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The Role of Purchasers in the Clinical Research Enterprise

INTRODUCTION

Patricia R. Salber, M.D., M.B.A.

Medical Director, Managed Care, Health Care Initiatives

General Motors Corporation in conjunction with The Permanente Company

This part of the workshop deals with the perspective of private purchasers, a perspective not often included in in-depth discussions related to clinical research. The goal is to understand how the Clinical Research Enterprise can better serve purchasers as they strive to provide high-quality, affordable health care benefits to employees, retirees, and dependents. During this session, purchasers will elucidate what they need from the Clinical Research Enterprise and outline their contributions to it. They will also speak about the challenges they face in translating research into practice. Translational blocks are encountered on the road from basic science to improved health and health care for individuals. The first and most familiar block is in the translation of basic science into clinically meaningful recommendations. The second translational block is in turning those recommendations into action. The ways in which purchasers are affected by both of these blocks will be discussed. Finally, consumer involvement in the Clinical Research Enterprise and its impact on purchasers will be explored.

WHAT PURCHASERS NEED FROM THE CLINICAL RESEARCH ENTERPRISE

Dale Whitney

Corporate Health and Welfare Manager

United Parcel Service

United Parcel Service (UPS) invests roughly $1.6 billion for health care coverage for its employees, retirees, and their families. Next year, that invest



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1 The Role of Purchasers in the Clinical Research Enterprise INTRODUCTION Patricia R. Salber, M.D., M.B.A. Medical Director, Managed Care, Health Care Initiatives General Motors Corporation in conjunction with The Permanente Company This part of the workshop deals with the perspective of private purchasers, a perspective not often included in in-depth discussions related to clinical research. The goal is to understand how the Clinical Research Enterprise can better serve purchasers as they strive to provide high-quality, affordable health care benefits to employees, retirees, and dependents. During this session, purchasers will elucidate what they need from the Clinical Research Enterprise and outline their contributions to it. They will also speak about the challenges they face in translating research into practice. Translational blocks are encountered on the road from basic science to improved health and health care for individuals. The first and most familiar block is in the translation of basic science into clinically meaningful recommendations. The second translational block is in turning those recommendations into action. The ways in which purchasers are affected by both of these blocks will be discussed. Finally, consumer involvement in the Clinical Research Enterprise and its impact on purchasers will be explored. WHAT PURCHASERS NEED FROM THE CLINICAL RESEARCH ENTERPRISE Dale Whitney Corporate Health and Welfare Manager United Parcel Service United Parcel Service (UPS) invests roughly $1.6 billion for health care coverage for its employees, retirees, and their families. Next year, that invest

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ment will increase by about 10%. Whenever the Board of Directors and share-holders make an investment, particularly one that increases at this rate, they want to know what UPS will receive for the additional investment. Will the workforce be 10% healthier? Will customer satisfaction increase by 10%? Will the investment somehow add to the bottom line of the enterprise or add to the public good? Or will the additional dollars simply be spent with no return? As we move toward a consumer-driven health care system, information must become available to the consumer, and not just to the purchaser or clinician. The information must support effective health care decision making at all levels of the system. A current concern is that treatment for the same clinical condition varies widely, raising several questions: If providers receive a similar education and read the same articles in the professional journals, why is there so much treatment variation within the system? Should employers provide coverage and benefits for all variations? Purchasers are looking for ways to promote and improve quality in providers. Although they are willing to change their contracts to support this goal, they have not yet found effective models. —Dale Whitney It has been said that employers are not willing to pay for quality in health care, but this is not the case. Purchasers are willing to differentiate and pay more for quality care because high-quality care saves money in the long run by improving satisfaction and performance in our workforce. Purchasers are looking for ways to promote and improve quality in providers. Although they are willing to change their contracts to support this goal, they have not yet found effective models. Gregg Lehman, Ph.D. President and Corporate Executive Officer National Business Coalition on Health The National Business Coalition on Health (NBCH), on behalf of its nearly 90 employer-led coalitions nationwide and their 8,000 employers and approximately 30 million covered lives, recognize the outstanding clinical research that has taken place to date. Therapeutic investigations, especially in the area of pharmaceutical products, have made the U.S.A. the leader in the development of new drugs and medical devices. Many of these products have resulted in a healthier and more productive workforce for purchasers. We are pleased that current therapeutic interventions are largely focused on the those conditions identified in the Institute of Medicine report Crossing the Quality Chasm: A New Health System for the 21st Century (Committee on Quality of Health Care in America, Institute of Medicine, 2001) that account for about 80% of health care spending

