oversight

Quality Assurance: A Comprehensive National Strategy for Health Care Is Needed

Published by the Government Accountability Office on 1990-02-21.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

GAO   Briefing Report to the Chairman,
      TJnited States Bipartisan Commission
                                             s,
      on Comprehensive Health Care



      QUALITY
      ASSURANCE
      A Comprehensive,
      National Strategy for
      Health Care Is Needed

                                        ii4
                                   11111
                                    IIIll
                                   140934
    United States
    General Accounting Office
    Washington, D.C. 20548

    Program Evaluation and
    Methodology Division

    B-237200

    February 21,199O

    The Honorable John D. Rockefeller IV
    Chairman, The Pepper Commission
    United States Bipartisan Commission on
      Comprehensive Health Care
I   Dear Mr. Chairman:

    In response to your request of August 11,1989, we have examined the
    issues that would need to be addressed in ensuring the quality of health
    care under any plan to expand health care coverage for the uninsured.
    We have assumed that the current system of multiple public and private
    purchasers of health care will remain in place for at least the immediate
    future. In addition, we have examined the adequacy of the knowledge
    base for structuring such quality assurance activities. However, because
    we believe that most of the quality assurance issues that would need to
    be addressed are generic, much of this report does not distinguish
    between quality assurance for the uninsured and for the general
    population.

    This briefing report presents the results of our work as discussed with
    your staff on January ‘23,199O. We begin by noting that quality is mul-
    tidimensional and that we have focused our attention on the appropri-
    ateness of care and the technical and clinical aspects of quality. We also
    note that health care system design has important implications for qual-
    ity, and we briefly describe the various levels at which quality assur-
    ance activities are currently conducted. We conclude that there is a
    considerable body of knowledge about, and experience with, the organi-
    zation and conduct of quality assessment and assurance activities and a
    growing interest in improving and expanding these activities among
    many of the participants, including the medical community, consumers,
    employers, and purchasers of care.

    In keeping with this growing interest, we suggest that a comprehensive,
    national strategy for assessing and assuring the quality of health care is
    needed. We see at least four elements as essential to a comprehensive
    national strategy: (1) national practice guidelines and standards of care;
    (2) enhanced data to support quality assurance activities; (3) improved
    approaches to quality assessment and assurance at the local level; and
    (4) a national focus for developing, implementing, and monitoring a
    national system. The reasons we see for needing a comprehensive



    Page 1                           GAO/PEMD-@O-MB&   Health   Care Quality   Assurance
B-237200




national approach and a brief discussion of each of its elements are con-
tained in section 2 of this report.

Our conclusions are based primarily on the studies of health care quality
assessment and assurance in a number of settings spanning the public
and private sectors that we have conducted over the past few years. We
have also incorporated concepts and information on quality assurance
contained in published sources, including the Institute of Medicine’s
report entitled Controlling Costs and Changing Patient Care? and the
Office of Technology Assessment’s report entitled The Quality of Medi-
cal Care: Information for Consumers. Finally, we convened a meeting of
experts in November 1989 for the explicit purpose of exploring these
issues and have had them review a draft of this report. (See appendix I.)
We have not conducted a comprehensive review and analysis of existing
quality assurance programs. Any references in this report to specific
quality assurance programs are examples used to illustrate particular
points and do not necessarily represent the “best” programs available.

Our work was performed in accordance with generally accepted govern-
ment auditing standards. We have incorporated the comments of our
experts but have not requested comments from any federal agency,
since none is evaluated in this work. Unless you publicly announce the
contents of this report earlier, we plan no further distribution until 30
days from its date. We will then make copies available to others upon
request. If you have any questions or would like additional information,
please call me at (202) 275-1854 or Mr. Robert York, Acting Director of
Program Evaluation in Human Services Areas, at (202) 275-5885. Other
major contributors to this report are listed in appendix II.

Sincerely yours,




                                       J
Eleanor Chelimsky
Assistant Comptroller General




Page 2                           GAO/PEMJMO-14BR   Health Care Quality   Amurance
Page 3   GAO/PEMD-fbO-14BR   Health   Care Qua&y   Ammrance
contents


Letter                                                                                                        1
  I
Section 1                                                                                                     6
                                                                                                              6
Qublity , Quality       Quality Is Multidimensional
                        Quality Assessment Should Be Distinguished From                                       7
Asburance, and the          Quality Assurance
Health Care System      Health Care System Design Influences Quality                                          8
  ~                     Quality Assessment and Assurance Occur at Many Levels                                 9

Se@ion2                                                                                                   12
                                                                                                          12
A comprehensive,        Reasons for a Comprehensive National Strategy
                        The Need for Balance                                                              13
NaItional Quality       Elements of a Comprehensive National Strategy                                     16
Assurance Strategy Is   The Role of Provider Accreditation and Certification                              22
                        The Importance of Consumer Education                                              23
Nekded                  Conclusion                                                                        23

Appendixes              Appendix I: Expert Panel on Quality Assurance Issues                              26
                        Appendix II: Major Contributors to This Report                                    28


Related GAO Reports                                                                                       32




                        Abbreviations

                        GAO       General Accounting Office
                        PRO       Peer Review Organization


                        Page 4                           GAO/PEMD-90-14BR   Health Care Quality   Assurance
Y




    Page 6   GAO/PEMD-90-14BR   Health   Care Quality   Assurance
&uality, Quality Assurance,and the Health
C+ireSystem

                       In this section, we begin with an overview of the concept of health care
                       quality and how we use it in this report. We draw a distinction between
                       quality assessment and quality assurance, which is important for our
                       discussion of the need for a national, comprehensive quality assurance
                       strategy in section 2. We note some instances in which the design and
                       operation of the health care system itself can influence quality quite
                       independently of any formal mechanism for reviewing the quality of
                       care. Finally, we briefly describe the different levels in the health care
                       system at which quality issues may be addressed.




Multidimensional       things to different people. Patients, health care providers, and purchas-
                       ers may have different notions about what constitutes high-quality care.

