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

CMS NCA document | source_status=Closed | review_type=8th Recon | public_comment_open=False | document_id=CAG-00085R8

The Centers for Medicare & Medicaid Services (CMS) finds that coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting is reasonable and necessary 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 under the following conditions: Patients with symptomatic carotid artery stenosis ≥50%; and Patients with asymptomatic carotid artery stenosis ≥70%. For both A and B above: Neurological assessment by a neurologist or NIH stroke scale (NIHSS) certified health professional before and after carotid artery stenting (CAS) must be performed. First-line evaluation of carotid artery stenosis must use duplex ultrasound. Computed Tomography angiography or magnetic resonance angiography, if not contraindicated, must be used to confirm the degree of stenosis and provide additional information about the aortic arch, and extra- and intracranial circulation. Intra-arterial digital subtraction (catheter) angiography may be used only when there is significant discrepancy between non-invasive imaging results, or in lieu of computed tomography angiography or magnetic resonance angiography if these are contraindicated. Prior to furnishing CAS, the practitioner must engage in a formal shared decision-making interaction with the beneficiary. The shared decision-making interaction must include: Discussion of all treatment options including carotid endarterectomy (CEA), CAS (which includes transcarotid artery revascularization (TCAR)), and optimal medical therapy (OMT)). Explanation of risks and benefits for each option specific to the beneficiary’s clinical situation. Integration of clinical guidelines (e.g., patient comorbidities and concomitant treatments). Discussion and incorporation of beneficiary’s personal preferences and priorities in choosing a treatment plan. Facilities must establish and maintain institutional and physician standards to support a dedicated carotid stent program. These standards must at least include and ensure the following: Facilities have a clearly delineated program for granting carotid stent privileges and for monitoring patient outcomes for individual physicians and the program as a whole. The oversight committee for this program shall be empowered to identify the minimum case volume for a physician to maintain privileges, as well as the (risk-adjusted) threshold for complications that the institution will allow before suspending privileges or instituting measures for remediation. Committees are encouraged to apply published standards from specialty societies and widely-used, published professional society guidelines to determine appropriate physician qualifications. Facilities have appropriately trained staff capable of fulfilling roles and responsibilities as delineated under the dedicated carotid stent program. Facilities have appropriate supporting personnel and equipment for imaging, emergency management, advanced physiologic monitoring, and other ancillary care. Facilities must ensure continuous quality improvement by assessing procedural outcomes and making necessary programmatic adjustments to assure patient safety. Please note: CMS or third-party facility approval, accreditation or certification are not required by this NCD for coverage purposes. In addition to the national coverage described above, Medicare Administrative Contractors (MACs) may make reasonable and necessary determinations under section 1862(a)(1)(A) for any other beneficiary seeking coverage for PTA of the carotid artery concurrent with stenting. See Appendix B for the NCD manual language. In summary, this final decision memorandum, which affects NCD 20.7 sections B4 and D, revises Medicare coverage for PTA of the carotid arteries concurrent with stenting by: Expanding coverage to individuals previously only eligible for coverage in clinical trials; Expanding coverage to standard surgical risk individuals by removing the limitation of coverage to only high surgical risk individuals; Removing facility approval requirement; Adding formal shared decision-making with the individual prior to furnishing CAS; and Allowing MAC discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.

Decision Memo: TO: Administrative File: CAG-00085R8 FROM: Coverage and Analysis Group (CAG) SUBJECT: National Coverage Determination for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting DATE: October 11, 2023 I. Decision The Centers for Medicare & Medicaid Services (CMS) finds that coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting is reasonable and necessary 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 under the following conditions: Patients with symptomatic carotid artery stenosis ≥50%; and Patients with asymptomatic carotid artery stenosis ≥70%. For both A and B above: Neurological assessment by a neurologist or NIH stroke scale (NIHSS) certified health professional before and after carotid artery stenting (CAS) must be performed. First-line evaluation of carotid artery stenosis must use duplex ultrasound. Computed Tomography angiography or magnetic resonance angiography, if not contraindicated, must be used to confirm the degree of stenosis and provide additional information about the aortic arch, and extra- and intracranial circulation. Intra-arterial digital subtraction (catheter) angiography may be used only when there is significant discrepancy between non-invasive imaging results, or in lieu of computed tomography angiography or magnetic resonance angiography if these are contraindicated. Prior to furnishing CAS, the practitioner must engage in a formal shared decision-making interaction with the beneficiary. The shared decision-making interaction must include: Discussion of all treatment options including carotid endarterectomy (CEA), CAS (which includes transcarotid artery revascularization (TCAR)), and optimal medical therapy (OMT)). Explanation of risks and benefits for each option specific to the beneficiary’s clinical situation. Integration of clinical guidelines (e.g., patient comorbidities and concomitant treatments). Discussion and incorporation of beneficiary’s personal preferences and priorities in choosing a treatment plan. Facilities must establish and maintain institutional and physician standards to support a dedicated carotid stent program. These standards must at least include and ensure the following: Facilities have a clearly delineated program