The new policy affirms coverage for surveillance testing to detect organ rejection in kidney, heart, and lung transplant patients.
CareDx announced the finalization of the Medicare Local Coverage Determination (LCD) process regarding molecular testing for solid organ transplant rejection. The final policy affirms coverage for transplant surveillance offerings in kidney, heart, and lung patients.
For kidney transplants, the policy affirms coverage of AlloSure Kidney for surveillance testing for up to six tests in the first year following a transplant and for up to four tests per year in the second and third years. Coverage for for-cause testing remains unchanged and is available when clinically indicated. According to CareDx, kidney patients currently receive an average of approximately three to four tests in the first year post-transplant.
In heart transplants, coverage is maintained for AlloMap and AlloSure Heart, including the use of both tests in combination when medically appropriate. The policy covers up to 12 surveillance tests in the first year and four tests per year in years two and three. Coverage for for-cause testing remains available when clinically indicated.
For lung transplants, the policy maintains coverage for AlloSure Lung for surveillance testing. This includes up to 12 tests in the first year and four tests in the second and third years. These criteria align with the clinical need for frequent monitoring during the early post-transplant period, according to the company.
“The final policy reinforces the role of molecular surveillance in transplant patient management, providing important clarity for patients and clinicians,” says Dr Jeffrey Teuteberg, chief medical officer of CareDx, in a release. “Our molecular testing services are integral to the clinical management of patients who have undergone kidney, heart, and lung transplants.”
A proposed draft of the LCD was initially released on July 17, 2025, and remained open for public comment through Aug 31, 2025. The final LCD was published on July 16, 2026, and is expected to take effect on Aug 30, 2026.
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