “Haas had finally brought all the pieces together. He had
developed a large-surface area dialyzer, he had found a workable membrane, with adequate
blood distribution, he employed the use of a blood pump, and finally he was able to utilize a
purified form of heparin, which overcame the previous problems with the allergic reaction to
hirudin.”39
However, in spite of all his success, Haas abandoned his research. Although Haas never
clearly gave a reason, a surviving relative suggested that politics with his medical colleagues
played a role in Haas walking away from his life’s work. 40 Many investigators and practitioners,
“thought that hemodialysis was too extreme a means of controlling uremia and chose to continue
the traditional methods of bloodletting, forced sweating, and dietary restrictions of protein.”41
Further, at the time his research was advancing, Haas took on duties as head of the medical
section. With Haas out of the picture, development and progress of treatments for renal failure
38
Nissenson and Fine, 5; also see, Weisse, 91.
Nissenson and Fine, 6.
40
Weisse, 92.
41
Ibid.
39
16
would be slow until one Dutch researcher took and interest in the plight of those suffering from
kidney disease. 42
The First Successful Artificial Kidney - Dr. Willem Kolff
Willem Kolff, born in Leiden, Netherlands, was the son of a physician who had no desire
to follow in his father’s footsteps. As a boy, Kolff watched his father care for patients at the
tuberculosis sanatorium. He recalled how difficult attempting to treat an incurable disease was on
his father. Kolff remembered seeing his father so saddened by the situation of the patients and
frustrated with the disease that he was brought to tears.43
However, Kolff changed his mind and chose a career in medicine. Although a reluctant
physician, Kolff became a crucial to the treatment of kidney disease. When he graduated as a
physician from the University of Leiden 1938, he took a position at the University of Groningen
in the Netherlands.44 According to Kolff, while at the University, “I was the youngest volunteer
assistant in the Department of Internal Medicine of the University of Groningen and my
responsibility was to take care of 4 patients. One of these patients slowly and miserably died of
uremia. If I could have removed only as much urea and other retention products from this man’s
blood as he would produce every day, the man could have lived.”45
Moved by the slow and miserable deaths of renal patients, Kolff conceived of a way to
treat these patients:
I had learned about the dialyzing capabilities of cellophane membranes….I also had
handled blood from outside the body for blood transfusion and plasma transfusion. The
42
Nissenson and Fine, 5-6.
Weisse, 93.
44
Ibid; also see, Willem Kolff, “Past, Present and Future of Artificial Kidneys,” Transplant Proceedings
13, no. 1 Suppl 1 (March 1981): 35.
45
Ibid.
43
17
problem became a rather simple one to build an apparatus with a large enough surface
area so that it would remove sufficient urea from a small volume of blood. I took a piece
of cellophane tubing and put only a small volume of blood in it. I added 400 mg/dl of
urea and shook it in a bath with saline. Within 5 min practically all the urea was removed
by dialysis. A simple multiplication taught me that a cellophane tubing 10 or 20 m long
containing 500 ml to 1 liter of blood would be required to remove sufficient urea from a
patient’s blood to keep the patient alive.46
As was the case with Haas before him, Kolff’s work was interrupted by war. When a
Dutch Nazi took over as the head of his department, Kolff’s position was untenable. He decided
that he could never work for a Nazi and thus felt as if it was best for him to leave his position
before his new supervisor took office.47 Kolff then accepted a position working as an internist at
a ninety-bed hospital in the little town of Kampen, Holland where between 1943 and 1944, he
constructed the first working dialyzer.48 49 Kolff’s device, “consisted of a rotating barrel, around
which were wound tubes of cellophane. These tubes of cellophane were in fact ordinary sausage
casing, but suited the purpose of dialysis admirably. The blood was led through the tubing, which
was immersed by the rotating drum in a rinsing fluid beneath the drum and, dialysis having
occurred in this process, was returned to the patient.”50
Remarking on his device Kolff stated:
The first patient treated in 1943 was a woman with chronic renal failure. Starting with
only 0.5 liter of blood per dialysis, we gradually increased the amount until we dialyzed
20 liters of her blood, and I saw a clear fall in the blood urea. In one patient with acute
renal failure we were able to remove 263 g of urea in one single dialysis, which I believe
still is a world record. We determined that creatinine, uric acid, certain phenols and
indoxyl were also removed by dialysis, and we demonstrated that the electrolytes could
46
Ibid.
Weisse, 94.
48
Merrill, 4.
49
Weisse, 94.
50
Merrill, 4.
47
18
be regulated. If the sodium was too high it was reduced, if it was too low it was
increased. Potassium could be rapidly removed from the blood, and the concentration of
electrolytes in the blood plasma water would approach those of the dialyzing fluid thus
being normalized. Patient 10 was the first who recovered. But he might have recovered
without dialysis had we catheterized his obstructed ureters first.51
Kolff’s first real success in significantly extending an individual’s life with dialysis was
in September of 1945 with a seventy-five year old woman named Sofia Schafstadt. Schafstadt
was brought to Kolff in a uremic coma due to acute renal failure. After receiving eleven hours of
dialysis, she recovered consciousness. Schafstadt lived another seven years before dying of
another illness. In a twist of irony, Kolff, a Dutch patriot and political liberal, had his first
medical success on Schafstadt, a Nazi sympathizer who was believed to have been an informant
who betrayed many of her countrymen to the Germans.52 When asked about why he, a political
liberal, would save the life of a Nazi sympathizer Kolff commented, “If a patient needs help to
save his life you give that help and don’t ask whether he is a National Socialist [Nazi] or
anything else”53
As the Nazi occupation began in Kampen, Kolff’s work came under scrutiny. The
medical officer from the local Wehrmacht garrison critically investigated Kolff’s invention.
When examining the machine the medical officer commented, “Ja. Das ist der Apparat den ich es
aus der Liteature Kenne.” (Yes. This is the apparatus as I recognize it from the literature).
54
Although Kolff had not yet published his findings, and the general public was not aware of his
advances in research, the officer felt compelled to act as if he knew about Kolff’s invention
51
Kolff, 35.
Weisse, 96-97.
53
Ibid., 97.
54
Ibid., 87.
52
19
which may be an indication of the magnitude of Kolff’s standing and the importance of his work
to the medical community.
As the war continued, Kolff continued his research on dialysis in Kampen. When the
Germans were close to retreating from the Netherlands they decided to transport a large portion
of the Dutch male population to Germany to work on fortifications. Among the prisoners were
the deaf and the blind, paralytics, mental defectives, as well as diabetics who were without
insulin.55 As the Nazi’s prepared to deport the prisoners, a local physician approached Kolff and
requested he help him to save the sick. Kolff approached the commander in charge and requested
permission to care for the ill. The commander replied, “Who will be responsible? All these
people are terrorists.”56 Knowing the consequences may be grave; Kolff believed in the value of
life and replied that he would be personally accountable. “Very well,” said the Nazi officer, “but
if they run away, you will be shot.”57
Even though his work was delayed by the war, when it ended Kolff and his team had the
resources to donate dialysers to hospitals around the world. Facilities that received the generous
gifts included facilities in Great Britain, Canada, and the United States. In the U.S., one of the
machines was donated to Mt. Sinai Hospital in New York. Consequently, he was invited to give
a demonstration on how to use the machine. Kolff’s invitation to Mt. Sinai was followed by an
invitation to other teaching hospitals including Harvard’s Peter Bent Brigham Hospital.58
Interested in the opportunity to further his research in the United States, especially to
advance his research from the artificial kidney to the heart-lung machine, and wary of the
55
Ibid., 97.
Ibid.
57
Ibid.
58
Ibid., 98.
56
20
Russians, Kolff made a permanent move to the United States in 1950.59 There he accepted a
position at the Cleveland Clinic and continued his work on the artificial kidney. While at the
Cleveland Clinic, he found, “the stainless steel version of the rotating drum artificial kidney
costing $6000 – whereas the old ones cost $200, both worked equally well.”60
Interestingly, in the 1950s at the beginning of treatment for kidney disease, Kolff, an
outsider to the health care system in the United States, realized a factor in escalating costs for
treatment. He was able to see that the high costs of treatment may be due in part to the expense
of the equipment. Further, Kolff had a simple suggestion for cost containment. While treatments
could be performed using a $6000 machine, why not use a proven system that was a fraction of
the cost. An interesting issue to consider is if using a $200 machine, rather than a $6000
machine, would have opened up treatments for kidney disease to more people making rationing
less necessary.
By 1959, Kolff noted the United States had numerous facilities where artificial kidneys
were found and where there were doctors had been trained by to run the facilities. Since the high
cost of dialysis continued to concern Kolff, he attempted to develop an alternative and less
expensive method to offer treatment to patients. His idea was to we adapt a washing machine so
that it could be used for dialysis. However, this concept was not well received by the makers of
washing machines. Maytag, in particular, was wary of the utilization of parts they manufactured
for dialysis, and was concerned with the legal consequences of the off label use of their
equipment.61
59
Ibid., 99.
Kolff, 36.
61
Ibid.
60
21
With washing machines no longer available for use, in 1967, Kolff moved from
Cleveland to Salt Lake City in order to attempt to use nose cones of rockets to continue his work
on the artificial kidney. However, although Kolff continued to make progress on the artificial
kidney, dialysis for the long-term maintenance of chronic kidney failure was complicated.
Repeated treatment was difficult because with each treatment the radial artery in the forearm
vein had to be cannulated surgically in an operating room, which is incredibly expensive as well
as time-consuming. Furthermore, and contributing to the problem of reoccurring dialysis, is that
the numbers of vascular access sites on a patient are limited. Nonetheless, an invention by a
professor from the University of Washington would bypass these barriers to chronic dialysis and
revolutionize the treatment for chronic kidney failure.
The Beginnings of Chronic Dialysis - Dr. Belding Scribner and the Teflon Shunt
The idea of maintaining a consistent mode of access to a patient’s blood stream was
brainchild of Dr. Belding Scribner. (Scribner, who received his medical degree from Stanford
University in 1945 and joined the faculty at the University of Washington after completing his
residency in medicine at San Francisco Hospital and a fellowship in Medicine at the Mayo Clinic
in Rochester, Minnesota, developed the concept for a device that could be permanently installed
in a patient’s arm to make long-term dialysis possible.62) Scribner chose medical research, not
clinical care because of his own personal experiences. According to his wife Ethel, “He’d had his
share of problems, getting along in life . . . They began when he was a young boy . . . He was
stricken with an eye disease that eventually required multiple corneal transplants . . . That is why
University of Washington News, “UW Mourns the Loss of Belding H. Scribner,” June 20, 2003.
www.washington.edu/newsroom/2003archive/06-03archiv e/k062003.html (accessed June 1, 2008).
62
22
he went into medical research.”63 Scribner decided that his visual problems would have made it
too hard for him to practice as a clinician full-time.64
It was encounter with a patient receiving short-term dialysis that inspired Scribner to
design a medical apparatus that would allow for repeated treatments. He credited his motivation
for the shunt to a Spokane patient whom Scribner had witnessed make a startling recovery
through the early form of dialysis, but who soon died after doctors could no longer find
undamaged arteries or veins by which to treat him.65 Scribner wanted to create a U-Shaped tube
that could be sewn into the arm between an artery and a vein. An opening in the tube would then
provide a space where the dialysis machine could be plugged when in use.66
With the concept of continuous access in his mind, it would be a chance encounter in a
stairwell with a University of Washington surgeon that would introduce Scribner with the idea of
using Teflon as a material for the permanent implant.67 With the aid of engineer Wayne Quinton
and after investigating Teflon and its properties, Scribner selected Teflon tubing to create the Ushaped tube that had the potential to allow physicians to maintain continuous access to a
patient’s blood stream. Quinton and Scribner worked until they developed a smooth cannula
intima, a tube that takes or delivers liquid from the intermost layer of a vein or artery, which
would help prevent blood products from accumulating on the surface of the device. Once
Tom Paulson, “Belding Scribner believed, to be a good doctor, one must be a patient,” Seattle Post, June
21, 2003 http://seattlepi.nwsource.com/local/127718_scribner21.html (accessed November 22, 2008).
64
Ibid.
65
“Belding Scribner. 1921-2003,” Columns: The University of Washington Alumni Magazine. Extras
www.washington.edu/alunmi/colums/sept03/extras_scribner.html (accessed June 1, 2008).
66
Ibid.
67
Ibid.
63
23
completed, the Teflon tube served as the delivery system to carry the patient’s blood outside the
body and through the artificial kidney.68
The use of Teflon for the shunt's tubing was suggested by Dr. Loren Winterscheid.
Winterscheid reasoned that Teflon would be the best material to use since it would not react with
human tissue. In retrospect, Scribner admitted that he chose Teflon for the wrong reason. Only
later, after use, did the team realize the real key to the shunt's success. Scribner and Quinton
discovered that Teflon’s non-stick feature was essential to continued functioning.69
Scribner recounts the story: "Winterscheid asked me, 'Have you ever heard of Teflon?'
and I said no, I've never heard of Teflon.' Well, go down to central service and you'll see some
rolls of it down there,' and sure enough there were these rolls of stuff that were stamped with
'electrical contractor' on the outside . . . so I took this to Wayne and he said, "This looks like
terrible stuff to me but I'll try to figure out how to use it.' We chose it for the wrong reasons—we
chose it because the surgeon said it wouldn't react with the tissues. It was only much later that we
found out it was the non-stick properties of the Teflon that really made the shunt work in the first
place because without the non-stick surface, the shunt always clotted."70 In the end, the U-shaped
Teflon tube exhibited the characteristics and accomplished the goals that both he and Scribner
wanted.71
The first experimental tube was made and secured on the arm of an individual dying from
Bright’s Disease.72 Astonishingly, on its first attempt, the tube was a success. The patient was
68
Nissenson and Fine, 19-20.
Nissenson and Fine, 19.
70
“Pioneers in Kidney Dialysis: From the Scribner Shunt and the Mini-II to the ‘One-Button Machine’ ”
http://www.washington.edu/research/pathbreakers/1960c.html (accessed November 7, 2008).
71
Nissenson and Fine, 19.
72
Bright’s Disease is a chronic inflammation of the blood vessels in the kidney with protein, specifically
albumin in the urine. See www.medicinenet.com accessed June 7, 2008.
69
24
literally saved from his deathbed. However, despite early success, there were problems with
utilization of the shunt to provide dialysis to large numbers of patients. “In the beginning, the
tubes wore out too fast, or clotted, or became infected and had to be removed and resewn into
other parts of the body. The early machines themselves were tricky to handle. The primary need
was to simplify the entire technique from a complicated ‘operating room’ type of procedure to a
relatively simple routine, like making X-rays. Until this was done, the technique would remain
more a research triumph than a new treatment.”73
The problems with the prototype of the shunt would be solved by tweaking the device
and using the altered product in the bodies of Clyde Shields, Harvey Gentry and Kathy Curtiss.74
These human research subjects provided the data and feedback that allowed Scribner to change
and improve the shunt to be less cumbersome and more flexible and therefore able to be used for
the masses.75 Shields was a forty-two-year old machinist who underwent the implantation of
eleven successive sets of U-shaped tubes. In spite of his ordeal as a human guinea pig, Shields
says that he felt better after the experiment than he felt at any time before his treatment began. 76
Dialysis was able to extend his life in spite of non-functioning kidneys for over two years.
Gentry was a shoe salesman who went through thirteen sets of U-shaped tubes. Regarding the
research he said, “I’ve given the docs a pretty bad time, but they’ve learned a lot from me and
they always manage to keep ahead somehow.”77 Thirty-seven-year-old housewife Curtiss
Shana Alexander, “They Decide Who Lives and Who Dies: Medical Miracle Puts a Moral Burden on a
Small Committee,” Life, November 9, 1962, 123.
74
Ibid., 123-124.
75
“Pioneers in Kidney Dialysis: From the Scribner Shunt and the Mini-II to the ‘One-Button Machine’. ”.
76
Alexander, 124.
77
Ibid.
73
25
revealed that treatments with the shunt in place allowed her to carry out a full schedule of
cooking and housekeeping for her husband and two teenaged sons.78
As the shunt was widely used, several changes were made to improve the quality of the
device. Eventually, the material was changed from Teflon to silicone. However, Scribner’s
creation, “changed kidney failure from a fatal to a treatable disease, prolonging the useful lives
of millions of patients.”79 The Scribner shunt changed renal failure from a disease that was
ninety percent fatal to a manageable condition that was ninety percent survivable.80
78
Ibid.
William Couser, “In Memoriam Belding H. Scribner, MD 1921-2003,” Journal of American Social
Nephrology 14, no. 10 (2003): 2419-2420.
80
Lorette Murry, “Hemodialysis Pioneers Receive Prestigious Lasker Award,” Family Focus 11 no. 4 (Fall
2002):8.
79
26
Chapter 2: Rationing and the God Squad
With Scribner’s invention of a device that would allow consistent mode of access to a
patient’s blood stream, the medical technology existed to offer continuous intermittent dialysis to
those suffering from kidney failure. Now that the technology existed, the question of how to
finance dialysis became a question for concern. In Seattle, where Scribner created the shunt, Dr.
John Hogness, then Medical Director of the University of Washington Hospital, agreed to
provide the funds for the treatment of the first patients’ dialysis.81 Hogness believed that, “a
moral obligation required that patients once admitted to dialysis could not be denied it” 82
However, as growing numbers of patients were admitted, Hogness discovered that it was
very expensive to provide dialysis. He explained to Scribner that, until he found an alternative
means to fund dialysis, no more patients would start on dialysis at the University of Washington
Hospital.83 A resourceful individual, Scribner turned to the John A. Hartford Foundation to
secure external funding to support dialysis. With a $100,000 grant, on January 1, 1962, Scribner
opened the Seattle Artificial Kidney Center (SAKC) at Swedish Hospital.84
Although the establishment of the SAKC was a momentous occurrence, before the doors
even opened, problems were anticipated. Planners, “estimated that between five and twenty
candidates existed among every one million people. The nine-bed capacity of the center would
81
Albert Jonsen, The Birth of Bioethics (New York, NY: Oxford University Press, 1998), 211-212.
Ibid., 212.
83
Ibid.
84
Ibid.
82
27
be stressed after its first year, since patients would need treatment indefinitely.” 85 With the influx
of patients, “costs would be staggering and would fall largely on parties other than the patients.”86
Scribner himself was not blind to the troubles with cost and access that were on the horizon. He
admitted that he “could see the handwriting on the wall.”87
Once the SAKC was opened, fears were confirmed. The demand for ESRD services far
outweighed the capacity to deliver. Scribner saw that there was a rapidly growing chronic
dialysis population and the SAKC had reached its capacity.88 Therefore, with limited resources,
difficult rationing decisions had to be made as to which patients would receive dialysis, and live,
and which patients would not get services, and die.
Rationing of ESRD services at the SAKC was done through committees appointed by
The Board of Trustees of the Seattle King County Medical Society. At the SAKC, two different
groups were utilized sequentially to determine whether the patient was worthy of receiving
dialysis. The first committee to evaluate the potential patient was the Medical Advisory
Committee, which was composed solely of physician members. The Medical Advisory
Committee evaluated the individual for physical, financial and mental health. Patients were
screened for diabetes, high blood pressure, bone disease, and other medical conditions that could
potentially pose a medical threat to the success of dialysis. More specifically, at the SAKC, the
health related selection criteria included:
A stable emotionally mature adult under the age of 45 who is disabled by symptoms of
uremia.
Absence of long-standing hypertension and permanent complications therefrom,
particularly coronary artery disease and cerebrovascualar or peripheral vascular disease.
85
Ibid.
Ibid.
87
Ibid.
88
Nissenson and Fine, 20.
86
28
Demonstrated willingness to cooperate in carrying out the prescribed medical treatment,
especially dietary restrictions.
Renal function should be stable or deteriorating slowly since any residual function
simplifies the therapeutic process.89
After passing the physical heath portion of the screening, the potential patients were then
evaluated on basis of their financial resources. Prospective patients would need to show the
committee evidence of at least $30,000 in assets (over $1 million in today’s money) in order to
cover their portion of the costs of three years of treatment. The financial screening criteria at the
SAKC specifically stated that there were to be, “No children or young adults who are not
potentially self-supporting.”90Thus, by excluding children, who are too young to be employed
and therefore may not have access to capital, and young adults, who may also be too young to
have substantial income from employment prospects, the SAKC criteria were attempting to
ensure that patients would have access to money. This may have been the committee’s way of
assuring that patients could support themselves, pay for the dialysis treatments and not be a
financial burden to the system. 91
Those individuals who passed the medically-based criteria also were assessed on their
psychological health, their ability to handle the stress of dialysis. Mental health, however, was
and is difficult to assess. It is hard to know exactly how a patient will handle the stress and
restrictions of treatment, or how a patient’s family will respond to the pressure of caring for the
Denise Rose, Glenda Harbert, Dick Goldman, and William Winslade, “The Law and Ethics of
Entitlement in End Stage Renal Disease,” unpublished paper, Instiute for the Medical Humanites, The University of
Texas Medical Branch at Galveston, 14.
90
Ibid.
91
“Political advocacy and chronic kidney disease.”, also see, Levinsky, 1395-1399, Jonsen, 212.
89
29
dialysis patient, or how the patient will respond to the financial burdens of the expensive
treatments, as a result, psychological health can be unpredictable. 92
However, if after careful assessment by the physician run committee, the patient was
deemed physically, financially and mentally appropriate to receive dialysis, the Medical
Advisory Committee at the SAKC, would recommend review by the Admissions and Policy
Committee for further judgment. 93
The Admission and Policies Committee of the Seattle Artificial Kidney Center at Swedish
Hospital
After meeting the qualifications of the Medical Advisory Committee, potential patients
were then reviewed by a committee that used a set of standards-based social criteria. The
Admission and Polices Committee of the Seattle Artificial Kidney Center at Swedish Hospital
was known as the “God Squad,” the “Death Squad,” or the “Life or Death Committee.” Here lay
people evaluated the patient’s “worth” to the community.94 The criteria used by the committee to
evaluate the patient’s social value included, “age and sex of the patient; marital status and
number of dependants; income; net worth; emotional stability, with particular regard to the
patient’s capacity to accept the treatment; educational background; nature of occupation, past
performances and future potential and names of people who could serve as references.” 95 The
culmination of these criteria would to allow the committee to determine who was deserving of
dialysis.
92
Ibid. also see, Levinsky, 1395-1399, Jonsen, 212.
“Political advocacy and chronic kidney disease.”
94
Alexander, 102-125.
95
Ibid., 106.
93
30
When asked to comment about the committees Dr. Willem Kolff, who invented the first
dialysis machine, stated in an interview, “At one point, there were death committees to decide
who should receive the dialysis treatment and who should be left to die. I strongly argued against
this deplorable system. By the mid-1960s, fewer than 800 Americans were sustained by
hemodialysis, although there were more than 10,000 qualified patients. This problem worsened
by the early 1970s, when the number of qualified but untreated patients exceeded 20,000.”96
Kolff continued, committees determined, “whether a patient was married or divorced, employed
or unemployed. If the answers were appropriate, he could be dialyzed, if not, he could not.”97
Although he offered no alternative means to make resource allocation decisions, Kolff regarded
God Squads as immoral. “I . . . kept wondering why a concept entirely foreign to a Western
philosophy has not met with more resistance,” he said.98
Seattle’s “God Squad” was comprised of seven members, who voted to establish a level
of anonymity within their committee. They agreed, at the first meeting, not to reveal their own
names; at the second, they agreed that did not want to know the real names of the patients. 99
Clearly, not to know the names of the patients they reviewed was understandable. Knowing the
names of the potential patients creates a real connection, a level of intimacy, which would cause
decision making and the denial of services even more difficult. Further, because they lived
within the community, it is possible that they may even know the person applying for dialysis.
To be acquainted with the potential patient could have damaging affects on the impartiality of
the decision-making of the committee. It could bias the committee member to vote for the
“Political advocacy and chronic kidney disease.”
Kolff, 36.
98
Ibid.
99
Alexander, 106.
96
97
31
potential patient, if they liked the individual, or against the patient, if they had negative feelings
toward the individual.
In addition, the desire to keep their identity unknown is reasonable. The gravity of the
decisions they were called to make, to allocate services to one individual so that he/she will live
and deny services to another individual who will die, could create safety issues for the member
and his/her family. Patients who are denied services are bound not to be happy with the decision.
If the public knew the names of the individuals responsible for the denial of care, members of the
committee could be in danger of censure or retaliation.
The members of the “God Squad,” or the Admission and Polices Committee of the
Seattle Artificial Kidney Center at Swedish Hospital, were a lawyer, a minister, a banker, a
homemaker, an official of state government, a labor leader and a surgeon.100 In general, the
committee members did not know one another and only had a vague idea of the purpose of the
committee.101 Clearly, when agreeing to serve, committee members knew that they would be
making difficult decisions about the allocation of dialysis services. However, until they began to
review actual charts of real people who were terminally ill and who would die without dialysis, it
is unlikely they had a clear understanding of how difficult and draining their roles would be.
Each month the committee members received approximately a dozen charts of
individuals with end-stage renal disease. Their unpleasant task was to then select one or two
individuals they considered “worthy.” Those selected received dialysis; those not selected did
not.102
100
Ibid.
Ibid.
102
Albert Jonsen, “The God Squad and the Origins of Transplantation Ethics and Policy,” Journal of Law,
Medicine & Ethics 35 Issue 2 (Summer 2007): 238-40.
101
32
At their first meeting in the summer of 1961, the Committee, “was briefed by two
physicians, both kidney specialists, who described the new Artificial Kidney Center then under
construction, and explained why some grim life-or-death choices would soon have to be made.
The doctors explained that the committee would never be asked to make medical decisions. All
prospective patients would be prescreened by a board of physicians which would weed out all
medically or psychiatrically unsuitable candidates.”103 The two physicians who conducted this
initial briefing told the committee, “there were no guidelines, they were on their own.”104
Through the prescreening and briefing process, the medical board in Seattle had made
some very important decisions for the committee. “the doctors recommended that the committee
begin by passing rules to reject automatically all candidates over 45 years of age. Older patients
with chronic kidney disease are too apt to develop other serious completions, the medical men
explained.”105 In addition to recommending the rejection of older patients, the doctors thought
that, the committee should reject patients that were too young. Their thought was that, “The
nature of the treatment itself might cruelly torment and terrorize a child, and there were other
purely medical uncertainties, such as whether a child forced to live under the dietary restrictions
would be capable of growth.”106
Below is the transcription of the dialogue that took place at one of the committee’s
meetings. It is important to note that this conversation is pieced together, not from actual
transcripts, but from the memories of those in attendance:
Lawyer: The doctors have told us they will soon have two more vacancies at the Kidney
Center, and they have a list of five candidates for use to choose from.
103
Alexander, 106.
Ibid.
105
Ibid.
106
Ibid.
104
33
Housewife: Are they all equally sick?
Dr. Murray: (John A. Murray, M.D. Medical Director of the Kidney Center.) Patients
Number One and Number Five can last only a couple more weeks. The others probably
can go a bit longer. But for purposes of your selection, all five cases should be considered
of equal urgency, because none of them can hold out until another treatment facility
becomes vacant.
Lawyer: Are there any preliminary ideas?
Banker: Just to get the ball rolling, why don’t we start with Number One – the housewife
from Walla Walla.
Surgeon: This patient could not commute for treatment from Walla Walla, so she would
have to find a way to move her family to Seattle.
Banker: Exactly my point. It says here that her husband has no funds to make such a
move.
Lawyer: Then you are proposing we eliminate this candidate on the grounds that she
could not possibly accept treatment if it were offered?
Minister: How can we compare a family situation of two children, such as this woman in
Walla Walla, with a family of six children, such as patient Number Four – the aircraft
worker?
State Official: But are we sure the aircraft worker can be rehabilitated? I note that he is
already too ill to work, whereas Number Two and Number Five, the accountant, are both
able to keep going.
Labor Leader: I know from experience that the aircraft company where this man works
will do everything possible to rehabilitate a handicapped employee . . .
Housewife: If we are still looking for the men with the highest potential of service to
society, then I think we must consider that the chemist and the accountant have the finest
educational backgrounds of all five candidates.
Surgeon: How do the rest of you feel about Number Three – the small businessman with
three children? I am impressed that his doctor took special pains to mention that this man
is active in church work. This is an indication to me of character and moral strength.
Housewife: Which certainly would help him confront the demands of the treatment…
Lawyer: It would also help him to endure a lingering death…
34
Minister: Perhaps one man is more active in church work than another because he
belongs to a more active church.
Banker: We could rule out the chemist and the accountant on economic grounds. Both do
have a substantial net worth . . .
Lawyer: Both these men have made provisions so that their deaths will not force their
families to become a burden on society.
State Official: But that would seem to be placing a penalty on the very people who
perhaps have been most provident . . .
Minister: And both these families have three children too.
Labor Leader: For the children’s sake, we’ve got to reckon with the surviving parent’s
opportunity to remarry, and a woman with three children has a better chance to find a
new husband than a very young widow with six children.
Surgeon: How can we possibly be sure of that? . . . 107
To the outsider who reads this transcript the decision making process should be troubling.
There are so many situations that seem shocking. The rationalization of excluding a potential
patient because she could not commute from Walla Walla for treatment, but could not afford to
moce closer to the facility; not choosing a potential patient because he is active in church and
that will help him better endure a lingering death; or not choosing patients because they have
made financial provisions so that their deaths will not force their families to become a burden on
society. How can this committee of seven be so confidant that they are right about the
assumptions they are making? Maybe the immediate and extended family of the woman in Walla
Walla will rally around her and financially support her move. Maybe the man who is active in
church is involved with his congregation as a social outlet, not because he has a comforting
relationship with God. Maybe those who have made financial provisions, have staggering debt
107
Ibid., 115.
35
that will liquidate all of their resources after they die, leaving their families penniless and
homeless.
The life altering and ending decisions made by the God Squad on the basis of criteria that
were unreliable, to say the least, is disturbing. What is clearly upsetting is that, at the result of
following their guidelines, the Seattle committee allowed, for example married churchgoers with
children to receive dialysis and live, while single men with criminal records were left to die of
kidney failure.108 Because of the proclivity of the committee at SAKC to select people just like
them, with a values set that corresponded with the middle class, Seattle was described as, “...no
place for Henry David Thoreau with bad kidneys.”109
Thoughts Regarding Their Role on the God Squad
In a ground-breaking article, “Medical miracle and a moral burden of a small committee:
They Decide Who Lives, Who Dies,” Shana Alexander exposed to the public the practices of the
Seattle God Squad. Alexander revealed the role of the Admissions and Policies of the Seattle
Artificial Kidney Center at Swedish Hospital. “Behind this magnificent polysyllabic façade,” she
wrote:
stand seven humble laymen. They are high-minded, good-hearted citizens, much like the
patients themselves, who were selected as a microcosm of society-at-large. They were
appointed to their uncomfortable post by Seattle’s King County Medical Society, and for
more than a year now they have remained there voluntarily without pay.
These seven citizens are in fact a Life or Death Committee. With no moral or ethical
guidelines to save their own individual consciences, they must decide, in the words of the
ancient Hebrew prayer, ‘Who shall live and who shall die; who shall attain the measure
New York Times, “Choosing a ‘God Squad,’ When the Mind Has Faded,”
http://www.nytimes.com/2006/08/29/health/29essa.html?_r=1&adxnnl=1&oref=slogin&adxnnlx=12074480047i9XI16atKuPYhlKQ/JeHA (accessed November 23, 2008).
109
Thoreau was single and had been jailed for refusing to pay his taxes. See Levinsky, 1395-1399.
108
36
of man’s days and who shall not attain it; who shall be at ease and who shall be afflicted.’
They do not much like the job.110
In her research, Shana Alexander had the opportunity to meet with each of the committee
members, the lawyer, the minister, the housewife, the banker, the state official, the labor leader
and the surgeon, to discuss their doubts, hopes and thoughts regarding their role on the “God
Squad.”
When asked about his position on the God Squad, the lawyer stated, “When I was first
invited to be on this committee, I said I would prefer not to serve. But I knew I was capable and I
felt I would be impartial. We are dealing in this work with life that is being artificially sustained
for experimental purposes. The so-called ‘rejected’ patients would have died with or without the
committee – as, of course, we all will some day. I cannot honestly say I am overwrought by the
plight of the patients we do not choose – the ones we do choose have an awfully rugged life to
look forward to. Not all men would wish it.”111 Although it is understandable that he would
rationalize his decisions, it is hard to believe that he truly felt as if death would be preferable to
dialysis, despite its restrictions and complications. Perhaps that may be what he told himself so
that he could sleep at night.
