Medicare rule against broader reimbursement for carotid stenting spurs debate

A decision by the Centers for Medicare and Medicaid Services not to expand coverage for carotid artery stenting has stirred mixed responses among physicians who are either outraged with the denial or satisfied that the decision was scientifically sound.

Following the Oct. 14 decision, Medicare reimbursement remains restricted to percutaneous transluminal angioplasty and carotid stenting for patients who are at high risk for carotid endarterectomy and have symptomatic stenosis higher than 70% or are enrolled in an approved clinical trial.

CMS decided against expanding the indication for reimbursement to patients with a less severe degree of carotid artery stenosis.

In justifying its decision, CMS argued that the published evidence was insufficient to be confident that patients in other categories would benefit from the procedure. The CMS benchmarks for revascularization with gold standard endarterectomy include asymptomatic patients with a 30-day stroke/death rate no higher than 3% and symptomatic patients with a stroke/death rate no higher than 6%.

The Society for Cardiovascular Angiography and Interventions, one of the societies providing position statements, expressed disappointment with CMS' decision. SCAI officials noted the CMS decision came only one day prior to publication of the Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy (SAPPHIRE) international trial. SAPPHIRE researchers found carotid stenting to be safe and effective with results comparable to endarterectomy. The American College of Cardiology and the Society of Vascular and Interventional Neurology agreed with the SCAI that the evidence was sufficient to justify reimbursement for more patients.

Not everyone agreed.

"The position of the Society of Interventional Radiology was that we will be willing to support more liberal reimbursement if CMS could be assured that outcomes will meet those 3% or 6% benchmarks," said Dr. David Sacks, immediate past president of SIR.

Those who believe carotid stenting is a superior revascularization technique insist patients will be harmed because they will not get access to a minimally invasive therapy that could prevent them from having a stroke, according to Sacks. In addition, they will be forced to undergo surgery with all the risks and potential complications it entails. But those who agree there is not enough evidence to support carotid stenting think CMS' decision will keep large numbers of patients from being treated with a technology that has not yet proven its benefit.

"That's kind of the Solomonic way of looking at it," Sacks said.

Many physicians have criticized the CMS ruling as a self-interest move to contain reimbursement spending. Others have noted, though, that CMS could hardly save any money by denying payment for carotid stenting if it has to pay for surgeries, which are not any cheaper.

Multiple stakeholders could be at odds with the CMS decision in the short term, Sacks said. There are patients for whom carotid stenting truly is a better alternative. The medical device industry, on the other hand, will certainly feel the pain if they cannot sell products they have heavily invested in according to expectations.

In the long-term, however, new randomized trials are pending. CMS will take a fresh assessment of their outcomes and make a new decision based on their evidence, Sacks told Diagnostic Imaging.

"At that time, if it's demonstrated that carotid stenting can reliably meet those 3% or 6% benchmarks, my prediction is that CMS will approve much wider reimbursement," he said.

The implementation of an accreditation program for all facilities performing carotid stenting could assure CMS those benchmarks will be met. SIR, along with a number of other professional societies, is working on such program, Sacks said.

"It's unfortunate that the issue of reimbursement for carotid stenting has aroused passions and harsh words," Sacks said. "All stakeholders want to do what's best for patients. We just have some discrepancies as to the interpretation of the evidence for how strongly it supports the benefit of carotid stenting at this time."

For more information from the Diagnostic Imaging archives:

Benefits of carotid artery stenting elude researchersCarotid stents gain Medicare coverage despite questions about clinical effectivenessCarotid stenting enhances cognitionCarotid artery stenting takes off despite limits