Medicare To Cover Angioplasty Of The Carotid Artery

The Health Care Financing Administration (HCFA) announced that Medicare will cover angioplasty of the carotid artery with stent insertion, a new treatment option for the prevention of stroke.  The treatment will be covered only under certain conditions.

The national coverage decision provides for Medicare coverage of percutaneous transluminal angioplasty of the carotid artery when performed along with the placement of a carotid stent that is furnished in accordance with a Food and Drug Administration approved protocol governing category B Investigational Device Exemption (IDE) trials.

"It's important to make new technologies in health care available to Medicare beneficiaries," said Health and Human Services Secretary Tommy G. Thompson.  "Older Americans are especially vulnerable to stroke and we believe this may help prevent stroke in high-risk patients."

Stroke is the third leading cause of death in the United States and the leading cause of serious, long-term disability.  Approximately 70 percent of all strokes occur in people age 65 and older.

The carotid artery is located in the neck and is the principal artery supplying the head and neck with blood.  The accumulation of plaque in the carotid artery can lead to stroke either by decreasing the blood flow to the brain or by having plaque break free and lodge in the brain or in other arteries to the head.

The new procedure involves inflating a balloon-like device in the narrowed section of the carotid artery to re-open the vessel.  A carotid stent, a small, metal mesh-like device, is then placed in the artery to prevent it from closing and from allowing pieces of plaque to enter the bloodstream.

"This is a promising new technology that may eventually be proven to prevent stroke in certain high-risk patients who would not be amenable to surgical removal of plaque from an obstructed carotid artery" said Jeffrey Kang, M.D., director of HCFA's Office of Clinical Standards and Quality and the agency's chief clinical officer.  "What we learn from this coverage decision also will help us consider this therapy as an alternative for other patients at risk for stroke."

The current standard of care for obstructed carotid arteries is carotid endarectomy, a surgical procedure that involves opening the artery and manually removing the plaque.

In 1995 HCFA, the federal agency that runs Medicare and Medicaid, issued regulations permitting the private contractors that process and pay Medicare claims to consider coverage on a local basis for certain investigational devices that are furnished in accordance with FDA approved protocols governing clinical trials.  An IDE from the FDA permits a device to be shipped lawfully for the purposes of conducting clinical trials of the device without complying with special controls or having marketing clearance.  The purpose of an IDE is to encourage the discovery and development of useful devices intended for human use while protecting the public health.

After a review of the scientific and clinical evidence, HCFA has determined that the evidence regarding carotid stenting concurrent with angioplasty, and the FDA's willingness to approve certain IDE trials involving carotid stents, are sufficient to provide limited access to this technology.  Prior to this new policy, Medicare would not allow payment for angioplasty of the carotid artery.