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Part I INTRODUCTION The committee's recommendations for the Quality Improvement Orga- nization (QIO) program, presented in Chapters 4 and 5, are built on a dual foundation. First is an extensive study of the QIO program conducted for this project. It included a review of the history and various aspects of the program, based on data gathered from the Centers for Medicare and Med- icaid Services (CMS), data gathered directly from the QIOs, information from representatives of the QIO community and stakeholders, a literature review, and original data analyses. The second foundation for the recom- mendations in this report is the recommendations presented in the com- mittee's first report in the Pathways to Quality Health Care series, Perfor- mance Measurement: Accelerating Improvement (IOM, 2006). That report presents a view of the future of health care delivery that includes a national system for coordinating the measurement and reporting of a broad set of quality measures, some of which will be used to implement provider pay- ment systems designed to reward quality and performance improvement. Provider payment systems are the focus of the committee's next report, which will be published in 2006. As noted in the introduction to the present report, Part I is policy ori- ented and includes the committee's judgments, while Part II provides the detailed evidence base on the QIO program, including data collected spe- cifically for this study, that helped inform those judgments. Part I consists of five chapters: 33

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34 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM Chapter 1 presents a historical overview of the QIO program and its predecessor organizations. Because this is the third time the Institute of Medicine has been asked to examine Medicare's quality assurance program, this chapter also includes some details from the previous two reviews. Chapter 2 provides a summary of the key findings discussed in detail in Part II and the conclusions the committee drew from those findings. Chapter 3 gives a summary of Performance Measurement: Acceler- ating Improvement (IOM, 2006). The first part of the chapter presents that report's key recommendations concerning measure sets and the system needed to promote their use. The second part provides a discussion of what is required to implement a national system for performance measurement and of how QIOs and other entities might carry out some of those tasks. Chapter 4 provides recommendations regarding future directions for the QIO program. Included is the rationale for those recommendations, which is based on the findings and conclusions presented in Chapter 2 and the committee's prior recommendations as summarized in Chapter 3, as well as additional information. Chapter 5 presents the committee's recommendations on the over- sight of the QIO program by CMS. This is a critical topic given that CMS will play a significant role in implementing a national system for perfor- mance measurement and payment incentives and has responsibility for the QIO program. The committee encourages those readers who would like a more in-depth description of the QIO program and its management to turn to Part II for the data used to support the findings, conclusions, and recommendations presented in Part I. REFERENCE IOM (Institute of Medicine). 2006. Performance Measurement: Accelerating Improvement. Washington, DC: The National Academies Press.

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1 A Historical Perspective and the Current QIO Program CHAPTER SUMMARY This chapter presents an overview of the health care quality assess- ment activities of Medicare from the early days of quality assurance through the evolution to quality improvement and the current Quality Improvement Organization (QIO) program. It focuses particularly on the QIO program from 2002 to 2005, the period evaluated in this report, and the next contract period, which is in- tended to achieve quality improvements through activities that will transform systems, processes, and outcomes of care. The federal government's interest in ensuring the quality of health care for Medicare beneficiaries in the United States originated with an emphasis on detecting the overuse and inappropriate use of Medicare benefits (pri- marily for cost-containment purposes). Over time, this interest expanded to include the measurement of improvements in the quality of care because such measurements are more reliable for monitoring the performance of health care providers. The Centers for Medicare and Medicaid Services (CMS) is now in the early stages of promoting transformational changes in the way providers deliver care.1 Over the course of more than 35 years and these shifts in emphasis, the priorities of the federal quality assurance pro- gram changed from utilization reviews of individual case records to col- laboration with providers for the improvement of overall patterns and pro- cesses of care. Such collaboration allows the federal quality assurance 1CMS views this transformation as taking place through the adoption of certain strategies (measurement and reporting, implementation of health information technology, process rede- sign, and changes in organizational culture). CMS believes the QIO program, along with other efforts, can lead to measurable changes in the health care delivery system to align with the six aims set forth by the Institute of Medicine (IOM, 2001) and CMS's vision of "the right care for every patient every time" (Pugh, 2005:2). 35

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36 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM program to play a more systemic role in improving the quality of health care and ultimately in yielding better health outcomes for beneficiaries. The history of the Medicare program for quality improvement offers several key insights that reflect this evolutionary process and are relevant to consideration of how the Quality Improvement Organization (QIO) pro- gram might be used most effectively in the future: Many QIOs emerged from the antecedent organizations and retain staff, boards, and executive leaders with long histories of involvement in the Medicare quality improvement program (see Chapter 7 for a discussion of the current structure and staffing of QIOs). This continuity represents a strength for most organizations, although in some cases it could lead to a lack of creativity that can accompany low turnover among leaders. Although the views of many providers have changed, some hospital executives still perceive QIOs as "regulatory agencies." This perception re- flects the previous activities of the organizations (Bradley et al., 2005; NORC, 2004; data from site visits). Frequently changing priorities required the QIO program and its contractors to demonstrate a flexibility and an ability to adapt to new priorities, expand activities, shift functions, and acquire new skills in re- sponse to tasks and priorities specified in CMS's statements of work. The flexibility and adaptability of the program bode well for its ability to carry out new functions in the future, but its constant changes have also created program discontinuities, stress for staff, and challenges to evaluation of the program (see Chapter 13). This chapter first provides a brief overview of the history of the QIO program and then describes the evolution of the program from the early days of Medicare. The discussion is most detailed for the two most recent contract periods (the 7th and 8th scopes of work [SOWs]).2 HISTORY OF THE QIO PROGRAM Certain challenges must be addressed when one is evaluating a complex public program with a lengthy history that has evolved in response to shift- 2CMS contracts with private organizations for QIO services in each state for 3-year periods. CMS uses the acronym SOW for both "scope of work" and "statement of work." In this report, the committee uses SOW only for "scope of work" and adopts the general usage of SOW by the QIO community, in which the term denotes either tasks required in general or the time period of a contract. When discussing specific details of QIO work, the committee refers to the contract itself. For example, the 7th SOW was from 2002 to 2005. It required all QIOs to provide technical assistance to nursing homes, and the contract for this SOW stipulated that QIOs must recruit 30 percent of nursing homes to develop a plan of action.

