WASHINGTON, January 20, 2021 – Alliance for Aging Research President and CEO Susan Peschin, MHS, issued the following statement on the Centers for Medicare & Medicaid Services’ (CMS) final National Coverage Determination (NCD) for Medicare coverage of mitral valve Transcatheter Edge-to-Edge Repair (TEER) to treat severe degenerative mitral regurgitation or functional mitral regurgitation:
Late yesterday, CMS issued its final national coverage determination (NCD) for mitral valve Transcatheter Edge-to-Edge Repair (TEER), also referred to as Transcatheter Mitral Valve Repair or TMVR (or TMVr). This final decision constitutes a breakthrough for patients and extends coverage of TEER for patients with functional mitral regurgitation (FMR), which is a disease of the left ventricle that leads to problems with the mitral valve and is often an outcome of heart failure. The standard of care for such patients is guideline-directed medical therapy (GDMT). These patients are frequently too sick to tolerate surgery, making medical therapy alone (until the recent introduction of TEER) their only option. In ongoing clinical studies, combining TEER with GDMT lowers risk of death by one-third and heart-failure hospitalizations by half when compared to GDMT alone. For these Medicare patients, the expanded access to TEER has life-and-death consequences.
We applaud CMS for the steps it has taken to advance innovation for Medicare patients, and we thank the agency for adopting recommendations from advocacy organizations representing patients, family caregivers, and providers outlined in our public comment submitted last fall and our July 2020 comment letter on the proposed NCD.
Although they lowered the volume requirements in the final NCD, the Alliance is concerned that CMS chose to include minimum surgical procedure thresholds for TEER. There is no evidence-based connection between surgical volume and TEER outcomes, as identified in studies published in the Journal of the American Heart Association and the Journal of the American College of Cardiology. However, we applaud CMS for incorporating feedback from the patient community to remove elevated requirements for new TEER programs in hospitals that would have limited access for appropriate patients, We are also pleased that CMS recognized the central role of heart failure cardiologists for patients with FMR, by including them in the evaluation requirements.
Overall, the Alliance is pleased with the final NCD on TEER. The expansion of coverage to patients with FMR will improve outcomes and provide a needed treatment option for this severely ill population. We applaud CMS for the steps it has taken to advance innovation for Medicare patients, and we thank the agency for adopting recommendations from advocacy organizations representing patients and family caregivers.
About the Alliance for Aging Research
The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance believes advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the National Institutes of Health and Food and Drug Administration; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers. For more information, visit www.agingresearch.org
Vice President of Communications