MolDX: Molecular Testing for Solid Organ Allograft Rejection
L40139
This contractor provides limited coverage for molecular diagnostic tests to evaluate solid-organ allograft rejection when the test informs AR or ACR/AMR status and is used to guide clinical decisions (e.g., replace biopsy, rule out rejection, further evaluate inconclusive biopsy, or perform validated surveillance). Tests must have demonstrated analytical and clinical validity for the intended population, complete a MolDX Technical Assessment, be ordered by qualified providers, and adhere to surveillance frequency limits (first-year: kidney 4, heart 12, lung 12; thereafter up to 2/year). Only one molecular test is allowed per patient encounter and concurrent biopsy is generally prohibited except in rare urgent, very-high-risk situations meeting specified criteria.
"The molecular test provides information about acute rejection (AR) status of a solid-organ allograft."