IDE Coverage Application Steps

Step 1. Complete Appropriate Cover Letter and Noridian pdf Form

IDE Medicare Parts A & B


Required Informed Consent Language for Noridian IDE Submissions:

Noridian requires that the Informed Consent contain the suggested language in the approved document.

Suggested language:
“The University of Utah Health Care and Principal Investigator receives funds from the sponsor, (enter sponsor name), to cover costs related to research." 

Note:
The suggested location of the above language may be entered in the “Background” section of the Informed Consent.

Step 2.   IDE Noridian Submission Document Review

To minimize Noridian submission delays, please take advantage of CRCE early review. Submit the below required documents electronically to Kristin Kolsch (kristin.kolsch@hsc.utah.edu) as you produce them.

  • Copy of the unredacted FDA "IDE Approval Letter" that demonstrates a CMS Reimbursement Category status
  • Copy of the Protocol/Billing Grid
  • Copy of the Clinical Protocol
  • Copy of the Patient Consent Form
  • Copy of all Agreements between sponsor and PI
  • Copy of Internal (PI) budget
  • Copy of Part A & Part B University of Utah Cover Letter
  • Copy of Part A & Part B Noridian PDF Form
  • Copy of the IRB Approval Letter

Step 3. Request Device Code for Proper Billing

To ensure proper IDE device billing you will need to obtain a device code for your uTRAC application, please email krisitin.kolsch@hsc.utah.edu with the following information:

  • IDE #
  • Device Name
  • Device Cost
      • Device is provided at no cost = $0
      • Device is purchased from the sponsor, please provide purchase price.  Remember the investigational device should be purchased at a cost NOT larger than that necessary to recover costs of manufacturing, research, development, and handling.
  • Cost Center (e.g. Clinic 5, University of Utah Hospital Operating Center, Cardiac Cath Lab)

Step 4. IDE Documents Final Review and Noridian Submission

Please provide electronic final documents (noted in Step 2) to kristin.kolsch@hsc.utah.edu

Step 5. Noridian Coverage Determination

Noridian coverage determination letter will be sent electronically to the Clinical Research Compliance and Education office and a copy will be provided to the PI.

Step 6. Amendments and Renewals

A copy of the approval letter for any time extension or other update must be submitted after the initial approval occurs.


If you have questions contact Kristin Kolsch, FDA Compliance Officer at (801)587-0835