Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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.

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It does not matter how many people outside, or inside, CMS support proposals to:

1. FUND FREE-FOR-ALL CAROTID ARTERY PROCEDURES (INCLUDING CAS which is more dangerous than CEA) on the most vulnerable Americans (older and/or disabled Americans and/or those with end-stage renal disease) who are labelled as having at least '50 or 70%' carotid stenosis

AND/OR TO

2. REMOVE CMS APPROVED PROCEDURAL STANDARDS.

Many, if not most or all, of these supporters are conflicted because of personal financial interests.

Moreover, none have a robust scientific argument to support such radical health policy change. None have shown that our analyses of the evidence base (submitted earlier to this CMS website and widely published) are incorrect. Our analyses show that all proposals currently under consideration by CMS in relation to carotid arterial disease are clearly inappropriate.

To quote a few words from a Veithsymposium lecture from Prof Peter Bell in relation to the possibility of widespread CAS, the public will have to 'cover their groins', and I would add, 'and run for their lives' if such evidence and patient-welfare contrary policy changes get through....

But these policy proposals MUST Not get through. They will cause net harm in terms of public health and use of precious healthcare resources. It is not too late to stop this disaster.

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August 10, 2023

Tamara Syrek Jensen, Director
Joseph Chin, Deputy Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, Maryland 21244

RE: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8)

Dear Ms. Syrek Jensen and Dr. Chin:

On behalf of the Multispecialty Carotid Alliance (MSCA or the Alliance), we are writing to reiterate our strong support for the proposed coverage decision for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8) (Proposed Decision Memo) and to respond to comments submitted by various stakeholders.

Seventy (70) years ago, a carotid endarterectomy (CEA) by Debakey ushered a new era in stroke prevention. Since then, the evolution of both medical management with statins, anti-platelet and blood pressure control, as well as the newer techniques for revascularization of carotid angioplasty and stenting and more recently transcarotid artery revascularization have resulted in significant adoption. The evolution of techniques has resulted in the entry of new disciplines engaging in the care of these patients. While the first carotid endarterectomy was performed by a cardiovascular surgeon, subsequently vascular neurosurgeons and head and neck surgeons also joined ranks in performing this effective operation, followed by vascular surgeons in the contemporary era. The endovascular revolution has been led by interventional radiologists and cardiologists and they contributed significantly to the science and practice of transfemoral and transradial carotid angioplasty and stenting (CAS), including the development and implementation of embolic protection. The transcarotid artery revascularization (TCAR) wave has been driven by vascular surgeons, reflective of increasing endovascular competencies. The stroke thrombectomy revolution, which frequently requires addressing acute carotid artery stenosis or thrombosis to gain intracranial access, has brought interventional neuroradiologists, neurologists and neurosurgeons to the forefront of physicians performing emergent and urgent carotid revascularization. Neurologists have further contributed to this progress, advancing the multifaceted treatments to prevent stroke and its consequences. The result of this progression is a cadre of physicians from multiple specialties who manage atherosclerotic carotid bifurcation disease with expertise. Accordingly, in spite of claims to the contrary, no single specialty can claim primacy of this disease state. In summary, improving treatment of carotid artery disease does not belong to any one specialty. Patients have benefitted - and will continue to benefit - from the involvement of a wide variety of dedicated professionals who demonstrate competency in treating patients and a commitment to improving care and outcomes.

As the originators of the request for reconsideration of the National Coverage Decision (NCD) on CAS, the MSCA has read with interest the many comments submitted by the variety of interested parties and stakeholders in this space. We are heartened by the overwhelming support for the thoughtful Centers for Medicare & Medicaid Services’ (CMS) proposal from colleagues of all specialties and professional societies, including the American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), the AANS/CNS Cerebrovascular Section, the Society of NeuroInterventional Surgery (SNIS), the Society of Vascular and Interventional Neurology (SVIN), the Society of Interventional Radiology (SIR), the Society for Vascular Medicine (SVM), the Society for Cardiovascular Angiography & Interventions (SCAI), the American College of Cardiology (ACC), the American Heart Association (AHA), the American Academy of Neurology (AAN), the VIVA Foundation (VIVA), the Neurocritical Care Society (NCS), and the Neurohospitalist Society (NHS), as well as the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA).

In the comments describing objections to the Proposed Decision Memo, we have identified several consistent themes, which generally address the following five topics:

1. The comparison between clinical evidence regarding CEA and CAS
2. The need to require participation in a national registry as a condition of coverage for CAS
3. Requirements for the use of use of validated shared decision-making (SDM) tool
4. Waiting for CREST-2 study data for CAS coverage to be expanded
5. The potential for inappropriate procedures done by inexperienced operators

We address each of these topics and the concerns raised by other commenters below.

1. Clinical evidence supports equipoise between CEA and CAS

The MSCA strongly disagrees with the commenters who have argued that the clinical evidence does not support equipoise between CEA and CAS. The argument that there is a lack of evidence supporting CAS as a proven and reasonable alternative to CEA is as patently wrong as it is tiresome. Frankly, that a group of physicians championing TCAR (which lacks a single randomized patient) and CEA (which has developed no comparative data on high surgical risk populations) would contend that the extent and voluminous clinical evidence for CAS in the modern era (i.e., using embolic protection, appropriate patient selection, etc.) is somehow inadequate makes it even more specious, and smacks of protectionism. The MSCA appreciates that CMS has based this Proposed Decision Memo on repeated Level 1 evidence from landmark randomized controlled trials (RCT) reporting results in >8,000 patients in multiple trials over the past decade (CREST, ACT 1, SPACE 2, ACST 2), all with consistent results demonstrating parity with endarterectomy—and no randomized trial in this era that did NOT show non-inferiority. It is also inappropriate, and opportunistic, to focus on the results of older studies (EVA3S, ICSS, SPACE, and any meta-analyses from the Carotid Trialists Collaborative or others that includes these studies), which are widely discredited as flawed in both design and conduct.

The four major randomized trials completed since the last NCD (CREST, ACT 1, SPACE 2, ACST 2) were all powered to specifically assess a composite endpoint—which was chosen because estimates of the rates of the individual components (death, stroke, and myocardial infarction) were so low and the expected difference between CAS and CEA outcomes was so small that only could a combined endpoint result in a realistic trial size. As previously described, all of these large, well-conducted trials showed no difference in the composite endpoint between CAS and CEA. While these were all landmark trials, vetted by the reviewers and editors of such venerable publications as The New England Journal of Medicine (CREST and ACT 1) and the Lancet (ACST-2), none was designed nor adequately powered to do subset analyses of the individual components of the composite endpoints. Any attempt to do so violates the statistical premise on which these trials were designed.

While stroke rates in all carotid procedures continue to improve, and are now uniformly in the low single digits, objections that CAS causes more overall stroke than CEA misses the fact that these are numerically very small differences driven by minor stroke, that major stroke (and death) rates are NOT different between the therapies, and that the minor strokes that occur in both groups are usually resolved without any deficit within 30 days. Omitted from many of the posted comments is the balanced observation that in the CREST Trial, myocardial infarction rates were twice as high in the CEA cohort as compared to the CAS cohort, and that myocardial infarction was associated with a profound increase in long-term mortality out to four years. Certainly there are opportunities for improvement in all interventions, including medical therapy; however, this is not a justification to exclude one proven therapy in favor of another.

The most recent carotid stent data from the Crest 2 registry (which parenthetically enrolled a substantial percentage of high-risk patients), data that are well vetted and adjudicated, demonstrated a 30-day stroke rate of 1.4% in asymptomatic patients, and 2.8% in symptomatic patients. These remarkable results from a wide variety of operators, in predominantly high-risk and fairly sick patients that did not qualify for a Crest 2 randomization, demonstrate that CAS is performed extremely safely and effectively in the contemporary era. Additional technological improvements will continue to enhance results. We are well on our way to stroke and death rates less than 1%. Indeed, many of us believe that the results will be superior to CEA at some point in the near future.

Comments posing objections to CAS with reference to non-randomized observational data, including claims data that are unvalidated, in the face of much more robust data from randomized controlled trials fail to acknowledge the value of level 1 evidence supporting CAS.

Comments regarding TCAR as a preferred alternative to CAS are prima facie invalid as this technology has never been randomly compared in an adequately powered long-term trial to either CAS or CEA. Relying on real-world evidence to benchmark CAS versus either TCAR or CEA is flawed as the requirements to perform CAS has created a high-risk, non-surgical cohort of patients that prohibits comparison to patients who would qualify for other treatment strategies (CAS and/or CEA). Treatment selection and outcome ascertainment biases in these comparisons are insurmountable. To be clear, MSCA agrees with inclusion of TCAR as a type of stent procedure, albeit with a different access, and supports coverage as described in the Proposed Decision Memo.

2. Participation in a national registry no longer should be required as a condition of coverage for CAS

Some commenters have argued that participation in a mandated registry should be required as a condition of coverage for CAS. MSCA strongly disagrees. TCAR data collection on individual patients is currently mandated for coverage by CMS. This Coverage with Evidence Development (CED) has been justified given the lack of any randomized data to date. In contrast, beyond the substantial data set from RCT’s of almost 8000 patients, over 50,000 CAS outcomes have already been reported from prospective, neurologically audited, post-market surveillance studies. Remarkably, while these registry data were primarily in high surgical risk patients, the outcomes achieved or exceeded AHA guidelines set for standard surgical risk patients – something never prospectively demonstrated by CEA before.

Additionally, more than 8,000 patients have been enrolled in the CREST-2 Registry, which represents a contemporary series. The outcomes from the first 2,219 procedures, performed by 187 interventionalists in 98 sites representing a wide variety of specialists, were published in 2019 and showed a very low 2% combined (standard and high surgical risk, symptomatic and asymptomatic) stroke rate: 45% of these predominantly high-risk patients were symptomatic, and the stroke rate among these patients was 2.8%. The stroke rate amongst asymptomatic patients was only 1.4%. In the TCAR Roadster 2 registry of 692 patients, the 30-day stroke rate in symptomatic patients was 4.4%. Despite comments to the contrary, published results of CAS have improved significantly over 20+ years resulting in equipoise in randomized trials, and these improvements are specifically tied to greater access with CMS coverage of registry activity. [1]

At this stage, centralized data collection is not warranted as a condition of coverage for CAS, given the maturity of the procedure and the foundational and favorable RCT comparisons to CEA, a procedure which does not require data collection as a condition of coverage. Moreover, concerns regarding “generalizability,” quality, and overutilization will not be assuaged by mandatory participation in a national registry. All quality and appropriateness oversight (of CEA, of TCAR, of CAS) is managed at a hospital/local level through peer review and credentialing processes. Registries cannot eliminate selection or ascertainment bias, cannot provide consistent data on long-term outcomes, and importantly do not have an enforcement function. In most cases, the data are self-reported. Perhaps more to the point, participation in registries has not been shown in any statistically valid study to improve quality or outcomes.

In conclusion, while we strongly support ongoing and future research on CAS and other carotid artery disease treatments, the evidence strongly supports CMS’s proposal to expand coverage for CAS without requiring participation in a centralized registry as a condition.

3. CMS should require practitioners to document a formal SDM interaction in the medical record, but should not require use of a validated SDM tool or that SDM be performed only by a physician who can perform all possible treatment options

MSCA agrees with CMS that a formal SDM interaction is necessary due to the “importance of individual patient anatomy, pathophysiology, and preferences, and as CAS and CEA entail different procedural (30-day) risks.” We strongly support the four elements that CMS proposes to be included in the SDM interaction, and in particular, we support the emphasis on patient-specific factors, such as the patient’s clinical condition and personal preferences, instead of one-size-fits-all criteria based on age.

Because there unfortunately are currently no validated SDM tools for this procedure, we urge CMS to use another option to ensure that SDM takes place. Rather than delaying patient access to CAS until an SDM tool can be developed and validated, we recommend that CMS require physicians to document the SDM interaction, which includes the four elements CMS identifies, in the medical record. This interaction should be individualized for each patient and document the clinical and non-clinical factors that were used to make the treatment decision. This approach would be consistent with the approach that CMS has taken in other national coverage analyses where CMS declined to require use of an SDM tool when there were no fully developed tools for the procedure at the time of the decision. [2]

MSCA believes strongly that individual physicians who offer CAS or any intervention for carotid artery disease should be fully cognizant of the indications; the alternative treatment options and the outcomes, risks, and benefits of each; and the current evidence and guidelines pertaining to that intervention. As is the case with those who perform other interventional procedures (for example, percutaneous coronary intervention), treating physicians are quite capable of fully informing patients and implementing shared decision-making regarding the patient’s medical choices regardless of whether they render all the treatments available. It is reasonable for surgeons who currently perform CEA, but do not perform CAS, to proceed with CEA after fully informing patients of their options with an SDM interaction, but without mandating interaction with a CAS operator. The same standard should apply to a CAS operator who does not perform CEA but is thorough and balanced in their SDM interaction with the patient. Mandating distinct interactions with different types of specialists would unnecessarily burden patients and delay care, particularly in rural and underserved areas.

That said, we strongly encourage a multidisciplinary approach to the diagnosis and treatment of our patients, consistent with European Society for Vascular Surgery recommendations. But we do not believe mandating the participation of specific types of providers in the SDM interaction as a condition of coverage for CAS is in the best interest of patients.

4. Clinical evidence is sufficient to expand coverage for CAS as CMS proposes today; waiting to do so until CREST-2 study results are available is not necessary

The MSCA believes that optimized medical therapy is the cornerstone of treatment for patients with atherosclerotic bifurcation carotid disease. We are strong supporters and proponents of the CREST-2 study, serving as investigators and on various national committees to assist in its management and conduct, and our members are committed to the completion of the trial. But we do not believe the coverage expansion should be delayed until the completion of the study for several reasons, which we describe below.

First, the CREST-2 study is not powered to compare outcomes between CEA and CAS; in fact, the National Heart, Lung, and Blood Institute (NHLBI) currently considers the two modalities equivalent. The results of the separate comparisons to medical therapy will determine the management of the asymptomatic patient going forward. If medical therapy proves superior in CREST-2, very few patients with asymptomatic carotid stenosis will undergo revascularization (CEA, CAS, or TCAR) as a first-line therapy. But until the long-term results of CREST 2 are known, likely in five or more years, the impact of modern medical therapy relative to CEA and CAS is entirely speculative and does not negate the results of prior RCT (e.g., Asymptomatic Carotid Atherosclerosis Study (ACAS), Asymptomatic Carotid Surgery Trial (ACST-1)) outcomes in the contemporary care of these patients.

Second, MSCA’s request to reconsider the NCD pertains only to patients deemed appropriate for revascularization. Those who are not appropriate for revascularization should be treated with optimal medical therapy. Regardless of the results of the CREST-2 study, there will continue to be patients deemed appropriate for revascularization, and those patients should have access to all options that have been proven to be safe, effective, and essentially equivalent based on the evidence provided from large RCTs.

While we eagerly await the CREST-2 results, MSCA believes it would be inappropriate to delay the coverage decision, and Medicare beneficiary coverage to CAS, until the study has been completed.

5. If coverage is expanded, other protections are in place to ensure that inappropriate procedures will not be performed by inexperienced operators

The MSCA agrees with comments emphasizing the need for appropriate training and patient selection in all modalities—CEA, CAS and TCAR—to optimize patient outcomes. We agree with many commenters who assert that, for some patients, one modality will likely be preferred, based on comorbidities, anatomy, and patient choice. In some instances, CAS is the optimal choice, and in others, CEA or TCAR. Most patients would likely have comparable results from any of these three treatment modalities.

We believe that the availability of Medicare coverage for all three treatment modalities ultimately will improve patient choice and overall outcomes. Comments that suggest that CAS should never be a choice for any individual patient, and that carotid artery disease should only be treated through one or two modalities fail to account for existing research described in depth above and in our request for reconsideration of the NCD.

The same applies to comments demonizing cardiologists and other practitioners as reckless clinicians. The vilification of a particular specialty as in the often-referenced New York Times article is misleading and has no place in serious health policy discourse and is entirely irrelevant to carotid artery revascularization. Physicians, like all humanity, are not immune to misconduct. However, the potential for misuse or overuse of elective surgeries is shared across all medical specialties. Moreover, no one specialty is uniquely qualified to care for all aspects of every patient with carotid artery disease. At our best we collaborate across specialties to provide the best possible care to our patients and use institutional peer review, credentialing, and societal guidelines to hold ourselves and our colleagues to higher standards.

Summary

Patients deserve access to all proven approaches to revascularization; similarly, they should expect high quality performance and optimal outcomes, regardless of specialty or modality chosen. Indeed, included in MSCA’s mission to broaden access to CAS is a commitment to educate and inform patients and providers, to promote training, and to improve results for all carotid procedures. MSCA intends to spearhead initiatives to enhance operator skillsets and to provide quality assurance tools for clinicians and hospitals. While we urge CMS to finalize an NCD that does not require use of a validated SDM tool, we recognize the benefits such a tool would offer to patients, their families, and physicians. MSCA is uniquely positioned to develop such a tool, and we look forward to working with CMS to put a validated tool into practice. We welcome all stakeholders, including clinicians from all specialties, to join MSCA in this endeavor.

The Multispecialty Carotid Alliance (MSCA)
- Thomas Brott, MD, Neurology, Mayo Clinic, Jacksonville, FL
- Daniel G. Clair, MD, Vascular Surgery, Vanderbilt University Medical Center, Nashville, TN
- William Gray, MD, Interventional Cardiology, Lankenau Heart, Main Line Health, Wynnewood, PA
- Donald Heck, MD, Interventional Neuroradiology, Triad Radiology Associations, Novant Health Forsyth Medical Center, Winston-Salem, NC
- Tudor Jovin, MD, Interventional Neurology, Cooper University Healthcare, Camden, NJ
- Sean Lyden, MD, Vascular Surgery, Cleveland Clinic, Cleveland, OH
- Chris Metzger, MD, Interventional Cardiology, Ballad Health CVA Heart & Vascular, Kingsport, TN
- Kenneth Rosenfield, MD, Interventional Cardiology and Vascular Medicine, Massachusetts General Hospital, Boston, MA
- Gary Roubin, MD, Interventional Cardiology, Chair of CREST2 Interventional Management Committee
- Ravish Sachar, MD, Interventional Cardiology, UNC-Rex Healthcare, Raleigh, NC
- Adnan Siddiqui, MD, Neurosurgery, Jacobs Institute, SUNY at Buffalo & Kaleida Health, Buffalo, NY
- Christopher White, MD, Interventional Cardiology, Ochsner Clinical School, University of Queensland, Australia and Ochsner Medical Center, New Orleans, LA

[1] Gray WA, Verta P. The Impact of Regulatory Approval and Medicare Coverage on Outcomes of Carotid Stenting. Catheter Cardiovasc Interv. 2014 Jun 1;83(7):1158-66.

[2] See, e.g., Decision Memo, Artificial Hearts and Related Devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00453N), Dec. 1, 2020, at section VII, https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=298&ncacaldoctype=all&status=all&sortBy=status&bc=17; Decision Memo, Transcatheter Mitral Valve Repair (CAG-00438R), Jan. 19, 2021, at section VIII, https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=297&ncacaldoctype=all&status=all&sortBy=status&bc=17; Decision Memo, Transcatheter Aortic Valve Replacement (CAG-00430R), June 21, 2019, at section VII, https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=293&ncacaldoctype=all&status=all&sortBy=status&bc=17.

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Regarding our earlier comments entitled:

'Why the United States Centers for Medicare & MedicAID Services (CMS) Should Still Not Extend Reimbursement Indications for Carotid Artery Angioplasty/Stenting or Other Carotid Artery ‘Revascularisation’ Procedures'.

We have 3 more expert collaborators who would like to be co-signatories with respect to the submission named above. These are:

Tim Stokes (Consumer Representative & Survivor of Stroke Misdiagnosis, Australia)
Kaitlyn Lillemoe (Neurologist, United States of America)
Mohamad AbdalKader (Interventional Neuroradiologist, United States of America)

That makes 88 total co-signatories (so far) for this August 2023 multinational, multispecialty, multidisciplinary evidence review and policy advice for US Medicare.

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To: Administrator Chiquita Brooks-LaSure
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Baltimore, MD

Date: August 10, 2023

Re: Feedback on the Proposed Decision Memo for PTA of the Carotid Artery with Stenting; CAG-00085R8

Dear Administrator Brooks-LaSure,

I am a vascular specialist and a member of the AHA, SVS, and Michigan society of vascular surgery an esteemed body dedicated to advancing vascular health through education, advocacy, and research. I wish to share our perspective on the proposed decision memo concerning NCD 20.7, specifically the Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting.

Safety Concerns:

My primary concern revolves around patient safety. Data from Medicare claims indicates a significant prevalence of carotid artery stenosis among beneficiaries. However, recent data suggests that the risk of perioperative stroke is notably higher for CAS when compared to CEA. we have found this to be true in our BMC2 Registry. The BMC2 Cardiovascular Consortium is a collaborative consortium of health care providers dedicated to improving quality of care and outcomes for cardiovascular patients across the State of Michigan. Consistently over the past decade of collecting data from both transfemoral carotid stenting ( TFCS) and carotid endarterectomy ( CEA) the risk of stroke has been statistically higher in TFCS. this is with the current model of TFCS being performed under strict supervision of registries and trials

Timing of the Decision:

While I recognize the effort to update and refine medical procedures, I believe it's crucial to await the results of the ongoing CREST-2 trial. This trial, funded by NINDS, promises to provide pivotal Level 1 evidence that could influence the treatment of asymptomatic carotid artery disease.

Impact on the Elderly:

Historical studies, including those from CAPTURE-2 and CREST, have consistently shown that elderly patients face inferior outcomes with TF-CAS. Given the significant elderly population among Medicare beneficiaries, this is a pressing concern.

Recommendations:

I urge CMS to:

1- Clearly define the term "Qualified Physician" and establish robust competency standards.
2-Make sure it is a “team” decision that the patient receives adequate counseling about conservative therapy ( which the CREST 2 may very well establish as best care) stenting and surgery.
3- Collaborate with stakeholders, including SVS, AHA, SVM, SNS, and others to develop these standards.
4- Reconsider the decision in light of the forthcoming CREST-2 trial results.

In conclusion, while I appreciate the intent behind the proposed changes, I believe that a more cautious approach, grounded in comprehensive data and collaborative decision-making, will best serve the interests of patients. Especially delaying the decision until after the landmark CREST -2 trial.

For any further discussions or clarifications, please feel free to reach out to me.

Warm regards,
Loay Kabbani MD
lkabban1@hfhs.org

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Current requirements for monitoring quality and safety of carotid stenting are critical in protecting patients, particularly in treatment of asymptomatic carotid disease. The proposed coverage expansion, rather than reducing bureaucratic hurdles for physicians, paves the way for a procedure with higher risks of stroke and death [1] to be employed with less scrutiny by providers which may not be able to adequately offer a full range of carotid treatment interventions. The coverage changes additionally appear unnecessary and premature with a large NIH-funded randomized trial of carotid interventions vs current standards of best medical therapy for asymptomatic disease (the CREST-2 trial [2]) not yet completed.

I do not believe there is sufficient evidence to support coverage expansion of carotid artery stenting beyond high surgical risk individuals and fear removing facility standards and approval requirements will lead to fewer protections for patients from potential procedural harm in carotid stenting care. However, if the agency moves forward with coverage expansion, I agree with the Society for Vascular Surgery’s suggestions to further revise and clarify the following aspects:

1. 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.
2. 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.
and
3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Again, the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and poses a threat to patient safety.

References;

1. Müller MD, Lyrer P, Brown MM, Bonati LH. Carotid artery stenting versus endarterectomy for treatment of carotid artery stenosis. Cochrane Database Syst Rev. 2020 Feb 25;2(2):CD000515. doi: 10.1002/14651858.CD000515.pub5. PMID: 32096559; PMCID: PMC7041119.

2. Brott, T, Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2), ClinicalTrials.gov ID NCT02089217, https://clinicaltrials.gov/study/NCT02089217 updated 6/29/23

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The proposed NCD reconsideration on carotid artery stenting (CAS) and the current decision to support this exposes many patients to a significant elevation in stroke risk.
Although the request of NCD reconsideration is generalized for all carotid stenting, and the supporting evidence provided by the requesting group involves all forms of carotid artery stenting, the undeniable data on the risks of carotid artery stenting with respect to stroke is highly dependent on the modality of delivery, i.e. whether the stent is placed via transfemoral means versus via transcarotid with surgical cutdown.

Again, the positive outcomes of carotid stenting that have been provided are largely driven by transcarotid artery stenting (TCAR) and not by the transfemoral approach, which, consistently has been shown to have double the risk of perioperative stroke even in the hands of chosen "experts" selected for the various national and international studies.

Once the coverage is extended to all forms of carotid artery stenting without any requirements for reporting and without any ability to enforce "shared decision making," given that many providers performing transfemoral carotid artery stenting do not have the ability to provide carotid endarterectomy or TCAR, the number of patients who would suffer perioperative stroke would double. This is proven, consistently, through multiple studies that are provided by even the authors proposing the NCD reconsideration.

I implore that the terms of coverage not be changed. The proposed change will have direct and damaging impact on patients resulting in an increased number of people suffering from periprocedural strokes that can be avoided.

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I am writing to you at this time to express my deepest concerns in regards to the proposed coverage expansion relating to NCD 20.7. I do think that there are several concerns as related to the proposed decision, which do need to be discussed and considered in the strongest sense.

#1 - The proposed decision to change the requirements for carotid artery intervention completely disregards years of meaningful data obtained through major trials such as NASCET, ACAS and CREST. Collectively, these trials have provided us with excellent data in regards to understanding which patients with what degree of stenosis is important for us to target for intervention. This would include no significant benefit in patients with symptomatic disease <70% and via subset analysis of asymptomatic patients those with <80% lesions.

#2 - The proposed decision ignores the strong data and thus conclusions obtained from CREST-1, which confirms the high stroke risk with transfemoral carotid artery stenting as opposed to carotid endarterectomy measured at 4.1% vs. 2.3% respectively. Thus, as a result of the proposed coverage expansion, we will likely be exposing more patients to a higher risk of procedural strokes.
- Stenting vs. Endarterectomy for Treatment of Carotid-Artery Stenosis https://www.nejm.org/doi/full/10.1056/nejmoa0912321

#3 - From the SVS Quality Initiative Assessment, it has been shown that transfemoral carotid artery stenting (TFCAS) has a higher stroke risk when compared to transcarotid angioplasty and stenting (TCAR). So again, we are ignoring strong data regarding the potential higher procedural risk associated with TFCAS with the proposed changes.
- Transcarotid artery revascularization versus transfemoral carotid artery stenting in the Society for Vascular Surgery Quality Initiative https://www.jvascsurg.org/article/S0741-5214%2818%2931054-1/fulltext

#4 - I do believe that the proposed coverage expansion recommendations are also premature as we are still collecting strong data in the CREST-II and Roadster trials (which remain open) regarding the benefit of carotid artery angioplasty and stenting as related to CEA along with the long-term benefit of medical management in these patients.

I submit the following recommendations/ solutions for consideration from the committee.

#1 - At minimum, allow the CREST-II trial to finish before any proposed changes are considered and certainly implemented.

#2 - Leave in place the requirements for operator training and certification before one can begin doing these procedures along with the facility requirements and tracking. This would allow a thorough review of ones qualifications before they begin and while they continue to do them through the years without causing harm to the community by an ill qualified interventionalist or institution.

#3 - As the ACC and SVS have joined to pool all of their data and quality assessments via VQI, allow this entity to continue to serve as the main hub for tracking outcomes and primary data assessment reporting directly to CMS in the future.

#4 – Leave in place the current indications for intervention, which is for greater than or equal to 70% stenosis in symptomatic patients and greater than or equal to 80% stenosis for asymptomatic patients.

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I would like to take this opportunity to thank you for your review of the current literature, evaluation and willingness to update the current guidelines regarding carotid stenting. I am a physician who performs carotid stenting and have seen the impact it has had in my patients lives, some of whom are alive and doing well 10 to 15 years after having undergone this procedure. I support this decision and ask that you finalize the proposal to expand coverage to asymptomatic patients with stenosis greater than 70% and symptomatic patients with stenosis greater than 50%.. I also support decision allowing MAC's to determine whether to cover carotid stents for other patients, to remove requirements for patients to participate in clinical trials, and to remove facility standard and approval requirements.

While I agree that physicians should enter a discussion of all the options regarding treatments, risks and benefits, of all modes of carotid revascularization, I would encourage you to avoid any delays in coverage of carotid stenting while the development of a validated shared decision making tool is being developed which could take years.

Lastly, I believe that mandating either CTA or MRA after carotid duplex ultrasound prior to carotid angiography will add cost, time and in the case of CTA, radiation and the potential for contrast induced nephropathy and should be left to the discretion of the physician.

Thank you.

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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 stunting. I feel that transfemoral stenting has a role in carotid stenosis. However, on the whole, our threshold to intervene on asymptomatic disease has only increased as medical therapy advances. In our own practice we target a threshold of >80% for asymptomatic patients for any intervention (CEA, CAS or TCAR). Why are we expanding intervention for patients who are more frequently being offered medical therapy?

Furthermore, we have access to high-fidelity quality registries to be able to track outcomes following carotid intervention. To date these registries (Vascular Quality Initiative) have been able to track outcomes across all three modalities mentioned above. With that they have demonstrated excellent safety of CEA for most patients, but also allowed for new technologies to be studied in formats outside standard clinical trials (TCAR). If TF-CAS if felt to have equivalent outcomes in carotid stenosis, then surely no harm can come of tracking that data in a quality registry. The safety of our patients depends on it!

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I appreciate the Centers for Medicare and Medicaid Services Coverage Advisory Group thoughtful analysis and proposal of expanded coverage for NCD20.7 percutaneous carotid artery stenting. As a vascular surgeon who performs all three treatment arms to treat carotid stenosis, I respectfully disagree with conclusions provided in the decision memo for the following reasons:

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

Thank you for your consideration.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

The MSCA is not interdisciplinary and does not reflect the majority consensus represented by the Society of Vascular Surgery.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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First, I would like to commend CMS for their very thoughtful and thorough review of the extensive and rigorous data regarding carotid artery stenting in the National Coverage Decision determination. This subspecialty- agnostic, balanced review of data will be the best way to make the correct decision on the matter. This has been many, many years in the making.

The opinions and thoughts that I express are those of a carotid stent operator and researcher with over 20 years of experience. I have been blessed to have a beautiful collaborative relationship with many of the leaders in Neurology, Vascular surgery, Interventional Radiology, Vascular Medicine, Neurosurgery, Neuro -interventional Radiology, and Interventional Cardiology. I/We have participated in many and most of the landmark research trials in this space, and in fact have been the leading enroll site of several of these (ACT 1, SAPPHIRE WW, PERFORMANCE 2, C-GUARDIANS, etc.), and we are actively enrolling in the randomized CREST 2 trial. We approach each patient with a multi-disciplinary, balanced approach and a careful individualized assessment of the risks and benefits of each treatment option for the patient, and then carefully have an informed discussion with the patient and the family. The opinions below are based on this longstanding experience as well as review of the data including that carefully reviewed by CMS. They are not a self-serving opinion, and also not a territorial “cut and pasted” opinion (which represents an easily recognizable theme throughout the public comments posted).

If one looks at the totality of the data in an un-biased fashion, CMS beneficiaries clearly deserve access to transfemoral carotid stenting as an option to their care. As carefully reviewed and provided by CMS, there are now five randomized controlled clinical trials with long-term follow-up showing that carotid stenting is equivalent to carotid endarterectomy. Additionally, there are more than 50,000 patients in prospective registry and IDE trials with independent neurologic adjudication showing safe and durable results for carotid stenting. By definition, the registry and IDE patients were high risk for carotid endarterectomy and still had good results. Many have argued that there was an excess of minor strokes with transfemoral stenting compared to carotid endarterectomy in randomized trials, which was correct, however that signal has not been seen in the latest trials. There is no difference in major strokes or death between the two therapies. Furthermore, carotid artery stenting has significantly less myocardial infarctions, cranial nerve injuries, or hospital length of stay compared to carotid endarterectomy. Both therapies have excellent and equivalent durability, with outstanding and equal patency long-term in published randomized data (CREST 10-year data, ACT 1 5- year data, both published in the New England Journal of Medicine) and duplicated in the most recent trials. Additionally, the carotid stent results continue to improve reflecting advances in technology and in patient selection and operator technique. There are very low stroke rates seen of 1.6% overall in CAS patients treated with proximal embolic protection which further improves outcomes (Robert Bersin, MD meta-analysis of more than 2300 trial patients treated with this technology). The contemporary CREST 2 registry data in more than 2000 patients shows 2% or less stroke or death rate with the majority of these being minor strokes. European data and other data suggest further improvements with newer technologies including micro-mesh carotid stents and novel “3-in-1” incorporated carotid stent design which include a 2nd filter with 40-micron poor size. These 2 technologies have just completed large scale prospective pivotal IDE trials in the U.S. as well. Both carotid endarterectomy and carotid stenting have equivalent and excellent safe, durable technologies which are complementary to Medicare beneficiaries, with specific advantages for both technologies over the other therapy in individual patient and anatomy subsets.

Within the public comments, I note many “declarations” of the superiority of surgical therapy including TCAR. However, endarterectomy is equivalent as discussed and reviewed in detail with randomized data. No such superiority declaration can be made for TCAR. One cannot declare a strategy “superior” in any scientific fashion in the absence of data simply by stating it repeatedly and loudly. TCAR has not had any randomized comparisons against any other strategy including transfemoral stenting. Furthermore, there has been no long-term data with this technology, with the potential for common carotid artery injury with surgical instrumentation and sheath placement which may not be seen in the short-term follow-up to date. The only data for this technology is subject to inherent potential bias, with two pivotal trials being industry sponsored by the maker of the technology, and often reported as a “per protocol analysis” rather than intention to treat. The only other data is that from a self-reported VQI database with retrospective review which clearly does not have the rigor of randomized control trials or prospective trials with independent neurologic education.

I believe that carotid artery disease should be treated with a collaborative, multi-disciplinary approach. All strategies discussed, including carotid endarterectomy, TCAR, and transfemoral stenting when performed correctly in the right patient offer unique potential therapies to Medicare patients. Optimized medical therapy should be a part of all revascularization strategies and is clearly the best solo treatment for many patients. I am disappointed by clear-cut territorial statements made by too many vascular surgeons that “they” are the “only” operators who should handle carotid artery disease to any extent. Many of these are the same individuals who stated that there would be “never” a role for stenting, but now advocate that this is the best strategy as part of a TCAR strategy, even with the open cell stent utilized and perhaps an inexperienced stenter performing the procedure. This exclusivity has been clearly expressed recently in the “SVS response” to the New York times article viewed by many. Too often this carotid coverage decision is somehow conflated with negative comments regarding atherectomy or inappropriate procedures, and these non-related subjects are somehow attributed to the non-vascular surgery subspecialties only. While this opinion does not reflect (I hope) the opinion of the majority of the vascular surgeons who treat this disease with excellence, too often recent surgical statements are disrespectful to many other individuals and subspecialties who have been leaders in this field for quite some time, and who themselves perform their consultations and procedures conscientiously and in the best interest of their patients.

While I agree and applied the CMS paper, there are 2 areas which need mild adjustment. I completely agree with the idea of “shared decision making” being applied to every patient. However, and very importantly, as CMS points out, there is not a currently “validated” such tool. To “require” this would only further delay appropriate access to carotid stenting. Furthermore, despite the lack of evidence for TCAR described above, no such tool was applied to that technology or to carotid endarterectomy, or many other interventional decision-making processes. I would instead require appropriate, individualized documentation of the decision-making process for each patient, and the documented discussion with the patient and family of treatment options. It would be very counterproductive to require a 2nd specialty consultation, as this would delay therapy, increase cost, and often lead to patient confusion an additional territorial issue. No 2nd specialty consultation is required for carotid endarterectomy or TCAR even for patients who have been at high risk for carotid endarterectomy. Instead, all of us should use a multi-disciplinary approach in the best interest of each patient after careful review.

