LCDActive
MolDX: Molecular Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis
L39427
Effective: August 7, 2025
Updated: December 31, 2025
Policy Summary
Coverage is limited to adult patients with confirmed moderately to severely active rheumatoid arthritis who have failed, are intolerant of, or have contraindications to at least one csDMARD and who are either b/tDMARD‑naïve or being considered for a different class due to failure/intolerance. Tests must predict response/non-response with accuracy and reproducibility superior to existing clinical data, demonstrate AV/CV/CU with peer‑reviewed evidence, be validated (algorithms in independent cohorts), and complete a MolDX Technical Assessment to be considered reasonable and necessary.
Coverage Criteria Preview
Key requirements from the full policy
"Patient is an adult (>=18 years) with a confirmed diagnosis of moderately to severely active rheumatoid arthritis (RA)."
Sign up to see full coverage criteria, indications, and limitations.