MolDX: Biomarker Testing for Risk Stratification in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis

Molecular or proteomic biomarker testing for assessment of liver fibrosis risk is covered for adults (>=18) with suspected or diagnosed MASLD/MASH when guideline‑based non‑molecular risk assessment does not indicate low risk (e.g., FIB‑4 >=1.3), LSM is indeterminate or not performed, and results will directly inform documented management decisions. Tests must have demonstrated clinical validity in peer‑reviewed studies, algorithm validation if applicable, and a satisfactory MolDX Technical Assessment; testing is limited to once per 12 months and is not permitted within 12 months after a liver biopsy. Tests for other chronic liver disease etiologies and tests that lack required validation or MolDX TA are not covered.

"Patient is an adult (>=18 years) with clinical suspicion or diagnosis of MASLD or MASH based on current professional society guidelines."

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