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These conditions represent not only large direct health care expense but also indirect costs in terms of absenteeism and lost productivity that often out-weigh the direct expense. Unfortunately, purchasers are without tools to measure the impact of both new and current interventions on the productivity of their workforce. The state-of-the–art work in the field of epidemiology has broadened our knowledge of the patterns of disease within subsets of the population as well as across the population. Although health services and outcomes research have made an effort to better understand the “real world” of health care, much more needs to be done. The NBCH member coalitions’ purchasers are committed to purchasing health care for their employees, dependents, and retirees based on value—high quality at an appropriate price. Yet research-based, standardized metrics to evaluate most of the dimensions of providers’ and hospitals’ performance are lacking. Nor has research identified optimal approaches for the dissemination of performance information to purchasers in support of their purchasing efforts. Health services research has also not fully addressed the translation of research into practice. For example, evidence-based medical guidelines, founded on significant clinical research, have been developed for many of the conditions identified in the IOM report Crossing the Quality Chasm: A New Health System for the 21st Century (2001). Yet health services researchers and others have found that physicians and other health care providers frequently do not follow such guidelines. Purchasers, and the country’s health care system as a whole, would greatly benefit from health services research that would help to define mechanisms by which purchasers, plans, and payers could encourage not merely the broad adoption of evidence-based clinical guidelines, but also their integration into the day-to-day delivery of health care services. We know that purchasers can play an integral role in “integrating research into practice” through contracting methodology as well as integrating the work of the Leapfrog group in implementing research-based patient safety standards. The country’s health care system as a whole, would greatly benefit from health services research that would help to define mechanisms by which purchasers, plans, and payers could encourage not merely the broad adoption of evidence-based clinical guidelines, but also their integration into the day-to-day delivery of health care services. —Gregg Lehman Research in the area of prevention and health promotion has yielded standardized clinical guidelines, which offer significant opportunities to improve the health of the current U.S. population. Unfortunately, these preventative services are often not received, even when a service is a covered benefit under the purchaser’s health plan. As an example, consider the variation in the following preventative services:

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Up-to-date Pap smear testing from 70% to 93% Cholesterol screening from 45% to 88% Tobacco cessation advice from 20% to 77% (Solbert et al., 2001) Purchasers would greatly benefit from health services research that aids in the understanding of the reasons for variation in receipt of preventative services as well as solutions to reduce the variation. For example, could changes in benefit design (e.g., change in co-pay) increase the receipt of preventative services? Or would time off from work to obtain needed services increase the percentage of employees that receive such services? NBCH coalitions and the purchasers that they represent are committed to value-based purchasing. As such they would benefit from increased health services research in the following areas: Development of metrics that would differentiate physician, hospital, and other health care provider performance Identification of incentive systems that would “reward” optimal provider practice, and similarly, identification of incentive systems that would encourage employees to proactively manage their own health and to seek care (preventative, episodic, and chronic) from top-performing providers Creation of metrics to quantify the impact on worker productivity of high-quality health care that is delivered in accordance with evidence-based clinical guidelines. Many chief financial officers want a business case to be made for the cost of quality improvement programs, i.e., a return on investment for paying for quality. Simply put, if outcomes associated with following guidelines can be measured and their impact in terms of dollars translated, the business case will be made. Purchasers are a long way from making that case. If a business case is made, a rapid realignment of incentives would follow. Many chief financial officers want a business case to be made for the cost of quality improvement programs. —Gregg Lehman Bruce Taylor Director of National Health Care and Policy Plans Verizon Dissemination of clinical information that is known to be effective is an important issue in improving the health care system. Best-practice clinical information and treatment plans should be in the hands of providers, purchasers, and consumers. For example, there is much concern about diabetes, heart disease,

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and other conditions that drive up health care costs. In tomorrow’s health care environment, the whole discussion could change dramatically when the prospects of the genome project are considered. Almost ‘overnight’ the focus could change from providing treatment to maintaining health and preventing disease. A key issue to patients and purchasers is “value,” which raises many questions: What do purchasers get for the additional expenditure involved? What value does the consumer receive, and what does the payer receive? Purchasers have tried many approaches to obtain quality care for their employees. The complaints often heard are that purchasers are not paying enough, with the reasoning that increased reimbursement for medical services will translate to better or higher quality care. And, many purchasers currently negotiate price rather than quality. Purchasers are now negotiating price rather than quality. The point is that there are employers who are trying to pay for quality. —Bruce Taylor Changing the cost paradigm is not easy. However, it is possible if clinical, quality, and cost goals are aligned. For example, several large employers recently expressed their willingness to pay more—in this case bonuses—to hospitals that were able to meet two Leapfrog safety standards for improving patient care. The point is that there are employers who are trying to pay for quality. Purchasers are eager to consider any ideas regarding how to push the agenda forward. It is known that, like manufacturing, improving the quality drives costs down while improving customer satisfaction. Helen Darling President Washington Business Group on Health As seen in the latest debate about the utility of mammography guidelines, fundamental research performed years ago was often not conducted in a way that allowed answers to basic questions. Today purchasers want new technologies and treatments to have been proven efficacious based on high standards of clinical empirical evidence. This type of research is not available in many cases. Studies should be well designed, well executed, and published in peer-reviewed journals. Regrettably, the percentage of studies meeting these criteria is shockingly low. Studies should be well designed and well executed, and results should be published in peer-reviewed journals. Regrettably, the percentage of studies meeting these criteria is shockingly low. —Helen Darling Ideally, results will be based on the gold standard—randomized controlled clinical trials—but this standard cannot

