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22
An Administration Response to the Institute of Medicine Report from the Agency for Health Care Policy and Research

Linda K. Demlo

In reviewing the Institute of Medicine (IOM, 1990) report on quality assurance in the Medicare program, I was struck by the magnitude of the undertaking. The report demonstrates a mastery of the complexities of conceptualizing and measuring quality, as well as the intricacies of operationalizing quality review that is truly impressive. I predict it will serve as a valuable reference for years to come.

THE AGENCY FOR HEALTH CARE POLICY AND RESEARCH

I will confine my comments to those portions of the report that deal primarily with research, since those functions are most germane to the mission of the Agency for Health Care Policy and Research (AHCPR). The agency was created last December by the Omnibus Budget Reconciliation Act of 1989. Its primary mission is to enhance the quality, appropriateness, and effectiveness of health care services and to improve access to such services. It accomplishes this by establishing a broad base of scientific research and by promoting improvements in clinical practice and in the organization, financing, and delivery of health care services.

The agency replaces the former National Center for Health Services Research and Health Care Technology Assessment, which had traditionally been the primary funder of investigator-initiated health services research. Many of the studies of quality assurance noted in the IOM report were funded by the center. This would include support for the early Experimental Medical Care Review Organizations (EMCROs); various approaches for measuring and improving the quality of patient care; development of measures of disability, health status, and severity of illness; and computerized



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Medicare: New Directions in Quality Assurance 22 An Administration Response to the Institute of Medicine Report from the Agency for Health Care Policy and Research Linda K. Demlo In reviewing the Institute of Medicine (IOM, 1990) report on quality assurance in the Medicare program, I was struck by the magnitude of the undertaking. The report demonstrates a mastery of the complexities of conceptualizing and measuring quality, as well as the intricacies of operationalizing quality review that is truly impressive. I predict it will serve as a valuable reference for years to come. THE AGENCY FOR HEALTH CARE POLICY AND RESEARCH I will confine my comments to those portions of the report that deal primarily with research, since those functions are most germane to the mission of the Agency for Health Care Policy and Research (AHCPR). The agency was created last December by the Omnibus Budget Reconciliation Act of 1989. Its primary mission is to enhance the quality, appropriateness, and effectiveness of health care services and to improve access to such services. It accomplishes this by establishing a broad base of scientific research and by promoting improvements in clinical practice and in the organization, financing, and delivery of health care services. The agency replaces the former National Center for Health Services Research and Health Care Technology Assessment, which had traditionally been the primary funder of investigator-initiated health services research. Many of the studies of quality assurance noted in the IOM report were funded by the center. This would include support for the early Experimental Medical Care Review Organizations (EMCROs); various approaches for measuring and improving the quality of patient care; development of measures of disability, health status, and severity of illness; and computerized

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Medicare: New Directions in Quality Assurance medical information systems to monitor patients and assist health care providers in diagnosing and treating illness. The new agency continues to support investigator-initiated general health services research. This is a fundamental component of our mission. What sets AHCPR apart from its predecessor is an increased attention to clinical practice and medical effectiveness and an explicit legislative charge to promote improvements in clinical practice and the organization, financing, and delivery of services. This is reflected in our mandate to stimulate the development of clinical practice guidelines and to expand our dissemination activities. We view the creation of the agency and its expanded mission as an opportunity to make quality assurance an important component of the Public Health Service agenda and to continue collaborative activities with the Health Care Financing Administration, other public and private organizations, and professional and consumer groups. The analyses and recommendations of the IOM report will be very instructive as we go about these tasks. For the remainder of my time, I would like to review our Medical Treatment Effectiveness Program (MEDTEP) and discuss some planned research and demonstration activities that focus on quality measurement and improvement and on medical liability. MEDTEP, in particular, has already been the beneficiary of helpful guidance and counsel from the IOM. We hope to be able to call upon many of you both individually and collectively for future assistance. MEDICAL TREATMENT EFFECTIVENESS PROGRAM AHCPR is responsible for implementing the Department of Health and Human Service's MEDTEP, which supports research to address fundamental questions about what difference medical care makes. Do patients benefit? What treatments work best? Are health care resources well spent? The goal of MEDTEP is to improve the effectiveness and appropriateness of health care services and procedures through a better understanding of the effects of health care practices on patient outcomes. MEDTEP is built on studies conducted during the past two decades that reveal wide variations in the type and amount of health care provided to apparently similar patients. Those outcomes analyses, combined with evidence that providers will change their behavior when they are given pertinent information about practice patterns and patient outcomes, support the belief that more effective health care is achievable. Toward this goal, we are working collaboratively with other public and private entities to learn more about the effectiveness of health care and to put the results of that research into practice. MEDTEP has four components. The first is health services research on the outcomes, effectiveness, and appropriateness of health care services and pro-

