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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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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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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.
Representative terms from entire chapter:
quality review