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always be met, either because the number of cases is small or because the treatment is already in practice. If it is not possible to meet the gold standard, then we should at least meet the best standards possible. Everyone involved in health care and coverage should be appropriately skeptical of claims in the absence of solid evidence. Developers of new technologies or treatments tend to be enthusiastic, and that is laudable. It should be recognized, however, that the drive and enthusiasm that make it possible for them to develop these treatments sometimes do affect their judgment and their assertions. To make matters worse, media reporting of new therapies often focuses on benefits with almost no attention given to harmful effects. Politicians, narrow special interests, and the courts all become involved and sometimes drive decisions that are fundamentally wrong and downright harmful. The result is not only harm but also lost opportunities. This nation has a $1.5 trillion health care industry. Many purchasers feel this amount is ample for health care in general. To find budgetary room for new technology and new treatments that are effective—that make a real difference in health and productivity—ineffective or less-than-effective technology must be driven out. Yet this is almost never done. In the United States new technology is often layered on the old. Both new and old are continued, partly because evidence is lacking. The Clinical Research Enterprise provides more innovation, more new technology, and more new drugs than any enterprise in the world. Purchasers are more than willing to help disseminate information on best clinical practices and reward hospitals, physicians, and others who are willing to meet best-practice standards. For this to happen, providers themselves must agree on best practices. It is hard to make changes if clinicians are ambivalent about what constitutes best practices, either because they are unfamiliar with the evidence or because the evidence is not available. Purchasers must do a better job of re-packaging health care information to make it accessible to consumers. Also, they need to know more about why agreed-upon practices are not performed by 100% of providers. Purchasers want providers to use evidence-based clinical guidelines. The important questions are, how do we identify those providers who follow the guidelines and obtain the outcomes that we are looking for, how do we pay for the high-quality care they provide, and what is the right amount to pay? PHARMACEUTICAL COSTS AND VALUE FOR PURCHASERS Patricia Salber, M.D., M.B.A. An important issue for purchasers is pharmaceutical costs. At General Motors, these costs now exceed inpatient costs with respect to many of our health plans. In the current environment of escalating health care costs, payers are

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focusing much attention on drug expenditures. Sometimes their methods do not make the best sense clinically because they lack information needed to make better decisions. In this regard, more head-to-head comparisons of the value of new versus existing therapeutic agents could help purchasers make more rational benefit design decisions. Jill Berger Corporate Health and Welfare Manager Marriott International Many purchasers are again experiencing double-digit inflation in medical costs, which is a large concern for Marriott. Marriott offers enrollment in 70 health maintenance organizations to its employees across the country. It also has a preferred provider organization that is managed to some degree. Marriott’s business strategy will not allow us to go forward with double-digit increases without understanding where the dollars are going. An area of great concern is pharmaceutical costs. As with General Motors, those costs are beginning to exceed inpatient costs. This situation is of concern to Marriott because many new drugs being brought into the marketplace will be very expensive, and the company will be forced to make difficult decisions regarding coverage. Purchasers will need research to help them make those decisions. No forum exists for assessing drug value in the U.S.A. today. Purchasers would like to see studies that include drug comparison, affordability, and safety. A number of stakeholders recently joined together to form RxValue Health. Consumers, providers, health plans, and employers are part of this effort. The members finance a great deal of the health care in the country, and their goal is to address the question of whether purchasers as well as their employees receive value in relation to the rapidly increasing pharmaceutical costs. The coalition’s combined members represent the interests of 135 million Americans as it attempts to assess and secure value for the resources spent on pharmaceuticals. The coalition members would like independent governmental agencies to fund research to help evaluate which drugs provide good value. Members are concerned with new expensive branded drugs that provide no more value than current agents. RxValue Health members want to use the answers to their questions to help inform policy makers as well as businesses and consumers. They advocate research in the following areas: Policy research to assess the market rules that impair open and effective competition Clinical research to differentiate new drugs from “improved” drugs or “me-too” drugs

