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Last Modified: 7/16/2020 Location: FL, PR, USVI Business: Part A, Part B

Requirements for investigational device exemption (IDE) studies approved by the Centers for Medicare & Medicaid Services (CMS)

Effective January 1, 2015, 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 (with a 2015 Food and Drug Administration (FDA) approval letter). The complete process change is available on the following website: https://www.cms.gov/Medicare/Coverage/IDE external link.
Prior to submitting claims for CMS-approved IDEs, sites participating in a CMS-approved IDE are requested to submit the following to First Coast at clinicaltrials@fcso.com:
A copy of CMS’ letter to the sponsor approving the IDE
A cover letter or email with the following information:
Name of the principal investigator
Point of contact name and email address
The name of the Part A facility and address where the services will be performed
The Agency for Health Care Administration (AHCA) for that facility. The facility AHCA number may be found at the following website address: http://www.floridahealthfinder.gov/FacilityLocator/facloc.aspx external link.
Note: For FDA IDE approvals prior to January 1, 2015, First Coast will continue to require investigational study sites to submit the required documents listed on the checklist available at https://medicare.fcso.com/Clinical_trials/157082.pdf pdf file for the contractor’s review to clinicaltrials@fcso.com.
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.