Transcatheter Aortic Valve Replacement (TAVR)

March 2, 2012

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

Dear Dr. Jacques:

We, members of the Divisions of Cardiology and Cardiac Surgery at Mayo Clinic, Rochester Minnesota, appreciate the opportunity to provide comments regarding the Proposed Decision Memorandum for Coverage with Evidence Development for Transcatheter Aortic Valve Replacement (TAVR). We support CMS coverage for FDA approved indications for TAVR. We believe that TAVR in its current and anticipated future iterations improves survival and quality of life in groups of patients that previously may not have been considered candidates for conventional (surgical) aortic valve replacement (AVR) due to very high or prohibitive perioperative risk. We believe that these five critical components are required to afford maximal benefit to current and future CMS beneficiaries:

1. Documented establishment at each TAVR facility of a multidisciplinary Heart Team consisting of cardiac surgeons; cardiologists with expertise in valvular heart disease, structural heart disease, interventional therapies, endovascular therapies, cardiovascular imaging; and ad hoc inclusion of radiology, cardiac anesthesiology, and other medical/surgical specialists for selection, performance, and postoperative care of TAVR patients
2. Facility and individual operator expertise to carry out these complex procedures:
   1. A minimum annual facility volume of 1000 cardiac catheterization procedures and 400 PCI cases
   2. TAVR interventional cardiologists should be performing an average annual minimum of 75 PCI cases over the last 5 years. Individuals with extensive structural heart disease procedural experience without coronary expertise may be capable of TAVR implantation, although coronary interventional expertise should be represented on the procedural team, and this model would be the exception rather than the rule.
   3. Interventional/structural cardiologists should be very experienced with balloon aortic valvuloplasty
   4. The interventional cardiologist and/or the surgeon performing the procedure should be experienced with large bore arterial access and complication management
   5. Surgeons performing TAVR should have significant experience (>100 cases) with high risk (STS score > 10) surgical AVR. Expertise in endovascular/catheter skills is desirable, but not mandatory as long as performed in conjunction with an interventional cardiologist meeting the above criteria
   6. Integrated procedural approach involving cardiologists and cardiac surgeons
   7. Intra-operative/intra-procedural echocardiography capability
3. Collection and review of individual patient outcome data in a registry format that is easily accessible and retrievable
4. Allow coverage and prospective registry inclusion of high risk cohorts not specifically addressed in PARTNER; do not utilize PARTNER trial exclusions as the basis for coverage/non-coverage. The appropriateness of TAVR should be made in the context of available clinical options for any specific patient, and the multidisciplinary team at each site should agree upon the appropriateness of TAVR for a given patient, with coverage based on that documentation.
5. Creating an environment that allows for continuous improvement of first generation technology

Further discussion of our perspective on these 5 issues is appended below for your reference. We are grateful for the opportunity to comment on this important issue.

Sincerely,

Verghese Mathew, M.D.
Co-Director, Cardiac Catheterization Laboratory

Charanjit S. Rihal, M.D.
Chair, Division of Cardiovascular Diseases

John F. Bresnahan, M.D.
Director, Cardiac Catheterization Laboratory

David R. Holmes, Jr., M.D.

Kevin L. Greason, M.D.

Rakesh M. Suri, M.D.
Director, CV Surgery Fellowship Program

Maurice E. Sarano, M.D.
Director, Valvular Heart Disease Clinic

Vuyisile T. Nkomo, M.D.
Co-Director, Valvular Heart Disease Clinic

Charles J. Bruce, M.D.
Director, Structural Heart Disease Program

The evaluation and management of patients with severe, symptomatic aortic stenosis becomes increasingly complex in the setting of multiple comorbidities. The decision to offer conventional surgery for aortic valve replacement and successful operative and postoperative management hinges on input from cardiologists with expertise in valvular heart disease management, cardiovascular imaging, cardiac surgeons, and a host of medical specialties that assess impact of comorbid conditions on short- and long-term outcome. Patients that meet entry criteria for PARTNER Cohort A or B are particularly high risk; Cohort B results confirm that TAVR results in better survival compared to medical management in patients felt to have a risk profile that prohibits conventional AVR and Cohort A results demonstrate non-inferiority compared to conventional AVR with respect to one year survival after TAVR in patients that are high risk (STS score > 10%) for conventional AVR. In our practice, it has become clear that the nuances of the clinical conditions and treatment planning of such patients are best discussed in an integrated, multidisciplinary manner. For us, this has included a weekly meeting and frequent off-line communications between cardiac surgeons; cardiologists with expertise in valvular heart disease, structural heart disease, interventional therapies, endovascular therapies, cardiovascular imaging; radiology; cardiac anesthesiology; research and practice coordinators; as well as numerous other specialists on an ad hoc basis. These discussions center around deciding which treatment options are best suited for complex patients with severe symptomatic AS; currently, those options include conventional AVR for some, no surgical treatment options for many others, and TAVR now as a viable option in patients in whom conventional surgery may not be well suited, but who otherwise might be expected to demonstrate a survival benefit or improvement in quality of life if aortic stenosis could be ameliorated. In other words, TAVR is a rational therapeutic alternative for those with severe AS who are judged by a multidisciplinary team to bear very high (>10%), or prohibitive perioperative risk for conventional AVR. It is only by working in a multidisciplinary fashion, that we can identify the appropriate treatment options for these patients.

Whereas the technical skills required for performance of TAVR are not entirely related to the performance of percutaneous coronary intervention (PCI), individual and facility PCI volumes correlate with performance and outcome measures, and as such PCI volumes may reasonably be considered as a surrogate of quality and technical expertise. We suggest that 1000 cases with 400 PCIs may be a reasonable annual facility volume requirement. Regarding individual operator metrics, the ACC/AHA criteria are 75 PCI cases per year for individual operator proficiency, with similar criteria (or 150 cases over 2 years) required for American Board of Internal Medicine (ABIM) re-certification in Interventional Cardiology. Although coronary complications are rare with TAVR, the treatment team must be capable of managing such occurrences. Individuals with extensive structural heart disease procedural experience without coronary expertise may be capable of TAVR implantation, although coronary interventional expertise should be represented on the procedural team, and this model would be the exception rather than the rule.

The PARTNER trial requirements mandated that cardiac surgeons involved in the trial document performance of at least 100 high-risk conventional AVR cases and we feel this level of experience should be required of surgeons entering into the program. Expertise in the surgical management of high-risk patients is central to successful treatment of these patient cohorts. Additional skill sets that are crucial for teams involved in the performance of TAVR includes expertise in balloon aortic valvuloplasty (BAV), vascular access and complication management (including endovascular repair) with large bore arterial sheaths, intraoperative/intra-procedural echocardiographic imaging. Currently, echocardiography is the imaging modality of choice to complement radiographic assessment intra-procedurally. Echocardiography is well suited to complementing the assessment of successful implantation and monitoring for potential complications related to aortic balloon valvuloplasty and prosthetic valve deployment and assessment for any of a number of complications that may occur as the result of the procedure including but not limited to significant perivalvular regurgitation, valve prosthesis malpositioning or malfunction, injury to the mitral valve leaflet, aortic dissection, or development of left ventricular systolic dysfunction. We advocate performance of TAVR procedures, both transfemoral and transapical approaches, by cardiologists and cardiac surgeons in concert.

Measuring and reviewing process performance and outcomes and comparing them to accepted standards of quality is a critical component of our clinical practice, and is particularly relevant as we embark upon new technologies and procedure types. Such review provides not only near term feedback to facilities and operators in order to gauge and refine practice patterns, but also serves to measure the longitudinal impact of newer therapies on survival and quality of life, and serves to guide practice patterns, patient selection, and technological development.

Important components of such a registry include:

The PARTNER Trial included very high risk patients with severe symptomatic AS. Nonetheless, many patients that otherwise met entry criteria were excluded from the trials for reasons that may have been appropriate from a clinical trials perspective, but in clinical practice may potentially benefit from TAVR, especially in comparison to surgical AVR. Broad examples of such patients would include patients with severe renal failure or requiring dialysis; recent stroke/TIA; recent acute coronary syndrome; severe left ventricular dysfunction; significant lung disease and pulmonary hypertension; TAVR with pre-existing valve prostheses in other locations; use of the Edwards devices for failed bioprosthetic valve in the aortic or other positions; and stable blood dyscrasias (anemia, leukopenia or thrombocytopenia). While such patients may be appropriate to exclude from a clinical trial, clinicians are asked to manage patients with severe symptomatic AS with such comorbidities with regularity, particularly at high volume referral centers such as ours. Clearly in the judgment of our multidisciplinary team, there are patients in whom such conditions exist that may well benefit from TAVR technology; in other words, despite serious co-morbidities, amelioration of severe symptomatic AS would be expected to improve survival and/or quality of life. It would be inappropriate to exclude from coverage these patients from consideration for TAVR purely on the basis of PARTNER trial exclusions, without considering the clinical context and whether or not such patients have other treatment options. Although not studied in PARTNER, we believe that it would be appropriate to cover TAVR technology in such cases as determined by the facility’s clinical expertise based on multidisciplinary team assessment. Such a team must necessarily include cardiac surgeons and cardiologists along with additional stakeholders as defined above.

Clinical processes and procedures are constantly being refined in response to observations of outcomes and limitations of current approaches. A critical component of this evolution is the development of devices that fulfill unmet needs. The proposed stipulation that all subsequent trials of TAVR must demonstrate superiority with respect to mortality over the recently approved Edwards TAVR is of great concern to us, as it may make the modification of existing technology and development of subsequent TAVR devices impossible from a number of perspectives. Such issues as achieving adequate trial sample size to demonstrate superiority and the ability to logistically complete such trials, and the cost of developing such technology and the trials to bring them to market may make it unattractive for future investment and effort into this arena. While the efficacy/outcomes data from PARTNER as well as the world-wide experience to date with the Edwards device is compelling in an important group of patients with severe symptomatic AS, there is room for improvement with respect to efficacy and safety endpoints. We believe that well designed trials demonstrating non-inferiority for a mortality endpoint compared with the Edwards device will ensure development of incrementally better devices to manage this group of patients. Non-inferiority trials are extremely effective ways of assessing new technology or iterative designs provided the trials are designed to answer the question as to whether the tested device is 1) safer to the patient and/or improves upon other non-mortality endpoints such as stroke, vascular complications or paravalvular regurgitation for example 2) less expensive to use, or 3) easier to use/perform the procedure, than existing technology. Additionally, as iterations of existing technology and expanded indications occur, it remains important that processes for determining coverage/payment remain flexible and timely rather than at a national coverage level, so as to positively impact as many potential patients as possible.

Less

March 3, 2012

Louis Jacques, MD
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-00430N)

Dear Dr. Jacques:

The American College of Cardiology (ACC) appreciates this opportunity to comment on the proposed decision memo. We strongly supports CMS’ proposal to link Medicare coverage to FDA-approved indications. We commend CMS’ decision to approach TAVR as a promising new technology that warrants further study. We hope that utilizing coverage with evidence development (CED) policy can bring this life-saving procedure to appropriate Medicare patients. CED that accumulates clinical data through robust registries is a valid strategy to accommodate emerging and developing technologies. We strongly endorse the concept that this transformational technology should be applied in expert centers by expert teams on well selected appropriate patients who can benefit optimally from it. However, we do believe there are aspects of the proposed coverage that can be improved.

Covered Indications

ACC supports CMS’ proposal to cover TAVR for FDA approved indications. Choosing this construct for coverage will allow the NCD to grow and evolve as TAVR technology and practice evolve without multiple formal reconsideration processes. We believe, however, that absent further clarification and explanation, the reference to FDA approved indications in Section A. 1. of the draft decision, along with the reference to “unlabeled uses” in Section B, may leave the coverage status of some patient populations ambiguous. We request that further clarity on the distinction between “on-indication” and “on-label” uses be written into the final coverage.

The FDA approval order for the Edwards SAPIEN Transcatheter Heart Valve states under Indications that the SAPIEN valve is “indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis.” A summary of FDA’s approval and labeling information is available at http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100041c.pdf. Contraindications include patients with active infections and those who cannot tolerate anticoagulation/antiplatelet regimens. The labeling information also includes, under the heading Precautions, an extensive list of patient populations in which safety and/or effectiveness and durability have not been demonstrated. Several of these patient populations match the conditions CMS proposes for national non-coverage in Section C. of the draft NCD, but others—for example, congenital unicuspid or congenital biscuspid valve—are not proposed for non-coverage.

We believe that CMS intends to extend coverage of TAVR to all Medicare beneficiaries who fit the indications outlined by the FDA with exception of those who have conditions listed under the FDA label contraindications and the indications explicitly listed as non-covered in the draft NCD. The ACC supports this intent. We are concerned, however, that without clarification, patients, physicians, and others may be unsure whether certain patients who meet the FDA approved indications but who also have one of the conditions listed under FDA’s precautions are eligible for coverage. It is essential that Medicare patients, as well as their physicians and facilities, have a clear understanding of who can be covered when the conditions in Section A are met, who must be enrolled in a clinical study that meets the conditions in Section B, and who is not covered. We urge CMS to ensure that the final decision memo discusses and clarifies the difference between coverage for an “FDA approved indication” and conditional “coverage for all unlabeled uses.”

Prospective National Registry

Research Questions

ACC supports use of a prospective national registry to monitor outcomes for patients eligible to be treated using the TAVR procedure. A national registry will also allow providers and researchers to update clinical practices on a routine basis to demonstrate continuous improvement of patient care. Data about the risk of stroke, bleeding, or death in certain populations could be used to determine when TAVR is appropriate. The registry could also clarify questions about institutional and provider requirements. We think final coverage would benefit if these types of questions were paired with the required outcomes from the outset so all interested parties understood the metrics on which CMS will consider future coverage. We suggest that CMS indicate coverage elements related to eligible patients. Institutional and operator requirements may also be updated to reflect conclusions drawn from prospective national registries in 2 years.

Stroke Data

CMS proposes in Section 5 of the draft NCD that the prospective national registry collects patient level data on the following outcomes:

1. Major stroke;
2. All-cause mortality;
3. Minor stroke/TIA;
4. Major vascular events;
5. Acute kidney injury;
6. Repeat aortic valve procedures;
7. Quality of Life measures.

CMS currently proposes to collect neurologic outcomes data, which include major and minor strokes after TAVR at baseline, 30 days and annually for 5 years. ACC agrees the risk of stroke is important and can exert a dramatic impact on the net benefits of TAVR. Validated stroke scales such as the NIH scale or modified Rankin, must be administered consistently over the 5-year follow-up period to clearly and accurately assess for and differentiate between major and minor stroke after TAVR. Unless this can be performed consistently with all patients for the 5-year period of follow-up, we think that the reporting and differentiation between major and minor stroke outcomes would lead to a large amount of missing data and that such data would not be missing at random. The data collected would then reflect a biased sample, rendering them as suspect for use in any research or benchmarking purposes. In our experience, accurate differentiation of major vs. minor stroke in clinical practice is likely to be fraught with error and misinformation. In our opinion, unreliable information is worse than no information. It is, therefore, our recommendation that capturing "stroke" without differentiation into major or minor has the highest likelihood of being able to obtain an accurate assessment of neurologic outcomes after TAVR. In addition, we think the short form Kansas City Cardiomyopathy Questionnaire (KCCQ) quality of life measures that will be added to the registry will provide important feedback regarding all patients’ physical limitations and quality of life.

Follow-up Period for Quality of Life

While we recognize the importance of health status and quality of life as outcomes for patients with severe aortic stenosis, the requirement to collect quality of life data through 5 years of follow-up is problematic for several reasons. First of all, the main differences in health status associated with TAVR vs. surgical valve replacement (or between alternative access sites) are likely to emerge in the first year of follow-up (as was seen in the PARTNER A trial). Although longer term outcomes might differ because of long-term consequences in valve performance, it is very likely that such differences would also manifest in other discrete outcomes such as rehospitalization, reoperation, or even mortality. Moreover, quality of life outcomes are highly sensitive to missing data. Previous experience with these instruments suggests that such missing data are unlikely to be "missing at random" (a key assumption of most analytic approaches). As a result, missing data in more than 10-20% of patients would likely raise serious questions about the validity of the remaining results, especially pertaining to representing the overall population. Finally, the need to actively follow all valve recipients (both TAVR and AVR) for up to 5 years could result in substantial burden to both patients and providers due to the cumulative nature of the study.

In light of these concerns, we would recommend that evaluation of health status be required at baseline, 30 days, and 1 year after TAVR. This would likely result in the maximum return on investment for the burden of data collection and a high rate of data completion required for valid scientific study. We recommend the KCCQ quality of life instrument, also used in the PARTNER trial, serve as the sole quality of life instrument required by CMS. Of note, the short form KCCQ can be completed by mailed questionnaire, which further limits the burden of data collection to the participating sites. We recommend final coverage specify that the follow-up include a combination of patient follow-up coupled with linked CMS MedPar data, and ideally the Social Security Master Death File as well to allow for thorough tracking during follow-up period.

Informed Consent

ACC notes that Section 5, which discusses registry requirements, includes reference to a requirement for informed consent. Although the specific language appears to apply to informed consent for the TAVR procedure itself, we want to ensure that CMS does not intend to require that facilities seek informed consent from patients for entry of data into the registry. ACC has extensive experience with clinical data registries and the accompanying obligation to comply with federal regulations governing protection of human subjects and privacy of health information.

ACC’s NCDR registries have qualified for a waiver of the requirement for informed consent under the following criteria that must be met for a study to qualify for a waiver of consent under 45 CFR 46 regulations:

1. The research involves no more than minimal risk to subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The research could not practicably be carried out without the waiver or alteration; AND
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The ACC and The Society of Thoracic Surgeons (STS) registries serve multiple roles for registry participants. ACC and STS offer web-based data collection tools to collect information for many of our registries. Currently direct identifiers such as patient name and social security number are collected via these web-based tools. The identifiers are collected so that data managers at the hospitals using the web-based data collection tools are able to easily query patients to correct data collection errors and improve the quality of data. Please note that although direct identifiers are collected, data obtained via the web-based data collection tools are partitioned so that they are independent of the database for which analysis is conducted. Analyses conducted for research purposes use only a Limited Data Set.

Further, neither the ACC nor the STS dictate the process by which participating centers collect data. In surveying data collection methods at participating centers in the other registries we have determined that the majority of centers collect data retrospectively. There is a population of centers that electronically abstract their data through interfaces established between the certified software application and the center’s health information systems. Data electronically abstracted from the existing electronic systems can occur at the point of entry and therefore may be considered prospective; however, the staff entering the data into the existing electronic system is often not aware that the data being captured are used for purposes of the registry.

The ACC has implemented processes to ensure that data captured in the web-based data collection tool as well as data maintained for research purposes are adequately protected through physical, technical, and administrative safeguards. The ACC has made significant efforts to mitigate risk associated with holding sensitive information of human subjects. The ACC believes that such safeguards appropriately mitigate incidents associated with identity theft similar to mitigation efforts undertaken by hospitals themselves. Although there is always a risk of an incident, ACC believes that adequate procedures are in place to protect the welfare and rights of human subjects.

In summary based on the facts above:

1. Registry activities represent minimal risk to privacy;
2. Because registry activities only require the collection of information from existing medical records and there is no intervention such as subject interview, the rights and welfare of the subjects are not compromised; and
3. Because data collection often occurs in a secondary manner after the subject has left the facility, it is not practical to obtain patient consent.

When the collection of patient identifiers that included SSN was initiated for the STS National Database, STS obtained legal advice from an experienced source with expertise in HIPAA and related regulatory requirements to ensure that STS was in compliance. To the extent that data are submitted to the National Database for quality improvement and other “health care operations” purposes, such submission is permissible under and protected by the Business Associate Agreement (BAA) that STS has entered into with all Database participants. BAAs mandate appropriate safeguarding of the PHI in accordance with HIPAA requirements. Because STS may use the data for some research purposes, it has obtained a waiver of the HIPAA patient authorization requirement from the Duke Institutional Review Board (IRB) to allow the collection of PHI for research purposes. Generally, only aggregated and/or de-identified data would be disclosed to researchers. STS /DCRI would obtain a separate IRB waiver and obtain permission of the affected participants if it were going to disclose PHI for research purposes. The HIPAA rules do not require each institution submitting data to a registry such as the STS National Database that may be used for research purposes to obtain separate approval from its own IRB. The Privacy Rule permits a covered entity to use or disclose PHI for research purposes without Authorization (or with an altered authorization), if the covered entity received proper documentation that an IRB or Privacy Board has granted a waiver (or an alteration) of the Authorization requirement for the research use or disclosure of PHI. However, STS recognizes that either because of a participant’s internal policy or obligations imposed as a condition of a participant’s receipt of federal funding, the Participant may determine that local IRB approval is necessary. Under STS’s participation and Business Associate agreements, the participant is responsible for knowing and following local institutional policies and regulations.

Because the STS Database receives no federal funds and it is not engaged in federally-regulated activities, it is not subject to the Common Rule and therefore is not required to obtain informed consent from patients. It has received a waiver of informed consent from the Duke IRB out of an abundance of caution and because some sites believe they must have such a waiver in place to participate in the registry. In fact, the Office of Human Research Protection has clarified that sites that merely collect identifiable patient information in the course of clinical care and submit it to external researchers care are not engaged in human subjects research and therefore are not required to obtain informed consent from such patients. See http://www.hhs.gov/ohrp/policy/engage08.html (Section II.B.6.). OHRP has also taken the position that where the Common Rule does apply to multi-center clinical trials or clinical registries, central IRB review and approval of waiver requests is appropriate and that local sites can rely on such central IRB approval.

With respect to the TVT Registry, determination of whether informed consent will be required will be determined through an Institutional Review Board (IRB) evaluation after the data collection protocol is finalized.

ACC recommends that the final NCD incorporate the following language in Section A.5. to address patient protection issues: “The Registry operator will be responsible for ensuring compliance with all applicable regulations relating to protecting human subjects including 45 CFR 46 and 21 CFR 50&56 as applicable.”

We note that the Department of Health and Human Services issued an Advance Notice of Proposed Rulemaking indicating the agency’s intent to revise regulations on human subjects’ research protections (the Common Rule). ACC believes it would be inadvisable for CMS to include any language in the NCD that might later be inconsistent with overarching federal regulation. Requiring that registries comply with applicable federal regulation would ensure appropriate patient protection and would allow compliance to be tailored to the specific operations of the registry.

Characteristics of High Quality Registries

To ensure data captured through registry programs are of the highest quality we strongly recommend that more specifics about what constitutes an “eligible” prospective national registry be added. Registries must demonstrate an adequate organizational structure that is multifunctional and unbiased; that employs evidence based science with standardized data elements and definitions, includes built in rigorous data quality procedures; and that offers timely support services and training to participating sites.

The STS/ACC Transcatheter Valvular Therapy (TVT) Registry has been designed to monitor device iterations as well as devices from a variety of manufacturers, with the first application of the registry serving as a device surveillance and outcomes evaluation tool for the Edwards Lifesciences SAPIEN transcatheter valve. The initial registry will capture data on all patients receiving TAVR in this country, and will also serve as the platform for future aortic and other valve device post market surveillance studies. Immediate comparison with surgical aortic valve replacement (AVR) will be possible by linkage to the existing STS Adult Cardiac Surgery Database. Future efforts may include patients in a more global area such as medical treatment of aortic stenosis via linkage with the National Cardiovascular Data Registry PINNACLE Registry (outpatient) thereby creating a truly disease based registry. You can view more information about the TVT Registry atwww.tvtregistry.org.

Definitions of the parameters to be collected have been harmonized to be consistent with definitions from the Valve Academic Research Consortium (VARC). The data analyses will be performed by the Duke Clinical Research Institute (DCRI) and will include long-term follow-up via a linkage with CMS MedPAR data. Reports can be tailored to meet the expectations of government agencies as well as those of industry and the national professional societies.

This operational model will streamline the process of device evaluation and will facilitate defining appropriateness of care, thereby minimizing the risk of overuse. The TVT Registry should serve as a prototype for registry-based data collection and analyses across the entire field of medicine.

Institutional and Operator Requirements

We were pleased with the decision to include preliminary guidance provided by STS, SCAI, AATS, and ACC regarding institutional and operator requirements. The final version of that document has now been completed, approved by the various societies and published online March 1, 2012. These recommendations update those provided to you on January 10th, 2012. This document provides extensive guidance on the infrastructure needed to support a TAVR program, as well as the characteristics of the optimal multi-disciplinary heart team to ensure a high quality program. The document also defines procedural criteria for this evolving field. You can view the entire document at http://content.onlinejacc.org/cgi/reprint/j.jacc.2012.02.016v1.pdf.

The requirements specified in the document represent the gold standard for high quality TAVR care. However, we have reviewed the comments submitted to CMS to date, and we are concerned that strict adherence to the TAVR Interventional program and interventional cardiologist requirements in Table 1 could significantly limit patient access in the current environment. In that context, we feel that 100 structural heart disease procedure requirement in the document is too high. We note the many commenters who suggested that even the proposed requirement of 50 structural heart disease procedures for a single interventional cardiologist is likely too high and would greatly limit access.

Because of the increasing emphasis on the importance of the Heart Team and institutional structural heart disease experience, we are updating our recommendation in this regard. We recommend that for purposes of establishing the minimal benchmarks for facilities and physicians eligible to perform TAVR for Medicare beneficiaries, CMS consider a modified version of the procedure volume requirements enumerated in the multi-society document. Specifically, the agency may wish to consider the following alternatives which reflect a more realistic assessment of current interventional cardiology experience in treating structural heart disease. These modifications reflect the emphasis on the team based approach.

For interventional programs:

• 1000 caths/400 interventional procedures (PCI and left heart structural procedures) per year of which >=+ 30 are left heart structural cardiovascular disease procedures including balloon aortic valvuloplasty, pulmonary valvuloplasty, mitral valve dilatation, percutaneous mitral valve repair (EVALVE), left atrial appendage closure, pulmonary vein dilatation, prosthetic leak closures, VSD closures, and EVAR or TEVAR which are performed by the interventional cardiologist. These structural cases include complex procedures that require elements needed for successful completion of TAVR procedures. The numbers do not include PFO or ASD closure procedures.

This alternative recognizes that some interventional cardiology programs may have very strong experience in treatment of structural heart disease—experience very relevant to TAVR—but a lower volume of PCI procedures. The combination of these elements will include relevant expert experiences that can be applied to TAVR.

For interventional cardiology requirements, we suggest the following criteria be applied to the entire interventional cardiology TAVR Heart Team:

• 50 lifetime structural procedures or 20 per year; including balloon aortic valvuloplasty, pulmonary valvuloplasty, mitral valve dilatation, percutaneous mitral valve repair (EVALVE), left atrial appendage closure, pulmonary vein dilatation, prosthetic leak closures, VSD closures, and EVAR or TEVAR performed by interventional cardiologists.

If CMS elects to set the interventional cardiology requirements at the less stringent levels noted above, we strongly urge that the professional societies and CMS work together to monitor procedure quality and patient outcomes through ongoing and frequent surveillance of data reported to the national registry.

