Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A60306 (Billing and Coding: MolDX: Biomarker Testing in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A60306: Billing and Coding: MolDX: Biomarker Testing in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis (Billing and Coding, effective 2026-10-01)
- Covered ICD-10-CM codes
- 116
- 2 groups
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 7
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| E11.00 | — |
| E11.01 | — |
| E11.10 | — |
| E11.11 | — |
| E11.21 | — |
| E11.22 | — |
| E11.29 | — |
| E11.311 | — |
| E11.319 | — |
| E11.3211 | — |
| E11.3212 | — |
| E11.3213 | — |
| E11.3219 | — |
| E11.3291 | — |
| E11.3292 | — |
| E11.3293 | — |
| E11.3299 | — |
| E11.3311 | — |
| E11.3312 | — |
| E11.3313 | — |
| E11.3319 | — |
| E11.3391 | — |
| E11.3392 | — |
| E11.3393 | — |
Procedure codes: 0003M, 0166U, 0344U, 0468U, 81479, 81517, 81599.
Coverage indications, limitations and medical necessity
This policy describes coverage for molecular and proteomic biomarker tests for aiding the evaluation 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 entities 3 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 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 evidence of liver dysfunction compatible with 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 integration of clinical evaluation and non-molecular/non-proteomic laboratory testing, [e.g., fibrosis-4 index (FIB-4) ≥ 1.3], as outlined by consensus guidelines, does not indicate low risk.
• Liver stiffness measurement (LSM) by imaging [e.g., vibration controlled transient elastography (VCTE), magnetic resonance elastography (MRE)] has not been performed within the prior 12 months or results were indeterminate.
• 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 / monitoring of 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 with definitive histologic interpretation by a pathologist.
• The test has satisfactorily completed a Technical Assessment (TA) by the Molecular Diagnostic Services Program (MolDX ® ).
• Clinical validity (CV) of any novel analytes must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population with comparability across subgroups.
• 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 must demonstrate equivalent or superior performance to analytes already covered under this policy for the same intended use.
• 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 when used for the same indication in the same intended use population.
Summary of evidence (opening)
Background
MASLD is a type of CLD defined by hepatic steatosis (>5 percent liver fat) in patients with at least 1 risk factor for cardiometabolic dysfunction (including obesity, hyperglycemia/type 2 diabetes mellitus (T2D), hypertension, and dyslipidemia). MASLD is commonly asymptomatic, and the natural history of the disease is usually fairly indolent with the majority of patients taking years or even decades to progress. The more severe form of disease, MASH, is diagnosed when histological evidence of inflammation and hepatocellular injury is present in addition to steatosis. As liver scarring accumulates, MASH may evolve to cirrhosis, which occurs more frequently in in those with T2D or prediabetes, morbid obesity, or more than 1 cardiometabolic risk factor. 4,5 Advancing stages of fibrosis are associated with poor liver-related outcomes (e.g., hepatocellular carcinoma (HCC), liver decompensation, need for transplantation) as well as increased all-cause mortality. 6 A meta-analysis of 1,495 subjects with 17,452 patient years of follow-up showed exponential increases in the liver-related mortality rate with each histologic stage of fibrosis. 6 Therefore, accurate stratification for risk of fibrosis is 1 of the primary objectives in patient evaluation.
Mirroring the obesity epidemic, the burden of MASLD has been increasing worldwide, with a rise of nearly 50% in the global prevalence over the past 3 decades. 7 Estimates of the prevalence of MASLD in the United States vary from 35 - 48%, with the highest rates among those of Hispanic origin. 8 A recent study of patients with T2D in the US outpatient setting showed that ~70% have MASLD and approximately 15% have stage ≥2 fibrosis. 9 Among North American patients with MASLD,~30% of those without an indication for liver biopsy were reported to have MASH; the proportion with MASH rose to 60% in the presence of an indication for biopsy. 5 MASH recently overtook Hepatitis C virus (HCV) as the leading etiology among US liver transplant patients with HCC, and remained second only to ALD in those without HCC. 10 In 2021-2022, MASH was the primary listing diagnosis for 6,299 liver transplant patients, compared to 10,011 with ALD, and only 1,793 with HCV. 10
Historically, lifestyle modifications with diet and exercise have been the mainstay of therapeutic recommendations, with limited pharmacologic interventions available outside of the setting of T2D. 11,12 However, in March of 2024, the Food and Drug Administration (FDA) approved resmetirom as the first pharmacotherapy for the treatment of adults with MASH, with moderate to advanced (stages F2-F3) liver fibrosis, on the basis of the randomized double-blind MAESTRO trial, which demonstrated significant improvement or resolution of liver scarring in patients receiving resmetirom compared to placebo. 13 The FDA-approved drug label for resmetirom does not require liver biopsy to confirm advanced fibrosis. 14 Additional agents are under active investigation. 15
the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2026-08-10
- Current revision effective
- 2026-08-10
- Last reviewed by the contractor
- 2026-05-14
- MCD version
- 3
Other related documents: A60459 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Wisconsin Physicians Service Insurance Corporation hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L40272 cover?
This policy describes coverage for molecular and proteomic biomarker tests for aiding the evaluation 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… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L40272 apply to?
Wisconsin Physicians Service Insurance Corporation applies it to Medicare claims in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L40272?
The companion billing and coding article A60306 lists 116 ICD-10-CM codes in 2 groups that support medical necessity; the first 24 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L40272?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.