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Testimony on AHCPR's Role in Health Care Quality by John M. Eisenberg, M.D.
Administrator, Agency for Health Care Policy and Research
U.S. Department of Health and Human Services

Before the Senate Committee on Labor Human Resources, Subcommittee on Public Health and Safety
February 11, 1998

Mr. Chairman, thank you for giving me the opportunity to address the Subcommittee on the programs and activities of the Agency for Health Care Policy and Research (AHCPR). AHCPR's mission is to provide good and objective science-based information that will improve decision making at all levels -- from patients, to clinicians, to health care system leaders, to public and private policymakers. AHCPR's goal is to ensure in an increasingly market-based health care system that state-of-the-science information drives informed decision making.

Many of the activities outlined here will be linked to our Fiscal Year 1999 performance plan that has been transmitted to Congress.

AHCPR was established by Congress in 1989 "for the purpose of enhancing the quality, appropriateness, and effectiveness of health care services and access to care." While we have met this objective during the past nine years, we recognize that health care in 1998 is very different from 1989, and the Agency has adjusted its agenda and priorities to meet the new challenges we face, while continuing our charge set forth by Congress. Here are our priorities:

• To conduct and support research on the outcomes and effectiveness of treatments;
• To ensure that clinicians, patients, health care system leaders, and policymakers have the information that will enhance quality of care; and
• To identify gaps in access to and use of health care services, achieving value for the Nation's health care dollar, and helping the market and policymakers find ways to address those gaps.

As the Subcommittee knows, the issue of health care quality is very much in the news and on your agenda. But what do we mean when we say "quality?" At the most basic level, quality means doing the right thing, at the right time, in the right way, for the right person. As someone who recently left clinical medicine, I am personally sensitive to the challenge clinicians face every day in knowing what the right thing is, when the right time is, and what the right way is.

As you well know, AHCPR is not a regulatory or enforcement agency, but a scientific research agency that sponsors, conducts and translates research. We follow the same rigorous evaluation and peer review standards for awarding research grants as does the National Institutes of Health. Three-quarters of AHCPR's research funds are used to support researchers throughout the country.

Since I have been at the Agency, we have been going through an extensive planning process. We are consulting our National Advisory Council, seeking input from our stakeholders, and receiving advice from the Subcommittee. We hope that the reauthorization process will provide an opportunity to gain additional insight from you and the other witnesses at this hearing as well as strengthen the relationship between AHCPR and this Subcommittee.

The planning process has focused our priorities on four primary customers: clinicians, patients, health care systems leaders, and policymakers, each of whom need information to enhance their contribution to improve the quality of care in this country. In the rest of my testimony, I will describe how we are serving our customers with research on outcomes, quality, cost, use, and access.

I. Providing Information That Helps Clinicians Provide Better Care and Patients Receive Better Care

I see AHCPR's clinical research as a continuum. First, we build the science base by conducting health services research that serves as the foundation for improved care. Second, we translate and disseminate the research in a format that can be used in clinical practice. Third, we evaluate the translation and dissemination of that research to make sure that it has reached the relevant audiences and is used appropriately.

Meassuring Health Outcomes

First, let me concentrate on how we serve decision makers with information on outcomes of clinical care.

AHCPR's sponsored research attempts to answer these questions for a wide variety of medical conditions and treatments. The findings of this research have been translated into useful tools for every day clinical practice. For example, AHCPR sponsored research at John Hopkins University developed a visual function index - the VF-14 - that measures the effects of cataracts on patients' ability to perform 14 everyday activities, including reading and driving. The index also allows for comparisons of patients' visual function before and after removal of a cataract.

The VF 14 index is a sensitive and reliable measure of the impact of cataracts on visual function. As a result, it can be used to help determine the value of cataract surgery for specific patients. In a study of more than 500 patients four months after cataract removal, changes in patients' ratings of satisfaction with their vision correlated more strongly with changes in VF 14 scores than with traditional ways of measuring changes in visual acuity. Compared with other outcome measurements, a changed VF 14 score was also the strongest predictor of changes in patients' satisfaction with their vision.

