Medicare AdvantageCoverageMedium impact
Clinical Trials Policy (Revised)
Humana·FL, KY, LA, SC, OH, IN, OK, VA · Oncology, Pharmacy, Internal Medicine +1 more·Medicaid
Effective date
Jul 22, 2026
We identified it
Jul 22, 2026
Summary
Humana revised its Clinical Trials Pharmacy Policy effective July 22, 2026, clarifying coverage criteria for routine care and services costs associated with FDA-approved and federally-funded clinical trials for cancer and life-threatening illnesses. The policy specifies what IS covered (medically necessary complications, conventional care items) and what IS NOT covered (investigational drugs themselves, data collection costs, sponsor-provided items, and non-standard services). For Medicaid members under 21 in Healthy Horizons plans, off-label/non-compendium treatments in clinical trials may be reconsidered under EPSDT criteria when no standard treatment exists.
Action Required
By July 22, 2026: Billing team must update prior authorization workflows to align with revised clinical trials coverage criteria. Specifically: (1) Implement verification that clinical trials are federally funded/approved by AHRQ, CDC, CMS, NIH, DoD, VA, or DoE before approving coverage; (2) Update claim denial logic to reject charges for investigational drugs/devices (except Category B IDE devices for Medicare members), data collection costs, and sponsor-provided items; (3) Train billing staff to distinguish between approvable 'routine care costs' (medically necessary complications and conventional care) versus non-approvable experimental/investigational services; (4) For Medicaid Healthy Horizons members under 21, flag cases for manual review using EPSDT criteria when off-label drugs are requested in clinical trials with no standard treatment alternative; (5) Update preauthorization request forms to require documentation of trial protocol, IRB approval, and scientific validity. Failure to implement these controls will result in improper claim denials or inappropriate approvals for non-covered experimental services.