Medicare's Requirement for Research Participation as a Condition of Coverage
Is It Ethical?
- Steven D. Pearson, MD, MSc;
- Franklin G. Miller, PhD;
- Ezekiel J. Emanuel, MD, PhD
- Author Affiliations: Department of Clinical Bioethics, National Institutes of Health, Bethesda, Md (Drs Pearson, Miller, and Emanuel); and Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (Dr Pearson).
- Corresponding Author: Steven D. Pearson, MD, MSc, Department of Clinical Bioethics, National Institutes of Health, Bldg 10, Room 1C118 Sixth Floor, Bethesda, MD 20892 (spearson99{at}yahoo.com).
Since this article does not have an abstract, we have provided the first 150 words of the full text.
Policy makers agree that the US health care system needs new and better ways to ascertain the risks, benefits, and costs of new medical technologies as they are introduced into practice.1-3 One central policy mechanism to develop such evidence is to link insurance coverage with a requirement that patients participate in relevant research, including registries and clinical trials. Medicare has introduced its own version of this approach, termed coverage with evidence development (CED), and has used it in several high-profile coverage decisions.4 But the policy has been criticized as coercive and unfair.5 The future of CED at Medicare and of similar approaches among private insurers may well depend on whether such approaches are viewed as ethical.
In this article, we argue that CED should not be viewed as coercive because Medicare patients are not entitled to new technologies that would not receive coverage in the …