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Economic research to assess the cost of proposals for patent and/or market exclusivity expansions Research on the costs of the delay of entry of generic pharmaceuticals to consumers and employers Unbiased drug studies not funded by the pharmaceutical industry Studies on the pediatric utilization of selections of drugs that receive pediatric-based exclusivity extensions (i.e., an additional six months of marketing exclusivity when the sponsor submits pediatric testing information relating to the use of the drug in the pediatric population) Purchasers also need help in setting their plan design regarding what to pay for and when, and how to pay for it. For example, three-tier co-pays are currently popular. In fact, Marriott included them in all health plans this year. The impact of the three-tier formulary on appropriate drugs needs to be examined. Marriott wants to make sure that the tiers are structured so that all appropriate drugs are available on all the tiers. TRANSLATIONAL BLOCKS Jon Hautz, C.E.B.S. Senior Consultant William M. Mercer Inc. It is important for purchasers to consider the health care information that ultimately filters down to the user level. Tomorrow, employers may not be the ones who choose health plans for their employees. A trend in this country is to move that purchasing decision down to consumers—to inform them about available benefits and available funds (i.e., a defined medical spending/savings account) and let them spend these contributed dollars on whatever medical care they wish. End users must have the information that they need to make wise choices. Do we put accurate information into the users’ hands? Pick up any popular women’s magazine and see how many surveys, research findings, or health recommendations are included. From month to month and year to year, startling conflicts can be found in the health information reported. Difficulty in communicating to the end users what works in health care is a translational block. If the research is unfocused at the top level, the people who are the recipients of that research are going to be totally in the dark. Do we put accurate information into the users’ hands? Pick up any popular women’s magazine and see how many surveys, research findings, or health recommendations are included. From month to month and year to year, startling conflicts can be found in the health information reported. —Jon Hautz

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Gregg Lehman, Ph.D. In 2001, the NBCH created the not-for-profit Clinical Performance Enhancement Center (CPEC). The mission of the CPEC is to provide a national setting and structure in which health care provider quality and effectiveness can be accurately evaluated at the clinical level and reported with the objectives of improving the health care provided to the general public regardless of payer, assisting providers in achieving best demonstrated practices, and making information available to further research into healthcare delivery. The Lipid Project (a “Project to Enhance Compliance with National and Local Evidence-Based Cholesterol Guidelines”) is the initial provider performance enhancement project of the CPEC. The project is funded by an unrestricted grant from AstraZeneca to the NBCH. When purchasers find out what is working, they need to build this information into their contract methodology and give incentives not just to providers but also to employees so that they maintain compliance with these interventions. —Gregg Lehman The goal of the multi-year project is to demonstrate, in an ambulatory care setting, a provider clinical performance reporting capability utilizing evidence-based medicine guidelines in a high-incidence, relatively low compliance and high risk condition (e.g., elevated cholesterol) and the applicability of expanding that capability to regional and/or national levels. The project is using two ambulatory settings for the study—a Philadelphia area provider site and a Baltimore area provider site. In January 2002, the lipid project will be expanded to a statewide initiative in Maryland and will expand purchaser involvement to the public sector. The CPEC lipid project demonstrates the effective partnership of purchasers, researchers, physicians and pharmaceutical manufacturers. The CPEC project also contains many of the facets of research that are important to purchasers. These elements include the evaluation of: Provider performance using evidence-based clinical guidelines Relative effectiveness of health plan interventions in changing physician practice patterns Impact of employee interventions in eliciting the desired behavior Potential mechanisms to support use of project data to support value-based purchasing The important outcome of this project is guidance on realignment of incentives. When purchasers find out what is working, they need to build this information into their contract methodology and give incentives not just to providers but