                   . To patients, “getting better” (that is, the outcome of care) is probably
                     the primary concern. In addition, having access to care that is afforda-
                     ble, conveniently available, and provided in a manner that respects their
                     concerns and preferences is important. The responsiveness of the deliv-
                     ery system may also be important-for       example, meeting patients’ indi-
                     vidual needs for emergency care, coordinating services, and making
                     appropriate referrals.’
                   . Health care providers may emphasize the decisionmaking process that
                     underlies diagnosis and treatment, the clinical content of care, and the
                     technical skill with which it is rendered.
                   l Purchasers may place greater weight on questions of cost-effectiveness,
                     including the need for individual diagnostic and therapeutic services,
                     the appropriateness of the setting in which care is delivered, and the
                     frequency, timing, and duration of services.

                       All these views of quality are legitimate and important. However, our
                       primary focus is on the appropriateness of medical services and their
                       clinical and technical quality. This implies a concern for such issues as
                       whether necessary care was provided, whether the outcome was accept-
                       able, whether unnecessary services were provided, and whether the
                       location of care (that is, hospital, nursing home, home, ambulatory set-
                       ting, and so on) was consistent with the patient’s needs.

                       There are important reasons for this focus. First, and perhaps most
                       important, providing appropriate medical care that is effective is the
                       common denominator of the preferences of all three groups. Second, pro-
                       viding improved access to inappropriate care or poor-quality care is not


                       Page 6                            GAO/PEMD-90-14BR   Health   Care Quality   Assurance
                     Section 1
                     6!udty, wty   Awurance,   and the Health
                     Care System




                     likely to result in improved health outcomes. Third, currently available
                     strategies for assessing and assuring quality are targeted especially to
                     the appropriateness of care and to technical aspects of quality. As a
                     result, focusing attention in these areas offers the greatest potential for
                     near-term improvements in quality.

                                                                                                                  -
                     It is important to distinguish between quality assessment and quality
Qu lity Assessment   assurance. Quality assessment involves the use of measures of quality,
Sh0”uld Be           based on either explicit or implicit criteria, to assess the structure, pro-
Disbinguished From   cess, and outcome of care and to monitor levels of quality over time.
                     Quality assurance goes beyond the simple assessment of quality to
Qu$lity Assurance    include its improvement. This requires identifying and confirming prob-
                     lems in the quality of medical care, planning interventions to lessen or
                     eliminate the problems, monitoring the effectiveness of the interven-
                     tions, and instituting additional changes and monitoring where
                     warranted.

                     Quality assessment is a prerequisite to quality assurance. It can be per-
                     formed by an external assessor, assuming that the information neces-
                     sary to assess the medical care is available and that criteria exist for
                     specifying the constituents of high quality. Under these conditions,
                     potential problems with the quality of care can be easily identified.

                     Successful quality assurance is more difficult, since it involves either
                     preventing poor-quality care from occurring or improving levels of qual-
                     ity, which frequently requires behavior change on the part of health
                     care providers. One example of an approach to preventing poor-quality
                     care is to require external approval of health care interventions before
                     the care is provided. This approach works because care that is not
                     approved is unlikely to be reimbursed and this lessens the likelihood
                     that the presumably inappropriate care will be provided.

                     But such approaches apply to individual services or procedures patient
                     by patient. They do little to encourage providers to change their behav-
                     ior or to create an environment for improving general levels of quality
                     over time. Accomplishing the latter is generally assumed to require the
                     commitment and involvement of the health care providers whose care is
                     under review. This involvement is particularly important in the “gray”
                     areas of medicine where there may be uncertainty about what the
                     proper course of treatment is and considerable variation among physi-
                     cians in how they currently care for patients. If physicians and other



                     Page 7                                     GAO/PEMDBO-14BR   Health   Care Quality   Assurance
                                                                                                                        *
                        section 1
                        Quality, Qnslity   Assurance,   nnd the Health
                        Care System




                        health care providers collectively examine information on current prac-
                        tice patterns and determine the reasons for variation and the preferred
                        methods of treatment, the potential payoff in terms of improving overall
  I                     levels of quality is considerable.

                        Quality assurance systems typically concentrate on quality assessment
                        and on the identification of the relatively small number of providers
                        whose care is obviously unacceptable. They do comparatively little in
                        attempting to directly improve the overall levels of quality provided by
                        the majority of health professionals, This is more difficult to accom-
                        plish, particularly if imposed on health professionals from the outside.
                        If we think of the performance of health care providers in terms of the
                        bell-shaped curve of a normal distribution, the challenge is to devise a
                        quality assurance strategy that not only deals appropriately with the
                        outliers but also assists in moving the entire distribution to a higher
                        level of quality.


                       Quality is potentially influenced by almost every aspect of the design
Health Care System     and performance of the health care system. While it is important to
Design Influences      have effective systems for monitoring the quality of care after it is pro-
Quality                vided, it is equally, if not more, important to try to “build it in” up front.
                       In particular, having access to needed services is a prerequisite for
                       receiving services of high quality. For example, if a program

                     . does not cover a range of preventive, acute, and continuing services that
                       are needed by the eligible population, then individuals may not have
                       access to needed services;
                     . does not allow adequate reimbursement for certain services, then prov-
                       iders may decline to provide those services and access to care may be
                       impeded;
                     . has inefficient or burdensome administrative requirements, then provid-
                       ers may choose not to accept patients covered by that program, again
                       curtailing access;
                     . has limited ability to direct patients to high-quality providers or to fos-
                       ter quality among participating providers, then the care patients receive
                       may be of varying levels of quality.

                       Systemic issues also affect quality. For example, an oversupply of a par-
                       ticular medical specialty or hospital service in a given area may mean
                       that no provider serves enough patients to develop and maintain neces-
                       sary skills or that unnecessary services will be provided in order to
                       maintain patient volume. Malpractice is another example. The fear of


                       Page 8                                            GAO/PEMDM-14BR   Health   Care QuaUty ~.mmme
                      malpractice suits may cause some providers to give care that is not
                      needed and, in the case of invasive procedures, put the patient at unnec-
                      essary risk. High malpractice premiums and judgments may contribute
                      to increasing health care costs, thereby lessening access to care for some
                      people. While a detailed consideration of these issues is beyond the
                      scope of this report, they are nonetheless important and deserve atten-
                      tion. Some of them are being addressed in other studies under way at
                      GAO.


