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First Coast Service Options Inc.
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Last Modified: 5/4/2012 Location: FL, PR, USVI Business: Part A, Part B

Coverage of devices and clinical trial background

Useful links

list item Devices and clinical trials -- clinical trials background information
list item Clinical trial coding and cost information form
list item Post-approval and 510K for carotid artery stenting (CAS) study continuation request
list item Post-approval and 510K extension studies for CAS approval requirements and request form
list item Humanitarian use device exemption (HUD/HDE)
list item Investigational device exemption (IDE) approval requirements and request form
list item IDE extension requirements and request form
list item Medicare Benefit Policy Manual (Pub. 100-02, Ch. 14), medical devices external pdf
list item Food and Drug Administration (FDA) clinical trial and investigational device exemption Web page external link
list item Frequently asked questions (FAQs) about clinical trials and device coverage
list item Contact MAC J9 FCSO Medical Policy & Procedures Dept. via email

Medicare coverage and billing requirements

Coverage and Billing Requirements
Routine Costs in a Clinical Trial
(non-IDE)
Category A IDE
Category B IDE
Device Payable?
NO
NO
YES
Associated Routine Costs Payable?
YES
YES
YES
Life Threatening Dx Required?
NO
YES
NO
IDE # in Item 23 Required on CMS-1500?
NO
YES
YES
IDE # in FL 43 Required on CMS-1450?
NO
YES
YES
Primary Dx V70.7 Required?
CMS-1500 only
NO
NO
Secondary Dx V70.7 Required?
CMS-1450 only
YES
YES
Modifier Q0 per Line Required?
NO
YES
YES
Modifier Q1 per Line Required?
YES
NO
NO
Revenue Code 624?
NO
YES
YES
list item
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.