TAVR is a new technology for U.S. providers. Although experience with credentialing numbers is limited, we believe that these modifications will create functionally qualified teams of surgeons and physicians. Our understanding of the criteria that will best ensure patient safety and optimal access is likely to evolve as we gain more experience. As mentioned above, we feel these requirements can and should be revisited and possibly updated as soon as enough registry data becomes available to draw conclusions about the qualifications and experience necessary to ensure the highest quality patient care.

Outcome Requirements

Finally, we recommend deletion of proposed requirements for existing TAVR centers to participate in randomized controlled trials or post-approval studies. It is inconsistent to impose this requirement as a condition of coverage for existing programs, but not new programs, and we see no reason to prevent a center from offering TAVR for FDA approved indications with participation in a registry. In addition, at this time we recommend that the final NCD not include the volume and outcome standards outlined in A.3.b.iii of the draft NCD. All these outcomes will be tracked through registry participation and should be reviewed when sufficient data have been collected and a reassessment of center approval made at that time.

Coverage for Clinical Trials

Trial Design

We agree that CED should be used to extend coverage for off-label indications. However, we strongly urge CMS to reconsider its proposal to limit coverage to clinical studies with a “superiority design”. We are concerned that such a requirement will effectively put an end to research into off-label uses in the U.S. because the thresholds for superiority trials are so high that studies would be too difficult to perform or would take many years. "Non-inferiority” studies would be too small and too short to meet this standard, which we believe would discourage manufacturers from conducting research in the U.S.

While we agree that superiority studies are the most useful, well-designed, and well-executed, equivalence or non-inferiority studies can provide useful data to support decisions about whether a new use of a device offers a net benefit to Medicare beneficiaries. ACC does not believe that the goal of Medicare coverage policy should be to identify the single best treatment for all patients. The data accumulated through clinical trials will never be adequate to do this. Other research designs can provide useful information to help CMS craft coverage policies that allow for patient-centered care decisions. We respectfully suggest the requirement that clinical studies be intended to demonstrate superiority be revised to allow equivalence and non-inferiority studies. This should include prospective, registry-based, observational studies. The critical issue for CMS to evaluate in determining whether a study is qualified for CED will be whether the study design is appropriate for the research question proposed and feasible for the patient population selected. Questions that deal with a mortality advantage in a potentially large patient population may be suited to a superiority design. Questions that deal with patient preference related to quality of life or with small patient populations may not be suited to a superiority design. To that end, we also think it would be useful for CMS to include more specifics about the characteristics of studies that are likely to receive a favorable decision on qualifying for the CED.

We were unable to determine to what baseline a clinical study is supposed to be compared, under the proposed NCD. It appears that a study could attempt to seek to demonstrate superiority to surgical AVR, to another device, to another technique, or even between patient populations. The current language does not define which of these is/are intended to be covered. We request CMS clarify this statement.

Investigational Device Exemption Trials

In addition, we urge CMS to clarify that the CED policy outlined in the NCD is not intended to interfere with the agency’s existing authority to cover TAVR procedures provided through FDA-approved Category B Investigational Device Exemption Trials. Continuing coverage for trials already underway and future trials for new devices is essential to advance knowledge in this field.

Collaborative Study Design

Finally, it may seem obvious, but we also suggest CMS highlight that prospective investigators who want their studies to qualify under the CED may take advantage of the opportunity to meet with CMS to discuss study design issues before launching the study.

Thank you for your careful consideration of these comments and your continued work on this complex issue. Please contact James Vavricek, Senior Specialist in Regulatory Affairs, at jvavricek@acc.org or 202-375-6421 if you have questions or need additional information.

Sincerely,

David R. Holmes, Jr., MD, FACC
President
ACC

Less

The Adult Congenital Heart Association supports policies which promote research in adult congenital heart disease and its translation into new treatments to improve the health and well-being of the over 1.5 million U.S. adults now living with congenital heart disease. Among complex congenital heart patients, valve abnormalities are near-universal, and many arrive in adulthood having already undergone three or more childhood open heart procedures. Less invasive valve replacement technologies hold tremendous promise for prolonging life and reducing the burden of disease on congenital heart patients.

ACHA lauds the FDA's goal of ensuring that utilization of catheter-based valve strategies meets the highest standards of clinical excellence. However, we are concerned that the requirement of demonstrated "superiority" may not include factors critically important to the congenital heart community. Less-invasive procedures may provide quality of life benefits to patients that must be considered when determining optimal treatment. Avoiding lengthy hospitalizations, shortening recovery times, and reducing wages lost are important factors for adults with congenital heart disease, many of whom are employed adults raising young children. Most importantly, it is essential that congenital heart patients for whom additional surgeries are no longer an option do not die needlessly due to lack of access to potentially-life-saving noninvasive surgical options. Thanks in advance for ensuring that the rules for TVR respond to the large and growing US population of adult congenital heart patients, many of whom require multiple valve replacements throughout their lifespan.

Less

March 5, 2012

VIA ELECTRONIC MAIL AND ELECTRONIC FILING

Louis Jacques, MD
Director
Coverage and Analysis Group
Office of Clinical Standards & Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard S3-21-08
Baltimore, MD 21244

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

Dear Dr. Jacques:

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 (“the NCD”) on Transcatheter Aortic Valve Replacement (“TAVR”).

I. General Comments

As a supporter of Medicare coverage for many life-saving and life-enhancing medical technologies, the FAH appreciates that CMS has proposed a NCD for TAVR. Consistent with our earlier comments, we urge CMS to be mindful of the potential for bias and conflicts of interest that the Society of Thoracic Surgeons (“STS”) and the American College of Cardiology (“ACC”) (“the Requestors”) may have regarding their request for a NCD for TAVR.

While the Requestors undoubtedly are interested in adopting medical advancements that can help their patient base, the potential for bias or even conflicts of interest can be a countervailing force to that interest. Bias or conflicts of interest can present themselves in a number of different ways here, whether it is a concern about control of, and fees associated with, the TAVR registry or a desire to protect historical utilization levels of, or a comfort level with, other more invasive and financially lucrative open heart procedures. We are certainly not questioning the Requestors’ motives for why they seek a TAVR NCD, but instead are simply pointing out that their potential self-interest may affect how they view the appropriate scope of a final TAVR NCD.

II. Scope of Coverage

The NCD would allow coverage when the procedure is furnished for indications approved by the Food & Drug Administration (“FDA”), with a complete valve and implantation system that has received FDA pre-market approval for this indication. The FAH supports this approach because it is appropriate and efficient for Medicare coverage to dovetail automatically with all uses indicated in FDA guidance documents. This approach will be effective, because it would allow coverage under the NCD to be adaptable if and when FDA guidance changes without requiring affirmative CMS action to amend the NCD. Also, this approach would not preclude Medicare coverage when physicians order the TAVR procedure for other clinical purposes. We think this approach is sensible for both the TAVR NCD and other Medicare NCDs that key off permissible FDA labeling requirements.

III. Patient Evaluation Requirement

The NCD proposes that two cardiac surgeons must evaluate the patient’s suitability for open valve replacement surgery as a condition of coverage. Consistent with the Scope of Coverage addressed above, the FAH strongly urges CMS to make the NCD’s patient evaluation requirement consistent with the FDA’s approved indication, which only requires one cardiac surgeon perform the patient evaluation. To do otherwise would create an unnecessary barrier to needy patients receiving this important treatment, because it will be difficult in particular locations to find two surgeons who are qualified to make this determination.

If CMS is inclined to maintain the proposed requirement for a two-physician patient evaluation, we urge CMS to require one physician to be a cardiac surgeon and permit the other physician to be an interventional cardiologist. This approach is appropriate clinically, and is more likely to address the patient access concerns we raise about certain geographic areas.

The NCD does not define the term “evaluate.” CMS may wish to address this issue in more detail, especially if the two-physician requirement for patient evaluation is finalized. In that case, CMS should make clear that only one of the two physicians needs to evaluate the patient in person, while the second physician’s evaluation may be conducted by chart review and/or consultation with the first evaluator. We would oppose any requirement that both physicians evaluate the patient together, or in person, because this may be very difficult to achieve as a practical matter, and thus creates a barrier to patient access. This could also increase the healthcare costs and time of assessing a patient for TAVR, resulting in delays for important patient care.

IV. Facility Requirements

The NCD’s facility requirements are satisfied based upon the degree to which the facility has furnished other cardiac procedures. We will address the procedure volume requirement proposals below in the appropriate subsections. As a threshold issue, we query whether the NCD should contain a training requirement for facilities and physicians, as is the case in other NCDs. We can envision appropriate TAVR-specific training programs provided through a combination of modalities, and which will provide a degree of protection for patients and the Medicare program from possible bad outcomes. While the FAH recognizes the strength of the current manufacturer training program, this training program should not be the only permissible training, as other modalities (e.g., fellowship training, preceptors, and other courses) would also be appropriate to satisfy this need. In contrast, specific training on the TAVR procedure should be differentiated from general education about TAVR and similar cardiac procedures, which we do not believe should be sufficient to meet the training requirement we envision.

The NCD sets forth specific volume requirements for surgical and interventional procedures performed by the facility to qualify to furnish covered TAVR procedures. This approach represents a marked change from the approach proposed in the previous National Coverage Analysis on TAVR (“NCA”) that was open for public comment last fall, and one that causes great concern. While procedure volume may correlate with outcomes, that metric is not determinative of the potential success of facilities in furnishing the TAVR procedure. Moreover, there is no independent, evidence-based research to support the proposed levels of the volume requirements. Thus, we do not believe volume requirements for other cardiac procedures are the proper determinants for facility qualification.

Nonetheless, the FAH recognizes the need to have facility standards in the NCD. We believe a better model than proposed is the approach that CMS takes in many other NCDs, where parameters for facility equipment, monitoring and other infrastructure requirements, among other things, serve as the qualification standards. Such an approach would be more in line with what CMS advanced in the recent TAVR NCA, which the FAH generally supported. In contrast, we have found no independent research data to support the proposed surgical volume requirements, and the proposed requirements seem to come only from information derived by the Requestors themselves.

If CMS is inclined to use volume requirements as the standard, it is premature to impose those requirements at this time. Currently, there is a lack of independent, scientific data to support the proposed volume levels, and we believe strongly that such a policy should have a sound, evidence-based foundation. Thus, we instead urge CMS to form a technical advisory panel to include industry-wide stakeholders that is directed to analyze and define proposed volume requirements. In the interim, CMS should implement interim facility requirements that are more in line with the approach used in the TAVR NCA.

In considering further a volume requirement proposal, the technical advisory panel should also consider counting “training-by-simulation” encounters toward any minimum facility volume requirements. Moreover, if volume requirements are pursued, clarification is needed on the following issues:

• Are the volume requirements per provider or per location? Some providers have multiple hospital campuses where cardiovascular procedures are performed. We urge CMS to clarify that volume requirements apply at the provider level, and not at the campus level.
• Further definition is needed for AVR procedures. Does the requirement include replacements only, or does it also include repairs? While repairs are a small subset of all AVR procedures, they should be included in the count toward satisfying the facility requirements.
• Further definition is needed for structural heart procedures. Shouldn’t this category include percutaneous performance of these procedures?
• For minimum endovascular aneurysm repair/thoracic endovascular aortic repair procedures, the NCD indicates that these procedures are left-sided, which is incorrect. Thus, the “left-sided” reference should be removed.

Finally, the term “institutionally-based” cardiac surgeon needs better definition. The definition should be flexible, and should not be limited to physicians who are employed by hospitals. Cardiac surgeons are rarely employed by hospitals, although they perform the majority of their procedures in hospitals under their hospital medical staff privileges.

The NCD includes TAVR experience requirements, including patient outcomes, for those facilities which were previously part of a TAVR clinical trial. We understand the rationale behind applying different criteria to facilities that have clinical trial experience. However, the NCD could easily disqualify appropriate facilities due to patient outcomes that were out of the facility’s control. While clinical trial results should be monitored, the outcomes of those trials should not be the sole determinant in a facility’s eligibility for Medicare coverage.

V. Physician Requirements

The NCD sets forth Board certification and professional experience requirements for surgeons and interventional cardiologists, including particular volume requirements. As stated above, the FAH does not believe service volumes should be the major factor in identifying qualified physicians. Consistent with our comment on facility requirements, we believe a better approach is to implement objective requirements that focus on qualifications of physicians and their training in the TAVR procedure, and should not focus on their volume performance related to other cardiac procedures. This approach is similar to how CMS sets policy in many other NCDs.

Again, we have found no independent research data to support the proposed surgical volume requirements, as the proposed requirements seem to come from the Requestors themselves. Given the potential bias or conflict of interest for Requestors’ members, we do not believe the proposed volume requirements should be acceptable without further independent, evidence-based verification. We are concerned that the volume requirements, as proposed, will likely hinder patient access to this new service.

Thus, if CMS is inclined to use volume requirements as the standard, it is premature to impose those requirements at this time. With a lack of independent, scientific data to support the proposed volume levels, the policy lacks a sound, evidence-based foundation. Instead, CMS should form a technical advisory panel to include industry-wide stakeholders that is directed to analyze and define proposed volume requirements. In the interim, CMS should implement interim physician requirements that are more in line with the approach used in the TAVR NCA.

VI. Registry Requirements

As indicated in our earlier letter, the FAH understands the desire for patient registries and the benefits of maintaining one for TAVR patients. Thus, we support the use of a TAVR registry. However, the cost associated with, and the amount of data required by, the TAVR registry, which is being operated by the STS and the ACC, is of great concern.

We understand that the cost of participation in the STS/ACC registry is approximately three times that of other cardiovascular registries, although there has been no indication – inside or outside of the NCD development process – why that is necessary. When you couple that fact with the fact that STS and ACC are the requestors for this NCD and have been the primary advocates for the registry, hospitals are concerned about the appearance of a conflict of interest with regard to the registry pricing.

Further, the proposed interventional cardiology requirements state that the treating physician team must participate in a prospective national registry that enrolls and tracks patients for a period of at least five (5) years from the time of the TAVR procedure. The NCD proposes the TVT registry to be the required registry for participation, yet this registry does not allow for follow up outside of the thirty (30) day period after the procedure. While we agree that it is appropriate to track outcomes, there are inherently difficulties in following patients for a period of five (5) years, both due to registry limitations and challenges with care coordination with patients’ local primary and specialty care physicians.

For these reasons, we request that CMS revisit the registry requirement and eliminate the five (5) year follow up at this time. While the FAH understands the need for the registry, we recommend that CMS consider an initial, smaller subset of required data. Registry requirements is an issue that could be considered by the industry-wide technical panel we proposed for assessing procedure volume requirements.

VII. Other Situations Where Coverage May Be Permitted

We agree with CMS that there is a need for sound scientific data from clinical trials. One role that the FDA plays is to determine whether the design of particular clinical trials has the proper scientific rigor, regardless of its status as a superiority or non-inferiority trial. It does not seem appropriate for an NCD to influence a particular type of trial design, as there are numerous examples of trials with both designs that have been appropriate clinically. Requiring superiority-only trials for coverage purposes under this NCD will impact negatively the cost to industry, length of time, and number of patients required to study. This could impact the costs of coverage, reduce industry innovation, decrease competition due to increasing prices, and limit access to important new treatment therapies.

* * * * * * * *

The FAH appreciates the opportunity to comment on the NCA. If you have any questions about our comments or need further information, please contact me or Jeff Micklos of my staff at (202) 624-1500.

Sincerely,

cc: Tamara Syrek Jensen, JD
Jyme Scafer, MD, MPH
Sarah Fulton, MHS
Lawrence Schott, MD, MS

Less

March 3, 2012

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

RE: Proposed Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

Dear Dr. Jacques:

Edwards Lifesciences ("Edwards") welcomes the opportunity to comment on the Proposed Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N). We are pleased that the Centers for Medicare & Medicaid Services (CMS) has proposed clear and flexible national coverage for TAVR for all severe symptomatic aortic valve stenosis indications when provided with a device that has received Food and Drug Administration (FDA) approval. We believe that such a policy benefits Medicare patients in need of treatment by providing uniform and timely access to new TAVR indications upon FDA approval. We support CMS' proposal to require that all TAVR patients be enrolled in a qualified prospective registry that tracks appropriate outcomes data at the patient level. We also commend CMS for recognizing the importance of the multi-disciplinary heart team in the treatment of TAVR patients.

Edwards believes that for appropriately selected Medicare beneficiaries, the evidence is more than adequate for CMS to conclude that TAVR improves health outcomes and should be considered reasonable and necessary under the Medicare statute if provided under the conditions stated above. As we previously noted in our comments submitted at the initiation of the National Coverage Analysis (NCA) for TAVR, Medicare coverage will ensure beneficiary access to a treatment that has been proven effective, is supported by substantial evidence, and has the power to significantly enhance patient well-being.

In a recently published expert consensus document on TAVR1, the national coverage determination (NCD) requestors and other cardiovascular professional societies provide compelling new support for this therapy. Specifically, the societies recommend TAVR for "patients with severe, symptomatic, calcific stenosis of a trileaflet aortic valve who have aortic and vascular anatomy suitable for TAVR and a predicted survival >12 months, and who have a prohibitive surgical risk..." They note that "TAVR is also considered a reasonable alternative to surgical AVR in patients at high surgical risk (PARTNER Trial Criteria: STS . 8%)"

The Placement of AoRTic TraNscathetER Valve Trial (PARTNER Trial), hailed as a landmark trial in cardiovascular medicine, provides the foundational evidentiary basis for FDA approval and Medicare coverage of TAVR. The trial demonstrated a clear and significant survival benefit for inoperable (Cohort B) patients and established TAVR as a less-invasive alternative to open-heart surgery for high-risk (Cohort A) surgical candidates, the vast majority of whom are Medicare patients. As importantly, the trial demonstrated the value of a collaborative approach to treating these very sick patients through the use of dedicated multi-disciplinary heart teams, and provided the first-ever controlled comparison of surgical valve replacement to transcatheter valve replacement. Two very recent data releases have demonstrated further positive results in TAVR patients: Cohort B patients followed out to two years, and Cohort A transapical patients who received TAVR through a continued access protocol. These findings contribute to the large and growing body of peer-reviewed published literature and systematic reviews of the evidence demonstrating that TAVR improves health outcomes.

As the leader in the research and development of heart valve replacement therapy for more than 50 years, Edwards remains dedicated to the continued development of more effective evidence-based treatment options for patients suffering from aortic stenosis and structural heart disease. We have always worked closely with clinical leaders in the field and regulatory agencies to design the most appropriate clinical trials to best address critical questions of safety and effectiveness.

TAVR technology is rapidly evolving, but is not new. The first procedure was performed over ten years ago and the SAPIEN transcatheter heart valve received CE Mark in Europe in 2007. To date, Edwards' transcatheter aortic valves have been implanted in more than 25,000 patients in 51 countries around the world. With the exception of Belgium, all Western European countries provide eligible patients with access to TAVR. On November 2, 2011, the Edwards SAPIEN transcatheter heart valve was approved for use in the US by the FDA for transfemoral delivery in inoperable patients.

CMS' proposed requirement limiting coverage for unlabeled uses to "superiority trials" undermines the agency's efforts to promote continued US-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes. Noninferiority and other clinical trial designs play an important role in the advancement of medical technology. The FDA has routinely approved noninferiority trial designs as the basis for device approvals, considering them the best methodological approach where existing standards of care are well-established and effective. Therefore, we believe patients benefit from continued evidence generation for new indications and next generation TAVR devices through continued coverage of Category B Investigational Device Exemption (IDE) trials approved by the FDA, including noninferiority trial designs.

Edwards also recognizes that an IDE trial may not be possible for some important, but small, patient populations that otherwise would not be eligible for coverage under the proposed decision. We support the requestors' proposed NCD language addressing Medicare coverage for certain unlabeled indications that would be most appropriately provided under Coverage with Evidence Development (CED). Specifically, we agree that the covered clinical circumstances should include, among others noted by the requestors, "valve-in-valve" patients, End-Stage Renal Disease (ESRD) patients, and patients with untreated clinically significant coronary artery disease requiring concomitant revascularization. Medicare coverage under CED for these populations should be allowed under circumstances where patient outcomes will be assessed through well-designed and controlled observational studies with participation in a prospective national registry.

Based on our experience conducting pivotal clinical trials and providing TAVR in hundreds of centers around the world, excellent patient outcomes are best achieved when TAVR programs are located in institutions that are highly experienced in cardiac care. It is also imperative that at least two engaged cardiothoracic surgeons and two interventional cardiologists at each site coordinate all clinicians to form a high-functioning multi-disciplinary heart team, a key concept integral to assuring TAVR success. Therefore, we support appropriate facility and heart team criteria-rather than traditional individual physician-based credentialing-in order to achieve this goal.

For patients too sick to undergo surgery, TAVR improved survival by 20 percentage points at one year. On this basis, the number needed to treat to save a life was approximately five. 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 10-year reduction in effective age. In addition, for high-risk operable patients, TAVR provides a less-invasive, clinically-proven alternative treatment option that does not require sternotomy or placing the patient on heart-lung bypass. TAVR also results in faster procedural times, shorter post-operative hospital stays, and shorter recovery periods. Finally, well-designed studies have indicated that TAVR is a cost-effective therapy compared to commonly utilized therapies for other highly comorbid conditions.

Edwards thanks you for your consideration of this submission. Our detailed comments are attached. If you have any questions or would like additional information, please contact me at 202-783-3901, or at Dirksen_Lehman@edwards.com.

Sincerely,

/s/
Dirksen Lehman
Vice President, Government Affairs and Reimbursement

cc: Jonathan Blum
Patrick Conway, MD, MSc
Jyme Schafer, MD, MPH
Lawrence Schott, MD, MS
Sarah Fulton

---

1 Holmes DR Jr., Mack MJ, Kaul S., et al. 2012 ACCF/AATS/SCAI/STS Expert Consensus Document on Transcatheter Aortic Valve Replacement, Journal of the American College of Cardiology (2012), doi: 10.1016/j.jacc.2012.01.001.

Attachment

Less

Submitted Electronically

March 2, 2012

Louis B. Jacques, MD
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: Proposed Medicare Coverage Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR)

Dear Dr. Jacques:

St. Jude Medical, Inc. is pleased to submit the following comments on the proposed Medicare coverage decision memorandum for Transcatheter Aortic Valve Replacement (TAVR) procedures that was posted on the Centers for Medicare and Medicaid Services (CMS) website on February 2, 2012. In its decision memorandum, CMS has proposed to restrict coverage of TAVR procedures for both labeled and unlabeled uses to studies conducted under Coverage with Evidence Development (CED). We have a number of specific comments on this document, including the conditions proposed for both the labeled and unlabeled uses of TAVR.

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is developing a TAVR device and is currently conducting a clinical study with this device in Europe.

Our comments are organized around the two patient indication groupings identified by CMS in the proposed coverage determination: the labeled use of TAVR—when the procedure is furnished for an FDA-approved indication with a complete valve and implantation system that has received FDA pre-market approval (PMA) for this indication, and the unlabeled uses of TAVR.

Labeled Uses of TAVR

Proposed Coverage Determination. As we stated in our October 28, 2011 comments on the initiation of the TAVR National Coverage Analysis, we consider the clinical evidence concerning the benefits of TAVR to be clear and conclusive. The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrates that TAVR is a superior alternative to medical management in patients with severe aortic stenosis who are not suitable candidates for surgery. Cohort B of the PARTNER trial shows that TAVR was responsible for a twenty percentage point reduction in the rate of death from any cause at one year when compared to standard therapy. In our view, this evidence is compelling, and the case for Medicare coverage is a strong one.

In the proposed coverage determination, CMS stated that it would cover the labeled uses of TAVR within the context of the Coverage with Study Participation form of CED, consistent with the coverage request made by the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) in September, 2011. That request suggested restricting TAVR coverage to specialized heart centers using a multidisciplinary team to co-manage decision-making and implantation procedures. The professional societies also suggested that a joint STS-ACC TVT Registry be used to follow patients. In the proposed coverage determination, CMS chose to cover TAVR when the procedure is furnished for an FDA-approved indication with a complete valve and implantation system that has received FDA pre-market approval (PMA) for this indication.

St. Jude Medical supports close monitoring of the outcomes associated with TAVR procedures through participation in a carefully monitored CED registry. We also support added safety protections for patients by restricting TAVR procedures to the most capable practitioners and facilities. We are pleased that beneficiaries will have access to this important new medical technology under CED.

Facility and Professional Requirements. St. Jude Medical supports taking steps to ensure the safety of patients eligible for TAVR procedures by restricting this procedure to certain sites where it is performed by the most experienced physicians. In the proposed coverage determination, CMS identifies a number of requirements—some very precise—that centers must meet in order to perform Medicare-covered TAVR procedures. The proposed coverage determination also provides detailed specifications for surgeons and interventionalists.

We believe that stakeholders would benefit from a more detailed explanation of how facility accreditation will be managed by CMS in the final coverage determination for TAVR procedures. In addition, we recommend that CMS require the criteria used for selecting both participating facilities and qualified physicians to be reviewed and updated as experience is gained with the TAVR procedure and as technology advances occur. We expect that these requirements will need to be periodically reviewed, fine-tuned and adjusted if beneficiaries are to receive the care they deserve, and we hope that various stakeholders, including medical device manufacturers, will be included in this process.

With regard to the criterion dealing with the required institutional follow-up of patients, we ask that CMS provide more specificity on the length of this required activity, as well as the type of information that would be necessary. Given patient referral patterns for these procedures, there may be challenges in tracking patients that will impact facility compliance.

CED Registry for TAVR. As mentioned above, St. Jude Medical supports a registry to monitor the outcomes of TAVR procedures. A TAVR registry will contribute to our knowledge of this important new medical advance, and it is likely to generate hypotheses that will be the subject of further study in clinical trials.

We anticipate that the registry will assist CMS in adjusting Medicare coverage policy with respect to the patient subgroups that would benefit most from this procedure. In addition, we believe that the registry will provide useful information on site-of-care restrictions and professional expertise requirements that are most appropriate for the TAVR procedure. This underscores the need for periodic review (and revision, if necessary) of the facility requirements that are put in place as recommended above.

We agree with the requirement in the proposed coverage determination that the registry must be designed to permit the identification and analysis of patient, practitioner and facility factors that predict patient outcomes. However, the outcomes that are specified are quite general, and leave much room for interpretation. For example, the outcomes identified include both major and minor stroke and acute kidney injury, but no specific definitions are provided.

If the TAVR registry is to provide meaningful data and lead to productive research, the outcomes that are tracked need precise definition. We suggest that you develop these definitions, and in doing so, consider the work in this area performed by the Valve Academic Research Consortium (VARC) for transcatheter aortic valve implantation. VARC has taken a collaborative approach to developing definitions of TAVR clinical endpoints, which include major and minor stroke and acute kidney injury, as well as a number of other outcomes. We understand that FDA is currently addressing these definitions as well, and we urge you to consider that approach.

We also note that CMS includes quality of life measures in its listing of required outcomes that must be tracked by the TAVR registry. Because this matter can be addressed in any of a number of ways, we suggest that CMS provide specific direction on how this outcome should be addressed in the registry.