                      Throughout the nation, many existing programs of quality assessment
Quality Assessment    and assurance can provide a foundation for the review of quality under
and;Assurance Occur   new initiatives to expand health care coverage. Purchasers of health
at R;rlanyLevels      care have instituted quality assessment and assurance programs to ful-
                      fill their fiduciary or public accountability responsibilities to persons
                      whose care they finance. The Health Care Financing Administration
                      conducts quality assurance activities for Medicare through its system of
                      Peer Review Organizations (PROS) for primarily hospital and some ambu-
                      latory care and through carriers and intermediaries for nonhospital
                      care. The Health Care Financing Administration’s annual release of hos-
                      pital mortality statistics and information on the quality of care in nurs-
                      ing homes are additional examples of such activities. State Medicaid
                      agencies have requirements to monitor the use of services by Medicaid
                      recipients; this is accomplished in a number of states through contracts
                      with the PROS.Finally, private insurers also have quality assessment and
                      assurance systems that resemble those of Medicare and Medicaid but
                      also vary, depending on the needs of the health care purchaser and
                      reimbursement methods.

                      The approaches above to quality assurance are sometimes referred to as
                      “external,” “ regulatory,” or “administrative” quality assurance. Their
                      intent is to make sure that the care for which payment is made is appro-
                      priate. There is an emphasis on utilization control, although outcomes
                      and other aspects of quality may also be examined, as exemplified by
                      the PRO’S use of generic quality screens. The reviews of care are fre-
                      quently conducted far from the site of care. While there may be some
                      interaction with, and feedback of information to, the providers whose
                      care is being reviewed, the providers themselves are not deeply involved
                      in the process of review. Quality assessment is a more dominant feature
                      of these activities than quality assurance.

                      The quality of care may also be monitored and influenced at the commu-
                      nity level or within a health service area. In addition to the review of


                      Page 9                           GAO/PEMD-90-14BR   Health   Care Quality   Assurance
Section 1
Quality, Quality   Assurance,   and the Health
Care System




the quality or appropriateness of individual services, quality-relevant
issues to be addressed include whether there is an appropriate supply
and distribution of health care providers of various types and special-
ties, whether the volume of services provided by individual providers is
high enough to maintain acceptable skill levels, and whether effective
mechanisms exist to refer patients to needed services, coordinate those
services, and place patients at appropriate levels of care. Because of the
highly individualized and dispersed nature of health care, many commu-
nities lack a structure for making such judgments and exerting leverage
on the health care system. However, there are some voluntary efforts to
develop community-wide programs. For example, a plan called Cleve-
land Health Quality Choice, involving the physician, hospital, and busi-
ness communities, is committed to evaluating the quality of hospital
care in the Cleveland area and directing patients to hospitals providing
high-quality care. In Minnesota, the Twin Cities Voluntary Health Care
Information Project is reviewing quality indicators for hospitals and
health plans in hopes of assisting health care purchasers and providers
in making purchasing decisions.

Finally, many health care institutions, as well as individual providers,
have voluntarily implemented their own internal quality assurance pro-
grams, reflecting a commitment to what has been termed “continuous
quality improvement.” The Harvard Community Health Plan, for exam-
ple, has developed and implemented a program to measure quality of
care that generates information to be used by clinicians and managers
for identifying the reasons for problems and instituting changes
intended to improve the quality of care. The Park Nicollet Medical
Center in Minneapolis has developed an internal system for monitoring
health care outcomes, concentrating initially on patients with heart dis-
ease and arthritis. Individual hospitals have instituted similar
approaches. Small physician practices, lacking an organizational struc-
ture and patient volume to warrant a structured, statistical reporting
system, have nevertheless implemented ongoing quality reviews
through such approaches as bringing in outside peer reviewers to review
their case records and to give them feedback on strengths and areas for
improvement. The key to these initiatives is that they are voluntarily
and internally generated. The health professionals involved are commit-
ted to determining the levels of quality of the care they currently pro-
vide, identifying opportunities for improvement, and seeing that
improvement occurs and quality is ensured.

Some health care analysts have viewed these various levels of quality
assessment and assurance as being either redundant or in opposition to


Page 10                                          GAO/PEMDM-14BR   Health   Care Quality   Assurance
Section 1
Quality, Quality   Assurance,   and the Health
Care System




one another, if not actually working at cross purposes. This is particu-
larly true when the paperwork and administrative requirements of
external reviews are burdensome and are not viewed as adequately
addressing and resolving true quality problems. However, there are
examples of situations in which the various levels have been comple-
mentary and mutually reinforcing. And, in some instances, the presence
of external review has provided an impetus for initiating internal
reviews.

We believe that the important thing to note is the considerable body of
knowledge about, and experience with, organizing and conducting qual-
ity assessment and assurance activities. There also appears to be grow-
ing interest in improving and expanding these activities among many of
the participants, including the medical community, consumers, employ-
ers, and purchasers of care. While this interest could be manifested in an
increased regulatory burden, it could also be developed into a more bal-
anced system of quality assurance that uses external entities to monitor
overall levels of quality of care and identify potential problems. More
direct interventions could be limited to instances in which serious qual-
ity problems are confirmed or when a provider’s internal quality assur-
ance mechanisms appear to have failed. The hope that a better balance
between internal and external quality assurance can be achieved has
shaped many of the observations and suggestions in the next section.