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A HISTORICAL PERSPECTIVE AND THE CURRENT QIO PROGRAM 37 ing health care priorities. One must choose certain time periods and pro- gram features on which to focus and develop criteria for assessment of the program's performance and impact. The evaluation must also be useful to various audiences: policy makers, those managing the program, those work- ing in the program both at the federal level and in contractor organizations, and those providers and practitioners who do and do not participate in the program. The QIO program has existed in various forms for more than 35 years. As noted earlier, beginning a few years after the creation of Medicare in 1965 and continuing through its first 20 years of existence, the Medicare quality assurance program placed a strong emphasis on utilization control and focused attention on hospital and physician outliers that provided sub- standard or unnecessary care. In 1990, in response to a congressional man- date, the Institute of Medicine (IOM) completed a major review of quality assurance activities and the Medicare program's contractors for local qual- ity services, called Peer Review Organizations (IOM, 1990). The IOM re- port recommended a shift away from utilization review and the traditional regulatory approach used to control aberrant providers and toward a focus on health care decision making, health outcomes, and the development of a professional capacity to improve care (IOM, 1990). The adoption of many of that report's recommendations contributed to further changes in the QIO program. One recommendation that was not adopted, however, called for the creation of a technical advisory panel that would assist with the evalua- tion of the recommended quality assurance program and with program management and operations. The program also evolved in response to changing definitions of "qual- ity." In a literature review conducted for its 1990 study, the IOM found over 100 definitions of quality of care. In 1974, the IOM had defined qual- ity only in the context of specifying the purpose of a quality assurance system ("to make health care more effective in bettering the health status and satisfaction of a population, within the resources which society and individuals have chosen to spend for that care" [IOM, 1974:12]). Defini- tions of quality were numerous and incongruent. In its 1990 report, the IOM expanded previous definitions to include both individuals and popu- lations, adopted outcome measures that linked processes to outcomes, and recognized the importance of patient and provider satisfaction. The IOM defined quality of care as "the degree to which health services for individu- als and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge" (IOM, 1990:21). Later, in its Quality Chasm series, the IOM developed a vision for the future of health care, which was based on six aims for the delivery of quality care: health care should be safe, effective, patient-centered, timely, efficient, and equitable. In addition to these six aims, the Quality Chasm report suggested

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38 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM ten rules for how care should be delivered, focusing on the point that health care should be viewed as a relationship between patients and providers aimed at yielding the best health outcomes, and specified various properties of the health care system itself that would help foster that relationship (IOM, 2001). The Committee on Redesigning Health Insurance considered looking back to 1990 to assess the QIO program's impact, to consider how the program evolved in response to the 1990 IOM report, and to examine the impacts of those changes on the health care system with respect to the vi- sion of high-quality health care set forth in the Quality Chasm series. Even if the QIO program had implemented all of the prior IOM report's recom- mendations, however, it would still be necessary to assess whether the pro- gram is now well positioned to foster quality improvement in the present and future health care environments. Fundamental changes in the Medicare program and the practice of medicine, as well as in the broader health care system, have occurred since 1990; these changes have contributed to new expectations and new needs for guidance and assistance in the adaptation of earlier practices and processes to new standards of care. For example, when the earlier IOM committee began its study nearly 20 years ago, it did not anticipate that Medicare would now be reporting national performance measures publicly by provider name for nearly all hospitals, nursing homes, and home health care agencies. It could not have known that some private purchasers would be implementing pay-for- performance systems or that the Medicare Payment Advisory Commission (MedPAC), created to support Congress with data and advice related to the operation of the Medicare program, would recommend that Medicare consider paying for performance as well. Also, the fact that the QIO pro- gram or an individual organization in a particular state did or did not do well during the 4th SOW might have little bearing on its performance dur- ing the 7th SOW because the nature of the work and the methods used to measure it have changed substantially. Rather than comparing the present performance of the QIO program against earlier recommendations and current expectations, the committee decided to supplement its evaluation with an assessment of how the pro- gram might contribute to future quality improvement efforts. A key factor in this assessment was the above-noted adaptable nature of the Medicare quality assurance and improvement program and the ability of QIOs to respond to new demands and changes in each CMS contract. Other, practical reasons influenced the committee's decision to limit its detailed review to a fairly recent period. The QIO program's management shifted direction during previous SOWs from requiring evaluations of local, specific projects to requiring statewide evaluations, which allowed the ag- gregation of data to show national effects. National measures, however,

