View Public Comments for Transcatheter Aortic Valve Replacement (TAVR)

October 28,2011

Louis Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Blvd.
Mail stop: C1-09-06
Baltimore, MD 21244

RE: National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-0043 ON)

Dear Dr. Jacques:

On behalf of Medtronic, Inc., I am pleased to submit comments to the Centers for Medicare & Medicaid Services (CMS) on the initiation of a national coverage analysis on trans catheter aortic valve replacement (TAVR). Medtronic is one of the world's leading medical technology companies, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to the continual research and development necessary to produce high-quality products and to support innovative therapies that improve patients' health outcomes.

As the manufacturer of the CoreValve® percutaneous aortic valve, we appreciate the opportunity to comment on the opening of the national coverage analysis for TAVR. Core Valve received CE marking in May 2007 and is commercially available in the European Union and other countries.^l We are in the process of enrolling for Medtronic's CoreValve U.S. Pivotal Trial (NLM Identifier: NCT01240902) and expect to pursue FDA approval following the anticipated completion of the trial.²

TAVR is an innovative procedure that provides an important treatment option for severe aortic stenosis, especially for older or sicker patients that are considered too high risk for conventional heart valve replacement, which requires open-heart surgery. The innovative role TAVR therapy plays to improve patients' lives makes it critically important to achieve a careful balance in Medicare coverage policy. Medtronic concurs that TAVR is a complex procedure that requires important safeguards to ensure that it is performed on the right Medicare patients by adequately trained providers in appropriate facilities. Medtronic also values the need to ensure that patients who are at the greatest need for this critical procedure have access to the therapy without unnecessary obstacles. We believe the development of a balanced Medicare coverage policy will further our mutual objective of ensuring appropriate access for patients with severe heart valve disease.

To that end, we put forward the following recommendations for the agency's consideration at this time:

1. CMS should provide Medicare coverage for clinically appropriate high-risk and extreme-risk patient populations receiving TAVR.
2. Medicare coverage policy should be flexible to expand for all other indications of TAVR found to be clinically appropriate. We believe the local coverage process provides the most efficient and timely way to respond to clinical and evidentiary advances in TAVR therapy.
3. Potential provider and facility requirements for performing TAVR as a condition of Medicare coverage should be balanced with ensuring equitable patient access and established through a transparent and publicly accountable process.
4. CMS should carefully consider how establishing coverage with evidence development (CED) policies for TAVR will impact all relevant stakeholders, including the provider community and patients.

a. Clinical Need for TAVR

Aortic stenosis (AS) is the most prevalent native valve disease.³ The prevalence of AS increases over time: at the age of 75, 2.5 percent of the general population has at least moderate AS, while 8.1 percent is affected by age 85.⁴ The mortality rate for untreated, symptomatic severe AS is up to 50 to 60 percent at two years in high-risk patients.

Surgical replacement ofthe aortic valve is the only effective treatment for severe AS currently approved in the United States. However, 33 percent of all patients older than 75 years of age with severe AS are declined for surgery as they are considered too high risk for open-heart procedures.⁵ For those subjects ineligible for open-heart surgery, therapeutic options include only the palliative measures of medical therapy or percutaneous aortic valvuloplasty. Percutaneous balloon aortic valvuloplasty has been suggested as an alternative to aortic valve replacement in subjects with AS. However, the high incidence of residual or recurrent stenosis and serious complications has limited the utility of this technique in the elderly.

A more viable long-term solution for high-risk or extreme-risk subjects for AS may be TAVR, which provides the benefit of valve replacement without the associated risks of open-heart surgery. TAVR is an emerging technology that addresses symptomatic severe AS. These patients, if deemed to be non-operative or high-risk, are considered to be optimal candidates for TAVR therapy. Subsequent studies are planned to assess the benefits of TAVR in other populations.

b. Description of the Medtronic Core Valve System

The Medtronic CoreValve System is a porcine pericardial valve mounted onto a self-expanding nitinol frame. The prosthetic valve is implanted with a retrograde approach via the iliofemoral or subclavian artery, as well as a direct aortic approach. The procedure can be performed under general anesthesia or conscious sedation, either percutaneously or with a surgical cut-down.

The frame of the CoreValve System is designed to allow placement within the aortic outflow tract over the native valve on the inflow aspect and distally within the ascending aorta on the outflow aspect. The middle part of the frame is shaped so as to accommodate the functioning leaflets of the prosthetic valve and to avoid interfering with the coronary ostia. The valve leaflets, constructed from single layer porcine pericardium, are sutured to the nitinol frame.

The intravascular Delivery Catheter System (DCS) is an "over the wire" delivery catheter. The delivery catheter is designed around a central tube allowing it to slide over a guidewire. Proximal to the catheter tip is a protective sheath which houses the prosthetic valve in a collapsed position. The proximal end includes a handle, which serves to execute deployment of the when positioned in the patient's aortic annulus. The DCS is 18Fr at the deployment end and the proximal shaft is 12Fr. The 18Fr deployment sheath covers the valve until the sheath retraction controls on the handle are activated to deploy the valve. The catheter handle features both a macro and micro retraction control actuators to facilitate accurate and controlled valve deployment.

c. Key Details on the U.S. IDE CoreValve Trial

The Medtronic CoreValve System is being investigated in two FDA-regulated, multi-site IDE trials, one evaluating patients who have been diagnosed as high risk for aortic valve surgery, and the second evaluating patients who have been deemed as extreme-risk for aortic valve surgery. The clinical sites across the U.S. are identified on www.c1inicaltrials.gov. Both studies began enrolling participants in December 2010. The clinical trials will involve nearly 1,400 patients at 45 sites in the U.S. The estimated study completion date (one year follow-up) is sometime in mid-2013.

