Transcatheter Aortic Valve Replacement (TAVR)

We appreciate the opportunity to comment on the Proposed Decision Memo for Transcatheter Aortic Valve replacement. We support changes to surgical aortic valve replacement volumes for new TAVR programs. Similarly, we feel that quantity does not necessarily equate to quality when it comes to percutaneous coronary intervention (PCI) volumes. As such, we would suggest reducing the annual PCI requirements from 300 to 200 per year. Such an approach would avoid creating perverse incentives for moderate volume centers to intervene upon borderline lesions and would instead support a thoughtful approach in which patients will be more likely to receive appropriate interventions when necessary and medical management when feasible.

Further, given anticipated FDA approval of TAVR for low risk cohort patients, and a trend of cardiac surgery program closure and consolidation nationally, we anticipate increased demand for this essential minimally invasive procedure. Therefore, fostering an opportunity for new programs to develop should help to provide access in rural areas and needed competition on price in busier metropolitan areas where large academic medical centers could otherwise operate in local monopolies. Thank you for the chance to provide these comments. We would welcome the opportunity to serve as a resource for CMS as this important effort moves forward.

Steven Driver, MD, MPH
Interventional Cardiology, Advocate Illinois Masonic Medical Center
Associate Medical Director, Advocate Physician Partners

Sorin Danciu, MD
Cardiovascular Disease Section Chair, Advocate Illinois Masonic Medical Center

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Some people are told they are too young or too healthy for TAVR or even told you can handle open heart surgery. TAVR needs to be available as an option to patients and they need to be able to share in the decision making process. The following are focuses areas where I believe the overall process can be improved.

1) The two surgeon rule can caused significant confusion and stress

Confusion and stress results when being evaluated by an interventional cardiologist and one surgeon and receiving consistent information regarding all options, and then being evaluated by a second surgeon that is confrontational and inconsistent with information provided in the previous evaluations. This just ends up complicating the evaluation process and adding undo stress to the patient. Simplifying the evaluation process to one professional specialized in all options with an unbiased approach to educating the patient would make the shared decision making process much more effective.

2) Focus on procedure quality over quantity

Procedure quantity should not be a deciding factor for TAVR availability. TAVR outcome quality and highly qualified doctors should be a more significant consideration. Maintaining a requirement of high volume could cause delay in patient treatment. Patients in a situation with a critical or severe diagnosis and experiencing symptoms for a significant period of time would experience further stress and risk of a life threatening event while having to wait for treatment.

3) Inability to find detailed information regarding hospital quality outcomes

Access to quality outcome data would add significant information to the decision making process.

4) Hospitals are not required to educate patients regarding the TAVR procedure if the hospital does not offer a TAVR program

Many have never heard of TAVR. Ending up in a situation of not being fully informed of all options and finding out after the fact that an alternative to open heart surgery existed would be extremely upsetting. Being fully informed enables correct decisions that will positively affect future quality of life. A patient knows their own history, wants and needs better than anyone, and a shared decision making process between patient and doctor is critical for the well-being of the patient.

I would encourage policy changes be focused on easing restrictions to increase access to TAVR and promoting education to help ensure that patients are fully informed so they can share in the decision making process to best increase their quality of life.

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[PHI Redacted] it is paramount when being diagnosed with valve disease, that the patient feels empowered to exercise all treatment options available, whether surgically or via transcather. In addition, knowledge of being eligible to receive the highest standard of care is crucial and can impact a patient’s perspective about his or her diagnosis, treatment and recovery.

By ensuring equitable access, overall quality and full transparency for patients, collectively, we can decrease the amount of re-hospitalizations, increase and improve the number of patient outcomes and overall, reduce the morbidity and mortality of heart patients.

Enjoying more of life’s precious moments by living a longer, stronger and healthier life that is not limited by valve disease simply should be at the forefront, NOT the discriminatory regulation of the heart - as EVERY heartbeat matters.

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I am an interventional cardiologist with more than 30 years of experience. I have been involved in structuring multiple cardiac interventional programs and surgical programs. I have also been involved with and have performed approximately 900 thoracic and abdominal aneurysm endoluminal grafting. A large percentage of these procedures have been of a complex nature. I currently serve as an endoluminal graft instructor for Medtronic. Our hospital center has also been involved with high volume carotid stenting and TCAR procedures. Our center was a part of the SAPHIRE carotid stenting world wide trial with exceptional outcomes.

Unfortunately, my group practices out of multiple hospitals. Even though we have the "number requirements" of percutaneous coronary interventions, to meet the TAVR criteria, the patients are not in one location. We however have the valve implant volume that meets the criteria at Harlingen Medical Center.

Our patients will be served well by having a center that can provide safe TAVR interventions. Our track record speaks volumes regarding our center's expertise and exceptional procedural outcomes.

I respectfully request that our facility, Harlingen medical center be considered for TAVR certification.

Sincerely,

Shereef Hilmy, MD
Chief, department of cardiology,
Director of the cardiac catheterization laboratory.

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Overall, CMS should be congratulated for developing a thoughtful, balanced and well considered draft of the new NCD for TAVR, which respects all stakeholders and maintains a patient-centered focus. Several important points in this document are worthy to highlight and are the subject of constructive comments.

The introduction and roll-out of TAVR has been a model for future therapies: iterative device evolution, clinical evidence-based extension of treatment populations, rigorous site training of multi-disciplinary Heart Teams, a comprehensive all-patient registry to monitor outcomes, and rational dispersion to sites to improve patient access. The proposed new NCD appears sufficient to maintain the excellent TAVR outcomes achieved in the U.S., while acknowledging that this is an interim step towards a quality-based program with equality in requirements for TAVR and SAVR and promoting the need for patient-centered shared decision-making to determine and enrich treatment choices.

Martin B. Leon, MD
Mallah Family Professor of Cardiology,
Columbia University Medical Center
Director, Center for Interventional Vascular Therapy
Founder and Chairman Emeritus, Cardiovascular Research Foundation
New York, NY

Maria C. Alu, MS
Cardiology Publications Manager,
Columbia University Medical Center
Manager, Scientific Publications Office,
Cardiovascular Research Foundation
New York, NY

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April 25, 2019

Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

Dear Ms. Syrek Jensen,

Edwards Lifesciences (“Edwards”) appreciates the opportunity to comment on the proposed decision memo for TAVR (CAG-00430R). Edwards greatly appreciates the Agency’s thoughtfulness in proposing this policy, as well as its engagement with all provider, patient, and industry stakeholders. This cover letter serves as a summary of our attached detailed comment letter, which describes our recommendations to assist the Agency as it finalizes the policy.

Edwards believes that all Medicare beneficiaries with aortic stenosis (AS) deserve to be helped by proven treatments which extend life and improve its quality. An ideal policy would ensure patients are evaluated by multidisciplinary Heart Teams that can present and discuss all treatment options and encourage shared decision making. Currently, there are two definitive treatments for AS – TAVR and surgical aortic valve replacement (SAVR). A TAVR-specific policy only provides half the solution.

While we continue to believe that establishing a uniform policy across the continuum of aortic valve replacement (AVR) care (whether surgical or transcatheter) is the best way to ensure high quality and appropriate access for all Medicare beneficiaries, we commend the Centers for Medicare & Medicaid Services (CMS) for proposing many changes that will broaden access to TAVR by modernizing and streamlining its coverage provisions. Edwards respectfully urges the Agency to consider two key recommendations summarized below:

Much of the debate in the lead-up to the proposed decision memo focused on the purported TAVR volume and outcomes relationship. Edwards continues to believe that the larger clinical issue which AS patients face today is the persistent and unacceptably high burden of under diagnosis and under treatment. To this end, our shared goals should be to ensure there is expanded and equitable access to high-quality care so that all people with heart valve disease have the ability to consider all safe and effective treatment options with their clinicians in a timely manner.

Edwards believes the proposed policy, with important refinements recommended in our detailed comment letter, will ensure a more streamlined care process under the direction of Heart Teams with appropriate expertise and infrastructure, while providing increased flexibility for programs to meet and maintain requirements. This is essential in an evolving AS treatment landscape. Edwards supports ongoing data collection to both ensure continued quality monitoring and also to address the remaining evidence gaps for this therapy. Finally, Edwards believes that validated outcome metrics should replace volume requirements in the future and that this transition could reasonably coincide with the discontinuation of Coverage with Evidence Development (CED).

Edwards thanks CMS for its consideration of our recommendations for the proposed decision memo. We look forward to working closely with CMS throughout the NCA process and to providing any additional information that the Agency may require. For further information, please contact me at 949-250-2500, or at Larry_Wood@edwards.com.

Sincerely,

Larry L. Wood
Corporate Vice President, Transcatheter Heart Valves

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April 25, 2019

Seema Verma
Administrator
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Administrator Verma:

The undersigned organizations are writing with our response to the Centers for Medicare & Medicaid Services’ (CMS) updated proposed decision on Medicare’s National Coverage Decision (NCD) for transcatheter aortic valve replacement (TAVR) (CAG-00430R). Collectively, we represent heart valve disease patients, family caregivers, aging organizations advocates for minority and women’s health, and cardiologists.

We applaud the agency’s movement toward making this policy less onerous for patient access, including the change in the two-surgeon evaluation requirement and reduction in TAVR program establishment requirements. We appreciate the agency is open to public reporting of health outcomes data and that CMS recognizes continued barriers to access for minority populations need to be addressed. We also appreciate that CMS will not require shared decision-making in the absence of an evidence-based decision aid that meets standards consistent with the National Quality Partners Playbook on Shared Decision-Making, while recognizing the importance of shared decision-making and urging its development.

We are extremely concerned that the proposed decision continues to prioritize patient access based on hospitals’ procedural volume ahead of equal access and quality care for all Medicare beneficiaries. The extensive data collected through the Transcatheter Valve Therapy (TVT) Registry and numerous randomized controlled trials have demonstrated that TAVR is a reasonable and necessary alternative to open-heart surgery. These data prove that TAVR improves health outcomes for Medicare beneficiaries with symptomatic severe aortic stenosis for FDA-approved indications. These data also affirm that a Coverage with Evidence Development (CED) is no longer needed. Therefore, we request CMS cover TAVR under a NCD for FDA-approved uses, removing the CED-based restrictions proposed.

We recognize that some may view TAVR as a disruptive technology to the current practice of cardiovascular medicine, but it has been demonstrated beyond doubt that TAVR is an important step forward, as shown by extensive reported data. Similarly, when large-scale change occurs, we recognize the benefits of having the power of CED applied when data are unavailable, but an enormous body of clinical data already exists in the case of TAVR.

The rationale for our recommendations (and the request to transition from an NCD with CED to an NCD with coverage to label) can be summarized as follows:

• The available evidence, which continues to grow, is more than enough to conclude that TAVR improves health outcomes for Medicare beneficiaries with severe symptomatic aortic stenosis for FDA-approved indications;
• Public reporting of hospital-based health outcomes data should be used in lieu of annual procedural volume requirements. Such volume requirements do not ensure quality and impede access for racial and ethnic minorities, women, and rural beneficiary populations and could continue to create service barriers for patients treated by the smaller hospitals that serve them;
• Health outcomes data for individual TAVR programs collected by the TVT Registry are kept private from the public, which impedes quality improvement—there is no defensible rationale for keeping that hospital-specific information private;
• If FDA approval expands TAVR indications to patients at low-risk for surgery, and the CED and its program maintenance requirements remain, waiting lists at larger hospitals will lengthen and patients may die due to delays;
• The continuation of the CED requirement is contrary to the Administration’s “patients over paperwork” initiative and places unnecessary regulatory burdens and costs on providers that do not improve care for patients.

Patients are stuck in the midst of a professional sea change in heart valve disease treatment involving the specialist clinician, as well as between major medical centers and smaller, community-based/ rural hospitals. We appeal to CMS to amend its TAVR coverage decision to one that will be of the most benefit to all older adults, all racial and ethnic minorities, women, and all rural beneficiaries Medicare is charged to serve.

Efforts to institute a NCD (with a CED requirement) for TAVR was initiated in September 2011, after the presidents of the American College of Cardiology (ACC) and Society for Thoracic Surgeons (STS) sent a joint request letter to CMS.¹ This request was sent in anticipation of the first U.S. Food and Drug Administration (FDA) approval of a TAVR device for the treatment of severe symptomatic aortic stenosis in older adults who needed an aortic valve replaced but were too ill or frail to survive open-chest surgery. The letter outlined what the preferred NCD would look like, including detailed operator and institution requirements. These included a call for the establishment of sophisticated “centers of excellence” and recommended that “access to TAVR should not be universal and immediate but should be implemented in a controlled and regulated fashion…. The complexities of the management of valvular heart disease will require the infrastructure available only in regional referral centers with acceptable patient volume in valvular heart disease as established by the ACC and STS.”²

Less than a year later, in May 2012, CMS issued a NCD for TAVR under CED (20.32)³, addressing the requests in the joint letter. The NCD with CED includes separate coverage requirements for those TAVR procedures provided according to FDA-approved indications and for those procedures provided outside of FDA-approved indications. For the former, the NCD includes conditions of coverage such as volume requirements for heart teams and hospitals, as well as mandatory participation in a prospective, national, audited registry. These conditions of coverage generally follow recommendations outlined in a 2012 joint consensus statement from the societies.⁴ For procedures provided outside of FDA-approved indications, the NCD requires TAVR procedures to be performed in clinical studies that meet requirements set forth in the NCD and approved by CMS.

As part of their initial request to CMS, the STS and ACC proposed development of the TVT Registry, which would be similar to other national registries they were managing at the time. The TVT Registry became operational on December 1, 2011. The “TAVR Data Collection Form v2.1” form, available on the TVT Registry website⁵, is eight pages long and includes the following sections:

• Patient demographics;
• The episode of care;
• History and risk factors;
• Pre-procedure status;
• Clinical data (medications, diagnostic catheterization and echo findings, detailed procedure information, information on whether any medications were given during the procedure, and device information);
• Post-implant procedure information;
• Adverse events and whether any interventions occurred;
• Post-procedure labs and tests;
• Discharge data (including a separate section on medications);
• Extensive follow-up data at 30 days and one year; and
• Detailed information on whether stroke and/or aortic valve re-intervention occurred.

According to a presentation at the 2019 Cardiovascular Research Technologies (CRT) conference (one of the world’s leading interventional cardiology conferences), as of January 22, 2019 the TVT Registry has collected information on 195,954 TAVR and 10,797 TAVR ViV (valve in valve) procedures, for a total of 206,751 patient records since 2012.⁶ The website also provides a list of 50 published manuscripts based on the registry.⁷

In addition to the national TVT registry, there have been 26 approved clinical studies of TAVR since 2012.⁸ From these clinical studies’ identifier numbers, ClinicalTrials.gov has automatically indexed 50 published studies.

There is no question that the CMS Coverage and Analysis Group (CAG) has conducted both the initial TAVR NCD and the 2018-2019 reconsideration process in a thoughtful and rigorous manner. The TVT Registry and TAVR clinical studies to-date have provided valuable insight for device innovation, facility and provider procedure optimization, clinical care improvements, and—most importantly—improved health outcomes for Medicare beneficiaries. The CED process has also identified important research and treatment access gaps that have yet to be fully addressed.

The question is, what is the evidence threshold needed to end the TAVR CED? Because CED falls under the NCD statutory authority, there is no specific enforcement mechanism to ensure timely research reporting compliance, which results in an ad hoc process that leaves Medicare beneficiaries in a state of uncertainty regarding their treatment. In an August 2011 article, “Improving the Quality and Efficiency of the Medicare Program Through Coverage Policy,” the authors state, “The current authority is sufficiently ambiguous to prevent CMS from fully developing and implementing coverage with evidence development consistently and systematically.”⁹

In its 2014 guidance on CED, within the section “Ending CED”, CMS states that the purpose of the studies is to “produce evidence that will lead to revisions in Medicare coverage policies,” and cites two examples of completed CED processes—NCDs for oncologic uses of FDG PET, and ventricular assist devices.¹⁰ The implication here is that there would be a clear beginning and end to the CED process. The “Ending CED” section further states that “a CED cycle is considered completed when CMS completes a reconsideration of the CED coverage decision and removes the requirement for study participation as a condition of coverage.”¹¹ The original conditions for imposing a CED program on TAVR no longer exist, and under CMS’ own rules, the conditions for ending the TAVR CED have been met.

As advocates who believe that all patients should have access to the right treatment at the right time and that all patients should have a voice in their own treatment decisions, we urge CMS to end the CED process for TAVR and transition it to a NCD with coverage to FDA-approved label. As outlined below, an extensive amount of evidence has been developed over the last seven years to support ending the TAVR CED process, and CMS can confidently declare success.

When it was first approved by the FDA in 2011, TAVR was an important advancement for older adults who needed an aortic valve replaced but were too ill or frail to survive open-heart surgery.¹² Over the last seven years, the success of the TAVR technology has been demonstrated. Previous randomized clinical trials of TAVR with both balloon-expandable valves^{13,14,15,16,17,18} and self-expanding valves^{19,20,21, 22} showed that, in patients who were at intermediate or high-risk for death with surgery, TAVR was either superior or non-inferior in health outcomes to standard therapies, including SAVR. Post-market registry data have shown comparable results to the clinical data.²³ The FDA has expanded TAVR approval²⁴ to include a large percentage of patients with aortic valve disease, and clinical practice guidelines have followed.²⁵

Two recent studies of low-risk patients published in the March 2019 issue of the New England Journal of Medicine also had promising results. One tested the self-expanding CoreValve, Evolut R, and Evolut PRO valves in a low-risk patient population, and found that the 24-month estimated incidence of death or disabling stroke was similar in the TAVR and surgical arms, meeting the definition of statistical noninferiority but not superiority.²⁶ The other study reported that treatment with the balloon- expandable Sapien 3 transcatheter heart valve was better than surgery for the prevention of death, stroke, and rehospitalization at 1 year, the study’s primary endpoint.²⁷ These studies were mentioned in the CMS proposed decision, and are being actively reviewed by CAG.

The TVT registry data indicate that patients who undergo TAVR have experienced significantly shorter hospital stays and lower incidence of some major complications throughout the study period. Between 2012 and 2017, registry data show that:

• Median length of stay in the hospital has decreased from six days to two days;
• In-hospital mortality has decreased from 5.7% to 1.7%;
• 30-day mortality has decreased from 7.5% to 2.8%; and
• One-year mortality has decreased from 26.4% to 14%.²⁸

Newer generation TAVR devices have also improved quality of life measures for patients in both the short (one month) and long term (one year) compared to previous-generation devices and SAVR.²⁹

According to the TVT registry data, the median age for TAVR patients ranged between 81 and 84 years between 2012 and 2017. ³⁰ One concern about TAVR is the lack of long-term durability data. In an octogenarian population, the focus on durability may be less of a concern. Even so, a 2017 study of core laboratory echocardiographic data five years post-procedure demonstrated excellent durability.³¹

In summary, TAVR has emerged from the seven-year NCD under CED as an effective and less invasive solution in management of patients with severe symptomatic aortic stenosis, with excellent clinical outcomes. TAVR has several advantages over SAVR, including shorter hospital stay and faster recovery, which is particularly relevant to older adults. For many patients, survival benefit is not the primary goal of treatment. In a recent study of patients undergoing TAVR (mean 84 years of age), only 7% stated that improved survival was their reason for seeking treatment.³² For most patients, maintaining independence (30%) or the ability to do a specific activity (48%) was the reason provided.³³

Further, risk-benefit calculations as one ages and for those with life-threatening diseases can vary throughout the lifespan and healthspan. For example, a recent study of patients with severe aortic stenosis indicated that patients over 60 years old would be willing to tolerate a 13.2% increase in risk of death and a 20.1% increase in risk of disabling, non-fatal stroke in exchange for the benefits of TAVR (reduced invasiveness and increased post-procedure independence).³⁴ Current TAVR procedural outcome data are well within this range of this Medicare beneficiary population’s tolerance levels.

The biggest debate regarding this coverage decision is about whether CMS should continue to require a minimum number of annual surgical and interventional cardiac procedures for a hospital to maintain a TAVR program. When the original policy was established in 2012, the number of annual procedures a given hospital or heart center performed was used as a surrogate for the quality of its care.³⁵

This requirement made sense when the technology was new because there was limited data, and there was a learning curve. Early studies showed that increased experience from higher volume facilities led to better outcomes in inoperable-risk and high-risk patients.36 However today enhanced technology, widespread training³⁷, and group learning effectively eliminate the learning curve and positively impact outcomes, independent of procedural volume. TAVR health outcomes are now found to be excellent in both high- and low-volume facilities.³⁸

A recent review of more than 61,000 cases from the TVT Registry puts the volume-outcomes debate to rest. The review, published in the February 2019 issue of Journal of the American College of Cardiology, found that with earlier-generation TAVR devices, once the learning curve was surpassed, the volume- outcomes relationship disappeared. The review also found that, with the use of current generation TAVR devices, there is no longer a detectable learning curve or demonstrable volume-outcomes relationship.³⁹

Unfortunately, despite the evidence, STS and ACC have suggested more than doubling the annual procedural volume requirements for hospitals to maintain their TAVR programs.⁴⁰ This inward-looking perspective is not only counterintuitive to what the data tell us, but the requirement would unnecessarily restrict patient access by causing some existing TAVR facilities to close and prevent new ones from opening. We are very concerned about this because studies have shown that patient proximity to a hospital impacts facility choice, even when reported health outcomes differ significantly.⁴¹

According to data from the Healthcare Cost and Utilization Project, greater than 90% of TAVR procedures in the United States are performed in urban, teaching hospitals, and 78% of patients served by these hospitals are in higher income zip codes.⁴² Additionally, safety net hospitals—those public hospitals that are often providers of last resort—perform approximately 20% of TAVRs.⁴³

There have been a few published studies that use TVT Registry data to support the volume-outcomes hypothesis, even as actual health outcomes from hundreds of thousands of procedures have accumulated in the registry. While CMS incorporated annual procedural volume requirements in the 2012 TAVR NCD, none of the registry-related questions posed by the agency asks for validation of these requirements. The latest of these studies was published in the April 2019 New England Journal of Medicine and analyzed data from the TVT Registry regarding procedural volumes and outcomes from 2015 through 2017.⁴⁴ On the other hand, the last annual report of the aggregate TVT Registry data (on patient characteristics, trends, and outcomes of TAVR procedures) was published two years ago and covers patient data only through the end of 2015.⁴⁵

The April 2019 study on the volume-outcomes relationship found that hospitals in the group with the lowest volume had the highest 30-day mortality rate, at 3.19%, compared to hospitals in the group with highest volumes at 2.66%—a statistically significant difference of .53%. However, the general association was inapplicable to the current NCD conditions of coverage. The study investigators noted, “We were not able to assess whether current CMS requirements reduced mortality after TAVR or whether continuing or removing the current thresholds would affect mortality.”⁴⁶

Importantly, the New England Journal of Medicine study did identify that hospitals with lower procedural volume were more likely to be in rural areas than those with higher volume (14% versus 3%), and they treated a greater proportion of African American and Hispanic patients (12.1% versus 7.8%).
This finding raises a question about whether the continued pursuit of annual procedural volume requirements may disproportionately impact treatment access for rural and minority beneficiaries.

We appreciate CMS’ spotlight on TAVR health disparities in general, and on racial, ethnic and gender differences and barriers highlighted on page 92 and 93. As noted, women have improved survival compared to men, but also have some increased risk of complications and death47. We are also pleased that issues raised in the July 2018 TAVR MEDCAC meeting acknowledging underdiagnosis and undertreatment of African Americans were noted.48 However, reference to proposed flexibility in the updated annual procedural volume requirements as a way to “reduce unintended barriers” does not acknowledge that the total number of annual procedures required has, in effect, increased by tenfold, while these procedures to these underserved groups continue to lag far behind.

Additionally, section VIII “CMS Analysis” of the proposed decision examines whether to continue the NCD under CED and notes on page 81 that “the evidence is insufficient for minority populations” before concluding that “We continue to believe that the current coverage regime under CED offers the appropriate balance of quality and access, while simultaneously stimulating innovation of devices, procedural techniques, and indications for use (for subpopulations and patients with various comorbidities), and so we propose to continue CED.” Citing lack of evidence on minority populations as part of the rationale to continue a policy that restricts access to those same populations is circular reasoning and we ask that it be removed from this section.

African American adults experience risk factors⁴⁹ for aortic stenosis at greater levels and at earlier ages than whites, including cardiovascular risk factors such as high blood pressure, diabetes, and high cholesterol, and chronic kidney disease. In the United States, at any decade of life, African Americans have a higher prevalence of hypertension than any other racial and ethnic subgroups—overall, 59% of African American men, and 56% of African American women have high blood pressure.⁵⁰ African Americans are 1.7 times more likely to have diabetes than whites and are more likely to develop serious complications.⁵¹ According to the 2018 United States Renal Data System Annual Data Report, the prevalence of chronic kidney disease among African Americans is approximately 3.5 times higher compared to whites.⁵²

Less is known as to whether health care providers are detecting and treating aortic heart valve disease in African Americans. A study in the August 2017 American Journal of Cardiology found that the odds of being referred to a cardiothoracic surgeon for treatment of aortic valve disease were 54% lower in African American patients compared with whites.⁵³ Additionally, research shows that African Americans with severe aortic stenosis are 33% more likely to refuse treatment than white patients.⁵⁴ Yet, when they were treated with TAVR, both groups had similar three-year survival rates.⁵⁵

African Americans with severe symptomatic aortic stenosis receive less surgical and transcatheter valve replacement than would be expected. While African Americans represent 13% of the US population, and 11% of the Medicare population, only 3-4% of TAVR patients^56,57 and 4.8% of surgical patients⁵⁸ are African American.

Differences in health outcomes for African Americans compared to whites vary by type of procedure for severe symptomatic aortic stenosis. A 2018 review of more than 113,000 Medicare claims found that African Americans have significantly higher 30-day readmission rates after surgery compared to whites, even after adjusting for comorbidities, as well as higher unadjusted 30-day and 1-year mortality, longer length of stay, and lower likelihood of discharge to home than whites. ⁵⁹ In the same study, race was not found to impact mortality, readmission, or discharge to home in use of TAVR. ⁶⁰

CMS’ proposed decision acknowledges the dispute by reducing some of the volume-metric requirements. However, the proposed NCD update continues to lean on the now-debunked volume- outcomes hypothesis to justify continuation of minimum volume metrics. The modifications will exacerbate patient access issues even further.

The TVT Registry reports on aggregate data. Hospital-specific information on TAVR health outcomes is not publicly available. The TVT Registry website states that “Hospital-specific registry data is not publically [sic] available and the registry cannot provide data without written permission from the hospital to do so.”⁶¹

We ask that this lack of transparency of health outcomes by facility be eliminated in the updated NCD. Under the Hospital Inpatient Quality Reporting Program, CMS collects quality data from hospitals paid under the Inpatient Prospective Payment System, with the goal of driving quality improvement through measurement and transparency by publicly displaying data to help consumers make more informed decisions about their health care. It is also intended to encourage hospitals and clinicians to improve the quality and cost of inpatient care provided to all patients. The hospital-specific data collected through the program are available to consumers and providers on the Hospital Compare website at: https://www.medicare.gov/hospitalcompare/search.html. We would like to see center-specific outcomes data for in-hospital and 30-day risk-adjusted mortality, broken out by SAVR and TAVR, included on Hospital Compare.

Immediate reporting of these data are already provided in New York State. Since 1989, the New York Department of Health (DOH) has published annual data on risk-adjusted mortality following coronary artery bypass surgery by hospital and surgeon.⁶² The state's Cardiac Surgery Reporting System (CSRS) was the first program in the country to produce public data on outcomes for cardiac surgery and is the nation's longest running program of its kind. DOH is advised in its activities by the Cardiac Advisory Committee (CAC), a group of independent, practicing cardiac surgeons, cardiologists and other professionals in related fields. The goal of DOH and the CAC is to improve the quality of care related to cardiac surgery in the state. Providing hospitals and cardiac surgeons in New York with data about their own outcomes for these procedures allows them to examine the quality of care they provide and to identify areas needing improvement, and it allows patients and family caregivers to research data on TAVR mortality outcomes in local hospitals. The program operates under the general authority of the DOH commissioner. Reporting on TAVR in New York State started in 2015 with hospital volume and moved to mortality rate reporting in 2017 by hospital for discharges from 2012-2014. The most recent report on mortality rates is from February 2018 for TAVR discharges between 2013 and 2015.⁶³ We know from the New York DOH that this can be done, and the TVT Registry should be doing it.

