DODFinal Rule
TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments
Healthcare
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Summary
This regulation changes how TRICARE (the health insurance program for military members and their families) covers experimental medical treatments and clinical trials. It also ends coverage for certain expanded access treatments that allow patients to try drugs not yet approved by the FDA.
Key Points
- 1TRICARE will now cover costs for eligible patients participating in clinical trials, making experimental treatments more affordable for military families
- 2The rule ends TRICARE's coverage of expanded access treatments, which are unapproved drugs that very sick patients could access outside of clinical trials
- 3Military members, retirees, and their families who participate in approved clinical trials will have their medical costs covered rather than paying out of pocket
- 4Patients currently receiving expanded access treatments may lose coverage for those drugs and will need to explore other options with their doctors
- 5This change balances giving military families access to new medical options through official trials while controlling costs by ending coverage of less-regulated treatment pathways
Impact Assessment
If you are a TRICARE beneficiary, this means your coverage for experimental treatments and certain FDA-unapproved drugs may be restricted or eliminated, potentially limiting access to cutting-edge medical options.
Impact Level
Significant
Geographic Scope
National
Compliance Cost
Moderate
Who is Affected
Healthcare ProvidersConsumersFederal Employees
Key Dates
Published
July 28, 2025
Regulatory Connections
Authorized By
Amends CFR Sections
32 CFR Part 199
This summary is for informational purposes only. It may not capture all nuances of the regulation. Always refer to the official text for authoritative information.
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