Patients who are considered at high surgical risk (> 15% risk of mortality at 30 days) are being randomized one-to-one to either TAVR with CoreValve or to surgical aortic valve replacement (SAVR). The primary endpoint for this trial is freedom from all-cause mortality at 12 months. Secondary endpoints include, but are not limited to, Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)-free survival, NYHA class, quality oflife, hospitalization length of stay, and stroke rates.

Patients who are considered at extreme surgical risk (>50% risk of mortality or irreversible morbidity at 30 days) are being enrolled in a single arm trial comparing TAVR to a historically derived performance goal. The primary endpoint for this trial is freedom from all-cause mortality and major stroke at 12 months. Similar to the high-risk study, secondary endpoints include, but are not limited to, MACCE-free survival, NYHA class, quality oflife, hospitalization length of stay, and stroke rates.

Each of the participating sites underwent a rigorous site qualification evaluation. Sites were required to have the appropriate facilities as well as procedural volumes to support the trial. Designated implanting physicians were required to have technical skill sets and experience in related catheter and surgical procedures. Additionally, sites were required to have high quality clinical trial experience.

Additional details can be found at www.clinicaltrials.govunder IDE NCT01240902.

Please see the Appendix of this letter for specific comments correcting certain descriptive statements in the request letter.

Medtronic strongly believes - and initial study results demonstrate - that TAVR has overall health benefits for high-risk and extreme-risk patients. The patient inclusion criteria in Medtronic's CoreValve U.S. Pivotal Trial are consistent with those described in the STS-ACC request letter. As a point of clarification, the patients enrolled in our IDE clinical trials categorized as "extreme-risk" are consistent with those described in the request letter as "inoperable. "

In Medtronic's IDE clinical trial, for high-risk candidates, one cardiologist and two cardiac surgeons must agree that a patient's co-morbidities result in a: (1) predicted risk that their operative mortality is ≥ 15 percent; and (2) that their predicted operative mortality or serious, irreversible morbidity risk is < 50 percent at 30 days.

For extreme-risk patients in our trial, one cardiologist and two cardiac surgeons must also agree that the patient has co-morbidities that preclude operation, based on the probability of death or irreversible morbidity exceeding the probability of meaningful improvement. And, specifically, that the patient's predicted operative risk of death or serious irreversible morbidity is ≥50 percent at 30 days.

Consistent with STS-ACC's inclusion criteria described in Section B-Nationally Covered Indications -Qfthe request letter, Medtronic strongly believes in the importance of ensuring positive coverage for TAVR for high-risk and extreme-risk Medicare beneficiaries as specified above. Because of this, we believe that Medicare should allow access ofTAVR to clinically appropriate Medicare beneficiaries following the approval ofthese technologies in the U.S. market.

There is promise that TAVR could provide an important clinical benefit beyond the high-risk and extreme-risk patient populations. It is therefore important that Medicare coverage policy for TAVR retain flexibility to respond easily and in a timely fashion to additional patient populations found to benefit from clinical and evidentiary advances in TAVR therapy. Medtronic recommends that coverage of these indications be left to the discretion of local contractors. Medtronic believes the local coverage process allows for flexible evidence-based decision making and enables contractors to use mechanisms that allow access to and diffusion of new technologies without granting unrestricted coverage.

These mechanisms include:

- The ability to implement and revise decisions quickly, if necessary, in response to new clinical evidence.
- The ability to make case-by-case detenninations for individual patients until use merits a fonnal coverage policy.
- The ability to obtain input from contractor advisory committees and local physicians in the development and application of local coverage reviews.
- The ability to allow gradual diffusion from clinical centers to the broader medical community, which reflects the natural development cycle, including the diffusion pattern, of new medical technology.

For an emerging technology like TAVR, the flexibility offered by the local coverage process is vital.

Medtronic also recognizes the need for continued evidence generation on other valuable uses of TAVR. The Category B IDE clinical trial policy is a valuable mechanism for supporting the continued evidence development of promising technologies, like TAVR. Increasing Medicare beneficiaries' opportunities to participate in research studies wi11lead to better evidence to understand the clinical benefits ofTAVR for additional circumstances. If Medicare coverage is not available for research to evaluate the effectiveness ofTAVR in a broader patient population in the context of an FDA-approved Category B IDE clinical trial, then the ability to study these opportunities appropriately will be compromised, and the full promise ofthe technology's benefits to patients may not be realized. Medtronic supports the local coverage process for such Category B IDE clinical trials.

Given the complex nature of the TAVR procedure, Medtronic recognizes the importance of provider and facility requirements. We also believe that it is equally important to develop such requirements publicly in the context of an open dialogue. The STS-ACC request letter states that the provider and facility requirements will be detailed in a consensus document, the draft of which was to be completed by the end of September, 2011. However, the consensus document has yet to be publicly released. CMS should ensure ample opportunity for timely and informed input on these requirements from all relevant stakeholders if the document is to be the basis for requirements in a future NCD.