Another option that we would support as an alternative would be for CMS to continue NCD under CED, with only the national registry requirement, and immediate, mandatory public reporting of both in-hospital and 30-day adjusted mortality by hospital.

If FDA expands TAVR indications to patients at low-risk for surgery, and the CED and its program maintenance requirements remain, waiting lists at larger hospitals will lengthen and patients may die due to delays

Aortic valve replacement (AVR), whether through open-heart surgery or TAVR, is indicated for severe symptomatic aortic stenosis, regardless of age. A seminal 1968 study on aortic stenosis found that more than half of patients will die within the next 12–18 months of symptom onset, unless the aortic valve is replaced.⁶⁴

Because many patients with aortic stenosis are evaluated electively on an outpatient basis, waiting time between recommendation for aortic valve replacement and the actual intervention may place the patient at risk for progression of heart failure or death. A study in the November 2014 Annals of Thoracic Surgery looked at the probability of death without an intervention at 1, 3, 6, 12, and 24 months after treatment was recommended. The study found that the cumulative probability of death among patients recommended to have TAVR was 3.8% at 1 month, 10.4% at 3 months, 23.3% by six months, 27.5% at a year, and 41.1% at two years.⁶⁵ The study concluded that “treatment delay beyond one month for patients with AS [aortic stenosis] should be avoided,” and that “patients and physicians should proceed with AVR in patients with AS on a semi urgent, rather than elective, basis.”⁶⁶

In the proposed decision, CMS designates that one surgeon (down from two in the 2012 NCD) must evaluate patient suitability for treatment. While we are pleased that this requirement was reduced, either a surgeon or cardiologist could serve this role and would lessen wait times. Maintaining a surgeon as the sole decision-maker will continue to create unnecessary bottlenecks, impacting patient access. This issue would become moot if the CED is removed.

In addition, during the past decade, recommendations for TAVR in patients with severe symptomatic aortic stenosis have been expanded to include patients with incrementally lower surgical risk. Current clinical practice has restricted the use of TAVR in patients who are at low risk and in younger patients, for whom surgery is standard therapy. The FDA is expected to approve the procedure for lower-risk patients within the next year.

With more patients eligible for this less-invasive procedure, demand will go up. This means waiting lists will be longer and patients will be at risk of dying from their disease while they wait or turning to open- heart surgery even if they prefer TAVR and would be eligible for the less-invasive procedure. This is one more reason for CMS to consider the transition from CED to a NCD with coverage to label.

We believe that the conditions for coverage in the existing NCD for TAVR do not meet CMS’ goals of putting patients first⁶⁷, nor are they consistent with CMS’ desired shift from paying for volume to paying for value.⁶⁸ As Secretary Alex Azar stated on March 5, 2018, in his remarks on value-based transformation:

We applaud CMS’ goal to increase access for patients; however, the proposed updated NCD continues to prioritize procedural volume over equal access and quality care for all Medicare beneficiaries.

We urge CMS to end the CED process for TAVR and transition it to a NCD with coverage to FDA-approved label. CMS and CAG have done an exceptional job managing the TAVR NCD under CED, despite the absence of a clear statutory foundation to support them. Extensive evidence has been developed over the last seven years to support ending the TAVR CED process and CMS can confidently declare success.

Our organizations urge CMS to phase out TAVR volume standards, and phase in hospital-based quality and outcomes data, as the primary metric for CMS TAVR coverage.

In summary, our organizations call on CMS to develop a solid coverage policy that provides all Medicare beneficiaries with severe symptomatic aortic stenosis access to all appropriate treatments. This is an important opportunity for the agency to offer hope and better access to more patients and families and to put true patient-centered care into practice.

CMS may insist on keeping the TAVR NCD under CED despite the evidence that it is a reasonable and necessary alternative to open-heart surgery and despite its own guidance on the CED process. If CMS decides to do this, it should keep only the national registry requirement, and require immediate, mandatory public reporting of both in-hospital and 30-day adjusted mortality by individual hospitals. Any additional requirements would impede access and potentially harm beneficiaries.

Thank you for the work you do to improve the health and well-being of our nation’s older adults, and for considering our views.

Sincerely,

Alliance for Aging Research
Alliance for Patient Access
Association of Black Cardiologists
Caregiver Action Network
HealthyWomen
Heart Valve Voice US
Mended Hearts
Men’s Health Network
National Black Nurses Association
National Hispanic Medical Association
National Medical Association
National Minority Quality Forum
Partnership to Advance Cardiovascular Health
RetireSafe

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Tamara Syrek-Jensen, JD
Director
Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

Dear Ms. Syrek-Jensen:

We write in response to the proposed decision memo for TAVR (TACMS VR) (CAG-00430R) on behalf of UPMC’S Heart and Vascular Institute, which is the Cardiovascular Service line for all UPMC facilities spread across Central and Western Pennsylvania. The service line consists of 18 cardiac surgeons and 226 cardiologists. The physicians represented by UPMC across the 5 of 23 UPMC hospitals that provide both cardiac surgery and interventional cardiology performed 749 TAVRs and 912 surgical aortic valve (or root) replacements (SAVRs) in 2018 demonstrating significant expertise in the field. The UPMC system strongly supports the concept of a multidisciplinary (Heart Team) approach to managing valvular heart disease in general, but very specifically for aortic stenosis for which TAVR is considered. In this same context we support CMS’s decision to change the requirement to reflect that 1 cardiac surgeon and 1 interventional cardiologist need to independently examine each patient being considered for TAVR. We, like most groups, have recognized that the redundancy of having two cardiac surgeons independently examine the patients (as per the current NCD) is no longer necessary. We also strongly support the decision to require that 1) both a cardiac surgeon and an interventional cardiologist jointly perform each TAVR and 2) that each site has appropriate hospital infrastructure with robust on-site open heart valve surgery and interventional cardiology capabilities. We believe the precise TAVR NCD language will be extremely important to inform hospital administrations in the United States to provide the proper infrastructure required to execute safe and successful TAVR treatment to Medicare beneficiaries.

In this regard, we are concerned that the phraseology in the current proposed decision memo for the new NCD stating the rather vague requirement of “50 open heart surgeries” in the year prior to consideration for eligibility for a new TAVR program is not adequately descriptive of the experience necessary for a site to be capable of delivering a safe and effective TAVR program. We suggest changing the language in the NCD to reflect that which all the major professional societies’ (AATS, STS, ACC & SCAI) Expert Consensus Systems of Care Document by Bavaria et al. endorsed as a requirement for new TAVR sites: notably, that a program should have performed 40 surgical aortic valve replacements in the prior year or 80 in the last 2 years . A policy as recommended by the four societies in this cited document would enable broad access to TAVRs nationally but would also ensure a minimally adequate cardiac surgical experience, infrastructure, and hospital system commitment to support a successful TAVR program as measured by quality of care and outcomes. Requiring only 10 aortic valve procedures a year would allow for sites with essentially no meaningful valvular heart disease program to start a TAVR program with inadequate expertise and infrastructure.

Moreover, in addition to requiring a minimum of 40 SAVRs and 300 PCIs (as also recommended in Bavaria et al.) by a program in the year prior to site initiation, we also strongly support a dictum that all TAVR sites participate in a prospective audited registry, as in the STS/ACC TVT registry, to allow for both individual site performance review compared to national benchmarks and data-rich regional and national audits for quality and outcomes surveillance to foster both quality control and systematic program advancement to the betterment of all health care system stakeholders, most notably the Medicare beneficiaries. We believe CMS should also require public reporting of outcome measures as organized by the auditing registry (e.g. TVT). The new volume thresholds as stipulated above will drive an increase in the number of TAVR programs in the United States, and thus satisfy the overarching desire by many of the health care stakeholders to broaden access to care. However, the additional new sites will likely be from lower volume programs, and thus given the recognized association between procedural volume and outcomes as most recently demonstrated by Vemulapalli et al. , it is imperative that robust risk-adjusted quality metrics with program site reporting requirements are mandated for TAVR programs in the US to ensure and maintain quality of procedural care across the country.

We thank you for allowing us to comment on this NCD proposal and for your consideration of our concerns.

Respectfully,

Thomas G. Gleason, M.D., FAHA, FACS, FACC, FACCP
Co-Director, UPMC Heart & Vascular Institute
Ronald V. Pellegrini Professor & Chief, Division of Cardiac Surgery
University of Pittsburgh School of Medicine
Member, STS/ACC TVT Registry Steering Committee

Joon S. Lee, M.D., FACC, FASCAI
Executive Director, UPMC Heart and Vascular Institute
Chief, Division of Cardiology
University of Pittsburgh School of Medicine

1. Bavaria JE, Tommaso CL, Brindis RG, Carroll JD, Deeb GM, Feldman TE, Gleason TG, Horlick EM, Kavinsky CJ, Kumbhani DJ, Miller DC, Seals AA, Shahian DM, Shemin RJ, Sundt TM, 3rd and Thourani VH. 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement: A Joint Report of the American Association for Thoracic Surgery, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2019;73:340-374.
2. Vemulapalli S, Carroll JD, Mack MJ, Li Z, Dai D, Kosinski AS, Kumbhani DJ, Ruiz CE, Thourani VH, Hanzel G, Gleason TG, Herrmann HC, Brindis RG and Bavaria JE. Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. N Engl J Med. 2019.

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America’s Health Insurance Plans (AHIP) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) national coverage analysis for Transcatheter Aortic Valve Replacement (TAVR).

We support CMS’ proposed decision to cover TAVR under a coverage of evidence development process, including the proposed safety mechanisms and additional monitoring guidelines.

We recommend that CMS ensures that the registry includes a mechanism to track regulatory compliance and ensure patient safety. Specifically:

For monitoring:

Again, we thank you for the opportunity to provide comments.

AHIP is the national association whose members provide coverage for health care and related services. Through these offerings, we improve and protect the health and financial security of consumers, families, businesses, communities and the nation. We are committed to market-based solutions and public-private partnerships that improve affordability, value, access, and well-being for consumers.

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[PHI Redacted]. However, when I asked for their outcome data on TAVR patients with severe radiation induced aortic stenosis, I was told simply “we have done plenty”. I was then given national incidence percentages for adverse events like mortality, stroke, bleeding, etc. When I came back to that institution a few weeks later with a list of questions for the interventional cardiologist, I was given terse, one word responses. The contacts that I had with this large volume center were totally unsatisfactory and forced me to leave my community to seek the information that I require to make an informed decision. Medicare stresses “Patient Care First” and unfortunately the lack of access to outcome data by institution has most likely shortened [PHI Redacted]life.

Please require outcome studies for each specific medical facility and require that information be given to patients upon request. TAVR programs have only been Medicare approved in the U.S. since May 2012 and are constantly changing. Please safeguard Medicare recipients so that they are truly informed when signing an “informed consent”. Based on my experience, a large volume center should NOT be a major criteria in the approval process at the expense of patient care and support.

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Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Blvd
Baltimore MD 21244

Dear Ms. Syrek Jensen:

Abbott welcomes the opportunity to comment on the Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) released on March 26, 2019.

Abbott is committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world in nutrition, diagnostics, medical devices and branded generic pharmaceuticals. We currently have a transcatheter aortic valve replacement device on the market in Europe and expect that it will be available on the US market in the future.

Abbott believes that TAVR therapy has achieved an established status and has demonstrated safety and effectiveness while quickly expanding to beyond the initial high surgical risk population. TAVR is no longer a new or unproven technology. CMS’ proposed update to hospital and operator requirements recognizes the progression of TAVR therapy to a safe and commonplace procedure.

Abbott applauds CMS’s movement towards more simplified and less restrictive requirements for establishing and maintaining TAVR programs. Specifically, we commend the following proposed changes which will enhance access to TAVR therapy:

• Reducing the requirement for 2 cardiac surgeons to review patient’s suitability for surgical aortic valve replacement (SAVR) vs TAVR to 1 cardiac surgeon
• Focusing on all open-heart procedure volumes for new TAVR center rather than focusing on SAVR procedures only
• Requiring that existing TAVR programs maintain a combined TAVR and SAVR procedure volume recognizing the evolving care pathway for aortic valve stenosis.
• Reducing the requirement from 400 Percutaneous Coronary Interventions (PCI) to 300 per year

A. Continue exploring the development of validated quality metrics

As noted by the requesters of the NCA and many commenters at the 2018 MEDCAC meeting, there is limited evidence supporting minimum volume thresholds as criteria for TAVR program initiation or continuation. Validated outcome measures are the most appropriate way to ensure excellent patient outcomes. The continued growth of TAVR therapy will ultimately result in sufficient data to evaluate these validated quality metrics, which will allow CMS to reduce the reliance on minimum volume threshold over time. We encourage CMS to continue the exploration of appropriate quality metrics and shift from volume-based requirements when quality metrics are feasible. We also recommend that CMS ensure changes are balanced toward maintaining or improving patient access.

B. Work with stakeholders to establish validated shared decision-making tools

A shared decision-making model is an important component to ensuring appropriate treatment. This is particularly relevant for the choice of TAVR vs. SAVR because the treatment decision for symptomatic aortic stenosis is based on multiple factors, including surgical risk, patient frailty, comorbid conditions, as well as patient preferences and values. We recommend that CMS continue to explore the development and implementation of shared-decision making tools which take all stakeholder needs into account. The successful implementation of shared decision making also requires continued and improved access to all therapies so that there is a full range of choices for all patients.

This proposal reflects an appropriate evolution in the NCD requirements which ensure that Medicare patients have access to this important therapy, while maintaining an emphasis on quality. With the continued growth of TAVR, quality metrics and shared decision making can eventually take the place of volume requirements, ensuring patient access to the most appropriate therapy.

Thank you for consideration of our comments.

Sincerely,

Barbara J. Calvert

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Charles N. Kahn III
President and CEO

April 25, 2019

Tamara Syrek Jensen, JD
Director
Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard S3-02-01
Baltimore, MD 21244

Re: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (CAG-00430R)

Dear Ms. Syrek Jensen:

The Federation of American Hospitals (“FAH”) is the national representative of over 1,000 investor-owned or managed community hospitals and health systems throughout the United States. Our members include teaching and non-teaching, short-stay and long-term care hospitals in urban and rural America, and provide a wide range of ambulatory, acute and post-acute services. We appreciate the opportunity to comment to the Centers for Medicare & Medicaid Services (“CMS”) on the Proposed Decision Memo on Transcatheter Aortic Valve Replacement (“TAVR”) (CAG-00430R).

We agree with the rationale for a TAVR National Coverage Determination (“NCD”) revision, in part due to greater experience with the procedure, advances in technology and improvement in outcomes since 2012 when the NCD was originally published. That said, the Proposed Decision Memo may inadvertently create a five-fold disparity between the initial aortic valve procedural volume required in the “Qualifications to begin a TAVR program for hospitals without TAVR experience” and the maintenance aortic valve procedural volume required in “Qualifications for hospital programs with TAVR experience.” As a result, inexperienced and potentially unsustainable TAVR programs may open under the proposed new program volume requirements which later fail to achieve the proposed existing program volume requirements. Consequently, we recommend that the Proposed Decision Memo better-align initial and maintenance aortic valve related procedural volume requirements for TAVR programs without and with TAVR experience. Our commentary is further outlined below.

We agree with the proposal to reduce the number of cardiac surgeons required to examine a patient prior to a TAVR procedure as outlined in the proposed NCD. This change will assist in reducing the burden for hospitals and providers.

Under “Qualifications to begin a TAVR program for hospitals without TAVR experience,” the Proposed Decision Memo includes an initial volume requirement of “≥ 20 aortic valve related procedures in the 2 years prior to TAVR program initiation.” Since this requirement applies only to hospitals without TAVR experience, we assume this would include all other surgical and transcatheter aortic valve related procedures. This would likely primarily be surgical aortic valve procedures, with a very low volume of aortic valvuloplasty, if any. We believe this volume criterion may not be well-aligned with the Proposed Decision Memo’s volume requirement for “Qualifications for hospital programs with TAVR experience”, as we describe below.

Under “Qualifications for hospital programs with TAVR experience” the Proposed Decision Memo includes a maintenance volume requirement of “≥ 50 AVRs (TAVR or SAVR) per year including ≥ 20 TAVR procedures in the prior year; or, ≥ 100 AVRs (TAVR or SAVR) every 2 years, including ≥ 40 TAVR procedures in the prior 2 years.” We believe this volume criterion may not be well-aligned with the Proposed Decision Memo “Qualifications to begin a TAVR program for hospitals without TAVR experience” (“≥ 20 aortic valve related procedures in the 2 years prior to TAVR program initiation”), as it essentially creates a requirement for a five-fold increase in aortic valve related procedural volume for program maintenance, compared to that required to open a new program. For example, ≥ 20 aortic valve related procedures over a 2 year period to open a program as compared to ≥ 100 aortic valve related procedures over a 2 year period to maintain a program. We also suggest, from the simplicity/consistency perspective, that relevant nomenclature be changed from “AVRs (TAVR or SAVR)” to “aortic valve related procedures”, as in the section for “Qualifications to begin a TAVR program for hospitals without TAVR experience.”

A five-fold difference between the aortic valve related procedural volume required to open a new TAVR program and that required to maintain it seems too disparate and may lead to the opening of inexperienced programs later destined to close for failure to achieve maintenance volume requirements. Although we believe that opening a TAVR program will increase that hospital’s aortic valve related procedural volume, in part since TAVR procedures would now be performed at that program, we do not believe we have seen this dramatic an increase in aortic valve procedural volume across the many TAVR programs that our members currently operate. In addition, since new TAVR programs would no longer be referring such patients to established programs, these established programs would no longer be receiving such patients and consequently be expected to experience a decline in aortic valve related procedural volume, perhaps resulting in their inability to achieve program maintenance volume requirements themselves. We therefore recommend closer alignment between program initiation and program maintenance aortic valve related procedural volume criteria in order to prevent the potentially futile development of questionably-sustainable programs.

To better-align initial and maintenance aortic valve related procedural volume requirements for TAVR programs without and with TAVR experience, we recommend that the Proposed Decision Memo include the following requirements related to aortic valve procedures:

≥ 50 open heart surgeries in the 1 year prior to TAVR program initiation, and;
≥ 25 aortic valve procedures in the 1 year prior or = 50 aortic valve related procedures in the 2 years prior to TAVR program initiation.

≥ 50 aortic valve related procedures including ≥ 20 TAVR procedures in the prior year; or,
≥ 100 aortic valve related procedures including ≥ 40 TAVR procedures in the prior 2 years.

We agree with the proposal to remove the catheterization procedure requirement and to reduce the required count of percutaneous coronary interventions as outlined in the proposed NCD. This change will reduce the burden for hospitals and providers providing TAVR services.

* * * * * * * *

The FAH appreciates the opportunity to comment on the proposed NCD. If you have any questions about our comments or need further information, please contact me or Steve Speil of my staff at 202-624-1529.

Sincerely,

cc: Seema Verma
Joseph Chin, MD, MS
Lori M. Ashby, MA
Daniel A. Caños, PhD
Rosemarie Hakim, PhD
Joseph Hutter, MD, MA
Sarah Fulton, MHS
Kimberly Long

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Dear Centers for Medicare and Medicaid Services:

This is a response to the proposed decision memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R) from the Penn Medicine Heart and Vascular Center (Penn HVC) which is the Cardiovascular Service Line for Penn Medicine in the Greater Philadelphia Region. The service line consists of 18 cardiac surgeons and 208 cardiologists in the Southeastern Pennsylvania and South Jersey region. The physicians represented by the Penn HVC performed 496 TAVRS and 773 broadly defined aortic valve procedures in 2018.

The Penn HVC would like to submit the following comments to your NCD decision summary:

1. The Penn HVC supports CMS’s decision regarding 1 cardiac surgeon independently examining the patient. This is a welcome change. (A.2.)
2. The Penn HVC strongly and enthusiastically supports the concept of the Heart Team in the overall management of TAVR patients and believes strongly in a true multidisciplinary approach to patient care. We believe that this paradigm improves the quality of patient care, patient satisfaction and treatment outcomes. We especially agree and applaud CMS for requiring that the heart team include both a cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis. (A.3.)
3. The Penn HVC strongly supports CMS’s decision summary requiring interventional cardiology and cardiac surgeon joint participation in the intraoperative performance of TAVR.
4. The Penn HVC supports the CMS decision memo regarding the requirement for appropriate hospital infrastructure with both robust onsite heart valve surgery and interventional cardiology. We believe the TAVR NCD language is extremely important to inform hospital administration in the United States to support proper infrastructure required to execute safe and successful TAVR treatment to Medicare beneficiaries.
   1. The Penn HVC believes that the use of the language “50 open heart surgeries” in the previous year prior to TAVR initiation is extremely vague and not prescriptive enough. We would suggest utilizing a number of broadly defined cardiac surgical aortic valve procedures (broadly defined SAVR’s) that would enable broad access to this procedure nationally, but would better ensure a significant cardiac surgical infrastructure and hospital system commitment to a legitimate overall cardiovascular service line. It is the Penn HVC’s belief that requiring only 10 aortic valve procedures a year actually amounts, in reality, to having no substantial cardiac surgical program at all. Other than the NCD 5.C.A., the Penn HVC generally agrees with the CMS decision summary regarding hospital program qualifications.
   2. Regarding the requirements for hospital program maintenance, the Penn HVC supports all CMS volume requirements and stipulations including the 300 PCI procedures per year.
5. The Penn HVC strongly supports the heart team and hospital participation in a prospective audited registry and believes, from our extensive experience in over 3,000 TAVRS, that the STS/ACC TVT registry has performed admirably in this regard over the past 7 years. It is our opinion that the STS/ACC TVT registry is improving continuously and the data is used by our health system on a frequent basis by multiple health system stakeholders. The PENN HVC congratulates CMS for continuing the use of the TVT registry by US TAVR sites.

The PENN HVC also agrees with CMS’s suggestions regarding quality in that particular section of the document. These new volume thresholds will increase the number of TAVR programs in the United States and will also impact our regional cardiovascular health system as we will most probably add more TAVR programs. We also recognize that most of these new programs will be lower volume sites and we would encourage CMS to prescribe robust quality measures for TAVR in the US. We will certainly use these quality benchmarks in assessing our own system TAVR programs.

In conclusion, the Penn HVC in general supports the TAVR NCD decision summary. We especially support the use of a functional heart team as a prerequisite for quality outcomes in TAVR. Our experience over the past 12 years has been very satisfactory utilizing a functional and robust heart team concept for the benefit of our Medicare TAVR patients. Additionally, we strongly support all CMS requirements and mandates for ensuring quality outcomes via risk adjusted quality outcome metrics as developed by the national database. It is clear to us that the NCD as written will probably increase the number of TAVR programs in the US by 200-300. The vast majority of these programs will be low volume and therefore in exchange for increased TAVR access, procedural quality should be measured and guaranteed. However, as noted above the Penn HVC would suggest more clarity and definition regarding the concept of “open heart surgeries” and would suggest utilizing a more specific SAVR (broadly defined) volume threshold.

Thank you for allowing us to comment on this NCD proposal and thank you for your consideration.

Sincerely,

Michael Acker, MD
On behalf of the Penn Medicine Heart and Vascular Center Service Line physicians

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Genesis HealthCare System (GHS) welcomes the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposal to update its national coverage policy for Transcatheter Aortic Valve Replacement (TAVR). GHS appreciates your staff’s efforts to update the coverage criteria for hospitals and physicians to begin or maintain a TAVR program—thus potentially expanding patients’ access to TAVR. GHS hopes that its comments are helpful in this endeavor.

GHS strongly supports CMS’ proposal to cover TAVR for the treatment of symptomatic aortic valve stenosis when furnished according to a Food and Drug Administration-approved indication. As a community hospital in Zanesville, Ohio, GHS believes that the current National Coverage Determination requirements, in particular procedural requirements that tie the ability to perform TAVR to the volume of surgical and interventional cardiac procedures performed, limit the ability of lower volume hospitals, from providing this key service to Medicare beneficiaries, even if they are high-quality hospitals. Studies indicate that TAVR has now become a safe, commonplace procedure, with indications expanding from high-risk now to intermediate risk patients. As such, GHS believes monitoring TAVR outcomes for quality should drive decisions as to whether a TAVR center should begin or continue to operate, and GHS agrees that the proposal provides more flexibility in how community hospitals, such as GHS, can meet the requirements for performing TAVR, while continuing to ensure good health outcomes for patients receiving the procedure. Specifically for GHS, this proposal will ensure that patients have the ability to access TAVR services locally—instead of driving to the nearest TAVR facility that is over one hour away from GHS.

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Centers for Medicare and Medicaid Services:

This is a response to the proposed decision memo for TAVR (TAVR) (CAG-00430R) from the University of Michigan Frankel Cardiovascular Center (FCVC) which is the Cardiovascular Service line for Michigan Medicine. The service line consists of 9 adult cardiac surgeons and 133 cardiologists serving the state of Michigan. The physicians represented by the FCVC perform between 250-300 TAVRS annually and approximately 550-650 broadly defined aortic valve related procedures annually.

The FCVC would like to submit comments to your NCD decision summary and are enclosed:

1. The FCVC supports CMS’s decision regarding 1 cardiac surgeon independently examining the patient. This is a welcome change. (A.2.)


2. The FCVC strongly supports the concept of the Multidisciplinary Heart Team (MDT) in the overall management of TAVR patients and believes strongly in a true multidisciplinary approach to patient care with shared decision making with the patient and family preference considered. We believe that this paradigm improves the quality of patient care, patient satisfaction and treatment outcomes. We recognize CMS for requiring that the heart team includes both a cardiac surgeon and an interventional cardiologist experienced in the care and management of aortic stenosis. (A.3.)


3. The FCVC strongly supports CMS’s decision requiring both an interventional cardiologist and a cardiac surgeon to actively participate in the operative performance of a TAVR in a collaborative manner.


4. The FCVC supports the CMS decision memo regarding the requirement for appropriate hospital infrastructure with both robust onsite heart valve surgery and interventional cardiology. We believe the TAVR NCD language is extremely important to inform hospital administrations in the United States to support proper infrastructure required to execute safe and successful TAVR treatment for Medicare beneficiaries.
   1. With respect to requirements for the initiation of a TAVR program the FCVC believes that the use of the language “50 open heart surgeries” in the previous year prior to TAVR initiation is extremely vague and does not reflect the need for institutional expertise in aortic valve surgery. We would suggest utilizing a number of broadly defined cardiac surgical aortic valve procedures (broadly defined SAVR’s) which would better ensure a significant cardiac surgical infrastructure and hospital system commitment to a legitimate overall cardiovascular service line. It is the FCVC’s belief that requiring only 10 surgical aortic valve procedures a year is inadequate and does not qualify as a program with a depth of knowledge and experience concerning aortic valve procedural indications, appropriate approaches or skill set to deal with the catastrophic complications of TAVR such aortic root rupture or aortic dissection. Other than the NCD 5.C.A., the FCVC generally agrees with the CMS decision summary regarding hospital program qualifications.
   2. Regarding the requirements for hospital program maintenance, the FCVC fully supports all CMS volume requirements and stipulations including the 300 PCI procedures per year.


5. The FCVC strongly supports the concept of mandatory participation of all TAVR programs in a prospective audited registry and believes, from our experience in over 1,700 TAVRS, that the STS/ACC TVT registry has performed admirably as a data repository over the past 7 years. We acknowledge the registry as a valuable tool to determine benchmark clinical outcomes analysis and provide results to sites for quality assessment and quality initiative actions to improve the quality of their program. We have participated in the TVT Registry since the inception of our program and have taken full advantage of our institutional data to further improve the quality of our program. It is our opinion that the STS/ACC TVT registry is continuously improving and the data can be used not only for specific site QA/QI initiatives but also by health system stakeholders for registry based research to answer questions concerning appropriateness of therapy and outcomes for future TAVR devices and technology. The FCVC congratulates CMS for continuing the use of the TVT registry with respect to quality outcomes. We believe that the main focus of the NCD should be to ensure safety and high quality clinical outcomes for Medicare beneficiaries. The new volume thresholds in the NCD memo will increase the number of TAVR programs in the United States and most of these new programs will be lower volume sites. Therefore, we would encourage CMS to prescribe robust quality measures for TAVR in the US.

