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1 Overview of the Study to Design a Strategy for Quality Review and Assurance in Medicare Kathleen N. Lohr The United States has a high level of quality in much of its health care. As individuals, people (especially the elderly) are usually satisfied with their own medical care and providers. Despite these positive impressions of the overall quality of care in the nation, a large literature documents areas of deficiencies in all parts of the health sector. Some of these problems relate to the overuse of unnecessary and inappropriate services, some to underuse of needed services, and some to poor skills or judgment in the delivery of appropriate services. Furthermore, recurring crises involving malpractice litigation reflect an undercurrent of quality problems exacerbated by a deteriorating patient- physician relationship. Great variations in rates of use of services in the population are not satisfactorily explained by variations in health needs or resources. Moreover, the growth of for-profit enterprises and of commer- cialism is seen as leading to possible conflict between physicians and pa- tients. Finally, and perhaps most germane, continuing increases in health expenditures and in the rate at which they rise have led to momentous changes in the health care environment, and these changes have conflicting implications for quality of care and quality assurance. Given this environment, the Congress of the United States had consider- able concerns about the quality of care for the elderly. To address these concerns, they commissioned a study through the Omnibus Budget Recon- ciliation Act of 1986 (OBRA 1986) to "design a strategy for quality review and assurance in Medicare." Section 9313 of OBRA 1986 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, and it specified eight legislative charges. These were, "among other items," to:

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2 KATHLEEN N. LOHR (A) identify the appropriate considerations which should be used in defin- ing 'quality of care'; (B) evaluate the relative roles of structure, process, arid outcome standards in assuring quality of care; (C) develop prototype criteria and standards for defining and measuring quality of care; (D) evaluate the adequacy and focus of the current methods for measuring, reviewing, and assuring quality of care; (E) evaluate the current research on methodologies for measuring quality of care, and suggest areas of research needed for further progress; (F) evaluate the adequacy and range of methods available to correct or prevent identified problems with quality of care; (G) review mechanisms available for promoting, coordinating, and super- vising at the national level quality review and assurance activities; (H) develop general criteria which may be used in establishing priorities in the allocation of funds and personnel in reviewing and assuring quality of care. STUDY COMMITTEE AND TECHNICAL ADVISORY PANEL Studies undertaken by 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 IOM committee for this study, which was established in the fall of 1987, consisted of 17 individuals and included experts in medicine, nursing, home health and social services, law, economics, epidemiology and statis- tics, decision analysis, and quality assessment and assurance. Committee members also represented major consumer, purchaser, and business inter- ests. The committee had a broad representation by age, sex, and geographic location. The OBRA 1986 legislation specified that the IOM should consult with specific organizations and with representatives of major groups that have interests in this issue. To this end, a Technical Advisory Panel (TAP) was appointed early in the study, with representatives from the following groups: American Health Care Association; American Hospital Association; Ameri- can Medical Association; American Medical Review Research Center; American Nurses Association; Blue Cross and Blue Shield Association; Group Health Association of America; Health Insurance Association of America; Joint Commission on Accreditation of Healthcare Organizations; National Association for Home Care; National Association of Quality As- surance Professionals; National Governors Association; National Medical Association; and Older Women's League.

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OVERVIEW 3 CONDUCT OF THE STUDY Phases of the Study The study was conducted in several phases. A planning phase lasted from summer 1987 through January 1988. During this time, a preliminary and then a final proposal were prepared for the Health Care Financing Administration (HCPA), the study committee was appointed, and IOM staff were hired. The major part of the data collection (described below) was performed between February 1988 and July 1989. Preparation of the IOM committee report (both Volume I and Volume II) was concentrated in the period from August 1989 through February 1990. The report was published and distributed and other dissemination activities (including a conference) were conducted between February and the end of the study in mid-1990. The work was financed by two grants from the Health Care Financing Administration (HCFA), one for He planning phase and one for the remain- der of the study. Data Collection and Other Study Activities Main Study Tasks The committee and IOM staff carried out several major activities during this study; they fall into the general categories of convening meetings, gath- enng background information, consulting broadly with groups across the country, and acquiring or producing technical documents. First, the com- mittee met nine times for two-to-three-day meetings; the TAP was inde- pendently convened twice. Second, a total of 10 background papers were commissioned; Table 1.1 shows the authors and titles of the papers. Several papers and reports were produced by IOM staff or consultants on various specific aspects of the study. These constitute the main portion of this volume of the report. A complex public hearing process was started in the early months of the study and continued for about six months (see Chapter 2~. It featured two formal public hearings~ne in San Francisco and one in Washington, D.C. at which a total of 42 groups gave oral testimony before the entire commit- tee. Written testimony was received from nearly 140 groups (of nearly 575 contacted), including those that were represented in person. The study committee placed considerable importance on developing a definition of `'quality of care" that would guide their thinking about a Medi- care quality assurance program. Testimony from the public hearings, among other sources, provided many ideas and proposals for such a definition.

