Kathy A. Marquis and Bette A. Ide
With the passage of Medicaid and Medicare legislation in the 1960s, quality-assurance systems received a focus of attention in the health care delivery system that had never before existed. Initially, quality-assurance activities were concentrated in hospitals, but they have now expanded into ambulatory care, primary care, long-term-care settings, and community and public health care programs. Even in the present period of debate regarding health care reform, every health care initiative, no matter how diverse, contains explicit commitments to quality care in some form.
In the 1970s, major right-to-die cases such as Quinlan and Saikewicz (Superintendent of Belchertown State Sch. v. Saikewicz, 370 N.E. 2nd 417 [Mass. 1977] and In re Quinlan, 355 A. 2nd 647 [N.J. 1976]) were decided. Since then, ethical debate and analysis have become commonplace in the health care delivery system, though ethical decision-making systems are not fully integrated into it. While ethics has always been an acknowledged and essential component of professional practice, the impact of medical technology and the sociopolitical evolution since World War II have resulted in an increasing awareness that ethical questions and issues arising in the health care environs extend far beyond a ''professional'' code of ethics and touch each individual within society and society as a whole. Organ transplantation, the use of fetal tissue for research and treatment, abortion, assisted suicide, genetic manipulation, and health care rationing are just a few of the issues confronting the health care delivery system. What is not always evident is that quality assurance and ethics are irrevocably interrelated and interdependent, conceptually and practically, when they are applied to the health care delivery system. The major purpose of this discussion is to demonstrate (1) the fundamental and indivisible relationship between qual ity assurance and ethics at both the national and clinical levels and (2) the significance and impact of this relationship upon the health and welfare of the elderly.
Historically, quality-assurance issues and decisions focused primarily upon clinical practice questions and dilemmas arising from individual patient and family interactions and/or upon the quality-assurance systems utilized within various health care institutions and agencies. The prototypic quality-assurance model developed by early leaders such as Donnabedian (1989) addressed three parameters: structure, process, and outcome. The model viewed the health care system as three subsystems consisting of (a) the client/patient; (b) the provider, which included not only the physician but health care organizations with their respective facilities, procedures, and skills; and (c) the environment, which included the social, genetic, physical, and psychological factors impacting health care interactions. In the model, the provider system was identified as the structure; process referred to the interaction of the patient/client with the provider; and outcome focused on what happened to the client as a result of the interaction of the three subsystems.
Initial quality-assurance efforts concentrated upon structure and process. Methods employed to measure structure included (and still include) licensing, credentialing, continuing education, accreditation, and like approaches to assure the continuing qualification of providers. Tools used to measure process include medical-record audits, peer review, and utilization review. Medical malpractice is also viewed by the legal profession as a quality-assurance tool for structure and process because it arguably acts as a deterrent to substandard practice. Today the dominant focus of quality-assurance efforts is outcome, even though systems approaches such as continuous quality improvement and total quality improvement intend to address all three parameters.
The focus upon outcome has, in great part, been stimulated by the continuous exponential increases in health care costs. Health care costs have increased at double-digit rates since the mid-1960s. In 1960, only 5.3% of the gross domestic product (GDP) was spent on health care. By the 1980s, that figure had increased to more than 12%. Projections indicate that by the year 2000, at least 19% of the GDP, more than $1.6 trillion per year, will go to health care. To put that cost into perspective, consider that the average family of four could be spending $30,000 per year for medical care, more than for food, clothing, transportation, and housing combined (Kassler, 1994). Some statistics indicate that we have already reached a level of $1 trillion per year, twice as much as in almost all other comparable nations (Kalb, 1996; Reinhardt, 1994; Sage, Hastings, & Ber-enson, 1994). Why? As is always true, there is no single answer.
For at least 20 years, much of the public, as well as physicians, hospitals, and insurance companies, has indicted the legal tort system and costly medical malpractice actions. The so-called medical malpractice crisis was precipitated, in this view, by ever-increasing medical liability insurance premiums. The rising premiums were, in turn, caused by outrageous and egregious compensation for injuries resulting from specious claims of negligent medical care. As is so often the case, the truth lies somewhere in between.
