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Take advantage of these tools to find information in current and draft LCDs.
A listing of useful links is provided regarding devices and clinical trial processes.
The clinical trial coding and cost form is required when submitting a request for a clinical trial or a clinical trial Extension.
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.
Medicare may provide extended coverage and reimbursement for certain investigational devices and services related to the use of those devices. Coverage is contingent upon meeting regulatory criteria and Florida medical director's approval.
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.
When submitting requests for continuations of your participation in the post-approval or a 510K for carotid artery stenting (CAS) study, please update your file with First Coast Service Options Inc. (First Coast).
CAS studies are limited to FDA-approved carotid artery stents (CAS). No other post-approval studies should be submitted to the Medicare administrative contractor for jurisdiction 9 (MAC J9), First Coast Service Options (FCSO), for approval.
Review answers to frequently-asked questions regarding clinical trials and device coverage.