for granting carotid stent privileges and for monitoring patient outcomes for individual physicians and the program as a whole. The oversight committee for this program shall be empowered to identify the minimum case volume for a physician to maintain privileges, as well as the (risk-adjusted) threshold for complications that the institution will allow before suspending privileges or instituting measures for remediation. Committees are encouraged to apply published standards from specialty societies and widely-used, published professional society guidelines to determine appropriate physician qualifications. Facilities have appropriately trained staff capable of fulfilling roles and responsibilities as delineated under the dedicated carotid stent program. Facilities have appropriate supporting personnel and equipment for imaging, emergency management, advanced physiologic monitoring, and other ancillary care. Facilities must ensure continuous quality improvement by assessing procedural outcomes and making necessary programmatic adjustments to assure patient safety. Please note: CMS or third-party facility approval, accreditation or certification are not required by this NCD for coverage purposes. In addition to the national coverage described above, Medicare Administrative Contractors (MACs) may make reasonable and necessary determinations under section 1862(a)(1)(A) for any other beneficiary seeking coverage for PTA of the carotid artery concurrent with stenting. See Appendix B for the NCD manual language. In summary, this final decision memorandum, which affects NCD 20.7 sections B4 and D, revises Medicare coverage for PTA of the carotid arteries concurrent with stenting by: Expanding coverage to individuals previously only eligible for coverage in clinical trials; Expanding coverage to standard surgical risk individuals by removing the limitation of coverage to only high surgical risk individuals; Removing facility approval requirement; Adding formal shared decision-making with the individual prior to furnishing CAS; and Allowing MAC discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7. II. Background Throughout this document we use numerous acronyms, some of which are not defined as they are presented in direct quotations. Please find below a list of these acronyms and corresponding full terminology: ACAS – Asymptomatic Carotid Atherosclerosis Stenosis ACST-2 – Asymptomatic Carotid Surgery Trial-2 ACT-1 – Asymptomatic Carotid Trial BMT – Best Medical Therapy CAS – Carotid Artery Stenting CEA – Carotid Endarterectomy CMS – Centers for Medicare & Medicaid Services CREST – Carotid Revascularization Endarterectomy versus Stenting Trial CREST-2 – Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial CTA – Computed Tomography Angiography ECST – European Carotid Surgery Trial ECST-2 – Second European Carotid Surgery Trial EPD – Embolic Protection Device FDA – Food and Drug Administration ICSS – International Carotid Stenting Study IDE – Investigational Device Exemption MAC – Medicare Administrative Contractor MI – Myocardial Infarction MRA – Magnetic Resonance Angiography MSCA – Multispecialty Carotid Alliance NASCET – North American Symptomatic Carotid Endarterectomy Trial NCA – National Coverage Analysis NCD – National Coverage Determination OMT – Optimal Medical Therapy PTA – Percutaneous Transluminal Angioplasty ROADSTER – Reverse Flow Used During Carotid Artery Stenting Procedure SAPPHIRE – Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy SDM – Shared Decision-Making SPACE-2 – Stent Protected Angioplasty versus Carotid Endarterectomy-2 TCAR – Transcarotid Artery Revascularization The terms “procedural” and “periprocedural” are used interchangeably in the literature, and in this NCD, as are the terms “best medical therapy or BMT” and “optimal medical therapy or OMT.” Strokes occur when blood flow to the brain is blocked (ischemic stroke) or sudden bleeding in the brain occurs (hemorrhagic stroke) (NINDS 2023). In the United States, more than 795,000 people experience a stroke annually and ischemic strokes comprise about 87% of all strokes (CDC 2023). The carotid arteries supply oxygenated blood to the brain and are susceptible to atherosclerosis which can result in carotid artery stenosis and plaque embolization (Sethi 2023). Carotid atherosclerosis develops when plaque, formed by cholesterol, fat, blood cells and other substances in the blood, builds up inside the carotid arteries, to narrow the arteries and reduce blood flow (NHLBI 2023, NINDS 2023). Carotid atherosclerotic disease accounts for about 10-20% of ischemic strokes, or about 150,000 strokes each year in the United States (Finn 2017). Treatment strategies for atherosclerotic carotid stenosis include aggressive medical therapy, carotid endarterectomy (CEA) and carotid artery stenting (CAS). Aggressive medical therapy may involve use of anti-platelet agents, statins, antihypertensives, anti-ischemic perioperative beta blockers, risk factor modification (including smoking cessation and diabetic control) plus lifestyle modification (e.g., exercise). CEA is a surgical procedure used to prevent stroke in which a surgeon removes fatty deposits or ulcerated and stenotic plaques from the carotid arteries, the two main arteries in the neck supplying blood to the brain. CAS is performed with a catheter, usually inserted through the femoral artery, and threaded up to the carotid artery beyond the area of narrowing. A distal embolic protection device or filter is usually placed first to catch emboli or debris that may dislodge during the procedure. A self-expandable or balloon-expandable, metal mesh stent is then placed to widen the stenosis and the protection device is removed. CAS procedures using the femoral access point are often referred to as transfemoral CAS (TF-CAS) following the advent of the newest CAS procedure, transcarotid artery revascularization (TCAR). TCAR accesses the carotid arteries percutaneously through an incision above the collarbone and uses a proximal embolic protection device involving blood flow reversal instead of distal embolic protection. III. History of Medicare Coverage Medicare first covered PTA of the carotid artery concurrent with stent placement in accordance with the FDA approved protocols governing Category B IDE clinical trials and later in FDA required post approval studies (Medicare NCD Manual 20.7B2, B3). Our proposals do not involve revisions to subsections B2 and B3. Effective March 17, 2005, Medicare expanded coverage for