Investigational device exemption (IDE) studies

Submission requirements for IDEs 

Interested parties (e.g., study sponsors) that wish to seek Medicare coverage for Category A or B IDE studies must submit a request for review and approval to CMS (Centers for Medicare & Medicaid Services). CMS Internet-Only Manual (IOM) Publication 100-02, Medicare Benefits Policy Manual, Chapter 14-Medical Devices contains instructions on seeking CMS approval of Category A and B IDE studies for purposes of Medicare coverage.

Additional information regarding submission of Category A and B IDE study review requests, along with the list of CMS-approved studies is available on the CMS coverage website.

Medicare claims for routine care items and services related to Category A or B IDE studies and Category B IDE should be submitted to First Coast that will identify routine costs for which Medicare payment is made for each related claim.

Note: For IDE trials which have received CMS approval to bill Medicare, First Coast requests certain information be sent to us before Part A claims are submitted. This will allow us to make necessary preparations for receipt of Part A claims.

Prior to submitting claims for CMS-approved IDEs, sites participating in a CMS-approved IDE are requested to submit the following to First Coast at medicalaffairs@guidewellsource.com: 

• Indicate Part A IDE Submission in the subject line of email
• Attach a copy of CMS’ letter to the sponsor approving the IDE and includes the 6-digit study and 8-digit NCT (National Clinical Trial) numbers
• Name of the principal investigator
• Point of contact name and email address
• Name of the Part A facility and address where the services will be performed
• The Agency for Health Care Administration (AHCA) for the facility. The facility AHCA number may be found at their website.

This information will allow First Coast to add information into our Part A claims payment system to ensure proper processing for Part A claims related to these IDE clinical trials.

Please refer to CMS Internet-Only Manual (IOM) Publication 100-04, Medicare Claims Processing Manual, Chapter 32 – Billing Requirements for Special Services, Section 68 – Investigational Device Exemption (IDE) Studies for information on claim submission.