Page 11                                          GAO/PEMDBO-14BR   Health   Care Quality   Assurance
Section 2

Ai Comprehensive,National Quality Assurance ’
StjrategyIs Needed

                    We believe that a comprehensive, national approach to quality assur-
                    ance is required. By comprehensive and national we mean that, regard-
                    less of the source of payment or individual patients’ circumstances,
                    similar individuals with similar medical needs should be assured of
                    receiving the same type of appropriate, high-quality care. This implies
                    that similar requirements for quality assessment and assurance should
                    apply across all purchasers, providers, and health care settings. We
                    begin this section by discussing why we believe that a comprehensive
                    national strategy is needed. We then discuss the desirability of blending
                    into a balanced national system an external quality assurance capability
                    together with a community of health care providers who are committed
                    to continuing self-assessment and improvement.

                    Finally, we describe the essential elements of a comprehensive national
                    strategy and discuss what is needed to move from the current quality
                    assurance environment toward a comprehensive national strategy. The
                    elements that we see as essential are national practice guidelines and
                    standards of care, enhanced data to support quality assurance activities,
                    improved approaches to quality assessment and assurance at the local
                    level, and a national focus for developing, implementing, and monitoring
                    a national system. Although components of each element exist today, it
                    will take time and effort to develop, implement, and refine the type of
                    comprehensive national strategy we envision. But much of the ground-
                    work has already been laid.


                    We believe that a comprehensive national strategy is important for sev-
Reasonsfor a        era1 reasons. The first is equity: the intent and stringency of quality
Comprehensive       assurance requirements should not depend on whether the care is
National Strategy   financed by Medicare, Medicaid, expanded employer mandates, or some
                    other arrangement for coverage expansion. However, some variation or
                    flexibility in the specific review approaches is probably warranted to
                    account for differences in covered populations, types of services, or
                    reimbursement methods. For example, the focus of review for a popula-
                    tion consisting primarily of mothers and children might be different
                    than that for predominantly middle-aged employed persons. Similarly,
                    assessment methods for persons enrolled in a prepaid group practice
                    might concentrate on potential quality problems associated with
                    underuse of services, while those for persons whose care is reimbursed
                    on a fee-for-service basis might concentrate on the potential for overuse.
                    Nevertheless, the overall intent and stringency of review requirements
                    should be similar.



                    Page 12                          GAO/PEMD-90.14BR   Health   Care Quality   Assurance
                        Section 2
                        A Comprehensive,  National Quality
                        Assurance Strategy Is Needed




                        Second, health considerations dictate a comprehensive approach. Meet-
                        ing the health care needs of individuals frequently requires providing
                        care in a variety of settings (that is, hospitals, physicians’ offices, nurs-
                        ing homes, home health agencies, and so on) over an extended period of
                        time. What occurs in one setting or at one time is often influenced by
                        what occurred in a different setting at a different point in time. Thus, it
                        is important to be able to track the contents, appropriateness, and out-
                        comes of care for an episode of illness, regardless of when and where
                        the care was provided or who paid for it. Most current quality assurance
                        systems do not have this capability.

                        Finally, certain operational aspects of quality assessment require a com-
                        prehensive approach. For example, many judgments about quality are
                        based on patterns of care rather than isolated instances. If one were to
                        examine only the patients cared for by a single provider and who had a
                        common insurer or payment source, the number of patients might not be
                        sufficient to provide an accurate assessment of that provider’s perform-
                        ance. However, by combining information on care provided by a single
                        provider regardless of the source of payment, more stable profiles of
                        care can be generated, permitting more definitive quality assessments.


                        In general, our view is that the quality of care emerges most effectively
Thts Need for Balance   from an internal commitment by providers to ongoing self-assessment
                        and quality improvement. However, an internal commitment is not suffi-
                        cient. There is also a need for external entities to monitor general levels
                        of quality, to identify areas in which improvements are needed, and to
                        use appropriate means to get providers to change their behavior when
                        required.

                        The case for continuous quality improvement has been made most elo-
                        quently by Donald Berwick of the Harvard Community Health Plan:

                        “Real improvement in quality depends . . . on understanding and revising the pro-
                        duction processes on the basis of data about the processes themselves. . . . When one
                        is clear and constant in one’s purpose, when fear does not control the atmosphere
                        (and thus the data), when learning is guided by accurate information and sound
                        rules of inference, when suppliers of services remain in dialogue with those who
                        depend on them, and when the hearts and talents of all workers are enlisted in the
                        pursuit of better ways, the potential for improvement in quality is nearly
                        boundless.“’


                        ‘D Berwick “Sounding Board: Continuous Improvement as an Ideal In Health Care,” New England
                        Journal of iedicine, 32O:l (1989), 64.



                        Page 13                                   GAO/PEMDBO-14BR      Health   Care Quality   Assurance



                                                             .I
      Section 2
      A Comprehensive,  National Quality
      Assurance Strategy Is Needed




-.,
      However, Berwick also acknowledges the need for external monitoring,
      noting that “politically, at least, it is absolutely necessary for regulators
      to continue to ferret out the truly avaricious and dangerously
      incompetent.“2

      We also believe that external reviewers have legitimate and necessary
      functions to serve. The primary function is overall surveillance and
      monitoring of the health care system. In addition, a number of develop-
      mental and technical assistance roles are essential to establishing a com-
      prehensive, national quality assurance strategy. They include assisting
      providers in the development of quality measurement tools, aggregating
      data on quality centrally to help providers learn from each other, pro-
      viding technical support and training in the principles of quality
      improvement, encouraging and funding studies designed to expand the
      knowledge base on medical care effectiveness, and specifying relevant
      quality review criteria.

      In order to establish and maintain an appropriate balance, both internal
      and external quality assurance workers must do their part. External
      reviewers can adopt attitudes and strategies that acknowledge and
      encourage the efforts of individual providers to ensure that their
      patients receive quality care. For example, an approach that focuses on
      developing information on variations among providers in treating par-
      ticular conditions and working with providers to reduce that variation
      may be more acceptable and effective than labeling aberrant providers
      as “bad” and demanding that they change. Providers who demonstrate
      that their behavior consistently conforms to established quality stan-
      dards might be reviewed less frequently or less intensively. Similarly,
      such providers might be given an advantage as purchasers develop con-
      tracts with selected provider groups. On the other side, it is the respon-
      sibility of providers to be attentive to new information on health care
      effectiveness as it becomes available and to develop and maintain pro-
      grams that demonstrably lead to continuing improvements in quality.