PTA and stenting of the carotid artery when performed on patients at high risk for CEA who also have symptomatic carotid artery stenosis ≥ 70% only when performed in a CMS approved facility for CAS with FDA-approved carotid artery stenting systems and embolic protection devices. Symptoms of carotid artery stenosis include carotid transient ischemic attack (TIA) (distal focal neurological dysfunction persisting less than 24 hours), non-disabling stroke (Modified Rankin Scale score < 3 with symptoms for 24 hours or more), and transient monocular blindness (amaurosis fugax) (Medicare NCD Manual 20.7B4). Effective April 30, 2007, Medicare maintained the existing coverage policy and included detailed facility recertification instructions in the NCD. Effective October 14, 2008, Medicare maintained the existing coverage policy, making no deletions, revisions or additions. Effective December 9, 2009, Medicare revised the NCD language to specify that FDA approved or cleared embolic protection devices may be used during CAS procedures. No changes were made to other coverage requirements or criteria. A. Current Request CMS received and accepted a complete, formal request to reconsider NCD 20.7 from the Multispecialty Carotid Alliance (MSCA). The request letter is available at https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id311.pdf . The scope of this reconsideration is limited to PTA concurrent with CAS including transcarotid artery revascularization (TCAR) procedures. B. Benefit Category For an item or service to be covered by the Medicare program, it must fall within one of the statutorily defined benefit categories outlined in the Social Security Act [§1812 (Scope of Part A); §1832 (Scope of Part B); §1861(s) (Definition of Medical and Other Health Services)]. PTA of the carotid artery concurrent with stenting qualifies as: Inpatient hospital services. Physicians’ services. Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service. IV. Timeline of Recent Activities Date Actions Taken January 12, 2023 CMS initiates this national coverage analysis. A 30-day public comment period begins. February 11, 2023 Initial 30-day public comment period ends. CMS receives 193 timely comments. July 11, 2023 Proposed decision memorandum posted. The second 30-day public comment period begins. August 10, 2023 Second 30-day public comment period ends. CMS receives 760 timely comments. October 11, 2023 CMS posts final decision memorandum. V. Food and Drug Administration (FDA) Status On August 30, 2004, the FDA approved the first carotid stent for marketing in the United States. The ACCULINK™ Carotid Stent System and the RX ACCULINK™ Carotid Stent System, used in conjunction with Guidant carotid embolic protection systems, was approved “ for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. Patients with neurological symptoms and ≥50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and ≥80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion .” ( https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040012 ). Since this first approval, the devices in Table 1 below have been approved for: Standard (i.e., non-high) surgical risk patients; and Stenting via direct carotid artery access (TCAR) vs. traditional femoral artery access (CAS). Table 1 below provides a timeline of carotid stent device approvals to date. Table 1 – FDA approved carotid stent devices Approval Date Device Indication/Surgical Risk 8/30/04 Abbott Vascular Acculink CAS High risk 9/6/05 Abbott Vascular Xact CAS High risk 9/22/06 Cordis Precise CAS High risk 10/27/06 Boston Scientific NexStent CAS High risk 1/24/07 Medtronic Vascular Protégé CAS High risk 10/23/08 Boston Scientific Wallstent CAS High risk 5/6/11 Abbott Vascular Acculink CAS Standard risk 5/18/15 Silk Road Medical ENROUTE TCAR High risk 4/28/22 Silk Road Medical ENROUTE TCAR Standard risk VI. General Methodological Principles When making national coverage determinations (NCDs) under section 1862(a)(1)(A) of the Social Security Act, CMS generally evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The critical appraisal of the evidence enables us to determine to what degree we are confident that: 1) the specific assessment questions can be answered conclusively; and 2) the intervention will improve health outcomes for beneficiaries. An improved health outcome is one of several considerations in determining whether an item or service is reasonable and necessary. A detailed account of the methodological principles of study design that the Agency utilizes to assess the relevant literature on a therapeutic or diagnostic item or service for specific conditions can be found in Appendix A. Public comments sometimes cite published clinical evidence and give CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. Public comments that contain personal health information that cannot be redacted will not be made available to the public. CMS responds in detail to the public comments on a proposed national coverage determination when issuing the final national coverage determination. VII. Evidence A. Introduction This section provides a summary of the evidence we considered during our review. The evidence reviewed to date includes the published medical literature on pertinent clinical trials of carotid artery stenting compared to carotid endarterectomy. Our assessment focuses on the key evidence questions below. B. Discussion of Evidence 1. Evidence Questions Q1. Does carotid artery stenting with embolic protection improve health outcomes similarly to carotid endarterectomy in symptomatic patients with carotid artery stenosis? Q2. Does carotid artery stenting with embolic protection improve health outcomes similarly to carotid endarterectomy in asymptomatic patients with carotid artery stenosis? Q3. Do specific patient characteristics impact which procedure, CAS or CEA, results in better health outcomes for individual patients? Q4. Are NCD criteria for physicians, care teams, and facilities performing CAS necessary or helpful to ensure that beneficial health outcomes seen in trials are achieved in broad community practice? 2. External Technology Assessments CMS did not request an external technology assessment (TA) on this issue. 