Clinical Laboratory: New LCD on Biomarker Testing — Submit Claims by August 10

This post addresses LCD L40197, which outlines coverage guidelines for biomarker testing in metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) as administered by Noridian. This is a Local Coverage Determination (LCD) effective August 10, 2026. The primary compliance implication is that labs will need to align their claims submission processes to include these new covered tests by the effective date.

Regulatory Background CMS has issued this LCD to clarify coverage for biomarker testing specific to MASLD and MASH, reflective of an increasing recognition of the importance of precise diagnostics in conditions associated with metabolic dysfunction. This effort responds to evolving clinical evidence demonstrating the relevance of these biomarker tests in managing patient care effectively. The intent is to facilitate appropriate coverage and reimbursement for laboratories performing these tests, ultimately supporting better health outcomes in affected patients.