P.O. Box 13247 • Austin, Texas 78711-3247 • 512-424-6500 • hhs.texas.gov
Long-Term Care Regulatory Provider Letter
Number: PL 2020-49 (Revised)
Title: Process to Request Free COVID-19 Point of Care Antigen Test Kits
Provider Types: Nursing Facility (NF), Assisted Living Facility (ALF),
Intermediate Care Facility for Individuals with an Intellectual Disability or
Related Conditions (ICF/IID), Home and Community-based Services (HCS)
Program Provider, and Home and Community Support Services Agency
(HCSSA)
Date Issued: March 25, 2021
1.0 Subject and Purpose
This provider letter has been revised to expand the availability of free
BinaxNOW COVID-19 point of care (POC) antigen test kits. All long-term
care providers can now request free BinaxNOW COVID-19 POC antigen test
kits. The requested test kits can now be used to test any individuals,
including residents, staff, and visitors. This letter describes the process to
request distribution of a limited number of free BinaxNOW COVID-19 POC
antigen test kits.
Providers can apply for BinaxNOW COVID-19 POC antigen test kits until
supplies are exhausted.
2.0 Policy Details & Provider Responsibilities
To request consideration for the free BinaxNOW POC antigen COVID-19 test
kits, an NF, ALF, ICF/IID, HCS program provider, or HCSSA must complete
the Attestation for Free Test Kits, LTCR Form 2198. An NF, ALF, ICF/IID, or
HCS program provider must submit the completed attestation to the HHSC
Regional Director or designee for the region in which the provider is located.
To request consideration for the free test kits for essential caregivers, a
HCSSA must submit the completed attestation to the HHSC Regional
Director or designee in the region in which the inpatient hospice unit is
PL 2020-49 (NF, ALF, ICF/IID, HSC, HCSSA)
March 25, 2021 Page 2 of 4
located. To request consideration for the free test kits for HCSSA staff going
into an NF or ALF, the HCSSA must submit the completed attestation to the
HHSC Regional Director or designee where the NF or ALF is located.
The Regional Director or designee will elevate the completed attestation
form to the State Operations Center in TDEM. Staff from HHSC Long-term
Care Regulation (LTCR) and the TDEM will review the completed attestation
form for accuracy and completeness. Staff may require and request
documentation from the provider to support the attestation.
2.1 Eligibility
The attestation criteria require a NF, ALF, ICF/IID, HCS, and HCSSA
program to:
• have a current Clinical Laboratory Improvement Amendment
(CLIA) Certificate of Waiver or a CLIA laboratory certificate;
• administer the test only by provider staff who successfully
complete training provided by Abbott Laboratories or who are
clinicians with appropriate education and training;
• follow all reporting requirements associated with the use of the
Binax cards; and
• report test results appropriately.
Any provider that meets the requirements listed above is eligible to
request free BinaxNOW COVID-19 POC antigen test kits.
2.2 CLIA Waivers
A provider must have a current CLIA Certificate of Waiver or a CLIA
laboratory certificate before it can receive and administer the free
BinaxNOW COVID-19 tests. To obtain a CLIA Certificate of Waiver for
the free BinaxNOW COVID-19 tests, complete Form CMS-116 available
on the CMS CLIA website or on the HHSC Health Care Facilities
Regulation - Laboratories webpage found under the Application
header. Email the form to the regional CLIA licensing group via the
HHSC HCF Regulation – Laboratories webpage.
Providers that have existing CLIA Certificates of Waivers and are using
a waived COVID-19 test are not required to update their CLIA
Certificates of Waiver. As defined by CLIA, waived tests are
categorized as “simple laboratory examinations and procedures that
PL 2020-49 (NF, ALF, ICF/IID, HSC, HCSSA)
March 25, 2021 Page 3 of 4
have an insignificant risk of an erroneous result.” The Food and Drug
Administration determines which tests meet these criteria when it
reviews a manufacturer’s application for a test system waiver.
For more specific guidance on the Certificate of Waiver application
process, refer to HHSC COVID-19 provider letters and frequently asked
questions (FAQs) applicable to the provider type.
2.3 Reporting COVID-19 Test Results
Providers performing the BinaxNOW COVID-19 testing authorized in
this provider letter must report test results (positive, negative, or
indeterminate) for each tested individual.
See provider letter 20-37, Reporting Guidance for Long-term Care
Providers, for reporting instructions.
For more specific guidance on the reporting requirements, refer to
HHSC COVID-19 Texas Administrative Code rules, provider letters and
FAQs applicable to the provider type.
3.0 Background/History
In October 2020, the State of Texas began receiving a limited supply of
BinaxNOW COVID-19 POC antigen test kits to distribute to providers under
limited circumstances.
In March 2021, additional supplies of BinaxNOW COVID-19 POC antigen test
kits allowed for the State of Texas to expand the eligibility for requesting
free BinaxNOW COVID-19 POC antigen test kits.
4.0 Resources
LTCR Form 2198, Attestation for Free Test Kits