3. Internal Technology Assessment We searched the databases PubMed and Embase for English language articles in peer-reviewed journals published since the last NCD, from 2009-2023, using the search terms ‘carotid artery stenting’, ‘carotid endarterectomy’, ‘transcarotid artery revascularization’ and “healthcare disparities” in various combinations. To ensure that we captured all the relevant articles, the search was conducted independently by the contractor International Consulting Associates (ICA), and the CMS Coverage and Analysis Group (CAG). We incorporated all the distinct, relevant references into a single reference database. We included other, relevant articles and documents cited by those in the reference database, or cited by the requester and public commenters, as well as expert opinion or commentary from online sources. We also searched for the most recent guidelines by medical societies, based in the U.S. and abroad, as well as relevant government reports (e.g., by the FDA or CDC). The final result was the identification of over 70 peer-reviewed documents relevant to the NCD analysis. 4. Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) A MEDCAC meeting was not convened on this issue. 5. Evidence Table VIII. Public Comment Public comments sometimes cite the published clinical evidence and give CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. CMS uses the initial public comments to inform its proposed decision. CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum. All comments that were submitted without personal health information may be viewed in their entirety by using the following link: https://www.cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaid=311 . Initial Comment Period: 1/12/2023-2/11/2023 During the 30-day public comment period following the release of the tracking sheet, CMS received 193 timely comments. All comments were published on the CMS website and considered for this proposed decision. The majority of comments, 146 comments, supported the expansion of coverage criteria in one or more areas. Of these 146 comments, 75 comments specifically supported removal of the requirement that patients are at high risk for CEA, 21 comments specifically supported removal of the operator and facility standards and approval requirements, and 3 comments supported expansion of coverage only for TCAR and not transfemoral CAS. Twenty-three comments did not support expansion. Of these 23 comments, 2 comments did not support removal of the requirement that patients are at high risk for CEA, and 4 comments did not support the removal of the operator and facility standards and approval requirements. Three comments supported expansion of coverage criteria in some areas and non-expansion in others. Twenty-one comments did not state a clear position regarding coverage criteria. Of these 21 comments, 10 comments were generally positive toward transfemoral CAS and 3 comments were generally positive toward TCAR. One comment supported independent facility accreditation for all carotid stenting procedures and operator guidelines provided by professional societies. One hundred fifty-six comments were submitted by healthcare professionals, with the majority (at least 145 comments) provided by physicians. Seven comments were provided by medical device companies. Seventeen commenters did not specify their titles and/or organizations. Thirteen comments were provided by national associations, professional societies, commissions, foundations, including the Intersocietal Accreditation Commission (IAC), the Multispecialty Carotid Alliance (MSCA), the Society for Cardiovascular Angiography and Interventions (SCAI), the Society of Interventional Radiology (SIR), the Society of NeuroInterventional Surgery (SNIS), the Society of Vascular and Interventional Neurology (SVIN), the Society for Vascular Medicine (SVM), the Society for Vascular Surgery (SVS), the Society for Vascular Surgery (SVS) Patient Safety Organization (PSO) Vascular Quality Initiative (VQI), the Vascular InterVentional Advances (VIVA) Foundation, a joint comment from the American College of Cardiology (ACC) and the American Heart Association (AHA), and a joint comment from the American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), and the AANS/CNS Joint Section on Cerebrovascular Neurosurgery. Numerous commenters provided references for our deliberation of this NCA. We very much appreciate this information. All such references were assessed for inclusion in our evidence review. Second Comment Period: 7/11/2023-8/10/2023 During the second 30-day comment period, after the posting of the proposed decision memorandum, CMS received 760 timely comments, including one comment with 88 cosigners from the Global Expert Collaboration. Comments were closely split on support and opposition to the proposed decision memorandum, with 381 comments expressing at least some degree of support for expanded coverage of CAS and 358 expressing opposition to expanded coverage. The remaining 21 comments did not express support or opposition and included three comments adding cosigners to the Global Expert Collaboration comment letter, other comments asking questions or for clarification of the proposed policy language and unintelligible comments (for example, one commenter appeared to paste a file location in the comment submission tool instead of the content of that file). Of 760 timely comments, 672 comments were provided by health care professionals, with most of these comments (at least 644 comments) provided by physicians. Ten comments were provided by academia. Six comments were provided by the Global Expert Collaboration. Two comments were provided by consumer representatives. Six comments were provided by medical device companies. Three comments were provided by trade associations. One comment was provided by a think tank. Four comments were provided by health care systems/organizations, including Cleveland Clinic, the OhioHealth Vascular Institute (OHVI), the University of Connecticut Healthcare System, and UnityPoint Health. Fifteen comments were provided by national associations/professional societies/foundations, including the American Academy of Neurology (AAN), the Multispecialty Carotid Alliance (MSCA), the Neurocritical Care Society (NCS), the Neurohospitalist Society (NHS), the Society for Cardiovascular Angiography and Interventions (SCAI), the Society of Interventional Radiology (SIR), the Society of NeuroInterventional Surgery (SNIS), the Society of Vascular and Interventional Neurology (SVIN), the Society for Vascular Medicine (SVM), the Vascular and Endovascular Surgery Society (VESS), the Vascular InterVentional Advances (VIVA) Foundation, a joint comment from the Society for Vascular Surgery (SVS) and the SVS Patient Safety Organization (PSO) Vascular Quality Initiative (VQI), a joint comment from the American College of Cardiology (ACC) and the American Heart Association (AHA), and a joint comment from the American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), and the AANS/CNS Joint Cerebrovascular Section. Forty-one comments did not specify a title and/or organization. Numerous commenters submitted multiple comments. For the purpose of summarizing and responding to the comments in a timely manner given the large volume received, each comment submitted is counted as a single comment and not combined with other comments submitted by the same commenter. The largest number of comments submitted by a single commenter, was seven. Some individual commenters were also cosigners on comment letters submitted by organizations or larger groups of individuals. Additionally, multiple form letters were submitted reflecting different opinions on the proposals. Many commenters appeared to modify some of the form letter content or the suggested language provided by larger organizations to both add and remove content. As such, distinct language varied across comments, even when conveying similar sentiments. Despite the large volume of comments, specific themes stood out across the comments which we have summarized and responded to below. Population Comment CMS received over 250 comments specifically addressing the appropriate patient population for expanded coverage. Of these, about 75 express specific support for coverage in patients at standard surgical risk, about 140 express specific support for coverage in patients with symptomatic carotid artery stenosis of 50% or more and about 145 express specific support for coverage in patients with asymptomatic carotid artery stenosis of 70% or more. Several commenters express general support for expanded coverage in asymptomatic and symptomatic patients and others recommend coverage in asymptomatic patients with 80% or more stenosis. Commenters that oppose expanded coverage largely offer no populations in which they believe coverage is appropriate, albeit in doing so, they focus on transfemoral CAS (TF-CAS) while separately categorizing and generally supporting coverage for TCAR. However, several of these commenters note that there may be patients who benefit from TF-CAS that are symptomatic, at high risk and cannot undergo CEA or TCAR. We summarize and respond to the points made by commenters in opposition to the proposed decision memorandum throughout the sections below. Response For the reasons detailed in the analysis section of the proposed and this final decision memorandum, as well as in our responses to comments below, we are finalizing coverage for patients with symptomatic carotid artery stenosis ≥ 50% and asymptomatic carotid artery stenosis ≥ 70% without restrictions based on risk for CEA. As discussed throughout this decision memorandum, a combination of contemporary RCTs, updated meta-analyses, and large registry data all support that CAS is a reasonable and sometimes preferable option compared to CEA for many patients, depending on their individual anatomy, pathophysiology, and preferences, all of which we believe should be considered by patients in shared decision-making with their practitioner(s). This is the basis for expanded coverage and related criteria provided in the NCD. Comment Several commenters request that CMS specify in the NCD that coverage is for an FDA-approved indication with one recommending language stating that coverage is for carotid stents “used in accordance with the FDA approved or cleared labeling and indications for use.” This commenter further requests that CMS include the FDA indications and labeling information in the NCD. Another commenter requests that CMS not limit use to “on-label” as the treating physician is best suited to determine which device is best for each patient. Response We believe that the coverage parameters specified in the NCD language, which do not include reference to FDA labeling or indications, accurately reflect what the clinical evidence supports to be reasonable and necessary under §1862(a)(1)(A) of the Act. Furthermore, we are allowing Medicare Administrative Contractors (MACs) to make reasonable and necessary determinations under section 1862(a)(1)(A) for any other beneficiary seeking coverage for PTA of the carotid artery concurrent with stenting in addition to coverage specified in the NCD. We believe there may be scenarios where “off-label” use may be reasonable and necessary to ensure optimal treatment for beneficiaries. Imaging Comment CMS received about 100 comments addressing the imaging related proposals in the proposed decision memorandum. Key points of criticism include: Many believe there may be instances when digital subtraction (catheter) angiography is needed, including when computed tomography angiography (CTA) or magnetic resonance angiography (MRA) are contraindicated (e.g., for patients at risk for contrast nephropathy). Thus also, use of CTA or MRA should not be an absolute requirement. Some support using both duplex ultrasound (US) and cross-sectional imaging (either CTA or MRA), and not just cross-sectional imaging alone, if there are no contraindications. Some believe that catheter angiography remains the gold standard, that other imaging modalities should thus not be required, and that it is useful to perform diagnostic angiography while the patient is on the procedure table (allowing the physician to both diagnose carotid stenosis and do the intervention at the same time). Some also express concern about radiation exposure with CTA, which they say is unneeded anyway because some combination of duplex US and catheter angiography provides a better diagnosis. As such, they argue that CTA would add time, expense and radiation exposure, while MRA is even less accurate; neither CTA or MRA add value. Response We agree that intra-arterial digital subtraction (catheter) angiography may still be necessary, not only if there is a significant discrepancy between non-invasive imaging results, but also if patients have contraindications to CTA or MRA (including risk factors for contrast-induced nephropathy). Exceptions and flexibility for patients with contraindications is basic to all of imaging – but we agree this needs to be explicitly stated; therefore, we have added relevant language to our NCD criteria. We note that conventional catheter angiography uses contrast and causes radiation exposure as well, but effective doses may be