MolDX: Molecular Testing for Solid Organ Allograft Rejection

Molecular diagnostic tests for evaluation of solid organ allograft rejection are covered only when the test addresses AR or ACR/AMR status, is used for one of the specified intended uses (e.g., replace biopsy for management, rule-out, adjunct after inconclusive biopsy), and has demonstrated analytical and clinical validity with peer-reviewed evidence and technical assessment. Tests must be used in the analytically validated population, ordered by appropriately qualified clinicians affiliated with a transplant center, and limited to one molecular test per patient encounter unless a second adjunct test is reasonable and necessary.

"Molecular diagnostic tests for evaluation/management of patients who have undergone solid organ transplantation to inform assessment of active rejection (AR)."

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