As recently as 1991, medical liability costs accounted for only 1% of health care expenditures (Billings et al., 1990; Sage et al., 1994). According to the Harvard Medical Practice Study, a full 1% of all hospital admissions actually do result in injuries caused by negligent medical care. In actuality, only 1 in 8 such incidences give rise to a medical malpractice claim, and of those only 1 in 16 receive any compensation. Unfortunately, of the suits that are filed, only 1 in 6 are based on persuasive evidence of actual negligence (Sage et al., 1994). In other words, there really are cases of injury that are not being compensated, but of the cases that are being compensated, many are not valid. Nonetheless, because of the practice of ''defensive medicine,'' the calls for legal tort reform continue.
Defensive medicine is the performance of tests and procedures that would not otherwise be performed but for the fear of litigation. While it is not possible to accurately measure the cost of defensive medicine, estimates of savings from malpractice reform range between $25 billion and $75 billion in a five-year period (Reinhardt, 1994). Even assuming that these figures are accurate, medical malpractice costs would amount to less than 3% of the overall health care costs per year. Further, the reasons for the use of unnecessary tests and procedures are far more complex than ''defensive medicine'' alone.
Industry waste and fraud have also received significant attention as major causes of escalating health care costs. The General Accounting Office estimates an annual cost of $80 billion per year, or 10% of health care spending (Sage et al., 1994). But it is medical technology that is the overwhelming trigger of ever-increasing health care costs.
Medical technology accounts for as much as 50% of all health care-sector inflation. At least half of the increased hospital costs is due to an increase in the intensity of medical services that are required by the technological changes (Kalb, 1996). In fact, medical services account for nearly one-third of the rise in all health care costs. In 1992 alone, health care employment figures topped 10 million, an increase of 43% in just four years. That total does not include those working in the insurance, pharmaceutical, or medical equipment and supply industries. In other words, one-seventh of the nation's economy was linked to health care (Kassler, 1994).
But what is most alarming is that the Office of Technology Assessment estimates that less than 20% of all present medical services and procedures have ever been shown to have any positive impact on patient outcomes (Billings et al., 1990; Jost, 1989; Kalb, 1996; Mariner, 1995). The growing recognition and acceptance of this fact, both within and outside the health care delivery system, coupled with the cost issues, have resulted in growing support for the development and use of clinical practice guidelines and outcomes research.
Clinical practice guidelines are defined by the Institute of Medicine as ''sys-
tematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances'' (National Health Lawyers Association [NHLA], 1995, p. 4). The primary focus of clinical practice guidelines is to enhance the quality, appropriateness, and effectiveness of health care and to facilitate the adoption of treatment approaches that are not only medically effective but also cost efficient (NHLA, 1995). Although clinical practice guidelines have been available to some extent for years, it has only been in the past decade that prestigious medical groups such as the American College of Obstetricians and Gynecologists, the College of Surgeons, and others have both supported them and become intimately involved in their development.
In 1989, the Agency for Health Care Policy and Research (AHCPR) was officially established with the mandate to develop broad-based studies directed toward improving the organization, financing, and delivery of health care. Established within the AHCPR was the Office of the Forum for Quality and Effectiveness in Health Care. Through the forum the AHCPR is responsible for facilitating the development, review, and updating of (1) clinically relevant guidelines to assist the health care provider in the prevention, diagnosis, treatment, and management of clinical conditions and (2) standards of quality, performance measures, and medical review criteria through which health care providers and other appropriate entities are assessed in order to assure the provision of quality health care (NHLA, 1995).
Because the goal of clinical practice guidelines is to promote treatment approaches that have the most effective outcomes, the guidelines are becoming core considerations for many quality-assurance programs in spite of concerns about ''cookbook medicine'' and the potential for rigid legalization of guidelines as standards of care. Physicians and other health care providers vary significantly in (1) the use of tests to make diagnoses; (2) the choice of treatment or management approaches such as watchful waiting versus medical or surgical intervention; (3) the decision to admit to the hospital; (4) resources available in each setting; and (5) timing of hospital discharge. The reasons for these variances range from simple disagreement to uncertainty as to the best way to proceed (Billings et al., 1990). This marked degree of variance is one reason why clinical practice guidelines and outcomes research will remain essential components of future quality-assurance efforts.
