NEW YORK – CareDx announced on Wednesday that its multimodal HeartCare transplant surveillance service has received Medicare coverage, effective April 1, 2023.
HeartCare will be covered for the first year of use, starting two months post-transplant. The service includes the AlloMap Heart gene expression test and AlloSure Heart cell-free DNA test, both of which are also covered individually by Medicare.
All three offerings are covered under MolDx LCD L38568 and will be listed on the Palmetto GBA DEX Exchange.
Earlier this year, Palmetto issued a revised billing article restricting coverage of molecular testing in solid organ transplantation to one test per patient encounter. The decision caused widespread confusion among stakeholders in the transplant space, who are still working to determine its impact in the field.
Brisbane, California-based CareDx had then planned to submit additional data for HeartCare to MolDx and to update its procedures in line with the revised billing article.
A spokesperson for CareDx said in an email that today's news shows that the company was successful in these efforts, stating that the decision "makes it clear that HeartCare, the combined testing of AlloSure Heart and AlloMap Heart, [is] now covered by Medicare together."
HeartCare gained inclusion into International Society for Heart and Lung Transplantation guidelines late last year, which supported its expanded use in routine heart transplant monitoring.
"Medicare's coverage of HeartCare reflects the growing scientific evidence supporting its use for routine graft surveillance in lieu of a biopsy," Jeffrey Teuteberg, a professor medicine and section chief of heart failure, cardiac transplantation, and mechanical circulatory support at Stanford University, said in a statement.
"We have witnessed a significant reduction in the need for endomyocardial biopsies in our clinical practice by incorporating paired testing with AlloMap and AlloSure, which provides complementary information about allograft health," he added.
CareDx also recently acquired Medicare coverage for its AlloSure Lung transplant rejection monitoring test.
"Today is a major milestone for heart transplant care and for the use of multimodality technologies to improve patient outcomes with HeartCare," CareDx President and CEO Reg Seeto said in a statement.