National Issues in Science and Technology 1993 (1993)

NATIONAL ACADEMY OF SCIENCES

INSTITUTE OF MEDICINE

A White Paper from the

NATIONAL ACADEMY OF SCIENCES

NATIONAL ACADEMY OF ENGINEERING

INSTITUTE OF MEDICINE

February 1993

We commend your commitment to health care reform, an endeavor that poses significant challenges and opportunities to us all in the months ahead. Constraining the rapid escalation of health care costs while extending health insurance coverage to all, the primary objectives of reform, will require significant improvements in the performance of our system for health care, especially since some of the factors increasing health care expenditures, such as the aging of the population, are external to the health care system and will continue. We believe that achieving effective change must include concrete steps to assure: that services are appropriate and effective, that universal access is actually accomplished, that resources are used efficiently to realize improvements in health status, that health care professionals are trained and deployed appropriately, and that better information is marshalled to improve performance. We also believe that performance improvements should be measured by advances in the health and well-being of Americans in addition to relief of the economic burden.

Based on work that this organization has done on many health care issues, we believe that improved performance will call for:

• strengthening our capability to measure and continuously improve the quality of care;

• enhancing value in health care through better information about people's health status, the outcomes and effectiveness of medical care, and the application of that information in the development and use of clinical practice guidelines;

• addressing the special health needs of pregnant women and children, the frail elderly, people with AIDS, individuals with severe mental disorders, and of the poor, minorities, and other special populations that are unlikely to be met adequately through health insurance coverage alone;

• restructuring the health care system to place more emphasis on primary care and less on the use of specialized services;

• reducing the incentives for some payers to achieve cost savings by avoiding those with higher health risks; and

• providing the information and knowledge that are essential if we are to improve access, quality, and health status while restraining cost increases.

The Institute of Medicine (IOM) has produced several reports that address these objectives and contain specific, detailed recommendations, based on the careful deliberations of committees of distinguished experts. (A list of the reports relevant to health care reform is appended to this paper.) In this paper, we highlight how the recommendations in these reports can help health care reform achieve greater impact on health status and greater efficiency in the use of resources devoted to health care, with special attention to four main topics:

• quality assessment and improvement;

• the value of health care;

• special populations: children and pregnant women; and

• health care data and information.

These four topics, together with universal access and cost containment, are not the only objectives that a health care reform package ought to embrace. Indeed, a parallel commitment to health promotion and disease prevention will be essential for improving the health and well-being of all Americans, and for some health problems will be more important than health and health care reform per se. In fact, the IOM has examined many other relevant topics over the years, including matters relating to the future of public health (IOM, 1988) and the nation's health goals for the year 2000 (TOM, 1990e). In our judgment, however, the four issues just listed will prove crucial to the ultimate success of health care reform.

A sound reform proposal should be able to assure the American people that control of the costs of health care is not being achieved through unintended reductions in the quality of those services. Many of the findings and recommendations in Medicare: A Strategy for QualityAssurance (IOM, 1990g) can be applied directly to a health care reform proposal that covers the entire population. We recommend that you include in your reform proposal the following three provisions concerning quality of care, which are derived from that report.

Your health care reform proposal should make quality of care an explicitobjective, based on a comprehensive definition of quality. Quality assurance cannot be an afterthought in the design and implementation of health care reform. To make sure that quality assurance and improvement are integral parts of the reform effort, quality needs to be an explicit objective in the statutes that authorize reform and in the regulations that implement those statutes. Any statement of this objective needs to proceed from a comprehensive definition of quality, such as that from our 1990 report: ''Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.''

The main emphases in this definition—on individual patients and populations, on health outcomes broadly defined, and on professional responsibility—are significant and support a commitment to private care and personal choice. An explicit reform objective incorporating this definition will underscore that cost containment and extension of health insurance coverage are not the only measures of success in your program. Developing a quality assurance venture based on this definition will require:

• adopting a broad set of outcome measures, including health-related quality of life and patient satisfaction, as well as the more conventional measures such as mortality;

• giving specific attention to lack of necessary and appropriate services as well as to inappropriate use of services and poor technical or interpersonal care; and

• basing the program on the best scientific knowledge about outcomes and effectiveness and the links between processes and outcomes of care.