Another tool developed by AHCPR-supported research should have a great impact on the quality of care provided to patients who suffer heart problems. An outcomes project funded by AHCPR recently found that many patients with heart attacks do not receive thrombolytic therapy (drugs to dissolve clots inside coronary arteries). Another research project at the New England Medical Center led to the development of a new tool to care for patients having a heart attack. The tool estimates whether a patient is likely to benefit from potentially lifesaving treatment with thrombolytic therapy in the emergency room. The information is provided to the doctor in "real time." The tool also calculates the patient's likelihood of developing serious complications, such as hemorrhagic stroke or major bleeding, if given thrombolytic therapy.

A trial to assess whether this instrument, which plugs into an existing EKG, will increase the proportion of eligible patients receiving recommended treatment is in progress. The researchers are also working with the major manufacturer of EKG machines to make this tool widely available.

Understanding Variation in Health Care. AHCPR's research emphasis has been on conditions that are common, costly, and for which there is substantial variation in practice. This research includes many of the conditions that represent a major expenditure for Medicare.

The issue of variation is not new to you. Dr. John Wennberg's work has shown that medical practice varies widely in this country. AHCPR has sponsored a substantial portion of Dr. Wennberg's work in the area of prostate disease. His research team found that the rate of radical prostatectomy for Medicare patients in Gary, Indiana is twice the rate in Kingsport, Tennessee (2.0 per 1000 Medicare enrollees versus 0.9 per 1000). These variations can vary region to region, State to State, or within States. For example, the rate for radical prostatectomy for Medicare patients in Baltimore, Maryland is approximately three times the rate in Salisbury, Maryland.

Variation provides us an opportunity to study what care is appropriate, how much is enough, and what is fair. This involves understanding when variation is due to issues of uncertainty, issues of access, and issues of overuse or under use. I would like to note that variation isn't inherently bad. The research that AHCPR supports and conducts helps us understand whether variation in medical practice should be celebrated or eliminated. In some cases, variation is caused by geographical, epidemiological, or cultural preferences. For example, we expect to have a higher rate of skin cancer in the South, and therefore more treatment for skin cancer.

Supporting Evidence-based Practice. A key issue in variation is professional uncertainty. If clinicians don't know what works and what doesn't work, they may be inadvertently providing inappropriate or ineffective care. Last fall, AHCPR named 12 Evidence-based Practice Centers (see appendix "A" for a list of the EPCs), or EPCs, which will be an important step in providing the scientific evidence that others will use to reduce unnecessary variation by reducing uncertainty. The 12 Centers will develop a scientific analysis, in a form of a report, of the evidence of the effectiveness of a particular treatment, technology, or procedure. This analysis will then be used by health care organizations, medical societies, physician practices, and others to develop their own quality improvement tools, including guidelines, quality improvement programs, and performance measures.

For example, the Agency developed an evidence-based practice report on the findings on colorectal cancer screening. The information contained in AHCPR's evidence report led to a clinical practice guideline that was developed by the American Gastroenterology Association on colorectal cancer, which in turn, contributed to Congress' decision to expand Medicare coverage for colorectal cancer screening.

An important component of AHCPR's Evidence-based Practice initiative is collaboration. The EPC topics were nominated by public and private sector organizations which will use and help us disseminate the information. The nominators are our partners. . For example, the American Academy of Pediatrics and the American Psychiatric Association nominated attention deficit/hyperactivity disorder as a topic, and they will incorporate AHCPR's evidence report into a guideline they are working on. Similarly, a consortium of patient and provider groups nominated management of urinary problems in paralyzed persons as a topic, and they will also create a guideline from it. And the Health Care Financing Administration asked us to evaluate swallowing problems in the elderly to help them determine their coverage policy for this area.

Translating Research into Practice

In addition to providing information on outcomes to clinicians and patients, we want to help them use the information to enhance the quality of care provided and received.

