March 20, 2008
Investigational Device Exemption extension request
When submitting a request for an extension of your participation in the IDE provision that allows billing to Medicare, please update your file with First Coast Service Options Inc. (FCSO) by sending the following items:
• Name and G# of study.
• Updated copies of the FDA letter and your financial agreement with the sponsor (if applicable).
• Copy of the IRB extension letter.
• A completed and signed cost and coding template if changed from the original submission.
• A list of Medicare beneficiaries that have received the device service/procedure under the protocol from the time of the original approval to present (beneficiary name, HIC #, date of initial device service/procedure)
• Documentation of the anticipated clinical trial completion date and estimated results and the publication date (you may need to consult with the principal investigator).
FCSO will make a coverage determination within 45 days of submission of all the required documentation. If you should require additional assistance please contact FCSO at Medical.Policy@FCSO.com.
