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Last Modified: 9/16/2020 Location: FL, PR, USVI Business: Part A, Part B

Frequently asked questions about clinical trials and device coverage

Clinical trials background

Q: What regulatory guidance addresses devices and clinical trials in the Medicare program?
Q: How can I check the status of an IDE/Carotid Artery Stenting (CAS) request for approval?
A: To check the status of a request, please contact First Coast at the following email address:
Q: How can I get approved for additional traditional Medicare patients in our IDE or CAS study?
A: In the event that the number of traditional Medicare patients requested exceeds the approved number based on the ratio listed in the FDA letter, an email or letter from the sponsor requesting a larger total number of traditional Medicare patients is required.
Q: Does First Coast Service Options (First Coast) approve IDEs or CAS Studies for Medicare C Plan patients?
A: No, First Coast approves certain Category B IDEs and Carotid Artery Stenting (CAS) studies for traditional Medicare patients only. The Medicare C Plan is responsible for beneficiaries in their plan. Providers should contact the appropriate plan.
Q: How long does it usually take to receive an approval letter from First Coast?
A: Consideration for approval of IDEs and other related device studies under NCD or Post-Market Approvals for CAS will occur within 45 days of receipt of all of the required documentation. As the Medicare administrative contractor (MAC) for jurisdiction N (JN), First Coast reviews each request in the order that it is received in the Medical Policy & Procedures Department. If the information submitted is incomplete, the study is pended until the missing document(s) are received, and the 45 day time clock resets. First Coast often sends approval letters within two weeks for requests that are complete when they are received. If you require additional assistance, or in order to check the status of a request, please send all inquiries to First Coast at:
Q: Please define modifiers “Q0” and “Q1.”
A: The modifier “Q0” is defined as an investigational clinical service provided in a clinical research study that is in an approved clinical research study (devices). The modifier “Q1” is defined as a routine clinical service provided in a clinical research study that is in an approved clinical research study (services).
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.