Nearly one-third of the public comments submitted to the Centers for Medicare & Medicaid Services (CMS) on a controversial proposed coverage decision affecting carotid stenting were from SVS members.
“We could not have been more pleased with our members’ response to a proposal that we, as a Society, believe will negatively impact patient care, result in unnecessary procedures, and increase the number of strokes across the vascular patient spectrum,” said SVS President Joseph Mills, MD.
Of approximately 760 responses, at least 237 were initially identified as being from SVS members, he said. “There may well be even more.”
In July, CMS released a proposed decision that would significantly broaden coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. The proposal would expand Medicare coverage of the procedure to individuals previously only eligible for coverage in clinical trials, remove the limitation of coverage to only high surgical risk individuals, and remove facility standards and approval requirements. The proposal adds shared decision-making with the patient prior to the procedure and allows Medicare Administrative Contractors (MAC) discretion for all other coverage of carotid artery PTA concurrent with stenting not otherwise addressed in the national coverage determination.
Comments were due by Aug. 10. In the weeks prior to that, SVS leaders wrote the Society’s formal comment and embarked on a careful campaign to solicit members to add their voices to the discussion. “We focused on patient safety, because we believe it is at risk if NCD 20.7 is finalized without our issues addressed,” Mills said.
A CMS decision is expected on or before Oct. 6. In its formal response, SVS made three recommendations.
First, mandate utilization of a standardized “shared decision-making” tool that would be designed in collaboration with applicable medical specialty societies and/or other relevant stakeholders.
“Shared decision-making is a vital component of allowing patients to receive a carotid treatment plan that best aligns with their wishes and values. Unfortunately, currently there is no validated carotid decision tool that captures the options offered in contemporary practice that are the subject of this NCD,” the Society said.
Second, revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing process and requirements for reporting standards. “These elements are critical for ensuring a high degree of patient safety,” the Society commented.
Third, revise the proposed decision memo to include a definition of a “qualified physician” with demonstrated core competency standards relating to carotid stenting. “CMS should work with relevant stakeholders to develop the core competency standards.”
In its conclusion, the response states the SVS believes the coverage expansion is “premature and jeopardizes patient safety.” If CMS finalizes the proposed expansion of coverage, the letter states, the “finalized memorandum should reflect the outlined recommendations.”
“SVS will continue to actively promote quality and safety for vascular patient care through its published guidelines, appropriate use criteria (AUC) documents, PSO-VQI Registry and other major initiatives such as the Vascular Verification Program. All practitioners caring for patients with vascular disease are encouraged to become familiar with these tools and to utilize them. SVS will continue to develop these resources and make them available.”
Mills pointed out that, among other concerns, clinical trial data from the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST-2) trial have yet to be released, and such a major expansion of coverage should not be implemented until data have been released and analyzed.
“Our primary focus remains, as it always has been, patient safety,” he said. “We are not anti-stent in the appropriate patient and setting. The sheer number and depth of responses from our members demonstrate the firm commitment of SVS members to quality and safety in the care of patients with vascular disease.”
A sample of SVS members who contributed individual comments before the deadline for public submissions passed follows:
- Edward Gifford, MD, Hartford HealthCare, Hartford, Connecticut: “As a young vascular surgeon, I feel this proposed decision does not do enough to monitor for the safety of patients after removing previous guardrails for carotid artery stenting. I feel that transfemoral stenting (TF-CAS] has a role in carotid stenosis. However, on the whole, our threshold to intervene on asymptomatic disease has only increased as medical therapy advances.”
- Katharine McGinigle, MD, University of North Carolina at Chapel Hill: “Before the new level 1 data is available, I do not think that it is appropriate to change practice patterns. I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD 20.7 is premature and jeopardizes patient safety.”
- Robert Molnar, MD, Michigan Vascular Center, Flint, Michigan: “Not only is [NCD 20.7] premature, given the pending CREST-2 trial, which specifically will address the outcomes of TF-CAS with best medical therapy, but it completely removes common sense safeguards needed to allow for all-inclusive TF-CAS.”
- Elsie Gyang Ross, MD, University of California San Diego (UCSD): “With the expansion, we will likely see new outpatient ‘stroke prevention centers’ whereby a number of specialists who can navigate to the carotid and place a stent will do so, without the true consideration of patient risk. It is an unfortunate byproduct of healthcare today in the U.S.”
- Ali Azizzadeh, MD, Cedars-Sinai Medical Center, Los Angeles: “Since the level 1 evidence regarding the use of TF-CAS, particularly in standard-risk patients, is evolving, it seems that it is too premature to jump to approval of TF-CAS, even in high-risk patients, and I would disagree with the decision memo.”
Read about the proposed decision at vascular.org/CarotidNCD. Read the formal response at vascular.org/NCDResponse.