Obviously, developing the information isn't enough. We need to make sure that it is available in a useful format to anyone who needs it. To achieve that goal, AHCPR, the American Association of Health Plans and the American Medical Association are working together to provide one-stop-shopping for best practices in clinical care. We are developing a National Guideline Clearinghouse that will make clinical practice guidelines available to every clinician, health system leader, patient, and policymaker who can use a computer.

AHCPR also is looking at the effectiveness of clinical preventive services, and the potential they have for saving lives and reducing health care costs. The medical literature increasingly recognizes that some clinical preventive services provide enormous benefit. We need to know which services are most appropriate and effective for which patients and when. The recently passed Balanced Budget Act expanded Medicare coverage for prevention services. The information AHCPR develops will be invaluable to you as you deliberate further expansions in coverage for preventive services.

As a central component of these efforts, AHCPR will support renewed activities of the U.S. Preventive Services Task Force. Their 1995 report provides clinicians with the information on the effectiveness and appropriateness of the full range of preventive care --screening tests for the early detection of disease, advice to help people change their risky health-related behaviors, and immunizations to prevent infections. AHCPR will support major new assessments of preventive services and updates of priority topics by the Task Force. As requested in the Balanced Budget Act, the Task Force will also work with the Institute of Medicine to evaluate the implications of including new preventive services under Medicare.

Supporting the U.S. Preventive Services Task Force will continue a long and productive partnership between the government and the leading primary care medical and nursing organizations. Our activities complement the major investment being made by the Centers for Disease Control and Prevention (CDC) in the study of preventive services in community-based settings. We look forward to working with the CDC on integrating our research in this area.

Finally, I want to thank the Subcommittee for providing the Agency with its new authority, the Centers for Education and Research Therapeutics or CERTS, under the Food and Drug Administration Modernization Act. The CERTS will improve the effective use of medical products, such as pharmaceuticals. This new authority builds on our existing research in this area.

For example, clinicians can receive the information they need to help reduce the costs of medical care through AHCPR's research on pharmaceuticals. With funding from AHCPR, Michael Fine of the University of Pittsburgh and colleagues found that using the antibiotic erythromycin for treating community-acquired pneumonia in most outpatients aged 60 and under significantly reduces treatment costs compared with the use of other antibiotics ($5.43 versus $18.51) and has no adverse effect on medical outcomes. About 600,000 of the 4 million Americans who develop community-acquired pneumonia are hospitalized each year. This

Because of a lack of evidence-based admission criteria and the tendency to overestimate the risk of death, many low-risk patients who could just as safely be treated as outpatients are instead admitted for more costly inpatient care. The two areas most likely to result in major cost savings for community-acquired pneumonia are reducing admissions of low-risk patients and reducing lengths of stay. These findings are being used to improve quality of care for Medicare beneficiaries.

Outcomes research -- which provides the basic knowledge of what works and what doesn't work, is the foundation for all efforts to improve the quality of health care services. We can use this knowledge to determine what the right thing is, when the right time is, and what the right way is, and whether we are getting value for what we spend.

II. Improving Decision Making in Health Care Systems

The health care system has gone through some significant changes over the past several years. These changes have created new structures, processes, and settings in which care is delivered. These changes have also raised a number of issues such as what is the impact on quality, what happens to patients' access to services, the cost of those services, how they are used, and the outcomes of patients who use the services. For example, some of the questions we can ask are: What happens when patients are discharged quickly from the hospital? How are managed care and traditional insurance changing and how are the new arrangements affecting access to care and the quality of that care?

Unfortunately, these changes are happening quickly and we have little scientific evidence regarding their impact on the health care system, generally, and on quality specifically. AHCPR is conducting and supporting research to fill this void.

Providing Research on Market Changes

I believe that outcomes research is more than measuring the outcomes of clinical treatments. Our customers need to understand the outcomes of the organizational and financial structures in the way medical care is delivered. It isn't enough to know that clinical services are safe, effective and appropriate if the structure for delivering that care is shaky or untested.