      213erwick,p. 64.



      Page 14                              GAO/PEMD-99-14BR   Health Care Quality   Assurance
                          Section 2
                          A Comprehensive,  National Quality
                          Assurance Strategy Is Needed




Elebents of a
Co#prehensive
National Strategy

Pra tice Guidelines and   We believe that national, publicly available practice guidelines and stan-
Sta1 dards                dards are an essential element of a comprehensive quality assurance
                          system. We use the term “practice guidelines” to refer to guidelines that
   I                      assist in determining how diseases, disorders, and other health condi-
                          tions can most effectively be prevented, diagnosed, treated, and clini-
   (
   ,                      tally managed. Nevertheless, the circumstances of individual patients
                          may justify deviations from practice guidelines. The term “standards” is
                          used to refer to a variety of either professionally or statistically derived
                          standards of quality, performance measures, and medical review criteria
                          through which health care providers and other appropriate entities may
                          assess or review the quality of health care.

                          The difficulties inherent in developing such practice guidelines and stan-
                          dards should not be understated. For example, it is important to base
                          guidelines and standards on sound scientific evidence about the effec-
                          tiveness of medical care whenever possible and to allow more flexibility
                          and variation in medical practice when uncertainty exists. The develop-
                          ment of practice guidelines and standards for some conditions and pro-
                          cedures is feasible.

                          However, there is general agreement that the knowledge base on the
                          efficacy and effectiveness of many aspects of medical care is weak or
                          nonexistent. Here, the development of guidelines and standards will
                          require additional information on medical care effectiveness. A mecha-
                          nism for the development and updating of practice guidelines and stan-
                          dards is needed. Other difficulties that will have to be resolved include
                          specifying appropriate methods for developing and reviewing guidelines
                          and standards, setting priorities for which guidelines and criteria to
                          develop and when to update and revise existing guidelines and stan-
                          dards, and pilot-testing, evaluating, and disseminating the guidelines
                          and standards.

                          In addition, simply developing the guidelines and making them public
                          will not, by itself, ensure quality. For example, the New England Journal




                          Page 15                              GAO/PEMD-90-14BR   Health   Care Quality   Assurance
Section 2
A Comprehensive,  National Quality
hseurance Strategy Is Needed




of Medicine recently published a study about the effect of cesarean sec-
tion guidelines on the use of cesarean sections3 Despite widespread
knowledge and endorsement of the guidelines by the obstetricians in
Ontario, Canada, and a belief that they had reduced their use of
cesarean sections, actual rates of cesarean section changed very little
after the introduction of the guidelines. However, the Maine Medical
Assessment Foundation has had some notable successes in changing
physicians’ practice patterns with a combination of education and feed-
back about how their practice patterns compare to those of their peers.

More research and experimentation is needed on the effectiveness of
alternative strategies for making guidelines available to physicians and
encouraging them to accept them and change their behavior as needed.
And the guidelines and standards will have to be incorporated into
effective internal and external programs for assessing and assuring
quality of care.

Finally, there has been considerable discussion about the potential for
the use of practice guidelines to reduce the provision of inappropriate or
unnecessary care, thereby reducing health care expenditures and possi-
bly saving sufficient money to pay for an expansion of coverage to per-
sons currently uninsured. This is an appealing concept. Partial estimates
of potential savings range from $139 million in Medicare Part B expendi-
tures if guidelines were used for a set of just eight specific procedures to
about $808 million if practice guidelines for the same procedures were
used by all purchasers of care. If, in addition to reductions in the inap-
propriate use of services, one could make reductions in the overall inten-
sity of services, average annual savings could be $22 billion.4

However, some of the estimates fail to account for the potential cost of
alternative treatments that might be provided in place of procedures
found to be inappropriate and the likelihood that a program intended to
reduce inappropriate care would never be fully successful. Some fail to
consider the possibility that the use of some practice guidelines might
actually increase expenditures over the long run by increasing the
number of services and procedures that are not now provided as often


3S.L. Lomas, et al., “Do Practice Guidelines Guide Practice?’ New England Journal of Medicine, 321
(lQSQ), pp. 1306-1311.

4These particular estimates were published in a technical appendix to National Leadership Commis-
sion on Health Care, For the Health of a Nation (Ann Arbor, Mich.: Health Administration Press,
1989).



Page 16                                      GAO/PEMD-90-14BR      Health   Care Quality   Assurance
                          section 2
                          A Comprehensive,  National Quality
                          Ammuwe    Strategy Ia Needed




    I                     as they should be. For these and other reasons, it is unclear whether
    I                     potential cost savings might be obtained by using practice guidelines.

                          Despite the difficulties involved in developing and using national guide-
                          lines and standards, the need for them has been recognized. The Council
                          of Medical Specialty Societies, the American Medical Association, and
                          other provider organizations have publicly endorsed the need for the
                          medical profession to step forward and take the lead in developing
                          guidelines and standards. The National Leadership Commission, the
                          Physician Payment Review Commission, the Institute of Medicine, and
                          others have recommended that effectiveness research and guideline
                          development be made a top priority. The Congress has created the
                          Agency for Health Care Policy and Research within the Public Health
                          Service

                          “to enhance the quality, appropriateness, and effectiveness of health care services,
                          and access to such services, through the establishment of a broad base of scientific
                          research and through the promotion of improvements in clinical practice and in the
                          organization, financing, and delivery of health care services.” (Public Law No. lOl-
                          229, sec. 6(a))

                          The Agency is to accomplish this purpose by conducting and supporting
                          a wide range of activities including research, evaluations, demonstra-
                          tions, education and training, data and data base development, informa-
                          tion dissemination, and development of practice guidelines and
                          standards.


