The Centers for Medicare & Medicaid Services (CMS) made changes to the IDE regulations (42 CFR 405 Subpart B). CMS outlined criteria for coverage of IDE studies and changed from local Medicare administrative contractor (MAC) review and approval of IDE studies to a centralized review and approval of IDE studies.
Important information notifying users of the requirements for approval of transcatheter aortic valve replacement and transcatheter mitral valve repair (TAVR/TMVR) studies.
Medicare may provide coverage and reimbursement for certain investigational devices and services related to the use of those devices. Coverage is contingent upon meeting regulatory criteria and contractor's approval.
CAS studies are limited to FDA-approved carotid artery stents (CAS). No other post-approval studies should be submitted to First Coast Service Options for approval.
Medicare covers the use of devices that are "reasonable and necessary for the diagnosis and treatment of an injury or illness or to improve the functioning of a malformed body member.”
FCSO may consider coverage of a humanitarian use device, intended to benefit a small patient population, when the provider follows the specific guidelines and submits the appropriate documentation.
Review answers to frequently-asked questions regarding clinical trials and device coverage.
First Coast Service Options (First Coast) strives to ensure that the information available on our provider website is accurate, detailed, and current. Therefore, this is a dynamic site and its content changes daily. It is best to access the site to ensure you have the most current information rather than printing articles or forms that may become obsolete without notice.