In our view, a consistent approach must be taken in defining each of the outcomes that have been identified for the TAVR registry, and we ask that CMS provides more detail on these metrics as it finalizes this coverage determination. If these general outcomes are to be defined after the coverage determination is finalized, we ask that the specific outcomes definitions be vetted through a stakeholder advisory group that includes medical device manufacturers.

We also have questions concerning how the information collected by this TAVR registry will be utilized. There is no mention in the proposed coverage determination concerning the end points of this clinical study, how the data that is collected will be verified, reviewed, and analyzed, or whether (and how) it will be made available. We believe that these are important matters that impact the credibility of the registry, and that they should be clarified for stakeholders.

Because St. Jude Medical is currently conducting a TAVR clinical study in Europe, we have a natural interest in the establishment and execution of the CED registry that has been proposed. However, we recognize that a number of data collection, study design, patient enrollment and other operational matters have already been addressed with what appears to be limited input from stakeholders. We ask that this registry be structured to ensure a full range of stakeholder participation, including medical device manufacturers, in these important matters in order to address any differences of opinion that might arise and to ensure its proper implementation.

Unlabeled Uses of TAVR

Proposed Coverage Determination. The proposed decision memorandum states that coverage of unlabeled uses of TAVR should be restricted to CED clinical trials (not a TAVR registry) performed by expert multi-disciplinary heart teams in facilities that meet specified requirements. In the proposed coverage determination, CMS states the concerns it has with covering TAVR for operable patients with severe symptomatic aortic stenosis, and proposes that clinical trials meeting specified criteria should be covered under CED for the purpose of generating evidence in this area.

St. Jude Medical understands the challenges that exist in distinguishing which of these operable patients would most benefit from the TAVR procedure, and agrees with CMS that additional evidence should be generated through CED clinical trials.

CED Clinical Trials. The proposed TAVR coverage determination states that coverage for unlabeled uses will only be provided in clinical trials that have a particular study design. Trials with a “superiority” study design are proposed to be covered, while trials with a “non-inferiority” study design would not be covered. Although St. Jude Medical is pleased that Medicare beneficiaries with severe symptomatic aortic stenosis (including those who are deemed candidates for surgical valve replacement) will have access to the TAVR procedure in clinical trials, we believe that the restrictions on study methodology that are set forth in the proposed coverage determination are not appropriate.

This restriction appears to contradict existing CMS guidance and instruction on the purpose and conduct of CED studies. The CED Guidance Document that is referenced in the proposed decision memorandum was developed in 2005 and published in final form by CMS in 2006. It states that “CMS will not routinely be involved in the design, review, or execution of research studies.” For CMS to exclude unilaterally a particular clinical trial study design from consideration for CED coverage appears to be a radical change in policy that could deter enrollment of Medicare beneficiaries in future clinical trials.

St. Jude Medical recognizes that CMS will have preferences in the type of study that might be most appropriate to generate the evidence necessary under CED to inform a national coverage determination. For example, in the proposed determination for TAVR, CMS expresses a preference for registry data for labeled indications and clinical trials for unlabeled indications. As for the specifics of the study design for these various indications, we recommend that CMS respond to the specific study designs that are presented by stakeholders without pre-judging the respective studies. We understand that CMS would not be bound to accept the study designs suggested by stakeholders, however we do not agree that CMS should rule out a particular study design in advance of reviewing the respective details of a clinical study plan.

We believe that a policy that preemptively covers only TAVR clinical trials with a “superiority” study design, and that rules out those with a “non-inferiority” study design, is extremely limiting and will adversely impact the ability to develop additional clinical evidence of this therapy going forward. When evaluating the most appropriate method of study to answer relevant clinical questions, many factors must be taken into consideration including the patient population, treatment alternatives, and the primary and secondary endpoints of the study. Non-inferiority trials have provided significant clinical evidence for various therapies, and may be the most appropriate study design for future studies depending on questions the study is intended to answer. We strongly encourage CMS to evaluate each specific clinical study design based on the totality of evidence to be obtained in the study, and not pre-determine what study designs will or will not be afforded coverage without first analyzing the study in detail. In order to support the generation of evidence to inform national Medicare coverage decision-making, which is the objective of the CED policy, CMS should evaluate each trial design on its own merits based on the research questions that are being addressed, recognizing that some trials may not fit neatly into one particular classification.

St. Jude Medical is also concerned that denying coverage to TAVR clinical trials without a “superiority” study design could have a negative impact on clinical trials that are currently underway. These trials may be conducted under FDA supervision as IDE trials, and the studies may provide important information concerning the impact of TAVR procedures. For CMS to eliminate a particular study design for a TAVR trial, as it proposes to do, would inappropriately deny beneficiaries access to promising care and negatively impact the trials themselves.

Other Proposed Standards for Clinical Trial Coverage under CED. In the proposed coverage determination, CMS cites a number of characteristics that clinical trials must meet in order to be covered under CED for unlabeled uses of TAVR. Many of these characteristics are drawn from the Medicare National Coverage Determination (NCD) for Routine Costs in Clinical Trials (Medicare Coverage Manual 310.1). These standards have applied to CED trials since July 9, 2007. Some relate to a requirement for clinical trials to be registered on the www.ClinicalTrials.gov website.

We note that the proposed coverage determination also includes additional requirements that have been added to certain of the required trial characteristics specified in the Medicare NCD for Routine Costs in Clinical Trials. The first situation in which this occurs deals with the required compliance with applicable Federal regulations concerning the protection of human subjects. The proposed coverage determination adds in a reference to the Code of Federal Regulations—45 CFR Part 46 (which applies to federally-funded studies), and goes on to specify that: “If a study is regulated by the Food and Drug Administration (FDA), it also must be in compliance with 21 CFR Parts 50 and 56.” The latter reference is to FDA IDE trials of medical devices.

By inserting the additional wording and regulatory references, CMS appears to be requiring that a medical device trial for FDA IDE purposes must meet both the requirements for federally-funded studies (45 CFR Part 46) and the applicable FDA IDE requirements (21 CFR Parts 50 and 56). These requirements differ in certain respects, though both sets of requirements share the same purpose.

We do not think it would be appropriate to require FDA IDE trials to comply with both requirements because the common rule requirements that apply to federally-funded studies and the FDA IDE trials have already been harmonized to the extent possible. If CMS intends that FDA IDE clinical trials of unlabeled TAVR uses must concurrently meet both of these requirements concerning the protection of human subjects, it should explain why this is necessary. Federally-funded studies should comply with the requirements set forth at 45 CFR Part 46; and FDA IDE trials should comply with the requirements set forth at 21 CFR Parts 50 and 56.

The second situation in which the proposed coverage determination includes additional requirements to the required trial characteristics specified in the Medicare NCD for Routine Costs in Clinical Trials deals with studies of toxicity or disease pathophysiology in healthy individuals. The new proposed requirement states that: “Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21CFR §312.81(a) and the patient has no other viable treatment options.”

The regulation that is referenced relates to FDA investigational new drug applications, not medical devices, and the requirement that trials must be restricted to life-saving situations where the patient has no other treatment alternatives appears to be at odds with the purpose of some of the TAVR CED clinical trials of unlabeled uses. The proposed coverage determination states that TAVR CED clinical trials are to include studies that address the risk and benefits of TAVR in operable patients with severe symptomatic aortic stenosis. We ask that CMS provide clarification of this new proposed requirement. It is clear from the proposed coverage determination that operable patients are expected to be included in CED clinical trials of unlabeled uses.

*****

Thank you for the opportunity to share our views on this important proposed coverage determination. Do not hesitate to contact me directly if you have any questions. I can be reached directly at 651-756-6576 or cvolker@sjm.com.

Sincerely,

Christopher R. Volker
Vice President, Health Economics
Cardiovascular Division

Less

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

Dear Dr. Jacques:

As a clinical interventional cardiologist, as a member of the steering committee for the STS-ACC TVT Registry, and as an investigator in the domain of valvular heart disease I respectfully submit these comments. There are six points for your consideration in the domain of qualifications and requirements for sites and individuals to perform TAVR.

1) Geographic issues related to patient access are critically important for a new technology that reduces mortality, improves QOL, and is cost effective. The burden for long distance travel for TAVR eligible patients and their families is especially pronounced. The draft NCD as well as the professional societies' consensus statement do not account for the need to provide access to patients who live in regions of our country where population density is low, distances are great, and medical institutions are smaller. The NCD should mandate geographic-based patient access to TAVR that trumps criteria that have been recommended that are relevant to only heavily populated regions of the US.

2) Institutions and individuals already involved in TAVR clinical trials and have established TAVR programs also must be considered separately. There are sites that have or soon will be involved in the clinical trials related to TAVR who may or may not meet the new requirements set forth by the professional societies. The same applies to sites that have already begun TAVR programs during the commercial release of Sapien. It is recommended that at the time of a final NCD announcement that these sites be considered approved sites by CMS. They have already undergone extensive scrutiny by the two medical device companies and have made large investments of resources in starting these programs. These efforts and the patients awaiting treatment should not be aborted by a CMS ruling only relying on professional society dictates.

3) The professional societies' consensus statement must be interpreted with caution by CMS. The change in requirements for operator and institution requirements from the initial proposal incorporated in the first CMS draft and the recently release professional society consensus statement demonstrates the difficulties in coming up with such standards and requirements related to quality of subsequent TAVR programs, the arbitrariness of some of the requirements, and the clear lack of an evidence base to support many of their recommendations. Despite their well meaning efforts the process of "consensus" development has also not been transparent to the cardiovascular professional community and there has never been a "public comment" period for any of us to respond. The process is therefore consensus among a few and release of final recommendations in the eleventh hour of the important CMS public comment period. Even amongst leadership of the involved professional societies there is disagreement that is not publically known.

4) As an editor of a recently released textbook on structural heart disease interventions I can attest to the unique fund of knowledge and skill sets involved in TAVR. The emphasis on these unique skill sets in the professional society consensus statement is appropriate especially during the initial phase of TAVR dissemination in the US. There is no outcome-volume relationship established in PCI and the use of PCI criteria has some but not major relevance to TAVR. It is also clear from European experience that surgical AVR volume does not predict outcomes for TAVR programs.

5) The voice of the medical industry involved in TAVR introduction over the last few years and in over 40 countries in the world now including the US must be heard. They do have experience in site selection, training, and determinants of optimizing outcomes. While their voice should not be the only voice, they should be able to provide their input into this most important question and process development.

6) How TAVR is "rolled out" to the US medical system will be importantly influenced by the final CMS NCD. It clearly has implications for subsequent new technologies, referral patterns, and the rise and fall of medical institutions. Thus the intensity of interest in the specifics of the CMS final NCD is justified. This is not a good approach to redesigning the US medical system. CMS needs to be wary of unintended consequences of this NCD.

I respectively submit these comments to you and hope they are constructive in your most difficult and important task.

John D. Carroll, MD
Professor of Medicine
University of Colorado Denver
Director, Interventional Cardiology
Medical Director, Cardiac and Vascular Center
University of Colorado Hospital
Office 720 848-6508
FAX 720 848-7315

Less

TAVR can be a lifesaving procedure for patients who are at high risk for conventional AVR. However, the avilability of TAVR is limited to only a few centers. CMS stipulation for interventionalists to have performed 50 structural interventions is ridiculous. Only operators that will meet these numbers are those from TAVR cenmters such as Cedar Sinai, Cleaveland clnic and Columbia. This will create jeoparady to a state such as West virginia. We will never be able to offer TAVR to our patients. Some of them cannot travel out of state to get evluated for TAVR due to limited family support, insurance and financial support. They will just die with repeat admissions to hospital for aortic stenosis symptoms. The reasonable number for interventionalists who wish to perform TAVR should be 12 or 15 Aortic balloon valvuloplasty cases. More important will be to have experience in vascular access management and use of devices such as AAA or TAA.

Less

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

Dear Dr. Jacques,

While I generally agree with the overall guidance with regards to the application of TAVR technology, I do have concerns regarding the restrictive availability inherent to the limitation of CMS coverage to facilities and operators that meet criteria listed in the January 10, 2012 ACC/STS request letter. Specifically, I take issue with the “Individual requirements”. I agree that professional structural procedural volume/experience may add to an operator’s competence in selecting appropriate candidates for TAVR and most certainly contributes to an operator’s technical capabilities however, such a restriction does not take into account pre-professional experience with structural heart interventions, including specific fellowship training. Aside from interventional cardiologists at PARTNER participating centers (i.e.: the vast majority of private practice interventional cardiologists as well as the majority of interventionalists in the academic setting) it would be remarkably difficult to identify operators who have performed 50 or more structural interventions (excluding ASD and PFO closures) in their professional career. To meet this requirement, aside from PARTNER site operators, a qualified operator by the outlined criteria will have had to either been in practice for an exceptionally long time or have been performing an unacceptably large number of balloon valvuloplasty procedures. These qualities do not necessarily describe the most qualified individuals to perform these procedures. In fact, these same requirements could conceivably exclude a number of PARTNER site operators from performing the very procedure that has now gained FDA approval based in part on their experience. Further, this restrictive definition of a qualified operator would essentially disqualify potentially remarkably well qualified operators, even those with specific training in structural heart disease including TAVR, from performing this procedure in a private or non-PARTNER participant institution if they are recently out of training. The ability to ethically select appropriate patient candidates and the application of tempered restraint when considering the performance of such invasive and technically demanding procedures such as TAVR should be considered the most important individual requirements. Unfortunately, there is no means by which CMS can reliably assess these attributes in individual operators. As such, it is understandable that an experience/volume criterion be applied as an “individual requirement” but the absence of an alternate means of identifying qualified operators does not make this specific requirement any more rigorous.

I would argue that at a minimum, institutional requirements should be met, including surgical and interventional program requirements for CMS coverage of TAVR as outlined in the ACC/STS letter. It is also imperative that all centers considered for CMS coverage of TAVR participate in a prospective national TAVR study and/or registry. The selection of qualified individual operators, however, should be internally dictated by the governing bodies within high quality cardiac centers as opposed to being based upon CMS determination. The proposed individual requirement will only restrict this technology to an insufficient number of centers, thereby depriving appropriate candidates from consideration of TAVR based on geographic isolation. To ensure adequate patient access, qualified hospitals should be granted coverage for this technology and given the opportunity to demonstrate the ability to deliver high-quality results, as opposed to being disqualified from coverage based on individual historical operator volumes.

Respectfully,
Jacob Green, MD
Tricity Cardiolovascular Consultants
Banner Heart Hospital
Mesa, Arizona

Less

Bronson Healthcare Group (BHG) is pleased to provide comments on the Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N). Bronson Methodist Hospital (BMH), the flagship hospital for BHG, is a 405-bed tertiary care hospital serving 9-counties in southwest Michigan with a population of approximately one million residents. BMH is a winner of the Malcolm Baldrige National Quality Award (2005), and has been recognized by Thomson Reuters as a Top 100 Hospital (2011, 2010, 2006) and a Top 100 Hospital for Heart Care (2008). Bronson has been named a Distinguished Hospital for Clinical Excellence by HealthGrades (2009-2012), and has received the HealthGrades Patient Safety Excellence Award for the past two years. In addition, Bronson is one of only 26 hospitals in the nation to be recognized in 2011 by the American College of Surgeons National Surgical Quality Improvement Program for exemplary surgical outcomes.

Bronson supports coverage for TAVR. We have concerns, however, about the Proposed National Coverage Decision (NDC) institutional requirements in Section 3.a.i.1 and interventionalist requirements in Section 4.b.ii.

Institutional Requirements:

Bronson is concerned that the institutional requirements of the proposed NDC will result in many patients having to travel a significant distance in order to have access to this life-saving technology. This travel requirement will be a substantial barrier to care, particularly for vulnerable populations such as the elderly, disabled and persons living in poverty. Research indicates that travel distance to health care has a significant impact on whether patients receive optimal care. This is especially true for older patients, patients living in zip codes with high concentrations of poverty, and patients in rural and small metropolitan areas. (Boscoe FP, et al. 2011; Strauss K, et al. 2006; Brual J, et al. 2010.) We know that only about one-half of patients with severe aortic stenosis are referred to a cardiothoracic surgeon today. (Bach DS, 2011.) Long travel-times for TAVR access will do little to reduce this dramatic gap in the receipt of optimal care and may exacerbate the problem.

Bronson proposes that geographic access to TAVR be improved, while preserving quality of care, by permitting multiple hospitals to collaborate in meeting institutional requirements in the NCD. Where two or more hospitals agree to create one experienced Heart Team, performing TAVR in one facility, Bronson proposes these hospitals be permitted to combine the experience of their Heart Team members to meet the institutional requirements of the NCD. Not only will this reduce barriers to care, but it will also enhance continuity and coordination of patient care by enabling engagement of critical physicians and services in the region beyond the Heart Team (e.g., primary care physicians, cardiologists, cardiac rehabilitation programs).

Interventionalist Requirements:

Bronson also has concerns about the interventionalist requirements in Section 4.b.ii. As has been stated in other public comments during the current comment period, we are unaware of evidence to indicate that interventional cardiologist experience with procedures such as patent foramen ovale or atrial septal defect repair is relevant to skills required for TAVR. Interventionalist requirements including significant experience with rarely performed balloon aortic valvuloplasties and percutaneous ventricular assist devices would exclude many high quality institutions and interventionalists from treating appropriate patients with TAVR. We propose that required experience for these latter two procedures be combined and significantly reduced.

Thank you for the opportunity to comment. We look forward to an NDC that creates appropriate access to TAVR for all patients that can benefit from this life-saving technology.

References:

Boscoe FP, et al. Geographic proximity to treatment for early stage breast cancer and likelihood of mastectomy. Breast. 2011 Aug;20(4):324-8.
Strauss K, et al. Driving distance as a barrier to glycemic control in diabetes. J Gen Intern Med. 2006 Apr;21(4):378-80.
Brual J, et al. Drive time to cardiac rehabilitation: at what point does it affect utilization? International J Health Geographics 2010; 9(27).
Bach DS, Prevalence and characteristics of unoperated patients with severe aortic stenosis. J Heart Valve Dis. 2011 May;20(3):282-3.

Less

Dear Sir or Madam:

We represent a cardiovascular team that has been actively preparing for two years to offer percutaneous aortic valve replacement to a metropolitan area with a primary patient base of over 500,000. We have read and evaluated the recent proposed decision memo for transcatheter aortic valve replacement and would like to offer comments for consideration.

Among our team are two board certified interventional cardiologists both relatively recent graduates of fellowship training at participant organizations in the PARTNER trial and who have direct experience with TAVR and have been active in structural heart disease since graduation. Our board certified cardiothoracic surgeons are partners in a busy practice that performed 200 aortic valve replacements, 250 mitral valve replacements and 1100 coronary artery bypass surgeries last year.

We are in strong agreement with the outlined physician qualification and reporting requirements but would like to offer our perspective on the institutional requirements.

Our metro area includes 5 hospitals that offer cardiac intervention and cardiothoracic surgery. Our surgical and interventional volumes per operator are easily within the specified requirements. However, patient preference and random allocation of coronary and valvular disease result in an even distribution of surgical procedures among the institutions in our area such that while having access to high quality operating rooms, cath labs and staffing we would likely would not meet the annual 50 case requirement at most hospitals. Perioperative care of open-heart patients whether following valvular, coronary bypass or vascular surgery is essentially identical and the insistence on a minimum AVR volume for the institution seems a curious benchmark.

The financial commitment to offer TAVR on the part of any hospital is not insignificant and while we are fortunate enough to have at least one hospital willing to support TAVR the AVR volume at this superb facility will fall short of the currently proscribed number.

Geographically, we are positioned as the only reasonable TAVR center for a significant patient population. In our experience, qualified patients are, many times, reluctant to travel even short distances to have pre-procedural testing much less the 150 miles that may be required for a major cardiac procedure. The effect of the institutional volume requirement, as currently written, would be tantamount to rationing this life-saving procedure to our patients.

We would ask that consideration be given to changing the institutional requirement to include an appropriate minimum total open-heart surgical volume or allowing consideration on a case-by-case basis to centers with appropriately trained and experienced operators who choose to offer TAVR at surgical centers that may fall short of the proposed AVR volume requirements.

Respectfully submitted,

John M. Galla, MD FACC FSCAI
Arthur G. Grant III, MD FACC FSCAI FAHA
Cardiology Associates of Mobile
3715 Dauphin St. Suite 4400
Mobile, AL 36608

Less

March 2, 2012

Louis Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Department of Health and Humans Services
Attention: CAG-00430N
7500 Security Boulevard
Baltimore, Maryland 21244-1850

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

Dear Dr. Jacques:

On behalf of the 3,000 cardiologists in private practice and within integrated medical organizations across the country that we represent, the Cardiology Advocacy Alliance (CAA) submits the following observations about the proposed National Coverage Decision for Transcatheter Aortic Valve Replacement (TAVR). CAA’s mission is to support the sustainability of the cardiovascular professional regardless of practice setting. CAA represents the common interests of the cardiovascular patient and professional on such issues and encourages its members to advocate for their patients and their practices.

CAA contends that the elements required for success in TAVR procedures will be based upon the very skillful patient selection for the program and a heart team capable of working together. The guidelines should therefore reinforce that the TAVR team, comprised of interventional cardiologists, cardiac surgeons, anesthesiologists, non-invasive cardiologists and many other hospital staff members, demonstrate their commitment to the heart team concept, receive training and have the professional experience to complete these procedures.

CAA is responding to the Preliminary Guidance from SCAI, AATS, ACCF and SCAI to CMS – Institutional and Operator Requirements for Transcatheter Aortic Valve Replacement. Specifically, under the proposed requirements for a new center to be considered for TAVR coverage, the policy would require new centers to report TAVR procedures into a national registry. Further, the policy would require as individual requirements both board certification and professional experience with 50 structural heart procedures.

CAA recommends that for the new center individual requirements that the policy:

• Stipulate that new centers demonstrate participation and reporting in the national TAVR registry, in addition to demonstrated patient follow-up, as part of their application
  
• Clarify the term “structural heart procedures” and include examples of qualifying procedures performed by an interventionalist
  
• Clarify the term “performed” in the context of the demonstration of physician qualification and experience (e.g., observation of another physicians performing the procedure; first assistant; primary operator; etc.)

Thank you very much for the opportunity to share our thoughts on this proposed coverage decision. Our members and staff are available as resources to you as you examine and address the concerns outlined above. Please feel free to contact Jen Searfoss, Executive Director, at 202-505-2221 or jen@cardiologycaa.com for any assistance.

Sincerely,

Dan Caldwell, President

Mark Victor, M.D.Vice President, Medical Affairs

Less

March 2, 2012

Marilyn B. Tavenner
Acting Administrator
Centers for Medicare and Medicaid Services
United States Department of Health and Human Services
Hubert H. Humphrey Building – Room 445G
200 Independence Avenue SW
Washington, DC 20201

Re: Proposed National Coverage Decision (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

Dear Ms. Tavenner:

Thank you for bringing to our attention that the Centers for Medicare and Medicaid Services (CMS) released a proposed national coverage decision for transcatheter aortic valve replacement (TAVR) on February 2, 2012. We commend you for the Centers’ innovative and flexible approach to Medicare coverage of TAVR, and appreciate your embrace of new technology. It is important that Medicare provide beneficiaries access to new and innovative medical therapies while providing measured safeguards to ensure that there is appropriate and safe utilization. We believe that CMS has proposed a responsible approach to coverage for Food & Drug Administration (FDA)-approved devices in this case, but we also have some serious concerns regarding CMS’s approach to coverage for unapproved devices in clinical trials that could impede innovation and patient access to the latest and best medical technology.

As you mentioned in your February 2nd blog posting , TAVR is new, less invasive approach to open heart surgery to treat severe aortic stenosis, a debilitating disease that typically results in death. Evidence published in the New England Journal of Medicine indicates this new therapy has the potential to save lives and significantly improve the quality of life for many Medicare beneficiaries who have no other options for treatment. We agree with you that because this technology is still relatively new, it is important that these procedures are performed by highly trained professionals in optimally equipped facilities. The proposed NCD would require that certain provider, facility, and data collection criteria be met to ensure beneficiaries receive the safest and most appropriate care. We agree with these approaches, particularly:

• Flexible coverage for all current and future FDA-approved uses of the technology. As you know, new medical devices go through rapid innovation cycles. In this case, a more advanced version of the medical device is already on the market in Europe, and multiple device manufacturers plan to seek approvals for new alternative devices and indications within a matter of months. Your proposed approach to coverage will allow new versions of the technology to reach expanded populations of patients immediately upon FDA approval without having to re-open CMS’s national coverage decision.
• Reasonable criteria for which hospitals and operators are authorized to provide the technology. We agree that it is important to establish certain criteria so that procedures are performed by highly trained professionals in optimally equipped facilities. While the criteria that have been proposed appear to be reasonable, we have heard from various constituencies and have observed in the public comments to date that there is some disagreement with how difficult it may be for some hospitals to meet the proposed criteria. CMS should consider the concerns of hospitals and clinicians to ensure that an appropriate balance is struck between safe use of the technology and patient access, particularly as it impacts patients that live in rural areas of the country.
• Collection of patient outcomes data through a national registry. While clinical trials provide excellent insight into how a therapy can help patients, it is important to have a method to continue monitoring and evaluation of post-market experience with this and future transcatheter devices and procedures. A standardized, evidence-based data source could offer insight into clinical practice patterns and patient outcomes to help improve quality. CMS should be careful to ensure that appropriate oversight and management of the registry ensures that data privacy is protected and responsible interpretation and reporting of the data occurs.

While TAVR is a relatively new procedure in the United States, we should be mindful that this technology is not new in many countries. When FDA approved the technology on November 2, 2011, it has been available in Europe for more than four years and has treated more than 50,000 patients throughout the world. Newer, better versions of the device are already being provided to patients outside the United States and manufacturers are currently working to conduct U.S. clinical trials so that Americans can get access to the latest version of the technology in the coming years.

It is with this in mind that we express our serious concerns with a provision of the proposed NCD limiting coverage to clinical trials that are designed to demonstrate “superiority.” As outlined in by FDA , superiority is an appropriate measure to establish the safety or efficacy of a medical device when there is no alternative therapy. But when there is an existing, established therapy (in this case, open-heart surgery), future clinical trials should only need to demonstrate clinical non-inferiority, based on the well-accepted premise that a much-less invasive procedure holds promise for substantial ancillary benefits, above survival. Because of this, since the early 1980’s FDA has considered and approved “non-inferiority” trials.