The lawyer continued, “In theory, I believe that a man’s contribution to society should
determine our ultimate decision.” But he apparently had some doubts about what that
contribution should be. “I’m not so doggone sure,” he said, “ that a great painting or a symphony
would loom larger in my own mind than the needs of a woman with six children.”112
110
Alexander, 115.
Ibid.,115.
112
Ibid.
111
37
The minister also did some soul-searching about his role. He said that, after the first
meeting of the God Squad, “I was very bothered. I felt forced to make decisions I had no right to
make, and I felt that, of necessity, our selections would have to be made on the basis of
inadequate information. Yet oddly enough, in the choices I have made, the correct decision
appeared quite clear to me in each case. The principle of this thing has bothered me more than
the practice.”113 As a minister, he no doubt believed in his ability to make moral choices, but to
say that he had no reservations about the patients he selected for treatment begs credulity. He
either is deluding himself or taking the “God” part of his committee assignment far too seriously.
Surely, he must have had occasions where he questioned his judgment or wished that the lifesaving treatments were available to others that needed care.
In his decision-making, the minister explained that he is inclined to, “favor those
candidates who have younger children. My thinking on this is – a child who is older has had the
privilege of a parent longer, and ought to be better prepared to face life alone. But I often wonder
– suppose I should somehow meet a man I had voted against? What would I say to him? I
believe I would face it. I would tell him my reasons.”114
The minister continued, “The purpose of our committee is to protect the medical men
from just such highly emotional situations. If they have to go through emotional stress, they
cannot conserve their energies for their own work. A doctor’s job is the practice of medicine. My
job is to help people form a set of life values. And to help them accept the fact that, like birth,
death itself is a part of life – not, wham, the door slams.”115 While his role as a minister may be
to help people accept life and death, to believe that this is a part of his role in the committee is to
113
Ibid., 115-117.
Ibid.
115
Ibid.
114
38
over-step his role. His role was to select patients for dialysis, not to educate physicians on life
and death.
The Housewife explained, “All my life I have always been disgustingly healthy. Perhaps
for that reason, I am not at all medically minded. In fact, the truth is I think that doctors are apt to
be terribly stuffy – especially about new things. So it is wonderful to me to have a chance to help
in a real breakthrough. This is not something like cancer, where you still don’t know. This
treatment works! That gives me terrific hope.”116
According to her interview, the decision-making of the housewife was clearly affected
by the information provided by the physicians. “You know, the doctors usually give us their
estimate of how long a patient will live without treatment, and this information affects our
thinking a good deal. We always have hope that by some miracle the facilities can be enlarged in
time to save the patient who has some chance of living longer without this treatment.” 117 By
letting estimates of how long a patient will live, the homemaker is allowing her decisions to be
affected by inappropriate information. Her decision was to be based on social worth and social
worth has nothing to do with the quantity of life and everything to do with its quality.
The banker explained, “I’ve never had any idea how a kidney works, and I still don’t. But
I do have reservations about the moral aspects, the propriety of choosing A and not B, for
whatever reason. I have often asked myself – as a being, do I have that right? I don’t really think
I do. I finally came to the conclusion that we are not making a moral choice here – we are
picking guinea pigs for experimental purposes. This happens to be true; it also happens to be the
way I rationalize my presence on this committee.”118
116
Ibid., 117.
Ibid.
118
Ibid., 117-118.
117
39
The banker further stated, “The situation, as I see it, is life and death, complicated by
limitations of money. In this situation our function is to take the pressure off the doctors. I don’t
know if we’re doing the right thing or not. Maybe this whole deal is futile. Probably it is, in a
sense now, but maybe some economies of operation can come out of it so that everyone who
needs treatment can have it, without becoming a burden to society. It cost $15,000 a year to keep
one of these patients alive. And once you put a man on the artificial kidney, it’s for life. His life.
Where is the money coming from?”119
As a banker, the committee member, clearly sees matters in a cost and benefit situation.
However, his job is to be basing his decisions on an individual’s worth to society. Is that
equivalent to whether someone will become a burden on society? At some point in life we are all
burdens on society. Children can be burdens on their parents. Sick people are burdens on the
medical system. The elderly can be burdens on their children. However, the fact that an
individual, at some point in his/her life, was a burden to society does not negate the contributions
that they have made over a lifetime. To evaluate an individual at one specific point in time, and
make a decision as whether he/she is a burden to society is unfair.
Regarding his role, the State Official stated, “The central problem here is that medicine
has moved forward so rapidly it has advanced beyond the community’s support. Our committee
must try to bridge the gap. Our chief problem so far has been inadequate information. We have
forced ourselves to make life-or-death decisions on a virtually intuitive basis. I do have real faith
in the ability of kindly, conscientious, intelligent people to do a good job guided simply by their
instincts, but we ought not to go this way.”120
119
120
Ibid.
Ibid., 118-123.
40
Although they were never allowed to do so, he said that the committee should be able to
ask the potential patient questions directly, rather than rely on information from a physician. “I
have come to believe we can tell the patient, if we say something like this: in order to help you
best – a person who has a chronic illness, and who may be expected to have it for a long time – it
is necessary to know as much about you as possible. I believe patients will understand our
attitude. The resources of the human spirit in adversity are truly remarkable. These people can
face more than we give them credit for!”121
The Labor Leader stated, “The way I look at it, if the Seattle trial is to be a pilot for other
committees, we cannot afford any human failures. Also, we just haven’t got the funds. So I want
to pick the man with the most will power, the fellow who is least likely to give up. Suppose we
take someone on the program, keep him going for three months, and then he blows up on us?
Suppose he fails to take care of himself, or follow his diet, or gets depressed and tries to take his
own life? That can happen in these cases, you know. Well, this would deprive another patient of
the opportunity we can offer.”122 As with other committee members, the labor leader may have
swayed from the charge of the committee. They were to be evaluating potential patients based on
social worth, but the labor leader indicated that a patient’s “will power” affected his decision,
which is not an indicator of his/her worth to society.
The labor leader explained that in order to make his decisions, he relied on information
about the individual’s life, “knowing about a candidate’s past life would rate so heavily with me
– it’s an indication of character. A man’s job, his education, his wealth – that means nothing to
me. But I do think a man ought to have some religion, because that indicates character. And I
121
122
Ibid.
Ibid., 123.
41
imagine a large family would be a great help – a lot of kids help keep a man from letting down,
even when the going gets rough.”123
The Surgeon stated, “Medically speaking, I am not a discipline of this particular approach
to kidney disease. But in the larger view, this project will not just benefit one disease – it will
benefit all aspects of medicine. We are hoping someday to learn how to transplant live organs.
So far, the body will not accept tissue from another person, but eventually we will find a way to
break this tissue barrier. Meanwhile I serve on this committee not as a doctor but as a citizen and,
I hope, a humanitarian.”124 Regarding his role on the committee he stated, “Being a medical man,
I sometimes hear it via the grapevine when a patient whom we have passed over dies. Each time
this happens there always comes a feeling of deep regret, and then dreadful doubt – perhaps we
chose the wrong man. One can just never face these situations without feeling a little sick inside .
. . ”125 At least he, like the minister, had his doubts about the committee’s decisions.
In the end, the patients selected by hospital committees, the God Squad at the SAKC, as
well as committees at other dialysis centers, to receive renal services, was an exceptionally
homogenous population. In the early stages of renal treatment, ethnicity, gender and age of the
average renal patient was markedly similar. In 1967, ninety-one percent of renal patients were
white, seventy-five percent of renal patients were male, and only seven percent of renal patients
were over fifty-five. Additionally, in 1967 only twenty-seven percent of renal patients had less
than a high-school diploma and only five percent were separated, divorced or widowed.126
123
Ibid.
Ibid., 123.
125
Ibid.
126
Levinsky, 1395-1399.
124
42
In Defense of the God Squad
Clearly the decisions that the God Squad at Seattle had to make were extraordinarily
difficult. Albert Jonsen, Emeritus Professor of Ethics in Medicine at the School of Medicine,
University of Washington, spoke out about the Seattle committee:
I do not know who nicknamed this group the God Squad . . . It probably seemed witty at
the time, a way to lighten a grim duty, yet it is a strange nickname. It picks out one
characteristic of the God of Christians and Jews: one who gives life and who also takes it
away. However, it ignores other features of that God: one who is compassionate, who is
lovingly concerned for the individual, and who is a personal, not an anonymous, Lord of
life. I am not here to give a sermon, of course, but to emphasize that the Admission and
Policy Committee was not a God squad but a very human group who shared the very
human features that we associate with the Jewish-Christian God of love and mercy. I
knew Dr. Scribner well; I knew Dr. James Haviland, who thought up the Committee; and
I knew the last surviving member of the Committee. Thirty years after its inception, these
three remembered the agony of those decisions. Sociologist Renée Fox vividly described
the work of the Committee in her book, The Courage to Fail. She quotes one member
saying, "We always came out of those meetings with empty feelings.127
Jonsen’s comment that the Committee was not a God squad but, “a very human group
who shared the very human features that we associate with the . . . God of love and mercy” is a
point for consideration.128 Remembering that the members of the committee were human, with
all the glory and imperfections of human beings, is important. Humans are by nature flawed,
unlike God who is perfect. Thus humans are bound to make mistakes, unlike God who is
flawless. Thus, being merely human, members of the God Squad may have made mistakes in the
selection of some patients and the denial of others. While this may be true, there is no way to
127
128
Jonsen, 2007: 238-240.
Ibid.
43
validate the assumption. Those who were declined by the committee and denied dialysis services
died and therefore cannot speak to the mistake.
Jonsen’s position that the members also maintained the feature of love and mercy is
difficult to understand. The denial of services, which, in effect, sentenced other people to death,
is not an act of love. Further, because the decision was based on not being socially worthy, it was
not a merciful act. Mercy and love imply compassion and forgiveness for sins. By denying a
potential patient access to life saving dialysis because they are not married, or do not have
enough children, or do not have an important enough job is not merciful or loving.
In addition to Jonsen, Dr. Scribner spoke out about the God Squad. Scribner was candid
about his feeling regarding the allocation of the finite renal resources. Dr. Scribner stated:
let me make it clear that, contrary to what was written, I had nothing directly to do with
the famous (or infamous) Seattle committee, which was the brainchild of Dr. James
Haviland and the board of directors of the King County Medical Society. My favorite
ridicule of that group came from a law review article "Pablo Picasso never would have
made it by that committee . . .
For all the furor and criticism over the Seattle committee, there was no precedent on how
to deal with the rationing of life-saving care, the decision that was faced in Seattle in the
early 1960s. Furthermore, during the first few years no other dialysis center had more
than a few long-term survivors, since transplantation was available elsewhere but not in
Seattle. And by the time other centers began to feel the pressure in the late 1960s, there
were enough new spaces opening up to ease the crunch. The patient selection procedure
that the King County Medical Society came up with may have been flawed; a lottery of
some sort might have replaced the Seattle committee. However, it broke new ground in
bioethics by dramatizing the dilemmas that were upcoming, took the pressure off
physicians, and most important of all, got a very difficult job accomplished.
In retrospect, it is easy for glib critics . . . to criticize the Seattle committee but at the time
we had to face it, this patient selection problem was unique to peacetime medicine. I
think that our well thought out selection system worked well . . . 129
Belding Scribner, “Rationing Dialysis: The Early Years,” Seminars in Dialysis 13 Issue 5 (December
2000): 339–339.
129
44
Clearly, Dr. Scribner was correct. Dialysis was a new technology and its ability to save
lives and return individuals to normal functioning was amazing. However, for all its glory, there
was no precedent on how to allocate the services. Faced this amazing responsibly the King
County Medical Society as well as The Admission and Polices Committee of the Seattle
Artificial Kidney Center at Swedish Hospital did what they believed to be the right thing to do.
Were There Better Ways to Make These Rationing Decisions?
Seattle was one of only eight dialysis programs that utilized lay people or a community
advisory board to make resource allocation decisions regarding dialysis services. However,
institutions that used physician committees to make the final selection of patients found
themselves using a process similar to the SAKC. An investigation of other dialysis allocation
committees found that “Such factors as congeniality of the patient as an individual, economic
burdens of dependants if the patient is not selected, “demonstrated social worth,” and “future
social contributions,” which have overtones of moral judgment and middle-class bias, were
considered of minor importance by the majority of centers, although from one-fifth to one-third
of the centers rated them important”130
To many in the health-care profession, it was not idea of a committee making a selection
that was disturbing. It was the idea of a committee made out of lay persons making life and death
decisions. Health-care professionals may have questioned how laypeople could possibly know
enough to make the right medical decision. Lay people are not trained in health care delivery;
they do not understand the day-to-day struggles of providers. However, even though lay people
130
Renee Fox and Judith Swazey, The Courage to Fail (Edison, NJ: Transaction Publishers, 2001), 254-
255.
45
may not know in detail how the kidney functions or the medical terminology for all the sideeffects of dialysis in the unique case of the allocation of renal services, lay people may have been
as qualified as anyone to make rationing decisions. The technology was so new and the outcome
of patients so unpredictable, that doctors, nurses and lay people had an equal chance of selecting
the “right patient,” an individual who would physically and mentally thrive during and after
dialysis.
To the public what was upsetting was the SAKC and other committee’s inclinations to
select candidates who were “good citizens.” Good citizenship does not necessarily equate to
social worth. Just because someone is a law abiding individual does not mean that they
contribute more to society than someone who has a checkered past. A person’s worth to society
is not necessarily reflective of their ability to abide by the law.
In retrospect, there were other of allocating services, other than based on social worth.
One would involve the ability to pay for services, thus those who could afford the services would
get them and those who did not have the financial resources would go without. Additionally, a
first-come first-served was suggested. Services are allocated to individuals down the line.
Further, there was the option of a lottery, which is equivalent to random selection. Potential
patients pick a number from a hat and the winner gets dialysis and lives while the losers go
without dialysis and eventually die. None of these was an appropriate choice. However, the
decision would be made moot by the advent of federal funding to support medical treatment for
individuals with ESRD.131
Although in retrospect there may have been alternative ways for the SAKC to make the
allocation decisions, it is important to remember the complexity of the charge the committee was
131
Fox and Swazey, 255.
46
given.
The choice of who would receive dialysis was, and for that matter still is, not a
straightforward black and white decision. Countless intricate factors muddy the waters of
decision making. What is clear however is that in the face of conflict and complexity, this
committee of lay individuals sincerely attempted to make the best decision they knew how to.
47
Chapter 3: From Social Insurance to Medicare
A landmark federal level event would facilitate the end of rationing renal services
through God Squads. Support for ESRD through Medicare would have a significant impact on
the way in which services were allocated. With funding guaranteed to practitioners and
organizations through the Medicare system, dialysis centers began to expand and open
throughout the U.S. Consequently, with a boom in the number of clinics, providers were able to
deliver renal services to those in need.132 Therefore, in effect, federal dollars make it possible to
end rationing and the reign of the all-powerful God Squads.
Although federal support for ESRD may have seemed to be an instant miracle to patients
suffering from kidney failure, the inclusion of ESRD under the Medicare umbrella was not a
straightforward occurrence. The roots of the addition of ESRD to Medicare can be traced to the
endorsement of social insurance. Subsequently, only after the acceptance of the concept of social
insurance, would there be the culture that would allow for the ratification of Medicare. Only
then, with the acceptance of a need for a Medicare system, could the ESRD program be
portrayed as a gap in health care system that should be filled by a federal program.
132
Nissenson and Fine, 22.
48
The Depression and World War II
Every president deals with crisis and conflict. Franklin Delano Roosevelt however was
challenged with commanding Americans through two of the darkest events in American and
World History: the Great Depression and World War II.
The Great Depression began in 1929 with the stock market crash. The great crash caused
an economic downward spiral that overwhelmed Americans. Factories closed, machines were
still and unemployment rose to devastating heights. In 1929, the year of the crash,
unemployment rates were below 2 million. By 1933 when Roosevelt was elected to the
presidency, unemployment rates were at an all time high. As FDR began his first term, upwards
of 13 million American workers, or one fourth of the labor force, were jobless.133
The exorbitant number of Americans who were unemployed caused a myriad of
challenges for the newly elected president. Among the problems FDR needed to address
immediately after his inauguration were the destitution of the public, homelessness, and the
destruction of families. The climate that Roosevelt stepped into was one in which;
Men and women lived in lean-tos made of scrap wood and metal, and families went
without meat and fresh vegetables for months, existing on a diet of soup and beans . . .
Americans suffered through year after year of grinding poverty with no let up in sight.
The unemployed stood in line for hours waiting for relief check; veterans sold apples or
pencils on street corners, their manhood – once prized so highly by the nation–now in
question. People left the city for the countryside but found no salvation on the farm.
Crops rotted in the fields because prices were too low to make harvesting worthwhile;
sheriffs fended off angry crowds as banks foreclosed long-overdue mortgages on once
prosperous farms.134
133
Robert Divine, T. H. Breen, George Fredrickson, and Hal Williams, America Past and Present (Old
Tappan, NJ: Addison-Wesley Educational Publishers, 2003), 762-763.
134
Ibid.
49
Roosevelt met the challenges facing the American nation head on. Once in the White
House, he immediately called Congress into session (popularly known as “The Hundred Days),
to make changes to help heal America. The results of FDR’s efforts were the programs of the
New Deal which included: the United States Bank Holiday; the Civilian Conservation Corps; the
Tennessee Valley Authority, the Federal Emergency Relief Administration, the Agricultural
Adjustment Act, the National Recovery Act, the Civil Works Administration, the Public Works
Administration, the Federal Deposit Insurance Corporation Securities Act, the Securities and
Exchange Commission, the Indian Reorganization Act, the Social Security Act, the Works
Progress Administration, the National Labor Relations Act, the Judiciary Act and the Fair Labor
Standards Act. These New Deal programs enacted and supported by FDR, established a vigilant
form of insurance to protect the public: social insurance. Backed by both the American people
and the federal government, including the president and both houses of Congress, social
insurance made its way onto the scene.
As America and Roosevelt dealt with the devastating effects of the Great Depression,
across the ocean, events were unfolding that would change the course of America as well as the
world. A combination of events including: Adolf Hitler gaining power in Germany in 1933 as the
head of the National Socialist movement; Benito Mussolini embarking on an aggressive foreign
policy in 1935; and the Japanese military domination of their own government marked the
beginnings of a European conflict that would escalate into World War II. 135
At the onset of World War II, Americans were entrenched in dealing with the effects of
the Great Depression. The war in Europe seemed remote and the problems at home seemed too
intense to allow for the extension of American efforts to a problem that did not affect America.
135
Waldo Heinrichs, Threshold of War: Franklin D. Roosevelt and American Entry into World War II
(New York, NY: Oxford University Press, 1988).
50
The public ethos was that of isolationism. The general feeling was that all energy and finances
should be committed to the American people in order to help bring the United States out of the
Depression.136
Although the American public did not back the European war, FDR quietly supported the
European Allies.
Publicly, he remained dedicated of the popular public view regarding
America’s neutrality. In private however, he was sympathetic to the efforts of the Allies, even
maintaining classified contact with England’s Prime Minister Winston Churchill.137
The public feelings of neutrality ended on December 7, 1941. At 7:55 a.m. squadrons of
Japanese carrier based planes bombed the American base in Pearl Harbor, Hawaii. Catching the
American fleet off guard, the Japanese devastated the base. The attack sunk eight battleships and
killed more that twenty-four hundred American soldiers. The next day FDR called a special
session to meet with members of Congress in which he asked for a declaration of war. With only
one dissenting vote, both branches passed the measure and America was involved in World War
II.138
In the midst of a devastating domestic crisis and involvement in an overseas conflict that
was predicated on the loss of American lives, FDR managed to lead Americans to recovery. A
commonly accepted indicator of the economic health of a nation is employment rates. As
Roosevelt took office in 1933, unemployment rates were at 13 million, after his first year in
office unemployment was at 10 million and at the end of his first term of office, unemployment
rates were at a little over 6 million. Moreover, not only did Roosevelt rebuild the job market, he
136
Divine, 795-801.
David Irving, “Churchill and U.S. Entry into World War II,” Journal of Historical Review 9, no. 3 (Fall
1989): 261-286.
138
Franklin Roosevelt, Address to Congress Requesting a Declaration of War on Japan, December 8, 1941
http://www.presidency.ucsb.edu/mediaplay.php?id=16053&admin=32 (accessed November 27, 2008).
137
51
brought hope to the American people and led them to aspire to the future. FDR accomplished the
impossible task of American revitalization through leadership and support. More specifically,
Roosevelt’s implementation of the New Deal and its policies of social insurance resulted in the
revival of America.139
By definition, social insurance was designed with certain features in mind for those
individuals who stand to benefit from its policies. Social insurance is the, “...organized effort
which people make, acting through their government, to assure that every family has the
essential goods and services needed for decent living...”140 It is meant to preserve self-respect
and prevent poverty and dependency. Generally, social insurance falls into one of five
categories: 1. old-age and survivors insurance; 2. unemployment insurance; 3. public assistance;
4. maternal and child welfare or 5. health insurance.
Through New Deal policies, FDR aimed to provide Depression era Americans the
security which they had lost after the stock market crash. However, while all of the New Deal
polices were designed to alleviate suffering and assure Americans the goods and services needed
for decent living, no policy was as intimately connected with the goals of social insurance as the
Social Security Act (SSA). In a message to Congress on June 8, 1934, FDR extolled the
importance of developing federal legislation in support of social insurance. “Security was
attained in the earlier days through the interdependence of members of families upon each other
and of the families within a small community upon each other. The complexities of great
communities and of organized industry make less real these simple means of security. Therefore,
we are compelled to employ the active interest of the Nation as a whole through government in
139
Divine, 762.
Wilbur Cohen, “Social Security and Family Stability,” Annals of American Academy of Political and
Social Science 272, no.1 (November 1950): 117.
140
52
order to encourage a greater security for each individual who composes it . . . This seeking for a
greater measure of welfare and happiness does not indicate a change in values. It is rather a
return to values lost in the course of our economic development and expansion . . .141
Backed by Roosevelt, SSA was originally signed into law on August 14, 1935. At its
inception, the act was designed to provide cash payments to the retired or unemployed
individual. An amendment was added just a few years after passing the act to allow the cash
payments to be transferred (in the case of the death of the employee) to spouses and any eligible
children of a retired or unemployed worker. Without support from the president or the public, the
SSA failed to provide federal assistance for health care insurance.
The United States from 1933-1945 was a highly industrialized nation with many workers
employed in manufacturing. However before the stock market crash and the beginning of the
Great Depression employees were highly unorganized. Trade and labor unions were not popular
with American workers. In fact at the onset of the Depression, fewer than 3 million workers were
union members. But, as conditions during the depression worsened, workers united giving rise to
two large union groups: the American Federation of Labor (AFL) and the Congress of Industrial
Organizations (CIO).142
The AFL was a decentralized organization which recognized the autonomy of each of its
member national craft unions. Individual workers were not members of the AFL but instead were
members of the affiliated local or national union. From the beginning the AFL emphasized the
organization of skilled workers into craft unions (composed of a single occupation such as
painters or electricians), as opposed to the organization of workers into industrial unions (where
141
Franklin D. Roosevelt, Message of the President to Congress, June 8, 1934
http://www.socialsecurity.gov/history/fdrstmts.html (accessed November 27, 2008).
142
Divine, 776; also see, Nelson Lichtenstien, Labor’s War at Home: The CIO in World War II
(Philadelphia, PA: Temple University Press, 2003).
53
all the workers in the automobile or steel industry would belong to one union). The AFL became
the largest labor federation in the United States, with a membership of over 10 million at the time
of its merger with the CIO in 1955.143
Within the AFL in the early 1930’s a strong minority faction developed. The splinter
group advocated for the organization of workers in the basic mass-production industries (such as
steel, auto, and rubber) on an industry-wide basis. The faction, named the Congress of Industrial
Organizations, immediately launched organizing drives in the basic industries. The enormous
success of the organizing drives, particularly in the automobile and steel industries, enhanced the
CIO's standing to the point where they seriously challenged the AFL's domination over U.S.
organized labor. The CIO grew rapidly, with an estimated membership of five million, until its
merger in 1955 with the AFL.144
The union provided a united voice for the single worker. Unions fought for improved
wages and better working conditions. Additionally during FDR’s presidency, unions fought for
health insurance coverage for their members. Union delegates called for public underwriting of
health risks. The union appealed for “compulsory, government administered health insurance for
the ‘common people’ . . . “145. William Green, president of the AFL from 1924-195, remarked
that, “serious illness would throw 90 percent of the population into ‘heavy indebtedness’”146.
Green encouraged state intervention, “to provide adequate health services for all”147 and
dismissed employer sponsored benefits as incapable of accomplishing this task.
AFL-CIO. “America’s Union Movement,” www.aflcio.org (accessed November 23, 2008).
Ibid.
145
Alan Derickson, “Health Security for All? Social Unionism and Universal Health Insurance, 19351958,” Journal of American History 80, Issue 4 (March 1994): 1339.
146
Ibid., 1338.
147
Ibid.
143
144
54
As America came out of the Depression and entered into World War II, the balance of
power between employees and employers shifted. While during the Great Depression workers
fought to be hired for jobs, in the post Depression era, employers fought to retain qualified
employees. The shortage in the supply of skilled workers, fueled by the War, and coupled with
the boom in production necessary to support wartime efforts left employers struggling to find
creative ways to keep their employees happy.
Many employers experimented with offering fringe benefits to keep their employees
happy, because unhappy employees left and found new jobs. Unarguably, turn-over increased
dramatically during the War. Turn-over went from 3.2 monthly separations per 100 workers in
September of 1940, to 6.3 monthly separations per 100 workers in September of 1943. Because
turn-over is so expensive for the employer in an effort to keep qualified and trained personnel
benefits such as pensions and health care insurance were offered.148
Employer efforts to retain employees through attractive fringe benefit plans were
reinforced by the federal government. In January of 1942 FDR established the National War
Labor Board (NWLB). The NWLB made a decision to tie wage increases to inflation, which in
effect froze wages. However, fringe benefits, such as health care insurance, were excluded from
the calculation of wages. Therefore, the NWLB wage freeze gave rise to fringe benefits.149
From 1933-1945, federally sponsored health care insurance was a hot topic on Capitol
Hill. One man in particular strongly advocated for government funding for health care services,
Senator Robert F. Wagner. During his time in the United States Senate, Senator Wagner was a
strong advocate of federally sponsored health care insurance. He introduced the Wagner Bill (S.
Frank Dobbin, “The Origins of Private Social Insurance: Public Policy and Fringe Benefits in America,
1920-1950,” American Journal of Sociology 97, no.5 (March 1992): 1434.
149
Ibid., 1416-1450.
148
55
1620) on February 28, 1939 which would have created the National Health Act of 1939. The
Wagner Bill was a, “national compulsory health insurance for almost all employees and their
dependents . . . Benefits were to include physician services, hospitalization, drugs, and laboratory
diagnostic services. Costs were to be covered through employer and employee contributions
which were to have been deposited in a health insurance fund”150 From April 29 to July 13 of
1942, there were Congressional hearings on the original Wagner Bill. The Wagner Bill died in
committee.151
Wagner made a second attempt to propose legislation to support federal funding for
health care insurance. On June 3, 1943 a revised Bill, the Wagner-Murray- Dingell Bill (S. 1161
and H.R. 2831) was reintroduced to Congress. Again, the revised Wagner Bill called for
comprehensive health insurance. The policies of the amended Bill would fall under the Social
Security Act. For the second time, Congress took no action and the Bill died in committee.152
The introduction of the Wagner Bill in 1939 and the reintroduction of the revised Bill in
1943 most definitely attest to Congressional interest in federal funding for health care insurance.
However, the fact that both of the Bills died in committee, is evidence of the lack of true
consensus by Congress that governmental involvement in providing health coverage for the
American populace was appropriate.
Stumbling Blocks - Opposition to Federally Sponsored Health Insurance
The American ethos during Roosevelt’s presidency had a major influence on federal
policies. Much of FDR’s legislation was created and passed only because of broad based public
Centers for Medicare and Medicaid Services, “Special Collections,” www.cms.hhs.gov (accessed
November 22, 2008).
151
Ibid.
152
Ibid.
150
56
support. Moreover, the development of Social Security Act was one of the polices in which
Roosevelt considered the culture of America and utilized it as a strategy to gain support.
As Congress began to pass New Deal legislation to ease the suffering of Americans
afflicted by the affects of the Great Depression, the American people had varied opinions
regarding the legislation. On the whole, the public supported most forms of social insurance.
Federal support for health care insurance, however, was not endorsed by the majority.
Opposition to federal legislation for medical insurance was rooted in a long standing
American fear of socialism. Compulsory health care insurance was viewed as, “paternalistic,
socialistic . . . ” and “undemocratic”153. Because federally sponsored medical care assistance
would be in the form of insurance, not cash payments, Americans believed that their autonomy
would be compromised. Congressional committees considered a:
variety of proposals to provide health care for the aged. One group in Congress contends
that . . . a massive program of health insurance should be grafted onto the existing social
security system financed through additional taxation on all covered employees (and their
employers) regardless of need or desire to participate. Thus far, social security has
provided benefits in one form only; namely, benefits in cash. This has enabled each
beneficiary to use the benefits and any other cash income and other liquid assets to buy
those goods and services necessary to meet his wants and desires and in quantities he
chooses to afford. Each person can budget whatever he chooses for food, clothing,
housing and the like. Only in this manner can each individual exercise his freedom.
Liberty in fact is rooted in freedom of choice.154
The benefactor of federal health insurance would have his/her choices limited by the
government. In turn, these limitations placed on choices were viewed as baring the beneficiary
from expressing their autonomy and thereby encroaching on an individual’s liberty.
Joseph Hirsh, “The Compulsory Health Insurance Movement in the United States,” Social Forces 18,
no. 1 (October 1939): 102-114.
154
Allen Marshall, “Social Security at the Crossroads,” Industrial and Labor Relations Review 14, no. 1
(October 1960): 116.
153
57
In addition to fears about federally sponsored health care insurance leading to
paternalism, Roosevelt was dealing with an American people who were not ready for drastic
changes. “The tide is still flowing strongly towards conservatism in everything domestic . . . it is
quite clear that the majority of Americans at this time what to return to normalcy . . . not
reforms”155. Over the course of a few short years, Americans lost the majority of their material
possessions as well as their hope for the future in the Great Depression. On the heels of their
Great Depression loses, families were faced with losing sons, husbands, brothers and uncles in a
European conflict. FDR knew that a radical change in the health care system would not be well
received and that it would not be prudent to propose federally sponsored health care insurance to
the American people.
Additionally, by 1933, the American Medical Association (AMA) was a powerful force
on Capitol Hill. Although AMA membership in 1936 was only in excess of 100,000, the power
wielded by the organization was intense. With all its force and political power the AMA and the
medical community lobbied against social insurance. The association was particularly adamant
in the fight against any policy in support of federally sponsored health care insurance. When
socialized health care bills were proposed, the AMA capitalized on the American public’s fears
of Communism. The AMA portrayed federally sponsored health insurance as "socialized
medicine". Not only did the AMA speak out against federally sponsored health insurance, but
they directly attacked individuals who supported government intervention. The AMA called
Edwin Witte, “American Post-War Social Security Proposals,” The American Economic Review 33, no.
4 (December 1943): 837.
155
58
white house staffers who supported federal health insurance "followers of the Moscow party
line".156
While the AMA vehemently apposed federal intervention in health care, they had their
own answer to address the health care needs of the nation. The AMA, “ . . . advocates voluntary
hospitalization and medical care insurance under the auspices of the medical societies, along
with better living conditions through improved housing, nutrition and sanitation.” Not only did
the AMA advocate saving for illness, the AMA continue to maintain this policy. In an article
written in 1945, the author noted that “This has been the A.M.A.’s answer to all proposals for
compulsory health insurance and legislation since 1935 . . . ”157.
