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Executive Summary

With great speed and relatively little public awareness, a significant change has occurred in the way some decisions are made about a patient's medical care. Decisions that were once the exclusive province of the doctor and patient now may be examined in advance by an external reviewer—someone accountable to an employer, insurer, health maintenance organization (HMO), or other entity responsible for all or most of the cost of the care. Depending upon the circumstances, this outside party may be involved in discussions about where care will occur, how treatment will be provided, and even whether some treatments are appropriate at all.

Such "utilization management" is part of a complex balancing act created by society's struggles with two important questions. First, how do we ensure that people get needed medical care without spending so much that we compromise other important social objectives? Second, how do we discourage unnecessary and inappropriate medical services without jeopardizing necessary high-quality care?

Experience indicates that these questions have no fixed answers. Rather, we find a series of working hypotheses and partial solutions that are continually revised, discarded, and even reinvented as changes occur in medical technology, social values, economic conditions, and other circumstances. In this preliminary report, the Committee on Utilization Management by Third Parties of the Institute of Medicine examines one current working hypothesis—that external review of the appropriateness of proposed medical services for individual patients can improve the way care is provided and, as one consequence, help constrain health benefit costs.



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Page 1 Executive Summary With great speed and relatively little public awareness, a significant change has occurred in the way some decisions are made about a patient's medical care. Decisions that were once the exclusive province of the doctor and patient now may be examined in advance by an external reviewer—someone accountable to an employer, insurer, health maintenance organization (HMO), or other entity responsible for all or most of the cost of the care. Depending upon the circumstances, this outside party may be involved in discussions about where care will occur, how treatment will be provided, and even whether some treatments are appropriate at all. Such "utilization management" is part of a complex balancing act created by society's struggles with two important questions. First, how do we ensure that people get needed medical care without spending so much that we compromise other important social objectives? Second, how do we discourage unnecessary and inappropriate medical services without jeopardizing necessary high-quality care? Experience indicates that these questions have no fixed answers. Rather, we find a series of working hypotheses and partial solutions that are continually revised, discarded, and even reinvented as changes occur in medical technology, social values, economic conditions, and other circumstances. In this preliminary report, the Committee on Utilization Management by Third Parties of the Institute of Medicine examines one current working hypothesis—that external review of the appropriateness of proposed medical services for individual patients can improve the way care is provided and, as one consequence, help constrain health benefit costs.

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Page 2 The validity of this hypothesis is of interest to everyone involved with health care—patients and potential patients, practitioners and others who provide medical services, employers, unions, insurers, and makers of public policy. Utilization management has become a growth industry, spurred by purchasers' search for control over rapidly escalating expenditures for health care. One recent survey reported average cost increases from 1987 to 1988 of 14 percent for employers with insured health benefit plans and 25 percent for employers with self-insured plans. In the private insurance sector, many commercial insurers, Blue Cross and Blue Shield plans, and HMOs have seen substantial losses, and some commercial insurers are withdrawing from the group health insurance market. To the dismay over rising health care costs has been added a growing perception that a significant amount of medical care is unnecessary and sometimes harmful. The studies that have contributed to this perception have also produced some optimism that external review of physician practice decisions could detect unnecessary care, influence physician behavior, and reduce costs without jeopardizing access to needed services. Such review has also appeared to offer an alternative to retrospective denials of claims for benefits and across-the-board cutbacks in health plan coverage. In this preliminary report, the Committee on Utilization Management by Third Parties examines several questions. • How effective is utilization management in limiting utilization and containing costs? • Are there unintended positive and negative consequences of bringing an outside party into the process of making decisions on patient care? • Are utilization management organizations and purchasers sufficiently accountable for their actions or are new forms of oversight, perhaps government regulation, needed? • What are the responsibilities of health care providers and patients for the appropriate use of health services? The focus is on the private sector, in which two-thirds of the nonelderly population are covered directly or as dependents under employer-sponsored health plans. An estimated one-half to three-quarters of the individuals in these plans are subject to utilization management. Current Status of Utilization Management Early in its discussions the committee realized that the term utilization management has no single, well-accepted definition. As with the labels cost containment and managed care, different people may mean different things by the term. In this report, the committee considers utilization management as a set of techniques used by or on behalf of purchasers of health benefits