In conclusion, the FCVC supports the TAVR NCD decision summary. We especially support the use of a MDT as a prerequisite for quality outcomes in TAVR. Our experience over the past 12 years has been very satisfactory utilizing a functional MDT concept for the benefit of our Medicare TAVR patients. Additionally, we strongly support all CMS requirements and mandates for ensuring Quality Outcomes via risk adjusted quality outcome metrics as developed by the TVT national database. It is clear to us that the NCD as written will increase the number of TAVR programs in the US by 200-300. The vast majority of these programs will be low volume and therefore in exchange for increased TAVR access procedural quality should be measured and guaranteed. However, as noted above the FCVC would suggest more clarity and definition regarding the concept of “open heart surgeries” and would suggest utilizing a more specific SAVR (broadly defined) volume threshold.

Thank you for allowing us to comment on this NCD proposal and Thank You for your consideration.

Sincerely,

Richard L. Prager, M.D.
Richard and Norma Sarns Professor of Cardiac Surgery
Interim Chair, Department of Cardiac Surgery
Director, Frankel Cardiovascular Center

Stefanie L. Peters, FACHE, MPA, LMSW
Chief Administrative Officer
Frankel Cardiovascular Center
Michigan Medicine

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I strongly urge you to continue coverage for the TAVR procedure. This less invasive procedure will continue to improve and reduce hospital stays and improve patient recovery time.

[PHI Redacted]

This procedure should become a first option for many patients. It is my hope that cardiologist and cardiac surgeons recommend this procedure more often in the future and open heart surgery becomes the last resort.

Continued, and increased, coverage for this procedure is imperative.

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Dear Ms. Syrek Jensen:

On behalf of Medtronic, I am pleased to respond to the Centers for Medicare & Medicaid Services’ (CMS’s) request for public comment on the proposed decision memo of the national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR).[1,2]

Medtronic is the world’s leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. As a global leader in heart valve therapies, including the CoreValve™ and Evolut™ transcatheter aortic valves, Medtronic maintains a robust technology and clinical development program on TAVR and we are committed to delivering meaningful, evidence-based solutions across the care continuum to provide the best possible outcomes for heart valve patients around the world.

Medtronic believes the broad framework of the existing TAVR NCD has been successful, enabling patient access to TAVR therapy while achieving high quality outcomes. Overall, we believe the proposed NCD maintains a strong balance between access and quality, taking a prudent and measured approach toward updating the TAVR policy. In particular, it recognizes the need for only one cardiac surgeon review prior to TAVR, offers some flexibility for hospitals/heart teams to meet volume requirements to offer TAVR, and expresses willingness to consider replacing volume standards with a quality outcome metric in the future.

Our comments focus on the following elements of the Proposed Decision Memo for the TAVR NCD:

• Procedural Volume Requirements: Medtronic supports CMS’s proposal to adjust procedural volumes required for new and existing TAVR programs to furnish TAVR, offering, in particular, greater flexibility for new TAVR programs to begin. Our analysis (based on 2017 data) shows that over 250 hospitals would become newly eligible to perform TAVR procedures as a result of the proposed NCD.


• Multi-Disciplinary Heart Team: Medtronic supports the continuation of multi-disciplinary (MDT) heart teams in the performance of TAVR implant procedures.


• Hospital Infrastructure Requirements: Medtronic supports the modification of the hospital infrastructure requirements, stating on-site heart valve surgery and interventional cardiology programs are required elements.


• Patient Evaluation: Medtronic supports the modification for patient evaluation of the most appropriate therapy, requiring review by only one cardiac surgeon and expanding review to the full range of therapy options. We recommend that this evaluation occur as a joint consultation between an interventional cardiologist and cardiac surgeon who are part of heart team to ensure that all treatment options are evaluated.


• Quality Measures: Medtronic supports CMS’s proposal to add a publicly reportable composite metric in the registry that explores procedure-related factors and patient health outcomes. We support the evolution of quality outcomes measurements that enable an objective assessment of center performance. When these measurements have been validated and accepted throughout the stakeholder community and/or the registry composite metric has collected sufficient data to warrant a decision, Medtronic believes quality measures may be appropriate to use in place of procedural volume requirements to assure high quality TAVR patient outcomes.


• Covered Indications: Medtronic supports the language in the existing NCD and proposed decision memo covering FDA-approved indications for symptomatic aortic valve stenosis.


• Coverage with Evidence Development (CED) and Registry Requirement: Medtronic supports the continuation of CED, and the use of the STS/ACC TVT Registry™ (TVT-R) to fulfill the CED requirements. We recognize the scope of the current TVT-R data collection creates a burden on hospitals and encourage CMS to consider how to effectively streamline data collection for the registry while ensuring the ability to answer the CED research questions.


• Clinical Trials: Medtronic supports the continued coverage for FDA-approved clinical trials, which permits the ongoing evolution of, and patient access to, new TAVR device platforms, techniques and indications.

The remainder of this submission provides further detail on these comments. We appreciate CMS’s review and consideration of this letter.

Medtronic believes the current coverage policy allows for appropriate patient access to TAVR therapy. We support evidence-based patient outcomes, and we believe there is insufficient data to warrant significant changes to this portion of the NCD at this time.

As stated in our letter to CMS during the initial 30-day comment period on the TAVR NCA, our analysis of Medtronic TVT-R data shows excellent outcomes under the existing NCD requirements. Furthermore, our analysis of Medicare claims using a weighted methodology showed little apparent relationship between outcomes and volume for hospitals that qualified to perform TAVR under the existing NCD.[3] TVT Registry analyses show that outcomes in the real-world have continued to improve and are now numerically better than our clinical trial results. This holds true across all risk categories outcome measures.[4] A recent study publication reported finding a relationship between hospital TAVR volumes and patient mortality[5]; however, it did not provide a conclusive definition of ideal procedural thresholds to ensure excellent patient outcomes.

In the proposed NCD, CMS maintains levels similar to procedural volumes in the existing NCD but with greater flexibility via the proposed updates to procedural volume requirements for hospitals and operators. The proposed volume requirements would permit TAVR centers to open in areas currently not providing the procedure. Medtronic’s analysis of the proposed hospital procedural volume requirements identified over 250 newly eligible centers. This is a very positive expansion of TAVR.

Medtronic believes continued use of procedural volume requirements in the TAVR NCD remains appropriate until quality metrics are established for TAVR outcomes that can replace procedural volume requirements as a proxy for quality in TAVR therapy delivery.

Medtronic agrees that a multi-disciplinary heart team (MDT) is well-accepted and helps improve care overall for Medicare TAVR beneficiaries. Medtronic supports the continuation of a requirement for a multi-disciplinary (MDT) heart team.

Medtronic supports the modification of the hospital infrastructure requirements, stating on-site heart valve surgery and interventional cardiology programs are required elements.

During the development of the original NCD in 2012, the only approved indication for TAVR was for extreme surgical risk, or inoperable, patients. This indication necessitated that two surgeons independently evaluate patients to determine their suitability for open aortic valve replacement, and per the NCD, reflected the requirements in the clinical trial that gained initial FDA approval for TAVR.[6]

Since the initial FDA approval, TAVR indications have expanded to patients with lower surgical risk profiles, and in subsequent trials, such as SURTAVI,[7] these requirements were reduced to only one surgeon examining the patient to make a determination of operability.

In accordance with the latest advancements in technique and technology, Medtronic supports the proposed decision memo which modifies the evaluation of patients for aortic valve treatment suitability to require only one cardiac surgeon. Furthermore, to ensure that all beneficiaries are engaged in a shared decision-making process that encompasses evaluation and discussion of all options, including SAVR, TAVR, medical or palliative therapy, we encourage CMS to specify that the pre-procedure consultation should be performed by a surgeon and interventional cardiologist who are part of the heart team.

This approach is consistent with existing society guidelines[8.9], stating that all patients who are eligible for a bioprosthetic heart valve should be evaluated by a multi-disciplinary heart team and engaged in a shared decision-making process.

Furthermore, current advancements in telemedicine may permit future comprehensive patient evaluations via telemedicine, which may help patient access and alleviate travel burdens in rural areas, while also facilitating shared decision-making with Medicare beneficiaries, their families, and their caregivers.

Medtronic encourages an adaptation of the evaluation requirements that can accommodate future advancements in patient evaluation formats without necessitating another reconsideration of the NCD. We suggest removing the “face-to-face” language from the surgeon’s examination and replacing it with language ensuring a comprehensive examination and evaluation.

We suggest the following update:

Medtronic supports the evolution of quality outcomes measurements that enable an objective assessment of center performance. Medtronic encourages the continued discussions and analysis of appropriate quality outcome measurements that would better track center and operator TAVR metrics, with an ultimate goal of validation and acceptance of TAVR quality measurements. Medtronic supports replacing procedural volume requirements with these validated and accepted quality measures, when applicable.

Medtronic agrees that currently there are not established quality measures to replace volume requirements and supports CMS’s proposal to add a publicly reportable composite metric that will include measures such as death, acute kidney injury (AKI), paravalvular leak and other measures that have been demonstrated to impact late mortality and patient reported quality of life (KCCQ).

Medtronic continues to support the evolution of quality outcomes measurements that enable an objective assessment of center performance. When these measurements have been validated and accepted throughout the stakeholder community and/or the registry composite metric has collected sufficient data to warrant a decision, Medtronic believes quality measures may be appropriate to use in place of procedural volume requirements to assure high quality TAVR patient outcomes.

Maintaining TAVR coverage for FDA-approved indications ensures timely Medicare beneficiary access to the most current platforms and devices for the treatment of symptomatic aortic valve stenosis. Approved technologies which demonstrate meaningful clinical benefits to patients ensure that ongoing TAVR coverage reflects beneficial technology development.

While positive clinical trial results have been released, Medtronic recognizes that no TAVR device is currently FDA-approved for patients with symptomatic aortic stenosis and low surgical risk. Medtronic appreciates that CMS is reviewing the recent clinical presentations regarding trials for this new indication [10] and supports the provisions in the current NCD that allow access to new technologies immediately upon FDA approval.

In the future, we note that language related to the treatment of symptomatic aortic valve stenosis may need to be modified to provide coverage of technologies found to improve care for other patient populations and/or indications, such as aortic stenosis that is not symptomatic, assuming sufficient evidence is available to conclude that transcatheter aortic valve replacement improves health outcomes for Medicare beneficiaries.

Medtronic supports the continuation of CED, and the use of the STS/ACC TVT Registry™ to fulfill the CED requirements. The current TVT Registry™ (TVT-R) is being utilized consistently across TAVR sites. Analysis of Medtronic data from TVT-R has demonstrated consistent results in a commercial, “real-world” population compared to the clinical trial cohorts. Medtronic TVT-R data furthermore shows continued improvement in 30-day and 12-month complication rates.[11]

In general, Medtronic believes the existing evidence based on TAVR is sufficient to demonstrate improvements in net health outcomes in the Medicare population, and that the technology is reasonable and necessary for the treatment of symptomatic aortic valve stenosis. At the same time, we observe that the current TVT-R data has some limitations and may not provide full information on long-term outcomes, including device durability, and adverse events.

We recognize the scope of the current TVT-R data collection creates a burden on hospitals and encourage CMS to consider how to effectively streamline data collection for the registry while ensuring the ability to answer the CED research questions.

In the future, CMS should consider ending the TAVR CED requirement, particularly with the goal of making the explicit finding that TAVR is reasonable and necessary for use in Medicare beneficiaries with aortic valve stenosis. CMS may also wish to consider coverage process reforms that enable the establishment of evidence generation approaches such as registries without having to conclude that a technology or service is not reasonable and necessary for use in the Medicare population.

Medtronic remains committed to rigorous evidence generation and innovation on TAVR and appreciates CMS’s coverage of TAVR in clinical trials. Medtronic encourages CMS to permit updates in design and platforms that may not reflect commercial requirements, when performed in as part of an FDA-approved trial.

In summary, Medtronic believes that enabling patient access to TAVR therapy while achieving high quality outcomes should be the critical goal of the TAVR NCD reconsideration. Any coverage policy and patient access decisions must be supported by high-quality empirical evidence.

We support the proposed modifications to procedural volume requirements that reduce burden on centers while also ensuring a robust surgical and interventional cardiology program is present. We also support other revisions that reduce patient burden on evaluation and facilitate shared discussion regarding patient treatment options for valvular heart disease.

Thank you for the opportunity to comment on the TAVR proposed decision memo. We appreciate CMS’s consideration of these comments. If you have questions or need further information, please feel free to contact me at (763) 526-0963 or bonnie.handke@medtronic.com.

Sincerely,

Bonnie Handke, RN, MBA
Vice President
Health Economics, Policy and Payment
Medtronic Coronary and Structural Heart

ENDNOTES
1. Centers for Medicare & Medicaid Services. “National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (20.32).” Issued May 1, 2012.
2. Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R), see https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=293&NCDId=355&ncdver=1&DocID=20.32&IsPopup=y&bc=AAAAAAAAQAAA&
3. Vang, E. (2018, July). “MedPAR analysis of TAVR and hospital volumes with mortality rates”. Presented at the meeting of Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), Centers for Medicare and Medicaid Services (CMS), Baltimore, MD.
4. Kappetein AP and Vang, E. (2018, July). Assuring High Quality Outcomes with Appropriate Patient Access to TAVR. Presented at the meeting of Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), Centers for Medicare and Medicaid Services (CMS), Baltimore, MD.
5. Vemulapalli, et al (2019 April). Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. The New England Journal of Medicine, DOI: 10.1056/NEJMsa1901109
6. Centers for Medicare & Medicaid Services. “National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (20.32).” Issued May 1, 2012.
7. Reardon, MJ et al. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. The New England Journal Of Medicine 2017 Apr 06; Vol. 376 (14), pp. 1321-1331. Date of Electronic Publication: 2017 Mar 17.
8. Nishimura RA,Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O’Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135:e1159–e1195. DOI: 10.1161/CIR.0000000000000503.
9. Baumgartner et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease - The Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal. 2017;00,1-53. DOI:10.1093/eurheartj/ehx391
10. Popma et al (2019, April). Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. Presented at American College of Cardiology (ACC) Annual Scientific Session, New Orleans, LA.
11. Kappetein AP and Vang, E. (2018, July). Assuring High Quality Outcomes with Appropriate Patient Access to TAVR. Presented at the meeting of Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), Centers for Medicare and Medicaid Services (CMS), Baltimore, MD.

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April 25, 2019

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Blvd
Baltimore MD 21244

Dear Ms. Syrek Jensen:

The Advanced Medical Technology Association (AdvaMed) is pleased to offer the following comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).¹

AdvaMed’s member companies produce the life-saving and life-enhancing 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.

AdvaMed applauds CMS’ decision to reopen the existing TAVR NCD and commends the Agency’s efforts to modernize, streamline and simplify many key elements of the TAVR NCD, particularly in light of how this therapy has evolved over time, and the evidence that has been generated in the years since the issuance of the original NCD in 2012. We support CMS’ efforts to modify requirements for hospital and providers to be more flexible and less burdensome. We appreciate this opportunity to comment on the proposed TAVR NCD.

It is well known that aortic stenosis is a deadly disease that is often underdiagnosed and undertreated. Access to comprehensive care remains a significant challenge for many. TAVR has dramatically improved the care of Medicare patients with aortic stenosis and has led to better outcomes, improved quality of care, and decreased costs. Recent data published on the low risk population further affirms the benefits this procedure provides.

AdvaMed agrees with CMS that the totality of evidence strongly supports the benefits of TAVR for patients with aortic stenosis. We also agree with CMS that the available evidence does not definitively identify procedural volume thresholds for hospitals or operators to begin or maintain TAVR programs. As noted below, AdvaMed would support a transition to direct measurement of quality at TAVR centers, in place of relying solely on procedural volumes as a proxy.

AdvaMed commends CMS’ proposal to reduce from two to one the number of cardiac surgeons that must independently examine the patient face-to-face and evaluate the patient’s suitability for SAVR, TAVR or medical or palliative therapy. Last year, we recommended that the requirement that two cardiac surgeons evaluate the patient should be removed.

Ultimately, the need for adequate patient access to necessary medical care cannot be understated. We emphasize that, with respect to the examination and evaluation of patients with aortic stenosis, the evaluating clinician must have expertise in and knowledge of all available treatment options, in order to ensure that patients have access to the most appropriate care.

More flexible volume requirements to start and maintain a TAVR program will reduce or diminish improper incentives and allow for the continued evolution of aortic valve disease treatment. This will help to ensure appropriate and timely access for a broader group of patients in need, especially as aortic stenosis remains an underdiagnosed and undertreated disease. AdvaMed supports the proposals in the draft NCD that are intended to provide greater flexibility in achieving or maintaining certain required procedural volumes.

The proposed NCD specifically covers TAVR for symptomatic aortic valve stenosis and could unintentionally preclude this NCD from applying to future TAVR indications for aortic stenosis currently being studied. AdvaMed recommends that as CMS continues to evaluate modifications to the existing NCD, it should acknowledge that additional indications for TAVR (e.g., for asymptomatic aortic stenosis patients) are under consideration. As this therapy continues to evolve, and as more evidence is generated for a broader range of patients, it will be important to ensure that the NCD does not create a barrier to appropriate access to the right treatment for the right patient.

AdvaMed supports the continued coverage under Coverage with Evidence Development (CED) for evidence development and data collection, including participation in a prospective, national, audited registry.

We also note that certain elements of the NCD have worked well and should be preserved as proposed, including coverage for FDA-approved indications (coverage to label); the requirement for a cohesive, multi-disciplinary heart team; appropriate hospital infrastructure; and the registry participation.

While the proposed TAVR decision does not ensure uniform policy standards across all AVR therapies, we believe that the proposal will facilitate greater patient access to care. In the case of patients seeking treatment of symptomatic aortic valve stenosis, the choice of proceeding with surgical aortic valve replacement (SAVR) as opposed to TAVR is based on multiple factors, including the surgical risk, patient frailty, comorbid conditions, and patient preferences and values. Noting the importance of shared decision-making for this patient population, we encourage CMS to continue to work with stakeholders to ensure the development and implementation of validated shared decision-making tools that speak to the needs of patients in their decision-making.

Finally, we agree with CMS that validated outcome measures are the most appropriate way to ensure excellent patient outcomes, and that ultimately such measures should be applied to all aortic stenosis therapies. Flexible volume requirements are a reasonable alternative in the short term; however, the infrastructure is in place to be able to measure program outcomes and quality. The availability of robust quality measures would reduce the need to rely on less precise measures, such as procedural volumes. AdvaMed supports replacing procedural volume requirements with validated quality metrics in the future. This could reasonably coincide with the discontinuation of the existing CED requirements.

Summary

Thank you for the opportunity to provide our comments on this important topic. AdvaMed is pleased with the direction of the proposed NCD and commends CMS once again for its efforts to improve coverage for this challenging health condition, especially in light of the growing body of evidence in recent years. If you have questions regarding these comments or if you require additional information, please contact me or Chandra Branham, JD, Vice President, Payment and Health Care Delivery Policy, at (202) 434-7219 or cbranham@AdvaMed.org.

Sincerely,

/s/

Donald May
Executive Vice President
Payment and Health Care Delivery Policy

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Avalere Health and the Heart Valve Initiative appreciates CMS’ reference to the importance of shared decision-making (SDM) in a variety of clinical scenarios including transcatheter aortic valve replacement (TAVR). We understand that in the current environment, there are limited choices for an evidence-based decision aid or tool for this patient population.

There is strong evidence to support that SDM increases a patient’s knowledge and accuracy of risk perceptions, and that decision making is associated with improved decision quality. As clinical practice has evolved, we gradually see broader application of SDM across various clinical areas. Evidence suggests that SDM may also be associated with improvements in clinical outcomes, especially for individuals with chronic conditions.

Effective management of patients relies on a shared-decision making process that includes a detailed understanding of the risk and benefits of deploying different treatment strategies. Through the shared decision-making process providers should discuss issues such as life expectancy, anticipated improvement in symptoms, hospital length of stay, estimated recover time, and when appropriate end of life planning. This SDM opportunity should allow for patients to ask their provider specific questions that are important when to that specific patient when assessing which treatment option should be undertaken. The decision to intervene and ultimately the type of intervention that occurs should be based on an individual risk–benefit analysis. The provider and the patient must weigh the risk of the procedure and intermediate-term mortality against the benefits of the procedure. There is value in eliciting patient values and preferences and describing risks and benefits to further shared decision-making.

In the case of patients seeking treatment of symptomatic aortic valve stenosis, the choice of proceeding with surgical aortic valve replacement (SAVR) versus TAVR is based on multiple factors, including the surgical risk, patient frailty, comorbid conditions, and patient preferences and values.³ Noting the importance of shared-decision making for this patient population, we strongly encourage CMS to continue to work with stakeholders to ensure the development and implementation of SDM tools that speak to the needs of patients in their decision making. Discussion with the patient and family should review the likelihood of symptom relief or improved survival, discuss possible complications and the expected recovery process, and ensure that patient goals and expectations are aligned with the possible procedural outcomes.³

As with other past NCDs, like the implantable cardiac defibrillators, we encourage CMS to consider the required use of an evidence-based decision aid or tool, as more tools are developed, tested and validated for future NCDs in this space.

Thank you for the opportunity to submit comments on the important coverage determination decision. Please let us know if you have any questions regarding our recommendation to include SDM in the future and/or about the Heart Valve Initiative.

REFERENCES:
1 CMS. "Beneficiary Engagement and Incentives Models: Shared Decision-Making Model.” December 2018. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-12-08-2.html.
2 L. Aubree Shay and Jennifer Elston Lafata, "Where is the evidence? A systematic review of shared decision making and patient outcomes," Medical Decision Making 35, no. 1 (January 2015): [114], doi:10.1177/0272989X14551638.
3 Otto CM, Kumbhani DJ, Alexander KP, et al. 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults With Aortic Stenosis: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2017 Mar 14;69(10):1313-1346.

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April 24, 2019

We appreciate the opportunity to submit in support of less stringent criteria for centers performing Surgical Aortic Valve Replacement (SAVR) to initiate a Transcatheter Aortic Valve (TAVR) program. The proposed volume requirements released on March 26th for the initiation and continuation of a TAVR center are inclusive to ensure innovative and therapeutic procedure can be offered to all patients equally, particularly in rural health systems like ours. Mandating transfer of our patients to a high volume regional TAVR facility would place an undue burden on patients and their families. The staff at Henry Ford Allegiance Health have witnessed patients turning down a lifesaving TAVR procedure at a regional center due to the extended drive, time away from their families, and financial concerns. Our Cardiovascular team has capable surgeons and interventional cardiologists with extensive career experience, high quality and the multidisciplinary infrastructure to support SAVR and TAVR. We must not limit access for patients seeking care at our center because of an arbitrary threshold.

As TAVR volumes have progressed to the point of surpassing SAVR volumes, the continued use of the higher requirement of SAVR volume is becoming even more problematic and only serves to limit access and/or delay care. Therefore, the prerequisite for one surgical evaluation instead of two will be better utilized, followed by a multidisciplinary infrastructure to better define and serve our local patient’s needs.

Utilizing the proposed lower surgical volume requirements as a baseline requirement for new programs wishing to perform TAVR does not lower quality but rather allows the measurement of quality metrics through the Transcatheter Valve Therapy (TVT) Registry as the ultimate determinant of success for New Structural Heart Programs.

Sincerely,
Matthew Jonovich, MD, MMM, RPVI, FACC, Interventional Cardiologist, Vascular Medicine Specialist
Usman Khokhar, MD, FSVM, FACC, Interventional Cardiologist/Vascular Specialist
Mahender Macha, MD, FACS, Cardiothoracic Surgeon, Director of ICU CV
Elizabeth Pielsticker, MD, FACC, Interventional Cardiologist, Cath Lab Medical Director
Vincent Simonetti, MD, FACS, Cardiothoracic Surgeon, Medical Director of Cardiac Surgery
Michelle Walker, RN, BSN, CNP, Henry Ford Allegiance Structural Heart Coordinator
Dana Snider, MBA, Administrative Director, Cardiovascular and Interventional Radiology Services

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[PHI Redacted]

I urge you to make the TAVR option as widely available everywhere. Every one facing a heart operation should by law be informed of the TAVR option and where they can get it. It should be open heart surgery itself that should be minimized as much as possible. TAVR will be much less costly to Medicare, i.e. the nation, and to the patients themselves.

We must not sacrifice the interests of the many for the sake of the few. The many being the patients and the nation at large. The few being the hospitals and doctors who still do only open heart surgery. The few must be given every incentive and encouragement to learn and adapt TAVR as fast as possible.

Thank you.

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April 24, 2019

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd.
Baltimore, MD 21244

RE: National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

Dear Ms. Syrek Jensen,

Boston Scientific Corporation (BSC) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). BSC is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We develop and supply medical devices in numerous clinical areas, including cardiology, which serve the needs of many patients, including Medicare beneficiaries. We have outlined key aspects of the proposal where we would like to express our support and/or provide additional comments.

Section A.2 - Independent Examinations

BSC is supportive of the CMS proposal to reduce the number of independent examiners from two cardiac surgeons to one cardiac surgeon who has independently examined the patient face-to-face, evaluated the patient's suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy, and has documented the rationale for their clinical judgment, and the rationale is available to the heart team. The current requirement for independent examinations by two cardiac surgeons is unnecessary and increases the burden on patients and providers and therefore potentially limits or delays appropriate treatment.

Section A.3 - Heart Team and Shared Decision Making

Boston Scientific supports the heart team approach to delivery of care, as described by the physician societies in their updated consensus statement, 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement. We also support the use of shared decision-making, which will allow patients, with the counsel of their providers, to evaluate personal priorities and options to determine the best care for them as individuals.

Section A.5 - Volume requirements for new and existing programs

Boston Scientific supports the goal of eliminating existing disparities in the treatment of patients with aortic valve disease. We appreciate the modification of TAVR site and operator requirements, which facilitates patient access while also setting appropriate thresholds to support continued quality in care delivery. We support the volume requirements as described by CMS in the proposed NCD, and advocate for their finalization in the NCD.

Boston Scientific believes that, at some point in the future, it may be appropriate to eliminate volume requirements in favor of outcomes measures. Until such measures have been defined and validated and consensus is reached among providers, we recognize the need to rely on surrogates such as the current volume requirements.

Summary of BSC Comments

BSC welcomes the opportunity to comment on this proposed NCD. In summary:

• BSC supports policy updates that may help to eliminate barriers to patient access, including a reduction in the number of independent evaluations.
• BSC supports the heart team approach, along with the use of shared decision making to inform patient care.
• BSC supports the proposed policy updates to modify the volume requirements for new and existing facilities and providers.
• BSC has no recommendations for further edits to the proposed NCD policy for TAVR.

Sincerely,

Maria Stewart
Vice-President, Global Health Economics and Market Access

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Aortic stenosis (AS) is the most common valvular heart disease requiring intervention in the United States, and the past decade has witnessed a profound, rapid evolution in treatment paradigms. Based on an unprecedented clinical trial effort, transcatheter aortic valve replacement (TAVR) has been approved and rapidly adopted for the treatment of intermediate and higher surgical risk patients with symptomatic severe AS. (Leon MB et al. NEJM 2016; Reardon MJ et al. NEJM 2017) Indeed, by 2017, the volume of transcatheter aortic valve replacement (TAVR) surpassed surgical aortic valve replacement (SAVR) in the United States. (Michaels J. Structural Heart Disease Summit, June 21, 2018) Recent clinical trials in low-risk surgical candidates have now provided further high quality evidence that TAVR is a reasonable option for the vast majority of patients with AS. (Mack MJ et al. NEJM 2019; Popma JJ et al. NEJM 2019) The new availability of evidence-based therapeutic alternatives for AS demands the incorporation of patient values and preferences into final decision making by an experienced heart team.

The extremely rapid change in treatment paradigms for AS presents a significant challenge for regulatory agencies and payers. We therefore appreciate the opportunity from CMS, in response to clinicians advocating for their patients (Drs. Pelikan, Robertson and Wright, CMS website), to reconsider the 2012 National Coverage Determination (NCD) for TAVR. Our recommendations for revisions to the new Proposed Decision Memo, along with rationale and data to support them, are humbly submitted below.

