TRICARE
will waive copayments or other cost-sharing (including deductibles
and Point-of-Service (POS) charges) for:
2.2.1.1 In vitro diagnostic tests,
including antibody or serology tests, that meet the requirements established
under the Families First Coronavirus Response Act (FFCRA) as amended
by the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
The United States Food and Drug Administration (FDA) remains responsible
for oversight of these in vitro diagnostic tests. A test that meets
the FFCRA and CARES Act criteria is one that:
2.2.1.1.1 Is approved, cleared, or authorized
under section 510(k), 513, 515, or 564 of the Federal Food, Drug,
and Cosmetic Act (21 United States Code (USC) 360(k), 360c, 360e,
360bbb-3).
2.2.1.1.2 The developer has requested,
or intends to request, emergency use authorization under section
564 of the Federal Food, Drug, and Cosmetic Act (21 USC 360bbb-3),
unless and until the emergency use authorization request under such
section 564 has been denied or the developer of such test does not
submit a request under such section within a reasonable timeframe.
2.2.1.1.3 Is developed in and authorized
by a state that has notified the Secretary of Health and Human Services
(HHS) of its intention to review tests intended to diagnose COVID-19.
2.2.1.1.4 Other tests that the Secretary
determines appropriate in guidance.
Note: TRICARE Policy Manual (TPM),
Chapter 12, Section 1.2, paragraph 1.2 permits
coverage overseas when unique health care issues or challenges arise
for services or supplies that would normally be excluded. The lack
of FDA regulated tests outside of the United States is a unique
situation permitting the overseas contractor to follow the established
guidelines/standards of care for COVID-19 testing for the country,
host-nation, and/or regional health authority (e.g., World Health
Organization (WHO)), where the beneficiary is treated. The Assistant
Secretary of Defense for Health Affairs (ASD(HA)) has directed the
Director, DHA to issue guidance to contractors implementing the
FFCRA, which includes the amendment added by the CARES Act. Therefore,
under paragraph (1)(D) of Section 3201 of the CARES Act, tests approved
by the overseas contractor under those established guidelines/standards
are determined to be appropriate tests for purposes of granting
waivers of cost-shares and copayments.
2.2.1.3 The evaluation of an individual
at TRICARE-authorized provider office visits, Urgent Care Center
(UCC) visits, or Emergency Room (ER) visits (to include covered
telemedicine visits) to determine the need for such an in vitro
diagnostic test listed in
paragraph 2.2.1.1 when those visits result
in an order for or administration of approved, cleared, or authorized
SARS-CoV-2/COVID-19 in vitro diagnostic products.