An Enhanced Data System   We believe that a data base that contains at least a set of minimum data
                          elements collected on each health care encounter regardless of pur-
                          chaser or setting and that integrates those data for analysis is an impor-
                          tant element of a comprehensive quality assurance system. The data
                          should include information not only on the medical care provided during
                          the encounter but also on any judgments about quality. An enhanced
                          data base would enable monitoring the quality of care provided to indi-
                          vidual patients across health care settings and providers. For example,
                          evaluating the outcome of a surgical intervention requires knowing
                          what happened to the patient after he or she left the hospital. An
                          enhanced data base would also allow for the profiling of individual pro-
                          vider practice patterns based on care paid for by all purchasers rather
                          than a single purchaser. Currently, these types of analyses are often not
                          possible. In addition, health and functional status information on sam-
                          ples of the population would be needed in order to track changes in the



                          Page 17                               GAO/PEMD-90.14BR   Health   Care Quality   Assurance
                        section 2
                        A Comprehensive,  National Quality
                        Assurance Strategy Is Needed




                        health of the population over time and identify variation in health out-
                        comes and functional status among population groups or geographical
                        areas. This would be useful in monitoring the performance of the health
                        system as a whole and setting national health priorities.

                        For hospital care, it would be possible to build upon existing claims for-
                        mats and fairly uniform hospital discharge data across purchasers.
                        However, for other settings, there is very little uniformity across pur-
                        chasers. An area of particular concern is the lack of experience with
                        obtaining detailed information from ambulatory care settings and par-
                        ticularly from physicians’ offices. For Medicare and some private insur-
                        ers, diagnostic data are now included on claim forms used for
                        ambulatory care. This will be useful but still quite minimal for quality
                        assessment purposes. Significant attention will have to be devoted to
                        defining an appropriate set of minimum elements for this type of health
                        care encounter and to ensuring that the information provided is reliable
                        and valid. The recent revision to the 1981 National Ambulatory Medical
                        Care Minimum Data Set by the National Committee on Vital and Health
                        Statistics provides a start toward specifying such a set of data elements.

                        Even with agreement on the appropriate data elements, the implementa-
                        tion of an integrated data system will not be simple. The resources
                        required for collecting, processing, and maintaining this data base will
                        be substantial and include both human resources and computer hard-
                        ware and software. The integration of data across settings, providers,
                        and purchasers will require the use of unique, common identifiers for
                        providers and purchasers as well as for patients. The data coming into
                        the system must be checked regularly to ensure their accuracy. The data
                        will have to be organized so that all encounters for an individual patient,
                        as well as all services provided by a particular provider, can be easily
                        collated and analyzed. The system must also be flexible enough to
                        accommodate the inevitable changes and improvements in data and
                        quality assessment methods that will come with time. Safeguards for
                        privacy and confidentiality will also need to be addressed.


An Improved System of   Our reviews of the literature as well as the results of some quality
Local Review            review programs leave little doubt that significant numbers of patients
                        are currently receiving inappropriate or poor-quality care. For example,
                        in past studies, we have cited estimates of rates of inappropriate use of
             u
                        surgical procedures ranging from 14 to 32 percent as well as rates of




                        Page 18                              GAO/PEMD-SO-14BR   Health   Care Quality   Assurance
Section 2
A Compreheneive,  National Quality
Assurance Strategy Is Needed




inappropriate hospital admissions ranging from 7 to 19 percent.” In
addition, our evaluations of current quality assurance programs suggest
that those programs are not identifying significant proportions of cases
with potential quality problems. For example, SuperPRO regularly
reviews a random sample of Medicare cases previously reviewed by PROS
and typically questions the appropriateness of hospital admission in
almost six times as many cases as the PROss6 Similarly, our review of the
initial screening of cases in military hospitals for occurrences indicating
potentially substandard care found that many such occurrences were
missed in the initial screening process.7

Despite the importance of continuous quality improvement strategies in
the long run, our past work has shown that improvements in external
quality assurance mechanisms are needed in order to achieve the goal of
appropriate, high-quality medical care for all Americans, We believe
that there are a number of key components for improving the conduct of
quality assurance within the framework of a comprehensive, national
strategy. First, the quality assurance activities need to be conducted by
local review entities that are held accountable for identifying instances
of poor quality and improving overall patterns of care within their geo-
graphical area. Second, the local review entities should have available a
uniform set of methods for reviewing care (including practice guidelines
and standards), developing and implementing interventions and report-
ing information on the results of reviews and interventions. Finally, a
national organization is needed to develop the national guidelines and
review methods and to coordinate and oversee the activities of the local
review entities.

By local review entities we mean organizations that are close enough to
the local health care community that appropriate recognition of the
unique circumstances of the community can be made and that the type
of balanced quality assurance system we advocated earlier can be fos-
tered and maintained. The state-level PRO program is one organizational
model that approximates this goal. The individual PROS are charged with
ensuring that the care provided to Medicare beneficiaries is appropriate
and of high quality and, at the same time, with maintaining a positive,
cooperative relationship with the provider community.

“U. S. General Accounting Office, Medicare: Improvements Needed in the Identification of Inappropri-
ate Hospital Care, GAO/PEMD-SO-7 (Washington, DC.: December 20,1989), pp. 3-4.

“U. S. General Accounting Office, Medicare, p. 3.
7U S General Accounting Office, DOD Health Care: Occurrence Screen Program Undergoing Changes
bui WeaknessesStill Exist, GAO/m-89-36     (Washington, D.C.: January 5,1989).



Page 19                                       GAO/PEMD-SO-14BR      Health   Care Quality   Assurance
                                                                               I




Section 2
A Comprehensive,  National Quality
Assurance Strategy b Needed




Greater uniformity and effectiveness in review methods, intervention
approaches, and reporting of results will be necessary in order to ensure
that all patients are receiving an equally high level of quality. However,
moving toward greater uniformity is not meant to imply that all reviews
must be identical. Some flexibility is needed to tailor review methods
and interventions to specific situations. For example, generally speak-
ing, reviewing the appropriateness of a hospital length of stay would be
reasonable. However, since the Medicare Prospective Payment System
reimburses hospitals a set amount regardless of the length of stay, the
incentive for hospitals is to release patients earlier rather than later.
Therefore, the review of the appropriateness of a hospital discharge
under Medicare generally focuses on the possibility that premature dis-
charge has occurred rather than on inappropriate days at the end of the
stay.

