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Device Trial Instructions

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Medicare may provide reimbursement for some investigational devices, humanitarian use devices, Phase I investigational drug trials and related services. These services may include those rendered in preparation for the use of the device/drug, contemporaneously with the device/drug, and necessary to the use of the device/drug, and as follow-up care after using the device/drug.

Submission to the local fiscal intermediary is required for Humanitarian Use Devices (HUD) as well. Jackson Health System policy requires these devices be submitted for approval as required by the local fiscal intermediary to ensure proper reimbursement.

Coverage is dependent upon the approval of the reimbursement application submitted to the Fiscal Intermediary (Medicare’s independent contractor). First Coast Service Options will make a coverage determination within 45 days of submission of all the required documentation.

The local Fiscal Intermediary is First Coast Service Options, Inc.
For additional information please visit www.floridamedicare.com or contact:

James J. Corcoran, M.D., M.P.H.
Office of the Medical Director, 20T
532 Riverside Ave.
Jacksonville, FL 32202

Additional Resources:


The Office of Research & Grants will submit the documentation for review by the local fiscal intermediary for community physicians and JHS physicians, subsequent to the physician providing the following applicable records:

Step 1: Prepare two packets pursuant to First Coast Service Options, Inc. checklist:

  • Investigational Device Exemption (IDE) Approval Requirements
  • Humanitarian use Device (HUD) Approval Requirements
  • Phase I Investigational Drug Approval Requirements*
  • Fiscal Intermediary Checklist*

*Phase 1 studies will be sent to the Fiscal Intermediary for review and approval before Jackson Health System can approve the study to commence in the hospital.

Step 2: Review and Signature

Clinical Trials

Office of Research & Grants
Jackson Medical Towers
1500 NW 12th Avenue
Miami, Florida 33136
305-585-7226 (office)
305-585-6144 (fax)

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