The 2nd point to review would be requirements for MRA or CTA in every patient. We all want to avoid a move towards “carotid angiography and possible stent” scenario in the absence of noninvasive data. All patients should have a full consultation performed and noninvasive imaging. Carotid duplex will likely be performed in all patients. CTA or MRA assessment of the aortic arch would be the 2nd step before carotid stenting in the majority patients. However, for patients with a relative contraindication for MRA or CT angiogram (example significant renal insufficiency, cost issues, etc.) that are well documented, carotid duplex could be coupled with arch aortography and conventional angiography for clear-cut relative contraindications to CTA.

In summary, I completely agree with the CMS expansion to allow access for CMS patients for carotid artery stenting in asymptomatic patients greater than 70% or symptomatic patients greater than 50% after appropriate noninvasive imaging, and well documented shared decision-making discussions with the patient and family.

I hope that all of us can use a multi-disciplinary, collaborative, patient centered approach that incorporates optimized medical therapy and the choice of the best revascularization strategy for patients who would also benefit from revascularization.

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These are data from the original CREST trial:

The 4-year rate of stroke or death was 6.4% with stenting and 4.7% with endarterectomy (hazard ratio, 1.50; P=0.03); the rates among symptomatic patients were 8.0% and 6.4% (hazard ratio, 1.37; P=0.14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P=0.07), respectively. Periprocedural rates of individual components of the end points differed between the stenting group and the endarterectomy group: for death (0.7% vs. 0.3%, P=0.18), for stroke (4.1% vs. 2.3%, P=0.01), and for myocardial infarction (1.1% vs. 2.3%, P=0.03). After this period, the incidences of ipsilateral stroke with stenting and with endarterectomy were similarly low (2.0% and 2.4%, respectively; P=0.85).

doi: 10.1016/j.jvs.2012.09.014. Epub 2012 Dec 20.

In other words there was no reason to approve CAS for use in either high risk or low risk subjects with regard to the endpoints of death or stroke. CAS should not have been approved then and since then the results with regard to stroke or death in various trials have almost always favored CEA. Before this procedure is turned loose for treatment of asymptomatic patients, why not at least wait for the results of CREST II. Once approved there will be no turning back on policy and there is no turning back for those with stroke or death. Caution is in order.

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I am a practicing vascular/interventional radiologist and neurointerventional surgeon with training and experience in carotid revascularization including during acute stroke intervention.

I support the decision to expand coverage for PTA with concurrent carotid artery stenting (CAS) to include individuals of standard surgical risk, patients with symptomatic carotid artery stenosis =50%, and patients with asymptomatic carotid artery stenosis =70%.

Patients deserve the choice of treatment options based on evidence-based medicine and patient-specific factors. Overall data support CAS in both symptomatic and asymptomatic patients. Multiple randomized trials with a total of 8000 patients have shown equivalence between CEA and CAS at 30 days, 1 year, 5 years, and 10 years.

There are no randomized controlled trials evaluating transcarotid artery revascularization (TCAR) and no high-quality study of TCAR has yet been performed so this must be considered.

I agree that shared decision-making (SDM) tools can be effective in facilitating a two-way conversation between patient and physician, incorporating patient preference and best available evidence (Elwyn 2010). Therefore, the use of SDM in the discussion around potential intervention for carotid artery stenosis seems appropriate. However, there currently exists no standardized nor validated SDM tool for management of carotid artery disease so greater clarification regarding the intended tool is needed. Specifically, any tool used is subject to unintended bias in its synthesis of the evidence, thus warranting review and validation by the multiple medical specialty societies representing the physicians who intend to use it.

I am against the proposed requirement of independent neurologic assessment before and after CAS. A neurological examination as part of the clinical assessment is well within the scope and standard of care of a physician involved in carotid revascularization.

I believe that cross-sectional imaging with CTA or MRA after carotid duplex ultrasound demonstrating significant carotid stenosis should be at the physician’s discretion.

Finally, carotid angiography remains the gold standard for assessment of carotid stenosis. In scenarios where invasive angiography is performed as part of stenosis evaluation (e.g. after discrepant non-invasive imaging results), concomitant CAS should be allowed if indicated.

Thank you for your consideration.

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I appreciate CMS for an incredibly thorough and critical review of the literature and data, and for a very well crafted/detailed proposed decision

I ENDORSE the expansion of coverage to include standard surgical risk patients, including asymptomatic pts with >70% and symptomatic patients >50% stenosis

We all look forward to results from the CREST 2 trial, which is still years away, but this is not relevant to the current decision and should not influence it.

Expanding coverage for CAS, as is proposed, will simply enable Medicare patients who are ALREADY deemed appropriate for revascularization to select amongst all the various options. CREST 2 seeks to define who is appropriate for revasc and who is not. The decision will not be relevant for those who do not need revascularization.

Thank you for allowing comment.

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I am extremely concerned regarding the potential adoption of NCD 20.7. Not only is it 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 safe guards needed to allow for all inclusive TF CAS. TF CAS is not a procedure that can be widely implemented without safeguards in place. The procedure is extremely complex, most notably in identifying potential complications and avoiding at risk situations. Certainly TF CAS has a role to play in the high risk patient population, but TF CAS is a high risk procedure that should not be wholly approved without safeguards in place. There are many patients that are at high risk for TF CAS, and those high risk criteria are not widely reported nor are they easily recognized. I can assure you that if TF CAS is allowed as presented in the NCD 20.7, there will be many patients harmed and the costs to our healthcare system will be enormous. I will again reiterate that there is a place for TF CAS, but it is not appropriate to unleash this procedure without surveillance, scrutiny and needed oversight. At a minimum, all TF CAS procedures should be required to be placed in a qualified registry with at least one year follow up. With such a provision, we can actually analyze and capture the real world data of such an implementation. Should there be evidence of risk > benefit, corrective actions could be implemented. Moms, Dads, Brothers and Sisters are in the cross hairs of this potential decision and I am glad that comments such as mine can be recorded and retrospectively reviewed. The proposed NCD 20.7, as it sits today, is putting our families, our patients, our communities and our healthcare system at risk. Flag it.

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I have been practicing vascular surgery for 50 years and have performed many cea, tfcas, and tcar for treatment of carotid artery disease. In my own experience and in observing others and reviewing the scientific literature as it develops, I have concluded that transfemoral stenting is the least safe of the three procedures. Yes, very experienced and talented individuals can perform tfcas safely. But the number of tfcas procedures in the seven hospitals in which our group practices has dropped dramatically. This means that in our community few individuals are gaining experience with tfcas.

By incentivizing interventionalists to perform tfcas with minimal regulation and requirements, cms is inviting real serious patient safety risks.

CMS has also recommended lowering the criterion for treating asymptomatic patients from the usually accepted 80% to 70%. I see scores of patients each year with 70% lesions in whom I would not recommend an intervention. I realize that this distinction is a bit arbitrary, but the change may result in subjecting asymptomatic patients to an unacceptable risk of stroke.
In discussing this proposal with an experienced and talented cardiology colleague recently, he sent me an email that stated, "now maybe our procedural volume will increase".
Is that what CMS desires, an increase in cath lab procedures performed by physicians with minimal experience with tfcas?

Respectfully submitted.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

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We strongly urge the Centers for Medicare & Medicaid Services to not implement the proposed changes to the coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting as they are dangerous for patients. There is no evidence on which to base changes such as: 1) allowing asymptomatic patients to receive the procedure outside of clinical trials at lower percentages of stenosis, 2) removing the requirements for high surgical risk and 3) removing all facility and operator requirements. These changes are not in the best interests of beneficiaries as they will expose beneficiaries to unnecessary risks and subject them to increased risk of stroke and other adverse events.

Carotid Artery Stenting (CAS) for Asymptomatic Patients Should Be Conditioned on Evidence-Backed Indications

Covering CAS for asymptomatic beneficiaries with stenosis greater than or equal to 70% not at high surgical risk is a significant change to current policy that should only be made if supported by equivalently compelling evidence; however, there is no evidence to support this change. In fact, in 2021, the United States Preventative Services Task Force reaffirmed their D rating for CAS for asymptomatic patients, determining that “the harms of surgical interventions compared with appropriate medical therapy appear to outweigh the benefits” and recommending against screening for carotid artery stenosis in asymptomatic patients. The ACST-2 trial did not show that CAS is equivalent or noninferior to carotid endarterectomy (CEA); instead, the 30-day risk of non-disabling strokes was significantly higher for CAS than CEA. Furthermore, there is an ongoing CREST-2 trial, which will compare CAS and CEA to intensive medical management. This is a high-quality randomized trial carefully designed to answer the question of which treatment is best for carotid stenosis – medical therapy, CAS or CEA. The proposed change in CMS coverage prior to completion of this trial would be premature, and dangerous. Additionally, it would severely jeopardize enrollment in this trial, which is still recruiting. Based on past experience with patent foramen ovale trials using atrial septal occluder devices and other procedures, when there is coverage (reimbursement) for procedures, doctors are extremely reluctant to enroll patients in a randomized trial often due to financial incentives. For this important reason, and as the existing National Coverage Determination already allows for asymptomatic patients to receive care in an appropriate setting—clinical trials—the proposed change is premature and should be abandoned.

CAS for Symptomatic Patients at Standard Surgical Risk is not Reasonable, Necessary, or Safe for Medicare Beneficiaries

There is not sufficient evidence for the Medicare population that CAS has better or equivalent outcomes to CEA for symptomatic patients at standard surgical risk. According to the latest available data, 86% percent of Medicare beneficiaries are over 65, and the two largest, most recent randomized controlled trials do not show that CAS is better for patients over 70 years old. In fact, in the CREST trial, CEA had better primary point outcomes for patients over 70 years old. While the mean age in the ICSS trial was 70, the trial was not powered to determine effects by age or any other subgroup. Furthermore, the report on the 10-year outcomes of the ICSS trial concluded that the trial provides evidence that CAS can be offered as a durable procedure for patients younger than 70 years old, as they are at similar or reduced risk for procedure-related stroke.

Furthermore, the reduction in the stenosis percentage requirement from greater than or equal to 70% to greater than or equal to 50% is not supported by the current evidence. As noted in the Proposed Decision Memo, the evidence for symptomatic patients with stenosis of 50%-69% from the CREST and ICSS trials is weaker than that of patients with stenosis of at least 70%. While it is suggested that formal patient-doctor shared decision making (SDM) may best address the impact of differences in patient characteristics, this process is not sufficient as a validated SDM tool does not exist.

Evidence Used in Proposed Change Does Not Represent the Medicare Population

The lack of gender and racial diversity in the trials used for this proposed change does not reflect Medicare population, and therefore their results are not generalizable to the Medicare population. According to the latest data, 55% of Medicare beneficiaries are female, and 27% are non-white. In contrast, the majority of the studies contributing evidence to these proposed changes did not report racial distributions, and in those that did, the vast majority of participants (90-93%) were white. Similarly, the highest percentage of female participants was 40%. This is a recurring issue not limited to this proposed change; our past research has shown that Medicare beneficiaries differ significantly from the participants in cardiovascular clinical trials relied upon for Medicare coverage decisions.

Facility and Operator Requirements Should Not Be Removed

The randomized control trials that form the basis for these proposed changes had requirements for operators. Then any policy that relies on the outcomes of these trials should also incorporate, to the fullest extent possible, the facility and operator requirements of the trials. Instead, however, the proposed change completely removes any facility and operator requirements. This is even more concerning given that research has shown higher mortality among lower volume operators. Consequently, we strongly recommend that CMS does not remove these requirements that are crucial for patient safety.

Rita F. Redberg, MD, MSc
Sanket S. Dhruva, MD, MHS
Sarah Bitter, BS, MA

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I support this proposed decision memo for stent to be as standard treatment option of 1) symptomatic carotid stenosis >50% stenosis 2) asymptomatic carotid stenosis > 70%

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Regarding our earlier comments entitled:

'Why the United States Centers for Medicare & MedicAID Services (CMS) Should Still Not Extend Reimbursement Indications for Carotid Artery Angioplasty/Stenting or Other Carotid Artery ‘Revascularisation’ Procedures'.

We have 4 more globally recognised experts in carotid arterial disease management and research who would like to be co-signatories with respect to the submission named above. These are:

Henning Eckstein (Vascular Surgeon, Germany)
Robert Chang (Vascular Surgeon, United States of America)
Jonathan Cardella (Vascular Surgeon, United States of America)
Caitlin Hicks (Vascular Surgeon, United States of America)

That makes 85 total co-signatories (so far) for this August 2023 multinational, multispecialty, multidisciplinary expert evidence review and policy advice for US Medicare.

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August 10, 2023

The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting; CAG-00085R8

Dear Administrator Brooks-LaSure:

The University of Connecticut Healthcare System has greater than 450 physicians in more than 50 subspecialities and is responsible for the clinical care of the citizens of the state, as well as conducting biomedical research and medical education.

Currently the Centers for Medicare & Medicaid Services (CMS) has a National Coverage Determination (NCD 20.7) for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. Section B4 of the NCD covers PTA of the carotid artery concurrent with the placement of a Food and Drug Administration (FDA) approved carotid stent with embolic protection for:

1. Patients at high risk for carotid endarterectomy (CEA) with symptomatic carotid artery stenosis = 70%
2. Patients at high risk for CEA with symptomatic carotid artery stenosis between 50 and 70% in accordance with the Category B Investigational Device Exemption (IDE) clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (NCD 310.1), or in accordance with the NCD on carotid artery stenting (CAS) post-approval studies (NCD 20.7, B3)
3. Patients at high risk for CEA with asymptomatic carotid artery stenosis = 80% in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (NCD 310.1), or in accordance with the NCD on CAS post-approval studies (NCD 20.7, B3)

CMS released on July 11, 2023, a proposed decision memo regarding its reconsideration of NCD20.7, which outlined the following modifications in coverage for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting:

1, Expanding coverage to individuals previously only eligible for coverage in clinical trials.
2. Expanding coverage to standard surgical risk individuals by removing the limitation of coverage to only high surgical risk individuals.
3. Removing facility standards and approval requirements.
4. Adding formal shared decision-making with the individual prior to furnishing CAS.
5. Allowing MAC discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.

As an institution in reviewing this information with our experts in Vascular Surgery, Vascular Medicine, Neurology, Interventional Neurology, Interventional Cardiology, and Interventional Radiology, we are concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. We respectfully request that CMS reconsider their position. We present our concerns and recommendations before CMS considers finalizing any updates to NCD 20.7.

Recommendation 1. 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 Transfemoral Carotid Artery Stent Registry is a CMS-approved prospective study, and it is utilized by clinicians to obtain reimbursement for transcarotid artery revascularization procedures. Both the transcarotid artery revascularization and transfemoral carotid artery stent registries contain more than 250 patient- and procedure-specific variables and in-hospital outcome data from more than 280 centers and 1000 physicians in the United States and Canada. Additionally, 30-day and 1-year mortality rates are determined through linkage to the Social Security Death Index. Carotid revascularization procedures in this registry were performed by vascular surgeons, cardiologists, neurosurgeons, general surgeons, neurologists, and radiologists. Patients with asymptomatic or symptomatic carotid disease were eligible for carotid stenting.

The Society for Vascular Surgery and the Patients Safety Organization which oversees the Vascular Quality Initiative believe the ongoing collection of real-world data to assess the clinical impact and safety of the CMS coverage decision is imperative. There are more than 1000 centers, including the University of Connecticut Health Science Center, across the United States and Canada participate and enter data into the VQI CEA/CAS registries. This registry captures the procedures, outcomes and one year follow up. This tool allows for ongoing real-world collection of data which will allow physicians responsible for performing these procedures to continue to monitor outcomes and make appropriate recommendations when changes may need to be made to improve patient outcomes.

Without continuing this form of procedural monitoring, this will allow unopposed utilization of this procedure. It can be predicted, from previous literature, that increasing number of physicians performing this procedure at a low annual rate, gradually through positive and negative outcomes (the learning curve) will those individuals finally overcome their struggle to reach appropriate annual numbers. But through this process there will be less than optimal result for Medicare beneficiaries as well as increase in cost for increased length of stay, increase hospital costs and increase in support services.

Recommendation 2. 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 an integral component that allows individuals with their physician to develop a carotid treatment plan that supports their valises and wishes. There is limited data available with respect to a validated tool to assist in the decision process. Since the development and FDA approval of transcarotid stenting (TCAR: the primary modality of placing carotid stents from the transcarotid approach). This technique has introduced subtle nuances into the decision-making process that requires guidance through decision and understanding. Specifically, TCAR has demonstrated through clinical trials and the use of datasets that TCAR appears to have a lower perioperative risk of stroke than transfemoral carotid stenting (TF-CAS) and has a faster recovery than carotid endarterectomy (CEA).Although, long term data is still being collected for TCARs use with respect to durability or expected rates of stroke, it requires full understanding of the different treatment modalities and the challenges associated with them. Again, a validated decision-making tool would assist in determining the best medical treatment between CEA, transfemoral carotid stenting (TF-CAS) and TCAR; however, none to date are available. Until such a time decision making will continue to rest upon the physician and the individual patient.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

The definition of a qualified physician is a physician with demonstrated competency in PTA of the carotid artery concurrent with stenting and who has staff privileges to perform PTA of the carotid concurrent with stenting in a hospital that participates in the Medicare program.

Several societies have published statements with respect to training and credentialling a physician who may perform CAS. The most recent one in 2015 (SCAI/SVM expert consensus statement on Carotid Stenting: Training and credentialing for Carotid Stenting) All societies involved in carotid stenting have suggested that all standard training pathways toward competency in CAS. The first pathway is a traditional Accreditation Council for Graduate Medical Education (ACGME)-certified residency or fellowship program (e.g., interventional cardiology, interventional radiology or neuroradiology, interventional neurosurgery, or vascular surgery) that offers a specific curriculum in CAS, in conjunction with peripheral interventional training. The second pathway applies to practicing physicians who have completed their formal training and are acquiring CAS training once in clinical practice. Both pathways include preparation for CAS training, elements of competency, Industry sponsored device certification, use of simulation and tracking outcomes.

To maintain high quality outcomes, it will be imperative that all CAS programs based on physician and institutional outcomes, should maintain a clearly delineated process for initial credentialing and re-credentialing of operators for CAS privileges. Maintenance of CAS privileges should rely on CAS volume, outcomes, and other quality metrics (e.g. conference attendance and continuing medical education credits). It has been highly recommended that institutions performing CAS participate in at least one national registry, such as the NCDR Peripheral Vascular Interventions (NCDR-PVI) or SVS Vascular Quality Initiative (SVS-VQI) database, to ensure consistent reporting and for bench marking.

The University of Connecticut Healthcare System believes that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is hasty and jeopardizes patient safety. If, however, the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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The outstanidng planned CMS changes below:

"Expand coverage to include CAS for standard surgical risk patients"
"Remove facility standards and approval requirements for CAS"
"Implement a requirement for a formal shared decision-making (SDM) interaction with the patient prior to CAS"

-Are vital for inclusive, patient-centered care of those patients with significant carotid disease. Carotid stenting has a clear role in managing a subset of carotid patients.
- This new policy will help patients make the best decision for themselves.

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I applaud CMS for a thorough and thoughtful analysis of the extensive body of clinical evidence and the public comments from healthcare professionals regarding carotid artery interventions.
Also, the Society of Vascular Medicine (SVM) strongly supports CMS’s proposal to update the patient selection criteria in the National Coverage Determination (NCD) to mirror results from this clinical research and to parallel existing access to carotid endarterectomy (CEA) by expanding coverage to include patients at standard surgical risk, patients with symptomatic carotid artery stenosis of at least 50%, and patients with asymptomatic carotid artery stenosis of at least 70%. SVM further supports CMS’s proposal to permit determination of facility and operator requirements through hospital credentialling processes and based on medical society guidelines, similar to requirements in place for other well-established interventional procedures.

Regarding the proposed imaging requirements, SVM recommends some modifications to the language in the proposal to reflect the current standard of care and needs of certain patients. In limited cases, additional magnetic resonance angiography (MRA) and computed tomography angiography (CTA) imaging may be contraindicated for a variety of reasons such as chronic or acute kidney disease or in patients with pacemakers. We do not recommend intra-arterial digital subtraction (catheter) angiography for first-line imaging, but it may be necessary for further imaging of carotid stenosis when there is (1) a significant discrepancy between non-invasive imaging results, (2) clinical contraindications to non-invasive imaging, or (3) a clinical need for additional information to inform optimal patient care.

With advances in technology and techniques, physicians can now perform selective angiography with an exceptionally low risk of complications.^1,2 Appropriate patient selection is paramount to achieving optimal outcomes for patients and their families and is applicable to all treatment options, including medical management, transfemoral CAS, transradial CAS, Transcarotid Artery Revascularization (TCAR), and carotid endarterectomy (CEA). SVM supports a shared decision-making (SDM) interaction with all patients that includes the four core elements outlined by CMS:

The Vascular InterVentional Advances (VIVA) Foundation is a not-for-profit, multidisciplinary organization dedicated to advancing the field of vascular medicine and intervention through education, research, advocacy, and collaboration. Our mission includes providing the premier education in vascular medicine and intervention to improve patient care within the peripheral vascular arena. We have a strong background in carotid artery disease and have held a Vascular Leaders Forum on Carotid Artery disease in 2019. The comprehensive management of atherosclerotic vascular disease, including diagnosis, medical therapy, revascularization, and follow up is standard practice for the community of clinicians who organize and participate in our meetings. Because we seek to ensure the highest quality of patient care and actively seek to improve it through education, research, and advocacy, we have a strong interest ensuring that a Medicare coverage policy for carotid artery stenting aligns with the multiple randomized controlled trials and current technology for the management of carotid artery disease.

VIVA strongly endorses updating NCD 20.7 to broaden the access of Medicare beneficiaries to PTA and carotid artery stenting and to remove the facility and operator requirements. The current paradigm does not permit clinicians to use the therapy best suited for their patients and renders surgery as the only therapy available in this setting. This limitation in potential therapies does not reflect the significant innovation and randomized controlled trials that have published since that time. Indeed, four RCTs have shown clinical equivalence between carotid artery stenting and carotid endarterectomy in broad asymptomatic populations 1-4. As a result of these randomized trials, performed in the United States and abroad, we support CMMS decision to update the patient selection criteria in the NCD to reflect the results of the extensive body of clinical research. We do not see how other types of evidence such as claims data, registries, or epidemiologic surveys, all lesser forms of testing medical therapies, can invalidate or diminish randomized controlled trials. We advocate changes in coverage on the basis of only the highest levels of evidence.

Concerning the current proposed coverage determination has three new requirements: a) through the use of noninvasive study to ensure best tool selection based on arterial anatomy b) thorough neurological evaluation and c) thorough shared decision making. These last two require refinement for implementation for routine application. In particular, shared decision making with the patient to understand all of the options is critical. In the absence of an existing validated SDM tool, coverage should not be withheld and creation and validation of a SDM tool is an urgent need. The endorsement for team-based care that involves multiple specialties is a model for all of vascular disease, as no one specialty may provide care for all aspects of any problem. Indeed, multispecialty care that places the patient at the center is the mission of VIVA.

We look forward to working with you to provide to expand access of Medicare beneficiaries to this widely studied, proved, and performed procedure. Should we be able to provide additional information or assist with any questions, please don’t hesitate to contact our Executive Director, Ms. Rebecca Hall at rhall@viva-foundation.org or 888-513-VIVA.

Sincerely,

Joshua A. Beckman, MD, MS
Immediate Past President
The VIVA Foundation

References:

1. Silver FL, Mackey A, Clark WM, Brooks W, Timaran CH, Chiu D, Goldstein LB, Meschia JF, Ferguson RD, Moore WS, et al. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2011;42:675-680. doi: 10.1161/STROKEAHA.110.610212
2. Rosenfield K, Matsumura JS, Chaturvedi S, Riles T, Ansel GM, Metzger DC, Wechsler L, Jaff MR, Gray W, Investigators AI. Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis. N Engl J Med. 2016;374:1011-1020. doi: 10.1056/NEJMoa1515706
3. Halliday A, Bulbulia R, Bonati LH, Chester J, Cradduck-Bamford A, Peto R, Pan H, Group A-C. Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy. Lancet. 2021;398:1065-1073. doi: 10.1016/S0140-6736(21)01910-3
4. Reiff T, Eckstein HH, Mansmann U, Jansen O, Fraedrich G, Mudra H, Bockler D, Bohm M, Bruckmann H, Debus ES, et al. Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2. International journal of stroke : official journal of the International Stroke Society. 2019;15:1747493019833017. doi: 10.1177/1747493019833017

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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Carotid artery stenting is and has been a safe alternative to carotid endarterectomy. Outcomes are easily found in a number of randomized trials.

TCAR (the surgical placement of a stent in the carotid artery) is actually quite more invasive and there is no good evidence to suggest it is safer or has better longterm outcomes. It actually requires riskier general anesthesia and requires two surgical incisions (one in the going and one in the neck) increasing risk of infection and adjacent tissue damage. If surgical placement of a stent is accepted and promoted, why would a percutaneous option with loads more supportive data not be accepted? It might be because the SVS *Society for Vascular Sugery" is playing politics and supporting a turf-war of sorts against practitioners in other subspecialties for the treatment of carotid artery stenosis. Does not CMS exist to see through these issues in support of patient care and access?

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I am a vascular surgeon in practicing at Upstate Medical University and the VA Medical Center in Syracuse, New York for the last 19 years. I am writing to express my support for the recommendations expressed in the memo from the Society for Vascular Surgery on the Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting; CAG-00085R8. There appears to be strong evidence that transfemoral carotid stenting has several drawbacks including a steeper and longer learning curve and a higher rate of neurologic events compared to transcervical carotid artery angioplasty and stenting. I am also concerned about the lack of any provision in the proposed changes for defining a qualified proceduralists and requiring the use of a registry to track patient outcomes. As a vascular surgeon and member of the Society of Vascular Surgery, I am committed to caring for patients with vascular disease based on evidence proven interventions that maximize patient benefit and minimize patient risk. I am writing to express my concern that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is not supported by the current available evidence and jeopardizes patient safety.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Based upon the clearest of data out of the Crest trial, and other trials, there was clear data the reveals that carotid artery stenting is associated with higher stroke rates then the previous gold standard of carotid endarterectomy. The only carotid stent procedure that has come out with stroke risk at least equivalent to CEA, is TCAR, based upon real world registry data such as out of the VQI. Previously the only "brake" that has been present to keep carotid interventions at least to a standard and to try to minimize risks to pts has been the high risk category, and the fact that CAS required certain facility minimum standards and credentialing standards. If most or all of these criteria are dissolved, the potential for WIDE OPEN carotid stenting with increased stroke risks as born out by the trials, by any vascular specialist, without particular training, in facilities that don't meet the important standards previously set, becomes all too real. Given the stroke risks of nearly double for trans-femoral CAS compared to CEA and TCAR, we are opening many patients to the potential of strokes that didn't have to happen, if these important "brakes" and "pauses" are removed. In addition it seems even more pertinent with the recent publication by the NY times regarding the overuse of vascular interventions, that we at least consider what the ramifications of potential OVERUSE of carotid interventions might look like. Certainly no one would argue that a stroke is not more deleterious to patient's than limb loss.

I believe that continuing the current cautionary holds and brakes on facility standards and credentialing standards as previously designed and in the NCD, as well continuing to keep CAS assigned to patient who are high risk for either of the two other procedures which have considerable better track record on stroke complications (CEA and TCAR) is warranted. But if some or all of the standards are removed from the NCD, I would say based upon the need for caution and patient safety that the following recommendations be considered.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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As a cardiologist who refers patients with carotid artery disease for appropriate management, I would like to express my support for this NCA proposal and convey that I am impressed by the careful review of the clinical trial evidence base on this topic. Based on my own review of the evidence, I would support the proposed expansion of coverage for CAS to include standard surgical risk patients, including asymptomatic carotid patients with >70% lesion stenosis and symptomatic patients with >50% lesion stenosis. I further support that facility and operator requirements be eliminated, in favor of enforcing hospitals to be accountable for quality oversight and monitoring, in accordance with professional society guidelines and third-party accreditation, as is standard for most procedures. I believe that participation in national registries is valuable, but would not feel that it should be mandated specifically for these procedures, since that again is not a national requirement for other procedures. I certainly agree with and endorse the support for shared decision-making, so that patients are aware of ALL the available options for treatment, including their potential benefits, advantages, disadvantages, and risks, and the recommendation that the SDM interaction be documented in the medical record. Since there is no “validated tool” for SDM, and no such standard exists for other procedures, it would seem reasonable to allow that standard documentation of an SDM conversation in the medical record would be adequate. I would likewise caution that it seems inappropriate in the NCA to require endorsement, prior to performing a carotid artery procedure, from another party or parties, such as a vascular surgeon having to sign off on an interventional radiologist or cardiologist, or vice versa. I certainly endorse that expanding coverage for CAS, as is proposed, is supported by current evidence and should enable Medicare patients who are deemed appropriate for revascularization to select amongst all the various and evidence-based options available to them by qualified operators.

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As a vascular specialist with formal fellowship training in both vascular surgery and interventional radiology with over 20 years of experience performing carotid endarterectomy (CEA), transfemoral carotid stenting (tfCAS), and TCAR I am deeply concerned that the Proposed National Coverage Determination for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting dated July 11, 2023 will result in inappropriate treatment and harm to Medicare patients with carotid artery disease.

This proposal:

-Will expand CMS coverage for tfCAS outside of clinical trials.
- Will remove facility standards and approval requirements
-Does not require registry participation or reporting of outcomes
- Requires the use of a “validated shared decision-making tool.”

Currently, there is no level 1 evidence that supports the use of tf-CAS over CEA or TCAR or medical management to support this decision. Moreover, the evidence from clinical trials cited in the proposed NCD clearly shows a higher 30-day incidence of stroke after tfCAS compared to either CEA or TCAR. There is an ongoing NIH funded clinical trial (CREST-2; https://clinicaltrials.gov/study/NCT02089217) that would provide Level 1 evidence towards this question, so the timing of this proposed NCD seems premature.

I am an early adopter of tfCAS and have significant experience performing tfCAS, but based upon both my personal experience and the published evidence I am convinced that both CEA and TCAR have less stroke risk than tfCAS. I currently offer tfCAS only to patients who are high risk for both CEA and TCAR. While there is a role for tfCAS, it should be limited until there are technical and procedural improvements and level 1 evidence supporting more widespread use.

There is a significant learning curve with tfCAS, and low-volume operators have clearly been shown in clinical trials and registries to have higher stroke rates, which highlights the importance of proper credentialing and following outcomes (especially for low-volume operators). However, credentialling and outcome reporting for tfCAS is not required in the proposed NCD. Registry reporting is a current requirement for TCAR and expanding tfCAS with requiring outcome reporting will lead to potential unchecked harm to Medicare beneficiaries. Moreover, the recent New York Times and ProPublica articles (https://propublica.org/article/maryland-dormu-minimally-invasive-vascular-medicare-medicaid https://nytimes.com/2023/07/15/health/atherectomy-peripheral-artery-disease.html) highlight the potential unintended consequences of patient harm when vascular procedures are performed without appropriate oversight or regulation.

Finally, inclusion of a shared decision requirement in the proposed NCD is confusing and premature. The memo requires use of a “validated shared decision-making tool” while also acknowledging that no such tool exists. While I am a strong supporter of shared decision-making and this is a laudatory goal of CMS, a tool first needs to be developed and validated before it is required by a NCD.

In conclusion, I am extremely concerned that adoption of this proposed NCD as written will result in unintended harm to Medicare patients. I urge CMS to reconsider and if there is a decision to expand coverage for tfCAS it must first be justified by new level 1 evidence demonstrating comparable safety of tfCAS to both TCAR and CEA. In addition, expanded coverage for tfCAS should also require registry participation and mandatory outcome reporting.

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Patients should be presented with all available treatment options as they have the right to make choices and decisions about the type and extent of medical care that they would want.

Multiple RCTs have shown equivalence between CEA and CAS at 30-days, 1-year, 5-years, and 10-years. No randomized trial of TCAR has been performed to date.

There is favorable data supporting CAS in patients who are symptomatic as well as asymptomatic.

The patient and physician discussion should be comprehensive and this should be documented in the medical record including all treatment options (types of revascularization), specific risks, benefits, and alternatives. There is no need for a formal shared decision making tool as no clear guidelines are present for its validation.

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I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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I have been a vascular surgeon for over 20 years and perform tfCAS, TCAR and CEA with excellent results. In the past four years, TCAR has largely replaced transfemoral carotid stenting in my practice because of its better safety profile while still offering a less invasive option. Despite the trials of tfCAS which were carefully designed with only expert operators, well past their learning curve, there is very clear registry data (the real world) that clearly shows a higher procedural stroke risk with tfCAS especially in the medicare population (>73yrs of age). This data should be a continued caution before unleashing tfCAS on patients at the hands of inexperienced, overzealous proceduralists. Furthermore, doing this and then turning a blind eye to quality, by eliminating any credentialing oversight and outcomes monitoring, is irresponsible and will result in harm to these patients. The margin for carotid artery treatments in asymptomatic patients is very slim and requires careful patient selection and an equipoise in the available treatment options including best medical therapy for the majority of asymptomatic patients. CREST data will be important to inform the role of BMT in the care of these patients and would help to revise the current NCD. This will require significant revision before we can honestly say that this is in the best interest of our patients.

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I am a neurointerventionalist who performs carotid artery stenting. I am grateful to hear that CMS has reviewed the recent clinical literature about this procedure for an update to treatment.

Neuroendovascular treatment of carotid stenosis has already been shown to be as safe and effective as carotid endarterectomy for symptomatic carotid disease. I support expansion of this coverage proposal for carotid stenting for >50% symptomatic stenosis and >70% asymptomatic stenosis as is shown safe and beneficial by current literature. All factors should be considered when deciding upon stenting vs endarterectomy with clear discussion with the patient, which is in concordance with the proposed formal shared decision making interaction. However, development of such a mandatory "tool" will likely take years to finalize and all that is needed is honest discussion with the patient about all options for optimal treatment at the bedside or in the office visit. CTA or MRA requirement for CAS is recommended and I agree upon this point. However, in the event that CTA or MRA is contraindicated then DSA should be included as acceptable in the workup for CAS or CEA.

It is disingenuous of us to say to our patients that only one method of treatment is effective and safe. I am in support of this proposal as it will allow our patients to be more informed to make educated decisions about available treatments for carotid disease.

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I am a physician who sees patients with carotid artery disease, and refers and performs carotid revascularization (carotid stent procedures). Thank you for your thoughtful review of the evidence in this field. Despite our enrollment in both CREST-2 and the CREST-2 registry, the situation regarding reimbursement of carotid stenting procedures has proven very challenging for my patients, and in this light in particular your decision to revisit the current reimbursement decisions is very welcome.

It is my sincere hope that you will finalize several key components of the proposed decision:

Expanding coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence, and without requiring patients to participate in clinical trials or requiring external facility standard and approval requirements, and further allowing Medicare Administrative Contractors (MACs) to determine whether to cover carotid artery stenting for other patients.

I do however recommend that CMS revise two aspects of the proposed decision:

First, the proposal requires physicians to have a shared decision-making (SDM) interaction with patients, and advocates doing so with a validated SDM tool. To develop such a “validated tool” would take years. While SDM is essential to all discussions of procedures for our patients, I believe that waiting until such a tool is developed and validated would not be in the spirit of patient-oriented decision-making that has thankfully become more and more paramount in clinical decision-making these days.

