Silk Road Medical has announced the Centers for Medicare and Medicaid Services (CMS) has extended coverage for the transcarotid artery revascularisation (TCAR) procedure under the existing National Coverage Determination 20.7. TCAR is eligible for coverage when patients are treated with any FDA-approved proximal embolic protection device and FDA-approved carotid artery stent system indicated for the transcarotid approach and entered into the new national TCAR Surveillance Project. The TCAR Surveillance Project is sponsored by the Society for Vascular Surgery (SVS) Patient Safety Organization (PSO) and has been deemed scientifically valid and clinically relevant by the Food and Drug Administration (FDA).
As outlined on the CMS Carotid Artery Stenting (CAS) Investigational Studies web page, this decision is effective immediately and provides coverage for TCAR procedures in hospitals participating in the Vascular Quality Initiative (VQI) of the SVS PSO. Reimbursement for TCAR will apply to Medicare beneficiaries who are deemed to be high risk for adverse events from traditional carotid revascularisation surgery, also known as carotid endarterectomy.
“We applaud the Society of Vascular Surgery for leading the discussions with CMS and FDA to establish this national surveillance project to provide Medicare beneficiaries access to a clinically proven, less invasive therapeutic option while broadening the real world evidence base for TCAR,” said Erica Rogers, CEO of Silk Road Medical, “we look forward to ongoing publications from this data base that support our overarching goal of reducing the morbidity and mortality associated with treating carotid artery disease.”
The TCAR Surveillance Project is a prospective, national, open ended observational registry. Hospitals and physicians participating in the VQI of the SVS PSO can obtain coverage for TCAR procedures by submitting claims under the National Clinical Trial (NCT02850588) as listed on ClinicalTrials.gov.
The Enroute Transcarotid Neuroprotection and Stent System are the first and currently only devices approved for the TCAR procedure by the U.S. Food and Drug Administration (FDA).