MolDx: Molecular Testing for Solid Organ Allograft Rejection

Molecular diagnostic tests for solid organ allograft rejection are covered only when they provide information about active rejection or ACR/AMR status, are used for one of the specified clinical purposes (e.g., to avoid biopsy, rule out AR, evaluate after pretest, or clarify an inconclusive biopsy), and have demonstrated analytical and clinical validity in the intended, validated population. Tests must complete a Technical Assessment, be ordered by a qualified physician at a transplant center with appropriate documentation, and are limited to one molecular test per patient encounter unless a documented adjunctive second test is reasonable and necessary.

"The molecular test provides information about active allograft rejection (AR) status."

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