Medicare plans expansion of carotid artery stenting coverage

Washington -- Medicare has proposed broadening its coverage of carotid artery stenting to more patients who are at risk for stroke.

The procedure has been covered for patients who have a sufficient level of arterial blockage and who have associated symptoms, such as paralysis, weakness or speech problems. The Centers for Medicare & Medicaid Services is proposing to expand coverage to patients who have sufficiently narrowed arteries but are asymptomatic.

At present, asymptomatic patients can only receive federal help with the procedure if they are enrolled in an approved clinical trial on stenting. Federal officials and many physicians hope that the expansion would give more patients added options in cases where stenting offers a potentially less-risky alternative than the more invasive carotid endarterectomy.

"The evidence on carotid artery stenting demonstrates its effectiveness in improving health outcomes for certain patients," said CMS Chief Medical Officer Barry Straube, MD.

CMS did not estimate how many more Medicare beneficiaries would be covered under the proposed national coverage determination. Abbott Vascular, a manufacturer of carotid artery stenting systems and the firm that requested the policy change, estimated that the market for the devices would expand by 50% to 75% as a result.

The CMS move would be a very important step forward for Medicare patients who are at risk for stroke and the physicians who treat them, said William A. Gray, MD, a cardiologist and the director of endovascular services at New York-Presbyterian Hospital/Columbia. Dr. Gray, who is also an associate professor of clinical medicine at Columbia University Medical Center in New York, was a lead investigator on several of the clinical trials that helped convince CMS to recommend changing its coverage of carotid artery stenting.

"Patients will have more options to gain access to approved technology and approved techniques," he said.

During the comment period on the draft coverage memo, Dr. Gray and others plan to ask CMS to expand its coverage of asymptomatic patients even more. Stenting would only be covered for these patients if they have carotid artery stenosis of 80% or more. But studies have shown that this treatment could be a good option for patients who have stenosis as low as 50%, he said.

The proposal would restrict coverage in other areas. Beneficiaries who are 80 or older would only be able to undergo the procedure as part of a federally approved clinical trial. Some studies have pointed to serious safety concerns associated with stenting in older individuals.

In addition, CMS has proposed requiring that a cardiovascular surgeon diagnose narrowed arteries and risk factors as a prerequisite to coverage. But Dr. Gray said this would be problematic because it shuts out internists and cardiologists who would have no potential conflict of interest when it comes to determining surgical risk.

"It also becomes onerous for the patient in that they have to move from one specialist to another, and it creates the primacy of one specialist over another," he said.

In a recent letter to CMS, the Society for Vascular Surgery challenged the contention that its members would have a patient treatment conflict. The group called for more clinical study before the agency expanded coverage to patients with less than 70% stenosis. "We have no vested interest in a specific procedure, rather a global perspective on an evidence-based approach to the treatment of carotid atherosclerosis and the prevention of stroke," wrote the society's executive council and its president, K. Craig Kent, MD.

CMS will accept comments on the draft decision through March 3. It expects a final decision in early May.