June 14, 2022 — The Society for Vascular Surgery Vascular Quality Initiative (SVS VQI), a nonprofit organization dedicated to improving the quality of vascular care within hospitals and outpatient facilities, announces that the Centers for Medicare and Medicaid Services (CMS) has expanded coverage for Transcarotid Artery Revascularization (TCAR) to include standard surgical risk patients within the VQI TCAR Surveillance Project. Effective May 31, 2022, the approval was a combined effort of the SVS VQI and the Society for Vascular Surgery Patient Safety Organization (SVS PSO), and should allow for enhanced patient treatment moving forward.
Launched in 2016 by the SVS PSO, the TCAR Surveillance Project uses real-world registry data to evaluate the safety and effectiveness of TCAR against the standard of care, carotid endarterectomy (CEA). In the TCAR procedure, a stent is inserted into the internal carotid artery through a small neck incision via the common carotid artery (transcarotid). Traditionally, carotid stents are inserted through an artery in the groin (transfemoral) with a long catheter that must pass through multiple diseased arteries, including the diseased internal carotid artery, before deployment—a potential source of emboli and stroke. During TCAR, stroke risk is further reduced by temporarily reversing blood flow direction in the internal carotid artery to prevent debris dislodged by the procedure from traveling to the brain. Due to these differences in technique, initial publications and data analysis suggest TCAR has a lower stroke rate than the transfemoral Carotid Artery Stent (CAS) technique. The CMS expansion of coverage decision will extend TCAR to standard risk patients in addition to high risk patients who are currently covered under the TSP.
The VQI TCAR Surveillance Project is directed by a SVS PSO Steering Committee that makes periodic analyses of data collected in the VQI CAS and CEA Registries. The expanded coverage for standard surgical risk patients will enable SVS VQI participating centers to extend the benefits of TCAR to a wider population of carotid artery disease patients and allow evaluation of outcomes in this broader patient population.
Notes SVS PSO Steering Committee Chair, Dr. Marc Schermerhorn, “This is wonderful news for patients as TCAR is a minimally invasive treatment with major complication rates equivalent to, or lower than, the standard surgical procedure, carotid endarterectomy. While the best course of action for patients will vary based on anatomy, the less invasive TCAR option will be more appealing than endarterectomy for many, if not most, patients. This is an excellent demonstration of the value of the VQI and its collaboration with the FDA and industry to answer important questions and accelerate the availability of new technology to the population.”
Adds Dr. Jens Eldrup-Jorgensen, Medical Director, SVS VQI, “The new coverage decision will allow providers to offer TCAR to all patients who they feel would benefit from the TCAR approach. Therefore, the choice of intervention will be dependent on provider and patient preference and will not be limited by predefined criteria for coverage.”
Hospitals and physicians participating in the TCAR Surveillance Project can obtain reimbursement for TCAR procedures by submitting claims under the existing National Clinical Trial number NCT02850588. Reimbursement for TCAR within the TCAR Surveillance Project will now apply to Medicare beneficiaries who are deemed to be at high risk and standard risk for adverse events from CEA.
Since its inception in 2011, SVS VQI has raised the bar for vascular care, quality improvement, and patient outcomes. Today the Initiative includes more than 925 participating centers overseeing 950,000+ procedures for individuals with vascular conditions. More than 6,000 physicians have incorporated vascular procedures across SVS VQI’s 14 vascular registries.
The SVS VQI will be available for discussions at the 2022 Vascular Annual Meeting in Boston through June 18 (Booth #610). You can also learn more at https://www.vqi.org.