Molecular Diagnostic Assays and Breath Testing for Transplant Rejection - Medicare Advantage

This Humana Medicare Advantage coverage article adopts CMS/MolDX requirements and specifies when molecular diagnostic assays and breath tests for transplant rejection are medically reasonable and necessary. It lists per-test coverage criteria (age, post-transplant timing, and absence of contraindications), explicit contraindications/exclusions for many named assays (AlloMap, AlloSure, Prospera, TruGraf, Tutivia, ViracorTRAC, VitaGraft, Heartsbreath), and requires that tests be ordered by the treating physician and used to manage the beneficiary's specific medical problem; MDTs/LDTs without MolDX approval or FDA labeling are not covered unless specific conditions are met.

"Molecular diagnostic assays for transplant rejection will be considered medically reasonable and necessary in lieu of a biopsy, when the following requirements are met: Analytic validity, clinical ..."