While FDR was the energy behind the social insurance policies of the New Deal, he gave
little effort to federal funding for health care insurance. As president Roosevelt was, “unwilling
to take the requisite steps during the New Deal.”158 Speculations for the reasons that President
Roosevelt did not back federally sponsored health insurance were that; he was fearful of the
AMA, FDR was engrossed with the reviving the failing American economy and Roosevelt was
preoccupied with the developments in Europe. For these reason Roosevelt kept his distance from
health care reform.159
However, he did upon occasion speak indirectly on behalf of the importance of federal
sponsorship of health care insurance. On January 7, 1943, in his State of the Union Address
Roosevelt expounded the importance of social insurance for all Americans that should endure for
Monte Poen, “National Health Insurance," The Harry S. Truman Encylopedia, by Richard S. Kirkendall
(Boston, MA: G.K. Hall, 1989), 251.
157
Edwin Witte, “1944-1945 Programs for Postwar Social Security and Medical Care,” Review of
Economic Statistics 27 (November 1945): 186.
158
Theodore Marmor, “The Politics of Heath Insurance: Lessons from the Past?,” Journal of
Interdisciplinary History 26, no. 4 (Spring 1996): 676.
159
Derickson, 1339-1340.
156
59
their lifetime, “When you talk with our young men and women, you will find that with the
opportunity for employment they want assurance against the evils of all major economic
hazards- assurance that will extend from the cradle to the grave. And this great Government can
and must provide this assurance.” 160
In his January 11, 1944, State of the Union Address Roosevelt outlined an economic bill
of rights which included the explicit mention of a federal provision for health care benefits, “In
our day these economic truths have become accepted as self-evident. We have accepted, so to
speak, a second Bill of Rights under which a new basis of security and prosperity can be
established for all-regardless of station, or race or creed. Among these are: . . . The right to
adequate medical care and the opportunity to achieve and enjoy good health; The right to
adequate protection from the economic fears of old age, and sickness, and accident and
unemployment . . . ” 161 To FDR, “All of these rights spell security. And after this war is won we
must be prepared to move forward, in the implementation of these rights, to new goals of human
happiness and well-being.”162
Again in January 6, 1945, President Roosevelt reminded the American public that access
to and support for health care was an essential element of the responsibility of an American
government, “In the State of the Union message last year I set forth what I considered to be an
American economic bill of rights. I said then, and I say now, that these economic truths represent
a second bill of rights under which a new basis of security and prosperity can be established for
all--regardless of station, race, or creed . . . the economic rights of American citizenship, such as
Franklin D. Roosevelt, “State of the Union Address, January 7, 1943,”
http://www.presidency.ucsb.edu/ws/index.php?pid=16386 (accessed November 27, 2008).
161
Franklin D. Roosevelt, “State of the Union Address, January 11, 1944,”
http://www.teachingamericanhistory.org/library/index.asp?document=463 (accessed November 27, 2008).
162
Ibid.
160
60
the right to a decent home, to a good education, to good medical care, to social security, to
reasonable farm income, will, if fulfilled, make major contributions to achieving adequate levels
of employment. The Federal Government must see to it that these rights become realities-with
the help of States, municipalities, business, labor, and agriculture. 163
Admittedly, FDR did not lobby for or use his presidential power to support the inclusion
of health care benefits in the social insurance policies passed and implemented during his tenure
as president of the United States. However, he did speak publicly about the need for good
medical care to be afforded to all Americans. Moreover, he quietly spoke out about the right of
citizens to good medical care.
Sluggish Progress - Federally Sponsored Health Care from FDR to JFK to LBJ
Even though FDR did not forthrightly champion federally sponsored health care
insurance, his successor Harry Truman did. On November 19, 1945, only seven months into his
presidency, in a speech to congress Truman proposed a new national health care program. In the
speech, Truman argued that the federal government should play a role in health care, saying that,
"The health of American children, like their education, should be recognized as a definite public
responsibility."164
President Truman's plan was to improve the state of health care in the United States by
addressing five separate issues. The first issue was the lack of doctors, dentists, nurses, and other
health professionals in many rural or otherwise lower-income areas of the United States. In a
Franklin D. Roosevelt, “State of the Union Address, January 6, 1945,”
http://www.presidency.ucsb.edu/ws/index.php?pid=16595 (accessed November 27, 2008).
164
Harry Truman, “Special Message to the Congress Recommending a Comprehensive Health Program.
November 19, 1945,” http://www.trumanlibrary.org/publicpapers/index.php?pid=483&st=&st1= (accessed
November 23, 2008).
163
61
special message to Congress, Truman argued that, “The Federal Government should provide
financial and other assistance for the construction of needed hospitals, health centers and other
medical, health, and rehabilitation facilities. With the help of Federal funds, it should be possible
to meet deficiencies in hospital and health facilities so that modern services--for both prevention
and cure--can be accessible to all the people. Federal financial aid should be available not only to
build new facilities where needed, but also to enlarge or modernize those we now have.”165
The second problem that Truman sought to rectify was the lack of quality hospitals in
rural and lower-income counties. “Our programs for public health and related services should be
enlarged and strengthened . . . Hospitals, clinics and health centers must be built to meet the
needs of the total population, and must make adequate provision for the safe birth of every baby,
and for the health protection of infants and children.”
166
Truman continued, “The health of
American children, like their education, should be recognized as a definite public
responsibility”.167
Truman's third initiative was related to the education of medical professional and
research. “The Federal Government should undertake a broad program to strengthen professional
education in medical and related fields, and to encourage and support medical research.
Professional education should be strengthened where necessary through Federal grants-in-aid to
public and to non-profit private institutions. Medical research, also, should be encouraged and
supported in the Federal agencies and by grants-in-aid to public and non-profit private
agencies.”168
165
Ibid.
Ibid.
167
Ibid.
168
Ibid.
166
62
The fourth issue addressed in Truman’s proposal was related to prepayment of medical
costs. “Everyone should have ready access to all necessary medical, hospital and related services.
I recommend solving the basic problem by distributing the costs through expansion of our
existing compulsory social insurance system. This is not socialized medicine.”169
He further justified his ideas by explaining,
Everyone who carries fire insurance knows how the law of averages is made to work so
as to spread the risk, and to benefit the insured who actually suffers the loss. If instead of
the costs of sickness being paid only by those who get sick, all the people--sick and well-were required to pay premiums into an insurance fund, the pool of funds thus created
would enable all who do fall sick to be adequately served without overburdening anyone.
That is the principle upon which all forms of insurance are based . . . ”170
Truman justified his concept by describing the benefits of prepayment. “A system of
required prepayment would not only spread the costs of medical care, it would also prevent much
serious disease. Since medical bills would be paid by the insurance fund, doctors would more
often be consulted when the first signs of disease occur instead of when the disease has become
serious . . . Prepayment of medical care would go a long way toward furnishing insurance against
disease itself, as well as against medical bills . . . ”171 He further explained, “The ability of our
people to pay for adequate medical care will be increased if, while they are well, they pay
regularly into a common health fund, instead of paying sporadically and unevenly when they are
sick. This health fund should be built up nationally, in order to establish the broadest and most
stable basis for spreading the costs of illness, and to assure adequate financial support for doctors
and hospitals everywhere.”172
169
Ibid.
Ibid.
171
Ibid.
172
Ibid.
170
63
The fifth and final of Truman’s recommendation was in relationship to protection against
the loss of wages from sickness and disability. As a, “fifth element of a comprehensive health
program, the workers of the Nation and their families should be protected against loss of
earnings because of illness. A comprehensive health program must include the payment of
benefits to replace at least part of the earnings that are lost during the period of sickness and
long-term disability. 173
In his recommendations, Truman made it clear that his plan would not be a system with
complete federal control of health care. “I repeat-what I am recommending is not socialized
medicine. Socialized medicine means that all doctors work as employees of government. The
American people want no such system. No such system is here proposed”174 However, he did
elucidate how important some federal sponsorship was to the health of Americans. "We are a
rich nation and can afford many things. But ill-health which can be prevented or cured is one
thing we cannot afford.”175
Truman's proposals came before Congress in the form of a Social Security expansion bill.
The bill was co-sponsored in Congress by Democratic senators Robert Wagner and James
Murray, along with Representative John Dingell.176 However even though the proposal was
supported by the president, once introduced to the House and the Senate the Wagner, Murray,
Dingell bill was defeated.
Subsequent to Truman, during Eisenhower’s administration the fight over federally
sponsored health care insurance continued. In January of 1954, President Eisenhower proposed a
173
Ibid.
Ibid.
175
Ibid.
176
Harry Truman, “This Day in Truman History November 19, 1945. President Truman Addresses
Congress on Proposed Health Program, Washington, D.C.”
http://www.trumanlibrary.org/anniversaries/healthprogram.htm (accessed November 23, 2008).
174
64
"re-insurance" measure, H.R. 8356 and S. 3114. Eisenhower’s re-insurance, “attempted to
implement a voluntary prepayment program of health reinsurance through which the federal
government would broaden the coverage, both of subscribers and services, of nonprofit and
private health insurers by assuming part of their liability for high-risk groups.”177 President
Eisenhower’s re-insurance plan had the objective of enabling private insurance companies to
broaden their coverage. The bill proposed a plan of Federal reinsurance for any private company
as protection against heavy losses resulting from health insurance. Ideally, after the first five
years, the program would become self-financing with funds derived from premiums paid by the
insurance companies.178 However, after hearings in both houses the legislation returned to
committee by the House, ending action on the proposal.
In July 5 of 1956, S. 4172 was proposed in order to establish insurance pooling. This bill,
S.4172, authorized the Secretary of the Department of Health, Education and Welfare to approve
voluntary agreements between private insurance organizations for pooling or coordinating their
resources and efforts in developing plans and policies regarding adequate health prepayment
protection.179 No action however was taken on the bill.180
Again in 1957, an attempt was made towards federally sponsored health care insurance.
On August 27, the Forand bill (H.R. 9467), was introduced. The object of the bill was to provide
health insurance for social security beneficiaries.181 Bouncing back and forth between the House
and the Senate, the bill was eventually killed in executive session on March 31, 1960. Following
177
Antonia Maioni, Parting at the Crossroads: The Emergence of Health Insurance in the United States
and Canada (Princeton, NJ: Princeton University Press 1998), 107-108.
178
Social Security Administration, “Special Collections,” http://www.ssa.gov/history/1950.html (accessed
November 23, 2008).
179
Ibid.
180
Social Security Administration, “Social Security History,” http://www.ssa.gov/history/cornignappa.html
(accessed November 23, 2008).
181
Ibid.
65
the immobilization of federal health care insurance, on June 3 the Ways and Means Committee's
called for a second vote on Forand bill, but again the bill was defeated. In an attempt to pass
some measure of federal health insurance, a stripped-down version of the Forand bill was
introduced. The new bill only provided beneficiaries with hospital benefits only, but was
defeated.182
Even though Eisenhower was not an outspoken supporter of federal health insurance,
one important measure was passed during his presidency. The Kerr-Mills bill (H.R. 12580) was
signed into law in September of 1960 as a part of the omnibus Social Security amendments bill.
The Kerr-Mills provided medical assistance for the needy aged. 183 “Under the Kerr-Mills
program, the Federal Government matches state funds—a little more than 3 to 1—for hospital,
nursing and some doctors' care for those oldsters willing to declare themselves "medically
indigent"—that is, possessed of enough resources to live, but not enough for stiff medical
bills.”184 There is wide variation among the states' thresholds for medical indigent, “some set
limits on cash reserves as low as $300, can require the liquidation of other assets such as cars . .
.” other states, “can require homeowners to mortgage their houses to the state, the title to change
after the death of both spouses”185
182
Ibid.
Maioni, 116-117.
184
“The A.M.A. and the U.S.A,” Time Magazine, July 7, 1961,
http://www.time.com/time/magazine/article/0,9171,872563,00.html (accessed November 23, 2008).
185
Ibid.
183
66
The Ratification of Medicare
On February 9, 1961, shortly after his inauguration, President John F. Kennedy sent a
special message to Congress on health and hospital care.186 Kennedy’s message began with
remarks on the importance of health, “The health of our nation is a key to its future--to its
economic vitality, to the morale and efficiency of its citizens, to our success in achieving our
own goals and demonstrating to others the benefits of a free society. Ill health and its harsh
consequences are not confined to any state or region, to any race, age, or sex . . . ”187 Following a
declaration of the significance of health for all citizens, Kennedy provided details as to how to
improve the health of the nation. “Only a part of the responsibility rests with the federal
government. But its powers and resources make its role essential in four areas for improving
health care: social insurance, facilities, personnel and research”188
President Kennedy recommended to Congress the enactment of a social insurance
program under the Social Security system that provided the following benefits:
First, inpatient hospital services up to 90 days in a single spell of illness, for all costs in
excess of $10 per day for the first 9 days (with a minimum of $20), and full costs for
the remaining 81 days. Because hospital costs place by far the heaviest and most
unmanageable burden on older persons, it is these services that should receive major
emphasis in any health insurance program.
Second, skilled nursing home services up to 180 days immediately after discharge from a
hospital. To provide an incentive for use of these less expensive facilities, an individual
could, in short, receive two days of skilled nursing home care in place of one day of
'hospital care when this satisfies his requirements.
Social Security Administration, “Special Collections,” http://www.ssa.gov/history/1960.html (accessed
November 23, 2008).
187
John F. Kennedy, “Special Message to the Congress on Health and Hospital Care. February 9, 1961,”
http://www.presidency.ucsb.edu/ws/index.php?pid=8222 (accessed November 22, 2008).
188
Ibid.
186
67
Third, hospital outpatient clinic diagnostic services for all costs in excess of $20. These
services, too, will reduce the need for hospital admissions and encourage early
diagnosis.
Fourth, community visiting nurse services, and related home health services, for a limited
period of time. These will enable many older people to receive proper health care in their
own homes.189
He proposed that these health insurance benefits be available to all persons aged 65 and over
who are eligible for social security or railroad retirement benefits.
To pay for the health care benefits, Kennedy proposed financing through social security
contributions. He recommended an increase in social security contributions of one-quarter of one
percent for both employers and employees as well as an increase in the maximum earnings base
from $4800 a year to $5000. Kennedy felt that the social security contributions would, “.amply
cover the cost of all insurance benefits provided” and the, “system would be self-supporting...”190
Further, President Kennedy maintained that, “This program is not a program of socialized
medicine. It is a program of prepayment of health cost”191
President Kennedy closed his speech to Congress on health and hospital care stating,
“The measures I have recommended recognize and strengthen the indispensable elements in a
sound health program--people, knowledge, services, facilities, and the means to pay for them.
Taken together, they constitute a necessary foundation upon which to build.”192 He continued,
“The health of the American people must ever be safeguarded; it must ever be improved. As long
as people arc stricken by a disease which we have the ability to prevent, as long as people are
chained by a disability which can be reversed, as long as needless death takes its toll, then
American health will be unfinished business. It is to the unfinished business in health--which
189
Ibid.
Ibid.
191
Ibid.
192
Ibid.
190
68
affects every person and home and community in this land--that we must now direct our best
efforts.193
Three days after Kennedy’s message, two heath care bills were introduced. Senator
Clinton Anderson (D-NM) introduced S.909 and Representative Cecil King (D-CA) introduced
H.R. 4222.194
The King-Anderson bill for health insurance for the aged entitled, “certain
hospital care, skilled nursing home care, home health care, and outpatient hospital diagnostic
services . . . for persons aged 65 and over who are entitled to old-age, survivors and disability
insurance or railroad benefits”195 Under the legislation, beneficiaries would be, “eligible during a
period of illness for up to 90 days of inpatient hospital services (subject to a deductible
contribution by the patient), including bed, board, nursing services, and other supplies and
services customarily furnished by a hospital; and up to 180 days of skilled nursing home care
following discharge from a hospital and for the condition for which the beneficiary was
hospitalized.”196
The King-Anderson bill proposed that hospital inpatient services required a patient copay. The patient would be responsible for $10 a day for the first nine days, with a minimum
deductible of $20. Skilled nursing home care included, “nursing care, physical, occupational and
speck therapy, medical supplies (other than drugs) and appliances for temporary use, and, . . part
193
Ibid.
Social Security Administration, “Social Security History: The Fourth Round,”
http://www.ssa.gov/history/corningchap4.html (accessed November 23, 2008).
195
Lenore Epstein and James Callison, “Financing Health Care for the Aged,” Law and Contemporary
Problems 27, no. 1 (Winter 1962): 113.
196
Ibid., 113-114.
194
69
time or intermittent home-maker services”197 Further, the program would pay for, “outpatient
hospital diagnostic services, subject to a $20 deductible contribution per diagnostic study”198.
After the introduction of the bills, President Kennedy explained to Congress to note that
the King-Anderson bill included, “provisions for payment of hospital bills, nursing care, outpatient care.” 199 According to Kennedy, the bill, “does not attempt to interfere in any way with
the relationship between the doctor and the patient and we have no plans to provide such
legislation.”200 Specifically, Kennedy made sure to remind legislators that the King-Anderson
bill was not designed to pay doctor’s bills, drug costs or other auxiliary benefits. The
legislation’s sole intention was to pay hospital bills.201
Although the introduction of the King-Anderson bill was of great consequence, the
momentum behind the bill was quickly stalled by a distracted president. Shortly after the
legislation was unveiled President Kennedy became preoccupied with foreign affairs; primarily
turning his attention to the cold war. Even though Kennedy was immersed in overseas matters
and no movement was made on the bills in Congress, the topic of Medicare did not lay dormant.
The American Medical Association (AMA) used this time to rally their troops for their cause.
The AMA established the American Medical Political Action Committee (AMPAC) to mount a
fight against Medicare legislation. The AMA deemed Medicare to be, "the most deadly challenge
ever faced by the medical profession" and carried out an attack on the King-Anderson legislation
by distributing anti-Medicare pamphlets, executing anti-Medicare radio and television
197
Ibid.
Ibid.
199
John F. Kennedy, “News Conference 34. May 23, 1962,”
http://www.jfklibrary.org/Historical+Resources/Archives/Reference+Desk/Press+Conferences/003POF05Pressconfe
rence34_05231962.htm (accessed November 22, 2008).
200
Ibid.
201
“Squared off,” Time. June 1, 1962.
198
70
commercials and performing anti-Medicare speeches. 202 In addition to a public appeal, the AMA
made an appeal to legislators. It was estimated that in the early portion of the 1960’s, the AMA
spent approximately $164,000 per year on lobbying efforts on Capital Hill.203
When it came to the issue of Medicare, the medical community was not the only group to
lobby. Senior citizens did their part to promote awareness and gain support for Medicare
legislation. Seniors united as the National Council of Senior Citizens for Health Care Through
Social Security in order to promote the Medicare cause. The National Council began recruiting
members through union retiree organizations such as the United Auto Workers, United Steel
Workers, and International Ladies Garment Workers. In a very short few months the organizers
of the National Council were able to build a loose confederation of senior citizen groups
numbering about 1 million individuals.204 United, members of the National Council began a
major education campaign among middle-aged people. They worked to raise awareness of how
costly and problematic hospital bills for the elderly could be.
With public and political attention turned towards the cause of health insurance for the
aged, the groundwork was laid for the ratification of Medicare. However, the momentum that
was initiated for the implementation of the legislation was stalled by the loss of one of its
valuable supporters. The assassination of President John Kennedy on November 22, 1963
suspended the energy behind the ratification of Medicare.
Following the death of President Kennedy, the debate over Medicare did not resume until
the spring of 1964. With a new president, Lyndon Baines Johnson, dedicated to the cause,
Medicare legislation was once again thrust forward. President Johnson’s commitment to
202
Social Security Administration, http://www.ssa.gov/history/corningchap4.html.
“Squared off.”
204
Social Security Administration. http://www.ssa.gov/history/corningchap4.html.
203
71
Medicare was publicly evident as he stated, “We are going to pass a medical assistance bill--if
not this week, if not this month, if not this year, at the earliest possible date."205
In his annual message to Congress on the state of the union on January 8th, 1964
President Johnson outlined his goals for the Congressional session, “Let this session of Congress
be known as the session which did more for civil rights than the last hundred sessions combined;
as the session which enacted the most far-reaching tax cut of our time; as the session which
declared all-out war on human poverty and unemployment in these United States; as the session
which finally recognized the health needs of all our older citizens; as the session which reformed
our tangled transportation and transit policies; as the session which achieved the most effective,
efficient foreign aid program ever; and as the session which helped to build more homes, more
schools, more libraries, and more hospitals than any single session of Congress in the history of
our Republic. All this and more can and must be done.”206
Unlike the Kennedy administration, the Johnson administration had three key elements
that made all the difference in forwarding the Medicare cause. First, during Johnson presidency
the public came to realize that Medicare was an idea whose time had come. The sharp decrease
in personal income coupled with the increase in medical needs of those who had reached
retirement age and the rapidly rising cost of medical care confirmed the need for some type of
government supported medical assistance.207
Secondly, public and political support for Medicare had improved. “Some observers
detected a significant fall-off of antagonism toward Medicare within the business community
during 1964-65. One sign was the fact that some local Chambers of Commerce reportedly broke
205
Ibid.
Lyndon B. Johnson, “Annual Message to the Congress of the State of the Union. January 8, 1964,”
http://www.presidency.ucsb.edu/medialist.php?presid=36 (accessed November 22, 2008).
207
Social Security Administration, http://www.ssa.gov/history/corningchap4.html,
206
72
with the position of the parent body in Washington, which had always stoutly resisted the
proposal.208 In addition, there was evidence of political support for Medicare legislation in the
polls. During 1964, polls indicated that approximately two-thirds of the electorate favored the
idea of some type of Medicare legislation.209
Finally, the political climate was progressively changing. In 1964 public support for the
President and the ruling party was at an unprecedented high. Public backing of the president and
his administration translated into a nation experiencing political stability.210
In January of 1965, the King-Anderson bill was submitted to the 89th Congress and had
the privilege of being the first bill introduced in both the House and the Senate (H.R. 1 and S. 1).
Immediately after introduction, Wilbur Mills, chairman of the House Ways and Means
committee, assumed responsibility for re-drafting the bill. Over a two month period, Mills
engaged a complex negotiation process. He met with various interest groups that would be
responsible for administration of the Medicare program, or who had a stake in the manner by
which it operated. Mills conferred with stakeholder groups of clinicians including physicians and
nurses, health care executives including hospital administrators and nursing home
representatives, political officials including State and federal welfare officials, and industry
representatives including labor leaders and insurance industry representatives. During
negotiations, there were conflicts over technical matters, some of which had important economic,
social, and political implications; but never during these months was the basic policy decision in
doubt.211
208
Ibid.
Ibid.
210
Ibid.
211
Ibid.
209
73
After careful consideration on March 23, 1965, the Ways and Means Committee voted
17-8 to substitute a drastically revised committee bill for King-Anderson. The next day,
Chairman Mills introduced this "Mills bill" (H.R. 6675) on the House floor. The Mills bill
provided for a mandatory hospital insurance plan (part A) and a supplemental voluntary plan
(part B). Part B of the Mills bill would cover physicians' services, services and supplies furnished
as an incident to a physician's professional service and diagnostic X-ray tests, diagnostic
laboratory tests, and other diagnostic tests.212
On April 8, after only one day of debate on the floor, the Mills bill passed the House,
without amendment, 313-l15. Following passage in the House, the Mills bill went to the Senate,
where the Finance Committee held hearings in late April and early May, which were followed by
extended executive sessions. The bill was finally reported out--with 75 committee amendments-on June 24 (by a vote of 12-5). During 3 days of debate on the Senate floor, some 250 additional
amendments were considered. Then, on July 9, the Senate passed the measure by a 68-21 vote. A
Senate-House conference committee labored for over a week in mid-July to reconcile a total of
513 differences between the two chambers, after which the final bill was approved in the House
and Senate, on July 27 and 28, respectively.
On July 30, 1965 President Johnson signed H.R. 6675, the Mills bill, into law as Title
XVIII of the Social Security Act. H.R. 6675. Medicare extended health care coverage to those
receiving retirement benefits from Social Security or the Railroad Retirement Board as well as to
Americans age 65 or over.213
President Johnson signed the legislation in Independence,
Jerald Schenken and James Carson, “Legislation and Regulation,” Archives of Pathology & Laboratory
Medicine (December 1997):1946-1996.
212
“Key Milestones in Medicare and Medicaid History, Selected Years: 1965-2003,” Health Care
Financing Review 27, no. 2 (Winter 2005): 1-3.
213
74
Missouri, in the presence of Harry S. Truman who had been a driving force for federal Medicare
legislation since 1945. At the signing, President Johnson remarked:
Many men can make many proposals. Many men can draft many laws. But few have the
piercing and humane eye which can see beyond the words to the people that they touch.
Few can see past the speeches and the political battles to the doctor over there that is
tending the infirm, and to the hospital that is receiving those in anguish, or feel in their
heart painful wrath at the injustice which denies the miracle of healing to the old and to
the poor. And fewer still have the courage to stake reputation, and position, and the effort
of a lifetime upon such a cause when there are so few that share it….
It was a generation ago that Harry Truman said, and I quote him: "Millions of our citizens
do not now have a full measure of opportunity to achieve and to enjoy good health.
Millions do not now have protection or security against the economic effects of sickness.
And the time has now arrived for action to help them attain that opportunity and to help
them get that protection.
Well, today . . . we are taking such action . . .
Because the need for this action is plain; and it is so clear indeed that we marvel not
simply at the passage of this bill, but what we marvel at is that it took so many years to
pass it . . .
There are more than 18 million Americans over the age of 65. Most of them have low
incomes. Most of them are threatened by illness and medical expenses that they cannot
afford.
And through this new law . . . every citizen will be able, in his productive years when he
is earning, to insure himself against the ravages of illness in his old age.
This insurance will help pay for care in hospitals, in skilled nursing homes, or in the
home. And under a separate plan it will help meet the fees of the doctors . . .
No longer will older Americans be denied the healing miracle of modern medicine. No
longer will illness crush and destroy the savings that they have so carefully put away over
a lifetime so that they might enjoy dignity in their later years. No longer will young
families see their own incomes, and their own hopes, eaten away simply because they are
carrying out their deep moral obligations to their parents, and to their uncles, and their
aunts.
75
And no longer will this Nation refuse the hand of justice to those who have given a
lifetime of service and wisdom and labor to the progress of this progressive country . .
.”214
The passage of Medicare was a watershed moment in American history, marking the first
large-scale intervention of the federal government in the healthcare financing arena.
Acknowledging the gravity of the federal legislation Kenneth Williamson (who was at the time
associate director of the American Hospital Association) remarked in behalf of the AHA “One
thing is certain: It is a new day in health affairs. Things are not the same either for hospitals or
physicians or the public. Things will never be the same again.”215
“Remarks with President Truman at the Signing in Independence of the Medicare Bill,” Public Papers
of the Presidents of the United States: Lyndon B. Johnson, 1965, Volume II, entry 394 (Washington, D.C.:
Government Printing Office, 1966) http://www.lbjlib.utexas.edu/johnson/archives.hom/speeches.hom/650730.asp
(accessed November 1, 2008), 811-815.
215
Eli Friedman, “End-Stage Renal Disease Therapy: An American Success Story,” Journal of the
American Medical Association 275, no. 1414 (April 10, 1996): 1118-1122.
214
76
Chapter 4: Federal Support for Kidney Disease: The Medicare Amendments
Once passed and implemented the Medicare legislation would have dramatic and
unanticipated affects on the operations of the U.S. health care system. At its inception, the
Medicare bill was only intended and designed to insure that the elderly would not be denied
access to the healthcare system because of a lack of financial resources. Legislators wanted to
insure that older individuals would not be without medical care. However, in 1972, several
amendments were made to the original Medicare bill that drastically altered the original
intentions and scope of Medicare.
The Social Security Amendments (P.L. 92-603), signed into law by then President
Richard M. Nixon, included provisions for, among other things, Medicare for the disabled as
well as the classification of chronic kidney disease as a disability for purposes of Medicare.
216
Per the amendments, Medicare coverage was to be extended to individuals who required
hemodialysis or renal transplantation for chronic renal disease. 217 This affirmed that individuals
with ESRD were to have Medicare coverage for their health care need regardless of their age. 218
Nissenson and Rettig, 161; also see, Robert Ball, “Social Security Amendments of 1972: Summary and
Legislative History,” Social Security Bulletin 36, no. 3 (March 1973): 3-25.
217
Other provisions included: Health Maintenance Organizations; Professional Standards Review
Organizations; Level-of-care requirements in skilled nursing facilities; Waiver of beneficiary liability in certain
situations where Medicare claims are disallowed; Advance approval of extended-care and home health coverage;
Hospital insurance for the uninsured; Medicare services outside the United States; Elimination of provisions
preventing enrollment under SMI more than 3 years after first opportunity; Coordination between Medicare and
Federal employees' plans; Uniform Medicare and Medicaid standards for nursing facilities; Reimbursement rates for
skilled nursing facilities and intermediate-care facilities; 14-day-transfer requirement for post-hospital extended-care
benefits; Medical social services; Waiver of registered-nurse requirement in skilled nursing facilities in rural areas;
Amount of supplementary medical insurance premiums; Change in SMI deductible; Automatic enrollment for SMI;
Coverage of chiropractors' services; Limitation on Federal participation for capital expenditures; Experiments and
216
77
ESRD as a Disability
Under the1972 amendments, chronic kidney disease was identified as a disability for
purposes of Medicare. Therefore, individuals with ESRD were to be viewed to be disabled by the
federal government. This classification was most likely meant to simply serve as a method by
which to organize and categorize beneficiaries. However, the disability classification may have
had an unexpected effect on the overall perception of kidney failure as a disease, as well as on
the perception of individual patients with ESRD.
Labeling patients with ESRD as “disabled” may have affected the manner in which the
healthcare community viewed these individuals. Disability implies devastation, an inability to
function or to carry out the activities of daily life. The word is most often attached to permanent
conditions, such as blindness or mental challenges. Illness, on the other hand, is often seen as a
temporary state of bad health. Thus, labeling ESRD as a disability creates expectations in respect
to patient attitude as well as disease maintenance that are far different than these held in regards
to patients who are seen as ill.
Since disabled patients are frequently in need of care for a long period of time,
physicians, clinicians and other staff have the opportunity to build a personal relationship that
may impact treatment. The bond may create a situation in which the staff is overly concerned
with the patient’s feelings or the family’s needs. Sympathetic toward the plight of the disabled
patient, some health care providers may give too much leeway to him/her. Staff may not expect
disabled patients to be as welcoming and cooperative as individuals who are seen as “merely” ill.
demonstration projects in prospective reimbursement and incentives for economy; Limitations on recognition of
increase in prevailing charge levels for medical and other health services. Ball, 3-25.
218
Levinsky, 1395-1399.
78
Furthermore, the label may alter the medical expectations providers have of disabled
patients. Since disability is often associated with continuing maintenance, rather than cure,
clinicians may not expect disabled patients to progress and improve as readily as patients who
are ill. It is true that ultimately improvement in the ESRD patient’s medical condition would
require a transplant; however, there are other ways to optimize the ESRD patient’s condition.
The patient who actively participates and cooperates in the management of his/her disease can
have more uncomplicated medical interventions, leading the patient to have to a healthier
outcome as well as an overall better quality of life.
In addition to a difference the expectations of providers and staff, the disabled patient
may have different expectations of him/herself. Patients, who are told they are ill, may see illness
as an obstacle to overcome. Sick patients can “beat” their illness by cheerful cooperation and
participation in their medical treatment. Disabled patients, however, may have a very different
view of their disease. To the disabled individual, disease or illness might be seen as a temporary
medical condition to actively deal with, rather it is a permanent situation that he/she must
grudgingly and passively accept.
Members of the patient’s personal support system might react different to a disability,
rather than an illness. An illness may be viewed as a temporary setback for the patient and
his/her support system to overcome together by working as a team, while a disabled patient may
conjure up images extensive languishing. This skewed image may negatively affect the patient’s
relationship with his/her support network by the impeding the devolvement of a constructive
relationship. The support network may be too involved in helping the disabled patient in
situations where the patient should be helping him/herself. In turn, the patient will overly rely on
79
their support network to do things that they should be doing themselves. This codependency is
neither good for the patient or the support network.
