MolDX: Molecular Testing for Solid Organ Allograft Rejection

This MolDX policy provides limited coverage for molecular diagnostic tests that evaluate solid organ allograft rejection when tests inform AR/ACR/AMR status, are analytically and clinically validated, and are used to guide clinical decisions such as immunosuppression assessment, biopsy triage, evaluation after inconclusive biopsy, or surveillance per validated cadences. Surveillance testing is limited to specified timepoints (kidney: 4, heart: 12, lung: 12 in year one; thereafter up to 2/year), only one molecular test is allowed per patient encounter, and tests must complete a MolDX Technical Assessment with peer-reviewed evidence of clinical validity and equivalence or superiority to established tests.

"Molecular diagnostic tests to evaluate patients who have undergone solid organ transplantation are covered when the test provides information about acute rejection (AR) status or specifically cellu..."