CMS’s proposed limitation to coverage of clinical trials with a “superiority design” contradicts past CMS and FDA policies in support of clinical research, and has many potential negative public policy implications if CMS is considering applying this requirement in future coverage decisions:

• Driving up costs of coverage: superiority trials are usually much larger, so Medicare would be responsible for covering a much larger patient population under this scenario.
• Reducing competition: superiority trials are particularly difficult to run when there is already a proven alternative technology on the market, thereby creating an unfair advantage to the first-to-market incumbent.
• Discouraging United States-based medical innovation: by adding yet another hurdle and cost to securing FDA approval and CMS reimbursement, CMS’s “superiority design” requirement would have the unintended consequence of discouraging the development of new innovations at the earliest stages of development.
• Driving clinical trials and jobs overseas: Assuming medical device companies find it financially infeasible to cover the medical charges of clinical trial participants in the United States, a potential outcome could be a company deciding to conduct the trial outside the United States.
• Reduce the discoveries for small, undertreated populations: For smaller populations, clinical trials may be impractical due to inadequate sample size and the lengthy time to enroll patients in a trial. Adding a “superiority” requirement to the trial would most definitely eliminate the opportunity for valuable research in these areas.

Therefore, we recommend that CMS eliminate the superiority design requirement from Sec. B(1)(i) of the Proposed NCD.

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

Sincerely,

Brian Bilbray
Member of Congress

Jim Matheson
Member of Congress

Copy: Jennifer Boulanger, Acting Director, Office of Legislation, Centers for Medicare & Medicaid Services

Less

Dear Sir/Madam,

We are writing to you in regards to the Proposed Coverage Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR).

We believe this to be an exciting new therapeutic modality able to provide life saving benefit to carefully selected patients. We wholeheartedly agree that use of this technology should be limited, at least in the initial period, to centers and operators that have the demonstrated expertise, interdisciplinary support and institutional infrastructure in place to provide this procedure safely.

We support the Memorandum as currently written but would like to bring to your attention to item A(4)(b)(ii) i.e. the Interventionalist should have “Professional experience with 50 structural heart disease procedures”.

We do not believe that this criterion has good discriminating ability to identify Interventionalists that will be able to perform TAVR safely and successfully. Furthermore, given the dearth of approved devices to treat structural heart diseases, it is likely that many centers renowned for their interventional expertise will be excluded from coverage, and therefore not be able to serve the needs of patients that would truly benefit from TAVR.

As an example, our own center, Essentia Health Saint Mary’s Medical Center, in Duluth, MN has one of the busiest cardiac catheterization labs in the state and a surgery program that would satisfy all the criteria listed in the memorandum. We have a long history of participating in research involving cardiac devices and familiarity with the rigorous process involved in limiting investigational therapies to carefully selected patient populations. Our institution meets or exceeds every criteria listed in the memorandum but may have a problem meeting the “50 structural heart disease procedures” and there are likely a number of other strong programs that could be similarly excluded because of this pre-requisite.

We propose instead, having a more stringent minimum PCI requirement (e.g. only considering programs that perform more than 1000 PCIs/ year) and/or including experience with peripheral vascular procedures for the interventionalists. Both of these metrics, we believe, are better indicators of the depth of experience of operators as well as identifying sites that have the staffing and infrastructure in place to support TAVR.

Thank you for your consideration.

Mudassar Ahmed, MD, MBBS, FACC
Director, Cardiac Catheterization Laboratory
Essentia Health Saint Mary's Medical Center

Wilson Ginete, MD, FACC
Section Chair, Cardiology
Essentia Health Saint Mary's Medical Center

Ron Seibert,
Dirctor Cardiovacular Services,
Essentia Health Saint Mary's Medical Center

Michael Mollerus, MD
Co-Chair, Essentia Health Cardiovascular Services

Thomas Patnoe, MD
President, Essentia Health

Less

Palmetto Health Heart Hospital is South Carolina's only freestanding hospital dedicated solely to the prevention, diagnosis and treatment of cardiovascular disease and serves as a regional referral center for comprehensive cardiovascular services. Our surgeons, cardiologists, and administrators share a firm commitment to delivering extraordinary care that meets the needs of patients in our region. Our hospital is fortunate to have the surgical and interventional cardiology talent that ensures we meet the wide-ranging needs of our patients, most notably the provision of extremely complex care. Currently, we are in the late stages of expanding our offering of hybrid interventions and heart assist device procedures.

The vast majority of both the institutional and provider requirements outlined in the proposed national coverage decision for TAVR seem both reasonable and necessary. However, I would propose adding an additional provision under number 4 for surgeons and interventionalists who are relatively early in their career. They may not meet some of the professional experience volume requirements as proposed; however, they could have trained in a program where they gained the necessary exposure to endovascular and structural heart procedures. As a result, they would possess both the knowledge and experience necessary to successfully perform TAVR procedures.

The additional pathway for these providers will ensure adequate access to care for patients across our country. Heart disease is the second leading cause of death in South Carolina and our state has the 17th highest death rate from cardiovascular disease in the country. Based on these statistics and the resulting patient population we treat on a daily basis it is essential that we don’t restrict access to care for patients in our region.

Thank you for your consideration.

Less

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’ Proposed Coverage Decision Memorandum for Transcatheter Aortic Valve Replacement dated February 2, 2012.

We continue to oppose the adoption of a national coverage decision at this time. While we believe that CMS has the best interest of patients at heart, we continue to be concerned that a rigid national coverage decision will be slow to evolve in a field of medicine that is rapidly changing and we believe that local coverage decisions could adapt more rapidly and appropriately. We wholeheartedly support the 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.

We and three other organizations recently published clinical competency criteria that we recommend be adopted by CMS, if it is determined to set uniform national standards. As you recall from discussions concerning Carotid Stenting coverage, SCAI is a supporter of the Accreditation for Cardiovascular Excellence (ACE) organization to provide ongoing accreditation of facilities. This organization is already developing a process for accreditation for transcatheter valve therapies involving multiple specialties. This would allow for quality oversight, consistent adherence to standards, and validation of data reported to the registries. At this early stage of expansion of TAVR beyond the investigational sites, the availability of an accreditation process would provide a mechanism for consistent quality monitoring and aid in the ongoing process of development of quality metrics.

We would like to emphasize our rationale for suggesting changes to several portions of the CMS Proposed Decision Memorandum:

• Requirement that all interventional cardiologists are either board certified or board eligible – While we support and encourage board certification, there are several unique circumstances that make a rigid criteria such as this inappropriate. Pediatric interventional cardiologists have been at the forefront of developing percutaneous structural cardiovascular procedures, but: they are not ABIM Board Eligible in Interventional Cardiology because they did not enter the field via internal medicine and its cardiology subspecialty.

  Pediatric interventional cardiologists enter this field through pediatric medicine and its cardiology sub-specialty and the pediatric board program has not established a sub-sub board in interventional cardiology. CMS should cover the services of BE/BC pediatric cardiologists who are trained or experienced in structural heart disease interventions and are part of the interventional operating team with the interventional cardiologist and cardiovascular surgeon.

• Requirement that covered clinical studies be designed to show superiority (not non-inferiority). – It isn’t clear whether this requirement means superiority to other percutaneous valves, surgery and/or medical therapy. Superiority to surgery also seems unnecessary and inappropriate for patients that may just want an equal but less invasive approach. Finally, designing a superiority trial against medical therapy may be impossible because of a difficult in identifying a patient population where there would be equipoise. While superiority trials are always welcome, this requirement is excessive and anti-competitive. It should be deleted from the final decision.

CONCLUSION
If CMS finalizes the proposed NCD, we recommend that CMS adopt the clinical competency criteria that SCAI and three other societies have published, that the requirement for BC/BE interventional cardiologists be eliminated and that the clinical trials whose patients would be eligible for coverage need not be superiority trials.

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 Wayne Powell, Sr. Director for Advocacy and Guidelines at 202.742.9869 or wpowell@scai.org, to make arrangements.

Sincerely,

/s/

Christopher J. White, M.D., FSCAI
President

cc: Lawrence Schott, MD, MS, CMS
Sarah McClain, MHS, CMS
Larry S. Dean, MD, FSCAI
James Blankenship, MD, FSCAI
Dawn R. Hopkins

Less

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

SUBMITTED ELECTRONICALLY

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

Dear Dr. Jacques:

The North American Society for Cardiovascular Imaging (NASCI) and American College of Radiology (ACR) applaud CMS’s proposed decision memo posted on February 2, 2012 allowing TAVR national coverage under Coverage with Evidence Development (CED).

Transcatheter Aortic Valve Replacement (TAVR) is a recently developed procedure that allows treatment of severe aortic stenosis in patients who are not surgical candidates. The procedure is less expensive than surgical aortic valve replacement and typically results in shorter hospital stays.

In PMA trials, patients were routinely assessed for suitability for the TAVR procedure by the performance of contrast-enhanced computed tomographic angiography (CTA) of the chest, abdomen and pelvis. The TAVR procedure involves passing a large catheter through the femoral and iliac arteries and the aorta. The prosthetic aortic valve is then advanced through this route in a collapsed form, positioned in the native aortic valve, and expanded in place, displacing the diseased native valves.

Because the catheters necessary to accommodate the collapsed prosthetic valve in TAVR are large, the TAVR procedure can only be attempted if the iliac and common femoral artery luminal dimensions are sufficiently large and without circumferential calcifications that would restrict the compliance of the vessels.

Furthermore, since the prosthetic valve projects into the aortic root, it is possible for the prosthesis to obstruct flow into the coronary arteries if they originate too close to the valve annulus. Therefore, it is important when planning the procedure to determine the distance from the valve annulus to the openings of both the left and right coronary arteries. Finally, pre-procedure knowledge of the 3-dimensional shape of the aortic valve annulus and the distribution of calcium on the valve is important in order to reduce the chance of catastrophic annular rupture during the procedure or perivalvular leak following the procedure.

The most accurate and reliable method for determining these measurements is computed tomographic angiography (CTA) of the heart/chest, abdomen and pelvis, using a cardiac-gated approach in the chest (AB Willson, et al. JACC, 2012; Jilaihawi H, et al. JACC, 2012). In fact, CTA is required by the device manufacturers to determine the suitability of the procedure for each individual patient.

We therefore recommend that CMS approve coverage of the use of CTA of the heart/chest, abdomen, and pelvis for assessing patient suitability pre-TAVR and for procedural TAVR planning.

Thank you for this opportunity to provide comment. NASCI and ACR are pleased to provide feedback and support the proposed decision memo. Please contact Anita McGlothlin at amcglothlin@acr.org with any questions.

Respectfully Submitted,

Geoffrey D. Rubin, MD
President, North American Society for Cardiovascular Imaging

Harvey L. Neiman, MD, FACR
Chief Executive Officer, American College of Radiology

Less

March 2, 2012

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

RE: CMS Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-0043ON)

Dear Dr. Jacques,

National Patient Advocate Foundation (NPAF) welcomes the opportunity to comment on the Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) to approve coverage under section 1862(a)(1)(E) of the Social Security Act, Coverage with Evidence Development (CED) for specific conditions of aortic value disease and at specific institutions.

Since its inception in 1996, NPAF has been the leading voice for millions of patients who have sought care during the diagnosis and treatment of a chronic, debilitating or life-threatening illness. The advocacy activities of NPAF are informed and influenced by the experience of patients who receive direct, sustained services from Patient Advocate Foundation (PAF), which provides professional case management assistance to patients with chronic, debilitating or life-threatening conditions, a great majority of whom suffer from cardiac disease and structural defects of the heart.

In 2011, PAF resolved over 110,000 patient cases and received more than five million additional inquiries from patients nationwide. Most requests were from patients needing assistance with accessing health care – either because they could not afford the care recommended, could not obtain services within reasonable proximity to where they lived, or were denied coverage for services and treatments within the purview of their health plan. Of note, one in four of these patients were Medicare beneficiaries and over 80% of all patients served had some form of medical insurance, whether public or private.

Through its advocacy work in the cardiac community, NPAF has been made aware of the developments in the non-surgical replacement of aortic valves and the advantages this approach promises for patients who are too sick or too debilitated to undergo open heart surgery. We offer these comments based on our 15 years of experience assisting patients with accessing the best care possible for their life-threatening and debilitating disease.

NPAF’s comments are also informed by additional protracted deliberations on TAVR. On February 25, 2012, PAF’s Executive Board and its Scientific Advisory Committee invited Edwards Lifesciences, the manufacturer of SAPIEN Transcatheter Heart Valve, to present at its semi-annual board meeting. A listing of PAF Board and Scientific Committee membership is attached to this letter. Board and Scientific Advisory Committee members were interested in learning more about TAVR, as well as its benefits and risks to patients. After a robust discussion with leadership from Edwards Lifesciences, both the PAF Board and the PAF Scientific Committee were in strong support of the procedure for patients for whom open heart surgery is not an option. Both bodies were satisfied that their concerns regarding possibility of plaque seepage and future strokes were adequately addressed.

NPAF supports the collaborative efforts of professional societies to guide CMS’s Proposed Decision to approve coverage under Section 1862(a)(1)(E) of the Social Security Act. We respectfully recognize the importance of the collaboration and effort demonstrated by the Society of Thoracic Surgeons (STS), American College of Cardiology (ACC), Society for Cardiovascular Angiography and Interventions (SCAI) and the American Association for Thoracic Surgery (AATS) in guiding CMS in its decision for coverage of TAVR. NPAF has long been a supporter of clinical guidelines and professional collaboration for evidence-based research and treatment and applauds the respective societies for their diligence and forethought in recommending an approach that balances the long-standing surgical experience with valve replacement with the innovation of interventional cardiology. We believe the proposed approach to cover TAVR under Coverage with Evidence Development is a prudent approach that respects the current and future clinical advancements in treatment for aortic valve disease.

We are especially supportive of the “team” approach that assures each patient will be thoroughly evaluated for care by both surgeons and interventional cardiologists. We encourage CMS to recognize the importance of informed consent and the value patients place on being an active partner in their treatment decisions. To that end, we recommend that CMS include language in the final coverage decision that emphasizes that patient’s preferences for treatments should be included in any discussion whether to have a surgical or interventional procedure and that treatment decisions be determined on an individual basis.

NPAF supports the inclusion of a prospective national outcomes registry and extends an open invitation for collaboration. NPAF is pleased that CMS’s approach for a prospective national outcomes database under Coverage with Evidence Development is consistent with and builds upon prior recommendations from thought leaders during the Food and Drug Administration’s review and approval process that adverse events associated with TAVR should be closely monitored.

NPAF is a recognized leader in patient access data and its data have informed many national policy decisions. Since its inception, NPAF has valued rigorous data collection and recognized the importance comprehensive, solid data provides policy makers who are charged with making difficult coverage and payment decisions. The PAF database includes data on over 700,000 resolved patient cases and is analyzed on an ongoing basis to determine a myriad of real-time access issues; e.g., barriers to obtaining insurance due to pre-existing conditions; medical debt; employment harassment and discrimination; trends in plan premiums and co-pays; regional, gender, and ethic variables; confusion regarding patients’ rights when claims are denied, etc. These issues are not disease-specific, but cut across all types of chronic disease states, including heart disease.

The results of these analyses are published in the annual Patient Data Analysis Report (PDAR). This document is an important one that can inform your deliberations on future coverage for TAVR during CED and beyond. As stated by Dr. Al Dobson, PDAR collaborator and author, “Overall, as the number of patients assisted by PAF grows, the demographic characteristics of these patients become more representative of the U.S. population.”

As with any patient population that has complex, multi-faceted medical problems, robust data is needed to anticipate and plan for coverage decisions that carefully balance access to care with cost containment. PAF data is often used by CMS, private payers, professional societies, health plans and members of Congress to determine the different types of ways in which patients struggle to receive the care they need. We extend to CMS and the professional societies an open invitation to explore how PAF data can assist in the prospective data registry for TAVR to better determine, for example, quality of life measures and access to care (e.g., disruption of services, denied claims, limits in plan coverage, restriction on providers, etc.).

NPAF encourages CMS to recognize that restrictions on facility and provider experience could limit patients’ access to the procedure. In 2010, 25% of the patients served by PAF were Medicare beneficiaries; about 58% of them qualified on the basis of age and nearly 41% qualified on the basis of a disability. Alarmingly, almost 30% of the Medicare beneficiaries who contacted PAF reported medical debt crisis as their primary issue, citing transportation costs as their primary financial strain. While NPAF recognizes and supports CMS’s decision to define facility and provider requirements for TAVR coverage, we are equally cognizant that many deserving patients who are clinically suitable for TAVR may be unable to have the procedure due to the out-of-pocket expense of traveling to a designated center.

The financial hardship of this patient population is illustrated in the chart below; the overwhelming majority of Medicare patients had annual incomes under $23,000. NPAF encourages CMS to recognize the potential for limiting patients’ access to TAVR either because of limits in health plan coverage or the inability to absorb the out-of-pocket expenses needed to travel.

	Income of All PAF Patients in 2010	Income of Uninsured PAF Patients in 2010:	Income of PAF Medicare Patients in 2010:	Income of PAF Medicaid Patients in 2010:
Less than $11,000:	28.73%	46.51%	16.83%	57.92%
$12,000 - $23,000:	34.27%	31.71%	49.24%	30.62%
$24,000 - $35,000:	18.11%	13.13%	20.80%	7.87%
$36,000 - $47,000:	8.23%	4.53%	7.37%	2.49%
$48,000 - $59,000:	4.30%	1.92%	2.98%	0.74%
$60,000 - $71,000:	2.76%	0.95%	1.26%	0.17%
$72,000 - $83,000:	1.41%	0.60%	0.67%	0.04%
$84,000 - $95,000:	0.66%	0.21%	0.20%	0.04%
$96,000 - $107,000:	0.58%	0.17%	0.20%	0.04%
$108,00 - $119,000:	0.28%	0.11%	0.14%	0.04%
$120,000 or more:	0.69%	0.17%	0.30%

NPAF recommends CMS explore ways to assure patients are not inappropriately denied access. NPAF read with dismay the comment in the Proposed Decision Summary which states,” The conclusion has been drawn that some patients with severe symptomatic AS [aortic stenosis] may be inappropriately denied access to potentially life-saving surgery (Bach 2009).” We encourage CMS to explore how the coverage decision parameters may exacerbate this unfortunate outcome and identify how to encourage safe and appropriate coverage.

NPAF encourages CMS to include quality of life measures on all patients considered for TAVR. NPAF is encouraged that quality of life measures will be included in the database and from its own experience, knows the value of the “whole-person” approach to clinical care and disease management. Nearly one-third of the patients served by PAF have multiple co-morbidities making accessing and coordination of care challenging. Considering the potential for landmark changes in the treatment of aortic stenosis that TAVR represents, NPAF recommends that CMS instruct the operators of the national database to look broadly across a spectrum of quality of life measures, including those related to access to care; e.g., out-of-pocket expenses, job/wage loss, mental wellbeing, etc. The valid and reliable measurement of quality of life data should be performed not only on those patients receiving the treatment, but should include similar measures for those who may have been candidates or may have come close to candidacy, yet did not receive TAVR treatment.

In conclusion, we submit these comments in a spirit of cooperation and encouragement that your deliberations will result in policies that put patients first and that access to life-saving procedures for aortic valve disease will result in a lessening of disease burden. We, at NPAF want to do our part. Please contact me at 202-347-8009 or nde@npaf.org should you have further questions or wish to discuss how our experience in helping patients access care can help refine your coverage determination.

Respectfully submitted,

Nancy Davenport-Ennis
Chief Executive Officer and President

Less

I read, with interest the CMS proposal for national coverage of TAVI. From the perspective of a Cardiovascular and Thoracic surgeon, I have several comments:

First, I think it is important to realize that this is a novel technique, combining several skill sets over varied physician specialties. However, in the next several years, there will certainly be physicians who are exposed and have developed a great deal of facility with this treatment, and will have all of the tools necessary to be competent in its application. This is not addressed in the proposal for coverage and alienates the future providers of this technique.

Along those lines, there is an obvious similarity between the relationship of AVR to TAVI, as there is in open abdominal aneursym treatment to endovascular treatment. To maintain appropriate use, it will be important to have the same physicians able to offer both procedures, but the volume requirements currently proposed will likely render many surgeons and interventionalists ineligible. There is little crossover between the traditional and catheter based procedures and so a large volume AVR experience does not seem to have a necessary application to this new and very novel technique. Additionally, there are very limited FDA approved indications for catheter based intervention in structural heart disease and so the structural heart requirements are currently far in excess of what would reasonably be attained by a interventionalist in a conventional practice, uless cases from formal training are applied.

Less

The TAVR program at Buffalo General Hospital has successfully completed its first seven implants in the Cohort B patient population as of March 1, 2012. As the Program Director of this program I strongly support the coverage of this procedure by CMS and while I agree with the overall policy of coverage I have some strong areas of concern. The proposed limitation of this procedure to centers that will need to have two interventional cardiologists with 50 "structural heart interventions" experience is absurd. The whole concept of a team approach is that the team represents people with different skills that benefit the patient. Similarly requiring two cardiac surgeons to deem the patient inoperable is also unreasonable since many centers may not have two Cardiac surgeons on staff. The inoperability criteria should be met as defined in the PARTNER B cohort and the surgeon must concur.

It is also critical that some of the exclusion criteria in the PARTNER B criteria not be used as absolutes. For example patients on Chronic hemodialysis would be excluded if the PARTNER criteria are strictly enforced. The primary issues are inoperability and an expectation that TAVR will improve patient survival and quality of life.

I am also deeply disturbed about the decision to cover only those clinical trials that have "superiority" as a design element. This will automatically eliminate the Cohort A patients. This completely takes patient preferences out of the equation and is extremely paternalistic in its approach.

I am as concerned as most people are about indication creep. The only way to limit is to make the exclusion criteria clinically reasonable. Any attempt to limit the dissemination of the technology should be guided by quality outcomes and not arbitrary criteria. It is reasonable to expect that centers that have excellent PCI and CABG/AVR oucomes and volumes will have good TAVR outcomes as long as they can create multidisciplinary teams that function well together. The participation of centers in the TAVR registry and their outcomes should be the bench mark by which all centers are judged.

The costs associated with this technology are considerable but this technology is also one of the first times that the field of cardiovascular medicine has been forced to create multidisciplinary teams focused on assessment of patients, performance of a procedure and outcomes. Allowing this philosophy of care to disseminate widely can only improve the overall quality of care for our patients.

sincerely,

Vijay Iyer MD PhD FACC

Less

I am writing as a Thoracic and Cardiovascular Surgeon to comment on the proposed TAVR, CMS coverage guidelines.

Our center enjoys a rich experience in the treatment of cardiovascular disease. Many of the number requirements are within our institutional experience or yearly averages. However, a couple of the requirements appear too stringent.

The interventional program requirements under 3.a.ii should allow counting TEVAR and EVAR performed by the Thoracic and Cardiovascular Surgery service in the 15 interventions per year. The requirement for the Cardiology interventionalist to have greater than 15 left sided "structural" heart cases per year is too high. Our interventionalists do not have high numbers annually in the rare procedures such as ASD closure, mitral clip, or aortic and mitral valve valvuloplasty. Our EVAR and TVAR procedures are done by the Thoracic and Cardiovascular Surgery service at our hospital. The Cardiologists enjoy a rich experience in coronary interventions and some peripheral vascular interventions. This requirement of 15 procedures as you described would make eligibility too regionalized and selective for this treatment modality.

In addition, the Surgeon tract makes no exception for the well trained, very well qualified young Surgeon who may have excellent catheter skills and rich Cardiac Surgical training. The proposed numbers would exclude the young surgeon. I suggest a young surgeon tract.

RWT

Less

Comment Regarding Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR)

Decision Summary Page 1….

A.2. Two cardiac surgeons have, according to the PMA protocol, evaluated the patient’ suitability for the open replacement surgery – Recommend the decision be made by a panel of three MD’s, 2 Surgeons and 1 Cardiologist (not the referring Cardiologist).
A.3.a.ii.1. greater than or equal to 400 caths/150PCI’s per year – Recommend 1000caths/500PCI’s per year minimum
A.3.a.ii.2. greater than or equal to 15 left-sided structural interventions per year – Recommend greater than or equal to 15 left-sided structural interventions over 2 years
A.3.c.i. – Participation in a prospective national TAVR study for ongoing enrollment and follow up of all TAVR patients – Requires clarification – does this mean participation on the STS/ACC TAVI Registry or an ongoing research based study such as the PARTNER Trial?
A.4. a.ii – Professional experience with: Define or be prescriptive regarding a defined timeframe per Surgeon
A. 4. b. ii - Professional experience with: Define or be prescriptive regarding a defined timeframe per Interventional Cardiologist
A.4.b.ii - Professional experience with 50 structural heart disease procedures- Recommend reducing from 50 procedures to 30 procedures over a consecutive 2 year period

Decision Summary Page 2….

B.1. TAVR is covered in clinical studies that fulfill criteria a-m below and have characteristics i-ii. – Change to read -TAVR is covered in centers where the procedure is performed by a multi-disciplinary heart team that includes Cardiologist(s) and Cardiac Surgeon(s) jointly participating in intra-operative technical aspects of TAVR.

Delete the “The clinical study must adhere ……..”
Delete “a-m”
Delete “Consistent with section 1142 of the Act…….”

C.How long will the non-covered conditions extend? Needs an associated timeframe.
Recommend a mechanism to allow off-label use when patient benefit out ways the restrictive nature of the exclusions.

Less

I would like to express my strong opposition to the proposed requirement that an interventional cardiologist perform at least 50 SHD procedures to be eligible to perform TAVR. Our institution has one of the largest and most experienced cardiovascular programs in a major metropolitan area. We were recently recognized by one prominent rating group as a Top 100 Heart Hospital and the best ranking program in our state. We have also been leaders in the use of new cardiology techniques, often participating in clinical trials that have contributed to bringing new treatment and technology to the field . However, among a staff of 15 highly experienced interventional cardiologists, none has performed 50 or more SHD interventions. The 50 SHD requirement creates an unnecessary barrier to participation In TAVR . Our institution supports the concept of threshold volumes of experience to provide quality care but feel the requirement for an experience of 50 SHD procedures is excessive, prohibitive and unnecessary to the development of a high quality TAVR program. It will preclude offering this service by a number of programs that serve large populations of patients with advanced valvular disease that have demonstrated the ability to provide high quality complex comprehensive cardiac care.

Less

1. The sections on aortic an iliofemoral disease are worded ambigously. My reading is that if there is prohibitive disease in the aorta, iliacs or femorals, and a transaortic or transapical approach is possible, the coverage is proposed. However, many of my colleagues, and co-investigators, interpret the phrasing to imply that non-iliofemoral access willnot be covered. We favor coverage of alternate approaches, assuming that the patient is medically suitable, as preliminary published literature supports the safety of such approaches, and cardivascular surgeons are very familiar wihtt he techniques needed for the direct aortic approach, since this is the approach that is routinely used for coronary artery bypass surgery.

2. The section on non-approved devices proposes coverage in patients enrolled in clinical trials that meet specified criteria and that are designed to test superiority rather than non-inferiority. It is unlikely, however, given the results of PARTNER cohort B, that we will ever see another superiority trial. As the officialas of CMS are no doubt aware, the mortality findings of TAVR compared with medical therapy in that trial caused the CoreValve US IDE trial in comparable patients to adopt a performance standard rather than a conventional control group. As trials are done in lower risk patients, the comparison group will inevitably be standard surgical AVR; it is highly unlikely that TAVR is superior to this treatment, and clinlically, the issue is comparability due to patient comfort and length of hospital stay rather thna superioritu. It is likely that all future trialas in this patient group will be of non-inferiority design.

