CMS’ revised rules are leaving some heart patients stranded

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.”