CMS' revised rules are leaving some heart patients stranded

CMS revised their national coverage determination for durable, intracorporeal left ventricular assist devices, and the change may prevent some patients from getting heart transplants or other advanced treatments, TCTMD reported Jan. 30.

CMS revised its rules in 2020, removing the current therapeutic intent-to-treat criteria of bridge-to-transplant and destination therapy. The result was that patients with advanced heart failure being considered for a LVAD no longer had to be reviewed by physicians at Medicare-approved heart transplant centers, and patients were no longer required to be placed on the active transplant waiting list.

An observational analysis conducted by Ann Arbor-based University of Michigan Medical School researchers found patients treated at a hospital with both LVAD-implantation and heart transplantation capabilities were more likely to receive a heart transplant. However, those treated at LVAD-only hospitals received the device and little more.

"The general driver of the policy was that there was emerging evidence that patients receiving LVADs as bridge-to-transplant or destination therapy did well and there might not be the need to maintain that affiliation [with transplant centers]," senior investigator Donald Likosky, PhD, told TCTMD. "By removing it, on the one hand, you can imagine it makes it more equitable to receive care at a center that doesn't offer transplant, but alternatively, you can imagine that it makes it more challenging given that transplant is the gold-standard treatment for patients with advanced heart failure."

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