Less

While the new CMS TAVR criteria are aimed to ensure patients' safety several issues are still unclear,namely on "professional experience"

It is the general understanding that this is an institutional effort, and as such the general infrastructure offered (hybrid OR, surgical and interventional volume, imaging capabilities and volume) are to be considered first.

With regard to the operators, the amount of cases proposed by the current criteria is rather arbitrary than rigurous.There are structural heart procedures that bear no relationship whatsoever with the skills required to perform TAVR.
It would make more sense, since this procedures can be associated with catastrophic complications, that the opearators should be for at least 5 years out in practice, have at least 1000 PCIs performed as primary operators, and that they have a very low complication rate in their practice. It would be also very meaningful to know the amount of structural heart cases performed by every individual operator for each PARTNERS and COREVALVE site when this sites were selected for these trials. These numbers would allow an estimate of the minimal experience one should have before becoming part of the heart team for these procedures.
It would be also helpful to know the amount of cases that were proctored by each PARTNERS and COREVALVE site before each site was operating on its own.

Since both trials were approved by the FDA, these criteria are easy to retrieve and apply to the proposed CMS document.

Less

To Whom it May Concern,
It recently came to my attention that the Center for Medicare Services may restrict transcatheter aortic valve replacement to centers with more than 50 "structural heart disease" procedures per year as per their National Coverage Determination criteria. I feel this would unfairly restrict the number of centers that perform this life-saving procedure and without reason. Performing "structural heart disease" procedures will likely encompass ASD/PFO closures along with a whole host of other congenital corrective procedures. Having trained to do some of these in fellowship, I must make clear, as you may know; these are very different procedures than TAVR. The skills sets needed to perform them and TAVR are quite different and therefore, that criteria seems flawed.

As a hospital with a lot of peripheral endovascular interventional procedures and experience we feel strongly that the skill set needed to perform these difficult procedures is a better watermark for those starting a TAVR program.
Renato Apolito

Less

To whom it may concern,
I have read the proposed guidelines for NCD for transcatheter heart valves. I disagree with the following:
1. Professional experience requiring 50 structural heart disease procedures. Does an atrial septal defect closure count the same as a balloon aortic vavuloplasty in this? I would submit that an balloon aortic valvuloplasty is a more difficult procedure than an atrial septal defect closure, and that only 10 aortic vavuloplasties be required as professional experience.
2. There is no mention of coronary interventional case volume as a prerequisite. I believe that at least 100 interventions per year would be needed for the operator to have the skills needed to perform TAVR.
3. In addition as complications may arise involving the peripheral arteries, an operator should have training, privileges, experience, and skills in percutaneous treatment of peripheral arterial disease.
Based on the above, I stongly recommend rewriting of the guidelines to include the above recommendations.
Sincerely,
Alex MacDonell, III, M.D., FACC

Less

March 2, 2012

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

Dear Dr. Jacques:

On behalf of Medtronic, Inc., I am pleased to submit comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed decision memo for transcatheter aortic valve replacement (TAVR). Medtronic manufactures the CoreValve® percutaneous aortic valve, which received CE marking in May 2007 and is commercially available in the European Union and other countries.¹ We are in the process of enrolling for Medtronic's CoreValve U.S. pivotal trial and expect to pursue FDA approval following completion of the trial enrollment in 2013.²

TAVR is an innovative procedure that provides an important treatment option for severe aortic stenosis, especially for older or sicker patients who are considered too high risk for the open heart surgery required of conventional heart valve replacement. Arriving at an appropriate balance in the national coverage determination (NCD) is critical to assuring patients have access to TAVR in a safe and effective manner.

Summary of Key Recommendations

Medtronic agrees with CMS that TAVR is a complex procedure requiring safeguards to ensure the procedure is performed on the right Medicare patients by adequately trained physicians in appropriate centers. We understand that CMS has an interest to fund clinical research that supports meaningful advancements in technology. We appreciate that CMS has proposed to cover the FDA-approved indications for TAVR. However, we are concerned that elements of the proposed decision memo may impede access to TAVR technology for appropriate Medicare beneficiaries. We are specifically concerned about the impact this proposed decision memo may have on current and future clinical research with TAVR devices. We respectfully request CMS to consider our comments outlined below as you move forward with finalizing the NCD. Our key recommendations are:

1. Current and future FDA-approved Category B Investigational Device Exemption (IDE) clinical trials should be exempted from Section B of the NCD.


2. CMS should exclude the current superiority requirement outlined in Section B(1)(i).


3. CMS should create a clear process for Medtronic and other relevant stakeholders to engage with CMS regarding the design and implementation of coverage with evidence development (CED) for TAVR.


4. CMS should clarify center and physician requirements to ensure patient access is not limited.

Discussion of Key Recommendations

1. Current and future FDA-approved Category B Investigational Device Exemption (IDE) clinical trials should be exempted from Section B of the NCD.

Medtronic requests that the agency clarify whether Section B . coverage for unlabeled uses of TAVR . applies to FDA-approved Category B IDE clinical trials. As written, Section B may be interpreted as applying to Category B IDE clinical trials for TAVR. Medtronic believes that the existing IDE clinical trials policy has been successful at achieving its goals of ensuring continued patient access to promising technologies, like TAVR, and supporting the continued evidence development of such technologies.³

The preamble to the 1995 IDE coverage regulation cites a federal mandate that agencies streamline their regulatory processes to make them less burdensome and more customer-focused.⁴ The IDE policy's original intent was to provide Medicare beneficiaries with greater access to advances in medical technology, while encouraging clinical researchers to conduct high-quality studies of newer technologies. Moreover, the policy is critical to generating evidence that is relevant to the Medicare patient population and for helping product sponsors evaluate valuable technologies in this important population.

A change in CMS' policy for covering patients in Category B IDE clinical trials goes against CMS' objectives to provide access for Medicare beneficiaries and ensure adequate representation in clinical studies, and would be a significant departure from previous policy. If it is CMS' intent to address research design issues with Category B IDE clinical trials and potentially more broadly, then we believe it would be more appropriate for such a discussion to take place first in a broader policy context, such as a guidance document or in regulation, not in the context of a NCD on a specific technology.

The agency has a track record for clarifying how an NCD aligns with the current IDE policy. In 2004, CMS revised the decision memo on implantable cardioverter defibrillators (ICDs) in response to misinterpretations by local contractors that the policy excluded unlisted indications in clinical trials. The decision memo was revised to include language that explicitly permitted coverage of implantable defibrillators in Category B IDE clinical trials, acknowledging that exclusion of coverage for IDE trials "might have significantly impacted clinical trials."⁵ In light of the potential for such unintended consequences to existing and future IDE clinical trials, Medtronic asks for a similar explicit clarification that Section B of the NCD does not apply to current and future IDE clinical trials.

The current Category B IDE clinical trials policy already ensures appropriate patient access to TAVR under the context of a clinical trial while supporting the collection of high-quality clinical evidence. Therefore, Medtronic recommends that all FDA-approved, Category B IDE studies be exempted from section B of the NCD.

2. CMS should exclude the current superiority requirement outlined in Section B(1)(i).

It is Medtronic's interpretation that the superiority requirement in section B(1)(i) in the TAVR NCD has been motivated by CMS' desire to promote new and innovative products that provide meaningful clinical benefit to Medicare beneficiaries. We agree with this sentiment and we have aimed to introduce products that offer substantive improvements over existing therapies and provide demonstrable value to patients and society. However, we do not believe clinical benefit can be deemed solely by a simple test based on whether a clinical trial is designed with a superiority hypothesis for the primary endpoint. The superiority design does not sufficiently distinguish between important breakthrough therapies and potentially less impactful iterative products.

Since the inception of non-inferiority trials and Blackwelder's seminal paper in 1982⁶, several conditions have been proposed to justify the proper and ethical use of non-inferiority clinical trials for important new therapies when it was impossible for placebo-controlled trials to be performed. Important and impactful new therapies that can provide advantages such as superior safety and tolerability are logically tested to have equivalent efficacy. Often, the decision to test such novel and valuable treatments for some indications under a non-inferiority hypothesis against a proven effective therapy is not an elective decision, but an ethical one, as it may be unethical to perform a placebo-controlled trial when an effective, albeit less desirable, therapy exists.

The circumstances in which to choose a superiority versus a non-inferiority clinical trial for promising new therapies have been proposed by many authors in the clinical trial literature, and include the assumptions, conditions, and statistical estimation of efficacy margins (against the historical placebo control) and non-inferiority margins that help determine the optimum trial design (including whether to do superiority vs. non-inferiority). Many authors stress the strong desire of investigator and regulatory agencies to test new candidate therapies with demonstration of equivalency (non-inferiority) of the major efficacy endpoint to the standard-of-care in order to establish a base for the other demonstrable advantages of safety and tolerability secondary endpoints. The presence of a non-inferiority hypothesis for the primary endpoint for any given clinical trial, therefore, does not simply signify the desire to only show equivalence of a candidate product to an extant standard-of-care on all levels that may provide value to the patient.

CMS has a strong history of recognizing the clinical benefit of items and services that may demonstrate comparability to the standard-of-care in some aspects but show improvements in others. For example, in the 2006 final decision on lumbar artificial discs, CMS stated: "When the investigational agent is believed to have comparable efficacy to the control, but has other advantages, for example fewer adverse events or less cost, a noninferiority trial is an option."⁷

Our concern about the superiority study requirement in the proposed NCD is not hypothetical. There are several studies on TAVR now underway, including Medtronic's pivotal US IDE study for CoreValve, which would not meet a superiority requirement. As written, the proposed decision memorandum does not reflect the current regulatory paradigm or the role that FDA has had in establishing these requirements. If CMS does not clarify the exclusion of Category B IDE trials from this decision, the superiority requirement as written could have a disruptive impact on the ongoing studies and future studies as well.

Medtronic supports the desire to drive innovation and provide breakthrough products such as the catheter-based approach to replace the aortic valve in patients at high risk for surgical valve replacement. But since TAVR has demonstrable advantages over surgery, such as quicker recovery, improved quality of life, fewer surgical complications, and lower hospital length-of-stay, it is very reasonable to test survival efficacy to be equivalent or better than surgery (non-inferiority primary endpoint test). While we do not offer a new classification scheme to provide a simple test for differentiating breakthrough innovative therapies from iterative improvements to existing therapies, we firmly believe that the application of a superiority hypothesis is not a sufficient discriminator. Therefore, Medtronic recommends that the final TAVR NCD exclude the superiority requirement outlined in Section B(1)(i).

3. CMS should create a clear process for Medtronic and other relevant stakeholders to engage with CMS regarding the design and implementation of coverage with evidence development (CED) for TAVR.

As stated in Medtronic's recent comments to CMS in the open comment period on CED policy, we believe CED should be limited to circumstances where the alternative is non-coverage. Medtronic believes that the evidence supporting the FDA-approved indication of TAVR is robust and sufficient for CMS to find TAVR reasonable and necessary for the Medicare population.

The California Technology Assessment Forum (CTAF), a reputable organization that has been cited by several decision-making bodies, including CMS, recently concluded in a draft assessment that the on-label use of a transcatheter aortic valve meets CTAF's criteria for safety, effectiveness, and improvement in net health outcomes.⁸ The assessment specified that while the PARTNER Cohort B trial was not methodologically perfect, none of the issues were of sufficient magnitude to explain the large one-year mortality difference between the two groups.⁹ 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. Further, the FDA has required two additional post-approval studies that will further evaluate long-term endpoints, including quality of life and safety.

As such, Medtronic does not believe that CED is appropriate for Section A . coverage for treatment of severe symptomatic aortic valve stenosis for an FDA-approved indication . given the robust evidence base supporting the on-label use of the technology.

In the case that CED is applied to the FDA-approved indication, Medtronic believes that it will be vital for CMS to establish a clear implementation pathway. As mentioned in Medtronic's comment letters on the TAVR National Coverage Analysis and the CED policy, we recommend that CMS establish a steering committee with broad stakeholder representation, including patients, hospitals, professional societies, and medical technology companies, to ensure that CED will advance the common goals of all stakeholders. Further, it will be important for Medtronic to be part of such discussions, given the unique differences between SAPIEN and CoreValve.

Medtronic believes that the final NCD should clearly outline the steps required for appropriate and effective implementation of CED. The final NCD should include an interim coverage policy, next steps for establishing a steering committee, and a definitive timeline for the committee to develop a framework for data collection. Clearly outlined next steps will ensure appropriate data collection through CED, while granting Medicare beneficiaries access to a promising medical advancement.

Following the final NCD, the steering committee should work with the Coverage and Analysis Group to develop a clear framework for data collection under CED. As such, the committee would aim to answer the following questions:

• What are the goals and research questions to be addressed under CED?
• What data elements will be collected?
• How should the evidence be collected to ensure analyses can be done on specific sub-populations?
• What is the expected duration that patients will be followed in the study?
• How will data be monitored to ensure quality?
• Who will have access to the data and how will access be achieved?
• Who will have ownership of the data and who will have publication rights?
• Who will fund the data collection and analysis of the data?
• Who will conduct the analysis of the data?
• What will be the time intervals for data analysis and review by CMS?
• What are the time limits for TAVR CED?

The answer to each of these questions has important implications for the success and scientific credibility of data collection through CED and should be considered in an open and transparent manner, led by a steering committee. The agency should provide further clarification before moving forward with CED. Moreover, the answers to these questions should be posted on the tracking sheet of the decision.

An additional concern relates to the time course for CED. In its draft decision memo on extracorporeal photopheresis (ECP)¹⁰, CMS emphasizes the need to put time limitations on NCDs that require enrollment in clinical studies for coverage. CMS acknowledges that a number of past circumstances could have been avoided by establishing time limits, including having a standing NCD without any CED clinical studies being conducted. Therefore, CMS proposes setting specific time limits for future CED NCDs. We request that CMS do so in the TAVR decision by articulating an appropriate sunset interval for the CED components in the TAVR decision. Failure to articulate these issues in an NCD with a CED requirement will put an undue burden on beneficiaries, providers, and other stakeholders, and ultimately, decrease the potential for meaningful data collection.

In summary, CED requirements should be developed and implemented through an open and transparent process that engages all relevant stakeholders on the technical, clinical, and financial factors related to CED.

4. CMS should clarify center and physician requirements to ensure patient access is not limited.

Given the complex nature of the TAVR procedure, Medtronic recognizes the importance of center and physician requirements. Such requirements must strike an appropriate balance to ensure quality care, while not limiting patient access. Medtronic is concerned that unclear or burdensome center and physician requirements may contribute to the unintended consequence of hindering patient access. To that end, we would like to raise specific concerns regarding the criteria outlined under Section A . coverage for treatment of severe symptomatic aortic valve stenosis for an FDA-approved indication.

CMS should exempt Category B IDE clinical trials from center and physician requirements. Medtronic asks for clarification that future and existing Category B IDE clinical trials are exempt from any new center and physician requirements. These trials already have significant safeguards for the centers and physicians included in the study site selection criteria, which are negotiated with the FDA. Any effort to add increased center and physician requirements for these current trials could have harmful effects on ongoing research. An exemption of IDE clinical trials from the new center and physician requirements would 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.

CMS should reconsider certain center and physician volume requirements. We ask for greater clarity around the requirements under Section A(3)(b).for centers with previous PMA clinical trial TAVR experience.as several questions remain unanswered, such as whether the numbers would be based on annual rates or whether they would be rolling rates (i.e., whether sites would need to maintain an average rate of the required number of procedures and outcomes at all times).

We also request that CMS consider the interventionalist requirement under Section A(4)(b)(ii) that requires professional experience with 50 structural heart disease procedures. The definition of a "structural heart disease procedure" should be provided.

We believe that it is important to acknowledge that physicians may have privileges at and perform procedures at multiple hospitals. For centers without previous PMA clinical trial experience it is cited in A(3)(a)(i) that there be ≥ 2 institutionally based cardiac surgeons. We request that CMS clarify this requirement to acknowledge that physicians may practice at multiple hospitals and still fulfill the requirement of being "institutionally based."

We ask for less burdensome requirements for the cardiac surgeons who wish to participate in TAVR. The requirements delineated in A(4)(a)(ii) are highly challenging for younger surgeons or for surgeons not practicing at the highest-volume valve centers. We understand the need for numerical targets but please consider a career experience of 50 AVR with 10 AVR per year as a more reasonable minimum threshold. There may be unintended consequences of maintaining the surgeon requirements at the proposed level including a) lack of involvement by younger surgeons in TAVR, b) lack of TAVR programs in areas of low population density and c) lack of TAVR programs in some high density population areas where competitive dynamics have resulted in an absence of high volume valve replacement institutions. We support the institutional requirements cited in A(3)(a) and A(3)(b), and we believe these requirements will limit TAVR to experienced, high quality sites dedicated to the Heart Team concept. These sites are in the best position to select surgical participants for their TAVR program.

CMS should clarify the center and physician credentialing process. In determining appropriate center and physician requirements for TAVR, it will be important for the agency to provide further information on the credentialing process. We believe that the proposed center and physician credentialing requirements should be viewed in totality as it relates to the TAVR program, rather than specific litmus test requirements that must all be satisfied. Qualified centers should be given more discretion to determine appropriate physicians for their TAVR program. By viewing requirements holistically, the agency will help ensure geographically dispersed sites and equitable patient access to TAVR. We believe a process in which individual centers are responsible for evaluating their own experience against any center or physician requirements and for self-reporting this information to the agency would be a feasible and minimally-burdensome approach for implementing the facility and operator requirements included in the NCD.

Conclusion

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,

/s/
Thomas L. Armitage, MD
Vice President of Clinical Research, CardioVascular
Medtronic, Inc.

---

1 CE Mark Reference: Issued by the National Standards Authority of Ireland on March 9, 2007, for product family Percutaneous Aortic Valve Replacement System. (Registration number: 252.673).
2 Safety and Efficacy Study of the Medtronic CoreValveR System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). June 2011. Available from: http://www.clinicaltrials.gov/ct2/show/NCT01240902?term=CoreValve&rank=4. NLM Identifier: NCT01240902.
3 Code of Federal Regulations (21CFR812) Investigational Device Exemptions. Revised as of April 1, 2011. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812&showFR=1&subpartNode=21:8.0.1.1.9.1
4 Department of Health and Human Services: Health Care Financing Administration. "Medicare Program: Criteria and Procedures for Extending Coverage to Certain Devices and Related Services." Federal Register. Vol. 60, No. 181: September 19, 1995.
5 Decision Memo for Implantable Defibrillators - Clinical Trials (CAG-00157R). March 12, 2004.
6 Blackwelder, W. C. "'Proving the null hypothesis' in clinical trials." Controlled Clinical Trials 3 (1982): 345-353.
7 Decision Memo for Lumbar Artificial Disc Replacement (CAG-00292N) May 16, 2006.
8 Tice, Jeffrey A. "Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis who Cannot Undergo Surgery." CTAF. February 8, 2012.
9 Leon MB, Smith CR, Mack M, et al. "Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery." N Engl J Med 363 (2010): 1597.607.
10 Draft Decision Memo for Extracorporeal Photopheresis (ECP) (2nd Recon) (CAG-00324R2). February 2, 2012

Less

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Mr. Jacques:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

General Comments

AHIP and our member health plans encourage CMS to ensure that all patients receive safe, effective and evidence-based treatments. Our members strongly suggest that CMS should limit coverage of TAVR to Medicare beneficiaries in statistically robust, well-designed, and appropriately sponsored clinical trials. While early evidence supporting TAVR is promising, additional evidence is necessary to address the safety of TAVR; the sub-populations in which it is most likely to be of benefit; the long-term durability of the procedure; and the qualifications and experience of the physicians who perform TAVR.

Our members agree that CMS should require reporting of TAVR procedures in a transcatheter valvular therapy (TVT) registry as one of several conditions of coverage. However, the maintenance of a registry as a condition of benefit coverage is insufficient. Based on the published literature, long-term studies are needed to prove the safety and efficacy of this procedure in patients with severe aortic stenosis. Our members also share CMS’s concern that adverse events may be more frequent when TAVR is provided in settings where the physician and or the facility have limited experience or procedure volume to establish and maintain adequate expertise. Based on the Society for Cardiovascular Angiography and Interventions statement regarding the PARTNER Trial Results, transcatheter aortic valve implementation (TAVI) was associated with a significant reduction in symptoms, but was also associated with more neurological events (including strokes), major vascular complications and major bleeding events as compared to the standard therapy group.[1] Thus it is imperative that the appropriate subpopulation to undergo TAVR be identified, so that it is clear that this procedure is offered to the appropriate population of patients and the potential advantages of the procedure outweigh the potential harms.

As more cardiovascular procedures move from the surgical suite to the cardiac catheterization laboratory, there is an opportunity to perform procedures with less morbidity than open surgery. However, there is also a danger of over-utilization and inappropriate utilization because of poor patient selection criteria and insufficient training and experience on the part of the proceduralists.

If long-term studies are conducted and exhibit favorable outcomes, TAVI/TAVR may prove to be a successful option in the future for high-risk patients with severe aortic stenosis who cannot withstand the rigors of open surgery. Because of the need for further study, coverage should be limited to eligible participants in statistically robust, well-designed, and appropriately sponsored clinical trials.

As such, our members support CMS’s proposed decision for TAVR coverage under evidence development (CED). Thank you for the opportunity to comment on this important issue.

Sincerely,

Carmella Bocchino

Executive Vice President

Clinical Affairs and Strategic Planning

---

[1] The Society for Cardiovascular Angiography and Interventions. 2011. Statement of the Society for Cardiovascular Angiography & Interventions Before the Food and Drug Administration’s Circulatory System Devices Advisory Panel Meeting. A Review of the Premarket Approval Application for the Edwards SAPIEN Transcatheter Heart Valve. Internet site, downloaded October 2011.

Less

March 2, 2012

Marilyn B. Tavenner
Acting Administrator
Centers for Medicare and Medicaid Services
United States Department of Health and Human Services
Hubert H. Humphrey Building – Room 445G
200 Independence Avenue SW
Washington, DC 20201

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

Dear Ms. Tavenner:

The California Healthcare Institute (CHI) appreciates the opportunity to comment on the recently proposed Centers for Medicare and Medicaid Services (CMS) national coverage decision (NCD) for transcatheter aortic valve replacement (TAVR).

CHI believes that CMS has proposed a responsible approach to coverage for FDA-approved therapies in this case – one that will provide Medicare beneficiaries access to new and innovative medical therapies while providing measured safeguards to ensure that there is appropriate and safe utilization. However, we are puzzled by CMS’ finding that the therapy is not “reasonable and necessary” for Medicare beneficiaries and we have serious concerns regarding CMS’s approach to clinical trials coverage that could impede patient access to important medical technology innovations. We also believe a more structured and open process for the implementation of the coverage with evidence development (CED) requirement would allow greater stakeholder involvement in the development of a TAVR registry and assure that the goals of CED are specified in a transparent manner and can be fully achieved in the proposed context.

CHI represents the broad biomedical sector of the California economy and unites nearly 300 of California’s leading universities and private research institutes, venture capital firms, and medical device, diagnostics and biopharmaceutical companies. Our mission is to identify, develop and support policies to encourage life sciences research, investment, development and innovation in California. California is home to more medical technology firms than any other state in the nation. And the more than 107,000 medical technology jobs in California represent roughly onequarter of the total U.S. medical technology workforce as well as the largest segment (40 percent) of the total 267,000 California life sciences jobs. The sector is the source of many of the medical technologies that improve patient and public health around the world.

In today’s difficult economic climate, it is critical that policymakers be especially cautious about proposals and decisions that could upset the fragile biomedical R&D ecosystem. For example, concerns over the unpredictability, inefficiency and uncertainty of regulatory review processes at the U.S. Food and Drug Administration (FDA) have been a significant factor in reduced venture capital investment in the U.S. medical device and biotechnology industries in recent years. Coverage and payment-related issues are similarly significant factors.

While TAVR is a relatively new procedure in the United States, it has been available in Europe for more than four years and has helped tens of thousands of patients worldwide. In fact, newer, improved versions of the device are already being provided to patients outside the United States and multiple manufacturers are currently working to conduct U.S. clinical trials so that Americans can truly get access to the latest and best technology available.

And that is why I am writing to express CHI’s views on CMS’ national coverage decision for TAVR, a new, less invasive approach to open heart surgery to treat severe aortic stenosis, which has the potential to significantly improve the quality of life for many Medicare beneficiaries. We believe that the evidence demonstrates that the therapy, for appropriately selected patients, improves health outcomes. Indeed, we note that the California Technology Assessment Forum recently concluded that TAVR met all its requirements for safety, effectiveness, and improvement in net health outcomes. We would suggest that CMS could still find this therapy “reasonable and necessary” while maintaining a registry that would allow CMS to apply appropriate conditions on coverage.

CHI agrees that, because this technology is still relatively new, it is important to establish certain criteria so that these procedures are performed by highly trained professionals in optimallyequipped facilities. At the same time, we must ensure that an appropriate balance is struck between safe use of the technology and patient access, particularly as it impacts patients that live in rural and other underserved areas of the country.

CHI appreciates CMS’ flexible coverage approach for all current and future FDA-approved uses of this technology. This proposed approach will allow new versions of the technology to reach expanded populations of patients immediately upon FDA approval without having to re-open CMS’s national coverage decision. Finally, while clinical trials provide excellent insight into how a therapy can help patients, CHI agrees that it is important to have a method to continue monitoring and evaluation of post-market experience with this and future transcatheter devices and procedures. Again, however, CMS must implement appropriate oversight and management of the registry to ensure that data privacy is protected and responsible interpretation and reporting of the data occurs.

CHI voices serious concerns with a provision of the proposed NCD limiting coverage to clinical trials that are designed to demonstrate “superiority” rather than “non-inferiority.” Non-inferiority trial design is used by FDA because it would be unethical or impractical to compare a new therapy to a placebo when death is a likely outcome.

CMS’s proposed limitation to coverage of clinical trials with a “superiority design” also contradicts past CMS and FDA policies¹ in support of clinical research, and has many potential negative consequences and serious public policy implications – driving up costs of coverage, reducing competition, discouraging U.S.-based medical technology investment and innovation, denying support to trial participants, driving trials and affiliated jobs overseas, and reducing discoveries for small, undertreated populations.

Recognizing these issues, CHI therefore recommends that CMS eliminate the superiority design requirement from Sec. B(1)(i) of the Proposed NCD.

Finally, while clinical trials provide excellent insight into how a therapy can help patients, CHI agrees that it is important to have a method to continue monitoring and evaluation of post-market experience with this and future transcatheter devices and procedures. The FDA has called for rigorous post-approval studies to accomplish these goals. If and as CMS moves forward with a CED requirement involving a national registry on TAVR, we believe it is critical for CMS to establish an open and transparent process, involving all stakeholders, to implement appropriate oversight and management of the registry to ensure that appropriate research questions are developed, the collected data are suitable to answer the research questions, and a process is developed for the ultimate phase-out of the CED requirement.