A recent issue of the journal Health Affairs featured AHCPR's research that presents the first comprehensive look at what is currently happening in the health care marketplace. The articles form an invaluable evidence-based core of information for current discussions of policy options by all health care system participants both public and private.

These studies, which had a two-year turnaround from funding to report, provide fundamental knowledge about the link between the financing and delivery of health care and the quality of services. These studies empirically and rigorously examine issues of how current, incentive-driven market decisions of multiple participants hospitals, physicians, health plans, employers, employees, and public, private and individual purchasers determine who gets health care, what kind of care, how much care, who pays and how much it costs.

Supporting Research to Improve Primary Care Systems. Issues of systems of care are not strictly limited to hospitals or other institutions. We need to understand how patients gain access to the system. AHCPR is the only Agency that has an expressed responsibility to study the structure and delivery of primary care services. This research is increasingly important as more care is delivered beyond the hospital walls.

More than half of all Americans are now covered by managed care plans, which often require the use of a primary care physician or gatekeeper to manage the referral of patients from primary to specialists. Access to specialists is a major concern among the public, and has been the subject of much debate. To strengthen the scientific base underpinning the referral policies of health plans, AHCPR issued a call in early 1996 for research applications on the referral of patients to specialists. As a result of this request for research applications, we have been able to fund eight grants on physician referrals, and we look forward to the results of these studies in the fall.

Measuring and Improving Quality of Care

Recent public debate has focused on the concern of many Americans that the growth of managed care has an adverse impact on the quality of health care, particularly for people with chronic conditions. But at this point, the evidence is unclear and, to the extent that the practices of managed care raise quality issues, it is unclear which practices produce the problem. There is evidence that managed care has improved the quality of care in some instances. Consequently, we need more information on when managed care is likely to improve health care quality and when quality may be harmed.

I believe that recent discussions of health care quality and how to improve quality have cast the issue too narrowly. Quality improvement should not be viewed solely as an issue for managed care. It is an effort that involves the health care system as a whole. For quality improvement to work, we need to address problems in the entire health care system for all patients, in all settings, and under all payment sources.

Preventing System Errors. AHCPR-supported research has demonstrated that the processes and systems used to provide care are often faulty and can lead to avoidable accidents. One conclusion of the research is that many of these accidents are not the fault of individuals, and therefore can be prevented by evaluating and improving the system.

In a recent AHCPR-funded study, Dr. Lucian Leape, a pioneer in research on how to reduce errors in medicine, estimated that the number of injuries caused by medical errors in hospitals alone could be as high as three million annually, resulting in costs as much as $200 billion each year. In his work on drug-related errors, Dr. Leape concluded that 70% of these errors are avoidable, and can be prevented by re-engineering the hospital systems which allowed the errors to occur. Other organizations, such as the Department of Veterans Affairs and the American Medical Association, are using this research to develop programs to reduce preventable errors.

AHCPR is also examining how changes within systems of care affect the delivery of services and their quality. The Health Resources and Services Administration, and the National Institute of Nursing Research, and AHCPR in 1996 convened a joint meeting of experts to set a research agenda on the impact of nurse staffing levels on the quality of care in hospitals.

AHCPR is working to refine existing measures and develop new measures that accurately reflect the changing health care system. An important component in our effort to develop and test valid measures is to anticipate future measurement needs. The goal of our efforts is to begin to identify and develop the "next generation" of quality measures for certain conditions, population subgroups, particularly vulnerable populations such as the chronically ill, and in the full spectrum of treatment settings, such as rehabilitation and home care.

The Agency is involved in collaborative projects with private sector organizations to develop their own quality measures. For example, AHCPR research found that elderly patients who receive beta blockers following a heart attack are 43 percent less likely to die in the first 2 years following the attack than patients who do not receive this drug. That same study found that patients who receive beta blockers are rehospitalized for heart ailments 22 percent less often than those who do not get beta blockers. However, only 21 percent of eligible patients receive beta blocker therapy.

