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In an effort to control health costs, payers are increasingly turning to step therapy (or "fail first") policies in pharmacy benefit design. These policies restrict coverage of expensive therapies unless patients have already failed treatment with a lower-cost alternative. More than other utilization management tools such as formulary tiering, step therapy raises important ethical concerns regarding the proper balance between cost control and the ability of patients and clinicians to tailor care to the needs of the individual patient. This article provides eight design criteria to guide the ethical development and evaluation of step therapy policies and describes six clinical scenarios in which step therapy may be appropriate. The ethical criteria and scenarios are intended to provide guidance and transparency for insurers, patients, clinicians, and policy makers in choosing and paying for the appropriate therapies., (Project HOPE—The People-to-People Health Foundation, Inc.)

Having patients weigh costs when making medical decisions has been proposed as a way to rein in health care spending. We convened twenty-two focus groups of people with insurance to examine their willingness to discuss health care costs with clinicians and consider costs when deciding among nearly comparable clinical options. We identified the following four barriers to patients' taking cost into account: a preference for what they perceive as the best care, regardless of expense; inexperience with making trade-offs between health and money; a lack of interest in costs borne by insurers and society as a whole; and noncooperative behavior characteristic of a "commons dilemma," in which people act in their own self-interest although they recognize that by doing so, they are depleting limited resources. Surmounting these barriers will require new research in patient education, comprehensive efforts to shift public attitudes about health care costs, and training to prepare clinicians to discuss costs with their patients.

To attain the anticipated benefits of increased investments in comparative effectiveness research, the results must translate into improved medical practice and policy. In this article we present an analysis of a case study of percutaneous vertebroplasty, a widely used invasive procedure to treat painful vertebral fractures by injecting bone cement into the spine. In August 2009, results from a pair of rigorous double-blind randomized controlled trials were published and reported that vertebroplasty provided no better pain relief than a sham procedure in which needles were introduced into the back without injecting cement. More than two years after publication of the two studies, insurers' coverage of the procedure continues unchanged. This raises serious questions about the policy mechanisms that exist in the United States to interpret and act upon "negative" research findings from studies of popular health care interventions.

Quality measurement and reporting have emerged as important tools that providers, health plans, and other stakeholders can use to identify gaps in quality and focus resources on improving care. Yet identifying, measuring, and evaluating the care that physicians and other health care providers deliver is complicated by limited data, privacy concerns, and the challenge of trying to compare data from diverse sources. This article describes an effort to pilot-test in Florida and Colorado a consistent approach to individual physician performance measurement using data compiled from multiple health plans. Our approach could be used as the basis for making comparable performance information available nationwide. Additional efforts are needed to address key issues, including ways to effectively engage providers in the use of performance information.

Medicare must find new ways to achieve cost control without limiting access to beneficial services. We propose a payment model incorporating comparative effectiveness research to encourage Medicare to pay equally for services that provide comparable patient outcomes. The model would include higher payments for services demonstrated by adequate evidence to provide superior health benefits compared to alternative options. New services without such evidence would receive usual reimbursement rates for a limited time but then be reevaluated as evidence emerged. In spite of the substantial political hurdles to changing Medicare reimbursement, efforts should be made to use comparative effectiveness research to reward superior services, improve incentives for cost-effective innovation, and place Medicare on a more sustainable financial footing.

Many policymakers believe that comparative effectiveness research will reduce "waste" in the U.S. health care system by providing guidance on what health care options work best for different patients. How such research will produce findings that identify waste has not been clearly elucidated. This paper presents a conceptual framework for different evidentiary categories of what we call "marginal medicine." This framework could help clinicians, researchers, and policymakers align the results of comparative effectiveness research with efforts to identify opportunities to improve the value of health care services.

As health care costs continue to rise, an increasing number of self-insured employers are using financial rewards or penalties to promote healthy behavior and control costs. These incentive programs have triggered a backlash from those concerned that holding employees responsible for their health, particularly through the use of penalties, violates individual liberties and discriminates against the unhealthy. This paper offers an ethical analysis of employee health incentive programs and presents an argument for a set of conditions under which penalties can be used in an ethical and responsible way to contain health care costs and encourage healthy behavior among employees.

Medical imaging is a prime example of an innovation that has brought important advances to medical care while triggering concerns about potential overuse and excessive costs. Many hopes are riding on comparative effectiveness research to help guide better decision making to improve quality and value. But the dynamic nature of medical imaging poses challenges for the traditional paradigms of evidentiary review and analysis at the heart of comparative effectiveness. This paper discusses these challenges and presents policy lessons for manufacturers, evidence reviewers, and decisionmakers, illustrated by an assessment of a prominent emerging imaging technique: computed tomography (CT) colonography.

Pay-for-performance (P4P) has become one of the dominant approaches to improving quality of care, yet few studies have evaluated its effectiveness. We evaluated the impact on quality of all P4P programs introduced into physician group contracts during 2001-2003 by the five major commercial health plans operating in Massachusetts. Overall, P4P contracts were not associated with greater improvement in quality compared to a rising secular trend. Future research is required to determine whether changes to the magnitude, structure, or alignment of P4P incentives can lead to improved quality.

In April 2005 the Centers for Medicare and Medicaid Services (CMS) posted on its Web site a draft guidance document describing a new approach to coverage policy called "coverage with evidence development" (CED). CED offered an option for coverage of promising drugs, biologics, devices, diagnostics, and procedures that would not otherwise meet Medicare's evidentiary standards for being "reasonable and necessary." An updated guidance was posted 12 July 2006, clarifying several key statutory, regulatory, and operational issues. This paper traces the history of this policy approach, explains the rationale behind the policy, and describes the major challenges that will need to be addressed for CED to become an important advance in evidence-based coverage decision making.

The growth of managed care in the United States has been paralleled by a rising tide of anti-managed care sentiment. The "managed care problem" is understood generally as the need to protect individuals against large companies that care more about their bottom line than about people. The premise of the BEST (Best Ethical Strategies for Managed Care) project is that the "managed care problem" is best understood as an ethical problem--a conflict of values that arises as the country changes from a patient-centered to a population-centered approach to health care. The BEST project team worked with nine managed care organizations to identify their most intractable problems. The team redefined these problems in terms of ethical dilemmas, then studied each organization in search of innovative, exemplary approaches. These exemplary approaches are being shared publicly with the aim that they be adapted and adopted by other organizations facing similar difficulties and by regulators and legislators hoping to improve the health care system.