While many major headlines over the past few weeks have tracked President George Bush's proposed plan to stave off the bankruptcy of the U.S. Social Security system, continued bankrolling of Medicaid would appear to be a problem looming even larger – and much more closely.

Last week, the Senate's rejection of the president's $14 billion budget cut in Medicaid funding was followed on Friday by an announcement from the Centers for Medicare and Medicaid Services (CMS; Baltimore) that 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 (CEA). The expanded reimbursement goes into effect immediately.

While the expanded coverage falls far short of the potential billions of dollars in new costs for expanded coverage of implantable defibrillators – announced earlier this year – it does suggest a more aggressive approach to reimbursements by CMS, especially in the heart disease and vascular sectors, together with a growing emphasis on reliance on clinical trial data.

A statement by CMS said the new carotid stenting coverage "reflects the latest evidence on the effective use of stenting, and includes support for development of better evidence in additional uses."

Mark McClellan, CMS administrator said that the agency "is committed to providing broader access to appropriate and innovative care to our beneficiaries in the management of their carotid artery disease. 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) expands coverage for carotid artery stenting specifically to high-risk patients, defined as having "symptomatic narrowing of carotid artery of 70% or more."

CMS said it 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 from 50% to 70% and asymptomatic high risk patients with carotid artery stenosis of 80% or more, in Category B investigational device (IDE) clinical trials. This will come under the category of a routine cost "under the clinical trials policy, or in post-approval studies," CMS said.

Under previous policy, CMS only covered carotid artery stenting in clinical trials being conducted prior to FDA approval (so-called Category B IDE clinical trial) and more recently in FDA-required, post-approval studies.

CMS said it is working with Guidant (Indianapolis) and the FDA "to expand the scope of post-approval studies [of carotid stenting] and increase the number of participating facilities and study enrollees."

Guidant, CMS noted, currently is the only company with an FDA-approved carotid stent and an ongoing post-approval study.

Guidant was the first company in the U.S. to receive FDA approval of a carotid stent with clearance last year of its Rx Acculink carotid stent and Rx Accunet embolic protection system to reduce the risk of stroke (Medical Device Daily, Sept. 2, 2004). CMS's commitment to expanding the coverage of the carotid stenting procedurecame in a statement from the agency immediately after the Acculink approval (MDD, Sept. 3, 2004).

The Acculink system is sold by the Vascular Intervention (Santa Clara, California) division of Guidant.

CEA is a surgical procedure, used to prevent stroke, fatty deposits or plaques are removed from the carotid arteries, the two main arteries in the neck. Carotid artery stenting is a less invasive alternative to CEA; in this strategy, a catheter is used to place the stent that will widen the narrowed artery.

Medicare said that to help ensure the best patient outcomes and to evaluate and monitor provider and facility performance, it will limit use of carotid stenting to facilities and providers determined "competent in performing the evaluation, procedure and necessary follow-up care."

Competency, it said, 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 guidelines specify physician training criteria, facility support and data collection to evaluate outcomes during a required reevaluation.

"The evidence on carotid artery stenting demonstrates its effectiveness in improving net health outcomes for certain patients," said Sean Tunis, MD, chief medical officer for CMS. "By requiring hospitals to certify their competency, CMS can help ensure patient safety and quality care for those undergoing this procedure."

Each year about 700,000 people experience a new or recurrent stroke. More than 70% of stroke victims are over 65 and thus eligible for Medicare.

Obstructive lesions in the carotid arteries have the potential to cause stroke, leading to substantial morbidity, mortality and long-term disability. 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 Senate's rejection of cuts in Medicare last week appeared to be a setback for the president's attempts to rein in the growing national deficit.

The more immediate effect of slashing the Medicare reductions from the budget, many commentators were saying, could be to scuttle adoption of this particular version of the spending plan.

And it suggests a bipartisan hot potato forming since somewhat more than a handful of Republican senators – specifically, seven – joined Democrats in approving the amendment striking down the cuts.

The amendment was offered by Sen. Gordon Smith (R-Oregon), with its supporters saying that the president's proposed reductions in Medicare spending would fall heaviest on the neediest recipients.

The next step will be an attempt to reconcile the Senate version of the budget with the House version, the House having approved the Medicare cuts, a move receiving as-expected praise from the president.