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A HISTORICAL PERSPECTIVE AND THE CURRENT QIO PROGRAM 39 were not broadly used until the 7th SOW contract period (2002 to 2005). Thus, comparable national data aggregated from each state were limited or nonexistent before the 7th SOW. Also, older data on program operations would have been more difficult to obtain. The committee determined that it would be most useful to focus atten- tion on describing the history of the QIO program as it existed during the 7th SOW, and, as noted above, the descriptive data and analyses of the program in Part II of this report relate primarily to the 7th and 8th SOWs. Nonetheless, the next section of this chapter describes selected elements of Medicare's quality programs from their beginning to the present contract period. An understanding of the QIO program's evolution can provide guidance for assessing the program's potential value in strengthening the quality improvement efforts of CMS and the role CMS could play in imple- menting the recommendations formulated in the recent IOM report Perfor- mance Measurement: Accelerating Improvement (IOM, 2006). Such an un- derstanding can also illuminate reasons for the need to restructure and strengthen the program. EVOLUTION OF MEDICARE'S QUALITY IMPROVEMENT PROGRAM Early Quality Review Programs Experimental Medical Care Review Organizations Soon after the enactment of the Medicare program in 1965, concerns developed about the quality and cost of health care services provided to beneficiaries (Bhatia et al., 2000). In addition to creating health benefits, the initial Medicare law (P.L. 89-97) focused on patient safety and access to care from competent health care providers. It required hospital-based utili- zation review, state licensure of physicians, and voluntary hospital accredi- tation by the Joint Commission on Accreditation of Hospitals (now called the Joint Commission on Accreditation of Healthcare Organizations) or state certification (Jost, 1989). In 1971, the U.S. Congress authorized Ex- perimental Medical Care Review Organizations (EMCROs) to evaluate the use of services provided to Medicare beneficiaries. EMCROs examined in- dividual Medicare cases and sought to reduce the unnecessary utilization of services in inpatient and ambulatory care settings through the education of physicians and research (IOM, 1990). EMCROs were voluntary groups of physicians who received grants from the National Center for Health Services Research (the predecessor agency to the current Agency for Healthcare Research and Quality) to review the services provided through the Medicare and Medicaid programs (Sprague, 2002). The EMCRO pro- gram itself existed from 1970 to 1975.

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40 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM Professional Standards Review Organizations In 1972, amendments to Title XI of the Social Security Act (P.L. 92-603) authorized the establishment of Professional Standards Review Organiza- tions (PSROs), new locally based organizations, to replace the EMCROs. PSROs were sponsored by physicians, and only local physicians could evalu- ate cases. Like the EMCROs, they used implicit review (decision making based on individual professional judgment) to determine the medical neces- sity of the services provided (Sprague, 2002). They targeted egregious cases by comparing the care given by the provider with local standards of care and practice patterns. Physicians regarded the PSROs primarily as adver- saries and as enforcers of cost containment that punished individual provid- ers by recommending sanctions (Bhatia et al., 2000; Sprague, 2002). Although the focus of the PSROs was still on retrospective utilization review of hospital admissions and lengths of stay, PSROs also participated in Medical Care Evaluation Studies (later called Quality Review Studies) to address concerns regarding quality of care (Jost, 1989). PSROs were not viewed as motivators for systemwide quality improvement, however (Sprague, 2002). Moreover, studies conducted in the late 1970s and early 1980s demonstrated that PSROs had little if any impact on the quality of care or the containment of expenditures (IOM, 1990). Utilization and Quality Control Peer Review Organizations In 1982, the Peer Review Improvement Act (P.L. 97-248) replaced PSROs with Utilization and Quality Control Peer Review Organizations (PROs). There was a total of 54 PROs, one for each state and territory.3 The PROs continued the focus on medical necessity and standards of care in the provision of Medicare services. Congress retained elements of local peer review by requiring the PROs to be physician-sponsored (which re- quired at least 10 percent of locally practicing physicians to participate as reviewers) or to be physician-access (which required at least one physician of each specialty in the area to be available to conduct reviews of medical records) (CMS, 2004b). New requirements were that physicians could not review their own close colleagues and that the PROs had to include at least one consumer representative on their governing board. Unlike PSROs, PROs could have for-profit status (Jost, 1989). Funding of the overall program shifted to an apportionment drawn directly from the Medicare Trust Funds instead of annual appropriations (IOM, 1990; Sprague, 2002). 3PROs were managed for each of the 50 states; the District of Columbia; Puerto Rico; the U.S. Virgin Islands; and the combined area of Guam, American Samoa, and the Northern Marianas.

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A HISTORICAL PERSPECTIVE AND THE CURRENT QIO PROGRAM 41 Although PROs continued to target inappropriate or unnecessary ser- vices and cost containment during the 1980s, implementation of the hospi- tal prospective payment system in 1983 drew attention to premature dis- charges (Rogers et al., 1990) and the potential underuse of necessary services. By the late 1990s, the development of Medicare managed care (Medicare+Choice, now Medicare Advantage) had added a further popula- tion of patients whose providers were subject to financial incentives to underuse services and who thus required the attention of the PROs (IOM, 1990; Sprague, 2002). Early Quality Improvement Contract Cycles In 1984, the Medicare program established contract cycles for the PROs and eventually lengthened those cycles to 3 years--the period often referred to as the SOW. Once the contracts had been awarded, they could be re- newed after 3 years for the next SOW or opened to competitive bidding on the basis of the performance of the PRO. The discussion in this and the next section highlights key features of each SOW. Each QIO contract is numbered. The 1st SOW, which began in 1984, lasted for 2 years (see Table 1.1). Subsequent SOWs lasted for 3 years each (except for the 3rd SOW, which had a 1-year extension). 1st Scope of Work The 1st SOW (1984 to 1986) for PROs emphasized reducing inappro- priate hospital admissions. PROs compared data from individual retrospec- tive case reviews with implicit, professionally accepted standards and made recommendations for financial sanctions on individual providers (Bhatia et al., 2000). In addition, an offending physician or hospital could be re- quired to create and follow a corrective action plan for improving the qual- ity of care in the future. Providers perceived this as a form of punitive over- sight, and it contributed to a hostile relationship between the PROs and providers (Bhatia et al., 2000). Also, some providers perceived this type of quality work as "cookbook" medicine and an affront to their profession (Sprague, 2002). 2nd and 3rd Scopes of Work The 2nd SOW (1986 to 1989) added more quality-monitoring and re- view responsibilities. Although most case review activities remained focused on hospital inpatient care, the Omnibus Budget Reconciliation Act (OBRA) of 1986 (P.L. 99-509) extended some review activities to cover other set- tings, including skilled nursing facilities, home health care agencies, hospi-

