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.
- 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.
- The study sponsor submits valid studies to the Center for Medicare and Medicaid (CMS).
- CMS will issue a letter to the study sponsor indicating that the study under review will be covered by Medicare.
- This pre-approval will be posted on the CMS website https://www.cms.gov/Medicare/Medicare-General-Information/MedicareApprovedFacilitie/Carotid-Artery-Stenting-CAS-Investigational-Studies.
- If UF plans to bill any Carotid Artery Stent (CAS) study services to study participants or their insurance, this pre-approval documentation must be included in the study’s OCR submission.
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 ClinicalTrials.gov NCT number.
- For more details, please see Use of Z00.6 &Q0Q1 Modifiers.