One small revision would additionally be to allow use of catheter-based angiography for diagnostic/planning purposes when CTA/MRA are contraindicated.

Thank you again for your attention to this critical issue for our patients.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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I am a stroke neurologist that cares for patients with symptomatic carotid and asymptomatic carotid disease. Over the last few year, carotid stenting has become nearly the preferred choice for all symptomatic patients given its safety, feasibility and tolerability by our stroke patients. We perform nearly 100 patients per year with extremely low rate of complications in a very sick population. Those patient undergo this procedure in less than 45 minutes and under minimal local anesthesia and conscious sedation without teh need for intubation. Recovery is imminent and require less than 1 day of hospitalization when performed as elective procedure. I strongly believe that stent is the very best option for many of patients and in experience hands I have seen minimal risk and tremendous clinical benefit. Because of that I support passing along the proposed national CMS Medicare coverage determination specific to Percutaneous Transluminal Angioplasty of Carotid Artery Concurrent with Stenting due to the following reasons:

1. Patients deserve the choice of treatment options and stent has consistently shown great clinical outcomes in real world data.
2. Multiple randomized trials with a total of 8000 patients randomized have shown equivalence between CEA and CAS at 30 days, one year, 5 years, and 10 years. There hasn’t been a single randomized trial of TCAR.
3. Data support CAS in both symptomatic and asymptomatic patients.
4. There should not be a need for a formal validated shared decision making tool. There are no clear guidelines on how to make or validate such a tool. It should be sufficient to document that a comprehensive discussion occurred between the physician and patient that all patient specific risks, benefits, and alternatives were discussed, including the options of all three types of revascularization and medical therapy alone.

I hope this reason help to diminish the disparity that payment is creating among physicians an provide the opportunity to patient to benefit from a well established therapy.

Respectfully,

Dr. who wants the best options for his patients.

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Individual Comments Template:

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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August 10, 2023

Via electronic submission at https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=311

The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Hubert H. Humphrey Building, Room 445-G
200 Independence Avenue, S.W.
Washington, DC 20201

RE: National Coverage Determination (NCD) 20.7 - Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8)

Dear Administrator Brooks-LaSure,

The Federation of American Hospitals (FAH) is the national representative of more than 1,000 leading tax-paying hospitals and health systems throughout the United States. FAH members provide patients and communities with access to high-quality, affordable care in both urban and rural areas across 46 states, plus Washington, D.C. and Puerto Rico. Our members include teaching, acute, inpatient rehabilitation, behavioral health, and long-term care hospitals and provide a wide range of inpatient, ambulatory, post-acute, emergency, children’s, and cancer services.

The FAH appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) regarding proposed revisions to National Coverage Determination (NCD) 20.7 - Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8).

Generally, the FAH supports the proposed changes in the NCD that will allow coverage for more beneficiaries in need of carotid artery stenting. However, we have concerns with certain aspects of the proposed NCD and would urge CMS to make changes to the final NCD to ensure physicians can provide the care best suited for each patient, as we describe below.

Evaluation of the extent and severity of carotid artery stenosis (Section B.2.)

a. If duplex ultrasound is used as first-line imaging, computed tomography angiography or magnetic resonance angiography must also be performed to provide additional information about the aortic arch, and extra- and intra-cranial circulation, for better patient selection.

The FAH disagrees with this proposal and believes CMS should rely on physician decision-making to drive care decision related to evaluation of carotid artery stenosis. The decision on how to proceed after first line testing should be physician directed and also patient centered. In many cases Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) testing can be limited by regional expertise/resources and patient comorbidities such as renal dysfunction, claustrophobia and extensive vessel calcifications. This proposal may result in unnecessary testing and increased cost. Of greater concern, it could increase harm to patients by exposing them to potential unnecessary radiation and contrast exposure as well as lead to delays in care.

c. Intra-arterial digital subtraction (catheter) angiography must not be used for first-line imaging, and may be used only when there is significant discrepancy between non-invasive imaging results.

The FAH disagrees with this proposal and encourages CMS to remove this requirement. This requirement will prevent patients from having the option of diagnostic angiography and treatment in the same setting which may be necessary for some patients.

Prior to furnishing CAS, the practitioner must engage in a formal shared decision-making interaction with the beneficiary.

The FAH understands the value of physicians and patients actively engaging in shared decision-making and support efforts to include patients more actively in their care. However, since a validated shared decision-making tool is not currently available, we are concerned with the proposal to require the use of one and recommend that CMS allow medical record documentation to support that a formal shared decision-making visit occurred. In addition, to remain consistent with NCD 20.4, the FAH recommends that the visit occur between the patient and physician or a qualified non-physician provider (physician assistant, nurse practitioner, or clinical nurse specialist).

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The FAH appreciates the opportunity to offer comments on this NCD on carotid stenting. If you have any questions or would like to discuss further, please do not hesitate to contact me or a member of my staff at (202) 624-1534.

Sincerely,
Don May on behalf of Charles N. Kahn

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To: Centers for Medicare and Medicaid Services Coverage Advisory Group

Re: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting Decision Memo, CAG-00085R8

Regarding the reimbursement of carotid artery stenting, I would like to point out several comments:

? The CREST-1 trial had a detailed list of inclusion and exclusion criteria which makes the conclusions less generalizable for standard risk patients.
? Multiple retrospective and prospective studies have shown inferior results with transfemoral CAS (TFCAS) compared to CEA in terms of perioperative stroke.
? We need to wait for the CREST-2 trial to see if medical arm is superior or equivalent to revascularization before generalizing TFCAS for asymptomatic patients.
? Studies showing similarity of CEA and TFCAS in standard risk patients lack adequate statistical power and can not be used as a level I evidence.
? Multiple retrospective studies have shown that even in high risk patients, CEA is superior to TFCAS and generalizing TFCAS particularly to standard risk patients seem premature.
? Studies showing superiority of CEA to TFCAS, however; show that transcarotid artery stenting (TCAR) is equivalent to CEA even in high risk patients. These include:
? Age, in older ages, CEA is superior to TFCAS but TCAR shows acceptable results particularly in symptomatic patients (PMID: 34082003).
? Calcified carotid lesions, TCAR demonstrated favorable outcomes compared with TFCAS among patients with calcification greater than 50% of the carotid circumference (PMID: 34592377).
? Contralateral occlusion, TCAR has lower odds of in-hospital stroke or death compared to TFCAS, independent of symptomatic status. Compared to CEA, TCAR seems to be a better option in asymptomatic patients, with lower odds of in-hospital stroke (PMID: 33601006).
? Recent MI, TFCAS is associated with worse perioperative outcomes compared to CEA. However, TCAR shows outcomes similar to CEA(DOI: https://doi.org/10.1016/j.jvs.2023.03.186).
? Long carotid lesions, TCAR appears to be safer than TFCAS with regard to the risk of in-hospital stroke/death (PMID: 35835322)

Since the level I evidence regarding the use of TFCAS particularly in standard-risk patients is evolving, it seems that it is too premature to jump to approval of TFCAS even in high-risk patients and I would disagree with the decision memo.

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As the Chief of Heart and Vascular Services at UNC-REX Hospital in Raleigh, NC, I strongly support the well thought out and well researched CMS proposed decision memo to expand reimbursement for carotid artery stenting. Our cardiovascular service-line at UNC-REX consists of cardiology, vascular surgery, and cardiothoracic surgery, all working together as one team to take care of our patients. We approach all patients in a multi-disciplinary manner and understand that no one specialty can take care of all patients or disease states. In our experience, this collaborative approach has always resulted in optimal patient care. Whether a patient sees a vascular surgeon, interventional cardiologist, radiologist, or interventional neurologist, all available treatment options are discussed. There is no need to see another physician as each of these physicians are perfectly capable of explaining all available treatment options to their patients, with the attendant individualized nuances, risks, and benefits.

With more than 8000 patients included in randomized trials which have shown equipoise between CAS and CEA, and an additional >50,000 patients included in prospective registries, the preponderance of data support CAS as a treatment option for patients with carotid artery disease. Newer devices with improved embolic protection have shown promise to reduce the event rates even further.

I have personally taken care of patients with carotid artery disease for more than 2 decades and have performed more than 2000 carotid stent procedures. While some patients may be better suited for CEA, and some may be better suited for CAS, most patients will do equally well with both therapies. The truth is that transfemoral or transradial carotid artery stenting can be performed very safely and effectively in the vast majority of patients, just like carotid endarterectomy and TCAR. I have seen time and time again the disappointment that patients and their families experience when, despite going through a shared decision-making process, they are unable to choose what they feel is the best option for them. This results in multiple visits to various physicians, delays treatment, and increases the burden and cost for patients. I commend CMS for the extremely well researched and well thought out proposed decision memo as it will increase the choices available to Medicare constituents, improve access to care, and improve outcomes.

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Dear Madams and Sirs:

I am an interventional cardiologist who has been active in performing carotid artery stenting and was involved in some of the early research on protection of the brain during these procedures. I would like to thank the CMS for its thoughtful review of the current state of CAS and the literature supporting its use. It has become very clear over the past years that the procedure is well-suited to treatment of carotid disease when patients are properly chosen and that in these circumstances mid-term and long-term results are similar to those achieved with the more invasive surgical endarterectomy. (CREST ten year results and other studies).

For this reason and from my own experience with hundreds of such cases I would ask the CMS to finalize the decision to extend coverage for CAS to symptomatic patients with = 50% stenosis and asymptomatic patients with =70% stenosis without requiring patients to participate in clinical trials. Would also approve allowing Medicare Administrative Contractors to approve coverage of other patients (e.g.: patients with clear recurrent TIA and stenoses < 50% and an ulcerated plaque on imaging) on a case by case determination.

I agree that shared decision making is key to any process of choosing a therapeutic option for a patient, but would not delay this coverage decision until a structured SDM tool can be proposed and validated which would realistically take many years.

Although I understand the rationale for requiring CTA or MRA prior to direct catheter DSA for consideration of CAS, as it discourages "ad hoc" intervention and may also show anatomic constraints militating agains CAS, there will be cases in which the ultrasound is clear and there are contraindications for CTA (contrast load) or MRA (implants, gado allergy). In these cases I would waive any requirement for CTA or MRA prior to catheter angiography for consideration of CAS.

Sincerely,

James R. Wilentz MD, FACC, FAHA

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7. I agree in a mandated utilization of a standardized “Shared Decision Making” tool that would be designed in collaboration with applicable medical specialty societies and/or other relevant stakeholders. Consideration should be made to provide physicians with education about what tools are considered appropriate and how documentation should be performed. I also agree with the suggested revision to the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards. I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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National Center for Health Research Public Comment on Centers for Medicare & Medicaid Services Proposed Decision Memo: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting

Decision No: CAG-00085R8

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We appreciate the opportunity to comment and support CMS’s mission of ensuring Medicare beneficiaries receive quality, evidence-based medical care. We agree that CMS has an obligation to enact policies that are in the best interest of the population it serves and are based on robust scientific evidence. Thus, we strongly oppose CMS’s proposed decision: “Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting.” In this comment we review the science that supports our recommendation.

CMS’s draft decision expands reimbursement to patient populations that have not been shown to benefit from carotid artery revascularization over optimal medical treatment (OMT). Proposing to extend coverage to patients with asymptomatic carotid artery stenosis of at least 70% instead of 80%, or patients with symptomatic stenosis of at least 50% instead of 70% is not evidence-based and will lead to unnecessary procedures. One of the largest, best-quality, randomized clinical trials, the European Carotid Surgery Trial, showed a statistically significant six-fold reduction in strokes at 3-years for asymptomatic patients with >80% CAS who underwent a carotid endarterectomy (CEA) compared to OMT. In addition, the North American Symptomatic Carotid Trial showed a statistically significant three-fold stroke reduction at 2-years in symptomatic patients with >70% stenosis who underwent CEA compared to OMT. In contrast, a sub-analysis of this same study showed that symptomatic patients with 50-69% stenosis who underwent CEA had no significant benefit of stroke reduction at 5-years compared with OMT alone. Since expanding CMS coverage to include populations who are at lower risk of stroke is not supported by the most current, best-quality, evidence, we conclude that it will lead to unnecessary procedures that have long-term consequences and is likely to cause harm to patients.

Carotid artery stenting (CAS) has not been demonstrated as an equivalent, non-inferior, or superior treatment to CEA or OMT and has a high rate of periprocedural complications. The strongest, most-contemporary evidence comparing CAS to CEA or OMT does not suggest that CAS is equivalent, non-inferior, or superior to CEA or OMT. It is crucial to remember that if statistical significance is not reached when comparing two treatment modalities (i.e., CAS to CEA) it does not mean the options are equivalent or non-inferior, especially when the studies are underpowered. Non-inferiority is only determined when the difference between the two treatment modalities is insubstantial and a non-inferiority margin is referenced and clearly demonstrated. This is of critical importance when studies are underpowered (such as the SAPPHIRE, CREST, SPACE-2, ACT-1, and ASCT-2 trials) and reach an inconclusive outcome, as the actual difference might be statistically significant and clinically meaningful when adequately powered. The CREST-2 Trial may eventually provide evidence that better informs CMS’s decision on CAS as a noninferior treatment option to CEA. However, since the CREST-2 trial is ongoing, it would be irresponsible to expand coverage for an otherwise experimental procedure on a lower-risk stroke population using the preliminary data that are currently available.

The most current and highest-quality studies comparing CAS to CEA or OMT have major limitations and are not generalizable to the typical patient population with vascular disease. The major relevant studies comparing CAS to CEA or OMT use data from homogenous study populations where most are male and almost all are white (when race is described) and received treatment at well-resourced academic facilities. This homogeneity greatly limits the generalizability of study outcomes, and results should not be extrapolated to the typical patient population with vascular disease. Other serious flaws with the key relevant studies comparing CAS to CEA or OMT are worth noting. We have included a summary table of the highest-quality, contemporary, studies comparing CAS to CEA, or OMT and highlight the major findings, limitations, and complication rates identified in each study. We strongly advise CMS to review our summary table as we show there is truly a lack of evidence to support CAS as a non-inferior approach to CEA or OMT and further note the high complication rates of CAS.

CAS is associated with a significantly higher 30-day periprocedural risk of major complications compared to CEA. Severe complications including stroke, myocardial infarction, and death occur at rates nearly double that of CEA. These are life-threatening, life-altering complications that require extensive medical resources to treat and place a tremendous emotional and economic burden on patients and their families. Higher 30-day periprocedural complication rates of stroke or death among CAS patients are highlighted in our summary table of contemporary evidence and have also been reaffirmed in the Vascular Quality Initiative database (CEA: 1.4%, CAS: 2.6%) and Medicare database (CEA: 3.5% CAS: 5.1%)— these databases show a near doubled rate of periprocedural stroke or death among patients undergoing CAS.

The evidence comparing CAS to CEA or OMT is inconclusive, which is reaffirmed by the United States Preventative Services Task Force, which reviewed the major evidence comparing treatment modalities among asymptomatic patients and rated it grade D (i.e., low-quality, contradictory, and/or inconclusive). A major reason these studies yield inconclusive results, despite being randomized controlled trials is that they were inadequately designed for establishing equivalence or noninferiority. A margin for clinical noninferiority of CAS against CEA or OMT has only been calculated in two trials (Long-Term Results of SAPPHIRE and ACT-1), both of which were substantially underpowered. Further, these trials were performed in patients at either a high-operative risk (SAPPHIRE) or with severe carotid artery stenosis (ACT-1), not among the lower-risk stroke population for whom CMS is proposing to expand coverage. While the ACST-2 trial data were based on an intention to treat analysis, it showed that CAS had a significantly higher rate of non-disabling strokes at 30-days compared to CEA; therefore, it should not be considered non-inferior. Moreover, no studies have ever evaluated a margin for relative efficacy when CAS is compared to a reference treatment (i.e., OMT) in patients with moderate stenosis—yet this is the exact population for whom CMS is proposing to expand coverage.

CMS proposes that physicians engage in formal shared decision-making using a validated tool prior to offering CAS; unfortunately, no such tool exists. There is no standardized or validated shared decision-making tool for the management of carotid artery revascularization, and so this objective proposed by CMS cannot currently be met. And, since not all physicians practice every treatment modality (CAS, CEA, and OMT), this will often undermine the transparency and objectivity of shared decision-making discussions. Expanding coverage without a validated shared decision-making tool or clear evidence-based guidelines in place creates a framework prone to extreme bias. Until a shared decision-making tool for carotid artery revascularization is validated and evidence-based guidelines on revascularization options are clearly adopted, we strongly urge CMA to revise its draft decision. Without such infrastructure in place, this decision jeopardizes patient autonomy, introduces bias, and potentially harms patient care.

In summary, the NCHR is committed to policies that are based on robust scientific evidence and limit harm, and so we strongly oppose CMS’s draft decision: “Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting.” The major limitations of the key randomized controlled trials comparing CAS to CEA or OMT were insufficiently addressed in CMS’s draft decision. These studies are grossly underpowered, have homogeneous study populations that are not representative of most Medicare patients, and conflate inconclusive results with equivalence and noninferiority. CAS may be substantially inferior to CEA or OMT in an adequately powered study with set noninferiority margins. And, CAS has been repeatedly shown to have a significantly higher risk of periprocedural complications compared to CEA.

We urge CMS to revise its draft decision regarding PTA reimbursement to better reflect current scientific evidence. There is no evidence that CAS is a beneficial treatment over optimal medical (non-surgical) care in patients with moderate carotid artery stenosis, nor enough evidence to show that CAS is a noninferior treatment to CEA in patients with high grade stenosis. However, there are real documented dangers to CAS that impact patient morbidity, mortality, and increase the cost of medical care. Enacting a policy that does not conform to evidence-based guidelines or rely on a validated shared decision-making model for carotid artery revascularization jeopardizes patient care and is likely to harm patients.

Summary Table of the Highest-Quality Evidence Comparing CAS to CEA or OMT:

Long-Term Results of SAPPHIRE Trial

Major Findings:

I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

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As a vascular and endovascular surgeon, I am extremely concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is wrong-headed, premature and jeopardizes patient safety. The incidence of stroke in asymptomatic patients with carotid stenosis is extremely rare, especially when managed with appropriate medical therapy, and there is very little to justify expanding reimbursement for CAS, as suggested in this proposal. In an era of shrinking medical resources, it is also a very expensive undertaking, which will cause more harm than good.

I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7:

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however, the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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Hello, I'm reaching out to ask for your valuable support regarding a crucial decision being made by CMS concerning carotid stenting indications and coverage. In 2009, CMS assessed the National Coverage Decision (NCD), resulting in limited coverage for carotid stenting solely for high-risk patients, whether symptomatic or asymptomatic, who were at high risk for Carotid Endarterectomy (CEA). Presently, CMS is considering an expansion of coverage based on new evidence from four RCTs. The proposed changes are as follows:

- Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.

- Covering CAS for standard surgical risk patients.
- Covering CAS without requiring participation in clinical trials.
- Allowing Medicare Administrative Contractors (MACs) to determine coverage for patients not described in the proposed decision.
- Requiring formal shared decision-making (SDM) with the patient before the procedure

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As a practicing vascular surgeon and as chief of the Division of Vascular Surgery in a tertiary quaternary inner-city hospital, which cares for a large proportion of underserved patients, I am very concerned about the coverage expansion out in the CMS’ Proposed Decision Memo relating to NCD 20.7. The decision is premature, and has the potential to jeopardize patient safety, and erode the already fragile trust that the public has in the management of disease in the peripheral vasculature. We are already overwhelmed by the increasing public announcements of over-utilization and frankly fraud, that a small number of physicians treating patients with vascular disease have demonstrated, putting financial gain over patient care and outcomes, and thus eroding public trust in the medical establishment. This expansion will serve to open a pathway which has potential to lead to higher-risk inappropriate but billable care.

Within the State of Michigan, I have reviewed and presented our BMC2 data which, in this high-quality state registry, has demonstrated a significantly higher 30- day neurologic deficit with trans-femoral carotid artery stenting (TF-CAS) (6.62%) as compared to that of carotid endarterectomy (CEA) (4.2%) or trans-carotid artery revascularization (TCAR) (3.9%) as well as a significantly higher mortality with CAS when compared to either CEA or TCAR. This inferiority of TF-CAS has been consistently present in the findings when looking at registry outcomes nationally as well (VQI). With this information at hand (and the data and with the information that we hope to gain from the soon to be completed CREST 2 trial, I would respectfully submit the following recommendations:

1. 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. I would politely emphasize that data is everything in establishing our foundation for our decision- making process for dealing with symptomatic or asymptomatic carotid artery disease.
2. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards. As the majority of physicians performing transfemoral CAS perform less than 10 annually (Michigan BMC2 data) it is imperative to establish rigid standards for qualifications and credentialling based upon training, qualifications, and on-going reportable outcomes.

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I appreciate CMS for proposing an updated coverage policy for CAS based on the available evidence.

I fully support the specific elements proposed in this decision, including:

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It is commendable for CMS to propose an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

1) 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.

2) 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.

3) Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Numerous randomized control trials and retrospective analyses have demonstrated that transfemoral carotid stenting carries a significantly higher periprocedural stroke rate and should be reserved for a select group of patients, as current guidelines from the Society for Vascular Surgery recommend.

Patients should have care based on data that protects them from potential harm. The carotid interventions available (endarterectomy, transfemoral stenting, and transcarotid stenting with flow reversal) should not be considered equivalent. While each may have a place in care there is a higher risk for transfemoral stent procedures causing stroke, which is the main endpoint the interventions are aimed at preventing. Carotid endarterectomy and transcarotid stenting in real world data appear to be and in practice are safer, and lack of regulation will open up patients to higher risks and potentially unnecessary procedures and complications.

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As a vascular surgeon and clinical researcher, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. It makes no sense to me that you would change the current coverage rules to encourage more transfemoral carotid stenting when there is no level 1 evidence that supports its use over carotid endarterectomy. The published literature is clear that the 30-day stroke risk with transfemoral stenting is higher than trans-cervical stenting and endarterectomy. There is an ongoing NIH-funded trial (CREST-2) that compares medical management vs stenting vs open surgical management of carotid stenosis. It is premature to change your policies before this level 1 evidence is available. It is also very concerning to me that there is no requirement to participate in a quality registry (as there is with trans-cervical stenting) as this would be a good way to follow outcomes and to ensure that Medicare beneficiaries are not suffering from increased stroke rate. I respectfully request that CMS consider these concerns and the following recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

As an active member of the vascular community, I care deeply about the safety of patients with atherosclerosis and risk for cerebrovascular events, but I also recognize that not all treatments are equal and there is a risk that they will cause, not prevent stroke. 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 NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

Sincerely,
Dr. Katharine McGinigle, MD MPH

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As fellowship trained neurointerventional physicians, we collectively represent over 80 years of experience in treating patients with cerebrovascular disease, including carotid artery stenting. We are a comprehensive stroke center that serves 1.2 million people and admits over 1500 stroke patients and performs over 290 stroke interventions a year. Carotid artery stenting is a very important tool in the limited armamentarium we have to deal with atherosclerotic disease of the extracranial carotid artery. We utilize carotid artery stenting with a multidisciplinary approach integrating medical management with stroke neurology, TCAR/CEA with vascular surgery, and ECA-ICA/STA-MCA bypass by neurosurgery. Losing reimbursement and restricting access to CAS would invariably lead to suboptimal patient care and potential harm affecting nearly a patient every 10 days.

We would like to commend the CMS for its thoughtful review of the clinical literature.

We request and support that CMS finalize key components of the proposed decision:
1. Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
2. Support coverage without requiring patients to participate in clinical trials.
3. Support allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.
4. Support removal of the facility standard and approval requirements.

We recommend that CMS revise two parts of the proposed decision:
1. Support requirements for physicians to have an SDM interaction with patients without delaying coverage until a validated SDM tool has been developed.
2. Recommend that CMS not require patients to undergo computed tomography angiograph (CTA) or magnetic resonance angiography (MRA) if contraindicated for the patient, and allow use of catheter-based angiography for these patients.

Respectfully,
Barbara Albani, M.D.
Gaurav Jindal, M.D.
Sudhakar Satti, M.D.
Thinesh Sivapatham, M.D.
Gregg Zoarski, M.D.

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Kudos to CMS for proposing an updated coverage policy for CAS based on the contemporary evidence. I support the specific elements proposed in this decision, including:

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To: Centers for Medicare and Medicaid Services Coverage Advisory Group

Re: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting Decision Memo, CAG-00085R8

Regarding the reimbursement of carotid artery stenting, I would like to point out several comments:

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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Many of my colleagues have previously outlined the evidence that does not support the expansion of carotid stenting in individuals who are not considered high risk for surgery or other revascularization means (e.g. TCAR). I concur that expansion will only increase costs to CMS and ultimately harm patients. 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. Current practice at least provides a roadblock to have patients more thoroughly evaluated by neurology, neurointerventional, vascular surgeons etc to determine whether a stent is really the best option for a patient and to proceed with other interventions that are generally safer - transcarotid stenting or carotid endarterectomy when possible. I have not seen overwhelming evidence to make a case for the expansion of stenting criteria as a way to improve access to care for patients. As previously mentioned it is likely better to wait for results of CREST-2, which can provide more clarity on the efficacy and safety of different carotid revascularization techniques in the modern era.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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I am a physician that takes care of patients with carotid stenosis with percutaneous approach. First, I would like to thank CMS for its thoughtful review of the clinical literature and current evidence. I would like to ask CMS to finalize key components of the proposed decision including the expansion of the coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence. Also support coverage without requiring patients to participate in clinical trials and support the removal of the facility standard and approval requirements. Also, support allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.

I would also recommend that CMS revise two aspects of the Proposed Decision:
The Proposal requires physicians to have a shared decision-making (SDM) interaction with patients, and advocates doing so with a “validated” SDM tool. To develop such a “validated tool” would take years. I would like to express support for an SDM interaction (including discussion about all options for treatment of carotid disease), but this should not to further delay coverage of CAS pending the development of a “validated” SDM tool.

The Proposal would require all patients considered for CAS to undergo computed tomography angiography (CTA) or magnetic resonance angiography (MRA) in advance of catheter-based angiography. Sometimes this is impractical as the patient may have allergies or pre-existing conditions (e.g. CKD). I would like to recommend that CMS allow use of catheter-based angiography when CTA/MRA are contraindicated.

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I commend CMS for proposing a coverage policy for CAS based on the current evidence. I fully support the specific elements proposed in this decision, including:  

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As a practicing vascular surgeon who has taken part in the care of stroke and prevention of stroke for over 20 years, the decision to provide funding for transfemoral carotid stenting would be taking a step back in what we know, as far as efficacy and safety for our patients.

Treatment trends go where funding goes and this change would not be supported by the data we have.

Select patients still need carotid stents from a femoral approach but this is still higher risk by and large than CEA or now TCAR in its first iteration! Let alone second third or fourth.

This will create a situation like PVIs where articles will highlight in appropriate and misuse. The majority SVS members including myself do not support this.

Thank you!

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I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

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With regards to NCD 20.7., it is understood that CMS has an obligation to expand access to CAS to as broad a population of APPROPRIATE patients as possible. However, CMS also has an obligation to assure that beneficiaries are being treated safely, effectively and appropriately as CMS is the gate keeper of reimbursement. If the recent flurry of articles describing the abuse of peripheral atherectomy has taught us anything. it is that sadly physicians are not all driven by the tenants of the Hippocratic Oath and when payers, i.e. CMS create easy opportunities for abuse of the system for personal gain, there is a cohort of physicians who will exploit it.

The problems with peripheral atherectomy in an OBL environment should come as no surprise and CMS must accept their role in the problem by allowing physicians to do procedures in a completely unregulated environment with no obligation for quality reporting and paying for a procedure that has no level 1 evidence of benefit. Why would anyone expect this situation to not be abused by the unfortunate nefarious among us. The same thing will happen with CAS if CMS does not REQUIRE that all CAS patients are entered into a quality registry that at a minimum includes clinical and objective anatomic data on the lesions being treated, and immediate and long term follow-up. There is absolutely no downside to CMS or patients with this requirement.

Currently, using VQI as an example, a physician doing 100 CAS procedures a year would likely need to allocate conservatively 15% of the reimbursement for the procedure for VQI participation on an annual basis. In most instances of current VQI participation, that cost is born by the institution and not directly by the physicians performing the procedure. Physicians who are truly committed to providing VALUE to their patients will not bat an eye in meeting a requirement for mandatory quality data reporting in order to get paid for care. Those physicians who see broadening the coverage for CAS a pathway to easy money doing cosmetic lumenology will be less likely to do procedures whereby they know their data and performance will be scrutinized. I beg CMS to learn from the OBL/atherectomy debacle and include mandatory quality registry reporting as a condition of payment as part of their expansion of coverage for CAS. There is only benefit to patients and to the healthcare system with such a mandate.

Scott S. Berman, MD, MHA, RVT, FACS, DFSVS
Director of Vascular Quality and Noninvasive Vascular Imaging

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I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

There is ample level I evidence supporting the above decision.

On the other hand it is very important to highlight that self reported registries are marred with underreporting of complications associated with TCAR.

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As a vascular surgeon I have significant concerns related to proposed CMS memo NCD 20.7. There is no data/evidence to support the expansion of CMS coverage for asymptomatic transfemoral stenting. Best evidence, true evidence, suggests a doubling of stroke rate for transferal scenting when compared to carotid endarterectomy, this is across numerous trials. Expanding these guidelines would result in harm to patients in the form of stroke.

Furthermore, as a Program Director tasked with training future vascular surgeons, this sends a message that we as a healthcare system are willing to accept inferior treatment. This sends the wrong message to our patients, our trainees and to the world. The United States should be leading the charge AGAINST inferior therapeutic options rather than supporting and encouraging them

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8.10.2023

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8)

Dear Ms. Syrek Jensen,

The American Academy of Neurology (AAN) is the world’s largest neurology specialty society representing more than 40,000 neurologists and clinical neuroscience professionals. The AAN is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a physician with specialized training in diagnosing, treating, and managing disorders of the brain and nervous system. These disorders affect one in six people and include conditions such as multiple sclerosis (MS), Alzheimer’s disease, Parkinson’s disease, stroke, migraine, epilepsy, traumatic brain injury, ALS, and spinal muscular atrophy.

The AAN is pleased to provide comments on the proposed decision memorandum on Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8). We commend the Centers for Medicare & Medicaid Services (CMS) for proposing to update the national coverage determination (NCD) for this procedure, including ending the requirement for some patients to participate in clinical trials, following successful completion of the evidence development activities required by the current version of the NCD. The AAN supports the goal of Coverage with Evidence Development (CED) to provide access to promising technologies while collecting data on how they work in Medicare beneficiaries. At the same time, we have been concerned about coverage policies that become outdated and cannot be adapted easily as standards of practice evolve. We have urged CMS to be nimble and allow access to care without CED requirements quickly when newly acquired evidence supports broader coverage. We greatly appreciate the thoughtful analysis CMS applied to the clinical evidence for carotid artery stenting (CAS).

We also support the specific elements of this proposed decision, namely:

- Covering PTA of the carotid artery concurrent with stenting with the placement of a Food and Drug Administration (FDA) approved carotid stent with an FDA-approved or cleared embolic protection device, for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%;
- Covering CAS for standard surgical risk patients;
- Covering CAS without requiring patients to participate in clinical trials;
- Allowing the Medicare Administrative Contractors (MACs) to determine coverage for patients not described in the proposed decision;
- Removing facility standards and approval requirements; and
- Requiring formal shared decision-making (SDM) with the patient prior to the procedure.

We ask CMS to finalize this proposed decision. To ensure that the final decision allows timely access to appropriate care for Medicare beneficiaries, we recommend that CMS revise two parts of the decision.

First, CMS should not require use of a validated SDM tool prior to the CAS procedure because there is no such tool now. SDM is critically important, and CMS appropriately identifies elements that must be included in the SDM interaction:

- Discussion of all treatment options for carotid stenosis to ensure the beneficiary is familiar with and aware of all treatment options including, but not limited to, procedures that fall within the parameters of this NCD.
- Explanation of risks and benefits for each option specific to the beneficiary’s clinical condition.
- Integration of clinical guidelines (e.g., patient life-expectancy).
- Discussion and incorporation of beneficiary’s personal preferences and priorities in choosing a treatment plan.

These elements should be finalized, and CMS should encourage development of a validated tool that includes these elements. Until such a tool is available, physicians should be able to satisfy the NCD’s requirements by documenting in the medical record that the SDM interaction occurred. CMS also could specify in the final decision that use of a validated SDM tool would provide adequate documentation of the interaction.

Second, CMS should not require use of CTA and MRA to evaluate the extent and severity of carotid artery stenosis in all patients. These procedures are contraindicated for some patients due non-MR safe implants, allergies or other comorbidities. The final decision should allow physicians to use catheter-based angiography when CTA and MRA are not appropriate for the patient.

In conclusion, the AAN applauds CMS for proposing an updated coverage policy for CAS that is based on the currently available evidence. We urge CMS to implement this decision, with the two revisions discussed above, to expand Medicare beneficiaries’ access to care.

The AAN appreciates the opportunity to provide input on this coverage decision. Please reach out to Matt Kerschner, the AAN’s Director, Regulatory Affairs and Policy at mkerschner@aan.com with any questions or requests for additional information.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

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I am a vascular neurologist and have been in practice for the last 10 years. I work in an academic center with neurology and neurosurgery trained neuro-interventionalists. I refer patients for both carotid endarterectomy and carotid artery stenting. I am a neutral stakeholder. I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

-Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis > or = 50% or with asymptomatic carotid artery stenosis > or = 70%.
-Covering CAS for standard surgical risk patients.
-Covering CAS without requiring participation in a clinical trial.
-Allowing Medicare Administrative Contractors (MACs) to determine coverage for patients not described in the proposed decision.
-Requiring formal shared decision-making with the patient before the procedure.

Thank you for your consideration.

Matthew Starr, MD
Associate Director of the UPMC Stroke Institute
Director of Vascular Neurology Fellowship at UPMC
Assistant Professor of Neurology

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I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

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I fully support CMS updating the coverage policy for CAS based on the available data from multiple randomized trials showing similar outcomes in early and late follow-up windows between CEA and CAS.

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August 10, 2023

Joseph Chin, MD
Acting Director, Coverage and Analysis Group
7500 Security Boulevard, Mailstop S3-02-01
Baltimore, MD 21244

RE: National Coverage Analysis – Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8) – Proposed

To Joseph Chin, MD:

On behalf of the Advanced Medical Technology Association (AdvaMed), we are writing to support CMS’ proposal for expansion of coverage for Percutaneous Transluminal Angioplasty (PTA) of the carotid artery concurrent with stenting (CAS). AdvaMed member companies produce the medical devices, diagnostic products, and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. We are committed to ensuring patient access to lifesaving and life-enhancing devices and other advanced medical technologies in the most appropriate settings.

AdvaMed recommends CMS finalize the proposed coverage criteria for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (CAS) for Medicare beneficiaries which will allow this important treatment in patients with symptomatic carotid artery stenosis ?50% and patients with asymptomatic carotid artery stenosis ?70%. We further recommend that the coverage criteria within the proposed NCD for PTA of carotid artery concurrent with stenting clarify that coverage would apply “for an FDA-approved indication.”

AdvaMed also supports expanding coverage to standard surgical risk individuals and permitting the Medicare Administrative Contractors (MACs) to make reasonable and necessary determinations under section 1862(a)(1)(A) of the Act for any other beneficiary seeking coverage for PTA with CAS. These proposals are consistent with CMS’ Health Equity strategy to facilitate access to life-saving procedures to all Medicare beneficiaries, regardless of race, ethnicity, socioeconomic status and geography.

