MolDX: Molecular Testing for Solid Organ Allograft Rejection

Medicaid/Medicare coverage is provided for molecular diagnostic tests to evaluate solid-organ allograft rejection when the test provides information on AR (ACR or AMR), is used for a policy-specified intended purpose, is ordered by a transplant-center-affiliated physician, and the test has demonstrated analytical and clinical validity (peer‑reviewed) and has passed a Technical Assessment. Tests must be used in the analytically validated population, follow accepted histologic concordance criteria (e.g., Banff for renal), and are limited to one molecular test per patient encounter unless a second test is justified as a necessary adjunct; tests lacking AV/CV or comparative performance are not covered.

"Molecular diagnostic tests are covered to evaluate and manage patients who have undergone solid organ transplantation to inform decision-making about active allograft rejection (AR)."