How the ESRD Amendment Became Attached to Medicare
The inclusion of ESRD in Medicare was very much the consequence of political
maneuvering. In particular, the powerful lobbying of several groups clearly affected the addition
of renal disease to the federal program. Both the National Association for Patients on
Hemodialysis (NAPH), as well as several key Congressmen, were undeniably responsible for the
incorporation of patients affected by kidney failure into the Medicare system. Shep Glazer, who
was Vice President of NAPH, testified before the House Ways and Means Committee’s hearings
on national health insurance on November 4, 1971. To make his testimony distinctly dramatic
and to capture attention, Glazer testified while attached to a dialysis machine. As he was
dialysized he commented, “Gentlemen, I am going to tell the Committee that if dialysis can be
performed on the floor of Congress, it can be performed anywhere.”219 As his wife, attached
Glazer to the dialysis machine, he continued, “Kidney patients don’t have to be confined to
hospitals, where expenses are $25,000 a year and more per patient. It’s much cheaper in a
satellite unit or at home. I want to show the Committee what dialysis is really like. I want them
to remember us.”220
During his testimony, Glazer asked the Committee to give the American people a
comprehensive health insurance program, which “will fully protect them in case of catastrophic
American Association of Kidney Patients, “NAPH Testifies Before Congress Shep Glazer Dialyzes,”
http://www.aakp.org/newsletters/Renalife-Magazine/Renalife-Articles/NAPH-Testifies-Before-Congress-ShepGlazer-Dialyzes/ (accessed November 22, 2008).
220
Ibid.
219
80
illness.”221 Regarding kidney disease, he stated that it is, “unique, because kidney patients, unlike
other terminal patients, can be returned to a fairly normal life.”He emphasized that renal patients
are, “productive members of society, pay our taxes and circulate money back into the country’s
economy.”222
Glazer’s testimony was theatrical, but he meant to do more than put on a show. His intention
was to humanize kidney failure. He aimed to point out to decision-makers the readily available
technology to “cure” a terminal illness for an individual patient. Glazer also meant to draw
attention to the concept that this particular technology and this particular disease were unlike
others. The technology was there and its use would allow Congress to save people and restore
them to a functional and productive life; people who, without treatment, would surely die.
Glazer’s demonstration had the effect that he had hoped it would. Congressmen paused and
watched as he was disconnected from the dialysis machine after the presentation. The Committee
members, “showed great interest, and they express it in the record.”223
Wilbur Mills, the Chairman, thanked NAPH for an excellent testimony and said that he
appreciated their efforts. Sam Gibbons (D-Fla.) said that NAPH’s testimony moved him because
a member of his family had been stricken with kidney disease. Charles Vanik (D-Ohio)
questioned the NAPH delegation further about insurance policies and the backlog of patients in
hospitals. Representatives Ullman (D-Ore.) and Brotzman (R-Colo.) praised the courage and
perseverance of the members of the delegation for their dramatic presentation.224
The clever testimony of members of the NAPH was not done without support. Internal
assistance from members of the federal government was key to the poignant presentation. When
221
Ibid.
Ibid.
223
Ibid.
224
Ibid.
222
81
asked about the ESRD amendment, Paul Rettig, Staff Director on the Ways and Means
Committee for the Health Sub-Committee, clarified the role of his administration. He
commented that, in particular, the Health Sub-Committee was responsible for the background
books given to those individuals who testified before Congress. 225 The information provided by
the committee would enable those who testified to further justify their arguments for including
ESRD in the Medicare program.
In addition to the powerful lobbying by Glazer and NAPH, the atmosphere surrounding
Congress had an effect on the passage of the bill and the inclusion of renal disease in Medicare.
According to those on Capital Hill at the time when the ESRD amendment was added to the
original Medicare legislation, there was very little else going on in medical news and activity. 226
Health care, in general, was not high on the national agenda. All public and political attention in
this small arena was focused on kidney disease.
One of the possible reasons for the lack of policy concerns about health care in the 1960’s
is found in the condition of the gross domestic product at that time. The GDP is considered to be
a measurement of national income and the total output of a nation. Further, the GDP is often
considered to be a legitimate indicator of the standard of living in an economy. The reasoning is
that all individuals are effected by the economic production, or of lack there of, in their
community.
In the 1960’s health care represented a much lower percentage of the gross domestic
product than it does today.227 In fact, in 1960 health care only represented approximately 5.1
225
Paul Rettig, interviewed by Edward Berkowitz. HCFA Oral History Interview Washington, DC, (August
14, 1995) http://www.cms.hhs.gov/History/Downloads/CMSOralHistoryBios.pdf (accessed November 23, 2008).
226
Ibid.
227
Levinsky, 1395-1399.
82
percent of the GDP. In 2004 health care represented approximately 16 percent of the GDP.228
That means that, when contrasted with what is produced today, health care in the 1960’s was a
much smaller portion of the nation’s output. Since it was a lesser portion of the GDP it is
reasonable to assume that health care, was not a major national political concern because it was
not a major financial concern.
Health care in the 1960s was not the 600 pound gorilla in the nation’s living room that it
is today. Most doctors were in private solo practices or small group practices, not large
conglomerates. Most medical institutions were public; for-profits facilities were few and far
between. Most hospitals were owned and operated by religious entities, local non-profit agencies
or the federal government, not for-profit entities owned and operated by remote corporate boards
with shareholders. The pharmaceutical companies were smaller operations, many of which were
still family-owned, not publicly-traded, money-making ventures obsessed with research and
development and patents.
Health care in the 1960’s was much more a cottage industry than a business. Physicians
practiced the art of medicine, not the business of medicine. Third-party payers were not the
dominant forces that they are today. Doctors were more concerned with building and maintaining
relationships with their patients than properly diagnosing to correspond with CPT codes, fighting
with insurance companies to defend tests and procedures, and feeling forced to justify length of
stays (LOS) with hospital administrators. With health care operating at a slower, more personal,
pace, the intensity of production on the provider side was vastly different than it would be four
decades later.
National Coaltion on Health Care, “Health Insurance Costs,” http://www.nchc.org/facts/cost.shtml
(accessed November 22, 2008).
228
83
In addition, in the 1960’s and 1970’s health care was not subject to the same level of
business-modeling and consumerism that it is today. In general, a patient of 40 years ago did not
shop around for the best amenities in a hospital before making a decision about where to have a
procedure. The patient did not chose a physician based on who was in network and who was out
of network, and what that would mean in terms of their co-pay and deductible. The patient did
not elect to have a procedure at an ambulatory surgery center (ASC) because parking and the
hours of operation were more convenient than at the local hospital. In the 60’s, generally patients
went to the hospitals their provider told them to go to, chose a family physician and stayed with
him (or, less likely, her) until either he died or moved or they did. Moreover, ASCs were few and
far between; so patients had procedures at the hospital.
Although the 1960s were not a dynamic period for health care on the individual level, at
the federal level, there was a prospect of significant change. Two ground shaking programs were
in the works, nationalized healthcare legislation (through the Kennedy-Mills bill) and a
children’s health insurance program (CHIP).229 The feeling on Capital Hill was that some form
of nationalized healthcare legislation was just around the corner.
With the prospect of nationalized healthcare on the horizon, the issue of attaching federal
funding for ESRD to the Medicare program emerged. When confronted with the idea of
attaching renal disease to the Medicare program, politicians were noticeably struck with fear.
Many politicians were terrified of being perceived as heartless, standing by while people died,
waiting for the slow wheels of the government to grind out nationalized health care funding for
ESRD. According to Leonard Shaffer, Administrator of the Health Care Financing Agency
(HCFA) from 1978-1980, “What politicians desperately fear is somebody dying because they
Richard Rettig, “The Social Contract and the Treatment of Permanent Kidney Failure,” Journal of the
American Medical Association 274, no. 14 (April 10, 1996): 1123-1126.
229
84
wouldn’t give them money and with end stage renal disease you will die if you don’t get
dialysis.”230
With kidney failure, the technology was already available, but the funds to support
treatment to those in need of dialysis were not. If federal dollars were given to the ERSD
program, politicians would not be tainted by the allegations that that they allowed sick,
vulnerable and treatable people to die. Moreover, if elected officials did force renal patients to
wait for federal support when nationalized healthcare passed, politicians who did not support the
ESRD amendments would look like callous villains who denied life saving treatments to helpless
renal patients. Thus, the advancing bandwagon of funding ESRD must have been an irresistible
ride to politicians. 231 And the bill, with its ESRD attachment, was passed in 1972.
How to Medically Address ESRD: Current Treatment Modalities
Regardless of how the ESRD became a part of the Medicare system, decisions have to be
made as to how to appropriately medically treat the condition. Currently, there are two types of
treatment modalities for individuals in kidney failure: hemodialysis and peritoneal dialysis (PD).
Hemodialysis
Hemodialysis is the process by which the patient’s blood is circulated through a machine
and the machine cleans the blood of toxins.232 During hemodialysis, blood is allowed to flow, a
few ounces at a time, through a filter that removes wastes and extra fluids. The clean blood is
then returned to the body. The removal of harmful wastes and extra salt and fluids helps to
230
Lenoard Schaeffer, interviewed by Edward Berkowitz. HCFA Oral History Interview (August 17, 1994)
http://www.cms.hhs.gov/History/Downloads/CMSOralHistoryBios.pdf (accessed November 23, 2008).
231
Levinsky, 2.
232
Paul Eggers, “Medicare’s End-Stage Renal Disease Program,” Health Care Financing Review 22, no. 1
(Fall 2000): 55.
85
control blood pressure and keep the proper balance of chemicals, like potassium and sodium, in
the body.233
With hemodialysis, one of the biggest adjustments the patient has to make is the
adherence to a strict schedule. Most patients will be treated at a dialysis center a minimum three
times a week for from three to five or more hours each visit. Even in the best situations, adjusting
to the effects of kidney failure and the time spent on dialysis can be difficult.234 Aside from the
“lost time,” the patient will also most likely have a reduction in their energy level. Many dialysis
patients will need to make changes in their lives, including their ability to work outside and the
home. At some point, the loss of energy will require all renal patients to give up or reduce some
of their activities and responsibilities.235
Before dialysis can begin, a vascular access site must be secured. The arteriovenous
fistula offers providers a location through which blood to be removed and returned to the body. It
is likely that vascular access will be prepared weeks or months before a patient begins dialysis.
The dialysis machine itself is about the size of a dishwasher.236 The dialyzer is a large canister
containing thousands of small fibers through which blood is passed. Dialysis solution, the
cleansing fluid, is pumped around these fibers. The fibers allow wastes and extra fluids to pass
from the blood into the solution, which carries them away. The dialyzer is sometimes called “an
artificial kidney.”237 The machine has three main jobs: to pump blood and watch flow for safety,
to clean wastes from blood and to monitor blood pressure and the rate of fluid removal from the
National Kidney and Urologic Diseases Information Clearinghouse, “Treatment Methods for Kidney
Failure: Hemodialysis,” http://kidney.niddk.nih.gov/kudiseases/pubs/hemodialysis/ (accessed November 22, 2008).
234
Ibid.
235
Ibid.
236
Ibid.
237
Ibid.
233
86
body.238 A dialysis center may use the same dialyzer more than once for an individual patient’s
treatments. Reuse is considered safe as long as the dialyzer is cleaned and tested before each use
to make sure the machine is still working, 239 While reuse on a patient is acceptable practice, the
dialyzer should not be shared between patients.240
The dialysis solution, also known as dialysate, is the fluid in the dialyzer that helps
remove wastes and extra fluid from the blood.241 The dialysate contains chemicals that make it
act like a sponge. Each individual patient will receive a specific dialysis solution for his or her
treatments. The formula will be adjusted based on how well the patient handles the treatments as
well as the results of the blood tests.242
The kidneys do much more than remove wastes and extra fluid. They also make
hormones and balance chemicals in the system. When the kidneys stop working, an individual
may have problems with anemia and conditions that affect the bones, nerves, and skin. Some of
the more common conditions caused by kidney failure are extreme tiredness, bone problems,
joint problems, itching, and restless legs.243
Fatigue in patients on dialysis is often attributable to anemia. Anemia is a medical
condition in which the volume of red blood cells in the body is low. Red blood cells have the
responsibility of carrying oxygen to cells throughout the body. Without oxygen, cells are unable
to use the energy from food, so an individual with anemia may tire easily and look pale.244
238
Ibid.
Ibid.
240
Ibid.
241
Ibid.
242
Ibid.
243
Ibid.
244
Ibid.
239
87
Anemia is very common in individuals with kidney disease because the kidneys produce
the hormone erythropoietin (EPO) which stimulates the bone marrow to produce red blood cells.
Diseased kidneys often can not make enough EPO, and so the bone marrow makes fewer red
blood cells. In order to combat the effects of a deficiency of EPO, a supplement can be given to
patients.245
Bone problems in individuals receiving dialysis are often attributable to renal
osteodystrophy. Renal osteodystrophy, or bone disease of kidney failure, affects 90 percent of
patients on dialysis. “It causes bones to become thin and weak or formed incorrectly and affects
both children and adults. Symptoms can be seen in growing children with kidney disease even
before they start dialysis. Older patients and post-menopausal women are at greater risk for this
disease.”246
In addition, many people who receive hemodialysis complain of itchy skin, which may be
intensified during or just after treatment. Itching in dialysis patients can be made worse by
wastes in the bloodstream that current dialyzer membranes are unable to remove from the blood.
The problem of itching can also be related to high levels of parathyroid hormone (PTH).247
To treat itching, phosphate binders, which act like sponges to soak up, or bind,
phosphorus while it is in the stomach, seem to help some people. Other patients find relief after
exposure to ultraviolet light. Others improve with EPO shots. A few antihistamines (Benadryl,
Atarax, Vistaril) have been found to help. Capsaicin cream applied to the skin may relieve
245
Ibid.
Ibid.
247
Ibid.
246
88
itching by deadening nerve impulses.248 Applying creams with lanolin or camphor also may
help.249
Patients on dialysis often have trouble sleeping. Some patients specifically have sleep
apnea syndrome, which is often signaled by snoring and breaks in snoring. Sleep apnea in
dialysis patients may be related to the effects of advanced kidney failure on the control of
breathing. Some of the treatments that tend to work with people who have sleep apnea include
losing weight, changing sleeping position, and wearing a mask that gently pumps air
continuously into the nose (nasal continuous positive airway pressure, or CPAP).250
Other dialysis patients have trouble sleeping because of aching, uncomfortable, jittery, or
“restless” legs. “Restless legs” result in the impulse to kick or thrash legs. The causes of restless
legs in dialysis patients may be attributable to nerve damage or chemical imbalances. To
homeopathically counter “restless legs,” patients can try moderate exercise during the day or
warm baths. Individuals with restless leg syndrome should reduce or avoid caffeine, alcohol, and
tobacco. If homeopathic remedies do not work, a class of drugs called benzodiazepines, brandnamed Klonopin, Librium, Valium, and Halcion, which are often used to treat insomnia or
anxiety, may help.251
Sleep disturbances such as sleep apnea and restless leg syndrome are significant medical
conditions. Over time, they can lead to “day-night reversal” (insomnia at night, sleepiness during
the day), headache, depression, and decreased alertness. Therefore, these conditions should be
addressed.252
248
Ibid.
Ibid.
250
Ibid.
251
Ibid.
252
Ibid.
249
89
For those individuals who have been on dialysis for more than five years, dialysis-related
amyloidosis (DRA) is a common side-effect. DRA develops when proteins in the blood deposit
on joints and tendons. While functioning kidneys filter out these proteins, dialysis filters are not
as effective. The result of the protein blood deposits can be in pain, stiffness, and fluid in the
joints.253
Hemodialysis is considered to be a universal standard of care for individuals with acute
and chronic kidney failure. Moreover, hemodialysis was the first, and remains the only, method
in which a machine is able to replace a failed internal organ.254
Peritoneal dialysis (PD)
Peritoneal dialysis (PD) is a unique form of dialysis that allows the patient to dialyze him
or herself. Treatments are done away from the hospital or dialysis clinic and can be performed in
a variety of settings including at home, at work, or even on trips. Because PD allows the patient
to give the treatments, he or she has more independence, as well as control. 255
In PD a catheter is used to fill the abdomen with a dialysis solution. The standard catheter
for PD is made of soft tubing that promotes the individual patient’s comfort. The cuffs of the
catheter are generally made of the polyester material Dacron. Dacron is used because it has the
ability to merge with the patient’s scar tissue and create a stable environment to keep the catheter
253
Ibid.
University of Washington, “UW Morns the Loss of Belding Scribner,” June 20, 2003,
http://www.washington.edu/newsroom/news/2003archive/06-03archive/k062003.html (accessed June 1, 2007).
255
National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC), ““Treatment Methods
for Kidney Failure: Peritoneal Dialysis,” http://www.kidney.niddk.nih.gov/kudiseases/pubs/peritoneal/index.htm
(accessed November 22, 2008).
254
90
in place. The end of the tubing is inside the abdomen and has numerous holes to allow the free
flow of the dialysis solution in and out of the abdomen.256
Because the walls of the abdominal cavity are lined with a semipermeable membrane,
peritoneum, waste products and extra fluid can pass from the blood into the dialysis solution.
The solution contains a sugar called dextrose that will pull wastes and extra fluid into the
abdominal cavity. These wastes and fluid then leave the body when the dialysis solution is
drained. The used solution, containing wastes and extra fluid, is then thrown away. 257 The
process of draining and filling, called an exchange, typically is about thirty to forty minutes in
duration. The period the dialysis solution is in the abdomen is known as the dwell time. A typical
PD schedule usually involves four exchanges a day, each with a dwell time of four to six hours.
However, different types of PD have different schedules of daily exchanges.258
One form of PD, continuous ambulatory peritoneal dialysis (CAPD), does not require a
machine. The patient is able to walk around with the dialysis solution in his abdomen. If the
patient chooses CAPD, “a fresh bag of dialysis solution drains into the abdomen. After 4 to 6 or
more hours of dwell time, the patient drainds the solution, which now contains wastes, into the
bag, then repeats the cycle with a fresh bag of solution. A machine is not needed for CAPD;
gravity fills and empties the abdomen. A doctor will prescribe the number of exchanges needed,
typically three or four exchanges during the day and one evening exchange with a long overnight
dwell time while the patient sleeps.”259
If CAPD is chosen, the patient, may have a problem with the long overnight dwell time.
It's normal for some of the dextrose in the solution to cross into the body and become glucose.
256
Ibid.
Ibid.
258
Ibid.
259
Ibid.
257
91
The absorbed dextrose does not create a problem during short dwell times. But overnight, some
people absorb so much dextrose that it starts to draw fluid from the peritoneal cavity back into
the body, reducing the efficiency of the exchange. Patients who have this problem, may be able
to use a minicycler (a small version of a machine that automatically fills and drains the abdomen)
to exchange the solution once or several times overnight while the patient sleeps. These
additional, shorter exchanges will minimize solution absorption and give the patient added
clearance of wastes and excess fluid.260
Another form of PD, continuous cycler-assisted peritoneal dialysis (CCPD), also
sometimes called automated peritoneal dialysis (APD), requires a machine called a cycler to fill
and drain the abdomen. CCPD uses an automated cycler to perform three to five exchanges
during the night while the patient is asleep. In the morning, the patient will begin one exchange
with a dwell time that lasts the entire day. If CCPD is used, there is the chance that there may be
a solution absorption problem with the daytime exchange, which has an extended dwell time.
Therefore, the patient may have the need for an additional exchange in the mid-afternoon to
increase the amount of waste removed as well as to prevent excessive absorption of solution.261
Infection and compliance are the most common problems for people who use PD to treat
their kidney failure. Providers do teach the patient how keep the catheter bacteria-free in order to
avoid peritonitis, an infection of the peritoneum. Additionally, improvements have been made in
the design of the catheter that helps to protect the patient against the spread of bacteria. However,
infection is still a risk. Signs of infection may include fever, nausea or vomiting redness or pain
around the catheter, unusual color or cloudiness in used dialysis solution, and a catheter cuff that
has been pushed out. To minimize the chance of infection, a patient pamphlet advises: “Store
260
261
Ibid.
Ibid.
92
supplies in a cool, clean, dry place; Inspect each bag of solution for signs of contamination
before you use it; Find a clean, dry, well-lit space to perform your exchanges; Wash your hands
every time you need to handle your catheter; Clean the exit site with antiseptic every day; and
Wear a surgical mask when performing exchanges.”262
Sometimes patients do not perform all of the exchanges prescribed by their medical team.
Some patients skip exchanges, while others may all together neglect to perform an entire
treatment days when using CCPD. Skipping treatments is highly dangerous. Missing PD therapy
has been shown to increase the risk of hospitalization, and even result in death. 263 As with
hemodialysis, PD has potential side-effects including anemia and erythropoietin (EPO)
deficiency, renal osteodystrophy, itching (pruritus), sleep disorders, as well as amyloidosis.
While PD is a remarkable technology, allowing the patient to have more control over
their medical treatment, freedom does not come without consequences. The flexibility and
independence of PD makes it especially important for the patient work closely with his health
care team, the nephrologist, the dialysis nurse, the dialysis technician, the dietitian, and the social
worker, as well as the members of his family, in order to assure care is being delivered
appropriately.264
The Realities of Being a Chronic Patient
Regardless of how dialysis is delivered, through hemodialysis or peritoneal dialysis,
patients who are subjected to prolonged medical treatments can experience not only serious
medical side effect but psychosocial side effects. Psychological stressors caused by ESRD and its
262
Ibid.
Ibid.
264
Ibid.
263
93
treatments have been demonstrated to originate from five major sources. The stressors include,
"Job and family crisis," "Worry about health and family being harmed," "Worry about daily life
being restricted and physical appearance being altered," "Fear of decline in social ability," and
"Fear of decline in physical function."265
Individually, or in combination, these psychosocial stressors can lead to psychological
illnesses. In particular, several studies have suggested that 20% to 30% of patients with renal
failure suffer from clinical depression. Most often, dialysis patients exhibit a depressive affect.
The depressive affect can mean that the ESRD patient exhibits signs of pessimism, anhedonia
(an inability to experience pleasure), sadness, as well as complaining of feeling helpless and
hopeless.266 In addition to the emotional changes a chronic patient may experience, clinical
depression can manifest itself in very physical ways. Clinically depressed individuals may
experience changes in sleep patterns, decreased ability to effectively concentrate, a fluctuating
appetite, declining activity level, and changes in libido.267
Where to Treat ESRD: Location, Location, Location
With the two major types of dialysis, hemodialysis and PD, established as medically
appropriate ways to manage kidney failure, the issue of where to physically provide services
would prove to be a challenge. Providers, politicians, proprietors, and patients would clash as to
what was the best and most appropriate location to provide ESRD services.
XQ Ye, Q. Chen, J. X. Lin, R. P. Wang, Z. H. Zhang, X. Yang, and X. Q. Yu., “Effect of Social
Support on Psychological-Stress-Induced Anxiety and Depressive Symptoms in Patients Receiving Peritoneal
Dialysis,” Journal Psychosomatic Research 65, no. 2 (August 2008):157-164.
266
Fredric Finkelstein, Diane Wuerth, Laura Troidle, and Susan Finkelstein, “Depression and End-Stage
Renal Disease: A Therapeutic Challenge,” Kidney International 74, no. 7 (October 2008): 843–845.
267
Ibid.
265
94
Providers and politicians had high hopes for at-home dialysis. Belding Scribner and other
clinicians believed that at-home dialysis could solve the problem of the limited number of
treatment spaces.268 In hospitals or clinics, there were a maximum number of patients that could
be dialyzed. However, if treatments were moved into the home an infinite number of patients
could be dialyzed. With an enlarged patient population, it would no longer be necessary to
rationing through God Squads would not be needed.
Politicians also supported dialysis at home, but not necessarily from the equity in access
standpoint. For some politicians, the financial benefits of home dialysis would be a reason to
champion the approach. When making the decision to include ESRD in the Medicare legislation
they were told that, “Kidney patients don’t have to be confined to hospitals, where expenses are
$25,000 a year and more per patient. It’s much cheaper in a satellite unit or at home.”269 So, from
a purely financial standpoint at home dialysis made sense.
Although at-home dialysis could expand the possibilities and reduce the cost of dialysis,
most patients did not then and do not now choose that method of delivery. Dialysis most
frequently occurs in hospital-based and freestanding facilities. Hospital-based dialysis units are a
department within the hospital. Where a hospital can be either for-profit of non-profit, so can a
hospital based dialysis unit. The unit within the hospital is subject to the rules and regulations of
the facility. Freestanding facilities are not a subsection of any hospital and, therefore, operate
under their own auspices. As with a hospital, freestanding facilities may be for-profit or nonprofit and a subject to their own set of external review standards.270
268
Nissenson and Fine, 20.
American Association of Kidney Patients, “NAPH Testifies Before Congress Shep Glazer Dialysizes”.
270
Rudolph Daniels, “Ligation and the American Dialysis Industry: Some Considerations about Monopoly
of Power in Renal Care,” American Journal of Economics and Sociology 50, no. 2 (July 3, 2006): 239.
269
95
Evidence for the lack of patient interest in home dialysis is the rapid and marked growth
in treatment facilities, especially on the for-profit side. Since July 3, 1973 when the ESRD
amendments became effective, the number of patients has grown exponentially while, “the
number of proprietary dialysis facilities has proliferated . . . ”271 National Medical Care (NMC),
a vertically integrated company with its own manufacturing and clinical laboratory divisions
owns more than 500 treatment units in the United States and treats more than 20% of all dialysis
patients. Other major chains include Vivra, which operates about 200 units; the Ren Corporation,
also vertically integrated, which has 60 to 70 units; and Renal Treatment Centers, at 70 units” 272
In comparison to the for-profit market share Dialysis Clinic Inc, one of the largest non-profit
chains, only operates approximately 100 facilities.273
The rapid growth in the for-profit sector of dialysis facilities has caused much
deliberation. The issue that is most troubling is that for-profit organizations are being financed
through public funds.274 For-profit organizations are essentially being operated by federally
collected social security payroll taxes. In addition, because they are for-profits, these
organizations are able to use their profits in any manner they see fit. So, investors in these forprofit dialysis clinics are raking in a stable and attractive return, which is the product of the
federal government’s investment in the medical treatment of a vulnerable population.
While other federal programs, such as food stamps, are paid for by the government but
spent at corporate grocery stores the visceral reaction to the concept is different. Clerks and
baggers at the local supermarket are not seen by the public in the same light as physicians and
nurses at dialysis clinics. Grocery store employees are seen as blue collar workers struggling to
271
Ibid., 223-224.
Rettig, 1123-1126.
273
Ibid.
274
Ibid.
272
96
make ends meet, not professional authorities who are extraordinarily highly paid. The disparity
in pay may lead to a resentment of physicians and result in doctors being viewed as fleecing the
federal government.
Reasons for lack of patient attraction to at home dialysis are complicated. Some patients
may just not want to take on the responsibility associated with dialysizing themselves at home. It
may be easier for the patient to allow providers and staff at the clinic to be accountable for the
quality of care than to take on personal responsibility. Additionally, in some cases, this may
force the patient to address the core reason why he or she is in kidney failure in the first place.
The patient, whose kidney failure can be traced to lifestyle choices that led to hypertension or
diabetes, may have to acknowledge that he or she is somewhat responsible for the disease.
Other patients may not feel confident in their, or their family’s, abilities to properly care
for themselves at home. Dialysis can seem like an overwhelming medical treatment. It is not as
simple as changing the dressing on a wound or remembering to take an antibiotic for seven day.
Dialysis, if not administered correctly, could lead to infection, increased illness or in the works
case, death. This awesome responsibly can be rightly intimidating.
Also, some patients may choose a dialysis unit over at home, because they prefer the
environment. At the clinic, in the old days, the patient would expect and receive personal
attention from the staff. This attention, while no longer as prevalent as it once was, may make
boost the patient’s ego by making them feel important. Additionally, at the clinic, the patient can
have a social outlet. Because of the nature of kidney failure, some patients may spend a
considerable amount of time in their homes. In some cases, interaction with other patients may
be the only contact the patient has with peers.
97
Chapter 5: The Politics of the ESRD Amendment
When the amendment that added funding for ESRD was attached to the Medicare
program, several notable, as well as dangerous, conjectures were made. First of all, legislators
made a misguided assumption in respect to the culture on Capital Hill. Policy makers believed
that the culture that had worked for other areas of the federal government, such as the Social
Security Administration, would work for the Medicare program and thus the ESRD program.
The premise that resulted in several setbacks was a product of the organization of the
programs. At its inception, Medicare was overseen by the House Ways and Means Committee
and Medicaid was under the Energy and Commerce Committee. Believing that combining the
two agencies was in the best interest of the programs in 1977, Joseph Califano founded the
Health Care Financing Administration (HCFA). When he created HCFA, Califino did so quickly
and without consultation. HCFA was created in 60 days with a relatively small number of people
working on it.275 Califano had high hopes for the united program. He believed that by combining
Medicare and Medicaid under one roof, the federal government would have more leverage to
negotiate better rates through collective bargaining, making the programs less of a financial
drain.276
Although collective bargaining was a creative idea, it did not have the impact that
Califino had imagined. One potential reason for the minimal financial impact could be
275
Fred Bohen, interview by Edward Berkowitz. HCFA Oral History Interview Manhattan, New York,
(September 13, 1996) http://www.cms.hhs.gov/History/Downloads/CMSOralHistoryBios.pdf (accessed November
25, 2008).
276
Rettig and Levinsky, 4.
98
inconsistent contracting by the federal government. If one federal employee was responsible for
negotiating Medicare reimbursement rates with a facility, while a different employees was
responsible for negotiating Medicaid reimbursement rates, the lack of cross-over negates any
potential bargaining power.
Another possible explanation for the diminished effect could be the general culture of
health care reimbursement in the 1960’s and 1970’s. During that period, most health care
insurance agencies paid health care bills fee-for-service. This meant that what the provider
charged, the provider was paid. This created an environment in which the government had too
much trust in physician’s billing decisions. And may not have done their own calculations of
cost. Without their own estimates of what services should cost, the federal government would be
at a disadvantage for negotiations with providers.
The reimbursement culture of the Social Security Administration (SSA) spilled over into
HCFA and, through it, to the Medicare and the Medicare ESRD program. The SSA culture
advocated prompt and obedient payment for services. Their theory was “When we get a bill, we
are going to pay it quickly, regardless of what it costs. Thus our goal is…to get the check on
time.”277 Federal employees assumed that whatever the cost the bill must be paid and took that
attitude with them to HCFA.278 This culture resulted in overpayment of costs by the government
and abuse of the system by providers. This was especially true in the treatment of kidney disease.
Leonard Schaffer, who was the administrator of HCFA in the late seventies commented that,
“There were a lot of bad actors in dialysis, it was filled with fraud.”279
277
Leonard Schaeffer, Inteviewed by Edward Berkowitz. HCFA Oral History Interview (August 17, 1994).
http://www.cms.hhs.gov/History/Downloads/CMSOralHistoryBios.pdf (accessed November 23, 2008).
278
Ibid.
279
Ibid.
99
Federal employees and agencies did not fully realize that making payments on time was
not the way to protect beneficiaries. Protection of the beneficiaries meant getting value for the
monies spent, which would translate into a financially healthy, as well as a stable, program.280
Those who created the ESRD program also failed to predict costs correctly. This failure
would have catastrophic consequences. According to Schaffer, the cost of Social Security to the
federal government is relatively easy to estimate, “There are actuarial tables, there’s a lot of
knowledge about how long people live, and there are also assumptions you can make about you
can make about calculating cost so that while Social Security is a big number, it was
knowable.”281 The difficulty was that Medicare and Medicaid were not. There was an ignorance
surrounding the best way to estimate Medicare cost. Schaffer blamed that ignorance on the
government’s use of some of the same techniques they used with Social Security to estimate
Medicare costs. “Those techniques were totally inappropriate,” Shaffer said.282
Unlike Social Security, estimates regarding Medicare costs were most likely flawed due
to the unpredictability of illness. There are no actuarial tables that will predict exactly how every
individual will react to a medical treatment. Each patient has a different response to the same, or
similar, procedures (which is why medicine is referred to as an art, not a science). The variance
in human response to treatment can make forecasting cost nearly impossible.
With little consideration of the randomness of individual response, policy makers were
advised, and made their decisions, based on ill-conceived approximations. Early estimates of the
280
Ibid.
Ibid.
282
Ibid.