The Multispecialty Carotid Alliance (MSCA) reconsideration request provides evidence from several large multicenter randomized controlled trial (RCTs) demonstrating equivalence between CAS and carotid endarterectomy (CEA) in procedure outcomes, long-term stroke, prevention, and durability. The scope of this reconsideration is limited to PTA concurrent with CAS including transcarotid artery revascularization (TCAR) procedures. CMS’ analysis of the recent evidence results in a similar conclusion. The evidence also indicates the current standard of care has evolved such that it is no longer necessary for CMS to require minimum standards for facility requirements. Elimination of this requirement will allow individual facilities to rely on well-established facility credential requirements and quality assurance programs. We also believe this will improve beneficiary access to this treatment.

AdvaMed supports the incorporation of shared decision-making interactions between the health care provider and beneficiary as part of any treatment plan, including CAS. We agree that this discussion should include a discussion of all the treatment options for carotid stenosis, including an explanation of the risks and benefits for each treatment option as appropriate for the beneficiary’s specific clinical condition. We also agree this discussion needs to incorporate the beneficiary’s personal preferences.

Although we support shared decision-making, we do not support the requirement that this important interaction requires the use of a “validated shared decision-making tool” and recommend CMS does not finalize this requirement. Shared decision-making can incorporate patient decision aids but requiring a validated tool provides an unnecessary barrier for access to PTA with CAS. In addition, we have not identified a “validated shared decision-making tool” for PTA with CAS. The US Preventive Services Task Force (USPSTF) recognizes the value of shared decision-making and does not require the use of validated patient decision aids.

AdvaMed appreciates the opportunity to submit comments on this significant technology. If you have any questions, please contact Tara Burke (tburke@advamed.org).

Sincerely,

/s/
Tara Burke, PhD
Vice President, Payment & Healthcare Delivery Policy

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. Revise the proposed decision memo to emphasize the collection of realtime 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

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I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

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I am a cardiologist who has referred patients for carotid artery stenting.

Thank you for your thoughtful review of the clinical literature and current evidence.

I support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.

I support coverage without requiring patients to participate in clinical trials.

I support removal of the facility standard and approval requirements.

I support allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.

I recommend that CMS revise two aspects of the Proposed Decision:

The Proposal requires physicians to have a shared decision-making (SDM) interaction with patients, and advocates doing so with a “validated” SDM tool. To develop such a “validated tool” would take years. Please express support for an SDM interaction (including discussion about all options for treatment of carotid disease), but not to delay coverage of CAS pending the development of a “validated” SDM tool.

The Proposal would require all patients considered for CAS to undergo computed tomography angiography (CTA) or magnetic resonance angiography (MRA) in advance of catheter-based angiography. Please recommend that CMS allow use of catheter-based angiography when CTA/MRA are contraindicated.

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I would STRONGLY encourage CMS to consider the recommendations and concerns stated by the SVS. Carotid surgery of ANY kind carries significant consequences when bad outcomes arise. Stroke, debilitation, and death are all possible consequences and as such, the vascular community has worked tirelessly over the years to minimize these risks through education, qualification, and standardization. Oversight and careful scrutiny of those performing these procedures is needed to minimize risk and avoid a "hobbyshop" approach to these patients.

I am in full agreement with the SVS position and encourage the CMS decision makers and leaders to consider these recommendations carefully and fully.

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The Medical Device Manufacturers Association (MDMA), a national trade association representing the innovative sector of the medical device market, is submitting this letter in response to the proposed coverage decision for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8). For nearly 30 years, MDMA has represented the medical device industry in Washington, DC, supporting policies that promote medical innovation and patient access to lifesaving and life-changing medical technologies.

MDMA commends CMS for working with the Multispecialty Carotid Alliance (MSCA) and other stakeholders on the proposed revisions to national coverage determination (NCD) 20.7. After a careful and thorough review of new clinical evidence, CMS has proposed to expand coverage for carotid artery stenting to patients who previously were eligible for this procedure only if they participated in a clinical trial, and to standard surgical risk patients. Coverage of carotid artery stenting for patients who are not described in the proposed decision would be decided by the Medicare Administrative Contractors (MACs). CMS also proposes to remove facility standards and approval requirements, and to require use of formal shared decision-making (SDM) with the patient before the procedure is performed.

MDMA has long supported the CMS’s efforts to expand access to innovative technologies while expanding the evidence base. We have encouraged CMS to work with knowledgeable stakeholders, including physicians, manufacturers, and patient advocates, to ensure that coverage with evidence development (CED)—along with other potential programs combining Medicare coverage with the collection of data on real world use—are implemented efficiently and employ appropriate research methods to answer important outstanding questions about a technology. Efficient implementation in relation to CED policies includes updating such coverage policies in a timely manner when data collection is no longer needed to support coverage.

We thank CMS for an updated coverage proposal that is based on the best evidence available, and we urge CMS to finalize this proposal, with suggested changes to ensure timely and appropriate access to care. Specifically, we recognize that there are currently no validated SDM tools and some stakeholders have expressed concern that that the cost and burden of the SDM requirement as proposed could act as a barrier to access. As a result, we urge CMS to eliminate the requirement for use of a validated SDM tool at this time, and instead require physicians to document an SDM interaction meeting the four specified criteria in the medical record. The development, assessment and validation of an SDM tool should not delay the finalization of this NCD or hinder patients’ access to care.

If you have any questions about our comments, please do not hesitate to contact me at (202) 354-7171 or dwaldmann@medicaldevices.org.

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I am a fellowship-trained Vascular Surgeon who just recently (July 2023) retired from clinical practice. I provided full-service Vascular Surgery care for patients with all types of vascular disease (arterial, venous, and hemodialysis access needs) at University Hospitals Cleveland Medical Center in Cleveland, OH for 18 years prior to closing my practice last month. I also served as Program Director for the Vascular Surgery Integrated Residency and Independent Fellowship training programs for the past 7 years, training future generations of Vascular Surgeons. The deliverance of carotid artery stenting as a treatment option for patients with carotid artery disease has been tightly governed by CMS guidelines and requirements during the entirety of my fellowship training (2003-2006) and professional practice period (2006-2023).

For the most part, the initial conception and maintenance of these guidelines has been for the great benefit of patients, including ensuring proper training of multi-specialty interventionalists and vetting of facilities appropriate for provision of such a specialized and technically challenging treatment technique. In my mind, this has provided a uniform standard of care for carotid artery stenting and resulted in the desired protection-from-harm for patients facing the need for treatment of their carotid disease, forcing consideration of medical and non-interventional treatment where appropriate, and of surgical treatment (i.e. carotid endarterectomy) where appropriate. In fact, it was always my thought that such universally accepted guidelines should be developed for other medical procedures, possibly avoiding such spectacles as the overuse (and abuse of Medicare payment) that we are seeing in recent media with regard to procedures such as peripheral arterial angioplasty without appropriate clinical indication, etc.

The medical literature is replete with data showing why liberalization of the current CMS policies regarding carotid artery stenting is NOT a prudent idea, and I will not reiterate that, as you likely have received many comments already with that information. However, I would like to emphasize the point that carotid artery stenting is a very specialized and technically demanding procedure, with disastrous consequences if performed poorly. Part of the reason such high quality results (and low complication rates) can be achieved with this procedure (and perhaps one reason why we do not see such good data with other interventional procedures) is that CMS has previously limited the indications and eligible circumstances for reimbursement of carotid artery stenting (all based on current medical literature/science), and implemented stringent requirements and standards for individual interventionalists and facilities who will provide this type of care. These are GOOD things! There must be a compelling reason to relax requirements that are protective of patients, and economic or political pressure from device companies or conflicted providers interested in a larger piece of the CMS pie are NOT compelling reasons to place the public (or taxpayer dollars) in jeopardy.

Honestly, the most concerning item of this Proposal is the relaxing of facility requirements - not even the most skilled interventionalist can provide quality care in a vacuum. We must not underestimate the effect teamwork and the team environment can have in healthcare, and the performance of high-quality, low complication rate carotid artery stenting is no exception. Particularly in a time when healthcare staffing/experience level and supply-chain stresses remain in crisis, patients undergoing procedures need protections in place. Just as providers require training, licensure, and credentialing to acceptable standards, so do the facilities require vetting of training and experience of staff (nurses, assistants, pharmacists, administrators); the workflow protocols and standards for providing appropriate monitoring and care (emergency responses, chain of command, etc.); the inventory and equipment available (fixed overhead equipment, disposables, and emergency supplies); and physical plant (cleanliness, sterility, HVAC and utilities, EVS protocols, waste disposal, etc.). For specialized procedures such as carotid stenting, which has been so tightly controlled and where previously not everyone in every facility has been allowed to perform these, simply opening the floodgates without any requirement for meeting a standard of care effectively states that there IS NO STANDARD of CARE! This is NOT a good thing!

When CMS restrictions regarding carotid stenting reimbursement first came out, they were an innovative, not-before-seen tether on a new technology to see how use would go. In my opinion, this worked, and could serve as a blueprint for how CMS can help establish recognized standards of care for many other types of medical care. You only need to examine other technologies and see how approaching them after their uncontrolled release is a very reactive way of looking at problems after the horse is out of the barn, so to speak. Developing a more proactive approach, with intensive data review, as with carotid artery stenting, would forgo the need for patients to suffer early on and loads of unnecessary or unindicated procedures to be done before any detailed examination is undertaken at any level, thus further undermining patients' confidence in their medical providers or their federal government insurer to protect them or their interests.

Finally, any guidance on how to establish an appropriate standard of care for treating patients with carotid artery disease should come from examining how expert care providers approach this disease using evidence-based medicine. Although there are many types of providers involved in carotid stent delivery, only one type of provider is specifically trained in the care of carotid artery disease in all its forms and practices daily the delivery of EVERY available form of carotid artery disease treatment (i.e. observational, medical, surgical, and interventional stenting), and that is a VASCULAR SURGEON. I beg you to examine the statement put out by the Society for Vascular Surgery regarding this CMS proposal and use it for guidance.

And Godspeed to you all for making the right decisions regarding Americans with vascular disease.

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Since 2000 I have performed over 600 tfCAS procedures and participated in the ADVANCE, VIVEXX, EMPIRE, SAPPHIRE, SCAFOLD, CREST, ACT-1, CREST-2 trials as a carotid interventionist. At our institution we have had a low stroke and death rate predominately through careful patient selection and avoiding high risk anatomy such as heavily calcified bifurcation, complex ICA lesions, free floating thrombus , severely tortuous carotid arteries, complex arch anatomy etc. all detected with pre-op CTA. The level of training and demonstrated expertise to participate in the carotid RCTs is why the results of tfCAS where as good as they were and cannot be extrapolated to what will happen in the real world if the NCD remains as is. This has been clearly demonstrated in registry data. If I hire a contractor to work on my house I have expectations around what results I expect for how much money Im spending. I keep an eye on things to make sure I'm satisfied with the end result. Why should our health care be any different? CMS has an obligation to ensure they are getting appropriate outcomes for the health care they pay for. Regardless of whether it is CEA, tfCAS , TCAR or which specialty you are. I remain deeply concerned that the current proposed NCD will result in a significant increase in strokes suffered by MEDICARE beneficiaries after ill-advised carotid stent procedures and that we will have no idea this is happening since CMS is not evaluating the outcomes.

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I am a Vascular Cariologist with Summa Health System in Akron Ohio. I would like to thank CMS for their timely, much needed, and thoughtful review of the Carotid Stent literature. I would encourage CMS to finalize and support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence. In addition, I would like to see CMS:

Dear CMS Committee Members:

I have spent several decades of my career, both while at the Cleveland Clinic Foundation and at the University of Kentucky involved in the care of patients with carotid arterial disease. Likewise, as the editor-in-chief of the leading interventional cardiovascular medicine journal globally, JACC: Cardiovascular Interventions, I have closely followed the science as well as the clinical application of carotid artery stenting. I also serve as a Special Government Employee as an advisor to other regulatory bodies separate from CMS. As such, I personally appreciate the thoughtful review CMS is making of the clinical and implementation science surrounding carotid artery revascularization, particularly regarding carotid artery stenting. I am supportive of the proposed changes and hope CMS finalizes the critical components of the proposed decision. It is time to advance the coverage and supported practice as CMS has proposed.

David Moliterno, MD, FACC, FESC, FACP, FAHA

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I am a board-certified vascular surgeon and part of a large clinical practice with significant experience managing carotid disease. I am concerned with the coverage expansion outlined in this CMS proposal. The decision to change coverage is premature and jeopardizes patient safety. Numerous randomized control trials and retrospective analyses have demonstrated that transfemoral carotid stenting carries a significantly higher periprocedural stroke rate and should be reserved for a select group of patients, as current guidelines from the Society for Vascular Surgery recommend. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

The coverage expansion in CMS proposed decision meme regarding NCD20.7 is premature, and has the potential to expose patients to unnecessary stroke risk. I strongly disagree with the coverage expansion. If however, the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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I am an interventional cardiologist who performs carotid artery stenting (CAS). I would like to thank CMS for your thoughtful review of the clinical literature and current evidence. I kindly ask CMS to finalize these key components of the proposed decision:

Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.

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As a Vascular Surgeon in a practice that treats a high volume of carotid disease, I oppose the proposed CMS expanded coverage. In our current practice, we perform CEA, TCar, and TF CAS. TF CAS has become nearly obsolete secondary to the effectiveness of CEA and TCar. TF CAS has proven increased risk of stroke, and this was demonstrated in many previous studies with hand selected practitioners. With the proposed expanded coverage, there will assuredly be a steep spike of procedures performed, and that steep spike will very likely be largely from physicians who are not able to perform CEA or TCar(without exposure). In addition, the results from the general population of practitioners as opposed to the meticulously selected practitioners in CREST,etc. will not reproduce the same results(which in the best hands were inferior). In addition(again), poor outcomes will forever be hidden in hospitals without VQI etc. as if they never happened.

— at the very least, wait until complete CREST II data out to make an informed decision

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I am a practicing vascular surgeon. I perform carotid endarterectomy and TCAR. I am quite concerned about the CMS Proposed Decision Memo relating to NCD 20.7. The proposed ruling would open transfemoral carotid stenting to nearly all interventionalists that wish to do them, especially if the local hospital does not have adequate credentialing and/or proctoring programs in place. This would reduce standardization of care across the country. Currently, transfemoral carotid stenting is done at few locations due to the lack of numbers. This is due to the increased risk from transfemoral carotid intervention as the carotid lesion must first be crossed without any embolic protection. This would place patients at higher risk of stroke, who could have otherwise had a procedure with lower intra-operative stroke risk (e.g. TCAR). Delegating privileges for transfemoral carotid stenting to hospitals disregards the steep learning curve for this sensitive procedure.

While increased patient access is important, I strongly feel that it should be done in a more calculated manner. The trials listed in the MSCA letter are not necessarily generalizeable to non-trial settings. The practitioners are all well experienced and are selected carefully for inclusion in the trials. At the very least, we need more real time, real world data on outcomes for transfemoral carotid stenting (as there are for TCAR and CEA through VQI).

Simply expanding coverage just so more providers can do the procedure is not patient centric. In a time when more patients are being treated medically, increasing coverage would lead to increased expenditure without necessarily reducing stroke risk. I implore CMS to reject the proposed ruling.

I am also fully in support of the Society for Vascular Surgery letter submitted on Aug 4th, 2023.

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I am a physician (interventional cardiologist) who performs CAS. I wish to thank CMS for its thoughtful review of the clinical literature and current evidence.
I would like to encourage CMS to finalize key components of the proposed decision:

Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
Support coverage without requiring patients to participate in clinical trials.
Support removal of the facility standard and approval requirements.
Support allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.

I also recommend that CMS revise two aspects of the Proposed Decision:

The Proposal requires physicians to have a shared decision-making (SDM) interaction with patients, and advocates doing so with a “validated” SDM tool. To develop such a “validated tool” would take years. I support an SDM interaction (including discussion about all options for treatment of carotid disease), but not to delay coverage of CAS pending the development of a “validated” SDM tool.

The Proposal would require all patients considered for CAS to undergo computed tomography angiography (CTA) or magnetic resonance angiography (MRA) in advance of catheter-based angiography. I also recommend that CMS allow use of catheter-based angiography when CTA/MRA are contraindicated.

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I have significant concerns around CMS’ proposed decision memo that would provide broad coverage of TFCAS, independent of patient symptom status and risk stratification. This coverage is not contingent on data entry into societal registries which would have served to establish what the outcomes for this procedure are in all rather than selected patients by all rather than selected operators. Furthermore, there are no guard rails for credentialing or for establishing quality control.

What is very clear is that patients warranting carotid revascularization already have two very safe and effective options that provide both open and minimally invasive (endovascular) solutions; carotid endarterectomy (CEA) and transcarotid artery revascularization (TCAR). Data from the Society for Vascular Surgery’s Vascular Quality Initiative transcarotid surveillance project (VQI TSP) reflect independent uncensored and comprehensive Real World Evidence across a broad range of patient cohorts, multiple health care environments and physicians who may have had little to no prior carotid endovascular expertise. TCAR has repeatedly been shown to be equivalent to CEA for the operative all- stroke risk (equivalence not being achieved by a reduction in the operative MI rates for TCAR). Furthermore, an unspecified number of patients with asymptomatic disease may not require revascularization at all and this will continue to be an unknown before the completion and report of CREST2.

Regarding effective shared decision making (SDM), as it serves to frame informed consent, the specialty that can offer BMT, CEA, TCAR and TFCAS is best positioned to aid in the decision-making process, otherwise, otherwise SDM becomes just a tag-line.

Finalizing the proposed decision will result in many unnecessary and hazardous TFCAS procedures and substantial harm to Medicare beneficiaries.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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CMS

Title: Vascular surgeon

Date: August 2, 2023

Comment:

Dear CMS,

I am grateful to have an opportunity to participate in public comment regarding proposed changes to National Coverage Determination (NCD) relative to percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. In formulating these comments, I have had an opportunity to thoroughly review the best available medical evidence, comments from CMS, position statements from various societies, the Multispeciality Carotid Consortium request letter, and input from colleagues concerning the proposal.

My experience has been that both the FDA and CMS have been appropriately diligent in developing policies that allow access to meaningful technology, with the primary goal being to protect patients' safety and facilitate quality of life. Given that the stroke risk reduction benefit from intervention may be relatively small, especially in asymptomatic patients, the number of patients needed to power studies to demonstrate differences in treatment options can be vast; therefore, resources and time investment into gaining actionable data is significant. The development of randomized control trials consequently requires considerable time and resources but remains extraordinarily valuable. The decision to construct precise policy that specifies the appropriate use of technology is justifiable when one considers the magnitude of the quality of life impact that may result from neurologic events.

Emerging evidence may support carotid stenting for standard surgical risk patients with symptomatic lesions greater than 50% and asymptomatic lesions greater than 70%, however a meaningful prospective trial titled CREST II may clarify the risk benefit analysis significantly. I agree that independent neurological assessment before and after carotid stenting must be performed, and I agree that providers must engage in a formal shared decision-making interaction with the beneficiary.

The shared decision-making process should include a thorough review of the risks and benefits of all management options available for long-term stroke risk reduction benefit including contemporary medical management, carotid endarterectomy, transfemoral carotid stenting, and trans carotid artery revascularization carotid stenting (TCAR). These discussions should also consider facility-specific and proceduralist-specific outcomes, including perioperative stroke, cranial nerve injury, hemorrhage, and other significant events. These discussions should include a review of the concept of the therapeutic index, explicitly addressing the patient's life expectancy and the magnitude of benefit that may be expected with the treatment plan. While a standard decision-making tool may not easily fit the goals of a shared decision-making interaction, standards provided by the Federation of State Medical Boards for the informed consent process may be a useful guideline for constructing policy.

I am particularly interested in data that suggests a trend toward lower periprocedural neurologic event rates in patients who undergo TCAR versus transfemoral carotid stenting. While I recognize that there has not been a robust randomized control trial comparing TCAR to transfemoral carotid stenting, I also acknowledge that there is an extensive registry database that raises a justifiable question concerning differences in outcome between TCAR and transfemoral carotid stenting, with TCAR showing lower periprocedural neurologic event rates when compared to transfemoral carotid stenting.
Specifically, a study titled “Association of Transcarotid Artery Revascularization vs. Transfemoral Carotid Artery Stenting with Stroke or Death among Patients with Carotid Artery Stenosis published in 2019 included 5251 patients who underwent TCAR and 6640 patients who underwent transfemoral carotid stenting. Of those identified in the prospective study, 3286 pairs were matched for comparison. Results revealed a statistically significant lower rate of in-hospital stroke or death in patients who undergo TCAR (1.6% vs 3.1%, p < 0.001)1. The Vascular Quality Initiative database is a powerful resource for assessing contemporary outcomes in patients undergoing carotid endarterectomy, TCAR, and transfemoral carotid stenting. Comments shared from CMS highlight that these points have been carefully considered. In light of the available evidence, I must raise the question of whether the lack of randomized controlled trial data comparing TCAR to transfemoral carotid stenting provides suitable equipoise when one considers the large number of patients enrolled in the VQI registry that has established TCAR as a safer procedure. Because of trends concerning the review of the VQI data, it appears prudent to suggest that practitioners participate in ongoing quality outcomes assessment, such as through the VQI quality registry.

In summary, I am concerned about the proposal for a relatively sweeping change in the NCD. Policy language should continue to require participation in registries and contain greater detail that mirrors societal guidelines such as those provided by the Society of Vascular Surgery. Given the significant quality of life impact that neurologic events carry, it is prudent to wait for maturation of randomized controlled trials before changing NCD policy. If the proposed changes to the NCD were to be made, I am concerned that significant patient harm may result.

I appreciate your consideration.

W. Kent Williamson Vascular surgeon, Asheville, North Carolina

1. JAMA 2019; 322(23): 2313-2322

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As a dedicated vascular surgeon, I'm alarmed by the coverage expansion proposed in CMS' Decision Memo for NCD 20.7. The proposed changes as written put patient safety at risk. I urge CMS to consider these concerns and recommendations prior to finalizing updates to NCD 20.7.

To maintain patient safety, it is imperative to continue to collect real-time data and continue the credentialing process.

Enforce a standardized "Shared Decision Making" tool, developed collaboratively with relevant medical societies and stakeholders, to empower patients in their healthcare choices.

Amend the decision memo to define "Qualified Physician" and establish core competency standards developed with stakeholders to formulate these standards.

In agreement with the Society for Vascular Surgery, I strongly contend that the proposed coverage expansion jeopardizes patient safety. If CMS proceeds with the expansion, it's imperative that the final memorandum integrates the outlined recommendations for the sake of patient well-being.

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I am a Vascular Surgeon practicing at a large academic medical center. After reading the proposed recommendation, I have significant concerns regarding the proposal. Being at a quaternary referral center I have seen complications of carotid based procedures being performed throughout the community. I believe that in order to maintain the quality of treatment of carotid diseases and to ensure patient receive the best treatment for their disease process (and not just what is available at a particular location) I would suggest the following modifications:

1. There should continue to be a continuing documented training and case requirement for all carotid interventions similar to what exists for CAS and TCAR now to ensure that operators are trained appropriately and have the necessary experience to reduction the potential for negative outcomes.
2. All operators of carotid interventions CEA, TCAR, and CAS should be require to reports outcomes in a registry, such as VQI, to ensure that quality is maintained.
3. That given the superior results in all studies to date of CEA and TCAR over CAS with regard to stroke and death, that a shard decision making discussion be mandatory for all patients being considered for CAS, regardless of who is offering the procedure, to ensure that all agree that CAS is the best options compared to TCAR and CEA.

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Recent articles in pro publica and nyt, about aggressive and unethical treatment by non board certified Vascular Surgeons and non SVS members highlight the importance of quality control.

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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The Vascular and Endovascular Surgery Society (VESS) would like to comment on the recent proposed decision memo for percutaneous transluminal angioplasty of the carotid artery concurrent with stenting by CMS. We are concerned that the proposed expansion of indication for transfemoral carotid stenting (CAS) to include asymptomatic standard risk patients while removing facility standards and approval requirements is unnecessary and will likely cause harm to patients with carotid disease.

CAS is one of the most studied procedures in vascular patients with multiple randomized trials using various composite endpoints to show non-inferiority to carotid endarterectomy (CEA). These have shown that there is a subset of high risk, symptomatic patients who are best treated with CAS over CEA or trans-carotid stenting (TCAR). However, where asymptomatic patients are concerned, the bar must be higher as there are patients in this cohort who should be treated with best medical therapy alone. If the ultimate goal of intervention on an asymptomatic patient is to prevent future strokes, then the interventions should be judged by their ability to do so; which in most studies has favored CEA or TCAR over CAS. In their decision memo, CMS included the ACT-1, SPACE-2 and ACST-2 trials as evidence of CAS safety equivalence to CEA. But in their own review they concede that the composite of any stroke or death in ACT-1 for CAS was almost double that of CEA (2.9% CAS vs 1.7% CEA). The SPACE-2 trial showed no difference in their 30-day outcome between groups, but this trial suffered from slow recruitment and lack of power as they only randomized 513 patients into two parallel cohorts when the original trial was designed to include 3640 patients. Finally, ACST-2 had a significantly higher rate of non-disabling strokes with CAS when compared to CEA (2.7% CAS vs 1.6% CEA). All three of these trials provide evidence that CAS is associated with a higher rate of stroke than CEA and should be reserved for patients who are considered high risk for CEA. Indeed, it is likely that the unfettered application of CAS to asymptomatic normal risk carotid patients will increase the number of 30-day strokes.

In the current memo, CMS argues that the CAS results obtained in highly controlled clinical trials are generalizable across all operators at all institutions, and, therefore the prior requirements for facility standards and approval are no longer necessary. We believe that this stance is misinformed and dangerous. Most of the physicians who performed CAS in the randomized trials were included because they had a high volume of experience that allowed them to achieve superior outcomes. However, with the low volume of CAS performed over the last decade, most operators will be hard pressed to produce even 5 cases from the last year. Thus, it is imperative for patient safety, that the facility standards and requirements for approval remain in place if the indication for CAS is to be broadened by CMS.

The requirement of maintaining a national registry of patients who have undergone TCAR has been beneficial to the safe implementation of this technique for carotid revascularization as it provides a higher degree of scrutiny to patient selection and facilitates continued evaluation of patient outcomes. Indeed, such observations have led to identification of the importance of clopidogrel resistance in patients undergoing carotid stenting. We believe that the expanded coverage of CAS without the requirement of an ongoing registry misses an opportunity to continue to improve patient outcomes in the area of carotid disease and will lead to patient harm in the future.

Finally, the shared decision component of the memo is confusing and will need to be further defined. The memo suggests a multidisciplinary approach to CAS where each patient is ideally evaluated by someone who performs CEA, someone who performs CAS and someone who provides medical therapy. They suggest that this will be accomplished by an online tool but to our knowledge, no such tool exists and if one is to be created by a taskforce of all physician stakeholders, it is likely that many patients who are entered in the tool will be considered reasonable for CEA, CAS, TCAR and best medical therapy. This will only serve to further confuse patients who just want to be treated safely. Thus, it is likely that true shared decision making will only be accomplished through a tumor board like structure that would immediately regionalize CAS treatment; which does not appear to be the goal of CMS.

In conclusion, the VESS is concerned that CMS has not considered the unintended consequences of the proposed coverage expansion of CAS and concomitant decrease in oversight proposed in their recent decision memo. We urge the agency to not finalize the current plan as written but rather make changes that will provide patient access to care with safety in mind. This includes a continued limited roll of CAS to select high risk patients, continued standard requirements for facilities and providers, mandating that all CAS procedures are entered in a registry and a better definition of what it means to provide shared decision making.

Respectfully,

Mark F. Conrad MD, MMSc
President, Vascular and Endovascular Surgery Society, on behalf of the VESS Executive Committee

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As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies representing the physicians who intend to use it.

The proposed requirement of independent neurologic assessment before and after CAS. A neurological examination as part of the clinical assessment is well within the scope and standard of care of a physician involved in carotid revascularization. Furthermore, we believe that cross-sectional imaging with CTA or MRA after carotid duplex ultrasound demonstrating significant carotid stenosis should be at the physician's discretion. Finally, carotid angiography remains the gold standard for assessment of carotid stenosis. In scenarios where invasive angiography is performed as part of stenosis evaluation (e.g., after discrepant non-invasive imaging results), concomitant CAS should be allowed if indicated.

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Dear administrators

How in the world we could even consider performing a less safe procedure is beyond me. The data done in several randomized perspective studies demonstrate considerably higher stroke, especially in women and especially in people over 80 years old. We have seen interventionalists do inappropriate balloons of renal arteries, lower extremity arteries for years.

This is clearly being driven by people who only have a needle. There are currently two equally safe options to treat the carotid artery standard Cea and Tcar. The consequences of failed procedures obviously are severe.

The fact we’re relitigating re-examining data that has been looked at again and again and again it’s just testament to the enduring aggressiveness and lack of patient care on the part of some of our colleagues.

Just say no

With respect Glenn E Esses MD, FACS

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As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies representing the physicians who intend to use it.

The proposed requirement of independent neurologic assessment before and after CAS. A neurological examination as part of the clinical assessment is well within the scope and standard of care of a physician involved in carotid revascularization. Furthermore, we believe that cross-sectional imaging with CTA or MRA after carotid duplex ultrasound demonstrating significant carotid stenosis should be at the physician's discretion. Finally, carotid angiography remains the gold standard for assessment of carotid stenosis. In scenarios where invasive angiography is performed as part of stenosis evaluation (e.g., after discrepant non-invasive imaging results), concomitant CAS should be allowed if indicated.

Thank you.

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I would like to provide some financial perspective based on the overwhelming data offered about pros and cons for NCD 20.7 proposal.

Facts:

There are an estimated 3 million patients in the US over 65 who have asymptomatic carotid artery stenosis greater than 50%. VEITHsymposium Bulletin. June 2022: https://www.veithsymosium.org/pdf/articles/vei/61.pdf

The estimated economic cost of a stroke per year in the US is $59,900. J Med Life 2021 Sep-Oct;14(5):606-619. Doi:10.25122/jml-2021-0361. To achieve benefit for asymptomatic carotid interventions, it is recommended that patient survival be greater than 5 years. If a Medicare patient with asymptomatic carotid stenosis develops a stroke as a result of any intervention; the estimated 5-year cumulative stroke cost in the US would be $299,500. Some live longer.

VQI 2021 registry numbers for patients treated for asymptomatic carotid stenosis totaled 17,6330: (2185 Transfemoral (TFem), 5589 TCAR, 9889 CEA). VQI carotid interventions represent ~30-40% of all patients treated within the US each year. Patients were treated with high-risk criteria guardrails in place for TFem, combined high risk and standard risk for TCAR and CEA criteria per surgeon decision.

VQI 2021 Stroke rates: TFem (high risk) were 1.9%, TCAR (high and std risk) 1.2% and CEA 0.8%. The reported stroke rates for TCAR and CEA have been consistently at these levels since TSP surveillance began in 2016 and is expected to remain similar to these values going forward. The stroke rate for TFem will likely increase given the caveats posited by CMS NCD 20.7 proposal with ‘all comers’ approach and liberalized credentialing criteria. It is inconceivable that an open doors approach will better than 1.9% as recorded for TFem in VQI.

The 2021 VQI total of 17,6330 asymptomatic patients being treated for their carotid disease represents 0.58% of the estimated 3 million Medicare patients in the US with >50% carotid stenosis. Let’s assume the number of patients being treated with TCAR and CEA stay roughly the same (given current vascular surgery restrictive mindset on treating asymptomatic carotid disease). Most interventionists project there will be increases in the number of patients treated for asymptomatic carotid disease with TFem after removal of high risk criteria and liberalization of credentialing. What is the projected number, is it a 5 fold increase, a 10 fold increase? Let’s assume a 10-fold increase of VQI TFem numbers, helping to account for the 60% of patients whose data is not entered in VQI. Therefore, TFem numbers in the US would be projected to increase to 21,850 (using 2021 values). Let’s also assume that the stroke rate will not be better than what is reported under high-risk guidelines above (with experienced operators) but may be worse. Even a conservative estimate stroke rate of 2.85% (50% increase of 1.9%) has a significant increase in patients having a stroke (N=623) saddled with an added 5Y estimated economic burden of $186,900,000!

While these projections can be debated on whether TFem stroke rates will change to the degree listed above, there remain many SVS members who believe stroke estimates above 3% will occur. It is safe to say that TFem numbers will increase rather than decrease and that stroke rates will likely also increase with expansion. To what degree is the question. Providing this exercise above hopefully will allow a pragmatic analysis of the true cost hidden in treating carotid artery disease when changes are made to treating a disease where the benefit to treatment is marginally better than the risk from the natural history of carotid stenosis. The social and economic burden of this decision is far reaching and not without considerable consequence to both patients and society.

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To: Centers for Medicare and Medicaid Services Coverage Advisory Group

Re: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting Decision Memo, CAG-00085R8

Regarding the reimbursement of carotid artery stenting, I would like to point out several comments:

I have some concerns regarding this issue, as a neurologist outside of the USA. Unfortunately, according to the current evidence-based medicine data CAS is still inferior to CEA, regarding efficacy and safety. CMS should support appropriate new research. Results from CREST-2 trial are expected in 2026. It is not applicable to remove procedural standards necessary in medicine. Key quality parameters concerning patients' treatments and outcomes should be included in quality monitoring. Since the strong influence of American medicine, uncontrolled (no monitoring) and unnecessary invasive treatments (especially of asymptomatic carotid disease) and unproven treatments (TCAR) might increase the incidence and burden of stroke globally.

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I am vascular surgeon and have been practice for 10 years. I perform a wide variety of surgical and endovascular procedures treating the full spectrum of vascular disease. This includes the use of transfemoral carotid artery stenting (TFCAS) and transcarotid artery stenting (TCAR) to treat carotid artery occlusive disease. From my experience as a vascular surgeon that treats carotid artery disease with medical management, surgery, and endovascular procedures, I am uniquely qualified to provide a balanced prospective on CMS’ Proposed Decision Memo related to NCD 20.7. It is with this context and experience that I write in opposition to this proposal.

Reimbursement for medical care and procedures greatly influence the adoption and dissemination of procedure, particularly in the setting of new technology. While this “power of the purse” is not the direct mandate of CMS, the impact on patient impact and patient safety is unmistakable. The most recent example of this is the coverage and reimbursement for peripheral vascular procedures, particularly atherectomy, that have been the subject of multiple articles in the press highlighting instances of overtreatment and abuse. In the case of NCD 20.7, it is disturbing to me that I first heard about this proposed change in an email from SilkRoad Medical that outlined the issue and subtly encouraging physicians to make supportive comment of this coverage expansion. Ultimately, based on the available published data, this change does not seem designed to benefit patients by improving safety, but instead seems to benefit the medical device industry which will likely experience significant increase in revenue from this change. Quite simply the data for expansion of TFCAS and TCAR and for expansion of coverage of carotid disease treatment more broadly is still pending. In particular, the NIH-funded randomized CREST-2 trial has still not been published and seeks to outlined appropriateness of treatment for the very patients impacted by NCD 20.7.

For the sake of patient safety, the requirement that only qualified physicians within qualified settings have coverage for these procedures should remain in place. These definitions should be detailed even further, and competency standards should be more fully developed. In addition, the requirement for collection of real-time data and outcomes, such as within a registry, should continue. It is only through these safeguards that unsafe practices fueled by financial incentives can be avoided. In addition to these measures, I strongly agree with the proposed coverage decision that a robust “Shared decision making” tool should be utilized in all treatment of carotid stenosis, where the available data is both complex and incomplete and the potential for patient harm is significant.

In conclusion, I agree with recent statements by the Society for Vascular Surgery in opposition to the proposed decision memo regarding NCD 20. I am very concerned that this coverage expansion is premature and will result in patient harm.