The National Committee for Quality Assurance (NCQA) used the findings of this study as the basis for changing the performance measurement for beta blocker use after acute myocardial infarction to include patients over 75 years of age in the most recent version of the Health Plan Employer Data and Information Set (HEDIS 3.0).

An important component of improving the quality of health care services is giving patients the information they need to make informed choices about their health care coverage, physicians, and treatment options.

AHCPR's Consumer Assessments of Health Plans Survey (CAHPS), which consists of a series of questionnaires designed to be used by public- and private-sector health plans, employers, and other organizations to survey their members and employees. The information from CAHPS questionnaires, presented in the CAHPS tested report formats can help consumers and group purchasers compare health plans and make more informed choices based on quality.

The CAHPS materials are designed for use with all types of health insurance enrollees (Medicaid and Medicare beneficiaries as well as the privately insured) and across the full range of health care delivery systems, from fee-for-service to managed care plans. In addition to a core set of items designed for use with all respondents, some additional questions are targeted for use with certain subgroups such as persons with chronic conditions or disabilities, Medicaid and Medicare beneficiaries, and families with children.

We are not suggesting that all providers and plans in every clinical setting and every region in this country be evaluated using the exact same measures. Measures and instruments should not be one-size-fits-all, but should reflect the diversity of needs and uses. We are advocating a "department store" of accepted quality measures, all based on science and validated for reliability and usefulness, where users of measures can pick the set that fits their need, whether that need is to compare health plans or providers, or to conduct a hospital quality improvement project.

III. Supporting Policymakers with Data and Information

Policy makers need to understand how dramatic growth of managed care, changes in private health insurance, and other dynamics of today's market-driven health care delivery system have affected, and are likely to affect, the outcomes, quality of, cost of, and access to the health care that Americans use.

Developing and Improving Information Technology. Informatics is another tool for improving the quality of health care services. There has been an explosion in the use of information technology in medicine, such as telemedicine and computerized medical records. These technologies have greater potential to improve the quality of, outcomes of, access to, cost of, and use of care. To achieve this potential, we need research to determine what works and what doesn't work in "high tech" health care.

Informatics is an area of research that is critical to every aspect of AHCPR's work . Let me explain. First, the revolution in information technology is critical to the ability of health care delivery systems to measure and improve the quality of care that they provide their patients. They need seamless information systems -- linking administrative, financial, and clinical data -- that can follow patients no matter where or from whom they receive care. I am delighted to note that much of the pioneering work in developing the prototypes and evaluating their usefulness in daily practice was supported by our predecessor, the National Center for Health Services Research. AHCPR has an important and continuing role to play in evaluating the impact of informatics on the cost, access, and quality of clinical care and health care systems. Last year we funded eight projects to do just that (see appendix "B" for a list of informatics projects).

Second, the type of research that AHCPR conducts and supports -- to assess what works best in clinical practice and how we organize and manage the systems in which care is delivered -- relies upon information technology at every step. The type of rapid analysis and dissemination of data on patient outcomes envisioned by some of the quality of care proposals under consideration by the Congress will not be possible if we do not advance the state of the technology and develop the common language that will let systems from various providers, plans, purchasers, and payers communicate with one another.

For both of these reasons, we have recently taken steps to integrate our informatics work into our other substantive research centers. This step will strengthen our commitment to informatics in the long run.

system, she has asked me to co-chair the Department-wide Data Council, which will become an increasingly important forum for decisionmaking in the area of information technology and carrying out the Department's statutory responsibilities. AHCPR's experts in informatics will help the Data Council as it addresses issues of advancing a common language for information technology systems and addressing questions of their appropriate use.

AHCPR's Medical Expenditure Panel Survey (MEPS) provides policymakers and others with up-to-date, highly detailed information on how Americans as a whole, as well as different segments of the population, use and pay for health care. This ongoing survey also looks at insurance coverage and other factors related to access to health care. MEPS is the only survey that collects expenditure data from the non-Medicare population.