Thank you for consideration of our views. We appreciate the opportunity to comment.

Respectfully Submitted,

/s/
Todd E. Gillenwater
Senior Vice President, Public Policy

---

1 For example, Decision Memos for Implantable Defibrillators (CAG-00157N) and for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085N)

Less

March 02, 2012

VIA ELECTRONIC SUMISSION

Louis B. Jacques, MD
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: Proposed Medicare Coverage Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR)(CAG-00430N)

Dear Dr. Jacques:

Boston Scientific Corporation appreciates the opportunity to provide comments in response to the Centers for Medicare & Medicaid Services’ (CMS) Proposed Coverage Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR).¹

As the world’s largest company focused on the development, manufacturing, and marketing of lessinvasive medicine, Boston Scientific supplies medical devices and technologies used by the following medical specialty areas, all of which provide beneficiary care in the hospital inpatient setting:

• Cardiac Rhythm Management;
• Cardiovascular;
• Neurovascular;
• Endosurgery; and
• Neuromodulation.

Boston Scientific is committed to the continued development of new technology, which supports our mission of “Delivering What’s Next” in less-invasive therapies. The Company products and technologies are designed to reduce risk, trauma, cost, procedure time and the need for aftercare. Our efforts are further grounded by our principal to put products into the marketplace that are safe, effective and appropriate for particular populations.

Medicare beneficiary access to the procedures which use these products is impacted by the coverage policies the Agency puts in place. Toward that end, in the context of TAVR, Boston Scientific urges CMS to:

• Remove the new “superiority” study requirement from the proposed NCD. (detailed comments can be found below these summary statements) The Agency offers no rationale for this requirement which seems to run in direct conflict with previous Agency positions. In addition, it will hinder execution of future non-inferiority studies, which are appropriate in many instances to facilitate the effective collection of evidence which can inform reasonable and necessary determinations.
• Remove the requirement that a patient be enrolled in, and the treating physician team is participating in a prospective national registry until some important questions are resolved. We believe that before any registry participation requirement is imposed on beneficiaries and providers there should be a consensus among relevant stakeholders on a clear clinical question that complements existing medical evidence. This consensus should contain well-defined endpoints that are not already addressed by FDA requirements. Detailed agreement should be reached on the elements of the study design (e.g. number of patients, length of follow up), and the amount of data collected should be appropriately scaled to capture only that data that will have a bearing on the ultimate determination of reasonable and necessary. Finally, any national registry should be affordable, in the public domain and data should be available to all stakeholders.
• If CMS moves forward on its thinking on the superiority requirement, detail is needed. Specifically, does the Agency expect to impose the superiority requirement in NCDs for other therapies that go through the NCD process? The superiority study design requirement has been perceived by some to reflect the Agency’s interest in establishing a significantly higher bar to the efforts of stakeholders to have procedures available to beneficiaries. Whether this is the case or not, the Agency should clearly articulate its thoughts in this area.

Further discussion on removing the new “superiority” study requirement from the proposed NCD

Valid endpoints
Requiring superiority for expanded labeling may lead to non-sensical endpoints just to meet the superiority definition. Many trial designs and endpoints are appropriately utilized today. The decisions made for the study protocol is multifactorial, including proof of safety, proof of efficacy, differentiation to alternative technologies, differentiation among patient subsets and other clinically based questions. Limiting reimbursement to superiority trials will add a non-clinically driven influence to study design, potentially resulting in inferior as well as fewer overall clinical studies for TAVR.

Rationale and consistency with previous Guidance
Limiting IDE study coverage to only those trials with superiority designs impacts beneficiary access to the latest procedures and we believe this is inconsistent with the intent of the 1995 FDA-CMS Interagency agreement. In addition, the Agency provides no rationale for this major shift in its approach to providing coverage for evidence development. This is especially perplexing given that CMS’ most recent CED guidance document states that: “CMS will not routinely be involved in the design, review, or execution of research studies.” Yet in the CMS proposed TAVR coverage determination it specifies that for unlabeled uses of TAVR, studies covered under CED must have a “[s]uperiority (not non-inferiority) TAVR study design.” The superiority requirement appears contrary to guidance CMS has provided to stakeholders. If the Agency intends to reverse direction on coverage requirements, we strongly encourage CMS to work publically with a full range of stakeholders to set parameters for the CED data collection.

The history of device trial design
Superiority study design is typically used for the break through novel technology. However, iterative technology improvements for interventional procedures have proven to be essential to the progression of patient care. Once a procedure is proven with first generation technology, clinical trial design for next generation product iterations frequently utilize a non-inferior design to the established standard. In particular, if a procedure is found to be superior to a predicate treatment option, it then becomes unethical for a trial testing a new technology to randomize to the predicate treatment approach in order to prove superiority. Therefore, superiority trials for a next generation technology in an established procedure are rarely appropriate. In the TAVR space, the technology iterations will be particularly important as reduction of stroke, reduction of vascular complications and operator learning curve are all objects of desired improvements for new system designs that have real benefit to the patient. While important, it may not be reasonable to establish superiority over the first generation device on these measures. Additionally, first generation devices are typically replaced by the company with new design iterations, essentially making it impossible to randomize to the device used in the breakthrough trial.

Aside from establishing safety and efficacy for a new technology, informing physicians and patients on treatment options according to specific patient and disease characteristics is also a critical role for clinical studies. While randomized trials are utilized to answer the primary clinical questions, registries play a critical role to informing the best treatment choices. Registries by nature are not designed for superiority and thus not reimbursed per the current proposal. By limiting the procedural reimbursement to superiority trials, it is felt that CMS will be limiting physician access to these valuable studies. In addition, data capture (registries, etc.) to inform physician-patient decision making is based on the proven standard for comparable options available for the beneficiary’s clinical condition.

Offering providers and beneficiaries choice
CMS should appreciate the benefit to having more than one device on the market place as it is good for beneficiaries, physicians, and payers to have multiple devices. To the extent that superiority requirements increase sample size overall study costs and time for enrollment increase and this could potentially limit access to beneficiaries. In large, cardiac-oriented studies, for example, superiority studies could raise sample size requirements significantly (i.e, 1,000 versus 8,000 patients) and add a tremendous burden.

Clinical Outcomes Focus Over Volumes

For centers without previous PMA clinical trial TAVR experience, CMS indicates the interventional program requirements include >400caths/150 PCI’s per year and > 15 left-sided structural EVAR (endovascular aneurysm repair0, TEVAR (thoracic endovascular aortic repair) interventions per year. While we appreciate that CMS is looking to set a high standard for physicians and centers which perform TAVR, we are not convinced volume is the correct measure. CMS may want to instead consider the ability of the board certified surgeons, board certified interventional cardiologists, and pediatric cardiologists to meet clinical outcome measurements. This would focus on quality care but not eliminate potentially good physician teams from providing TAVR to their beneficiaries.

In summary, Boston Scientific is concerned that the proposed coverage determination for TAVR, with its severe limitations – particularly regarding coverage for an unlabeled use in the context of a clinical trial – signals a trend toward significantly higher hurdles in order for Medicare beneficiaries to access FDAPage approved advances in medical technology. This trend may have a chilling effect on innovation, and a negative impact on beneficiary access to new and innovative technologies that can improve care and health outcomes.

We request that CMS:

• Remove the new “superiority” study requirement from the proposed NCD.
• Remove the requirement that a patient be enrolled in, and the treating physician team is participating in a prospective national registry until some important questions are resolved
• If CMS moves forward on its thinking on the superiority requirement, detail is needed.

Boston Scientific appreciates the opportunity to comment on the TAVR Proposed Coverage Decision Memorandum , which we believe to be relevant not only within the context of the TAVR coverage decision, but can have broader implications with respect to future CMS coverage determinations.

If you have questions regarding these comments or if you require additional information, please contact Tom Meskan (Director of Cardiovascular Health Economics & Reimbursement, 763-494-2016; tom.meskan@bsci.com) or Kristen Hedstrom, MPH (Director Healthcare Policy, 202-637-8021).

Sincerely,

/s/
Parashar B. Patel
Global Vice President, Health Economics & Reimbursement
Boston Scientific Corporation

---

1 “Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR)(CAG-00430N),” February 2, 2012; see http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decisionmemo.aspx?NCAId=257&ver=5&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=AgBAAAAAIAAA&

Less

March 3, 2012

Louis Jacques, MD
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: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

Dear Dr. Jacques:

On behalf of The Society of Thoracic Surgeons (STS), the largest organization representing cardiothoracic surgeons in the United States and the world, I am pleased to respond to the Centers for Medicare & Medicaid Services’ (CMS) request for public comments on the proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR).

STS is a not-for-profit organization representing more than 6,400 surgeons, researchers, and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. Our membership possesses extensive experience and expertise making clinical judgments on appropriate procedures for specific conditions and employing technologies to address the needs of patients.

STS appreciates the opportunity to comment on the proposed decision memo. We support the decision by CMS to approach TAVR as a promising new technology that warrants further study by linking Medicare coverage to the FDA approval process. As STS has stated previously, we believe that the physician community and professional societies have the ability and the responsibility to play an active role in coverage with evidence development (CED) for TAVR. It is essential that the Transcatheter Valve Therapy (TVT) Registry is tied to CED. The STS/ACC TVT Registry was jointly developed to track real-world outcomes related to TAVR. We believe there are important best practices illustrated by our experience with the TVT Registry that should be explicitly encouraged with the new CED guidance.  We hope that utilizing coverage with CED policy can bring this life-saving procedure to appropriate Medicare patients. CED that accumulates clinical data through robust registries is a valid strategy to accommodate emerging and developing technologies.

Institutional and Operator Requirements

The final version of guidance provided by STS, SCAI, AATS, and ACC regarding institutional and operator requirements was approved by the various societies and published online March 1, 2012. STS fully supports this document as it provides an extensive guidance on the infrastructure needed to support a TAVR program, as well as the characteristics of the optimal multi-disciplinary heart team to ensure a high quality program. The document also defines procedural criteria for this evolving field. You can view the entire document at http://content.onlinejacc.org/cgi/reprint/j.jacc.2012.02.016v1.pdf.

As a point of clarification the institutional requirements for interventional cardiology which include 1000 catheterizations and 400 PCIs should be revised to allow left heart structural procedures to replace the volume requirement for PCIs. In addition and with respect to the heart team concept we believe that a surgeon and cardiologist on the heart team should both individually fulfill requirements as set forth in the published credentialing document. That is, at least one member of the surgical team must have a lifetime experience of 100 AVR cases or 25  per year as described and the interventional cardiologist must have 50 lifetime structural procedures or 20 per year; including balloon aortic valvuloplasty, pulmonary valvuloplasty, mitral valve dilatation, percutaneous mitral valve repair (EVALVE), left atrial appendageclosure, pulmonary vein dilatation, prosthetic leak closures, VSD closures, and EVAR or TEVAR performed by the interventional cardiologist.  This will allow maximum patient safety and outcomes and will allow less experienced interventional cardiologists and surgeons to join the team

As a final point of clarification we believe that the institutional and individual surgeon and interventional cardiology requirements should be applied to new TAVR programs and that after successful implementation of the program the TAVR volume and outcome requirements as outlined in A.3.b.iii should be the performance measures for continuation of the program.

Follow-up Period for Quality of Life

While we recognize the importance of health status and quality of life as outcomes for patients with severe aortic stenosis, the requirement to collect quality of life data through 5 years of follow-up is problematic for several reasons. First of all, the main differences in health status associated with TAVR vs. surgical valve replacement (or between alternative access sites) are likely to emerge in the first year of follow-up (as was seen in the PARTNER A trial). Although longer term outcomes might differ because of long-term consequences in valve performance, it is very likely that such differences would also manifest in other discrete outcomes such as rehospitalization, reoperation, or even mortality. Moreover, quality of life outcomes are highly sensitive to missing data. Previous experience with these instruments suggests that such missing data are unlikely to be "missing at random" (a key assumption of most analytic approaches). As a result, missing data in more than 10-20% of patients would likely raise serious questions about the validity of the remaining results, especially pertaining to representing the overall population. Finally, the need to actively follow all valve recipients (both TAVR and AVR) for up to 5 years could result in substantial burden to both patients and providers due to the cumulative nature of the study.

In light of these concerns, we would recommend that evaluation of health status be required at baseline, 30 days, and 1 year after TAVR. This would likely result in the maximum return on investment for the burden of data collection and a high rate of data completion required for valid scientific study. We recommend the KCCQ quality of life instrument, also used in the PARTNER trial, serve as the sole quality of life instrument required by CMS. Of note, the short form KCCQ can be completed by mailed questionnaire, which further limits the burden of data collection to the participating sites. We recommend final coverage specify that the follow-up include a combination of patient follow-up coupled with linked  CMS MedPar data, and ideally the Social Security Master Death File as well to allow for thorough tracking during the follow-up period.

Informed Consent

Section 5, which discusses registry requirements, includes reference to a requirement for informed consent. Although the specific language appears to apply to informed consent for the TAVR procedure itself, we want to ensure that CMS does not intend to require that facilities seek informed consent from patients for entry of data into the registry. STS has extensive experience with clinical data registries and the accompanying obligation to comply with federal regulations governing protection of human subjects and privacy of health information.

STS registries serve multiple roles for registry participants. STS offers web-based data collection tools to collect information for many of our registries. Currently direct identifiers such as patient name and social security number are collected via these web-based tools. The identifiers are collected so that data managers at the hospitals using the web-based data collection tools are able to easily query patients to correct data collection errors and improve the quality of data. Please note that although direct identifiers are collected, data obtained via the web-based data collection tools are partitioned so that they are independent of the database for which analysis is conducted. Analyses conducted for research purposes use only a Limited Data Set.

Further, STS does not dictate the process by which participating centers collect data. In surveying data collection methods at participating centers in the other registries we have determined that the majority of centers collect data retrospectively. There is a population of centers that electronically abstract their data through interfaces established between the certified software application and the center’s health information systems. Data electronically abstracted from the existing electronic systems can occur at the point of entry and therefore may be considered prospective; however, the staff entering the data into the existing electronic system is often not aware that the data being captured are used for purposes of the registry.

When the collection of patient identifiers that included social security number was initiated for the STS National Database, STS obtained legal advice from an experienced source with expertise in HIPAA and related regulatory requirements to ensure that STS was in compliance. To the extent that data are submitted to the STS National Database for quality improvement and other “health care operations” purposes, such submission is permissible under and protected by the Business Associate Agreement (BAA) that STS has entered into with all Database participants. BAAs mandate appropriate safeguarding of the PHI in accordance with HIPAA requirements. Because STS may use the data for some research purposes, it has obtained a waiver of the HIPAA patient authorization requirement from the Duke Institutional Review Board (IRB) to allow the collection of PHI for research purposes. Generally, only aggregated and/or de-identified data would be disclosed to researchers. STS/DCRI would obtain a separate IRB waiver and obtain permission of the affected participants if it were going to disclose PHI for research purposes. The HIPAA rules do not require each institution submitting data to a registry such as the STS National Database that may be used for research purposes to obtain separate approval from its own IRB. The Privacy Rule permits a covered entity to use or disclose PHI for research purposes without authorization (or with an altered authorization), if the covered entity received proper documentation that an IRB or Privacy Board has granted a waiver (or an alteration) of the authorization requirement for the research use or disclosure of PHI. However, STS recognizes that either because of a participant’s internal policy or obligations imposed as a condition of a participant’s receipt of federal funding, the Participant may determine that local IRB approval is necessary. Under STS’s participation and business associate agreements, the participant is responsible for knowing and following local institutional policies and regulations.

Because the STS Database receives no federal funds and it is not engaged in federally-regulated activities, it is not subject to the Common Rule and therefore is not required to obtain informed consent from patients. It has received a waiver of informed consent from the Duke IRB out of an abundance of caution and because some sites believe they must have such a waiver in place to participate in the registry. In fact, the Office of Human Research Protection has clarified that sites that merely collect identifiable patient information in the course of clinical care and submit it to external researchers care are not engaged in human subjects research and therefore are not required to obtain informed consent from such patients. See http://www.hhs.gov/ohrp/policy/engage08.html (Section II.B.6.). OHRP has also taken the position that where the Common Rule does apply to multi-center clinical trials or clinical registries, central IRB review and approval of waiver requests is appropriate and that local sites can rely on such central IRB approval.

With respect to the TVT Registry, determination of whether informed consent will be required will be determined through an Institutional Review Board (IRB) evaluation after the data collection protocol is finalized. STS recommends that the final NCD incorporate the following language in Section A.5. to address patient protection issues: “The Registry operator will be responsible for ensuring compliance with all applicable regulations relating to protecting human subjects including 45 CFR 46 and 21 CFR 50&56 as applicable.”

We note that the Department of Health and Human Services issued an Advance Notice of Proposed Rulemaking indicating the agency’s intent to revise regulations on human subjects’ research protections (the Common Rule). STS believes it would be inadvisable for CMS to include any language in the NCD that might later be inconsistent with overarching federal regulation. Requiring that registries comply with applicable federal regulation would ensure appropriate patient protection and would allow compliance to be tailored to the specific operations of the registry.

Outcome Requirements

At this time we agree that the final NCD include the volume and outcome standards outlined in A.3.b.iii of the draft NCD. All these outcomes will be tracked through registry participation and should be reviewed when sufficient data have been collected. 

Coverage for Clinical Trials

STS agrees that CED should be used to extend coverage for off-label indications that includes prospective, registry-based, observational studies.  STS currently sees one important patient population that CMS might consider under CED.  This is End Stage Renal Disease patients.  The results of TAVR in ESRD patients are less than ideal with one year mortality reaching as high as 40% in some centers.  However, ESRD patients undergoing conventional AVR have a high one year mortality.  It is unclear whether the impacts of open heart surgery and cardiopulmonary bypass and the difficulty of post-op fluid and electrolyte/acid base balance is a contributing factor.  Appropriate treatment for AS in this population would best be studied in a CED using the TVT registry rather than a clinical trial as enrollment would be very low and the trial difficult to complete.

Thank you for your careful consideration of these comments and your continued work on this complex issue. Please contact Phil Bongiorno, STS Director of Government Relations, at pbongiorno@sts.org or 202-787-1221 if you have questions or need additional information.

Sincerely,

/s/
Jeffrey B. Rich, MD
President

Less

I am amending my previous statement with additional comments regarding 4.b.ii., 3.c.ii., qualifications and quality.

I disagree with proposed criteria that have over emphasized structural heart case volume (4.b.ii. “professional experience with 50 structural heart disease procedures”). Qualified centers including ours may not qualify for reimbursement under the National Coverage Determination (NCD). It has been rumored that “structural heart procedures” may be defined as balloon aortic valvuloplasty (BAV) and transcatheter aortic valve replacement (TAVR) only. This one standard is highly misguided, is not a meaningful measure of quality, is an incentive to perform BAV, and would effectively disqualify excellent programs. Proficiency in BAV is part of any successful TAVR program, but is an inadequate indicator of adequate training and preparation to perform TAVR. If implemented as written and defined above, 4.b.ii. may result in CMS coverage to < 100 US centers and thereby limit access to this life saving technology, reducing the overall quality of care in our aging population with aortic stenosis.

The proposed criteria do not place enough emphasis on the “heart team” make up and function (3.c.ii. Commitment to Heart Team concept). In my experience, the quality of the heart team is the mission critical factor that ensures careful patient evaluation, appropriate case selection and successful procedure completion. Item 3.c.ii. should be amplified and detailed with an emphasis on site qualifications, team experience and team function. Volume measures should be interpreted in the context of the institution and team structure, character, function and outcomes. Edwards Life Sciences has identified our institution as a site that has the infrastructure, personnel, expertise, has a collaborative heart team that can safely perform TAVR, has invited our program to participate in PARTNER II and is the first TAVR site in the State of Oregon. Significant time and resources have been invested by Providence Heart and Vascular Institute and team individuals over several years. We have received training from expert programs both domestic and abroad. We have an excellent program that is performing TAVR safely today. Yet our quality program may not qualify for reimbursement if 4.b.ii. is accepted as written and defined as above.

Robert Hodson MD
Co-Medical Director, Providence Valve Center
Providence Heart and Vascular Institute
Portland, Oregon

Less

Although I am a fellow of both the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions, I strongly disagree with their recommended qualifications of interventional cardiologists to be able to perform TAVR. The recommended number of 50 previous structural heart procedures is excessive, prohibitive, and arbitrary. Implementing such restrictive criteria will severely limit access to this technology to only a limited number of university hospitals in USA. TAVR is treated almost like a heart transplant! Our colleagues in Europe have been performing this procedure for 5 years and we have learned significant knowledge, lessons and tips from their experience. This should offer an excellent board-certified interventionalist a reasonably quick learning curve. I believe that lowering the required number of structural heart procedures to 10 and emphasizing proctoring requirement as the British did is more reasonable and allows our patient access to this life-saving procedure which is the only option for many patients. Also, the institutional 50 aortic valve replacement surgeries per year is arbitrary and there is no data indicating that hospitals doing 25/year would be less successful with TAVR. My hope is that those numbers are not politically-motivated or out of self-interest of a few programs to limit access to the new procedure. This would be a shame, especially considering that our patients have been wating for TAVR for years after the rest of the world had access to it.

Less

The CMS requirement for Interventional Cardiologists to have “professional experience with 50 structural heart disease procedures” is poorly defined and of little relevance in determining physician and institutional readiness for performing this revolutionary procedure. This technology can be skillfully performed in the hands of high volume peripheral and coronary operators. The emphasis by CMS on “structural heart disease procedures” is misdirected. This criterion quite obviously limits this procedure to institutions who were original participants in the clinical trial and does not allow access for many sick, elderly patients who are unable to travel to those institutions. It also discounts the patient physician relationship. Many patients wish to remain with their physician’s who they have strong relationships with. These physicians are invested in their patient’s long-term quality of life and not just the procedure at hand. What is truly required for good outcomes, and high standards of care are physicians, both interventional cardiologists and cardiac surgeons working in an institution that has developed a strong infrastructure and share common goals of care.

Less

The Alliance for Aging Research advocates for policies that promote research in human aging and its translation into interventions that improve the health and quality of life for people as they grow older. The Alliance has a long history of encouraging advances in science, both breakthrough and incremental. We recognize the particular strengths each bring when providing care to older patients who sometimes have complex health needs. Less-invasive procedures provide benefits to patients that must be considered when deciding coverage. Avoiding complicated surgeries, shortened recovery times, limited periods of disability, and lower risk of infection are all important factors that improve an experience for patients. We feel that this proposed determination requiring an intervention to not only show that it is safe and efficacious to the FDA and reasonable and necessary to CMS, but also superior to the existing standard of care as a condition of reimbursement sets a precedent with the potential to negatively alter the course of future research and development, particularly where advances are made to improve the patient experience.

Less

March 1, 2012

Louis Jacques, M.D., Director
Coverage & Analysis Group, OCSQ
Centers for Medicare and Medicaid Services
7500 Security Boulevard, C1-14-15
Baltimore, MD 21244

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

Dear. Dr. Jacques:

I have reviewed with interest the draft NCA on TAVR and appreciate the opportunity to provide feedback during this public comment period. On the whole, I feel the draft NCA strikes a fair balance between providing initial coverage for this important new technology, with the ability to somewhat flexibly expand coverage as FDA indications evolve, while supporting ongoing evidence development under the CED mechanism as suggested by the professional society leaders who requested the NCD. Importantly, given that one valve system is already FDA approved for “inoperable” patients with severe, symptomatic aortic stenosis, the draft decision suggests that this critical patient population will have access to TAVR under the Medicare program, which it should.

I do, however, have concerns about two specific aspects of the draft analysis. These are the requirement that unlabeled uses of TAVR can only be covered in the context of a superiority, and not a non-inferiority study design, and the requirement that a device not only be implanted for an FDA approved indication, but that the specific device being used must have FDA approval for that indication. The draft decision memo does not provide a compelling rationale for either of these requirements.

The requirement for superiority over non-inferiority designs for coverage does not make much sense in the context of TAVR, at least if trials are going to use appropriate outcomes like mortality and major morbidity as primary end points. The only situation where a superiority trial using these kinds of end points would have been feasible was the PARTNER cohort B (“inoperable”) population. Now that PARTNER is complete, the likelihood of a superiority trial being repeated in that population is remote – it wouldn’t be ethical or feasible. This does not mean, however, that non-inferiority trials are without merit, as FDA clearly recognizes their legitimacy in adopting a “least burdensome” approach to medical device regulation. A well done non-inferiority trial can establish that alternative technologies or therapies are reasonably equivalent in terms of primary outcomes, but may involve tradeoffs for secondary outcomes (such as specific complications, functional status, quality of life, speed of recovery, etc.) that are of greater or lesser importance to different stakeholders, most importantly, patients. In my opinion, the CMS should not use coverage policy to discourage manufacturers from adopting non-inferiority study designs, when appropriate. This could place undue regulatory burden on manufacturers, potentially discouraging innovation to improve products—such innovation is clearly in the interests of Medicare’s beneficiaries.

As this issue is not specifically discussed in the draft memo, the agency’s motivation for this position is unclear. Perhaps this has something to do with a more general desire to avoid paying for investigational devices in the setting of IDE studies, and thereby subsidizing research that sponsors perhaps should be supporting instead. If so, this is an important policy matter that should be addressed elsewhere, not in this particular NCD. There are cogent arguments to be made on both sides of this issue. The practical matter is that going forward, most TAVR trials are likely to involve non-inferiority designs, so implementation of this measure will mean that CMS will not cover investigational devices during trials in this field at all, unless study designs are altered.

My other concern relates to the precise wording of condition 1 for coverage, which stipulates that “the procedure is furnished for an FDA approved indication, with a complete valve and implantation system that has received FDA premarket approval (PMA) for this indication.” On its surface this seems like an innocuous statement. However, a very literal interpretation of the second clause (“…for this indication”) suggests that CMS will not support coverage of any TAVR device for any use outside the labeling of that particular device under any circumstance. If that is the intent of the policy, then the consequences of this must be carefully considered.

While it is understandable for CMS to want to discourage widespread off-label use of TAVR devices, particularly during the early rollout of this new technology, it is not difficult to envision scenarios under which such a policy might actually conflict with patients’ best interests. For example, imagine that a new generation TAVR device is developed and studied in high risk surgical candidates, and that FDA approves the device for that indication. Will this mean that the new device will not be covered for inoperable patients, because it is not labeled by FDA for that indication? What if the new device offers real advantages compared with an earlier generation device that was approved for inoperable patients? Will clinicians be forced to use the older device because of limitations to the new device’s labeling? Once >1 TAVR device is approved and marketed, shouldn’t qualified clinical teams be granted the latitude to decide which device is best for a given patient without encumbrance by coverage policy? Again, these questions are germane in the case of TAVR, because it will become increasingly difficult with time to study new devices in the highest risk patients. If CMS is to adopt this position, it would seem that some harmonization between CMS and FDA on the approval of new devices for old indications may be needed in order to avoid unnecessary restrictions on clinicians’ choice of device.

