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

• 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.

Device Trial ListServ

• Prior to any implant/use of a study CAS, email  Device-Trials-L@LISTS.UFL.EDU so that claims can be coded and properly processed.
• For more information, see Device Trials Listserv.