The Centers for Medicare & Medicaid Services (CMS) today announced it is expanding coverage of Percutaneous Transluminal Angioplasty (PTA) of the carotid artery concurrent with stent placement to patients who are at high risk for carotid surgery—also known as carotid endarterectomy or CEA. The coverage expansion reflects the latest evidence on the effective use of stenting, and includes support for development of better evidence in additional uses.
“CMS is committed to providing broader access to appropriate and innovative care to our beneficiaries in the management of their carotid artery disease,” said CMS Administrator Mark B. McClellan, M.D., Ph.D. “We are working with health professionals and product developers to reduce the occurrence of stroke in our population, and getting the maximum health improvements possible by soliciting and responding to public comments on the most effective way to provide improved coverage.”
The national coverage determination (NCD) issued today expands Medicare coverage for carotid artery stenting to high risk patients with symptomatic narrowing of carotid artery of 70 percent or more.
Medicare also will cover patients who meet the FDA labeled criteria for carotid stents (who are at high risk for CEA and have symptomatic carotid artery stenosis between 50 percent and 70 percent and asymptomatic high risk patients with carotid artery stenosis of 80 percent or more) in Category B IDE clinical trials, as a routine cost under the clinical trials policy, or in post approval studies.
Under previous policy, CMS only covered carotid artery stenting in clinical trials being conducted prior to Food and Drug Administration (FDA) approval (so-called Category B Investigational Device Exemption [IDE] clinical trial) and more recently in FDA required post approval studies.
CMS and Guidant Corporation are working with the FDA to expand the scope of post approval studies and increase the number of participating facilities and study enrollees. Guidant Corporation is currently the only company with an FDA approved carotid stent and an ongoing post approval study.
CEA is a surgical procedure used to prevent stroke in which the surgeon removes fatty deposits or plaques from the carotid arteries, the two main arteries in the neck supplying blood to the brain. Carotid artery stenting is a less invasive, alternative procedure to CEA, in which a catheter is used to place the stent that will widen the narrowed artery.
To help ensure optimal patient outcomes and to evaluate and monitor provider and facility performance, Medicare is limiting use of carotid stenting to facilities and providers who have been determined to be competent in performing the evaluation, procedure, and necessary follow-up care.
Competency will be based on published clinical guidelines that outline physician training and facility support requirements for carotid artery stenting. Facilities must also meet CMS’ minimum standards in performing carotid artery stenting.
These standards outlined in the coverage determination include physician training criteria, facility support requirements and data collection to evaluate outcomes during a required reevaluation. Facilities can provide a written affidavit to CMS attesting that the facility has met these standards.
Each year about 700,000 people experience a new or recurrent stroke. More than 70 percent of stroke victims are over 65 years of age and eligible for Medicare.
Obstructive lesions in the carotid arteries have the potential to cause stroke, leading to substantial morbidity, mortality and long-term disability. Stroke prevention includes the following measures:
- treating hypertension and diabetes,
- smoking cessation,
- limiting alcohol intake, and
- controlling diet and obesity.
Some medical conditions or anatomical risk factors that increase the risk for CEA include congestive heart failure (CHF), unstable angina, and recent heart attack (myocardial infarction).
“The evidence on carotid artery stenting demonstrates its effectiveness in improving net health outcomes for certain patients.” said CMS chief medical officer Sean Tunis MD, MSc. “By requiring hospitals to certify their competency, CMS can help ensure patient safety and quality care for those undergoing this procedure.”
The final decision memorandum is available for review at the www.cms.hhs.gov/coverage. The new coverage will be effective today.