Device Trial Steps to be Completed
Step 1. Complete Appropriate Cover Letter and Noridian pdf form(s) below.
IDE Medicare Parts A & B
- IDE Medicare Part A (U of U Cover Letter)
- IDE Medicare Part A (Noridian pdf Form)
- IDE Medicare Part B (U of U Cover Letter)
- IDE Medicare Part B (Noridian pdf Form)
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.
The suggested location of the above language may be entered under the “Cost and Compensation to Participants” in the Informed Consent.
HDE Medicare Parts A & B
Please review the following link regarding HDE coverage:
IMPORTANT!!! Contact the CRCE Office 801-213-3601 early-on to discuss proper HDE billing requirements.
Carotid PTA Medicare Parts A & B
Step 2. Prepare 1 packet for each Noridian coverage requested (e.g. 1 packet for Medicare Part A, 1 packet for Part B and 1 packet for the CRCE office) including the information below:
- Copy of the FDA "IDE Approval Letter" that demonstrates a CMS Reimbursement Category status, OR FDA HDE letter Copy of the IRB approval letter(s)
- Copy of the Protocol/Billing Grid
- Copy of the Clinical Protocol
- Copy of the IRB approved Patient Consent Form
- Copy of all Agreements between sponsor and PI
- Copy of Internal (PI) budget
- 2 FedEx US Airbills including your FedEx Account Number, and contact information
Step 3. Reviews and Signatures
Please provide completed scanned packets to Clinical Research Compliance and Education for review: CRCE Attn: Kristin Kolsch FDA Compliance Officer firstname.lastname@example.org
Step 4. Approval
Noridian coverage determinations will be sent to the Clinical Research Compliance and Education office and a copy will be provided to the PI.
Step 5. Amendments and Renewals
A copy of the approval letter for any time extension or other update must also be submitted after the initial approval occurs.
If you have questions contact Kristin Kolsch, FDA Compliance Officer at (801)587-0835