MolDX: Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis

Molecular testing for hereditary transthyretin amyloidosis (hATTR) is covered when patients have a clinical diagnosis of ATTR or present with cardiac features suggestive of ATTR‑cardiomyopathy or progressive sensorimotor/autonomic neuropathy plus supporting factors (African American ancestry, a first‑degree relative with hATTR, or other guideline‑based features). Coverage requires pre‑test counseling, that results will be used to inform treatment decisions, that the test includes guideline‑based minimum genetic content, and that the test has passed the contractor's technical assessment; single‑variant testing is allowed only for documented familial variants. Tests with harmful additional genetic content, lacking minimum content, or without TA completion are not covered.

"Molecular testing is covered for patients with a clinical diagnosis of ATTR (transthyretin amyloidosis)."