less, and are more in the control of the operator. We also agree that a combination of duplex US and either CTA or MRA are needed for greater accuracy and to evaluate other relevant arterial anatomy in addition to the carotid stenosis. This again applies only when there are no contraindications to CTA or MRA. As such, we disagree that a combination of duplex US and catheter angiography provide a better default diagnostic work up; rather, we believe catheter angiography should be used only when CTA or MRA are contraindicated. The limited radiation from CTA may be acceptable given that catheter angiography also involves radiation and has association with stroke. We have updated the NCD accordingly. This combination of non-invasive imaging is consistent with ACST-2 trial inclusion criteria (the latest and largest ever CAS v CEA trial), and with the most recent guidelines (Naylor 2022) that considered ACST-2 results. For ACST-2, duplex US was the primary imaging modality, and to be eligible for the trial patients also needed “CT or MRI confirmation of suitability for CAS and for CEA (which would also have been used to exclude from trial entry any patient without sufficient stenosis to justify intervention)” (Halliday 2021). The guidelines in turn recommend: “For a patient where carotid artery stenting is being considered, it is recommended that any duplex ultrasound study be followed by computed tomographic angiography or magnetic resonance angiography, which will provide additional information on the aortic arch, as well as the extra- and intracranial circulation” (Naylor 2022). Again, we agree there needs to be an explicit exception for contraindications. As for special circumstances where more information may be needed by digital subtraction (catheter) angiography, which could not be obtained by two non-invasive imaging modalities, we note that the MACs are structured to consider such case-by-case situations when the need arises. However, we remain firm that digital subtraction (catheter) angiography should be the exception, not the rule, for diagnostic imaging to assess patients for possible carotid procedures. Here we are distinguishing between, on the one hand, diagnostic imaging used for assessing stenosis, other plaques and their characteristics, and general arterial anatomy – all of which should inform shared decision-making (SDM) before the patient is on a procedure table – and on the other hand, use of minimal angiography during an interventional procedure for purposes of stent placement. Rarely, there may be instances when the latter leads to recognition that the non-invasive imaging (required by this NCD) that got the patient onto the procedure table was clearly incorrect. The expectation is that the procedure would then not be performed. We noted in our NCD analysis that digital subtraction (catheter) angiography itself is associated with stroke; non-invasive imaging is not, and has seen significant technological advances, with more in the pipeline. When a patient is receiving their diagnostic imaging test on a procedure table (with catheter angiography), there is increased incentive and pressure to just do the procedure. There is also less ability to then decide that CEA (or OMT) may, after all, be more appropriate. Indeed, this would undercut the whole point of SDM, at the outset, which should involve discussion of the patient’s anatomy and other factors, and ideally would involve the patient’s primary care physician as well as specialists. A scenario where it would be helpful to do diagnostic imaging, combined with possible intervention, with the decision making happening while the patient is on the procedure table, is an acute setting; however, this NCD applies to chronic carotid artery stenosis only, not emergent care. Finally, while our conclusions rely on our independent analysis based on our review of the literature, along with consideration of public comments, we include the below from the 2023 ESVS guidelines (Naylor 2022) for the public to see how another entity has independently evaluated this topic, in their own words: “2.5. Imaging strategies in carotid artery disease During ECST and NASCET, all participants underwent intraarterial angiography. This policy has now been abandoned because of angiogram related stroke. In the Asymptomatic Carotid Atherosclerosis Study (ACAS), 30 day death/stroke after CEA was 2.3%, but half of the peri-operative strokes were angiogram related. 195 Colour DUS [Duplex US] is the first line imaging modality due to low cost and accessibility and there are consensus criteria for diagnosing stenosis severity. 196-198 Alternatives include CTA or MRA which can simultaneously image the aortic arch, supra-aortic trunks, carotid bifurcation, distal ICA and intracranial circulation, which is important if CAS is being considered. Contrast enhanced MRA (CEMRA) has higher accuracy than non-contrast MRA (time of flight) but requires paramagnetic contrast agents (gadolinium). In a Health Technology Assessment meta-analysis of 41 nonrandomised studies, DUS, MRA and CTA were equivalent in detecting significant stenoses, 199 but it was advised that centres relying on DUS before CEA should perform a second DUS, preferably by a second operator. 199 A combination of two imaging modalities (DUS + CTA or DUS + MRA) improves accuracy and is routine practice in many centres 200 ” (Naylor 2022). Neurological Assessment Comment CMS received about 20 comments regarding the proposed requirement that an independent neurological assessment be performed before and after CAS. Of these comments, one expresses support for the proposed requirement. Fourteen commenters disagree with this proposal. Of these, one states that there is no need for an independent neurologist unless there is a major event. Ten commenters disagree with an independent assessment because a neurological assessment is well within the scope of practice for the physicians involved in the intervention. One commenter opposes because not all facilities have a nearby neurologist to fulfill the independent neurologic assessment requirement and another commenter asserts that asymptomatic patients typically have not seen a neurologist so adding a mandated visit before and after CAS will increase cost, delay care, and add burden to patients. Four commenters acknowledge that independent neurological examinations before and after treatment are an optimal method of assessment but ask for clarification regarding how CMS defines who performs the test, for