MolDX MASLD/MASH Biomarker Coverage: What the August 2026 LCD Requires

ScreenMyGene Team·Published August 27, 2026·8 min read·Clinically reviewed by Dr. Ashraf, Ph.D.
Clinical laboratory scientist reviewing a blood specimen and fibrosis biomarker results at a hospital lab bench

Short answer: On August 10, 2026, all four MolDX Medicare Administrative Contractors put identical LCDs into effect covering molecular and proteomic biomarker testing for liver fibrosis in MASLD and MASH. Coverage is second-line only: the patient must not be low-risk on first-line assessment, must lack a definitive liver stiffness measurement from the prior 12 months, and the test must have cleared MolDX Technical Assessment.

This is the first Medicare coverage pathway of its kind for non-invasive liver fibrosis biomarkers, and it arrived as a category-level policy rather than an approval of any named assay. For laboratories running ELF, NIS4/NIS2+, FibroSure, LiverFAS, OWLiver CIMA, or NASH NEXT — or planning to launch a MASH panel — the practical question is no longer whether Medicare covers this class of test. It is whether your specific test, your ordering workflow, and your claim configuration satisfy every gate the policy imposes.

What actually took effect on August 10, 2026

The MolDX program published four parallel Local Coverage Determinations, one per MAC, all titled MolDX: Biomarker Testing in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis, and all with an effective date of August 10, 2026:

The companion billing and coding article, A60306, carries the same original effective date and supplies the operational detail: which diagnosis codes must appear, how many tests are payable, and where the DEX Z-Code goes on the claim. Between the four LCDs, the policy reaches Medicare beneficiaries in every state, which makes this effectively a national coverage floor for the test category even though it was issued as local policy.

Four MACs, one policy, one effective date Identical MolDX LCDs for MASLD/MASH biomarker testing L40187 Palmetto GBA L40197 Noridian L40199 CGS Administrators L40272 WPS Effective for services on or after August 10, 2026 Billing & coding article A60306 shares the same original effective date Source: CMS Medicare Coverage Database, LCDs L40187 / L40197 / L40199 / L40272 and Article A60306.
All four MolDX contractors adopted the same MASLD/MASH biomarker policy with a single effective date.

Coverage is second-line, and the gates are sequential

The most important structural feature of this LCD is that it embeds the test inside a clinical pathway rather than approving it as a standalone service. A claim is only defensible when the record shows the patient moved through the pathway in order.

The patient must be an adult with clinical evidence of liver dysfunction compatible with MASLD or MASH, assessed against current professional society guidelines. Notably, the final policy tightened this from the draft language of "clinical suspicion or diagnosis," which means a suspicion alone no longer supports the claim — the chart needs documented, guideline-concordant evidence.

First-line risk assessment, based on integrating clinical evaluation with ordinary non-molecular laboratory testing, must not indicate low risk. The policy cites FIB-4 of 1.3 or greater as the example. Commenters including Roche and MetaSight pushed MolDX to abandon a rigid FIB-4 cutoff; MolDX did not remove the gate but softened it into a clinical-risk-assessment concept rather than a bare threshold.

Liver stiffness measurement by imaging must not have been performed within the prior 12 months, or its result must have been indeterminate. This is the change most likely to surprise ordering practices. A patient who had an adequate VCTE or MRE ten months ago is outside coverage, regardless of how appropriate the blood test would otherwise be. Siemens and AdvaMed argued that this privileges elastography, which can be unavailable or operator-dependent; MolDX kept the condition and added the explicit 12-month window.

The result must inform a documented management decision, repeat-testing limits must be met, and the test itself must have satisfactorily completed MolDX Technical Assessment for the claimed intended use. Testing is barred within 12 months after a liver biopsy only when there was a definitive histologic interpretation by a pathologist — a clarification MolDX added after AMP and Guardant objected that inconclusive or unsuccessful biopsies should not lock the patient out.

The coverage pathway: every gate must be documented 1 Adult with clinical evidence of liver dysfunction compatible with MASLD/MASH 2 First-line assessment does NOT indicate low risk (e.g. FIB-4 ≥ 1.3) 3 No definitive liver stiffness measurement in the prior 12 months 4 Result will inform a documented management decision; repeat limits met 5 Test has cleared MolDX Technical Assessment for the claimed intended use Source: CMS Medicare Coverage Database, MolDX MASLD/MASH LCDs effective 08/10/2026.
Coverage criteria operate as sequential gates; failing any one makes the claim indefensible regardless of the others.

The billing rule most likely to generate denials: two ICD-10 groups

Article A60306 imposes a diagnosis-coding requirement that differs from most molecular policies. A claim must carry at least one code from Group 1 and at least one code from Group 2. One code alone will not do.

Group 1 contains just seven codes, all establishing evidence of liver dysfunction: K74.00 (hepatic fibrosis, unspecified), K74.01 (early fibrosis), K74.02 (advanced fibrosis), K75.81 (nonalcoholic steatohepatitis), K76.0 (fatty change of liver, not elsewhere classified), R74.01 (elevation of liver transaminase levels), and R94.5 (abnormal results of liver function studies).

Group 2 contains 108 codes establishing cardiometabolic risk factors — the type 2 diabetes E11 family, obesity codes E66.3 through E66.9, the dyslipidemia codes E78.00 through E78.5, essential hypertension I10, and the abnormal-glucose R73 family including R73.03 for prediabetes. Roche specifically asked MolDX to add codes reflecting real MASLD clinical contexts, and MolDX confirmed those additions were made to the article.