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There is absolutely zero data support expanding coverage for asymptomatic transfemoral stenting. There is no evidence to support this, and every single study that has been done in comparing transfemoral stenting vs. CEA or TCAR shows transfemoral to have at least double the stroke rate. If CMS should go down this route of expanding coverage for transfemoral stenting, then every patient undergoing a carotid procedure should be required to be evaluated by a physician who can perform both revascularization via stenting or CEA, as this would be the only way a patient can be informed accurately regarding the risks and benefits of the procedure.

If CMS decides to expand coverage, then any patient undergoing a carotid procedure must be evaluated by a physician who can perform CEA, TCAR and Transfemoral carotid stenting, otherwise it is not possible for the patient to be accurately counseled regarding all three procedures.

The CMS proposed decision is not backed by any evidence, and it would be a public health disaster to allow this proposed decision to go forward.

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Carotid standing, is demonstrably equal to carotid endarterectomy in most cases, with significantly lower risk of cranial nerve injury, and without disfiguring scar.

The age of open surgery for the majority of patience for carotid disease is long over, and the only practitioners advocating for its persistence, are those who stand to personally benefit monetarily.

You will note that the New York Times recently had to publish a damning investigation of unethical use of atherectomy, which rocked the vascular Interventional world. I worry that if we were to advocate for open endarterectomy when there is no longer evidence, a similar editorial would be in our future.

Carotid stenting is without a doubt the future of our field.

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I have significant concerns around CMS’ proposed decision memo that would provide broad coverage of TFCAS, independent of patient symptom status and risk stratification. This coverage is not contingent on data entry into societal registries which would have served to establish what the outcomes for this procedure are in all rather than selected patients by all rather than selected operators. Furthermore, there are no guard rails for credentialing or for establishing quality control.

What is very clear is that patients warranting carotid revascularization already have two very safe and effective options that provide both open and minimally invasive (endovascular) solutions; carotid endarterectomy (CEA) and transcarotid artery revascularization (TCAR). Data from the Society for Vascular Surgery’s Vascular Quality Initiative transcarotid surveillance project (VQI TSP) reflect independent uncensored and comprehensive Real World Evidence across a broad range of patient cohorts, multiple health care environments and physicians who may have had little to no prior carotid endovascular expertise. TCAR has repeatedly been shown to be equivalent to CEA for the operative all- stroke risk (equivalence not being achieved by a reduction in the operative MI rates for TCAR). Furthermore, an unspecified number of patients with asymptomatic disease may not require revascularization at all and this will continue to be an unknown before the completion and report of CREST2.

Regarding effective shared decision making (SDM), as it serves to frame informed consent, the specialty that can offer BMT, CEA, TCAR and TFCAS is best positioned to aid in the decision-making process, otherwise, otherwise SDM becomes just a tag-line.

Finalizing the proposed decision will result in many unnecessary and hazardous TFCAS procedures and substantial harm to Medicare beneficiaries.

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The CMS Proposed Decision Memo notes “that a standardized, nationwide registry – for all carotid artery procedures – would be helpful to monitor procedural safety, further evolve patient risk stratification, and to facilitate auditing and quality improvement, including comparison of local outcomes to national and other benchmarks. It would be helpful wherever possible that large-scale, data-collection enterprises (registries) collaborate, include all patients, and build off existing infrastructure rather than create anew. Similar collection of outcomes data for patients on OMT alone would be informative. Results of ongoing trials, such as CREST-2 and ECST-2, may better inform registry content.” Then, in a bewildering 180-degree about face, the CMS Decision Summary argues in favor of expanded coverage for carotid stenting by expanding coverage to standard risk individuals and proposes “removing facility standard and approval requirements.” As a CREST-2 site credentialed sonographer, I have already seen the effects of carotid stenting mania resulting in drastic negative effects for our CREST-2 enrollments. Yet CREST-2 is the very study that is going to resolve the most basic question that needs to be answered with Level 1 evidence, namely: Is there any properly defined, at-risk stroke group that benefits from extracranial carotid revascularization in addition to best medical therapy?

This CMS proposal is an amalgamation of astonishingly contradictory statements and logic-chopping conclusions that will likely lead to widespread misuse of carotid stenting technology. Using CTA and MRA complementary imaging is not going to improve matters. Rather than detail all the fine technical details and reference the literature demonstrating that CTA and MRA are used just as much as carotid ultrasounds to overcall carotid stenosis leading to a surgical intervention, let’s look at the published conclusions from a recent original contribution in Stroke, “Variation in Carotid Artery Stenosis Measurements Among Facilities Seeking Carotid Stenting Facility Accreditation,” which found that “Real-world operators tend to overestimate carotid artery stenosis compared with external expert reviewers. Measurements from facilities granted initial accreditation were closer to expert measurements than those from facilities whose accreditation was delayed. Since decisions regarding carotid revascularization are often based on percent stenosis, such measuring discrepancies likely lead to increased procedural utilization” (Stroke. 2023;54:00–00. DOI: 10.1161/STROKEAHA.122.041397 June 2023). That study examined the variation in real-world assessors’ evaluations of cervical carotid stenosis undergoing CAS at facilities that were actively and voluntarily pursuing accreditation by the Intersocietal Accreditation Commission (IAC), so these are stent interventionists with a higher degree of oversight, experience and rigor in patient selection than what this CMS proposal would turn loose on the world.

Yet in Aesopian language, the authors concluded, “Stenosis measurements from facilities that were granted initial IAC accreditation were closer to expert measurements than those from facilities whose accreditation was delayed. Since decisions regarding carotid revascularization are often based at least partially on percent stenosis, such measuring discrepancies inevitably lead to a higher volume of procedures, which may in turn represent a degree of procedural overutilization.” If this is happening with proceduralists seeking to meet a high bar and wanting outside oversight, then it is fair to say we should all be highly alarmed by the CMS proposal to open the floodgates wide for surgical revascularization!

Even the Society for Vascular Surgery, an organization that certainly can’t be accused of wanting to put the brakes on beneficial surgical revascularizations, is urging opposition to this completely misguided green light to expanding carotid TF-CAS use “With the proposed decision that is ‘leaning toward access’, many new providers who will offer TF-CAS will be inexperienced and low volume. In the proposed decision summary, there is no recommendation or requirement for procedural or center certification and no requirement for monitoring outcomes. None of the RCT’s or studies referenced in the proposed decision provide any evidence that the previous lengthy (estimated >50- 200) learning curve has decreased over time. The influx of a large volume of inexperienced, inadequately trained, low volume providers may well lead to an increased rate of post-TF-CAS stroke.” https://vascular.org/sites/default/files/2023-08/SVS_NCD%2020.7%20Reconsideration%20Comments_Final_8-4-23.pdf To put it plainly, the CMS proposal is guaranteed to lead to grave patient harm!

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I have significant concerns around CMS’ proposed decision memo that would provide broad coverage of TFCAS, independent of patient symptom status and risk stratification. This coverage is not contingent on data entry into societal registries which would have served to establish what the outcomes for this procedure are in all rather than selected patients by all rather than selected operators. Furthermore, there are no guard rails for credentialing or for establishing quality control.

What is very clear is that patients warranting carotid revascularization already have two very safe and effective options that provide both open and minimally invasive (endovascular) solutions; carotid endarterectomy (CEA) and transcarotid artery revascularization (TCAR). Data from the Society for Vascular Surgery’s Vascular Quality Initiative transcarotid surveillance project (VQI TSP) reflect independent uncensored and comprehensive Real World Evidence across a broad range of patient cohorts, multiple health care environments and physicians who may have had little to no prior carotid endovascular expertise. TCAR has repeatedly been shown to be equivalent to CEA for the operative all- stroke risk (equivalence not being achieved by a reduction in the operative MI rates for TCAR). Furthermore, an unspecified number of patients with asymptomatic disease may not require revascularization at all and this will continue to be an unknown before the completion and report of CREST2.

Regarding effective shared decision making (SDM), as it serves to frame informed consent, the specialty that can offer BMT, CEA, TCAR and TFCAS is best positioned to aid in the decision-making process, otherwise, otherwise SDM becomes just a tag-line.

Finalizing the proposed decision will result in many unnecessary and hazardous TFCAS procedures and substantial harm to Medicare beneficiaries.

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I am an interventional cardiologist who regularly evaluates patients with carotid disease and have been performing carotid stent procedures since 2003 . First of all, I would like to thank CMS both for their thoughtful and thorough review of the extensive amount of rigorous data that exists on this topic as well as allowing us the opportunity to advocate for our patients in this public forum.

I take the treatment of extracranial carotid disease very seriously and tend to be conservative in recommending carotid revascularization. Typically I will start with appropriate medical therapy including intensive lipid lowering therapy and in asymptomatic patients will often repeat imaging to look for additional disease progression before considering carotid revascularization.

With this in mind, I would I strongly support the following proposed decisions:

1. Proposal to expand coverage for CAS to patients with symptomatic carotid stenosis greater than or equal to 50% and asymptomatic stenosis greater than or equal to 70% consistent with the large body of data across multiple RCTs.
2. Providing coverage without a requirement to participate in clinical trials or ongoing registries given the large number of patients already studied in this context and the potential for such a requirement to limit access to this therapy.
3. Removal of facility standard and approval requirements. I think it is incumbent on relevant vascular societies to continue to refine clinical practice guidelines / appropriate use criteria for all therapeutic options (medical, CAS, TCAR, and CEA) as additional data becomes available and for hospitals to not only adhere to this, but also to develop rigorous credentialing and peer review processes to ensure high standards of quality are met. However, I think this proposed requirement as is will have an untoward effect of limiting access for patients, especially in underserved communities.
4. Allowing MACs to determine whether to cover CAS for other patients.

I would also recommend that CMS revise two aspects of the Proposed Decision:

1. While I very strongly advocate for a thorough shared decision-making encounter (including multidisciplinary discussion of options when more than one reasonable option exists), I do not feel that doing so with a validated tool is necessary. Currently, no such tool exists, and the development / validation process would take years and unnecessarily delay coverage.
2. I agree that additional non-invasive imaging modalities such as CTA should be utilized when clinically appropriate. I have personally found that MRA can overcall severity of a stenosis and it is not my preferred imaging modality to evaluate the severity of disease. However, there are certain situations that these imaging modalities may not be appropriate. Examples include patients with significant renal dysfunction and in circumstances where disparate results exist among non-invasive imaging studies. In these circumstances, providers should have the opportunity to perform catheter-based angiography so that an appropriate management plan can be developed for the benefit of patient care.

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I am an interventional cardiologist who regularly evaluates patients with carotid disease and performs carotid stent procedures. First of all, I would like to thank CMS both for their thoughtful and thorough review of the extensive amount of rigorous data that exists on this topic as well as allowing us the opportunity to advocate for our patients in this public forum.

With this in mind, I would I strongly support the following proposed decisions:

1. Proposal to expand coverage for CAS to patients with symptomatic carotid stenosis greater than or equal to 50% and asymptomatic stenosis greater than or equal to 70% consistent with the large body of data across multiple RCTs.
2. Providing coverage without a requirement to participate in clinical trials or ongoing registries given the large number of patients already studied in this context and the potential for such a requirement to limit access to this therapy.
3. Removal of facility standard and approval requirements. I think it is incumbent on relevant vascular societies to continue to refine clinical practice guidelines / appropriate use criteria for all therapeutic options (medical, CAS, TCAR, and CEA) as additional data becomes available and for hospitals to not only adhere to this, but also to develop rigorous credentialing and peer review processes to ensure high standards of quality are met. However, I think this proposed requirement as is will have an untoward effect of limiting access for patients, especially in underserved communities.
4. Allowing MACs to determine whether to cover CAS for other patients.

I would also recommend that CMS revise two aspects of the Proposed Decision:

1. Although I very strongly advocate for a thorough shared decision-making encounter (including multidisciplinary discussion of options when more than one reasonable option exists), I do not feel that doing so with a validated tool is necessary. Currently, no such tool exists, and the development / validation process would take years and unnecessarily delay coverage.
2. Although I agree that additional non-invasive imaging modalities such as CTA and MRA can be very useful in the assessment of patients with carotid disease and should be utilized when clinically appropriate, there are certain situations that these imaging modalities may not be appropriate. Examples include patients with significant renal dysfunction and in circumstances where disparate results exist among non-invasive imaging studies. In these circumstances, providers should have the opportunity to perform catheter-based angiography so that an appropriate management can be obtained to the benefit of patient care.

Thank you again for all of your exhaustive work on this important topic and I look forward to a decision that will hopefully allow all vascular providers to provide access to the spectrum of modern treatment options to our patients.

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I am an interventional cardiologist who has been doing carotid stenting for over 10 years. I am extremely glad that after reviewing the state of the art literature and evidence on carotid stenting, CMS is considering expanding the indications for the procedure to include asymptomatic patients with lesions more than 70% and patients at normal risk for carotid surgery outside of the clinical trial setting. I am also supportive of the removal of facility standards and approval requirements for carotid stenting.

I think that having a shared decision making discussion with the patient regarding carotid stenting and alternative management options would be appropriate but waiting for the development of a validated tool would unnecessarily delay delivering the best care for our patients. I also feel that the decision regarding appropriateness of carotid stenting can be made by both CTA/MRA or direct angiography, if CTA/MRA is not felt to be safe for the patient.

I am hopeful that the public comment process will support this change in the CMS guidelines soon.

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I am an epidemiologist and I have been studying carotid disease and the prevention of vascular health outcomes for 16 years, with a particular focus on racial and ethnic disparities.

My personal opinion is that US Medicare should reconsider proposals to fund any procedure known as 'carotid stenting' in anyone age 65 and older with at least 50% or 70% carotid stenosis as well as proposals to remove externally applied procedural standards. I am advocating for minority populations with respect to research regarding carotid arterial disease: Women, those with significant medical comorbidities, particular anatomical characteristics, the elderly, frail, Black, Hispanic and other non-White populations. Although these groups may be considered minorities and are often under-represented in clinical research studies, they comprise a large percentage of the global population, and are at highest risk for stroke and other vascular outcomes.

They may have been the minorities in the randomized trials of CEA versus non-invasive care alone (ACAS, NASCET and ECST-1) but they are not minorities on a global, or even national scale. Those randomized trials involved highly selected patients, making it more likely to find an overall benefit from surgery compared to non-invasive care alone. Those unlikely to benefit have been largely excluded. People who are NOT white, generally fit AND older (but not elderly) men cannot be assumed to have the same risk of stroke or death with or without a carotid artery procedure. This has already been established by the existing clinical evidence. Currently, there is no clear evidence supporting the procedural benefit in any population of individuals with carotid arterial disease compared to using non-invasive care alone (encouraging healthy lifestyle habits and appropriate use of medication).

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Based on clinical data and multiple trials, approval of carotid artery stenting is overdue. This will advance patient care in a very positive way. Evolution of technology made this procedure safe and easily applicable in clinical practice. The patients will benefit the most . Therefore, my vote is to

-Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
-Support coverage without requiring patients to participate in clinical trials.
-Support removal of the facility standard and approval requirements.
-Support allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.

Recommend that CMS revise two aspects of the Proposed Decision:

-The Proposal requires physicians to have a shared decision-making (SDM) interaction with patients, and advocates doing so with a “validated” SDM tool. To develop such a “validated tool” would take years. Please express support for an SDM interaction (including discussion about all options for treatment of carotid disease), but not to delay coverage of CAS pending the development of a “validated” SDM tool.
-The Proposal would require all patients considered for CAS to undergo computed tomography angiography (CTA) or magnetic resonance angiography (MRA) in advance of catheter-based angiography.

Please recommend that CMS allow use of catheter-based angiography when CTA/MRA are contraindicated.

Thank you for your consideration

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I strongly support the expansion of CMS coverage for carotid artery stenting and offer this procedure to a wide group of patients regardless of their risk category. CMS needs to be congratulated and thanked for this bold decision. I have been doing transfemoral carotid artery stenting for about 12 years after graduating from a rigorous cardiovascular fellowship training program. The training program included complex stroke and carotid intervention. Carotid artery stenting is safe, effective and comparable to CEA in long term randomized studies and my experience confirms it. In our practice we have validated these findings with low complication rates and a very low incidence of stroke after CAS of less than 1 %.

I congratulate CMS for this long overdue decision and service to our patients. Patient should have a choice to any contemporary efficacious procedures such as CAS similarly as they have a choice between transcatheter Aortic valve replacement and surgical aortic valve replacement.. CEA is excellent surgical procedure with great outcomes but CAS is non inferior to CEA and provides a durable alternative to CAS. This should be available to all patients. TCAR on the other hand is new upcoming procedure with safety data in various observational studies but lacks any randomized clinical trial and any comparable trials to CEA or CAS. It cannot be standard of care and cannot be regarded above CAS. Obviously patient selection is extremely important and both anatomical and risk factors should be considered in offering CEA or CAS. Its time we advocate for patient care and offer CAS to all patients.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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I have been performing carotid stent procedures since 1996 and have helped a large number of patients over the past several decades who chose to avoid surgery. My complication rate has been as low or lower than that seen with carotid surgery. I urge you to expand the indications for carotid stenting to make this well-studied procedure standard of care for appropriate patients when the procedure is performed by well trained, experienced interventionalists. Although the Shared Decision Making proposal has merit, the practical considerations of developing such criteria would take years and would delay the implementation of new guidelines unnecessarily. Further, the proposal to require CTA or MRA prior to carotid stenting is unnecessary. Many patients with lesions of borderline severity already undergo such imaging but to require such imaging in patients with truly critical disease would result in unnecessary treatment delays not to mention avoidable radiation and contrast which may well be significant as many such patients have chronic kidney disease. A final point is that CTA and MRA are still not as accurate or definitive as invasive carotid angiography. In summary, I urge you to approve the proposal for expanded indication for carotid stenting without required Shared Decision Making and without the requirement for CTA or MRA.

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I am an Interventional Cardiologist refers for CEA and has credentials to do Trans-femoral stenting.
Appreciate CMA for the thoughtful review of the clinical literature and evidence.

Recommend that CMS revise two aspects of the Proposed Decision:

Shared Decision making is an important step for CAS. First of all it is not done in CEA. Also Validated SDM tool takes time. Would suggest not to delay the coverage while waiting for the "Validated Tool".
Suggest to include Catheter Based Angiography as an additional imaging modality with CTA and MRA. Invasive Angiography can be performed with less contrast and it would help in the pre-planning of the Stenting Procedure.

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I am a Registered Nurse in Australia, and worked in Interventional Radiology. I am currently employed as a Lecturer in Nursing at Monash University - ranked 5 in the world on the Shanghai Ranking Of Academic Subjects I have seen countless patients who have presented with stroke who have been treated under best evidence based practice. The proposal to allow asymptomatic patients to have procedures that have a risk element, without evidence does not make sense. There is no evidence that supports offering carotid atery procedures on any person over 65 with 50% or more stenosis is beneficial to the patient. The evidence actually shows that there is greater risk of further complications including death and Myocaridal infarction in sympomatic patients 30 days post procedure. It is more risky than carotid endatectomy.

Having worked with patients, the assumption that there will be shared decision making does not take into account the lack of health literacy of the general population in America. Research by Coughlin et al (2020) shows that 36% of U.S. adults had basic or below-basic health literacy (Magnani et al., 2018); non-whites are more likely to have limited health literacy than whites (Mantwill et al., 2015); and that low socioeconomic status is the most important determinant of health literacy (Stormacq et al., 2019).

Shared decision making relies on health literacy. If a patient doesn't understand the complexities of the medical information provided by their physician, then there is no shared decision making. Patients are heavily dependent on their doctors opinion of best treatment and the US does not have a validated shared decision making tool that ensures patients are properly given informed consent for a carotid artery procedure. This proposal is not evidence based. It appears to be based on a plan to increase the income for the proponents. This is not a reason to change. America's health system is underfunded and the evidence shows that any proposal that has no net benefit to patients will make the matter worse.

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To whom it may concern,

As Chief of Neurovascular surgery i felt it important to comment to support the proposed coverage decision. I would like to thank CMS for its thoughtful review of the clinical literature and current evidence. I am in support of the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence. I support coverage without requiring patients to participate in clinical trials. I support removal of the facility standard and approval requirements. I support allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.

I recommend that CMS revise two aspects of the proposed decision. The Proposal requires physicians to have a shared decision-making (SDM) interaction with patients, and advocates doing so with a “validated” SDM tool. To develop such a “validated tool” would take years. Please express support for an SDM interaction (including discussion about all options for treatment of carotid disease), but not to delay coverage of CAS pending the development of a “validated” SDM tool. The Proposal would require all patients considered for CAS to undergo computed tomography angiography (CTA) or magnetic resonance angiography (MRA) in advance of catheter-based angiography. Please recommend that CMS allow use of catheter-based angiography when CTA/MRA are contraindicated.

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I have been doing carotid stenting for 25 years. I have been involved in trials and registries and have seen the progression of outcome improvement with experience and device development. It iis not unreasonable to desire to open up access to TFCAS as the data from many studies show near equivalent results. However, the outcomes from carotid intervention either with CEA, TECAR and TFCAS depend on rigorous training and outcomes review. The restricted access imposed by the NCD has limited the broad application of TFCAS to practitioners that have qualifications and oversight that would not be in place with removal of the NCD. Depending on credentialling and local control of who is qualified to do TFCAS is a mistake that will result in performance of a highly technical, very technique dependent procedure by an expanded pool of practitioners who will not provide the safe/effective treatment that is seen in the studies referenced in the request for recension of the NCD. It is essential that there be credentialling requirements that are rigorous and I think any expansion of TFCAS without such credentialling would result in large numbers of un-neccessary and poorly performed TFCAS that result in much higher stroke rates than reported in the studies cited to support removal of the NCD.

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Carotid artery stenting has not yet been proven safe and effective for the long-term management of asymptomatic carotid artery stenosis.

Carotid artery disease poses a significant health concern due to its potential to cause stroke, a leading cause of morbidity and mortality. Three primary treatment options have emerged for carotid artery disease: carotid artery stenting (CAS), carotid endarterectomy (CEA), and best medical management consisting of a combination of antiplatelet therapy, statins, smoking cessation, and optimization of other comorbidities (e.g., hypertension, diabetes). The effectiveness of these interventions has been extensively studied, with recent interventional trials such as SPACE 2 and CREST 2 shedding light on their comparative outcomes.

Both CAS and CEA have shown some effectiveness in preventing strokes in appropriately selected patients. CAS offers a minimally invasive alternative to CEA with unproven long-term outcomes, appealing to “high-risk” patients who may not tolerate surgery well. CEA, on the other hand, provides long-term durability and remains the gold standard for symptomatic patients with moderate to severe carotid stenosis.

The Stent-Protected Angioplasty in Symptomatic Carotid Artery Stenosis versus Endarterectomy (SPACE 2) trial compared CAS and CEA in patients with symptomatic carotid artery stenosis. The trial demonstrated that CAS was non-inferior to CEA in terms of the composite primary endpoint of death, stroke, or myocardial infarction (MI) at 30 days. However, when MI was excluded as a component of the composite endpoint, CEA was superior to CAS. In other words, it may not be appropriate to consider death, stroke, and MI as equivalent outcomes.

The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Study 2 (CREST 2) trial evaluated CAS and CEA for asymptomatic carotid stenosis. The trial showed no significant difference in the primary composite endpoint of stroke, MI, or death within 30 days or subsequent ipsilateral stroke up to 4 years between CAS and CEA. This trial underscored the importance of individualized decision-making based on patient characteristics. The same argument holds true. Generally, MI does not affect the patient as dramatically as stroke.

The effectiveness of carotid artery stenting has not been proven to prevent strokes through various clinical trials, including SPACE 2 and CREST 2. These trials have helped guide treatment decisions for both symptomatic and asymptomatic carotid stenosis. Medicare reimbursement for CAS has evolved to accommodate a broader range of patients, while Medicaid reimbursement varies by state. As medical evidence continues to accumulate, ensuring equitable access to effective treatments like CAS remains a critical consideration for policymakers, healthcare providers, and patients alike. Reimbursement for CAS for asymptomatic carotid stenosis will come at a dramatic cost to the US healthcare system, without any proven clinical advantage over best medical therapy. It is incumbent on CMS and public health officials to be cautious at this time and further analyze the data from CREST 2 to best determine the cost effectiveness of CAS in the asymptomatic patient, prior to a determination to approve broader reimbursement for this procedure.

Mark A Adelman, MD
Professor of Surgery, Chief of Vascular Surgery (Ret.)
NYULangone Medical Center

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The performance of stenting the carotid artery for asymptomatic disease is a very tight window for risk v. benefit. The absolute most critical step is avoidance of stroke intraoperatively.

The largest Randomized control trials have demonstrated time after time that transferal carotid stenting carries at least DOUBLE the procedural stroke risk compared to CEA and TCAR, even when being performed by vetted providers. If these rule goes through, the entire medicare population will be exposed to a much larger group of interventionists who can only offer Transfemoral stenting and thus will dramatically increase the number of patients at risk for DOUBLE the stroke rate.

The equipoise outcomes in the RCT are inappropriate for determining safety in this procedure as the NSTEMI rate was higher with surgery. Coronary demand ischemia is no where near as devastating to a patient as a stroke.

Please do not pass through this initiative. It will put thousands of Americans at risk of unneeded stroke.

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I am a board certified vascular surgeon and I do not support this change.

Carotid stenting is one of three main procedures that deal with the management of carotid artery stenosis. Despite being a minimally invasive procedure, several trials have noted an increased stroke rate in patients when compared to traditional surgery (carotid endarterectomy). Furthermore, outcomes are quite worse in patients over the age of 70. As such, it has limited use in the modern management of carotid artery disease.

I have several concerns about this change.

First of all, the requesting body calls itself the "Multispecialty Carotid Alliance." This "Alliance" is composed of several different specialties that treat carotid disease that include interventional radiologists, interventional cardiologists, interventional neuroradiology, neurosurgery, neurology, and lastly, vascular surgery. While it is great that this group is multidisciplinary, it is not a formally recognized entity, and certainly NOT recognized by the Society for Vascular Surgery. As such, despite the presence of TWO vascular surgeons, their comments, support and signature of this document DO NOT represent me in ANY WAY. The only Societal statement that I fully support is that provided by the SOCIETY FOR VASCULAR SURGERY.

My second concern is about the consequence of making such a change. Whatever CMS approves to cover impacts the care of millions of Americans. For example, when office-based procedures were covered for peripheral arterial disease (atherectomy/angioplasty), there was a sharp increase in its use nationwide. This was beneficial for patients with conscientious physicians, but there are several examples of "bad apples" that subjected patients to many unnecessary procedures that led to amputations and even death (as shown in a recent New York Times article). There is no doubt in my mind that as soon as this change is made, at least tens of thousands of patients will be subjected to unnecessary stenting with some of these patients getting a stroke from the procedure.

Furthermore, there are unanswered questions in the field of carotid disease. Many of our current recommendations come from clinical trials performed 30 years ago. Our understanding and use of medical therapy (statins, antiplatelets, and anticoagulation) and the quality of perioperative care (ie. anesthesia) has improved significantly in these last three decades. As such, it is quite possible that we may already be overtreating patients, particularly those with asymptomatic disease.

Finally, carotid disease affects mostly the elderly. This is a very VULNERABLE patient population. Their generation is one that tends to trust their physician, especially when being told that they have a "ticking time bomb" that will cause permanent harm if they don't have their procedure done. It is truly a disservice to our patients to lower the bar and offer them a subpar treatment.

My plea comes from not only being an expert in the management of cerebrovascular disease, but also because I've taken care of many patients who had unnecessary procedures from other physicians, and it truly breaks my heart to see harm done when it could have been prevented in the first place.

Thank you for allowing us to comment on this very important issue.

Carlos E. Pineda, M.D.
Fellow of the Society for Vascular Surgery

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Tamara Syrek Jensen, Director
Joseph Chin, Deputy Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, Maryland 21244

RE: Comments on Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8) Proposed Decision Memo

Dear Ms. Syrek Jensen and Dr. Chin:

The Society of NeuroInterventional Surgery (SNIS) expresses its strong support for the Centers for Medicare & Medicaid Services’ (CMS) proposed coverage decision for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8). We firmly believe this decision will help ensure Medicare beneficiary access to carotid artery stenting (CAS) and ask CMS to finalize it with one important modification as discussed below.

SNIS is a multidisciplinary group of interventional neuroradiologists, endovascular neurosurgeons, and interventional neurologists with shared interest and expertise in the endovascular treatment of vascular neurologic disease, including ischemic stroke. Within the Medicare population, our members perform the vast majority of mechanical thrombectomies, by far the most efficacious surgery for ischemic stroke. Pursuant to our multidisciplinary nature, our members additionally have expertise in the diagnosis and medical as well as open surgical management of neurovascular disease, including carotid stenosis. Thus, we feel highly qualified to make recommendations regarding the CMS’ coverage policy for CAS.

SNIS fully supports CMS’ proposed expansion of the indications for CAS to symptomatic patients with 50% or greater carotid stenosis and asymptomatic patients with 70% or greater carotid stenosis, without requiring patients to participate in clinical trials. We also agree that unnecessary facility requirements should be eliminated, and Medicare Administrative Contractors (MACs) should make coverage determinations for Medicare beneficiaries who don’t meet the coverage criteria outlined in the Proposed Decision Memo. In addition, SNIS supports CMS’ deference to the treating provider’s management of the patient, rather than imposing any requirement that specific specialists be consulted.

As noted in our comment letter submitted February 7, 2023, we agree with CMS that medical care should be optimized for all patients with carotid artery stenosis, taking into account individual risk factors and other medical conditions, including the comorbid conditions of the patient, the age, the body habitus, and very importantly the vascular anatomy. Patients must be adequately informed of the diagnosis and treatment options, and providers must understand the patient’s clinical status and preferences.

As CMS notes, there is currently no validated, evidence-based shared decision-making (SDM) tool for CAS, and, therefore, we do not believe that the use of such a tool should be required. We believe that CMS can accomplish its goal of truly informed patient decision-making by requiring that physicians document in the medical record an SDM conversation that involves (1) discussion of all treatment options for carotid stenosis; (2) explanation of risks and benefits for each such treatment option; (3) integration of clinical guidelines; and (4) discussion and incorporation of beneficiary preferences. CMS could, indeed, state that, in the future, a validated SDM tool can be used to meet these requirements and, thus, encourage clinicians and societies to develop such a tool. However, we are concerned that requiring a validated SDM tool up front would delay access to CAS when provider documentation is sufficient to meet CMS’ goals.

We greatly appreciate CMS’ thorough and well-reasoned proposed coverage decision. CMS’ considered proposal reflects advances in research and medical practice since CMS’ issuance of the original CAS NCD. We thank CMS for its continued, dedicated work to ensure Medicare beneficiaries have access to all appropriate treatment options for carotid artery disease.

Sincerely,

Mahesh Jayaraman, MD
President

J Mocco, MD
Immediate Past President

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Good afternoon. I am a board certified vascular surgeon in San Diego. I have been in practice since 2006. I have been performing carotid stenting and carotid surgery since starting practice in 2006. Starting in 2017 I began to perform transcarotid artery revascularization/stenting (TCAR). I now perform both CEA and TCAR for appropriate patients with carotid disease. Based on evidence based research, I now rarely perform transfemoral carotid stenting as the rates of stroke have been found to be consistently higher and outcomes consistently worse.

It would be an absolute travesty and would directly harm patients if CMS were to approve CAS across the board for all patients. There are nuances to he data but suffice it to say that approving this NCD will cause irreparable harm to patients and lead to significantly increased use of an inappropriate and inferior procedure compared to TCAR and CEA. CMS should reject this NCD as the result will be impossible to justify.
Sincerely, Scott E Musicant, MD,

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I am a Neurointerventional Radiologist that performs a high volume of CAS on patients with radiation related carotid disease. Thank you for your very thoughtful review of the literature.

Sincerely,
Stephen Chen, MD
Associate Professor
Neurointerventional Radiology

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I am a vascular surgeon in clinical practice in Portland, Oregon. I completed all of my medical training in the United States and I am board certified in vascular surgery by the American Board of Surgery. I write today to express my concerns about the proposed update to NCD 20.7 regarding angioplasty of the carotid artery with stenting.

The current safety standards around coverage for carotid artery stenting are robust. This is necessary since the existing evidence around this procedure suggest an increased risk of periprocedural stroke as compared to carotid endarterectomy. The best published data are from the CREST trial (N Eng J Med 2010; 363:11-23), in which the reported rate of periprocedural stroke was nearly twice that for endarterectomy. In addition, these published results for transfemoral stenting were achieved by highly experienced operators in centers required to undergo a certification process. It is unlikely that these results can be replicated to the same degree of safety going forward without these safeguards. In my view, the net result of this proposed update will undoubtedly be an increase in volume for transfemoral stenting, and I am skeptical that this will improve public health outcomes, to say nothing of the additional expense to CMS over best medical therapy. The current regime with the requirements for real-time data reporting, a credentialing process, and coverage determination based on clinical criteria are vital for maintaining the current safety profile of the procedure.

I respectfully urge CMS to reconsider this update. The forthcoming results of the CREST 2 trial may yet shed more light on appropriate criteria for carotid intervention and I strongly believe that the status quo should be preserved until these results are published.

Thank you.

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As a vascular surgeon who performs CEA, tfCAS, and TCAR I have substantial concerns about the proposed NCD changes.

Those of us who made it through the process of credentialing for CREST and the registries understand the rigorous criteria employed, and that not all who applied were given access. This led to better outcomes than had been previously seen but cannot be assumed to be generalizable to the broad community. The CMS requirements for local credentialing committees and collection, review, and reporting of outcomes to CMS led to local restriction of privileging to the few proceduralists who had the experience and volume to be able to have reasonable outcomes. To take away the credentialing requirements and do away with data collection and reporting will open the door to anyone wanting to do the procedure without any credentialing or monitoring of outcomes. Large real-world registries are our best hope of detecting an increase in adverse outcomes as this is rolled out. For a prophylactic procedure with a small margin of benefit particularly in asymptomatic patients, this seems foolish and dangerous and an abdication of responsibility.

All of the RVT and registry studies demonstrated an age effect in that the elderly did worse with tfCAS. Comparative studies showed that this was not the same for CEA and CEA was significantly better above age 73. Since the majority of Medicare beneficiaries who would undergo this procedure are above this age it should be a great concern to those making this decision.

Having performed over 500 tfCAS procedures and taught dozens of others to perform this procedure, I agree with every study that evaluated the learning curve in their finding that 50-200 cases are required before optimal and acceptable outcomes are achieved on a large scale. This also should bring great concern to those making this decision as the current plan of allowing broad access to this procedure without credentialing or monitoring or a training paradigm. It will almost certainly be impossible to get all providers through the learning curve and to have adequate annual numbers to actually have a positive benefit on patients.

All studies showed a stroke/death benefit of CEA over tfCAS. Even in asymptomatic patients where event rates are lower the effect size and direction of outcome benefit were similar to symptomatic patients, but low event rates made it difficult to demonstrate statistical significance without meta-analysis which did subsequently demonstrate superiority of CEA.

TCAR is an example of a procedure that has a minimal learning curve (for stroke/death) and has been subjected to rigorous analysis with mandatory outcome reporting in the VQI where it has been demonstrated to have equivalent outcomes with CEA. If tfCAS is to be expanded it seems only reasonable that a similar mechanism be in place to track outcomes as this is expanded widely to truly demonstrate if the initial RCT and registry (with rigorous participation criteria) results are generalizable and even if this is so, to compare the effectiveness of tfCAS to CEA and TCAR. Despite what was suggested we currently have no data to show this is the case. All registries quoted by the alliance had rigorous selection criteria.

I agree that TCAR should be evaluated in an RCT vs CEA and perhaps tfCAS. I would also support outcome reporting for CEA to have better comparisons in registries and again to assure appropriate outcomes for asymptomatic patients.

