US CMS Affirms Coverage for cfDNA Testing for Transplant Surveillance, Supported by ISHLT Advocacy Work
The U.S. Centers for Medicare & Medicaid Services (CMS) recently decided to reverse a proposal that would have restricted coverage for non-invasive blood-based surveillance testing used to detect rejection in transplant patients. This decision is a victory for the transplant community, as it preserves access to a tool transplant professionals use to detect and treat allograft rejection as early as possible.
The proposed policy would have required that surveillance testing be performed only as an alternative to invasive biopsies, a change that could delay detection of allograft rejection, particularly in cases where biopsies are not routinely performed for surveillance or are contraindicated. There was also concern about the way the proposed policy was developed, without expert input from the medical and patient communities.
In response to the potential impact of these changes, ISHLT, through its Advocacy Committee, along with other advocacy groups and stakeholders, engaged with CMS to emphasize the clinical importance of maintaining coverage for these non-invasive tests, and object to the lack of transparency and expert input in the creation of policies that limit physicians’ options. Through coordinated advocacy efforts, ISHLT highlighted how these tests provide insights into graft health, enabling timely and less invasive interventions that improve patient prognosis.
Thanks to these efforts, CMS chose not to finalize the proposed restrictions, leaving existing coverage criteria in place, thus ensuring that heart, lung and kidney transplant recipients in the U.S. continue to have access to non-invasive surveillance testing so that allograft rejection may be detected and treated as early as possible.
This case underscores the importance and value of ISHLT advocacy in protecting and advancing healthcare policies everywhere that directly impact patient care.