The Association of Black Cardiologists issued a joint statement along with the Alliance for Aging Research, Heart Valve Voice US, and Mended Hearts in response to the Centers for Medicare and Medicaid Services’ proposed decision to cover Transcatheter Aortic Valve Replacement (TAVR) for the treatment of symptomatic aortic valve stenosis through Coverage with Evidence Development (CED).

This week, the Centers for Medicare and Medicaid Services (CMS) released its updated proposed decision on Medicare coverage for a less-invasive heart valve disease treatment called transcatheter aortic valve replacement (TAVR). We applaud the call for the public reporting of health outcomes data and evidence-based shared decision-making tools, change in the evaluation requirement to one cardiac surgeon, reduction in TAVR program establishment requirements, and recognition of continued barriers to access for minority populations.

Unfortunately, the update continues to base patient access on hospitals’ procedural volume ahead of equal access and quality care for patients. The extensive data from seven years of TAVR procedures shows that there is no longer a relationship between volume and health outcomes, and to that end, shows that a Coverage with Evidence Development (CED) is no longer needed.

When it was first approved by the Food and Drug Administration (FDA) in 2011, TAVR was an important advancement for older adults who needed an aortic valve replaced but were too ill or frail to survive open-chest surgery. But due to concerns that such a new technology could have some risks, CMS imposed a National Coverage Determination (NCD) in 2012 under Coverage with Evidence Development (CED). CED requires the collection of data in a registry intended to be used as the basis for future coverage decisions.

Seven years later, tens of thousands of patients have been successfully treated with this therapy and hundreds of studies have been published comparing TAVR to traditional open-heart surgery. Such studies have found improved outcomes with TAVR, much shorter hospital stays and recovery times, better quality of life measures, and lower incidences of some major complications.

The intent of the CED should dictate that CMS declare it a success and issue a straightforward “yes” decision to cover TAVR nationally according to its FDA-approved indications. CED is not intended as a permanent system to collect post-market data. But, Medicare’s evidence-based decisions have been influenced by professional societies who banded together in 2018 on a consensus statement, arguing that the therapy only performs as well as it does when it is delivered by specialty hospitals with high volume.

Health outcomes data for individual TAVR programs collected by the registry are kept private from the public, which makes the volume-outcomes hypothesis difficult to refute. Despite this lack of transparency, a recent review of more than 61,000 cases from the TVT Registry™ should have put the volume-outcomes hypothesis to rest. The review, published in the February 2019 issue of Journal of the American College of Cardiology, found that once the learning curve was surpassed, the volume-outcomes relationship disappeared. The review also found that, with the use of current generation TAVR devices, there is no longer a detectable learning curve or demonstrable volume-outcomes relationship.

CMS’ proposed decision gives a nod to the dispute by reducing some of the volume-metric requirements. However, it continues to lean on the now-debunked volume-outcomes hypothesis to justify its continuation of minimum volume metrics. The modifications will likely have little impact on patient access and may even restrict it further.

Significant disparities already exist for those who do get TAVR, based on race, ethnicity, income, and where people live: registry data shows 94 percent of patients currently receiving TAVR are white, 90 percent of TAVR procedures are done in teaching hospitals and nearly 8 in 10 patients served by these hospitals reside in high-income zip codes. By comparison, safety net hospitals only perform about 20 percent of TAVRs. Arbitrary volume requirements harm patients, particularly racial and ethnic minorities who are already undertreated.

Two recent studies of “low-risk” patients published in the March 2019 issue of the New England Journal of Medicine found significantly lower rates of death and stroke with TAVR than with surgery. If FDA approves this TAVR expansion, the number of patients that could be helped by this therapy will grow considerably. If the CED and its annual procedural volume requirements remain, waiting lists at larger hospitals could lengthen and patients will die due to delays.

Transitioning the CED to national coverage for FDA-approved use has the potential to expand treatment access to more hospitals that offer Medicare shared-savings programs. We want to see CMS pay for TAVR at hospitals that demonstrate performance based on quality outcomes, regardless of volume.

Patients are stuck in the middle of a professional sea change in heart valve disease treatment among the specialists; and among larger hospitals and smaller, community-based, and rural hospitals. We appeal to both CMS Administrator Verma and U.S. Health and Human Services Secretary Azar to amend its TAVR coverage decision to one that will be of most benefit to all the older adult beneficiaries they are charged to serve.

 

Sue Peschin. MHS, is President and CEO of the Alliance for Aging Research

Cassandra McCullough, MBA, is CEO of the Association of Black Cardiologists

Aaron Horne, Jr., MD, Chair, Association of Black Cardiologists Structural Heart Committee

Marilyn Serafini, MA, is Executive Director of Heart Valve Voice US

Norm Linsky, MA, MPAff, is Executive Director of Mended Hearts