Heart Valve Voice US welcomes the proposed National Coverage Determination (NCD) from the Centers for Medicare & Medicaid Services (CMS) recognizing that Transcatheter Edge-to-Edge Repair (TEER) for functional mitral valve regurgitation is reasonable and necessary. Mitral valve regurgitation is the most common form of valvular disease, affecting an estimated 9.3 percent of the population age 75 or over. This proposed NCD represents an important step forward for these patients. We are also encouraged that the “Coverage with Evidence Development” designation has been removed.
We are concerned, however, by three elements of the proposed NCD. Heart Valve Voice US, along with most other concerned entities, had anticipated a broader NCD, potentially covering a range of emerging mitral valve technologies, including transcatheter mitral replacement devices. We believe such a step would facilitate ease of access and coverage for patients, while also providing a predictable coverage pathway for manufacturers.
Also, the proposed NCD retains a requirement for “face-to-face” consultations between a patient and the various members of their heart team (although the requirement is waived during the COVID-19 public health emergency). Going forward, we urge CMS to weigh the value of such in-person interactions versus the potential burden to patients, especially if multiple appointments are required. As we have seen both before and during the COVID-19 pandemic, telehealth offers significant advantages to patients of all types, including and especially older Americans with mobility and other age-associated health conditions. We believe telehealth is not a trend but an important tool to facilitate safe, convenient, efficient access for patients.
Finally, CMS continues to rely on unrelated surgical volume requirements for both existing and potential new TEER programs. We are concerned that such requirements will discourage the initiation of new programs in areas of need. Of note, this NCD was drafted prior to the publication of two high-quality studies, that demonstrate there is no relationship between mitral valve surgical volumes and transcatheter mitral valve repair outcomes. Such surgical volume requirements needlessly restrict patient access, especially in rural areas of the Midwest and Southeast and among Black and Hispanic populations. We are hopeful CMS will consider this new evidence in its final NCD.
Heart Valve Voice US looks forward to providing detailed comments to CMS.
 Vemulapalli S. et al. Mitral valve surgical volume and transcatheter mitral valve repair outcomes: Impact of a proposed volume requirement on geographic access. Journal of the American Heart Association. 27 May 2020. 9(11):e016140. https://www.ahajournals.org/doi/10.1161/JAHA.119.016140.
 Barker CM et al. Association between institutional mitral valve procedure volume and mitral valve repair outcomes in medicare patients. JACC: Cardiovascular Interventions. 11 May 2020. https://interventions.onlinejacc.org/content/13/9/1019 DOI: 10.1016/j.jcin.2020.02.008