Device trials follow a different set of rules, and applying drug trial habits to them is a reliable way to create billing errors. This session explains the Category A and Category B IDE framework, why device categorization and payer approval processes matter, and what has to be in place before a single claim goes out. We will cover the documentation required for coverage, how the device itself is handled, and the treatment of related routine care items and services. Common pitfalls, including the timing of approvals and missing modifiers or condition codes, will be discussed in detail. Attendees will leave with a checklist for starting a device study on solid footing.