Introduction to the Study and This Report

CONGRESSIONAL CHARGE

The commission from the Congress of the United States to “design a strategy for quality review and assurance in Medicare” was contained in Section 9313 of the Omnibus Budget Reconciliation Act of 1986 (OBRA 1986). It called for the Secretary of the U.S. Department of Health and Human Services (DHHS) to solicit a proposal from the National Academy of Sciences (NAS) to conduct the study that would address eight legislative charges, namely “among other items,” to:

  1. identify the appropriate considerations which should be used in defining “quality of care”;

  2. evaluate the relative roles of structure, process, and outcome standards in assuring quality of care;

  3. develop prototype criteria and standards for defining and measuring quality of care;

  4. evaluate the adequacy and focus of the current methods for measuring, reviewing, and assuring quality of care;

  5. evaluate the current research on methodologies for measuring quality of care, and suggest areas of research needed for further progress;

  6. evaluate the adequacy and range of methods available to correct or prevent identified problems with quality of care;

  7. review mechanisms available for promoting, coordinating, and supervising at the national level quality review and assurance activities;

  8. develop general criteria which may be used in establishing priorities in the allocation of funds and personnel in reviewing and assuring quality of care.



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Medicare: A Strategy for Quality Assurance - Volume I Introduction to the Study and This Report CONGRESSIONAL CHARGE The commission from the Congress of the United States to “design a strategy for quality review and assurance in Medicare” was contained in Section 9313 of the Omnibus Budget Reconciliation Act of 1986 (OBRA 1986). It called for the Secretary of the U.S. Department of Health and Human Services (DHHS) to solicit a proposal from the National Academy of Sciences (NAS) to conduct the study that would address eight legislative charges, namely “among other items,” to: identify the appropriate considerations which should be used in defining “quality of care”; evaluate the relative roles of structure, process, and outcome standards in assuring quality of care; develop prototype criteria and standards for defining and measuring quality of care; evaluate the adequacy and focus of the current methods for measuring, reviewing, and assuring quality of care; evaluate the current research on methodologies for measuring quality of care, and suggest areas of research needed for further progress; evaluate the adequacy and range of methods available to correct or prevent identified problems with quality of care; review mechanisms available for promoting, coordinating, and supervising at the national level quality review and assurance activities; develop general criteria which may be used in establishing priorities in the allocation of funds and personnel in reviewing and assuring quality of care.

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Medicare: A Strategy for Quality Assurance - Volume I STUDY METHODS Studies undertaken by the NAS and the Institute of Medicine (IOM) are conducted by expert committees. These committees comprise individuals selected for their expertise who can provide information and insights from all disciplines and social sectors that are important to the topic of the study. The 17-member IOM committee for this study included experts in medicine, nursing, home health and social services, law, economics, epidemiology and statistics, decision analysis, and quality assessment and assurance. Committee members also represented major consumer, purchaser, and business interests. The committee had a broad representation by age, sex, and geographic location. The OBRA legislation required consultation with specific organizations and representatives of major groups with an interest in this issue. To this end, a 14-member Technical Advisory Panel (TAP) was appointed; it met twice during the study, and IOM staff maintained regular contact with TAP members. Review of the congressional charges reveals that the scope of this study could have been extraordinarily, and possibly unmanageably, broad. The committee thus decided to constrain the breadth of the work in several ways. First, it considered quality issues only as they relate to elderly Medicare beneficiaries. Second, it focused on three major settings of care: inpatient hospital care, outpatient physician-office-based care, and home health care. Collectively, those locales and types of care provide important insights in problems of and opportunities for quality review and assurance not only in their own right but for other settings (such as ambulatory surgery) that could not be studied in depth. Third, the study included both fee-for-service and prepaid group practice but did not look in detail at different types of prepaid, capitated, or managed care arrangements. Another decision was to emphasize long-range issues, that is, specifically to respond to the congressional call to “…design a strategy The committee elected to consider the elements of a strategy that might be put in place over the decade of the 1990s; the aim was to articulate a goal for the year 2000 and the major steps that need to be taken to reach that goal. Thus, the emphasis of this study is on strategy, not immediate tactics, although some recommendations deal with nearer-term changes and activities. The study was conducted in three phases: planning (summer 1987 through January 1988); data collection and report preparation (February 1988 through February 1990), and dissemination (through May 1990). The work was financed by two grants from the Health Care Financing Administration (HCFA), one for the planning phase and one for the remainder of the study. HCFA also asked that the IOM undertake a second effort, mandated in Section

