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This rule finalizes provisions published in two interim final rules with request for comment, which temporarily added coverage for the treatment use of investigation drugs under U.S. Food and Drug Administration (FDA) approved expanded access 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. 

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.

Alternatives:

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).

Benefits:

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.

Risks:

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.