Overall periprocedural death and stroke rates have declined in patients undergoing carotid artery stenting (CAS). Long-term, CAS may be on even footing with endarterectomy and possibly have an edge for event-free survival. On a less-than-positive note, 30-day mortality rates vary by hospital. Given these results, will payers revisit reimbursement policies for CAS?
The current Centers for Medicare & Medicaid Services (CMS) policy limits Medicare reimbursement for CAS to certified facilities; the process requires hospitals to meet minimum standards―physician training, facility device inventory and support and submission of outcomes data.
CAS advocates charge that scientific evidence calls for an expanded policy, but they may not get their wish. Although stenting has lived up to its promise, reimbursement appears unlikely for a variety of reasons. The specter of the sequestration continues to haunt CMS. Compounding the problem is the issue of potential abuse, which could increase under a more favorable reimbursement policy. It may be more likely that CAS is wrapped into general payment reform aligned with the move toward accountable care organizations (ACOs) and bundled payment.
As far as hospital-by-hospital mortality rates, CMS could tap recent data to audit hospitals identified as underperformers.
CAS data at a glance
If CMS were to re-evaluate the National Coverage Determination (NCD), it would need to consider new data relevant to the decision. These data include the CREST dataset (N Engl J Med 2010;363:11-23), which demonstrated comparable four-year outcomes between stenting and endarterectomy and anticipated results from ACT-1. Stent-makers Abbott and Cortis also have gathered prospective post-market data, demonstrating good outcomes with CAS, including in high-surgical risk patients.
SAPPHIRE, a worldwide trial of 20,000 patients, will likely show similar excellent results, predicts William A. Gray, MD, director of endovascular services at Columbia University Medical Center/NewYork-Presbyterian Hospital in New York City. “This is a real-world slice of carotid stenting that includes hundreds of operators in 800 sites. It isn’t randomized, but it’s meaningful.” Overall, multiple studies and clinical experience show outcomes have improved over time; complication rates have been halved over the last decade.
Yet, Gray dubs the mostly supportive data “problematic.” That’s because CMS is likely to avoid revisiting the CAS question.
One option had been coverage with evidence development, akin to the transcatheter aortic valve replacement (TAVR) policy. A similar multispecialty initiative that included vascular surgeons, cardiologists, neurosurgeons, CMS, the FDA and stent-makers had gathered momentum and even generated enthusiasm among CMS representatives, says Gray.
“Unfortunately, when it came time to propose coverage with evidence development, CMS told us it did not have the time or manpower to consider it, blaming the sequestration and overall reduced staffing,” Gray says.
But there may be more to the story than the sequestration. CMS data show approximately 90 percent of carotid revascularizations in the U.S. are performed on asymptomatic patients. Revascularization is recommended for any patient with stenosis greater than 60 to 70 percent. However, research is starting to suggest that the percent stenosis is not the culprit in stroke; the nature of the plaque―whether it’s vulnerable or not―may be the key factor.
Skeptics charge that some of these asymptomatic patients may not need any treatment. CMS approval could open the floodgates to abuse as a wide swath of specialists from vascular surgeons to neurosurgeons to cardiologists float a stent and perform the procedure.
CREST 2 should provide the answer to the riddle, says William H. Brooks, MD, chairman of the neuroscience center at Baptist Health in Lexington, Ky. The trial will randomize asymptomatic patients to best medical therapy, endarterectomy or stenting.
Imaging, performance & expertise
The gold standard to determine whether or not a patient needs revascularization would be a noninvasive way to assess plaque composition and determine whether or not it is vulnerable.
Imaging may be a way to better identify appropriate patient candidates prior to procedures. Baptist Heart and Vascular Institute in Lexington, has deployed optical coherence tomography (OCT) pre-therapy to determine whether a plaque is stable or unstable.
OCT, a high-resolution, light-based