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Requirements for investigational device exemption (IDE) studies approved by the Centers for Medicare & Medicaid Services (CMS)
Last Modified: 7/16/2020
Location: FL, PR, USVI
Business: Part A, Part B
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 
.
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 na
me and email address
The name of the Part A facility and address where the services will be performed
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