DOD: TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments

Federal Register

Jul 28, 2025

Notice of final rule from the Department of Defense (DOD) Defense Health Agency (DHA) finalizing provisions published in two interim final rules (IFRs) that temporarily added coverage for the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-authorized expanded access (EA) programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19. Among other things, this rule discusses the DOD's decision not to make permanent the coverage of treatment use of investigational drugs under FDA EA programs while updating language for care associated with their administration and broadens the COVID-19 clinical trial benefit to include coverage of clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute to treat or prevent infectious diseases associated with a pandemic or epidemic. This rule is effective August 27, 2025.

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