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. Ex p e r ts a n d 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.

Health policy and financing reforms place increasing emphasis on the ability of doctors and patients to make informed, cost-conscious care decisions. The federal government is supporting new initiatives in Medicare to increase the supply of reliable information on the benefits and risks of health care technologies. Medicare also is working with the Agency for Healthcare Research and Quality (AHRQ) to evaluate the comparative effectiveness of prescription drugs and other items or services. The value of these efforts will depend on coordination among individuals and institutions in the public and private sectors; clarity about focus, purpose, and priorities; and adequate and reliable long-term funding. M an y c u r r e n t ly p o pu l a r a p p r oac h e s to improving quality, reducing cost, and expanding access to care depend on doctors' and patients' ability to make informed, cost-conscious decisions about their health care. This popularity evolved in large part from the expanding body of evidence demonstrating inefficient and inconsistent use of health care services and unsustainable trends in health care spending. If patients, clinicians, and other decisionmakers are responsible for making critical health care decisions, they need access to reliable information on the quality, outcomes, and costs of care. Despite considerable progress in producing this kind of information over the past several decades, much more is required to meet these decisionmakers' needs. This paper addresses federal initiatives, particularly those pursued by the Centers for Medicare and Medicaid Services (CMS), designed to support the efficient development of information about the benefits, risks, and costs of health care technologies.w 1 4 0 2 6 J a n u a r y 2 0 0 7

Payers point to the lack of unbiased evidence for making coverage decisions for new and often costly technologies. This paper provides a case study of a new approach to developing information to meet the needs of a payer: Medicare's coverage with evidence development (CED) policy. Medicare's decision to condition coverage of cancer therapies on clinical trial participation is an early application of CED and signals Medicare's interest in developing evidence on new technologies for beneficiaries. This paper reviews the rationale and challenges Medicare faces in applying its CED policy and discusses the implications of payers' using and generating evidence. Many criticized the inadequacy of current public and private investments in clinical research to produce "an adequate volume or quality of information to support policy decision-making."1 Purchasers and payers specifically pointed to limited unbiased evidence on which to base coverage decisions for new and often costly drugs.n A challenged clinical research enterprise. Evidentiary requirements defined by regulatory agencies such as the Food and Drug Administration (FDA) drive drug manufacturers' investments in clinical research on drugs. The goal of most FDA-focused studies is to ensure the safety and efficacy of a drug, rather than to C o l o r e c t a l C a n c e r D r u g s

In making evidence-based coverage decisions, The Centers for Medicare & Medicaid Services (CMS) often must balance the need for rigorous evaluation of medical technologies with the public's demand for rapid access to new services. During the mid-1990s, this dilemma was apparent with regard to a promising, yet unproven, new procedure for emphysema patients known as lung volume reduction surgery (LVRS). In a unique decision, CMS provided coverage for LVRS only under the protocol of the National Emphysema Treatment Trial (NETT), which it cosponsored with the National Heart, Lung, and Blood Institute. The CMS has recently revised its coverage policy for LVRS based on the results of the NETT. This paper provides a history and rationale for CMS's approach to paying for LVRS. It also discusses lessons learned from the NETT experience and potential implications for future collaborations between health plans and the clinical research enterprise that would provide better information for coverage treatment decisions.