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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 clinicaltrials@fcso.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 the following website address: https://quality.healthfinder.fl.gov/Facility-Provider

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.