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Medicare: New Directions in Quality Assurance cedures. The second is data base development. Third is the development of clinical practice guidelines, and fourth is the dissemination of research findings. We are currently funding five patient outcome research teams to develop and test methods to reduce inappropriate variations in the treatment of low back pain, heart attacks, cataracts, prostate gland enlargement, and knee replacement. About 26 other research projects address other issues pertaining to outcomes and effectiveness, and we expect these activities to grow over time. Facilitating the development of clinical practice guidelines, standards, and performance measures is the responsibility of our Office of the Forum for Quality and Effectiveness in Health Care. Here, it is important to emphasize our facilitation role. The results of these efforts will not be practice guidelines developed by federal employees. Rather, they will be developed by representatives of the professional community. Our role is to manage the process for facilitating guidelines development. The guidelines will be created by practicing physicians; be based on science; and be practical, explicit, and subject to revisions as needed. We expect this process to include the full participation of professional and specialty organizations, scientific bodies such as the IOM, academic medical centers, standard-setting and quality measurement organizations, and research institutions. Consumer groups must also be involved to ensure that the program's processes and guidelines are relevant and understandable from the patient's perspective. Our current activities include developing a methodology for guideline formulation to foster consistency in the development process and putting in place a set of activities to involve the practicing community in generating guidelines. We are legislatively required to develop an initial set of three guidelines by January 1991. As patient outcomes research and guidelines are completed, the results will be widely disseminated through journal publication, information networks, and conferences. We will also utilize the resources and expertise of the National Library of Medicine and the Health Resources and Services Administration. In particular, the Bureau of Health Professions will convey appropriate information to geriatric education centers, family medicine departments, general internal medicine departments and the wider network of area health education centers. We will also explore new approaches to health professional education to ensure that research findings are incorporated into academic curricula, continuing education, and other professional education activities. QUALITY EVALUATION AND IMPROVEMENT INITIATIVE Let me now turn to some proposed activities dealing with quality improvement and evaluation. We believe that the effectiveness of ongoing

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Medicare: New Directions in Quality Assurance quality assurance programs is influenced by many factors in addition to clinical practice guidelines. Therefore, we propose to mount a major research and demonstration initiative on methods for health care quality evaluation and improvement. Here again, the IOM report on quality assurance will be most helpful. A major portion of what the IOM refers to as basic research will be encompassed by the research supported as part of our MEDTEP program. This would include research on patient outcomes and the effectiveness and appropriateness of medical care. One might add to that the generation of basic information on the distribution of quality problems and the ''burdens of harm,'' to use the IOM phrase, including information on the extent of poor technical and interpersonal quality, overuse, and underuse. Such information can guide choices about optimal approaches and emphases in the design of quality assurance programs. We plan an increased emphasis on applied or operational research aimed at developing tools and methods for ongoing quality assurance and evaluating their effects. Topics that warrant investigation include the relative effects of generic quality screens versus condition-specific review criteria; the integration of treatment information and claims data across multiple providers, payers, and health care settings; the effects of incentives versus sanctions in changing provider behavior; the roles of internal continuous improvement models of quality assurance versus external monitoring in sustaining changes in overall levels of quality over time; and the utility of the continuous improvement model in dealing with clinical problems encountered in ordinary medical practice, such as poor physician decisionmaking. We would also be interested in examining operational links between quality assurance and utilization management and review, considering both prospective and retrospective review criteria and areas of complementarity and disagreement. The effects of the use of clinical practice guidelines would also be important. For example, we would be interested in examining whether quality of care has improved, whether cases are properly classified as exhibiting good or poor quality, what the effects are on malpractice, the feasibility and likelihood of "gaming," the effects on cost, and various systems design and operational issues. We plan to convene a working conference in late fall or early winter to help develop a research and demonstrations agenda with the expectation that the funded projects will be about evenly split between research and demonstration activities. Our intent is to bring together the "doers" of quality assurance and the research community and see whether we can help to move the field forward. MEDICAL LIABILITY PROGRAM Finally, we are initiating another research and demonstration program in the area of medical liability. I do not need to note the widespread concern

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Medicare: New Directions in Quality Assurance that the current system for resolving claims of medical malpractice is not working well. Concerns focus on the escalating cost of liability insurance, the patient-provider relationship, and the inadequacy of the civil court system to resolve conflict. Many states have enacted tort reforms, which may be expected to have a positive impact on the medical liability problem. However, changes are occurring in health care delivery itself that may further alter the liability environment. Here I have in mind, for example, the potential conflict between malpractice law and cost containment. As physicians respond to declining reimbursement by limiting the performance of procedures once considered necessary, they may be exposed to liability unless legal standards shift to accommodate these new constraints and new standards of practice. As increasing competition drives hospitals and physicians to engage in joint ventures and in joint risk management programs, this sharing of cost, risk, and responsibility raises legal issues such as participation in peer review activities versus possible antitrust exposure and the locus of responsibility for institutional risk management. To address these and other issues, we will initiate a program of research and demonstrations intended to improve the malpractice liability system. We are interested in supporting activities such as demonstrations and evaluations of the effects of tort reform on medical liability claims, studies of the results of medical effectiveness research as they may pertain to medical liability, and systematic analyses of claims for medical negligence to determine the types of events that lead to bad outcomes, the settings in which they occur, and the circumstances surrounding their occurrence. SUMMARY To summarize, the Agency for Health Care Policy and Research has already charted a course intended to expand the knowledge base about the outcomes, effectiveness, and appropriateness of health care and of systems assessing and improving the quality of care. We see the IOM report as an extremely valuable contribution along this path. We look forward to continuing discussions. REFERENCE Institute of Medicine. Medicare: A Strategy for Quality Assurance. Volumes I and II. Lohr, K.N., ed. Washington, D.C.: National Academy Press, 1990.