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42 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM TABLE 1.1 QIO Contract Cycles Cycle Name of Quality Name of Responsible or SOW Dates Improvement Entities Federal Agency 1st SOW 19841986 Peer Review Organizations Health Care Financing (1983) Administration 2nd SOW 19861989 Peer Review Organizations Health Care Financing Administration 3rd SOW 19891993 Peer Review Organizations Health Care Financing Administration 4th SOW 19931996 Peer Review Organizations Health Care Financing Administration 5th SOW 19961999 Peer Review Organizations Health Care Financing Administration 6th SOW 19992002 Quality Improvement Health Care Financing Organizations Administration/Centers for Medicare and Medicaid Servicesa 7th SOW 20022005 Quality Improvement Centers for Medicare and Medicaid Organizations Services 8th SOW 20052008 Quality Improvement Centers for Medicare and Medicaid Organizations Services aThe Health Care Financing Administration changed its name in 2001 to become the Cen- ters for Medicare and Medicaid Services. tal outpatient care settings, and eventually the physician's office setting (Jost, 1989). OBRA also mandated an IOM study of the current state of quality in Medicare (IOM, 1990). Among other things, the IOM report recommended that the PROs become more proactive in their data collection activities to examine patterns of care and offer feedback to providers. The study con- cluded that PROs "constitute a potentially valuable infrastructure for qual- ity assurance" that should "be improved and built on, not dismantled" (IOM, 1990:3). The report noted in particular that the PROs had estab- lished valuable organizational relationships and provided professional staff expertise. However, the report concluded that certain priorities needed to be revised: quality review and assurance should be emphasized over utiliza- tion and cost control; PROs should pay more attention to average practice patterns than to outliers; and PROs should be more involved in health care settings beyond inpatient hospital care. Additionally, the IOM report noted the burdens on providers imposed by the PRO program, its lack of positive incentives and punitive attitude toward providers, the hostile perceptions of

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A HISTORICAL PERSPECTIVE AND THE CURRENT QIO PROGRAM 43 the program among many physicians, and its redundancy with other qual- ity assurance programs. The IOM recognized that the PRO program had a vast and varied list of responsibilities and a budget amounting to less than 0.5 percent of an- nual Medicare expenditures on services, roughly the same proportion allot- ted to the PSRO program 10 years earlier. The IOM report concluded that this investment was unlikely to be sufficient to accomplish the tasks as- signed to the PROs. The report recommended a reassessment of certain functions, such as some case reviews, appeals, and beneficiary outreach, to determine whether they might be performed nationally or regionally and by other agents (e.g., intermediaries and carriers). The 1990 IOM report also noted that neither the PSRO nor the PRO program had conducted a comprehensive self-examination or been able to demonstrate its impact on the quality of care for Medicare beneficiaries. The report called for the creation of a technical advisory panel that would, among other things, advise the secretary of the U.S. Department of Health and Human Services on program evaluation. It stressed that the emphasis of the evaluation should be on documenting the impacts of the state organi- zations on the quality of care and their successes in working with providers on internal quality assurance efforts. Also emphasized was the importance of both the availability of objective evaluation criteria that could be used to assess each state's performance and the use of various methods, such as site visits by a panel of peer experts; however, no specific methods were recom- mended. Although the intent of the IOM recommendations to increase at- tention to quality assurance in more care settings was met, and objective criteria for the evaluation of each state's performance were eventually imple- mented, the impact of the PRO program was not evaluated. In addition, some of the new organizational structures recommended in the IOM re- port, including a technical advisory panel, were not created. The 2nd and 3rd SOWs (1986 to 1993) continued to focus on retro- spective case reviews and the detection of inappropriate use of services. During that period, however, PROs also shifted toward collaboration with providers to improve the overall delivery of care instead of focusing solely on punishing outliers (IOM, 1990; Bhatia et al., 2000). Prior methods rely- ing on retrospective case data and peer review appeared to be increasingly inadequate for achieving the goal of quality improvement (Rubin et al., 1992). Finally, it became apparent that the standards of care themselves needed attention. In 1992, the Health Care Financing Administration (HCFA), the predecessor of CMS, implemented the Health Care Quality Improvement Initiative to move from targeting individual provider errors toward focusing on practice patterns and care outcomes at the institutional and national levels (Bhatia et al., 2000).

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44 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM 4th and 5th Scopes of Work PROs continued to evolve by undertaking nationwide quality improve- ment projects on heart failure, diabetes, and other clinical conditions; improving data collection methods; emphasizing collaboration among gov- ernments, providers, and consumers; and dropping some case review activi- ties. PROs did not explicitly promote collaboration with private plans and vendors. The first project under the Health Care Quality Initiative was the Cooperative Cardiovascular Project, which was pilot tested in four states. This project focused on care for acute myocardial infarction in the hospital setting (Sprague, 2002). Pilot efforts were designed to improve care pro- cesses through the PROs' development of epidemiological and computer capabilities and the use of new data analysis methods. The PROs worked cooperatively with hospital staff on the development and use of practice guidelines to create quality indicators for patient care (Jencks and Wilensky, 1992). Data abstracted from hospital medical records were used to measure the impact of the quality improvement pilots. The guidelines and the risk- adjusted patterns of care that were obtained were compared, and it was found that the results of the Cooperative Cardiovascular Project had gener- ally been positive. The project became a national effort at the beginning of the 5th SOW (Ellerbeck et al., 1995; Marciniak et al., 1998). The Health Care Quality Improvement Initiative expanded to include other diseases and incorporated continuous quality improvement and total quality management concepts. Beginning in 1994, HCFA introduced these concepts to its staff and those of the QIOs through special training sessions. The staffs learned how to use the PDSA (Plan, Do, Study, Act) Cycle method to produce more rapid results during interventions with providers. The ac- tivities in the 5th SOW were based on accountability through consistent performance measurement. HCFA promoted the development of measures, data collection tools, and reporting systems for uniform tracking of the progress of each state on a few selected clinical conditions (personal com- munication, J. Kelly, June 29, 2005). HCFA had previously developed two Clinical Data Abstraction Centers to improve the efficiency of data collec- tion efforts and the quality of the data collected (Bhatia et al., 2000). Recognizing that the PRO program had not been thoroughly evaluated, HCFA planned to conduct such an evaluation internally. To enhance out- side acceptance of the evaluation and its credibility, in 1994 HCFA com- missioned the IOM to assess HCFA's evaluation strategy. HCFA asked the IOM to review and critique within a very brief time period its preliminary evaluation strategy and then its final, revised evaluation plan. Given the time constraints on this study, the IOM Committee on the Medicare Peer Review Organization Evaluation Plan issued two letter reports, in January