281
100
cost of the program were approximately $250 million per year.283 However, during the first year
of the ESRD program, “Actual costs . . . were three to seven times higher than projected . . . ”284
From initial miscalculations, costs of the ESRD program continued to steadily and
rapidly rise. In 1976 (just four years after the passage of the amendments to expand Medicare to
include the ESRD program), the estimate of the cost of the program to the Social Security
Administration was $300 million per year.285 By 1979, only seven years after the ESRD
amendments, costs of the program to Medicare reached an astonishing $1 billion per year. 286 By
1987 Medicare ESRD expenditures reached $2.4 billion per year; by 1991 they reached $5.7
billion; by 1995 Medicare ESRD expenditures reached $8.1 billion; by 1998 annual ESRD
expenditures reached $12.3 billion; and by 2003 costs to Medicare per year reached a whopping
$18.1 billion. 287
Proponents of the ESRD program, who had pushed for federally funded care for persons
with kidney failure, have been criticized for manipulating the data, and possibly for a deliberate
underestimation of the likely costs of the program.288 Critics claim ESRD supporters not only
underestimated its costs, they overestimated its benefits. When presenting the ESRD program to
policy-makers, some supporters indicated that the ESRD program could be selfsupporting. Advocates “even suggested that after an initial cost of $400 to $500 million over
several years, the restored productivity of ESRD patients would render the ESRD program
283
Eggers, 55-60.
John Moskop, “The Moral Limits to Federal Funding for Kidney Disease,” The Hastings Center Report
17, no. 2 (April 1987): 11-15.
285
Eggers, 58.
286
Ibid.
287
Moskop, 11; also see, Nissesnson, 164, Eggers, 58, United States Renal Data System, “United States
Renal Data System: Volume 2, Costs of ESRD,” http://www.usrds.org/atlas.htm. (accessed on November 22, 2008).
288
Levinsky, 1395-1399.
284
101
‘budget neutral.”289 Glazer himself directly stated to Congress that kidney disease is “unique,
because kidney patients, unlike other terminal patients, can be returned to a fairly normal life”.
He emphasized that renal patients are “productive members of society, pay our taxes and
circulate money back into the country’s economy.”290
The fatal flaw in the idea of the program being self supporting was attributable to
misconception that ESRD patients would replace the funds they withdrew from Medicare.
Medicare is funded through Social Security payroll taxes. Individuals who work contribute to
Social Security and, therefore, to Medicare and the ESRD program. Therefore, in order to put
back what they took out, ESRD patients would have to return to work.
However, ESRD patients were not quickly returning to work. The medical management
of ESRD is a long-term treatment of a chronic disease, not a temporary delivery of health care
for a finite period of time. Today’s providers and staff are not simply helping patients get back
on their feet. They are often delivering services to a stable patient population. Without
transplantation, ESRD patients will require dialysis for as long as they live. This fact seems to
have been ignored in the calculations of cost.
Another mistake made was that funding the renal program based on the characteristics of
the early population receiving ESRD services. The early renal patient was appreciative for and
compliant with life-saving dialysis. Generally, they quietly adhered to their dialysis treatment, as
well as to the dialysis unit administrative rules. The God Squads, which selected patients for
treatment, ensured patient obedience by screening out “inappropriate” candidates and choosing
only those who would behave.
Moskop, 11; also see, American Association of Kidney Patients, “NAPH Testifies Before Congress
Shep Glazer Dialyzes.”
290
American Association of Kidney Patients, “NAPH Testifies Before Congress Shep Glazer Dialyzes.”
289
102
However, when ESRD services were opened up to all individuals in need, many
“challenging” patients were encountered. Patients who do not follow medical advice, who were
late or missed appointments, and who were hostile or abusive to staff or other patients, require a
different and more extensive level of service. The patient, who chooses not to follow the
prescribed diet, creates challenges as well as additional work for the staff and the clinic. The
patient who is late for, or misses, appointments makes extra work for the scheduling department,
while the patient who misses appointments can exacerbate his or her medical condition, thus,
producing more work for the medical staff which must now stabilize the sicker patient. Further,
the patient who is abusive destabilizes the environment for the entire staff.
Effects of the ESRD Amendment
The inclusion of kidney failure under the umbrella of Medicare would shape not just the
Medicare system, but the entire operations of treatment for renal failure. The ESRD amendments
would have two very profound effects. The first consequence, the end of the Life or Death
Committees, was to be anticipated and even welcomed. However, the second outcome, the
dramatic change in the make-up of the patient population receiving renal services, was utterly
unexpected and therefore poorly planned.
End of the God Squads
With the inclusion of ESRD in the Medicare program, there was no longer a monetary
reason to ration care for this patient population. The influx of federal dollars would offer the
support necessary to enable providers to develop and deliver renal services for those who needed
them. Therefore, in effect, the introduction of federal support for ESRD would revolutionize the
103
way in which services allocated. However, while a flood of money did help to lessen the need for
rationing, it would not be the sole reason for the end of the reign of the God Squads.
The God Squad was, in some way, responsible for its own demise. In 1965, the God
Squad rejected a young girl, Caroline Helm, whose medical condition was deteriorating due to
renal failure. The reasons were lack of space in the program and the patient’s age. One of
Helm’s parents was a friend of Dr. Albert (“Less”) Babb, professor of biomedical engineering at
the University of Washington in Seattle. As luck would have it, Dr. Babb met Dr. Belding
Scribner, who invented the Scribner Teflon shunt for vascular dialysis access, at a lecture Dr.
Scribner gave to the University of Washington’s School of Engineering.291 At their meeting, Dr.
Babb explained to Dr. Scribner he would like to build a machine that would save his friend’s
daughter. Together, Babb and Scribner set up an experimental research project in order to create
a way to circumvent the committee’s ruling against the young girl.292
Babb and Scribner aspired to create an alternative means to dialyze patients. Their plan
was to develop a method by which to perform dialysis at a patient’s home without the aid of a
trained medical professional. Before home dialysis could be achieved, however, there needed to
be several technical aspects of the artificial kidney.293
The first problem addressed by Babb was how to overcome the limitations of the current
system of creating dialysis solution in large batches. The thought was that, producing a
substantial quantity of solution and chilling it, providers would inhibit bacterial growth. Babb
and his colleagues believed that, instead of creating and storing large quantities of dialysis
Davita Dialysis, “Political Advocacy and Chronic Kidney Disease”.
Ibid.
293
Nissenson and Fine, 20.
291
292
104
solution, a continuous proportioning system would work. He proposed, “synchronizing three
pumps to deliver a properly proportioned amount of water, electrolytes, and bicarbonate.”294
Another concern of Babb’s was the use of bicarbonate in the process. He noted that the
utilization of bicarbonate caused significant problems because of the bicarbonate-calcium
affinity. He suggested, “if a buffer was necessary, acetate could be substituted for bicarbonate,
since acetate could be premixed in the electrolyte concentrate.”295 In addition to the advantage of
acetate not having a bicarbonate-calcium affinity, the substitution allowed for the simplification
in the system of the artificial kidney through the elimination of one of the three pumps.296
Ultimately, Babb suggested the use of a 34:1 mixture of water and concentrate.
Conveniently, the new proportions eased the management of preparing the dialyzing fluid. Most
importantly the innovative mixture provided a more efficient as well as easier to use dialysis
system.297
With the problem of the creation and storage of solution addressed, the next question
Babb and his colleagues needed to undertake was how much solution was needed. In the past, the
standard procedure called for the use of two liters per minute. However, Babb suggested that,
“500 ml/minute provided the same efficiency as 2000 ml/minute dialysate flow rate . . . ”298 In
fact, he pointed out that a flow rate of 500 ml/minute was not only as effective, but was also
cheaper and easier to manage.299
Once the issues surrounding the dialysis solution had been addressed, Babb and Scribner
turned to the more technical issues surrounding the problems with the machine itself. The
294
Ibid., 20.
Ibid.
296
Ibid.
297
Ibid.
298
Ibid.
299
Ibid.
295
105
concern was that in a home environment, without medical personnel to operate the equipment,
the machine would have to be self-regulating. To address this concern, Babb and Scribner
incorporated various fail-safe measures. In the end, the mechanism that was developed that
would allow for at home dialysis was the implementation of a proportioning machine. The
proportioning machine allowed for safe, at-home self-administered overnight unattended
dialysis.
When speaking about their creation Scribner stated, “…because the daughter of a friend
of my engineering colleague, Les Babb, was turned down, he was inspired to come up with the
first home hemodialysis machine in record time. That remarkable device became the prototype
for all single-patient dialysis machines in use today. ”300 With the aid of her mother, and this new
equipment, the student was able to administer dialysis at home and at home. Home hemodialysis
was born.
With the availability of the home system, access to the medical equipment necessary for
dialysis increased significantly. The potential for the use of home dialysis, in conjunction with
the influx of federal dollars to support ESRD, would make Life or Death Committees
unnecessary. Most of the God Squads were disbanded in the late sixties and early seventies.
Interestingly, many scholars consider the role played by the Life or Death Committee in the
rationing of dialysis services to be the beginning of the field of bioethics (medical ethics).301
300
Robert Lockridge, Maureen Spencer, Viola Craft, Mary Pipkin, Dolores Campbell, Lesley McPhatter,
Jeanette Albert, Helen Anderson, Floyd Jennings, and Terry Barger, “Nocturnal Home Hemodialysis in North
America,” Advances in Renal Replacement Therapy, 8, Issue 4 (October 2001): 250-256.
http://www.lynchburgnephrology.com/index.php?pmenu=NHHD&info=/Articles/Advances_in_Renal_Replacement
_Therapy_October_01/Page_1.php&tmenu=left&p= (accessed November 25, 2008).
301
Davita Dialysis, “Political Advocacy and Chronic Kidney Disease”.
106
Changes in the Renal Population
While the end of rationing may have been anticipated, the changes the 1972 amendments
would make to the ESRD patient population were unforeseen. The unanticipated change in
patient demographics, from the population that was eligible for the ESRD program at its
inception to the current population receiving services paid for by the Medicare ESRD program,
would have a significant effect on the overall operations of the program. Changes in the ethnic
and gender make-up of the ESRD population, changes in the age and the financial status of the
ESRD patient, along with changes in patient compliance with treatment, have unexpectedly
altered the financial demands on the Medicare program, as well as manner by which renal
services are delivered.
Before payment for ESRD services were covered by Medicare, the patient population
who received medical treatment for kidney failure was greatly restricted. Limitations on
treatment were due two factors, the exorbitant cost of medical services for kidney failure and the
limited number of dialysis machines.302 Because of the limited dialysis machines, extremely few
treatments were available. Those patients who could access what was available were either the
exceptionally wealthy, who could afford to pay for dialysis treatments, or the exceptionally lucky
who were chosen to receive treatments by the God Squads.303
However, when financial restrictions to access were removed for renal patients, the
population undergoing dialysis changed. While the population accessing renal services was once
302
303
Eggers, 55.
Davita Dialysis, “Political Advocacy and Chronic Kidney Disease”.
107
educated, young, white males, the population after the amendment was passed was more diverse,
a cross-section of the America population.304
Ethnic Changes
Prior to the inclusion of ESRD services in the Medicare legislation, African -Americans
only constituted 10 percent of the treated ESRD patient population.305 However in 1980, only
eight years after the original Medicare legislation was amended to include coverage for the
treatment of end-stage renal disease, there were 4,875 African Americans ESRD patients. This
represented 27 percent of the total ESRD population.306 With the stoke of a pen and a short eight
years, the number of African-Americans who were able to access services for ESRD nearly
doubled.
African-Americans have continued to be a considerable component of the ESRD patient
population. In 1991, African-Americans represented 29 percent of the total population and 28
percent of all new ESRD patients.307 And, in 1996 African Americans accounted for one-third of
all ESRD patients and 30 percent of new patients.308 Today kidney failure is nearly 4 times as
frequent among African-Americans as in whites. In 2004, the Centers for Medicare and
Medicaid Services reported 29,033 African-American ESRD patients, which represents 29
percent of the total ESRD population for 2004. 309
304
Daniels, 222.
Rettig Richard and Norman Levinsky, Kidney Failure and the Federal Government, (Washington D.C.:
National Academies Press, 1991).
306
United States Renal Data System, “Annual data report, 2004” Minneapolis, MN: USRDS Coordinating
Center; 2004. http://www.usrds.org/adr_2004.htm (accessed November 22, 2008).
307
Rettig and Levinsky, 5.
308
Nissenson and Rettig, 163.
309
United States Renal Data System, “Annual data report, 2004”.
305
108
ESRD in African-Americans are linked to high rates of hypertension and diabetes
mellitus. A study conducted in conjunction with the Center for Medicare and Medicaid Services,
the Center for Beneficiary Choices, Wake Forest University School of Medicine, the Georgia
Medical Care Foundation and Emory University examined demographic and clinical information
from a random sample of adult in-center hemodialysis patients from October through December
of 1998. The study found that, in Non-Hispanic Blacks, 40 percent of ESRD was attributable to
diabetes mellitus, 36 percent to hypertension, and 11 percent glomerulonephritis.310 Reduction in
life expectancy, years of life lost, for African-Americans with ESRD is 1.09 years for African
American women and 1.10 years lost for African-American men, in comparison to .32 years of
life lost for white women and .40 years of life lost for white men.311
Another ethnic group that utilizes ESRD services in disproportionate numbers is
Hispanics. According to US Census data in 2000, Hispanics comprised 12.5% of the US
population and make up the fastest growing minority group in the US.312 The US Hispanic
population increased 57.9 percent from 1999 to 2000, compared to a 13.2% increase in the total
population over the same time period. Within the Hispanic population from 1999-2000,
Mexican-Americans increased by 52.9 percent, Puerto Rican-Americans by 24.9 percent and
Cuban-Americans by 18.9 percent. By 2009, Hispanics are projected to become the largest
minority group in the US.
In 1996, Hispanics represented 11 percent of the total ESRD patients or 8,889
individuals. By 2004, Hispanics represented 13 percent or 13,533 individuals receiving treatment
Dianne Frankenfield, Michael Rocco, Sheila Roman, and William McClellan, “Survival Advantage for
Adult Hispanic Hemodialysis Patients? Findings from the End-Stage Renal Disease Clinical Performance Measures
Project,” Journal of American Society of Nephrology 14, no. 1 (2003): 180-186.
311
Bryce Kiberd and Catherine Clase, “Cumulative Risk for Developing End-Stage Renal Disease in the
US Population,” Journal of the American Society of Nephrology 13, no. 6 (2002):1635-1644.
312
Frankenfield, 183.
310
109
for ESRD. 313 Further, it is estimated that the average yearly rate of increase for Hispanics ESRD
patients is 12.7 percent.314 Data collected from the United States Renal Data System indicate that
the number of Hispanic patients receiving in-center hemodialysis has nearly doubled from 1995
to 1999. 315 The Mexican-American subgroup alone has a 2.4 to 3.2 times higher rates of treated
ESRD than non-Hispanic whites.316
As in the African-American population, ESRD in Hispanics are linked to a high rate of
diabetes mellitus and hypertension.317 One study that examined demographic and clinical
information from a random sample of adult in-center hemodialysis patients from October
through December of 1998, found that 55 percent of ESRD in Hispanics is attributable to
diabetes mellitus, 16 percent of ESRD in Hispanics is attributable to hypertension, and 13
percent of ESRD in Hispanics was found to be attributable to glomerulonephritis.318
Two additional ethnic groups, Native-Americans and Asian-Americans, represent a lesser
portion of ESRD patients. In 1980, Native Americans represented 1 percent of the total ESRD
patient population. In 1990, CMS reported 592 ESRD Native American patients or 1.2 percent of
the total ESRD patient population. Then in 2000, CMS reported 1,201 Native American ESRD
patients or 1.3 percent of the total ESRD patient population and in 2004 1,171 or 1.1 percent.
Asians represented a small portion of ESRD patients. In 1980 CMS reported 104 Asian ESRD
patients, which represented 1 percent of the entire ESRD patient population. In 1990, CMS
313
It was not until 1995 that the Centers for Medicare services began to collect data on Hispanic ESRD
patients.
314
Rettig and Levinsky, 5.
Frankenfield, 183.
316
Rettig and Levinsky, 5.
317
Frankenfield, 182-185.
318
Ibid.
315
110
reported 1,194 Asian ESRD patients or 2.4 percent of the ESRD patient population. In 2000,
CMS reported 3200 Asian ESRD patients or 3.4 percent of the ESRD patient population and in
2004 3,714 Asian ESRD patients or 3.6 percent of the total ESRD patient population.319
Due to the link between hypertension, diabetes mellitus and ESRD, changes in the ethic
make-up of the ESRD population to include an increasing number of African- Americans and
Hispanics are clearly due to the prevalence of diseases among these communities. Furthermore,
because of the continued pervasiveness of hypertension and diabetes among this segment of the
population, it stands to reason that African-Americans and Hispanics will continue to place a
great demand on the ESRD system. This type of demand on the federal government by a
vulnerable minority population may make changing the ESRD system challenging. The provider,
or politician, who champions any measure that cuts services or reimbursement to a system that is
serving not only the vulnerable, but a minority group as well, will be not be well-received by the
public, minority-serving agencies or public interest groups.
Hypertension and diabetes, which are many times the root cause of ESRD, are
manageable, and sometimes preventable, conditions. Further, hypertension and diabetes can be
linked to lifestyle choices. Therefore, it may be assumed that, if individuals strived to address not
only the ESRD but also the root cause of their renal failure, they could live healthier, more
productive and more satisfying lives.
Changes in Age of Patients
Along with the changes in the ethnicity of the population served, the ESRD program has
seen a transformation in the age of the population served. Persons over 65 years old accounted
319
Ibid.
111
for 20 percent of total enrollment in 1978, 29 percent of total enrollment in 1987, and, in 1996,
patients who were 65 or older constituted one-third of all renal patients. 320 Eight years later, in
2004, ESRD patients 65 or older constituted 45 percent, nearly half, of all renal patients.321
In 1993, approximately half of new patients entering the ESRD program were 65 or
older.322 New Medicare ESRD patients over 75 constituted 5.4 percent of patients in 1978, 14.0
percent of patients in 1988, and 20 percent of patients in 1996.323 While Medicare ESRD patients
over 85 constituted 0.3 percent of patients in1978, 1.5 percent of patients in 1988, 5,556 or 8.1
percent of patients in 1994, and in 14,166 or 14 percent of patients in 2004. 324
As the number of older ESRD patients has risen, the mean age at the start of ESRD
therapy has steadily increased. In 1980, the average age at the beginning of ERSD therapy was
52.8. In 1984, the average age was 55.4, in 1990 the average age was 58.3, in 1994 the average
age was 60.1, in 2000 the average age was 62.2 and then by 2004 the average age of individuals
beginning ESRD therapy was 62.7.325 Consequently, in a twenty year span the average age at the
beginning of ESRD therapy has increased by approximately seven years.
In addition to the increase the in elderly ESRD patients, there has been an increase in
pediatric renal patients. Incidence of treated ESRD among infants and children under 5 tripled
from 37 to 129 from 1978 to 1987. Children in the 5 to 9 year age group increased 36 percent
from 1978 to 1987. Further, African-American children and white children have similar
incidence rates of renal disease until their early teens. However, after the early teen years,
Nissenson and Rettig, 161-179; also see, P. W. Eggers, “Health Care Policies/Economics of the
Geriatric Renal Population,” American Journal of Kidney Disease 16, no. 4 (October 1990):384-391.
321
United States Renal Data System, “Annual data report, 2004”.
322
Levinsky, 1395-1399.
323
Niessenson and Rettig, 163.
324
United States Renal Data System, “Annual data report, 2004”.
325
Ibid.
320
112
incidence rates among African-Americans begins to exceed those among whites. At 16 to 18
years, rates among African-American teens are about twice that of comparably aged whites.326
The aging of the ESRD patient population is more than likely attributable to extended life
expectancy. Americans are living longer than ever before. In the 1970s, when ESRD was
attached to Medicare, the average life expectancy for males was approximately 67 years and for
females approximately 74 years. Today, the average life expectancy is 75 for males and 80 for
females. As we extend life, we have an increasing need to manage the medical conditions, such
as ESRD, that may be a factor of aging.
Changes in Gender
Gender differences in patients receiving ESRD services have remained relatively
consistent, according to the Centers for Medicare and Medicaid services. In 1980, CMS reported
10,037 male ESRD patients, which represents 56 percent of all ESRD patients for the year 1980,
and 7,969 female patients or 44 percent or ESRD patients for the year 1980. In 1984, male ESRD
patients numbered 15,222 or 55 percent of all ESRD patients for the year 1984, while female
ESRD patients numbered 12,347, or 45 percent of all ESRD patients for the year 1984. In 1990,
CMS reported 27,333 male ESRD patients, which represents 53 percent of all ESRD patients,
and 23,564 female patients, which represents 46 percent of all ESRD patients for the year 1990.
In 1994, male ESRD patients numbered 37,039 or 53 percent of all ESRD patients, while female
ESRD patients numbered 32,898, or 47 percent of all ESRD patients. In 2000, CMS reported
50,244 male ESRD patients, which represents 53 percent of the total ESRD population and
43,682 female ESRD patients, which represents 47 percent of all ESRD patients for that year.
326
Ibid.
113
Lastly, in 2004, CMS reported 57,553 male ESRD patients, which represents 55 percent of all
ESRD patients and 46,777 female ESRD patients, which represents 45 percent of all ESRD
patients.327
Changes in Financial Status
There are, “no direct measurements of ESRD patients’ income.”328 However, other
factors can be used to draw inferences about their financial situation and about the relationship of
the disease to economic status. One factor that may assist in the measurement of the economic
situation of the ESRD patient is employment. Data collected by the Centers for Medicare and
Medicaid services from May of 1995 to June on 2005 found that only 8.3 percent of ESRD
patients are employed full-time. Further CMS found that only 1.7 percent of ESRD patients are
employed part-time. 329 Of the remaining population, 4.5 percent of ESRD patients indicate that
they are homemakers, 19.1 percent of ESRD patients are retired because of disability, and 19.4
percent are unemployed.330 Therefore, since so few ESRD patients are able to maintain
employment during treatment, they may be without a steady income. Further, a lack of stable
income may put individuals at risk for economic challenges.
The rise in ESRD patients with potential economic challenges is a complex issue. One
explanation could be the availability of ESRD services to all individuals. Prior to the inclusion of
ESRD in Medicare, patients were carefully screened for financial stability. Those individuals
without appropriate financial reserves were screened out and therefore not a part of the ESRD
327
Ibid.
Nissenson and Rettig, 164.
329
United States Renal Data System, “Annual data report, 2004”.
330
Ibid.
328
114
community. The patients that were left to receive ESRD services had the resources to support the
financial demands of ESRD treatments.
But, with the demise of God Squads and the opening of ESRD services to all medically
qualified individuals, there were no longer any financial requirements for patients. Any and all
individuals who were qualified by disease status for ERSD services, regardless of their economic
status, received them. This likely led to an increase in the number of patients with the potential
for economic instability.
Another possible explanation for the economic challenges of the ESRD patient is the
decline in familial accountability. Often, in the 1960s and the 1970s, the family unit was a valued
resource. Immediate, and even extended, families worked together to address crisis. Moreover,
the community in which the patient resided was a resource to families. Churches, synagogues
and neighbors rallied around those in need to help out, personally, spiritually, medically and
even fiscally.
However, as the typical family unit has changed, responsibility to the family has
transformed. Many families no longer feel an unwavering obligation to one another. A potential
contributing factor is that many families are dispersed, members do not live in close proximity.
No longer are relatives around the block or in the next neighborhood over. Children, parents,
aunts and uncles have scattered not just throughout the United States, but around the globe.
While we do not see our family, we do not know our neighbors. The community of the
21st century is a transient one; an average of one out of every three families moves each year.
People often are not connected to their neighbors and the network of support that once existed
may no longer be a foundation for those in need.
115
Changes in Compliance
Lastly, ESRD patients have undergone a change in respect to compliance with treatment.
The early renal patient was very grateful for and cooperative with life-saving dialysis. He or she
faithfully adhered to the prescribed dialysis regiment, as well as dialysis unit administrative
rules.331 Those few patients, who did not comply actively with treatment, behaved in a relatively
passive manner. A study conducted in 1972 with 43 dialysis patients revealed that
noncompliance was often simply associated with frustration, little ability to delay gratification
and high gains from the sick role.332
In contrast to the passivity of the non-adhering patient the difficult or disruptive patient
often displays more aggressive or hostile conduct that can be antisocial or combative.333
Frequently, the difficult or disruptive patient exhibits behaviors which are considered to be
abusive. Conduct such as yelling, using profane language or insults (verbal abuse) or abuse that
is physical in nature (the treat of or an actual bodily attack or actual physical harm to another
individual) can both be regarded as characteristic of the difficult or disruptive patient.334 “Verbal
threats are ‘any words (written or oral) expressing an intent to harm, abuse or commit
violence”335 While physical threats include, “gestures or actions expressing an intent to harm,
331
Rose, 25-26.
Judith Bernardini, “Ethical Issues of Compliance/Adherence in the Treatment of Hypertension,”
Advances in Chronic Kidney Disease 11, no. 2 (April 2004): 222-227.
333
Stella Smetanka, “Who Will Protect the ‘Disruptive’ Dialysis Patient,” American Journal of Law and
Medicine 32, no. 1 (January 2006): 53-91.
334
Rose, 25
335
Ibid.
332
116
abuse, or commit violence . . . ”336 Physical harm is, “any bodily harm or injury, or any attack
upon facility staff, medical staff, their representatives, patients, families or others”337
While there may have been a few early patients who did not comply, for the most part
early renal patients were cooperative. Early compliance may have been due in part to the
extremely limited availability of dialysis resources. When patients knew that there were others
standing in line, ready and willing to take their place on the dialysis machine, they were likely to
quietly follow along with the treatment procedures. It was either go along with treatment and get
along with the providers, or risk being thrown out of the program. Death would follow shortly.
Patient compliance in these early years may be attributable to a lack of alternative
treatments. The only ways to sustain life for an extended period of time, for individuals in kidney
failure, are either dialysis or transplantation. Transplantation was not a viable option. There were
a limited number of organs for transplantation, and the success rate for such surgeries was not
very high. Dialysis may have been the only option for extending the patient’s life,. Therefore,
most were more than willing to comply with the healthcare provider’s treatment agenda, as well
as the dialysis clinic’s guidelines.
The early dialysis patients may have been submissive, but, over the past decades, dialysis
providers have seen an increase in the “challenging” or non-compliant renal patient
population.338 In 2002, the Mid Atlantic Renal Coalition ESRD Network 5 had 88 contacts from
facilities regarding difficult or disruptive patient situations.339 This was up from zero only a few
336
Ibid., 25-26.
Ibid., 26.
338
Bernardini, 223.
339
Karen King, and Alvin Moss, “The Frequency and Significance of the “Difficult” Patient: The
Nephrology Community’s Perceptions,” Advances in Chronic Kidney Disease 11, no. 2 (April 2004): 234-239.
337
117
decades before. In the reported situations, noncompliant patients were abusive to staff, which
ultimately resulted in the patients’ discharge or termination from the facility.
The rise of the noncompliant patient may be due to several factors. As the Medicare
program gave individuals with ESRD federal coverage, patient attitudes may have changed. The
renal patient, knowing that the federal government was going to pick up the bill for his/her
medical needs, could have had an elitist attitude. This attitude of privilege may have spilled over
into the manner in which he/she viewed and treated the medical personnel at the dialysis unit.
Additionally, as federal dollars freely flowed through the ESRD program, the number of
locations at which patients could receive services multiplied. ESRD services that were once only
delivered at the hospital began to be delivered in out-patient clinics located in freestanding
settings that were not in the vicinity of a hospital. With more choices available to them, patients
may have felt empowered to challenge the staff, as well as clinicians, knowing that if there was a
heated dispute, they could make arrangements to obtain services at an alternative facility. They
could take their government-guaranteed payments elsewhere. This was a significant threat in the
for-profit healthcare arena.
Implications of the Change in the Patient Population
The changes in the patient population after ESRD services were made available to all
would have dramatic effects over the entire continuum of ESRD services. In particular, and of
great consequence, the transformation in the age groups that made up the renal patient population
would have a considerable effect on the cost of delivering services. Additionally, and equally as
significant, the change in compliance with prescribed medical treatment would have an effect on
the delivery of ESRD services.
118
In 1976, estimates of the incurred cost of the ESRD program to the Social Security
Administration were approximately $300 million. The total annual cost of hemodialysis per
patient in 1976 was between $20,000 and $25,000, with Medicare covering 80 percent of the
cost.340 In a short three years, by 1979, the ESRD program reached $1 billion in expenditures.341
According to Leonard Schaeffer, director of the Health Care Financing Administration from
1978-1980, “There was an ignorance surrounding the best way to estimate Medicare cost . . .
There was an ignorance about estimating its costs because they used some of the same
techniques they used with Social Security to estimate Medicare costs, and those techniques were
totally inappropriate. They looked at the number of people, the ages of those people, their life
span and that sort of thing. Those factors alone totally ignore the changes in medical science, all
the changes in diagnostic and treatment. So, although it was fairly disciplined, they
underestimated the medical costs.”342
By 1996, ESRD expenditures on ESRD reached $14.6 billion, or $46,382 per person per
year.343 In 2000, CMS reported expenditures of $12,605,411,362 on ESRD patients or $47,920
per person per year. Then in 2004, CMS reported expenditures of $18,362,659,228 or $57,851
per person per year on ESRD patients.344
It stands to reason, that the change in the age of the patient would result in an increase in
the expenditure per person. Older patients tend to be sicker. Further, older patient tend to have
advanced disease severity, as well as co-morbidities to go along with their primary renal
Lynda Baydin, “The End-Stage Renal Disease Networks: An Attempt through Federal Regulation to
Recognize Health Care Delivery,” Medical Care 15, no. 7 (July 1977): 586-598.
341
Eggers, 58.
342
Schaeffer.
343
Nissenson and Rettig,164.
344
United States Renal Data System, “Annual data report, 2004”.
340
119
condition. Therefore, with their greater medical needs comes a greater demand for health care
services, including costly services such as inpatient care.345
Information collected by the Centers of Medicare and Medicaid Services supports the
conclusion that the increase in elderly renal patients places an added strain on the program. In
1996, estimates of Medicare spending per beneficiary per year for an ESRD patient aged 24 and
younger was $36,000 per year. For those aged 75 and older, Medicare spending per beneficiary
per year was estimated at $51,000 per year.346 By 2000, CMS was spending $36,072 per patient
for ESRD patients under age 44 and $59,962 per patient aged 75 or older. Then by 2004, CMS
was spending $44,625 per patient for ESRD patients under age 44 and a staggering $71,032 per
patient aged 75 or older.347
This increased demand by the elderly population shows no signs of receding. As dialysis
maintains life, renal patients are living longer. A longer life span can mean not only getting older
but can also mean getting sicker. Moreover, because the elderly do not have one disease,
providers cannot treat ESRD in isolation. The co-morbidity of disease will make treating ESRD
in the elderly time consuming for the provider and staff, as well as expensive for the federal
government.
In addition to the elderly utilizing ESRD services for a lengthy period of time, the
increase in child renal patients puts an added strain on the ERSD program. In 1980, CMS
reported only 323 ESRD patients aged 14 and younger. However by 2004 CMS reported 722
ESRD patients aged 14 and younger.348 As a consequence of their youth, children stand to
345
Nissenson and Rettig,164.
Ibid.
347
United States Renal Data System, “Annual data report, 2004”.
348
Ibid.
346
120
consume renal services for a long period of time. Therefore, younger patients add financial
pressure to the ESRD program to continue to provide services over their entire lifespan.
For both age groups, the elderly and the young, dialysis is no longer a temporary fix. It is
not just a stop gap on the way to transplantation. For some ESRD patients, dialysis can become a
way of life. This may be due in part to a shortage of organs for transplantation. Regardless, the
demand to maintain individuals, whether old or young, on dialysis for an extended period of time
places a great strain on the health care system, as well as a considerable financial cost to the
federal government
The intensified demand for renal services may have resulted in financial struggles for
those who provide renal services. According to physicians, updates in payment for those who
provide renal services are long over due. To address the issue of financial pressure on providers,
42 CFR 405 was passed in August 2005, and goes into effect January 1, 2006.349. Bill 42 CFR
405 establishes increased payment for physician services. The changes will ensure that payment
systems are updated to reflect changes in medical practice and the relative value of services. This
proposed rule also addresses geographic locality changes, payment for covered outpatient drugs
and biologicals, supplemental payments to federally qualified health centers (FQHCs), coverage
of screening for glaucoma, and payment for telehealth services.
