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
(US) Food
and Drug Administration (FDA) remains responsible for oversight
of these
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
are normally
excluded.
The lack of FDA regulated tests outside of the
US 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
(Health
Affairs
) (ASD(HA)) has directed the Director,
DHA to issue guidance to
the contractor
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
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
IVD products.