Abstract

This chapter examines the ethical issues and policy implications of coverage with evidence development (CED). CED is an approach that grants Medicare coverage for a new medical intervention provided that eligible patients participate in research designed to generate further, more robust evidence of safety and net health benefit. However, the CED policy has sparked ethical controversy, with particular concerns voiced that it is coercive and unfairly restricts access to beneficial treatments. This chapter offers a normative analysis of CED and presents a policy justification for this approach to insurance coverage of a new drug or technology. It also considers a range of ethical concerns, such as coercion, the therapeutic misconception, and the right to medical care, and asks whether research participation under CED should be mandatory. Finally, it discusses the distinction between coverage tied to randomized clinical trials and to registries and its implications for research ethics and informed consent.