About this policy
Jurisdiction: J15 MAC Part B. States: Kentucky, Ohio. Type: Active LCD
Coverage indications
This policy describes coverage for molecular or proteomic biomarker tests for the diagnosis and management of liver fibrosis in the setting of metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). In accordance with American Association for the Study of Liver Disease (AASLD) guidance,1 the term MASLD will be used as a replacement for non-alcoholic fatty liver disease (NAFLD), and MASH as a replacement for non-alcoholic steatohepatitis (NASH). As comparisons have found a near complete overlap between the recently-defined MASLD population and the historical NAFLD population,2 results from biomarker validation studies among patients with NAFLD/NASH will be considered applicable to patients with MASLD/MASH. Other types of chronic liver disease (CLD) [including but not limited to metabolic dysfunction- and alcohol-associated liver disease (MetALD), alcohol-associated liver disease (ALD), viral hepatitis and autoimmune hepatitis] are considered separate entities3 with distinct etiologies, natural histories and management, and are therefore not encompassed under this policy. Criteria for Coverage Molecular or proteomic biomarker testing for the assessment of risk of liver fibrosis in the setting of MASLD or MASH is considered reasonable and necessary when ALL the following criteria are met: The patient is an adult with clinical suspicion or diagnosis of MASLD or MASH based on current professional society guidelines [e.g., AASLD, American Gastroenterological Association (AGA), American Association of Clinical Endocrinologists (AACE)]. A primary risk assessment based on non-molecular/ proteomic laboratory testing, as outlined by consensus guidelines, does not indicate low risk [e.g., fibrosis-4 index (FIB-4) ≥ 1.3]. Liver stiffness measurement (LSM) by imaging [e.g., vibration controlled transient elastography (VCTE), magnetic resonance elastography (MRE)] is indeterminate or not performed. The results of the test will be used to directly aid in pending management decisions (e.g., referral to a specialist, performance of liver biopsy, eligibility for pharmacologic therapy) as documented in the patient’s medical record. Testing is not performed more than once within a 12-month period nor within 12 months following a liver biopsy. Clinical validity (CV) of any analytes or profiles must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population with demonstrated reproducibility across clinical study cohorts. If the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm. The test has satisfactorily completed a Technical Assessment (TA) by the Molecular Diagnostic Services Program (MolDX ® ). Molecular and proteomic tests utilizing a similar methodology or evaluating similar analytes as a test for which existing coverage has been established must demonstrate equivalent or superior test performance (i.e., sensitivity and/or specificity) when used for the same indication in the same intended use population. New tests that become available with significantly improved performance may render older tests no longer compliant with this policy.
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.
| Code | Code system | Status in this policy |
|---|---|---|
| 81479 | CPT | Covered |
| 81517 | CPT | Covered |
| 81599 | CPT | Covered |
| 0003M | HCPCS | Covered |
| 0166U | HCPCS | Covered |
| 0344U | HCPCS | Covered |
| 0468U | HCPCS | Covered |
| E66.3 | ICD10CM | Covered |
| E66.811 | ICD10CM | Covered |
| E66.812 | ICD10CM | Covered |
| E66.813 | ICD10CM | Covered |
| E66.89 | ICD10CM | Covered |
| E66.9 |