In addition to the age of the patient population the change in the compliance of the ESRD
population program has had a staggering effect on the manner in which renal services are
delivered. Patient noncompliance falls into three categories: the non-adherent, self destructive
“Proposed Rules,” Federal Register 70 no. 151 (August 8, 2005): 45763-45812.
http://bulk.resource.org/gpo.gov/register/2005/2005_45796.pdf (accessed November 22, 2008).
349
121
dialysis patient; the hostile, abusive dialysis patient; and the self-destructive transplant patient.350
In particular, two noncompliant patient behaviors have had a profound influence on the delivery
of ESRD services: the patient who is abusive and the patient who is noncompliant with his/her
treatment.
Verbal abuse can be to other patients or to the staff at the facility. If the patient is verbally
abusive to another patient, “the physician’s or nurse’s responsibility to the other patients
outweighs their responsibility to the abusive patient”.351 The patient who is physically abusive
creates a considerable challenge for the physician, staff and the facility. However, before any
patient, non-adherent or difficult/disruptive, is involuntarily discharged from a dialysis facility,
attempts are often made to salvage the relationship between the patient, the physician and the
staff.
One method that has been recommended for the resolution of conflict between the
provider and/or staff and the patient is mediation wherein a third party is involved in the
resolution of the dispute.352 However, while mediation can be an effective approach towards the
resolving a dispute, the most common approach to the management of a difficult or disruptive
patient is behavioral contracting. In the renal facility, the behavioral contact is a written
agreement that not only outlines specific behaviors that are not allowed but delineates the
facility’s expectations of the patient.353 Additionally, the behavioral contract establishes what
will occur if the patient violates the terms of the agreement.354
If attempts to manage the patient’s abusive behavior fail, the facility has several options.
One option is to make arrangements for the patient to receive dialysis at another facility on some
350
Rose, 24-26.
Rose, 26.
352
King and Moss, 236.
353
Ibid.
354
Ibid.
351
122
days and return to home clinic other days. An additional, but still mild option is for the facility to
refuse to see the patient altogether and refer the patient to the Emergency Room for dialysis
services. However, if the physician and the staff are truly fearful of the patient the facility can
have the abusive patient permanently removed by having him/her arrested. Furthermore, “When
the patient’s behavior reaches a severe level and threats have been made or actual harm has
occurred, and clinic staff are fearful for their safety, courts have agreed that a patient may forfeit
his or her right to treatment. Federal regulations correspond with these standards, requiring that
clinics provide a ‘safe’ environment for patients and providers”355
When the decision is made to terminate treatment altogether, the facility must carefully
manage the situation. If the patient is shown the door and, “given a printout of the other dialysis
centers’ contact information and is told to seek dialysis at one of those” when the, “the
discharging facility knows that no other facility will accept him” questions may arise about the
moral principles of the organization. 356
Facilities that do involuntarily discharge non-adherent or difficult/disruptive patients run
the risk of being perceived as abandoning patients. However, “case law permits a physician, and
a dialysis facility by extension, to abandon a patient so long as that physician or facility gives
notice to the patient that is adequate to provide reasonable opportunity for the patient to acquire
services from another physician. Some versions of this duty merely require that the physician
provide sufficient notice to the discharged patient in order to allow the patient to find another
physician. Others include imposing the requirement on the physician to make suitable
arrangements for another physician to car for the former patient, while yet others state that the
355
356
Rose, 27.
Smetanka, 40-41.
123
physician must locate a transferee physician. The physician who fails to do at least one of these
things before dismissing a patient commits the tort of abandonment”357
Although by involuntarily discharging the patient the physician and facility may not be
technically or legally abandoning the renal patient to situation in which there is no medical care
(and thereby sentencing the patient to die) finding services for an involuntarily dismissed patient
may be exceptionally difficult. When seeking a new location for health care services, “the
probable fact that the prior nephrologist has . . . discharged the patient serves as a clear warning
sign to the newly approached facility”. Therefore, the discharge itself can make the process of
getting services problematical or even impossible.358
A patient who is noncompliant has many affects on the manner in which renal services
are delivered. Primarily though, the outcome of the noncompliant patient has been a strain the
provider/patient relationship. Without a doubt, the patient who is abusive to the provider, the
staff or other patients damages the physician/patient relationship. When a patient verbally attacks
those in the clinic, it may be hard for the staff to maintain a positive working relationship with
the individual. Moreover, when the patient is physically aggressive, it may be nearly impossible
to continue a supportive, medically constructive relationship.
However, while physicians may find it challenging to build a physician-patient
relationship with the non-adherent patient and may not agree with their decision-making, to deny
them access to services because of their attitude would be unethical. Patients cannot be denied
services just because the physician or nurse does not like them. As long as the patient does not
endanger the lives of other patients or put the staff in jeopardy, ethically nurses, physicians, and
other renal care providers should not to base treatment decisions on their own personal or moral
357
358
Ibid.
Ibid., 40.
124
beliefs on how a patient should behave.359 Provided they are not abusive, patients, regardless of
whether they habitually miss appointments, have the right to standard treatment on demand
whenever they arrive at the clinic.360 Further, if the provider’s bias against the non-adherent
patient results in the denial of medical care, the patient’s rights may have been violated and the
patient could have a rights claim against the provider as well as the dialysis facility. If the patient
believes their rights have been violated they can then choose to enter a formal grievance against
the physician and the facility through the ESRD network.361
Both verbal and physical abuse may place the patient’s own health, safety and well
being at risk. Because abuse by creates an unhealthy environment in which providers and staff
may not feel free to perform, the patient’s care may be compromised. The patient who is abusive
to the point of being barred from a facility will have his/her care interrupted until alternative
arrangements can be made. Suspension in treatment may result in a patient who becomes ill or
whose medical condition has worsened.
Patients who are noncompliant with treatment by being late to or skip dialysis treatments
as well as patients who are uncooperative with adhering to physician orders, such as a prescribed
diet, are not only being self-destructive, but they are indirectly harming other patients. The
patient who is noncompliant with prescribed orders can upset, “the clinic and staff performance .
. . ”, while the no-show or late patient can disturb “the smooth progression of the daily
schedule”.362 Through their uncooperative conduct, some ESRD patients may cause a strain in
their relationship with the staff. Staff members and providers may feel irritated with the patient
who does not follow instructions.
359
Rose, 44.
Ibid., 44.
361
Ibid., 29.
362
Ibid., 28.
360
125
Chapter 6: The ESRD Entitlement Program
Whether the patient is old or young, compliant and noncompliant the ESRD program is
an entitlement program. Thus, all patients are legally guaranteed financial support for a certain
set of services. Because the ESRD program is an entitlement program, it essential to examine the
meaning entitlement. Further, we must consider if the services patients are entitled to are the
right set of services.
What Does “Entitlement” Mean?
In order to be eligible for Medicare ESRD benefits the individual must, “have a diagnosis
of chronic renal failure; and have applied for benefits or be the ‘spouse or dependent child’ of
such a person.”363 Under the legislation, qualifying ESRD patients would be eligible for both
Medicare part A and B. Eligibility for coverage would begin the third month after the month in
which a course of renal hemodialysis began and would run through the twelfth month after the
month in which an individual had a transplant or dialysis was terminated. This, “near universal,
disease specific entitlement . . . ” became effective July 1, 1973.364
At its inception, the objectives of the Medicare ESRD program were to,
“1. Provide for the total health needs associated with the treatment of ESRD
2. Maintain or create necessary availability and distribution of resources.
363
364
Nissenson and Rettig,161.
Ibid., 161-162.
126
3. Assure quality through effective peer review.
4. Promote effective utilization of resources through the establishment of minimum
utilization rates and contain the cost of covered services”365
With the inclusion of ESRD patients, Medicare no longer was intended solely to meet the
medical needs of the elderly. A new group was entitled to coverage and their eligibility was
based only on disease status. To date, ESRD is the only disease-specific population that is
entitled to federal coverage for health care services on virtually a universal basis. No other
medical condition or diagnosis has a right to claim federal sponsorship for their health care
needs.
An entitlement has been defined as, “a right or claim that has been furnished” or,
according to the Internal Revenue Code, “a legally enforceable right”366 Upon origination, the
Medicare program was designed to be a federal entitlement. Individuals do not have to meet
extensive and restrictive criteria in order to qualify for federal Medicare assistance. Medicare
coverage is granted to individuals on the basis of exceptionally straightforward criteria. Any
individual who receives retirement benefits from Social Security or the Railroad Retirement
Board, as well as all Americans age 65 or over, have a right to claim Medicare coverage for their
medical needs.367
The ESRD program is also an entitlement program. With the passage of amendments to
the original Medicare legislation in 1972, individuals who required hemodialysis or renal
transplantation for the management or treatment of chronic renal disease have a right to claim
365
Baydin, 589.
Rose, 6.
367
“Key Milestones in Medicare and Medicaid History: Selected Years 1965-2003,” Health Care
Financing Review 27, no. 2 (Winter 2005): 1-3.
366
127
federal Medicare financial support. As with Medicare, the eligibility criteria for ESRD are
relatively straightforward, “a person (must) be ‘fully insured or currently’ under Social Security;
have a diagnosis of chronic renal failure; and have applied for benefits or be the ‘spouse or
dependent child’ of such a person.”368 When passed by Congress, the amendment to include
coverage for the ESRD patient’s health care needs, “authorized a program under which the
federal government would pay for dialysis regardless of the patient’s age.”369 In effect, the
Medicare ESRD program became “as close as anything in American medicine to a universal
entitlement.”370
An entitlement applies equally to all individuals; everyone who qualifies for an
entitlement, and needs, it receives it.371 In both the Medicare and the ESRD program, eligibility
criteria have been established, and the individual who meets the criteria cannot be denied his/her
claim to federal sponsorship for coverage. Moreover, in an entitlement situation, inequity is
unacceptable. In the Medicare and ESRD programs, the implied equality of entitlement should
afford all qualifying individuals the same access to federal coverage for health care needs.
Because both the Medicare and ESRD programs are entitlement programs, the
government has an obligation to provide funding for health care services for those who meet the
requirements of eligibility. If the government fails to meet its obligation (in the case of the
Medicare and ERSD programs, if the government fails to provide financial support), legal
recourse is available for those who feel their health care needs have not been fulfilled.372
368
Nissenson and Rettig, 161.
Schaeffer.
370
Nissesnson, 162.
371
Rose, 6.
372
Ibid.
369
128
Current Medicare Coverage
Currently, Medicare provides specific services to those who qualify for the ESRD
program. For dialysis services, Medicare part A and/or Part B covers and pays part of the costs
for:
Inpatient dialysis treatments (if the patient is admitted to a hospital for special care)
Outpatient dialysis treatments (when the patient gets treatments in any Medicare
approved dialysis facility)
Self-dialysis training (includes instruction for the patients and for the person helping with
the home dialysis treatments)
Home dialysis equipment and supplies (including alcohol, wipes, sterile drapes, rubber
gloves, and scissors)
Certain home support services (may include visits by trained hospital or dialysis facility
workers to check on home dialysis, to help in emergencies when needed, and check
dialysis equipment and water supply)
Certain drugs for home dialysis
Outpatient doctors’ services
Most other services and supplies that are a part of dialysis, such as laboratory tests. 373
The most common drugs that Medicare Part B covers are heparin and the antidote for heparin,
when medically necessary, topical anesthetics, and Epogen or Epoetin alfa.
Medicare does not pay for:
Paid dialysis aides to help with home dialysis
Any lost pay for the patient and the person who may be helping the patient during selfdialysis training
A place to stay during treatment
Centers for Medicare and Medicaid Services, “Medicare Coverage of Kidney Dialysis and Kidney
Transplant Services,” http://www.medicare.gov/Publications/Pubs/pdf/10128.pdf (accessed November 22, 2008).
373
129
Blood or packed red blood cells for home self dialysis, unless part of a doctors’ service or
is needed to prime the dialysis equipment
Transportation to the dialysis facility. 374
Medicare Part A and/or B covers and pays part of the cost for transplant services
including:
Inpatient hospital services in an approved hospital
Kidney Registry Fee
Laboratory and other tests needed to evaluate the patient’s medical condition
Laboratory and other tests needed to evaluate the medical conditions of potential kidney
donors
The costs of finding the proper kidney for transplant surgery (if there is no kidney donor)
The full cost of care for the kidney donor (including all reasonable preparatory,
operation, and postoperative recovery costs)
Any additional inpatient hospital care for the donor in case of problems due to the
surgery
Doctors’ services for kidney transplant surgery (including care before surgery, the actual
surgery, and care after surgery)
Doctor’s services for the kidney donor during their hospital stay
Immunosuppressive drugs
Blood (whole or units of packed red blood cells, blood components, and the cost of
processing and giving the patient blood . . . 375
374
375
Ibid., 24.
Ibid., 34.
130
Medicare does not pay for the actual kidneys for a transplant. If an individual is covered by
Medicare only because of a diagnosis of ESRD, Medicare will only pay for transplant drugs, that
is, immunosuppressants, for 36 months after the transplant.376
Is Medicare Funding the Right Set of Services?
The Medicare legislation has clearly defined the services it will cover for ESRD patients.
However, an issue to consider is whether these services are meeting the needs of the patient
population. More specifically, is what the government is paying for, the best (and most cost
effective) way to address and manage the disease for patients and providers. In order to answer
these questions, it essential to consider what services the program is providing to patients and if
the reimbursement the program is offering providers in any way affects the delivery of care.
The Changing Needs of ESRD Patients
As the racial and ethnic make-up of ESRD patients has changed to include more diverse
populations, the program will have to respond to the needs of patients who represent a variety of
races, ethnic groups and cultures. These groups, which constitute an increasing percentage of
ESRD patients, share a common link to the disease. Thus, the proper management of ESRD may
require similar approaches to treatment of a patient population with distinctly different cultural
backgrounds.
For two groups, African-Americans and Hispanics, ESRD is on the rise. ESRD in the
African-American population is more common and more life threatening then it is in other racial
or ethnic groups. In African-American men and women, the risk of ESRD is one in twelve
376
Ibid., 36.
131
(compared to one in forty for white men and one in fifty for white women). ESRD causes more
loss of life than either colorectal or prostate cancer in African-American men and as much loss of
life as breast cancer in African-American women.377 Further, ESRD in African-Americans is
linked to high rates of hypertension and diabetes mellitus.
Hispanics are the fastest growing minority group in the US. Similar to the situation in the
African-American population, causes of ESRD in Hispanics are linked to high rates of diabetes
mellitus and hypertension.378 Given the rapidly increasing number of Hispanics in the general
population, the high prevalence of diabetes mellitus, and the increased incidence of ESRD in this
ethnic group, it is likely that the percentage of Hispanics in the Medicare ESRD program will
dramatically increase in the coming years.379
Because, for many African-American and Hispanic ESRD patients, hypertension and
diabetes are the root medical cause of renal failure, the health care needs of these groups are
closely tied to these diseases. Therefore, providers and other staff who treat ESRD in these
patient populations will need to be educated and trained not only on how to address kidney
disease, but the root causes of kidney failure. They must be prepared to address both diabetes and
hypertension, since early measures to education patients can prevent the onset of diabetes and
hypertension, as well as delay organ devastation and the need for dialysis therapy. 380
Tackling the origin of ESRD, may require providers and staff to consider non-traditional
methods of approaching and educating patients, since education allows patients to make
informed choices of renal replacement therapy, improves the timing for the initiation of therapy,
Bryce Kieberd, “The Chronic Kidney Disease Epidemic: Stepping Back and Looking Forward,” Journal
of American Society of Nephrology 17, no. 11 (2006): 2967-2973.
378
“Incidence of End-Stage Renal Disease among Persons with Diabetes—United States, 1990-2002,”
Journal of the American Medical Association 294, no. 23 (December 21, 2005): 2962-2963.
379
Ibid.
380
Frankenfield, 185
377
132
increases the likelihood of continued employment and may also increase the likelihood of
compliance.381 In a patient population that has ESRD because of the mismanagement of the
precipitating condition, lecturing may not be well received. Obviously, at some point in time the
patient was lectured by a provider on how diabetes and hypertension could lead to ESRD, but
took no notice. Therefore, a meaningful and heartfelt conversation may be more effective. Like
lecturing, scare tactics may not help. Previous providers may have attempted that approach.
Instead, a casual discussion with a peer about the effect that ESRD has had on his/her lifestyle
might lead to a turning point in the patient’s thinking.
Although Medicare covers a certain level of instruction about ESRD and its antecedent
diseases in at the unit, education (even non-traditional education) in a clinical environment may
not be enough. In the present patient population, at-home support services may be necessary to
optimize the patient’s behavior regarding his/her condition. Currently Medicare covers mostly
material items for at-home care, such as equipment, supplies and drugs. While these doubtlessly
assist patients, in order for ESRD treatments to be most effective, non-material items may be
necessary.
Some studies indicate that physicians can be less communicative with minorities than
with other segments of the population. Clinicians tend to deliver less information, provide less
supportive talk, and offer less proficient clinical performance to African-American and Hispanic
patients.382 However, provider-patient communication has been linked to patient satisfaction,
compliance, and even health outcomes. Further, in multicultural and minority populations, the
Thomas Golper, “Patient Education: Can It Maximize the Success of Therapy,” Nephrology Dialysis
Transplant 16, suppl. 7 (2001): 20-24.
382
Brian Smedley, Adrienne Stith, and Alan Nelson, Unequal Treatment: Confronting Racial and Ethnic
Disparities in Health Care (Washington DC: The National Academies Press, 2003), 552-593.
381
133
issue of communication may be even more important. Linguistic and contextual barriers may
prevent effective provider-patient communication.383
In order to counteract communication problems, at-home personalized visits could be
utilized. At home visits could involve visits with social workers to simply check in on the
patient’s mental well being, visits with a nutritionist to see what food items the patient has in the
home, home visits with a occupational therapist to help the patient maximize his/her abilities to
care for him/herself at home, or even visits with a physical therapist to help the patient develop
an exercise routine.
While a portion of at-home visits from health care providers is considered to be purely
educational and therefore billable services, for the patients, the meaning has nothing to do with
money. There are intangible benefits. Personal relationships built with their health care team may
offer the individual much needed emotional support to face the disease. Further, because of the
changing nature of families and communities today, some patients may not be receiving
emotional support at home and may only get support from their health care providers. Thus, for a
patient facing a chronic and long-tem condition like ESRD, it may be reasonable to believe that
the real or perceived emotional support given through at-home care is as valuable as personalized
education, medical supplies or even kidney dialysis itself.
Emotional support is clearly not just a benevolent act; it can have medical advantages
when considered in relationship to patient compliance with treatment. Because individuals with a
chronic disease may feel a weakened sense of control over their lives, they may seek other ways
to re-establish control over their medical care. As a result, patient compliance with ESRD
J. R. Betancourt, J. E. Carrillo, and A.R. Green, “Hypertension in Multicultural and Minority
Populations: Linking Communication to Compliance,” Current Hypertension Reports 1, no. 6 (December 1999):
482-488.
383
134
treatments is an issue facing today’s ESRD providers.
384
Patients may choose non-compliant
behaviors as a way to deflect the perceived intrusion of kidney disease and dialysis into their
daily lives.385
In particular, in African-American and Hispanic populations, patient compliance is a key
issue that stands to shape the success of the medical treatment. Again, in these populations the
root cause of ESRD is diabetes and hypertension, which, in most cases, are controllable
conditions. Physicians, “commonly believe that patient noncompliance with prescribed
antihypertensive therapy is a primary issue in hypertension control.” 386 Hypertension is most
likely to be controlled with the right drug or combination of drugs that the patient “tolerates,
finds convenient, and finds effective.”387 But that combination cannot be found if the patient is
unwilling to cooperate with health care providers managing his/her care.
Since controlling hypertension requires patient adherence to prescribed therapy,
researchers have conducted several studies on the management of blood pressure and patient
compliance. They found that, “Compliance with medications was better than compliance with
lifestyle changes.”388 Patient adherence to pharmaceutical intervention, “suggests that patients
may feel medication will manage their hypertension; so they do not feel the need to change their
lifestyle”.389 Although hypertension can be controlled with the right medications, behavior
modification is also key to successful management. Patients who control their weight, exercise,
Nancy Kutner, Rebecca Zhang, William McClellan, and Steven Cole, “Psychosocial Predictors of NonCompliance in Hemodialysis and Peritoneal Dialysis Patients,” Nephrology Dialysis Transplant 17, no. 1 (2002) 9399.
385
Ibid.
386
Bernardini, 222-227.
387
Ibid.
388
Ibid.
389
Ibid.
384
135
reduce their sodium intake, quit smoking and drink only in moderation tend to be more
successful in the management of hypertension than those who rely on medication alone.
Therefore, for some individuals, compliance or disobedience may be a choice. Patients
are choosing not to manage their diabetes through a modified diet, manage their hypertension
through an exercise regiment or manage to show up at the clinic, on time or at all, for dialysis.
However, emotional support may change levels of compliance. ESRD patients, who are
emotionally supported and feel as if their health care team is invested in their success or failure,
may make the choice to be more compliant with prescribed treatments. This, in turn, stands to
optimize their medical condition, making the ESRD patient a happier and perhaps healthier
patient.
Critics may complain that personalized services, such as education or personal support at
home, will overburden an already stressed Medicare system. Payors will claim that at-home
visits are more expensive than the patient visiting the clinic. Providers may complain that athome visits take up too much time. Going to a patient’s home takes away from the hours during
which the provider can offer services to other patients in the clinic.
Although at home visits may initially have an added expense, it is reasonable to think that
in the long run they could pay off. If there are at home visits, patients may feel as if their health
care providers are truly invested in their health. This may lead the patient to invest more in their
own physical well-being and to manage the root cause of their ESRD. Therefore, added
involvement through at home visits may lead the patient to realize a healthier lifestyle, which
may translate into improved health related outcomes.
The economic consequences of an illness can be disruptive to any household. However,
the economic consequences of a debilitating disease, such as kidney failure, can be
136
devastating.390 With a debilitating illness, such as ESRD, the major source of disruption is the
loss of job-related productivity. Treatment for ESRD is extremely time-consuming for the
patient. Hemodialysis is administered at least three times per week, with each session lasting
four to five hours. Some times hemodialysis is administered in more frequent sessions, as often
as two to three hours in duration given five to six times per week.391 Although, peritoneal
dialysis (PD) does not require travel to a dialysis center and the exchange can be done at the
patient’s home or while the individual is sleeping, the process is still time consuming. The
exchange must be done on a continuous and daily basis.392
While at home treatments for ESRD can shorten the time patients spend in a hospital or
clinic, they are not regularly utilized. Even though hemodialysis and PD can be administered in
locations alternative to a dialysis center, it estimated that only 14 percent of individuals receive
some type of ESRD treatment at home.393 At this time, patient preference is to receive renal
services at a dialysis unit.
The complication of ESRD treatment which requires multiple days at dialysis center
makes holding down a full-time job nearly impossible. In their collection of demographic
information, the Centers for Medicare and Medicaid services found that only 8.3 percent of
ESRD patients maintain full-time employment.
394
Without full-time employment, ESRD
patients run the risk of being without a steady income, which puts them, as well as their families,
at risk for significant economic challenges. Therefore, the susceptibility of ESRD patients to
390
Nissesnson and Rettig, 164.
The National Kidney Foundation of Canada, “Hemodialysis,”
http://www.kidney.ca/page.asp?intNodeID=22130 (accessed November 23, 2008).
392
National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC), “Treatment Methods
for Kidney Failure: Hemodialysis.”
393
Home Dialysis Central, “Medicare FAQs,” http://www.homedialysis.org/pros/medicarefaq.php (accessed
November 23, 2008).
394
Data collected from May of 1995 to June on 2005.
391
137
medically induced economic devastation requires special consideration to the needs of this
economically vulnerable population.
However, the current Medicare legislation does not take into account the economic needs
of the ESRD population. Medicare clearly states that it does not pay for any lost wages for the
dialysis patient or for the person who may be helping during self-dialysis training. Training,
which is often done at the clinic during business hours, may require the patient and his caregiver
to take off work. In an economically strapped situation, a day of lost wages may be unfeasible.
Therefore, the lack of finical support by Medicare may be a deterrent to patients choosing home
dialysis.
Further, Medicare does not pay for transportation to the dialysis facility. With the soaring
cost of gas, which is dramatically increasing the cost of private and public transportation,
patients may not be able to afford to get to the facility. This may be a non-controllable
explanation for patient non-compliance. Patients may want to be able to get to the unit for
dialysis but cannot because they are unable to be able to afford transportation and Medicare will
not cover the expense.
The Changing Needs of ESRD Providers
Regardless of how providers are viewed by the public, benevolent and selfless caregivers
or money-hungry entrepreneurs, they do need reimbursement for their services in order to keep
their operations running. Without income, facility doors would close and providers would be out
of business. Recently, there has been much attention given to the issue of appropriate
reimbursement to ESRD providers for their services. Interest has been focused on whether flat or
138
falling reimbursement rates have had a negative impact on the quality of care delivered to renal
patients.
To examine a possible connection between provider reimbursement and quality of care,
Richard Rettig and Norman Levinsky completed a study for the Institute of Medicine (IOM) on
the Medicare End-Stage Renal Disease Program. A portion of their analysis examined the issue
of federal financing. Rettig and Levinsky concluded that rates for outpatient dialysis that had
been established in 1973 remained unchanged until 1986. Moreover, during this thirteen year
period, no adjustment was made for inflation. In real dollars, payment rates per dialysis treatment
have actually fallen steadily over the program’s history. The outpatient dialysis reimbursement
rate was $138 in 1974 and $125 in 1989. “When adjusted for inflation by the GNP price deflator,
the 1989 reimbursement rate was less than $54 in 1974 dollars, a 61 percent reduction over this
period”395 Ten years after Rettig and Levinsky’s investigation, in 1999, it was reported that, the
reimbursement rates, in constant dollars, had dropped two-thirds since 1973.396According to
Rettig and Levinsky, “No other part of the Medicare program has been subjected to a similar
reimbursement policy”397
Some policy-makers argue that the rationale for the current reimbursement rates is a
forced response to the unexpectedly high costs of the ESRD program to the Medicare system. In
the early years of the ESRD program, technical advances and economies of scale reduced the
cost of dialysis treatment, but as the ESRD program evolved, bringing with it higher-than
395
Rettig and Levinsky, 11.
Smetnaka, 53-91.
397
Rettig, 11.
396
139
expected costs, policy-makers insisted that, the government had no other option but to “to ratchet
down payments to providers.” 398
Attempts by the federal government to decrease payments to providers have led to,
“widespread criticism that the quality of care was being eroded to the point that the health and
even the lives of the patients were endangered.”
399
Much finger pointing has ensued among
providers, patients and officials at the Health Care Financing Administration (now Centers for
Medicare and Medicaid Services). Providers blame federal officials for reducing reimbursement
below the cost of good-quality dialysis. Federal administrators, “collect data that demonstrate to
their satisfaction that most providers make a profit and that payments are adequate to provide
good-quality care”400 Critics maintain that the, “dominant role of federal financing of ESRD care
has resulted in continuing claims that reimbursement polices have jeopardized quality.”401
Rettig and Levinsky examined the effect of reimbursement on several indicators of
quality of care including mortality, hospitalization, staffing and innovation. Rettig and Levinsky
found that evidence was, “suggestive but not conclusive” that a relationship existed between
decreased reimbursement rates and increased mortality. 402
To reach their conclusion, the committee’s report cited two studies that focused on the
effects of reimbursement on mortality. The first study was conducted by the Urban Institute.
Data from this study indicate that, “there is an inverse correlation between patient mortality and
the standardized prices that dialysis facilities receive.”403 This suggests that, “higher standardized
398
Levinsky. 1398.
Nissenson, 168-169
400
Ibid.
401
Ibid.
402
Rettig, 214.
403
Ibid., 213.
399
140
prices tend to be associated with lower mortality rates.”404 Rettig and Levinsky regarded the
Urban Institute findings as, “suggestive but insufficient to establish firmly a direct effect of
reimbursement on mortality.”405 Rettig and Levinsky went on to conclude that the empirical
evidence collected by the Urban Institute did not “support or to refute the hypothesis that . . .
changes in reimbursement have adversely affected mortality directly”406
The second study, cited by Rettig and Levinsky was conducted by Lowrie and Lew who
analyzed a data sample of 12,000 ESRD patients. In analysis of more than 12,000 patients treated
in National Medical Care units, Lowrie and Lew found that shorter treatment times were
associated with higher mortality. Based on their analysis of the available research, the IOM
committee concluded that the data suggest the “possibility that decreases in reimbursement may
have led to increase in mortality indirectly via an economic incentive to shorten treatment times,
which in turn led to increased mortality. (Shortened treatment periods reduce costs by permitting
nurses/technicians to treat more patients in a given shift.) ”407 The report noted, however, that
the “committee believes that no firm conclusion can be drawn, however, because factors other
than changes in payments have probably influenced the trend to shorten treatment times.”408
In their investigation of the possible relationship between decreased reimbursement rates
and decreased quality of care, Rettig and Levinsky considered the effect of reimbursement rates
on the hospitalization of ESRD patients. Because data are limited, the authors concluded, “no
firm conclusion can be drawn that there is a direct effect of reimbursement on morbidity
404
Ibid., 213.
Ibid., 214.
406
Ibid.
407
Ibid.
408
Ibid.
405
141
(hospitalization)”409 However, the IOM report did conclude that, as with mortality, there is the
suggestion of “an indirect effect mediated via changes in length of dialysis treatment, i.e., that
decreased reimbursement is associated with decreased length of treatment, which in turn is
associated with increased hospitalization.”410
In addition, the IOM study examined the effect that decreased reimbursement may have
on staffing, because Rettig and Levinsky believe staffing to be a structural measure of quality.
Their investigation found that, “Data strongly suggest that decreased reimbursement has led to
decreased staffing in dialysis units, to shifts from nurses to technicians, and to important
reductions in social worker and dietician staffing.”411 Even though staffing has clearly been
affected by reimbursement the authors noted, “There is no evidence that these changes in
patterns have affected quality. However, professional opinion favors this connection.”412
Finally, the IOM report investigated the possible connection between reimbursement
rates and innovation in the field of renal research. Rettig and Levinsky found that reimbursement
policy appears to have had mixed effects on innovation.413 Originally, payment policy
encouraged cost-reducing technical change in equipment and supplies.414 More recently,
however, reductions in reimbursement and elimination of support for dialysis research appear to
be restricting further technical improvements.415
After their comprehensive study Rettig and Levinsky made the following recommendations
in 1991 in regard to reimbursement policies for the ESRD program:
409
Ibid., 217.
Ibid.
411
Ibid., 230.
412
Ibid.
413
Ibid.
414
Ibid.
415
Ibid.
410
142
1. Evaluate the justification for the rate differential between hospital-based and
independent facilities, especially in terms of patient complexity and retain or eliminate
the differential on the basis of that analysis.
2. Establish a separate rate for hospital backup units that treat inpatients as well as
outpatients and that support to independent units in the care of complex outpatient cases.
3. Establish a separate rate for ESRD pediatric patients.
4. Evaluate the need for separate rate for rural facilities.416
Before any significant changes were made to reimbursement polices, there was a need for
further investigation of a possible relationship between quality of care and reimbursement. A
comprehensive taskforce was created, consisting of the Health Care Financing Administration
(HCFA; now the Centers for Medicare and Medicaid Services, CMS), the Association for the
Advancement of Medical Instrumentation (AAMI), the Renal Physicians Association (RPA), and
the National Institutes of Health (NIH). The committee reviewed the available ESED related
science and literature to develop guidelines and research recommendations. The aim of the
committee was to improve the diagnosis and management of chronic kidney disease and its
complications.417
The efforts of the committee resulted in the publication of the Dialysis Outcomes Quality
Initiative (DOQI) which was officially endorsed by the National Kidney Foundation (NKF).
Published in 1997, and updated in 2005, the guidelines were mostly clinical in nature. 418 While
416
Ibid., 259.
National Kidney Foundation, “National Kidney Foundation. Kidney Disease Outcomes Quality
Initiative: Annual Report 2005,” www.kdoqi.org (accessed November 23, 2008).
