CMS policy change could increase disparities in heart transplant receipt
In 2020, CMS made a policy change to increase access to left ventricular assist devices. It could have unintended consequences in increasing disparities in who receives a heart transplant, according to a research team.
In an analysis published in November in JAMA Network Open, Thomas M. Cascino, MD, MSc, a clinical instructor in the division of cardiovascular medicine at the University of Michigan Medical School at Ann Arbor, and colleagues found that among 22,221 patients with advanced HF who received an LVAD between April 2012 and June 2020, those who received their device at an LVAD/transplant center were 79% more likely to receive a bridge-to-transplant designation and 33% more likely to receive a transplant than those who received their device at an LVAD-only center.
The researchers wrote that the CMS policy change could increase the number of LVAD procedures at LVAD-only centers, which could increase the gap in odds for a transplant depending on what type of center the LVAD implant was performed in.
Healio spoke to Cascino about the reasons for the CMS policy change, the potential to increase disparities in who receives a heart transplant and steps that can be taken to reduce inequities in care of advanced HF.
Healio: What were the drivers behind the 2020 CMS policy change?
Cascino: LVADs were historically studied in trials by the therapeutic intent-to-treat of either bridge-to-transplant or destination therapy. For patients receiving an LVAD for destination therapy, the LVAD was the definitive therapy because they were not candidates for heart transplants. The major driver of the policy change was emerging evidence that patients who received LVADs as either bridge-to-transplant or destination therapy did well, and that the designation was no longer needed. As part of removing the therapeutic intent, the policy change eliminated prior requirements for patients who were being considered for LVADs at centers that didn’t do transplants to have a relationship and evaluation with centers that did perform transplants if a patient was a transplant candidate.
Healio: What was your team hoping to learn from this study?
Cascino: We hope that one day any patient with HF will be able to walk into any hospital and get the therapy that would best support them. We wanted to understand if having a transplant program and an LVAD program changed how patients were evaluated for transplant at the time of LVAD and if there were differences in patients getting a transplant in the 2 years following LVAD compared to programs that only did LVADs.
Healio: What are the most important findings from this study?
Cascino: Our study had two key findings. Using the Society of Thoracic Surgeons (STI) Intermacs database, we found that receiving an LVAD at centers that also performed heart transplants was associated with an increased likelihood of being considered a transplant candidate at the time of LVAD and that patients were more likely to receive a heart transplant in the subsequent 2 years.
Healio: Why do you think the transplant rate numbers played out as they did?
Cascino: The study's retrospective nature does not allow us to say the reason definitively. Determining transplant eligibility is complex. We hypothesize that transplant centers are more aggressively pursuing transplants for patients, especially when they were initially considered not to be candidates.
Healio: How might the developments resulting from the CMS policy change affect inequities in access to transplant?
Cascino: By removing the requirement for relationships with transplant centers for centers that don’t perform transplants, one potential barrier to establishing a program no longer exists. This is a positive change as there are many people with HF who may benefit from an LVAD and could potentially have improved access to centers that perform LVADs. At the same time, heart transplant remains the gold standard therapy for end-stage HF, and it is critical to ensure patients are considered for a transplant. This is particularly needed as there have been changes to the Organ Procurement and Transplantation Network(OPTN)/United Network for Organ Sharing (UNOS) adult heart allocation system that make it much less likely that patients with LVADs can get transplanted. As a result, there is the potential for increased disparities in access to heart transplants if patients who would be eligible are not considered for transplant before receiving an LVAD.
Healio: Is LVAD a worse outcome than transplant in this population?
Cascino: While LVAD and transplant are both lifesaving, transplant remains the gold standard treatment for end-stage HF because of greater improvements in quality of life and survival.
Healio: What can be done to reduce inequities in care of patients with advanced HF?
Cascino: Ultimately addressing disparities and inequities will require changes at the policy, health system and provider levels. In the short term, centers should standardize the evaluation process for heart transplants and LVADs using evidence-based practices to best ensure all patients are considered for both therapies. Longer-term, there is also an opportunity to use registries like STS Intermacs and UNOS to provide feedback to centers on their performance to ensure therapies are being used equitably.
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For more information:
Thomas M. Cascino, MD, MSc, can be reached at tcascino@med.umich.edu.
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