Carotid Artery Stenting (CAS)

If UF plans on billing items or services in an Carotid Artery Stenting (CAS) study to subjects/insurance, the study must be pre-approved by FDA, the Center for Medicare and Medicaid Services (CMS), and our local Medicare contractor prior to study start-up.

FDA Review

  • Medicare Pre-approval of CAS studies is limited to FDA-approved carotid artery stents (CAS).
  • The study sponsor is responsible for submitting the study to FDA.
  • The FDA will review and issue a letter acknowledging a valid study.

CMS Pre-approval

FCSO Pre-Approval Process & Form

  • The OCR Coverage Analysis and Budget (CAB) team will ensure that the CAS FDA and CMS pre-approval documentation is uploaded to OnCore and that the UF Health Research Billing Office (RBO) is notified.
  • RBO will submit the CAS study to our local Medicare contractor First Coast Service Options (FCSO) using the FCSO CAS Approval Submission Form.

Private Insurance Coverage of CAS Devices

  • If any subjects have private insurance, you MUST obtain written pre-authorization for the CAS from the carrier BEFORE enrolling the participant into the study.
  • Some private insurers will follow the Medicare benefit policy; however, they also have discretion to deny coverage regardless of Medicare’s coverage determination.

CAS Device Claims Coding

  • The study team must ensure that each billable item/service in the study is pre-identified as “M0” or M1” on the billing grids so that the UF Health Research Billing Office (RBO) will know the correct coding for claims.
  • These pre-approved CAS studies will also require the Z00.6 diagnosis code, the CAS PMA or 510(K) number, and the NCT number.
  • For more details, please see Use of Z00.6 &Q0Q1 Modifiers.

Device Trial ListServ