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Coverage With Evidence Development: Ethical Issues and Policy Implications

Miller, Franklin G. PhD; Pearson, Steven D. MD, MSc

doi: 10.1097/MLR.0b013e3181789453
Original Article

Coverage with evidence development (CED) is an evolving method of providing provisional access to novel medical interventions while generating the evidence needed to determine whether unconditional coverage is warranted. In this article we review the policy rationale for CED and present a normative analysis that addresses ethical concerns and policy implications.

From the Department of Bioethics, National Institutes of Health, Bethesda, Maryland.

The opinions expressed are the views of the authors and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the US Department of Health and Human Services.

Reprints: Franklin G. Miller, PhD, Department of Bioethics, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892-1156. E-mail: fmiller@nih.gov.

© 2008 Lippincott Williams & Wilkins, Inc.