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.
“The <Facility Name> and <PI Name>, the study doctor for this trial, receives funds from the Sponsor – <Sponsor Name> - to cover the costs related to this research. This payment is compensation for the time and resources required for study administration and performance. The study doctors are not receiving additional funding from <Sponsor Name> for participating in this study. They have no financial interest in <Sponsor Name>, including stocks or stock options. Additionally, they do not receive money for activities such as speaking or consultations, honoraria, grants to fund ongoing research or compensation in the forms of equipment or supplies."
Note: The suggested location of the above language may be entered in the “Background” section of the Informed Consent. If the above statement is not accurate and the PI is receiving additional funds, please contact Kristin Kolsch (Kristin.firstname.lastname@example.org) to formulate a new financial statement.
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 (email@example.com) 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 firstname.lastname@example.org 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.
- Device Cost
- 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 email@example.com
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.