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CGS Administrators Aligns Medicare Coverage for CareDx AlloSure Tests

NEW YORK – Medicare Administrative Contractor CGS Administrators released a local coverage determination aligning with Palmetto GBA's expanded decision to cover CareDx's AlloSure tests for organ transplants. 

CGS will provide limited coverage for AlloSure Kidney when used to determine the probability of allograft rejection in kidney transplant recipients and to inform clinical decision making about the need for renal biopsy in patients at least two weeks post-transplant. It will also cover AlloSure Heart when used with the AlloMap test to determine allograft rejection probability in heart transplant recipients with clinical suspicion of rejection and to inform clinical decision making about the need for a heart biopsy in patients at least 55 days post-transplant.  

The LCD combines the coverage for these tests in one document after AlloSure Kidney was previously covered. The non-invasive blood tests measure transplant injury via donor-derived, cell-free DNA. The LCD also provides coverage for tests with similar indicated uses and performance to AlloSure, although it doesn't mention any other tests by name. The decision goes into effect Dec. 28. 

Last month, Noridian also aligned its coverage terms with Palmetto's final decision. Palmetto previously issued a draft LCD for AlloSure Heart used with AlloMap in August 2019.   

Separately this week, CareDx said that it has received final reimbursement pricing of $2,753 from Palmetto's MolDx program for AlloSure Heart.