oxford handbook of bioethics

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Resource Allocation, Access, and Justice Considerations: Health Care Reform in the 1990s

Resource allocation is an ethical issue whenever there are insufficient resources to meet demand, whether for reasons of natural scarcity (such as in the case of solid organs) or created constraints (cost containment in closed systems). There are resource allocation issues throughout the delivery of health care, of course, at the level of paying for patient care, managing the health of populations, and for health care at the macro level. In addition, there are issues surrounding how to allocate specific kinds of resources, such as organs for transplant. This discussion will focus on health care reform and cost containment throughout the 1990s as a historical example of how public health issues have influenced bioethics.

When Faden and Kass (1991) surveyed the landscape of bioethics literature in the 1980s on resource allocation, they found an emphasis in two areas: (1) justice issues, framed as access to health care, including whether and to what extent moral rights or entitlements to health care services existed, and (2) utilitarian considerations, framed as rationing through cost containment. The health care reform efforts in the 1990s and related ethical debates are exemplified by the failure of President Clinton’s health care reform proposal.

Debates about the advantages of a single payer system and managed care dominated discussions about health care in the United States during the early part of the 1990s. President Clinton put forth a proposal for comprehensive reform of the US health care system in September 1993 whose centerpiece was referred to as managed competition. The primary objectives of Clinton’s Health Security Act were twofold: the provision of health services to all Americans and control of health care costs. There were at least four key initiatives designed to meet these objectives. First, a guarantee of a comprehensive package of benefits to all. Second, a requirement that all employers provide health insurance for their employees (employer mandate) with the opportunity for some premium cost sharing between the employer and employee. Third, government intervention and oversight through the creation of a National Health Board and regional health alliances. These bodies would, among other things, develop the uniform benefits package, contract with health plans, set premiums targets, payment schedules, and budgets (global budgeting), and provide information to consumers about their health insurance options. And fourth, coverage of costs through new taxes and on savings from reform (Cordone 1996 – 7).

The failure of Clinton’s health care reform initiative is well documented (Dougherty 1996; Johnson and Broder 1996; Morone and Belkin 1994; Skocpol 1997). Each of the components was controversial on many levels and supported or opposed by the numerous players involved in the health care system. In addition, the proposal lost public support as people began to feel threatened that their own health care was at risk, prompted in part by a series of advertisements produced by

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an advocacy group representing health insurers, the Health Insurance Association of America.

The White House Task Force on Health Care included a thirty-one-member ethics working group, known as Working Group 17. Nonetheless, an articulation of ethics concerns was not a central aspect of the Clinton proposal. Indeed, the ethics working group was appointed after all other working groups had already begun their work, and began meeting in March 1993, just six months before the Clinton administration issued their reform proposal.

Among the products delivered to the Task Force was a statement of proposed ethical values and principles of the new health care system. The ethics working group identified fourteen principles, divided into three main sections:

(1) caring for all, which included universal sharing of risk, financing based on ability to pay, and generations standing together; (2) making the system work, which included allocating wisely, treating effectively, ensuring quality, and managing efficiently; and (3) choice and responsibility, which included individual choice, personal responsibility, professional integrity, and fair procedures (Secundy 1994).

Daniels (1994) questioned the working group’s failure to connect their principles to broader notions or concepts of justice, equality, and community. Instead, the group chose to focus on shared principles that did not require consensus at the level of theory, given their own diversity of opinion and an acknowledgement that similar diversity exists among the American public. In the end, they took their task to be an effort to articulate a working basis for thinking about fairness in the context of health care reform (Daniels 1994).

Both during the time of the Task Force’s efforts and now in retrospect, some have speculated as to how much the inclusion of an ethics working group was for the purpose of substantive ethics consideration, and how much was to lend credibility to the process with the ‘seal of approval’ offered by ethics professionals (Englehardt 1994). While it would be wrong to suggest that their thinking was not reflected in the final product, it is unclear what sort of impact, if any, the working group’s conclusions had on the Task Force deliberations, its subsequent report, and the President’s ultimate proposal. Finally, the experience of Working Group 17 is instructive in a number of ways: (1) the recognition that health care policy carries ethical implications; and (2) that the role of bioethics in health care policy making has limits, in that it can help describe the contours of the ethics landscape in health care but not provide quick answers to issues (O’Connell 1994). Resolving difficult health policy issues requires contributions from a range of key constituents and areas of expertise, bioethics among them.