Consistent with that provision, your proposal should also adopt specificquality assurance goals. An effective reform program should be willing to be held accountable for:

• continuously improving the health of the population;

• enhancing the capabilities of health care organizations and clinicians of all kinds to improve performance for everyone, not just the "bad apples"; and

• identifying and overcoming system and policy barriers to improved performance.

These goals are consistent with the principles of continuous quality improvement and total quality management that have been successful in improving performance in the industrial and manufacturing sectors. In those arenas, applying these quality improvement techniques can lead to greater efficiencies in production and performance. Improving efficiency is, in our view, a significant step toward addressing the unfairness of our present health care system; making quality of care one of the core principles of your health care reform package thus promises to support the other critical aims of reform.

Achieving these goals will require an effective quality oversight and monitoring capability that is external to health care provider organizations; it will also call for better internal capacities for providers to continuously improve the quality of the care they render. The IOM report on Medicare quality assurance offers 15 attributes on which such efforts can be based and later judged, and the strategy for accomplishing all these ends applies directly to the broader environment of health care reform. It argues for:

• a strong emphasis on patient outcomes and individual well-being;

• appropriate measurement of the processes of care;

• consideration of the continuity of quality assessment across all settings in which health care is given, which we regard as particularly important when so many services are moving outside traditional institutional settings; and

• expanded efforts to collect, analyze, and feed back information on quality of care and performance to health care providers and consumers.

Finally, your reform plan should provide for investment in the researchand data necessary for quality assurance. The above goals will not be attained unless support is given now to the development of essential knowledge and information about the effectiveness and appropriateness of health care and about the effectiveness of techniques to measure and improve quality. Although much has been learned about these issues in recent years, much more needs to be known and applied. Any commitment to quality of health care in a reform proposal implies a long-term effort to build the knowledge base and the capacity for quality assurance and improvement. Later in this paper we discuss steps that will be essential in developing and applying the knowledge necessary for a quality assurance approach that will monitor and guide health care toward desired outcomes.

A principal objective of health care reform is to reduce the rate of increase in health care expenditures. Given the other objectives of reform, however, cost control can only be approached effectively from the perspective of value. What are we getting for our expenditures? Are we using resources efficiently and appropriately to achieve desired health outcomes,

including preventive services? That we have only partial answers to these questions accentuates our concerns about the share of national resources devoted to health care. Several IOM reports suggest how we might obtain fuller information about the value achieved for different kinds of health care spending.

Your health care reform plan should provide adequate support foreffectiveness and outcomes research. IOM committees have addressed the promises and limitations of research on effectiveness and outcomes in health care in a series of reports (IOM, 1989, 1990a,b,d,f). This work stresses the important distinction between effectiveness and efficacy. Efficacy is typically defined as the outcome of an intervention when it is applied in "ideal" circumstances, such as those in prospective randomized clinical trials. In contrast, effectiveness refers to the outcome of an intervention when applied in the daily practice of medicine to the medical problems of typical patients.

Among the key aspects of effectiveness research are generating accurate, valid, and reliable data; following patients over time and across settings of care; comparing alternative approaches to care; and tracking a broad range of patient-relevant outcomes including quality of life and health status as reported by patients. The creation of the medical effectiveness program of the Agency for Health Care Policy and Research (AHCPR), which was established in late 1989 in the U.S. Public Health Service, was an important step in expanding research on effectiveness and outcomes.

Effectiveness research complements the biomedical research that provides the scientific substrate of both clinical medicine and clinical epidemiology, which emphasizes the incidence and prevalence of disease. Effectiveness research adds an important dimension to these efforts by helping physicians, other health professionals, patients, the public, and policymakers better understand what can be expected from alternative courses of care, a key requirement for making determinations about value. Adequate support of effectiveness research as well as biomedical research, therefore, is a necessary and integral part of any health care reform plan that hopes to improve the value received for our investments in health care.