There are many lessons learned from CMS' decision on left ventricular assist devices (LV AD) as destination therapy. In this case, CMS did not establish permanent facility requirements in its original decision so that it could have sufficient time to develop accreditation standards. By choosing to open a reconsideration of the NCD, CMS was able to establish temporary criteria and work with the public through its NCD process to establish its formal facility criteria.⁶ Indetermining what facility or provider requirements are appropriate for TAVR, it will be important that the agency allow for sufficient input on key issues that are currently outstanding, including: specific volume requirements, criteria for credentialing, the expected length of time to establish a credentialing body, and appropriate members for the credentialing body. This will ensure that the facility and provider criteria strike an appropriate balance of ensuring quality of care, while not limiting patient access

Medtronic is concerned that overly burdensome credentialing and operator requirements may limit available facilities and contribute to the unintended consequence of hindering patient access. In 2007, the agency limited coverage for LV AD as destination therapy by requiring the medical centers that perform the procedure to be certified by the Joint Commission. A 2010 study demonstrated the burden on many community hospitals of establishing a new destination therapy program, as a result of CMS' coverage requirement. Only 79 medical centers in the U.S. were certified for destination therapy as of201O. These centers are located predominantly in the northeastern quadrant of the country.⁷

The request letter specifically states in Section B (2)-Facility Requirements-"to qualify as a regional center, a hospital must have ... minimal volume requirements for the treatment of aortic valve disease" as defined by the yet-to-be released consensus document. This focus on case volume thresholds as a surrogate for procedural expertise is understandable. However, this requirement may disadvantage hospitals in less populous parts of the country that may be challenged in meeting and maintaining pre-specified volume thresholds. CMS recognized this in its 2003 decision on LV AD therapy and stated that facilities that were unable to meet the volume threshold may apply and include a request for an exception based on factors, such as geographic location of the center. Similarly, we recommend that consideration be given to patient accessibility ofTAVR. The need for patients and caregivers to travel the distance to a regional TAVR site should not be prohibitive.

Additionally, several details around operator requirements must be clarified, particularly regarding the multidisciplinary team suggested in the STS-ACC request letter. Medtronic agrees with the need to develop a multidisciplinary team to ensure appropriate use ofTAVR; however, we recommend that the agency offer flexibility for the sites to determine an effective multidisciplinary team at their own discretion. Mandated criteria may likely add an unnecessary burden to facilities and consequently limit patient access.

To that end, we recommend that the site quality qualifications be viewed in totality, rather than establishing specific litmus test requirements, such as an inflexible case volume threshold. By viewing requirements holistically, the agency will help ensure geographically dispersed sites and equitable patient access to TAVR.

In our view, the STS-ACC letter proposes the creation of three separate CED mechanisms. First, it would require enrollment of patients in covered indications into a national registry operated by STS and ACC. Second, it would provide coverage for patients in Category B IDE trials. Third, for a category of off-label patients outside the covered indications, the STS-ACC proposes a CED mechanism for prospective clinical trials or future clinical studies, though these are not required to be IDE studies.

Medtronic is supportive oflong-tenn data collection on patients receiving TAVR in the U.S. We are committed to supporting long-tenn evidence collection and outcomes analysis on TAVR as we strongly believe these efforts are vital to affirming TAVR's effectiveness and understanding additional applications and improvements to the technology going forward.

At the same time, we would express the concern that a coverage registry requirement has the potential to increase provider burden and impede patient access. It is therefore important to ensure that the implementation of a registry advances the common goals of patients, providers, payers, and medical technology companies. To that end, the mission of the registry must be scientifically sound and feasible, without providing undue burden or expense to ensure appropriate patient access to TAVR procedures. To meet this standard the following questions need to be answered before moving forward with the registry requirement:

1. What are the key research questions that the registry is intended to answer?
2. What is the expected duration that patients will be followed in the registry?
3. What are the provider reporting requirements, including ease of data collection and submission?
4. What data elements will be collected by the registry that will facilitate clinical research?
5. How should the evidence be collected to ensure analyses can be done on specific subpopulations?
6. How long will it take to establish the registry?
7. How will registry requirements align with FDA post-market requirements?
8. Who will have access to the data?
9. Who will have ownership ofthe data?
10. Who will fund the registry and the analyses of the data collected?

The answer to each of these questions has important implications for the success and scientific character of the registry and should be considered in an open and transparent manner. For example, without alignment between such a registry and FDA post-marketing requirements, there is a greater chance for duplicative evidence collection efforts. In the absence of a detailed registry proposal, we suggest that the agency take a thoughtful approach when considering a registry as a condition for coverage.

Moreover, in order to ensure that a registry advances the common goals of patients, providers, payers, and medical technology companies, Medtronic recommends establishing a registry steering committee with broad stakeholder representation. The STS-ACC request letter recommends that the TVT registry have a dedicated steering committee including "trial design individuals, surgeons, and interventional cardiologists." While Medtronic agrees with the need for a steering committee, we recommend broadening this committee to include all relevant stakeholders, such as hospitals, professional societies, and medical technology companies that develop the devices used in TAVR.

As the agency considers whether to require enrollment in a registry as a condition of coverage, we believe it is helpful to draw from challenges experienced in the past to improve future efforts. In the case of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), the burden of third parties (e.g., medical technology companies and hospitals) to provide financial support has steadily increased. Established in 2005, the registry was initially funded by the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services (DHHS). However, starting in 2010, the contract renewal requires INTERMACS to become mostly self-funded by 2015. As of April 2011, the registry is now funded 38% by NIH, 38% by hospitals, and 22% by industry.⁸ As a result, each hospital participating in INTERMACS will pay $10,000 per year and industry will pay an increasing rate, starting at $500 per patient enrolled to cover the costs of the registry.⁹ Due to these increasing costs, hospitals may choose to stop participating in the registry, which would ultimately impede Medicare beneficiaries' access to the procedure. As the INTERMACS case demonstrates, establishing a sustainable and fairly distributed funding program is a difficult endeavor that needs to be carefully considered within clearly defined conditions.

