Medicare AdvantageCoverageMedium impact
Clinical Trials Policy (Revised)
Humana·FL, KY, LA, SC, OH, IN, OK, VA · Oncology, Internal Medicine, Pediatrics +1 more·Medicaid
Effective date
Aug 1, 2025
We identified it
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.
Action Required
By August 1, 2025: Billing and clinical teams must implement updated clinical trial authorization protocols. (1) Verify 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. (2) Update 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. (3) For Medicaid members under age 21, flag claims for EPSDT review when non-compendium supported drugs are involved and standard treatment is unavailable. (4) Audit current clinical trial claims in billing system to identify any non-compliant authorizations and communicate corrections to providers and members. (5) Train billing and authorization staff on distinction between off-label (supported by literature, coverable) vs. off-evidence (experimental, not coverable) drug uses. Failure to apply these criteria will result in claim denials and patient financial liability.