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Page 3 to manage health care costs by influencing patient care decision-making through case-by-case assessments of the appropriateness of care prior to its provision. The dominant utilization management strategy is prior review of proposed medical or surgical services, which includes several related techniques such as preadmission review, continued-stay review, and second surgical opinions. Prior review provides advance evaluation of whether medical services planned for a specific patient conform to provisions of health plans that limit coverage to medically necessary care. Typically, all elective hospital admissions are subject to such review before the patient enters the hospital, all emergency admissions must be reviewed within a short period following admission, and the need for continued hospital care is assessed periodically. High-cost case management is a more focused strategy that concentrates on the relatively few people in any group who have generated or are likely to generate very high expenditures. The management process involves an assessment of an individual's health care needs and personal circumstances to determine whether extra assistance in planning, arranging, and coordinating a specialized treatment plan will permit appropriate but less costly care. If the individual's health plan does not cover some elements of the treatment plan, individual exceptions to these coverage limitations may be approved. Empirical evidence on the effects of utilization management is fairly limited and suffers from a number of methodological weaknesses. Despite these limitations, the committee believes that available evidence, taken together, indicates that utilization management has had some impact on health care use and costs. Specifically: • Utilization management has helped to reduce inpatient hospital use and to limit inpatient costs for some purchasers beyond what could be expected from other factors such as growth in outpatient resources, changes in benefit plan design, and shifts in methods for paying hospitals. Employee groups with higher initial levels of hospital use tend to show more change than groups with lower initial hospital utilization. • The impact of utilization management on net benefit costs is less clear. Savings on inpatient care have been partially offset by increased spending for outpatient care and program administration. Some of this offset is an expected and acceptable result of utilization management (and other factors), and some is an unwanted consequence of moving care to outpatient settings, where fewer controls on use and price now operate. • Although it probably has reduced the level of expenditures for some purchasers, utilization management—like most other cost containment strategies—does not appear to have altered the long-term rate of

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Page 4 increase in health care costs. Employers who saw a short-term moderation in benefit expenditures are seeing a return to previous trends. Systematic evidence about the impact of utilization management methods on the quality of care and on patient and provider costs is virtually nonexistent. Purchasers have not demanded such evidence, and researchers have found the measurement of these effects even more costly, time-consuming, and uncertain than the measurement of effects on purchasers' costs. During the course of this study, the committee did not locate documented anecdotes or other information to suggest that prior review programs in the private sector are jeopardizing patient safety. However, the processes of prior review and associated changes in courses of treatment may cause anxiety and inconvenience to some patients. And utilization management does add to the administrative burdens on practitioners and institutional providers and contributes to resentment about reduced professional autonomy and satisfaction. More positively, the committee has some confidence that high-cost case management is easing some financial and emotional burdens on catastrophically ill patients and those who care for them. Several features of utilization management are important to keep in mind. First, utilization management as it currently operates in the private sector is highly variable, which makes generalizations difficult. Second, until recently utilization management has focused on the site, duration, and timing of medical care. The unnecessary use of the hospital, rather than the actual need for a particular service, has been the main target. The primary strategy has been discussion and negotiation about appropriate care. Refusals to certify benefits appear uncommon, perhaps 1 to 2 percent of cases. Third, utilization management in the private sector operates under few explicit legal restrictions. There is, however, considerable awareness among review organizations and major purchasers of the legal risks inherent in efforts to influence patient care decisions and operationalize the terms of health benefit plans. And there appears to be growing recognition of the conventional—but not infallible—protections offered against liability by good management, good judgment, good faith, and good documentation. The lack of good research on the effectiveness and impact of utilization management is a frequent theme in this report, which likewise notes that research on the effectiveness of many medical procedures is also limited. As utilization management expands its review of the actual need for specific procedures, the clinical foundation for such assessments becomes more important. Good research is a critical base for good utilization management. Moreover, the research on feedback and education strategies to influence physician decisions suggests that utilization management criteria will be

