![Large peridevice leaks after left atrial appendage occlusion (LAAO) are incredibly rare and not associated with a greater risk of adverse outcomes, according to new research published in JACC: Clinical Electrophysiology.[1] Smaller residual links are more common, however, and associated with a risk of thromboembolic and bleeding events.](/sites/default/files/styles/top_stories/public/2018-08/olderpatient-doctor.jpg.webp?itok=Cv18wcDr)
CMS has proposed expanding Medicare coverage of artificial hearts and ventricular assist devices, removing certain requirements so that these devices are available to more patients.
First, patients would no longer be required to be enrolled in a clinical study for artificial hearts to be covered. If finalized, the change would put such decisions in the hands of local Medicare Administrative Contractors.
“With about 6.5 million American adults living with heart failure, today’s proposal ensures a patient-centered approach to treating end-stage heart disease without delaying care,” CMS Administrator Seema Verma said in a statement. “Our updated criteria better reflects the individualized needs of patients with heart failure and expands physicians’ ability to offer the most appropriate treatment options to their patients, both of which will lead to better health outcomes for Medicare beneficiaries.”
In addition, the proposal would relax the rule that says patients must be on the Organ Procurement and Transplantation Network waitlist to have a left ventricular assist device (LVAD) covered. And the implanting site, if a different location than the Medicare-approved transplant center, would no longer need to receive written permission from that transplant center for the LVAD to be implanted.
Patient selection criteria previously used only for destination therapy LVADs would also be applied to all LVADs.
The full proposed national coverage determination is available here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.