CareDx, a leading precision medicine diagnostics company in transplant, specialty oncology, and cell therapy, announced the finalization of the Medicare Local Coverage Determination (LCD) process related to molecular testing for solid organ allograft rejection. The final policy affirms coverage across CareDx’s transplant surveillance offerings in kidney, heart, and lung.

Kidney: The policy affirms coverage of AlloSure Kidney for surveillance testing for up to six tests in the first-year post-transplant and for up to four tests per year in years two and three. Coverage of for-cause testing is unchanged and available when clinically indicated. AlloSure Kidney patients currently receive an average of approximately three to four tests in the first year following transplant.

Heart: Coverage is maintained for AlloMap and AlloSure Heart, including use of the two tests in combination when medically appropriate. The policy covers up to 12 surveillance tests in the first-year post‑transplant and four tests in years two and three. Coverage of for-cause testing is unchanged and available when clinically indicated.

Lung: Coverage is maintained for AlloSure Lung for surveillance testing, including up to 12 tests in the first-year post‑transplant and four tests in years two and three. These coverage criteria are consistent with the clinical need for frequent monitoring in the early post-transplant period for lung transplant patients.

"The final policy reinforces the role of molecular surveillance in transplant patient management, providing important clarity for patients and clinicians,” said Dr. Jeffrey Teuteberg, Chief Medical Officer of CareDx. “Our molecular testing services are integral to the clinical management of patients who have undergone kidney, heart, and lung transplants.”