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also to employees so that they maintain compliance with these interventions. Employers are very concerned about not only the direct cost of the drugs used to treat diseases but also the indirect costs associated with the disease states—how these conditions impact productivity and how they impact absenteeism, for example. Dale Whitney Research that has a real impact will involve the physician who actually sees 500 patients a month. Purchasers need to learn from such providers how they absorb research findings and apply them to their practice. This important piece is often overlooked. It is not surprising that providers have difficulty incorporating research findings into practice when health care guidelines and recommendations are constantly changing. Providers are expected to know these guidelines by rote, but why should this be so when technology is available? Technology needs to be brought into the mix so that providers have all relevant information at their fingertips, not just in their minds. There is just too much health care information today, and it changes too often for anyone to be expected to remember it all. Imagine if UPS tracked its packages in its employees’ minds rather than by computer! It is not surprising that providers have difficulty incorporating research findings into practice when health care guidelines and recommendations are constantly changing. —Dale Whitney CHALLENGES FOR PURCHASERS IN THE CLINICAL RESEARCH ENTERPRISE Patricia Salber, M.D., M.B.A Purchasers seem to be “marching to a different drummer” than academic researchers because of the urgency of their need for answers to the questions that they face, particularly in light of double-digit inflation of health care costs in the context of an economic downturn. Effective partnerships are those that provide the flexibility to address both short-term and long-term needs, yet purchasers’ short-term needs often cannot be met by the slow pace of the research process. To cite an example, Gen Purchasers seem to be “marching to a different drummer” than academic researchers because of the urgency of their need for answers to the questions that they face, particularly in light of double-digit inflation of health care costs in the context of an economic downturn. —Patricia Salber

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eral Motors spent three or four months putting together a grant proposal for funding the development of a return-on-investment methodology. The company waited another six or seven months for the public agency to hear whether it had been recommended for funding. Although the proposal did receive a high score and was recommended for funding, General Motors is now in its third month of waiting to hear whether that recommendation will translate into dollars. A one-year time frame before the research begins does not work well for purchasers. There needs to be a mechanism that will allow a faster track review for priority purchaser research issues. Dale Whitney One challenge to purchasers is the conflict of interest in funding research efforts. Several times a year a representative from a pharmaceutical company promotes drug-based disease management programs at UPS. It is difficult to evaluate a program in which most evidence for its utility is from studies funded by the pharmaceutical industry. UPS would like evidence from studies funded by sources that have no conflict of interest before trying out a program on its 750,000 beneficiaries. Bruce Taylor A particular challenge faced by purchasers is how to make what they spend for health care more valuable. Verizon tells its employees that there is no money tree. Rather, available resources are constantly reallocated. Similarly, the Clinical Research Enterprise needs to address how the $1.5 trillion available for health care can best be utilized for the benefit of not only today’s patients but also tomorrow’s. The $1.5 trillion expended annually for health care in the U.S.A. certainly seems to be plenty of money. The number of dollars is unimportant. What is essential is the value received for that investment. In a discussion a few years ago between several employers, including Verizon, and the director of the National Institutes of Health, the employers recommended that research support ought to be broad-based, and that it should not come from any particular segment of society. Perhaps part of the general income tax should be used for this purpose. And, there should be a clear sense of the amount of support available for all levels of research. Helen Darling An important challenge is the proper evaluation of research. The Department of Health and Human Services used to earmark a certain amount of money for evaluation. As a consequence, much evaluation was performed that would

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not have been done otherwise. As a nation, we need to earmark some portion of every health institution’s budget that can only be spent on this kind of application and translation. The amount should be reasonable, perhaps 5% of the budget. All members of the research community should pool their interests and desires and declare that the value will be gained if translation of health care information can be improved. Such an effort will help consumers, taxpayers, and purchasers, and it will help the Clinical Research Enterprise itself. Perhaps we could all work together toward that goal. As a nation, we need to earmark some portion of every health institution’s budget that can only be spent on [evaluation research]. —Helen Darling David Rimoin, M.D., Ph.D. Chairman of Pediatrics and Director of Medical Genetics Birth Defects Center Cedars Sinai Medical Center Genomics will pose new challenges for purchasers in coming years. Purchasers want good productivity indices and more value for their health care dollar; yet they are frustrated because the research studies coming out are non-uniform or ambiguous. In the future, studies will become even less uniform and more ambiguous because of the genome project. Through pharmacogenomics, researchers are finding that individuals will vary tremendously in their response to a given pharmaceutical agent or treatment method based on their particular genetic predisposition. Finding out what works for a particular patient means allowing individuals to expose themselves genetically. First, there must be much better protection against genetic discrimination in insurance coverage and in the workplace. Genetic differences might affect job performance and absenteeism, and they might affect the cost of individual health care. Individuals must be examined as individuals to find out what is best for them in terms of health treatment, but we must also protect them from “pulling down their genes.” In the end, results will be much better if people are treated as individuals genetically, but this effort will require a monetary investment and an understanding that there is not a uniform answer for everything. Greg Lehman, Ph.D. The area of pharmacogenomics is fascinating and also frightening to the employer community for the very reasons just mentioned. Targeted intervention for subgroups within disease states is a fascinating topic, but the costs and benefits are unknown. The area warrants in-depth study, and there are many un

