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DOD/DODOASHA RIN: 0720-AB83 Publication ID: Fall 2023 
Title: TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments 

The Department of Defense is finalizing an interim final rule to amend 32 CFR part 199 to include coverage that was temporarily added for National Institute of Allergy and Infectious Disease-sponsored clinical trials for the treatment or prevention of COVID-19. This rule will also finalize the temporary addition of the treatment use of investigation drugs under U.S. Food and Drug Administration-approved expanded access programs for the treatment of coronavirus disease 2019 (COVID-19) from the interim final rule titled "TRICARE Coverage of Certain Medical Benefits in Response to the COVID-19 Pandemic” (32 CFR part 199, 0720-AB82), which published in the Federal Register on September 3, 2020 (85 FR 54914-54924).



Agency: Department of Defense(DOD)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 32 CFR 199   
Legal Authority: 5 U.S.C. 301    10 U.S.C. ch 55   
Legal Deadline:  None

Statement of Need:

This final rule is required to finalize certain temporary flexibilities enacted in interim final rules published in 2020 in response to the COVID-19 pandemic.

Pursuant to the President’s national emergency declaration and as a result of the worldwide COVID-19 pandemic, the Assistant Secretary of Defense for Health Affairs hereby temporarily modified the regulation at 32 CFR 199.4(e)(26) to permit TRICARE coverage for National Institute of Allergy and Infectious Disease (NIAID)-sponsored COVID-19 phase I, II, III, and IV clinical trials for the treatment or prevention of coronavirus disease 2019 (COVID-19). This provision supports increased access to emerging therapies for TRICARE beneficiaries.

Summary of the Legal Basis:

This rule is issued under 10 U.S.C. 1073(a)(2) giving authority and responsibility to the Secretary of Defense to administer the TRICARE program.


1) No action

2) The second alternative the DoD considered was implementing a more limited benefit change for COVID-19 patients by not covering phase I clinical trials. Although this would have the benefit of reimbursing only care that has more established evidence in its favor, this alternative is not preferred because early access to treatments is critical for TRICARE beneficiaries given the rapid progression of the disease and the lack of available approved treatments.

Anticipated Costs and Benefits:

Any cost to beneficiaries would be consistent with existing costs under the TRICARE Program (such as cost-shares and copayments). Finalizing TRICARE coverage of clinical trials will benefit TRICARE beneficiaries by ensuring they continue to have access to emerging therapies in the safest setting possible.

In the interim final rule, DoD estimated the total cost for TRICARE participation in NIAID-sponsored COVID-19 clinical trials would be $3.2M for the duration of the national emergency, with an additional $4.0M for continued care for beneficiaries enrolled in clinical trials prior to termination of the national emergency. There were several assumptions we made in developing this estimate. The duration of the COVID-19 national emergency is uncertain; however, for the purposes of this estimate, we assumed the national emergency would expire on September 30, 2021. As of the drafting of the IFR, there were 27 NIAID-sponsored COVID-19 clinical trials begun since the start of the national emergency. We assumed 6.2 new trials every 30 days, for a total of 126 trials by September 2021. We assumed, based on average trial enrollment and that TRICARE beneficiaries would participate in trials at the same rate as the general population, that 4,549 TRICARE beneficiaries would participate through September 2021. Each of the assumptions in this estimate is highly uncertain, and our estimate could be higher or lower depending on real world events (more or fewer trials, a longer or shorter national emergency, and/or higher or lower participation in clinical trials by TRICARE beneficiaries).


These changes expand the therapies available to TRICARE beneficiaries in settings that ensure informed consent of the beneficiary, and where the benefits of treatment outweigh the potential risks. Participation in clinical trials may provide beneficiaries with benefits such as reduced hospitalizations and/or use of a mechanical ventilator. Although we cannot estimate the value of avoiding these outcomes quantitatively, the potential long-term consequences of serious COVID-19 illness, including permanent cardiac or lung damage, are not insignificant. Beneficiary access to emerging therapies that reduce these long-term consequences or even death can be considered to be high-value for those able to participate.

TRICARE providers will be positively affected by being able to provide their patients with a broader range of treatment options. The general public will benefit from an increased pool of available participants for the development of treatments and vaccines for COVID-19, as well as the evidence (favorable or otherwise) that results from this participation.


None . This rule will not directly affect the efficient functioning of the economy or private markets. However, increasing the pool of available participants for clinical trials may help speed the development of treatments or vaccines for COVID-19. Once effective treatments or vaccines for COVID-19 exist, individuals are likely to be more confident interacting in the public sphere, resulting in a positive impact on the economy and private markets.

Action Date FR Cite
Interim Final Rule  10/30/2020  85 FR 68753   
Interim Final Rule Effective  10/30/2020 
Interim Final Rule Comment Period End  11/30/2020 
Final Action  02/00/2024 
Additional Information: The interim final rule was titled "TRICARE Coverage of National Institute of Allergy and Infectious Disease Coronavirus Disease 2019 Clinical Trials." The final rule will be titled "TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments."
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Related RINs: Related to 0720-AB81, Related to 0720-AB82 
Agency Contact:
Jennifer Stankovic
Department of Defense
Office of Assistant Secretary for Health Affairs
16401 E Centretech Parkway,
Aurora, CO 80011-9066
Phone:303 676-3742