Though the present commitment to clinical practice guidelines and outcomes research is definitely a constructive step in the quest for improved quality of care, it is still but a piece of the quality puzzle. While outcomes research should eventually help in more appropriate use and adoption of medical technology, costly new technology continues to be introduced and adopted with little or no demonstrable evidence of its actual effectiveness. Further, the question of whether a given technology should be developed initially is not even being raised. Even the developing science of technology assessment, which addresses questions of technology efficacy and value, does so only after the technology is on the market, not prior to its development (ten Have, 1995).
Further, while clinical practice guidelines may assist in greater consistency of care, most efforts are directed toward the cure and/or treatment of medical illnesses or diseases, while minimal study is directed toward preventive efforts. The major diseases that confront the health care system today arise from social circumstances and lifestyle choices upon which present medical intervention strategies have little overall impact, at least regarding occurrence. Major chronic illnesses such as coronary artery disease, hypertension, and even some cancers are strongly correlated to lack of exercise, inadequate nutrition, smoking, and alcohol. No less challenging and resistive to medical intervention strategies are the morbidity and mortality associated with illicit drug usage, AIDS, motor-vehicle accidents, domestic violence, homelessness, homicide, suicide, and environmental toxins, known and unknown.
Quality-of-care questions also relate to issues of availability and accessibility. What care shall be provided to whom? Who decides? What can our society afford not only regarding money per se, but also the use and direction of resources? Unfortunately, while there is little disagreement regarding the need for quality in health care, ''the debate on how it is to be measured has increased inversely with the decline in resources to support health care in the United States. As those resources have become scarce, conflicts have arisen in the health care system between responsible provision of service to all and the highest quality of care for selected populations'' (A. G. Taylor & Haussmann, 1988, p. 84). Integral to this debate, whether it is addressing strictly clinical concerns or resource allocation on a national level, are the implicit and explicit value systems held by individual participants in the health care system and society as a whole. In fact, the very definition of quality is dependent upon, and is and will be derived from, these value systems.
As noted previously, the imperative for health care reform is being driven by a national concern for the exorbitant cost of just maintaining our health care system as it is. Besides the costs already discussed, major expenditures arise from publicly funded health care programs. Medicare and Medicaid cost approximately 15 cents for every tax dollar. Of the money spent on health care, it is estimated that eight times more is spent on those over the age of 65 than on the average citizen (Lamm, 1989). In fact, approximately one-third of the federal budget goes to programs to aid the elderly (Moody, 1992, p. 3). Some estimate that by the year 2050, 20% to 25% of the population will be over the age of 65, and as early as the year 2020, 1.7 million elderly over the age of 65 will eventually enter a skilled nursing facility (SNF) (Murtaugh, Kemper, & Spillman, 1990). Thus the impact of the care of the elderly population upon future health care costs cannot be overestimated. However, this distribution of resources to the elderly should not be viewed simply as a function of an aging society with its associated array of medical problems. It should also be recognized as a symptom of our unfettered advocacy for medical technology.
Consider the following data: Of insured persons, 75% of households accounted for 30% of total health spending, and another 5% for 38%, but 72%
accounted for only 9%. Roughly 6% of households absorb almost 70% of all health care spending. The increase in the degree of concentration of health care spending in fewer and fewer households is due, at least in part, to medicine's increasing willingness and ability to address catastrophic illnesses with bold but very expensive medical interventions whether in the young or old (Reinhardt, 1994, pp. 107-108). In view of these data, there is little doubt that allocation decisions are going to have to be made regarding the continued utilization of resources or technology, which benefits, in reality, fewer and fewer people.
