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PERSPECTIVEEvidence-Based Medicine In The United States—De Rigueur Or Dream Deferred?
Although evidence-based medicine (EBM) is an important concept for promoting value in health care, meaningful application of EBM tools in commercial settings has proceeded slowly. Barriers to the use of EBM include patient preference, physician resistance, the lack of automated decision support systems, managed care failures, lack of research on which to base decisions, and the inherent subjectivity of interpretations of evidence. Political concern has mirrored these barriers; consequently, Medicare still lacks clear authority to apply many evidence-based decision tools. Dialogue and consensus will be critical in bridging public concern and the eagerness of researchers to apply EBM.
Experts and researchers have long predicted the inevitable adoption of evidence-based medicine (EBM) in clinical practice and when making decisions on public resources. The principle of using the best evidence to make decisions for a patient or population makes sense. EBM can be a tool for assessing the effectiveness of a new technology and designing medical benefits around proven technologies. Has it lived up to its promise? Earl Steinberg and Bryan Luce describe its prominence in all levels of clinical decision making, suggesting that it is de rigueur, an accepted standard.1 In fact, the evidence suggests that major barriers persist, and the gap in thinking about applying evidence to medical decisions between researchers and the public remains formidable.
All clinicians and managed care plans believe that their decisions are based on evidence, and principles of evidence are used in particular to promote disease management, technology assessment, and Medicaid pharmaceutical cost containment. However, despite this visibility, there is little evidence of EBM’s success in influencing behavior and as a well-accepted foundation for how patient care should be organized, delivered, and financed. The most widespread application of EBM is in the development of clinical practice guidelines. The National Guideline Clearinghouse (NGC) provides health professionals and providers with a database of clinical practice guidelines, with the goal of promoting their dissemination, implementation, and use.2 In October 2004 the NGC contained 1,411 individual summaries of clinical guidelines. However, despite their accessibility, a number of studies have demonstrated poor adherence to established clinical guidelines.3 Managed care was heralded as a tool to encourage more appropriate use of health services through greater coordination and better care management. Today, managed care has experienced mixed success in applying utilization management tools that encourage more appropriate care. Challenges faced by managed care plans include providers’ willingness to adhere to evidence-based guidelines and a widespread belief among providers and the public that managed care policies are colored by perverse financial incentives.4
Physician-patient relationship. One major barrier to the adoption of EBM is the overwhelming support for preserving the physician-patient relationship. Patients expect their doctor to tailor care to their individual condition, incorporating their medical history and preferences, the doctor’s experience with similar patients, the most current research, and alternative therapies. However, despite the extensive investment in developing clinical guidelines, most clinicians do not routinely integrate them into their practices. In a recent study of U.S. adults, Elizabeth McGlynn and colleagues found that more than half did not receive the recommended preventative care, acute care, or care for their chronic conditions.5 Barriers to adopting clinical guidelines include lack of awareness of, familiarity with, or agreement with the guidelines; limited applicability of recommendations for actual management; lack of description of the patient population to which the guidelines apply; and uncertainty of the effects on health outcomes. Organizational barriers, such as plans’ administrative policies and the need to adapt guidelines to reflect local standards of care, have also been suggested as reasons for limited integration.6 Integration of cost-effectiveness research into clinical practice faces even more barriers than integration of clinical guidelines does. A survey of physicians found that although physicians regard cost-effectiveness as an important and appropriate component of clinical decisions, they believe that only the physician and patient should decide the value of a treatment option.7 Others attribute the lack of integration to the short-term financial perspective of practitioners, which is at odds with the societal perspective of most cost-effectiveness analyses. Also, these analyses have been characterized by a lack of standardization.8 Lack of automation. A second barrier to achieving evidence-based clinical practice is the lack of automation in the practice setting. It is unrealistic to expect doctors to be able to easily reference a clinical guideline in a busy practice setting. The promise of health information technology (HIT)—specifically, electronic medical records (EMRs) and electronic prescribing—is its potential to improve quality, safety, and efficiency through the development of clinical decision-support systems, which may provide real-time, evidence-based treatment recommendations.9 Adoption of computerized decision-support systems paired with EMRs have been shown to improve compliance with clinical guidelines for patients with diabetes and depression.10 Yet the use of HIT is not widespread, and while a few leading private-sector plans have started experimenting with financial incentives, most purchasers (including Medicare) have done little to promote the adoption of such systems.11 Lack of evidence. EBM cannot be meaningfully practiced in the absence of good clinical studies. Lack of evidence is a major limitation of applying such principles—especially for technologies and medical practices that are not new and might not have been thoroughly tested. Although policymakers may want medical product companies to invest heavily in head-to-head studies, post-market surveillance, and cost-effectiveness studies, scarce research dollars will inevitably be applied to maximize commercial advantage. As payers continue to push toward better evidence, all stakeholders must acknowledge that limitations exist. Subjective standards. Finally, EBM standards are often developed in a subjective way. Steinberg and Luce point to the reliance on qualitative evidence in EBM in the assessment process. For example, organizations from the U.S. Preventive Services Task Force (USPTF) to the Food and Drug Administration (FDA) develop recommendations through a process of reviewing clinical evidence and assessing experts’ recommendations.
