A Medical Device Daily

The Centers for Medicare & Medicaid Services (CMS) reported that it is proposing to expand its coverage policy for carotid artery stenting (CAS).

Carotid stents are inserted via a small puncture in the groin and threaded through the blood vessels and into the carotid artery in the neck. The goal is to keep the arteries clear of fat deposits that can break off, drift to the brain and cause strokes.

A proposed National Coverage Determination (NCD) posted on Thursday includes a coverage expansion that reflects the latest evidence on the effective use of stenting, a procedure that reduces the occurrence of stroke in the Medicare population.

Stroke is the third leading cause of death in the U.S. and the leading cause of serious, long-term disability. About 70% of all strokes occur in people age 65 and older.

“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 Acting Administrator Leslie Norwalk. “We are working with health professionals and others to reduce the occurrence of stroke in the Medicare population.”

Under Medicare’s current policy, patients with no symptoms of CAS (narrowing of the arteries) and who are at high risk for carotid endarterectomy (CEA) are only covered when CAS procedures are performed in FDA Category B Investigational Device Exemption (IDE) trials, FDA-approved post approval studies, or in accordance with the Medicare clinical trial policy.

Medicare is proposing to expand coverage for CAS to this group of patients who have greater than 80% carotid artery stenosis.

Medicare is also proposing to modify coverage for patients who are 80 years of age and older becaue of what it said were “significant concerns regarding the safety of CAS” when performed in this older patient population. This proposed decision allows for coverage of patients age 80 and above only when CAS procedures are performed in Category B Investigational Device Exemption (IDE) trials, FDA-approved post approval studies, or in accordance with the clinical trial policy.

These proposed modifications in coverage enable Medicare to better serve its beneficiaries by providing access to this important service while ensuring safety, CMS said. Additionally, this proposal formalizes the certification and recertification process for hospitals that are inserting carotid stents.

This NCD has resulted from extensive collaborations between CMS and various CAS stakeholders including medical professional organizations, other government agencies and hospitals. These collaborations, CMS said, have been essential in meeting the agency’s goal of transparency and have been critical in ensuring that this important procedure is both safe and accessible for appropriate Medicare beneficiaries.

“The evidence on carotid artery stenting demonstrates its effectiveness in improving health outcomes for certain patients.” said CMS Chief Medical Officer Barry Straube, MD. “By requiring hospitals to certify their competency, CMS can help ensure patient safety and quality care for those undergoing this procedure.”

Several medical device makers have U.S. regulatory approval for carotid stents, including Abbott Laboratories (Abbott Park, Illinois), Boston Scientific (Natick, Massachusetts), Johnson & Johnson (New Brunswick, New Jersey), Ev3 (Plymouth, Minnesota) and C.R. Bard (Murray Hill, New Jersey).