Shining a light on the results of all of these procedures is the most appropriate way for us to see the best path in the future. Hiding in the darkness with our eyes closed and ears covered is not.

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I believe that the coverage decision is a welcome change and quite fair, allowing multiple options for treatment of patients without symptoms but significant disease. Depending on patient anatomy and operator skill/comfort, they can be treated with TCAR, transfemoral, or transradial carotid stenting. These approaches have similar outcomes in the modern era based on current data. Allowing for patient choice is important as well and broadening coverage allows for this. The shared decision making model also allows for oversight rather than leaving decision to proceed to just the operator.

We have been waiting years for what is a long overdue decision. The TCAR carotid stent data confirmed the efficacy of carotid stents in comparison to CEA in the asymptomatic population. Broadening coverage to different access approaches allows for more options for patients and providers regardless of operator specialty.

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The Society for Vascular Medicine (SVM) is a non-profit professional association with over 600 members representing the majority of practicing vascular specialties in the United States, including but not limited to vascular medicine, cardiovascular medicine, interventional cardiology, interventional radiology, and vascular surgery. Most of our members and member specialties manage patients with carotid artery disease. Several SVM members are considered thought leaders in the field of carotid artery disease and have contributed to multidisciplinary expert consensus statements on physician training and credentialing guidance to facilitate the safe and effective incorporation of carotid artery stenting (CAS) into clinical practice. One of our mission statements is – “Promoting interdisciplinary clinical excellence in the diagnosis and treatment of vascular disease through the creation of care standards and by engaging in quality improvement activities.” SVM has a very “patient centric” philosophy. For that reason, we have a strong interest in ensuring that a Medicare coverage policy for CAS aligns with the available, voluminous data and the current state of technology for the management of atherosclerotic extracranial carotid artery disease.

SVM applauds CMS for a thorough and thoughtful analysis of the extensive body of clinical evidence and the public comments from healthcare professionals regarding carotid artery interventions. SVM strongly supports CMS’s proposal to update the patient selection criteria in the National Coverage Determination (NCD) to mirror results from this clinical research and to parallel existing access to carotid endarterectomy (CEA) by expanding coverage to include patients at standard surgical risk, patients with symptomatic carotid artery stenosis of at least 50%, and patients with asymptomatic carotid artery stenosis of at least 70%. SVM further supports CMS’s proposal to permit determination of facility and operator requirements through hospital credentialling processes and based on medical society guidelines, similar to requirements in place for other well-established interventional procedures.

Regarding the proposed imaging requirements, SVM recommends some modifications to the language in the proposal to reflect the current standard of care and needs of certain patients. In limited cases, additional magnetic resonance angiography (MRA) and computed tomography angiography (CTA) imaging may be contraindicated for a variety of reasons such as chronic or acute kidney disease or in patients with pacemakers. We do not recommend intra-arterial digital subtraction (catheter) angiography for first-line imaging, but it may be necessary for further imaging of carotid stenosis when there is (1) a significant discrepancy between non-invasive imaging results, (2) clinical contraindications to non-invasive imaging, or (3) a clinical need for additional information to inform optimal patient care. With advances in technology and techniques, physicians can now perform selective angiography with an exceptionally low risk of complications.1,2

Appropriate patient selection is paramount to achieving optimal outcomes for patients and their families and is applicable to all treatment options, including medical management, transfemoral CAS, transradial CAS, Transcarotid Artery Revascularization (TCAR), and carotid endarterectomy (CEA). SVM supports a shared decision-making (SDM) interaction with all patients that includes the four core elements outlined by CMS:

I refer patients for CAS and I am thankful CMS reviewed this an agrees that carotid stenting is a procedure that is safe and efficacious and deserving of expansion of coverage to standard risk patients. I ask that CMS

The American College of Cardiology and the American Heart Association appreciate the opportunity to provide comment on the National Coverage Determination (NCD) 20.7 for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting. There have been significant developments since the last consideration in 2009, and we strongly support updating NCD 20.7 to broaden the coverage indication to Medicare beneficiaries to reflect those developments.

The American College of Cardiology (ACC) is the global leader in transforming cardiovascular care and improving heart health for all. As the preeminent source of professional medical education for the entire cardiovascular care team since 1949, and now with more than 56,000 members from over 140 countries, the ACC credentials cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. Through its world-renowned family of JACC Journals, NCDR registries, ACC Accreditation Services, global network of Member Sections, CardioSmart patient resources and more, the College is committed to ensuring a world where science, knowledge and innovation optimize patient care and outcomes. Learn more at www.ACC.org or follow @ACCinTouch.

The American Heart Association (AHA) is the nation’s oldest and largest voluntary organization dedicated to fighting heart disease and stroke. Our 100+ years of work supporting patients and eradicating the root causes of heart disease and stroke have brought together over 40 million volunteers representing communities across the United States and those involved in their health care. Learn more about our work at heart.org.

Expansion of Coverage
Carotid Artery Stenting (CAS) was first introduced in 1994 and the field has matured in the last three decades. Comprehensive management of atherosclerotic vascular disease is now standard practice in cardiovascular medicine and interventional cardiology training programs and carotid artery stenting is a well-established treatment option. ACC and AHA are pleased to see that the Centers for Medicare and Medicaid Services (CMS) expanded coverage to individuals previously only eligible for coverage under clinical trials and removed the limitation of coverage to only high-risk individuals.

CAS and CEA are complimentary techniques with some patients being more suited for one versus the other. Published, peer-reviewed evidence supports CAS as a reasonable alternative to CEA in both high and average surgical risk patients and is reflected in multiple guidelines, endorsed by a broad range of relevant professional societies. We support the expansion of coverage in Medicare patients for carotid artery angioplasty and stenting in asymptomatic patients with = 70% stenosis and patients with symptomatic carotid artery stenosis = 50% and agree with eliminating the requirement that patients be at high risk for CEA. These procedures are complimentary and are not mutually exclusive for the indicated patient population. These indications would align coverage with the CREST trial and the 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/ SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease (1).

Changes to Facility and Operator Requirements
ACC and AHA support the removal of the facility and operator requirements for CAS consistent with the current state of the published literature and standard clinical practice. The facility and operator requirements are more appropriately handled through hospital credentialling processes and medical society guidelines as is done for other well-established procedures. Guidance for such monitoring and quality oversight has been provided by the Society for Cardiovascular Angiography and Interventions (SCAI) and the Society of Vascular Medicine (SVM)(2).

Role of Registries
The current NCD requires data collection and submission to CMS, though CMS placed a moratorium on the data submission requirement in 2017. There are decades worth of solid data through several large randomized controlled trials (RCT) that have shown equivalency of CAS to CEA for primary endpoints of death and stroke with or without including myocardial infarction; and there has been ample tracking of CAS outcomes in several real-world registries. While CMS is proposing to no longer require data collection, there is a great deal of value in the registry model for continuous monitoring of outcomes and quality measures. The ACC and AHA agree with CMS in no longer requiring data collection, as such a requirement could have unintended consequences in limiting access to CAS based on registry participation and as noted above, there are sufficient data regarding outcomes with this procedure. We, however, will continue to encourage facilities to participate in data collection through registries, as participation will continue to create value for future patients, clinicians, and facilities as a mechanism of quality improvement, safety, and appropriate use verification especially as coverage indications are expanded and particularly for newer techniques such as transcarotid artery revascularization (TCAR) where the data for its safety and efficacy is less robust.

Neurologic Review
The undersigned organizations are requesting further clarification regarding the requirement for an “independent neurologic assessment” before and after the procedure. In a clinical setting, requiring a physician to complete the neurologic review before and after the procedure would be impractical and costly. We would support the inclusion of language to specify that “a neurologic assessment” be performed by any NIH stroke scale trained health professional, including a physician assistant, nurse practitioner, or clinical nurse specialist, as is current practice for carotid endarterectomy. The use of the term “independent” is vague—it could mean someone other than the operator, someone outside the practice, a neurologist, etc.—and such language has proven problematic in other policies, as discussed further below.

Shared Decision-Making
CMS is proposing that a shared decision-making (SDM) interaction must involve the use of a validated SDM tool and must include discussion of all treatment options for carotid stenosis, an explanation of risks and benefits for each option specific to the beneficiary's clinical condition, and discussion and incorporation of the beneficiary's personal preferences and priorities in choosing a treatment plan. SDM is critical in helping patients make appropriate decisions and we are highly supportive of SDM. ACC has developed a number of SDM tools through the CardioSmart forum. However, to date, no validated SDM tool that includes the provisions proposed in the CAS decision memo exists; and therefore, a SDM requirement is premature. Similarly, CMS did not require SDM for TAVR given the of lack of decision aids available at the time the NCD was updated. Additionally, the current standard of care for carotid revascularization for CEA is an in-person patient and physician discussion. At this time, we would advise that the same standard of care be applied in the case of CAS while a SDM tool is developed and then validated.

Providing Clarity on "Validated Shared Decision-Making Tool"
The undersigned organizations are seeking further clarification as to what constitutes an "evidence-based tool", or in the case of the CAS decision memo, a "validated shared decision-making tool". This is a key question for implementation of all the CMS NCDs that include a SDM requirement. In the Implantable Cardioverter Defibrillator (ICD) decision memo, CMS pointed to “an existing SDM tool for ICDs” created and studied with funding from two large research grants. CMS goes on further to specify why this tool is highlighted as an example of an “evidence-based decision tool” stating, “The decision aid tools… were developed based on research study findings and interviews with patients"(3). This CMS explanation reflects best practices in decision aid developing and testing.

User-centered design is an essential aspect of a SDM tool as alluded to by the CMS statement above and outlined in “Systematic Development of Patient Decision Aids: An Update from the IPDAS Collaboration"(4). This manuscript highlights 11 key features in decision aid design and testing, including engagement of “potential end users” and “health professionals” and outlining a need for 3 or more iterative cycles with changes implemented between each iteration. A “minimal,” “medium,” or “maximal” process is described with an emphasis on real-world conditions: “In practice, teams must make decisions about the strategies they will employ to develop decision aids based on considerations related to time, costs, and urgency of the topic. It is also important to note that the development process is ongoing and should continue as the decision aid is used in real world decision making and as new data arise about new decision-making needs, adaptations for additional user groups, and so on(4)."

It is our recommendation that any future requirement of the use of decision-making tools include language to guide real-world clinical teams in design or selection of tools, thus leading to greater implementation. At one extreme, it is not appropriate for a physician to simply execute a drawing to guide complex discussions, and at the other extreme, it is not feasible to require every tool be created through Patient-Centered Outcomes Research Institute (PCORI) grants. Methodologies and best practices exist on how to develop a SDM tool based on trials, such as the International Patient Decision Aid Standards (IPADS)(5). We recommend that CMS adopt such standards and provide a definition of a "validated shared decision-making tool" so that tools can be developed that meet CMS's SDM requirements. The ACC and AHA would be happy to take this up as a separate topic of discussion, relevant to many coverage topics.

Providing Clarity on “The Practitioner”
In the current decision memo, SDM must be led by "the practitioner." While the wording appears intentionally vague, it could be more read that the physician performing the procedure must be the one to carry out an SDM process with a decision-making tool. Most cardiovascular practices are now team-based, and physicians recognize the strengths and skillsets of their colleagues, particularly as it relates to patient education, values clarification, and shared decision-making. While we agree that the physician performing the procedure should engage in an SDM process (defined as making a decision among choices) prior to an informed consent process (defined as providing a one-way stream of information about final risks/benefits of the choice already made), this discussion is often made stronger by SDM processes with decision-support tools by other members of the cardiovascular team which could serve as documentation of the team process as a whole.

In recognition of the importance of team-based care models, the 2018 National Coverage Determination for ICDs expanded the team members that could participate in the SDM process, including “a physician (as defined in Section 1861(r)(1)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5))”(6). This was distinct from the 2016 NCD for left atrial appendage closure (LAAC), in which the "formal shared decision making interaction" was required to occur with "an independent non-interventional physician"(7). There was much concern raised about the burden for beneficiaries to travel for a third appointment for SDM to occur if the referring clinician was a primary care physician uncomfortable with the SDM process for this decision, or a care team member such as an advanced practice provider (APP) which includes nurse practitioners and physician assistant. Confusion remains regarding the meaning of “an independent non-interventional physician” that has impacted patient access and coverage of LAAC as well as physician reimbursement. Therefore, we recommend adopting the same approach to execution of SDM as deployed in the ICD decision memo.

The ACC and AHA thank CMS for the opportunity to provide comment on the proposed NCD 20.7 for PTA of the Carotid Artery Concurrent with Stenting. We support expansion of access to this widely performed procedure that has well-established safety and health outcomes. Please direct any questions or concerns to Amanda Stirling, Regulatory Affairs Associate, at (202) 375-6553 or astirling@acc.org.

Sincerely,
B. Hadley Wilson, MD, FACC
President, American College of Cardiology

Joseph C. Wu, MD, PhD, FAHA
President, American Heart Association

1. Brott TG, Halperin JL, Abbara S, et al. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. J Am Coll Cardiol. 2011 Feb 22;57(8):1002-44.

2. Aronow HD, Collins TJ, Gray WA, et al. SCAI/SVM expert consensus statement on carotid stenting: Training and credentialing for carotid stenting. Catheter Cardiovasc Interv. 2016 Feb 1;87(2):188-99.

3. Centers for Medicare & Medicaid Services. Implantable Cardioverter Defibrillators (ICDs). https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=288

4. Witteman HO, Maki KG, Vaisson G, et al. Systematic Development of Patient Decision Aids: An Update from the IPDAS Collaboration. Med Decis Making. 2021;41(7):736-754.

5. International Patient Decision Aid Standards (IPDAS) Collaboration. http://ipdas.ohri.ca/ipdas_checklist.df

6. Centers for Medicare & Medicaid Services. Implantable Cardioverter Defibrillators (ICDs). https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=110

7. Centers for Medicare & Medicaid Services. Percutaneous Left Atrial Appendage Closure (LAAC). https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=367

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Re: Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting; CAG-00085R8

The mission statement of CMS is: “The CMS seeks to strengthen and modernize the Nation’s health care system, to provide access to high quality care and improved health at lower costs.” The recent CMS proposed coverage expansion of percutaneous transluminal angioplasty and stenting (NCD 20.7) is at striking odds with its mission statement.

To provide a brief background to my personal response, I am a board-certified, fellowship-trained vascular surgeon and have been managing patients with carotid occlusive disease for over 35 years. I was a site PI of the NASCET, ACAS and CREST (credentialed for CAS and CEA) trials when I was a faculty member at the University of Arizona and have performed over 1000 CEAs, hundreds of TF-CAS stent procedures, and a modest number of TCAR procedures. I have also directed ACGME-accredited vascular surgery resident and training programs for the last 29 years. I have a research and publication record in the diagnosis and management of carotid disease.

I strongly believe this proposed coverage decision is premature, flawed, and is very likely to cause patient harm. It is antithetical to the provision of “high quality care and improved health at lower costs.” I base these conclusions on the following major points:

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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As President-Elect of the Society for Vascular Surgery, I disagree with CMS’ proposed decision relating to NCD 20.7 and expansion of coverage for carotid artery stenting. The expansion to include standard risk and asymptomatic patients should be delayed until the results of the CREST II study are available, as this would add valuable information to our decision-making process. The lack of this important data hinders our ability to formulate an appropriate “Shared Decision Making” tool among the applicable specialty societies and care providers. Currently, a validated shared decision-making tool is not available for implementation, and the development of one without the results of CREST II would be premature. In addition, a definition of “Qualified Physician” and demonstrated core competency standards relating to these procedures needs to be developed with input from the relevant stakeholders. Lastly, we must assure patient safety through real-time and real-world outcomes assessment linked with the continuation of credentialing and following reporting standards guidelines. All clinical care providers are dedicated to assuring patient safety as our primary concern. In order to best guarantee patient safety, the development and implementation of a shared decision-making tool based on the best available data, the assurance of appropriately trained providers, and critical assessment of patient outcomes is imperative to assure quality patient care and patient safety.

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If, however, the agency moves forward to finalize the proposed expansion coverage, the finalized memorandum should reflect their outlined recommendations.

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The overwhelming preponderance of peer reviewed evidence DOES NOT support use of trans-femoral carotid angioplasty and stenting (TF-CAS) for asymptomatic patients. A 2-3 fold higher perioperative stroke risk is evident in large database analyses and across various RCTs. Notably, the higher stroke rates occurred in controlled settings even when 'expert' stenters were doing these procedures. Accordingly, it would be irresponsible to allow coverage of TF-CAS for asymptomatic carotid artery stenosis indications. Using the argument that it should be used in 'anatomic high risk' or 'physiologic high risk' patients still should not be applied in the asymptomatic cases. Contemporaneous medical therapies are excellent at reducing annualized stroke risk even among patients with asymptomatic high-grade carotid artery stenosis. Also, historical trials had 75-80% 5-year survival in their medical vs. CEA cohorts reflecting 'good risk' patients since patients need to live long enough to derive benefit from the prophylactic revascularization. This is why using 'high physiological' or 'anatomical risk' criteria probably should not be used to justify procedures in normal or high-patients (e.g., you're not supposed to offer prophylactic carotid revascularization for asymptomatic indications in poor risk patients!).

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To Whom It May Concern:

I am a physician who performs carotid artery stenting. Thank you CMS for your thoughtful review of the clinical literature and current evidence of carotid artery stenting. I ask you to finalize key components of the proposed decision:

-Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis greater than or equal to 50% and patients with asymptomatic carotid artery stenosis greater than or equal to 70%, as supported by the current clinical evidence.
-Support coverage without requiring patients to participate in clinical trials.
-Support removal of the facility standard and approval requirements.
-Support allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.

I recommend that CMS revise two aspects of the Proposed Decision:

-The Proposal requires physicians to have a shared decision-making (SDM) interaction with patients, and advocates doing so with a "validated" SDM tool. To develop such a "validated tool" would take years. I express support for an SDM interaction (including discussion about all options for treatment of carotid disease), but not delay coverage of CAS pending the development of a "validated" SDM tool.
-The Proposal would require all patients considered for CAS to undergo computed tomography angiography (CTA) or magnetic resonance angiography (MRA) in advance of catheter-based angiography. I recommend that CMS allow use of catheter-based angiography when CTA/MRA are contraindicated.

Thank you,
Charles D. O'Shaughnessy, M.D., FACC, FSCAI, FAHA

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August 9, 2023

Tamara Syrek Jensen, Director
Joseph Chin, Deputy Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, Maryland 21244

RE: Comments on Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8) Proposed Decision Memo

Ms. Syrek Jensen and Dr. Chin,

The Neurocritical Care Society (NCS) appreciates the opportunity to submit comments on the Centers for Medicare & Medicaid Services’ (CMS) Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting. NCS is proud to be the only professional society representing multi-disciplinary teams of neurocritical care providers around the world whose mission is to improve outcomes for patients with life-threatening neurological illnesses. Comprised of physicians, nurses, pharmacists, advanced practice providers, researchers, and scientists, the neurocritical care team serves patients with life-threatening brain and spinal cord emergencies and injuries, using training in areas like advanced brain and nervous system monitoring and pharmacotherapy, with one goal — to bring their collective knowledge to drive the best possible outcomes.

We believe that the Proposed Decision Memo accurately reflects recent advances in research and treatment and aligns with our members’ approach to care. We appreciate that it would expand Medicare beneficiary access to carotid artery stenting (CAS) without requiring additional evidence collection. It also would allow Medicare Administrative Contractors to make broader coverage determinations than the national coverage policy, as clinical evidence to evolves. NCS supports CMS’s decision not to adopt specific clinician, care team, or facility requirements in its proposal and to, instead, defer to societal guidelines and decisions of local facilities. We encourage CMS to finalize the Proposed Decision Memo to facilitate access to CAS without restricting or prescribing the involvement of specific specialists and care team members as this can delay or impede care particularly for symptomatic patients.

While we support the need for shared decision-making, NCS urges CMS to finalize the proposal without requiring the use a validated shared decision-making tool. Indeed, no validated shared decision-making tool exists, and it would take years to develop and validate one. Rather, CMS should require providers to document their formal shared decision-making conversation in the electronic health record. This documentation should include:

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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I am an Interventional Cardiologist who has performed carotid stenting since 1997.

I want to thank CMS for their review of the literature and current evidence.

I support the proposal to expand coverage to those patients with symptomatic stenosis >50% and asymptomatic stenosis >70% , while also supporting coverage for patients without participating in clinical trials. I support the removal of faculty standards and approval requirements and support allowing MAC's to determine whether to cover CAS for other patients,

I would like to see the requirement to have a shared decision making interaction with a validated SDM tool removed. It will take years to develop such a validated tool. I do support an SDM interaction to discuss all options for treatment of carotid disease , but do not support the need for a validates SDM tool, If an MRA or CTA is contraindicated , i would like to support the use of catheter based angiography .

i have had the pleasure of treating over 1500 patients with carotid stenting over the past 20 plus years, and feel this important technology should be available to more physicians and patients and this current CMS proposal can do jus that.

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The Society for Cardiovascular Angiography and Interventions (SCAI) has dedicated its work to advancing the profession and is the designated society for guidance, representation, professional recognition, education, and research opportunities for invasive and interventional cardiology professionals. For more than 40 years, SCAI has personified professional excellence and innovation globally, fostering a trusted community of more than 5000 members dedicated to medical advancement and lifesaving care for adults and children with cardiovascular disease.

SCAI has a strong interest in ensuring that Medicare coverage policy for CAS aligns with the available and voluminous data and the current state of technology for the management of atherosclerotic bifurcation carotid artery disease (CAD). SCAI appreciates the opportunity to comment on this national coverage determination.

SCAI strongly supports the analysis by CMS in the proposed decision memo and the conclusion to expand coverage to include patients at standard surgical risk, patients with symptomatic carotid artery stenosis of at least 50%, and patients with asymptomatic carotid artery stenosis of at least 70%. SCAI confirms that no specific physician, care team, or facility requirements are needed as standards adequately exist in our societal guidelines and outcomes at local facilities can be audited or reviewed by appropriate entities, just as those requirements are managed for other well-established procedures.

SCAI supports the proposal that the treating provider has primary responsibility for care management. Requiring a patient to see multiple physician specialists as a condition for coverage could delay or limit patient access and may be unavailable in certain regions thus limiting care access to vulnerable patients if made mandatory. All qualified treating physicians, regardless of specialty, are well-versed in providing patients with up-to-date information and personalized advice on all treatment options and their associated risks and benefits even if they do not personally offer all possible treatment options. This practice and level of physician education is true of all established areas of medicine with multiple treatment options and is commonly performed by the SCAI membership in discussions of endovascular PCI versus surgical CABG revascularization.

While SCAI supports the continued advancement of care through clinical research, SCAI concurs with no requirement for participation in a national registry as a condition for coverage. Clinical equipoise between CAS and carotid endarterectomy (CEA) has been supported by 4 RCTs reported since 2010, consistently demonstrating equivalence in procedural outcomes, long-term stroke prevention, and durability. Each hospital system locally monitors its outcomes through quality assurance and peer-review processes.

Regarding diagnostic imaging, SCAI recommends some modifications to the language in the proposal to reflect the current standard of care and its continued advancement over time. Additional magnetic resonance angiography (MRA) and computed tomography angiography (CTA) imaging may be clinically contraindicated in clinical scenarios including in the presence of chronic renal failure or in patients with implants that are not MRI-conditional. Intra-arterial digital subtraction (catheter) angiography is not recommended for first-line imaging, but it can be useful for further imaging of carotid stenosis when there is (1) significant discrepancy between non-invasive imaging results, (2) clinical contraindications to non-invasive imaging, or (3) when additional information can be provided to inform optimal patient care. With advances in technology and techniques, physicians can now perform selective angiography with an exceptionally low risk of complications compared to previous approaches.

SCAI supports a shared decision-making (SDM) interaction with all patients and concurs with the four core elements outlined by CMS:

As a vascular surgeon that recently completed a vascular surgery fellowship, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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 which is very important to me.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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I am writing in support of expanding coverage to Carotid Artery Stenting. Many patients go untreated because of the lack of Carotid Artery Stenting (CAS). The negative impact of the lack of coverage of CAS is mainly felt by minorities and people with low resources. Randomized clinical trials have demonstrated that CAS is equivalent to carotid artery endartectomy (CEA). CAS is safer for patient with advanced cardiovascular disease who cannot tolerate the surgical CEA.

Thank you so much if you have any questions, please call my cell phone [PHI Redacted]

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I would like to thank CMS for its thoughtful review of the clinical literature and current evidence of Carotid artery stenting.

As a dual fellowship trained physician in peripheral Endovascular and Endovascular Neurosurgery who has been treating cervical carotid disease for over 22 years. I respectfully support CMS in finalizing key components of the proposed decisions:

I Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
I Support coverage without requiring patients to participate in clinical trials or registries (most of which have now closed).
I Support removal of the facility standard and approval requirements.
I Support allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.
I support the decision that all patients considered for CAS to undergo computed tomography angiography (CTA) or magnetic resonance angiography (MRA) in advance of catheter-based angiography.

I would recommend CMS revise one aspects of the Proposed Decision:

The Proposal requiring physicians to have a shared decision-making (SDM) interaction with patients, and advocates using a “validated” SDM tool. While I support this idea, I believe to develop such a “validated tool” would take years. I don't believe developing this tool should delay coverage of CAS. I believe without reservation CMS's decisions are are firmly based on multiple well designed, multi center, RCT trails AND on over 20 years of real would patient care with respect to CAS.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

Personally, I am distressed by the pending decision. There are too many unnecessary procedures being done on the arterial (and venous) system(s) by non-vascular surgeons. (see the recent New York Times article; the primary offender in lower extremity interventions was a cardiologist). CMS should not encourage these procedures. In particular, trans-carotid stenting (TCAR) has been shown to have lower stroke risk than the femoral artery approach. (the approach to be used by most, if not all, of the newly approved 'qualified physicians' who will be frothing at the bit to jump on the CAS bandwagon). Currently, surgeons performing TCAR must report their data. The same should be mandated for all CAS.

Thank you.

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For any who haven’t done it… here is a handy step by step

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Thank you for the opportunity to comment on CMS’s Proposed Decision Memo relating to NCD 20.7:

I am a vascular surgeon who has experience leading studies informing the treatment of carotid disease. Generally, I support the expansion of coverage for transfemoral carotid artery stenting in selected patients with asymptomatic severe carotid stenosis. There are excellent outcomes with long term follow up from randomized trials comparing transfemoral carotid artery stenting and carotid endarterectomy in which physicians were rigorously vetted for quality, experience, and continuing proficiency, as a requirement for participating in the trial.¹ Contrary to the draft memo, ACT 1 was conducted with diligent screening of surgeons and interventionists at the physician level, a lead in phase prior to randomized cohort enrollment, and masked ongoing external quality assurance with enforcement through enrollment suspension.² It will be essential to monitor the outcomes of carotid interventions after expansion of coverage to verify that generalized outcomes are equivalent to those currently reported.

Regards,
Jon Matsumura, MD

1 Matsumura JS*, Hanlon B*, Rosenfield K, Voeks J, Howard G, Roubin GS, Brott TG on behalf of the ACT 1 and CREST Investigators. Treatment of Carotid Stenosis in Asymptomatic, Non-Octogenarian, Standard Risk Patients with Stenting versus Endarterectomy; A Pooled Analysis of the CREST and ACT 1 Trials. J Vasc Surg, Apr 2022;75:1276-83. doi:10.1016/j.jvs.2021.10.020. *contributed equally as first coauthors.

2 Rosenfield K*, Matsumura J*, Chaturvedi S, Riles T, Ansel G, Metzger D, Wechsler L, Jaff M, Gray W. N Engl J Med. Mar 2016;374:1011-20. doi:10.1056/NEJMoa1515706. *contributed equally as first coauthors.

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My name is Dr. Gary Ansel MD, FACC, FSCAI

I am the immediate past System Medical Chief, Vascular Services for OhioHealth which is a large and growing health system of14 hospitals and over 200 access points in 47 counties. The OhioHealth system has a long history of specialty collaboration in the treatment of patients with vascular disease in an integrated fashion utilizing the OhioHealth Vascular Institute (OHVI). The OHVI allows for collaboration and quality efforts for the health system. The member hospitals range from community level to tertiary care, and small town to large metropolitan areas. This Institute includes Vascular Surgery, Interventional Cardiology, Interventional Radiology and Vascular Medicine. The OHVI is managed by a multi-specialty executive team. There is also a history of a direct relationship with the Neurologic Service Line for the treatment of carotid artery disease including independent neurologic evaluation of all patients undergoing any carotid treatment no matter if open surgical or endovascular. Outcomes are routinely reviewed. An active research foundation allowed for continued transfemoral carotid treatment via CREST 2 enrollment, TCAR via the VQI database, and of course more traditional CEA. It should be noted that several of the cardiologists were TCAR trained as well. Carotid procedures often included the cooperation and working together of the various specialties. The OHVI included physicians that served as the co-international primary investigator, site primary investigators, and training site for the various transfemoral carotid stent device trials. OHVI also included a site for the first TCAR trial in the United States. The OHVI physicians have multiple carotid treatment publications in peer reviewed journals.

Having recently retired from clinical practice, I have no direct conflict of interest to drive patients to one treatment or another and as when I was the system chief my focus is to improve the treatment of the patients with cardiovascular disease. I feel my experience allows me a unique perspective as I was the direct administrative lead for the vascular service line and the OHVI for all the specialties involved vascular care. This experience has allowed me to see beyond any one specialty and to note that physicians, irrespective of their specialty certainly can be quality driven and will typically work for the best outcome of their patients. Having a “quality” focus has been associated with exceptional outcomes in the treatment of carotid disease by OHVI membership, again, irrespective of the treatment type offered to the patient. The OHVI reinforced treatment by physicians focused on the patient not the treatment modality. The OHVI supported physician and patient choice for carotid procedures with excellent outcomes for all the treatment modalities utilized.

I fully support the CMS coverage proposal for broadening the TFCAS guidelines. In my experience, no single technique has been proven superior in all patients to any other technique. Each individual patient has variables that the physician and the patient themselves can discuss, to optimize treatment. Broadening TFCAS may allow the CMS patient population more access to efficacious treatment outside the major metropolitan areas where there are current shortages of all the various specialties. No matter the specialty, these carotid disease patients can best be served by physicians focused on their care, in environments that focus on patient outcomes. It should be up to the healthcare delivery sites, physicians and patients as to the treatment chosen for any individual patient. The current CMS proposal requesting quality focus and shared decision making with the patient is appropriate for all medical procedures, not just TFCAS. The inclusion TFCAS for the treatment of appropriately selected patients with carotid disease is an important step forward as the procedure has been demonstrated to be a safe and efficacious option for many patients.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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Hello: I think the expanded indications for carotid stenting are excellent. I would not modify anything, I have been performing carotid stents for over 22 years within multiple research trials and find the results to be comparable to carotid endarterectomy. We have analyzed out data along with CEA data and find them equal with respect to all outcomes measured.

CMS needs to separate financial gain and politics from the vascular surgeons, from what is most beneficial for patients

Carotid stenting is a well established procedure that has stood the test of time in multiple comparison trials, and is clearly at least as safe, if not safer than CEA. Interesting that TCAR is now available by the vascular surgeons who for years have told us of the risks associated with stenting, yet now perform these same stent procedures themselves!

I look forward to the day when we can offer patients an unbiased choice of the various techniques to address their critical carotid lesions

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I would like to thank CMS for taking this step. I’m interventional cardiologist and I take care for carotid artery disease.

I would like to truly thank CMS for its thoughtful review of the clinical literature and current evidence.

I kindly request to expedite the key components of the proposed decision. I truly support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence. I also support coverage without requiring patients to participate in clinical trials. I also support the removal of the facility standard and approval requirements.

However, I recommend that CMS revise two aspects of the Proposed Decision:

The Proposal requires physicians to have a shared decision-making (SDM) interaction with patients, and advocates doing so with a “validated” SDM tool. To develop such a “validated tool” would take years. Instead, I express my support for an SDM interaction (including discussion about all options for treatment of carotid disease), but I am against the use of non-validated tool that can result in significant delay of coverage of CAS pending the development of a “validated” SDM tool. I think a clear documentation of the shared decision making process is sufficient as it is shown in other procedures like TAVR and other structural cardiac procedures, where no SDM tool was needed.

Also, while I support the need for CTA/MRA for diagnosis and management of carotid disease, I believe catheter-based angiography should be allowed by CMS as the first diagnostic modality when CTA/MRA are contraindicated.

Overall, I strongly support this step by CMS.

Regards

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Hello there,
I'm a neurointerventionalist who performs CAS.
First, I would like to thank CMS for its thoughtful review of the clinical literature and current evidence.

I would like to voice my support for CMS to finalize the proposed decision, mainly on the following:

* expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
* coverage without requiring patients to participate in clinical trials.
* removal of the facility standard and approval requirements.
* allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.

I would also like to recommend that the following 2 aspects to be revised:
The Proposal requires physicians to have a shared decision-making (SDM) interaction with patients, and advocates doing so with a “validated” SDM tool. Unfortunately, To develop such a “validated tool” would take years. I completely agree with SDM interaction (including discussion about all options for treatment of carotid disease), but not to delay coverage of CAS pending the development of a “validated” SDM tool.

Lastly, I would like to recommend being able to do catheter-based angiography as first diagnostic tool (on a case-by-case basis) when MRA/CTA is either contraindicated or not deemed useful as first screening test.

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As a neurosurgeon who performs both CEA and CAS, I see no reason why both options, particular now with TCAR and radial options, do not have the same indications. CAS is proven to be a safe and effective method of carotid revascularization. There is enough data to prove its effectiveness is similar to CEA. In fact, when there is restenosis of a previously treated CEA patient, most, if not all, of these patients are treated with CAS. In addition, a formal angiogram prior to revascularization avoids treating patients unnecessarily, as many times ultrasound and/or CTA can exaggerate the amount of stenosis present. As such, if CEA is offered to patients for asymptomatic disease, we should similarly be offering CAS to those patients as well to allow them to make an appropriately informed medical decision.

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I am a Board Certified Interventional Radiologist as well as a Program Director of the IR Residency program at my institution. We have a multidisciplinary practice and training program. I perform CAs and train both IR and Vascular Surgery trainees in this procedure. I feel well equipped to comment the recent NCD.

First I would like to thank CMS for their thoughtful review of the entirety of the clinical literature and current evidence.

I support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence. While clinical trials have been the basis for expanded coverage or contracted coverage, I believe the totality of the evidence supports your decision for coverage without requiring patients to participate in clinical trials.

I also support removal of the facility standard and approval requirements and allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.
There are aspects of the proposed decision that I do feel are worth specifically commenting on, as I do not feel they reflect an achievable requirement at most institutions. The use of SDM is clearly a benefit to patients and their care. However, I am not certain there is a clear "validated" tool to allow for this to occur. I believe this can and should be developed; however, this does not and should not supersede the preponderance of evidence that is in support of expansion of CAS coverage in the proposed decision.

As a board certified Interventional Radiologist, I understand the value of non-invasive cross-sectional imaging such as CTA/MRA in planning and deciding the best route of treatment. However, there are instances where these imaging modalities would be contraindicated such as CKD patients or those with metallic implants where additional iodinated contrast(outside the episode of angiography and intervention) or MR imaging would not be appropriate. I think the provision for CTA/MRA is well-intended, but there will be instances where this is not possible or in the best interest of the patient. I do believe the vast majority of patients should and will receive this type of imaging in advance, but an addendum or provision to allow for deviation from this requirement is recommended.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. Multiple well performed randomized studies have demonstrated an increased risk of stroke when carotid artery stenting is performed from a transfemoral approach, as compared to a direct carotid approach with flow reversal or an open carotid endarterectomy.

I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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I commend CMS for proposing an updated coverage policy for CAS based on the available evidence.

