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Precision medicine is poised to have an impact on patients, health care delivery systems and research participants in ways that were only imagined 15 years ago when the human genome was first sequenced. While discovery using genome-based technologies has accelerated, these have only begun to be adopted into clinical medicine. Here we define precision medicine and the stakeholder ecosystem required to enable its integration into research and health care. We explore the intersection of data science, analytics and precision medicine in creating a learning health system that carries out research in the context of clinical care and at the same time optimizes the tools and information used to delivery improved patient outcomes. We provide examples of real world impact, and conclude with a policy and economic agenda that will be necessary for the adoption of this new paradigm of health care both in the United States and globally.

A new trend in research funding has emerged: directed philanthropy, in which the donor plays an active, hands-on role in managing the research by applying a “business model.” Although such efforts ...

Increasing knowledge of the genetic basis of disease is changing the landscape of health care. Two critical aspects are growth in biotechnology and growth in personalized health care, particularly targeting medicines based on genetic information (pharmacogenomics). This paper provides an overview of the health policy implications of the integration of biotechnology and pharmacogenomics. I examine four factors that determine whether relevant technologies will be successfully adopted, using case studies for illustration. Key policy challenges include determining the appropriate role of policy in (1) providing incentives to develop socially beneficial interventions and (2) facilitating development of the evidence base.

Biotechnology has figured prominently in recent Medicare coverage and payment policies. Biotech treatments push policy boundaries for several reasons: They attract strong patient demand; they often treat rare or life-threatening diseases; they may have uncertain evidence of health benefits; and they are often costly. This paper considers case studies of Medicare coverage for off-label uses of biotech cancer drugs and payments for anemia biopharmaceuticals. The cases suggest Medicare's ongoing challenge to balance access considerations, the role and strength of evidence, and cost consequences of new treatments.

This study estimates how out-of-pocket drug costs could change for vulnerable populations (racial and ethnic minorities, the near-poor, and seniors with a greater burden of chronic conditions) who qualify for the standard Medicare drug benefit. Although the new benefit might be associated with modest-to-moderate declines in out-of-pocket spending for seniors who do not qualify for subsidies, the savings might not be shared equitably and therefore might not reduce financial barriers to medication use for these populations.

We describe barriers to care reported by racial/ethnic groups and explore the extent to which barriers vary between persons enrolled in managed care and those in non-managed care plans, using data from the 1996 Medical Expenditure Panel Survey (MEPS). Most respondents expressed satisfaction with their care; however, a substantial percentage reported experiencing barriers. Minorities, particularly Hispanics and Asian Americans, were more likely than non-Hispanic whites were to report barriers. Managed care enrollees across racial/ethnic groups faced different types of barriers than non-managed care enrollees did. Although managed care enrollees were more likely to report having a usual source of care and greater continuity of care, they also reported more difficulties obtaining care and less satisfaction with their care.

PROLOGUE: Proponents of managed care often tout the ability of managed care plans to coordinate patient care, including the screenings, counseling, and immunizations that constitute preventive care...