418
“target hematocrit of 33% to 36% along with a minimum Kt/V of 1.2 (single pool) and/or a
recommendation that to reduce morbidity related to vascular access, the use of simple fistulas should be increased
from current levels of 10% to 15% (compared with 50% in other parts of the world) and suggested that
complications may be reduced through the use of jugular vein cuffed catheters, rather than subclavian temporary
catheters.” National Kidney Foundation, “Kidney Disease Outcomes Quality Initiative: Annual Report 2005”; also
417
143
the intention was to improve management of chronic kidney disease, the recommendations made
few suggestions regarding the financial management of the disease. According to John Davis,
Chief Executive Officer of the National Kidney Foundation, by using the guidelines
recommended by the Dialysis Outcomes Quality Initiative medical professionals will be able to
detect and treat chronic kidney disease (CKD)earlier, but, “More importantly, the overall
outcomes of our patients with CKD will be optimized”419
While the Dialysis Outcomes Quality Initiative made little attempt at correlation between
provider reimbursement and quality of care, pressure from the renal community, forced the
federal government to examine reimbursement rates. The result was revealed in the Federal
Register Volume 70, Number 151, entitled “Medicare Program; Revisions to Payment Policies
Under the Physician Fee Schedule for Calendar Year 2006; Proposed Rule.” issued on August 6,
2005.
With enough external pressure, actions proposed regarding reimbursement in 42 CFR
Part 405, et al to the Centers for Medicare and Medicaid services were to update reimbursements
by clarifying the resource-based practice expense relative value units (PE RVUs).420
“We are
proposing these changes to ensure that our payment systems are updated to reflect changes in
medical practice and the relative value of services. This proposed rule also discusses geographic
locality changes; payment for covered outpatient drugs and biologicals; supplemental payments
see, Alan Collins, Tricia Roberts, Wendy St. Peter, Chen Shu-Cheng, Jim Ebben, and Edward Constantini, “United
States Renal Data System Assessment of the Impact of the National Kidney Foundation-Dialysis,” American
Journal of Kidney Diseases 39, no. 2 (April 2002): 784-795.
419
National Kidney Foundation, “Kidney Disease Outcomes Quality Initiative: Annual Report 2005”.
420
“refine the resource-based practice expense relative value units (PE RVUs) and propose changes to
payment based on supplemental survey data for practice and revisions to our methodology for calculating practice
expense RVUs, as well as make other proposed changes to Medicare Part B payment policy We are also proposing
policy changes related to revisions to malpractice RVUs, in addition to revising the list of telehealth services. In this
proposed rule, we also discuss multiple procedure payment reduction for diagnostic imaging, and several coding
issues.” Federal Register, “Proposed Rules,” 70, no. 151 (August 8, 2005).
144
to federally qualified health centers (FQHCs); payment for renal dialysis services; the national
cover decision (NCD) process; coverage of screening for glaucoma; private contracts; and
physician referrals for nuclear medicine services and supplies to health care entities with which
they have financial relationships”421 Specifically related to the ESRD program, the proposal
suggests Revised Pricing Methodology for Separately Billable Drugs and Biologicals Furnished
by ESRD Facilities422, Adjustment to Account for Changes in the Pricing of Separately Billable
Drugs and Biologicals, and the Estimated Increase in expenditures for Drugs and Biologicals423,
as well as Proposed Revisions to Geographic Designations and Wage Indexes Applied to the
ESRD Composite Payment Rate424
The final rule, entitled, “Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule for Calendar Year 2006 and Certain Provisions Related to the
“Proposed Rules,” Federal Register 70, no. 151 (August 8, 2005).
‘payment for the top 10 separately billable ESRD drugs billed by freestanding facilities would be based
on the acquisition cost of the drug, as determined by the OIG, updated by the Producer Price Index (PPI). The
remaining separately billable ESRD drugs would be paid at the ASP + 6 percent for freestanding facilities. We also
determined that hospital-based facilities would continue cost reimbursement for all drugs with the exception of
erythopoeitin (EPO) which would be paid the acquisition cost, as determined by the OIG, updated by the PPI.”
Federal Register. “Proposed Rules,” Federal Register 70, no. 151 (August 8, 2005).
423
“two provisions that describe how the drug add-on adjustment will be implemented in the ESRD
payment. First, that the add-on adjustment reflects the difference between payment methodology for separately
billed drugs under the drug price in effect in CY 2004 and current drug pricing and, second, the aggregate payments
for CY 2005 must equal aggregate payments absent this MMA provision.” “Proposed Rules,” Federal Register 70,
no. 151 (August 8, 2005).
424
“Because of the significance of labor costs in determining the total cost of care, the prospective payment
system systems (PPSs) which we administer to traditionally have used a wage index to account for differences in
area wage levels. The labor-related shares of costs used to develop the composite rates were 36.78 percent for
hospital-based facilities and 40.65 percent for independent facilities. The current composite payment rates are
calculated using a blend of two wage indexes, one based on hospital wage data for fiscal years ending in CY 1982,
and the other developed from CY 1980 data from the Bureau of Labor Statistics (BLS). The wage indexes are
calculated for each urban and rural area based in 1980 U.S. Census definitions of metropolitan statistical areas
(MSAs) on their equivalents, and areas outside of MSAs in each State, respectively…..we are…proposing to
recalculate the ESRD wage indexes based on acute care hospital wage and employment data for FY 2002, as
reported to us in connection with the development of the wage index used in the inpatient hospital prospective
payment system. In addition, we are also proposing to update the labor portion of the ESRD composite rate to which
the wage index is applied” “Proposed Rules,” Federal Register 70, no. 151 (August 8, 2005).
421
422
145
Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B” was published on
November 21, 2005.425 The rule, “changes how Medicare pays for services to beneficiaries with
end-stage renal disease (ESRD).”426More accurate payments means that, “...providers of ESRD
care will be paid more fairly for the treatments required for the different types of patients,
providing better financial incentives for appropriate care.”427
The final rule attempted to address and rectify the issue of reimbursement’s effect of
quality of care. “The intent of the changes in payments to ESRD facilities was to appropriately
pay facilities based on the characteristics of the patients they treat, as well as the wage levels for
the areas in which they are located . . . While the result of the changes we have made to the wage
adjustment result in redistributing payments to individual facilities, these changes more
accurately pay facilities based on local wage levels. We understand the concerns expressed by
these patients and have provided for a transition from the old, outdated wage adjustments to the
revised adjustment to help mitigate any adverse impact to individual facilities.”428 The final rule
went into effect on January 1, 2006.429
425
In this final rule, both independent and hospital-based facilities will receive an 8.7 percent increase in
their composite payment rate, in addition to a 1.6 percent update for services under the proposal.
426
American College of Nuclear Physicians, “Medicare Announces Increases in Final Physician Payment
Rule for 2005,” http://acnp.snm.org/index.cfm?PageID=3251&RPID=1951 (accessed November 23, 2008).
427
Ibid.
428
“Proposed Rules,” Federal Register 70, no. 151 (August 8, 2005).
429
Ibid.
146
Chapter 7: The Future of the ERSD Program
The attachment of ESRD to Medicare was a significant development in U.S. health policy.
Never before and never since has one particular population been given near universal federal
coverage for their health care needs on the basis of a medical diagnosis. The inclusion of ESRD
under the Medicare umbrella put an end to the disturbing practice of rationing life-sustaining renal
services. Although quite possibly dazzled by the availability of new technology, the drama of the
powerful lobbying efforts and the fantasy of being considered rescuers, legislators who
championed the cause did so with primarily good intentions. By agreeing to support funding for
ESRD services, legislators were well aware that countless lives would be saved.
Although propelled by a humanitarian impulse, the end of the God Squads and the
inclusion of ESRD were done without much thought to the consequences. The all-inclusive
program for ESRD had unanticipated effects. These would have a significant impact not only on
the Medicare system, the patient population, the provider community, but on the overall perception
of the U.S. health care system.
By including all patients in renal failure in Medicare, legislators bypassed the difficult task
of confronting the finite nature of health care resources. They failed to address the harsh reality
that, although services may exist and are potentially available to everyone, the health care system
may not be able to (or want to) provide care to meet everyone’s needs. Therefore, by insuring all
ESRD patients, policymakers swiftly avoided a conversation about rationing.
This may have contributed to the public’s belief that the U.S. health care system has the
potential to support all health care needs. By providing comprehensive financing to ESRD patients,
147
the federal government was in essence declaring to the public, “If we just had the money, everyone
will have the services they need and we can save lives.” However, we do not have the money to
provide health care services to everyone: so hard decisions must be made about how to ration
services.
Once the decision was made to incorporate ESRD into Medicare, the number of individuals
receiving ESRD services sky-rocketed. Thus the demand for renal services, as well as for
providers of ESRD services, mushroomed. Furthermore, and exceptionally significant, with the
opening of access, the demographic make-up of the patient population radically changed. A
primarily small, White, well-educated, early stage, under age 55 renal patient population became a
much larger, diverse, uninformed, sicker and older one.
As a result of these changes in the ESRD population, the ESRD program became a
bureaucratic nightmare. Costs began to rise rapidly and uncontrollably. Though legally bound
(through Public Law 92-603, Section 2991- The Social Security Amendments of 1972) to pay for
medical care for those who qualified, the legislators, bureaucrats, and external parties began to
re-examine the role of the federal government in the financing of ESRD services.
Critics of the ESRD program began to ask if, and why, it was ethical to entitle medical
services to one segment of the population, while other individuals went without federal
assistance for medical care. But such questions came too late. Because the federal government
had issued a promise to provide ESRD care, proponents of the program declared that it would be
unfair, unjust, and unethical to revoke federal monies that had been promised. With costs of
ESRD care spiraling if, after meticulous consideration, the decision was made to drastically
curtail federal support, or to even eliminate the ESRD program altogether, what would a
withdrawal of federal support mean for the ESRD patient?
148
Should We Fix It? - Is Government Support for ESRD Patients Ethical?
If ESRD patients are entitled to lifesaving procedures, why not federally sponsor care for
all patients who are in similar straits? Renal disease is not the only potentially fatal illness for
which treatments are available. With a significant infusion of federal funding, medical
professionals could save individuals afflicted with the other disease entities, or, at the very least,
improve the quality of life. For example, diseases, such as cancer, HIV-AIDS, and Parkinson’s,
are some of the potentially life-threatening. They are mostly manageable with medical
interventions. Why not federally fund, under the Medicare system, the treatments for all lifethreatening conditions? Why give special consideration to renal patients?
Other Life-Threatening Diseases
Cancer
After heart disease, cancer is the second most common medically-related cause of death.
In 2006 there were 1,399,790 new cases.430 Furthermore, in 2006, 564,830 Americans were
expected to die of cancer, which computes to approximately 1,500 individuals a day. The overall
cost of cancer to the health care system in 2005 was $209 billion, with $74 billion spent on direct
medical care.
Certain cancers can be prevented or even cured. Cancers related to the use of tobacco, or
cancer deaths related to nutrition, physical inactivity, or obesity, are preventable with early
education and intervention. Further, cancers of the skin can be completely prevented through
behavioral changes. Other cancers related to infectious agents, such as Hepatitis B, Human
American Cancer Society, “Statistics for 2008,” http://www.cancer.org/docroot/stt/stt_0.asp (accessed
November 23, 2008).
430
149
Papillomavirus (HPV), can be treated with antibiotics. Although not all cancers can be cured,
certain cancers can be much more manageable if caught early. These include cervical, breast,
colorectal and prostate cancer.431 Even though not all cancers can be treated successfully,
treatment can afford those with the disease a longer life of higher quality.
HIV/AIDS
At the end of 2005, the Centers for Disease Control and Prevention estimated that there
were 437,982 people living with AIDS in the United States. At the end of 2005, 44 percent of
people living with HIV/AIDS were African-American, 35 percent were Non-Hispanic White, 19
percent were Hispanic, and 1 percent was classified as other. Since the beginning of the AIDS
epidemic in the early 1980s, it is estimated that 550,394 people with AIDS have died in the
United States alone.432 The number of deaths among people with AIDS has remained relatively
stable since 1999, with an estimated 17,011 deaths in 2005. Federal spending for AIDS reached
$10.8 billion in 2000, which computes to $1,359 per patient per month.433
As a disease transmitted through certain behaviors, such as unprotected sex or the sharing
of needles, education is the key to preventing the spread of HIV, the virus that causes AIDS. If
not prevented through education, early screening and detection make it easier to cope with the
disease, psychologically and medically. Cases that cannot be prevented can be managed through
lifesaving medical intervention. Medications, such as Nucleoside Reverse Transcriptase
Inhibitors (NRTIs), Protease Inhibitors (PIs), Fusion Inhibitors, Entry Inhibitors (CCR5 co-
431
Ibid.
Advert: International AIDS Charity, “United States Statistics Summary,”
http://www.avert.org/statsum.htm (accessed November 23, 2008).
433
The White House, “The HIV/AIDS Epidemic: 20 Years in the U.S.,”
http://www.whitehouse.gov/onap/facts.html (accessed November 23, 2008).
432
150
receptor antagonist) and HIV integrase strand transfer inhibitors, can extend and improve the
quality of life for the individual living with HIV/AIDS.
Parkinson’s Disease
In 2000, 15,600 deaths were attributed to Parkinson’s disease, a rate of 5.5 percent per
100,000 people in the total population.434 The combined direct and indirect cost of Parkinson’s,
including treatment, Social Security payments, and lost income from inability to work, is
estimated to be nearly $25 billion per year. Medication costs for an individual patient average
$2,500 a year and therapeutic surgery can cost up to $100,000 per patient.435 While Parkinson’s
cannot be cured, early detection is important to the management of the disease. 436 Cases can be
managed through drugs, such as Sinemet (levodopa/carbidopa), Dopamine agonists, Symmetrel
Anticholinergics (Artane, Cogentin), Eldepryl and Deprenyl, Tasmar, and Comtan (COMT
Inhibitors)
Cancer, HIV/AIDS and Parkinson’s disease share similarities with ESRD. All are lifethreatening conditions. Moreover, due to their chronic nature, each of these diseases requires
medical management. Safe and effective drugs, as well as medical technology, are available to
those patients with access to the health care system. Furthermore, and most importantly, both
medical management and access to the health care system could extend and improve the quality
Phamasave, “Parkinson’s Disease,”
http://content.nhiondemand.com/psv/HC2.asp?objID=100241&cType=hc (accessed November 23, 2008).
435
Parkinson’s Disease Foundation, “Ten Frequently Asked Questions about Parkinson’s Disease,”
http://www.pdf.org/pdf/Fact%20Sheet_General%20PD%20Facts.pdf (accessed November 23, 2008).
436
Susan Mayor, “Managing Parkinson's 'Wearing-Off' Symptoms - Part I,” Health and Age
http://www.healthandage.com/public/health-center/18/article/2897/Managing-Parkinson-Wearing-Off-SymptomsPart-I.html (accessed November 23, 2008).
434
151
of life of people with cancer, AIDS and Parkinson’s, in the same way as treatments for ESRD
patients.
Why Not Fund All Life-Threatening Diseases
Even though a variety of life-enhancing treatments are available, the federal government
does not provide the same level of sponsorship for people with cancer, AIDS or Parkinson’s as it
does for people with ESRD. The reason is money. Realistically, we do not extend federal
coverage for care at the bedside for all individuals in need of life-saving treatments because of
the expense. If expenditures per person for medical care of patients with ESRD are ten times
higher that that of the population as a whole, the cost of extending medical care to other
potentially-fatal diseases would be a substantial burden on the already stressed healthcare
system.437 Therefore, it probably is safe to assume that end stage renal disease is the only
disease-specific entitlement program that the federal government will politically and financially
support and continue to fund.
Although this may seem unjust to those with medically manageable life-threatening disease,
all is not lost. The federal government has not abandoned cancer, HIV/AIDS and Parkinson’s
patients. Support for care is provided indirectly via funding for research. Federal funding though
grants promotes research efforts and, therefore, results in innovations in care, which can improve
and enhance the lives of those with potentially terminal illnesses.
Even though there is substantial federal funding for research, it is important to note that the
distribution of monies is not equal. Some diseases have found support in the press, such as breast
cancer through the Susan B. Komen Foundation. Other diseases have been championed by
437
Levinsky, 1395-1399.
152
celebrities, for example Ronald and Nancy Reagan raising awareness of Alzheimers. The
addition of external campaigning can give the appearance of certain diseases being more
“popular” than others, which may have lead to pressure on legislators to support and approve
increased research funding levels for research and treatment.
Although federal funding for research is valuable, just funding research and not bedside care
seems unjust. There are many gravely ill individuals, with diseases other than ESRD, who could
greatly benefit from federal sponsorship for their direct medical needs. Furthermore, to provide
ESRD patients assistance for their care gives the impression that there exists a hierarchy of the
importance of life-threatening diseases. Because patients get complete funding from the federal
government, end-stage renal disease has the appearance of being a more “important” lifethreatening illness than the others. Without access to Medicare to support their health care needs,
those with cancer, HIV/AIDS and Parkinson’s and others seemingly fall below ESRD on the
hierarchy of illness.
Since Medicare, and, therefore, the ESRD program, is funded from Social Security payroll
taxes, to which all workers must contribute, the entitlement of only one part of the population to
federal assistance seems inequitable. Some workers, who are contributing to Social Security,
may be afflicted with other treatable diseases, but are ineligible for Medicare coverage because
of the nature of their illness. Without federal support, a number of patients with these lifethreatening diseases may not get the care necessary to manage their situation. Sadly, some sick
individuals may be shut out altogether from the healthcare system. Unable to access the services
they need, their lives most likely will be shortened and uncomfortable.
As a result, there have been challenges to the continued support for the ESRD program.
Critics believe that the “principle of justice [demands] that all cases should be treated alike.”
153
Why, asked John Moskop in “The Moral Limits to Federal Funding for Kidney Disease,” should
the federal government provide support for patients with one catastrophic condition, ESRD, to
the relative neglect of patients with all the various other life-threatening medical problems”438
For those others who are ill, but without financial backing, the lack of support from the federal
government is nothing short of discriminatory. Clearly, to include some life-threatening diseases,
but to neglect others, does not offer equality of opportunity to the health care delivery system. 439
If, from the perspective of justice, “the moral function of the health-care system must be to help
guarantee fair equality of opportunity,” the ESRD program is without doubt unjust.440
Certain theories of distributive justice are particularity applicable to the question of the
Medicare ESRD program. In particular, both utilitarianism as well as communitarianism
provides the theoretical framework to reject the ESRD program.
Utilitarianism has been called the “greatest happiness” principle. Happiness, for the
utilitarian, is the result of the intended pleasure of an action. Not only is happiness a consequence
of pleasure, but, for happiness to exist, utilitarianism requires a reduction in, or absence of, the
experience of pain. On an individual level, utilitarianism is not concerned with happiness; rather
the focus for the utilitarian is choosing an option that will produce the greatest overarching good.
However, before a choice can be made, the utilitarian asserts that the consequences of the action
must first be examined. To make a “right” choice based in utility requires that the end result must
438
Moskop, 13.
Norman Daniels, Just Health Care: Studies in Philosophy and Health Policy (New York, NY:
Cambridge University Press, 1991), 36-56.
440
Daniels, 41.
439
154
be happiness for the most persons possible. Further, the more happiness the action produces, the
more desirable is the action.441
As a theory of distributive justice related to medical treatment, utilitarianism has its
strengths and weaknesses. The foremost strength of utilitarian distribution is its ability to
maximize overall happiness through allocating goods (e.g. health care services) based on the
needs and choices of the many. When deciding how to distribute goods, the utilitarian result will
be that the greatest number of individuals will receive the benefits of distribution. In addition,
utilitarianism encourages impartiality. By establishing a system of distribution founded on an
attempt to produce the most happiness, individuals are not favored; instead, utilitarian
distribution encourages a more balanced allocation of resources. However, utilitarianism is not
without problems. The essential difficulty is that utilitarianism necessitates the sacrifice of the
individual. Because decisions are made with an eye towards allocation that will maximize the
good for the many, the individual is ignored or required to experience oppressive self-sacrifice.
The few suffer, or go with out resources, so that the many can prosper.
The allocation of healthcare resources based on utilitarian concepts can afford a more
impartial distribution; it stands to result in the greatest good or greatest health for the greatest
number. The focus of a utilitarian healthcare distribution is on the wellbeing of society, not on
the wellbeing of the individuals. Because utilitarianism focuses on society not the individual,
utilitarians would conclude that the ESRD program is not just.
The ESRD program allots significant health care services to a small segment of the
population, those with kidney failure. ESRD patients are granted considerable resources for their
441
Karen Lebacqz, Perspectives from Philosophical and Theological Ethics: Six Theories of Justice
(Minneapolis, MN: Augsburg Publishing House, 1986), 15-32.
155
health care needs, based only on the presence of a particular disease. Other members of society,
who may be in need of health care, go without, just because they do not have kidney failure.
Thus, by affording health care coverage to a small segment of the population, resources are not
being distributed in order to produce the greatest overarching good. Some individuals, those with
ERSD, receive more than their fair share of health care, and others get considerably less, or none
at all. Therefore, the Medicare ESRD program does not distribute services so that the wellbeing
of society is maximized.
Communitarianism also rejects the justice or fairness of the ESRD program.
Communitarianism emphasizes the responsibility of the community to the individual. However,
the individual has his/her own responsibilities to the community.442 Communitarians do not
agree with models of society that base human relationships on rights and contracts, and that
attempt to construct a single theory by which to judge every society. 443 What is due to
individuals within a community depends on the standards of the community. Although
individuals may object to the decision of the community, they are not being subjected to social
compulsion.444
Like utilitarianism, a communitarian theory of distributive justice is not about individual
freedom or individual choice. The community decides that this is how “we” do things and how
“we” will live our lives. 445 This imposition on freedom may seem oppressive to some critics. As
for justice, in a communitarian sense, it is a less central virtue of social life, and is only necessary
442
Tom Beauchamp and James Childress, Principles of Biomedical Ethics (New York, NY: Oxford
University Press, 1994), 232-233.
443
Ibid.
444
Mark Hall, Making Medical Spending Decision (Oxford, UK: Oxford University Press, 1997), 25.
445
Ibid.
156
when communal values have broken down into conflicts.446 While critics claim that collective
decision-making may be oppressive, it can be viewed as one the greatest assets of
communitarianism. Collective decision-making can result in a cohesive group that establishes a
values set, or mode, by which to allocate services that will serve the entire community well.
The theory can be applied to the distribution of health care services. As long as the
community agrees that health care is due to members, then the community is supportive of health
care allocation. Additionally, as a collective group, the community must determine what services
to allocate. Since communitarianism requires the community to determine how to allocate health
care resources, the ESRD program would be deemed unjust. It is doubtful that, in the current
environment, the community would consider ESRD worthy of unique total federal support for
health care services. Therefore, individuals with ESRD would not be entitled to health care
services. They would be sacrificed for the common good.
While federal support for one disease may be unjust, it is not unethical for the government to
continue to provide access to Medicare for ESRD patients and not to other patients with lifethreatening illnesses. Because the ESRD program has been established as entitlement program,
the federal government has a responsibility and a duty to ESRD patients and ESRD patients only.
The promise means that an ESRD patient is “entitled to ‘specific services,’ to ‘have payment
made for him or on his behalf’. . . . ”447
Public Law (Section 2991, Public Law 92-603), has established that Medicare will provide
coverage to virtually all individuals with ESRD who require dialysis or transplantation to sustain
life.448 This law established a social contract between the federal government and those
446
Beauchamp, 646.
Rose, 43
448
Eggers, “Medicare’s End-Stage Renal Disease Program,” 55-60.
447
157
individuals with ESRD wherein the federal government made a promise to provide funding for
end stage renal disease. Even though it may be unfair to others with life-threatening diseases,
until the law is changed, renal patients will remain a special class. In the eyes of the law, it
makes no difference that the ESRD program is the only disease-specific federal program.
Through the entitlement agreement, the government is legally and morally accountable for
providing access to federal support for health care for ESRD patients. “All persons who are
serious about living a moral life already grasp the core dimensions of morality. They know not to
lie, not to steal property, to keep promises, to respect the rights of others, not to kill or cause
harm to innocent persons. All persons serious about morality are comfortable with these rules
and do not doubt their relevance and importance.”449 Morality requires the federal government
keep the promise made to the ERSD patient.
That the federal government made a promise to the ESRD patient, and to no others with lifethreatening illnesses, was not a wrong, or even a bad, decision. Political lobbyists and legislators
championed the cause for honorable reasons. By providing funding, they could put an end to
rationing based on social worth and save the lives of fathers, mothers, sons, and daughters.
Individuals who would otherwise die of a treatable, manageable disease were rescued from the
brink of death by the legislators’ promise of monetary support.
Truly, for the ESRD patient, the promise of federal support was life-altering. According to
William May, promises, such as that made by the government through the ESRD program, are of
great consequence. Promises are more than just descriptive statements such as: it will be sunny
outside or the storm has passed. Promises are performances utterances in which, “one does not
449
Beauchamp and Childress, 3.
158
merely describe a word; in effect, one alters the world by introducing an ingredient that would
not be there apart from the utterance.”450
For those individuals without kidney disease, no promise was made to directly provide
funding for bedside care. Because ESRD is the only disease that has been promised federal
sponsorship, morality does not require the federal government to insure all individuals with lifethreatening illness. At this point, the federal government is not ethically accountable for the
medical care of those with cancer, HIV/AIDS or Parkinson’s.
However, while done with good intensions, the promise of federal sponsorship to ESRD
patients may have had negative affects of the rest of the population. The exorbitant cost and the
complexity of the ESRD program may have been an obstruction in forwarding the movement to
extend health care to all members of society. As the cost of the ESRD program skyrocketed,
surely the federal government reexamined its responsibility to provide universal health care.
Ethically, there was no duty to create an ESRD entitlement program, but, now that it exists,
it would be unethical to break the promise made. A promise to provide funding for health care
has been established and to, “to go back on a promise is a very solemn matter precisely because a
promise is world-altering.”451
One of the most compelling reasons that the federal government cannot terminate support for
the ESRD program is that such action may be viewed as morally wrong. To end the program
would be discrimination against an entire segment of the population -- vulnerable, sick
individuals in kidney failure, who happen to constitute an increasing number of minorities
including African-Americans and Hispanics. A good deal of legislation, court rulings and public
pronouncements in the last half century determined that discrimination is both illegal and
450
451
May, 95.
Ibid.
159
immoral. Thus, current laws do not tolerate discrimination in our schools, military,
neighborhoods and offices on the basis of race, ethnicity, physical capabilities, socio-economic
status; so why should we be able to discriminate against the ESRD population by eliminating the
source of their health care funding?
The mere fact that the patient population has grown and changed in its race, age, economic,
and compliance make-up does not mean that the government can abruptly withdraw support.
Consider if a part of your city, which was once a nice middle class White neighborhood with
single family homes, became a neighborhood dominated by low income housing. Minorities now
constitute the majority of the people living in the area. Residents who have moved in do not care
for the homes and nearly all are falling into disrepair. Many of the houses have been subdivided
into apartments and duplexes, which are over-crowded. Does the fact that the neighborhood
changed and now requires more services give the government the right to discontinue the
promised: garbage, sewage, police, and fire protection? While in the neighborhood the
discontinuation of support potentially means chaos, the termination of support to ESRD patients
is death.
Although dialysis and treatment for ESRD are developing all the time, as is the practice
of medicine as a whole, basic ethical principles cannot be abandoned.452 When the Medicare
legislation was signed into law in 1972, it granted an entitlement of treatment to a group of
individuals based solely on their affliction of renal failure, regardless of their race, age, socioeconomic status, or level of compliance with treatment. The law made no judgments based on
452
Rose, 42.
160
the background or on the behavior of the patient. It set a new standard for the treatment of
ESRD, removing the previous standard of rationing based on “worth.”453
The Future of the ESRD Program
Even though it would be unethical to revoke federal support for the ESRD program
because of the current and future demand on Medicare, a meaningful reexamination of the
promised assistance may be unavoidable. The skyrocketing cost of health care, the ageing of the
baby boomers into the Medicare system, and the increase in number of individuals with ESRD
all are contributing to stress on the health care system. This may force the federal government to
reduce support. The question then becomes, “If it becomes necessary to reduce support
significantly, how should the newly-limited funds be distributed?”454
To answer that question, we must answer other, larger, ones. These questions deal not
with the treatment of a single disease, but deal with the social and ethical dimensions of health
care in a modern society:
What kind of social good is health care? What are its functions, and do these make it
different from other commodities?
Are there social obligations to provide health care?
What inequities in its distribution are morally acceptable?455
What Kind of Good is Health Care?
Some individuals contend that health care is in a special category as a social good.
Because health care is necessary for the continuation and preservation of life, it is not in the same
453
Ibid.
Moskop, 11.
455
Norman Daniels, ix.
454
161
category as private goods, such as clothing or cars. Fancy cars and expensive clothing are nice to
have, but, without them, we will not die. However, without medical intervention, such as proper
medication to maintain a healthy blood pressure, or surgery to remove the ruptured appendix,
people will perish. Therefore, some people may feel that the importance of health care to life
makes it a unique social good.
At this point it is essential to mention that some kinds of health care goods and services
are more important than others. Too often, medical interventions are viewed as health care
“needs,” when, in fact, they are just health care “wants.” Health care needs (not health care
wants) must be met in order to achieve, maintain and restore species-typical normal
functioning.456
When health care needs go unfilled, it can impair, and even prevent, normal species
functioning. Moreover, when normal species functioning has been diminished, the range of
opportunity to construct plans the future is reduced.457 Additionally, “If an individual’s fair share
of the normal range is the array of life plans he may reasonably choose, given his talents and
skills, then disease and disability shrinks his share from what is fair”458 Assuring that all
individuals can construct a reasonable life plan for themselves will require the maintenance of
normal species functioning, which, in turn, requires the fulfillment of health care needs.
Appealing to the federal government to meet the health care needs of individuals, not the
health care wants, will not avoid the need to ration health care services. Already, whether we like
to admit it or not, we ration health care. We ration by insurance status (those who have
insurance, either provided by their employer or the government, may be able to access the health
456
Ibid., 32.
Ibid.,27.
458
Ibid., 34.
457
162
care services they need), by mercy (there may be free clinics with Good Samaritan physicians
and nurses who will treat patients with little to no financial resources), or by federal laws
(EMTALA establishes the right of all individuals to stabilizing treatment regardless of their
financial resources).
While we prefer not to acknowledge that we ration health care, it is important to come to
terms with the fact that rationing not only occurs, but also can be a desirable way to control
medical expenditures.459 Once it is acknowledged that the rationing of health care is inevitable,
law and policy-making bodies can set out to develop a morally defensible manner by which to
allocate resources.
To develop a morally justifiable, as well as desirable, rationing scheme requires the
determination of the purpose or goals of health care. What does the federal government seek to
achieve in health care? What are the federal government’s goals?460 If it happens that it is
determined that “to each according to his needs” is to be the goal of federally sponsored health
care, the only morally defensible rationing scheme that achieves “to each according to his needs”
centers on fair equality of opportunity to health care goods and services.
Are There Social Obligations to Provide Health Care?
As a society, it is our responsibility to assure that others achieve normal species
functioning, and that will require fair equality of opportunity to health care services. Fair
opportunity discounts characteristics such as gender, race, IQ, native language, national origin,n
459
Hall, 5.
Larry Churchill, Self-Interest and Universal Health Care: Why Well Insured Individuals Should Support
Coverage for Everyone (Cambridge, MA: Harvard University Press, 1994), 12-15.
460
163
and social status.461 These characteristics, which are distributed through the natural lottery of life,
are irrelevant and do not provide morally acceptable reasons for discriminating between persons
in resource allocation.462
The fair opportunity rule says that, “no person should receive social benefits on the basis
of undeserved advantageous properties (because no persons are responsible for having these
properties) and that no person should be denied social benefits on the basis of undeserved
disadvantageous properties (because they also are not responsible for these properties).”463
Moreover, fair opportunity requires that the disadvantaged receive the benefits they need to
ameliorate the unfortunate effects of life’s lottery.464 Therefore, American society, as represented
by the federal government, has an obligation to protect the individuals from the negative effects
of a natural lottery over which they have no control.
Protection from life’s lottery may require unequal distribution of health care resources,
rationing health care services to some individuals, while providing additional services to benefit
the least advantaged members of society (unequal distribution of the health care pie). 465
However, unequal distribution and rationing of health care resources is justifiable if the
disproportion helps the worst off, or least-advantaged, members of society reach the same state
of wellness as those who hold the winning ticket.466 This rationing scheme, based on receiving
unequal share of health care resources, is morally defensible because it ensures that each citizen
461
Beauchamp and Childress, 235.