Additionally, the NCDR Implantable Cardioverter Defibrillator (ICD) registry provides important lessons on the need to fully vet the details ofthe design and funding of a registry. The ICD registry was made a condition of Medicare coverage for ICDs in 2005 and this requirement is still in place today. While the registry has been successful in aggregating data on ICD implantations, several challenges have been observed in its implementation.

Researchers identified certain data elements that were absent in the original version of the registry, noting that it did not contain ICD firing data, metrics to assess longer follow-up for recording complications that occur after discharge such as infection and lead dislodgement, and long-term survival data. Mayo Clinic clinician Dr. Stephen Hammill noted that the ability of the original ICD Registry to answer coverage questions based on the data collected remained uncertain: "some were skeptical whether data from this registry would ever be useful in refining coverage decisions; with little/no history of using observational data to affect coverage and with no control group, some view using such data to change coverage as unlikely, especially after nearly a half-decade of established use."¹⁰ In April 2010, version 2.0 ofthe registry was launched to meet many of these limitations.

As noted above, Medtronic believes the Category B IDE clinical trial policy is a valuable mechanism for supporting the continued evidence development of promising technologies, like TAVR, and we support the policy.

As CMS contemplates coverage for TAVR, we believe it is important to give special consideration to existing and future FDA-approved Category B IDE clinical trials. Medtronic acknowledges that the TAVR procedures are high-risk services that must be placed through certain facility and operator requirements to ensure proper use and the safety of patients. However, we recommend that CMS exempt future and existing FDA-approved IDE clinical trials from any new facility or operator requirements in an NCD. These trials already have significant safeguards for the facilities and operators included in the study site selection and review. In the case of existing IDE trials, if requirements are retroactively applied, the number of participating providers would surely decrease, disrupting the collection of data and potentially limiting patient access. Any effort to add increased facility or operator requirements for these current trials would have harmful effects on ongoing research.

Further, we recommend that CMS exempt patients with devices implanted as part of a Category B IDE study from any further CED requirements. Any effort to add IDE trials to a registry as part of a Medicare coverage requirement has the potential to harm the scientific integrity of these studies through early reviews or analyses of the data. Furthermore, an exemption of IDE study patients from a registry requirement does not create a public health risk. The FDA is informed of any IDE study via the IDE approval process and is updated on its progress through the submission of mandatory annual reports by the sponsor. In addition, IDE studies commonly utilize a Data Safety Monitoring Board (DSMB) to intermittently review the status of the study; the DSMB can recommend early termination of a study if there are unexpected types or frequency of adverse events.

c. Proposed Section D CED Provisions

While Medtronic agrees that there may be potential clinical value of TAVR for the unique circumstances outlined in Section D of the request letter-National Coverage with Evidence Development (CED)-we believe that the Category B IDE clinical trial policy is a sufficient mechanism for studying the clinical effectiveness ofTAVR in these unique circumstances. We intend to further evaluate the use ofTAVR in other indications through Category B IDE clinical trials in the future.

Medtronic appreciates this opportunity to provide comments to CMS on this national coverage analysis. We appreciate your consideration and are happy to provide further information or assist with any additional questions. Please feel free to contact me at 763.505.8402 or tom.l.armitage@medtronic.com should you have any questions or wish to discuss our comments in further detail.

Sincerely,

1. Melody is not a TAVR device. On pages 6 and 13 of the Supplement, the Medtronic Melody device is erroneously listed as an aortic valve replacement device. The Medtronic Melody device is a trans catheter pulmonic valve. The device is implanted in a congenital heart defect population, which is typically a pediatric or adult population. This population is not typically of Medicare age.
2. On page14 of the Supplement, the Medtronic CoreValve device is erroneously characterized as a bovine pericardial valve. The Medtronic Core Valve device is a porcine pericardial valve.
3. The multiple references to access sites are not characterized consistently in the request letter and may cause confusion. In recognition that anatomic approaches to TAVR may evolve further, we suggest that ifthe agency chooses to move forward with an NCD, it be written to reference: 1) trans arterial access and 2) transapical access, rather than specifying individual vessels.

OctoberXX,2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE:     National Coverage Analysis for Transcatheter Aortic Valve Replacement(CAG-00430N)

Dear Dr. Jacques:

Sanford Health appreciates the opportunity to comment on the opening of a National Coverage Analysis (“NCA”) for Transcatheter Aortic Valve Replacement (“TAVR”) (CAG-00430N). Sanford Health believes that TAVR can improve clinical outcomes and the quality of life for individuals who currently have limited care options and we hope to soon be able to offer this procedure to our patients. 

I.        Sanford Health / Sanford USD Medical Center

With over 19,000 employees, 1.5 million patients served annually, and 199 facilities across five states, Sanford Health, an integrated health system, is the largest, rural not-for-profit health system in the United States. With headquarters in Sioux Falls, South Dakota, the geographic presence of Sanford Health covers over 60,000 square miles in this state as well in North Dakota, Iowa, Nebraska, and Minnesota. The System consists of hospitals, clinics, long-term care facilities, a foundation, clinical research centers and seven basic research centers. Sanford University of South Dakota (“USD”) Medical Center, one of the Sanford Health’s flagship tertiary centers, has over 500 inpatient beds and the Sanford Clinic, a multi-specialty group of over 800 physicians, serves patients in 150 facilities across the region. As the largest employer in both North and South Dakota, Sanford Health has a significant economic impact on the region.

