will
waive copayments or other cost-sharing (including deductibles and
Point-of-Service (POS) charges) for:
2.2.1.1 In vitro diagnostic
(IVD) 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
(U.S.) Food and Drug Administration
(FDA) remains responsible for oversight of these
in
vitro diagnostic IVD 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 are normally
be excluded.
The lack of FDA regulated tests outside of the
United
States U.S. 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
the contractor
s 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 IVD 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 IVD products.