I support the specific elements proposed in this decision, including:

Please don’t hesitate to contact me if there are any questions.

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I find it horrifying that this is even being considered. Does CMS not even consider data anymore? I am a vascular surgeon with twenty years of experience and have been trained in all modalities, both endovascular and open. Transfemoral stenting has been proven to be inferior to CEA and TCAR. If this measure goes forward, the well controlled and monitored management of carotid disease will transition into the 'Wild West.' Many patients will be needlessly hurt.

I beg you to reconsider.

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To Whom It May Concern:

The physicians from the OhioHealth Vascular Institute comprise a multi-specialty group of thirty- five physicians consisting of vascular medicine doctors, vascular surgeons, interventional radiologists, and cardiologists.

We, as a collective body, roundly support the proposed decision from CMS to expand coverage of carotid artery PTA and concurrent stenting with an FDA approved embolic protection device. We acknowledge that this decision stems from the numerous randomized trials with approximately 8,000 patients, demonstrating equipoise between CEA and CAS at 30 days, one year, 5 years, and 10 years.

We also support the need for shared decision-making in order to provide the safest and most appropriate patient care, and would encourage CMS to consider developing a validation tool to help achieve this directive. Finally, we recognize that in order to continue the level of efficacy and safety demonstrated in the RCTs that propelled CMS to this proposal, we would advocate for the rigorous monitoring of patient outcomes, tracked and reviewed on a regular basis, with the ability to develop quality initiatives as needed, and would caution against absolute removal of facility standards and approval requirements for CAS.

We are grateful for the opportunity to comment.

On behalf of the OhioHealth Vascular Institute (OHVI) Executive Team,

John A. Phillips, M.D.
Director, OhioHealth Vascular Institute (OHVI)

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I am an interventional cardiologist (semi-retired) and high volume peripheral vascular endovascular specialist who regularly evaluates patients with carotid disease and performed >500 carotid stent procedures (with < 1% adjudicated major or minor neurologic event rate), and was an enrolling investigator in >10 RCTs of TF carotid stenting, including both CREST and CREST2. I have stented many patients referred from vascular surgery, and also refer many patients for CEA. First of all, I would like to thank CMS both for their thoughtful and thorough review of the extensive amount of rigorous data that exists on this topic as well as allowing us the opportunity to advocate for our patients in this public forum.

Several very important points need to be kept in mind:

- TF carotid stenting has shown equipoise c/w CEA in both historical and randomized fashion
- Formal training, operator experience, and patient selection have been proven to be a critical part of this success
- TCAR has not been evaluated with anywhere near the volume or quality as TF CAS

With this in mind, I would I strongly support the following proposed decisions:

1. Proposal to expand coverage for CAS to patients with symptomatic carotid stenosis greater than or equal to 50% and asymptomatic stenosis greater than or equal to 70% consistent with the large body of data across multiple RCTs.
2. Providing coverage without a requirement to participate in clinical trials or ongoing registries given the large number of patients already studied in this context and the potential for such a requirement to limit access to this therapy.
3. I think it is incumbent on relevant vascular societies to continue to refine clinical practice guidelines / appropriate use criteria for all therapeutic options (medical, CAS, TCAR, and CEA) as additional data becomes available and for hospitals to not only adhere to this, but also to insist on RIGOROUS credentialing (i.e. requiring formal training) and peer review processes to ensure high standards of quality are met.
4. Allowing MACs to determine whether to cover CAS for other patients.

I would also recommend that CMS revise two aspects of the Proposed Decision:

1. Although I very strongly advocate for a thorough shared decision-making encounter (including multidisciplinary discussion of options when more than one reasonable option exists), I do not feel that doing so with a validated tool is necessary. Currently, no such tool exists, and the development / validation process would take years and unnecessarily delay coverage.
2. Although I agree that additional non-invasive imaging modalities such as CTA and MRA can be very useful in the assessment of patients with carotid disease and should be utilized when clinically appropriate, there are certain situations that these imaging modalities may not be appropriate. Examples include patients with significant renal dysfunction and in circumstances where disparate results exist among non-invasive imaging studies. In these circumstances, providers should have the opportunity to perform catheter-based angiography so that an appropriate management can be obtained to the benefit of patient care.

Thank you again for all of your exhaustive work on this important topic and I look forward to a decision that will hopefully allow all vascular providers to provide access to the spectrum of modern treatment options to our patients.

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As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies representing the physicians who intend to use it.

The proposed requirement of independent neurologic assessment before and after CAS. A neurological examination as part of the clinical assessment is well within the scope and standard of care of a physician involved in carotid revascularization. Furthermore, we believe that cross-sectional imaging with CTA or MRA after carotid duplex ultrasound demonstrating significant carotid stenosis should be at the physician's discretion. Finally, carotid angiography remains the gold standard for assessment of carotid stenosis. In scenarios where invasive angiography is performed as part of stenosis evaluation (e.g., after discrepant non-invasive imaging results), concomitant CAS should be allowed if indicated.

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As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies representing the physicians who intend to use it.

The proposed requirement of independent neurologic assessment before and after CAS. A neurological examination as part of the clinical assessment is well within the scope and standard of care of a physician involved in carotid revascularization. Furthermore, we believe that cross-sectional imaging with CTA or MRA after carotid duplex ultrasound demonstrating significant carotid stenosis should be at the physician's discretion. Finally, carotid angiography remains the gold standard for assessment of carotid stenosis. In scenarios where invasive angiography is performed as part of stenosis evaluation (e.g., after discrepant non-invasive imaging results), concomitant CAS should be allowed if indicated

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As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies representing the physicians who intend to use it.

The proposed requirement of independent neurologic assessment before and after CAS. A neurological examination as part of the clinical assessment is well within the scope and standard of care of a physician involved in carotid revascularization. Furthermore, we believe that cross-sectional imaging with CTA or MRA after carotid duplex ultrasound demonstrating significant carotid stenosis should be at the physician's discretion. Finally, carotid angiography remains the gold standard for assessment of carotid stenosis. In scenarios where invasive angiography is performed as part of stenosis evaluation (e.g., after discrepant non-invasive imaging results), concomitant CAS should be allowed if indicated.

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I am an interventional neuroradiologist who routinely cares for patients with acute stroke and carotid artery disease on a daily basis.

I work with a multidisciplinary group (neurosurgery, vascular neurology, neuroradiology) that performs the full array of open and endovascular cerebrovascular procedures, including CAS and CEA. Our group strongly and unanimously supports the new CMS recommendation on the basis of a comprehensive literature review and realistic assessment of clinical supply-demand for this patient population.

Carotid artery stenting has been rigorously tested over two decades in randomized controlled trials (RCT) and large clinical registries. Over time, the CAS procedure has shown improved safety and is complementary with the current best medical management guidelines.

The criticisms of the CMS recommendation could significantly reduce access to this procedure, resulting in treatment delays. These delays will translate to recurrent strokes on a population level, resulting in preventable morbidity and disability. I strongly advocate against a requirement for clinical trial registration or a mandate for shared-decision making tools, as such requirements would invariably delay treatment.

Our group believes in a 'best treatment for each patient' approach to carotid artery disease. This approach allows us to rapidly treat patients according to their disease state, vascular anatomy, and personal goals in a neutral fashion. The new CMS recommendation empowers us to continue this patient-centered approach.

I sincerely hope that criticism of the CMS recommendation is earnest, but I am concerned that a professional desire to limit supply (through restricting CAS indications) is driven by physician (and professional organization) self-interest, not the patient's best interest.

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As an interventional radiologist and vascular medicine physician, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies representing the physicians who intend to use it.

The proposed requirement of independent neurologic assessment before and after CAS. A neurological examination as part of the clinical assessment is well within the scope and standard of care of a physician involved in carotid revascularization. Furthermore, we believe that cross-sectional imaging with CTA or MRA after carotid duplex ultrasound demonstrating significant carotid stenosis should be at the physician's discretion. Finally, carotid angiography remains the gold standard for assessment of carotid stenosis. In scenarios where invasive angiography is performed as part of stenosis evaluation (e.g., after discrepant non-invasive imaging results), concomitant CAS should be allowed if indicated.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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Recent media articles (New York Times, ProPublica) have drawn attention to the actions of several endovascular interventionalists who have put profit over patient care with disastrous results. The current CMS initiative to expand the indications for carotid stenting via transfemoral approach will similarly put patients at risk. Open carotid surgery as well as trans carotid surgical stenting have proved highly successful in treating both asymptomatic and symptomatic patients. These procedures are performed by board-certified vascular surgeons and have led to an exceedingly low stroke rate and postoperative morbidity mortality rate. Expanding the indication for transfemoral stenting will increase the variability of carotid disease treatment, discourage shared clinical decision making and undermine best practices.

In our own community, we recently accepted a transfer patient from an interventional radiologist who placed a transfemoral carotid stent that occluded and needed to be surgically explanted. The patient needed to be transferred 2 hours away to Catholic Medical Center New Ham for care as his community would not take him (Portland, Maine). He spent several days intubated in the hospital in the ICU. This is not what patients should expect or tolerate. As board-certified vascular surgeons, we represent a minority of endovascular interventionalists but we have spent our lives training, diagnosing, and treating all aspects of carotid disease. We are most suited to provide these services to patients and this has consistently been demonstrated for over 40 years (ACAS trial NASCET and Roadster). Patients treated by board-certified vascular surgeons benefit from a wealth of experience, years of scientific rigor and operative skill. Treatment of carotid disease is complex and must be individualized. Patient factors, longevity, technical skill and training, medical optimization and organizational experience must be taken into account. Opening up transfemoral stenting which has carried a much higher risk of stroke will expose patients to undue harm and must be discouraged.

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

Heather Hall, MD

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As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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Regarding our earlier comments entitled:

'Why the United States Centers for Medicare & Medicaid Services (CMS) Should Still Not Extend Reimbursement Indications for Carotid Artery Angioplasty/Stenting or Other Carotid Artery ‘Revascularisation’ Procedures'.

We have 4 more experts in carotid arterial disease management and research from around the world who would like to be co-signatories with respect to the submission named above. They are:

1. Kimberley Hammar (PhD Candidate & Resident [Emergency Medicine], Sweden).
2. Jean Panneton (Vascular Surgeon, United States of America).
3. Maarit Venermo (Vascular Surgeon, Finland).
4. Joshua Willey (Neurologist, United States of America).

That makes 81 total co-signatories for this August 2023 submission for US Medicare. There may be more who want to join. Some people are coming back from leave and only just discovering what is going on and the opportunity to respond.

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As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies representing the physicians who intend to use it.

The proposed requirement of independent neurologic assessment before and after CAS. A neurological examination as part of the clinical assessment is well within the scope and standard of care of a physician involved in carotid revascularization. Furthermore, we believe that cross-sectional imaging with CTA or MRA after carotid duplex ultrasound demonstrating significant carotid stenosis should be at the physician's discretion. Finally, carotid angiography remains the gold standard for assessment of carotid stenosis. In scenarios where invasive angiography is performed as part of stenosis evaluation (e.g., after discrepant non-invasive imaging results), concomitant CAS should be allowed if indicated.

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I support the proposed NCD expanding coverage for carotid stenting. This important decision eliminates reimbursement as a factor in formulating treatment plans, and empowers physicians to offer the most appropriate method of carotid revascularization, if any, considering only the best interest and wishes of the patient.

I support the development of a shared decision making tool, although as none exists, advise against requiring use of such a tool. The standard for almost all elective surgeries is that the treating physician will discuss all of the options, listen to the patients concerns and preferences, and formulate a treatment plan. Physicians should specifically document that discussion in the medical record, as suggested by the NCD.

No one physician, regardless of specialty, possesses superior expertise in all facets of caring for a patient with carotid disease, which include not just expertise in CEA, TCAR, and percutaneous (femoral or radial) CAS, but also expertise in neurologic diagnosis, the full spectrum of neuroimaging, and the medical management of hypertension, dyslipidemia, diabetes, renal insufficiency, and other chronic disease. All physicians who care of patients with carotid disease have variable strengths and weaknesses, and all have bias. It is unavoidable that the way information is presented to a patient will vary. To the end of mitigating the variability, development of a shared decision making tool is desirable. However, it will be difficult for “experts” to agree on what information such a tool should convey. Further, the tool will need to be flexible to accommodate future improvements in both medical and surgical treatments. Developing and agreeing on a tool will be a long process, but it is a worthy endeavor.

Some have suggested that reimbursement should be linked to usage of on-label devices. The FDA does not, and never has, regulated the practice of medicine. It would be equally ill-advised for CMS to regulate the practice of medicine through reimbursement policies requiring specific device use. The use of off-label medications and devices is very common in medicine, the latter is particularly common in endovascular surgery. For decades vascular specialists placed stents, only approved for use in the biliary system, in a variety of systemic arteries. No one suggested, nor should they have, that those procedures should not be reimbursed. Most carotid stents in common use today would not be on-label for the proposed expansion of coverage, but they are approved for use in the carotid arteries. Requiring additional studies to obtain new labeling would be expensive and is unnecessary. Further, forcing a physician to use an on-label device in lieu of a device he or she deems better suited to the task is not in the best interest of the patient. The person best suited to decide which device is best for any given surgery is the treating physician. The FDA recognizes this; so should CMS.

Some have also suggested that any expansion of coverage to asymptomatic patients should await the results of CREST 2. As an investigator in CREST 2 and a frequent enroller, I eagerly await the results of the trial and am doing all I can to see it completed. The results may significantly alter the number of patients whom are offered surgical treatment. However, even if CREST 2 shows equivalence of surgical and medical therapies for asymptomatic carotid stenosis at four years, CEA will still be reimbursed, and there will still be patients who reasonably decide that they prefer surgical treatment. (For example, a young, healthy patient with a 25 year life expectancy). Those individuals should have access to the full gamut of surgical options.

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Dear Centers for Medicare and Medicaid Services Coverage Advisory Group,

We appreciate consideration of expansion of reimbursement for endovascular carotid revascularization. However, for two reasons, we feel this is premature.

1. First, the CREST-2 trial (NCT02089217) is still underway, and represents a major investment by NINDS. It would seem to be premature to expand the use of carotid artery stenting until this randomized trial has reported its results.

2. 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, there is no validated carotid decision tool that captures the options offered in contemporary practice that are the subject of this NCD.

There are four primary studies that have sought to develop decision tools for patients with carotid stenosis (PubMed IDs: 21477967, 22218277, 31101429, 34297713). Only two of these studies included patients with known carotid stenosis. Perhaps the most important limitation of these available instruments is that none of them included to transcarotid artery revascularization (TCAR), the primary modality of placing carotid stents from the transcarotid approach. This is important, since TCAR has added important nuances into the decision-making process that could be guided by a decision aid. Specifically, TCAR appears to have a lower perioperative risk of stroke than transfemoral carotid stenting (TF-CAS) and has a faster recovery than carotid endarterectomy (CEA). However, no large studies have yet published long-term data on TCARs durability or expected stroke rates. Furthermore, no level 1 evidence exists to support TCARs use. These tradeoffs can be challenging to understand and would be greatly aided by a validated shared decision-making tool that includes best medical therapy, CEA, TF-CAS, and TCAR. To date, this does not exist.

As such, it seems premature to expand this coverage under the notion that level 1 evidence is still in development, and patients and their treating physicians may not yet engage in a shared decision-making conversation guided by a validated tool.

Thank you for your consideration.

Philip P. Goodney, MD, MS
Section Chief and Professor, Vascular Surgery
Dartmouth Health
Co-Chair, Research Advisory Committee, Vascular Quality Initiative

Richard J. Powell, MD
Director and Professor, Heart and Vascular Center
Dartmouth Health
Chair, BEST-CLI Credentialing Committee

Jesse Columbo, MD, MS
Assistant Professor, Vascular Surgery
Dartmouth Health
K08 Awardee, National Heart Lung and Blood Institute

Brianna Krafcik, MD, MS
Resident, Vascular Surgery
Dartmouth Health

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I strongly object to this move to effectively declare "open season" on carotid stenting, for all comers with no oversight. This will result in enormous harm to the patients, who will be duped into believing that they are actually being helped by this procedure. There is overwhelming evidence that carotid stenting causes more strokes than carotid endarterectomy and that strokes in asymptomatic patients is exceedingly rare when treated with appropriate medical therapy. Consequently, by allowing reimbursement for asymptomatic carotid stenosis to be treated with stents, we are likely to see a dramatic rise in strokes in the US. With no oversight, interventionists with little knowledge of the disease process all over the country, will be permitted to over treat these patients.

There has been a growing body of evidence, for over a decade, that modern medical management is extremely effective in substantially reducing the rate of strokes in patients with asymptomatic carotid disease. So much so, that most EU countries, the UK and Australia have modified their guidelines to be more circumspect in recommending surgery, to prevent strokes. In the US, these guidelines have not yet been changed substantially, as there is a perspective that until the results of the CREST-2 trial are available, we should continue to offer carotid endarterectomy (NOT carotid stenting) for asymptomatic carotid stenosis. Perhaps the adjudicating panelists should review the guidelines from other countries, along with their supporting literature, before opening the floodgates and removing all barriers to carotid stenting.

In most of the country, vascular surgeons don't even have access to an IAC-Accredited Vascular Lab to be able to perform an accurate and reproducible carotid duplex scan. This then leads to abuse and inappropriate interventions, based on inaccurate studies. We are already spending more than most countries on healthcare, with poorer outcomes, specifically because we are doing way too many unnecessary and unindicated procedures. Allowing for a "free-for-all open season" of carotid stenting will increase the costs of care exponentially, not just for the procedure itself but also the costs of taking care of patients who have strokes as a result of the procedure.

The petition to permit reimbursement for a "no-holds-barred" approach to carotid stenting, is being driven by purely financial motives and, in my view, if approved, will be a travesty and an unmitigated disaster for our patients. We have already seen 2 major exposes in the recent NYT article and the Propublica Article, showing how overuse of unindicated procedures has led to costly disasters for patient's lives and limbs. If this measure is approved, we will see something similar occur when it comes to stroke care, with a dramatic rise in stroke and deaths amongst the Medicare population.

The adjudicating panel MUST resist this move!

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I am a physician who performs transfemoral and transradial CAS. I also refer patients to my surgical colleagues for TCAR.

I would like to thank CMS for its thoughtful review of the clinical literature and current evidence.

In this regard, I would ask CMS to finalize key components of the proposed coverage decision:

1. Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
2. Support coverage without requiring patients to participate in clinical trials.
3. Support removal of the facility standard and approval requirements.
4. Support allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.

I would recommend that CMS revise two aspects of the Proposed Decision:

1. The Proposal requires physicians to have a shared decision-making (SDM) interaction with patients, and advocates doing so with a “validated” SDM tool. To develop such a “validated tool” would take years. I support implementation of a SDM interaction (including discussion about all options for treatment of carotid disease), but not to delay coverage of CAS pending the development of a “validated” SDM tool.
2. The Proposal would require all patients considered for CAS to undergo computed tomography angiography (CTA) or magnetic resonance angiography (MRA) in advance of catheter-based angiography. I would recommend that CMS allow use of catheter-based angiography when CTA/MRA are contraindicated per the discretion of care providers.

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Why the United States Centers for Medicare & Medicare Services (CMS) Should Still Not Extend Reimbursement Indications for Carotid Artery Angioplasty/Stenting or Other Carotid Artery ‘Revascularisation’ Procedures

8th August 2023

This analysis is based on a cut-down version of our updated evidence review and policy advice for US Medicare which was publicly posted in February 2023 (please see: https://www.cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaId=311&fromTracking=Y&). This analysis will be sent for journal publication.

Co-Signatories for this CMS Submission: 77
Anne Abbott (Neurologist, Australia); Omar Ayoub (Neurologist, Saudi Arabia); Yogesh Acharya (Vascular Surgeon, Ireland); Nishath Altaf (Vascular Surgeon, Australia); Pier Luigi Antignani (Angiologist, Italy); Hernan Bazan (Vascular Surgeon, United States of America); Peter Bell (Vascular Surgeon, United Kingdom); Ruth Benson (Vascular Surgeon, New Zealand); Aleš Blinc (Cardiologist/Vascular Physician, Ljubljana); Alejandro Brunser (Neurologist, Chile); Hrvoje Budincevic (Neurologist, Croatia); Alun Davies (Vascular Surgeon, United Kingdom); Gert J. de Borst (Vascular Surgeon, the Netherlands); Aaron Gaekwad (Neurologist Physician Trainee, Australia); Harry Gibbs (General and Vascular Medicine Physician, Australia); Rishad Faruqi (Vascular Surgeon, United States of America); Vassilis Hadjianastassiou (Vascular Surgeon, United Kingdom); Hannah Gardener (Epidemiologist, United States of America); Richard Genova (Registered Vascular Technologist, United States of America); George Geroulakos (Vascular Surgeon, Greece/United Kingdom); Athanasios Giannoukas (Vascular Surgeon, Greece); Peter Gloviczki, (Vascular Surgeon, United States of America); Anders Gottsäter (Vascular Physician, Sweden); Guillaume Goudot (Vascular Physician, France); Jose Gutierrez (Neurologist, United States of America); Robert Harbaugh (Neurosurgeon, United States of America); Eitan Heldenberg (Vascular Surgeon, Israel); Michal Juszynski (Vascular Surgeon, Poland); Anthony Kam (Neuroradiologist, Australia); Zubair Kareem (Neurologist, United States of America); Stefan Kiechel (Neurologist, Austria); Tien Khoo (Internist [General & Acute] Medicine, Australia); Timothy Kleinig (Neurologist, Australia); Michael Knoflach (Neurologist, Austria); Simona Lattanzi (Neurologist, Italy); Ian Loftus (Vascular Surgeon, United Kingdom); Fedor Lurie (Vascular Surgeon, United States of America); Jonas Malmstead (Vascular Surgeon, Sweden); Devender Mittapalli (Vascular Surgeon, United Kingdom); Branimir Nevajda (Neurologist and Stroke Specialist, United Kingdom); Wesley Moore (Vascular Surgeon, United States of America); Bibombe Patrice Mwipatayi (Vascular Surgeon, Australia); Fernando Picazo Pineda (Vascular Surgeon, Australia); Achim Neufang (Vascular Surgeon, Germany); Alexander Oberhuber (Vascular Surgeon/Endovascular Specialist, Germany); Malay Patel (Vascular Surgeon, India); David Pelz (Neuroradiologist, Canada); Bartlomiej Piechowski-Jozwiak (Neurologist, United Arab Emirates); Holger Poppert (Neurologist, Germany); Alkoredi Fatai Radji (Neurologist, France); Jean-Baptiste Ricco (Vascular Surgeon, France); Peter Ringleb (Neurologist, Germany); Jenni Robertson (Consumer Representative and Stroke Survivor, United Kingdom); David Robinson (Vascular Surgeon, Australia); Sara Rostanski (Vascular Neurologist, United States of America); Tatjana Rundek (Neurologist, United States of America); David Saloner (Arterial/Biomedical Imaging Specialist, United States of America); Felix Schlachetzki (Neurologist, Germany); Lawrence Schott (Neuroradiologist, Ireland); Saeid Shahidi (Vascular Surgeon, Denmark); Joseph Shalhoub (Vascular Surgeon, United Kingdom); Francesco Spinelli (Vascular Surgeon, Italy); Daniel Staub (Angiologist, Switzerland); Francesco Stilo (Vascular Surgeon, Italy); Sherif Sultan (Vascular Surgeon, Ireland); Costas Thomopoulos (Cardiologist, Greece); Raffi Topakian (Neurologist, Austria); Francesco Torella (Vascular Surgeon, United Kingdom); Olise Uyagu (General Medical Practitioner, Australia); Claude Vaislic (Vascular Surgeon, France); Martin Veller (Vascular Surgeon, South Africa); Fred Weaver (Vascular Surgeon, United States of America); Tissa Wijeratne (Neurologist, Australia); Mary-Ann Williams (Consumer Representative and Stroke Survivor, Australia); Roz Williamson (Allied Health, Australia); Kim Wootton (Consumer Representative and Stroke Survivor, Australia); Wei Zhou (Vascular Surgeon, United States of America)

Executive Summary

We classify the types of misinformation being used to errantly push US Medicare to expand reimbursement indications for carotid artery stenting (CAS) and a new hybrid procedure known as trans-carotid arterial revascularization (TCAR). This is already an environment with too many unnecessary carotid procedures done in the name of stroke risk reduction. Founding members of the Faculty Advocating Collaborative and Thoughtful Carotid Artery Treatments (‘FACTCATS’, see https://factcats.org/) explained in 2012 why reimbursement indications for CAS should not be expanded.^1,2 The fundamental reasons were higher risks with CAS (stroke, death and myocardial infarction) compared to carotid endarterectomy (CEA) and declining carotid procedural indications due to greatly improved non-invasive stroke risk reduction methods. The situation has not changed, except that the excessive hazards with stenting are clearer, non-invasive medical intervention for stroke risk reduction has improved further and the safety and efficacy of TCAR remain unproven. Once again, we advise that expanding reimbursement indications for carotid procedures ‘would have serious negative health and economic repercussions for the USA and any other country that may follow such inappropriate action’.¹

Introduction

Since 2005, US Medicare – known as the Centers for Medicare & Medicaid Services (CMS) – has limited carotid stenting (CAS) reimbursement indications to individuals considered at high-risk from carotid surgery (carotid endarterectomy, CEA) who are symptomatic with >70% carotid stenosis and to other high-CEA-risk patients if used in appropriate studies (those with 50-70% stenosis if symptomatic or >80% stenosis if asymptomatic).³ High-CEA-risk is defined by CMS as having major comorbidities and/or anatomic risk factors (including current life-threatening cardiac conditions).³ The definition is open to interpretation. CMS also created minimum standards upon which CAS coverage (reimbursement) is dependent.³

As per the January 2023 online CMS announcement ⁴, a 'multispecialty alliance' (the ‘Alliance’) asked that US Medicare:

1. Expand CAS reimbursement indications to all individuals with >70% asymptomatic carotid stenosis and any symptomatic person with >50% stenosis (including those not considered high-CEA-risk).
2. Eliminate the minimal standards for facility requirements.
3. Leave coverage for any CAS procedure (including TCAR) not described by the CMS National Coverage Determination (NCD) to the discretion of the local Medicare Administrative Contractors.

Founding members of the Faculty Advocating Collaborative and Thoughtful Carotid Artery Treatments (‘FACTCATS’, see https://factcats.org/) published evidence reviews and advice to US Medicare in 2012 and 2013 outlining why reimbursement indications for CAS should not be expanded.^1,2 The main reasoning then was the higher risk of stroke and death with CAS compared to CEA, as well as declining carotid procedural indications due to greatly improved non-invasive stroke risk reduction methods (risk factor identification and amelioration using lifestyle interventions and medication). The situation has not changed, except that the excessive hazards with CAS are clearer, non-invasive medical intervention for stroke risk reduction has improved further and the safety and efficacy of TCAR remain unproven.^5-10

CMS reimbursement indications were not expanded following the 2012 Medicare Evidence Development & Coverage Advisory Committee (‘MEDCAC’) Meeting.⁵ The results have been greatly limited access to procedural ‘carotid revascularization’ by non-surgically trained practitioners, the saving of up to several million older Americans from unnecessary, excessively dangerous carotid procedures, the saving of up to at least 60 billion American healthcare dollars and an excellent global health policy example.^5,11 This analysis is a cut-down version of our updated evidence review and policy advice for US Medicare which was publicly posted February 10th 2023, with 71 co-signatories (please see: https://www.cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaId=311&fromTracking=Y&).

The ‘Alliance’ used an online letter to CMS and a 2022 review article as the case for ‘new evidence’ supporting expansion of reimbursement indications for CAS, TCAR and any other procedure they may consider under the umbrella of CAS in the future.^4,12,13 However, the case for expansion consists of misinformation favouring procedural over-use and lacks a cost-effectiveness analysis. We have classified the most important forms of misinformation encouraging procedural overuse into 4 types: factual errors (untrue statements), fact distortion (a fact is conveyed then misconstrued), omitted information (omission of information relevant to clinical decision making) and speculation. We would like to emphasize that we are not targeting individuals, rather we are addressing misinformation. Further, this misinformation is common in the medical literature.

Factual Errors

1. CAS is not Equivalent, or Noninferior, to CEA as Claimed^12,13
CAS is more dangerous for patients than CEA. In every adequately powered randomized trial comparison, CAS (when used for primary or secondary stroke risk reduction) was associated with approximately 1.⁵–2.0 times as many peri-procedural strokes or deaths as CEA.⁵ Several individual randomized trials of symptomatic patients showed a statistically significant higher periprocedural rate of stroke or death from CAS compared to CEA (including ‘ICSS’, ‘CREST-1’, ‘EVA-3S’).⁵ Registries and administrative databases have also consistently shown higher periprocedural rates of stroke or death with CAS compared to CEA.^2,5,14

By contrast, no individual randomized trial of CAS versus CEA in patients with asymptomatic (or recently asymptomatic) carotid stenosis has been sufficiently powered for this comparison because of low event rates and, hence, the requirement for larger study samples.^5,15,16 Underpowered trials involving asymptomatic patients include ‘ACST-2’ published in 2021.^17,18 However, all individual randomized trials of asymptomatic, or recently asymptomatic patients, with more than 200 subjects have shown trends towards more periprocedural stroke or death with CAS than CEA. For example, in ACST-2, the OR for 30-day peri-procedural death or stroke with CAS versus CEA was 1.35 (95% 0.91-2.03). The comparison reached statistical significance in a 2019 meta-analysis of randomized trials (8 trials and 3,467 patients: OR 1.64, 95%CI 1.02-2.64)¹⁵ and borderline significance in a 2020 meta-analysis of randomized trials (7 trials and 3,378 patients: OR 1.72, 95%CI 1.00-2.97).¹⁶.

In randomized trials, myocardial infarction was generally less common with CAS than CEA. However, where published, in randomized trials of CAS versus CEA involving symptomatic and/or asymptomatic patients, peri-procedural stroke (mostly caused by CAS) was overall 4.6 times more common than clinically defined myocardial infarction.¹⁹ Further, periprocedural death was 34% higher with CAS and periprocedural stroke, death, and clinically defined myocardial infarction were 1.6 times more common after CAS than CEA.^5,19 The difference in this latter, triple-composite outcome measure reached statistical significance in meta-analyses involving symptomatic patients.^5,15,16

There are still insufficient randomized trial data to adequately power this triple-composite comparison for asymptomatic patients.^5,15,16 However, randomized trial results indicate that it is highly likely that if CAS is rolled out into routine practice (involving many more asymptomatic patients than in trials with/or without lower procedural standards) it would cause significantly more strokes, deaths and myocardial infarctions than CEA. That would be clinically and economically highly significant.⁵

Further, in adequately powered randomized trial comparisons, rates of periprocedural stroke or death and later ipsilateral stroke have been higher with CAS compared to CEA for as long as patients have been followed up.⁵ Rates of new ipsilateral stroke beyond the periprocedural period were generally similar with each procedure. This indicates that patients who have a periprocedural stroke tend to live long-term with their stroke. Meanwhile, those that die in the periprocedural period do not recover. Therefore, compared to CEA, the harm from CAS is durable.⁵ Differing results have been reported with respect to ‘protection devices’ for lowering the CAS-associated risk of stroke or death.⁵ Further, severe carotid re-stenosis is more common after CAS than CEA and CAS tends to cost more.^20,21 Complications (apart from stroke and death) that are more likely with, or particular to, CAS compared to CEA include hemodynamic instability (severe hypotension or bradycardia, including the need for a permanent pacemaker) and retroperitoneal haemorrhage.⁵

2. Age is Not the Only Risk Factor for Harm from CAS as Claimed^12,13
In randomized trials, CAS has not been shown to be more beneficial than CEA or non-invasive medical intervention alone in any subgroup of patients. Particularly vulnerable to stroke from CAS compared to CEA are:

• The most senior patients (aged >70 years). Randomized trial comparisons in younger patients have been underpowered, probably because of lower event rates and less representation.⁵
• Those who are most recently symptomatic (especially within the previous 7–14 days, which is when best practice CEA is most likely to be beneficial).⁵,²²
• Women. However, men are also at higher risk of stroke or death from CAS compared to CEA. ⁵
• Those with certain carotid anatomical features, such as longer, angulated, or tandem lesions.⁵
• Those who have CAS in low volume centers or outside trials.⁵

3. Regression of Carotid Plaque Has Been Seen from Non-invasive Medical Intervention Alone, in Contrast to What was Claimed^12,13
Studies have shown that statin and ezetimibe therapy can cause carotid plaque regression and content stabilization.^23-28 Moreover, statins, ezetimibe and PCSK9 inhibitors reduce the risk of stroke and other arterial disease morbidity and mortality whether or not individuals undergo a carotid artery procedure.^29-31

Fact Distortion

1. Inappropriate Dismissal of ‘Minor’ or ‘Nondisabling’ Strokes in Attempt to Justify CAS ^12,13
The most severe or fatal periprocedural strokes are usually defined as being associated with a modified Rankin score of >3.⁵ Fortunately, severe strokes are less common than milder strokes. A well-recognized method of falsely claiming equivalence between CAS and CEA is to ignore milder strokes.¹⁹ However, this distorts the facts in two ways. Firstly, so-called ‘minor’ strokes may impose significant disability and reduced quality of life and should not be discounted.^32,33 Secondly, past randomized trials of CAS versus CEA were underpowered to compare the peri-procedural rate of the most severe strokes. Therefore, it is incorrect to claim that CAS and CEA are similar with respect to causing severe strokes.⁵

2. Inappropriate Use of Periprocedural Myocardial Infarction to Justify CAS^12,13
As explained above, in all adequately powered randomized trial comparisons, CAS was associated with significantly more periprocedural stroke, death and clinically defined myocardial infarction than CEA.^15,16,19 However, because myocardial infarction was often more frequent with CAS than CEA in randomized trials, including it in a primary outcome measure with stroke and death means the adverse outcomes are more evenly distributed between CEA and CAS. Therefore, larger sample sizes are required to show statistically significant procedural differences. As explained above, this has been achieved in meta-analyses of randomized symptomatic patients.^15,16 Underpowered triple-composite outcome comparisons camouflage the statistically significant higher periprocedural rate of stroke or death with CAS compared to CEA. ‘No statistically significant difference’ is often due to underpowering, and this is demonstrated with meta-analyses involving larger subject numbers.^5,15,16,19

3. Inappropriately Using the SAPPHIRE Trial to Justify CAS in High-CEA-Risk Patients^12,13
The SAPPHIRE trial was inappropriate to determine a role for carotid artery procedures in individuals considered at high-CEA-risk because it lacked a non-invasive-treatment-only option.³⁴ Performing randomized trials of only procedures and concluding that a procedure is best, or indicated, constitutes procedural bias.19,35 Outcomes with non-invasive treatment alone have not been measured in these patients. Further, high-surgical-risk medical comorbidities (such as unstable angina, congestive cardiac failure and advanced age) identify individuals with high rates of procedural complications and not likely to live long enough to benefit from a carotid artery procedure.^36-40 Interestingly, patients deemed high-CEA-risk using CMS criteria do not appear better off with CAS compared to CEA.⁴¹

The SAPPHIRE trial had other major limitations for applicability in clinical practice. It included myocardial infarction in the primary outcome measure (the pitfalls of this are described above). Further, myocardial infarction was unusually defined as a ‘creatinine kinase level >2 times the upper limit of normal with a positive myocardial band (MB) fraction.’³⁴ However, elevated cardiac enzymes are not necessarily indicative of significant heart damage, are not rare after non-cardiac surgery, and are perhaps more common after CEA than CAS.^42-44 Further, the SAPPHIRE sample size was very small (334, 70% asymptomatic) with only 17 total 30-day periprocedural strokes or deaths (OR for CAS versus CEA: 0.9, 95% CI: 0.3 to 2.3) and 55 total strokes or deaths by one year (OR for CAS versus CEA: 0.6, 95% CI: 0.3 to 1.1). The trial was underpowered, particularly with respect to analysis of asymptomatic and symptomatic patients separately. As far as we know, the SAPPHIRE trial is the only randomized procedural trial of high-CEA-risk patients.^12,13 SAPPHIRE’s limitations, and unknown outcomes with current best practice non-invasive treatment alone, underscore the lack of evidence supporting a procedural approach in ‘high-surgical-risk’ individuals and an outstanding over-reliance on SAPPHIRE in health policy and guidelines.⁴⁵

4. Inappropriately Using Outdated and Overreaching Guidelines to Justify CAS^12,13
It is inappropriate to cite outdated procedural standards (such as a 30-day periprocedural stroke or death rate <2-3% for asymptomatic carotid stenosis patients or <6% for stroke or TIA patients with carotid stenosis) to encourage ongoing routine use of carotid artery procedures, let alone reimbursement expansion. The randomized trials upon which such guidelines and standards are based are long outdated due to ongoing advances in non-invasive stroke prevention.^5,45 Further, prevailing guidelines encourage carotid artery procedures for many more patient subgroups than have ever been shown to benefit (see below).^5,45.