Similarly, your plan should support the development and effectiveapplication of guidelines for clinical practice. The development and appropriate use of clinical practice guidelines helps us translate the knowledge gained from research into better health care. In ClinicalPractice Guidelines: Directions for a New Program, and later in Guidelinesfor Clinical Practice: From Development to Use, IOM committees defined practice guidelines as "systematically developed statements to assist practitioners and patient decisions about appropriate health care for specific clinical circumstances" (IOM, 1990a, 1992c). The IOM has urged that such guidelines should describe the strength of the scientific evidence behind them and the outcomes and costs expected from their application.

Practice guidelines cannot be viewed as the solution to the health care cost problem. Systematically developed, science-based guidelines should, however, improve the quality of care (and its measurement) and help reduce the financial costs of inappropriate, unnecessary, or dangerous care. Practice guidelines, validated over time by outcome measures, are useful tools to improve the value in health care even when the result is additional, but appropriate, services.

In addition to its mandate to conduct effectiveness research, AHCPR is also promoting the development of practice guidelines, an effort that builds on and augments the work of many professional and research organizations that are committed to improved clinical practice. To advance these undertakings, the IOM's reports (IOM 1990c, 1992a) have defined the attributes of good guidelines; discussed their effective and appropriate application in quality assurance and improvement, cost management, and risk management and medical liability; and described a framework for improving the future development and use of guidelines.

We recommend that your health care reform proposal strongly endorse efforts to develop, apply, and evaluate practice guidelines and actively promote the effectiveness and biomedical research that builds the scientific base for guidelines. In your support for these endeavors you should adopt a long-term view, because sound programs to develop and apply authoritative guidelines are truly in an early stage of evolution. More directly, placing costs and cost containment strategies in the context of value, as well as building the quality assurance and improvement infrastructure, will require sustained support and commitment.

Universal access to health insurance, significant as it will be on ethical and practical grounds, does not equal access to health care. Thus, a thorough health care reform proposal must give attention to certain special groups (such as AIDS patients, the frail elderly, those with severe mental disorders, minorities, and the poor) to ensure that changes aimed at the broader population do not inadvertently leave segments of the population still facing difficult barriers to high, quality, affordable health care and improved health status.

For no group is this concern more acute than for children and pregnant women, especially those who are at high risk, either medically or socioeconomically. We recommend, therefore, that your reform package give specific attention to these parts of our nation's population in three major areas.

Your health care reform plan should include, as part of its packageof benefits, those cost-effective services that are critical to thehealth and well-being of children and pregnant women. In IncludingChildren and Pregnant Women in Health Care Reform, the IOM and National Research Council (NRC) (IOM/NRC, 1992b) assessed whether the current array of proposals for health care reform adequately addressed maternal and child health needs. The gaps in many plans were appreciable. As discussed in that report, meeting the health needs of this population means that the benefit package must cover critical and cost-effective services, including routine immunizations, well-child care, family planning services, dental care, and nutritional supports. Another recent IOM report (IOM, 1991b), Disability in America: Toward a NationalAgenda for Prevention, also makes similar points about prenatal diagnosis and care, family planning, maternity outreach, and related services for women in high-risk groups.

Even persons who do have insurance of some type (including Medicaid) may find that the health services they need are not those that are covered. Fewer than half of private insurance plans, for example, cover immunizations, and in an effort to control costs, some managed care plans now decline to pay for more than 24 hours of hospital care following normal childbirth,

thus reducing the opportunity to monitor newborns in the critical first one or two days after birth and to teach new mothers how to care for their babies. These missing pieces of primary and preventive services ought, in our view, to be a fundamental part of your Administration's reform plan.