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Medicare: A Strategy for Quality Assurance - Volume I 9305 of OBRA 1986, to examine the capacity of standards used for hospitals to meet the Conditions of Participation for Medicare to assure the quality of hospital care. The IOM included this work in the larger effort. The committee and IOM staff carried out several major activities during this study; they fall into the general categories of convening, gathering background information, consulting broadly with groups across the country, and acquiring or producing technical documents (some of which are in Volume II). The committee met nine times for two-to-three-day meetings. A total of 10 background papers was commissioned; in addition, several papers and reports were produced by IOM staff or consultants on various specific activities of the study. Early in the study two sets of focus groups were conducted. Eight focus groups were carried out among elderly Medicare beneficiaries in four cities (New York City, Miami, Minneapolis, and San Francisco); an additional eight groups were done among practicing physicians in five cities (Philadelphia, Chicago, New Orleans, Los Angeles, and Albuquerque). A public hearing process was also carried out in the early months of the study. It featured two formal public hearings, one in San Francisco and the other in Washington, D.C., at which a total of 42 groups gave oral testimony before the entire committee; in addition, written testimony only was received from nearly 100 groups (of nearly 575 contacted). The most extensive study task was a series of site visits across the country. In the major site visits (two-to-three-day trips to the states of California, Georgia, Illinois, Iowa, Minnesota, New York, Pennsylvania, Texas, Virginia, and Washington), committee and staff visited Medicare Peer Review Organizations (PROs), hospitals and hospital associations, home health agencies and aging groups, health maintenance organizations (HMOs), state departments of health, and other organizations; in addition, meetings with practicing physicians, hospital administrators, and other individuals were organized. The shorter site visits were to specific organizations (e.g., multispecialty clinics or HMOs) that appeared to offer particular insights into approaches for quality assurance. Altogether, site visitors spoke with more than 650 individuals. To address the congressional charge of prototypical criteria and standards, a special expert panel was convened late in the study to develop recommendations concerning the criteria by which quality-of-care criteria and appropriateness or practice guidelines might be evaluated. Other consultants were used to advise on different study topics, such as legal and regulatory issues. For instance, we acquired data on staffing and costs of quality assurance programs from a survey that was being conducted at the same time by a large multihospital system. Additionally, at several of its meetings, the committee heard from a range of experts in quality assurance and related topics. Finally, committee and staff consulted with staff at

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Medicare: A Strategy for Quality Assurance - Volume I HCFA and at several federal and congressional agencies with interests in the Medicare quality assurance program. ORGANIZATION OF THIS REPORT This report first examines concepts of quality of care and of assessing, assuring, and improving quality of care. Chapter 1 presents the committee’s definition of quality of care and examines the topic of the quality of health care as a public policy issue. Chapter 2 focuses on a conceptual framework and models for implementing quality assurance and continuous improvement programs and explores the key attributes of a quality assurance program. The report then turns to a description of the context and environment for quality assessment and assurance in Medicare. Chapter 3 discusses aspects of the elderly population. Chapters 4, 5, and 6 examine the Medicare program and its quality assurance efforts (hospital conditions of participation in Chapter 5 and the peer review programs, particularly the PRO program, in Chapter 6). Chapter 7 examines quality problems and the burdens of harm they pose to the elderly; these include poor technical or interpersonal performance of practitioners, overuse of services, and underuse of services. Conceptual and practical issues posed by setting and payment systems are dealt with in Chapter 8, and Chapter 9 discusses certain strengths and limitations of key quality measurement and assurance approaches. Chapter 10 deals with the special topic of desirable characteristics of quality-of-care criteria sets, practice guidelines, and case-finding tools. Chapter 11 presents the committee’s views about long-range needs for research and for capacity building for quality assurance. Finally, Chapter 12 presents the committee’s quality assurance strategy for Medicare. It highlights the committee’s conclusions about the current program, states the committee’s recommendations about new directions for a Medicare quality assurance program, and suggests the steps and the time-table by which such a new program might be put into place. Volume II of this report contains major background documents. We expect this report to be of interest to a wide audience. Its principal purpose is to address the strategic concerns of Congress about a viable approach to maintaining and improving the quality of care for the elderly. We believe it will be useful for those who lead the development of quality assurance programs at the local level, by documenting the wide array of tools and the rich store of quality assurance experience in the country today. The considerable research agenda called for by remaining unanswered questions about the measurement and assurance of quality should be of value for investigators in health policy, health services research, and educa-

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Medicare: A Strategy for Quality Assurance - Volume I tion. Finally, we believe it will provide guidance for policymakers responsible for designing a farsighted yet pragmatic quality assurance program for Medicare. KATHLEEN N.LOHR Study Director, Study to Design a Strategy for Quality Review and Assurance in Medicare

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