II.       Sanford USD Medical Center

Sanford USD Medical Center has provided nationally-recognized, comprehensive cardiac care since the 1970s. In 2012, Sanford USD Medical Center will enhance its already outstanding cardiac services with the opening of the Sanford Heart Hospital. This 205,000 square foot facility will feature 58 inpatient beds, hybrid operating rooms, catheterization labs, critical care units, cardiovascular testing, and physician offices. The facility will be attached to the USD Medical Center in order to afford patients easy access to other specialty services as needed.

Sanford USD Medical Center has multidisciplinary heart teams (cardiologists, cardiothoracic surgeons and anesthesiologists), including a dedicated heart valve clinic; state-of-the-art facilities and hybrid technology (Siemens Zeego); participation within national registries (Society of Thoracic Surgeons, American College of Cardiology) , and Core Measures); and standardized protocol training physicians.  

III.       The Need for Innovative and Effective Cardiac Care

The reason Sanford USD Medical Center has invested these resources is due to the fact that heart disease is the leading cause of death in the Sanford Health region, with 25 percent of deaths in South Dakota alone attributed to heart disease.^[1] With 10 American Indian Reservations between North and South Dakota, Sanford USD Medical Center also cares for a population that is disproportionately impacted by heart disease. Indian Health Services data from 2011 indicates that the heart disease death rate is higher for American Indians than any other ethnic group. For years, Sanford USD Medical Center has provided high-quality cardiac care with great success. In fact, Sanford Health ranks alongside some of the top cardiology and heart hospitals in the country. By example, both Sanford USD Medical Center and the Cleveland Clinic in Ohio have a heart attack death rate of 14.1 percent.^[2]

IV.      Support for TAVR

Sanford USD Medical Center is supportive of an affirmative national coverage determination (“NCD”) for the TAVR procedure. As the Centers for Medicare and Medicaid Services (“CMS”) is aware, the Placement of Aortic Transcatheter Valves (“PARTNER”) trial decreased the 30-day and one-year death rates for high-risk surgical patients who underwent TAVR.^[3] We acknowledge the CMS concern regarding the stroke and death rates associated with TAVR for inoperable patients, but seek to remind the agency that the 30.7 percent death rate at one-year represents a 20 percentage point decrease from the control group one-year death rate.^[4] In addition, among these inoperable patients, TAVR resulted in significant improvements in their health-related quality of life that were maintained for at least one year.^[5] While CMS is concerned that some facilities may not be able to prevent or ameliorate potential TAVR-related adverse events, the long history at Sanford USD Medical Center of excellent cardiac care and considerable resources and expertise preclude the system from being grouped into such a category.

V.       Volume Requirements

The STS/ACC proposal letter asserted that in order to perform TAVR, a facility must meet yet-to-be-determined volume requirements. In addition to denying access to this promising procedure to individuals in rural regions, imposing a volume requirement incorrectly suggests that volume is the biggest determinant of clinical outcomes. One study printed in the New England Journal of Medicine that examined the relationship between volume and surgical AVR outcomes found no correlation between the two factors^[6]. Multiple other studies suggest that other characteristics such as physician expertise and state-of-the-art facilities play a much greater role in influencing outcomes^[7]. Sanford USD Medical Center’s outstanding dedicated cardiac clinic, first-class physicians, and numerous resources have and will continue to enable Sanford Health to produce excellent clinical outcomes. Essentially, when establishing conditions for coverage, CMS should not use volume-requirements as a threshold but instead consider factors that actually measure physicians’ and facilities’ ability to provide quality care to patients.  

VI.      Unpublished Consensus Document

While Sanford USD Medical Center supports an NCD to cover TAVR, we oppose predicating the ability to provide TAVR on a set of unpublished conditions. In their request letter, STS and ACC recommend that only regional centers of excellence be permitted to offer TAVR. The characteristics of a regional center of excellence, such as physician credentialing and minimum volume requirements, are currently unknown and will not be revealed until a specialty society consensus document is released by STS and ACC.

Sanford USD Medical Center agrees that providers of TAVR should be held to high standards and concurs with many of the specific provider and facility requirements listed in the STS/ACC letter. Sanford USD Medical Center also agrees that a multi-disciplinary team should be utilized during TAVR procedures and currently has the personnel and resources to support such a team.

Sanford USD Medical Center does not believe, however, that hospitals should be forced to acquiesce to a highly-restrictive, and unpublished consensus document. Basing conditions for coverage on unpublished guidelines would hinder the ability of stakeholders and the American public to exercise their right to effectively comment on the NCA process.

Sanford USD Medical Center is concerned that a highly restrictive consensus document could limit the provision of this procedure to large academic medical centers.  Such a document would also create access issues for many Americans. Patients in rural areas already are required to travel long distances to obtain care. Preventing health systems such as Sanford USD Medical Center from meeting the guidelines of participating hospitals that can provide TAVR would increase this distance by hundreds of miles. Furthermore, such an action would impede unjustly the ability of equally-deserving citizens residing in rural regions from obtaining innovative cardiac care.

Sanford USD Medical Center recognizes the value of the government seeking input from professional societies. However, when a society’s recommendations have the full force of law, undue power is afforded to a private organization. The criteria for a regional center of excellence should be transparent and evidence-based. Sanford Health supports a positive NCD for TAVR and implores CMS to prohibit an unpublished document to dictate the conditions for coverage.

