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. While there are similar offerings in all four states, there is wide variation in the amount of drugs covered, how drugs are accessed by beneficiaries, and prior authorization requirements. Plans with lower premiums are more likely to have additional formulary tiers and no coverage in the "doughnut hole"-the gap faced by many beneficiaries between $2,250 and $5,100 in costs. Given the many choices facing beneficiaries, the Centers for Medicare and Medicaid Services should monitor experiences to determine whether plans are meeting the needs of Medicare beneficiaries, particularly the frail and disabled.

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. Dialogue and consensus will be critical in bridging public concern and the eagerness of researchers to apply EBM.

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 $1.1 billion for comparative effectiveness research, and in 2010 the Patient Protection and Affordable Care Act established a federal institute to organize the federal investment in comparative effectiveness research going forward. Over the past several years, comparative effectiveness research from the public and private sectors has begun to provide a foundation for innovation within the insurance and life sciences industries. Health plans and other payers are experimenting with nuanced coverage and reimbursement policies informed by comparative effectiveness evidence. Anticipating changes in payer, patient, and provider behaviors, drug manufacturers are refocusing their efforts on the development of novel and better-differentiated medications. As more comparative research becomes available in the future, continued innovation in payer and manufacturer strategies appears likely.

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. 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.

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. This paper reviews the rationale and challenges Medicare faces in applying its CED policy and discusses the implications of payers' using and generating evidence.

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. 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.