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knowns for the employer community. If targeted interventions can produce a lasting effect, health care savings may be substantial. PROPOSAL FOR A NATIONAL CLINICAL RESEARCH ENTERPRISE COORDINATING ACTIVITY William Crowley, M.D. Professor of Medicine, Harvard University, and Director of Clinical Research, Reproductive Endocrine Unit Massachusetts General Hospital Purchasers, in aggregate, are unhappy about the rising costs of health care and the decreasing information on quality and variability in the implementation of practices, guidelines, and safety. Purchasers respond in some cases by jiggling the reimbursement level as the “carrot and stick” at the same time. Other efforts include conducting the applied studies mentioned above. The Clinical Research Roundtable has been examining a Clinical Research Enterprise coordinating activity in which payers, purchasers, patients, investigators, and government agencies work together to examine ways of using for research a national pool of money that superseded, but received contributions from, all the members of the coordinating activity. Would purchasers be interested in participating in this coordinating activity by putting 1% of total health care dollars into a pool that they could direct and use to determine the types of outcomes and ask the kinds of questions that are not currently being addressed? Money is chemotactic and people will move toward it. We have been considering the concept of not just payers and providers, but also each of the governmental agencies that funds this effort, and potentially the Pharmaceutical Research and Manufacturers of America (PhRMA), the biotechnical industry, pulling together in an evenhanded way, with an economic incentive, to create an infrastructure for the Clinical Research Enterprise. Would purchasers find this method a better way of collectively leveraging the enterprise than what is done now? Speaker Response to the Enterprise Coordinating Activity Proposal Helen Darling of the Washington Business Group on Health began the discussion by noting that the concept of a national Clinical Research Enterprise coordinating activity is a good one. She commented that purchasers are changing their role, and that they cannot simply be reactive in the current environment. Jon Hautz of William M. Mercer Inc. also applauded the proposal and asked whether a business case can be made and whether the coordinating activity would add value and not just additional expense. Bruce Taylor of Verizon was intrigued by the idea, noting the breakthrough in funding will come if this coordi

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nating activity becomes a national priority and if the funding comes from a national set-aside. Dale Whitney of United Parcel Service noted that the coordinating activity would provide an additional way for participants to work on the quality dialogue that has currently begun. He noted that those in the corporate office who are responsible for cost containment will want to know what the return will be for this particular investment. Jill Berger of Marriott mentioned the importance of coordinating the research effort. She noted that purchasers are trying many different approaches to determine what provider and member incentives bring about changes in behavior, but that these efforts are not coordinated. Gregg Lehman, Ph.D. of the National Business Coalition on Health stated that is it hard to argue with a multi-stakeholder approach to problem solving and concurred that it is a laudable idea. He suggested that the National Quality Forum be a key player in this approach and proposed that a number of roundtable members sit on the purchaser council of the forum. The forum already represents a collaborative effort among the various stakeholders in health care. Dale Whitney noted that before wholly embracing the concept, purchasers need to have a clear picture of what the expected outcomes will be. He concluded that the enterprise coordinating activity will move purchasers from being reactive to proactive and will probably allow the goals of the research community to be accomplished more quickly. THE IMPORTANCE OF PREVENTION RESEARCH Hugh Tilson, M.D., Dr.P.H. Senior Advisor to the Dean School of Public Health, University of North Carolina An important question for purchasers is, what is the role of the employer in prevention? Keeping a worker healthy is a better investment; therefore, partnering with local and state public health efforts must part of the employer’s strategy. Important questions remain unanswered in the public health practice and systems research agenda. One important question is whether prevention and public health systems research is a priority for the employer. Bruce Taylor One view from the health plan perspective is that a member may not stay a member for long. An employer might have the same view, especially in the post-September 11 environment in which downsizing, early retirement, and a variety of other programs are being considered. Both health plans and employers may question what their investment should be in the members’ or employees’ long-term interest. There are responsible employers who see the link between prevention and benefit. For example, Verizon has a fairly mature workforce composed of workers who are likely to remain with Verizon throughout their working career and into