One of the first issues, and perhaps the most fundamental one, to be addressed is whether or how resources will be distributed to the benefit of the individual versus society as a whole or vice versa. A certain tension has always existed between these two perspectives, primarily because of the strongly held ethic in American society respecting individual autonomy. In fact, the very predominance of medical technology is logically consistent with this ethic and the consequent value placed upon the life of each individual. Yet the values of individual autonomy and the sanctity of each life have themselves become antagonists because of the technological ability to maintain physical life even when this is contrary to the autonomous desires of given individuals.
A survey in 1995 reported that 47.8% of physicians were unwilling to withdraw life support from comatose or critically ill patients or remained neutral about it even when such action reflected the wishes of the patient and family (Asch & Christakis, 1995). Other statistics indicate that 40% to 70% of patients do not die until after do-not-resuscitate orders are written. This results not only in prolonged suffering for patient and family, but in expenditures greater than $2.5 billion per year (Mondragon, 1987, p. 441). Even with the U.S. Supreme Court decision in Cruzan v. Director (1990), which upheld the validity of refusing life-sustaining treatment, the varying ethical beliefs of providers and patients and continuing concerns regarding liability dominate end-of-life decisions.
Concern on the part of providers regarding the law is somewhat warranted by confusing messages generated recently in a few court decisions involving medical futility cases. For example, in 1991, 85-year-old Helga Wanglie was in a persistent vegetative state, unable to breathe or eat on her own. The family was informed that continued aggressive therapy would be of no medical benefit and should be discontinued. The husband disagreed, and eventually the hospital filed for the appointment of a conservator. The reason for the filing was to have a neutral person appointed so treatment could be stopped. The court appointed the husband and bypassed addressing the real issue in the case (In re Wanglie, 1991).
To date, in every known case where a provider has sought court approval for discontinuing treatment that offered no benefit, the courts have found for not discontinuing the treatment (Daar, 1995, p. 223). Though these decisions seem contrary to the intent of cases such as those of Cruzan and Quinlan, the consistency is that the courts are most likely to view all end-of-life decisions first from the apparent perspective of the patient and then the family, but not the provider. Arguably, such questionable ethical and legal decision making by the courts is also generating to some degree increased costs and human suffering. The reality, however, is that these legal cases are few, and providers do make such decisions daily, generally unhampered by legal intervention, with and without patient and family input, under the aegis of medical decision-making prerogatives. It is equally important to note that these decisions are, in effect, resource-allocation or rationing decisions; they are not confined to end-of-life scenarios.
Each day, again with or without full patient and family input, physicians decide who will receive an organ transplant, coronary angiography, end-stage renal dialysis (ESRD), or cardiopulmonary resuscitation. Though it is true that third-party administrators (TPAs) and other designated reimbursement administrators are having increased input into such decisions, the physician remains the primary allocator. Estimates indicate that almost 75% of such decisions are in the hands of the individual physician (Ficarra, 1989, p. 208).
To many, such decision making by physicians is a logical consequence and responsibility because they are the persons with the needed knowledge base to make these very decisions. But studies clearly demonstrate that a significant percentage of so-called medical decisions are based not on medical data, but on idiosyncratic behavior such as geographic location; personal or professional value systems regarding individual autonomy, professional autonomy, or cultural, racial, or gender biases; and/or beliefs or convictions about age or ability to pay. Note the following findings:
1. Since the 1970s the number of cesarean sections (C-sections) performed has increased 5.5% to 22% of all births. While the medical reasons for this are not evident, it has been noted that significantly more C-sections were performed in hospitals with higher malpractice insurance premiums and with larger numbers of malpractice claims filed against the hospital or physicians on staff (Localio, Lawthers, & Bengtson, 1993). Another study found that repeat C-sections were more likely to occur in for-profit hospitals (Stafford, 1991).
2. Some surgeons use management strategies for coronary artery bypass graft (CABG) procedures that impact costs far more than outcomes with no apparent medical rationale (L. R. Smith, et al., 1994).
3. A mother's race, early use of prenatal care, and insurance status may influence the likelihood that her very low birthweight (VLBW) infant will have access to neonatal care (Goldenberg, Bronstein, & Haywood, 1995).
