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Investigational device exemption (IDE) process for studies approved by the Centers for Medicare & Medicaid Services (CMS)
Last Modified: 5/6/2019
Location: FL, PR, USVI
Business: Part A, Part B
The Centers for Med
icare & Medicaid Services (CMS) made changes to the IDE regulations (42 CFR § 405 Subpart 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/index.html 
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Assuming all applicable requirements for the program are met, an approval for a Category A (Experimental) IDE study allows coverage of routine care items and services furnished in the study, but not of the Category A device, which is statutorily excluded from coverage. An approval for a Category B (Nonexperimental/investigational) IDE study will allow coverage of the Category B device and the routine care items and services in the trial. The CMS review is generally a request from the principal investigator, and CMS will post the study title, sponsor name, NCT number, IDE number, and CMS approval date on the following website:
https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.html .
In order to administer the MAC JN claims for CMS approved studies prior to submission of these claims; the provider must submit a copy of the CMS approval letter to the MAC JN medical policy department (
clinicaltrials@fcso.com).
For FDA IDE approvals prior to January 1, 2015, First Coast will continue to require investigational study sites to submit for the contractor’s review all documentation that is currently required. Please refer to the following article titled “Investigational device exemption (IDE) approval requirements” and request form for a complete list of items the contractor requires for each investigational site. Study sites should submit all of the documentation electronically 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.