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retirement. The company is interested in how to engage them proactively. That engagement is difficult. Verizon has conducted a few programs— admittedly pilot projects that are not broad-based. One is a healthy babies program and the other involves freedom from back pain. These programs attempt to engage employees or dependents in improving compliance with treatment standards. Verizon provides the coverage absolutely free if individuals follow the prescribed protocols. Initial results show that this approach helps individuals become engaged in their health care. There are responsible employers who see the link between prevention and benefit. —Bruce Taylor Helen Darling Most employers believe that prevention can play an important role if it is packaged in appropriate words and not overdone. Talking about preventing disease to improve quality of life and productivity is likely to “hit home.” Softening the language can increase employer involvement. The Washington Business Group on Health has a number of projects in partnership with the Centers for Disease Control, in which they are trying to translate prevention information into meaningful messages for their members. One area in which prevention and public health could become extremely important is the epidemic of obesity in this country. Obesity is a very large problem for employers and results in many negative health consequences. Not nearly enough information is available regarding health risk, the impact of obesity on disease, or effective interventions. Struggling with excess weight is admittedly a difficult problem for many people. In this nation, food is readily available everywhere. Every airport is full of all sorts of rich and fattening foods, and restaurants customarily serve large to enormous portions. This situation poses a public health crisis and ultimately burdens the entire nation. Jon Hautz, C.E.B.S. Sometimes the issue of prevention is not brought to the forefront because the focus is on actual health care expenses and not on the potential savings from preventive health behaviors. Choosing to be healthy is a life change, a decision to live differently. Unless the environment changes, the individual is not likely to change. The issue goes beyond what a health plan can provide. Plans can send out all the fliers they want, but if they cannot change the environment The issue goes beyond what a health plan can provide. Plans can send out all the fliers they want, but if they cannot change the environment in which the individual makes lifestyle decisions, they will not be able to reinforce the switch to healthier behaviors. —Jon Hautz

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in which the individual makes lifestyle decisions, they will not be able to reinforce the switch to healthier behaviors. George Isham, M.D. Medical Director and Chief Health Officer HealthPartners Prevention is a cost issue for employers as well. For example, employees at the extreme of the body mass index chart, at 35 or 40, may incur substantial costs associated with bypass operations needed to treat heart conditions related to diabetes. The expenditure for operations such as these is so large that it over-whelms all existing preventive budgets. Many links that are known to be associated with overweight have no good studies, however, and funding is not forthcoming. There is an extreme dearth of funding for health promotion and disease prevention. Employers are encouraged to use whatever language is required to promote interest in this issue, and they are encouraged to pursue the appropriate funding of not only the obesity issue but also the activity issue and the tobacco issue. CONSUMER INVOLVEMENT Myrl Weinberg, C.A.E. President National Health Council In this meeting and in many others, there is much discussion of the increasing role of the patient or consumer in influencing the health care system and the delivery system, particularly with respect to what health care is provided. In nearly every case, however, when meeting participants discuss convening groups of stakeholders to identify problems, examine the challenges, set priorities, and come up with solutions, they mention every stakeholder except the consumer or patient. Discussion often centers on shifting costs to the consumer or patient, or potentially shifting decision-making responsibility to them, but very little is said about working together with them on these issues. When an employer has the primary responsibility for the health care decisions for its employees, these employees should be included the design of the plan. Helen Darling Thirty years of health policy in this country has shown that it is difficult to identify consumers or a consumer. Good literature exists to guide proper selection when employees wish to involve consumers in decision making. Large- and medium-sized employers do much surveying of their employees. Most employ

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ers consider themselves in frequent contact with their employees, retirees, and dependents. E-mail and the Internet have made possible a constant feedback loop in most corporations. Involving consumers in the changes that have been discussed is possible, but it is difficult. Increases in health care costs for the coming year have been estimated at close to 14%. This estimate does not take into account either the impact of the events of September 11 or the potential effect of passage of the health care legislation currently before Congress. The actual dollars that consumers will have to pay for health care next year, on a monthly basis and a cost-sharing basis, will be two to four times more than a year or two ago. Consumers will take action because they will be spending much more of their money on health care than before. Dale Whitney The switch to a consumer-driven health care system will occur over a number of years. For UPS employees, the switch has been taking place over the last few years and will continue. The company’s role is to provide employees with information and the tools that they need to work with their physicians, and within their health care plans, to make effective decisions. Some employees are ready to do that today; some are challenging their physicians regarding their treatment plans. Others will not do that five years from now. They will still want the physician to dictate their treatment plan. The switch to a consumer-driven health care system will occur over a number of years. —Dale Whitney Many employers survey their employees on a regular basis regarding benefits. UPS conducts annual surveys and multiple focus groups. Some questions discussed are, how do you use the health care system, how can we best help you to use the health care system, and what do we need to change in the way we provide benefits? PUBLICATION OF A RESEARCH PRIORITIES PROPOSAL Richard Rettig of RAND started a discussion regarding publication of a clinical research priorities proposal by noting that an asset for purchasers and payers is an immense amount of claims data, which provide a running account of the annual burden of disease in this country. He asked if it might be possible for purchasers and payers to compile an annual statement of 5 to 10 high priority clinical research projects that purchasers would like to see conducted in the coming year. He suggested the statement be published in the Journal of the American Medical Association or the New England Journal of Medicine. Medical researchers typically set the priorities for clinical research. He suggested that purchasers and payers consider entering the discussion of priority setting for

