Last Modified: 9/5/2018
Location: FL, PR, USVI
Business: Part A, Part B
Investigational device exemption (IDE) process for studies approved by the Centers for Medicare & Medicaid Services (CMS)
The Centers for Medicare & 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 
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 
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.In order to administer the MAC JN claims for CMS approved studies prior to submission of these claims, the provider must submit to the MAC JN medical policy department (clinicaltrials@fcso.com) the CMS approval letter, as well as, the cost and coding form so that the claims system (FISS) is updated to allow payment. This will avoid claims from being inappropriately denied for an IDE study that has been approved by CMS.
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.
Link to First Coast Service Options Inc. (First Coast) cost and coding form:
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