Comparative effectiveness research in the United States: a catalyst for innovation.

Recent calls for value in the US healthcare system have spurred an increase in comparative effectiveness research, which generates evidence on competing treatment options to inform healthcare stakeholders. As a large healthcare purchaser, the federal government has made several significant investments in comparative effectiveness research. Notably, in 2009 the American Recovery and Reinvestment Act allocated $1.

Federal initiatives to support rapid learning about new technologies.

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.

Medicare's coverage of colorectal cancer drugs: a case study in evidence development and policy.

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.

Assessing Medicare prescription drug plans in four states: balancing cost and access.

Success of the Medicare prescription drug benefit depends on private organizations offering beneficiaries appropriate access to medications while controlling costs. There is limited guidance, however, as to what constitutes best practice in benefit and formulary design. This issue brief examines Medicare stand-alone prescription drug plans in the four most populous Medicare states-California, Florida, New York, and Texas.

Using clinical trials as a condition of coverage: lessons from the National Emphysema Treatment Trial.

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.

Evidence-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.