5. Patient Choice in Treatment Decisions^12,13
The ‘Alliance’ repeatedly referred to patient choice, or preference, as a reason to expand reimbursement indications. Patient preference, and informed consent, are prerequisites for any medical intervention.⁴⁶ This is usually the last ‘bastion’ in protecting patients.⁴⁶ However, patient preference strongly depends on the way information is presented (or omitted). This has already been demonstrated with decision-making in asymptomatic carotid stenosis patients.⁴⁷ This demonstrates the importance of how physicians talk to patients. Meanwhile, ‘shared decision-making’ could be a way of making patients take responsibility for treatment that, rather than help, is more likely to harm them.

Omitted Information

1. Implications of Improved Non-invasive Risk Reduction^12,13
The efficacy of any carotid procedure in stroke risk reduction can only be established using sufficiently powered comparisons against current best practice non-invasive medical intervention alone (healthy lifestyle habits and appropriate medication). This point was consistently missed by the ‘Alliance’. Mention was made in the 2022 review of very low (approximately 1%) annual stroke rates in asymptomatic carotid stenosis patients leading to new trials (‘CREST-2’ and ‘ECST-2’) comparing procedures to non-invasive treatment alone.¹³ In the ‘Alliance’ letter of request, ‘expanded’ non-invasive medical intervention was deemed ‘experimental’, instead of the gold standard against which all procedures should be compared.^5,12

The ‘Alliance’ advocating for expansion of CAS reimbursement neglected to explain an evidence base showing that stroke rates have dropped by >50-65% with non-invasive care alone in asymptomatic and symptomatic individuals with carotid stenosis, and other cerebrovascular disease populations, since all past randomized trials of CEA versus non-invasive treatment alone.⁵,7,8,48-53 The ‘Alliance’ did not mention that these outstanding achievements with non-invasive care mean that there is no current evidence of patient benefit from any carotid procedure. However, there are ongoing reported rates of periprocedural stroke or death of >1–6%.14 Even if procedural stroke and death rates of consistently zero were possible, this is insufficient to justify carotid procedures in the absence of a clinically significant benefit compared to current best-practice non-invasive care alone.⁵,54

2. Degree of 50-99% Asymptomatic Carotid Stenosis Does Not Justify a Procedure^12,13
The ‘Alliance’ cited a recent Oxford Vascular Study publication describing how patients with 80-99%, compared to 50-79%, asymptomatic carotid stenosis had a higher ipsilateral stroke rate.^12,13,55 However, they did not explain that the highest average annual ipsilateral stroke rate seen in that study approximated only 3%, not high enough to ensure a procedural benefit if ACAS results are used as an indicator.^51,54,56 Furthermore, they neglected to explain that the non-invasive stroke prevention treatment used in that study (and particularly in the associated meta-analysis studies) was suboptimal. Therefore, it is highly likely that the 3% average annual ipsilateral stroke rate is higher than that achievable with current best practice non-invasive care alone.⁵⁴

3. TCAR Has Not Been Shown to be as Safe as CEA or More Effective than Non-invasive Care^12,13
Even with large numbers of registry patients, there is no clear evidence that TCAR is as safe as CEA in terms of the risk of stroke or death, at least in standard-surgical-risk patients.^32,57-61 TCAR (like CEA) appears to be safer than CAS in the Vascular Quality Initiative (VQI) registry ^57-59 However, definitive interpretation of TCAR studies is impossible because of underpowering, lack of randomization, mismatch in patient comorbidity loads, combined patient symptomatic status, predominance of asymptomatic patients, retrospective interrogation and lack of comparison with current best practice non-invasive care.^9,10,61,62 CEA remains the safest carotid revascularization procedure and should still be considered in selected symptomatic patients.^5,10 However, patients and their carers need to understand that the evidence for an overall CEA benefit compared to non-invasive care alone was collected decades ago and needs re-evaluation.^5,63

4. Differentiating ‘Asymptomatic’ and ‘Symptomatic’ and Those Shown to Benefit^12,13
The ‘Alliance’ request expansion of reimbursement in ‘selected candidates.’ However, no details are provided about how to select patients. Definitions are not given for asymptomatic or symptomatic patients or for categorizing degree of carotid stenosis.^12,13Further, the ‘Alliance’ omitted to explain the patient subgroups ever shown to have an overall benefit from a procedure (only CEA) compared to non-invasive treatment alone in randomized trials.^48-51,64 The overall CEA benefit was small (approximately 1%/year for asymptomatic/recently asymptomatic carotid stenosis patients and up to approximately 3.2%/year for symptomatic patients with ipsilateral carotid stenosis).⁵ Further, patients had to satisfy all trial selection criteria, have a life expectancy of at least 3-5 years and fit into one of the 4 following groups:⁵

i. Men aged <75–80 years with 60–99% asymptomatic (or recently asymptomatic) carotid stenosis (defined using conventional intra-arterial angiography or ultrasound and ‘NASCET’ criteria)^51,64
ii. Symptomatic Women with 70–99% stenosis (defined using conventional intra-arterial angiography and NASCET criteria and without near occlusion) having CEA within 2–3 weeks of their last same-sided non-severe stroke or TIA).⁶⁵
iii. Symptomatic Men with 50–69% stenosis (defined using conventional intra-arterial angiography and NASCET criteria) having CEA within 2–3 weeks of their last same-sided non-severe stroke or TIA.⁶⁵
iv. Symptomatic Men with 70–99% stenosis (defined using conventional intra-arterial angiography and NASCET criteria and without near occlusion) having CEA within 3 months of their last same-sided non-severe stroke or TIA. However, the CEA benefit fell rapidly over this time and was highest within the first 2–3 weeks.⁶⁵

There has never been evidence of procedural efficacy for any other subpopulation of carotid stenosis patients. Further, evidence for the groups defined above is outdated. A ‘lean to’ approach with respect to procedural reimbursement (or ‘access’) in other subpopulations is inappropriate, given the large numbers of additional implicated patients, and especially when there is evidence of net harm.⁵ Prevailing policy should be reevaluated with appreciation of the health and economic importance of appropriate ‘exnovation’ and independent monitoring of outcomes with all treatment modalities (procedural and nonprocedural).^5,66 Further, it needs to be recognized that a randomized trial is not always needed to answer clinical question. For example, if ipsilateral stroke rates associated with carotid arterial disease are clearly sufficiently close to zero with non-invasive care alone, then randomized procedural trials are not required.⁵

5. Categorizing Degree of Stenosis (and Risk) has Changed, and is Fraught with Error^12,13
The dominant method of measuring carotid stenosis in previous randomized trials was catheter-based digital subtraction angiography and the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria for stenosis.67 Ultrasound was used to some extent in ACAS and was used in ACST-1.^51,64 However, most arterial imaging is now non-invasive. Furthermore, there is inherent error with each imaging modality and correlation is far from perfect.^5,68,69 Concerningly, angiography using magnetic resonance imaging and computed tomography, and ‘real world’ operators, tend to overestimate carotid stenosis severity, encouraging procedural overuse.^70-72 Changes in imaging methodology for categorizing degree of carotid stenosis and measuring risk, along with major advances in noninvasive care and the lack of enforcement of procedural standards outside trials, are major reasons why the original randomized trials of CEA versus non-invasive intervention alone are outdated and/or non-applicable, and the ‘Alliance’ requests are inappropriate.^5,73-75

Speculation

It is speculation that outcomes with CAS may improve.^12,13 This speculation is not relevant to funding decisions currently under discussion. In fact, the evidence base indicates that CAS (at least by the transaortic route) should be avoided.

Conclusions

In summary, rather than expansion, the evidence base clearly demonstrates that it is time for ‘exnovation’ when it comes to reimbursement indications for carotid artery procedures.⁶⁶ There are many reasons, and any reason alone could lead to net patient harm:5^</p>

1. Prevailing guidelines advocate for carotid procedures on many more subgroups than have ever been shown to benefit.
2. CAS is more dangerous than CEA, and TCAR has not been shown to be as safe as CEA.
3. Procedural complication rates, when measured, are usually higher in practice than in trials.
4. There is no current randomised trial evidence of carotid procedural benefit for any patient subgroup compared to current best practice non-invasive care alone. Further, all patients should receive current best practice non-invasive care. Plus, randomised trials are not required to answer every clinical question. For example, if ipsilateral stroke rates are clearly sufficiently close to zero with non-invasive care alone, then randomised procedural trials in such patients are unnecessary and may be unethical.
5. Methods of categorizing carotid stenosis have changed and lack reproducibility.
6. Routine procedural reimbursement blocks new, critically needed research (such as CREST-2 and SPACE-2) to assess carotid procedural efficacy against non-invasive care alone.^5,76
7. Healthcare system sustainability in the US (and elsewhere) is threatened by rising costs, including from poor quality care.^77,78

CMS, and other payers of health services, are key in protecting patients and healthcare resources. This is particularly pertinent in an environment already compromised by misinformation and self-serving practices.^35,79,80 Overuse of carotid artery procedures is a global problem driven by entrenched misdirected incentives.^5,81,82 It can be overcome by redirecting wasted resources to effective interventions, new research, and establishing outcomes-based, rather than activity-based, medicine.^5,83 Patient welfare focused medicine requires putting aside pressure from those likely to gain directly or indirectly, in terms of funds and/or popularity, and objectively sorting the scientific facts. Further, it means insisting on independently maintained clinical standards which ensure healthcare excellence, free from conflict of interest, and which protect patients from harmful or unproven treatment.

References

1. Abbott AL, Adelman MA, Alexandrov AV, Barnett HJ, Beard J, Bell P, Bjorck M, Blacker D, Buckley CJ, Cambria RP, et al. Why the United States Center for Medicare and Medicaid Services (CMS) should not extend reimbursement indications for carotid artery angioplasty/stenting. Eur J Vasc Endovasc Surg. 2012;43:247-251.
2. Abbott AL, Adelman MA, Alexandrov AV, Barber PA, Barnett HJ, Beard J, Bell P, Bjorck M, Blacker D, Bonati LH, et al. Why calls for more routine carotid stenting are currently inappropriate: an international, multispecialty, expert review and position statement. Stroke. 2013;44:1186-1190.
3. US Centers for Medicare & Medicaid Services (CMS). National Coverage Determination [NCD] for Percutaneous Transluminal Angioplasty [PTA] 20.7. Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=201&ncdver=10.
4. US Centers for Medicare & Medicaid Services (CMS). Percutaneous trans-luminal angioplasty (PTA) of the carotid artery concurrent with stenting: National coverage analysis. CAG–00085R8. Available at: https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=311. 12th January, 2023.
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Explanation of Trial Abbreviated Names

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UnityPoint Health appreciates this opportunity to provide comments on the Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting proposed decision memo (CAG-00085R8). UnityPoint Health is one of the nation’s most integrated health care systems. Through more than 32,000 employees and our relationships with more than 360 physician clinics, 36 hospitals in urban and rural communities and 14 home health agencies throughout our 8 regions, UnityPoint Health provides care throughout Iowa, central Illinois, and southern Wisconsin.

At the request of the Multispecialty Carotid Alliance (MSCA), CMS is considering a revision of NCD 20.7 to
(1) cover PTA and CAS with embolic protection in patients with asymptomatic carotid artery stenosis = 70% and in patients with symptomatic carotid artery stenosis = 50%;
(2) remove the requirement that patients are at high risk for CEA;
(3) remove the facility and operator requirements; and
(4) leave coverage for any CAS procedure not described in the NCD to MAC discretion.

UnityPoint Health is opposed to the proposed revision of NCD 20.7 as offered by the MSCA. This revision significantly expands transfemoral carotid PTA and stenting (TFCAS) procedures, which has long been reserved for high-risk AND symptomatic patients outside of the VA system. A high-risk AND symptomatic patient population has been targeted because TFCAS has roughly twice the risk of stroke (including contralateral stroke to the side of the procedure due to traversal of the aortic arch) seen in the ‘gold standard’ of care with carotid endarterectomy (CEA). This heightened risk has been validated when comparing NASCET (symptomatic patients) and ACAS (asymptomatic) patients treated with CEA.

UnityPoint Health cautions adopting procedures used for symptomatic patients and transferring them to asymptomatic patients without demonstrating significant reduction in risk. In this proposal, asymptomatic patients are exposed in TFCAS procedures to a heightened and unacceptable risk. It is undisputed that TFCAS has been studied rather extensively, including with CREST1 & 2 as well as ACST1 & 2. All have continued to show a higher risk of stroke than CEA but reported risk at ‘less than 3% threshold’ of the perioperative stroke rate. This 3% threshold compares to a 1-2% CEA stroke risk. In practice, vascular surgeons strive for stroke risks less than 1%. For symptomatic patients who only have an ~2-3% annual risk of stroke (ACAS trial data) from even severe lesions, a 3% risk threshold of procedural stroke for asymptomatic patients is unacceptable.

This proposal uses flawed reasoning to expand TFCAS procedures based on results for transcarotid artery revascularization (TCAR) procedures. As background, TCAR was initially developed and gained wide acceptance based on the ROADSTER clinical trial. The ROADSTER clinical trial demonstrated a risk of stroke of 1.4% even in the initial pivotal trial (which often sees higher event rates due to operator learning curve). All trial participants were either symptomatic or asymptomatic WITH high-risk criteria (either anatomic or physiologic). Recently, the ROADSTER2 clinical trial was completed, which opened the TCAR procedure to less experienced operators and yielded consistent results. Roughly a year ago, TCAR was approved for all patients either symptomatic or asymptomatic (even WITHOUT high-risk criteria).

TCAR and TFCAS are inherently different procedures, and TFCAS has a heightened risk profile. Due to the way embolic protection must be delivered with TFCAS, it is unlikely to ever be as safe as TCAR in regard to the procedural stroke risk profile. TFCAS has additional associated risk of contralateral stroke due to the traversal of what is often a diseased aortic arch. As many lesions are NOT appropriate for carotid stenting, expanding TFCAS operators to clinicians without experience in the full breadth of treatment options for carotid disease may lead to inappropriate use of TFCAS. In conclusion, TCAR and TFCAS are not interchangeable, and the expansion of carotid stenting for asymptomatic patients is not supported by evidence and permits procedures that will lead to worse overall patient outcomes.

UnityPoint Health urges CMS maintain the current practice and not adopt the proposed revision in its entirety.

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As a vascular surgeon with 35 years of active practice in the management of carotid atherosclerosis in an attempt to reduce the risk of stroke, I have witnessed the significant evolution of management of this disease. Initially, somewhat misguided attempts at intervening with CEA, and now with percutaneous methods, on all asymptomatic patients with carotid atherosclerosis have been shown to be overly optimistic and in some cases harmful. Improvement in medical management of atherosclerosis has demonstrated a significant decrease in the morbidity of vascular disease, particularly with stroke and coronary disease. The pending results from the CREST-2 trial should provide substantial information in guiding the application of interventional techniques, both open and endovascular. This trial will be critical in guiding CMS policy in the management of asymptomatic disease going forward.

It is clearly premature for CMS to consider reducing the bar for transfemoral carotid stenting, which has almost universally been demonstrated to have a higher stroke rate. The recent publications in Pro-Publica and the New York Times regarding the morbidity and fraud suffered by over-generous application of questionable interventions should give further pause to this approach, because clearly stroke is a much more serious outcome than major amputation, which many have suffered when there is little oversight of indications and treatments.

Robert B. Patterson, M.D., FACS, DFSVS

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I do not think that CMS should widen the coverage for transferal carotid artery stenting. Transfemoral carotid stents have a higher incidence op peri procedural strokes than either transcervical carotid artery stenting or carotid endarterectomy. There is a strong belief among many vascular care givers that the number of carotid procedures in asymptomatic patients should be reduced, and that more of these patients should be medically managed. Many physicians are increasing the amount of asymptomatic carotid stenosis that should be present before recommending carotid intervention, with a significant number suggesting that 80 percent stenosis is an appropriate cutoff. The cost of medical care is rising. It does not seem prudent to increase medical costs and the number of peri procedural strokes by approving transfemoral carotid stenting for asymptomatic greater than 70 percent carotid stenosis, which is currently under review by CMS.

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With respect to these proposals before US Medicare, it is hard to imagine how health policy in relation to carotid arterial disease could be designed to inflict more damage in terms of public health and the protection of precious healthcare resources. The science behind current best management of carotid arterial disease has been explained simply and comprehensively in our submissions below (by Abbott and Abbott with 76 others).

As mentioned by us below, there are many supporters of these proposals to:

* Fund free-for-all carotid artery procedures (including CAS which is more dangerous than CEA) on any US Medicare ‘beneficiary’ (any American aged at least 65 years or receiving certain disability benefits or having end stage renal disease) and labelled as having at least '50 or 70%' carotid stenosis (when there is no current evidence of procedural benefit compared to non-invasive measures alone, there is evidence of net procedural harm and we have no widely reproducible way to measure carotid stenosis)
AND
* Remove CMS approved procedural standards (the brake on operators with excessive procedural stroke and death rates).

However, most of these supporters are proceduralists and stand to gain financially if these proposals go through. Moreover, they all lack scientific evidence to support their call for such dramatic change to US health policy.

It is alarming that patient interests and the scientific process are being swept away by these proposals. Clearly, those with financial conflict of interest, and/or lacking proper scientific argument, should ‘STAND ASIDE’ and allow proper scientific process and the public's best interests to prevail.

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I do not think CMS should consider coverage of carotid artery stenting (CAS) among patients with asymptomatic carotid artery stenosis. Stroke risk has declined among patients with asymptomatic carotid artery stenosis. There is a very real risk of 30-day stroke and death among older adults who undergo carotid procedures. Therefore, there may be no benefits from this surgery to patients but there may be real risks of harm. Coverage of CAS may increase risks to older patients, increase unnecessary use of this procedure and potentially waste government funds. The epidemiologic literature is clear, stroke risk from asymptomatic carotid stenosis has declined in the era of modern medical therapy (see references below). In addition, the data we have from carotid endarterectomy trials conducted over 20 years ago where surgery was compared to medical therapy is outdated. There is an ongoing NIH trial in which CAS is being directly compared to medical therapy (https://www.crest2trial.org/). Why not wait for the CREST 2 results before making coverage decisions?

References:

Medical (nonsurgical) intervention alone is now best for prevention of stroke associated with asymptomatic severe carotid stenosis: results of a systematic review and analysis - PubMed (nih.gov)
Comparative Effectiveness of Carotid Stenting to Medical Therapy Among Patients With Asymptomatic Carotid Stenosis - PubMed (nih.gov)
Comparative Effectiveness of Carotid Endarterectomy vs Initial Medical Therapy in Patients With Asymptomatic Carotid Stenosis - PubMed (nih.gov)
Screening for Asymptomatic Carotid Artery Stenosis in Adult Patients: Unclear Benefit but Downstream Risks - PubMed (nih.gov)

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I find this proposal troubling. There is a well-known issue with stenting being done with the degree of stenosis not being greater than 70% when the patients are asymptomatic. Revascularizing asymptomatic carotid arteries remains controversial with stunting and the efficacy is currently being tested in the NIH funded CREST-2 study. The well-informed aspect of the proposal is also troublesome, and in my practice as a non-surgeon and as a vascular neurologist I have found that many patients are not aware of the absolute risk reduction being very marginal with asymptomatic stenosis, as well as how the the risk is to begin with in those who are treated with best medical therapy and are surprised when I quote those numbers. At best such a informed discussion should include both a surgeon and non-surgeon in a similar way that cardiac valve surgery requires a multi-disciplinary team of surgeons, internationalists, nursing, and vascular neurologists being involved in the case and documentation of such a team meeting. If this is approved it will lead to countless of unnecessary procedures being done with subsequent patient harm, as well significant cost to the Medicare budget.

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I am writing to express my support for the proposed decision regarding Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting. As a neurosurgery resident who treats patients for CAS, I would like to thank CMS for its thoughtful review of the literature and the expanded Medicare coverage proposal.

I fully support the key components of the proposed decision, particularly the expanded coverage for patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%. The current clinical evidence strongly supports the efficacy of this procedure for these patient populations.

Furthermore, I believe it is crucial to provide coverage without requiring patients to participate in clinical trials. While clinical trials are important for advancing medical knowledge, requiring participation as a condition of coverage could potentially delay timely access to this life-saving technology. Therefore, I recommend that CMS does not impose such a requirement.

Lastly, I would like to address the issue of requiring providers to use a validated shared decision-making tool as a condition of coverage. As of now, no such tools exist, and implementing this requirement would further delay access to this life-saving procedure. I recommend that CMS does not mandate the use of a validated shared decision-making tool until such tools are available and proven effective.

Thank you for considering my comments. I appreciate the opportunity to provide input on this important matter.

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[PHI Redacted], I am concerned with the possible expansion outlined in CMS’ Proposed Direction Memo relating to NCD20.7. I am particularly concerned with comments relating to patients having the choice of treatment options. [PHI Redacted], I could not imagine having to discuss the options suggested here. It is overwhelming, especially when you are unwell, or your life is under immediate threat. I want my physician to choose the option that is best for me and considers my individual risk and chance of benefit. I do not want an option that increases my risk of stroke or is chosen primarily to make my doctor wealthy. I do not want to take responsibility for a decision that may result in an unnecessary procedure and could be used to absolve others from accountability. US health policy, research and practice has a strong influence in other countries, including Australia. For example, just look at how influential American studies such as ACAS and NASCET have been globally in terms of guidelines and practice. I fear that the proposed change to funding in the USA will have profound consequences for our healthcare system in Australia.

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To Whom it May Concern:

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. Transfemoral carotid stenting is known to have a higher perioperative stroke risk than carotid endarterectomy or Trananscarotid artery revascularization (TCAR). Expanding coverage to allow insufficiently trained physicians to treat asymptomatic patients would inevitably lead to significant harm. Not only would individual patients suffer undue disability, but the cost to society would be vast. Please reconsider this expansion.

Respectfully,
Kathryn L. Davis, MD, FACS, RPVI, FSVS

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To Whom It May Concern,

Please accept this as endorsement of CMS’s proposal to update the patient selection criteria in the National Coverage Determination (NCD) to mirror results from this clinical research and to parallel existing access to carotid endarterectomy (CEA) by expanding coverage to include patients at standard surgical risk, patients with symptomatic carotid artery stenosis of at least 50%, and patients with asymptomatic carotid artery stenosis of at least 70%. SVM further supports CMS’s proposal to permit determination of facility and operator requirements through hospital credentialling processes and based on medical society guidelines, similar to requirements in place for other well-established interventional procedures.

This decision will allow for a broader patient population to benefit from therapies shown to be effect and safe over decades of clinical trials. I commend CMS for updating their patient selection criteria.

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Joseph Chin. MD, Acting Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, Maryland 21244

Re: Proposed National Coverage Determination for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8)

Dear Dr. Chin:

We appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed decision memo Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8) which is proposing to revise sections of the national coverage determination (NCD) for coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (NCD 20.7). Abbott is a leading manufacturer of medical technologies for the diagnosis and treatment of cardiovascular disease, including carotid artery stents and embolic protection devices.

In general, we support the changes that CMS is proposing. We are particularly encouraged to see that CMS is proposing to update its coverage to reflect the current landscape of carotid artery stenting. By expanding coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, Medicare is enabling more beneficiaries to have access, when medically necessary, to this life-saving therapy.

As we noted in our comments in the initial comment period earlier this year, since the last reconsideration of NCD 20.7, additional published, peer-reviewed clinical evidence supporting carotid artery stenting (CAS) procedures as a reasonable alternative to carotid endarterectomy (CEA) has become available. This evidence has demonstrated the appropriateness of CAS in treating a broader patient population to include asymptomatic patients as well as those who are not at high risk for CEA.[1-5]

We also appreciate that CMS, in addition to evaluating the safety and effectiveness of the therapy, reviewed the literature in terms of health disparities in the CAS population, and came to the conclusion that it was better to “[lean] toward access”[6] by expanding coverage rather than restrict it. This approach aligns with Abbott’s efforts in advancing health equity as we recognize that people face real barriers to living healthy.

In our earlier comments, we also noted that given the current maturity of CAS procedures and operator experience, along with extensive additional clinical evidence supporting the safety and effectiveness of CAS, it was no longer necessary for CMS to still include facility and operator requirements in the NCD. We therefore support CMS’ decision to remove these because such requirements should currently be handled by the credentialing processes of the hospitals and hospital systems in which CAS is performed.

In the proposed NCD, CMS included a requirement that all providers engage in a shared decision-making interaction with patients. Abbott agrees with CMS that a formal shared decision-making process can help ensure that patients are well informed of their options when considering any therapy, including all therapies for treating carotid artery disease. However, we recommend that the specifics of the process—including what to include and whether there should be a validated tool to help facilitate the process—be determined by the physicians and hospitals providing these procedures. Giving them the flexibility to adjust the process to best reflect the current evidence base and meet the individual needs of patients not only ensures that Medicare beneficiaries are getting the most up to date care, but it is also more consistent with the level of oversight that CMS is recommending in the other changes in this proposed NCD. CMS is working to remove unnecessary barriers to access to care for their beneficiaries. Expanding the patient population and removing hospital and practitioner requirements does this, as would recommending a shared decision-making process be used and documented, but not requiring the development of a new validated tool.

Finally, Abbott supports CMS’ proposal to allow MACs to determine coverage for those patients who may be candidates for PTA of the carotid artery concurrent with stenting but do not meet the NCD criteria. These patients may still benefit from the procedure if it is medically necessary and allowing MAC’s the discretion to determine that allows for an appropriate amount of flexibility.

Thank you again for the opportunity to comment on CMS’ proposed decision memo and for CMS’ efforts to lean toward access for these patients. Please contact us with any questions.

Sincerely,

James Hasegawa
Senior Director, Health Economics & Reimbursement
Abbott

References:

1. Silver FL, et al., Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2011;42:675-80.
2. Rosenfield K, et al., Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis. N Engl J Med. 2016;374:1011-20.
3. Matsamura JS, et al., Treatment of Carotid Stenosis in Asymptomatic, Non-Octogenarian, Standard Risk Patients with Stenting versus Endarterectomy: A Pooled Analysis of the CREST and ACT I Trials Journal of Vascular Surgery. 2021.
4. Reiff T, et al., Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2. Int J Stroke. 2019:1747493019833017.
5. Halliday A, et al., Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy. Lancet. 2021:1065-73.
6. Centers for Medicare & Medicaid Services. National Coverage Analysis Proposed Coverage Decision Memorandum for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8). July 11, 2023. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&ncaid=311

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I am an interventional cardiologist who regularly evaluates patients with carotid vessel disease and performs carotid stent procedures (CAS). I would like to thank CMS for their thoughtful and thorough review of the extensive amount of rigorous data that exists on this topic.

With this in mind, I strongly support the following proposed decisions:

1. Proposal to expand coverage for CAS to patients with symptomatic carotid stenosis greater than or equal to 50% and asymptomatic stenosis greater than or equal to 70% consistent with the large body of data across multiple RCTs.
2. Providing coverage without a requirement to participate in clinical trials or ongoing registries given the large number of patients already studied in this context and the potential for such a requirement to limit access to this therapy.
3. Removal of facility standard and approval requirements
4. Allowing MACs to determine whether to cover CAS for other patients.

Please consider revising the following aspects of the Proposed Decision:

1. I strongly agree that a shared decision-making encounter with the patient is required. However, it should not require the use of a validated tool. The development of such a tool would take years and require substantial resources to create as well as likely unnecessarily delay coverage. Please recommend the support of a SDM interaction but not with the requirement to develop a “validated” SDM tool.
2. Please recommend that CMS permit the use of catheter-based angiography in cases where CTA/MRA are contraindicated.

Thank you for the opportunity to express our thoughts and opinions in this open forum.

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Thank you for allowing additional public comment on proposed changes to NCD 20.7 4. I am a retired vascular surgeon who has performed about a thousand CEAs, TF-CAS and some TCAR. I have been a long-time member of the Society for Vascular Surgery and was on the Medicare Carrier advisory committee for KY for 26 years. I am alarmed at the proposals to eliminate standards for facilities, expand carotid stenting to basically all patients with carotid disease, and mandating standardized "Shared Decision Making" (SDM).

I believe that Anne Abbott in her posted comments are spot on and entirely correct. There is a lot of shading of data in the field of carotid stents and the TCAR proponents like to forget that their data is cherry picked patients that eliminate those at highest risk. Ms. Abbott and her group has done a fantastic job of elaborating some of those data "problems" which do exist. It is extensively well supported by the references and I cannot write a better rebuttal to expansion of indications for CAS.

There is no standard "Shared Decision Making" documents and may take a long time to develop. Moreover I do not believe that is would replace the standard informed consent process that tort law presently requires. Even if CMS mandates the SDM, it may not be adopted by all insurance companies including the Medicare Advantage plans. Thus, this may introduce some confusion as this is not done in coordination with all insurance plans.

As one who provided all of the options I was able to provide what is best for the patient. It appears that many of the groups supporting expansion are not able to provide the best option for the patient and thus want to expand indications so they can do more procedures. This will cause more strokes when done in an unaccredited facility. There is no question that high risk procedures done in facilities without adequate training and experience have worse outcomes. There are reasons why a rural hospital cannot just start doing Coronary Artery Bypasses with just a few a year. They have to prove they have the equipment, trained people to take care of those patients. The diseased carotid artery is NOT forgiving as most diseased arterial beds, including the coronary arteries. Only by keeping standards can carotid stenting not create numerous strokes. The collection of real time data is one of the best ways to ensure continued good results.

Just because a few studies indicate good results does not mean that can be expanded to all patients and physicians in all settings. An analogy would be that since the US has an "acceptable" level of auto accidents that we should eliminate all driver license requirements and remove the alcohol drinking age. I think most would agree that would be a terrible idea. The increase in harm to CMS beneficiaries would be similar.

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8200 Coral Sea St NE
Mounds View, MN 55112
Tel: 763-514-4111
www.medtronic.com

August 8, 2023

SUBMITTED ELECTRONICALLY

Sarah Fulton, MHS
Joseph Hutter, MD
Coverage & Analysis Group
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd
Baltimore MD 21244

Re: National Coverage Analysis Proposed Decision Memo: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting; CAG-00085R8

Dear Ms. Fulton and Dr. Hutter,

On behalf of Medtronic, we appreciate the opportunity to respond to CMS’ request for public comment on the proposed decision memo for PTA of the carotid artery concurrent with stenting.

Medtronic is the world’s leading medical technology company specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life and is committed to transforming vascular disease management with a full portfolio of versatile endovascular treatment options and products to provide the best possible outcomes for patients.

Medtronic is supportive of CMS’ proposed decision to expand coverage for PTA of the carotid artery, concurrent with stenting and applaud CMS for proposing this important change in policy. We believe broadening access to this minimally invasive technique is a positive step.

The proposed decision memo appropriately considers recent clinical evidence which demonstrates the clear benefits of carotid stenting. The proposed criteria rightly focus on degree of stenosis as the key factor guiding treatment, not surgical risk status. Clinical trials now demonstrate carotid stenting achieves excellent stroke prevention similar to carotid endarterectomy, across standard and high surgical risk patients. This equalizes access and by providing coverage for carotid stenting alongside the existing coverage for endarterectomy, CMS allows physicians to choose the most appropriate treatment for each patient's individual circumstances. This individualized, evidence-based approach will improve outcomes and reduce risks in patients with carotid stenosis.

Notably, traditional transfemoral carotid artery stenting and the newer Trans Carotid Artery Revasularization (TCAR) approach should have equivalent coverage. Both are rigorously studied procedures that produce comparable results. Limiting Medicare coverage to one delivery method over another is not supported by the current evidence.

In summary, we support CMS’ thorough review of the clinical literature which informs this proposed expansion of patient-centered coverage. This coverage aligns Medicare policy with current best practices and the latest research on effective management of carotid artery disease. Broadening access to this proven carotid procedure will benefit many Medicare beneficiaries.

Thank you for considering these comments.

Sincerely,

Bonnie Handke
Vice President, Health Economics, Policy & Reimbursement
Medtronic, PLC

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I strongly urge CMS to finalize The Centers for Medicare & Medicaid Services’ (CMS) Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (“Proposed Decision Memo”).

I enthusiastically support CMS’s proposal to expand coverage to patients at standard surgical risk, patients with symptomatic carotid artery stenosis =50%, and patients with asymptomatic carotid artery stenosis of =70%, without further evidence development.

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Expansion of coverage for tf CAS = more Americans disabled by stroke.

I recognize that there are well educated, skilled, and ethical physicians currently performing tf CAS with good outcomes. And the need for those skills is real. However, those good outcomes are occurring with appropriate guardrails in place. CMS must ensure that physicians have adequate training to understand the nuances of carotid artery disease. Expanding coverage of tf CAS (which has debatable indications) without establishing strict credentials that delineate required qualifications for reimbursement will open the arena to the less educated, less skilled, and less ethical. It will lead to the same overutilization and rash of adverse events that we have seen with unregulated treatment of venous disease and PAD.

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This proposed rule is bad for Medicare beneficiaries. Widespread use of transfemoral carotid stenting will lead to increased and unnecessary procedures. I strongly believe that it would lead to more neurovascular events and strokes than the natural history of carotid occlusive disease if these patients were treated with simple medical therapy.

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I am an interventional cardiologist who sees patients with carotid artery stenosis in my clinic. I would like to thank CMS for a thoughtful review of the literature. I support finalization of key components of the proposed decision, specifically:

1) Expanded coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
2) Coverage without requiring patients to participate in clinical trials.
3) Removal of the facility standard and approval requirements.
4) Allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS for other patients.

I recommend that CMS revise two aspects of the proposed decision:

1) The Proposal requires physicians to have a shared decision-making (SDM) interaction with patients and advocates doing so with a “validated” SDM tool. However, development of such a “validated tool” would take years. I support an SDM interaction (including discussion about all options for treatment of carotid disease) but not a delay in coverage of CAS pending the development of a “validated” SDM tool.
2) The Proposal would require all patients considered for CAS to undergo computed tomography angiography (CTA) or magnetic resonance angiography (MRA) in advance of catheter-based angiography. I recommend that CMS allow use of catheter-based angiography when CTA/MRA are contraindicated.

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I am a neurosurgeon with neurointerventional training who performs CEA and CAS.

I support the following:

Support requirements for physicians to have an SDM interaction with patients without delaying coverage until a validated SDM tool has been developed.

Recommend that CMS not require patients to undergo computed tomography angiograph (CTA) or magnetic resonance angiography (MRA) if contraindicated for the patient, and allow use of catheter-based angiography for these patients.

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To whom it may concern,

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. 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.

Recommendation 2. 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.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If however the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

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