Medicare Policy Tweak on LVADs May Reduce Access to Transplant

A recent change in Medicare policy designed to increase access to left ventricular assist devices (LVADs) may have had the unintended consequence of increasing inequalities in access to heart transplant for patients with advanced heart failure.

In December 2020, the Centers for Medicare & Medicaid Services (CMS) relaxed restrictions on centers that implant LVADs but don’t perform heart transplants. Specifically, they dropped the requirement that LVAD-only centers obtain permission from a Medicare-approved heart transplant center authorizing LVAD implantation with “bridge-to-transplant” (BTT) intent, meaning the patient is a transplant candidate.

While the relaxed requirement has the potential to increase access to LVADs for appropriate patients, a look back at 22,221 LVAD recipients found that patients who received LVADs at transplant-capable centers had a 79% higher likelihood of receiving a BTT LVAD designation.

The 2-year heart transplant rate following LVAD implant was 25.6% for patients who received an LVAD at a heart transplant center, compared to 11.9% at LVAD-only centers.

Thomas Cascino, MD, with University of Michigan Health Frankel Cardiovascular Center, Ann Arbor, and colleagues report their findings in JAMA Network Open.

Differential Assessment?

Nontransplant LVAD centers are increasing in number in the US now that the CMS has made establishing an LVAD-only center easier.

“Although there should be enthusiasm for the potential of LVAD-only centers to increase access to LVAD, it appears that receiving an LVAD at a center that does not perform transplants results in differential assessment of transplant eligibility at the time of LVAD implant and inequities in receipt of transplant,” Cascino and colleagues say.

“Being cared for at a center that does not perform heart transplant should not result in a lesser chance to receive a heart transplant,” Cascino adds in a university news release. “Our study shows that this disparity existed before the policy change, and we think it will likely grow larger now that there is less collaboration.”

The CMS policy will likely “further challenge equity in access to transplant for patients seeking care at nontransplant centers and may have the unintended consequence of contributing to increasing inequities in access to transplants, as has been feared,” the researchers add in their article.

They also note that recent changes in the adult heart allocation system under the United Network for Organ Sharing (UNOS) have significantly reduced the likelihood of transplant after durable LVAD implant unless candidates are listed as being at higher urgency status owing to an LVAD complication or clinical deterioration.

“The reality is that durable LVADs are much less likely to be a bridge to the best therapy (ie, transplant) in the current allocation system. As a result, there is a critical need to select appropriate durable LVAD and transplant candidates at the initial evaluation,” the authors say.

“This puts the onus on the transplant community to select appropriate LVAD and transplant candidates during the initial evaluation. We need a system in which any patient can walk into the same hospital and get the right therapy for them,” Cascino adds in the release.

The research was supported in part through funding from the University of Michigan Health Department of Cardiac Surgery and t he National Institutes of Health, National Heart, Lung, and Blood Institute. Cascino has received grants from Johnson & Johnson. A complete list of author disclosures is available with the original article.

JAMA Netw Open. Published November 7, 2022. Full text

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