1. Current wording: “One cardiac surgeon has independently examined the patient face-to-face, evaluated the patient's suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy, and has documented the rationale for their clinical judgment, and the rationale is available to the heart team.”

Recommendation: “Both a cardiac surgeon experienced in surgical approaches and a cardiologist experienced in transcatheter approaches to aortic valve disease have independently examined the patient face-to-face, evaluated the patient's suitability for all options including surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy, and have documented the rationale for their clinical judgment, with the rationale available to the heart team.”

Although the randomized data on low surgical risk patients were not available at the time of the formulation of the proposed NCD, we believe that it is profoundly important to account for these landmark trials when proceeding with a coverage decision that is likely to have a lasting impact on clinical practice. Along with the existing evidence base, these trials unequivocally establish that TAVR is at least equivalent to SAVR with respect to important early clinical outcomes, including death, stroke, and rehospitalization. TAVR also offers a more rapid recovery and improvements in quality of life, particularly when performed from the transfemoral access route. It is therefore no longer appropriate that cardiac surgeons act as “gatekeepers” and unilaterally control patient access to this therapy. Indeed, it is of particular concern that approximately half of all SAVR centers in the United States currently do not offer TAVR, and it is unclear whether patients at these centers will have equal access to TAVR. We urge CMS to treat all patients with AS equally, regardless of the therapy for which they are initially referred, and mandate a true heart team approach with a shared decision making process for every patient.

Shared decision making is a process in which clinicians perform 3 distinct tasks: they 1) present all of the reasonable options available to patients, along with their risks and benefits; 2) listen to patients’ informed values and preferences and 3) use those preferences to deliberate with patients and families, and come to consensus on a decision. (Hess EP et al. Circ CV Qual and Outcomes 2014; Barry MJ, Annals of Int Med 2002) CMS has several precedents for mandating shared decision making in NCDs: lung cancer screening, left atrial appendage (LAA) closure and implantable cardioverter defibrillators (ICD). Evolution of how National Coverage Decisions can most effectively respond to stakeholder input regarding mandates for a shared decision making process led to a broader inclusion of team members, including advanced practice providers (as in the ICD NCD).

The current TAVR NCD moves to the other end of the spectrum, requiring only a cardiac surgeon speak with the patient about the choices available to them, recording their interaction somewhere that a “heart team” can review. There is no evidence that cardiac surgeons alone have the interest or skillsets to lead patients and their families through the decision making process for the treatment of aortic stenosis, with equal consideration of all options as listed in the proposed NCD. In fact, the literature suggests that individual physicians continue to fall short when it comes to shared decision making, suggesting the importance of the heart team approach in this specific task. (Hsu, et al. Med Dec Making 2017; Taylor, et al. JAMA Surgery 2017; Coylewright et al. Circ CV Qual and Outcomes 2016). Therefore, we recommend using the precedent of the transcatheter mitral valve repair NCD, written in 2014, that calls for both a surgeon and a cardiologist experienced in valvular heart disease to meet with the patient and their family, and present all reasonable options that are available to the patient.

2. Current wording: “CMS supports patient shared decision making in AVR but there is not a fully developed tool available at this time.”

Recommendation: “A formal shared decision making encounter must occur between the patient and a member of the heart team, with patient values and preferences documented in the medical record. Current best practices include use of an independent patient decision aid when available.”

The TAVR NCD, breaking in precedent from recent decisions including those covering other preference-sensitive decisions such as stroke prevention in atrial fibrillation (LAA closure NCD) and prevention of sudden cardiac death (ICD NCD), does not highlight a major role for shared decision making. In the proposed NCD background information, there is recognition that recent Expert Consensus Documents highlight the importance of this approach. (Otto CM, et al. JACC 2017; Bavaria JE, et al. JACC 2019; Nishimura RA et al. JACC 2019) However, CMS raises concern that there are not adequate tools available to support shared decision making. Indeed, there are at least 3 available patient decision aids publically available, developed using rigorous standards and with independent support from the American College of Cardiology and the Patient Centered Outcomes Research Institute (PCORI). These decision aids cover intermediate, high and prohibitive risk patients (see sharedcardiology.org, “tools”).

Notably, the shared decision making literature is clear that patient decision aids are helpful, but not necessary, to lead to a shared decision making process. This process is defined by the elicitation of informed patient values and preferences, and incorporation of these patient goals into final decision making. While decision aids are important, clinician skillsets in shared decision making are even more critical, and favorable clinician attitudes surpass both in the requirements for implementation of shared decision making. (Joseph-Williams, et al. 2017 BMJ) Clinician attitudes towards shared decision making are clearly shaped by health policy requirements, and thus the TAVR NCD has an opportunity to embed shared decision making within the clinical visit for aortic valve disease even as patient decision aids are being refined and made more readily available.

3. Current wording: “The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.”

Recommendation: “The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.” (no change)

In order to maintain the excellent outcomes seen in the randomized clinical trials and national registries, it is essential that the skillsets of the proceduralists are highly developed and maintained. Several analyses demonstrate the existence of learning curves and volume-outcome relationships in the setting of TAVR. (Carroll J, et al. JACC 2017; Vemulapalli et al. NEJM 2019) A recent publication by prominent cardiac surgeons that are highly skilled in TAVR implored their professional societies to move towards “an emergency overhaul” of training for cardiac surgeons to ensure the development of appropriate skills for transcatheter procedures. (Nguyen TC, et al. J Thorac Cardiovasc Surg in press 2019) We are in full support of the need for development of wire and catheter-based skills amongst cardiac surgeons for the intra-operative aspects of TAVR, as in interventional cardiology. (Raphael C, et al. Circ Cardiovasc Interv 2017) At present, we believe that maintenance of a team approach to the intra-operative technical aspects of TAVR is most likely to ensure reproducibility of the excellent safety profile demonstrated not only in trial settings, but through the national registries that serve us well.

In conclusion, we believe that the heart team approach remains critical for decision making regarding which options are reasonable to offer to patients with severe AS; for true engagement of patients and families in shared decision making about those options; and for appropriate partnering in the intra-operative technical aspects of TAVR, with continued evolution of training programs. Therefore, we recommend a heart team approach for all patients with severe AS considering aortic valve replacement.

Sincerely,
Megan Coylewright, MD; Dartmouth-Hitchcock Medical Center
John K. Forrest, MD; Yale University School of Medicine
James M. McCabe MD; University of Washington Medical Center
Tamim M. Nazif, MD; Columbia University Irving Medical Center

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April 25, 2019

Tamara Syrek-Jensen, JD
Director
Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

Dear Ms. Syrek-Jensen:

The Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography & Interventions (SCAI) are pleased to submit joint comments below on the CMS proposed decision memo for TAVR. The societies recognize the significant time and effort that produced the decision memo, including listening to feedback from the clinical community and a variety of stakeholders. We appreciate the inclusion of certain elements for which the societies advocated. It is also evident that CMS strove to balance differing interpretations of evidence that results in a decision memo rooted in pragmatic compromise. While understandable, we strongly believe this approach as it currently stands is likely to produce suboptimal patient outcomes.

We have previously conveyed our insights and recommendations to CMS in multiple venues and appreciate CMS’s willingness to consider this letter in formulating the final TAVR NCD. Our comments on the draft NCD and suggested improvements are provided below with an appendix of additional background information included at the end of this letter.

TAVR has been the subject of CED as a new form of valve replacement and a disruptive technology. CMS has articulated the need for continuing evidence development and data collection through CED in a revised NCD for TAVR. The societies strongly support CMS’s proposal to maintain the requirement for data collection through an approved registry as a mechanism to answer key questions and fill evidence gaps. The CED questions that CMS propose, and the addition of a CED question regarding morbidity and procedure-related factors’ role in patient outcomes as well as long term valve durability, performance of new, not yet approved valves and performance in low risk patients, align with the CED questions that we suggested in our comments on the national coverage analysis. The societies look forward to answering these and other questions such as the intermediate and long-term safety and efficacy of new device iterations through high quality data collection. We also remain committed to continuously improving the STS/ACC TVT Registry to optimize sites’ user experience by decreasing the burden of data collection while improving TAVR standards and outcomes.

The societies are supportive of the CMS proposal to revise the existing requirement for pre-procedure consultation with two cardiac surgeons to a requirement for pre-procedure consultation with one cardiac surgeon. The existing requirement was a carryover of pivotal clinical trials but is now commonly an obstacle to care as the technology has dispersed. The societies further affirm that patient evaluation is optimally performed jointly in a multidisciplinary valve clinic and that patient preferences with regard to surgical aortic valve replacement (SAVR) or minimally-invasive TAVR and outcomes that matter most to them be considered. The multidisciplinary valve clinic is a preferred venue for shared decision-making as opposed to separate “face to face” consultations with cardiologist and surgeon. We recommend that CMS provide clarification in coverage condition 2 by specifically noting that the pre-procedural consultation be performed by a surgeon and interventional cardiologist who are part of the heart team.

We also support the revision and updated language to include consideration of suitability for SAVR, TAVR, medical, or palliative therapy.

Finally, consistent with the 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement,¹ the societies support the continued emphasis on joint participation in intra-procedural technical aspects of the procedure by the heart team’s interventional cardiologist(s) and cardiac surgeon(s). While some interventional cardiologists may consider surgical presence as unnecessary and some cardiac surgeons may consider their presence burdensome, the professional societies remain committed to maximizing patient safety and affirm that a multidisciplinary approach meets that goal for the following reasons. First, 1-2% of TAVR procedures have potentially fatal complications of coronary occlusion, annular rupture, aortic dissection, cardiac perforation, sudden cardiogenic shock, valve embolization, and other complications that require the immediate involvement of a cardiac surgeon. Second, approximately 5%-10% of TAVR cases require alternative access that necessitates surgical skills. Finally, cardiologists and surgeons in existing TAVR programs have jointly performed many procedures and they each contribute to intra-procedure decision making and procedure performance. Since CMS has proposed relaxed requirements to start a TAVR program, hundreds of new and in all likelihood low volume programs will likely emerge as a result of this change in requirements. To balance this change, CMS has an even greater responsibility to require the enhanced patient safety net provided by the presence of a multidisciplinary team.

CMS has proposed revisions to the procedure volume requirements for maintaining a TAVR program and opening new sites. By proposing a maintenance threshold of 50 annual aortic valve replacements (AVRs) with at least 20 of them being TAVRs, or 100 biennial AVRs with at least 40 of them being TAVRs, the proposed coverage could accelerate the trend of fewer SAVRs and more TAVRs performed in the coming years. This approach is clever in its flexibility and could be useful—if the thresholds are adjusted. Again, we are extremely concerned that the proposed volume requirements will translate into a proliferation of low volume TAVR programs at increased risk for having suboptimal outcomes.

The reduced aortic valve replacement volume requirements are inconsistent with the expert consensus document and recently published findings on the inverse association of mortality with hospital and operator TAVR volume, as well as the new data on the inverse association of mortality with hospital SAVR volume, and the major limitations in assessing TAVR and SAVR performance and outcomes when volumes are low.

The volume thresholds should be adjusted and increased for several reasons. First and most important is that newly published TVT Registry data reaffirm the rationale for the societies’ prior recommendations that each center perform at least 50 TAVRs annually. The article published in the New England Journal of Medicine² summarized TVT Registry data from 2015 through 2017. It describes a clear relationship between hospital and operator procedural volume and 30-day risk-adjusted mortality post-TAVR. Even after the exclusion of the first 12 months of a center’s TAVR procedures, mortality at 30 days was higher and more variable at hospitals with low procedural volume than at hospitals with high procedural volume. In another study using the New York Statewide Planning and Research Cooperative System data registry,³ there was a similar inverse relationship between operator volumes and in-hospital outcomes. The volume-outcomes relationship persisted even after accounting for an initial learning curve. The same volume outcome inverse relationship also exists for SAVR.

The second reason to increase the volume thresholds is that without an adequate denominator, quality measurement becomes problematic due to the statistically wide confidence limits inherent with small volumes.⁴ Some of these statistical challenges can be addressed by using rolling aggregated 3-year volume and outcomes data as is currently done by the STS National Database in assessing SAVR outcomes. Importantly, adequate annual case volumes are needed to properly measure quality of clinical outcomes.

Third, under the new proposed volume requirements, a site could conceivably perform 50 TAVRs and zero SAVRs. This would greatly undermine the important role the cardiac surgeon plays on the structural heart team and the surgical expertise available within the institution to care for complications, conversions and non-TAVR candidates.

For all the reasons above, we argue that higher volume standards for TAVR are necessary. The same applies to SAVR volumes which are also addressed in the 2018 expert consensus document. Consistent with the 2018 expert consensus document, the societies reiterate the recommendation that optimal patient care by a site requires performance of ≥50 TAVR cases per year or 100 cases over 2 years. That is paired with a requirement for performance of ≥30 SAVRs per prior year or 60 over 2 years. Under a combined AVR approach, that would be ≥80 AVR cases per year with ≥50 of those being TAVR or ≥160 AVR cases over 2 years with ≥100 of those being TAVR.

Ensuring high quality patient care for Medicare beneficiaries is a critical mission of CMS and professional societies. We recognize that CMS grappled to find an ideal balance between center volume requirements and patient access. However, we strongly believe that there is no evidence demonstrating that a TAVR access problem exists beyond the rural and socioeconomic access issues faced across the U.S healthcare system. We provided evidence to CMS in support of this position at and after the MEDCAC. The proposed decision memo suggests that CMS has been persuaded by the “access problem” argument and that reducing the barrier to entry for new TAVR programs will facilitate more TAVR sites in rural and socioeconomically distressed areas. We expect most new TAVR sites will open in already well-served and saturated urban locations, consistent with the trend we’ve seen over the last 18 months. If CMS’s priority is to facilitate opening more sites with relaxed requirements, the societies believe it is incumbent on CMS and facilities to do more to assure optimal patient care and continuous quality improvement.

Data completeness and data quality are essential for high fidelity quality measurement and assessing the key questions CMS seeks to answer through CED. We strongly recommend the NCD include more specifics regarding data completeness. Currently the NCD requires participation in a national registry, then goes on to list the characteristics of the registry. However, registry effectiveness is driven by completeness and accuracy of the data submitted by sites. Sites should be required to achieve certain thresholds of data completeness, as defined by the registry. This could be done by adding language to coverage condition 6 that addresses outcomes tracked by the registry. Revised language might say, “The heart team and hospital must submit required data that is complete and accurate to a prospective, national, audited registry…” instead of requiring that they be “participating.”

Data collected by the TVT Registry is already available and reported to sites through an online dashboard that is refreshed weekly with benchmarks re-aggregated on a quarterly basis. Hospitals can monitor outcomes and trends on a near real-time basis and drill-down to the patient level on metrics which include in-hospital mortality, significant cardiac events, bleeding events, vascular complications, quality of life metrics, and others. Registry staff know from experience that high performing sites routinely utilize these reports to look for signals that could indicate gaps in their care and strive for continuous quality improvement. Registry staff also know that approximately 40% of sites, many of which are low-volume, do not access the patient drill-down feature on their dashboard reports.

CMS could require sites to make use of benchmark quality reports and implement quality improvement actions if persistently low performance is documented through a registry for consecutive quarters by adding language to this effect in coverage condition 5 which addresses hospital infrastructure. All sites, no matter what volume of TAVR is performed, need quality assessment and continuous quality improvement. Furthermore, the final NCD must specify mechanisms by which patients and families can have confidence that a site meets reasonable performance metrics.

The TVT Registry is committed to a program of voluntary hospital public reporting and has developed the methodology and operational plan to implement. The publicly reported metrics that will be reported by the TVT Registry include commercial transfemoral TAVR volume, in-hospital risk-adjusted mortality, and 30-day risk-adjusted mortality. The public reporting program will be based on a 3-star rating system very similar to that used for SAVR and hosted on the STS website and the ACC CardioSmart website. The 3-star rating system will be implemented and validated this year with a target delivery date for public viewing of August 2020. Additional measures including a 30-day composite performance metric, quality of life, and 1-year outcomes suitable for public reporting are under development. Public reporting will be a significant incentive for sites to maintain high-quality programs and provide patients, families, and referring clinicians with objective data on site performance rather than hospital promotional marketing without objective performance metrics. CMS should incorporate a flexible requirement for public reporting that can grow with the program and public reporting capabilities.

Another mechanism of assuring the public that a program meets standards as outlined in the final NCD is through external programmatic review. There is precedent to CMS requiring this in the cardiovascular care arena. Credentialing requirements for sites offering ventricular assist devices are mandated by the credentialing organization which in turn is required by CMS. CMS could require TAVR-SAVR sites to be certified by an approved credentialing organization.

Certification products are available to assist hospitals performing surgical and transcatheter valve repair and replacement. An external review and certification process that guides hospitals in meeting standards for multidisciplinary teams, formalized training, shared decision-making and registry performance could be a way for CMS to facilitate implementation of best practices and continue ensuring the high quality demonstrated under the first NCD. Hospitals participating in certification programs must participate in an established national clinical database, something the current and proposed NCDs already require. Sites that consistently underperform on quality metrics in comparison to national benchmarks would have access to quality improvement professionals and resources to assist with improvement activities under these programs.

As a tool for continuous quality improvement that aligns with the existing requirement for data collection, certification would be a low-burden mechanism for CMS to pair with the increased site flexibility it has proposed with an enhanced commitment to infrastructure and processes known to gird quality outcomes.

The societies recommend CMS incorporate the following mechanisms in the final NCD to promote quality of care in the management of patients with aortic stenosis:

1. Sites must participate in a national clinical registry for both TAVR and SAVR that provides regular reports of a site’s performance with national benchmarks.


2. Sites must meet data completeness and accuracy requirements of the registries, as discussed further below.



3. CMS should require public reporting of outcome measures as discussed above. Initially the report should include existing TAVR measures such as procedure volume and 30-day risk-adjusted mortality, with built-in flexibility to allow for incorporation of a risk-adjusted, composite quality metric that can supplant volume as a surrogate for quality.

   This could be accomplished flexibly by adding a requirement to coverage condition 5. “d. The heart team and hospital publicly report TAVR procedure volume and at least one other outcome measure.”

   Additional details of the program planned by the TVT Registry described above follow in the Appendix.

4. An external certification process for TAVR-SAVR programs should be identified as a mechanism any site can use to verify infrastructure and quality standards, and that underperforming sites would find useful to improve outcomes.

If CMS needs to reissue a proposed decision memo with an additional comment period to achieve this end, it would be preferable to going through the entire process of reconsidering the NCD again in the relative short term.

A fundamental principle of optimizing decisions and making recommendations is that patient evaluation should be performed jointly in a multidisciplinary valve clinic, as recommended in the draft NCD. Patient preferences with regard to SAVR or minimally-invasive TAVR should be incorporated in a shared decision-making process. This was well described and supported in the expert consensus document.

The societies appreciate CMS’s sensitivity about creating a requirement that cannot be met. Further, the societies have been cautious about recommending use of a specific SDM tool. The societies strongly support a shared decision-making process in the expert consensus document. Adding, “through a shared decision-making process,” at the end of the second sentence in coverage condition 3 would appropriately emphasize the role of SDM.

Similar to the existing NCD, the proposed Decision Memo would require that a new site deploy a comprehensive heart team approach that includes at least two cardiovascular surgeons and at least one interventional cardiologist who have experience with procedures related to TAVR. However, in the draft proposal, it is not necessary for any of the members of the team to have experience actually performing a TAVR. A requirement does exist for the interventional cardiologist to complete manufacturer-required device specific training. We believe the cardiothoracic surgeons should also undergo device specific training as they currently do. That requirement should be added as item b. under the surgeon requirements. Second, even at a new site, some amount of TAVR experience should be required. The 2018 expert consensus document recommends a TAVR proceduralist—which could be either a cardiothoracic surgeon or interventional cardiologist—at a new program have experience participating in 100 transfemoral TAVRs lifetime, with 50 of those serving as the primary operator. At a minimum, there should be some requirement for performance of TAVR as a primary operator in addition to device specific training. Requiring no prior TAVR experience is inadequate and inappropriate given that there are more than 600 sites and >2,000 operators currently performing TAVR.

During discussion of a possible future role for outcome measures instead of procedural volume requirements, CMS states, “We are also proposing that outcome measure results be made public.” We infer that CMS is referencing the existing requirement in clinical study criterion k. that “results must be made public within 12 months of the study’s primary completion date.” This would be different than the public reporting program the societies discussed above. It does not appear that CMS intended to propose a more ambitious program of public reporting a la Hospital Compare or a star rating system.

However, CMS does propose that CED question iv. must be addressed through a composite metric. Since the only composite metric of which the societies are aware is the one being developed by STS and ACC for 30-day mortality-morbidity, it would seem that is the metric to which CMS is referring. It would be helpful for CMS to provide clarification on this matter in the final decision memorandum.

Thank you for considering these comments as you and your team work through the NCD process. To summarize:

1. The societies support continued CED to answer outstanding clinical questions.


2. The societies support revising the two-surgeon pre-procedure consultation requirement to a heart team consultative requirement that includes one surgeon and one interventional cardiologist.


3. The societies recommend that CMS revise the volume requirements to reflect the most current literature showing improved outcomes at sites that perform at least 50 TAVRs annually.


4. If CMS does not revise volume requirements, it should move expeditiously toward a system that where outcome measures replace volume requirements. Public reporting of procedure volume and at least one significant outcome measure, e.g., 30-day risk adjusted mortality aggregated over 3 years, should be required.


5. Sites may participate in an external certification process, as described above.

Please contact James Vavricek at jvavricek@acc.org should you need any additional information in follow-up to these comments. We look forward to the final NCD and continuing to work with CMS to ensure patients have access to high-quality aortic valve therapies.

Sincerely,

David Cox, MD, FSCAI
SCAI President

David R. Jones, MD
AATS Secretary

Robert S.D. Higgins, MD
STS President

Richard Kovacs, MD, FACC
ACC President

This draft NCD addresses TAVR program requirements, but there are several clinical and broader perspectives we wish to communicate to CMS as an important clinical overview and structural context which informed our specific comments and recommendations for modifications of the draft NCD.

• The NCD is a regulatory and coverage document but it also outlines aspects directly impacting on the clinical management of patients with aortic stenosis. Thus, guidance from professional medical societies is essential to produce a final NCD that is solidly grounded on a robust evidence base built from decades of clinical experience and clinical trials in order to optimize the care of patients.
• This NCD has broader implications than just TAVR. This NCD establishes a precedent regarding the distribution and organization of centers involved with treating patients with valvular heart disease as transcatheter and surgical therapies rapidly evolve.
• TAVR has become an established method of replacing the stenotic aortic valve. In fact, in 2017 TAVR was performed more commonly than surgical aortic valve replacement (SAVR) in the US. Two recently published trials show equivalency and, in one trial, superiority of TAVR to SAVR in selected patients at low risk for SAVR. These trials, followed by expected FDA expansion of TAVR indications, set the stage for the next major clinical transformation in patient care. The final NCD must provide structure and requirements to monitor this transformation and optimize the quality of care.
• Our broader clinical and patient-centric perspective make it essential for evidence development and data collection beyond TAVR to the overall management of aortic valve disease, including its prevention, and the rapidly evolving roles of both modalities of aortic valve replacement, TAVR and SAVR. SAVR, while not the subject of an NCD and thus not regulated in the same fashion as TAVR, is also undergoing a major realignment as to when it should be considered to treat aortic valve disease and it remains the best treatment for some patients. Furthermore, the need to routinely assess SAVR outcomes beyond the 30-day post-operative period and to gather patient-reported outcomes including quality of life after SAVR are now apparent as we apply these same yard-sticks to TAVR and face the increasing need to provide clinicians and patients with similar datasets on SAVR and TAVR to make informed choices.
• With the aging of the American population we are now faced with the emergence of a major public health issue from degenerative valvular heart disease effecting an increasing percentage of the population. In addition, the management challenges in the large pool of patients who have previously had surgical aortic valve replacements with a tissue valve have emerged. Structural deterioration of tissue valves necessitates considering either surgical redo or transcatheter valve-in-valve. TAVR, also a tissue valve, is now being performed in patients with life expectancies exceeding 10 years, and therefore we foresee a similar post-TAVR management challenge growing in frequency over the next decade.
• We share with CMS’ perspective that to achieve the goals for health care in the United States requires consideration of both reasonable access to care and a high quality of care including all domains of quality as articulated by the Institute of Medicine.
• Furthermore, the rising costs of health care require careful planning in preventing excessive redundancy of facilities and services, inappropriate utilization, disproportionately high pricing of medical devices in the US, and waste especially of high-technology and expensive facilities and services such as needed for heart valve replacement
• Regulatory decisions, such as the final NCD, as well as routine patient management, must be based on robust scientific evidence, the needs of patients, and carefully avoid biases, political pressures, and various forms of conflicts of interest.

• The 30-day risk adjusted mortality metric will be reported to the sites. This is reported as an Observed/Expected ratio. This will be available for public reporting by 2020. Sites will be required to meet a data completeness threshold level in order to qualify for the TAVR 30-day risk adjusted mortality measure.
• A 30-day Composite Outcome metric that will include Death, Stroke, Major Bleeding, AKI, Paravalvular leak has been developed. These metrics are being chosen as they are empirically based on their contribution to late (1 year) mortality and patient reported health status (KCCQ). This quality metric will be implemented this year, validated and available for hospital review in 2020 and publicly reported in 2021. Sites will be required to meet a data completeness threshold level in order to qualify for the TAVR Composite Quality measure. The composite metric is superior for public reporting because in medical procedures where there is low mortality it allows greater ability to discriminate differences in quality between centers.
• The Composite metric would be sent to the sites as a “Star Rating” where one- and three-star sites are statistically worse or better than expected.
• CMS can also support the transition to the 3-star rating system when it has gone through the steps outlined above. Subsequently, the reporting of one-year outcomes including quality of life data should be encouraged.

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April 25, 2019

Tamara Syrek-Jensen, JD
Director
Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (“TAVR”) (CAG-00430R)

Dear Ms. Syrek-Jensen:

Baylor Scott & White Health (BSWH) is the largest not-for-profit healthcare system in Texas and one of the largest in the United States with over 1,000 access points. Our organization employs more than 47,000 and affiliates with more than 7,500 physicians, attending to more than seven million patient encounters annually. As a fully-integrated delivery system, our accountable care organization (ACO) and Scott & White Health Plan cover more than half a million lives through both public and commercial contracts, including Medicare Advantage. In 2018, BSWH received an exceptional performance adjustment in the inaugural year of the Quality Payment Program. It is our ambition to be a trusted leader, educator, and innovator in value-based care delivery. In our system, we currently deliver care to Medicare beneficiaries in both urban and rural areas of Texas in 14 cardiac catheterization laboratories, eight cardiac surgery programs and four TAVR programs. We are tentatively planning on opening two more TAVR programs based upon the proposed TAVR NCD revision. Collectively, we have extensive experience in all aspects of TAVR and care for patients with aortic stenosis, having performed > 3,300 TAVR procedures since 2012 with 749 procedures performed in 2018.

As experienced TAVR operators and leaders, we represent the consensus viewpoint of the TAVR providers in the BSWH Cardiovascular Service Line. We all believe that these are very exciting times for this transformational technology. We have all carefully reviewed the Proposed Decision Memo for TAVR. Based upon our own experience as well as published peer reviewed data, we have the following comments and recommendations:

1. We totally support continuation of the pre-procedure consultation requirements with a revision to require evaluation by a cardiologist and single surgeon with elimination of the two surgeon requirement.


2. We are somewhat concerned about the proposed volume requirements. While we understand the goal of providing optimal access to care, we feel that the proposed requirements are too lax and may adversely affect outcomes. Our own experience reflects the current published literature of an inverse volume-outcome relationship for TAVR. Projections are that with the currently-proposed criteria both to start and maintain a TAVR program, an additional 250 to 300 programs would potentially be added for a total of > 900 TAVR programs in the US. We feel that this is more than is necessary to address the access to care issue and would lead to wide variability in quality of care outcomes.

   From our own experience, we feel there is a "learning curve" of at least 50 TAVR procedures with approximately 200 procedures required before a TAVR program is optimally performing in all aspects of care.

