This article examines the issue of coverage for routine medical expenses for clinical trial patients by third party payers from both a medical and political policy perspective. It is critical for patients, investigators, and sponsors to know who is responsible for paying these costs. This issue affects the willingness of patients to enter clinical trials and has the potential to affect which diseases will be the subjects of clinical trials. This presentation first summarizes the basics of clinical trials and then explores the definition of routine care in clinical trials. Medicare reimbursement, an issue that has been the subject of recent decisive action, is the starting point. The article provides explanation and discussion of the possible models, federal and state, for mandated coverage by other third party payers of routine patient care in clinical trials. A policy discussion and analysis follow, which includes information on the potential effects of this change on third party payers as well as researchers and patients. The placement of the cost liability for these expenses is related to other issues of patient protection; there is a brief discussion of the dangers of research on human subjects past and present to place this issue within the larger context of patient protection. In general, this mandated coverage is sensible and would create good public policy. However, it is important that patient protection remain the top priority in what could be an increased number of trials. The wording of the mandate should be careful not to shift costs that are rightfully borne by the trial sponsor to others.
Dina Berlyn, Routine Patient Care in Clinical Trials: Whose Cost Is It Anyway?, 16 J.L. & Health 77 (2001-2002)