A variety of existing methods of quality assessment could serve as the
core of the common review approaches. Reviews could be done prior to
care being received (prospective review) that typically focus on the need
for particular procedures, the appropriateness of the proposed setting
(often the hospital), and the proposed length of stay. The limited infor-
mation available suggests that these reviews are cost-effective.

Reviews could be done while the care is being delivered (concurrent
review) and would typically focus on the need for continued care but
might also address a lack of expected progress or improvement. This
type of review tends to be expensive and is often limited to potentially
high-cost cases.

Reviews could be done after the care is completed (retrospective
reviews) that examine the process and outcomes of care based on infor-
mation contained in the medical record or on the claims form. Reviews
based on the medical records are relatively expensive but can address a
wide range of appropriateness and quality concerns, including both
overuse and underuse.

Reviews could be done of aggregate data from either claims or medical
records (profiling; small area variation analysis) that focus on identify-
ing providers who differ in one way or another from their peers in their
process or outcome of care. These could be used to target both prospec-
tive and retrospective reviews.

Reviews could be done of prescription drug use, prospectively or retro-
spectively, that focus on ensuring appropriate use and limiting adverse


Page 20                              GAO/PEMD-90.14BR   Health   Care QuaBty Assurance
Section 2
A Comprehensive,  National Qua&y
Assurance Strategy Is Needed




reactions and also allow the targeting of educational and other interven-
tions for both patients and providers.

Similarly, a number of intervention approaches that have been tried
could serve as the basis for developing a uniform set of interventions for
use by local review entities.

One approach is that of undertaking educational interventions aimed at
providing the medical community with information on the appropriate
uses and costs of various medical services. The evidence on the effec-
tiveness of this approach in changing provider behavior is mixed.

Another is to provide feedback of review results to providers, either on
individual cases or on aggregate practice patterns. While generally
viewed as more effective than simple educational interventions, its use-
fulness has been limited by the unavailability of comprehensive data
across purchasers and settings.

Yet another approach consists of restrictions on providers’ use of partic-
ular services (such as the total number of laboratory tests) or on their
practice (such as hospital or operating room privileges). Restrictions
have sometimes been met with resistance and often change behavior
only as long as they remain in place.

One more approach is to offer incentives (such as increased reimburse-
ment, more patients, reduced administrative requirements) for provid-
ers to conform to particular standards of medical practice. These are
being increasingly used, particularly in managed care organizations such
as preferred provider organizations and health maintenance
organizations.

Last, monetary sanctions can be imposed or providers can be excluded
from the program (as in the Medicare program) if they provide poor-
quality care and are unwilling or unable to change their practice
patterns.

Additional development, experimentation, and evaluation of both
assessment and intervention techniques will be needed in order to create
an effective, comprehensive, national strategy.

Finally, even though some flexibility in the implementation of reviews
and interventions is necessary, a common set of reporting requirements,
and particularly reporting categories, will be needed in order to oversee


Page 21                            GAO/PEMLMO-14BR   Health   Care Quality   Assurance
                            Section 2
                            A Comprehensive,  National Quality
                            Assurance Strategy Is Needed




                            and evaluate the quality assurance activities at a national level. One of
                            the greatest weaknesses of the current system of quality assurance is
                            that there is no simple way to compare information on quality of care
                            from one program to another or to monitor changes in levels of quality
                            over time. This is another area in which developmental work is needed.


A National Organizational   We believe a national organizational focus is required to accomplish the
Foe’s                       many developmental, implementation, and evaluation tasks needed to
   u                        set up and operate a comprehensive, national system of quality assur-
                            ance. Some of the developmental tasks have been alluded to above-
                            supporting research on the effectiveness of medical care and developing
   I                        improved quality assessment and assurance techniques. Others include
                            developing practice guidelines and standards, uniform reporting require-
                            ments for both medical data and data on the results of quality reviews,
                            and methods of changing provider behavior, including approaches for
                            fostering internal quality assurance activities, Implementation will
                            require the development and oversight of local review organizations
                            that have the necessary tools and skills in data integration and analysis,
                            quality assessment, and quality assurance. Finally, the national organi-
                            zation will also require considerable expertise in data analysis, evalua-
                            tion, and management in order to integrate the information coming from
                            the various local review entities into a national picture of health care
                            quality, to evaluate the performance of the local review entities, and to
                            identify areas in which greater attention to quality is needed.


                            Most of the discussion of quality assurance to this point pertains to the
The Role of Provider        review of care provided to individual patients. However, it is also impor-
Accreditation and           tant to review the credentials, facilities, staff, and administrative proce-
Certification               dures of health care providers (so-called “structural” quality assurance)
                            to determine a provider’s capability or potential for providing high qual-
                            ity care. While such review cannot ensure that quality care is actually
                            provided, it is important for ensuring that at least the necessary ele-
                            ments for providing quality care exist and that providers without those
                            elements are not allowed to participate.

                            Established accreditation or certification programs exist for hospitals,
                            nursing homes, and many ambulatory care settings. However, one set-
                            ting in which little review of this type occurs is the individual physi-
                            cian’s office. We believe that such review may be particularly important
                            for physicians who do not have hospital admitting privileges and who
                            are not part of a larger medical network through which their care might


                            Page 22                              GAO/PEMLMO-14BR   Health   Care Quality   Assurance
                        Section 2
                        A Comprehezwive,  National Quality
                        Aeaurance Strategy Is Needed




                       be scrutinized. For selected physicians in this category, on-site visits
                       might be warranted to ensure that medical records are legible, inte-
                       grated, and filed; that X-ray and laboratory equipment is properly cali-
                       brated, maintained, and used; and that the process of care (as revealed
                       through a review of patients’ records) is appropriate and high in
                       quality.