The failure of Clinton’s health care reform plan stimulated greater attention to the development of incremental approaches to health care reform. Discussions about the value of a single payer system continue to rumble below the surface (DeGrazia 1996; Woolhandler et al. 2003). Whatever changes emerge from ongoing and future

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incremental reform (Medicare Part D, physician pay-for-performance, consumerdriven health care) will bring a host of new ethical issues as the United States struggles to incorporate financial considerations and population-based thinking into the provision of individual health care in the quest for high quality, universal health care coverage coupled with cost containment.

Public Health Genomics

A revolution in new genetic technologies and an explosion of knowledge about genetics emerged in the 1990s and early 2000s. This included the massive undertaking and completion of the Human Genome Project (HGP) to chart the entire genome (NIH – NHGRI 2003; Pennisi 2003) and the initiation by an international consortium of the International HapMap Project designed to map genetic variation within the human genome (NIH – NHGRI 2002; Couzin 2002, 2005). With these advances and technological innovations that speed genomic analysis has come a corresponding interest in understanding how genomics can contribute to improving the public’s health through disease prevention and health promotion (Austin et al. 2000; Holtzman 1997; Holtzman and Andrews 1997; Khoury 1996, 1997, 2003; Omenn 1996; Schull and Hanis 1990; IOM 2005).

Public health genomics has been described as an ‘emerging field [that] assesses the impact of genes and their interaction with behavior, diet, and the environment on the population’s health’ (IOM 2005: 63). The field covers all the public health sciences, and the scope of activities encompassed within it is vast; e.g. population initiatives in genetic screening and testing, all aspects of research and derivative applications involving genetic epidemiology, pharmacogenetics, ecogenetics, banking and use of tissue samples, and many others. Each of these areas has to contend with traditional ethical tensions that arise in public health policy and practice discussed earlier. In addition, an ongoing debate has emerged in practice and policy as to whether the inherent nature of genetic information requires that it be treated differently and with a heightened level of scrutiny and protection in comparison to other health-related information (Rothstein 2005; Ross 2001; Lemmons and Austin 2001; Murray 1997; Annas et al. 1995).

Population-based genomic applications, like research and more individualized therapeutic applications, raise ethical issues of privacy and confidentiality, psychosocial risks, discrimination, and stigma (see e.g. Wolf 1995; Stone and Stewart 1996; Annas and Elias 1992; Macklin 1985; Kodish 1997; Holtzman and Watson 1998; Holtzman and Andrews 1997; Gostin 1995; Chadwick 1998; Caulfield 1995; Murphy and Lappe 1994; Campbell and Boyd 1996; APHA 1988; Annas 1995). The potentially high cost of new technologies has also raised classic public health issues of appropriate resource allocation, access by poor and underserved populations to scientific and clinical advancements, and related issues of social justice (see e.g. Buchanan et al. 2000; King 1992; Caplan 1994).

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Much has been written about the importance of addressing genetic privacy concerns and their attendant psychosocial risks to individuals and families (see e.g. Annas 1995; Gostin 1995; Holtzman 1997; Macklin 1985, 1992; Rothstein 1997; Billings 2005; Beskow et al. 2004). Genetic information by its nature may reveal the most basic and private information about inherited disease and susceptibilities about individuals and their families. In the public health context, the collection and use of genetic information in epidemiological efforts to assess disease incidence and prevalence, for example, is critical to our understanding of disease. At the same time, it raises the possibility that such personal information may be linked not only to individuals and families, but to groups or distinct populations, in ways that might embarrass or stigmatize them or even lead to potential employment or insurance discrimination.

