Coverage of Medical Devices

10 - Coverage of Medical Devices (Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15) The Food and Drug Administration (FDA) defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: • Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or • Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. For dates of service on or after November 1, 1995, Medicare may cover certain FDA- approved and Institutional Review Board (IRB)-approved investigational devices and services incident to, provided the investigational device meets certain requirements, including: • The device or services associated with the use of a device were provided to the beneficiary within the start and end dates contained in the master file; • There are no regulations, national coverage policies, or manual instructions that would otherwise prohibit Medicare coverage. Devices that may be covered under Medicare include the following categories: • Devices approved by the FDA through the Pre-Market Approval (PMA) process; • Devices cleared by the FDA through the 510(k) process; • FDA-approved Investigational Device Exemption (IDE) Category B devices; and • Hospital IRB-approved non-significant risk devices. • NOTE: Study sponsors are not required to seek Medicare coverage in order to conduct their studies or trials.