Therefore, we would propose the following criteria:

• The number of open-heart surgeries required to initiate a program should be > 100 rather than 50.
• We propose that there should be > 50 aortic valve procedures in the two years prior for TAVR program initiation rather than the proposed > 20.
• For maintenance of a TAVR program, sites should perform > 50 per year with at least 25 surgical aortic valve replacements (“SAVR”) per year. We feel that it is important for all programs including low-volume programs to maintain surgical experience for conversions, management of complications and providing optimal care to patients who are not candidates for TAVR or who in TAVR is not indicated.
• A surgeon should have performed at least 75 to 100 open heart cases in the previous 12 months and at least 25 of them being aortic cases prior to initiating a program.
• An Interventional Cardiologist should have performed at least 50 TAVRs instead of 50 "structural heart disease cases" prior to initiating a program as the current recommendation states

3. We support mandatory reporting of outcomes to national registries for both TAVR and SAVR. Efforts should be directed toward mandating completeness and accuracy of data with minimization of the burden to clinical sites for data collection and reporting to those data necessary for quality assessment and improvement.


4. There should be a robust quality metric that all centers should meet and maintain including 30 day risk -adjusted mortality and complications and optimally one year outcomes to include survival and patient reported outcomes. Program outcomes should be transparent with public reporting of 30 day mortality and annual procedural volume mandated. Use of a 3 star public reporting outcome metric harmonized with the outcomes reporting now in place for SAVR would be ideal. This is particularly important as most new sites that open if proposed volumes are maintained are likely to be low procedural volume sites. Assurance of maintenance of quality outcomes in these (and all sites) is critical.


5. We also believe that SAVR be held to the same standards and outcomes as TAVR and that patients have equal access to both procedures.

Thank you for the consideration of our comments

Sincerely,

Angel Caldera, MD
Katherine Harrington, MD
Reddy Konda, MD
Mark Lawrence, DO
Amir Malik, MD
Tim Mixon, MD
Srini Potluri, MD
Robert Stoler, MD
Molly Szerlip, MD
William Bohannon, MD
David Brown, MD
Jeffrey Michel, MD
Kevin Whelan, MD
Michael Mack, MD

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I am reading with interest the discussion that is occurring regarding funding for TAVR procedures. [PHI Redacted] I also went through the experience of attending all pre-op appointments and listened to the decision making process when [PHI Redacted] needed an aortic valve replacement. [PHI Redacted] was initially scheduled to have a traditional AVR but due to a prior history of breast cancer and radiation treatments that left her sternum very thin and fragile, she was not likely to heal well and risked sternal infection and other complications. For that reason her surgery was cancelled and she was sent to be evaluated for a TAVR. Fortunately, she was determined to be a good candidate for this. This was a very thorough evaluation process. She had many appointments; cardiology, interventional cardiology, her own primary physician to evaluate her current health and a cardiac surgery appointment to re-evaluate risk and recovery if she had the AVR the traditional way. She had the TAVR procedure about one month after her original heart surgery was cancelled. During that one month of waiting and evaluating [PHI Redacted] was depressed and extremely worried she wouldn’t be able to have the procedure. I hadn’t realized how important this surgery was to her. They asked her many questions about quality of life during one appointment and I was shocked to hear her responses. If she had to continue living the way she was, with constant shortness of breath, an impending feeling of doom with any minimal activity and chest pressure with walking form her chair in the living room to the kitchen, she didn’t want to continue pursuing other treatment and would just rather determine that she was going to die sooner rather than later. The realization of the dysfunction and distress she was in was shocking as she suffered mostly in silence.

[PHI Redacted] had her TAVR and immediately after returning to her cubicle for further recovery, she had to use the bathroom. The sheath had been pulled and the appropriate amount of time had passed and she was able to get up to the restroom. She had to walk down the hall and back. Prior to the procedure she would take 5-10 minutes to “catch her breath” after walking. She used pursed lip breathing and was visibly short of breath just from that minimal activity like walking from the car to the house. After the procedure, she hopped off the cart, walked down the hall and back and got back onto the cart. She wasn’t short of breath at all! I pointed this out to her and she was ecstatic. It was such an amazing transformation of her physical status. She continues to do very well and is even able to work out in her garden again this spring. Without the TAVR procedure, she wouldn’t have had the desire to continue living and not just living, living an active and meaningful lifestyle that includes volunteering, gardening and socializing with her many family members and friends.

I also see this decision from the perspective of a nurse. I am currently the Director of Critical Care in a community hospital. I have been a Critical Care Educator and Nursing Director and a critical care RN at the bedside for a total of 36 years. Watching elderly patients recover from a valve or bypass surgery is concerning. Often they don’t do well or have prolonged recoveries, not because of errors or avoidable complications, simply because of their own risk factors. We do our best to anticipate and avoid complications but that simply is not always possible. Comparing [PHI Redacted] I strongly believe that we should be using the TAVR for many more patients. This is a transformational procedure for higher risk patients who need a valve replacement. It gets them back to a better lifestyle faster and with less recovery. From a financial perspective the TAVR procedure has the following benefits: reduced length of stay, reduced complications like infections, falls, delirium, reduced time on the ventilator and reduced need for a nursing home or SNF. I know this first hand as a nurse caring for these patients.

I highly recommend that the TAVR funding be greatly increased and that we look at expanding the criteria of those who should qualify for this life saving and life changing procedure. At a minimum, we should continue funding TAVR programs and reimburse these procedures as they truly are life changing. It was a “miracle” for [PHI Redacted].

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Below are the comments of our letter that HealthyWomen will also be submitting via email.

April 25, 2019

The Honorable Seema Verma
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mail Stop C4-26-05
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Administrator Verma:

HealthyWomen is the nation’s leading independent, nonprofit health information source for women, and we are concerned about appropriate access for women to quality clinical care through physical access to treatment options and clinicians, appropriate reimbursement that does not discriminate against women, and inclusion of women in clinical research at all levels.

We are writing about the Proposed Decision regarding Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R), and would urge CMS to consider the important benefits TAVR has for women, and how expanding Medicare coverage would improve access for women – particularly in rural and other areas where access may now be limited.

First, we believe that with the increasing capabilities of electronic health records – and the capabilities for analyzing the data from those records – that focusing on actual quality of outcomes is a better route for evaluating facilities than volume alone. Second, we would urge CMS to similarly utilize existing health information as much as possible for any registry or other requirements (e.g., CED) to minimize additional paperwork requirements that could hinder access for women by deterring potential quality providers from offering TAVR as an option for appropriate patients. Third, we support shared-decision making between a woman and her clinicians, so would urge CMS to keep coverage decisions abreast with current clinical data and FDA approvals.

As you know, women have differences in physiology and anatomy (such as smaller valves and blood vessels that may make TAVR an important option), and as such women may be harmed by reimbursement rules that do not consider those differences. Similarly, women may be harmed by systemic clinician or other biases that exist today and that can be reinforced by reimbursement or other regulatory rules or requirements. For example, in the cardiovascular area, women with atrial fibrillation have higher risks of blood clots, which can cause strokes, but women are less likely to be prescribed an oral anticoagulation medicine than a man.(1)

Specific to TAVR, the Proposed Decision Memo points out that studies have shown that compared to men, “women had improved survival after TAVR.(2) We do recognize that women also had higher risk of strokes, major bleeding and other complications, which are reasons to focus on actual outcomes rather than volume in making coverage decision changes. For these reasons we also concur with CMS that an all-women registry would be beneficial, just as we also support inclusion of women in all clinical trials and the ability to separately analyze such trial data by gender.

Thank you for your consideration of this letter and our recommendations.

Sincerely,

Beth Battaglino, RN, CEO, HealthyWomen
Beth@HealthyWomen.org

1. Sex-Based Differences in Pain Perception and Treatment. Paller CJ, Campbell CM, Edwards RR, Dobs AS. Pain medicine (Malden, Mass.). 2009;10:289-299.
2. Conrotto F, D'Ascenzo F, Presbitero P, et al. Effect of gender after transcatheter aortic valve implantation: a meta-analysis, Ann Thorac Surg. 2015;99(3):809-16. And O'Connor SA, Morice MC, Gilard M, et al., Revisiting sex equality with transcatheter aortic valve replacement outcomes: A collaborative, patient-level meta-analysis of 11,310 patients, J Am Coll Cardiol. 2015;66(3):221-228

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I am writing this comment to support efforts that will allow the Medicare review board to discontinue (or at least minimize) restrictive directives which are currently in place to regulate access for the TAVR procedure that may have been necessary at the time of inception for initial review, but are no longer necessary. I am advocating that the quantifying hospital requirements give way to qualitative assessments that benefit all patients who are candidates for the TAVR.

[PHI Redacted]

So, I am very grateful that a TAVR is part of my life. Please take the necessary steps to ensure that other persons with the same affliction can have access to this procedure and the benefits of a full life. TAVR should be accessible to anyone who can benefit from it.

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Getting good treatment and controlled TAVR surgery is paramount to success of such a wonderful procedure. I have witnessed 1st hand TAVR patient success that would be completely different if they did not receive quality TAVR surgery.

I encourage CMS to expand access to TAVR and remove overly strict requirements Medicare has had in place for seven years for patients to get the procedure. Impactful people in my life that helped me [PHI Redacted] would not be alive without a high quality TAVR procedure.

I urge CMS to change the information release for patients and everyone to see how well the TAVR procedure is successful at your local hospitals so patients can make informed choices about where to get their care.

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Transcatheter aortic valve replacement is a life-saving procedure and limiting access to care is hurting patients.

I live in El Paso, Texas and access to care is difficult and sometimes not possible due to our geographic isolation. I have had several patients die with aortic stenosis because they are unable to travel to large centers due to socio economic reasons, money, frailty, etc.

Data clearly shows that low volume and high-volume centers have had similar outcomes. Our data should not be based on volume but rather quality. I support the criteria that have been proposed.

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[PHI Redacted] we are concerned about the current status of the decision making process for the TAVR. [PHI Redacted] had a surgical valve replacement with open heart surgery in September 2017 so she has been both a patient and a caregiver. The comparative differences in the procedure vs. the surgery are tremendous. Following the TAVR, [PHI Redacted] was out of the hospital in two days vs. 9 with the open heart surgery, and rehab experience was less traumatic and shorter in length. [PHI Redacted] surgical experience was overwhelming for her and she had a difficult rehab process that took several months.

Our experiences confirm for us that the TAVR should be readily available to a wider variety of patients as a treatment of choice for aortic valve disease. The process of approval is long, complicated and unnecessary for this valuable treatment option. In the beginning this was important to ascertain safety and appropriateness of choice. Now however, many TAVR procedures have been done safely with outstanding outcomes, shorter recovery times, and shorter hospital stays with few complications. For these reasons, access to this option must be broadened across our country. The hospital and doctor volume requirements place an inordinate barrier of care access to a large number of patients who could benefit from the procedure with less pain and short recovery times.

We are also concerned that many of the TAVR guidelines are based on quantity rather than quality. Changing this policy guideline could improve the accessibility of the procedure. In my state, [PHI Redacted] traveled over 75 miles to access this treatment and had to be seen and "approved" by three doctors who spent an amazing amount of time asking questions and determining eligibility. This took a lot of valuable time during which [PHI Redacted] had major symptoms that interfered with daily life. During this time, finding data or information on TAVR was difficult if not impossible.

CMS must consider granting public access to data on TAVR so that the public can make an informed decision regarding their care. [PHI Redacted] Men and women should not have to suffer the trauma of open heart surgery for a valve replacement when the TAVR is so successful in providing positive outcomes. My wife is a nurse and I am a medical social worker and we know the health care system. This was an advantage in navigating the process. Many other persons, both diagnosed and undiagnosed with valve disease likely do not have that advantage. We would ask that the Centers for Medicare and Medicaid determine a more open policy as the coverage determination for the TAVR. There is more than sufficient evidence available from patients that it is indeed the wiser choice for replacing a diseased valve regardless of the age of the patient. [PHI Redacted]

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Proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

I am an Interventional Cardiologist and Co-Director of the Structural Heart Program at Morristown Medical Centre in New Jersey. I have served as the primary or co- investigator on more than 20 clinical trials and have been published more than 300 times in peer-reviewed cardiology journals. I have been active in research but in the clinical setting and have seen the evolution of TAVR and the amount of data generated to support this technology. Specifically, The PARTNER 3 Trial results published in The New England Journal of Medicine demonstrated that TAVR in low-risk patients was superior to surgery at one year on a composite primary endpoint of all-cause mortality, all stroke and rehospitalization. It is my opinion that at this stage of this therapy, that all indications for the surgical treatment of aortic stenosis should be applied to TAVR. In fact, with this most recent data, TAVR should be considered as the first line approach, with SAVR used when the patient anatomy is not suitable for a TAVR. The optimal therapy should be based on anatomical suitability with input with the patient through Shared Decision Making. While I applaud CMS’ actions in reducing the cardiac surgeon signoff from two (2) to one (1), I believe that this requirement should be modified to allow for an interventional cardiologist to be an alternative to sign off a patient for TAVR. Ideally, patients should be referred to a Heart Team where he/she could be best assessed for suitability for a TAVR or SAVR.

As the Primary Investigator for the asymptomatic patients with severe AS trial (EARLY TAVR) that is currently enrolling, the term “symptomatic” should be removed when used to describe aortic stenosis. There are additional ongoing clinical trials underway evaluating the safety and efficacy of TAVR in asymptomatic patients as well. CMS should update its coverage language from “symptomatic aortic valve stenosis” to “aortic valve stenosis.”

Finally, I was pleased to read the flexible volume requirements in the draft decision memo and CMS’ efforts to streamline the patient path to treatment to provide equitable access to care for patients. The burden of aortic stenosis is high and it remains an underdiagnosed and undertreated disease. Patients are not always able to travel far distances to get this type of care and therefore, the volume requirements for centers to begin a TAVR program are reasonable, provide a baseline to establish center proficiency, and support patients.

I ask that CMS take the above points in consideration.

Sincerely,

Dr. Philippe Genereux
Co-Director of the Structural Heart Program at Morristown Medical Centre in New Jersey

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Comments from a Caregiver:

[PHI Redacted] was 88 when she had her TAVR procedure. She is now well on her way to 91. The year prior to her TAVR procedure I could see her slowing down, having a harder time doing things she loves. Her overall health was very good, but she kept needing to stop to catch her breath. The driveway was too long. I began to worry that she would need in-home care and other support[PHI Redacted]. [PHI Redacted] had asked to see Chichen Itza’s Temple of the Sun, requiring the ability to walk several miles. I asked her to work on walking more. It became evident that she was not able to go any distance. After additional consults with her primary MD she saw a heart specialist and was told she had stenosis in her aortic heart valve. It became clear that this was a plumbing problem.

The team explained the options of open heart surgery or a potential newer option of TAVR. She dreaded the idea of open heart surgery. [PHI Redacted] had undergone 2 bypass surgeries and she was terrified of having her chest opened. The many TAVR protocols required testing and multiple visits with various specialists and an angiogram. She just wanted it to be over and get the TAVR procedure done so she could get on with her life. You’ll see [PHI Redacted] has a full plate, she teaches courses at the University for Seniors on Opera Appreciation; takes numerous courses; and has an extensive travel itinerary including the Panama Canal, Mexico and has booked a trip to see South America. She maintains a large flower garden and home. She loves to entertain guests and visitors from all around the world. She is an active volunteer in her community.

Prior to the TAVR procedure she was less engaged and was not able to keep up with activities. I was alarmed when she told me that she had a bowl of cereal for her dinner. [PHI Redacted] is an amazing cook, this was a dramatic downshift. Once all the approvals were received, the TAVR procedure was completed. She was discharged from the hospital after only 36 hours. I don’t really have the words to thank you[PHI Redacted]. The complex valve – a beautiful crown - the team of experts at the Heart Valve Clinic have given [PHI Redacted] a new lease on her life to take on pretty much anything she sets her mind to do.

[PHI Redacted] did not have any complications post TAVR procedure, bruising at the insertion point was the only visible issue. She was careful to follow all the discharge instructions.

As a caregiver, the post TAVR procedure help she needed was minimal. The hardest thing was to get [PHI Redacted] to lay down for a rest. She did not like taking the blood thinner, but understood the reasoning and followed those instructions to the letter.

All of the follow-up post TAVR procedure has also been helpful, for [PHI Redacted], to reassure her she is on the correct path, and for me as the caregiver, to ensure her new valve is working properly. [PHI Redacted] has enjoyed being a “star” patient.

My situation is a happy story, I would hope that in the future the path is made easier for others to benefit from a life changing procedure that reduces hospital and aftercare and makes a world of difference in quality of life.
Thank you

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Thank you for considering comments regarding TAVR program qualifications. On behalf of Swedish Covenant Hospital’s cardiac patients we are in favor of the new proposed qualifications for TAVR program. Our hospital has provided high quality cardiac care for nearly 20 years. We have an excellent open heart surgery and interventional cardiology program that continuously produces great quality outcomes. Having the ability to offer TAVR at our facility would be a huge benefit to our community. This would eliminate the crosstown trek that our patients currently do in order to have a TAVR procedure performed.

We have trained cardiologists and surgeons available to do TAVR, our only stumbling block is the current high AVR volume requirement. As more TAVR procedures are performed AVR volumes will continue to decline making the current standards impossible to reach. The proposed standards would allow us to implement a program that would grant TAVR access to more patients in the community allowing them to stay close to home and have treatment by highly skilled cardiologists, surgeons, and staff that they already know and trust.

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To whom it may concern,

McLaren Health Care, a Michigan health care organization with four active TAVR sites, is responding to the CMS Decision Summary that outlines specific hospital infrastructure to provide treatment of symptomatic aortic valve stenosis. Our physicians who are active participants on the TAVR multidisciplinary teams at our four sites would like their comments considered in CMS’s final NCD decision. Their comments are as follows:

1. We would like CMS to amend the volume proposal for a program to maintain reimbursement for a TAVR program that states, “At least 50 AVRs (TAVR or SAVR) annually or 100 every two years, including 20 or 40 TAVRs over those respective timeframes” to include a reasonable number of SAVRs for the same time-period. We believe that the same volume requirements as stated for TAVRs would be reasonable for SAVRs.
2. CMS is also recommending another proposed change from the current national coverage determination that CMS would require just one cardiac surgeon to sign off on the multidisciplinary evaluation for TAVR, SAVR or palliative care. Our physicians are recommending that one cardiac surgeon be required to independently examine the patient face-to-face and sign-off on the evaluation but that a second surgeon be required to review the case and document the rationale for the heart team’s rationale.

We ask that you will consider our comments in making your final decision on the NCD.

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The body of knowledge regarding the safety and efficacy of TAVR, especially with regard to SAVR, continues to increase at a rapid pace. I had the opportunity to participate, as one of the representatives from our healthcare system, at the Medicare Evidence Development and Coverage Advisory Committee - Procedural Volume Requirements for TAVR on July 25, 2018.

It was clear, in that meeting, that there was a perception that the credentialing requirements for TAVR operators and centers were overly restrictive and limited access to TAVR for some populations in the US.
It is my opinion that the recent proposed changes to those requirements result in the potential for significantly poorer overall outcomes for patients with critical aortic stenosis than is desirable. Furthermore, the apparent insistence on cardiac surgeons as the sole gatekeepers of access to TAVR is inappropriate.

As evidenced by recent published clinical trials ( NEJM, March 16, 2019), not available at the July 2018 meeting, comparing TAVR to SAVR in low surgical risk populations there is a clear advantage of TAVR over SAVR in terms of reduced 30-day mortality, stroke and re-hospitalization. These findings are similar to the results from previous randomized trials in higher risk populations. This raises the issue of the role of gatekeeper for these procedures. In our hospital, it is a shared decision between the TAVR credentialed cardiologist and the SAVR/TAVR credentialed CV Surgeon. Excluding one or the other is inappropriate. Furthermore, with the current evidence, the question of whether isolated SAVR hospitals should be allowed in the Medicare population should be seriously considered.

Additionally, a recent publication (NEJM, April 3, 2019) clearly demonstrated a significant increase in mortality in TAVR patients treated in hospitals with annual TAVR volumes less than 100 and by TAVR operators with an annual volume less than 40. These new findings should result in the annual procedural guidelines for both TAVR centers and TAVR operators increasing from those currently proposed.

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The Leapfrog Group is writing in full support of CMS’ recent national coverage decision for transcatheter aortic valve replacement (TAVR).

The Leapfrog Group, our Board of Directors, and members collectively comprise hundreds of the leading purchaser and employer organizations across the country. We are committed to improving the safety, quality and affordability of healthcare with meaningful metrics that inform consumer choice, payment and quality improvement. In 2001, developed one of the first national hospital volume standards for high-risk procedures. Now, almost two decades later the literature supporting the volume-outcome relationship for certain procedures has only grown stronger.

The Leapfrog Group would offer the following comments on the national coverage decision:

• As decades of research has shown, for certain high-risk procedures, such as cardiac procedures and cancer resections, a “volume-outcome” relationship exists, whereby higher hospital and surgeon volumes are associated with better patient outcomes. The Leapfrog Group, who has recognized and rewarded this volume-outcome relationship in its own Leapfrog Hospital Survey for 20 years, is in full support of CMS’ decision to maintain volume thresholds for both hospitals and individual surgeons performing TAVR. The recently released study in the New England Journal of Medicine by Vemulapalli, et al., which found that TAVR patient mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume, is a recent illustration of how this relationship continues to hold true.
• While The Leapfrog Group believes that procedural volume is an excellent proxy for patient outcomes for many high-risk procedures, The Leapfrog Group fully supports the NCD requirement that hospitals and surgeons that perform TAVR need to participate in a registry the tracks patient outcomes (as an example, the TVT registry co-developed by STS and ACC). The Leapfrog Group hopes that at a point in the future, the TVT registry outcome data could be used by CMS and other health care payers and purchasers for public reporting, pay-for-performance programs, and the possible identification of Centers of Excellence.
• Critics of setting minimum volume standards often voice concerns that minimum volume standards restrict a patient’s access to the procedure if they do not live near, nor can travel, to a hospital that meets these standards. Leapfrog is sensitive to the access concern and we would ask that CMS and others identify possible ways of tracking patient access or loss of access to TAVR. These data could be helpful in the CMS’ next NCD decision.

The Leapfrog Group appreciates the opportunity to comment on CMS’ decision around the coverage of an important, but still risky, procedure.

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To some, the proposed NCD is a reasonable compromise between assuring competency of TAVR services to Medicare beneficiaries and allowing access to such services.

I suggest, however, that consideration be given to two salient unintended consequences of the proposed volume requirements of this NCD.

1. It is completely unclear to me how percutaneous coronary intervention (PCI) was chosen as the most important surrogate for the annual hospital volume requirement. PCI does not require a team approach, does not require imaging specialists, does not require cardiac surgeon involvement, and is largely driven by emergency cases out of the control of the hospital and physicians. In most of California there is purposeful dissemination of PCI centers to allow immediate access to this critical service for patients with acute myocardial infarction (AMI). As such, in traffic-clogged areas such as Los Angeles County these patients are distributed to many hospitals - since most PCI's are performed in such non-scheduled patients the fixed number of AMI patients in the County limits the number of total PCI's that most centers perform per year. The 300/year PCI requirement would eliminate the majority of AMI centers in California from performing TAVR. According to available data from the State of California, even the majority of medical schools in the State would NOT be allowed to be reimbursed for TAVR if this annual PCI volume requirement were to remain in place: institutions that do not currently meet the 300/year minimum include UC San Francisco, UC Irvine, USC, and Stanford University.

   If CMS feels strongly that annual volume somehow ensures quality, then my suggestion would be to instead use a total of all of the procedures performed in the hospital cardiac catheterization labs per year (instead of just PCI procedures), perhaps 500 cases/year. Importantly, this would include structural cases (such as left atrial appendage occlusion) that more closely approximate the heart-team approach needed for TAVR and are far more likely to represent the skill sets needed to successfully perform TAVR.

2. There will be perverse incentives should annual minimum requirements for specific services be required to perform TAVR. Patients in whom a choice of procedures could be appropriate might easily be swayed to undergo a specific procedure if the annual volume requirement at that hospital - say for surgical AVR, or for TAVR, or PCI - had not yet been met. As per the above discussion, one way around this would be to broaden the minimum number of cases/year to include other cardiac surgical (such as mitral cases) or cath lab procedures (such as including all structural cases).
3. It is easy to measure volume and partially for this reason annual volume requirements have been in place for decades. However, we can now measure quality as well. Since volume is a surrogate for quality, we should stick with the real marker and mandate that quality metrics be met to assure payment for procedures. High volume, low quality centers should not be paid for their work; low volume, high quality centers should be.

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Hendrick Medical Center (HMC) is a West Texas Hospital ((564 Licensed bed facility) located in Abilene Texas with a service area that covers 24 counties, (400,000+ Population). We are interested in starting a TAVR program and meet all of the requirements of the National Coverage Determination (NCD) for TAVR (20.32) with the exception of the SAVR volume of the previous year.

The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure.

TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality. Although nearly 500 TAVR programs exist throughout the United States, in some regions patients have little access or cannot travel to larger cities for their care.

We are proud to say those we serve in our facility are receiving the same, or better care, here in their hometown as they could receive in a larger, metropolitan area. Our hospital has invested capital for diagnostic and therapeutic modalities to perform these procedures.

Expanding the ability for high quality centers to provide this procedure will enable hospitals like ours to better serve patients and provide this procedure locally to a population who cannot travel 3-4 hours to a larger facility. When someone has a serious or chronic health condition, travel can be very dangerous as well as stressful for the patient and their family. They are also burdened with unnecessary travel expenses in addition to costly time away from work for the individual and their family members.

Expanding availability of this procedure is truly in the best interest of the patient. It is our hope you will implement new parameters to allow the initiation and maintenance of a TAVR program for lower SAVR volume centers.

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Thank you for considering our comments on the proposed decision regarding TAVR program qualifications.

For nearly 20 years our open heart program has provided our community with high quality, comprehensive care with over 40,000 cardiac patient visits each year. With open heart surgery mortality rates at or near 0%, our cardiac surgical team continues to perform, on average, 150 open heart surgeries per year. However, aortic valve surgery volume is just below the current required volume for TAVR and will continue to decline as TAVR volume increases.
As a safety net hospital, patients in our community and their families rely on our organization for their health care. Today, by limiting TAVR to high volume facilities, patients with inadequate resources must travel for care that can safely and successfully be provided at our hospital. In addition, with low risk TAVR indications most likely being established in the future, along with an aging population, a greater number of patients will require more access, not less, to TAVR.

Our organization has the resources and the talent to perform TAVR but is unable to establish a TAVR program due to our aortic valve surgical volume. For the past several years our cardiologists and cardiac surgeons have focused on performing TAVR by taking patients to other institutions increasing the cost of care and placing undue burden on our patients and their families who wish to receive care in their own community.
The current NCD requirements have limited access and created inequities. The focus should be on the qualifications of the interventional cardiologist as well as the cardiac surgeon and the quality of the organization and therefore the minimum institutional requirements relating to PCI and SAVR volumes should be reduced.

Thank you for your consideration.

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[PHI Redacted]

First of all, I am pleased that CMS finally decided to reconsider and revise the NCD for the TAVR process. I am also pleased that some significant changes have been made in this proposed draft.

But I am just so disappointed that everything is seeming still volume based for doctors and hospital. This should NOT be about volume, but rather should be about quality of care and success. I know that many low volume institutions provide excellent care, and some very high volume institutions do notvolume simply does not, nor should not factor into the equation. [PHI Redacted] And as the years go by, and TAVR becomes more widespread in use, the whole volume issue becomes increasingly moot.

In fact, focusing on volume will still provide barriers to access TAVR for many individuals in poor and lesser served areasa great disservice to them. And if hospitals are worried about keeping their TAVR spproval numbers, I worry that they will even do additional TAVRs when perhaps surgery might have really been the appropriate treatment.

I am just so disappointed that the medical community is again (still) choosing to be self-serving by counting rather than by assessing success, and publicizing the success rates of hospital and doctors.

[PHI Redacted] please don't be so short sighted when changing the NCD that you make only minor tweaks, rather than opening up the possibilities of TAVR to so many other patients who are struggling with aortic stenosis.

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VOLUME OUTCOMES RELATIONSHIP FOR TAVR:

CLINICAL SIGNIFICANCE vs. STATISTICAL SIGNIFICANCE

As the TAVR NCD proposed revision is considered, two articles^1,2 with seemingly opposing findings have been published. The purpose of these comments is to review and compare these articles, so that the Medicare Coverage and Analysis Group (CAG) will not be misled by conflicting data. As such, it is my hope that the CAG will not be influenced to further restrict hospitals from performing TAVR based on arguments which use statistical significance rather than clinical significance.