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Page 5 more likely to win acceptance and change behavior if they are based on clear clinical evidence from respected academic and professional sources. How Utilization Management Is Evolving The continuing evolution of utilization management is most evident in its scope and its operational efficiency. The reasons for these developments are several. First, the initial savings from shifting the site and timing of care have largely been realized, and the survival of review organizations may depend on their continuing ability to affect benefit costs. Second, review organizations are being influenced by researchers' beliefs that much care is still inappropriate and unnecessary. Third, the administrative and other costs of review programs, including physician dissatisfaction and employee confusion, make simplification and efficiency important objectives. Thus, based on survival instincts and evidence of continuing utilization problems, the emphasis of utilization management is beginning to expand from the site and duration of care to include the actual need for specific types of inpatient and outpatient services. Again, the availability of sound clinical criteria for assessing medical necessity is one constraint on this movement. Legal concerns are another factor. At this time, the committee does not see utilization management moving toward intentional rationing of clinically necessary medical services. A decision not to approve payment for an unnecessary service is not rationing per se. However, the committee recognizes that there may be instances when review nurses or physicians may apply implicit cost-effectiveness judgments. In high-cost case management, such judgments may be explicit, but the intention is to determine whether services normally excluded from a benefit plan should be covered to permit less costly but still appropriate care for a particular patient. With respect to administrative costs, frequently mentioned priorities include greater computerization, expanded use of treatment protocols in high-cost case management, and greater targeting of reviews to high-payoff categories of problems and services. In some cases, gains in operational efficiency should reduce administrative burdens on patients, physicians, and institutional providers of care. Issues For the Future The committee has identified some shortcomings in utilization management or gaps in the knowledge of it that raise concerns about patient protection, particularly given the growing focus on the appropriateness of

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Page 6 specific proposed procedures. If the positive potential of utilization management for improving the cost-effective use of health resources is to be encouraged, then the committee believes that several issues need attention. • Objective methods and resources for evaluating the impact of utilization management on health care costs, use, and quality are limited and must be improved. There needs to be more confidence about what works and what does not and under what circumstances. • The review criteria used by those engaged in utilization management (including hospitals and HMOs) should be available for outside scrutiny. Physicians, purchasers, and patients should know the basis for judgments about the site, timing, and need for care. • Systematic investigation of the effects of utilization management not only on purchaser costs but also on patient and provider costs and attitudes should be a higher priority. A more complete picture of costs and benefits is needed. • The opportunities for patients and physicians to appeal review decisions should be clearly described and free from unreasonable complexity, delay, or other barriers. This is an essential protection for patients. • The explicit links between utilization management and quality assessment and assurance mechanisms need to be clarified and strengthened. Review organizations should have standard operating procedures for responding to the quality problems they uncover. Recommendations For the Near Term The committee believes that utilization management has sufficient promise that a number of short-term and long-term efforts should be made to promote its positive potential and guard against its shortcomings. A prudent course in the near term is for the parties involved in utilization management—purchasers, review organizations, physicians, and patients— to accept greater responsibility for the reasonable and fair conduct of utilization management and the appropriate use of medical care. Responsibilities of Employers and Purchasers As financers of both utilization management and health services, employers are in the best position to exert influence on the conduct of utilization management. Although such an effort may be beyond the resources of small employers, larger purchasers should investigate the operating procedures and capabilities of the organization or organizations from which they purchase review services. This review should include organizations such as HMOs that provide prior review and high-cost case management as part of a broader package of services. Purchasers can visit review organizations,

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Page 7 request detailed information and references, and seek advice from business coalitions, consultants, and other similar resources. Human resources staff should be trained to respond to employee questions, assist with problems, and handle grievances. Employers should also examine other aspects of their health benefit plans for impediments to the appropriate use of medical services or the rational payment for these services. Moreover, workers must be clearly informed of their responsibilities and rights. Also, although employers have the right and responsibility to take vigorous actions to manage the costs of employee health benefits, they should respect both the confidentiality of medical information about employees and the primary obligation that physicians have to serve their patients. Responsibilities of Utilization Management Organizations Any supplier of services has responsibilities to purchasers that are intrinsic to the concept of a buyer-seller relationship. It is in the business interest of review organizations to anticipate and respond to purchaser demands for information about the organization, its services, and its results. Further, it is in the legal interest of these organizations to manage their activities rationally, to act in good faith, and to maintain careful records. Although good business and legal judgment should dictate prudent behavior, those who provide utilization management services also have a moral obligation not to harm the patients whose medical care they review and influence. Harm includes discouraging appropriate care and mishandling confidential information. When organizations perform prior review and high-cost case management for individually purchased insurance plans (with no employer sponsorship), they have a particular responsibility to provide good educational materials and appeals processes for beneficiaries who have no employer or other sponsor to act as their agent and aid. They should also develop guidelines for what to do when they discover quality of care problems. With respect to practitioners and individual providers of care, good business sense should dictate that review organizations encourage provider acceptance and cooperation by • using sound clinical criteria that are open to examination, • involving the medical community in criteria development, • minimizing the administrative burdens placed on hospitals and physicians, and • clarifying and simplifying processes for appealing negative judgments. The committee is aware that further steps, in particular, making clinical criteria available, raise difficulties given the competitive environment of

