Meeting News

Experts debate reimbursement, accreditation for carotid stenting

HOLLYWOOD, Fla. — Foot-dragging by CMS and disagreements among professional societies are the most common reasons cited for why reimbursement for carotid stenting is limited in the United States, but there are more factors in play, a panel of experts said during a roundtable at the International Symposium on Endovascular Therapy.

Turf wars between vascular surgeons, neurologists and interventional cardiologists and radiologists have played a role in restricting reimbursement for carotid stenting in patients with carotid stenosis, according to Barry T. Katzen, MD, chief medical executive, Miami Cardiac and Vascular Institute, clinical professor of radiology and surgery at Florida International University Herbert Wertheim College of Medicine, Miami, and founder of ISET.

However, Katzen said, this may be changing.

Barry T. Katzen

“What drove a lot of the turf issues earlier was a question of shifting from vascular surgery to somebody else,” he said. “The most recent trials have been done in a space that’s multidisciplinary and everybody’s engaged to one extent or another. Has there been enough of a change in the culture to present a different face to CMS?”

Vascular surgeons have traditionally expressed concern that carotid stenting confers risk for stroke, but many have embraced newer technologies designed to address those concerns, particularly the transcarotid artery revascularization procedure (Enroute Transcarotid Stent and Enroute Transcarotid Neuroprotection System, Silk Road Medical), said Thomas G. Brott, MD, professor of neurology and director for research at the Mayo Clinic in Jacksonville, Florida.

“I think that’s changed the playing field,” Brott said.

Thomas G. Brott

However, he said, reimbursed carotid stenting procedures fell from 82,000 in 2003 to 48,000 in 2014, so CMS “may be sensing that we’ve got enough people taking care of the asymptomatic patients and we don’t need more people doing it.”

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Russell H. Samson, MD, RVT, FACS, clinical professor of surgery (vascular) at Florida State University Medical School, Tallahassee, questioned why efforts persist to gather evidence on conventional carotid stenting when it may be usurped by newer technologies.

“What confuses me is that we’re going around with CREST when we’ve got a whole new paradigm now with the Silk Road device,” Samson said. “Maybe we should be rethinking the whole situation.”

Although carotid stenting is evolving to become a lower-risk procedure, medical therapy also is improving, making it harder to demonstrate a case for an invasive procedure, according to Frank J. Veith, MD, professor of vascular surgery at NYU School of Medicine and Cleveland Clinic, and the chairman of VEITHsymposium.

Frank J. Veith

“With the new PCSK9 inhibitors, plaque is actually shrinking, so now there is a moving target as to what [approach] is going to be best,” Veith said. “To get level 1 evidence is going to be very difficult, and that is what convinces CMS.”

Kenneth Rosenfield, MD, MHCDS, FACC, F SCAI, section head of vascular medicine and intervention at Massachusetts General Hospital, president of the Society for Cardiovascular Angiography and Interventions and a member of the Cardiology Today’s Intervention Editorial Board, said aside from turf wars, a factor limiting reimbursement for carotid stenting is “a concern that it’s going to be like letting the horse out of the barn, and people are going to be stenting like wild, almost like with atherectomy now, where some is appropriate and some may not be, but there is little meaningful evaluation or monitoring.”

Kenneth Rosenfield MD, MHCDS, FACC, FSCAI
Kenneth Rosenfield

The best way to address that, Rosenfield said, is “to actually require submission of data, to require enrollment in the registries, and have [operators] certify, and then to monitor that. And to limit the operators to those who have adequate volume and adequate experience.”

In reviewing cases for the CREST 2 registry, Guilherme Dabus, MD, director of the fellowship program in interventional neuroradiology and neurointerventional surgery at Miami Cardiac and Vascular Institute and Baptist Neuroscience Institute, Miami, said he has seen “really poorly indicated cases. It’s not uncommon to see 50% stenosis in an asymptomatic patient being stented and reported as 90% stenosis. The best way to control the outcomes is to control who’s doing it and require them to submit data.”

Rosenfield said he suggests looking at coronary intervention as a model because it “has done a pretty good job of collecting data and doing appropriate use criteria and monitoring that. We could definitely imitate that.”

He added that, while valid criticisms of carotid stenting may exist, there is now enough evidence for it to warrant CMS coverage.

“There are now two very large-scale randomized controlled trials, both published in The New England Journal of Medicine and conducted in North America, comparing current therapy with [carotid endarterectomy] to [carotid artery stenting] for both symptomatic and asymptomatic standard surgical risk patients,” he said. “Both of those landmark studies, CREST and ACT 1, provided level I evidence that [stenting] is equivalent to [surgery]. As such, there is much more evidence than usually is required for CMS to approve reimbursement. There is no justification for withholding this therapy from Medicare patients who desire [carotid artery stenting] as an alternative to [surgery] at this time. I support reimbursement with mandatory data collection, case reporting, and quality monitoring.” – by Erik Swain

Reference:

Katzen BT, et al. Concurrent Session IV: Optimizing outcomes in carotid therapy. Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.

Disclosure : Brott and Veith report no relevant financial disclosures. Dabus reports consulting for Medtronic, Microvention and Penumbra and holding equity in InNeuroCo, Medtronic/Medina, Struken/Sunross and Three Rivers. Katzen reports serving on advisory boards for Boston Scientific, Graftworx, Philips Healthcare, PQ Bypass and W.L. Gore & Associates. Rosenfield reports financial ties with numerous pharmaceutical and device companies. Samson reports speaking for W.L. Gore and Associates.

