MolDX: Biomarker Testing for Risk Stratification in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis
L40198
Molecular or proteomic biomarker testing for assessing liver fibrosis is covered for adults with suspected or diagnosed MASLD/MASH when non-molecular risk assessment does not indicate low risk (e.g., FIB-4 ≥ 1.3), liver stiffness imaging is indeterminate or not done, and results will directly inform documented management decisions. Coverage requires demonstrated clinical validity in peer-reviewed studies, independent validation for algorithm-based tests, and completion of a MolDX Technical Assessment; testing is limited to once per 12 months and must not occur within 12 months of a liver biopsy. Tests intended for other chronic liver diseases (e.g., ALD, viral hepatitis, autoimmune hepatitis) are excluded.
"Patient is an adult with clinical suspicion or diagnosis of MASLD or MASH based on current professional society guidelines."
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