Off-label use of potentially expensive medical technologies is a tricky issue – while some off-label practices may not serve patient’s best interests, some off-label practices do provide real benefit and do not simply represent unnecessary medical spending. The CED mechanism seems like one potentially useful avenue for exploring the value of off-label practice, but for this to be true, coverage cannot be so restrictive as to equate all off-label care with inappropriate care or fraud.

Respectfully,

Matthew R. Reynolds, MD, MSc

Less

Long term TAVR has the potential to become an important adjunct to our current treatment of critical aortic valve disease. As a surgeon supporting a new program, we are equally committed to excellent outcomes. Programs should have board certified surgeons with extensive experience in aortic valve and root replacement, aortic dissection repair,and bypass grafting. Given the complexity of current cases, a program doing in excess of three hundred and fifty open heart cases and at least three surgeons to provide continuous coverage should be able to meet all procedural expectations. The program should also be able to offer thoracic stent grafting and experience in vascular arterial repair. These skills will provide the depth of experience necessary to perform cardiac placement of the device as well as to provide our cardiology team members assistance to care for treatable complications.
Timothy Hunter, MD

Less

St. Joseph's Hospital has earned a national reputation for clinical excellence in the delivery of cardiac services. Due to our outstanding cardiologists (medical and surgical), St. Joseph's has consistently been named a five star hospital for both cardiac surgery and interventional procedures. St. Joseph's has also been named in the top 5% - 10% in the Nation for both services.

Too, the latest harvest from the ACC shows St. Joseph's in the 99th percentile for percutaneous mortality and the STS latest harvest also shows a total open heart mortality for the past five years at the 99th percentile.

St. Joseph's is also one of the few institutions in the world to perform robotic percutaneous procedures.

What's more, St. Joseph's vascular surgery program ( a critical component of a TAVR program) has been ranked #1 in New York State for 2012 as well as in the top 5% in the nation.

I beleive these outcomes(in addition to being by far the largest provider of cardiac surgery and in terventional procedures in the Central New York region)were responsible for being selected by the Edwards Company as the sole provider of TAVR in the Central New York region.

By including 50 structural heart disease procedures in the National Coverage Determination CMS would significantly reduce access to Central New Yorkers for this life-saving procedure.

I would respectfully request that CMS eliminate this provision from the National Coverage Determine for the provision of TAVR services.

Sincerely,

John Cannizzaro
Administrator - Cardiac Services
St. Joseph's Hospital Health Center

Less

March 1, 2012

Louis Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd
Baltimore, Maryland

Dear Dr. Jacques:

The U.S. Food and Drug Administration approval of transcatheter aortic valve replacement (TAVR) in November of 2011 provides hope for American patients suffering from the debilitating effects of severe aortic stenosis, who have been told by their physicians that they cannot be treated by conventional means. These patients now know that they have the possibility of treatment, and the next step in providing more certain access to this therapy is through the National Coverage Decision (NCD) to be finalized and issued by CMS.

On behalf of the Society for Women’s Health Research (SWHR), I would like to draw attention to several important points of discussion in the draft NCD. The Society for Women’s Health Research is a national non-profit organization based in Washington, DC, that is widely recognized as the thought leader in research on sex differences and is dedicated to improving women’s health through advocacy, education, and research. Due to SWHR’s efforts, women are now routinely included in most major medical research studies and scientists are beginning to consider biological sex as a variable in their research.

A small study published in the February 7, 2012, issue of the Journal of the American College of Cardiologyⁱ, speaks to our mission and also provides encouraging results on the benefits of TAVR for women. French researchers analyzed data on 260 TAVR patients, with a mean age of 83.1, and – while no gender-based advantage was seen in the 30-day mortality rates – at one year post-TAVR, women had better survival (76% vs. 65% for men). Importantly, female representation in this study was 131 patients as compared to 129 male patients, and women were found to have better baseline clinical characteristics.

Studies of this type make organizations like the SWHR optimistic about not only new therapies that can be accessed by women in the United States, but also the promise of additional research into the impact of gender on procedural outcomes with these new therapies. We want to preserve opportunities for the companies developing these new technologies to investigate them in the way that the FDA, based on sound scientific principles, deem most appropriate.

While we agree and support many of the proposals you recommend designed to manage the responsible deployment of new therapies in a commercial setting – for example, stipulating reasonable criteria for the facilities or professionals that will have access to new technology – we are concerned about applying overly-rigorous constraints to clinical research. Limiting the types of research that companies can conduct confines scientific knowledge and discovery, particularly when the therapy is designed for specialized groups of patients like the inoperable or high-risk individuals treated with TAVR.

With all of this in mind, SWHR urges CMS to eliminate from its draft Decision the provision that TAVR only be covered in clinical studies with a superiority design. Establishing statistical superiority, even when an established standard of care is available, is often impractical and costly (requiring large samples sizes and lengthy studies) and would push the timelines for bringing novel innovations to market. Non-inferiority trials have been acceptable to the FDA since the early 1980’s. SWHR believes it would be detrimental to advancing research and innovation and a great disservice to patients, to create this restriction.

We are encouraged that the U.S. is moving one step closer to aligning all of the necessary elements to make this life-saving and life-improving therapy of transcatheter aortic valve replacement available not only from a product approval standpoint, but also through appropriate reimbursement. We urge you to keep at the forefront of your decision making the needs of patients with severe aortic stenosis who have few or no other treatment options – and implement a National Coverage Decision that provides all of them with adequate and equitable access to a therapy that has demonstrated an ability to relieve symptoms and allow many patients to resume productive, fulfilling lives.

Phyllis Greenberger, MSW
President and CEO
Society for Women’s Health Research (SWHR)

---

i Hayashida K, et al "Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis" J Am Coll Cardiol 2012; 59: 566-571. http://content.onlinejacc.org/cgi/content/short/59/6/566

Less

To whom it may concern:
The proposed recommendations for TAVR do not make any sense to me. If followed, there is potential for multiple cath lab disasters. I have outlined some of my concerns below.
The main area of complications involve the peripheral arteries, especially as we will have to use the first generation device rather than the third generation device currently used in Europe. There is no mention of training in this area of expertise. I would recommend that a person performing percutaneous valve replacement should have hospital privileges and at least 5 years of experience for peripheral vascular interventions.
The issue of 50 structural heart cases is equally bizarre. Someone who performs 51 atrial septal defect closures is qualified but someone who does 49 aortic valvuloplasties is not qualified??!! That would be the same as saying that winning a tennis tournament qualifies that person to play in the Masters Golf Tournament. There is absolutely no relationship! I believe the operator should have performed ten or more valvuloplasties before performing TAVR.
The operator should also be experienced in complex coronary interventions as will the hospital. If the operators are not performing over 200 coronary and peripheral interventions per year then they are not experienced enough for this procedure. Certainly the hospital should be performing over 1000 interventions in their cath lab to assure adequate experience in the lab. There should also be a thoracic surgeon who specializes in valve procedures and performs an adequate number of valve repairs and replacements.
As your recommendations do not give any consideration for appropriate expertise and experience, it makes me wonder what the true motives are behind these bizarre reccomendations.
I would appreciate a complete rewriting of the National Coverage Determination for TAVR.

Sincerely,
G. Leslie Walters, M.D., F.A.C.C.

Less

We have successfully implemented TAVR at our institution since approval by the FDA for commercial use. As with any new interventional technological modality, I am in full support of requisite yet reasonable physician and institutional training requirements to ensure that appropriate patient choice and clinical expertise is met. These requirements however should not be prohibitive such that the expected value for the patient is negated. TAVR provides large value for appropriately screened patients in a very challenging patient population. The current proposed stipulation that requires an experience of 50 structural heart procedures per individual interventional cardiology operator is problematic for a number of reasons. First, the definition of structural heart is vague and implies expertise in percutaneous balloon aortic valvuloplasty (BAV), atrial septal closure and mitral valve repairs. Secondly, of these, only BAV is pertinent to TAVR. Thirdly, the proposed stipulation for 50 cases is prohibitive on the one hand and redundant on the other hand since very few interventional cardiologists perform BAV in clinical practice. Fourthly, few if any interventional training programs graduate fellows with this degree of BAV experience. Finally, having performed BAV personally for more than 20 years, I contend that it is a skill that is easily grasped by well trained interventionalists working within a team of TAVR physicians. A minimum expertise requirement of no more than 5 BAV’s should be considered reasonable.

Less

Looking at the proposed NCD for transcatheter heart valves, most of the individual and institutional volume requirements appear reasonable. The institutional requirements for an interventional program seems too low. Our recommendation would be to significantly increase the required PCI procedures per year (300?), rather than the current recommendation of 150 PCI procedures. The minimum ACC requirement for proficiency in PCI is 75 cases per interventional cardiologist per year - a TAVR team needs two interventional cardiologists, and we believe their program should have significantly more than the minimum case volume required for proficiency to offer this complex procedure.

Also, we are concerned about the requirement of “professional experience with 50 structural heart disease procedures”. There should be a clear definition of what counts as a structural heart case. If referring to patent foramen ovale (PFO) or atrial septal defect (ASD) repair, these skills do not translate to TAVR so do not seem relevant as a requirement. If referring to left atrial appendage (LAA) procedures, these are not currently FDA approved. Balloon aortic valvuloplasty (BAV) and percutaneous ventricular assist device implants (PVAD) are the most relevant procedures, but most high volume and high quality centers do not perform 50 of these cases. BAV, as an example, is not the standard of care in the treatment of patients with aortic stenosis. Limiting the count to 50 BAV or PVAD could rule out the majority of programs already successfully performing TAVR. Our recommendation would be to change the requirement to "professional experience with 10-20 balloon aortic valuloplasty or percutaneous ventricular assist devices" or if there is need to broaden the definition, we would suggest clarification that the 50 structural heart procedures include the broader (though less clinically relevant) list of PFO/ASD/LAA/BAV/PVAD.

Presbyterian Hospital is one of the hospitals that have launched TAVR since the FDA gave commercial approval in November 2011. The TAVR initiative brings together a group of highly skilled professionals working collectively for the benefit of patients who previously had no hope. This high-risk, high-benefit procedure needs to be tightly managed to ensure quality and safety but not in such ways that patient access is prohibitive and this transformational technology languishes from limited expansion.

Less

As a practicing interventional cardiologist I find the proposed CMS number of 50 "structural heart" procedures for each individual cardiologist to be onerous. I believe the focus for CMS regarding TAVR should be on building and maintaining a Heart Team approach to patient care. The skill set required to perform these procedures is readily attainable. I agree with prior commentors that well thoughtout team approach, wire skills, and critical care management are crucial for successs. This is an amazing life saving device and being so restrictive defeats the ideal of advancing patient care, and will restrict access to many who could benefit from it.

Less

I have a concern about the proposed requirement that an inventional cardiologist perform at least 50 SHD procedures to be eligible. Our institution has a large cardiovascular program, performing over 4500 caths per year and 400 plus open heart surgeries. Amongst our 75 cardiologists we have 15 interventional cardiologists. I fear that none has done 50 or more SHD interventions. This provides a great barrier to participation despite our significant valvualar heart disease, PVD, and EVAR experience. In the presence of skill and experience with these disciplines such SHD experience is excessive and should not be required. This would limit our ability to offer this important service to our patients.

Less

I have been involved in the PAVR world for over a decade and performed some of the initial first in man procedures in Paraguay that validated the concept. I am the program director in a 200 plus bed communnity hopsital that is a critical care access site, and is a ubiquitous site for cardio-vascular research. We have over a hundred publications in the last several years and we BC cardiologists come to our facility from others to learn sophisticated techniques; although we do not have a university affiliation or fellowship training program.Current proposed guidelines are strongly biased toward university and training facilities--excellent care is often provided there, however, if community hospitals that are active in c-vasc research and treatments are excluded due to guidleines biased towards training programs, patients will suffer. Many of my patients cannot afford to travel for 4 hours to the nearest huge hospital: they cannot leave their families or have their families pulled from their communities, employment or suffer the consequences of a complication miles from home. As well, any focus on large trainng hospitals alone for research or for procedures, leaves a significant bias in any conclusions as the milieu is certainly not similar and cannot be generalized to where most care is rendered. We are in an era of frugal care-- we need the best value for dollar spent-- leaving patients without an option, hours from their homes and communities, is not viable and will lead to increasing debilitation, strokes and heart failure, as they prefer to stay local and suffer the consequences of a seriously debilitating and life threatening illness. Communities and hospitals such as ours should not face a lack of access because we have not performed 15 (arbitrary) left sided procedures over the course of the last year (s).

Less

The TVT registry fee of $25,000 and $10,000 annually is excessive for such a small database. The amount of data that is tracked through this database is not in proportion to the cost to the institutions for the registry. The STS database that tracks all open heart surgeries is not as expensive as the newly proposed TVT registry. The cost of the TVT registry needs to be reevaluated, especially if it going to be a CMS mandate for reimbursement. It should be fairly priced similarly to the already existing database, as opposed to being overpriced based on new technology.

Less

I am a board certified interventional academic cardiologist, though I do not personally perform valve interventions.

I am writing in support of the TAVR NCA proposal. Specifically, I strongly support the formal limitations of coverage to institutions and operators meeting specific volume and outcomes standards, and the requirement to participate in a robust database. It is unfortunate that similar requirements were not instituted in the early days of PCI.

I do wonder if the requirement for acceptance of a Team approach is sufficiently defined. To perform TAVR well requires involvement by experts in imaging and anesthesia, among others, using high quality equipment; perhaps this needs to be better spelled out.

Less

I disagree strongly with the proposal for TAVR reimbursement based on interventional cardiologist volume requirements. The concept of this reimbursement being based on arbitrary volume requirements is faulty as it assumes that quality outcomes is tied to 50 structural heart cases. The number is arbitrary, chosen by society (ACC/STS) leaders, and will serve to exclude the majority of small, medium, and large private and community hospitals who have excellent heart and vascular programs.

The volume requirements proposed for interventional cardiologists are based on experience with 50 prior structural heart cases. Structural heart cases are ill defined and is a new umbrella term for interventions including valvuloplasty but also atrial septal defects, PFO closures, septal ablations; none of which with the exception of valvuloplasty has anything to do technically with TAVR. The skills needed for ASD/PFO closures and septal ablation are not related to TAVR anymore than the skills for PCI and interventional cardiology. Yet these other (ASD/PFO) procedures could be used by certain hospitals and interventional cardiologists as justification for being a "qualified" operator under this proposal. This would be at the exclusion of other very qualified interventionalists who have more valvuloplasty experience but not perhaps the "magic" 50 total number.

The wording of "experience with" is also new as a requirement from any governing body in cardiology because this could include primary operator, secondary operator, experience as a trainee fellow, or just as a reviewer of the case. The term "experience with" is so broad and without precedent that it could be used as justification for or as exclusion against certain hospitals depending on how strict its interpretation is. Also unless the interventionalist is the primary or secondary operator, then the technical skill benefit is almost negligible with regards to being used as a justification for being a "qualified" operator.

With regards to valvuloplasty case volume, aortic valvuloplasty has had limited indication until the availability of TAVR, and thus a high volume requirement will limit the use of this technology to either prior TAVR sites or to operators who had previous excessive usage of this procedure.

The interventional cardiologist volume requirements are incorrect and should be removed both in concept and in the unreasonable number of cases. The volume requirement will not enhance quality in this situation. This requirement will only serve to limit TAVR procedures to previous TAVR sites and exclude very qualified heart and vascular teams at small, medium, and large private community hospitals across the country. This will subject the public to limited access to this life saving technology and impose a hardship on this very sick population who may have to travel or leave their regional hospital centers that could ordinarily provide this care.

Less

Dear CMS,

As the director of a multi-disciplinary valve clinic at a regional hospital in Northern Michigan I wanted to comment on the TAVR CMS process.

Our hospital serves 22 counties in Northern Michigan and over the last 8 months have made very large strides in the diagnosis and treatment of valvular heart disease. Our site covers 1/2 the upper peninsula and the entire Northern portion of Michigan. Already, patients have to drive 4 hours at times to see us. Having them drive an additional 5 hours to TAVR sites in Southern Michigan is a lot to ask of our patients. We hope to be a site for this new technology, but with the current way it is written, this may eliminate us from the process.

Our surgeons are new here over the last 2 years, and while our institution numbers may not seem large, given their 20 years each of experience, they have no shortage of individual experience. In addition, our hire in July 2011 of an interventional cardiologist with TEVAR, PFO closure, MitraClip experience gives us considerable experience at this position as well. Again, while out institution numbers for advance structural disease may be low, our experience is vast.

Finally, I believe that imaging plays a vital role in the safety of this procedure. As a Level III echocardiographer who has performed over 800 transesophageal echos in the last 18 months with a vast experience in 3D, I feel more than qualified to help complete our team. I trained at a TAVR institution at the University of Michigan and trained with leaders in the field of echo (William Armstrong, David Bach)

In conclusion, patient access and safety should be involved in this decision process on TAVR sites. In addition, provider experience should be more important than individual site experience as providers often change jobs and institutions are investing in physician experience in preparation for TAVR.

Please contact me if any additional information is needed. I hope this helps add to decision process.

David Corteville, MD
Medical Director of Echocardiography
Valve Clinic Director
Northern Michigan Regional Hospital
Petoskey, MI

Less

February 29, 2012

Louis B. Jacques, MD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C 1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Medicare Coverage Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR)(CAG-00430N)

Dear Dr. Jacques:

The Advanced Medical Technology Association is pleased to offer the following comments on the Centers for Medicare & Medicaid Services' (CMS) Proposed Coverage Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR).¹ In the proposed decision memorandum, CMS proposes to limit Medicare coverage for TAVR under Coverage with Evidence Development (CED).

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 member companies have always faced a number of challenges and risks in the process of inventing, developing and manufacturing medical devices. However, the industry has seen a marked increase in the hurdles that they must overcome in order to enter the U.S. market. While much of the past debate has focused on the U.S. Food and Drug Administration's (FDA) burdensome regulatory approval process, companies in this sector are increasingly finding that Medicare coverage and reimbursement are additional hurdles to providing patients access to innovative, life-saving technologies. The proposed TAVR National Coverage Decision has broad implications for the medical device industry beyond the therapy it addresses, and we urge CMS to consider AdvaMed's comments as it proceeds.

AdvaMed supports the use of sound evidence to inform medical practice, and as such, has generally believed that CED may be a means to generate additional evidence in cases where the available evidence regarding a promising medical technology or procedure is not sufficient to support national coverage. In such circumstances, coverage that is contingent on the development of additional evidence can enable beneficiary access to state-of-the art medical treatments when the alternative may be non-coverage.

CED allows CMS to provide coverage within the context of studies that conform to standards spelled out in Medicare's Clinical Trial Policy.² The research meeting these standards can include studies that range from randomized clinical trials to observational research; and AdvaMed has been pleased that CMS has relied on a range of research approaches in its various applications of CED.

Our primary concerns relate to two issues:

1. the proposed requirement that, in the case of unlabeled uses of TAVR, coverage will be permitted in the context of a clinical study only if that study has a superiority (rather than non-inferiority) study design; and
2. issues related to open-ended data collection requirements under coverage with evidence development.

Below we describe in greater detail our concerns with the TAVR proposed decision memorandum, which we believe have broader implications than the TAVR decision itself and should be addressed by CMS in the final coverage decision.

Requirement for Superiority Study Design

The proposed coverage determination specifies that for unlabeled uses of TAVR, studies covered under CED must have a "[s]uperiority (not non-inferiority) TAVR study design." However, the proposed TAVR decision memorandum does not detail CMS' rationale for this decision, leaving the reader with little understanding of the reasoning behind the requirement.

CMS' most recent CED guidance document asserts that: "CMS will not routinely be involved in the design, review, or execution of research studies." In implementing CED over the past several years, there have been a number of instances where CMS has indicated its willingness to consider coverage in CED studies. To our knowledge, in these instances CMS has not provided specific instructions on the design of the studies that would be eligible for coverage; and neither has CMS ruled out particular methodological approaches.

This explicit direction in the proposed coverage determination with respect to study methodology appears contrary to the advice and guidance CMS has provided to stakeholders since the CED program was initiated. If the agency intends to reverse direction on this policy, we believe there should be adequate engagement with a full range of stakeholders in setting parameters for the CED data collection. Medical technology providers need to have transparency and predictability in the coverage and payment process in order to develop new and innovative medical therapies.

AdvaMed has significant concerns that this superiority requirement will deny patients access to innovative treatments, curtail innovation and discourage competition. Furthermore, the superiority requirement will impact studies currently underway for this technology and other similar technologies that have been designed without a superiority requirement after close consultation with the FDA. Coverage for TAVR under such a study would not be permitted under the proposed coverage determination, though the study was designed to answer valuable and valid clinical research questions.

Medical device innovation is unique compared with other innovative products, particularly because significant advances are often realized through a series of incremental changes. Given the incremental nature of medical device development, it is not unusual for a new device to show small improvements in outcomes compared with a comparator. However, improvement over an earlier generation device may allow for advancements in products, techniques and treatment protocols that will optimize patient care as the health care system collectively learns. For example, a study may be designed to measure non-inferiority to conventional treatment, but the results of the study may demonstrate superiority in terms of other measures, such as reduced pain, decreased recovery time or shorter hospitalizations.

Mandating superiority in order to obtain national coverage adds significant costs for sponsors, and limits access for patients. Many medical devices and technologies are developed for relatively small populations. A medical device may be developed for use with a very limited number of patients with a given medical condition, for which it would be difficult to achieve a large sample size in a clinical study, particularly if the study required a superiority design. In large, cardiac-oriented studies, for example, superiority studies could raise sample size requirements significantly (i.e., 1,000 versus 8,000 patients) and add a tremendous burden.

Non-inferiority or equivalence trials are used to demonstrate that two treatments work equally well, and CMS should not deny coverage for beneficiaries when they are participating in noninferiority trials or equivalence trials in conformance with the CMS clinical trial policy standards. Therefore, the new "superiority" study requirement should be removed from the proposed determination.

Open-Ended Data Collection Requirements Under Coverage with Evidence Development (CED)

AdvaMed recently submitted comments to CMS regarding its CED guidance, and many of the same concerns we raised in our comment letter are relevant with respect to the proposed TAVR decision. We want to reiterate that when Medicare coverage is contingent on the collection of additional clinical or scientific evidence (beyond FDA requirements for safety and efficacy). CMS should work closely with stakeholders to clearly identify the data collection objectives, to consider the minimum data necessary to achieve those objectives, and to determine study endpoints and the duration of data collection in advance.

When implementing coverage under CED, it is important that CMS:

• Collaborate with stakeholders to determine in advance the clinical question to be addressed by the CED data collection exercise. This would include determining the appropriate study endpoints, the number of patients required, and the duration of data collection after a practical consideration of the costs associated with this effort. CMS and the interested stakeholders should agree in advance to a clear data analysis plan.

• Require the collection of only the "minimum necessary" data. Data collection is costly and can be burdensome for providers and other stakeholders. Therefore, CED should not become an exercise in attempting to gather as much data as possible, without regard to the specific research questions involved. It is critical for CMS to ensure that CED-related data collection involves only the "minimum necessary" data to answer the specific clinical questions that the study will address, and that will have a bearing on the ultimate determination as to whether the item or service is reasonable and necessary for the purpose of Medicare coverage. To the extent possible, data collection should not place an additional burden on the parties involved.

  With respect to registries, CMS must clearly support the collection of only the minimum data needed to achieve a "reasonable and necessary" determination. Therefore, registries should not be used to collect additional information that is not necessary to resolve the particular research question.

• Ensure Appropriate Endpoints to CED-Required Data Collection. CED-required data collection should have a well-defined endpoint that is established before the data collection begins. We have recommended that CMS provide more specificity regarding the duration of the data collection or the specific issues or questions CMS seeks to address through data collection, in order to create "stopping rules" for data collection. Without such specificity, a registry or other data collection method could continue for years without a clear end point, and without regard to the reporting burden and costs.

As currently drafted, the registry requirements related to the proposed NCD do not appear to include any limitations on time, number of patients or follow-up period, and appear to be openended. As stated above, we believe reasonable limits must be decided upon up front. The cost of maintenance and continual enrollment in the registry will become a considerable burden that could eventually outweigh the benefit.

In summary, AdvaMed is concerned that the proposed coverage determination for TAVR, with its severe limitations - particularly the requirement for a superiority study design for coverage in the context of a clinical trial- signals a trend toward significantly higher hurdles in order for Medicare beneficiaries to access FDA-approved advances in medical technology. This trend may have a chilling effect on innovation, and a negative impact on beneficiary access to new and innovative technologies that can improve care and health outcomes.

AdvaMed appreciates the opportunity to comment on these issues, which we believe to be relevant not only within the context of the TAVR coverage decision, but can have broader implications with respect to future CMS coverage determinations.

If you have questions regarding these comments or if you require additional information, please contact Chandra Branham, JD, Vice President, Payment and Health Care Delivery Policy, at (202) 434-7219 or cbranham@AdvaMed.org.

Sincerely,

/s/
Ann-Marie Lynch
Executive Vice President,
Payment and Health Care Delivery Policy

---

1 "Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR)(CAG-00430N)," February 2, 2012; http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=257
2 National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1), effective 7/9/2007; see http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&bc=AgAAgAAAAAAAAA%3d%3d&

Less

In the Cardiovascular Surgery and Interventional Cardiology literature, volumes and experience correlate with improved outcomes. Given this I would expect your requirements to exclude small centers and encourage that TAVR be performed at medium to large centers with an expertise in cardiovascular medicine. This must be balanced against nation wide accessibility for the elderly patient. To encourage the appropriate mix of facility and operator experience, I would recommend the following changes:
1. Facility surgical AVR volumes 75-100 cases/year
2. Facility PCI volumes 750-1,000 cases/year
3. The vascular endograft volume requirements appear appropriate especially given the risk of major vascular complications.
4. The Interventional operator requirement of 50 structural heart cases/year appears irrelevant if this means TAVR or BAV. TAVR is not yet commercially available and BAV, balloon aortic valvuloplasty, has no documented safety or efficacy data and therefore very few of either procedure are being performed even at medium to large cardiac centers (which is your presumed target). If 50 structural heart procedures refers to ASD, VSD closures and other congenitial heart procedures then this requirement may be reasonable as a measure of an operator's breadth of experience.
5. Perhaps a better requirement of operator experience for the Interventional Cardiologist would be a minimum of 150 therapeutic interventional cases/year.

Less

The current recommendations regarding potential CMS reimbursement of physicians and centers providing Transcatheter Aortic Valve Replacement (TAVR) fail to recognize the expertise and volume of specialized procedures routinely performed at non-academic centers across the United States. Throughout Europe, TAVR has become a legitimate alternative to surgical repair of aortic stenosis in high risk patients, and one would predict a similar course will be followed in the US. Requiring critically ill patients to travel to a limited number of regional centers to receive this care is an unrealistic expectation.

Mandating that TAVR centers have at least a moderate volume in surgical and catheter based procedures and urging that a multispecialty team approach be utilized is appropriate. Requiring physicians to have extensive experience in aortic valvuloplasty is not appropriate given the current lack of indications for this procedure. I reiterate other's opinions that the suggested volume of >50 structural heart procedures for interventional cardiologists include transcatheter correction of ASD's and PFO's as well as other complex catheter based procedures.