Ibid., 236.
463
Ibid., 235-236.
464
Ibid., 236.
465
Lebacqz, 38.
466
Beauchamp and Childress, 236; also see, Daniels, 40.
462
164
will have a fair opportunity to realize a normal opportunity range and be able to make reasonable
life plans.467
Those with ESRD have incurred the negative effects of life’s lottery. They have a disease
that can kill them if left untreated. While it is possible that some individuals with ESRD may
have contributed to their renal failure with certain behaviors, for example poor diet and lack of
exercise that has contributed to hypertension or diabetes, ESRD patients should be considered
disadvantaged and, therefore, in need of protection. However, those with other life-threatening
diseases, such as cancer, AIDS and Parkinson’s disease, can also have also incurred the negative
effects of life’s lottery. They have an illness that is a direct threat to their lives. Therefore, under
the concept of society’s responsibility to protect those who are affected by life’s natural lottery,
they should be protected as well.
If Health Care is Not a Social Good Do We Still Have an Obligation to ESRD Patients?
Not everyone agrees that health care is a unique social good. However, regardless of
whether it is special, or whether society has an obligation to help patients with life-threatening
disease achieve normal species functioning, or whether society has a duty to protect the
vulnerable from life’s lottery, a promise has already been made to protect ESRD patients.
Further, I would contend that the Medicare ESRD program is more than just a promise, more
than just a legal contractual agreement; it is secular covenant between society, through its elected
representatives, and ESRD patients. The federal government has made a special promise to care
for ESRD patients that it has not been made to other individuals.
467
Ibid., 52.
165
While the ESRD amendment is a legally binding agreement, the relationship between
ESRD patients and the federal government is not simply a legal arrangement. A contract implies
that both parties have a role in determining norms and the rule of participation.468 The ESRD
program is by no means this type of arrangement. The rules of participation in the ESRD
program were clearly defined solely by the federal government. To be eligible for the program,
“a person (must) be ‘fully insured or currently’ under Social Security; have a diagnosis of chronic renal
failure; and have applied for benefits or be the ‘spouse or dependent child’ of such a person.”469 Lay
persons had little input into the federal requirements for inclusion in the ESRD program.
In addition to requiring participation by both parties in the determination of the norms of
the agreement, a contract requires a sharing of authority and responsibility.470 Clearly, each of
the parties in the Medicare ESRD program does not share equal amounts of authority and
responsibility. The authority is in the hands of the federal government. It determines what health
care services will, as well as what will not, be covered under Medicare. The responsibility for
maintaining the fiscal health of the Medicare program falls on the shoulders of the federal
government. The individual ESRD patient has no direct role in ensuring that the Medicare
program continues to remain fiscally viable.
Further, a contract requires that both parties have informed consent, not blind trust.471
While ESRD patients may have some information, it is hard to believe that they can, or want to,
understand the complexities of the Medicare program. It is most likely that Medicare ESRD
participants experience blind trust. ESRD enrollees trust that the federal government will honor
468
Robert Veatch, The Physician-Patient Relationship: The Patient at Partner, Part 2 (Bloomington, IN:
Indiana University Press, 1991), 31-32.
469
Nissenson and Rettig, 161.
470
Veatch, The Physician-Patient Relationship: The Patient at Partner, Part 2, 14.
471
Lammers and Verhey, 130.
166
the agreement and the promise that it has made to provide for the medical needs of those
individuals in renal failure.
Therefore, the ESRD program should be considered a covenant rather then a contractual
agreement. A covenant involves an “original experience of a gift between soon to be covenanted
partners.”472 The covenant promise is based on an exchange of gifts, labors, or services.473
Certainly by including ESRD in the Medicare program, legislators made a gift from the federal
government to ESRD patients, the gift of sponsorship, in the form of financial support, for the
health care needs of ESRD patients. This gift of federal sponsorship created a bond between
ESRD patients and the government. Patients grew to rely on the Medicare system to pay for
health care that saved their lives.
Moreover, a covenant, unlike a contract, entails a flesh and blood relationship.474
Contracts often are far removed from the contracted parties. However, a covenant involves two
parties who are intimately intertwined. Thus, a covenantal relationship is more similar to a
family-like relationship then a legal relationship. The ESRD program is a familial relationship;
there is an element of profound caring in the program. Like a parent worries about the well-being
of a child, out of concern, the federal government espoused a health care amendment that would
allow dying individuals access to medical care.
Where a contract functions to protect the interests of both parties, the covenant is a
relationship built and trust and fidelity.475 ESRD patients have trust in the government. They
believe that the promise that was made will continue to endure, that the federal government will
honor its agreement to take care of the health care needs of those in kidney failure.
472
May, 88.
Ibid.
474
Robert Veatch, A Theory of Medical Ethics (New York, NY: Basic Books, 1977), 8.
475
Ibid.
473
167
While in a contract both parties have equal rights, in a covenant there is a power
differential.476 This clearly exists in the ESRD program. The federal government wields the
power. The ESRD patient is defenseless against the choices made. The government can make the
decision to cut reimbursement to physicians, forcing clinics to cut back on staff thereby affecting
the quality of care delivery, and the individual patient will have little recourse.
Essential to the continued obligation of the federal government to support the ESRD
program is that a covenant is responsible for changing the shape of the whole life of the
covenanted.477 A covenant involves, “not only an involvement with a partner in time, and a
responsive contract, but the notion of a change of being; a covenanted people is changed utterly
by the covenant”478 Without a doubt, the ESRD population was changed by the inclusion of
ESRD in the Medicare program. An entire cross section of the population, Whites, AfricanAmericans, Hispanics, old and young, rich and poor, was saved, and continues to be saved, by
the availability of federal payment for renal services. To now deny ESRD patients their promised
coverage would destroy and potentially end the lives of many individuals.
Most importantly to continuation of the ESRD covenant is that individuals, especially
those in the federal government, which is the foundation of society in which we live, must be
accountable to the vows they have made to one another. “We are born within covenants of life
with life. By nature, choice, or need, we live with our fellowmen in roles or relations. Therefore
we must ask, what is the meaning of the faithfulness of one human being to another . . . ? ”479
The federal government, by choice, made a promise to take care of ESRD patients. That promise
476
Ibid., 122
May, 89.
478
Ibid., 88.
479
Paul Ramsey, The Patient as Person: Explorations in Medical Ethics (New Haven, CT: Yale University
Press, 2002), xlv.
477
168
created a moral bond and an intimate relationship wherein vulnerably ill ESRD patients have
come to depend on the government, not just to address their health care needs, but to “save”
them. Thus, regardless of the stress ESRD patients may be causing the Medicare system, the
community and the federal government must be faithful to the covenant that has been created.
Ideas for the Management of the Medicare ESRD Program
While at first glance, the binding covenant between ESRD patients and the government
may not seem just, I argue that it is. ESRD patients have been promised Medicare. To deny that
claim would be utterly unjust. Even though it may be unfair that other individuals are forced to
go without services, while ESRD patients receive comprehensive federal support for their
medical needs, patients cannot be denied their claim to Medicare. It is unfortunate that others
who are ill have to go without, but not unfair. Therefore, I believe that the most ethical solution
is not to cut support to the providers and facilities, but to develop more creative means of
managing the disease.
One idea is to prevent ESRD before it occurs. Because ESRD it linked to hypertension
and diabetes, education is the key to prevention. Early intervention with those populations most
at risk, African Americans and Hispanics, on the behaviors that will contribute to the
development of ESRD, has the potential to decrease the incidence of renal failure. In addition,
providing vulnerable individuals with a support system can help prevent ESRD. Meetings with a
nutritionist to design appropriate diets, as well as time spent with a physician or recreational
therapist to design realistic exercise programs, can stop ESRD before it starts.
An additional solution to management of ESRD is to invest more in research and
development. Although, on the front end, investment in R&D may be expensive, it can save
169
money in the long run. New drugs and technologies can lead to less expensive methods and
approaches to treatment of the disease. Further, for institutions, there is an economic value to
research. With the passing of the Bayh-Dole Act of 1980, which allows for the transfer of
technology from the academic institution to the market place, academic intuitions not only can
improve the medical treatment of ESRD patients, but also make money.480
One final, but possibly controversial, solution to the management of ESRD is to change
the organ donor pattern. Currently, in order to donate organs, an individual must opt in or
consent to donate. If it was presumed that all individuals opted in, consented to donate, rather
than opted out, the availability of organs for transplantation would greatly rise. While there are
most definitely critics to the idea of presumed consent to donate, it has the potential to alleviate
some of the financial pressure on the Medicare system, as one-time transplantation is less
expensive than life-time dialysis. Further, transplanting appropriate ESRD patients can improve
the quality of life of individuals. They will not be chained to the dialysis machine, affording
them the opportunity to return to work and contribute once again to society.
The Medicare ESRD program is a clearly a covenant between society and ESRD patients.
It is a unique promise that has been made to provide financial support for one life-threatening
illness. Because a covenantal relationship has been established, the most ethical solution to the
management of the program is to provide care more efficiently and economically. This in no way
means cutting services or reimbursement. It will take creative thinking in order to protect the
promise that has been made to those with end stage renal disease.
Council on Governmental Relations, “The Bayh-Dole Act: A Guide to the Law and Implementing
Regulations,” http://www.cogr.edu/docs/Bayh_Dole.pdf (accessed November 23, 2008).
480
170
Bibliography
Advert: International AIDS Charity. “United States Statistics Summary.”
http://www.avert.org/statsum.htm (accessed November 23, 2008).
AFL-CIO. “America’s Union Movement.” http://www.aflcio.org/ (accessed November 23,
2008).
Alexander, Shana. "They Decide Who Lives Dies: Medical Miracle Puts Moral Burden on Small
Committee." Life, November 9, 1962, 102-125.
"The A.M.A. and the U.S.A." Time, July 7, 1961.
http://www.time.com/time/magazine/article/0,9171,872563,00.html (accessed November
23, 2008).
American Family Physician. “Kidney Failure.” http://www.aafp.org/afp/20030615/2539ph.html
(accessed November 22, 2008).
American Association of Kidney Patients. "NAPH Testifies Before Congress Shep Glazer
Dialyzes.” http://www.aakp.org/newsletters/Renalife-Magazine/Renalife-Articles/NAPHTestifies-Before-Congress-Shep-Glazer-Dialyzes/ (accessed November 22, 2008).
American Cancer Society. “Statistics for 2008.” http://www.cancer.org/docroot/stt/stt_0.asp
(accessed November 23, 2008).
American College of Nuclear Physicians. “Medicare Announces Increses in Final Physician
Payment Rule for 2005." http//acnpsnm.org/index?PageID=3251&RPID=1951 (accessed
November 23, 2008).
Ball, Robert. "Social Security Amendments of 1972: Summary and Legilsative History." Social
Security Bulletin 36, no. 3 (March 1973): 3-25.
Baydin, Lynda. "The End-Stage Renal Disease Networks: An Attempt through Federal
Regulations to Recognize Health Care Delivery." Medical Care 15, no. 7 (1977): 586598.
Beauchamp, Tom L., and Childress, James F. Principles of Biomedical Ethics. New York, NY:
Oxford University Press, 1994.
“Belding Scribner. 1921-2003.” Columns: The University of Washington Alumni Magazine.
Extras. www.washington.edu/alunmi/colums/sept03/extras_scribner.html (accessed June
1, 2008).
Bernardini, Judith. "Ethical Issues of Compliance/Adherance in the Treatment of Hypertension."
Advances in Chronic Kidney Disease 11, no. 2 (April 2004): 222-227.
171
Betancourt, J. B., J. E. Carrillo, and A. R. Green. "Hypertension in Multicultural and Minority
Populations: Linking Communication to Compliance." Current Hypertension Reports 1,
no. 6 (December 1999): 482-488.
Bohen, Fred, Interview by Edward Berkowitz. HCFA Oral History Interview Manhattan, New
York, (September 13, 1996)
http://www.cms.hhs.gov/History/Downloads/CMSOralHistoryBios.pdf (accessed
November 25, 2008).
Centers for Medicare and Medicaid Services. “Medicare Coverage of Kidney Dialysis and
Kidney Transplant Services.” http://www.medicare.gov/Publications/Pubs/pdf/10128.pdf
(accessed November 22, 2008).
—. “Special Collections.” www.cms.hhs.gov (accessed November 22, 2008).
Chmielewski, Christine. “Renal Anatomy and Overview of Nephron Function.” Nephrology
Nursing Journal 30, no. 2 (April 2003): 185-193.
Churchill, Larry. Self-Interest and Universal Health Care: Why Well Insured Individuals Should
Support Coverage for Everyone. Cambridge, MA: Harvard University Press, 1994.
Cohen, Wilbur. "Social Security and Family Stability." Annals of American Acadeny of Political
and Social Science 272, no. 1 (November 1950): 117-126.
Collins, Alan, Tricia Roberts, Wendy St. Peter, Chen Shu-Cheng, Jim Ebben, and Edward
Constantini. "United States Renal Data System Assesment of the Impact of the National
Kidney Foundation-Dialysis." American Journal of Kidney Disease 39, no. 2 (April
2002): 784-795.
Council on Governmental Relations. “The Bayh-Dole Act: A Guide to the Law and
Implementing Regulations.” http://www.cogr.edu/docs/Bayh_Dole.pdf (accessed
November 23, 2008).
Couser, William. "In Memorian: Belding H. Scribner, MD 1921-2003." Journal of American
Social Nephrology 14, no. 10 (2003): 2419-2420.
Daniels, Norman. Just Health Care: Studies in Philosophy and Health Policy. New York, NY:
Cambridge University Press, 1991.
Daniels, Rudolph. "Ligation and the American Dialysis Industry: Some Considerations about
Monopoly of Power in Renal Care." American Journal of Economics and Sociology 50,
no. 2 (July 2006): 223-242.
Davita Dialysis. “Political Advocacy and Chronic Kidney Disease.”
http://www.davita.com/dialysis/lifestyle/a/892 (accessed November 1, 2008).
172
Derickson, Alan. "Health Security for All? Social Unionsim and Universal Health Insurance,
1935-1956." Journal of American History 80, no. 4 (March 1994): 1333-1356.
Divine, Robert, T. H. Breen, George Fredrickson, and Hal R. Williams. America Past and
Present. Old Tappan, NJ: Educational Publishers, 2003.
Dobbin, Frank. "The Origins of Private Social Insurance: Public Policy and Fringe Benefits in
America, 1920-1950." American Journal of Sociology 97, no. 5 (March 1992): 14161450.
Eggers, Paul W. "Medicare's End-Stage Renal Disease Progam." Health Care Finacing Review
22, no, 1 (Fall 2000): 55-60.
Eggers, P. W. "Health Care Policies/Economics of the Geriatric Renal Population." American
Journal of Kidney Disease 16, no. 4 (October 1990): 384-391.
Epstein, Lenore, and James Callison. "Financing Health Care for the Aged." Law and
Contemporary Problems 27, no. 1 (Winter 1962): 113-140.
Finkelstein, Fredric, Dianne Wuerth, Laura Troidle, and Susan Finkelstein. "Depression in EndStage Renal Disease: A Theraputic Challenge." Kidney International 74, no. 7 (October
2008): 843-845.
Fox, Renee, and Judith Swazey. The Courage to Fail. Edison, NJ: Transaction Publishers, 2001.
Frankenfield, Dianne, Michael Rocco, Sheila Roman, and William McClellan. "Survival
Advantage for Adult Hispanic Hemodialysis Patients? Findings from the End-Stage
Renal Disease Clinical Performance Measures Project." Journal of American Society of
Nephrology 12, no. 1 (2006): 180-186.
Friedman, Eli. "End-Stage Renal Disease Therapy: An American Sucess Story." Journal of the
American Medical Assoication 275, no. 14 (April 1996): 1118-1122.
Friedman, Eli, and John Bower. "Physicians Share Experiences on the Medicare ESRD
Program." Renalife 17, no. 6 (May 2002). http://www.aakp.org/aakp-library/Physicians-on--Medicare-ESRD/ (accessed November 22, 2008).
Golper, Thomas. "Patient Education: Can It Maxamize the Sucess of Therapy." Nephrology
Dialysis Transplant 16, suppl. 7 (2001): 20-24.
Hall, Mark. Making Medical Spending Decisions. Oxford, UK: Oxford University Press, 1997.
Heinrichs, Waldo. Threshold of War: Franklin D. Roosevelt and American Entry into World War
II. Oxford, UK: Oxford University Press, 1990.
173
Hirsh, Joseph. "The Compulsory Health Insurance Movement in the United States." Social
Forces 18, no. 1 (October 1939): 102-114.
Home Dialysis Central. “Medicare FAQs.” http://www.homedialysis.org/pros/medicarefaq.php
(accessed November 23, 2008).
"Incidence of End-Stage Renal Disease among Persons with Diabetes—United States, 19902002." Journal of the Ameican Medical Assoication 294, no. 23 (December 21, 2005):
2962-2963.
“Invasive Methicillin-Resistant Staphylococcus aureus Infections among Dialysis Patients United States, 2005.” http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5609a3.htm
(accessed November 22, 2008).
Irving, David. “Churchill and U.S. Entry into World War II.” Journal of Historical Review 9, no.
3 (Fall 1989): 261-286.
Johnson, Lyndon B. “Annual Message to the Congress of the State of the Union. January 8,
1964.” http://www.presidency.ucsb.edu/medialist.php?presid=36 (accessed November
22, 2008).
Jonsen, Albert. The Birth of Bioethics. New York, NY: Oxford University Press, 1998.
—. "The God Squad and the Origins of Transplantation Ethics and Policy." Journal of Law,
Medicine and Ethics 35, Issue 2 (Summer 2007): 238-240.
Kaplan, Sherrie, Sheldon Greenfield, and John E. Ware, Jr. “Assessing the Effects of PhysicianPatient Interactions on the Outcomes of Chronic Disease.” Medical Care 27, suppl. 3
(March 1989): S110-S127.
Kennedy, John F. “News Conference 34.May 23, 1962.”
http://www.jfklibrary.org/Historical+Resources/Archives/Reference+Desk/Press+Confer
ences/003POF05Pressconference34_05231962.htm (accessed November 22, 2008).
—. "Special Message to the Congress in Health and Hosptial Care. February 9, 1961.”
www.presidency.ucsb.edu/ws/index.php?pid=8222 (accessed November 22, 2008).
"Key Milestones in Medicare and Medicaid History: Selected Years 1965-2003." Health Care
Financing Review 27, no. 2 (Winter 2005): 1-3.
"Kidney in a Suitcase." Time, January 5, 1976
http://www.time.com/time/magazine/article/0,9171,947623,00.html (accessed November
23, 2008).
174
Kieberd, Bryce. "The Chronic Kidney Disease Epidemic: Stepping Back and Looking Forward."
Journal of American Society of Nephrology 17, no. 11 (November 2006): 2967-2973.
Kieberd, Bryce, and Catherine Clase. "Cumulative Risk for Developing End-Stage Renal
Disease in the US Population." Journal of American Soceity of Nephrology 13, no. 6
(2002): 1635-1644.
Kilger, Alan. “How CKD Affects Your Body,” Kidney Beginnings: The Magazine 3 (June/July
2004)
http://www.aakp.org/aakp-library/how-ckd-affects-your-body/ (accessed November 7,
2008).
King, Karen, and Alvin Moss. "The Frequency and Significance of the ‘Difficult’ Patient: The
Nephrology Community's Perceptions." Advances in Chronic Kidney Disease 11, no. 2
(April 2004): 234-239.
Kolff, Willem. "Past, Present, and Future of Artificial Kidneys." Transplant Procedings 13, no. 1
suppl. 1 (March 1981): 35-40.
Kutner, Nancy, Rebecca Zhang, William McMlellan, and Steven Cole. "Psychosocial Predictors
of Noncompliance in Hemodialysis and Peritoneal Dialysis Patients." Nephrology
Dialysis Transplant 17, no. 1 (2002): 93-99.
Lammers, Stephen, and Allen Verhey, eds. On Moral Medicine: Theological Perspectives in
Medical Ethics. Grand Rapids, MI: William B. Eerdmans, 1998.
Lebacqz, Karen. Perspectives from Philosophical and Theological Ethics: Six Theories of
Justice. Minneapolis, MN: Augsburg Publishing House, 1986.
Levinsky, Norman. "The Organiztion of Medical Care-Lessons from the Medicare End-Stage
Renal Disease Program." New England Journal of Medicine 329, no. 19 (November 4,
1993): 1395-1399.
Levy, Andrew, Josef Coresh, Ethan Balk, Annamaria T. Kausz, Adeera Levin, Michael W.
Steffes, Ronald J. Hogg, Ronald D. Perrone, Joseph Lau, and Garabed Eknoyan.
“National Kidney Foundation Practice Guidelines for Chronic Kidney Disease:
Evaluation, Classification, and Stratification.” Annals of Internal Medicine 139, no. 2
(July 15, 2003):137-147.
Lichtenstein, Nelson. Labor's War at Home: The CIO in World War II. Philadelpha, PA: Temple
University Press, 2003.
Lockridge, Robert, Maureen Spencer, Viola Craft, Campbell Pipkin, Dolores McPhatter, Janette
Albert, Helen Anderson, Floyd Jennings, and Terry Barder. "Nocturnal Home
Hemodialysis in North America." Advances in Renal Replacement Therapy 8, Issue 4
175
(October 2001): 250-256.
http://www.lynchburgnephrology.com/index.php?pmenu=NHHD&info=/Articles/Advan
ces_in_Renal_Replacement_Therapy_October_01/Page_1.php&tmenu=left&p=
(accessed November 25, 2008).
Maioni, Antonia. Parting at a Crossroads: The Emergence of Health Insurance in the United
States and Canada. Princeton, NJ: Princeton University Press, 1998.
Marmor, Theodore. "The Politics of Health Insurance: Lessons for the Past?" Journal of
Interdisciplinary History 26, no. 4 (Spring 1996): 676-670.
Marshall, Allen. "Social Security at the Crossroads." Industrial and Labor Relations Review 14,
no. 1 (October 1960): 113-118.
May, William. Ethics in Medicine: Historical Perspectives and Contemporary Concerns. Edited
by Stanley Joel Reiser, Arthur J. Dyck, and William J. Curran. Cambridge, MA: MIT
Press, 1977.
Mayor, Susan. “Managing Parkinson's 'Wearing-Off' Symptoms - Part I.” Health and Age
http://www.healthandage.com/public/health-center/18/article/2897/Managing-ParkinsonWearing-Off-Symptoms-Part-I.html (accessed November 23, 2008).
Merrill, J. P. "Early Days of the Artificial Kidney and Transplantation." Transplant Procedings
13, no. 1, suppl. 1 (March 1981): 4-8.
Murray, Lorette. “Hemodialysis Pioneers Receive Prestigious Lasker Award.” Family Focus 11
no. 4 (Fall 2002): 8-9.
National Coaltion on Health Care. “Health Insurance Costs.”
http://www.nchc.org/facts/cost.shtml (accessed November 22, 2008).
National Kidney and Urologic Diseases Information Clearinghouse. “Your Kidneys and How
They Work.” http://kidney.niddk.nih.gov/kudiseases/pubs/yourkidneys/ (accessed
November 22, 2008).
—. “Treatment Methods for Kidney Failure: Hemodialysis.”
http://kidney.niddk.nih.gov/kudiseases/pubs/hemodialysis/ (accessed November 22,
2008).
—. “Treatment Methods for Kidney Failure: Peritoneal Dialysis.”
http://www.kidney.niddk.nih.gov/kudiseases/pubs/peritoneal/index.htm (accessed
November 22, 2008).
176
National Kidney Disease Education Program. “Kidney Disease Information.”
http://www.nkdep.nih.gov/patients/kidney_disease_information.htm#1 (accessed
November 22, 2008).
National Kidney Foundation. “National Kidney Foundation. Kidney Disease Outcomes Quality
Initiative: Annual Report 2005.” www.kdoqi.org (accessed November 23, 2008).
The National Kidney Foundation of Canada. “Hemodialysis.”
http://www.kidney.ca/page.asp?intNodeID=22130 (accessed November 22, 2008).
New York Times. "Choosing a ‘God Squad,’ When the Mind Has Faded."
http://www.nytimes.com/2006/08/29/health/29essa.html?_r=1&adxnnl=1&oref=slogin&
adxnnlx=1207448004-7i9XI16atKuPYhlKQ/JeHA (accessed November 23, 2008).
Nissenson, Allen, and Richard Fine. Clinical Dialysis. New York, NY: McGraw-Hill, 2005.
Nissenson, Allen, and Richard Rettig. "Medicare's End-Stage Renal Program: Current Status and
Future Prospects." Health Affaris 18, no. 1 (January/February 1999): 161-179.
Parkinson’s Disease Foundation. “Ten Frequently Asked Questions about Parkinson’s Disease.”
http://www.pdf.org/pdf/Fact%20Sheet_General%20PD%20Facts.pdf (accessed
November 23, 2008).
Paulson, Tom. "Belding Scribner Believed, To Be a Good Doctor, One Must Be a Good
Patient." Seattle Post, June 21, 2003.
http://seattlepi.nwsource.com/local/127718_scribner21.html (accessed November 23,
2008.
Phamasave. “Parkinson’s Disease.”
http://content.nhiondemand.com/psv/HC2.asp?objID=100241&cType=hc (accessed
November 23, 2008).
"Pioneers in Kidney Dialysis: From the Scribner Shunt and the Mini-II to the ‘One-Button
Machine’." http://www.washington.edu/research/pathbreakers/1960c.html (accessed
November 7, 2008).
Poen, Monte. "National Health Insurance." In The Harry S. Truman Encyclopedia, by Richard
Kirkendall, 251. Boston, MA: Hall, 1989.
“Proposed Rules.” Federal Register 70 no. 151 (August 8, 2005): 45763-45812
http://bulk.resource.org/gpo.gov/register/2005/2005_45796.pdf (accessed on November
22, 2008).
177
Public Papers of the Presidents of the United States: Lyndon B. Johnson. 1966.
http://www.lbjlib.utexas.edu/johnson/archives.hom/speeches.hom/650730.asp (accessed
November 23, 2008).
Ramsey, Paul. The Patient as Person: Explorations in Medical Ethics. New Haven, CT: Yale
University Press, 2002.
“Remarks with President Truman at the Signing in Independence of the Medicare Bill.” Public
Papers of the Presidents of the United States: Lyndon B. Johnson, 1965, Volume II, entry
394 (Washington, D.C.: Government Printing Office, 1966)
http://www.lbjlib.utexas.edu/johnson/archives.hom/speeches.hom/650730.asp (accessed
1, November 2008).
Rettig, Paul, Interview by Edward Berkowitz. HCFA Oral History Interview (August 14, 1995)
Washington, DC, http://www.cms.hhs.gov/History/Downloads/CMSOralHistoryBios.pdf
(accessed November 23, 2008).
Rettig, Richard. "The Social Contract and the Treatment of Permanent Kidney Failure." Journal
of the American Medical Assoication 275, no. 14 (April 10, 1996): 1123-1126.
Rettig, Richard, and Norman Levinsky. Kidney Failure and the Federal Government.
Washington DC : Institute of Medicare: National Academies of Press, 1991.
Roosevelt, Franklin D. "Address to Congress Requesting a Declaration of War on Japan."
December 8, 1941.
http://www.presidency.ucsb.edu/mediaplay.php?id=16053&admin=32 (accessed
November 27, 2008).
—. "Message of the President to Congress." June 8, 1934.
http://www.socialsecurity.gov/history/fdrstmts.html (accessed November 27, 2008).
—. "State of the Union Address." January 7, 1943.
http://www.presidency.ucsb.edu/ws/index.php?pid=16386 (accessed November 27,
2008).
—. "State of the Union Address." January 11, 1944.
http://www.teachingamericanhistory.org/library/index.asp?document=463 (accessed
November 27, 2008).
—. "State of the Union Address." January 6, 1945.
http://www.presidency.ucsb.edu/ws/index.php?pid=16595 (accessed November 27,
2008).
178
Rose, Denise, Glenda Harbert, Dick Goldman, and William Winslade. "The Law and Ethics of
Entitlement in End Stage Renal Disease." unpublished paper. Institute for the Medical
Humanites, The University of Texas Medical Branch at Galveston.
Schaeffer, Lenoard. Inteviewed by Edward Berkowitz. HCFA Oral History Interview (August
17, 1994). http://www.cms.hhs.gov/History/Downloads/CMSOralHistoryBios.pdf
(accessed November 23, 2008).
Schenken, Jerald, and James Carson. "Legislation and Regulation." Archives of Pathology and
Laboratory Medicine (December 1977): 1946-1996.
Scribner, Belding H. "Rationing Dialysis: The Early Years.” Seminars in Dialysis 13 no. 5
(December 2000): 339–339.
Smedley, Brian, Adrianne Stith, and Alan Nelson. Unequal Treatment: Confronting Racial and
Ethnic Disparities in Health Care. Washington, DC: National Academies Press, 2003.
Smetanka, Stella. "Who Will Protect the Disruptive Dialysis Patient.” American Journal of Law
and Medicne 32, no. 1 (January 2006): 53-91.
Social Security.“Social Security History.” http://www.ssa.gov/history/cornignappa.html
(accessed November 23, 2008).
—. “Social Security History: The Fourth Round.” www.ssa.gov/history/corningchap4.html
(accessed November 23, 2008).
—. “Special Collections.” www.ssa.gov/history/1950.html (accessed November 23, 2008).
—. “Special Collections.” www.ssa.gov/history/1960.html (accessed November 23, 2008).
"Squared Off." Time Magazine, June 1, 1962.
Truman, Harry. “Special Message to the Congress Recommending a Comprehensive Health
Program. November 19, 1945.”
http://www.trumanlibrary.org/publicpapers/index.php?pid=483&st=&st1= (accessed
November 23, 2008).
—. “This Day in Truman History November 19, 1945. President Truman Addresses Congress on
Proposed Health Program, Washington, D.C.”
http://www.trumanlibrary.org/anniversaries/healthprogram.htm (accessed November 23,
2008).
United States Renal Data System. “Annual Data Report, 2004.”
http://www.usrds.org/adr_2004.htm (accessed November 22, 2008).
179
—. “United States Renal Data System: Volume 2, Costs of ESRD.”
http://www.usrds.org/atlas.htm (accessed on November 22, 2008).
University of Washington. “UW Morns the Loss of Belding Scribner.” June 20, 2003.
http://www.washington.edu/newsroom/news/2003archive/06-03archive/k062003.html
(accessed June, 1 2007).
Veatch, Robert. The Physician Patient Relation: The Patient as Partner Part 2. Bloomington,
IN: Indiana University Press, 1991.
—. A Theory of Medial Ethics. New York, NY: Basic Books, 1977.
Weisse, Allen. Medical Odysseys: The Different and Sometimes Unexpected Pathways to
Twentieth-Century Medical Discoveries. Piscataway, NJ: Rutgers University Press, 1991.
The White House. “The HIV/AIDS Epidemic: 20 Years in the U.S.”
http://www.whitehouse.gov/onap/facts.html (accessed November 23, 2008).
Witte, Edwin. "1944-1945 Programs for Postwar Social Security and Medical Care." Review of
Economic Statistics 27, no. 4 (November 1945): 185-196.
—. "American Post-War Social Security Proposals." American Economic Review 33, no. 4
(December 1943): 825-838.
Ye, X. Q, W. Q. Chen, J. X. Lin, R. P. Wang, Z. H. Zhang, X. Yang, and X. Q. Yu, "Effect of
Social Support on Psychological-Stress-Induced Anxiety and Depressive Symptoms in
Patients Recieving Peritoneal Dialysis." Journal Psychosomatic Research 65, no. 2
(August 2008): 157-164.
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VITA
Amanda Walters Scarbrough
Amanda Walters Scarbrough was born on September 28, 1974 in Madison, Wisconsin
She is married to Charles Terry Scarbrough, Jr. and has three children: Sydney Leah, Carter
Timothy and Caroline Julia. Scarbrough was a lecturer at the University of Houston-Clear Lake
in the Department of Healthcare Administration from 2000-2007. She is currently an Assistant
Professor at Texas State University, in San Marcos, Texas in the Department of Healthcare
Administration.
Education
B.A., May 1996, DePauw University, Greencastle, Indiana
M.H.S.A, May 2000, The George Washington University, Washington D.C.
181