CMS finalized most of its proposed changes to the conditions for coverage of VADs as a DT, and like the draft decision, did not make any changes to the patient selection criteria for VADs as a BTT or postcardiotomy.
CMS finalized its proposal to no longer require VAD providers to participate in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) to be eligible for coverage. Instead, CMS will cover VADs as a DT as long as the facility where the procedure is performed meets strict requirements, such as having an experienced multidisciplinary heart team in place and accreditation by a CMS-approved program. CMS reaffirmed that coverage of VADs for right ventricular support and biventricular support in patients under 18 years old or with complex congenital heart disease, is at the discretion of local contractors. Finally, despite continued pressure from commenters, CMS affirmed its draft decision not to extend coverage of VADs to include “bridge to candidacy” patients who are neither on the official transplant waitlist (BTT) nor defined as ineligible for a transplant (DT). CMS, however, noted that VADs for such use could be covered in the context of Category B investigational device exemption clinical trials if the relevant CMS criteria are met.
Although the final decision removes a burdensome data collection requirement, a handful of commenters including one VAD manufacturer did not support CMS’ removal of the registry requirement. Some argued that INTERMACS provides a robust source of clinical evidence that can be leveraged to improve the quality of future technology, and asked CMS to upgrade INTERMACs rather than dismantle it. Given that the revised NCD for VADs is still restrictive and INTERMACS participation is no longer mandatory, VAD manufacturers will need to determine how to continue developing the evidence base for VADs in order to get CMS to further relax coverage restrictions in the future.