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Page 8 benefit plan administration. Organizations that have invested their own resources in developing criteria will be reluctant, on the one hand, to make them available to competitors with less initiative and, on the other hand, to reveal some details to practitioners and institutions for fear of their ''gaming the criteria'' by providing misleading information. Though these are reasonable concerns, on balance, they are outweighed by the need to move toward open criteria and standards. Responsibilities of Practitioners and Institutions The committee found the responsibilities of physicians and other health care providers in utilization management the most troublesome to analyze and define, a situation typical of many current ethical and policy issues in health care today. On five basic issues, the committee agreed that health care practitioners and institutions are responsible for • cooperating with the reasonable efforts of payers, including utilization management, to ensure that payments are for appropriate care within the terms of a patient's benefit plan; • constructively challenging unreasonable utilization management programs and specific decisions that threaten patient safety or damage patient privacy; • informing patients about treatment options, risks, and benefits and then considering their preferences; • seeking to ensure that patients get needed services, which may mean locating an alternative source of care if the patient cannot pay and the provider cannot give free treatment; and • staying current with scientific literature on the necessity and effectiveness of medical services in their areas of practice. Although some difficult situations with insurers and review organizations may be more conveniently and quickly dealt with in the short term by misrepresenting patient symptoms, diagnoses, or treatments, the committee believes that it is in the patient's, physician's, and society's interest over the long term for physicians to deal honestly with reviewers and claims administrators and to challenge questionable criteria, procedures, and decisions directly. Manipulation and evasion can have serious risks. Specifically, incorrect information may enter the patient's medical records or insurance history with later negative consequences. Moreover, perceptions by purchasers that physicians are gaming the system undermine professional credibility and stimulate the sorts of auditing, second-guessing, and external oversight to which practitioners object.

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Page 9 Responsibilities of Patients In many respects, patients and potential patients are the weakest strand in the web of responsibilities for the appropriate use of medical services. When ill, individuals may not be able to act in an informed and prudent way. And whether well or ill, individuals may find both their benefit plans and their medical care difficult to understand and evaluate. Nonetheless, health plan members should try to understand their responsibilities under the plan. The challenge for those involved in health care delivery and financing is to help all kinds of patients make informed decisions about getting or not getting care. Longer-Term Recommendations and Questions As noted earlier, the committee views utilization management as, essentially, a working hypothesis—one of several partial and overlapping strategies for balancing health care expenditures, access, and quality. When knowledge advances, economic conditions change, and social values shift, these partial strategies are revised, integrated, and sometimes discarded. However, even if some of the techniques now employed by utilization management organizations are abandoned or the organizations themselves change, improvements in the criteria for judging appropriate care and for monitoring the provision of care will continue to be relevant. The longer-term recommendations of the committee focus on the foundations for improving effective and safe decision-making about patient care: knowledge development, knowledge utilization, and value clarification. The recommendations cover three areas: • research on the effectiveness of medical services and the effectiveness of utilization management and related techniques, • formulation and dissemination of guidelines for medical practice and criteria for utilization review, and • possible oversight of utilization management. Research On Effectiveness Utilization management can be no better than the clinical evidence and expertise on which it is based. Although review organizations today may not be effectively using all available research, they are still constrained by the large areas of undocumented impact and clinical uncertainty involving many major medical procedures. Policymakers are increasingly recognizing that the free market system is unlikely to invest sufficiently in outcomes research and data collection because those making the investment cannot capture all the benefit but

