 has decided to retire a draft Local Coverage Determination (LCD) that would have limited coverage for non-invasive blood tests used to monitor organ transplant rejection){kind=link}
The Centers for Medicare and Medicaid Services (CMS) has decided to retire a draft Local Coverage Determination that would have limited coverage for non-invasive blood tests used to monitor organ transplant rejection. This move, combined with the upcoming removal of restrictive language in a related billing article, effectively restores Medicare coverage for tests such as AlloSure® and AlloMap®, according to CareDx.
These blood tests, AlloSure and AlloMap, are tools for monitoring the health of transplanted organs without the need for invasive procedures like biopsies. The March 2023 Billing Article had required that non-invasive tests be used in place of a biopsy, but this requirement was problematic for many transplant centers, especially those that do not perform surveillance biopsies for kidney transplants. As a result, the use of these non-invasive tests had declined.
CareDx’s CEO, John W. Hanna, expressed gratitude toward CMS and its local contractors for considering the input of patients and clinicians who advocated for the importance of these tests. He emphasized that their efforts were key in restoring the broader Medicare coverage that had previously been in place.
AlloSure and AlloMap are non-invasive tests that evaluate the health of transplanted organs by assessing indicators like allograft injury and immune system activity. Their clinical value has been supported by numerous peer-reviewed studies, making them a vital part of transplant care.