TRICARE Boosts Trial Coverage for Rare Diseases, Ditches Drug Access Perk
Published Date: 7/28/2025
Rule
Summary
If you’re on TRICARE, some new rules are changing how clinical trials and special treatments get covered. TRICARE won’t cover investigational drugs under expanded access programs forever, but it’s now covering more NIH-approved clinical trials for serious diseases, including pandemics. These changes start right away and could help many get access to cutting-edge care without extra costs.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
No Permanent EA Drug Coverage
TRICARE will not make permanent coverage for the treatment use of investigational drugs provided through FDA-authorized expanded access (EA) programs. The rule finalizes that temporary COVID-19-era coverage will not continue as a permanent benefit for EA treatment use.
Broader NIH Clinical Trial Benefit
TRICARE will cover services and supplies provided with Phase I, II, III, and IV clinical trials that are NIH-sponsored or NIH-approved when the trial involves a new treatment or cure for a specific condition or treats a currently uncontrolled symptom, and the condition is severely debilitating, life-threatening, or a rare disease. This expands the clinical trial benefit to more phases and to trials for severe or rare conditions.
NIH-Wide Pandemic Trial Coverage
TRICARE expands coverage of clinical trials beyond NIAID to include clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute when they treat or prevent infectious diseases associated with a pandemic or epidemic. This broadens which NIH-sponsored or -approved pandemic/epidemic trials TRICARE will cover.
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