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Page 10 must share it with those who have not invested. Since the public gains from investments in such research, public financing and priority setting are appropriate, although they should add to rather than replace initiatives being undertaken by private researchers, health care organizations, and others. The creation of an agenda to strengthen knowledge of what is effective in medical care is well under way, and the Institute of Medicine is actively involved with many other private and public organizations in developing and implementing this agenda. It is, however, important to have realistic expectations. In the first place, there are practical and ethical limits on clinical effectiveness research—too few researchers, long time horizons, and numerous procedures where clinicians would balk at research protocols that require withholding treatments generally thought to be useful or providing treatments generally thought to be inappropriate. Second, much care does not really focus on the effectiveness of care in an average setting or population, nor does it evaluate the impact of care on quality of life and many other outcomes that society now considers important. Third, effectiveness research that relies on existing claims and other records, although less expensive and time-consuming than most clinical trials, is not quick or suitable for many questions. Fourth, research cannot resolve some questions, for example, whether use of a specific procedure for a specific problem is prudent given other uses to which limited financial resources could (and would) be put. Fifth, sound clinical research does not automatically affect behavior. The research on what works in medical care should be complemented by research on how to ensure that such knowledge is used effectively and efficiently. Such programmatic research is, for the most part, a low priority today. It is expensive, methodologically troublesome, and slow to pay off. As part of the overall strategy for containing total health care costs and improving the appropriateness of health care for all citizens, the committee urges federal and private consideration of carefully targeted research projects to test prior review and case management strategies and build methodologies for documenting the effects of ongoing programs. Practice Guidelines and Review Criteria Translating effectiveness research into valid, reliable, and usable guidelines for medical practice and utilization management is a complicated undertaking. The committee has identified a number of questions about the process of developing, disseminating, and updating practice guidelines that need attention. They include the following: • Should there be some kind of oversight of guidelines developed by different sources—a sort of quality review mechanism that assesses both

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Page 11 the method and the substance of specific guidelines? What should happen when different sources develop conflicting guidelines? • To what extent should patient preferences or cost-effectiveness analyses be considered in the development of practice guidelines? How should these issues of value be dealt with in the application of guidelines or in other strategies? • Should adherence to guidelines provide physicians with protection against malpractice charges? Over the long term, should a role for community or local standards continue? • What considerations should apply in the translation of guidelines into criteria used in prospective or retrospective review programs? These questions are relevant to much of the Institute of Medicine's work. Further exploration of these issues is under way and will draw on the expertise of the Committee on Utilization Management by Third Parties, the Committee to Design a Strategy for Quality Review and Assurance in Medicare, the Council on Health Care Technology, and other parties inside and outside the Institute. Oversight of Utilization Management The protections offered by caveat emptor, self-regulation, and tort liability, although important, do not respond to all concerns about the impact of utilization management on patients, providers, and overall health care costs. The committee believes that incompetent review organizations need to be weeded out and that some form of oversight seems advisable. However, premature or misguided regulation to accomplish this could stifle worthwhile innovations, lock in ineffective methods, or so paralyze utilization management that purchasers abandon it for more onerous methods of controlling their costs. The experience of the federal government in overseeing peer review organizations (PROs) shows how difficult the oversight function is. At this time, the committee feels that neither it nor other parties are in a good position to make sound specific recommendations about oversight for utilization management. The committee has posed several questions that it intends to explore further. • How do we decide whether oversight is necessary and feasible? • If an oversight mechanism is necessary and feasible, should it be public or private? • What should be its focus? • Should utilization management conducted by different kinds of organizations, for example, HMOs, be subject to different kinds of oversight?

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Page 12 • Can anything be learned from government oversight of PROs or the accreditation process managed by the Joint Commission on the Accreditation of Health Care Organizations? These are not simple questions. Answering them demands more information and more thoughtful debate over how to judge the strengths and weaknesses of utilization management versus those of other strategies to control costs and influence patient care decisions. This, in turn, will depend on better evidence about the impacts of different cost containment strategies. Finally, recommendations about oversight will require more deliberation about the legitimate but sometimes conflicting needs, interests, and values of the parties involved in utilization management. In a broader sense, the limits of utilization management and any other single strategy, even any combination of strategies, need to be recognized. The issue is not whether utilization management does everything that needs to be done but whether it produces desirable results in reasonable ways at an acceptable cost. Is it, on balance, better to use it than to discard it? How can it be improved, and what other strategies are needed to supplement it? This report provides a progress report and some preliminary views on these issues. The Institute of Medicine will continue its efforts to better define what role utilization management might play in helping society find an acceptable balance of efficiency, access, and appropriateness in health care. This clearly must be a shared venture. Fortunately, the quest to know what is useful and how to apply it universally are now central issues in medical research and public policy.