Coverage analysis sits at the intersection of the protocol, payer rules, and the study budget, and getting it wrong affects every downstream process. This session reviews the foundations of reimbursement analysis in clinical research, including qualifying clinical trial criteria, routine costs, and items and services that must be billed to the sponsor. We will examine how the Medicare Clinical Trial Policy, national and local coverage determinations, and payer-specific policies shape billing designations. The session also addresses how coverage analysis findings feed the budget, the informed consent form, and charge capture. Practical examples will illustrate common gray areas and how to document decisions defensibly.