VII.     Conclusion

As physician leaders, and practicing Board Certified Interventional Cardiologists and Cardiothoracic Surgeons, we believe that Sanford Health deserves the TAVR valve program and supports a positive coverage decision for both inoperable and high risk surgical patients. Since the 1970’s, Sanford’s comprehensive Heart Program has produced outcomes that consistently meet or exceed the national average. We believe that evidence-based guidelines should shape the conditions for coverage instead of a restrictive, unseen consensus document. 

Once again, we appreciate the opportunity to comment on this NCA. We would be happy to further discuss this issue and provide additional information if desired. 

Sincerely,

/s/
Daniel Blue, M.D.
President, Sanford Clinic
/s/
Charles O’Brien, M.D. 
President, Sanford USD Medical Center    
/s/
Tomasz Stys, M.D. 
Medical Director
Sanford Cardiology Services 
/s/
John Vander Woude, Jr., M.D.
Medical Director
Sanford Cardiothoracic Services

[1] http://www.cdc.gov/chronicdisease/states/pdf/south_dakota.pdf

October 28, 2011

Donald M. Berwick, MD, MPP
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building – Room 445G
200 Independence Avenue SW
Washington, DC 20201

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

Dear Dr. Berwick:

As Chair of the California State Assembly’s Select Committee on Biotechnology, I am writing to express my support for a flexible approach to Medicare coverage of the Transcatheter Aortic Valve Replacement (TAVR) technology. TAVR can provide patients suffering from heart valve disease with a minimally invasive alternative to open-heart surgery. This is an example of the kinds of new technologies that pioneering California companies can create to improve the healthcare system for all Americans.

I have some concerns with the process that Centers for Medicare & Medicaid Services (CMS) took in initiating a National Coverage Analysis on TAVR before it has been approved by the Food & Drug Administration (FDA). I believe that this change in approach to Medicare coverage could create some confusion for this important industry that currently employs 270,000 Californians, and could have a chilling effect on innovations that could help patients.

Nevertheless, I urge CMS to adopt a policy that ensures new technologies that frequently go through rapid innovation cycles can be provided assurance of Medicare coverage as they develop. For example, in this case, the current device being reviewed for approval by FDA has been on the market in Europe for four years and is available in 41 other countries. New iterations of the device are on the near horizon.

Additionally, CMS should be careful not to be too restrictive on how many hospitals would be eligible to provide new technologies such as TAVR to patients. While it is important that hospitals have adequate facilities and training to maximize clinical outcomes, it is usually the purview of state hospital licensing boards to ascertain hospital eligibility for technologies. An overly-restrictive national policy could mean some patients could be denied access based on geographic challenges.

Finally, I encourage CMS not to adopt TAVR patient eligibility criteria that is overly restrictive. It is important that patients and their physicians work together to make an educated decision about the appropriate treatment.

Thank you in advance for taking these comments into account as you develop your policy on TAVR technology.

Sincerely,

October 25, 2011

Louis Jacques, MD, Director
Coverage & Analysis Group, OCSQ
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21224

VIA Electronic Submission

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

Dear Dr. Jacques:

The Society for Cardiovascular Angiography and Interventions (SCAI) is a non-profit professional association with over 4,000 members representing the majority of practicing interventional cardiologists in the United States including those currently performing transcatheter aortic valve replacement (TAVR) procedures. SCAI promotes excellence in invasive and interventional cardiovascular medicine through physician education and representation, and the advancement of quality standards to enhance patient care. SCAI has reviewed CMS’ announcement of plans for a “National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)” and finds the proposal to invoke National Coverage Determination (NCD) for TAVR to be premature and the wrong avenue for addressing the immediate need to ensure Medicare beneficiary access to these life saving procedures. If however the Agency continues to develop a NCD, our recommendations for what that policy should be, follow.

TAVR Technology Rapidly Developing – Supporting LCD Process Over NCD Process
While we are cognizant that the NCD process certainly assures greater uniformity and the opportunity for input by all stakeholders in regards to coverage policy development, by its’ very nature it is, slower and more un-wieldy. We do not believe the NCD process was designed to grant immediate protection to access and coverage. Rather the NCD process is better suited to ensuring uniformity amongst coverage policy with input by all stakeholders when inconsistencies amongst Local Coverage Determinations (LCDs) or disparate positions amongst stakeholders arise. We fear beginning the TAVR NCD process while this technology is rapidly evolving will require CMS to base the initial NCD on limited available information and require numerous reconsideration requests as new scientific literature becomes available. Rather, due to the rapidly developing nature of TAVR technology with immediate need to ensure Medicare beneficiary access to, and coverage for, TAVR, we urge CMS to request that all the local Medicare Administrative Contractors Medical Directors (CMDs) issue Local Coverage Determinations (LCDs) ensuring Medicare beneficiary access to TAVR, as the LCD process specifically grants authority to local CMDs to act immediately in issuing LCDs that grant and expand coverage; protecting Medicare beneficiary access.

For TAVR, we believe there is an immediate need to assure Medicare beneficiary access to these life saving procedures and that this can be best accomplished by the LCD process, which is designed for situations such as that being faced with TAVR where there is rapidly developing supporting scientific evidence. We would wholeheartedly support considering the possible creation of an NCD for TAVR in the future, should the LCD process result in unacceptable variability in regards to Medicare beneficiary coverage and access to TAVR or once the body of literature has matured.