Questions are being raised about how best to balance the potential health benefits of genetic information with the attendant privacy risks. For example, removing identifiers from data adds to the protection of individual privacy and confidentiality, but at the cost of losing useful public health information such as the ability to provide health services and follow cases. An alternative is to seek the informed consent of individuals for the collection and use of information about them, an approach that has run into unique challenges such as the unforeseen use of previously collected data and DNA samples (ASHG 1996; Clayton et al. 1995; McEwen and Reilly 1994; Sankar 1997).

The transition from individual applications of genetic testing to populationbased prevention programs involving genetic screening has raised additional ethical and practical considerations. Early challenges and experiences with government sponsored genetic screening programs date back to the 1960s and included problems with test accuracy, false positives, and misinterpretations and misuses of test results (see e.g. Markel 1997). Despite these problems, ultimately the public health benefits of early interventions offered by newborn screening programs in the United States were determined to outweigh some of the more traditional autonomy-based concerns arising in informed consent; the vast majority of state programs rely on an opt-out approach to parental consent (GAO 2003). Today tandem mass spectrometry technology allows rapid processing of genetic samples and therefore an ability to include greater numbers of genetic tests in screening panels, such as those used in newborn screening. Rather than rely on the market availability of genetic tests to determine the content of screening panels, many have concluded that decisions to include new tests require cautious consideration and oversight with specific attention to ethical, social, and clinical issues (NIH – DOE 1997; NIH – SACGT 2000; Burris and Gostin 1997; Cunningham 1997). Many of the considerations described in the frameworks developed by Childress et al. (2002) and Kass (2001), discussed earlier, are echoed in the discussions and criteria developed for adoption and expansion of genetic screening programs, e.g. the probability of population health enhancement, efficient and just uses of resources, resource availability, and

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public engagement (Burris and Gostin 1997; Chadwick 1998; Cogswell et al. 1999; Coughlin et al. 1999; Coughlin and Miller 1999; Cunningham 1997). Current issues in the area of newborn screening panels more specifically include the need for ‘evidence-based criteria to determine the disorders included in the newborn screening panel, the informed consent process and parent/provider education and assurance of systems of follow up for medical care after screening’ (Khoury 2003: 263).

Many ethical issues posed by genetics were highlighted in conjunction with the development of genetic technologies. In fact, a percentage of funding for the HGP (through the U.S. National Institutes of Health and Department of Energy) was earmarked at its initiation for study of its ethical, legal, and social implications (ELSI). The ELSI program has had a profound effect on the bioethics community’s research focus, with substantial resources devoted to research on ethics and genetics issues at both the individual and public health levels. Specifically in public health, the US Centers for Disease Control and Prevention (CDC) established the Office of Genomics and Disease Prevention. The CDC has drawn special attention to some of the ethical, legal, and social implications of public health genomics, such as informed consent issues arising in population-based research (Beskow et al. 2001). US regions and states have developed genetic service programs (e.g. state departments of health, the Council of Regional Networks for Genetic Services). In addition, US schools of public health, such as those at the universities of Washington, Michigan, and Pittsburgh, now have curricula designed to train future public health researchers and professionals in genetics, and each program includes attention to ethical considerations (Austin et al. 2000). This increased interest and attention has provided opportunities for collaboration, discussion, and understanding of the intersection of public health and genomics and its relevant ethical, legal, and social considerations.

Despite the potential benefits accruing from the emerging discipline of public health genomics, public health has had to overcome a history of distrust in this area. Some are wary of public health involvement in genetics, as the eugenics programs of the early twentieth century were motivated and justified by public health goals and principles (Pernick 1997; Proctor 1992; Paul 1994). Other contributing factors leading to the potential for suspicion of public health genetics include the negative and stigmatizing experiences of African Americans with public health screening for sickle cell disease, concerns about our understanding of the public health goal of ‘prevention’ in the age of prenatal screening and abortion, and stories of genetic engineering (Dula 1991, 1994; Gamble 1993; King 1992). This potential for distrust underscores the need to ensure that genetic information is used by public health authorities in a way that is ethically appropriate. Certainly, a challenge to public health in the future will be how to achieve the public health goals of identification and prevention of genetic diseases in populations while preventing the ethically

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unacceptable aspects of eugenics, the misuse of genetic information, and the unjust distribution of genetic resources.

