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First Coast Service Options Inc.
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Clinical trials

Modified: 7/29/2011
A listing of useful links is provided regarding devices and clinical trial processes.
Modified: 7/29/2011
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.
Modified: 7/29/2011
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.
Modified: 7/23/2011
The clinical trial coding and cost form is required when submitting a request for a clinical trial or a clinical trial Extension.
Modified: 7/23/2011
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.
Modified: 7/23/2011
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. (FCSO).
Modified: 6/18/2011
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.”
Modified: 5/31/2011
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.
Modified: 4/20/2011
Review answers to frequently-asked questions regarding clinical trials and device coverage.

First Coast Service Options (FCSO) 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.