Food and Drug Administration (FDA)-Approved Investigational

20 - Food and Drug Administration (FDA)-Approved Investigational Device Exemption (IDE) Studies (Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15) NOTE: Throughout this section, the terms “study” and “trial” are used interchangeably. The FDA assigns a special identifier number that corresponds to each device granted an IDE. For purposes of assisting the Centers for Medicare & Medicaid Services (CMS) in determining Medicare coverage of items and services in IDE studies, the FDA will place all approved IDE devices in one of two categories: Category A (Experimental) device, which refers to a device for which “absolute risk” of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective; or Category B (Non-experimental/investigational) device, which refers to a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type. The FDA notifies CMS when it notifies the IDE study sponsor (i.e. manufacturer) that the device is categorized as either Category A or Category B. Routine care items and services refers to items and services that are otherwise generally available to Medicare beneficiaries (that is, a benefit category exists, it is not statutorily excluded, and there is not a national non-coverage decision) that are furnished during a clinical study and that would be otherwise furnished even if the beneficiary were not enrolled in a clinical study.