MEPS data is used by Congress; Federal agencies, including HCFA and other components of the U.S. Department of Health and Human Services, Office of Management and Budget, and Department of the Treasury. If MEPS data were available during my tenure on the Physician Payment Review Commission, it would have been an invaluable source of information in helping to make recommendations to Congress on payment for physicians.

These data also are used widely in the private sector by researchers at The Heritage Foundation, Lewin-VHI, Urban Institute, RAND Corporation, Project Hope, as well as by health insurance companies, pharmaceutical firms, and other health-related businesses.

Using MEPS data on the first six months of 1996, AHCPR researchers Philip F. Cooper and Barbara Steinberg Schone have found that as many as six million Americans choose not to accept health insurance when offered it by their employers. The study found that the number of workers declining employment-based health insurance increased by 140 percent between 1987 and 1996 while the number of employers offering health insurance increased during those years. Those most likely to turn down insurance are young (under age 25), single, Hispanic or black, and work for low wages. Possible factors driving this trend include the decline in real wages, higher employee contribution rates, and [state legislation aimed at enhancing insurance coverage which may have increased costs.]

AHCPR's assistance is not limited to Federal policymakers. An important AHCPR program is the User Liaison Program (ULP), which plays a critical role in providing technical assistance to States and local policy makers on a wide range of issues. For example, the ULP program conducted a workshop geared toward State policymakers to examine the latest research findings on the uninsured and what State governments have been doing to solve the problem.

In 1998, the ULP will provide technical assistance to help State legislators and executive branch officials plan for and implement the State Children's Health Insurance Program (CHIP) recently enacted by Congress.

One of AHCPR's statutory responsibilities is to conduct assessments of new technologies for the Medicare program (HCFA) and the Department of Defense. This information is invaluable to Federal policymakers and in some case drives coverage policy in the private sector. A case in point is AHCPR's technology assessment on lung volume reduction surgery (LVRS). This technology assessment concluded that there was insufficient evidence upon which to make a scientific judgment regarding the effectiveness of LVRS. AHCPR recommended that coverage be granted within the scope of a clinical trial, which is now being conducted by the National Institutes of Health. AHCPR is supporting the cost-effectiveness component of that trial. It is our hope that the collaborative efforts between the agencies will yield the information needed to make an informed coverage decision on LVRS.

AHCPR's new Evidence-based Practice Centers will continue to produce timely technology assessments that will assist Federal, State, and private sector decision-makers make difficult coverage decisions.

Private sector policymakers also use our research to make informed health care decisions. Recently, the Pharmaceutical Research and Manufacturers of America included AHCPR's research finding on atrial fibrillation to promote the use of blood thinning drugs in an advertisement touting "three ways pharmaceuticals are ganging up against health care costs."

AHCPR's research and data give policymakers the "big picture" on the cost, use, and access to health care in this country for them to use in making decisions about clinical policy, coverage, quality improvement, and spending.

V. Conclusion

In order for health services research to fulfill its potential to improve the quality of the health care system, the foundation on which it rests must be strong. This foundation includes the tools that can be used to improve health care, the training to nurture and promote the best researchers, and the teams that foster partnerships and collaborations among the public and private sectors.

All of these elements will enable AHCPR to meet the challenges we face. Mr. Chairman and members of the Subcommittee, I respectfully request that you reauthorize AHCPR so that we can help our Nation's health care system by:

• conducting and supporting research on the outcomes and effectiveness of treatments;
• ensuring that clinicians, patients, health care system leaders, and policymakers have the
• information that will enhance quality of care; and
• identifying gaps in access to and use of health care services, achieving value for the
• Nation's health care dollar, and helping the market find ways to fill those gaps.

These issues are critical to a sound, high quality health care system. I look forward to working with the Subcommittee in the months ahead to find ways to improve health care decision making.

Appendix A
Evidence-based Practice Center Topics