4. Minority preschoolers, blacks and Hispanics, receive lower-quality overall asthma care than white children. While emergency-room treatment and hospital length of stay are essentially equivalent, nonwhites are less likely to be prescribed nebulizers for home use and are less likely to have taken inhaled steroids or cromolyn sodium (Finkelstein, 1995).
5. Coronary angiography and aggressive intervention strategies are employed far more often for men than for women (Gatsonis, Epstein, & McNeil, 1995).
6. When end-stage renal dialysis was originally implemented, few individuals over the age of 65 were considered candidates because of the decreased potential for positive outcomes. Presently over 42% of new ESRD users are the elderly, but without any substantive data that outcome has improved (Moss, 1994). It is also probable that once reimbursement was approved, there was an increased willingness to provide the technology to the elderly.
Another observation frequently made is that widely heralded new technologies that will supposedly save money by decreasing long, costly hospital stays actually increase overall costs. When coronary angioplasty was developed in the 1970s, the incidence of open-heart surgery was to have decreased. Instead, angioplasties increased from 26,000 in 1983 to 227,000 in 1988, and the number of bypasses increased from 191,000 in 1983 to 500,000 in 1993 (Kassler, 1994, p. 9). While the increasing number of aged and repeat surgeries can account for some of this escalation, the fact that internists do angioplasties and surgeons do bypasses is as probable a cause. Simply, each group chooses the approach with which it is most familiar. In any instance, the significant fact is that decisions are being made to a substantive degree based on other factors than objective medical rationales.
Another important consideration in analyzing these situations is that many decisions simply are not medical. If five people of varying ages are all ''medically'' qualified to receive a heart transplant, the decision concerning who receives it is no longer a medical question. Rather, it becomes a societal issue of how such decisions should be made, and who shall have what kind and amount of input. This question necessarily reflects back to the previously raised issue of the public good versus individual rights.
Richard Lamm noted in his speech ''The Brave New World of Health Care'' (1989) that ''the sum total of all ethical medicine as currently defined is... unethical public policy... .Doctors consider a patient's health, but a society must consider the total health of its citizens.'' In other words, society has a responsibility to at least attempt to define or reach consensus on a set of principles or ethical guidelines by which resources can be equitably allocated. One of the major results of such guidelines is that quality-of-care parameters will be more easily defined and very likely significantly redefined from what they are today.
Because of the role that behavior plays in the occurrence of many of today's health problems, it has been suggested that many of these so-called health problems be demedicalized (B. Jennings, 1986). For example, illicit drug use, alcoholism, domestic violence, motor-vehicle accidents, and homicide are ills arising from and impacting upon the whole of society and not just the health care system. Demedicalization is intended to foster a multifaceted and integrated strategy for solving the given problem by utilizing and incorporating other rel evant systems such as criminal justice, social rehabilitation, education, and/or employment. If such demedicalization occurred, outcome measurements for health would be established that specifically addressed only those activities and results for which the system could reasonably be responsible. For example, safe detoxification and/or supervised withdrawal for the chemically dependent could be one valid outcome measure.
If national ethical guidelines directed more resources toward the health of society generally, emphasis would be placed upon prevention, or at least mitigation, of commonly occurring sources of health care problems. However, a public health emphasis will frequently impinge, to some degree, upon individual rights. Historically, public health measures have included quarantine, mandated immunizations, and required reporting of certain communicable diseases. More recent examples include seat-belt laws, motorcycle-helmet laws, and prohibition of smoking in public places. Outcome measurements for these interventions should include epidemiologic data of prevalence and morbidity and mortality statistics as well as cost-benefit analysis from a societal perspective. Health care resources would be directed toward the educational programs and enforcement activities required to carry out the selected prevention programs. But two important ethical questions arise. How far do we want to go in regulating individual behavior? Again, whose or what ethical and moral values would dictate what these behaviors should be?
In addition to the redirection of resources toward prevention, decisions from a public perspective also mean answering questions about who gets the resources that are directed toward the well-being of the individual. If a service or procedure is ''not clinically indicated,'' does this mean that the patient will not benefit from it or that limited resources should not be used for this person? Arguably there is no group for whom the answers have greater import than the elderly.