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A HISTORICAL PERSPECTIVE AND THE CURRENT QIO PROGRAM 45 and June 1994 (IOM, 1994). The reports welcomed HCFA's plan to mea- sure the quality of care instead of merely obtaining cost savings from the reduced use of services. The committee did note, however, that the "lack of a strong, clear vision of where the agency would like to go with the PRO program over the coming decade or so is a major drawback to the proposed evaluation strategy" (IOM, 1994:5). The committee questioned the pro- grammatic purpose of the evaluation, its criteria for judging the success of PRO projects, and how and to whom the results would be disseminated. The committee encouraged attention to failures as well as successes, be- cause failures could also serve as useful learning experiences. In addition, the committee raised the question of how HCFA would implement the rec- ommendations resulting from the agency's own evaluation. The committee concluded that the effectiveness of the PRO program could not be fully reflected in a simple aggregation of the impacts of the various cooperative improvement projects. The IOM letter reports advocated the use of a phased approach with a "formative evaluation" as the initial focus. The formative evaluation would include pilot or demonstration projects to provide an iterative learn- ing experience whereby HCFA would use information to modify and im- prove ongoing projects. The use of a "summative evaluation" of long-term goals was also recommended to evaluate the effectiveness of the completed program in achieving its objectives. The committee observed that the pro- gram would benefit from more involvement of informed consumers. It also recommended that HCFA involve people with experience and skills in for- mal program evaluation and continuous quality improvement as soon as possible. HCFA used these letter reports as the basis for focusing on formative evaluations, and each PRO conducted evaluations of its individual projects. Because the quality improvement projects varied from state to state and neither uniform data nor consistent methods were used, however, the evalu- ations were of limited use in assessing the national program or in guiding policy. No summative evaluation was ever conducted. During the 5th SOW, in addition to case reviews and beneficiary educa- tion, PROs worked on both nationally defined and locally selected quality improvement projects in the areas of acute myocardial infarction, diabetes, and preventive care for breast cancer (see Table 1.2). Standardized mea- sures were used to demonstrate statewide improvement in each clinical area (Sprague, 2002). HCFA chose these clinical priority areas because they ac- counted for a significant amount of morbidity and mortality in the Medi- care population, there was strong scientific evidence that specific interven- tions in these areas would likely lead to improved outcomes, and providers agreed on the recommended care processes (Bhatia et al., 2000).

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46 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM TABLE 1.2 Evolution of QIO Core Contract Task Fifth SOW (19961999) Sixth SOW (19992002) Task 1 National HCQIP National HCQIP Projects in specific topic areas with standardized HCFA-directed projects indicators for each setting: Statewide impact AMI expected Heart failure Proportional Pneumonia involvement of M+C Stroke beneficiaries Diabetes Projects for: Breast cancer AMI Diabetes Preventive care PRO-initiated cooperative projects Task 2 PRO designs projects Three required local QI projects: based on local needs Choose one indicator from Task 1 and show Statewide impact reduction in a disparity in a disadvantaged group expected Develop project in a setting other than acute care Proportional hospital or M+C involvement of M+C Develop a project for local needs beneficiaries Task 3 Project must include QI projects with M+C plans measurable indicators Each plan must annually implement two performance improvement projects: Beneficiary protection One on a topic of national interest, as selected by and information HCFA activities One selected by the plan on the basis of the needs Education and of its enrollees outreach Projects started each year continue as new projects Hotline are added Task 4 Mandatory case review Payment Error Prevention Program Multiple categories Two projects required: including: Unnecessary admissions Beneficiary complaints Miscoded DRG assignments HINNs Task 5 EMTALA review Other mandated activities Cataract surgery All mandatory case reviews assistants Beneficiary outreach and education Gross violations Task 6 Hospital-requested Special studies higher-weighted DRG adjustments NOTE: AMI = acute myocardial infarction; DRG = diagnosis-related group; EMTALA = Emergency Medical Treatment and Labor Act; HCQIP = Health Care Quality Improvement

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A HISTORICAL PERSPECTIVE AND THE CURRENT QIO PROGRAM 47 Seventh SOW (20022005) Eighth SOW (20052008) National HCQIP Assisting providers with developing capacity for Projects in specific topic areas with and achieving excellence standardized indicators for each setting: Projects in specific topic areas with standardized Nursing home indicators for each setting: Home health Nursing home Hospital (AMI, heart failure, Home health pneumonia, surgical infection) Hospital (heart failure, pneumonia, AMI, Physician office (diabetes, cancer, surgical infection) immunization) Rural and critical access hospitals Underserved or rural populations Physician office (immunization, diabetes, M+C (also included in all settings) cancer, underserved, Part D, information technology) Medicare Advantage may be included in all tasks Information and communication Reserved for possible future use Promote use of performance data Transition to hospital-generated data Other mandated communications activities Medicare beneficiary protection activities Protect beneficiaries and the Medicare program Beneficiary complaint resolution Beneficiary complaint resolution program program (includes mediation) (including mediation) Hospital Payment Monitoring Program Hospital Payment Monitoring Program Other beneficiary protection activities Other beneficiary protection activities HINN and NODMAR review HINN and NODMAR review M+C appeals and grievances M+C appeals and grievances EMTALA review EMTALA review Other mandatory review as needed Other mandatory review as needed Developmental activities (special studies) Developmental activities (special studies) Project; HINN = Hospital-Issued Notice of Non-Coverage; M+C = Medicare+Choice; NODMAR = Notice of Discharge and Medicare Appeal Rights; QI = quality improvement.