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4 TABLE 1.1 Commissioned Papers KATHLEEN N. LOHR Title of Paper Authors Medicare Quality Assurance Mechanisms and He Law PROP Review of Medicare Heals Maintenance Organ~zanons and Competitive Medical Plans Quality of Health Care for the Older People . ~ . In Amenca Strengths and Weaknesses of Health Insurance Data Systems for Assessing Quality Reflections on the Effectiveness of Quality Assurance Quality Assurance: Ethical Considerations Issues Related to Quality Review and Assurance in Home Heals Care Study on International Aspects of Quality Assurance Considerations in Defining Quality in Health Care Quality of Care for Older People in America Andrew Heath Smith Maxwell Mehlman Margaret O'Kane Norma Lang Janet Kraegel Leslie L. Roos Noralou Roos Elliot S. Fisher Thomas A. Bubolz Avedis Donabedian Gail Povar Catherine Hawes Robert L. Kane Evert Reerink R. Heather Palmer Miriam E. Adams Laurence Z. Rubenstein Lisa V. Rubenstein Karen Josephson aPRO, Peer Review Organization. Chapter 5 presents the analysis and interpretation of that material and the committee's final definition of quality of care. Early in the study two sets of focus groups were conducted. Eight focus groups were held among elderly Medicare beneficiaries in four cities (Mi- ami, New York City, Minneapolis, and San Francisco), and an additional eight groups were done among practicing physicians in five cities (Philadel- phia, Chicago, New Orleans, Albuquerque, and Los Angeles). Chapter 3 discusses the issues raised through the focus groups. The most extensive study task was a series of nine major site visits and several smaller site visits to states and cities across the country; these are described in Chapter 4. In the major site visits two-to-three-day trips to the states of California, Georgia, Illinois, Iowa, Minnesota, New York (two separate site visits), Pennsylvania, Texas, Virginia, and Washington-com- mittee members and staff visited hospitals and hospital associations, home health agencies, health maintenance organizations (HMOs), state depart- ments of health, and other organizations. In addition, meetings were organ

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OVERVIEW s ized with practicing physicians, hospital administrators, representatives of aging, consumer, and community groups, and with other individuals. A major effort was made to visit a representative set of Medicare Peer Review Organizations (PROs). The shorter site visits were to specific organizations (e.g., multispecialty clinics or HMOs) that appeared to offer particular in- sights into approaches for quality assurance. Altogether, site visitors spoke with over 650 individuals. Much of the value of the site visits was in learning about and being able to document the wide variety of quality assessment and quality assurance activities being conducted throughout the country. To give a sense of the richness of the efforts beyond the Medicare program, Chapter 6 presents an extensive sampler of methods, instruments, and tools drawn from the site visits, the published literature, and other sources. Study staff and the committee also carried out several other activities. To address the congressional charge of developing prototypical criteria and standards for defining and measuring quality of care, a special expert panel was convened late in the study to develop recommendations concerning the attributes and standards by which quality-of-care criteria and appropriate- ness or practice guidelines might be evaluated. This was reported in Chap- ter 10 of Volume I. Consultants were used to advise on different study topics, such as legal and regulatory issues. We also acquired data on staff- ing 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 on quality assurance and related topics. Finally, the committee and staff con- sulted with staff at HCFA and at several federal and congressional agencies with interests in the Medicare quality assurance program. Hospital Conditions of Participation HCFA requested the IOM to conduct a second study, which had been mandated in Section 9305 of OBRA 1986, that would examine whether standards used for hospitals to meet the Conditions of Participation for Medicare could assure the quality of hospital care. The IOM folded this study into the larger effort, and that review is reported mainly in Chapter 7 of this volume. Medicare Peer Review Organizations The existing program in Medicare for quality assurance is the PRO pro- gram. It, together with predecessor programs (Experimental Medical Care Review Organizations and Professional Standards Review Organizations), was described and discussed in Chapter 6 of Volume I. Much important

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6 KATHLEEN N. LOHR information about the PRO program, some of which relates directly to evalu- ative comments in Volume I, could not be retained in that chapter because of space considerations. Thus, a more complete and detailed history and description of the program and its many complex activities are given in Chapter ~ of this volume. CONCLUDING REMARKS This volume of source materials is intended to provide documentation of the diverse activities carried out over the two years of this project. The complexities of quality assessment and quality assurance in conceptuali- zation and in practical application are such that much of the study committee's final report (Volume I) was oriented to those issues. This volume, therefore, provides much of the "raw material" that underlay the committee's deliberations, findings, conclusions, and recommendations, with the intent that it be a useful reference book well beyond the study's conclu- sion.