                       Expanding access to care may bring some patients into the traditional
   Importance of       health care system for the first time. They will need assistance in learn-
   sumer Education     ing to access the system appropriately, select primary care physicians,
                       and understand the importance of an ongoing relationship with an
                       “accountable” provider. Providers will need assistance in working with
                       these new patients and helping them to use the system wisely. All con-
                       sumers will need assistance in using the increasingly available informa-
                       tion on the appropriateness and quality of care to make prudent choices
                       among providers.


                       We believe that a comprehensive national quality assurance strategy is
Conclusion             needed in order to ensure that all Americans receive high-quality medi-
                       cal care. A comprehensive national strategy is important for several rea-
                       sons: (1) to ensure that the treatment of individuals does not depend on
                       how the care is financed; (2) to be able to examine the contents, appro-
                       priateness, and outcomes of care, regardless of when and where the care
                       was provided or who paid for it; and (3) to meet the legitimate needs for
                       information on quality of the many different actors in the health care
                       system.

                       We see four essential elements of a comprehensive national strategy:

                     . national practice guidelines and standards of care,
                     . enhanced data to support quality assurance activities,
                     . improved approaches to quality assessment and assurance at the local
                       level, and
                     . a national focus for developing, implementing, and monitoring a national
                       system.

                       We believe that the basic elements necessary to move toward a compre-
                       hensive national strategy currently exist. However, additional time and
                       resources will be required to fully develop, implement, and evaluate the




                       Page   28                             GAO/PEMD90-14BR   Health   Care Quality   Assurance
                                                                                           4.

Section 2
A Comprehensive,  National Qudty
Amuance   Strategy Is Needed




components that will make the system truly effective. The understand-
ing and cooperation of health care providers, purchasers, consumers,
and policymakers are also essential.




Page 24                            GAO/PElblD-SO-14BR   Health   Care Quality   Awurance
Y




    Page 26   GAO/PEMD-90-14BR   Health   Care Quality   Assurance
                                                                                          c
Appendix I                                                                                    .i

Ekpert Panel on Quality AssuranceIssues                                                             ’


               Robert Brook, M.D., Sc.D.
               Deputy Director, Health Program
               The Rand Corporation

              John W. Bussman, M.D.
              Medical Director
              Oregon Medical Professional Review Organization

              Robert Keller, M.D.
              Executive Director
              Maine Medical Assessment Foundation

              Kathleen N. Lohr, Ph.D.
              Senior Professional Associate
              Institute of Medicine
              National Academy of Sciences

              Barbara Matula
              Director
              North Carolina Division of Medical Assistance

              Michael R. McGarvey, M.D.
              Corporate Vice President, Health Affairs
              Empire Blue Cross and Blue Shield

              Leslie Michelson
              President and Chief Executive Officer
              Value Health Sciences, Inc.

              R. Heather Palmer, M.B., BCh., S.M.
              Department of Health Policy and Management
              Harvard School of Public Health

              Gerald Plotkin, M.D.
              Medical Director, Medical Groups Division
              Harvard Community Health Plan

              Cary Sennett, M.D., M. Phil.
              Medical Director and Director of Technology Assessment
              AETNA Life and Casualty




              Page 26                         GAO/PEMDBO-14BR   Health   Care Quality   Assurance
,
        Appendix I
        Expert Panel on Quality   Assurance   Issues




        Michael Stocker, M.D.
        Executive Vice President
        U.S. Health Care

        Leon Wyszewianski, Ph.D.
        Department of Health Services Management and Policy
        The University of Michigan School of Public Health

        Edward Zalta, M.D.
        Chairman of the Board and Chief Executive Officer
        Capp Care




    w




        Page 27                                        GAO/PEMDQO-14BR   Health   Care Quality   Assurance
Appendix II

M&or Contributors to This Report


                     Linda Demlo, Assistant Director for Program Evaluation in Human
Program Evaluation      Services Areas
and Methodology      Roger Straw, Project Manager
Division




                     Page 28                       GAO/PEMD-90-14BR   Health   Care Qudity   Assurance
Page 29   GAO/PEMD-90-14BR   Health   Care Quality   Assurance
Page 30   GAO/PEMlHO-14BR   Health   Care Qudty   Assurance
Page 31   GAO/PEMD-Wl4BR   Health   Care Quality   Assurance
1 RelatedGAO Reports


                Medicare: Improvements Needed in the Identification         of Inappropriate
                Hospital Care (GAO~PEMD-90-7,December 20, 1989).

                Medicare: Assuring the Quality of Home Health Services (GAOIHRD-90-7,
                October 10, 1989).

                VA Health Care: Improvements Needed in Procedures to Assure Physi-
                cians Are Qualified (GAO/HRD-89-77, August 22, 1989).

                Health Care: Initiatives in Hospital Risk Management (GAO/HRD-89-79,
                July 18, 1989).

                Prescription Drugs: Information on Selected Drug Utilization Review
                Systems (GA~/PEMD-~~-~~, May 24, 1989).

                DOD Health Care: Occurrence Screen Program Undergoing Changes but
                Weaknesses Still Exist (GAO/HRD-89-36, January 5, 1989).

                Medicare: An Assessment of HCFA’s 1988 Hospital Mortality Analyses
                (GAO~PEMD-89-ll~R, December 13, 1988).

                Medicare PROS:Extreme Variation in Organizational Structure and Activ-
                ities (GAOIPEMD-89-n?s, November 8, 1988).

                VA Hospital Care: A Comparison of VA and HCFA Methods for Analyzing
                Patient Outcomes (GAO~PEMD-89-29,June 30, 1988).

                Medicare: Improved Patient Outcome Analyses Could Enhance Quality
                Assessment (GA~/PEMD-~~-~~, June 27,1988).

                Medicare: Improving Quality of Care Assessment and Assurance (GAO/
                PEMD-88-10, May 2, 1988).

                VA Health Care: Assuring Quality of Care for Veterans in Community
                and State Nursing Homes (GAO/HRD-88-18, November 12, 1987).

                Medicare: Preliminary Strategies for Assessing Quality of Care (GAO/
                PEMD-87-16BR,July IO, 1987).

                Medicare: Reviews of Quality of Care at Participating Hospitals (GAO/
            Y
                HRD-86-139,September 15, 1986).




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