Medicare AdvantageCoverageMedium impact
Gene Expression Profiling for Noncancer Indications - Medicare Advantage (Revised)
Humana·Pulmonology, Genetics, Internal Medicine +1 more·Medicare Advantage
Effective date
Aug 3, 2026
We identified it
Aug 4, 2026
Summary
Humana Medicare Advantage updated its coverage policy for Gene Expression Profiling (GEP) tests used for noncancer indications, effective August 3, 2026. The policy establishes medical necessity criteria for GEP tests including Envisia Genomic Classifier for idiopathic pulmonary fibrosis and EpiSign Complete for epigenetic/imprinting disorders, requiring tests to be MolDX-approved, FDA-cleared, or meet clinical utility standards where CMS guidance is lacking. Billing teams must ensure claims align with jurisdiction-specific LCD requirements and document that test results directly impact patient treatment decisions.
Action Required
Before August 3, 2026: Billing team must verify coverage criteria for gene expression profiling claims in your jurisdiction by consulting the applicable MAC LCD (L37919, L37905, L37887, L37891, L37857, or L35000 depending on state). Update prior authorization protocols to require: (1) confirmation that the test is MolDX Program approved, FDA approved/cleared, or meets clinical utility standards; (2) documentation that the patient matches the population/indication for which the test was developed; and (3) clinical notes showing results will directly impact treatment/management decisions. Providers must document medical necessity on requisition forms. Update billing software rules to deny claims lacking required clinical documentation. For jurisdictions with established LCDs, follow those specific criteria. For jurisdictions without LCDs (J6/JK, JH/JL, JN), apply Humana's general criteria referenced in this policy.