For patients with Medicare, the Centers for Medicare and Medicaid Services (CMS) determines whether costs associated with routine care and the investigational devices are covered. To support this determination, the FDA categorizes IDE-approved devices based on whether available data demonstrates that initial questions of safety and effectiveness have been resolved. IDE-approved devices are assigned to one of two categories:
- Category A – Experimental
- Category B – Non Experimental/Investigational
The FDA communicates the assigned category in a formal letter sent to the study sponsor. The sponsor submits the letter to CMS, which considers the FDA-assigned category and other factors to determine whether or not a device meets the requirements for Medicare coverage. The background and criteria associated with the FDA’s categorization process is described in the guidance document titled, “FDA Categorization of IDE Devices to Assist CMS with Coverage Decisions.”
