The decision received widespread support from U.S. medical societies, including those in the fields of neurology, radiology and cardiology. More than 800 comments were received during the CMS review process, with the majority expressing support for the expanded coverage.
"There were 14 medical societies or organizations that came out in favor, that includes the American Association of Neurology, and all of the cardiac, radiology and neurology communities entirely coming out in favor," explained Ken Rosenfield, MD, MSCA member and section head of vascular medicine and intervention, and chairman of STEMI and Acute MI Quality Improvement Committee at Massachusetts General Hospital.
He said MSCA worked to show consensus among many of the experts from the various specialties involved in carotid care and submit the request for review that included a clear and referenced outline of the clinical evidence.
The new CMS national coverage determination has greatly broadened the number of patients eligible for reimbursement when they undergo minimally invasive, catheter-based stenting. The biggest thing the CMS change does is lift off the restriction of payment being the deciding factor for care rather than what is best for a patient.
"I don't think it changes the hospital's business model or bottom line, but I think what it really does is improves patient quality outcomes. Because what you have now is the option to do multiple approaches to a patient without restriction by payment. So if medical therapy is the right thing to do, that's what you do. And if I'm a carotid center, but I think the right thing to do is endarterectomy because a patient has a bulky lesion or a type 3 arch or something like that, I'm going to send 'em a surgery and there's no inhibition for crossing over for the therapeutic which is most appropriate for the patient. And in the end, that reduces total mortality and total neurologic complications," Gray explained.
Rosenfield said patients will also benefit from having more informed decision-making.
"One thing that was important in the decision that CMS finally issued was that there should be a shared decision-making process that patients go through with their physician, be it a surgeon, a cardiologist, a radiologist, a neurologist or a neurosurgeon, and that all of the options are required to be presented to the patient so that the patient can make an informed decision. Now, in many instances, it might be the most appropriate thing to do an endarterectomy or to do optimal medical therapy. But in some instances, it will be clear that stenting is the right approach, and then there's going to be this big gray zone where patients will have the option of transcarotid artery revascularization (TCAR) using stenting or endarterectomy. And in that case, now the patient will actually be able to make their own informed decision for elective procedures," Rosenfield explained.
CMS now approves carotid stenting for asymptomatic patients with a stenosis of 70% or more, and symptomatic patients with more than 50% stenosis, Gray said. The decision allows for various catheter vascular access options including transfemoral, transradial or transcarotid.
While many patients may opt for the less invasive procedure if they have a choice, he said there are a lot of good clinical reasons for open surgical procedures, including the presence of comorbidities or anatomic issues that make catheter navigation difficult. Each patient case will have different circumstances, so ideally there should be a team-based approach to CEA or CAS.
"That doesn't necessarily mean that you have to have sign off for carotid procedure by one or another specialty. In fact, CMS rejected that and they agreed that anybody who's managing carotid disease should have full knowledge of all of the different options and their pluses and minuses and should present a balanced approach to the patient. The Multi-Specialty Carotid Alliance is really keen on ensuring that we end up with optimal outcomes for these patients that we think quality should be monitored and assured and that patients deserve that. So we're going to work very intensively on that with all of our colleagues from all different specialties to try to achieve that," Rosenfield said.
Often in medicine, when a solution to a problem is developed, such as a drug or device, the screening for patients with that condition increases and it is often found there is much larger patient population that originally thought. This certainly happened with the development of transcatheter aortic valve replacement (TAVR) as an alternative to open heart surgery, where much larger population of of aortic stenosis patients came out of the woodwork and surprised cardiology in the past decade. The same thing happened when the FDA cleared use of transcatheter closure devices for patent foramen ovale (PFO), Gray said.
"When you create a therapy for patients, we find those patients and there's more surveillance for that problem. When you have limited options for that, it becomes less attractive. It's not great. I mean, that's not the way medicine should be practiced, but that's the reality of it," Gray explained.
Rosenfield said if CAS procedure volume goes up, it also will likely spur new investment to develop better interventional therapies. Keep in mind that the currently available stents, catheters and embolic protection systems for CAS were developed 15-20 years ago with little new innovation since. Rosenfield said the lack of innovation is mainly due to the lack of reimbursement and resulting lower numbers of CAS patients.
"I think that one of the things that happened as a result of the lack of coverage for CAS is a complete absence of investment in the carotid innovation space. There are a couple of notable exceptions, but by and large, there hasn't been a lot of innovation in this space," he said. I firmly believe we're going to get there."
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