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View Public Comments for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

Stewart, Maria
Vice President, Global HEMA
Boston Scientific Corporation

April 24, 2019

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

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

Dear Ms. Syrek Jensen,

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

Section A.2 - Independent Examinations

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

Section A.3 - Heart Team and Shared Decision Making

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

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

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

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

Summary of BSC Comments

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

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


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