In considering whether volume of TAVR procedures should be used as a surrogate for quality, and whether, therefore, to use TAVR volume as a surrogate criterion for hospital approval to perform TAVR, learning curve and ongoing case volume have been conflated. Learning to play the piano requires intensive time practicing. Once an accomplished pianist, this is no longer required. The same holds true for medical procedures.

As shown by Russo et al.1 in an analysis of nearly 62,000 TAVR cases, there is a learning curve of 200 cases for earlier balloon-expandable TAVR valves, but with the Sapien 3, there is no longer a learning curve, and no volume-outcomes relationship. The authors conclude that increased use of conscious sedation, improved CT imaging to plan the procedure, improved TAVR valve technology, best practices and collaborative knowledge programs have all made TAVR safe and effective for programs, independent of procedure volume.

Vemulapalli, et al.² analyzed 113,662 TAVR procedures. They, too, found that 30 day mortality dropped as devices improved and knowledge spread. Mortality for TAVR was 7.5% in 2012, dropped to 2.5 to 3% in 2017. They go on to state that there was “a significant nonlinear association between mortality (unadjusted and adjusted) and annualized hospital volume of transfemoral TAVR procedures.” However, this statement, and the data upon which it is based, should be analyzed in detail. In fact, TAVR 30 day mortality was 3.19% (CI 2.78 to 3.67) in the lowest volume hospitals, and 2.66% (CI 2.48 to 2.85), in the higher volume hospitals. While this absolute mortality difference of only 0.5% generated a p value of 0.02, and was thus called “significant,” is this reflective of a significant medical difference? I argue the answer is no. Please consider:

First, a mortality difference of 0.5%, that is, a difference of mortality of 5 patients in 1000, is so small as to likely be medically insignificant, especially in comparison to the need for rapid delivery of TAVR to the US population without reduced patient access.

Second, Vemulapalli, et al.² failed to get data for mortality on 7,858 patients (8.2%) and failed to get 30-day composite outcome data on 12.773 patients (13.3%). With this much data missing, is a minimal mortality difference of only 0.5% clinically relevant or even statistically credible? I suspect not.

Third, Vemulapalli, et al.² did not restrict their analysis to balloon expandable valves. Since the self -expanding TAVR valve has been shown to have higher risk of need for pacemaker, their data may reflect alterations in practice pattern between valve types and their attendant complications.

Fourth, performing statistical comparisons on huge data sets is known to show statistical significance for minimal absolute differences in measured variables. Thus, looking at over 100,000 TAVRs, a minimal difference of 0.5% may generate a significant p value, simply due to the size of the data analyzed.

Should any suggestions be made that Vemulapalli’s article can be used to support restricting TAVR to high volume centers, this should be viewed as a statistical argument that lacks medical meaning.

Both articles show that TAVR has become safe and effective. With the spread of knowledge, improved procedural techniques, and streamlined TAVR prostheses, TAVR can be performed at multiple hospitals, both high and low volume.

I urge the committee not to further restrict patient access and hospital performance of TAVR, and, in fact, as I have stated before, to abandon volume criteria as a surrogate to predict TAVR quality outcomes. Quality should be measured directly, and used to determine whether hospital programs may perform TAVR.

Peter Pelikan, MD, FACC, FSCAI
Medical Director, Coronary and Structural Intervention
Pacific Heart Institute
Santa Monica, California

References

1. Russo MF, McCabe JM, et al. Case Volume and Outcome after TAVR with Balloon-Expandable Prostheses. J Am Coll Cardiol 2019;73427-40.
2. Vemulapalli S, Carroll JD, et al. Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. N Engl J Med 2019; 1-11. NEJM.org

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Proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

As the associate director of the Division of Cardiology of Medstar Washington Hospital Center, I have seen the evolution of transcatheter aortic valve replacement (TAVR) since it was covered by Medicare with the first NCD in 2012. It has matured significantly, and it can be now be viewed as a proven technology that has been in use for the past 17 years. The amount of data that has been generated supports this statement. Specifically, the PARTNER 3 trial results published in The New England Journal of Medicine demonstrated that TAVR in low-risk patients was superior to surgery at one year on a composite primary endpoint of all-cause mortality, all stroke and rehospitalization. Working at a center that does 400 TAVRs per year, I have had the privilege to be a part of the evolution of TAVR through clinical trials and clinical practice, as well as having the opportunity to train many physicians on the procedure.

I was pleased to read the flexible volume requirements in the draft decision memo and CMS’s efforts to streamline the patient pathway to treatment to provide equitable access to care for patients. The burden of aortic stenosis is high, and it remains an underdiagnosed and undertreated disease. Patients are not always able to travel long distances to get this type of care, and therefore, the volume requirements for centers to begin TAVR programs are reasonable, provide a baseline to establish center proficiency, and support a patient-centric approach.

Second, in my experience, the volumes of procedures do not definitively equate to quality outcomes. Mandating 300 PCIs per year is not a reflection of how well a physician will conduct a TAVR, is probably an unrealistically high volume to assure proficiency and may even have the opposite effect – preventing excellent institutions from maintaining a TAVR program. Good training of physicians leads to better-quality outcomes. I do not feel that having this criterion will help in defining a high-quality center. I have seen low-volume centers with outstanding outcomes and high-volume centers with poor outcomes – for both surgery and TAVR. Having each hospital report and be measured on their outcomes is the best manner to determine quality of a program. I encourage CMS to continue to move in this direction.

Sincerely,

Dr. Ron Waksman
Associate director of the Division of Cardiology, MedStar Heart & Vascular Institute, Medstar Hospital Center
Director of Cardiovascular Research and Advanced Education at the Heart Institute
Clinical professor of Medicine (Cardiology) at Georgetown University.
Washington, DC

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[PHI Redacted]

I am posting this because in the following 2 years I have met several folks that needed to have their aortic valve replaced and did not know about this extraordinary alternative to open heart surgery simply because their cardiologist didn’t mention or suggest it. In this day and age I think it is unconscionable that a cardiologist would not offer the TAVR procedure vs. open heart surgery. This is exacerbated by the fact that most valve patients in the area where I live don’t even know about TAVR and trust their cardiologist with what is presented to them.

A case in point. A dear friend needed his aortic value replaced. He went to his cardiologist who only recommended open heart surgery. He knew from our conversations that [PHI Redacted] aortic valve replaced awhile back with a rather simple procedure. I told him about TAVR. Armed with this information he went back to his cardiologist and asked about TAVR. His cardiologist told him that he didn’t qualify and told him that there are six criteria for TAVR and he only met one. I told him to get a second opinion at a major medical center which he did and was finally able to have the TAVR procedure done.

So the purpose of this post is to make the public and in particular aortic valve replacement patients aware of this extraordinary procedure. It is also my hope that cardiologists realize that open heart surgery is no longer the gold standard for replacing aortic valves.

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Living in the city of almost 1,000,000, we have small fractionated hospitals. Although the volume of the city meet the 2012 recommendations. The physicians although homogenous are unable to complete the volume requirement in one hospital related just to space. The geographical location and isolation of El Paso discourages our patients to leave to receive what is considered standard of care. And sadly they pass away without care they would receiving any other city the size. The inter-disciplinary panels recommendation, that is quality driven along with a reasonable volume is a reasonable requirement to be able to bring a much-needed service to a very underserved community. The quality component should be well monitored.

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The initial TAVR NCD (2012) was a visionary document. In the setting of great uncertainty around a completely novel technology, providers, industry, and regulatory agencies worked together to develop a set of policies that not only created a pathway for the responsible adoption and diffusion of TAVR but also facilitated its evolution into a disruptive therapy. The rollout of TAVR should serve as a model for the introduction of novel device therapies.

However, as TAVR has changed the treatment paradigm for severe symptomatic aortic stenosis (SSAS), the focus of this updated NCD must shift to account for these new realities. The current risk facing patients, the medical community, and policymakers are not that TAVR will grow too rapidly and without evidence to support its use. With seven “Original Articles” based on randomized clinical data published in the New England Journal of Medicine since 2012, there is overwhelming data to guide the application of TAVR in the treatment of SSAS. At present, the greater risk is that patients afflicted with this otherwise lethal disease (SSAS) are not gaining access to therapy rapidly enough.

The guiding principle of this update NCD must be to ensure that the maximum number of those afflicted with SSAS, which is fatal in the absence of treatment, receive prompt access to appropriate and high-quality treatment. This will be most readily accomplished by pursuing the following: (1) a diseaserather procedurespecific NCD; (2) decreasing obstacles to treatment; (3) ensuring high-quality outcomes are offered to the maximum number of patients; and (4) requiring operators to have sufficient training and preparation to perform the procedure

1. A disease, rather procedure, specific NCD. Any national policy related to the treatment of aortic stenosis should be that a disease-based policy on aortic stenosis—and not procedure specific. With the current body data, there are few if any cardiovascular conditions with the same level of evidence to guide treatment. We now have 2 therapies that are proven to improve survival, functional status, and quality of life over large populations of patients. Given the overlapping patient populations for SAVR and TAVR, any policy focused on SSAS should require that all SSAS patients being evaluated for treatment undergo a multidisciplinary review for both TAVR and SAVR by physicians certified to perform these procedures. As part of this process, the involved providers should be required to educate the patients on the risks and benefits of each therapy prior to treatment in order to engage the patients in a shared-decision making approach to care.


2. Decrease obstacles to treatment. There is also an overwhelming body of evidence that demonstrates if untreated SSAS results in death. Moreover, additional studies have shown that even brief delays in treatment (on the order of a few weeks) are associated with a measurable increase in mortality (Malaisrie, 2019; Elbaz-Greener G, 2019). Despite this, it is estimated that only one-half of patients in the US with SSAS undergo treatment, and even after diagnosis and referral, many others are subjected to long waiting time prior to treatment (Pellikka PA, 2005; Charlson E, 2006; Jan F, 2009; Bach DS, 2009; Freed BH, 2010). Though we possess 2 highly effective treatments that should address the needs of the overwhelming majority of SSAS patients, tens of thousands of SASS patients die annually in the US. Given SSAS is largely a disease of advanced age and therefore the overwhelming majority are covered under Medicare, lack of insurance cannot explain this treatment gap. Rather the barriers to treatment are more likely to include: the lack of prompt diagnosis and referral for therapy; the need for extensive, in some respects an over-burdensome, evaluation process; and immobility, distance, and transportation. Specifically, single surgeon "sign-off" for TAVR should be embraced; Medicare providers should be pushed to offer more rapid case review for both necessary diagnostic testing and treatment; and requirements for SAVR and TAVR sites must be revisited. In regards to site requirements, there are currently in the US twice as many centers performing SAVR compared with TAVR sites. Given there are more TAVRs than SAVRs performed in the US and this delta is growing, this current distribution of centers is not consistent with the current volumes, trends, or interests of patients.


3. Ensuring high-quality outcomes are offered to the maximum number of patients. There is an increasing body of evidence suggesting that even low volume centers can achieve excellent outcomes. Two recent analysis of the national experience contained in the TVT Registry that found no relationship between center volume and the risk of death or stroke in largely (Russo M 2019) or exclusively (Carroll J 2017) transfemoral experiences. A 3rd analysis (Vemulapalli, 2019) concluded that though there was a statistically significant volume-outcomes relationship for TAVR, the absolute difference in mortality at 30 days between high volume and volume sites was 0.5%. Further, the authors noted that low volume sites were more likely to serve rural and other underserved populations. These data help guide us in striking a balance between maximizing outcomes and access. Considering the available data, addressing the access issue appears most urgent.


4. Requiring operators to have sufficient formalized training and preparation to perform the procedure. While there is great debate around the question of center volume, less attention has been paid to individual operators' experience and skill set. A more rigorous preparation process should be implemented to ensure that operators have sufficient understanding of requisite imaging modalities (ie CT and echo) and root/peripheral anatomy. In addition, b/c vascular access was shown to have a significant and ongoing learning curve in 2 recent studies of the TVT Registry (Russo M 2019; Carroll J 2017), there should be an emphasis on ensuring operators develop sufficient expertise in obtaining large bore access and managing related complications. These necessary skills are not otherwise typically part of most ICs and cardiac surgeons scope of practice.

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[PHI Redacted]

Not everyone is so lucky. Some people are too sick to make a multi-hour trip, or they don’t have the resources to make multiple trips and overnight stays. Some people are told “you are too young/ too healthy for TAVR.” Today, TAVR is not provided at any facility in the state of Wyoming. Today, thousands of people who want TAVR are being told they do not qualify. Today, decisions can be made to improve patients’ access to TAVR.
TAVR has been proven, and patients need access to this life-saving treatment. If a patient prefers a minimally invasive treatment and if TAVR is a medically appropriate solution, then patients need to be informed of ALL their options, even if the referring provider/facility does not provide TAVR. Just because a patient can/will survive open heart surgery, doesn’t mean that is the best treatment. [PHI Redacted] Newer treatments have evolved and now radiation is rarely used at all to treat Hodgkin lymphoma. With medical advancements, gold standard treatments evolve. The gold standard for valve replacement is evolving.
It’s not enough to look at a treatment and say, “Without this treatment, the patient will die.” We must look at a treatment and say, “With this treatment, the patient will live.” And we must ask ourselves further, “What impact will this treatment have on the quality of the patient’s life?”

I respectfully ask, from the patient perspective, increase patient access to TAVR and increase patients’ quality of life.

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In evaluating the TAVR coverage policy, I urge CMS to please ask the following questions about what we have learned from the 200,000 TAVR procedures completed over the past 7 years in the USA:

1. Is the TAVR procedure still considered experimental by CMS?
2. Have the best practices of the TAVR procedure been proven, documented, and widely distributed?
3. Is the outcome of every TAVR procedure recorded in a registry available for analysis?
4. How do these outcomes compare to the alternative treatment: surgical aortic valve replacement (SAVR)?
5. When given a choice, do most aortic valve stenosis patients prefer a TAVR procedure or undergoing open heart surgery?
6. Isn’t it time that CMS ensure more people, irrespective of their risk level or of where they seek care, can benefit from the TAVR procedure?
7. Why not expand access now? If not now, then when?

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Tamara Syrek-Jensen, JD
Director
Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

With regards to the Proposed National Coverage Decision Memo for Transcatheter Aortic Valve Replacement (CAG-00430R)

Dear Ms. Syrken- Jensen:

I have read carefully the document referenced above and I would like to offer the following comments:

1. I applaud the proposal to require only one Cardio-Thoracic Surgeon rather than two to participate in face-to-face required patient evaluation. I believe it is imperative that an Interventional Cardiologist also be a required participant in this process. I also believe the two physicians should be members of the heart valve team ultimately in charge of the procedure (rather than external to the team).


2. I am concerned about the low volumes required to maintain a TAVR program. Recent data (i) supports a volume – quality relationship for TAVR. Furthermore, once low risk TAVR becomes commercially available, TAVR volumes will dramatically increase across the country. A volume of 50 TAVR a year would be reasonable and easily achieved by most programs (especially in a low risk TAVR environment).


3. I am concerned about the lack of requirement that programs maintain a minimum Surgical AVR volume (SAVR). One could imagine programs where TAVR is exclusively performed and where SAVR expertise is lost. Case selection in such programs would very likely be impacted. One would also be concerned about the ability to perform bailout SAVR and rescue surgery when major TAVR complications occur (Root rupture, valve embolization etc). Recently published data supports best outcomes in centers combining high caseloads of both TAVR and SAVR (ii) . I believe that, just as a minimum volume of TAVRs is required for program maintenance, a minimum volume of Surgical AVRs should be required as well. A reasonable number would perhaps be 20 SAVR / year or 40 SAVR over 2 years).


4. I am concerned that the document seems to allow the initiation of a TAVR program in centers where no operator has TAVR experience. Today TAVR programs and experienced operators are abundant in the US (this was not the case when the prior NCD was published). This reality makes it hard to justify starting a TAVR program without using an experienced TAVR operator (at least until local operators gain experience). A learning curve has been clearly documented for TAVR. While the presence of an experienced operator may not prevent all mishaps, having an experienced operator as part of the team may make a major difference in the ultimate outcome of complications. While proctoring for new procedures and techniques remains extremely valuable, new TAVR programs should be started and ideally led by physicians with experience in the procedure. The number of 100 lifetime TAVR procedures proposed by the AATS/ACC/SCAI/STS is a reasonable one and should be endorsed in the NCD.


5. I am concerned that in identifying criteria for TAVR program initiation and continuation, the document fails to identify criteria for individual operator members of TAVR teams. Conceivably, a facility may start a TAVR program with an interventional cardiologist meeting the specified criteria and add any number of interventional cardiology / surgical operators not meeting ANY criteria. I believe this is more than a purely theoretical risk as most new program development will occur in low volume, community and likely private practice settings. I believe the NCD should specify minimal requirements for physicians to be primary operators in TAVR procedures (for interventional cardiologists, the 100 career structural heart disease procedures / = 30 left sided procedures in the past year would be a reasonable requirement). The document should also consider specifying a minimum annual TAVR volume requirement to maintain proficiency (20 TAVR / year or 40 TAVR in 2 years would be reasonable).

Please feel free to contact me directly for any clarifying or additional information on my comments.

Sincerely,

Andrei Pop MD, FACC, FSCAI, RPVI
Interventional Cardiology,
Park Ridge, IL
Andrei.Pop@amitahealth.org

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Regarding qualifications to begin a program: the requirement for 60 BAVs seems excessive in the modern era in view of the fact that fewer BAVs are performed as isolated procedures and we're moving away from doing BAV at the time of TAVR implantation.

Secondly, it seems reasonable to remove the requirement of having both a CV surgeon and interventional cardiologist physically at the table doing the procedure together in well established programs as long as there are two operators wit enough experience to meet the qualifications requirement (ie, 2 interventional cardiologists working together with a CV surgeon on stand by if needed- similarly to PCI in a hospital with surgical backup

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I agree with the proposed measures and fully support the change of requirements. With increased TAVR implementation and improved outcomes, with expansion of accepted indications to lower risk groups and by achieving results equal or superior to surgery (SAVR), expansion of access for patients to well- trained operators will improve overall access and outcomes for the US population with aortic valve disease. Continued efforts to monitor usage, safety and outcomes will be important going forward.

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I'm writing to urge Medicare give full approval to the TAVR procedure. [PHI Redacted] many people my age and older aren't physically able to undergo it. That's why the TAVR is so miraculous for these people. [PHI Redacted]

Thus, I urge you to give full, rather than restricted, approval for the TAVR procedure. Many people's aortic valve wears out in time, and living a healthy lifestyle doesn't prevent this. TAVR truly is a lifesaver for all of them.

Thanks for your consideration.

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I urge CMS to make the TAVR procedure more widely available. [PHI Redacted] Because [PHI Redacted] was considered at low risk for traditional surgery, [PHI Redacted] was only able to have the TAVR by entering a clinical trial. This restriction should be removed.

I am sure that TAVR is far less expensive than traditional open-heart valve replacement and will result in much better patient outcomes.....[PHI Redacted]

Thank you.

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The TAVR NCD should be revised to focus on the treatment of aortic stenosis and not just on the performance of TAVR.

We believe that the focus of reimbursement and certification programs should be on increasing quality, improving access, and facilitating patient-centered evidence based care within health care systems. To this end, reimbursement and quality initiatives should be designed around the comprehensive treatment of AS, and include both TAVR and SAVR. Rules directed solely at TAVR without inclusion, or accompanying revision of SAVR practices will fall short of intended improvements in overall patient care and will do little to unify the heart team.

There is no mention of volume requirements for maintenance of a SAVR program or for SAVR quality certification. Based on the proposed regulations, many centers may not meet requirements for a TAVR program and yet could continue to offer SAVR – currently there are roughly 600 TAVR centers and 550 SAVR only centers. This regulation appears short sighted with respect to enhancing care for patients with aortic stenosis. By subjecting TAVR to greater regulatory scrutiny and standards than SAVR, some AS patients will receive suboptimal care.

Comprehensive Heart Team evaluation of aortic stenosis

Although the NCD requires a cardiac surgeon to independently evaluate every patient prior to TAVR, no similar recommendation is made for a cardiologist to independently evaluate every patient prior to SAVR. Insisting that a cardiac surgeon but not an interventional cardiologist be the gatekeeper regarding candidacy for TAVR is counter to the concept of a heart team approach. If both professionals are involved in the procedure, why would either not be required to evaluate the patient prior to the procedure? The use of risk scores and other risk prediction tools can aid consistency in risk stratification and avoid unnecessary additional physician visits. As currently written, the NCD requirement can be fulfilled solely by a cardiac surgeon who may not be well versed in TAVR and whose understanding of high risk TAVR features including specific risk for permanent pacemaker or perivalvular leak may be inadequate. The NCD should encourage the comprehensive, collaborative evaluation and treatment of all patients with AS at centers that provide both treatments, void of intrinsic bias.

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I am writing to urge you to make the TAVR valve readily accessible for treatment of Aortic Va,ve Stenosis as well as Mitral Valve replacement. [PHI Redacted]

I also want to make you aware of [PHI Redacted] THIRD open heart surgery for Mitral Valve replacement. When the surgeon had [PHI Redacted] heart open he discovered he could not replace the defective tissue valve since there was no tissue left to sew a new valve to. Instead he used a TAVR valve inside the defective second replacement valve. This use of a TAVR saved [PHI Redacted] life and it continues to work very well.

I believe if you compare morbidity data, you will find the TAVR is a safe and effective alternative to open heart surgery particularly for those who are a poor risk for open heart surgery and would be less expensive for other Aortic Valve Stenosis patients.

Thank you very much,

George S. Harris
Captain, U.S. Navy (Retired)

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We are excited by CMS’ continued enthusiasm regarding the use of shared decision making (SDM) to promote high quality, person-centered care in the context of complex decisions such as the one to pursue TAVR, SAVR, or symptom-focused care for AS. We believe that CMS’s decision to mandate the documented use of evidence-based patient support tools to for primary prevention ICDs and LAAO were the correct ones, and we strongly urge CMS to consider including such a mandate in the NCD for TAVR.

To build upon the description in the proposed decision memo, we would like to call attention to another suite of evidence-based decision aids meant to support conversations between clinicians and patients considering options for AS treatment. The Colorado Program for Patient Centered Decisions, in cooperation with the American College of Cardiology, has created and made freely-available both brochure and video based decision aids, specifically addressing trial-based estimates of risks and benefits using PARNTER 1 and PARTNER 2 data. These tools were created with the input of diverse clinician and patient stakeholders, and are available for free use on the ACC’s CardioSmart website at https://www.cardiosmart.org/SDM/Decision-Aids/Find-Decision-Aids/Aortic-Stenosis

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The need for 2 surgical opinions, particularly in light of new data, is redundant and subjects patients who often need to travel long distances to excessive clinic visits. I agree that this should be removed as a requirement.

I strongly oppose the new recommendations for the criteria to start a new TAVR program. The volume requirements have loosened significantly, and there is too much vagueness regarding the experience required of an interventional cardiologist to perform such a procedure. It should be required that the operators have dedicated training to perform TAVR or at the very least outline specifically what constitutes a 'structural heart procedure' as part of the requirement. By relaxing requirements to start and expanding requirements to maintain a program, there stands to be a large number of programs who meet criteria to open, but will be unable after 2 years to maintain necessary volume requirements. THis will lead to closures of many newly started programs and a tremendous loss of time and resources that could have been dedicated to direct patient care.

The requirement to have 2 operators (one surgeon and one interventional cardiologist) is also redundant, and in my opinion, no longer required. This leads to many delays in patient care as scheduling of surgeons and interventional cardiologists on the same day is tremendously resource-intensive.

Finally, with new data presented regarding TAVR versus SAVR in low risk patients, the decision to proceed with surgical AVR should require consultation with an interventional cardiologist experienced in TAVR prior to proceeding.

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Thank you for the opportunity to submit comments to the proposed Medicare draft National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement. I commend CMS for drafting a policy that contains many elements that improve flexibility and reduce overall burden and will result in better access to care, and I appreciate the opportunity to provide additional suggestions to the draft below outside of those submitted on behalf of the Association of Black Cardiologists (ABC).

I had the honor of presenting at MEDCAC in my role as the co-chair of the ABC’s Structural Heart Disease Taskforce, and the opportunity to be deeply engaged on this issue as a practicing interventional cardiologist who performs TAVR and as someone who believes that engagement in the policy process is crucial to moving US healthcare forward to achieve the “triple aim.” As you are aware, Aortic Stenosis (AS) remains a significantly underdiagnosed and undertreated condition, affecting millions of Americans, many of them underserved, minorities, and women living in communities (both rural and urban) with poor access to optimal care. I agree with CMS that the totality of evidence strongly supports the benefits of TAVR for patients with aortic stenosis, and that an NCD reconsideration is vital to improving the care of these patients.

Although I believe that we can only truly succeed in addressing the problem of AS treatment – and especially that of underserved populations – by creating a policy that measures and holds providers accountable based on the quality of AS care they provide, I commend CMS on publishing a draft TAVR policy which provides greater flexibility (and thereby reduces burden on patients, caregivers, and their providers) and access to TAVR for patients in need. While there continues to be no evidence generated that shows a meaningful link between previous volume of aortic valve replacements, PCIs, or other structural interventions and TAVR outcomes, I agree that the baseline requirements proposed in the draft will assure site proficiency to start and maintain a program until and when quality metrics can be established and implemented across all AVR therapies.

As a practicing interventional cardiologist and TAVR operator since its introduction in the US, I have seen first-hand the implications on access to care of many of the outdated elements of the current NCD, now in place since 2012. Many patients who meet current coverage criteria, who wish to have TAVR, and who have a heart team that believes it is the best option for them, are continuing to be denied care – often leading to refusal of surgery altogether and a life lost unnecessarily. This requirement is adversely affecting African-American patients’ who have a less than 4% penetration of getting access to this technology nationally. Further restricting growth and/or contracting these centers runs the very real risk of further exacerbating lack of access to a technology for a disease state that has a disproportionately high mortality among cardiovascular disease states. I hope that CMS will truly embrace the potential gravity of this situation and how this decision might further restrict diverse patient populations from getting access to this life saving treatment.

This is particularly acute in populations where access to TAVR is limited or providers aren’t knowledgeable about all treatment options, or who don’t practice in centers that provide the standard of care now established for treating AS. With continued device improvements, and the overwhelming evidence supporting TAVR now in all STS-PROM surgical risk levels, the decision about what therapy is best for each patient is optimally determined by a comprehensive heart team evaluation and a true understanding of that individual patient’s unique preferences and desires.

As such, the continued requirement of a cardiac surgeon evaluation alone continues to perpetuate a belief that alone, the cardiac surgeon is best positioned to provide their opinion to the heart team as it relates to a patient’s appropriate treatment options. Furthermore, the continuation of this outdated requirement (a legacy from the original inoperable only approval, now reduced from 2 surgeons to one) obviates the true intent of the heart team process; that is, for a multi-disciplinary team, inclusive of at least one cardiac surgeon and interventional cardiologist, to work together with the patient to determine the best treatment option, up to and including palliative care where appropriate.

At this point in time, determinations regarding suitability for TAVR are significantly linked to anatomical considerations. That is, for most patients, we rule out TAVR when for anatomical reasons it’s not possible to guide the catheter through the femoral arteries and over the aortic arch. Generally, it’s unlikely that a surgeon evaluating a specific patient would have the capabilities or infrastructure to make this determination – this is the important role of the multi-disciplinary heart team, comprised of both surgeons, interventionalists, imagers, and other critical members that support the care of structural valve disease patients. I urge CMS to remove this unnecessary, confusing, and outdated requirement altogether.

I strongly recommend that the policy should be finalized to recognize that, as appropriate, either a cardiac surgeon or interventional cardiologist perform this evaluation and provide their findings to the heart team.

Once again, I appreciate the opportunity to comment.

Respectfully,

Aaron Horne, Jr., MD, MBA, MHS

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The Proposed Decision Memo for Transcatheter Aortic Valve Replacement offers some creative solutions to the aortic valve replacements volume requirements at a hospital offering TAVR. CMS should be commended for this well considered advancement.