Adequate nutrition services are especially critical for this population. Your plan should make provision for the delivery of basic, patient-centered, individualized nutritional care as an integral part of primary care for every woman of child-bearing age and her infant, beginning before conception and extending throughout the period of breast feeding. The specific components of such care are described in two recent reports (IOM, 1992b; 1992c): Nutrition During Pregnancy and Lactation and Nutrition Services in Perinatal Care.

Your reform proposal should also support the training and deploymentof the primary care personnel, as well as the operations of the healthcare systems, necessary to ensure access to essential maternal andchild health services. Ample evidence exists that many areas of the country have too few primary care practitioners (doctors, nurses, dentists, and other health professionals providing primary care) and health clinics, that the nation's medical schools and graduate training programs continue to produce more specialists than primary care physicians, and that we train far too few mid-level practitioners such as certified nurse-midwives. We would note that changing the emphasis in the U.S. health system towards primary care is important for the population as a whole, not just for mothers and children. In 1978, an IOM report noted the decline in the number of primary care practitioners available to provide adequate primary care to the entire population and recommended that at least 50 percent of physicians be trained as primary care practitioners. (IOM, 1978). We would emphasize that, in addition to training more primary care practitioners, the conditions and rewards of practice need to be changed to make career pathways in primary care more attractive.

The support of public sector networks, such as special grant programs that provide children and pregnant women with health and social services, is essential to ensure access to necessary services for this population. Strong evidence also exists that, especially for low-income, high-risk children and families, care offered through comprehensive community-based centers, involving a team of health professionals, is more effective than the care provided through private physicians, because the needs of the population are often greater than a single office-based practice can accommodate.

Accordingly, we recommend that your Administration's proposal for health care reform support the existing network of comprehensive services for children and pregnant women. Such systems need to be reviewed, strengthened, and increased in underserved communities; a review of European networks of special centers for children, pregnant women, and families may have great relevance to reform ideas for the United States.

Your reform plan should provide for effective mechanisms of administration,cost management, and quality assurance that take the needs of childrenand pregnant women directly into account. This population is not well equipped, as a general proposition, to cope with complicated administrative structures that cut across the public and the private sectors. Furthermore, the challenges of utilization management requirements, as well as the often formidable financial barriers posed by cost-sharing requirements, may prove significant obstacles to obtaining appropriate, effective, and timely maternal and child health services. A vigorous,

well-financed system of quality assurance and an energetic program of health services research will help protect against some of these problems, as discussed earlier in this report. In addition, we advise that your plan acknowledge all these special concerns about children and pregnant women so that other potential oversights or even threats to their well-being as reform moves ahead can be successfully averted. A particular issue is that, for this population, care outside of hospitals and nonmedical factors, such as food supplements, is particularly important, and measures of utilization and outcomes may be more difficult.

Investment in health services for mothers and children will pay dividends for society, not only in savings of future health care costs, as documented in our reports, but in broader social and economic benefits as well. We commend your prior commitment to this objective as shown by your actions as Governor.

Successful health care reform will require more and better data and information about health care, especially if the health care system is under stress as it tries to hold down expenditures while expanding access and maintaining high-quality care. Such a circumstance will require an improved ability on the part of health care providers, patients, the public, and policymakers to make informed choices and trade-offs.

Previous sections of this paper have already indicated the need for improved data and information for operations, evaluation, and research. A comprehensive quality assurance system will require a greatly enhanced data base on use of services, patient outcomes, and the process of care. The creation of that data base, only the foundations of which currently exist, will be a major undertaking that will take a number of years to implement fully. This makes more important the commitment we believe your reform proposal needs to make to the development and implementation of a firm plan for a data base for quality monitoring and improvement.

Your health care reform plan should support development and universaladoption of a computer-based patient record. In a recent report, The Computer-based Patient Record: An Essential Technology for HealthCare, an IOM committee explored the problems of today's patient records, which are still predominantly paper based, and the opportunities afforded by a shift to computer-based systems (IOM, 1991a). Universal adoption of a computer-based record promises all the following: (1) better patient information to support clinical decisions; (2) improved management of care by making quality assurance procedures and clinical practice guidelines more accessible to health care professionals at the time and site of patient care; (3) reduced administrative costs; and (4) more relevant, accurate data necessary for provider and consumer education, technology assessment, health services research, and related work concerning the appropriateness, effectiveness, and outcomes of care.

