Dive Brief:

• Healthcare professionals have voiced support for Abbott’s request for CMS to stop using the terms bridge-to-transplant (BTT) and destination therapy (DT) in regard to ventricular assist devices.

• Meanwhile, the responses to SynCardia’s request to permit the use of artificial hearts outside of clinical trials were more mixed. The American Heart Association sided with SynCardia, but the Society of Thoracic Surgeons and other groups argued against the proposal.

• The feedback came during the public comment period that closed Wednesday on a national coverage analysis for artificial hearts and certain ventricular assist devices​, slated for a proposed decision memo in August.

Dive Insight:

Last month, CMS agreed to reconsider how it covers ventricular assist devices​ and artificial hearts. The action followed the submission of requests by Abbott and SynCardia, which argued data generated since the artificial heart and VAD coverage were last determined in 2008 and 2013, respectively, render aspects of the current system outdated.

Abbott’s request was based on results from a clinical trial of its left ventricular assist device HeartMate 3, a rival to Medtronic’s HeartWare. The trial found HeartMate 3 achieved similar outcomes in BTT and DT patients, leading researchers to argue the terms “should be abandoned in favor of a single treatment indication.”

The proposal received support from cardiologists, many of whom criticized the use of the terms BTT and DT on the grounds that they, at best, poorly describe real-world patients and, at worst, create a barrier to access to the most appropriate treatment. The Society of Thoracic Surgeons, alongside the American College of Cardiology and other groups, criticized the practice of classifying patients as BTT or DT. 

"These types of definitional issues confuse the intent of the use of these devices to improve patient longevity and quality of life and further disadvantage patients with an arbitrary label that may prevent them from accessing needed care," a joint comment from the professional societies said. 

The feedback is light on opposition to Abbott’s request.

By contrast, responses to the review triggered by SynCardia’s request featured some pushback, notably from the Society of Thoracic Surgeons. The professional society said it does “not agree with the proposal to remove the requirement for coverage with evidence development (CED) for artificial hearts and related devices.”

In making its pitch to CMS, SynCardia pointed to the survival rate in a study that reported results in 2018 to argue for the liberalization of the coverage of artificial hearts. Currently, BTT use of artificial hearts is only permitted under CMS’ CED.

The Society of Thoracic Surgeons wants that restriction to stay in place, arguing that "many clinical questions about artificial hearts ... still need to be answered" and that ongoing data collection is needed. Other respondents were more sympathetic to SynCardia’s position, with the American Heart Association supporting the removal of the CED restriction and the use of artificial hearts outside of clinical trial settings. That position is underpinned by a mix of data and unmet need. 

“There is an extensive body of evidence presented in the reconsideration request that shows that the [Total Artificial​ Heart] is a safe and effective therapeutic option. Furthermore, there is currently no other viable alternative in existence that has been approved by the US Food and Drug Administration,” the AHA wrote.

The feedback will inform CMS’ next steps. The agency plans to release a proposed decision memo by Aug. 3, setting it up to complete its analysis of the national coverage determination by the start of November.