CareDx’s HeartCare Multimodality Service Receives Medicare Coverage for Heart Transplant Surveillance

CareDx, Inc. (Nasdaq: CDNA), announced Medicare coverage for HeartCare, a multimodality testing service that includes both AlloMap® Heart and AlloSure® Heart, in a given patient encounter, for heart transplant surveillance. Coverage is effective April 1, 2023.  AlloMap Heart and AlloSure Heart are also covered by Medicare individually.

“Today is a major milestone for heart transplant care and for the use of multimodality technologies to improve patient outcomes with HeartCare,” said Reg Seeto, CEO and President of CareDx. “I could not be prouder of our organization’s unwavering commitment to serving patients and leading transplant innovation. I want to thank MolDX for recognizing the critical clinical value of multimodality in heart transplant surveillance.”

“Medicare’s coverage of HeartCare reflects the growing scientific evidence supporting its use for routine graft surveillance in lieu of a biopsy. 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,” said Jeffrey Teuteberg, MD, Professor of Medicine, Section Chief of Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support, Stanford University.

Studies showed that multimodal testing with HeartCare, including both AlloMap and AlloSure, dramatically reduced dependency on endomyocardial biopsies (EMBs).^1,2 These publications showed a reduction in biopsies with HeartCare when compared to prior use of an AlloMap-only protocol, without impacting outcomes.^1,2 

These studies also showed that when using HeartCare, a negative AlloMap result that accompanied a positive AlloSure result was associated with fewer biopsies than if every AlloSure result above threshold led to a biopsy.^1,2  When both tests were negative, 99.5% of biopsies were deferred.^1,2

“Since the introductions of AlloMap gene expression profiling and AlloSure donor-derived cell-free DNA, followed by their subsequent incorporation in ISHLT guidelines, we’ve seen widespread adoption of these noninvasive testing services at leading heart transplant centers in the U.S.,” said Eugene DePasquale, MD, Medical Director, Heart Transplant Program, Keck Medicine, USC. “The additive value of both biomarkers will lead to a new standard of care, from routine endomyocardial biopsies to noninvasive surveillance, using HeartCare as a robust strategy for the surveillance of heart transplant recipients.”

The use of HeartCare has been supported by the new International Society for Heart and Lung Transplantation (ISHLT) guidelines recommending the use of AlloMap gene expression profiling (GEP) and donor-derived cell-free DNA (dd-cfDNA), as in AlloSure, in routine heart transplant surveillance: AlloMap  has been in the ISHLT guidelines since 2010 and both in the 2022 update.³   In a guide published in the Journal of the American College of Cardiology: Heart Failure, the transition from routine invasive EMBs to a less invasive acute rejection monitoring protocol was described for clinicians.⁴

AlloMap became commercially available in 2005 and has the distinction of being the only gene expression profiling test that has been FDA cleared for use in heart transplant patients.⁵ In 2020, CareDx launched HeartCare, which includes both AlloMap GEP and AlloSure dd-cfDNA, to provide a comprehensive view of organ rejection by assessing immune quiescence and graft injury. HeartCare is currently used in over 1 in 2 newly transplanted patients and in over 90 percent of heart transplant centers in the U.S.⁵

AlloMap Heart, AlloSure Heart, and HeartCare are covered by Medicare under MolDX LCD L38568 and will be listed on the Palmetto GBA Dex Exchange.  HeartCare is covered for the first year, starting two months post-transplant.