MedicaidCoverageMedium impact
Non-FDA Approved Medications (Revised)
Humana·FL, KY, LA, SC, OH, IN, OK, VA · OB-GYN, Pharmacy·Medicaid
Effective date
Jun 3, 2020
We identified it
Jun 25, 2026
Summary
Humana revised its Non-FDA Approved Medications policy (effective June 3, 2020, revised March 19, 2026) for 8 state Medicaid programs. Non-FDA approved medications are excluded from formularies by default unless the Humana P&T Committee specifically reviews and approves them as safe and effective. Coverage is limited to plan year duration with annual renewal. The policy clarifies that unapproved drugs differ from generic drugs and emphasizes that only P&T Committee-approved non-FDA medications (such as 17-alpha-hydroxyprogesterone for preterm delivery prophylaxis) will be covered.
Action Required
Immediately: Billing and pharmacy teams must verify that any non-FDA approved medication claims submitted for Medicaid members in FL, KY, LA, SC, OH, IN, OK, or VA have prior P&T Committee approval documented. Before processing claims, check Humana's formulary or contact Humana's Pharmacy Department to confirm whether the specific non-FDA approved medication is on the approved list. Do NOT assume generic or established medications are approved—verify each claim. Claims for non-approved non-FDA medications will be denied. For prescribers: educate providers that only P&T Committee-approved non-FDA medications qualify for coverage; provide list of approved medications (e.g., 17-P for preterm delivery). Update billing system rules to flag non-FDA medications for manual review before submission to Humana.