Medicare, with its forty-one million beneficiaries and annual expenditures above $280 billion, is the largest U.S. purchaser of health care.12 Because Medicare is a public program, its administrators are accountable not only to beneficiaries but also to the public. The Centers for Medicare and Medicaid Services (CMS), which administers Medicare, has moved toward EBM-based decision making in developing a variety of policies, ranging from quality initiatives, to programs to improve the delivery of health care to the chronically ill, to decisions to pay for specific items and services.13 In 1965 Medicare’s original framers prohibited any interference by Medicare in the practice of medicine or the manner in which medical services were provided.14 Yet, the secretary of health and human services (HHS) was given the authority to prohibit any payments for items and services not found to be "reasonable and necessary."15 The CMS has not defined "reasonable and necessary" in regulation and the public must evaluate the agency’s rationale for and the outcome of individual coverage decisions to understand what the CMS considers to be reasonable and necessary. This sluggishness has resulted largely from the immense political difficulty the agency faces in framing major societal decisions on cost-effectiveness in the absence of political support for this concept. The CMS’s coverage decisions are based on an evidence-based assessment of an item or service’s overall risks and benefits through a review of evidence; this includes published and unpublished studies, clinical guidelines, technology assessments, recommendations from the Medicare Coverage Advisory Committee (MCAC), expert opinion, and public comments.16 Recent national coverage determinations have demonstrated that the CMS is increasingly choosing to limit coverage to well-studied indications, for specific patient populations. Coverage of specific items and services has also been restricted to facilities that meet criteria developed either by the CMS or by an external organization, such as in the case of lung volume reduction surgery (LVRS) and left ventricular assist devices (LVADs).17 Finally, in a recent coverage decision concerning positron emission tomography (PET) scans to screen for Alzheimer’s disease and dementia, coverage was restricted to a specific population: those enrolled in an approved clinical trial.18 The evolution of the CMS’s interpretation of reasonable and necessary toward narrower coverage policies raises concerns regarding its appropriateness and whether these policies infringe upon the practice of medicine. Sean Tunis, the CMS’s chief medical officer, has acknowledged this tension in stating that payers are "inevitably resented when they prevent payment for a medical service that a patient and a physician have concluded is desirable."19 This tension is exacerbated for public programs because most politicians share the concerns of patients and doctors and continue to hold fundamental reservations about the application of EBM in clinical practice.
There is no doubt that our health care system needs more application of EBM and that the field needs to be developed over time. However, formidable barriers have prevented the widespread application of these concepts. There is also a persistent disconnect between patients’ desire to access the latest and best technology and researchers’ eagerness to create a more rational health care system. Dialogue about EBM among the public, providers, and payers needs to grapple with fundamental questions: How should patients’ and physicians’ preferences be integrated? What is the role of cost? What type of evidence should be considered? When is it appropriate to develop payment or coverage policies that may affect patient outcomes and access to items and services, and when is it appropriate to leave treatment decisions to physicians? In addition to honest dialogue among key stakeholders, it will be necessary to engage in serious policy debate. The barriers and limitations associated with EBM will not be solved without the engagement of senior White House officials and House and Senate leadership. Researchers and practitioners of EBM need to be careful not to overreach in their claims about the use and application of evidence during this critical and formative period in the evolution of the EBM field.
Dan Mendelson is president of the Health Strategies Consultancy in Washington, D.C., and adjunct professor of business administration at the Fuqua School of Business, Duke University, in Durham, North Carolina. Tanisha Carino (tcarino{at}healthstrategies.net) is a manager at the Health Strategies Consultancy. The authors thank their colleagues at the Health Strategies Consultancy for outstanding, substantive support and review of this manuscript. All opinions expressed here are solely those of the authors.
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EBM Prevalence
Barriers To EBM Adoption