FDA Approval, Coding, Reimbursement and Coverage for TAVR

FDA Approval for TAVR is in Development
There are several devices in development for TAVR. However, possible Food and Drug Administration (FDA) approval is only imminent for the Edwards’ transfemoral approach SAPIEN device. FDA consideration of the Edwards’ transapical approach device is not expected until the first quarter of 2012 with formal approval not possible for several months after that. The Medtronic TAVR device is not expected to obtain an FDA decision until July of 2014. It would not be appropriate for CMS to consider issuing a potentially enduring coverage policy at the national level addressing coverage for a procedure that involves a device for which FDA approval of the device is not imminent, as is the case for the CoreValve TAVR device. This could potentially set enduring coverage policy without appropriate review of the available published literature on the science by the public. But, we certainly do not want to see any delay in patient access and coverage, especially for those TAVR devices for which there is established FDA approval. Hence, an additional reason to favor the LCD process, as local Carrier Medical Directors LCD are empowered to grant immediate expansion of coverage as additional TAVR devices receive FDA approval.

Coding and Reimbursement for TAVR are in Development
As CMS is aware, coding, reimbursement and coverage, while interrelated, are established through separate and distinct processes. Currently TAVR is reported using AMA Category III codes which are carrier priced through direct negotiation between the provider(s) and the local Carrier Medical Director. SCAI is working in concert with the American College of Cardiology (ACC), Society of Thoracic Surgeons (STS), and American Association for Thoracic Surgery (AATS) on the submission of an application to convert the existing Category III codes to Category I codes that would be nationally valued. However, due to the AMA’s established CPT and RUC Panel processes, the earliest that Category I codes will be available is 2013. This requires physicians to work with their local carriers to establish reimbursement rates for these procedures throughout 2012. We do not support any attempt to expedite coding and valuation at the national level for TAVR by circumventing the established AMA CPT and RUC processes. As providers will continue to have to negotiate reimbursement for TAVR throughout 2012 at the carrier level, it makes additional sense to address coverage for these procedures at the local carrier level through the LCD process, as well.

Coverage for TAVR – Immediate Need
Regretfully, several MACs have issued blanket LCDs which deny coverage for all Category III codes outside of a clinical trial or absent a specific policy granting coverage otherwise. As clinical trials for the Edwards devices have concluded, there is an immediate need for several MACs to issue LCDs to ensure continued Medicare beneficiary access and coverage for TAVR. We hope that CMS national will urge all MACs to issue LCDs ensuring immediate protection to access and coverage, as the available science currently supports. We consider such blanket denials of coverage for all procedures with Category III CPT codes to be an abrogation of the carriers duty to make independent decisions regarding medical necessity and appropriateness.

Appropriate Training and Credentialing – Future Need
SCAI concurs with the requesters, ACC and STS’s conclusion that “based on clinical trial data, that the most successful patient outcomes occur when the following criteria are met: the procedure is performed in a specialized heart center and managed using a multidisciplinary team in which each member has appropriate training and credentialing (for which requirements are currently under development), the procedure is performed in a modified conventional cardiac laboratory or hybrid operating room that contains the specialized equipment necessary for the procedure, and the multidisciplinary team uses a planned approach to co-management decision making as well as technical insertion of the device.” Like CMS, SCAI also has concern that the frequency of adverse events could become more frequent if TAVR were to be furnished in settings where the physician and or the facility have limited experience or procedure volume to establish and maintain adequate expertise. SCAI is actively working with ACC, STS and AATS to develop a clinical competency document clearly delineating what “appropriate training and credentialing” for TAVR will be. As soon as these recommendations become available, they could be quickly incorporated into any existing LCDs with only a 30-day public comment period required.

Registry Reporting – Future Need
Additionally, SCAI is also supportive of the creation of a registry and the requirement to participate in a registry to continue to gather data for TAVR and linking this requirement to continued coverage. However, such a registry is not currently operational. Medicare beneficiaries’ access to TAVR should not be thwarted while a registry is developed. Again, this requirement could quickly be incorporated into any existing LCDs with only a 30-day public comment period required.

Reasonable and Necessary Treatment for Identifiable Subset of Patients
SCAI finds that TAVR is a reasonable and necessary treatment option for a subset of patients who are deemed inoperable or at high risk for open surgical repair as well as those that refuse the open surgical alternative. SCAI supports that this determination should be made by a multidisciplinary team including a thoracic surgeon and an interventional cardiologist in concert with the patient.

Conclusion
We do not believe using the NCD process will address the immediate need of Medicare beneficiaries in regards to ensuring patient coverage and access to TAVR. While we do support the development of coverage policy for TAVR we believe this is best addressed through the LCD process at this time. This affords a shorter reconsideration process. We support the creation of LCDs to ensure Medicare beneficiaries receive these procedures from qualified providers, at appropriate facilities and that coverage should currently be limited to a subset of patients deemed to be inoperable or at high risk for surgery as well as those refusing the open surgical alternative.

Should CMS elect to move forward with the creation of an NCD despite the concerns we’ve raised and the alternative solution recommended, we would expect an NCD to find that TAVR is a reasonable and necessary treatment option for a subset of patients who are deemed inoperable or at high risk for open surgical repair as well as those that refuse the open surgical alternative. We would also urge CMS to craft an NCD in such a manner as to ensure all FDA approved indications for all FDA approved TAVR devices are automatically covered by the NCD without needing to continually reopen the policy for formal reconsideration. Finally, should CMS elect to move forward with the creation of an NCD, SCAI supports and is aligned with the recommendations of the ACC/STS proposal for coverage for TAVR, as follows:

In closing, SCAI appreciates the opportunity to provide comment and urges CMS to utilize the LCD process in lieu of the NCD process to address the immediate needs and concerns in regards to the availability of TAVR to Medicare beneficiaries. If we can provide any additional information regarding these procedures or if you would like to arrange a conference call or face-to-face meeting to discuss this proposed NCD, please contact Ms. Dawn R. Hopkins, Director of Reimbursement & Regulatory Affairs at (800) 253-4636, ext. 510 or dhopkins@scai.org, so that she can arrange.