However, there remain some points which were not completely addressed, and should be reconsidered. Most important is the requirement for 300 PCI’s per year. Although it is recognized that this is a decrease from the prior 400/year, this still has the potential from preventing qualified programs from offering to their patients what is soon to be the standard of care for the majority of those with aortic stenosis. It is estimated that ~300 hospitals might be at risk for establishing or maintaining a TAVR program based upon this PCI volume requirement, that is hospitals that do 200-350 PCI’s per year. Currently there are 500-600 hospitals offering TAVR. It is reasonable to believe that over one third of otherwise eligible hospitals will not be able to start or maintain a TAVR program. Precise numbers could undoubtedly be made available to CMS via the ACC database on PCI.

It seems incorrect to be limiting access to care to patients of a standard-of-care treatment based upon a requirement that has no scientific bases of having any impact on the quality of care for that treatment. As was highlighted by many others, there have been papers and discussions regarding the role of AVR volumes on AVR outcomes, but there is no data on PCI volumes and AVR outcomes. Yet that requirement may undermine the ability of one-third of US hospitals in being able to provide the cardiac care their patients should be receiving.

There are 3-4 times more valve surgeries performed in hospitals less than 500 beds in size, than in hospitals over 500 beds in size (California OSHPD data). So cutting out 1/3 of eligible hospitals may have an even greater impact on percentage of patients effected – perhaps over half of patients needing treatment would have to seek it out at a different hospital than they prefer, which is likely to lead to a significant number of patients not receiving their needed and appropriate therapy. All because of a requirement with zero scientific support.

Although this argument means that there is little justification for any threshold number, if CMS is committed to this requirement, it would certainly be less problematic if the number were lower. If the cut-off were below 200 PCI’s per year, it is estimated that would only affect about 50 hospitals, and therefore have much less of an impact on patient access, (while still having zero impact on scientifically studied quality of care for TAVR).

Finally, it is appreciated that the requirements for two surgeons to see the patient is being reduced to one, but it seems at this time unnecessary to mandate that the requirement be specifically a surgeon, since surgical suitability is so much less of an issue. Why not make it that a TAVR operator be required to evaluate the patient? It is notable that the major hurdle for a hospital to achieve is for PCI volume, the work of the interventionalist, whereas the gatekeeper is a surgeon instead of the interventionalist. Perhaps this discrepancy could be better addressed.

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I support continued use of the Heart Team approach with participation by both a Cardiac Surgeon and an Interventional Cardiologist. Both need to be present and participate.

As "low risk" patients are considered for TAVR, I believe greater emphasis should be placed on shared decision making as risks and benefits as well as multiple unknowns play a role in the decision between TAVR & SAVR.

I do not support the ongoing use of the "second surgical opinion" as it is resource heavy and does not add to the care of the patient.

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[PHI Redacted]

[PHI Redacted] I recently had a friend whose father was 90 years old and he was told he needed open heart surgery to replace his aortic valve. Can you imagine? [PHI Redacted] He was ready to do it because he didn’t know of any other options. Luckily, my friend called me and I told her to ask the surgeon about TAVR. He did end up choosing TAVR and this man was only in the hospital for a day or two and released to his daughter’s care for another couple of days. Soon, he returned to his own home and now lives an independent life. Isn’t that what we all want? Quality time and independence for as long as possible? What a different story this could have been if he had just “gone along” with the open heart surgery. I also had [PHI Redacted] who had a TAVR last year. She lives in a small town on the border between Texas and Louisiana and she has other health issues that prevented her from being a good candidate for OHS. But, what was she to do since TAVR is not offered anywhere near her? She came to Houston and she had a successful TAVR procedure. But, after her TAVR, she had a long drive home and a long drive back for follow ups. Why is TAVR not readily available in other areas?

I am also an Accredited Visitor for Mended Hearts and visit heart patients [PHI Redacted]. I see TAVR patients each week without fail because it is a prevalent procedure and nearly everyone I see is in the hospital for a very short time. What a difference I see between the CABG and OHS patients and the TAVR patients! Besides the hospital stay, the TAVR patients have much lower risk for complications post-surgery and immediately feel better with a new valve. When I see patients before they have open heart surgery they are all worried about “not waking up” and when I see patients post-surgery, the question is always, “when will I be normal again?” Well, for the OHS patients the answer is always, “it’s a slow process; it takes time.” The TAVR patients don’t ask me this question, because they get back to normal so much quicker. [PHI Redacted] I was so impressed with the technology and advancement of heart valves, but literally blown away by the change in delivery method for aortic valves. All new heart valves are life-saving, but this procedure is life-altering because it means fear is minimized, hospital stays are shorter, complications fewer, and people can return to quality life so much faster.

[PHI Redacted] TAVR needs to be more widely available. It should be a patient’s decision whether this treatment option is right for them. It should be available in more hospitals and barriers to receiving this treatment should not include items such as the size of a hospital, or if the hospital is in a rural area. And, it should be available as an option to lower risk patients. [PHI Redacted] And, no one should have to run the scenario in their head that their heart won’t restart once the heart-lung machine is switched off. Ask yourself, would you want your mom, your wife, your sister, your daughter to have to undergo OHS if there was a less-invasive option available? [PHI Redacted]

Please consider reducing strict requirements and barriers to this very proven treatment option. Let more hospitals train and offer TAVR. Expand access and watch more people receive treatment. How many people do you think just don’t do anything because fear paralyzes them? How long do they live with AS before their life is taken because they could not find the courage to face OHS? How many are in towns too small to know about TAVR and end up with a life-threatening complication? [PHI Redacted] I urge you to consider expanding the availability of this incredible procedure.

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[PHI Redacted]
I am writing to strongly urge revision in the proposed TAVR coverage documentation: The current focus on Volume of cases a hospital performs - in order to conduct TAVR procedures, should be changed to Quality of the hospitals heart operations. Restrictions on a hospitals status and acceptability to perform TAVR procedures should be revised. Eliminate volume of procedures performed as a rule, to - quality of TAVR procedures performed. TAVR procedures, today, are equal to or better than open heart procedures as far as success and improving quality of the patients lives. Medical science has made tremendous strides in improving heart disease treatment with the TAVR procedure.

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I, my administration, and my heart team believe that the changes to the NCD are primarily positive but do have some comments and recommendations which echo many of my peers and physicians making comments.

1. I would like to propose that TAVR can be done by one operator, either cardiac surgeon or IC, especially given the low incidence of conversion to open heart surgery and need to utilize cardio-pulmonary bypass. Continuing to require both in the room severely limits the time and days available to do the procedures. That being said, I also think this should only apply to trans-femoral approach. Any alternative access approach should require both a surgeon and an IC.


2. To provide a full and accurate assessment for all patients undergoing aortic valve replacement, I propose that we include that all aortic stenosis patients being evaluated for SAVR also have to be seen by a structural heart IC.

This proposed NCD is a very important and large step towards making TAVR more accessible to patients especially in light of the data of the low risk trials that were presented at ACC.19 this year.

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As you are aware, Wyoming is the only state in the country that does not have a TAVR center. We are excited by the fact that the newly proposed regulations are favorable for Wyoming Medical Center (WMC) to open a TAVR center which will become the hub for a structural heart program in our region. The original requirements precluded us from starting a TAVR center at WMC because of the volume requirements for SAVR. The number of aortic valve cases performed at our program were too low to meet the requirements to open a TAVR program even though we met all the other requirements. With the advent of TAVR we saw a further decline in our aortic valve numbers, since many patients in Wyoming that were candidates for TAVR left our state to have procedures done in other states such as Colorado, Montana and Utah. With the excellent results being reported for TAVR, it became apparent that if we did not ramp up our efforts to obtain the volume requirements to start a TAVR program, our entire cardiovascular program would soon be at risk. With the loss of surgical cases it would be difficult to maintain a quality open heart program. This in turn would have a domino effect on the cardiology program, With the loss of cardiac surgery, the cardiologists would be limited in the complexity of interventional cases that could be performed at WMC without surgical back-up, This in turn would affect the care of all the other patients in our region and would have a profound affect on the viability of our hospital and the tertiary care in our region. Due to the long distances involved in transferring our patients out of state for higher level of care, if we were to lose our cardiac program, many patients presenting with acute coronary artery syndromes and STEMIs would suffer and have significantly worse outcomes because of the increased distances and time involved to transfer these patient out of state.

CMS is the steward of medical care in our country for our elderly patients. As part of that responsibility I believe that CMS must ensure that this technology is available to all patients regardless of the area in which they live. This technology should be made available in rural, low volume centers, just as it is available in larger urban areas. The hardships our patients report to us when they travel out of state for these procedures are quite daunting. Many of these patients are frail and very sick, and it is difficult for these patients to travel long distances to larger urban areas. Many of our patients are not experienced enough and as such, are very intimidated by having to navigate around larger medical centers and larger cities. They clearly would be better served in a smaller city and medical center such as ours, as long as we can produce quality results. With that in mind, I am in favor of the proposed volume requirements to start a TAVR center. I am glad that CMS did not adopt the volume requirements proposed in the consensus document, since it would be more difficult for lower volume rural centers such as ours to meet those requirements, which in turn would limit access to those patients living in rural areas such as Wyoming.

I still have concerns about the requirements for maintenance of a TAVR center. At our current rate of SAVRs, and the number of TAVRs that currently migrate out of our state, I believe that we can probably meet those requirements as we move forward with the development of our TAVR program. If I understand correctly, the proposed requirements are that we perform 50 SAVR+TAVR every year or 100 in two years. What will happen to our program if we fail to meet those requirements. Will we then be forced to shut down our program and take away this technology from the good people of Wyoming? Will our patients then be required to travel long distances out of state to receive their care? Given this scenario, I am asking CMS to reconsider this requirement. Perhaps it should be 75 or 80 cases every 2 years as opposed to 50 cases in one year or 100 in two years. The other issue CMS must consider is that the cash outlay and resources required to move forward with a TAVR center are quite substantial. If the proposed volume requirements are not met and CMS then has the right to deny payment to an existing center, what effect will that have on the viability of these smaller, rural institutions if the rug were pulled out from underneath them? How will that then affect the care for those patients that rely on those rural institutions? Keep in mind that not every patient needing TAVR can be treated at a large academic center.

As I look back on the development of new procedures in medicine, I don’t recall such a huge emphasis on the number of procedures one had to do to be certified to perform that procedure. In my own experience I have introduced several new procedures into my practice over the last 20 years. In those cases, I went to watch someone do the procedure, then had someone proctor me on that procedure for the first one or two cases before I was doing them on my own. I am not saying that is what should be done with TAVR, but I also don’t believe that an individual operator should be required to participate in 100 TAVRs before they are qualified to start a new TAVR center. Everyone draws upon their personal procedural experience when learning how to do new procedures and everyone has a different threshold and comfort level before they are comfortable doing a new procedure. Clearly it is up to each individual operator to define their own level of comfort so as not to injure the patients they are treating. I personally do not believe it is the role of CMS to define the volume requirements for a procedure for board certified practitioners; instead it should be left to the certifying boards and the judgement of the individual board-certified operators to define that criteria.

In closing, I would like to recommend that CMS not increase any of the volume requirements being set forth in the new guidelines but would like CMS to consider reducing the volume requirements for the individual operators. I would also like CMS to consider decreasing the volume requirements for maintenance of a TAVR center as well. Thank you for your consideration of my letter.

Sincerely, Eric Munoz, MD, MBA
Chairman Division of Surgery WMC
Chief of Cardiac Surgery WMC

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Dear members of the CMS panel, I congratulate you for making the effort to revisit the NCD TAVR recommendations from 2012.

As a busy and experienced implanter who has witnessed the spectacular evolution and impact of TAVR in patients with aortic stenosis, it astound me that after many years of robust clinical data with unprecedented clinical outcomes, we continue to restrict access to TAVR; a procedure that has become mainstream, that saves lives, improves quality of life, and reduces hospitalizations.

-Why limit access to TAVR any longer?
-Why risk or ignore the lives of thousands of Americans that die while waiting or simply have no access?
- Why retrains physicians from caring to those in need?
- Why TAVR, and not SAVR or any other major CV procedure?

Perhaps we should shy away from the selfish reasons that protect our interests, and welcome the opulence of TAVR by increasing access to those in need. Perhaps we should focus on promoting and implementing more TAVR programs, through the mandate of robust training to mimic best practices.

I vote strongly in favor for the reduction of any preexisting requirement that facilitates access to TAVR (ie. PCI <300, One Surgeon), and commend a minimal volume threshold of 50 TAVRs per year, along with the establishment of a minimal "Quality Outcome" threshold to maintain TAVR certification.

Respectfully,

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I have carefully read the draft of the NCD and there are three areas of concern.

1) Since there is either equipoise or superiority of TAVR compared to SAVR across all surgical risk subsets in the true spirit of patient centered care and shared decision making, patient preferences should be considered when deciding which form of aortic valve replacement should be offered. This should be clearly stated in the NCD

2) Item number 4 states that the heart teams interventional cardiologist and surgeon must jointly participate in intraoperative technical aspects of the procedure. While this joint effort was critical in the early days of TAVR with first and second generation equipment which was large, awkward and associated with lots of complications, this situation is no longer the case. New generation TAVR technologies are miniaturized and complications are far less common. the role of the two operator mandate is less important now and consumes resources which could be directed elsewhere. I would favor wording more closely aligned with the MitraCLIP NCD which allows for two operators when needed but does not require it. A straight forward transfemoral TAVR may not need two operators but complex TAVR should have two operators working together. I urge CMS to reconsider changing the requirement for the mandatory 62 modifier to an optional one.

3) Volume requirements-The heart team has many moving parts, and a successful TAVR program depends on all the moving parts working well. As such, heart team needs to do enough TAVR procedures to ensure that the components are all working well together. Access to care should not mean access to bad care. There is clear data to support certain volume requirements for operators and programs. One should not just ignore the published data and the opinions of the thought leaders in the field.

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The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure.

TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality. Although nearly 500 TAVR programs exist throughout the United States, in some regions patients have little access or cannot travel to larger cities for their care.

Our hospital, Shannon Medical Center, is an example of a facility that does not meet the current volume requirement to initiate a TAVR program. Shannon is a regional, community based hospital serving an expansive area of 25 counties in West Texas. Due to our remote location, we cover 10% of the land area of Texas that includes only about 1% of the population. We have a historically innovative cardiac program, performing the first cardiac catheterization and first open heart surgery in this region. We average more than 38,000 cardiac patient visits each year. Currently, our heart team performs an average of 20 aortic valve replacement procedures each year, consistently over the last 10 years.

Our hospital was recently named an IBM Watson Health 50 Top Cardiovascular Hospital. This honor ranks hospitals based on outcomes from objective, public data including mortality, complications, length of stay, cost and readmission rates. We are proud to say those we serve in our facility are receiving the same, or better care, here in their hometown as they could receive in a larger, metropolitan area. Our hospital has invested capital for diagnostic and therapeutic modalities to perform these procedures, and our Heart Team has undergone specialized and individualized training to acquire proficiency to perform these procedures successfully. As in many other smaller institutions with a coordinated “heart team” approach, our 2 interventional cardiologists and 2 cardiovascular surgeons are within the same medical practice. They communicate, review films and patient history on a daily basis. Some of the patients are even their best friends or neighbors. Their education, experience, expertise and the facilities would allow safe performance of TAVR. However, these physicians are not allowed to provide this care locally due to “numerical” restrictions.

Expanding the ability for high quality, smaller centers to provide this procedure will enable hospitals like ours to better serve patients and provide this procedure locally to a population who cannot travel 3-4 hours to a larger facility. When someone has a serious or chronic health condition, travel can be very dangerous as well as stressful for the patient and their family. They are also burdened with unnecessary travel expenses in addition to costly time away from work for the individual and their family members.

Expanding availability of this procedure is truly in the best interest of the patient. It is our hope you will implement new parameters to allow the initiation and maintenance of a TAVR program as “lower volume” centers

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1. Surgeon & IC must be present intra-procedure: is un-necessary requirement that delays patient care. TAVR is far more refined, planned, predictable procedure than many other things we do in cath lab or operating room. This is well evidenced by extremely low rate of "conversion to open surgery" in latest clinical trials. While co-participation of IC+surgeon intraprocedurally should be encouraged (case by case basis like MitraClip), mandating both is a waste of important resources and delay in patient care.
2. Only 1 cardiac surgery opinion needed. Welcome change but once again does not make sense. TAVR is equal and now even superior to SAVR in some cases. It should be the other way round: mandate that no SAVR (for aortic stenosis) can be done without evaluation by an Interventional Cardiologist who does TAVR. This is the only way we can make sure, patients are offered information on both procedures (specially the one that has lower mortality and lower stroke).

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I am writing this memo to comment on the CMS proposed decision memo for Transcatheter Aortic Valve Replacement (CAG-00430R). First, I would like to applaud those at CMS involved in drafting this updated National Coverage Decision for TAVR. This work represents an important update to the prior NCD, especially in the face of the significantly expanded indications for TAVR that have come to fruition since the original NCD was published many years ago.

That being, said, I have some concerns with regard to the proposed volume requirements that have been recommended both for qualifications to begin a TAVR program as well as for requirements to maintain a TAVR program. As the medical director of a TAVR program at a moderate volume TAVR center (< 100 combined TAVR + SAVR’s per year), my concern lies in the following: I feel that while the recommended qualifications to begin a TAVR program for heart teams without TAVR experience have been significantly relaxed, the recommended volume requirements for maintaining TAVR programs has been significantly increased. This seems counterintuitive to me – in my interpretation of this, it would now be easier to BEGIN a program, but more challenging to MAINTAIN that program. While I feel that requiring a center to perform 50 SAVR procedures in a 12-month span (per the prior NCD) is not realistic in today’s day and age of expanded indications for transcatheter valve therapy, I also feel as though relaxing the requirement to a total of 50 (nonspecific) open heart surgeries in the prior year, with only 20 aortic valve related procedures in the prior TWO years is incredibly lenient. Conversely, increasing the number of AVR procedures that need to be performed by an established TAVR program from 20 TAVR’s to a total of 50 AVRs (TAVR or SAVR) of which at least 20 need to be TAVR’s, while understandable and acceptable on its own, seems overly stringent relative to the relaxed indications for starting a TAVR program.

As an experienced structural heart interventionalist who has been performing TAVR procedures since 2009 and currently serves patients from both urban and rural areas, I am fully supportive of the approach of making a life-saving technology such as TAVR more readily available to patients from an access perspective. My inherent concern with the approach taken in the proposed NCD, however, lies in the fact that the new proposed volume requirements would make it significantly easier for a program to begin, but because the requirements for maintaining a program are increased, the likelihood of new programs starting and then subsequently shutting down after a year or two because the volume cannot be maintained potentially increases. In addition, because there is the very real potential (as significantly more programs establish themselves) of diluting procedural volumes across the spectrum, the likelihood of experienced TAVR programs shutting down due to diluted volumes also increases. I think that we can all agree that neither of these potential outcomes aligns with the goals of increasing patient access to TAVR while simultaneously maintaining quality clinical outcomes.

I would therefore propose that one (or both) of the following changes to the proposed decision memo be considered: 1) increase the volume qualifications to begin a TAVR program for hospitals without TAVR experience (for example, increase the number of AVR’s that need to be done in a 12 month period), and/or 2) decrease the volume requirements for existing TAVR programs to maintain their accreditation (for example, decrease the total number of AVR’s to 40, of which 20 need to be TAVR procedures in the prior year, or 80 and 40 in the prior two years).

Thank you for your consideration of these comments on the proposed NCD for TAVR. If you have any questions, please do not hesitate to reach out to me directly.

Sincerely,

Michael S. Kim, MD, FACC, FSCAI
Medical Director, Structural Heart & Valve Disease Program
Cardiovascular Institute of North Colorado
Banner Health
Greeley, CO
Michael.Kim@bannerhealth.com

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Working for an organization that provides care for the undeserved population, I strongly believe that limiting TAVR access to high volume centers would negatively impact these patients. From personal experience, if we have had to refer to a high volume center, there has been a delay in access to care and patients have decompensated.

It is unfair to patients who receive care at facility that is properly qualified to perform TAVR and has excellent outcome data to be sent to another facility solely based on volume requirements.

If a benchmark should be used, it should be based on outcomes not volume.

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On behalf of our structural heart team, at a community hospital in Southern California, we find the required proposed NCD requirements a fair determination. We feel the cumulative volume requirements (SAVR and TAVR) are achievable by academic centers and community hospitals alike, without jeopardizing patient safety or closing a majority of 'low volume' quality TAVR programs across the country. We also feel there should be a stronger emphasis on engaging the heart team on outcomes, and helping each member understand the purpose of the TVT registry, and how we can use it to our advantage in improving patient outcomes and processes. We think this is the cornerstone of a successful program, more so than volume requirements.

Secondly, we feel that one CT surgeon consultation prior to TAVR, is sufficient and more efficient than the current requirements. Arranging for 2 consults delays the TAVR procedure (which evidence shows can add to mortality), and overall does not add value. Furthermore, in light of the new evidence presented on low risk patients at ACC 2019, this can be considered a moot point since the vast majority of patients will not elect invasive heart surgery when minimally invasive strategy for AVR is available to them, regardless of what a CT surgeon says.

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1. In addition to one cardiac surgeon, I propose to also include one interventional cardiologist to independently examine the patient face-to-face, evaluate the patient's suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy, and to document the rationale for the clinical judgment, and the rationale is available to the heart team.
2. I propose that CMS should pay for a permanent pacemaker procedure post TAVR, if required, as it is a complication that is not under the TAVR operators' control and can happen with or without anticipation.

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We have many patients that travel hours to come for evaluation for TAVR in our clinic. Many of them wait hours in our clinic waiting for their second CT surgeon opinion to save themselves another drive to our facility. We have a lot of trust in our entire heart team and open communication between all members (interventional cardiologists and cardiothoracic surgeons) and dialogue regarding the best option for our patients. At our facility, as I am sure as is similar to many others, the second opinion is simply redundant and not in the patient's best interest.

In addition, our clinic appears "booked" when patients are sitting and waiting in our rooms and we are unable to fill to our capacity. We have a lot of volume but are at times hindered in getting patients in as quickly as we (or our referring physicians) would like or are able to accomodate. So from a financial and volume perspective, the second opinion can be a hindrance to throughput in our clinic.

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To whom it may concern:

As a practicing structural interventional cardiologist in a growing southern Arizona retirement community, we see many cases of aortic valves stenosis that is severe in an aging population. Our work up times for our TAVRs has been as high as six weeks. Which is unacceptable. The patient can have an open SAVR within a few days at the hospital with a Cardiothoracic surgeon whom, we all must point out, is not required to have a structural interventional cardiologist see the patient prior to SAVR. I have never seen nor heard of in ANY other modern medical field where another doctor from another special is required to see and/or participate in the procedure such as what we see in present day TAVR procedures. This may have been appropriate early on in the birth of transcatheter valve therapy; however the time has come to relax some of the strict team requirements. This has been a huge burden to our work up and through-put process in our Cath Lab.

As many others have proposed, I will also continue the proposal that TAVR could be performed by a single operator: EITHER a Structural interventional cardiologist OR cardiothoracic surgeon. They both should not be required in the procedure. When both are required in the procedure, it limits the days and times available to do the procedure. This also creates conflict with scheduling and increases the TAVR work up even longer. I believe that it is very appropriate to only have ONE surgeon see the patient in the pre-work up. This will save on fewer office visitation and consults for the patients and a shorter work up.

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The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure. TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality. Although nearly 500 TAVR programs exist throughout the United States, in some regions patients have little access or cannot travel to larger cities for their care.

Our hospital, Shannon Medical Center, is an example of a facility that does not meet the current volume requirement to initiate a TAVR program. Shannon is a regional, community based hospital serving an expansive area of 25 counties in West Texas. Due to our remote location, we cover 10% of the land area of Texas that includes only about 1% of the population. We have a historically innovative cardiac program, performing the first cardiac catheterization and first open heart surgery in this region. We average more than 38,000 cardiac patient visits each year. Currently, our heart team performs an average of 20 aortic valve replacement procedures each year, consistently over the last 10 years.

Our hospital was recently named an IBM Watson Health 50 Top Cardiovascular Hospital. This honor ranks hospitals based on outcomes from objective, public data including mortality, complications, length of stay, cost and readmission rates. We are proud to say those we serve in our facility are receiving the same, or better care, here in their hometown as they could receive in a larger, metropolitan area. Our hospital has invested capital for diagnostic and therapeutic modalities to perform these procedures, and our Heart Team has undergone specialized and individualized training to acquire proficiency to perform these procedures successfully. As in many other smaller institutions with a coordinated “heart team” approach, our 2 interventional cardiologists and 2 cardiovascular surgeons are within the same medical practice. They communicate, review films and patient history on a daily basis. Some of the patients are even their best friends or neighbors. Their education, experience, expertise and the facilities would allow safe performance of TAVR. However, these physicians are not allowed to provide this care locally due to “numerical” restrictions.

Expanding the ability for high quality, smaller centers to provide this procedure will enable hospitals like ours to better serve patients and provide this procedure locally to a population who cannot travel 3-4 hours to a larger facility. When someone has a serious or chronic health condition, travel can be very dangerous as well as stressful for the patient and their family. They are also burdened with unnecessary travel expenses in addition to costly time away from work for the individual and their family members. Expanding availability of this procedure is truly in the best interest of the patient. It is our hope you will implement new parameters to allow the initiation and maintenance of a TAVR program as “lower volume” centers.

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The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure.
TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality. Although nearly 500 TAVR programs exist throughout the United States, in some regions patients have little access or cannot travel to larger cities for their care.

Our hospital, Shannon Medical Center, is an example of a facility that does not meet the current volume requirement to initiate a TAVR program. Shannon is a regional, community based hospital serving an expansive area of 25 counties in West Texas. Due to our remote location, we cover 10% of the land area of Texas that includes only about 1% of the population. We have a historically innovative cardiac program, performing the first cardiac catheterization and first open heart surgery in this region. We average more than 38,000 cardiac patient visits each year. Currently, our heart team performs an average of 20 aortic valve replacement procedures each year, consistently over the last 10 years.

Our hospital was recently named an IBM Watson Health 50 Top Cardiovascular Hospital. This honor ranks hospitals based on outcomes from objective, public data including mortality, complications, length of stay, cost and readmission rates. We are proud to say those we serve in our facility are receiving the same, or better care, here in their hometown as they could receive in a larger, metropolitan area. Our hospital has invested capital for diagnostic and therapeutic modalities to perform these procedures, and our Heart Team has undergone specialized and individualized training to acquire proficiency to perform these procedures successfully. As in many other smaller institutions with a coordinated “heart team” approach, our 2 interventional cardiologists and 2 cardiovascular surgeons are within the same medical practice. They communicate, review films and patient history on a daily basis. Some of the patients are even their best friends or neighbors. Their education, experience, expertise and the facilities would allow safe performance of TAVR. However, these physicians are not allowed to provide this care locally due to “numerical” restrictions.

Expanding the ability for high quality, smaller centers to provide this procedure will enable hospitals like ours to better serve patients and provide this procedure locally to a population who cannot travel 3-4 hours to a larger facility. When someone has a serious or chronic health condition, travel can be very dangerous as well as stressful for the patient and their family. They are also burdened with unnecessary travel expenses in addition to costly time away from work for the individual and their family members.
Expanding availability of this procedure is truly in the best interest of the patient. It is our hope you will implement new parameters to allow the initiation and maintenance of a TAVR program as “lower volume” centers.

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The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure.
TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality. Although nearly 500 TAVR programs exist throughout the United States, in some regions patients have little access or cannot travel to larger cities for their care.

Our hospital, Shannon Medical Center, is an example of a facility that does not meet the current volume requirement to initiate a TAVR program. Shannon is a regional, community based hospital serving an expansive area of 25 counties in West Texas. Due to our remote location, we cover 10% of the land area of Texas that includes only about 1% of the population. We have a historically innovative cardiac program, performing the first cardiac catheterization and first open heart surgery in this region. We average more than 38,000 cardiac patient visits each year. Currently, our heart team performs an average of 20 aortic valve replacement procedures each year, consistently over the last 10 years.