In a 1993 survey conducted by the Wirthlin Group for Mercy Healthcare Arizona, the general public slightly favored health care reform that emphasized the rights of the individual but really indicated a desire to have it all. The public wants quality, cost efficiency, availability, and protection for society as a whole. Physicians and insurers also preferred a system likely to emphasize individual rights, but administrators and ethicists were more likely to favor a system that promoted the good of society as a whole (''Public Professionals,'' 1993, p. 155).
The public and physicians agreed that it was ethically acceptable to put a cap on health care spending and to consider a patient's age, likelihood of survival, and the cost in deciding whether to withhold or give treatment options. All groups agreed that it was not appropriate to base decisions upon a person's expected contribution to society. Interestingly, none of the groups thought that rationing was appropriate even though both cost and age considerations are arguably rationing precepts. Perhaps it is the public's very perception of quality of health care that provokes this apparent contradiction.
For the past 50 years, quality medical care has been marketed as synonymous with sophisticated medical technology. The concept of rationing may provoke a sense of potential abandonment of these ''lifegiving'' technologies by passage of broad-stroked legislation. Specifically enumerated and limited allocation actions would thus be more palatable. In any instance, age, whether implicitly or explicitly acknowledged, is going to be, and already is, a primary consideration regarding health care reform nationally and the appropriate utilization of resources clinically.
The cost of care of the elderly is undisputed, as is the probability that these costs can only escalate if the health care system remains unchanged. More and more one reads or hears the growing fears that such costs are robbing our children of their future opportunities at life. Questions are also raised about the legitimacy of providing limited resources to an individual with short-life-span probabilities. But, as Daniel Callahan (1994) observes, there is no assurance that monies saved will be redirected for other health care and thus no reason to exempt any person from any treatment that may be of benefit. In other words, until there is a system that assures that the withholding of benefits for one person will result in an equitable distribution to others, there is no reason to limit anyone.
Related to these concerns are discussions about issues such as the ethics of advance directives, assisted suicide, euthanasia, ''benign neglect,'' ''slow codes,'' and appropriateness of specific treatment decisions in the context of caring for the aged. For example, how valid are advance directives obtained at the point of entry into an acute-care or skilled nursing facility when significant stress is present? If life is valued for itself, can age or functional capacity be valid considerations in end-of-life decisions? If quality of life is the guiding ethical principle, what guidelines and processes should be put in place to protect judgments of quality as defined by the person's culture, religion, or life choices?
Clearly, profound ethical questions and dilemmas exist within the health care delivery system in both national and clinical contexts that actually and potentially affect the health status of each member of society. Clearly, decisions about these dilemmas are being made daily, albeit often by no action or default rather than by thoughtfulness and discourse. Many of the individuals who are affected by these decisions are not aware that they are being made.
Over 20 years ago, Paul Ramsey insightfully predicted the ethical dilemmas underlying the political impasse that today has halted any real health care reform:
If there are moral dilemmas in modern medicine; if, as some would say, there is a moral crisis in the medical profession, this does not result from recent triumphs in medical research or the great promise and grave risks stemming from medical technology. The fundamental reason is the continuing moral crisis in modern culture. ... It can no longer be assumed . . . that we are agreed on moral action guides, the practice of virtue, the premises and principles of the highest, most humane, most bracing ethics, or what a moral agent owes to anyone who bears a human countenance. (1973)
As O'Connell noted more recently, the present health care debate is symptomatic of our culturally diverse society and its increasing polarization of ideologies. ''It should be no surprise then that politicians are incapable of crafting legislation on health care reform'' (1994, p. 1).
Polarization of ideologies is not only the major obstacle to health care reform nationally, but, as has been noted, is also a significant reason for much of the diversity and inconsistency that exists at the clinical level. As long as the goals of health care remain ill defined both nationally and clinically, quality-of-care decisions will remain subject to health care delivery system nuances and lack of mutuality between providers and patients. The issue now is not whether there will be discussion, but the degree of depth, scope, reflection, and openness and the direction it will take.
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