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.