Our hospital was recently named an IBM Watson Health 50 Top Cardiovascular Hospital. This honor ranks hospitals based on outcomes from objective, public data including mortality, complications, length of stay, cost and readmission rates. We are proud to say those we serve in our facility are receiving the same, or better care, here in their hometown as they could receive in a larger, metropolitan area. Our hospital has invested capital for diagnostic and therapeutic modalities to perform these procedures, and our Heart Team has undergone specialized and individualized training to acquire proficiency to perform these procedures successfully. As in many other smaller institutions with a coordinated “heart team” approach, our 2 interventional cardiologists and 2 cardiovascular surgeons are within the same medical practice. They communicate, review films and patient history on a daily basis. Some of the patients are even their best friends or neighbors. Their education, experience, expertise and the facilities would allow safe performance of TAVR. However, these physicians are not allowed to provide this care locally due to “numerical” restrictions.

Expanding the ability for high quality, smaller centers to provide this procedure will enable hospitals like ours to better serve patients and provide this procedure locally to a population who cannot travel 3-4 hours to a larger facility. When someone has a serious or chronic health condition, travel can be very dangerous as well as stressful for the patient and their family. They are also burdened with unnecessary travel expenses in addition to costly time away from work for the individual and their family members.
Expanding availability of this procedure is truly in the best interest of the patient. It is our hope you will implement new parameters to allow the initiation and maintenance of a TAVR program as “lower volume” centers.

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The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure.
TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality. Although nearly 500 TAVR programs exist throughout the United States, in some regions patients have little access or cannot travel to larger cities for their care.

Our hospital, Shannon Medical Center, is an example of a facility that does not meet the current volume requirement to initiate a TAVR program. Shannon is a regional, community based hospital serving an expansive area of 25 counties in West Texas. Due to our remote location, we cover 10% of the land area of Texas that includes only about 1% of the population. We have a historically innovative cardiac program, performing the first cardiac catheterization and first open heart surgery in this region. We average more than 38,000 cardiac patient visits each year. Currently, our heart team performs an average of 20 aortic valve replacement procedures each year, consistently over the last 10 years.

Our hospital was recently named an IBM Watson Health 50 Top Cardiovascular Hospital. This honor ranks hospitals based on outcomes from objective, public data including mortality, complications, length of stay, cost and readmission rates. We are proud to say those we serve in our facility are receiving the same, or better care, here in their hometown as they could receive in a larger, metropolitan area. Our hospital has invested capital for diagnostic and therapeutic modalities to perform these procedures, and our Heart Team has undergone specialized and individualized training to acquire proficiency to perform these procedures successfully. As in many other smaller institutions with a coordinated “heart team” approach, our 2 interventional cardiologists and 2 cardiovascular surgeons are within the same medical practice. They communicate, review films and patient history on a daily basis. Some of the patients are even their best friends or neighbors. Their education, experience, expertise and the facilities would allow safe performance of TAVR. However, these physicians are not allowed to provide this care locally due to “numerical” restrictions.

Expanding the ability for high quality, smaller centers to provide this procedure will enable hospitals like ours to better serve patients and provide this procedure locally to a population who cannot travel 3-4 hours to a larger facility. When someone has a serious or chronic health condition, travel can be very dangerous as well as stressful for the patient and their family. They are also burdened with unnecessary travel expenses in addition to costly time away from work for the individual and their family members.

Expanding availability of this procedure is truly in the best interest of the patient. It is our hope you will implement new parameters to allow the initiation and maintenance of a TAVR program as “lower volume” centers.

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The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure. TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality. Although nearly 500 TAVR programs exist throughout the United States, in some regions patients have little access or cannot travel to larger cities for their care.

Our hospital, Shannon Medical Center, is an example of a facility that does not meet the current volume requirement to initiate a TAVR program. Shannon is a regional, community based hospital serving an expansive area of 25 counties in West Texas. Due to our remote location, we cover 10% of the land area of Texas that includes only about 1% of the population. We have a historically innovative cardiac program, performing the first cardiac catheterization and first open heart surgery in this region. We average more than 38,000 cardiac patient visits each year. Currently, our heart team performs an average of 20 aortic valve replacement procedures each year, consistently over the last 10 years.

Our hospital was recently named an IBM Watson Health 50 Top Cardiovascular Hospital. This honor ranks hospitals based on outcomes from objective, public data including mortality, complications, length of stay, cost and readmission rates. We are proud to say those we serve in our facility are receiving the same, or better care, here in their hometown as they could receive in a larger, metropolitan area. Our hospital has invested capital for diagnostic and therapeutic modalities to perform these procedures, and our Heart Team has undergone specialized and individualized training to acquire proficiency to perform these procedures successfully. As in many other smaller institutions with a coordinated “heart team” approach, our 2 interventional cardiologists and 2 cardiovascular surgeons are within the same medical practice. They communicate, review films and patient history on a daily basis. Some of the patients are even their best friends or neighbors. Their education, experience, expertise and the facilities would allow safe performance of TAVR. However, these physicians are not allowed to provide this care locally due to “numerical” restrictions.

Expanding the ability for high quality, smaller centers to provide this procedure will enable hospitals like ours to better serve patients and provide this procedure locally to a population who cannot travel 3-4 hours to a larger facility. When someone has a serious or chronic health condition, travel can be very dangerous as well as stressful for the patient and their family. They are also burdened with unnecessary travel expenses in addition to costly time away from work for the individual and their family members.

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The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure.
TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality. Although nearly 500 TAVR programs exist throughout the United States, in some regions patients have little access or cannot travel to larger cities for their care.

Our hospital, Shannon Medical Center, is an example of a facility that does not meet the current volume requirement to initiate a TAVR program. Shannon is a regional, community based hospital serving an expansive area of 25 counties in West Texas. Due to our remote location, we cover 10% of the land area of Texas that includes only about 1% of the population. We have a historically innovative cardiac program, performing the first cardiac catheterization and first open heart surgery in this region. We average more than 38,000 cardiac patient visits each year. Currently, our heart team performs an average of 20 aortic valve replacement procedures each year, consistently over the last 10 years.

Our hospital was recently named an IBM Watson Health 50 Top Cardiovascular Hospital. This honor ranks hospitals based on outcomes from objective, public data including mortality, complications, length of stay, cost and readmission rates. We are proud to say those we serve in our facility are receiving the same, or better care, here in their hometown as they could receive in a larger, metropolitan area. Our hospital has invested capital for diagnostic and therapeutic modalities to perform these procedures, and our Heart Team has undergone specialized and individualized training to acquire proficiency to perform these procedures successfully. As in many other smaller institutions with a coordinated “heart team” approach, our 2 interventional cardiologists and 2 cardiovascular surgeons are within the same medical practice. They communicate, review films and patient history on a daily basis. Some of the patients are even their best friends or neighbors. Their education, experience, expertise and the facilities would allow safe performance of TAVR. However, these physicians are not allowed to provide this care locally due to “numerical” restrictions.

Expanding the ability for high quality, smaller centers to provide this procedure will enable hospitals like ours to better serve patients and provide this procedure locally to a population who cannot travel 3-4 hours to a larger facility. When someone has a serious or chronic health condition, travel can be very dangerous as well as stressful for the patient and their family. They are also burdened with unnecessary travel expenses in addition to costly time away from work for the individual and their family members.

Expanding availability of this procedure is truly in the best interest of the patient. It is our hope you will implement new parameters to allow the initiation and maintenance of a TAVR program as “lower volume” centers.

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1. The data is strongly in favor of TAVR compared to SAVR. The decision as to which procedure should a patient receive should not be only determinant on the CT surgeon evaluation. Rather it has to be a decision by both Interventional Cardiologist and CT Surgeon. The current proposed decision weighs heavily on the CT surgeon evaluation and literally gets the "gatekeeper" status.
2. The TAVR procedure should be allowed to be performed by 1 or 2 Interventional Cardiologist OR 1 interventional Cardiologist and 1 CT surgeon. There is really no additional benefit to have a CT surgeon in the room as they do not always have the skills necessary to perform the procedure. Therefore having both options is really fair when 2 Interventional Cardiologists are performing the procedure. It also frees the CT surgeon. However there need to be a CT surgeon in house when the procedure is being performed. There are several countries which have this system in place.
3. There need to be clarification for fellows who are graduating from 1 year Interventional fellowship and are not primary operators in TAVR procedures. Thus there need to be a standard for these fellows and if the cases the PARTICIPATE in should be counted towards the procedure numbers.

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Comments:

1. The requirement that a “cardiac surgeonhas independently examined the patient face-to-face” defeats the purpose of the Heart Team. Cardiac surgeons should be evaluating patient together WITH the interventionalist, imager and other members of the multi-disciplinary heart team.
2. A cardiac surgeon is not required to perform this procedure (which not infrequently is performed under monitored anesthetic care) thus should not be required to “jointly participate” in a TAVR. However the surgeon should be “on the premises and rapidly available” if needed.
3. The requirements for hospital programs with TAVR experience needs to be amended based on the recent publication in the New England Journal of Medicine (April 3, 2019, DOI: 10.1056/NEJMsa1901109). For these programs, you have not listed an individual operator volume requirement but this article shows that there is a hospital AND operator, inverse volume-mortality relationship. The current proposed Decision Memo uses a low hospital volume requirement of only =20 TAVRs per year which would be associated with higher mortality. The 24.3% risk reduction between the low operator (mean annualized volume of 11 TAVRs/yr) and the high operator (mean annualized volume of 70 TAVRs/yr) suggests operator volume should be added to the requirement. Leveling of the 30d mortality curve appears to occur around 100 TAVR’s/ year for the hospital and for an operator, about 40-50 per year.

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I generally support the changes in the NCD proposed by the CMS, but I would like to emphasize several points for consideration.

1. In the US, the byproduct of TAVR was the new concept of “Heart Team”. This concept is now embedded in the culture of Transcatheter therapies starting from the original TAVR RCTs and the subsequent CMS recommendation. What we learned is that the shared decision making not just with the patients, but also between the cardiac surgeons and the interventional cardiologists led to synergy that ultimately benefited the patients. The heart team will ever be important especially with the low risk approval around the corner. The next step for TAVR is to identify which patients will benefit with SAVR rather than TAVR and this must be done with the discussion within the heart team. We cannot have the pendulum swing all the way to TAVR, like it did with CABG/PCI. This concept should never be sacrificed to accommodate physician’s efficiency nor financial reasons.
2. Additionally, it is imperative to have a surgeon and a interventionalist to perform TAVR together, and not move toward single operator nor a combination of 2 procedurelists. TAVR is one of the only field in structural heart therapy that has conducted multiple RCTs that led to evidence based medicine. We must not forget that in all the trials, the presence of a surgeon and a interventionalist was required. The different knowledge and technical expertise of the two different specialties allowed us to navigate through difficult cases, and has ultimately benefited these patients.
3. The most recent NEJM article showed persistent volume-outcome relationship in TAVR. The mean number of cases in the lower quartile which had the worst outcome was 27 TAVRs/year. The proposed NCD requires =20 TAVRs/yr for maintenance. I propose the minimal requirement to be increased to =30 TAVRs/yr, and should also require some degree of quality control in all centers to accommodate the volume-outcome relationship.

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I am writing on behalf of the Division of Cardiothoracic Surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center.

We have embraced TAVR as an important therapy for patients with severe aortic stenosis and expect TAVR to become an integrated part of every cardiac surgeon’s clinical practice. The Centers for Medicare & Medicaid Services proposed changes to the National Coverage Decision regarding Transcatheter Aortic Valve Replacement (TAVR) are generally well-founded and reasonable changes based on evolving practices and current data. However, certain points warrant careful consideration.

First, it is imperative that 1 surgeon and 1 cardiologist evaluate patients for TAVR specifically in order to provide a balanced, unbiased set of opinions to patients with aortic valve disease. Two surgeon evaluation is not needed, given that risk approval will likely be granted, TAVR has been shown to be safe in the short term, and outcomes in the short-term are outstanding. The removal of two surgeons will speed up the evaluation process with no degradation of quality, and thereby facilitate optimal patient care. The dual specialty evaluation approach prevents unrestricted application of TAVR in anatomies which may be higher risk than surgery and which are currently off-labelled and not full tested (bicuspid valves, severe LVOT calcium, multi-valve disease, aortic valve disease with severe coronary disease).

Second, based on extensive personal experience, we feel it is critical that two implanting operators continue to be mandated for quality purposes. These two operators should not be two surgeons or two cardiologists, but specifically should be a surgeon and cardiologist. Both have integral but different knowledge bases, understanding of anatomy, and technical skills. This team concept has worked exceptionally well in mandated trials, as evidenced by the 6-8 successful randomized controlled trials over the past 8 years in high, intermediate and low risk TAVR. There is no question that these results could not have been achieved without combined support of the two specialties. Likewise, there is compelling evidence from multiple fields of medicine that team-based, patient-centered approaches to complex medical disease are superior to single doctor therapies, removes treatment and selection biases, and facilitate shared decision making with our patients. Removing this mandate risks creating a complex situation that would jeopardize patient care for no obvious benefit. In fact, it is likely that the real-world situation would eventually resemble the excesses and inappropriate uses which emerged in the unregulated PCI-CABG scenario– which has required joint society intervention to prevent inappropriate use and suboptimal patient care. The collaborative heart team approach works extremely well and should be extended to all valve procedure evaluation and implantation: transcatheter valve replacement and repair for the aortic, mitral and tricuspid valves.

Third, the volume requirement changes are reasonable and reflect declining volumes of both PCI and SAVR. However, a baseline number of TAVR procedures must be performed to maintain competency, and 40 per two years is inadequate. I would propose keeping the volume requirements as they stand, as changes in volume given low-risk data will increase TAVR numbers overall and make low-volume sites busier. Should changes need to be made in 2-3 years, based on data and results, these numbers can then be amended.

Finally, I would propose removing the unnecessary testing of the 5 meter walk test and KCCQ questionaire. These are not used in current clinical SAVR evaluation and were primarily instituted for clinical trial use. Especially as we incorporate more lower risk patients without overt heart failure, these metrics are no longer relevant to shared decision-making. It is our hope that careful consideration of these points will support the continued excellent progress that has been made in caring for patients with valvular heart disease.

Thank you for your consideration.

Isaac George on behalf of the Division of Cardiothoracic Surgery, NewYork-Presbyterian Hospital/Columbia University Medical Center

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We have received with great joy the newly proposed regulations for Transcatheter Aortic Valve Replacement (TAVR) coverage by Centers for Medicare and Medicaid Services (CMS). We find these recommendations appropriate for our unique situation in Casper, WY. From our perspective we strongly advocate that these remain as such in the final version to come.

Wyoming Medical Center is an important referral center situated in the middle of a very large state with a low population density. Wyoming is much the opposite of overpopulated, oversaturated urban communities. It is the only state in the county which does not have a TAVR program.
The patients which are in need of TAVR here are currently referred to out of state facilities where they do receive highest level of care provided by best of experts. However we, their referring cardiologists, are often told afterwards that they wish this could be done in Casper so that they would not have to go through so much hardship. These patients are mostly in their 80’s, being sick and fragile, having to drive for 4-7 hours during very bad weather conditions (strong winds, ice, snow, wildlife crossing etc) which predominate during the calendar year in Wyoming. Some patients had car accidents while driving to get their care in locations very remote to them. Other patients preferred to not receive such care and to rather die at home or at their ranch. With advancements in technique and as demonstrated by recent research, even more patients should and will get TAVR in the near future. Thus the number of persons upon which such burden will fall will increase if our medical center cannot provide this service.
We have not been able to open a TAVR program here yet as we found that both the national coverage decision (NCD) issued 2012 and the societal document issued 7/2018 were restrictive relative to our lower volume situation.

Not opening a structural heart program here will make us clearly unable to offer appropriate care for our patients. But we are afraid that cardiac care will get even worse. As the need of TAVR will increase, need of cardiac surgery will decrease. We will likely lose our cardiac surgical program. This will then lead to a decline in complexity of interventional coronary procedures which we are able to provide here, besides other consequences. All this will much diminish the cardiac care we can provide altogether. We will not even be able to continue providing what we are offering now. Much more transfers of care to remote locations will follow.
This should not happen in an important referral facility which serves a large part of our state. Such a facility should constantly evolve, bring new technologies and not decline.

The new CMS decision, however will allow us to start a structural interventional program and to bring appropriate care to our state.
As we continue to train in TAVR and as we improve our understanding in this field we find that when judiciously and appropriately done, this technique can be well performed in our situation with provision of good quality of care for our population.
We do feel that our cause was understood and is supported.
Again, from our perspective we strongly advocate that these new recommendations remain as such in the final version.

Sincerely,
Adrian Fluture, MD, FACC, FSCAI
Director Regional Cardiac Care, Wyoming Medical Center
Director Cardiac Catheterization Laboratory, Wyoming Medical Center
Wyoming Cardiopulmonary Services, PC

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RESPONSE TO THE PROPOSED DECISION MEMO FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) (CAG-00430R)

Peter Pelikan, MD, FACC, FSCAI
April 1, 2019

The Proposed Decision Memo for the TAVR National Coverage Decision (NCD) was published on March 26, 2019. Following my request to the CMS Coverage and Analysis Group (CAG) to reconsider the TAVR NCD, there was a full day meeting at CMS in July, 2018, during which various parties expressed opinions on how the NCD should be revised, and even whether an NCD was still needed. Now, after eight months of deliberation, the CAG has proposed changes to the NCD, some of which will improve hospital’s ability to perform TAVR, but which overall remain based on procedural volume and not hospital quality. If this proposal is approved, then many high quality hospitals will be unable to provide TAVR to their patients in need.

An NCD should assure that care of the covered procedure is delivered with the highest quality, best outcomes, and highest patient safety. The need for an NCD is understandable for a new and high-risk procedure, when physician operators and hospitals are just learning and a knowledge base is being developed. For an established procedure, with excellent safety and outcomes, an NCD no longer should be necessary to assure quality.

If an NCD is to be left in place, then it should, by its requirements, achieve the goals of safety and excellent outcomes.

The initial NCD used hospital procedure volumes (e.g., open heart surgery, cardiac catheterization, coronary stenting) as a surrogate to assure quality in the performance of TAVR. In my submission to the CAG, I clearly showed that the relationship between quality and volume of an individual procedure is either nonexistent, or tenuous, at best. Furthermore, and most importantly, the relationship between non-TAVR procedure volumes and TAVR quality outcomes is absolutely non-existent. The learning curve for TAVR operators which was present years ago is no longer present. This is because the newer devices are safer, and the sharing of knowledge, through training programs, literature, research publications, and proctoring have produced a group of TAVR operators who are skillful and safe.

Despite the above, the TAVR revision still proposes to use volume as a surrogate for quality, and, in fact, does not require any minimum TAVR quality of the performing TAVR operator or hospital program.

The NCD revision does propose adequate training for the TAVR operator, requiring 100 career structural heart cases or 30 left-sided heart cases per year. Given that this will likely establish the operator as safe and effective, what additional benefit is there to requiring minimum hospital procedure volumes?

The most glaring example is the requirement that the hospital program maintain a minimum of 300 coronary stent cases (Percutaneous Coronary Intervention, PCI) per year. This raises multiple problems and issues:

1. No correlation between PCI volume and TAVR quality has ever been demonstrated.
2. The AHA/ACC/SCAI Consensus Document of 2013 for PCI stated that PCI, even 6 years ago, had become safe, and that a volume/quality relationship was difficult to discern. There was a possible volume quality signal for PCI at 200, not 300, cases per year, but in no way described a correlation between PCI volume and TAVR quality. No logical process could arrive at a requirement of 300 PCI/year to maintain a TAVR program.
3. PCI volume is dropping, as more research has provided understanding that medical therapy for coronary disease is frequently better than PCI.
4. The proposed volume requirement will not assure TAVR quality, and will also put undue pressure on programs to maintain PCI volume: the potential for patient care decisions being inappropriately influenced to maintain volume by this requirement cannot be underestimated.

The CAG must reconsider the proposed TAVR NCD changes. Require quality, not minimum procedural volumes which have no proven bearing on TAVR quality. Do not place undue pressure on physicians and hospitals to maintain procedure volumes which could affect adversely affect decision making in care delivery.

Multiple trials were just presented at the recent ACC Meeting in March, 2019, showing that TAVR in low risk patients has better outcomes and is safer than open heart surgery. Now that TAVR will ultimately no longer be restricted to intermediate and high-risk patients, TAVR volume will mushroom. Patient wait times will increase, which has been shown to only provide risk for the patients with delayed procedures. Patient access, especially for the indigent and needy, will be worse than it currently is. (As presented in July, 2018, for example: 3% of TAVRs are performed in African Americans, while 13% of the population is African American—a clear cut access issue).

In California, for example the OSHPD data ) base suggests that in 2017, 344 of about 380 (90%) of California hospitals perform less than 300 PCIs/year, and thus would not be able to provide TAVR to their patients. This includes prominent county and teaching hospitals, who likely take a higher percentage of poor and needy patients. (file:///C:/Users/ppeli/Downloads/volume_final_2017_formatted.pdf)

The proposed TAVR NCD still restricts hospitals from developing and providing therapy for their patients. Consider a hospital, high in quality, performing 200 PCIs/year, who recruits or has a high-quality proven TAVR operator on staff. They will not be able to provide high-quality TAVR, since they do not meet the minimum PCI volume of 300 cases/year. They will not be able to respond to developing needs of their community patients. Or, consider a TAVR program of high quality, whose PCI volume drops from 330 cases/year down to 275. Does this mean that their TAVR quality has dropped and the program should be closed? Since there is no correlation of TAVR quality and PCI volume, I say no.

In conclusion:

1. Is a TAVR NCD necessary, now that the procedure is safe, streamlined, and disseminated to multiple physician operators? I argue it is no longer needed.
2. If, for some reason, it is deemed better to have an NCD, I urge the CAG to abandon 20th century concepts that volume confers quality. Instead, require that the operator and hospital perform high quality TAVR, safely and with excellent outcomes.
3. If a PCI volume threshold must be maintained, although logically and medically unsupported, the data suggesting a possible quality signal at 200 cases/year should be followed, not 300 cases/year.

Respectfully,

Peter Pelikan MD, FACC, FSCAI
Medical Director, Coronary and Structural Heart Intervention
Pacific Heart Institute
Santa Monica, California

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Dear NCD:

The proposed introduced is overall very strong and incorporates reasonable changes based on changing practices and current data.

First, it is imperative that 1 surgeon and 1 cardiologist evaluate patients for TAVR specifically in order to provide a balanced, unbiased set of opinions to patients with aortic valve disease. Two surgeon evaluation is not needed, given that risk approval will likely be granted, TAVR has been shown to be safe in the short term, and outcomes in the short-term are outstanding. The removal of two surgeons will speed up the evaluation process with no degradation of quality.

This prevents unrestricted application of TAVR in anatomies which may be higher risk than surgery and which are currently off-labelled and untested (bicuspid valves, severe LVOT calcium, multi-valve disease, aortic valve disease with severe coronary disease).

It is critical that two operators continue to be mandated for quality purposes. These two operators should not be two surgeons or two cardiologists, but specifically should be a surgeon and cardiologist. Both have integral but different knowledge bases, understanding of anatomy, and technical skills. This team concept has worked exceptionally well in mandated trials, as evidenced by the 6-8 RCT over the past 8 years in high, intermediate and low risk TAVR. There is no question that these results could not have been achieved without combined support of the two specialties. Likewise, there is good evidence that team based approaches to complex medical disease is superior to single doctor therapies, removes treatment and selection biases, and informs patients better. Removing this mandate will create a complex situation that jeopardizes patient care for no obvious benefit. In fact, it is likely that the real-world situation would eventually resemble the current PCI-CABG scenario which is currently faced – which required high-level intervention to prevent inappropriate treatment practices. The team concept works very well and should be extended to all valve procedures: transcatheter valve replacement and repair for the aortic, mitral and tricuspid valves.

The volume requirement changes are reasonable and reflect declining volumes of both PCI and SAVR. However, a baseline number of TAVR must be performed to maintain competency, and 40 per two years is inadequate. I would propose keeping the volume requirements as they stand, as changes in volume given low-risk data will increase TAVR numbers overall and make low-volume sites busier. Should changes need to be made in 2-3 years, these numbers can be amended.

Finally, I would propose removing the unnecessary testing of the 5 minute walk and KCCQ. These are not used in SAVR evaluation and were primarily for clinical trial use. Esp in lower risk patients without overt heart failure, these metrics are not relevant to decision making any longer.

Thank you for your consideration.

Isaac George

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Comanche County Memorial Hospital is located in Southwest Oklahoma. It has the only program with advanced cardiovascular services. We cover an area extending from North West Texas border to Ardmore, Chickasha, Carnegie, Hollis, Mangum and all the cities in between with the 2 biggest ones being Altus and Duncan. We do over 300 PCI a year and over 1000 diagnostic angiograms. We do an excess of 200 peripheral intervention a year. We have two cardiovascular surgeons with extensive experience in coronary bypass as well as valvular surgeries and thoracic and abdominal vascular surgeries as well. Prior to 2016, we were doing in excess of 50 valves a year. Over the last 3-4 years, the number of valve surgeries is dropping. We are seeing a significant valve migration to programs that offer TAVR. in addition, we are unable to offer TAVR to our patients since we are unable ANYMORE to meet the numbers criteria. We do advanced peripheral interventions in addition to percutaneous thoracic and abdominal aortic procedures.

The new CMS proposal is crucial to the survival of well established and strong rural programs which have not been able to meet the previous number criteria. The patients and her families will end up paying the price for this. When we referred them to other programs, it is usually 70-200 miles distance. Two of our physicians have traveled before with their patients to perform TAVR at other institutions.This is not feasible on the long run. The current CMS proposal not only will ensure that well established cardiovascular programs can continue to advance and offer their patients new technologies, but will also safeguard the care and the wellbeing of these patients in their local communities and local hospitals.

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I completely agree with the current CMS proposal.
I strongly support the decision to restrict surgical evaluation for TAVR to only one surgeon. I would like to propose that we should also mandate an interventional cardiologist evaluation for SAVR.
I would also propose to allow an interventional cardiologist to perform TAVR without surgeon in the room considering low procedural mortality in this group based on randomized trials and TVT registry. We are already performing high risk PCIs without surgeon in the room (these PCIs have higher procedural mortality compared to TAVR).

Thanks
Syed Shumile Zaidi, MD, FACC,FSCAI

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I would suggest adding the same criteria for SAVR that all the patients suffering from severe aortic stenosis need to be seen by an interventional cardiologist in a face-to-face consultation, an independant examination and evaluation for best possible therapetic modality such as medical management, TAVR or SAVR with their rationale documented and available to the Heart Team.

I am not sure with such an overwhelming data in favor of TAVR why do the patients still need to see both an interventional cardiologist and a cardiac surgeon any more.

I would also request that CMS to seriously consider adding the indication for the Low Risk patients to be able to be treated with and have an option of TAVR available to them given the favorable data presented recently at the American College of Cardiology Conference in New Orleans.

Thank you.

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The new Decision Memo is an improvement but I suggest two considerations:

1) Add: FOR PATIENTS RECEIVING SAVR, ONE INTERVENTIONAL CARDIOLOGIST has independently examined the patient face-to-face, evaluated the patient's suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy, and has documented the rationale for their clinical judgment, and the rationale is available to the heart team.

2) Physician scheduling is a huge challenge for busy TAVR programs. MANY patients sit in the hospital for many extra days or wait weeks at home for the availability of both a surgeon and an interventional cardiologist. What is the rationale for requiring both a surgeon and interventional cardiologist to jointly participate in the intra-operative technical aspects of TAVR? The requirement should be for a well-trained, experienced physician, either surgeon or interventional cardiologist, to perform the procedure. Requiring both an interventional cardiologist and a surgeon is redundant, and vastly increases costs due to a) the increased cost of hospitalization due to patients waiting for both physicians to be available and b) two physician fees instead of one.

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We are a new TAVR program as of Jan 2019 based at a 269-bed community hospital located in a semi-rural region. Our team fully supports the proposed decision memo for TAVR. The proposed TAVR+SAVR and TAVR volume thresholds are realistic and appropriate for our setting. The requirement that one cardiac surgeon, rather than two, must evaluate suitability for TAVR is logical and help streamline the screening process.

Our team fully supports the ACC recommendation that TAVR be made available as a Medicare-covered option for low-surgical risk patients, based on the 2 successful low-risk trials presented at the 2019 ACC Scientific Session.

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