Sincerely,

[Endorsed copy sent via email]
Christopher J. White, MD, FSCAI
President

October 27, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

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

Dear Dr. Jacques:

Edwards Lifesciences welcomes the opportunity to comment on the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG.00430N). Edwards believes that TAVR should be covered for Medicare beneficiaries suffering from severe symptomatic aortic stenosis who are determined to be inoperable or at high risk for surgery and who currently have limited or no viable treatment options. A positive National Coverage Determination (NCD) will ensure beneficiary access to a treatment that has been proven effective, is supported by the evidence and has the power to significantly enhance patient well-being.

As a leader in the research and development of heart valve replacement therapy for more than fifty years, Edwards Lifesciences is dedicated to more effective evidence.based treatment options for patients suffering from aortic stenosis and structural heart disease. TAVR is just such a treatment, enabling critically ill patients with severely diseased and compromised aortic valves to receive a new bioprosthesis through a less.invasive approach. It is in this spirit that we submit the attached supplemental information. It includes Edwards' review of the pertinent clinical evidence, a discussion of - and some proposed revisions to - the Requestors' proposed coverage policy, and a comprehensive bibliography and description of our literature research methodology.

Edwards Lifesciences has led the development of TAVR globally since the inception of transcatheter heart valves in the mid.1990s. In 2007, Edwards received its first CE mark in Europe for this therapy and, to date, Edwards' transcatheter aortic valves have been implanted in over 25,000 patients in 51 countries around the world. For most European patients, coverage of this therapy is provided. Currently, the Edwards SAPIEN transcatheter heart valve (THV) is pending approval in the United States (US) by the Food and Drug Administration (FDA) (P100041). In July 2011, on a 9.0 vote (with 1 abstention) the FDA's Circulatory Systems Device Advisory Panel agreed that the benefits of the SAPIEN THV outweigh the risks for use in the indicated patient population. In addition, the company has a large, randomized US.based follow.on study underway, The PARTNER II Trial^*, which is evaluating the Edwards SAPIEN XT transcatheter heart valve.

Treatment of severe symptomatic aortic stenosis represents a compelling medical need in the Medicare population. These patients suffer from angina, fatigue, shortness of breath and a significant degradation of their quality of life. Without a new valve, approximately half of these patients will die within two to three years of symptom onset.^1,2 While consensus treatment guidelines recommend surgical valve replacement for these patients, some are at high risk or are not candidates for open.heart surgery. TAVR meets this medical need and gives these patients new hope.

The PARTNER Trial (The Placement of AoRtic TraNscathetER Valves) provides the foundational evidentiary basis for Medicare coverage of transcatheter aortic valve replacement. The trial has demonstrated a clear and significant survival benefit for inoperable patients and established TAVR as a less.invasive alternative to open.heart surgery for high.risk surgical candidates, the vast majority of whom are Medicare.aged patients. As importantly, the trial demonstrates the value of a collaborative approach to treating these very sick patients though the use of dedicated multidisciplinary heart teams and provides the first.ever controlled comparison of surgical valve replacement to transcatheter valve replacement. These findings have been confirmed by a large and growing body of peer.reviewed published literature.

For patients too sick to undergo surgery, TAVR improves survival by 20 percentage points at one year compared to the current standard of care. On this basis, the number needed to treat to save a life was approximately five.³ These TAVR patients also report a profound improvement in their quality of life - tantamount to a two-level improvement in New York Heart Association (NYHA) functional class and a ten-year reduction in effective age.^4,5 In addition, for high.risk operable patients, TAVR provides a less.invasive, clinically.proven alternative treatment option that doesn't require sternotomy or placing the patient on heart.lung bypass and results in faster procedural times, shorter post.operative hospital stays, and shorter recovery periods.^6,7 Lastly, well designed studies have indicated that TAVR is a cost.effective therapy compared to commonly utilized therapies for other highly comorbid conditions.^8**

Edwards thanks you for your consideration of these recommendations. We look forward to working closely with the Centers for Medicare and Medicaid Services (CMS) throughout the NCA process and to providing any additional information that CMS may require. For further assistance, please contact me at 202.783.3901, or at Dirksen_Lehman@edwards.com.

Sincerely,

Dirksen Lehman
Vice President, Government Affairs and Reimbursement

cc: Jonathan Blum
Patrick Conway
Sarah McClain
Jyme Schafer
Larry Schott

Attachment

Dr. Lawrence Schott
Lead Medical Officer
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Schott:

This letter is submitted in response to a request for comment on the National Coverage Analysis for Transcatheter Aortic Valve Replacement (CAG-00430N). This is an exciting new technology that offers great promise for patients considered high-risk or non-operable for open heart surgery.

The prospective randomized clinical trial of 1,040 patients testing this treatment produced positive results. The New England Journal of Medicine published the results of this trial and noted that "in patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI [transcatheter aortic valve implantation], as compared with standard therapy, significantly reduced the rates of death from any cause."

As CMS reviews the comments and evidence surrounding TAVI, it should strive to create a workable policy that promotes access and the right of patients to work with their doctors to determine what is best for their treatment. If you should need any further information, please contact Laura Holland in Rep. Price's office at (202) 225-4501 or Katie Meyer in Rep. Paulsen's office at (202) 225-2871.

Yours truly,