Post-Market PTA with Carotid Stenting & Embolic Protection Coverage Application Steps

Step 1. Complete the Appropriate Cover Letter and Form

Carotid PTA Medicare Part A (U of U Cover Letter)
Carotid PTA Medicare Part A (Noridian pdf Form)

Step 2. Post-Market 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.

Post-Market Study:

  • Copy of the FDA acknowledgement letter with assigned “P” number
  • IRB Approval
  • Copy of the Patient Consent Form

Post-Market Extension Study:

  • Copy of the FDA acknowledgement letter and the original Post-Market Approval (PMA) number from the original FDA post-approval study
  • Copy of the CMS letter providing coverage for the extension study
  • IRB approval
  • Copy of the Patient Consent Form

Step 3. Final Review and Noridian Submission

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


Step 4. 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 5. 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.