WASHINGTON, July 1, 2020 – Alliance for Aging Research President and CEO Susan Peschin, MHS, issued the following statement on the Centers for Medicare & Medicaid Services’ (CMS) draft National Coverage Determination (NCD) for Medicare coverage of mitral valve Edge-to-Edge Repair (TEER) (previously referred to as Transcatheter Mitral Valve Repair, or TMVR) to treat severe degenerative mitral regurgitation or functional mitral regurgitation:
The Alliance for Aging Research is encouraged by CMS’ draft national coverage determination (NCD) for mitral valve Edge-to-Edge Repair (TEER) and—except for some conditions of coverage that should be modified—believes this is a significant step forward for Medicare patients with mitral valve disease. We thank CMS for adopting several points raised by patient and family caregiver advocacy organizations in our public comment submitted last fall.
Patients with mitral valve disease fall into two categories: 1) primary or degenerative mitral regurgitation (DMR); and 2) secondary or functional mitral regurgitation (FMR). DMR means there is something intrinsically wrong with the mitral valve itself that causes it to leak. It can be related to age, a birth defect, or underlying heart disease. FMR does not involve an abnormality of the valve itself but is a disease of the left ventricle, which leads to problems with the mitral valve and is often accompanied by heart failure.
CMS’ proposed decision shows increased flexibility and expands patient access to TEER for both degenerative and functional mitral valve disease in several ways:
- CMS ended its coverage with evidence development (CED) requirement for TEER in DMR and is allowing providers to provide transcatheter options to all Medicare patients with mitral valve disease meeting clinical guidelines without requiring them to join a registry or participate in a clinical trial.
- In its expansion of coverage for TEER to FMR, CMS accepted data collected from non-randomized controlled clinical trial study designs. Previous CMS requirements precluded potential Medicare coverage of observational studies, and trial designs agreed upon between sponsors and the U.S. Food and Drug Administration, such as a single-arm pivotal trial or a non-randomized arm within a larger study program. This is significant for patients who have advanced heart failure and would otherwise die without mitral valve repair. A randomization study requirement in such cases would be unethical.
- We appreciate CMS’ reference to shared-decision making (SDM) and the agency’s call for standardized decision aids or tools using the National Quality Forum’s (NQF) published standards, which the Alliance endorses. Requiring an unvalidated tool that cannot meet NQF’s standards may have an unintended negative effect on provider uptake and patient access.
The Alliance remains concerned about CMS’s proposed minimum surgical procedure thresholds. The draft NCD for TEER for FMR includes increased, unnecessary conditions of coverage requirements on hospitals to perform a minimum number of surgical procedures, which have little relation to the ability of a hospital to perform this procedure. While thoracic specialty societies may favor volume requirements, these restrictions do not help patients with advanced heart failure in need of mitral valve repair. The standard of care for such patients is guideline-directed medical therapy, not surgery. These patients are frequently too sick to tolerate surgery, let alone invasive open-heart surgery, which has not demonstrated a clinical benefit in such patients, making medical therapy alone (until the recent introduction of TEER) their only option.
In fact, two recently published studies (one in the Journal of the American Heart Association and the other in the Journal of the American College of Cardiology) showed that there is no established connection between a hospital’s or surgeon’s mitral valve surgical procedure volumes and TEER outcomes. Further, the draft TEER NCD recommends separate new and established program requirements, which will create new, unnecessary hurdles for smaller and rural hospitals that likely cannot meet the volume requirements. Finally, the draft NCD would require separate face-to-face patient examinations by a cardiac surgeon and interventional cardiologist, creating an additional barrier for patients in obtaining TEER.
The evolution of heart valve disease treatment to less-invasive options significantly affects the ecosystem of hospitals and specialty physicians who make a living treating these conditions. Thoracic surgeons have been saving heart valve disease patients for decades through open-heart surgery; however, interventional cardiologists perform most transcatheter procedures. Patients are stuck in the middle of a professional sea change in heart valve disease treatment involving the specialist clinician, and between major medical centers and smaller community-based and rural hospitals.
CMS’ role is not to referee these provider issues, but to adopt an evidence-based coverage decision that will most benefit Medicare beneficiaries. Unfortunately, the minimum threshold and separate program requirements included in the draft decision today will exacerbate current access issues and disparities for minority and rural populations.
For the most part, the Alliance is pleased with the proposed decision on TEER. 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. The Alliance will submit a public comment to CMS urging the agency to reevaluate its coverage requirements of TEER in FMR and we encourage other organizations and patients to do the same before CMS’ July 30th deadline.
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