example, a board-certified neurologist, an associate partner not treating the patient, a physician of another specialty or a certified nurse practitioner stroke specialist? Another commenter asks if CMS will stipulate that the independent neurological assessments may be conducted in the normal course of patient care without requiring a unique visit. One commenter contends that “independent” is vague and problematic when used in policies and recommends including language to specify that “a neurologic assessment” be performed by an NIH stroke scale trained health professional, including a PA, NP or CNS which is current practice for CEA. Response Based on public comments, we recognize that our proposed language was too vague, and that there are certain real-world clinical scenarios where a truly “independent” neurological assessment would be logistically problematic. We also note that there is no requirement for an independent neurological assessment before and after CEA, and that in the large German registry (discussed in our Analysis) this was not mandated, and in an early analysis of that registry only about half of the patients received a neurological assessment (Theiss 2004). Nonetheless, such assessments before and after the procedure are recommended by the latest guideline (Naylor 2022) and have variably been a requirement in trials. A key reason CMS is taking a step back from our previous, more intensive oversight of facilities and physicians is the belief that there is adequate infrastructure and oversight in place to identify proceduralists who are not meeting acceptable outcomes and take appropriate action. What constitutes acceptable outcomes is evolving as technology, techniques, training, and patient selection all improve, and these outcomes are explicitly stated in guidelines. We believe evaluation of neurological outcomes is important to the integrity of this system. To strike this balance, we therefore are requiring that “Neurological assessment by a neurologist or NIH stroke scale (NIHSS) certified health professional before and after carotid artery stenting (CAS) must be performed” for the purpose of assessing procedural harms. We are thus striking the word “independent” from our proposed criteria and clarifying who may perform the assessment. Neurological assessments may be conducted in the normal course of patient care without requiring a unique visit. Oversight Facility Standards and Approval Requirements Comment About 110 comments support the proposal to remove the facility standards and approval requirement from the NCD. Nine commenters assert that establishing facility and operator requirements is more appropriately addressed by the hospital credentialing process and medical society guidelines, with some noting that this is consistent with other well-established procedures. Three commenters similarly support removal of the facility standards and approval requirements stating that it should be handled instead by the credentialing processes of the hospitals and hospital systems where CAS is performed and two support deferring specific clinician, care team and facility requirements to societal guidelines and decision of local facilities. Three commenters contend that removing these requirements from the NCD is consistent with the current state of published literature and standard clinical practice. One commenter supports the removal of minimum standards for facilities as it will allow facilities to rely on well-established facility credentialing requirements and quality assurance programs. Another commenter agrees that physician, care team and facility requirements are not needed since standards adequately exist in societal guidelines and outcomes at local facilities can be audited or reviewed by appropriate entities, like with other well-established procedures. One commenter supports elimination of these requirements in favor of enforcing hospitals to be accountable for quality oversight and monitoring in accordance with professional society guidelines and third-party accreditation, which is standard for most procedures. Four commenters assert that 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 adhere to this and insist on rigorous credentialing (i.e. requiring formal training) and peer review processes to ensure high standards of quality are met. About 180 comments oppose removing facility standards and approval. Of these comments, about 150 assert that continued credentialing is critical to ensure a high degree of patient safety. Six commenters assert that facilities should be required to meet standards. One commenter states that procedures should only be allowed at certified stroke centers. One commenter supports maintaining these requirements to ensure CAS is performed in controlled centers by trained staff, noting that facility approval requirements can help deter inexperienced physicians from “dabbling” in CAS raising patient safety concerns. About 155 comments contend that if coverage is expanded, the final NCD must include a definition for “qualified physician” and demonstrated core competency standards relating to carotid PTA concurrent with stenting. These commenters assert that CMS work with relevant stakeholders to develop core competency standards. Seven other commenters support requirements for operators such as specialized training and case requirements. Some commenters cite the steep learning curve associated with TF-CAS to support the need for credentialing and training requirements. Other commenters note that outcomes depend on operator expertise so removing standards will remove the brake on centers performing these procedures, increasing stroke and death rates. One commenter contends that only a qualified provider should be able to perform TF-CAS and another commenter asserts that rigorous credentialing requirements are needed for TF-CAS. One commenter states that carotid procedures are best performed by providers with training and experience in all aspects of the management of cerebrovascular disease. Another commenter specifically states that implanters should be trained and perform over 50 carotid angios with intracranial and extracranial interpretations. One commenter requests that CMS explain what “qualified physician” means. Nine commenters assert that only vascular surgeons can make the best decision for patients because they offer all three revascularization options. One commenter contends that only interventional neurologists and vascular surgeons should be allowed to perform