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48 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM 6th Scope of Work In the 6th SOW (1999 to 2002), PROs were renamed QIOs, and they continued their individual statewide projects as well as the implementation of national programs. Standardized measures were increasingly introduced to determine the frequencies of either the services provided or the outcomes achieved. QIOs formed national partnerships with the Joint Commission on Accreditation of Healthcare Organizations, the American Hospital As- sociation, and other groups to align quality improvement efforts (CMS, 1999; Bhatia et al., 2000; personal communication, J. Kelly, June 29, 2005). These efforts focused on six national priority areas: acute myocardial in- farction, breast cancer, stroke, diabetes, heart failure, and pneumonia. HCFA also promoted a shift from the previous PRO methods of beneficiary and provider education to interventions focused on systemic changes. In addition, the 6th SOW required QIOs to perform certain projects at the local level, including projects in settings other than acute care hospitals. QIOs initiated some quality improvement projects for nursing homes, home health agencies, and organizations participating in Medicare+Choice (Table 1.2). In addition, a new task, the Payment Error Prevention Program, was aimed at protecting the Medicare Part A Trust Fund from unnecessary ad- missions and miscoded diagnosis-related group assignments. On the basis of retrospective reviews of medical records, QIOs examined inpatient cod- ing to ascertain both the overpayment and underpayment of claims. The 6th SOW also allowed selected QIOs to conduct special studies (CMS, 1999). During this period, QIOs claimed improvements resulting from two- thirds of more than 2,000 separate projects. However, HCFA failed to dem- onstrate any overall quantifiable impact of the projects on the quality of care (HCFA, 1998). QIOs Today4 7th Scope of Work The 7th SOW (2002 to 2005) continued to focus on quality improve- ment based on the measurement of changes in national performance indi- cators and the production of incremental changes. At the beginning of the 7th SOW, CMS released the results of performance on a limited set of national measures for the 50 states, Puerto Rico, and the District of 4This section is a summary of the detailed description of the technical assistance for quality improvement tasks of the 7th and 8th SOWs in Chapter 8, the beneficiary education and communications tasks in Chapter 11, and the protection of beneficiaries and program integ- rity tasks in Chapter 12.

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A HISTORICAL PERSPECTIVE AND THE CURRENT QIO PROGRAM 49 Columbia.5 The aggregate national performance results showed improved quality between 19981999 and 20002001 on 20 of 22 indicators for Medicare fee-for-service inpatient and outpatient care, and all states showed improvement on a majority of the indicators (Jencks et al., 2003). However, the study identified considerable room for improvement and noted that cross-sectional data could not show conclusively that the im- provements had resulted specifically from QIO quality improvement efforts. The 7th SOW was a performance-based contract that used evaluation criteria more detailed and specific than those used in the 6th SOW. In addi- tion, evaluation of the performance of each QIO was based on its achieve- ment of specific targets and was unrelated to the performance of the other QIOs (see Chapter 10 and Table A.3 in Appendix A). Throughout the 7th SOW, the QIOs continued to provide technical assistance for quality improvement through collaborations with providers (see Chapter 8 for definitions and discussion of technical assistance). The SOW expanded to include required projects in different health care settings: home health agencies and nursing homes, as well as managed care plans and physician offices, in addition to hospitals (CMS, 2002). QIOs contin- ued to improve their data collection and dissemination activities related to the use of performance data. The QIO program set national goals for each indicator, and each state's QIO had to comply with every task of the SOW, using a nationally consistent set of indicators and measures. Each QIO had discretion in determining how to carry out the required projects, but all had to meet the formal national targets, regardless of local demographics and provider differences. The QIOs were no longer required to perform projects to serve local needs, and they did not receive funds in their core budget for projects initiated locally. Home health carerelated tasks addressed mea- sures of health status improvement. Hospital-related tasks focused on acute myocardial infarction, heart failure, pneumonia, and the prevention of post- surgical infections. Nursing homerelated tasks addressed chronic care and postacute care concerns, such as pain management and improvement in mobility. Physician officerelated tasks encompassed diabetes care, mam- mography screening, and adult immunizations (CMS, 2002). Many of the quality improvement tasks from the 6th SOW were sustained. The QIOs were also expected to pay special attention to rural and underserved popu- lations as well as Medicare+Choice beneficiaries (CMS, 2002). Participa- tion in QIO quality improvement projects by providers and practitioners continued to be voluntary (Sprague, 2002). 5The total number of QIOs is 53; data for this study were not available for the U.S. Virgin Islands.

