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A proposed (NCD) would ease some requirements for Medicare reimbursement of artificial hearts and left ventricular assist devices (LVADs).

Under the new policy, "coverage with evidence development" would be eliminated for artificial hearts, meaning beneficiaries with advanced heart failure would no longer have to be enrolled in a clinical study in order to have such biventricular replacement devices covered.

Additionally, coverage of artificial hearts would be determined by local Medicare Administrative Contractors (MACs) going forward, the Centers for Medicare & Medicaid Services (CMS) announced.

"We believe this proposed decision is in the best interest of Medicare beneficiaries since careful patient selection is important, and the MACs are structured to take into account a beneficiary's particular clinical circumstances to determine which patients will benefit from receiving an artificial heart," the agency said.

Proposed changes to LVAD coverage included the removal of two major requirements in bridge-to-transplant.

First, CMS would eliminate the rule that the patient has to be on the transplant waitlist maintained by the Organ Procurement and Transplantation Network. Second, it would no longer be required that the implanting site (if different than the Medicare-approved transplant center) receive written permission from the Medicare-approved transplant center before VAD implantation.

In addition, patient selection criteria for destination therapy LVADs could be extended to all LVAD procedures.

These proposals applied only to durable LVADs. They would not apply to temporary VADs or extracorporeal membrane oxygenation, CMS cautioned.

"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," said CMS Administrator Seema Verma in a press release. "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."

The public commenting period for the proposed NCD is now open.

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