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clinical research, thus strengthening the demand for research that pertains to improved clinical practice. Bruce Taylor responded that employers do have “piles” of data but they do not have the resources or clinical knowledge to convert the data into information, knowledge and appropriate actions. Verizon has looked for researchers with whom to partner and has located some who are willing to help identify key questions. However, few researchers take up the offer. Many employers, including Verizon, would welcome this type of partnership, because it leverages the information that is already available. Jon Hautz mentioned that sometimes the data that purchasers hope to find is buried in a variety of systems that do not “talk” to each other, and sometimes the quality of the data is poor. Purchasers sometimes discover that the information technology infrastructure is not as robust as expected. Helen Darling stated that an examination of health care utilization reinforces much that has been brought out in the workshop. Many people are not getting the care that they should. No more research is needed to verify that issue. From the age of the workforce and the distribution, it is possible to determine the most prevalent diseases and the most commonly prescribed drugs. The diseases in older workers are heart disease, cancer, diabetes, gastrointestinal disorders, and depression, not necessarily in that order. In a younger population, the diseases are depression, allergies, asthma, as well as accidents many emergency department visits. Obesity will be at the top of the list for new research in the future. SUMMARY The goal of the session on the role of purchasers in the Clinical Research Enterprise was to shed light on how the Clinical Research Enterprise can better serve purchasers as they strive to provide high-quality, affordable health care benefits to employees, retirees, and dependents. Representatives from corporations (General Motors Corporation, United Parcel Service, Marriott International, and William M. Mercer, Inc.) and from business organizations (the National Business Coalition on Health and the Washington Business Group on Health) presented their views on what purchasers need from the Clinical Research Enterprise, how the enterprise has met purchasers’ needs, and what purchasers are willing to contribute to the enterprise (see box). The representatives of the purchaser organizations also examined the problems of translating basic research findings into clinical guidelines, translating clinical recommendations into best evidence-based practice, and providing consumers with accurate information to guide their health and health care choices. They responded to a proposal presented by William Crowley of Harvard University for a National Clinical Research Enterprise Coordinating Activity, in which purchasers, payers, investigators, consumers, and government agencies would contribute to a national fund and would collectively direct and use the fund to

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examine research questions of national significance that are not currently being addressed. They explored the role of purchasers in furthering research in preventive health care and in encouraging members to adopt healthier lifestyles. They discussed the imminent shift to a consumer-driven health care system in the U.S.A. and the implications of that shift for purchasers. Finally, they considered the usefulness of compiling and publishing a list of clinical research projects that purchasers and payers consider top priority.

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Highlights of the Session on the Role of Purchasers in the Clinical Research Enterprise What do purchasers need from the Clinical Research Enterprise? Purchasers need research that can inform benefit design decisions as well as research that sheds light on what they can do to better understand clinical variation and to implement programs that address inappropriate variation. They need to know which new technological innovations and treatments have been proven efficacious through high-quality empirical evidence. They need further research to help them put incentive programs into place that support clinical quality and efficiency. Studies providing such evidence must be well designed, well executed, and published in peer-reviewed journals. To make budgetary room for new technology and treatments, the Clinical Research Enterprise must apply rigorous standards of evidence to identify and drive out ineffective or less-than-effective treatments or technology. The Clinical Research Enterprise needs to address the blocks in translating basic research findings into clinically meaningful recommendations and in translating those recommendations into action. Purchasers need to understand why agreed-upon clinical practices are not always performed. They need to know why there is wide variation in clinical practice and what solutions can be developed collaboratively to reduce this variation. Purchasers are concerned about rising pharmaceutical costs and need unbiased comparisons of new versus existing therapeutic agents. The Clinical Research Enterprise needs to encourage physicians and hospitals to incorporate current technology into their practices. The Clinical Research Enterprise needs to provide a mechanism for fast-track review for priority research issues. The Clinical Research Enterprise must provide better protection against genetic discrimination in insurance coverage and in the workplace. What are purchasers willing to contribute to the Clinical Research Enter prise? Purchasers help disseminate information to consumers on best clinical practices, and they reward hospitals, physicians, and others who are willing to meet best-practice standards. Purchasers are willing to pay for quality in health care, but they need to know what they will receive for their investment. Some purchasers participate in partnerships with researchers, physicians, and pharmaceutical manufacturers; such efforts can provide guidance on realignment of incentives for providers and employees. In the shift to a consumer-driven health care system, purchasers can play a role in preventive health by educating their members and encouraging healthy lifestyle behaviors. Purchasers may be interested in contributing to a national fund used to examine research questions of national significance, but they need to know what the return would be for the investment.