MolDX: Molecular Testing for Solid Organ Allograft Rejection

This policy provides limited coverage for molecular diagnostic tests to evaluate solid organ allograft rejection when tests inform AR, ACR, or AMR status and are used for specified clinical intents (e.g., replace biopsy when biopsy would guide immunosuppression, rule out AR in validated populations, post-pretest evaluation, or after inconclusive biopsy). Covered tests must have analytical and clinical validity demonstrated in the intended population with peer‑reviewed evidence, meet comparative performance requirements, complete a required Technical Assessment, be ordered by transplant‑center‑affiliated physicians, and are limited to one test per patient encounter unless a second adjunctive test is reasonable and necessary.

"Molecular diagnostic tests for solid organ transplant recipients are covered to assist evaluation and management for active rejection (AR) when ordered by a qualified physician affiliated with a tr..."