Institutional support, physician experience, and a multispecialty physician approach are all key to a successful transcatheter valve program. Economic benefit appears to be of limited motivation to those providing transcatheter aortic valve replacement as return on investment in all but the highest volume centers is measured in years if not decades. Rather, the motivation appears to be a genuine interest in furthering the advancement of transcatheter technology, and providing services to patients not previously available. I would hope that CMS will not dampen this enthusiasm by withholding reimbursement to well qualified programs.

Less

I think the requirement to have 50 cases of balloon aortic valvuloplasty and/or TAVI is unreasonable and restrictive to providing good medical care. Many of the current operators doing TAVI did not have this type of experience prior to starting their TAVI program and many do not have that many today. The criteria for this device should be set by a diverse group of physicians without a conflict of interest. It should not be set up by those who are the only ones who meet the criteria. Secondly, many patients especially in the more rural areas such as the midwest do not like to travel. Many of these patients may not want or can not physically travel long distances to get this procedure. It needs to be available in many areas of the country. This is a procedure which requires a skill set that can be acquired by most interventional cardiologists and CT surgeons working together. CMS needs to help facilitate the training and implementation process for these doctors to help their patients not impede the process through obstructionist policies.

Less

I have significant concerns regarding the requirement of 50 structural heart disease interventions per operator.

As has been previously mentioned, this requirement is not specifically defined.

If this refers only to valvular interventions, it is highly restrictive.

By definition, patients who meet criteria for TAVR are elderly, frail, and have congestive heart failure. Travelling long distances is often not possible. By confining TAVR to only institutions with senior operators, patient who cannot travel would be denied life-saving therapy. No other life-saving intervention is meted out in such a fashion.

The requirement of 50 structural interventions also prohibits almost all younger interventional cardiologists from participation in TAVR. Given that balloon aortic valvuloplasty carries a class C recommendation from the ACC, this is (and was) not routine practice, at least prior to TAVR.

The future of the treatment of valvular heart disease is percutaneous and/or hybrid. This is not the time to limit application of this revolutionary technology.

Less

cardiogists have professional experience with 50 structural heart disease procedures. First of all, it is not clear as to what procedures would be included in the requirements. Also, it is not a standard of care for valvuloplasty or similar procedure to be performed and would make it extremely difficult for cardiologists to meet this criteria for competency.
We would like our comment included in the public comment section on the CMS decision regarding TAVI reimbursement. We would also request a reply confirming receipt of this email. Thank you for the opportunity to make comment on this procedure.

Less

We are a regional referral system with a top 10% cardiovascular surgical program performing 700 cardiac surgical cases and 6000 caths each year. The structural heart requirements for the interventional cardiologist are onerous and seem to be purposefully placed to limit the availability of the device to a few places. The interventional requirements take into account procedures that are not widely practiced and have no bearing on the proposed procedure. We think the interventional requirements should be lowered. Additional options would include combined expertise or having a lead Cardiologist with more structural experience.

Please reconsider this option as it might limit many excellent centers with years of experience and limit access to many patients

Less

February 28, 2012

Louis B. Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail Stop S3-02-01
Baltimore, Maryland 21244

Jerry Menikoff, M.D., J.D.
Director
Office for Human Research Protections
Department of Health and Human Services
1101 Wootton Parkway
Suite 200
Rockville, MD 20852

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

Dear Dr. Jacques and Dr. Menikoff:

These comments from Public Citizen's Health Research Group are being submitted in response to the Centers for Medicare & Medicaid Services' (CMS) February 2, 2012 proposed decision memo referenced above:

1. While we support the collection of data on the safety and effectiveness of TAVR for the treatment of severe symptomatic aortic valve stenosis, we object to the proposed requirement for Medicare beneficiaries to participate in a research registry as one of the conditions of coverage for TAVR because such a policy would fail to comply with the requirements for obtaining informed consent for research under the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 C.F.R. § 46.116. In particular, we note the following:
   1. The decision memo fails to stipulate that the informed consent of the subjects for participation in the registry research will be obtained in accordance with these HHS regulations;
   2. By allowing coverage for TAVR only for Medicare beneficiaries who agree to enroll in the research registry, the informed consent of the subjects would not be obtained under circumstances that minimize the possibility of coercion or undue inftuence;and
   3. Medicare beneficiaries who refuse to participate in the research registry will be penalized (i.e., they will be denied coverage for TAVR treatment of severe symptomatic aortic valve stenosis with a device approved by the Food and Drug Administration (FDA) for that use), in direct violation of the requirements of HHS regulations at 45 C.F.R. § 46.116(a)(8).
2. We urge CMS and the Office for Human Research Protections (OHRP) to work together to develop an alternative approach for implementing the research registry for TAVR under which:
   1. The voluntary informed consent of the subjects of the proposed research registry is obtained in accordance with all requirements of the HHS regulations at 45 C.F.R. § 46.116; and
   2. The few Medicare beneficiaries who may decline to consent to such research are not penalized by being denied coverage by CMS for their T AVR procedures.

I. FDA status of T AVR medical devices

On November 2, 2011, the FDA approved the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve. This FDA-approved device is indicated "for transfemoral [via the femoral artery in the leg] delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing comorbidities would not preclude the expected benefit from correction of aortic stenosis.:"¹

II. CMS's proposed national coverage decision for TAVR

In response to a request from the Society of Thoracic Surgeons and the American College of Cardiology, CMS initiated a national coverage analysis for TAVR.² CMS proposes that TAVR would be covered only for the treatment of severe symptomatic aortic valve stenosis and only when five conditions are all satisfied. The first condition is that the procedure is furnished for an FDA-approved indication, with a complete valve and implantation system that has received FDA premarket approval. T AVR treatment with the Edwards SAPIEN Transcatheter Heart Valve would satisfy this condition. The second through fourth conditions, which specify criteria for (a) the pre-procedure clinical evaluation of the patients, (b) the qualifications for the treating medical facility, and (c) the qualifications and experience of the treating physicians performing the procedure, appear to be appropriate.

The fifth condition, which we find objectionable, is as follows:

The patient is enrolled in, and the treating physician team is participating in a prospective national registry that consecutively enrolls TAVR patients and tracks at least the following outcomes at the patient data level for a period of at least five years from the time of the TAVR procedure.

1. Major stroke;
2. All cause mortality;
3. Minor stroke/[transient ischemic attack (TIA)];
4. Major vascular events;
5. Acute kidney injury;
6. Repeat aortic valve procedures;
7. Quality of Life measures.

The registry must be designed to permit identification and analysis of patient, practitioner and facility level factors that predict patient risk for these outcomes. The patient must have, after being informed of the reported risks of TAVR and reasonable alternative management strategies, given informed consent.

III. The proposed national registry involves research with human subjects and does not qualify for any exemption

HHS regulations at 45 C.F.R. § 46.1 02(d) define research as follows:

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

The proposed prospective national registry for Medicare beneficiaries undergoing TAVR clearly meets this definition. Under the CMS coverage with evidence development policy, this registry is primarily intended to develop generalizable knowledge about the risks, benefits, and quality of life impact of TAVR in the Medicare beneficiary population. Such a registry also falls within the scope of what would be considered research as described in the handbook issued by the HHS Agency for Healthcare Quality and Research (AHRQ) entitled, "Registries for Evaluating Patient Outcomes: A User's Guide."³

HHS regulations at 45 C.F.R. § 46.1 02(f) define a human subject as follows:

A living individual about whom an investigator (whether professional or student) conducting research obtains

1. Data through intervention or interaction with the individual, or
2. Identifiable private information .

... Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may be readily ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Again, the research registry proposed under the CMS coverage decision will involve human subjects as defined by the HHS regulations because the information is private (medical information) and will have to be recorded in a manner that allows the identity of the subjects to be readily ascertained by the investigators (Le., the registry data will have to be recorded in a manner that allows subjects to be identified so that serially collected medical data for each patient undergoing TAVR can be linked in the registry).

Finally, this human subjects research does not qualify for any exemption under HHS regulations at 45 C.F.R. § 46.101 (i). In particular, the registry does not qualify for the exemption at 45 C.F.R. § 46.101(i)(4) - research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subject - because the data and records for the proposed research registry would not be existing at the time the research is proposed.

IV. Informed consent for subjects enrolled in the research registry must be obtained in accordance with the requirements of 45 C.F.R. § 46.116

For non-exempt human subjects research, HHS regulations at 45 C.F.R. § 46.116 require the following:

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence ... [Emphasis added]

Furthermore, HHS regulations at 45 C.F.R. § 46.116(a)(8) requires that the following information be provided to each subject when consent is being sought:

A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subjects is otherwise entitled. [Emphasis added]

As noted above, in describing the proposed requirement for Medicare beneficiaries to enroll in a research registry as a condition for obtain coverage for TAVR, CMS stated that the "patient must have, after being informed of the reported risks of TAVR and reasonable alternative management strategies, given informed consent."⁴ We presume this statement is referring to clinical informed consent for undergoing the TAVR procedure itself, and not for participation in the mandated research registry. The need to obtain informed consent for the research registry in accordance with the requirements HHS regulations at 45 C.F.R. § 46.116 is not specifically mentioned in this part of the proposed coverage decision.

More importantly, the proposed coverage decision would be incompatible with the requirements of 45 C.F.R. § 116 noted above for two reasons. First, by allowing coverage for TAVR only for Medicare beneficiaries who agree to enroll in the research registry, the informed consent of the subjects would not be obtained under circumstances that minimize the possibility of coercion or undue influence. Second, Medicare beneficiaries who refuse to participate in the research registry will be penalized (Le., they will be denied coverage for TAVR treatment of severe symptomatic aortic valve stenosis with a device approved by the FDA for that use), in direct violation of the requirements of HHS regulations at 45 C.F.R. § 46.116(a)(8).

The importance of obtaining the informed consent of subjects enrolled in research registries was highlighted by AHRQ in its handbook on registries.⁵ It is important that CMS follows HHS's own guidance on research registries.

Although the HHS regulations at 45 C.F.R. § 46.116(d) provide an avenue for institutional review boards (IRS) to waive the requirements for obtaining informed consent, the third criteria for such a waiver - the research could not practicably be carried out without the waiver - would not be satisfied for the proposed research registry. The informed consent of the prospective subjects for enrollment in the registry could be easily obtained at the time they present for their TAVR procedure. Furthermore, it is highly likely that nearly all Medicare beneficiaries eligible for treatment with TAVR with the Edwards SAPIEN Transcatheter Heart Valve (or any future TAVR devices approved under a PMA by the FDA) would agree to participate in the research registry; thus, loss of results from the few patients who decline to volunteer to participate in the research registry is unlikely to lead to significant bias that would adversely affect the study. Therefore, a waiver of the informed consent requirements by an IRS would not be appropriate for the proposed research registry.

V. Proposed solution

We urge CMS and OHRP to work together to develop an alternative approach for implementing the research registry for TAVR under which (a) the voluntary informed consent of the subjects of the proposed research registry for TAVR is obtained in accordance with all requirements of the HHS regulations at 45 C.F.R. § 46.116; and (b) the few Medicare beneficiaries who may decline to consent to such research are not penalized by being denied coverage by CMS for their TAVR procedures.

This could be accomplished by revising the fifth condition for coverage of TAVR as follows (see new language in bold):

The patient is asked to voluntarily enroll in, and the treating physician team is participating in a prospective national registry that consecutively enrolls TAVR patients and tracks at least the following outcomes at the patient data level for a period of at least five years from the time of the TAVR procedure.

1. Major stroke;
2. All cause mortality;
3. Minor stroke/TIA;
4. Major vascular events;
5. Acute kidney injury;
6. Repeat aortic valve procedures;
7. Quality of Life measures.

The registry must be designed to permit identification and analysis of patient, practitioner and facility level factors that predict patient risk for these outcomes. The patient must have, after being informed of the reported risks of T AVR and reasonable alternative management strategies, given informed consent for the clinical procedure. The registry must be conducted in accordance with the requirement of the HHS regulations for the protection of human subjects at 45 C.F.R. part 46, including the requirements for obtaining informed consent of the subjects at 45 C.F.R. § 46.116.

Thank you for the opportunity to comment on the proposed national coverage decision memo.

Sincerely,

/s/
Michael A. Carome, M.D.
Deputy Director
Public Citizen's Health Research Group

/s/
Sidney M. Wolfe,
Director
Public Citizen's Health Research Group

---

1 Foreman C. Letter from the Food and Drug Administration's Center for Devices and Radiological Health to Edwards Science LLC approving the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve. November 2,2011. Available at http:!{www.accessdata.fda.gov{cdrh docs!pdf1 0!P1 00041 a.pdf. Accessed February 23, 2012.
2 Centers for Medicare & Medicaid Services. Proposed decision memo for Transcatheter aortic valve replacement (TAVR) (CAG-00430N). Available at http://www.cms.gov!medicare-coverage-database/details/nca-proposed-decisionmemo. aspx?NCAld=257&ver=5&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=AA AAAAAAIAAA&. Accessed February 23, 2012.
3 Agency for Healthcare Research and Quality. Registries for Evaluating Patient Outcomes: A User's Guide (2nd Edition). Available at http://www.effectivehealthcare.ahrq .gov/ehc/productsl7 4/531/Registries%202nd%20ed%20final%20to%2OEisenberg%209-15-10.pdf. Accessed February 23, 2012.
4 Centers for Medicare & Medicaid Services. Proposed decision memo for Transcatheter aortic valve replacement (T AVR) (CAG-00430N). Available at http://www.cms.gov/medicare-coveragedatabase/details/nca-proposed-decisionmemo.aspx?NCAld=257 &ver=5&NcaName=Transcatheter+Aortic+Valve+Replacement+(T AVR)&bc=AAAAAAAAIAAA&. Accessed February 23, 2012.
5 Agency for Healthcare Research and Quality. Registries for Evaluating Patient Outcomes: A User's Guide (2nd Edition). Available at http://www.effectivehealthcare.ahrg.gov/ehc/products!74/531/Registries%202nd%20ed%20final%20to%2OEisenberg%209-15-10.pdf. Accessed February 23,2012.

Less

I am a TAVR implanting Cardiologist in the PARTNERS Trial with an extensive experience in structural heart interventions for the past 28 years. I would like to make the following comments;

Section A:

1. The procedure is furnished in a facility that meets the following institutional requirements:
   
   1. For centers without previous PMA clinical trial TAVR experience
      1. Surgical program requirements:
         1. = 50 total aortic valve replacement (AVR) procedures/year, including = 10 patients with STS (Society of Thoracic Surgeons) Score = 6;
         2. = 2 institutionally based cardiac surgeons.
      2. Interventional program requirements:
         
         1. = 400 caths/150 PCI’s (percutaneous interventions) per year;
            This Requirement is not stringent enough. The hospital volume in structural heart interventions should be at least 30/year and the PCI volume should be at least 500.
         2. = 15 left-sided structural (EVAR [endovascular aneurysm repair], TEVAR [thoracic endovascular aortic repair], etc.) interventions per year.
2. The procedure is performed by physicians with the following qualifications and experience:
   1. Surgeon requirements: OK
      1. Board Certified/Eligible in Cardiovascular Surgery;
      2. Professional experience with:
         1. = 100 AVR/career including 10 high risk patients; OR
         2. = 25 AVR/year or 50 AVR in 2 years; AND
         3. = 20 in the last year prior to TAVR.
   2. Interventionalist requirements: OK
      1. Operators must be Board Certified/Eligible in Interventional Cardiology
      2. Professional experience with 50 structural heart disease procedures
3. The patient is enrolled in, and the treating physician team is participating in a prospective national registry that consecutively enrolls TAVR patients and tracks at least the following outcomes at the patient data level for a period of at least five years from the time of the TAVR procedure.
   1. Major stroke;
   2. All cause mortality;
   3. Minor stroke/TIA;
   4. Major vascular events;
   5. Acute kidney injury;
   6. Repeat aortic valve procedures;
   7. Quality of Life measures.

The registry must be designed to permit identification and analysis of patient, practitioner and facility level factors that predict patient risk for these outcomes. The patient must have, after being informed of the reported risks of TAVR and reasonable alternative management strategies, given informed consent.

Section C:
We propose national non-coverage of TAVR for all indications other than those noted above, and further specify non-coverage of TAVR in patients with:

• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+);
• Isolated aortic regurgitation;
• Untreated clinically significant coronary artery disease requiring revascularization;
• Hypertrophic cardiomyopathy with or without obstruction;

This is a difficult one. Many patients with severe AS have significant left ventricular hypertrophy. It would be very difficult to clearly insure a given patient did not have hypertrophic cardiomyopathy when they have severe LVH secondary to the aortic stenosis.

• Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• Significant aortic disease, including ( add the word “untreated” here) abdominal aortic or thoracic aneurysm defined as maximal luminal diameter = 5 cm; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if > 5 mm, protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta, unless the patient qualifies for a transapical or other aortic or subclavian approaches;
• Iliofemoral vessel characteristics that would preclude safe placement of an introducer sheath such as severe obstructive calcification, severe tortuosity or small vessel size (applicable for transfemoral patients only), unless the patient qualifies for a transapical, (add “temporary Iliac conduit” here) or other aortic approach.

Less

Regarding CMS NCD proposal for TAVR.
1. Agree that TAVR should only for severe symptomatic Aortic Stenosis. However, thee requirement that ALL of the conditions are met is way too restrictive for a procedure that has been shown to provide mortality benefit when compared to medical treatment.
a. 15 TEVAR/EVAR Procedure. This requirement should be delegated to the TAVR Team instead of just interventional team. This is a procedure that requires a good collaborations between CT surgery and Interventional Cardiologist. Hence, it makes more sense to be part of the institution/team.
b. Professional Experience with 50 structural heart disease procedure. Definition should be clarified that it includes any structural heart procedure such mitral and aortic valvuloplasty, ASD and PFO closure.

Less

As a practicing cardiac surgeon, I view TAVR as a tremendous potential benefit to patients to whom I currently cannot offer surgical treatment. I perform over 100 valve procedures each year, as do my two partners. We have a great deal of experience in the treatment of patients with heart valve disease. It is unfortunate to read that CMS has defined such stringent criteria for participating Cardiologists including that each must have experience with 50 structural heart cases. This criterion will prevent many institutions, such as our own from providing this treatment. TAVR is a surgical procedure and as such, should initially be performed primarily by surgeons with Cardiology support. As such, Cardiologist lacking experience in structural heart treatment could gain the necessary experience and meet the spirit of the CMS criterion over time.

Less

There is quite a discrepancy between the surgeon and interventionalist prior experience in order to get reimbursed for this procedure. Functionally the surgeon requirements of performing AVR including high risk AVR is essentially requiring the surgeon to be a surgeon. However, the interventionalist requirement of 50 structural cases is unnecessary for performance of this procedure particularly when a team approach is utilized (interventional cardiologists and surgeons). Crossing of severe aortic stenosis and catheter manipulations required for TAVI is an extension of mundane angioplasty and vascular techniques. Balloon aortic valvuloplasty has been a rarely performed procedure for the last 20 years and there has not been until now any major indications for this procedure. The requirements for the interventional cardiologist should simply include a certain amount of experience performing diagnostic AS cases as well as a larger experience performing coronary angioplasty. These criteria demonstrate a tremendous bias toward the surgeons who have markedly less experience performing catheter and wire based techniques. The requirement of 50 structural (whatever that means specifically) cases should be eliminated.

Less

I agree with the majority of the material provided in the proposed NCD. However, I am very concerned about the requirement that CMS will only cover investigational uses of TAVR in an FDA-approved “superiority” trial. This policy is unnecessarily restrictive and will both inhibit the medical device industry from introducing appropriate iterations of current generation devices and also force future trial designs to either unrealistic sizes or, more likely, to adopt composite endpoints of uncertain clinical significance. For example, one of the major advantages of TAVR is the more rapid post-procedural recovery compared with surgical AVR. If one were to want to test TAVR in patients at low to moderate risk of adverse outcomes with surgical AVR, the requirement for a superiority design would likely force industry to conduct a trial with early health status recovery or quality of life as a primary endpoint. While such a trial would be certainly be feasible, it might actually be too small to answer critical questions around device safety and longevity that would be of interest to both patients and CMS. A far better approach would be to conduct an adequately powered non-inferiority trial for serious adverse outcomes with secondary endpoints related to health status. If this criterion in the proposed NCD is not corrected, I fear that TAVR in the US will advance very slowly (if at all) and the studies that are conducted will not provide meaningful information to patients, clinicians, or payers.

Less

Our site has been implanting the Edwards Sapien valve since Jan/2012, and this technology truly represents one of the most important advances I have experienced in 20+ years of interventional practice. My specific comments center on the institutional requirements and 2 of the exclusion criteria (that were lifted from the PARTNER TRIAL). I agree with the need for the institution to have a credible experience with surgical valve replacement, but would suggest that this include ALL valves for a total >50. Request for cardiology substantial experience in "structural heart disease" is very vague and NOT relevant to necessary skill set. An active PCI program, with numbers greater than suggested 150 (ie. 300) would establish the necessary case volume for a hospital to support such a time intensive program. Experience with aortic stent grafting is a very reasonable precursor to establishing a TAVR program, but should not be considered as an absolute pre-requisite as in most institutions it is done by neither cardiovascular surgeons or cardiologist. Exclusion of patients based on the presence of an aortic aneurysm or the inability to gain femoral access is unnecessary. Obviously someone who qualifies for commercial TAVR with an AAA of some size cannot have AAA surgery BEFORE the TAVR, and too fix the AAA with endovascular stent graft my make it MORE difficult to perform subsequent TAVR. This places the patient in the position of double jeopardy. From an anatomical standpoint, if the AAA lumen is of sufficient size without extraordinary intraluminal thrombus/debris, then TAVR should be allowed to proceed and receive coverage. Since the trans-apical/aortic approach is not yet approved, patients who would otherwise qualify but have small external iliac arteries that preclude passage of the device still merit the procedure/coverage should a simple conduit to the common iliac arteries be feasible.

As written the proposal doesn't exclude "valve in valve" for failed surgical bioprosthetic aortic valves in patients who are at high risk of repeat operation. Indeed just last week we had a patient die in the setting of critical stenosis of his second bioprosthetic valve. I would strongly recommend coverage of these patients who are increasingly frequent, with exacting reporting in the proposed PMS registry.

Much is made of the fact that symptomatic octogenarians can safely have aortic valve surgery, but regardless a large number of the elderly absolutely refuse surgery. I believe that a provision be made in your coverage decision that allows for freedom of choice in those of advanced age, absent their STS score or other medical co-mordities. Many of the durability questions are frankly irrelevant in the advanced age group, and if appropriately counselled regarding the stroke risk and alternative surgical options I believe that they should be allowed to also participate in the potential benefits of TAVR. At this time in Illinois we are receiving reimbursement for the hospital that barely covers the cost of the valve, and as of yet NO physician reimbursement. The coverage decision for reimbursement needs to reflect the time, effort and expenses incurred by physicians and institutions alike in adhering to the very strict guidelines for care, the time commitment required to perform the procedure with at least 2 operators per case, and provide aftercare to these very ill and complicated patients.

Less

The Centers for Medicare & Medicaid Services (CMS) proposes that coverage for TAVR be approved under Coverage with Evidence Development (CED) only for the following conditions and as specified below:
Under item 4 – It is proposed that an Interventionist have professional experience with 50 structural heart disease procedures. This number appears disproportionate and may include some interventionists use of antiquated practices to support number requirements for TAVR participation. It would appear to be more appropriate to identify patient outcome data relative to professional practice not total number of cases.

Less

For proposed requirement of Interventional Cardiologist qualifications (4. "b.Interventionalist requirements:
i.Operators must be Board Certified/Eligible in Interventional Cardiology
ii.Professional experience with 50 structural heart disease procedures"), qualifications should offer participation and implantation of device to interventional cardiologists with significant structural experience even if not certified in Interventional cardiology. For example, the current proposal would exclude experienced operators such as pediatric cardiologists with significant structural experience.

Less

TAVR has been developed and has been shown to be of benefit in a tightly selected group of patients. The so called Cohort B patient with aortic stenosis as the primary major health problem. I think TAVR should be approved in the application. The document outlines very strick criteria for patient selection and for site selection which I think is appropriate and will be essential for a successful roll out of this procedure nationally. The temptation to move this procedure to less criticall ill patients will be a major concern as will the use of this procedure in clinical setting that are less experienced. The greater issues about applicability will be when this procedure is applied to patients who otherwise are candidates for conventional AVR but hat is a disscussion for another time.

In summary I support the proposal as it is written.

Less

I commend CMS for providing a clear pathway for physicians to safely apply this new technology, one that will absolutely ensure that the patients are correctly identified and the procedure performed with a high level of skill likely to produce excellent outcomes. My only concern is the specific language as follows:
"Two cardiac surgeons have, according to the pivotal PMA trial’s protocol, evaluated the patient’s suitability for open valve replacement surgery."
This could be revised to specifically indicate the consideration that the surgeons must make regarding operability, or state something more general such as two cardiac surgeons agree that the conditions are met to permit TAVR.

Less

Your institutional guidelines are overly restrictive. Rather than an institution, the guidelines should be imposed on the implanting physicians. In our instance, our large group covers 2 large hospitals and our surgical volume is split between the two. We easily meet the surgical numbers as a group, but not as an institution. In medium sized towns, this will require physicians to select one hospital as the valve center. This will not be good for the financial health of our facilities. We can designate one as the TAVR center, but removing surgical AVRs from one to facilitate another does not help our community or our hospitals. Please reconsider the institutional numbers. Any hospital which does hundreds of bypass operations and valve surgeries per year should be able to provide adequate nursing/physician expertise for this procedure. Total valve cases, not just AVRs, should also be considered as part of the institutional experience. Total annual physician AVRs, regardless of institution, should be considered as the standard.

Less

The proposed requirement of 50 structural heart cases needed for qualification of the interventional cardiologist is not necessary and will greatly reduce the availability of this life saving technology. There is little, if any, relevance of the skill set involved in structural heart intervention (ASD/PFO closures, etc) to perform TAVR, let alone a need for extremely extensive proficiency at this. Even if one includes balloon aortic valvuloplasty (BAV) under "structural heart" cases, BAV has not been extensively used in recent years due to it's relative ineffectiveness, therefore few will have 50+ cases of an ineffective treatment. The skill sets which are most relevant are PCI and ICU management. As a member of a team currently performing TAVR, I fully support a careful, thoughtful and team approach to this new procedure, but I do not feel there should be a minimum structural heart case number.

Less

The career requirement for 50 "structural heart disease" cases is unclear. Aren't most of those cases done by pediatric cardiologists? How many cardiologists with an extensice structural heart disease practice are board-certified in interventions as well? Furthermore, how does an extensive experience with structural cases like ASD repairs, PFO's, or mitral clipping — all of which are done transvenously — relate to TAVR?

This requirement, as written, appears unnecessarily restrictive.

Less