Complete development and adoption of a computer-based record will be a lengthy and challenging task. Initial steps have been taken to implement the detailed strategy set out in the IOM report; these include creation of a computer-based patient record institute and research on topics such as privacy and confidentiality of health records. Stating in your health care reform proposal a commitment to move toward computer-based patient record systems will provide a

further impetus to complete this technological and behavioral revolution, and it will underscore the importance your Administration might place on information and electronic technologies as a bedrock of progress on controlling costs, expanding access, and improving quality.

Your plan should commit your Administration to use specific outcomeand utilization indicators to monitor access to personal health services. In the debate about health care reform, lack of health insurance coverage is often equated with lack of access. In fact, insurance coverage, although a factor that clearly influences access to care, is actually a rather crude and imprecise proxy for access to and use of needed and appropriate services. Until recently experts have not agreed on a set of more meaningful indicators of access. In Accessto Health Care in America (1993), the IOM offers a set of reliable and valid indicators that will map directly to comprehensive health reform efforts. These indicators include access-sensitive outcomes (levels of screening for treatable diseases such as breast and cervical cancer) and measures of utilization of health services (e.g., rates of persons with acute illness who have no physician contact in a year) that are known to be linked to desired patient outcomes; all can be derived from existing data sources.

If these indicators are tracked over time, then the nation will have a much better gauge of the effects of policies and programs intended to improve access. Because guaranteed universal coverage is a core principle of your reform plan, it seems to us imperative that your Administration put in place a means of monitoring progress and identifying other barriers to access that are not removed by extending health insurance coverage. This may be especially critical for certain special populations, such as children and pregnant women. The IOM's access indicators will be crucial evaluation tools for health care reform, and efforts should be made now, through survey techniques and other means, to establish the baselines against which progress and failure can be measured over time.

Your reform plan should also provide for a national health care surveythat can track progress and identify problems in the implementationof your Administration's reform efforts. From the time of the first national census in 1790, an important role of the federal government has been to provide objective statistical information to inform and guide the individual decisions and social policies of a free society. The National Center for Health Statistics (NCHS) has long carried out important parts of this federal role in the health field, especially with regard to vital statistics and national survey data about health status and utilization of health services.

In light of the rapid changes in health care and the prospect of further changes, the NCHS has proposed an innovative national health care survey intended to greatly improve our knowledge about the functioning of the health care system. A joint IOM/NRC committee, in Toward aNational Health Care Survey: A Data System for the 21st Century (IOM/NRC, 1992a). has made suggestions for this survey to ensure that it will be an even better source of data about the use and effects of health services. These national data would complement information derived from health care operations, such as insurance claims forms and computer-based patient records. Knowledge derived from the survey and the resulting database would also create new opportunities to understand patterns of care, costs of care, health status and other characteristics of individuals receiving care, and their demand for and use of services over time and across a

broad range of providers and service settings. The improved information will help improve professional performance and equip consumers to make better choices about health care.

By providing objective data, consistent over time and across the country, the NCHS survey would provide an important evaluation tool for health care reform. We regard its early development and implementation by your Administration as a critical component of an effective long-term reform strategy.

Your commitment to significant health care reform is clear and widely welcomed. We expect that specific details of your plan will focus initially on universal access and cost containment. The purpose of our suggestions and recommendations in this paper is to underscore the importance of other key elements of reform, without which, in our view, even the most well-conceived and well-implemented reform efforts may not realize their full potential. In our judgment, your Administration's plan should address quality assessment and improvement, the value of health care, special populations (especially children and pregnant women), and health care data and information. The IOM stands ready to assist you and your Administration in a comprehensive effort to improve the health and well-being of the American people through major health care reform during your first term of office.

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