This paired requirement is a predictable denial generator. A hepatology practice that submits K75.81 alone, or a primary care order carrying only E11.9, produces a technically incomplete claim even when the patient genuinely qualifies. The fix belongs at order entry, not in the appeal. Our guide to ICD-10 codes for genetic testing covers the broader pattern of diagnosis-code mismatches that sink otherwise legitimate molecular claims.

Two code groups are required on every claim GROUP 1 Evidence of liver dysfunction 7 codes K74.00 · K74.01 · K74.02 · K75.81 K76.0 · R74.01 · R94.5 + GROUP 2 Evidence of cardiometabolic risk factors 108 codes E11.x (type 2 diabetes) · E66.3–E66.9 (obesity) E78.00–E78.5 · I10 · R73.01–R73.9 At least one code from EACH group must appear on the claim Source: CMS Billing and Coding Article A60306, effective 08/10/2026.
The paired-group requirement is unusual among molecular policies and is easy to miss at order entry.

Z-Code placement, units, and frequency

Article A60306 is explicit about claim mechanics. Only one test may be billed per patient per 12 months, and the claim must carry one unit of service. The DEX Z-Code identifier must be entered adjacent to the CPT code in the comment or narrative field — for Part B, Loop 2400 or SV101-7 on the 5010A1 837P, or Box 19 on a paper claim; for Part A, line SV202-7 on the 837I or Block 80 on the UB-04. CMS adds a specific warning not to append extra characters or information to the SV101-7 documentation field.

Which tests are actually covered is not answered in the LCD. CMS directs readers to the DEX registry at dexzcodes.com, where tests evaluated for compliance with the policy's criteria are listed as covered or non-covered. This is the practical consequence of a category-level LCD: naming ELF, NIS4/NIS2+, or MASEF in the evidence review does not confer coverage on them. Coverage depends on satisfying every LCD criterion and completing Technical Assessment. If your test has not cleared TA, the LCD's existence does not help you. Our overview of Medicare coverage for genetic testing: LCD, NCD and MolDX explains how the Z-Code and TA layers interact with coverage determinations more generally.

What labs should do before the next claim cycle

Confirm Technical Assessment status first, because nothing else matters without it. Reconfigure order entry so that both ICD-10 groups are captured — ideally by presenting the ordering clinician with the Group 1 and Group 2 options rather than relying on free-text history. Add an intake check for prior liver stiffness measurement within 12 months and for prior biopsy with definitive histologic interpretation, since both are absolute exclusions the lab cannot see from the requisition alone. Verify the Z-Code lands in the correct claim field for both Part A and Part B formats. Finally, build the once-per-12-months frequency check into accessioning, not into the denial worklist.

Most of these are the same upstream controls that prevent denials across the molecular menu — the difference is that this policy compresses five independent failure modes into a single test. Reconciling a chart against coverage criteria before the order goes out is exactly the workflow ScreenMyGene automates, and it is the difference between a defensible claim and a preventable write-off.

Frequently asked questions

When did the MolDX MASLD/MASH biomarker LCD take effect?
The policy applies to services furnished on or after August 10, 2026. Four parallel LCDs — L40187 (Palmetto GBA), L40197 (Noridian), L40199 (CGS) and L40272 (WPS) — share that effective date, as does billing and coding article A60306.

Does the LCD cover a specific test like ELF or NIS4?
No. It creates category-level coverage for molecular or proteomic biomarker testing of liver fibrosis. CMS states that mentioning specific biomarkers in the evidence review does not imply coverage. A test must satisfy all LCD criteria and complete MolDX Technical Assessment, with status listed in the DEX registry.

Which ICD-10 codes are required on the claim?
At least one code from Group 1 establishing liver dysfunction (K74.00, K74.01, K74.02, K75.81, K76.0, R74.01, R94.5) and at least one from Group 2's 108 cardiometabolic risk factor codes, which include the E11 diabetes family, obesity, dyslipidemia, hypertension and abnormal-glucose codes.

Can a patient be tested if they had a FibroScan last year?
Generally no. The policy requires that liver stiffness measurement by imaging was not performed within the prior 12 months, or that its result was indeterminate. A recent definitive VCTE or MRE result precludes coverage of blood-based biomarker testing.

How often can the test be billed?
Article A60306 permits only one test per patient per 12 months, billed at one unit of service. Testing is also barred within 12 months following a liver biopsy that produced a definitive histologic interpretation by a pathologist.

Educational disclaimer: This article summarizes Medicare coverage and billing concepts as of August 2026 for general informational purposes. LCDs, billing articles, MolDX Technical Assessment requirements and DEX registry status change over time and vary by contractor. This is not billing, legal, or medical advice; verify against current CMS and payer policy with qualified billing professionals. ScreenMyGene is clinical decision support and does not replace independent professional judgment.

Sources: CMS Medicare Coverage Database — LCDs L40187 (Palmetto GBA), L40197 (Noridian), L40199 (CGS), L40272 (WPS), MolDX: Biomarker Testing in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis, effective 08/10/2026; CMS Billing and Coding Article A60306; CMS Response-to-Comments Article A60449; Discoveries in Health Policy, "MolDx Finalizes LCD: Liver Disease Risk Stratification," July 9, 2026; DEX Diagnostics Exchange registry (dexzcodes.com).