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50 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM Public reporting was a major driver of the activities performed under the 7th SOW (see Chapter 11). In November 2002, CMS launched the Nurs- ing Home Quality Initiative, which included making nursing home perfor- mance measures available to the public. This effort sought to help benefi- ciaries and their families make informed choices, as well as to encourage nursing homes to improve upon the quality of care they delivered. CMS also initiated public reporting in home health care and hospital settings (CMS, 2004a). The public's increased awareness of and access to informa- tion about a provider's performance motivated providers to pay attention to performance measurement. Particularly for hospitals, CMS worked with the National Quality Forum, the Joint Commission on Accreditation of Healthcare Organizations, the National Committee for Quality Assurance, and other organizations to ensure that the performance indicators used by CMS and the QIOs were consistent with other commonly used measures. This collaborative effort was first attempted in the hospital setting and was then expanded to other settings so providers could collect and report the same data to Medicare and the QIOs in addition to other agencies (CMS, 2004a) (see the discussion of the Hospital Quality Alliance in Chapter 11). Another important QIO function under the 7th SOW was the educa- tion of beneficiaries on the publicly reported performance measures. As part of this function, beneficiaries had greater involvement as QIO advi- sors. Consumer representatives were added to advisory panels, and QIO hotlines were made available for beneficiaries. Other tasks aimed at im- proving the information provision and communications activities of QIOs continued, as did specific beneficiary protection functions, such as the me- diation of complaints. All QIOs participated in Medicare beneficiary protection activities (CMS, 2002, 2004a). A new beneficiary complaint resolution program was aimed at resolving quality concerns raised by Medicare beneficiaries through alternative means (see Chapter 12). The complainant could choose media- tion instead of the normal administrative case review process if the case involved no serious safety concerns. With mediation, beneficiary and pro- vider were brought together voluntarily to resolve the issues, which often involved communication problems. The Hospital Payment Monitoring Program (HPMP) was designed to protect the Medicare Part A Trust Fund as well as Medicare beneficiaries (CMS, 2004a) (see Chapter 12). Under this program, QIOs reviewed a ran- dom sampling of cases to estimate statewide payment error rates. The re- view focused on coding validity, the medical necessity of the services pro- vided, and the appropriateness of the setting used for the provision of those services. Finally, all QIOs were still bound to traditional case review func- tions for a growing range of case categories (CMS, 2002) (see Chapter 12).

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A HISTORICAL PERSPECTIVE AND THE CURRENT QIO PROGRAM 51 During the 7th SOW, CMS formally designated a separate QIO to serve as a national resource on each specific task and for each provider setting. Often, the QIO had conducted a special study or other work related to the task during the previous SOW. The QIO was funded as a QIO Support Center (QIOSC), in addition to its core contract, to provide background educational materials, tools, and scientific evidence; facilitate communica- tions among practice communities; and train all QIOs to help them perform the given task (see Chapter 8). 8th Scope of Work When the 8th SOW was developed, the prior rates of improvement were viewed as neither fast enough nor deep enough to achieve the pro- gram's goal of "the right care for every person every time" before the year 2024 (Jencks and Rollow, 2004). Under the 8th SOW (2005 to 2008), there- fore, the QIOs are required to create an environment in which quality im- provement will occur more quickly and with a greater impact (see Part II for a more detailed discussion of the tasks in the 8th SOW). This approach is aimed at creating "transformational change" (Rollow, 2004), and CMS considers it to be the next program phase necessary to achieve "results, processes, and care outcomes that are both person centered and reliable" (Pugh, 2005:3). The QIO apportionment of $1.265 billion for the 3-year contract includes approximately 68 percent for the 53 core QIO contracts. The remaining 32 percent of the total apportionment funds the QIOSCs; special studies conducted by selected QIOs; and support contracts to other entities for program operations, such as the data system for the whole QIO program. Many of the support contracts relate to broad issues of quality improvement in the Medicare program, such as the development of a series of consumer surveys of patient experiences. The QIOs are directed to work intensively with a subset of individual providers. Statewide quality improvement measures are given less empha- sis. During the 8th SOW, the program aims to initiate changes with the identified participants that will close the recognized gap between current and ideal standards of care. The main change for the QIOs is working with providers and practitioners to help them redesign care delivery systems and care processes and to implement organizational changes that will pro- mote more rapid quality improvement. Provider assistance is focused on areas that represent both a discrepancy between known best and actual practices and a great potential for improved performance. Some of the clinical areas of focus include adult immunization, breast cancer screening, prevention of pressure ulcers, elimination of restraints and surgical com- plications, promotion of vascular access for hemodialysis, and workforce

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52 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM retention (CMS, 2005). Additional clinical areas receive attention in each provider setting. The physician office setting is the focal point for major changes, with a particular emphasis on small practices and on those caring for underserved populations. Also, QIOs are initiating the Doctor's Office QualityInformation Technology program nationally to promote the use of health information technology. Finally, with physician office projects, QIOs are also to pay special attention to Medicare Advantage beneficiaries and the new Medicare Part D prescription drug benefit (CMS, 2005). The 8th SOW, like the 7th SOW, uses performance-based contracting, includes tasks in a variety of inpatient and outpatient provider settings, and addresses issues related to protecting beneficiaries and the Medicare Trust Funds. CMS recognizes the increased complexity of the 8th SOW, and there- fore includes options for subcontracting those tasks for which the QIOs have been unable to demonstrate competency (competency is demonstrated through successful evaluation of performance under a previous SOW or other CMS-approved means). In the 8th SOW, the distribution of the fed- eral apportionment among the QIO core contracts, QIOSCs, special stud- ies, and the support contract is roughly similar to that in the 7th SOW. Overall, the 8th SOW is aimed at achieving transformational change rather than sustaining the current rate of incremental change (CMS, 2005). SUMMARY The evolution of the quality assurance program into a quality improve- ment program and the functions of the QIO in each state reflect the shifting priorities and changing approaches to quality care among health care man- agers and policy makers. Over the last 35 years, the overall philosophy of the QIO program has shifted from quality assurance (which focuses on individual cases) to quality improvement (which aims to improve overall patterns of care). A 2002 MedPAC report describes the difference as fol- lows: "Quality assurance standards are designed to ensure a minimum level of quality and to identify and potentially punish individuals within the sys- tem who may be providing sub-standard care. In contrast, quality improve- ment standards are designed to ensure that the entities have an effective process for continually measuring and improving the care delivered by all providers" (MedPAC, 2002:5). In the 8th SOW, the QIO program's philosophy has changed, as the term "quality of care" has evolved to include the transformation of systems and processes, as well as the development of tools for improving care (Rollow, 2004). These changes are propelled by the increasing interest in public reports of quality and related performance measures and programs that reward providers financially for offering better-quality care. More pub- lic reporting requirements and rewards for performance will likely encour-

