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HumanaMedicare Advantage · Coverage · Medicaid · FL, KY, LA, SC, OH, IN, OK, VA · Oncology, Internal Medicine, Pediatrics +1 moreMedium impact

Clinical Trials Policy (Revised)

Act
by Aug 1, 2025
Effective date
Aug 1, 2025
Identified
Jun 25, 2026

Summary

Humana revised its Clinical Trials Pharmacy Coverage Policy effective August 1, 2025, clarifying coverage eligibility for routine care costs in federally funded or approved clinical trials for cancer and life-threatening illnesses across multiple Medicaid states and Medicare. The policy establishes strict criteria for trial approval, distinguishes between routine care coverage and non-covered investigational costs, and includes special provisions for pediatric Medicaid members under age 21 using EPSDT guidelines.

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What to do

by Aug 1, 2025 · 6 steps
01Billing and clinical teams must implement updated clinical trial authorization protocols.
02Verify all clinical trial referrals meet criteria: federally funded/approved by NIH, CDC, CMS, AHRQ, DoD, VA, or qualified nongovernmental entity with peer-reviewed IRB approval.
03Update pre-authorization workflows to ensure claims are submitted only for 'routine care' costs (medically necessary complication treatment or conventional care items) and explicitly exclude investigational drugs/devices (except Category B IDE devices for Medicare only), data collection costs, sponsor-provided items, and redundant testing.
04For Medicaid members under age 21, flag claims for EPSDT review when non-compendium supported drugs are involved and standard treatment is unavailable.
05Audit current clinical trial claims in billing system to identify any non-compliant authorizations and communicate corrections to providers and members.
06Train billing and authorization staff on distinction between off-label (supported by literature, coverable) vs. off-evidence (experimental, not coverable) drug uses.
If missed: Failure to apply these criteria will result in claim denials and patient financial liability.

Original notice

Clinical Trials Policy (Revised)
mcp.humana.com · Always check the source before changing claims.
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Related changes

See all Humana changes →
Clinical Trials Policy (Revised)MediumEffective Oct 19, 2016 · MedicaidClinical Trials Policy (Revised)MediumEffective Jul 22, 2026 · MedicaidBrowse every Humana change in the policy list

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Humana policiesFL policy changesKY policy changesLA policy changesSC policy changesOH policy changesIN policy changesOK policy changesVA policy changesOncologyInternal MedicinePediatricsPharmacy

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