Coverage with evidence development: ethical issues and policy implications.
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.
Miller
Franklin G
FG
Department of Bioethics, National Institutes of Health, Bethesda, Maryland 20892-1156, USA. fmiller@nih.gov
Pearson
Steven D
SD
D003068:Coercion; D004059:Diffusion of Innovation; D019317:Evidence-Based Medicine; D006801:Humans; D007258:Informed Consent; D019458:Insurance Coverage / Q000941:ethics*; D007348:Insurance, Health / Q000941:ethics*; D037141:Mandatory Programs; D028701:Patient Rights; D011050:Policy Making