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A HISTORICAL PERSPECTIVE AND THE CURRENT QIO PROGRAM 53 age greater provider participation in quality improvement projects. They will also create an increased need for beneficiaries to understand how the use of publicly reported quality information can improve their health. In this new phase, CMS and its QIO program aim to achieve transformational change, focusing on the overarching processes and systems of health care delivery instead of individual episodes of care to create a new culture and environment in which the ideals of quality of care can thrive. REFERENCES Bhatia AJ, Blackstock S, Nelson R, Ng TS. 2000. Evolution of quality review programs for Medicare: Quality assurance to quality improvement. Health Care Financing Review 22(1):6974. Bradley EH, Carlson MDA, Gallo WT, Scinto J, Campbell MK, Krumholz HM. 2005. From adversary to partner: Have quality improvement organizations made the transition? Health Services Research 40(2):459476. CMS (Centers for Medicare and Medicaid Services). 1999. 6th Statement of Work (SOW). [Online]. Available: http://www.cms.hhs.gov/qio [accessed April 9, 2005]. CMS. 2002. 7th Statement of Work (SOW). [Online]. Available: http://www.cms.hhs.gov/qio [accessed April 9, 2005]. CMS. 2004a. CMS Briefing on QIO Programs. Unpublished. June 22. Baltimore, MD: Cen- ters for Medicare and Medicaid Services. CMS. 2004b. Quality Improvement Organization Manual. [Online]. Available: http://www. cms.hhs.gov/manuals/110_qio/qio110index.asp [accessed May 11, 2005]. CMS. 2005. 8th Statement of Work (SOW), Version 080105-1. [Online]. Available: http:// www.cms.hhs.gov/qio [accessed November 4, 2005]. Ellerbeck EF, Jencks SF, Radford MJ, Kresowik TF, Craig AS, Gold JA, Krumholz HM, Vogel RA. 1995. Quality of care for Medicare patients with acute myocardial infarction: A four-state pilot study from the Cooperative Cardiovascular Project. Journal of the Ameri- can Medical Association 273(19):15091514. HCFA (Health Care Financing Administration, Office of Clinical Standards and Quality). 1998. PRO Results: Bridging the Past with the Future. Washington, DC: Health Care Financing Administration. IOM (Institute of Medicine). 1974. Advancing the Quality of Health Care. A Policy Statement by a Committee of the Institute of Medicine. Washington, DC: National Academy Press. IOM. 1990. Medicare: A Strategy for Quality Assurance, Vol. 1. Washington, DC: National Academy Press. IOM. 1994. An Assessment of the HCFA Evaluation Plan for the Medicare Peer Review Orga- nization. Washington, DC: National Academy Press. IOM. 2001. Crossing the Quality Chasm: A New Health System for the 21st Century. Wash- ington, DC: National Academy Press. IOM. 2006. Performance Measurement: Accelerating Improvement. Washington, DC: The National Academies Press. Jencks SF, Rollow WC. 2004. What CMS Hopes to Learn from the IOM Study of the QIO Program. PowerPoint Presentation to the Committee on Redesigning Health Insurance, August 3, Washington, DC. Jencks SF, Wilensky GR. 1992. The health care quality improvement initiative. A new ap- proach to quality assurance in Medicare. Journal of the American Medical Association 268(7):900903.

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54 MEDICARE'S QUALITY IMPROVEMENT ORGANIZATION PROGRAM Jencks SF, Huff ED, Cuerdon T. 2003. Change in the quality of care delivered to Medicare beneficiaries, 19981999 to 20002001. Journal of the American Medical Association 289(3):305312. Jost TS. 1989. Administrative law issues involving the Medicare utilization and quality control peer review organization (PRO) program: Analysis and recommendations. Ohio State Law Journal 50:171 Marciniak TA, Ellerbeck EF, Radford MJ, Kresowik TF, Gold JA, Krumholz HM, Kiefe CI, Allman RM, Vogel RA, Jencks SF. 1998. Improving the quality of care for Medicare patients with acute myocardial infarction: Results from the Cooperative Cardiovascular Project. Journal of the American Medical Association 279(17):13511357. MedPAC (Medicare Payment Advisory Commission). 2002. Report to the Congress: Applying Quality Improvement Standards in Medicare. Washington, DC: Medicare Payment Advi- sory Commission. NORC (National Organization for Research at the University of Chicago). 2004. Final Re- port: Physician Meetings on Take-Up of Electronic Health Records. Unpublished. Wash- ington, DC: National Organization for Research at the University of Chicago. Pugh MD. 2005. Final Report: CMS Quality Group Planning Project QIOSC Contract 500- 02-WA02 Final Report, Revised. Unpublished. Pueblo, CO: Pugh Ettinger McCarthy Associates, LLC. Rogers WH, Draper D, Kahn KL, Keeler EB, Rubenstein LV. 1990. Quality of care before and after implementation of the DRG-based prospective payment system. A summary of ef- fects. Journal of the American Medical Association 264(15):19891994. Rollow WC. 2004. Evaluating the HCQIP Program. PowerPoint Presentation to Quality Im- provement Organization Subcommittee, October 4, Baltimore, MD. Rubin HR, Rogers WH, Kahn KL, Rubenstein LV, Brook RH. 1992. Watching the doctor- watchers. How well do peer review organization methods detect hospital care quality problems? Journal of the American Medical Association 267(17):23492354. Sprague L. 2002. Contracting for Quality: Medicare's Quality Improvement Organizations. National Health Policy Forum Issue Brief 774. Washington, DC: National Health Policy Forum.