procedures. One commenter recommends requiring a consultation with a surgeon if the procedure is to be performed by an interventionalist specialty. Two commenters state that vascular surgeons should not be the only specialty allowed, with one noting that cardiologists have the wire skills and vascular surgery only recently started to furnish endovascular procedures as their surgical volume decreased. Six commenters contend that the treating provider has primary responsibility for care management without requiring patients to see multiple physician specialists with one noting that such a requirement could delay care. Two other commenters recommend against any requirement for other physicians from different specialties to sign off prior to performing CAS and one asserts that the treating surgeon will do what is best for the patient and not only what he can offer. Response We appreciate the thoughtful comments aimed at ensuring safety for Medicare beneficiaries. When we proposed to remove the facility standards and approval requirements, we did not envision that CAS procedures would be performed in facilities and by physicians that did not meet standards and requirements as directed by medical specialty societies and other guidelines as implemented by facilities locally. Our intention was to move the responsibility and direction from CMS to facilities. We recognize that the proposal appeared to abandon standards. In response to public comments highlighting significant concerns about procedures being performed in inappropriate facilities and/or by physicians without training or experience, we have decided to maintain standards for facilities to perform CAS procedures and have finalized standards largely consistent with those established in 2005. Since facilities have over 18 years of experience establishing and maintaining CAS programs as specified in the 2005 NCD, we no longer believe that it is necessary for facilities to undergo an approval process by CMS to perform CAS procedures. Given the maturity of the technology, we believe facilities are capable and should be fully responsible for ensuring that the CMS standards are met and adhered to as specified. The modified facility standards retain the basic elements of the 2005 NCD, while removing the facility approval and data submission process and allowing flexibility so facilities may establish customized programs based on up-to-date specialty society guidelines that are tailored to their institutional, community and practitioner goals and needs, ensuring optimal outcomes and addressing any suboptimal results swiftly. These standards do not specify exact training, experience, volume or other requirements that must be met by individual operators or facilities, but instead, similar to the 2005 requirements, direct facilities to have a dedicated CAS program that institutes such requirements for the facility and its operators. As such, we are not establishing a definition of “qualified physician” but encourage specialty societies to identify appropriate physician standards, as well as other standards, to assist facilities in developing, establishing and maintaining high-quality programs. Mandatory Data Collection/Registry Participation Comment More than 180 commenters support requiring data collection, registry use (many support mandated data submission for CAS procedures to the Society for Vascular Surgery Vascular Quality Initiative (SVS VQI)), and/or data monitoring. About 150 commenters recommend that CMS require real time data collection and reporting if coverage is expanded. Commenters contend that such mandated data collection is important for patient safety, tracking short and long-term outcomes, measuring the impact of reimbursement, confirming/disproving if the randomized trial results are generalizable to real world practice, to inform changes in policy or develop initiatives to address bad outcomes. Some note that requiring participation in a registry that reports outcomes would deter unskilled and inexperienced operators from performing CAS. About 110 other commenters support coverage without requiring participation in a clinical trial (as coverage under section B3 of NCD 20.7 for certain TCAR procedures, due to coverage restrictions since 2005 under section B4, requires that procedures are performed in studies including the SVS VQI TransCarotid Revascularization Surveillance Project which involves registry participation). Several commenters support expanding coverage without requiring additional evidence collection and others contend that CMS should not require data registry participation, with one commenter noting that they add significant cost to hospitals. Response In the Analysis section of the proposed decision memorandum, and repeated in our response to comments on trial evidence below, we note 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. However, for a technology that has been investigated and used widely in various forms, we do not believe mandated registry participation or data submission is necessary for coverage purposes. Recognizing and supporting the value of registries is separate and distinct from mandating participation for coverage purposes under Medicare. We acknowledge that some interested parties strongly disagree with use of CAS entirely, most specifically, TF-CAS, unless data is collected in a national registry. We understand the desire for ongoing research and information gathering to optimize patient treatment options, and we believe, for a technology that has gone through nearly 30 years of clinical investigation with FDA marketing approvals beginning in 2004, that coverage is reasonable and necessary without further mandated evidence generation for optimally selected patients. CMS believes that there is value in registry participation, albeit not for coverage purposes in this NCD. Predicted Consequences of Coverage Expansion Comment Many commenters opposing the proposed decision to expand coverage and discontinue facility standards and approval requirements with no required data submission assert that such changes in policy will result in inexperienced interventionalists performing CAS (many commenters specify TF-CAS) on inappropriate patients in inadequate facilities resulting in poor outcomes, including significant increases in strokes and high costs to society. Commenters warn that expanding coverage without any “guardrails” (largely in the form of facility and operator requirements and data submission and tracking) will lead to overu