Privacy and the Collection of Health Information

While collection of genetic information about populations is a growing concern for the future, collection of other health information about populations is ongoing and increasingly efficient as both states and health care payers use information about groups to guide a variety of health policies. Powerful epidemiological and statistical methods and their applications have been developed to yield important population data of increasingly better quality. The information has tremendous application in service of the public’s health, but its collection and use also raise ethical concerns and responsibilities. Access to information about populations is basic to epidemiological research, and larger and more detailed databases promise more and better information about the public’s health.

The collection of health-related information about individuals for public health purposes isn’t new — many states have registries for vaccinations, birth defects, and cancer cases, and all states collect and test blood samples from live births on Guthrie cards — and this information is often accessible to researchers with a legitimate interest in it (APHA 1996; Coughlin and Beauchamp 1996; McEwen and Reilly 1994). The public health community has rightly argued that the protection of personal information is not absolute, and should be balanced with the societal benefits to be gained by research access to personal data (APHA 1996; Bankowski et al. 1991; Chapman 1997; Coughlin and Beauchamp 1996; Gostin 1991; Gostin et al. 1996; Schindler 1994; Soskolne 1995).

But the classic tension between public benefit and individual privacy is growing in light of improved access to health information through technological innovations and computerization. The public’s fear about potential disclosure of health information reflects concerns about control of personal information and the potential for embarrassment, discrimination, and stigma (Gostin et al. 2001). Public concern over the protection of individual privacy has led to heated debate over health data collection efforts and to the restriction of the use of existing medical data (APHA 1996; Bankowski et al. 1991; Chapman 1997; Gold 1996; Gostin 1991; Gostin et al. 1996; National Research Council 1997; Soskolne 1995; Varmus and Satcher 1997). The reorganization of health care into a system where the majority of people are in some kind of managed care has created the ability to track outcomes for large populations. This creates the opportunity for beneficial epidemiological and outcomes research that may be unprecedented, but at the same time raises ethical concerns. State health departments and health care systems are working together to share information and create even larger and more powerful data sets, but adequate privacy protections may not exist in either setting (Chapman 1997; Coughlin and Beauchamp 1996; Gostin et al. 1996; Schindler 1994; Harman 2006).

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As privacy concerns and increasing access to better information lead to conflict in population-based research, the tension underscores an important point. The public health and bioethics communities have an opportunity to participate in the debate over privacy and access to health information, and to inform the debate about how to balance the importance and value of data collection and research on groups (important community and utilitarian values) with the important value of individual privacy. Education of the public is crucial and necessary, so as not to undermine the already fragile trust in the government’s access to and use of private information about us. Recognition of these issues is leading to new policy initiatives, including restrictions on the use of health information and assurances to individuals of the use, privacy, and security of personal health information (Gostin et al. 2001; Harman 2006).

CONCLUSION

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We hope to have shown that bioethics and public health is a growing area of scholarship, and an area whose impact will be seen as debate continues about the many public health issues that have ethical dimensions. These efforts will become increasingly relevant as ethics training becomes integrated into the education of public health professionals pursuant to recent Institute of Medicine recommendations identifying ethics as a core component of public health professional education (IOM 2003: 2). Bioethics education, scholarship, and research have all been affected by public health and the growing attention it demands. Bioethics’ traditional focus on issues of medicine and biomedical research have understandably led to an emphasis on the importance of respecting individuals and their rights. But this emphasis is challenged by the pressing group interests and population issues faced in public health, with its very real ethical challenges. Bioethics must help address the very real tensions in public health between individual rights and the importance of protecting populations and their interests. Strongly held principles can and do conflict — autonomy versus utility versus justice, and so on. The ethical challenges posed by public health are only likely to increase, as public health programs receive increasing attention in the post-9/11 world. ‘Pandemic response programs’, ‘bioterrorism preparedness’, and the like are terms that would have been uttered only as science fiction a few short years ago, but are now with us to stay. Public health issues have assumed a new role in our lives, and bioethics has a role to play in informing how that role takes shape.

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