 

 

HOLLYWOOD, Fla. — Foot-dragging by CMS and disagreements among professional societies are the most common reasons cited for why reimbursement for carotid stenting is limited in the United States, but there are more factors in play, a panel of experts said during a roundtable at the International Symposium on Endovascular Therapy.

Turf wars between vascular surgeons, neurologists and interventional cardiologists and radiologists have played a role in restricting reimbursement for carotid stenting in patients with carotid stenosis, according to Barry T. Katzen, MD, chief medical executive, Miami Cardiac and Vascular Institute, clinical professor of radiology and surgery at Florida International University Herbert Wertheim College of Medicine, Miami, and founder of ISET.

However, Katzen said, this may be changing.

Barry T. Katzen

“What drove a lot of the turf issues earlier was a question of shifting from vascular surgery to somebody else,” he said. “The most recent trials have been done in a space that’s multidisciplinary and everybody’s engaged to one extent or another. Has there been enough of a change in the culture to present a different face to CMS?”

Vascular surgeons have traditionally expressed concern that carotid stenting confers risk for stroke, but many have embraced newer technologies designed to address those concerns, particularly the transcarotid artery revascularization procedure (Enroute Transcarotid Stent and Enroute Transcarotid Neuroprotection System, Silk Road Medical), said Thomas G. Brott, MD, professor of neurology and director for research at the Mayo Clinic in Jacksonville, Florida.

“I think that’s changed the playing field,” Brott said.

Thomas G. Brott

However, he said, reimbursed carotid stenting procedures fell from 82,000 in 2003 to 48,000 in 2014, so CMS “may be sensing that we’ve got enough people taking care of the asymptomatic patients and we don’t need more people doing it.”

PAGE BREAK

Russell H. Samson, MD, RVT, FACS, clinical professor of surgery (vascular) at Florida State University Medical School, Tallahassee, questioned why efforts persist to gather evidence on conventional carotid stenting when it may be usurped by newer technologies.

“What confuses me is that we’re going around with CREST when we’ve got a whole new paradigm now with the Silk Road device,” Samson said. “Maybe we should be rethinking the whole situation.”

Although carotid stenting is evolving to become a lower-risk procedure, medical therapy also is improving, making it harder to demonstrate a case for an invasive procedure, according to Frank J. Veith, MD, professor of vascular surgery at NYU School of Medicine and Cleveland Clinic, and the chairman of VEITHsymposium.

Frank J. Veith

“With the new PCSK9 inhibitors, plaque is actually shrinking, so now there is a moving target as to what [approach] is going to be best,” Veith said. “To get level 1 evidence is going to be very difficult, and that is what convinces CMS.”

Kenneth Rosenfield, MD, MHCDS, FACC, F SCAI, section head of vascular medicine and intervention at Massachusetts General Hospital, president of the Society for Cardiovascular Angiography and Interventions and a member of the Cardiology Today’s Intervention Editorial Board, said aside from turf wars, a factor limiting reimbursement for carotid stenting is “a concern that it’s going to be like letting the horse out of the barn, and people are going to be stenting like wild, almost like with atherectomy now, where some is appropriate and some may not be, but there is little meaningful evaluation or monitoring.”

Kenneth Rosenfield MD, MHCDS, FACC, FSCAI
Kenneth Rosenfield

The best way to address that, Rosenfield said, is “to actually require submission of data, to require enrollment in the registries, and have [operators] certify, and then to monitor that. And to limit the operators to those who have adequate volume and adequate experience.”

In reviewing cases for the CREST 2 registry, Guilherme Dabus, MD, director of the fellowship program in interventional neuroradiology and neurointerventional surgery at Miami Cardiac and Vascular Institute and Baptist Neuroscience Institute, Miami, said he has seen “really poorly indicated cases. It’s not uncommon to see 50% stenosis in an asymptomatic patient being stented and reported as 90% stenosis. The best way to control the outcomes is to control who’s doing it and require them to submit data.”

Rosenfield said he suggests looking at coronary intervention as a model because it “has done a pretty good job of collecting data and doing appropriate use criteria and monitoring that. We could definitely imitate that.”

He added that, while valid criticisms of carotid stenting may exist, there is now enough evidence for it to warrant CMS coverage.

“There are now two very large-scale randomized controlled trials, both published in The New England Journal of Medicine and conducted in North America, comparing current therapy with [carotid endarterectomy] to [carotid artery stenting] for both symptomatic and asymptomatic standard surgical risk patients,” he said. “Both of those landmark studies, CREST and ACT 1, provided level I evidence that [stenting] is equivalent to [surgery]. As such, there is much more evidence than usually is required for CMS to approve reimbursement. There is no justification for withholding this therapy from Medicare patients who desire [carotid artery stenting] as an alternative to [surgery] at this time. I support reimbursement with mandatory data collection, case reporting, and quality monitoring.” – by Erik Swain

Reference:

Katzen BT, et al. Concurrent Session IV: Optimizing outcomes in carotid therapy. Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.

Disclosure : Brott and Veith report no relevant financial disclosures. Dabus reports consulting for Medtronic, Microvention and Penumbra and holding equity in InNeuroCo, Medtronic/Medina, Struken/Sunross and Three Rivers. Katzen reports serving on advisory boards for Boston Scientific, Graftworx, Philips Healthcare, PQ Bypass and W.L. Gore & Associates. Rosenfield reports financial ties with numerous pharmaceutical and device companies. Samson reports speaking for W.L. Gore and Associates.

 

 

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